Systems and methods for holding a flexible elongated device in a pose

Abstract

Disclosed herein are systems and methods for holding a flexible elongate device in a posture, which disclose a series of hardening mechanisms or systems that help or are capable of holding the posture or shape of a flexible body. These hardening mechanisms may be part of a steering mechanism, may be individually actuated and / or itself may also steer the flexible elongate device. Furthermore, the hardening mechanism may use information from a sensor system, such as a shape sensor in the form of an optical fiber, a plurality of EM sensors distributed along the length of the flexible device, and / or a navigation system, to inform a control system that subsequently controls the shaping and retention of the shape of the flexible body. The navigation system, such as a sensor system, calculates an approximate position of a medical device, such as a flexible body, within a patient's anatomy and / or an approximate position of a medical tool delivered through a main lumen of the flexible body.

Description

[0001] This application is a divisional application of Chinese patent application 2019800263031 (PCT / US2019 / 037954) filed on June 19, 2019 and entitled “System and method for maintaining a flexible, elongated device in a posture”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Patent Application Serial No. 62 / 687,120, filed on June 19, 2018, the disclosure of which is expressly incorporated herein by reference. Technical Field

[0004] The present disclosure relates to remote operating systems, and in particular to remote operating systems involving the use of flexible elongated devices. Background Art

[0005] The flexible, elongated device may be used in a range of applications requiring access to restricted openings such as for exploration of ducts or in medical procedures, particularly minimally invasive medical techniques.

[0006] Minimally invasive medical techniques are designed to reduce the amount of tissue damaged during a medical procedure, thereby reducing recovery time, discomfort, and harmful side effects for the patient. Such minimally invasive techniques can be performed through natural orifices in the patient's anatomy or through one or more surgical incisions. Through these natural orifices or incisions, a physician can insert a minimally invasive medical device (including a surgical instrument, a diagnostic instrument, a therapeutic instrument, or a biopsy instrument) to reach the target tissue location.

[0007] One such minimally invasive technique is to use a flexible and / or steerable elongated device (such as a flexible catheter) that can be inserted into an anatomical passage and navigated toward an area of ​​interest within the patient's anatomy. In some applications, the flexible and / or steerable elongated device needs to be maintained in a specific shape to achieve or improve the safety of the procedure. It would be advantageous to provide improvements in systems and methods for maintaining a flexible elongated device in a desired posture. Summary of the invention

[0008] Disclosed herein is a series of stiffening mechanisms / reinforcement mechanisms (stiffening mechanisms) or systems that contribute to or can maintain the posture or shape of a flexible body. These stiffening mechanisms can be part of a steering mechanism, can be actuated separately and / or themselves can also steer a flexible elongated device. In addition, the stiffening mechanism can use information from a sensor system and / or a navigation system to notify a control system, which then controls the formation and maintenance of the shape of the flexible body. The sensor system is a shape sensor such as an optical fiber, a plurality of EM sensors distributed along the length of the flexible device, and the navigation system is such as a sensor system that calculates the approximate position of a medical device (such as a flexible body) within the patient's anatomical structure and / or the approximate position of a medical tool delivered through the main cavity of the flexible body.

[0009] One embodiment includes a flexible, elongated device having a flexible body, a support structure, and a hardening mechanism. The flexible body has a proximal end, a distal end, and at least one lumen extending between the proximal end and the distal end. The flexible body has sufficient flexibility to form a certain posture. The support structure is coupled to the flexible body. The support structure includes a plurality of sub-elements arranged in series. At least a portion of the sub-elements is configured to spread apart when the flexible body is flexed into the posture. The hardening mechanism has at least one hardening element extending along at least a portion of the flexible body and is configured to be actuated independently of the support structure. Actuation of the at least one hardening element hardens the support structure to maintain at least a portion of the posture of the flexible body. The hardening element includes a compression feature configured to engage the support structure.

[0010] In another embodiment, the support structure comprises a coil and the sub-elements comprise windings of the coil. In another embodiment, the support structure comprises a spine.

[0011] In various embodiments, the hardening mechanism includes an expandable system / inflatable system, wherein the expandable system includes a balloon configured to engage the support structure. The balloon can be configured to extend between the sub-elements. For example, the balloon can be configured to extend between the sub-elements due to the application of vacuum pressure, thereby causing the balloon to collapse to the outside of the support structure and to collapse between the sub-elements. In another embodiment, the balloon is configured to extend between the sub-elements due to the application of expansion pressure, thereby causing the balloon to expand to the interior defined within the support structure and between the sub-elements.

[0012] In other embodiments, the balloon system includes multiple balloon portions. For example, the balloon portion can be selectively expanded / inflated to maintain at least a portion of the posture. The balloon portion can be positioned between the sub-elements. In addition, the balloon portion can be spiraled between the sub-elements.

[0013] In another embodiment, the stiffening mechanism can include a plurality of control elements extending along the flexible body and configured to exert tension on the flexible body in conjunction with selective expansion of the balloon portion to further maintain at least a portion of the posture.

[0014] Other embodiments may include a shape sensor configured to determine a posture of the flexible body and a controller. The controller may be communicatively coupled to the shape sensor, and the controller is configured to activate the stiffening mechanism to maintain at least a portion of the posture of the flexible body.

[0015] In another embodiment, a medical system includes a flexible body, a shape sensor, a stiffening mechanism, and a controller. The flexible body has a proximal end, a distal end, and at least one lumen extending between the proximal end and the distal end, wherein the flexible body includes a plurality of subsections. The shape sensor extends along at least a portion of the flexible body. The stiffening mechanism has a plurality of stiffening elements, each of the stiffening elements being positioned within one of the plurality of subsections, wherein the subsections extend along the flexible body. The controller is communicatively connected to the shape sensor, the controller being configured to selectively activate the stiffening element based in part on data received from the shape sensor.

[0016] In another embodiment, the controller is further configured to selectively activate the stiffening elements based in part on the type of instrument used to be inserted through the flexible body. For example, the controller can be configured to activate selected ones of the stiffening elements to reduce the curvature of the flexible body to match a hard type of instrument.

[0017] In another embodiment, the controller is further configured to selectively activate the stiffening elements based in part on the anatomical information. The anatomical information may also be information identifying a target region of the anatomical structure, and wherein the controller is further configured to actuate selected ones of the stiffening elements to protect the target region of the anatomical structure.

[0018] In another embodiment, the shape sensor includes at least one of a shape sensing fiber extending along the flexible body or a plurality of EM sensors extending along the flexible body.

[0019] In other embodiments, the stiffening mechanism comprises a longitudinal balloon array having a plurality of balloon portions, and wherein each of the stiffening elements is one of the plurality of balloon portions.

[0020] In another embodiment, the flexible body comprises a coil having a plurality of adjacent windings, and wherein each of the balloon portions is configured to extend between adjacent windings when pressure is applied. In addition, the controller can be configured to selectively apply pressure to each of the balloon portions to drive the adjacent windings apart to shape the flexible body.

[0021] Other embodiments further include a steering mechanism configured to control the distal portion of the flexible body. For example, the steering mechanism may include a plurality of pull wires, and wherein the controller is further configured to adjust the tension in the pull wires with the selective activation of the stiffening element to maintain the portion of the flexible body in a posture.

[0022] In other embodiments, the plurality of stiffening elements include a plurality of nitinol actuators. For example, the flexible body may include a wall structure, and the plurality of nitinol actuators are embedded in the wall structure. The plurality of nitinol actuators may be distributed circumferentially within the wall structure.

[0023] Other embodiments include a method of maintaining at least a portion of a posture of a flexible body. The method may include engaging a stiffening element of a stiffening mechanism within a space between at least one pair of subelements of a plurality of subelements extending along the flexible body.

[0024] In another embodiment, engaging the stiffening element includes driving a portion of the stiffening element into a space between at least one pair of sub-elements of the plurality of sub-elements.

[0025] In another embodiment, actuating the portion of the stiffening element includes one of inflating or deflation of the stiffening element.

[0026] In another embodiment, actuating a plurality of pull wires extending within the wall structure of the flexible body includes adjusting tension in the plurality of pull wires upon selectively activating the stiffening element to maintain a posture of the flexible body.

[0027] Other embodiments include a method of maintaining a posture of a flexible body using a controller. The method includes: measuring a current configuration of the flexible body based at least in part on a sensor coupled to the flexible body; determining a desired configuration of the flexible body; and selectively activating a stiffening mechanism to position the flexible body from the current configuration to the desired configuration, wherein the stiffening mechanism includes a plurality of stiffening elements distributed along a length of the flexible body.

[0028] In another embodiment, positioning the flexible body in the desired configuration includes independently actuating each of the plurality of stiffening elements.

[0029] In another embodiment, the current configuration includes a measured shape of the flexible body.

[0030] In another embodiment, the method may include identifying small radii in the measured shape, wherein selectively activating the stiffening mechanism includes activating selected ones of the plurality of stiffening elements to increase the bending radius of the flexible body at the identified small radii in the measured shape.

[0031] In another embodiment, the method may include receiving information describing a stiffness of an instrument to be delivered by the flexible body, wherein identifying a small radius in the measured shape includes determining a minimum bend radius corresponding to the stiffness of the instrument.

[0032] In another embodiment, determining the desired configuration includes: receiving information identifying a target region of the anatomical structure; and setting the desired configuration to activate selected ones of the plurality of stiffening elements at the identified target region of the anatomical structure. The received information identifying the target region of the anatomical structure may be based on real-time imaging.

[0033] In another embodiment, determining the desired configuration includes: receiving a preoperatively recorded surgical image; registering the flexible body to the preoperatively recorded surgical image using sensor data from a sensor coupled to the flexible body; and based on the registration, identifying a portion of the flexible body positioned within a target region of the identified anatomical structure. The received information identifying the target region of the anatomical structure is based on the preoperatively recorded surgical image.

[0034] In other embodiments, the plurality of stiffening elements comprises a plurality of nitinol actuators extending within the wall structure of the flexible body, and wherein selectively activating the stiffening mechanism comprises energizing at least one of the plurality of nitinol actuators.

[0035] In other embodiments, the plurality of stiffening elements comprises a plurality of balloons, and wherein selectively activating the stiffening mechanism comprises inflating or deflation of at least one of the plurality of balloons.

[0036] Embodiments of the present invention provide a number of advantages. For example, in the context of an articulated device that navigates the tortuosity of the human anatomy, it is advantageous to securely maintain a twisted position of the device as the instrument is being delivered through the device. Typically, a device passing through an articulated device will apply a force that has a tendency to straighten the twisted and articulated portion of the device. Embodiments of the present invention provide various apparatus and methods to maintain the posture of a catheter in a twisted position to stably deliver an instrument. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 is a simplified diagram of a teleoperated medical system according to some embodiments.

[0038] Figure 2A is a simplified diagram of a medical device system according to some embodiments.

[0039] Figure 2B is a simplified diagram of a medical device with an extended medical tool according to some embodiments.

[0040] Figure 3A and Figure 3Bis a simplified diagram of a side view of a patient coordinate space including a medical device mounted on an insertion assembly according to some embodiments.

[0041] FIG. 4A to FIG. 4C is a simplified diagram of a flexible elongated device according to some embodiments.

[0042] Figure 5 is a simplified cross-sectional view of a control element catheter according to some embodiments.

[0043] FIG. 6A to FIG. 6D is a simplified diagram of a stiffening mechanism or system according to some embodiments.

[0044] 7A to 7D is a simplified diagram of a hardening mechanism or system according to some embodiments.

[0045] FIG. 8A to FIG. 8E is a simplified diagram of a hardening mechanism or system according to some embodiments.

[0046] FIG. 9A to FIG. 9B is a simplified diagram of a method of using a flexible elongated device with a stiffening mechanism according to other embodiments.

[0047] FIG. 10A to FIG. 10B is a simplified diagram of a hardening mechanism or system according to some embodiments.

[0048] Fig.11 is a simplified flow chart of a method for identifying a target region of an anatomical structure and activating a stiffening mechanism according to some embodiments.

[0049] Fig.12 is a simplified flow chart of a method for identifying an external force and activating a stiffening mechanism according to some embodiments. DETAILED DESCRIPTION

[0050] In the following description, the specific details of some embodiments consistent with the present disclosure are set forth. Many specific details are set forth in order to provide a thorough understanding of the embodiments. However, it is obvious to those skilled in the art that some embodiments may be practiced without some or all of these specific details. The specific embodiments disclosed herein are intended to be illustrative rather than restrictive. Although not specifically described here, it will be appreciated by those skilled in the art that other elements are within the scope and spirit of the present disclosure. In addition, to avoid unnecessary repetition, unless otherwise specifically stated or if one or more features will render an embodiment inoperative, one or more features shown and described in association with an embodiment may be incorporated into other embodiments.

[0051] In some instances, well-known methods, procedures, components, and circuits have not been described in detail so as not to unnecessarily obscure aspects of the embodiments.

[0052] The present disclosure describes various apparatuses and parts of apparatuses according to their states in three-dimensional space. As used herein, the term "position" refers to the position of an object or a portion of an object in three-dimensional space (e.g., three translational degrees of freedom along Cartesian x, y, and z coordinates). As used herein, the term "orientation" refers to the rotational placement of an object or a portion of an object (three rotational degrees of freedom, e.g., roll, pitch, and yaw). As used herein, the term "posture" refers to the position of an object or a portion of an object in at least one translational degree of freedom and the orientation of the object or a portion of an object in at least one rotational degree of freedom (up to six degrees of freedom). As used herein, the term "shape" refers to a set of postures, positions, or orientations measured along an object.

[0053] Figure 1 is a simplified diagram of a teleoperated medical system 100 according to some embodiments. In some embodiments, the teleoperated medical system 100 may be applicable to, for example, surgical procedures, diagnostic procedures, therapeutic procedures, or biopsy procedures. Although some embodiments are provided herein for such procedures, any reference to medical devices or surgical instruments and medical methods or surgical methods is non-limiting. The systems, devices, and methods described herein may be used for animals, human cadavers, animal cadavers, portions of human or animal anatomy, non-surgical diagnostics, and industrial systems and general robotic systems or teleoperation systems.

[0054] like Figure 1 As shown, medical system 100 generally includes a manipulator assembly 102 for operating medical instruments 104 when performing various procedures on patient P. Manipulator assembly 102 can be a remotely operated, non-remotely operated, or a hybrid of remotely operated and non-remotely operated assembly, having selected degrees of freedom of movement that can be motorized and / or remotely operated, and selected degrees of freedom of movement that can be non-motorized and / or non-remotely operated. Manipulator assembly 102 is mounted on or near operating table T. Master control assembly 106 allows an operator (e.g., Figure 1 The surgeon, clinician, or physician (shown) observes the intervention site and controls the manipulator assembly 102. The master control assembly 106 typically includes one or more control devices for controlling the manipulator assembly 102.

[0055] The manipulator assembly 102 supports the medical device 104 and may optionally include a plurality of actuators or motors that drive inputs on the medical device 104 in response to commands from a control system (e.g., the control system 112). The actuator may optionally include a drive system that, when coupled to the medical device 104, can advance the medical device 104 into a natural anatomical orifice or an anatomical orifice created by surgery. Other drive systems can move the distal end of the medical device 104 with multiple degrees of freedom, which may include three linear motions (e.g., linear motions along the X, Y, Z Cartesian axes) and three rotational motions (e.g., rotations around the X, Y, Z Cartesian axes). In addition, the actuator may be used to actuate the articulated end effector of the medical device 104 to grasp tissue in a fixture of a biopsy device and / or the like. Actuator position sensors such as rotary transformers, encoders, potentiometers, and other mechanisms can provide sensor data describing the rotation and orientation of the motor shaft to the medical system 100. The position sensor data may be used to determine the motion of an object being manipulated by the actuator.

[0056] The teleoperated medical system 100 may include a sensor system 108 having one or more subsystems for receiving information about the instruments of the manipulator assembly 102. Such subsystems may include a position / location sensor system (e.g., an electromagnetic (EM) sensor system); a shape sensor system for determining the position, orientation, speed, velocity, posture, and / or shape along the distal end and / or one or more segments of the flexible body that may comprise the medical instrument 104; and / or a visualization system for capturing images from the distal end of the medical instrument 104.

[0057] The teleoperated medical system 100 also includes a display system 110 for displaying images or representations of the surgical site and medical device 104 generated by the subsystem of the sensor system 108. The display system 110 and the main control component 106 can be oriented so that the operator O can control the medical device 104 and the main control component 106 with a sense of remote presentation / telepresence. The display system 110 can present images of the surgical site recorded before or during surgery using image data from imaging techniques such as computed tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and / or the like. The preoperative or intraoperative image data can be presented as a two-dimensional image, a three-dimensional image, or a four-dimensional (including, for example, time-based or velocity-based information) image and / or as an image of a model created from a preoperative or intraoperative image data set. In some embodiments, the display system 110 may display a virtual navigation image in which the actual position of the medical device 104 is registered (ie, dynamically referenced) to a pre-operative or concurrent image / model, often for the purpose of imaging-guided surgical procedures.

[0058] In some embodiments, the display system 110 can display a virtual navigation image in which the actual position of the medical device 104 is registered with the preoperative or concurrent image to provide the operator O with a virtual image of the medical device 104 within the surgical site from an external viewpoint. An image or other graphical or alphanumeric indicator of a portion of the medical device 104 can be superimposed on the virtual image to assist the operator O in controlling the medical device 104. As described herein, a visual representation of the data points can be rendered to the display system 110. For example, the measured data points, the moved data points, the registered data points, and other data points described herein can be displayed on the display system 110 in a visual representation.

[0059] The remotely operated medical system 100 may also include a control system 112. The control system 112 includes at least one memory and at least one computer processor (not shown) for implementing control between the medical device 104, the main control component 106, the sensor system 108, and the display system 110. The control system 112 also includes programming instructions (e.g., a non-transitory machine-readable medium storing instructions) to implement some or all of the methods described according to the various aspects disclosed herein, including instructions for providing information to the display system 110. Although in Figure 1The control system 112 is shown as a single box in the simplified schematic diagram of , however, the system may include two or more data processing circuits, wherein a portion of the processing is optionally performed on or adjacent to the manipulator assembly 102 and another portion of the processing is performed on the main control assembly 106 and / or the like. The processor of the control system 112 can execute instructions, which include instructions corresponding to the processes disclosed herein and described in more detail below. Any of a variety of centralized or distributed data processing architectures may be employed. Similarly, the programming instructions may be implemented as multiple separate programs or subroutines, or the programming instructions may be integrated into multiple other aspects of the remote operation system described herein. In one embodiment, the control system 112 supports wireless communication protocols such as Bluetooth, IrDA (infrared data communication), HomeRF (home radio frequency), IEEE 802.11, DECT (digital enhanced wireless communication system), and wireless telemetry.

[0060] In some embodiments, control system 112 may receive force and / or torque feedback from medical device 104. In response to the feedback, control system 112 may transmit a signal to master control assembly 106. In some examples, control system 112 may transmit a signal instructing one or more actuators of manipulator assembly 102 to move medical device 104. Control system 112 may optionally further include a virtual visualization system to provide navigation assistance to operator O when controlling medical device 104 during an image-guided surgical procedure.

[0061] During a virtual navigation procedure, the sensor system 108 can be used to calculate the approximate position of the medical device 104 relative to the anatomical structure of the patient P. The position can be used to generate macroscopic (external) tracking images of the anatomical structure of the patient P and virtual internal images of the anatomical structure of the patient P. The system can implement one or more electromagnetic (EM) sensors, fiber optic sensors, and / or other sensors to align and display medical instruments with preoperatively recorded surgical images (such as images from a virtual visualization system). For example, PCT Publication WO 2016 / 191298 (published on December 1, 2016) (disclosing "Systems and Methods of Registration for Image Guided Surgery") discloses such a system, and the PCT publication is incorporated herein by reference in its entirety.

[0062] Figure 2A 2 is a simplified diagram of a medical device system 200 according to some embodiments. The medical device system 200 includes an elongated device 202, such as a flexible catheter, coupled to a drive unit 204. The elongated device 202 includes a flexible body 216 having a proximal end 217 and a distal end or tip portion 218.

[0063] The medical device system 200 further includes a tracking system 230, as described in further detail below, for determining the position, orientation, speed, velocity, posture, and / or shape of the distal end 218 and / or one or more segments 224 along the flexible body 216 using one or more sensors and / or imaging devices. The entire length of the flexible body 216 between the distal end 218 and the proximal end 217 can be effectively divided into the segments 224. The tracking system 230 can optionally be implemented as hardware, firmware, software, or a combination thereof that interacts with or is otherwise executed by one or more computer processors, which can include Figure 1 A processor of the control system 112 in the system.

[0064] Tracking system 230 can optionally track distal end 218 and / or one or more of segments 224 using shape sensor 222. Shape sensor 222 can optionally include an optical fiber aligned with flexible body 216 (e.g., provided within an internal channel (not shown) or mounted externally). In one embodiment, the diameter of the optical fiber is approximately 200 μm. In other embodiments, the size can be larger or smaller. The optical fiber of shape sensor 222 forms a fiber optic bend sensor for determining the shape of flexible body 216. In an alternative, an optical fiber including a fiber Bragg grating (FBG) is used to provide strain measurement of the structure in one or more dimensions. Various systems and methods for monitoring the shape and relative position of an optical fiber in three dimensions are described in U.S. patent application Ser. No. 11 / 180,389, filed Jul. 13, 2005 (disclosing “Fiberoptic position and shape sensing device and method relating thereto”); U.S. patent application Ser. No. 12 / 047,056, filed Jul. 16, 2004 (disclosing “Fiber-optic shape and relative position sensing”); and U.S. Pat. No. 6,389,187, filed Jun. 17, 1998 (disclosing “Optical Fiber Bend Sensor”), which are incorporated herein by reference in their entirety.

[0065] In some embodiments, the tracking system 230 may alternatively and / or additionally track the distal end 218 using a position sensor system 220. The position sensor system 220 may be a component of an EM sensor system, wherein the position sensor system 220 includes one or more conductive coils that can be subjected to an externally generated electromagnetic field. Each coil of the EM sensor system then generates an induced electrical signal, the characteristics of which depend on the position and orientation of the coil relative to the externally generated electromagnetic field. In some embodiments, the position sensor system 220 may be configured and positioned to measure six degrees of freedom (e.g., three position coordinates X, Y, Z and three orientation angles of pitch, yaw and roll indicating a base point) or five degrees of freedom (e.g., three position coordinates X, Y, Z and two orientation angles of pitch and yaw indicating a base point). Further description of the position sensor system is provided in U.S. Patent No. 6,380,732 (filed on August 11, 1999) (disclosing "Six-Degree of Freedom Tracking System Having a Passive Transponder on the Object Being Tracked"), which is incorporated herein by reference in its entirety. In some examples, a series of position sensors (not shown) such as electromagnetic (EM) sensors similar to the sensors in position sensor 220 can be positioned along flexible body 216 and then used for shape sensing. Flexible body 216 includes channel 221 that is sized and shaped to receive medical instrument 226.

[0066] Figure 2B is a simplified diagram of a flexible body 216 with an extended medical device 226 according to some embodiments. In some embodiments, the medical device 226 can be used for procedures such as surgery, biopsy, ablation, illumination, irrigation, or aspiration.

[0067] The medical device 226 may further house a cable, linkage, or other actuation control (not shown) extending between its proximal and distal ends to controllably bend the distal end of the medical device 226. Steerable instruments are described in detail in U.S. Patent No. 7,316,681 (filed on October 4, 2005) (disclosing "Articulated Surgical Instrument for Performing Minimally Invasive Surgery with Enhanced Dexterity and Sensitivity") and U.S. Patent Application No. 12 / 286,644 (filed on September 30, 2008) (disclosing "Passive Preload and Capstan Drive for Surgical Instruments"), which are incorporated herein by reference in their entirety.

[0068] The flexible body 216 may also house a cable, linkage, or other steering control (not shown) extending between the drive unit 204 and the distal end 218 to controllably bend the distal end 218 (as shown, for example, by a dashed line depiction 219 of the distal end 218). A steerable elongated device is described in detail in U.S. Patent Application No. 13 / 274,208 (filed on October 14, 2011) (disclosing "Catheter with Removable Vision Probe"), which is incorporated herein by reference in its entirety. In embodiments where the medical device system 200 is actuated by a remotely operated assembly, the drive unit 204 may include a drive input that is removably coupled to and receives power from a drive element (such as an actuator) of the remotely operated assembly. In some embodiments, the medical device system 200 may include a clamping feature, a manual actuator, or other components for manually controlling the movement of the medical device system 200. The elongated device 202 may be steerable, or alternatively, the system may be non-steerable and have no integrated mechanism for operator control of the bending of the distal end 218. In some examples, one or more lumens are defined in the wall of the flexible body 216 through which a medical device may be deployed and used at a target surgical site.

[0069] Information from tracking system 230 can be sent to navigation system 232 where it is combined with information from visualization system 231 and / or preoperatively acquired models (e.g., anatomical models of the patient's anatomy) to provide real-time position information to a physician or other operator. In some examples, the real-time position information can be displayed on a Figure 1on the display system 110 for controlling the medical device system 200. In some examples, Figure 1 The control system 116 can use the position information as feedback for positioning the medical instrument system 200. Various systems using fiber optic sensors to align and display surgical instruments with surgical images are disclosed in U.S. Patent Application No. 13 / 107,562 filed on May 13, 2011, which discloses “Medical System Providing Dynamic Registration of a Model of an Anatomical Structure for Image-Guided Surgery”, which is incorporated herein by reference in its entirety.

[0070] In some examples, the medical device system 200 may be Figure 1 In some embodiments, Figure 1 The manipulator assembly 102 of the apparatus may be replaced by direct operator controls. In some examples, the direct operator controls may include various handles and operator interfaces for handheld operation of the apparatus.

[0071] Figure 3A and Figure 3B is a simplified diagram of a side view of a patient coordinate space including a medical device mounted on an insertion assembly according to some embodiments. Figure 3A and Figure 3B As shown, the surgical environment 300 includes a patient P, who is positioned at Figure 1 The instrument bracket 306 or the insertion table 308 may include an actuator (not shown) such as a servo motor that controls the movement of the instrument bracket 306 along the insertion table 308. The elongated device 310 is coupled to the instrument body 312. The instrument body 312 is coupled and fixed relative to the instrument bracket 306. In some embodiments, a fiber optic shape sensor 314 is fixed at a proximal point 316 on the instrument body 312. The shape sensor 314 measures the shape from the proximal point 316 to another point (such as the distal end 318 of the elongated device 310). The point collection instrument 304 can be substantially similar to the medical instrument system 200. The position measurement device 320 provides information about the orientation of the instrument body 312 as it moves along the insertion axis A on the insertion table 308. The orientation measurement device 320 may include a rotary transformer, an encoder, a potentiometer, and / or other sensors that determine the rotation and / or orientation of the actuator that controls the movement of the instrument bracket 306 and thus the movement of the instrument body 312. In some embodiments, the insertion stage 308 is linear. In some embodiments, the insertion stage 308 can be curved or have a combination of curved and linear sections.

[0072] Figure 3A The instrument body 312 and instrument bracket 306 are shown in a retracted position along the insertion station 308. Figure 3B , the instrument body 312 and the instrument holder 306 have been advanced along the linear track of the insertion table 308, and the distal end 318 of the elongated device 310 has been advanced into the patient P.

[0073] FIG. 4A to FIG. 4C is a simplified diagram of a flexible elongated device 400 according to some embodiments. Figure 1 In some embodiments consistent with FIG. 3 , the flexible elongated device 400 may correspond to the elongated device 202 of the medical device system 200. Figure 4A As shown, the flexible elongated device 400 may include a proximal section 402, a distal section 404, and a transition section 406 between the proximal and distal sections.

[0074] The flexible elongated device 400 may include a flexible body 410 having a flexible wall with a thickness extending from an inner surface to an outer surface of the flexible body 410. A main lumen 411 may extend within the flexible body 410 through the proximal section 402, the transition section 406, and the distal section 404. The main lumen 411 may provide a delivery channel for a medical tool inserted through the flexible body 410, such as an endoscope, a biopsy needle, an ultrasound (EBUS or IVUS) probe, an ablation tool, a chemical delivery tool, and / or the like. According to some embodiments, a plurality of control element lumens 412 extend through the flexible wall of the flexible body 410, the plurality of control element lumens 412 being circumferentially arranged in the flexible wall around the main lumen 411. According to some embodiments, a sensor lumen 419 extends through the flexible wall of the flexible body 410. The sensor lumen 419 can extend from the proximal end of the flexible elongated device 400, through the proximal segment 402, the transition segment 406, and terminate at the distal portion of the distal segment 404. In some examples, the flexible body 410 can include various other types of lumens for wires, optical fibers, sensors, small medical devices, chemical delivery, and / or the like. In alternative embodiments, the flexible body 410 can include a general lumen that can be used for multiple purposes, including accommodating multiple simultaneously inserted instruments, control elements, sensors, and / or the like.

[0075] like FIG. 4A to FIG. 4CAs shown, within each of the control element lumens 412, a coil or tube 423 can extend through the proximal segment 402 of the flexible body 410, thereby providing a channel through which multiple control elements 421 extend. In some examples, the control elements 421 may include pull wires, tendons, push rods, and / or the like. The tube 423 terminates in a transition segment 406 proximal to the distal segment 404. The control elements 421 extend out of the tube 423 at the transition segment 406, pass through the control element lumens 412 into the distal segment 404, and are attached to the distal mount 422. One or more control elements 421 can be used to actuate the distal segment 404 of the flexible elongated device 400. As shown in FIG. Figure 4B and Figure 4C As shown, four control elements 421 may be disposed within the control element lumen 412 and evenly spaced around the circumference of the flexible elongate device 400 .

[0076] exist Figure 4B In the illustrative example provided in , a pair of lumens including one of the sensor lumen 419 and the control element lumen 412 are approximately centered along the sides of the rounded square formed by the main lumen 411. Therefore, neither the sensor lumen 419 nor the control element lumen 412 are centered along the sides of the rounded square. In addition, because the control elements 421 are equally spaced around the perimeter of the rounded square, no control element lumen 412 is centered relative to the rounded square. As a result, the square formed by the control elements 421 and the rounded square formed by the main lumen 411 are offset by approximately 30 degrees. However, it should be understood that different numbers and / or arrangements of the control elements 421 are possible. For example, the control elements 421 can be unevenly spaced around the perimeter of the flexible, elongated device 400 and / or centered relative to the sides of the main lumen 411.

[0077] The distal segment 404 is actuated by applying an actuation force to the control element 421 (e.g., pulling and / or pushing the control element 421 in an unequal manner). Applying the actuation force causes the distal segment 404 to bend in a direction defined by the net actuation force. In some examples, the actuation force can be applied manually, automatically, and / or similarly. For example, the actuation force can be applied by using an actuator 430 positioned at the proximal end of the flexible elongated device 400. The conduit 423 transfers the actuation force applied to the control element 421 from the proximal end of the proximal segment 402 to the distal end of the proximal segment 402 at the transition segment 406. Therefore, even when unequal actuation forces are applied to the control element 421, there is almost no actuation force in the proximal segment 402. In some examples, the conduit 423 can be flexible to maintain the flexibility of the proximal segment 402. Further examples of conduits are provided in PCT patent application PCT / US14 / 62188, filed on October 24, 2014, and entitled “Flexible Instrument with Embedded Actuation Conduits,” which is incorporated herein by reference in its entirety.

[0078] Any bending along the length of the proximal section 402 of the flexible elongated device 400 results in a change in the length of the control element lumen 412. For example, referring to Figure 4A , if the flexible body is bent in a downward motion, the length of the control element lumen 412 on the lower portion of the flexible body 410 will decrease, while the length of the control element lumen 412 on the upper portion of the flexible body will increase. Therefore, the conduit 423 may have to slide axially within the control element lumen 412. In some examples, the conduit may be constrained (e.g., fixed and / or prevented from sliding proximally along the longitudinal axis of the conduit) at the proximal end of the flexible elongated device within the actuator 430 and may terminate at the transition section 406. The conduit may be constrained (e.g., fixed and / or prevented from sliding distally along the longitudinal axis of the conduit) at the transition section 406. In this example, within the transition section 406, a stopper 425 is coupled between the conduit 423 on the proximal side of the stopper and the axial support structure 424 on the distal side of the stopper. The stopper 425 prevents the conduit 423 from displacing distally along the flexible elongated device 400. In an alternative example, the conduit may be fixed to the stopper 425.

[0079] Within the distal segment 404, an axial support structure 424 is configured to bend in response to an actuation force applied to the control element 421. Thus, when unequal actuation forces are applied to the control element 421, the distal segment 404 bends in a direction defined by the net actuation force. The axial support structure 424 supports the distal segment 404 against an axial load generated by the actuation force applied to the control element 421. In particular, the axial support structure 424 can prevent or reduce deformation, compression, and / or collapse of the distal segment 404 under an axial load. Other examples of axial support structures are provided in U.S. Provisional Patent Application No. 62 / 378,943, entitled “Axial Support Structure for a Flexible Elongate Device,” which is incorporated herein by reference in its entirety.

[0080] Despite Figure 4A The axial support structure 424 is depicted as having a spine-like structure, but other structures are possible. In some examples, the axial support structure 424 can be formed as a single large coil surrounding the main lumen 411. In addition, although Figure 4C The control element 421 is shown within the control element lumen 412, in contact with the Figure 4B In a similar configuration of the proximal section 402 shown, the axial support structure 424 may include a conduit similar to the conduit 423. In some embodiments, the conduit 423 may continue to travel through both the proximal section and the distal section of the flexible body 420. In alternative embodiments, separate conduits 423 may travel in the proximal section and the distal section. Although the conduit of the conduit 423 is concentrically arranged around the control element 421 to offset the actuation force applied to the control element 421, the conduit of the axial support structure 424 may deviate from the control element 421 (e.g., located at a different orientation around the periphery of the flexible body 410) to allow the axial support structure 424 to bend in response to the actuation force. Alternatively or additionally, the conduit of the axial support structure 424 may be more flexible (e.g., smaller diameter and / or constructed using a smaller wire gauge) than the conduit of the conduit 423.

[0081] In some examples, one or more of lumens 411, 412, 419 and / or sections thereof may be keyed. That is, a lumen and / or a portion of a lumen may have a non-circular cross-sectional shape to prevent or constrain rotation of a tool (e.g., a medical device, sensor, optical fiber, wire, actuator, and / or the like) having a matching non-circular cross-sectional shape when inserted through the lumen. Figure 4B As depicted, main lumen 411 of proximal section 402 is keyed. In particular, main lumen 411 has a rounded square cross-sectional shape that supports four keying orientations.

[0082] In some examples, a positioning sensor 426, such as an optical fiber of the shape sensor 222, extends through the sensor lumen 419. Like the conduit 423, the positioning sensor can be constrained at each end of the flexible elongated device 400 (e.g., fixedly attached and / or prevented from axial sliding). In one example, the positioning sensor is fixedly attached to the distal mount 422, free floating within the sensor lumen 419, and fixedly attached at the actuator 430. In some examples, a service loop can be provided within the actuator 430 between the fixed positioning attachment and the proximal end of the flexible elongated device 400 to accommodate the length of the sensor lumen 419 that varies due to bending. In alternative examples, a service loop can be provided between the actuator 430 and the distal end of the flexible elongated device 400 or within the flexible elongated device.

[0083] In some examples, the cross-sectional shape of lumens 411 to lumens 419 may vary between proximal section 402 and distal section 404. For example, main lumen 411 may be keyed in proximal section 402 and non-keyed in distal section 404. Figure 4C As shown, the main lumen 411 of the distal section 404 is non-keyed, having a circular cross-sectional shape that does not constrain rotation of a medical device inserted therein. Examples of keying lumens are discussed in more detail below with reference to FIG.

[0084] In some examples, the diameter of lumens 411-419 can vary between the proximal section 402 and the distal section 404. Thus, lumens 411-419 (e.g., a keyed lumen on the proximal side and a non-keyed lumen on the distal side) can taper within transition section 406 to provide a gradual transition between different cross-sectional shapes.

[0085] In some examples, the flexible wall of the flexible body 410 can vary between the proximal segment 402 and the distal segment 404. In some examples, the required bending flexibility and / or compressive strength can vary along the length of the catheter based on potential positioning within the patient's anatomy. Therefore, the flexible wall can include multiple layers that can vary within the proximal segment flexible wall and within the distal segment flexible wall.

[0086] Although the above-described construction of the flexible, elongated device 400 has the advantage of being able to actuate the distal segment 404 of the flexible, elongated device 400 by, for example, operation of a control element 421 within a conduit 423, in some cases, once the flexible, elongated device 400 is positioned in a desired posture, it is difficult to attempt to maintain the shape of the flexible body in a desired configuration. Additionally, situations occur where it would be advantageous to adapt the shape of the flexible body 410 based on known information about the surrounding anatomical structure and / or the instruments inserted through the main lumen 411 or other lumens. To this end, a series of stiffening mechanisms or systems are described that assist or enable maintaining the posture or shape of the flexible body 410. These stiffening mechanisms can be part of a steering mechanism, can be actuated separately and / or can themselves also steer the flexible, elongated device 400. In addition, the stiffening mechanism can use information from a sensor system and / or a navigation system to inform the control system 112, which then controls the formation and maintenance of the shape of the flexible body 410. The sensor system is such as a shape sensor 426 in the form of an optical fiber, multiple EM sensors distributed along the length of the flexible device, and multiple force sensors distributed along the length of the flexible device. The navigation system is such as the sensor system 108, which calculates the approximate position of a medical device (such as the flexible body 410) within the patient's anatomy and / or the approximate position of a medical tool delivered through the main lumen 411.

[0087] In some embodiments, the stiffening mechanism, particularly a stiffening mechanism having sub-elements, exhibits behavior that can be used to stiffen the shape of the flexible body 410. In one embodiment, as FIG. 6A to FIG. 6D As shown, for example, the stiffening system or stiffening mechanism 500 uses the properties of the coil 423 within the lumen 412 of the control element to stiffen the posture of the flexible body 410.

[0088] Figure 5 4 is an enlarged schematic diagram showing an example of a tube or coil 423 extending around a control element 421 (such as a pull wire) within a control element lumen 412. Notably, in this example, the coil 423 includes a plurality of windings 504. In this configuration, the windings 504 of the coil 423 extend linearly in a stacked array with little (or no) distance between the windings 504. The windings 504 are shown as rings, but the coil 423 can be a helical structure extending helically along the central axis of the control element lumen 412. The control element lumen 412 and the control element 421 are shown in a straight or unbent configuration.

[0089] FIG. 6A to FIG. 6DThe stiffening mechanism 500 shown includes a restriction balloon 502 sleeved on the coil 423. During the actuation and steering of the flexible elongated device 400, the restriction balloon is in a passive state or natural state. Once the flexible elongated device has been positioned at the desired target location, a vacuum can be applied using a pump (not shown) to deflate the balloon 502 to interdigitate in the space between the plurality of windings 504 of the coil. The interdigitation hardens to maintain the shape of the coil 423, and subsequently maintain the shape and posture of the flexible elongated body 400, and provide a more stable platform for delivering the device through the flexible body 410.

[0090] Fig. 6A A cross-sectional view of the control element lumen 412 and the stiffening mechanism 500 including the balloon 502 is shown. The outer circle represents the outline of the control element lumen 412, within which is the balloon layer or inner wall 506a. The balloon wall extends around (e.g., over) the coil 423. FIG. 6A to FIG. 6D In the illustrated embodiment of , the balloon 502 can be formed as a tubular structure having an open central lumen such that the balloon 502 can extend between the coil 423 and the inner surface of the control element lumen 412 . Figure 6B A cross-sectional view taken along the longitudinal axis of a portion of the flexible body 410 is shown.

[0091] Figure 6C A cross-sectional view of the control element lumen 412 is shown bent into a bent position with the surrounding wall structure of the flexible body 410 under tension (or other force and its application) from the control element 421. In this bent position, the windings 504 of the coil 423 are spread out on the outer curvature due to tracing a longer path, and are compressed more together on the inner curvature when tracing a shorter path. The balloon 502, which is not yet under inflation pressure or deflation vacuum pressure, is passively bent with the control element lumen 412 and the coil 423.

[0092] exist Fig.6DIn the embodiment, the hardening mechanism is activated by applying suction pressure or vacuum within the lumen of the balloon 502 using a pump. The suction pressure draws the compliant balloon wall 506a inwardly, so that it maintains conforming contact with the windings 504 of the coil 423. Typically, on the outer curvature where the windings are dispersed, the balloon wall 506a fills the gaps between adjacent pairs of windings. Even on the inner curvature formed in the coil 423, the balloon wall 506a can achieve some staggered engagement between the windings 504. In this embodiment, the adhesion of the balloon wall 506a strengthens the relationship between it and the windings 504, thereby causing friction that interferes with the coil 423, thereby maintaining it in its current configuration or posture. The presence of the balloon wall 506a between the windings 504 can wedge the adjacent pairs of windings 504 into a dispersed relationship.

[0093] 7A to 7D Another embodiment using a balloon 502 is shown, which is similar to FIG. 6A to FIG. 6D The embodiment of the present invention is different in that the balloon 502 is positioned within the coil 423 so that the outer balloon wall 506b is positioned along the inner surface of the coil 423. 7A to 7D In the illustrated embodiment, as Fig. 7A As shown, balloon 502 can be formed as a tubular structure with an open central lumen, so that balloon 502 can extend between control element 421 and coil 423. In an alternative embodiment, no pull wire is used to control the actuation of elongated flexible device 400, so balloon 502 can be positioned within the lumen of coil 423, filling the entire coil lumen when expanded. In either configuration, the balloon is expanded ( FIG. 7C to FIG. 7D ) to adhere to the windings 504 of the coil 423 and interleave between the windings 504. Depending on the desired level of friction or mechanical resistance and the strength of retention, this embodiment can be used with FIG. 6A to FIG. 6D Combination or replacement of embodiments FIG. 6A to FIG. 6D embodiments (or used with other embodiments within the scope of the present disclosure).

[0094] although FIG. 6A to FIG. 6D as well as 7A to 7D A single coil 423 is shown, but it should be understood that multiple coils may be distributed within a single elongated flexible device 400. For example, as described above FIG. 4A to FIG. 4C As shown in the embodiment of FIG. 4 , there are four control element lumens 412, and each control element lumen may include one or more balloons 502 extending on the coil 23 within the lumen 412. Alternatively or additionally, in another example without a pull wire, such as Fig. 10AAs shown, a single coil 1023 can surround the lumen 1011 of the elongated flexible device 1000 including the flexible body 1010. Regardless, multiple coils 423 with multiple balloons 502 or balloon portions can be used for one, several, or all control elements 421 used in the flexible elongated device 400. Depending on the shape or posture of the flexible body 410, each of these balloons 502 can be selectively drawn inward using vacuum to engage the individual windings 504 of the coil, or expanded outward using pressure to engage the individual windings 504 of the coil. In addition, separate balloons or balloon portions can be distributed along the length of each coil so that the stiffening or retention of the coil orientation can vary along the length of the coil. Therefore, by controlling the amount and distribution of vacuum and pressure applied to different balloons or balloon portions, the entire length of the flexible body can be actively controlled according to the location and stiffness and shape required for a specific anatomical structure or a specific medical procedure.

[0095] As described above, the axial support structure 424 of the flexible body 410 may include a single large coil surrounding the main lumen 411. In other embodiments, the structure of the larger coil (eg, coil 423) may be used to stiffen the flexible body 410 in a certain posture or shape. FIG. 10A to FIG. 10B 1023 that surrounds the lumen 1011 of the elongated flexible device 1000 including the flexible body 1010. In one embodiment, a single balloon 1002 may extend helically between the windings of the coil 1023. Fig. 10A As shown, the balloon is in a deflated configuration, showing an inwardly curved cross-section. In this embodiment, the balloon can be inflated (not shown) to force the windings of the coil 1023 to expand against adjacent windings, thereby causing the flexible body 1010 to harden or maintain the current posture. In an alternative embodiment, a group of separate balloons or a single balloon can be divided into balloon portions 1002a to 1002d, each balloon portion being positioned within a different winding of the coil 1023. Fig. 10B As shown, each balloon portion 1002a to 1002d is selectively expanded or deflated to stiffen the flexible body 1010 in a bent configuration. In this example, the selective expansion of balloon portions 1002a and 1002c can maintain the angle between adjacent segments of the coil support structure 1023 and the shape of the flexible body 410. On the inner bend of the flexible body 1010, balloon portions 1002b and 1002d are deflated to allow compression of adjacent segments along the inner bend.

[0096] The actuator 430 may include actuation for controlling both a pump to inflate the balloon or draw a vacuum in the balloon and a control mechanism to change the amount of tension in the control element 421. Thus, the actuator 430 may change the inflation and / or vacuum in the balloon and the tension of the control element 421 in a coordinated relationship to achieve the desired amount of hardening of the shape or posture of the flexible body 410. The control system 112 actuation of the balloon 502 (or other hardening element) and the control element 421 may be based on feedback from various sensors (such as positioning sensors 426) to accomplish other goals, such as adapting the instrument or avoiding damage to sensitive structures or withstanding different load profiles. In this case, the shaping function of the control element 421 may be facilitated by the hardening mechanism 500, rather than simply using the hardening mechanism to strengthen and maintain the current posture or shape of the flexible body 410.

[0097] Balloon 502 can generally be constructed of similar materials as balloons used in other medical applications, such as for deployment of other medical devices, such as cardiovascular devices. Such balloons can have different starting and ending shapes depending on the process and molds used in their creation. For example, a balloon with a large inflated diameter can be compressed into a compact configuration due to careful folding or forming. However, in general, FIG. 6A to FIG. 6D and 7A to 7D The balloon used in the embodiments of the invention benefits from being tough enough to withstand multiple uses and the friction of interacting with the support structure - such as being able to be caught or clamped between the windings 504 of the coil 423. At the same time, the balloon benefits from being flexible enough to conform to the dispersed coils 423 to achieve a sufficient amount of friction or blocking for a higher stiffness to maintain posture under a range of loading conditions.

[0098] The hardening mechanism 500 may also employ other hardening elements to maintain the shape of the flexible body 410. For example, a foam may expand between the coil 423 and the control element lumen 412, or MEMS technology may be employed to drive a wedge or barrier between the dispersed windings 504. The balloon 502 may also be deployed in an array of multiple balloons, and the balloon itself may be shaped to have features, such as a wedge shape, which is configured to be used for pushing between the dispersed coils if expanded or vacuumed to contact the coil 423. Although the use of the illustrated coil 423 works particularly well due to the nature of the windings 504 that form a stack, adjacent elements are dispersed during bending. The balloon may also be employed with other support structures other than the coil. For example, an interconnected linkage may be used in conjunction with (or as) the control element 421, wherein the linkage has a shape that is hardened when adhered to or wedged between the balloon or articulated relative to each other. The spacing and shape of the sub-elements can also be configured to work well with the shape and features of the hardening elements of the hardening mechanism. For example, the wedge-shaped spaces between the sub-elements of the support structure can be locked by inserting a conforming wedge-shaped hardening element.

[0099] It should be noted that some embodiments of the present invention work well with any type of flexible elongated device 400 having a flexible body 410, wherein the flexible body has some altered structural properties that can be captured, blocked, adhered to, or otherwise interfered with the operating elements of the hardening mechanism 500 to harden the posture or shape of the flexible body. In the previously described embodiments, the structural properties were within the coil. However, in alternative or additional examples, a support structure such as an axial support structure 424 can be used in conjunction with one or more balloons surrounding the support structure or positioned in the lumen of the support structure. Particularly useful are support structures that use multiple sub-elements arranged in series, wherein the sub-elements exhibit different properties (e.g., dispersion) when adjusted into various shapes by flexing or shaping the flexible body 410 in which the sub-elements are embedded.

[0100] FIG. 8A to FIG. 8EAnother embodiment of a stiffening mechanism 800 for a flexible, elongated device is shown, wherein a flexible body 801 defines a lumen 811 and is divided into a plurality of portions or segments 812. In this embodiment, the stiffening mechanism includes a plurality of nitinol wires 810 distributed circumferentially around each of the plurality of segments 812. Typically, selective activation or excitation of the nitinol wire 810 causes it to engage a portion of the flexible body by changing its length to maintain or change its posture. The controller of the stiffening mechanism 800 can then modulate the excitation of the nitinol wire 810 based on feedback from various sensors such as sensor 826 to maintain posture under changing conditions. In another aspect, the nitinol wire 810 is employed to maintain the posture of only that portion of the flexible body 801, rather than participating in the shaping or steering of the flexible body 410.

[0101] Fig. 8A Nitinol wires 810 are shown, which in one aspect can be embedded in the wall structure of the flexible body 801. For example, four Nitinol wires 810 are distributed circumferentially at approximately 90 degrees therebetween. Also, Fig. 8A A sensor lumen, such as sensor lumen 819, is shown defined within the wall structure of the flexible body 801 with equal distance between two of the nitinol wires 810. This distribution of the nitinol wires 810 and the positioning of the sensor lumen 819 (with sensors 826, such as fiber-based shape sensors extending therein) facilitates 360 degree bending control of the flexible body 801 by selectively controlling the amount of excitation of the four nitinol wires 810 based on feedback from the shape sensors. The sensors 826 within the sensor lumen 819 may include one or more additional sensors in place of or in addition to the fiber optic shape sensors. For example, the sensors 826 may include a plurality of EM sensors distributed along the length of the flexible body 801, a plurality of force sensors distributed along the length of the flexible body 801, and / or a navigation system such as the sensor system 108 that calculates the approximate location of a medical device (such as the flexible body 801) and / or a medical tool delivered through the main lumen 811 within the patient's anatomy to inform the control system 112, which then controls the formation and maintenance of the shape of the flexible body 801. Depending on the desired amount and distribution of actuation and retention forces from the stiffening mechanism 800, it is possible to have fewer or more embedded nitinol wires 810 with different relative distributions within the wall structure.

[0102] FIG. 8B to FIG. 8E812. Each segment is a short cylindrical portion of the entire flexible body 801. In this embodiment, the nitinol wire 810 is a short length that starts and ends in the segment. The actuator 430 can be coupled to each of these lengths of nitinol wire 810 and can actuate those wires to be able to maintain or adjust the posture of the segment. Fig.8D and Fig. 8E It shows how the segments 812 are arranged end to end to form a longitudinal array 814 and a larger portion (or entirety) of the flexible body 801. In addition, Fig. 8E It is shown how cumulative changes in the posture of each segment 812 result in the shape of the flexible body 801 being changed and / or maintained.

[0103] The Nitinol wire is composed of a shape memory material in the form of a nickel-titanium alloy having a transition temperature. The actuator 430 can selectively change the length of the Nitinol wire by heating the Nitinol wire (such as using electricity) through the transition temperature to change between shapes. For example, the memory shape of the Nitinol wire can have a length shorter than the starting length. Therefore, the Nitinol wire is heated to shorten it, and then the posture of the segment is changed by compressing the segment 812. The memory shape can also be various curves or other configurations to help shape. It is worth noting that embodiments of the present invention may also include shape memory materials other than Nitinol or mechanical devices that can expand, contract and / or change shape to cause and maintain posture changes.

[0104] In the previously described balloon and nitinol wire embodiments, the flexible body can be driven to a target position using a pull wire or other control element 421 for steering, wherein the balloon portion or nitinol wire is deactivated or otherwise in a natural configuration. Once in place, a shape sensing system such as tracking system 230 can be used to measure the current shape of the flexible body 410 or 801. The balloon portion 508 or nitinol wire 810 can then be selectively inflated, deflated, or actuated in varying amounts to help maintain the measured shape.

[0105] In the case of a nitinol wire, using data from an optical fiber or other shape sensor, the controller system 112 can be configured to stimulate the appropriate nitinol wire 810 of a longer composite tube (having multiple segments) to maintain its shape. Moreover, using shape data from the optical fiber sensor, such as sensing deviations from a desired pose or shape, forces can be applied in appropriate areas to maintain the measured shape. Additionally, when a hard instrument is inserted through the device, the nitinol wire 810 can be used to apply greater forces to increase the bending moment.

[0106] In another example, the balloon portion 508 can be inflated / deflated or the nitinol wire can be activated, and the pull wire can additionally controllably change tension to maintain the measured shape. Both examples include using the pull wire to maintain the measured shape or automatically maintain posture to further stiffen the flexible body 410.

[0107] In other embodiments, the flexible body 410 / 801 can navigate within a tortuous anatomical structure 516 in a flexible state, park within the anatomical structure to position the distal end of the flexible body 410 / 801 at a target location, and then harden or rigidify selected portions of the flexible body according to different conditions. For example, during the pre-procedural planning stage, a user can identify a target area of ​​the anatomical structure on a preoperative model or preoperative map, and one or more portions of the flexible body 410 / 801 near the target area can be selectively rigidified. For example, the target area of ​​the anatomical structure may include particularly sensitive anatomical structures (e.g., a lung airway near the pleura, or in different applications, the path of the flexible body 410 / 801 is near an organ). Alternatively or additionally, imaging technology can be used to automatically identify the target area of ​​the anatomical structure. Registration and reference using the flexible elongated device 400 FIG. 2A to FIG. 2B Real-time tracking is previously described, and by identifying a target area of ​​the anatomical structure, the flexible body 410 / 801 can be parked at the target, and then portions of the flexible body 410 / 801 proximal to the target area of ​​the anatomical structure (e.g., discrete portions along the length of the flexible body 410 / 801) can be selectively and discretely reinforced using a stiffening mechanism such as stiffening mechanism 500 / 800 to provide protection for the target area of ​​the anatomical structure (e.g., a sensitive anatomical structure) during delivery of the device through a catheter.

[0108] In another embodiment, Fig. 9A As shown, the flexible body 410 / 801 is positioned in a tortuous anatomical structure 516, forcing it to adapt and form sharp turns. Therefore, it is challenging to deliver a hard device through the working lumen of the flexible body. Using the selective stiffening control of the above embodiments, the sharp turn 518 can be identified as a target area of ​​the anatomical structure manually by the user, by the control system using imaging technology to analyze the preoperative model, and / or by the control system 112 using shape sensing data and a threshold setting for the minimum bend radius. Fig. 9B As shown, along the length of the catheter positioned about a sharp turn 518, the control system 112 can command the actuator 430 and the stiffening mechanism 500 / 800 to reconfigure the shape of the flexible body 410 to a larger radius to allow for delivery of a stiff device.

[0109] More generally, in some embodiments, the control system 112 measures the current configuration of the flexible body 410 / 801 and determines the desired configuration of the flexible body 410 / 801. The current configuration of the flexible body 410 / 801 may include a current posture, for example, measuring the current configuration includes measuring the shape of the current posture (such as the radius of the curve along the flexible body 410 / 801). As described above, shape sensing data from a fiber optic sensor or other shape sensor (e.g., a plurality of EM sensors or strain sensors) along the length of the flexible body 410 / 801 can be used to determine the current posture. Alternatively, the shape can be determined using kinematic data describing the flexible body 410 / 801 and the actuator 430 (such as which actuators are activated, the tension in the actuator, or the pressure applied by the actuator).

[0110] The control system 112 can determine the deviation from the current configuration of the flexible body 410 / 801 to the desired configuration. In response to the determined deviation, the control system 112 can command the actuator 430 to selectively harden one or more hardening mechanisms 500 / 800 along the length of the flexible body 410 / 801 to apply force in the appropriate area to position the flexible body from the current configuration to the desired configuration. For example, the hardening mechanism can include a plurality of balloon portions 508 / 1002 and / or nitinol wires 810 distributed along the length of the flexible body 410 / 801 to harden discrete portions of the flexible body 410 / 801 along the length of the flexible body 410 / 801. Each of the hardening mechanisms (e.g., each of the balloon portions 508 / 1002 and / or each of the nitinol wires 810) can be independently activated by the actuator 430.

[0111] Following the above example, the control system 112 can determine the deviation of the measured radius (e.g., current configuration) and the minimum bend radius (e.g., desired configuration) of the curve at the location along the flexible body 410 / 801. The minimum bend radius can be determined by the control system 112 based on receiving information describing the stiffness of the device to be delivered by the flexible body 410 / 801. Therefore, the control system 112 can command the actuator 430 to selectively stiffen some of these stiffening mechanisms along the length of the flexible body 410 / 801 to apply force in appropriate areas to position the flexible body to increase the bend radius of the curve at the location along the flexible body 410 / 801.

[0112] Again following the above example, the control system 112 may determine the desired configuration by identifying a target region of the anatomy. Fig.111 is a simplified flow chart of a method 1100 for identifying a target area of ​​an anatomical structure and activating a hardening mechanism performed by a control system 112 according to some embodiments. For example, the target area of ​​the anatomical structure can be identified based on the control system 112 receiving a real-time image or a preoperatively recorded surgical image and identifying a portion of the flexible body 410 / 801 near the target area of ​​the anatomical structure. For example, at 1102, the control system 112 receives a real-time image or a preoperative image. The image can be received from an imaging technique such as computed tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and / or the like. In one embodiment, a preoperative model can be generated from the preoperative image.

[0113] At 1104, a target region of the anatomical structure may be identified within the preoperative model by a user or automatically using imaging techniques. In another embodiment, the target region of the anatomical structure may be identified within the captured real-time image (by a user or automatically using imaging techniques). For example, the identified target region of the anatomical structure includes sensitive anatomical structures or anatomical structures having sharp turns (e.g., small radius bends, where the radius is less than a minimum bend radius) within an anatomical passage.

[0114] At 1106, while the flexible body is navigating within the anatomical structure, the control system 112 can be used to register the flexible body 410 / 801 to the real-time image or pre-operative model using sensor data from one or more sensors 426 (or 826) positioned along the flexible body 410 / 801. The registration of the flexible body 410 / 801 to the pre-operative model / real-time image is based on the relative known position between the position / shape sensor (e.g., fiber optic shape sensor, EM sensor, etc.) and the hardening mechanism component 502 / 1002 / 810. U.S. Patent Application No. 13 / 107,562, filed May 13, 2011 (disclosing "Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery") provides various systems for registering and displaying surgical instruments and surgical images using fiber optic sensors, which application is incorporated herein by reference in its entirety. PCT application PCT / US2017 / 017433 filed on February 2, 2017 (disclosing “Systems and Methods for Using Registered Fluoroscopic Images in Image-Guided Surgery”) and PCT application PCT / US17 / 17391 filed on February 2, 2017 (disclosing “Systems and Methods of Pose Estimation and Calibration of Perspective Imaging System in Image Guided Surgery”) provide systems for aligning a real-time imaging device to a preoperative image or imaging system, and the above applications are incorporated herein by reference in their entirety.

[0115] The information from the tracking system 230 may be sent to the navigation system 232 where it is combined with information from the visualization system 231 and / or a preoperatively acquired model (e.g., an anatomical model of the patient's anatomy) to provide real-time position information to a physician or other operator. At 1108, the control system 112 receives the real-time position information including the current configuration of the flexible body 410 / 801. At 1110, based on the real-time position information of the flexible body 410 / 801 and the identified target region of the anatomy, the control system 112 may identify a portion of the flexible body 410 / 801 that is positioned at the target region of the anatomy. At 1112, the control system 112 can command the actuator 430 to selectively harden one or more hardening mechanisms 500 / 800 along the length of the flexible body 410 / 801 near a target area of ​​the anatomical structure (a determined portion of the flexible body 410 / 801) to provide protection to a sensitive anatomical structure or to reconfigure a specific length of the flexible body to form a larger bend radius that is greater than or equal to the minimum bend radius.

[0116] In some examples, real-time location information can be displayed on Figure 1 The display system 110 of the medical device system 200 is displayed for use in controlling the medical device system 200. In some examples, the virtual image of the flexible body can be overlaid or integrated into the preoperative model, and the identified target areas (such as sensitive anatomical structures and / or sharp turns) can be displayed. The virtual image of the flexible body can be updated based on the real-time position information obtained from the tracking system 230.

[0117] In another embodiment, the flexible body 410 / 801 is positioned in an anatomical structure that can exert an external force on the flexible body 410 / 801. For example, the anatomical structure can exert an external force as part of respiration, circulation, or excretion. Using the selective discrete stiffening control of the above embodiments, upon detecting an external force at a distal location or along the length of the flexible body 410 / 801, the control system 112 can command the actuator 430 to selectively stiffen a discrete portion along the length of the flexible body 410 / 801 at the location of the external force.

[0118] Fig.12 1 is a simplified flow chart of a method 1200 for identifying an external force and activating a stiffening mechanism performed by the control system 112 according to some embodiments. At 1202, the control system 112 receives sensor data from one or more sensors 426 (or 826) positioned along the flexible body 410 / 801 to detect the application of an external force. At 1204, the control system 112 determines whether any of the received sensor data is outside a predetermined threshold value for identifying the application of an external force to the flexible body 410 / 801.

[0119] For example, external forces may be detected based on detecting a change in the shape of the flexible body 410 / 801 as determined by a shape sensor. In some examples, external forces may be detected based on a change in shape determined by a shape sensor or a change in shape observed by real-time imaging, which is not a result of control by the actuator 430 or movement of a medical device through the main lumen 411 / 811. In other words, external forces are detected based on a change in shape determined by a shape sensor, which is independent of the operation of the actuator 430 or movement of a medical device through the main lumen 411 / 811. In another example, a fiber optic shape sensor may be configured to calculate both shape and force along the length of the flexible body 410 / 810.

[0120] In another example, external forces can be detected based on readings from one or more force sensors positioned along the length of the flexible body 410 / 801. The force sensors can include one or more of a strain gauge, a load cell, a force sensing resistor, or any other suitable force sensor. Each of the force sensors can correspond to a specific location, region, or segment of the flexible body 410 / 801.

[0121] At 1208, the control system 112 identifies the corresponding position, area, or segment of the flexible body 410 / 801 where the sensor data exceeds the threshold. For example, the control system 112 identifies the corresponding position, area, or segment of the flexible body 410 / 801 where an external force is being applied to the flexible body 410 / 801. At 1210, when one of the force sensors detects that an external force is being applied to the position of the flexible body 410 / 801, the control system 112 can command the actuator 430 to selectively harden the flexible body 410 / 801 at the corresponding position of the external force. In some examples, the external force detected based on the force sensor is unrelated to the operation of the actuator 430 or the movement of the medical device through the main cavity 411 / 811.

[0122] In one embodiment as described above, the flexible body 410 / 801 is completely positioned in the anatomical structure so that the distal end of the flexible body 410 / 801 is positioned at or near the anatomical target to serve as a working channel for delivering therapeutic tools / or diagnostic tools. In order to protect the anatomical structure, the controller can selectively harden discrete portions of the flexible body. Shape sensing and / or external force measurement can be used to determine whether a portion (or portions) of the flexible body 410 / 801 is currently configured to bend in a sharp radius or is subjected to external forces. Additionally or alternatively, shape sensing is used in conjunction with a preoperative model of a target area of ​​the anatomical structure that has previously been identified to determine whether a portion (or portions) of the flexible body 410 / 801 is currently configured to bend in a sharp radius (e.g., a radius less than the minimum bending radius) or is subjected to external forces due to the current positioning of the flexible body 410 / 801 in the anatomical structure. The controller may then selectively activate discrete stiffening elements 502 / 1002 / 810 to selectively stiffen portions of the flexible body 410 / 801 located at determined portions of the flexible body 410 / 810.

[0123] In an alternative embodiment, the flexible body is navigated through the anatomical structure, and as a portion of the flexible body is actively inserted through a portion of the anatomical structure that has been identified as a target area of ​​the anatomical structure (e.g., a sharp turn, a sensitive anatomical structure, etc.), the controller selectively activates the portion within the target area of ​​the anatomical structure. In one example, shape sensing can be used by the controller in conjunction with the registered preoperative model to determine which portion of the flexible body is currently positioned within the target area of ​​the anatomical structure. In another example, the controller can use shape sensing and / or force sensing to immediately determine which portion or portions of the flexible body are positioned within a sharp turn or are subject to excessive external forces exceeding a threshold. The controller can then selectively activate discrete hardening elements 502 / 1002 / 810 to selectively harden portions of the flexible body 410 / 801 located at a determined portion of the flexible body, which is positioned within the target area of ​​the anatomical structure, subject to a sharp turn, and / or subject to excessive external forces. As the flexible device is inserted into the anatomical structure, the controller can propagate the selective hardness along the length of the flexible device. Thus, the flexible body can be hardened in a controlled manner into a desired posture that protects the anatomical structure from the flexible body when the flexible body is inserted into the anatomical structure. For example, when the most distal segment of the flexible body is positioned near a target area of ​​the anatomical structure, the controller selectively hardens only the most distal segment. Then, as the flexible body is further inserted into the anatomical structure, the most distal segment relaxes, while segments proximal to the most distal segment are selectively hardened. Thus, as the flexible body is inserted into the anatomical structure, the flexible body can be positioned in a known and controlled posture to protect the anatomical structure, rather than allowing a fully flexible device to potentially rub or press against the anatomical structure wall.

[0124] The above embodiments disclose embodiments of a stiffening mechanism 500 that provide selective stiffening of portions of an elongated body along the length of the elongated body and actuation of discrete balloons, nitinol wires, or other stiffening elements for selective stiffening to maintain a posture or shape. In other embodiments, in addition to maintaining the posture of the flexible body 1010 of the elongated flexible device 1000, the selective expansion and contraction of the balloon portions 1002a to 1002d can also be used to additionally or alternatively actuate and control the steering of the elongated flexible device 1000. The same ability to steer the flexible body 410 can be employed to maintain the posture or shape of the flexible body 410. For example, feedback from the shape sensor 426 can be used to selectively adjust the pressure in the balloon to maintain the posture or shape of the flexible body 410.

[0125] Other Examples

[0126] 1. A method for maintaining a posture of a flexible body using a controller, the method comprising:

[0127] measuring a current configuration of the flexible body based at least in part on a sensor coupled to the flexible body;

[0128] determining a desired configuration of the flexible body; and

[0129] A stiffening mechanism is selectively activated to position the flexible body from the current configuration to the desired configuration, wherein the stiffening mechanism includes a plurality of stiffening elements distributed along the length of the flexible body.

[0130] 2. The method of Example 1, wherein positioning the flexible body in the desired configuration comprises independently actuating each of the plurality of stiffening elements.

[0131] 3. A method according to example 1 or 2, wherein the current configuration includes a measured shape of the flexible body.

[0132] 4. The method according to Example 3 further includes: identifying a small radius in the measured shape, wherein selectively activating the hardening mechanism includes: activating selected ones of the multiple hardening elements to increase the bending radius of the flexible body at the identified small radius in the measured shape.

[0133] 5. The method according to Example 4 further includes: receiving information describing the stiffness of the instrument to be delivered by the flexible body, wherein identifying the small radius in the measured shape includes determining a minimum bending radius corresponding to the stiffness of the instrument.

[0134] 6. The method of any one of Examples 1 to 5, wherein determining the desired configuration comprises:

[0135] receiving information identifying a target region of an anatomical structure; and

[0136] The desired configuration is set to activate selected ones of the plurality of stiffening elements at an identified target region of the anatomical structure.

[0137] 7. The method of any one of Examples 1 to 5, wherein determining the desired configuration comprises:

[0138] receiving information identifying an anatomical passage including a small radius bend; and

[0139] The desired configuration is provided to activate selected ones of the plurality of stiffening elements at the shallow bend.

[0140] 8. A method according to Example 6 or 7, wherein the received information is based on real-time imaging.

[0141] 9. The method of example 6 or 7, wherein determining the desired configuration further comprises:

[0142] Receive surgical images recorded preoperatively;

[0143] registering the flexible body to the preoperatively recorded surgical image using sensor data from the sensor coupled to the flexible body;

[0144] A portion of the flexible body is identified as being positioned within the target region or the small curvature of the identified anatomical structure based on the registration.

[0145] 10. A method according to Example 6 or 7, wherein the received information is based on the surgical images recorded preoperatively.

[0146] 11. A method according to any one of Examples 1 to 10, wherein the current configuration includes an external force applied to the flexible body.

[0147] 12. A method according to any one of Examples 1 to 11, wherein the plurality of stiffening elements include a plurality of nitinol actuators extending within a wall structure of the flexible body, and wherein the selective activation of the stiffening mechanism includes energizing at least one of the plurality of nitinol actuators.

[0148] 13. A method according to any one of Examples 1 to 11, wherein the plurality of stiffening elements comprises a plurality of balloons, and wherein selectively activating the stiffening mechanism comprises inflating or deflation of at least one of the plurality of balloons.

Claims

1. A medical system, comprising: A flexible elongated device comprising: a flexible body having a proximal end, a distal end, and at least one lumen extending between the proximal end and the distal end; a support structure coupled to the flexible body, the support structure comprising a plurality of subelements arranged in series, wherein at least a portion of the subelements are configured to spread apart when the flexible body is flexed into a pose; as well as A stiffening mechanism having at least one stiffening element extending along at least a portion of the flexible body and configured to be actuated independently of the support structure, wherein after the flexible body is flexed into the posture, actuation of the at least one stiffening element causes the support structure to stiffen to maintain at least a portion of the posture of the flexible body, wherein the at least one stiffening element includes a compression feature configured to engage the support structure. 2 . The medical system of claim 1 , wherein the support structure comprises a coil and the sub-element comprises a winding of the coil.

3. The medical system of claim 1, wherein the support structure comprises a spine.

4. The medical system of claim 1, wherein the stiffening mechanism comprises an expandable system.

5. The medical system of claim 4, wherein the expandable system comprises a balloon configured to extend between the subelements.

6. The medical system of claim 5, wherein the balloon is configured to extend between the subelements by causing the balloon to collapse outside of the support structure and between the subelements as a result of application of vacuum pressure.

7. The medical system of claim 5, wherein the balloon is configured to extend between the subelements by causing the balloon to expand into an interior defined within the support structure and between the subelements as a result of application of inflation pressure.

8. The medical system of claim 5, wherein the balloon is sleeved over the support structure.

9. The medical system of claim 5, wherein the balloon is one of a plurality of balloons, each balloon being positioned along a portion of the flexible body, wherein the plurality of balloons are selectively inflatable to maintain the at least a portion of the posture.

10. The medical system of claim 1, further comprising a plurality of control elements extending along the flexible body and configured to exert tension on the flexible body to control the posture of the flexible body.

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