Physical twin endoluminal robotic human input device

Abstract

An input controller, including a base to receive input and generate a signal for transmission to a navigation system to move a navigation catheter in an axial direction, a control catheter mounted on the base, where articulation of the control catheter generates a signal for transmission to the navigation system to articulate the navigation catheter.

Description

PATENT APPLICATIONA0012329W001 (00017-01271PCT00)PHYSICAL TWIN ENDOLUMINAL ROBOTIC HUMAN INPUT DEVICEBACKGROUNDTechnical Field

[0001] The present disclosure relates to input devices for robotic and motorized endoluminal navigation systems.Description of Related Art

[0002] Current endoluminal navigation systems often employ catheters with a single curve. Navigation of the natural lumens (e.g., airways, GI tract, vasculature, etc.) with the single curve devices is typically achieved via a series of push and rotate operations. Push the catheter to advance into the natural lumen and then rotate to change directions for further advancement (e.g., at a bifurcation in an airway). When adding motorization or robotics to endoluminal navigation systems, the catheters and the control systems often seek to achieve omnidirectional or dual-plane distal motions (e.g., articulating catheters with multiple pull wires). The existing motorized and robotic endoluminal navigation systems have tended to default to two types of input controllers. One form of input controller is a game-controller and the second is a wheel and track ball system.

[0003] Typically, the game-controller includes two joysticks operated by the user’s thumbs, two triggers operated by the user’s index fingers, and one or more buttons operated by the user’s thumbs or other fingers. Through manipulation of the joysticks, triggers, or other buttons the user is able to provide inputs to drive and articulate the robotic endoluminal navigation catheter. Some of the inputs generated by manipulation of the joysticks, triggers, and buttons are to the drive motors of the robotic endoluminal navigation systems (e.g., to advance, retract, articulate, or rotate the catheter). Other inputs are directed to the navigational software which may be presented in one or more user interfaces on a display associated with the robotic endoluminal navigation system. Thus, the same joystick, trigger, or button used to provide inputs to the motors may also be associated with a variety of different features such as selecting screens, identifying targets within images, and others. As will be appreciated, this multiplicity of associated features can lead to operator error when it is believed that the manipulation of the joystick, trigger, or button is associated with one type of input but in fact it is associated with a different input. Generally, there are safeguards within the software to prevent any damage to tissue or injury to the patient, but the mistaken use and the need to correct the input remains frustrating to the user and results in increased procedure times. The occurrence of these errors may be even more pronounced where the user employs two different robotic navigationPATENT APPLICATIONA0012329W001 (00017-01271PCT00) systems in their practice. It is not uncommon for the same type of manipulation of the joystick, trigger, or button to generate very different inputs in the two unrelated robotic navigation systems.

[0004] Another format for an input controller employed in a robotic endoluminal navigation system employs a trackball and wheel configuration. The wheel is rotated about its axis to adjust the advancement and retraction of the catheter (i.e., z-direction movement) into the patient’s natural lumen. The trackball is used to adjust the articulation of a distal portion of the catheter. Signals from the trackball trigger motors linked to pull-wires (typically at least four), so that omni-directional articulation can be achieved. While providing some benefits over a game-controller, the trackball and wheel configuration is also not without its challenges. Not least is that as the trackball allows for articulation not just left-right and up-down but in all planes in between (i.e., omni-directional) the input can be challenging for many users to manage and master increasing both frustration with the endoluminal navigation system and again procedure times.

[0005] Adding to these challenges is the understanding that as endoluminal navigation systems increase in complexity, the number of degrees of freedom (DOFs) also increases. For example, when navigating to chambers of the heart, the catheters may include two telescoping catheters, each of which must be separately articulated to achieve the desired location and orientation all while taking great care not to impact certain structures within the heart while simultaneously navigating the catheters past these structures. With multiple bending sections, two or more telescopic catheters, lockable sections, and other features being incorporated into the endoluminal catheters the ease of use of current inputs systems (e.g., game-controller or wheel and trackball) is even further diminished and it becomes increasingly difficult for a user of an robotic endoluminal navigation system to achieve a desired shape of the endoluminal catheter and successfully navigate the catheter to a desired location, again increasing frustration of the user and procedure times.

[0006] In part the challenges in navigation when using a game-controller or wheel and trackball style input device is due to the lack of useful feedback to the user. Users of endoluminal navigation systems (e.g., bronchoscopists and thoracic surgeons) have long grown accustomed to the manual manipulation of their tools (e.g., an endoscope) and to utilize the natural feedback from the resistance imparted on these tools by the tissues of the body to inform the users on how and whether to proceed. In contrast, robotic endoluminal navigation systems cannot provide any natural feedback as the inputs (e.g., the game-controller) is necessarily physicallyPATENT APPLICATIONA0012329W001 (00017-01271PCT00) removed from the drive systems of the catheter or other tools. In an attempt to address this challenge, some feedback mechanisms have been developed including combinations of sound (e.g., alarms, buzzers, etc.), color (e.g., via the user interface changing color), or vibration (e.g., via vibratory motor). However, these are quite different from the natural feedback that clinicians have grown accustomed to, and thus are less informative to the clinician than natural feedback. The lack of useful and intuitive feedback can result in indecision and reluctance to perform an action and again increase procedure times for endoluminal navigation.

[0007] As a result of the shortcomings of the current solutions in robotic and motorized endoluminal navigation systems and the expected advancements in complexity of endoluminal catheter construction, improvements are desired.SUMMARY

[0008] A system of one or more computers can be configured to perform particular operations or actions by virtue of having software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions. One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the actions. One general aspect of the disclosure is directed to an input controller including a base configured to receive input and generate a signal for transmission to a navigation system to move a navigation catheter in an axial direction. The controller also includes a control catheter mounted on the base, where articulation of the control catheter generates a signal for transmission to the navigation system to articulate the navigation catheter. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

[0009] Implementations may include one or more of the following features. The input controller where the control catheter includes a plurality of flexible segments. The lock prevents relative movement of two adjacent segments of the two telescoping catheters. The lock includes an indicator on the control catheter. The control catheter is formed of two telescoping catheters. The base is a space mouse. The control catheter further may include at least one tendon or pull wire. The control catheter further may include at least one sensor configured to detect articulation of the control catheter. The sensor is one of a fiber-bragg grating, an electromagnetic sensor, a capacitive touch sensor, a force sensor, or a linear encoder. The fiber-bragg grating detects one or more of a shape of the control catheter, a strain appliedPATENT APPLICATIONA0012329W001 (00017-01271PCT00) to the flexible catheter, or a location at which force is applied to the control catheter. The sensor is a linear encoder detects movement of the tendon or pull wire to detect a change in shape of the control catheter. The signal is representative of a force applied to the navigation catheter by tissue of a patient. The signal from the navigation system when applied to the servomotor provides haptic feedback to a user by increasing or decreasing resistance to manipulation of the control catheter. The signal from the navigation system when applied to the servomotor resists movement of the space mouse. Mechanical properties of the control catheter are substantially similar to the mechanical properties of the navigation catheter. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.

[0010] Another aspect of the disclosure is directed to an input controller including a grip operably connected to a base, the base including at least one position configured to generate a signal for transmission to a navigation system for movement of a navigation catheter in an axial direction. The controller also includes a control catheter extending from the grip, where the control catheter includes at least one flexible segment, where manipulation of the control catheter generates a signal for transmission to the navigation system to articulate the navigation catheter. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

[0011] Implementations may include one or more of the following features. The input controller where the control catheter includes at least one tendon or pull wire and a linear encoder, where movement of the tendon or pull wire relative to the linear encoder generates a signal for transmission to the navigation catheter of an articulation of the at least one flexible segment. The servomotor is configured to receive a signal from the navigation system representative of resistance to motion of the navigation catheter, where the signal when applied to the servomotor provides haptic feedback to a user by increasing or decreasing resistance to manipulation of the control catheter. The control catheter is formed of two telescoping catheters, each of the two telescoping catheters including at least one of the at least one flexible segment. The input controller may include a lock preventing axial movement of the two telescoping catheters. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium. This disclosure is directed at improved input controller and improved feedback systems.PATENT APPLICATIONA0012329W001 (00017-01271PCT00)BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Various aspects and embodiments of the disclosure are described hereinbelow with references to the drawings, wherein:

[0013] FIG. l is a schematic depiction of an input controller in accordance with the disclosure;

[0014] FIG. 2 is a schematic depiction of a portion of a physical twin in accordance with aspects of the disclosure;

[0015] FIG. 3 is a schematic depiction of a portion of a physical twin in accordance with aspects of the disclosure;

[0016] FIG. 4 is a schematic depiction of a portion of a physical twin in accordance with aspects of the disclosure;

[0017] FIG. 5 is a schematic depiction of a portion of a physical twin in accordance with aspects of the disclosure;

[0018] FIG. 6 is a schematic depiction of a portion of a physical twin in accordance with aspects of the disclosure; and

[0019] FIG. 7 is a schematic depiction of an input controller in accordance with the disclosure.DETAILED DESCRIPTION

[0020] The disclosure is directed to input controllers for robotic endoluminal navigation systems. As noted above, the current input controllers either game-controllers or wheel and track ball controllers may present challenges for users when navigating endoluminal spaces, particularly when employed with navigational catheters with complex features such as multiple controllable telescoping catheters each with articulation to achieve desired curves, locking features and others. Further, the current input controllers may be limited in the feedback provided to the user. Accordingly, aspects of this disclosure are directed to addressing these and other shortcomings of existing input controllers for endoluminal robotic and motorized navigation systems.

[0021] FIG. 1 depicts an exemplary input controller 100 in accordance with the disclosure. The input controller is 100 includes a grip 102 mounted on a space mouse 104. The space mouse 104 allows the grips 102 to be moved forward and backwards, but when released returns to an unbiased center position. In accordance with the disclosure, movement of the grip 102 and the space mouse 104 in a first direction sends signals to the endoluminal robotic navigation system to advance a catheter. Movement of the grip 102 and the space mouse 104 is a second direction opposite the first direction sends signals to the endoluminal robotic or motorized navigation system to retract the catheter. Accordingly, movement of the grip 102 and spacePATENT APPLICATIONA0012329W001 (00017-01271PCT00) mouse 104 controls z-direction movement of the catheter into and out of the patient. Though a space mouse 104 is described herein, other forms of a mouse may be utilized in connection with the disclosure without departing from the scope of the disclosure.

[0022] Extending from the grip 102 is a physical twin 106 of an endoluminal catheter driven by the robotic endoluminal navigation system. The physical twin 106, as shown in FIG. 1 is a form of a control catheter having a similar shape and maneuverability as the endoluminal or navigation catheter. Indeed, the physical twin 106 is a model of the endoluminal or navigation catheter to be navigated within the patient. As shown in FIG. 1, the physical twin 106 is composed of two separate telescoping catheters 108a and 108b, though a single nontelescoping catheter 108 may be employed as a physical twin 106 without departing from the scope of the disclosure. Each catheter 108a, 108b may include multiple segments 110a and 110b. As described in greater detail below, the physical twin 106 may include a lock 112. The lock 112 may be engaged during use of the physical twin 106 to prevent further movement of the first telescoping catheter 108a, while allowing the second telescoping catheter portion 108b and particularly segments 110a and 110b to be manipulated by the user.

[0023] FIG. 2 depicts a further aspect of the physical twin 106. The physical twin 106 of FIG. 2, includes multiple segments 110, each one of which many be individually manipulated by the user to achieve a desired shape of the physical twin 106. Each segment may include a lock 112 to prevent relative movement of two adjacent segments and allow formation of physical twin 106 into the desired shape and to secure the physical twin 106 in that desired shape.

[0024] FIG. 3 depicts the motions of the physical twin 106. As can be seen the distal or second telescoping catheter 108b can be articulated as well as advanced ore retracted (Z-direction movements) relative to the proximal or first telescoping catheter 108a. In addition, the proximal or first telescoping catheter 108a can also be articulated relative to the grip 102. The lock 112 may be a touch sensitive lock, whereby contacting a portion of the first telescoping catheter 108a by a user prevents its further advancement relative to the second telescoping catheter 108b. The lock 112 may display its status on the physical twin 106 on or near a location where further movement of the first or second telescopic catheter 108a, 108b is prevented. As will be appreciated, by articulating the proximal or first telescoping catheter 108a, the second telescoping catheter 108b will necessarily also be articulated.

[0025] In accordance with one aspect of the disclosure, an input for the advancement or retraction of an endoluminal catheter within the patient to a point within the natural lumen is provided using the grip 102 and space mouse 104. A user manipulates the grip 102 and spacePATENT APPLICATIONA0012329W001 (00017-01271PCT00) mouse 104 to slide the space mouse 104 in a first direction signals are generated and transmitted to the robotic endoluminal navigation system to drive the endoluminal catheter in the first direction (e.g., advancement of the endoluminal catheter). Natural lumens of a patient (e.g., the airways) are not straight and require articulation of the endoluminal to effectively navigate. Manual articulation of one or both of the telescoping catheters 108a, 108b by a user is detected by the input controller 100 and converted into a signal provided to the robotic endoluminal navigation systems. The signal drives motors operably connected to the endoluminal catheter to drive the endoluminal catheter such that its shape mirrors that of the physical twin 106. As a result, the shape of the physical twin 106, which is visible to and formed by the user is mirrored in the endoluminal catheter.

[0026] As an example, if navigation of the right upper lobe of a patient’s lung is desired, the endoluminal or navigation catheter may be navigated past the main carina to the second bifurcation. Articulation of the endoluminal catheter by bending the distal portion of the first telescoping catheter 108a results in signals to the endoluminal robotic or motorized navigation systems to articulate the endoluminal catheter such that the endoluminal catheter is oriented into the second bifurcation. Once satisfied with the orientation of the endoluminal catheter, the first telescoping portion 108a may be locked in that orientation by selection of the lock 112. Further input to the space mouse 104 via grip 102 causes the endoluminal catheter to be driven by the robotic endoluminal navigation system further into the right upper lobe. As each particular bifurcation in the right upper lobe is approached, the second telescoping catheter 108b may be further articulated (e.g., via one manipulation of one or more of the segments 110a, 110b) to ensure that the endoluminal catheter is aligned with the correct airway. The endoluminal catheter may then be further advanced via inputs received from the space mouse 104 until a distal portion of the endoluminal catheter is in a desired proximity to target tissue (e.g., a tumor or lesion for biopsy or therapy).

[0027] Following the inputs described herein above, the endoluminal catheter and the physical twin 106 have substantially the same shape. This shape may substantially match a pre-planned shape of a pathway within the natural lumen within the patient (e.g., from the mouth of a patient to a tumor or lesion within the lungs). The manual manipulation of the control catheter or physical twin 106 allows the user to manually manipulate a facsimile of the endoluminal catheter and observe the results of that manual manipulation (e.g., via fluoroscopy or endoluminal navigation software) on the movements of the endoluminal catheter within the patient. The endoluminal catheter may include one or more sensors (e.g., shape orPATENT APPLICATIONA0012329W001 (00017-01271PCT00) electromagnetic sensors) which can detect the movements of the endoluminal catheter within the patient, and also detect resistance to movement. The sensors of the endoluminal catheter are connected to the robotic endoluminal navigation system and an accurate depiction of the shape and relative positioning of the endoluminal catheter to the natural lumens within the patient can be displayed.

[0028] Though described herein that the inputs to the physical twin 106 are immediately imparted on the endoluminal catheter, the disclosure is not so limited. Instead, while under visualization (e.g., fluoroscopy, cone-beam CT, etc.) the inputs to the physical twin can be employed to generate a representation of the endoluminal catheter. The representation can be overlaid on the images from the visualization system. As the physical twin 106 is manipulated, the shape of the representation is altered to conform to the physical twin. This enables the surgeon to visualize the impacts of the input to the physical twin without causing the endoluminal catheter to move. This allows for more trial-and-error navigation without concern of negative impacts on the tissue with the endoluminal catheter. As the representation of the endoluminal catheter, overlaid on the images, changes its shape the surgeon can make assessments of the impact, make modifications to the shape and position changes, and satisfy themselves as to the adjustments, and then once satisfied, the endoluminal catheter can be robotically driven to take the shape and orientation of the physical twin 106. Further, as the endoluminal catheter is driven to match the shape of the representation, any in ability of the endoluminal catheter to achieve the desired shape and orientation is readily apparent by comparison to the representation enabling further adjustment of the physical twin in an effort to achieve the desired shape and orientation of the endoluminal catheter within the patient.

[0029] FIG. 4 depicts a portion of the physical twin 106 (e.g., one of the telescoping catheters 108a or 108b). The physical twin 106 includes one or more sensors 114 along its length. The sensors detect the shape of the physical twin 106 and generate a signal. That signal is transmitted via the input controller 100 to which the physical twin 106 is attached to the robotic endoluminal navigation system to drive one or more motors to change the shape of the endoluminal catheter within the patient in accordance with the change in shape of the physical twin 106. In one aspect of the disclosure, the sensors 114 are fiber-Bragg grating sensors. The fiber-Bragg grating sensors can detect the shape of the physical twin based 106 on changes in light transmitted along the fiber-Bragg grating sensors. In addition to shape, fiber-Bragg grating sensors can also be used as strain detector (e.g., measurement of forces applied to physical twin) as well as a temperature. Through the use of shape, strain, and temperaturePATENT APPLICATIONA0012329W001 (00017-01271PCT00) sensing, a location and magnitude of the input to change the shape of the physical twin 106 is detected and applied via the input controller 100 to the robotic endoluminal navigation system.

[0030] One or more of the sensors 114 may alternatively take the form of an electromagnetic (EM) sensor formed in the wall of the physical twin 106. The input controller 100 may be placed on a magnetic field generator generating a mapped magnetic field. As the physical twin 106 is manipulated, changes in the magnetic field are detected by the EM sensor 114. The detected changes in magnetic field result in changes in current induced in the EM sensors 114. By comparing the induced current to the mapped magnetic field, a location of the EM sensor within the EM field can be determined. As a result, as changes are made to the physical twin 106, these changes are detected by the EM sensors, and the induced current in the EM sensor provides a signal to the input controller 100 which can be converted (e.g., via an analoguedigital converter), into a signal for transmission to the robotic endoluminal navigation system to drive one or more motors and articulate the endoluminal catheter such that it takes on the shape of the physical twin 106. The EM sensors 114 may be for example coils of wire wrapped around locations along the physical twin forming a hollow core sensor or alternatively may be tunnel magneto-resistant (TMR) sensors, or other EM sensors without departing from the scope of the disclosure.

[0031] In still a further aspect of the disclosure, the sensors 114 may be capacitive touch or force sensors which detect contact with the physical twin 106 and the force applied to the physical twin to estimate changes in shape. As an example, the lock 112 may be engaged by a touch sensor, wherein touching of the physical twin at the lock location engages the lock 112. Alternatively, detection of touch at a point along the physical twin 106 and the detection of a magnitude of the force applied at the detected location to achieve a desired articulation of the physical twin 106 generates a signal for transmission to the robotic endoluminal navigation system to drive one or more motors and articulate the endoluminal catheter such that it takes on the shape of the physical twin 106.

[0032] As an alternative or in addition to the sensors 114 described above, the sensors 114 may take the form of linear encoders, as depicted in FIG. 5. Pull wires or ribbons 116 located within the physical twin 106 extend from an articulating region 118 of the physical twin 106 to the liner encoders 114. The linear encoders 114 may be located in the grip 102 or another portion of the input controller 100. As the articulating region 118 changes shape by application of force to the physical twin 106 by the user the pull wires or ribbons 116 move relative to the liner encoders 114 (i.e., extending or retracting with the articulation). The movement of thePATENT APPLICATIONA0012329W001 (00017-01271PCT00) pull wires or ribbons 116 relative to the linear encoders 114 is detected and measured. The detected movement of the pull wires 116 or ribbons is converted to a signal for transmission to the robotic endoluminal navigation system to drive one or more motors and articulate the endoluminal catheter such that it takes on the shape of the physical twin 106.

[0033] FIG. 6 is a further illustration of aspects of the disclosure. In FIG. 6 the physical twin 106 is formed of a flexible shaft 120 that allows multiple curvatures to be imparted along its length. Tendons 122, which extend along the length of the physical twin 106, move as a result of the articulation of the flexible shaft. As shown, by manipulation of the flexible shaft 120, a desired shape is formed in the physical twin. One desirable feature of the input controller 100 is the ability to accurately manipulate the distal end of the physical twin 106, and there with the endoluminal catheter such that the opening at the distal end of the endoluminal catheter is oriented to a desired target so that a tool (e.g., a biopsy or therapy tool) can be inserted into the endoluminal catheter to perform a desired procedure (e.g., biopsy or therapy). The physical twin 106 makes this alignment of the opening of the distal end of the catheter with a target (e.g., as observed in a 3D model or in live imaging) more intuitive for users.

[0034] As will be appreciated, though the physical two 106 is generally described as being at or near the robotically driven endoluminal catheter that is navigating the patient the disclosure is not so limited. Rather, the physical twin 106 may be located in a different room and remotely driving the endoluminal catheter. Further, the physical twin 106 can be employed in telesurgery applications where the patient is remote from the surgeon by hundreds or even thousands of miles. In one example, with military operations where a surgeon may not deployed to a warzone, but instead equipment including the robotic endoluminal catheter system is deployed and the surgeon is able to utilize the equipment remotely via the physical twin 106 to treat the patients in need. A similar need may be found in rural hospitals having limited specialization but with the ability to set-up and facilitate robotic endoluminal catheter systems. The specialized surgeon, can thus treat patients far removed from the location of the surgeon and the patients can receive the treatment in more local hospitals without needing to travel, which might be challenging for them given the medical conditions necessitating the surgery.

[0035] Another aspect of the disclosure is directed at user feedback. As an initial matter, the physical constraints of the endoluminal catheter, and its ability to articulate or flex is mirrored in the physical twin 106. Thus, when a physical limit of a flexure or articulation of the endoluminal catheter is reached, the mechanical aspects of the physical twin 106 inform thePATENT APPLICATIONA0012329W001 (00017-01271PCT00) user of reaching these limits and provide tactile feedback to the user and limit any attempt to apply greater levels of force.

[0036] As will be appreciated, the physical limitations of the endoluminal catheter are not the only feedback that the user will benefit from. There are also the constraints or resistance to movement imparted on the endoluminal catheter by the patient’s tissue. In accordance with the disclosure, the current driving the motors of the endoluminal robotic, or motorized navigation system is monitored. As will be appreciated, the greater the resistance to a desired movement of endoluminal catheter the greater amount of current must be applied to the motor to achieve the desired movement. With the signal representing the magnitude of the current detected (e.g., representative of the resistance to movement), a signal can be generated and transmitted to the input controller 100. The input controller 100 includes a plurality of servomotors. Each servomotor is connected to one of the tendons 122 or the pull wires 116 or ribbons. Where, for example, the servomotors are direct-current (DC) servomotors, the force necessary to rotate the servomotors by manipulation of the physical twin 106 can be increased or decreased depending on the polarity of the applied voltage.

[0037] The application of a voltage to the servomotors simulates the resistance to movement of the endoluminal catheter caused by the patient’s tissue. As a result, the user experiences not just the mechanical feedback of the physical twin itself, but also a simulation of the feedback caused by resistance to movement of the endoluminal catheter. As will be appreciated, this haptic feedback much more closely resembles the feedback that a user experiences when manually inserting an endoluminal catheter (e.g., a bronchoscope) into a natural lumen (e.g., the airways of a patient). This haptic feedback may be associated with other forms of feedback common in robotic applications including sounds, lights, etc. Accordingly, the user of the endoluminal robotic or motorized navigation system is able to feel the resistance to motion the endoluminal catheter is experiencing while attempting to achieve a desired shape or orientation with the physical twin 106.

[0038] Similarly, the movements of the space mouse 104 may be similarly impacted the detected current of the drive motor of the robotic endoluminal navigation system. The detected current can be employed to generate a signal resisting movement of the space mouse 104, and therewith provide a sensible resistance to movement that can be felt by the user and inform the user of the resistance of the tissue being navigated.

[0039] The resistances to movement of the servomotors and the space mouse 104 may be increased to a point where no movement in a desired direction is possible. These limits onPATENT APPLICATIONA0012329W001 (00017-01271PCT00) movement in a particular direction can be based on a combination of the physical limits of the endoluminal catheter as well as resistances to movement experienced by the endoluminal catheter during navigation to inform the user of the progress of the procedure. In combination these resistances provide haptic feedback for a robotic endoluminal navigation system in a manner which is impossible in current input controllers.

[0040] With regard to a further aspect of the disclosure, there are instances of endoluminal navigation where extraction or retraction of an endoluminal catheter must be undertaken in a specific order. This order ensures that tissue that is sensitive to impact is avoided during the retraction of the endoluminal catheter. In accordance with the disclosure, the robotic endoluminal navigation system can employe a learning mode. The learning mode is enabled at the beginning of the endoluminal navigation procedure. As a result, during the process of endoluminal catheter navigation to the target tissue the pathway navigated and order of articulation of the endoluminal catheter can be stored in memory. If any movements of the endoluminal catheter are to be excluded from the learning, these movements may be selectively excluded from the learned pathway by the user. Once the pathway and movements (articulations) of the endoluminal catheter to arrive safely at the target tissue are stored in memory, their order may be simply reversed, and a known safe extraction navigation process executed by the robotic endoluminal navigation system retracts the endoluminal navigation catheter.

[0041] In yet a further aspect of the disclosure, a user manipulates the physical twin 106. But rather than applying the signals to the endoluminal catheter immediately, the signals generated by the input controller 100 are provided to an application that displays a virtual representation of the endoluminal catheter, for example within a 3D model of the relevant anatomy of the patient. In this manner movements and articulations of the physical twin 106 and input controller 100 may be undertaken without causing any change in the endoluminal catheter. Based on the observed changes in position and orientation of the virtual endoscopic catheter in the 3D model, adjustments or alterations can be made to the physical twin 106 prior to application of those articulations and movements to the endoluminal catheter. Once an acceptable movement or articulation of the virtual endoluminal catheter is observed 3D model, the movement or articulation can be accepted and the signals output from the input controller 100 can be directed to the drive motors of the robotic endoluminal navigation system to drive the endoluminal catheter to a desired position or orientation.PATENT APPLICATIONA0012329W001 (00017-01271PCT00)

[0042] A further aspect of the disclosure is directed to the maintenance of a desired shape and orientation of an endoluminal catheter. As described above, the input controller 100 and the physical twin 106 are employed to input changes or position and orientation of an endoluminal catheter. Once navigated within a certain proximity to target tissue (e.g., within 2-3 cm) and with the opening at the distal end of the catheter oriented towards the target tissue, one or more tools may be inserted into the endoluminal catheter. The tools may, for example, be biopsy or therapy tools. The tools typically include sections which while potentially short (e.g., 4-5 cm) in length are substantially rigid. The rigidity of these sections as they pass through a curved endoluminal catheter can alter the shape of the endoluminal catheter, particularly at curves near a distal end of the endoluminal catheter. This shape of the endoluminal catheter may be monitored (e.g., via the drive motors and pull wires) and as the shape of the endoluminal catheter changes, a comparison to the input shape (e.g., from the physical twin) can be undertaken and the robotic endoluminal navigation system can actively adjust the shape of the endoluminal catheter to match the physical twin 106. Additionally, the shape of the endoluminal catheter may be observed (e.g., via fluoroscopy) and the physical twin 106 may be manipulated as the tool traverses the endoluminal catheter. In this manner, the user can actively adjust position and orientation of the physical twin 106 as the tool traverses the endoluminal catheter to ensure accurate alignment and orientation of the opening in the endoluminal catheter with respect to the target tissue.

[0043] For robotic applications with curved instruments, such as a curved endoluminal catheter, robotic rotation or roll of the endoluminal catheter may be disabled. With a curved device, particularly one with multiple curved sections, it can be difficult to predict the effect of rotation, and with the endoluminal catheter traversing a lumen of the body (e.g., airways, blood vessels, etc.), the stresses on the tissue of these lumens could cause damage. In accordance with aspects of the disclosure, the grip 102 may include a rocker feature (e.g., similar to the space mouse 104) that allows for inputs of rotational movement to the endoluminal catheter via the input controller 100. As with the space mouse 104, the grip with the rocker feature may be biased to a neutral position, such that when the grip 102 is released the rotation ceases. The rocker feature many be bi-directional such that the endoluminal catheter can be rotated either clockwise or counterclockwise depending on which direction the grip is rotated. This rotation may in some instances be limited to 10, 15, 20, 25, 30, 35, 40, or 45 degrees in either direction.

[0044] FIG. 7 depicts a further aspect of the disclosure. In FIG. 7, the input controller 200 includes a base 202. The base 202 may include a movement detection mechanism such as anPATENT APPLICATIONA0012329W001 (00017-01271PCT00) optical sensor. The movement detection mechanism may be configured to detect movement in, e.g., an axial direction, substantially comporting with an axial direction of movement of an endoluminal catheter. As will be appreciated, other forms of detection and translation of movement the base 202 into signals for the navigation or endoluminal catheter. This axial direction may be defined by the physical twin 206 secured to the base 202 via a support 204. The physical twin 206 substantially comports to physical twin 106 described in greater detail above. As with the input controller 100, the input controller 200 allows for easy user visualization of the physical twin 206 so that manipulations of the physical twin can be mirrored in the endoluminal catheter. The ability to visualize the shape of the endoluminal catheter, impart haptic feedback, and adjust the physical twin to achieve complex shapes of complex catheter devices results in instinctive and precise navigation of the endoluminal catheter in ways that may not be as feasible with game-controllers or wheel and track ball controllers. These features may help reduce the mental burden on the user, increase the precision and accuracy of the navigation, and improve the outcome for the patients undergoing the procedures.

[0045] The input controllers 100, 200 may include tremor or bump filtering. As a result, temporary unintended inputs to the input controllers 100, 200 are ignored rather than having them manifest in the endoluminal catheter. This may be achieved via a short delay (e.g., 500 ms) or another mechanism to prevent unintended movements being undertaken by the robotic endoluminal navigation system.

[0046] Though described herein a related to robotic endoluminal navigation systems, the aspects of this disclosure are not limited to robotic systems and the features described here can be implemented in any motorized or motor-assisted surgical system. Still further, those focused on endoluminal navigation, this disclosure is not so limited and the manipulation and control of a catheter device in laparoscopic, open, or other surgical applications is considered within the scope of the disclosure.EXAMPLESExample 1 - An input controller, including a base configured to receive input and generate a signal for transmission to a navigation system to move a navigation catheter in an axial direction, and a control catheter mounted on the base, wherein articulation of the control catheter generates a signal for transmission to the navigation system to articulate the navigation catheter.PATENT APPLICATIONA0012329W001 (00017-01271PCT00)Example 2 - The input controller of example 1, wherein the control catheter is comprised of a plurality of flexible segments.Example 3 - The input controller of examples 1 or 2, wherein the control catheter is formed of two telescoping catheters.Example 4 - The input controller of any of examples 2-3, further comprising at least one lock, wherein the lock prevents relative movement of two adjacent segments of the two telescoping catheters.Example 5 - The input controller of example 4, wherein the lock includes an indicator on the control catheter.Example 6 - The input controller of any of examples 1-5, wherein the base is a space mouse.Example 7 - The input controller of any of examples 1-6, wherein the control catheter further comprises at least one tendon or pull wire.Example 8 - The input controller of any of example 7, wherein the control catheter further comprises at least one sensor configured to detect articulation of the control catheter.Example 9 - The input controller of example 8, wherein the sensor is one of a fiber-Bragg grating, an electromagnetic sensor, a capacitive touch sensor, a force sensor, or a linear encoder. Example 10 - The input controller of example 9, wherein the fiber-Bragg grating detects one or more of a shape of the control catheter, a strain applied to the flexible catheter, or a location at which force is applied to the control catheter.Example 11 - The input controller of example 8, wherein the sensor is a linear encoder detects movement of the tendon or pull wire to detect a change in shape of the control catheter.Example 12 - The input controller of example 7, further comprising at least one servomotor configured to receive a signal from the navigation system, wherein the signal is representative of a force applied to the navigation catheter by tissue of a patient.Example 13 - The input controller of example 12, wherein the signal from the navigation system when applied to the servomotor provides haptic feedback to a user by increasing or decreasing resistance to manipulation of the control catheter.Example 14 - The input controller of example 12, wherein the signal from the navigation system when applied to the servomotor resists movement of the space mouse.Example 15 - The input controller of any of example 1-14, wherein mechanical properties of the control catheter are substantially similar to the mechanical properties of the navigation catheter.PATENT APPLICATIONA0012329W001 (00017-01271PCT00)Example 16 - An input controller including a grip operably connected to a base, the base including at least one position configured to generate a signal for transmission to a navigation system for movement of a navigation catheter in an axial direction, and a control catheter extending from the grip, wherein the control catheter includes at least one flexible segment, wherein manipulation of the control catheter generates a signal for transmission to the navigation system to articulate the navigation catheter.Example 17 - The input controller of example 16, wherein the control catheter further comprises at least one tendon or pull wire and a linear encoder, wherein movement of the tendon or pull wire relative to the linear encoder generates a signal for transmission to the navigation catheter of an articulation of the at least one flexible segment.Example 18 - The input controller of any of examples 16-17 including at least one servomotor, wherein the servomotor is configured to receive a signal from the navigation system representative of resistance to motion of the navigation catheter, wherein the signal when applied to the servomotor provides haptic feedback to a user by increasing or decreasing resistance to manipulation of the control catheter.Example 19 - The input controller of any of examples 16-18, wherein the control catheter is formed of two telescoping catheters, each of the two telescoping catheters including at least one of the at least one flexible segment.Example 20 - The input controller of example 19, further comprising a lock preventing axial movement of the two telescoping catheters.

[0047] Although embodiments have been described in detail with reference to the accompanying drawings for the purpose of illustration and description, it is to be understood that the inventive processes and apparatus are not to be construed as limited. It will be apparent to those of ordinary skill in the art that various modifications to the foregoing may be made without departing from the scope of the disclosure.

Claims

PATENT APPLICATIONA0012329W001 (00017-01271PCT00)We claim:

1. An input controller, comprising: a base configured to receive input and generate a signal for transmission to a navigation system to move a navigation catheter in an axial direction; and a control catheter mounted on the base, wherein articulation of the control catheter generates a signal for transmission to the navigation system to articulate the navigation catheter.

2. The input controller of claim 1, wherein the control catheter is comprised of a plurality of flexible segments.

3. The input controller of claims 1 or 2, wherein the control catheter is formed of two telescoping catheters.

4. The input controller of any of claims 2-3, further comprising at least one lock, wherein the lock prevents relative movement of two adjacent segments of the two telescoping catheters.

5. The input controller of claim 4, wherein the lock includes an indicator on the control catheter.

6. The input controller of any of claims 1-5, wherein the base is a space mouse.

7. The input controller of any of claims 1-6, wherein the control catheter further comprises at least one tendon or pull wire.

8. The input controller of any of claim 7, wherein the control catheter further comprises at least one sensor configured to detect articulation of the control catheter.

9. The input controller of claim 8, wherein the sensor is one of a fiber-Bragg grating, an electromagnetic sensor, a capacitive touch sensor, a force sensor, or a linear encoder.

10. The input controller of claim 9, wherein the fiber-Bragg grating detects one or more of a shape of the control catheter, a strain applied to the flexible catheter, or a location at which force is applied to the control catheter.

11. The input controller of claim 8, wherein the sensor is a linear encoder detects movement of the tendon or pull wire to detect a change in shape of the control catheter.

12. The input controller of claim 7, further comprising at least one servomotor configured to receive a signal from the navigation system, wherein the signal is representative of a force applied to the navigation catheter by tissue of a patient.

13. The input controller of claim 12, wherein the signal from the navigation system when applied to the servomotor provides haptic feedback to a user by increasing or decreasing resistance to manipulation of the control catheter.PATENT APPLICATION A0012329W001 (00017-01271PCT00)14. The input controller of claim 12, wherein the signal from the navigation system when applied to the servomotor resists movement of the space mouse.

15. The input controller of any of claim 1-14, wherein mechanical properties of the control catheter are substantially similar to the mechanical properties of the navigation catheter.

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