Powered and maneuverable systems, computer-implemented methods, and computer program products for navigating elongated surgical devices through internal lumens in patients.

Abstract

The present invention relates to a powered, maneuverable system (101) for navigating an elongated surgical device (102), having an outer tubular body (7) and an elongated actuating element (2) nested within the outer tubular body (7), through a patient's internal lumen, particularly within the cerebrovascular system. The maneuverable system (101) comprises an actuating unit (3) configured to be coupled to the elongated actuating element (2) to actuate the elongated actuating element (2); an input interface configured to receive inputs, particularly user-generated inputs (52), specifying the curved geometric shape (41) of a bendable section (4) at the distal end portion (71) of the outer tubular body (7); a control unit (5) operably coupled to the input interface and configured to calculate control commands based on the inputs; and an output interface operably coupled to the control unit (5) and configured to transmit control commands to the actuating unit (3). The actuating unit (3) is adapted to deflect the bendable section (4) to the curved geometric shape (41) based on the control commands.

Description

Technical Field

[0001] The present invention relates to a powered operable system, a method implemented by a computer, and a computer program product for navigating a slender surgical device having an outer tubular body and an elongate actuating element through a body lumen of a patient. The elongate actuating element can be, for example, a tension-responsive, compression-responsive element, or a combination thereof.

[0002] The present invention is particularly suitable for performing neurovascular applications that require precise and accurate operability within the intricate neurovascular system of the brain.

Background Art

[0003] Existing slender surgical devices used within a body lumen, such as intravascular guidewires / catheters, often rely on manual manipulation to reshape the distal tip of the slender surgical device or even require the advancement of additional / different surgical devices such as guidewires having specially pre-shaped distal tips.

[0004] Various systems for navigating slender surgical devices known in the prior art within the vascular system rely on the skills of the clinician, particularly manual dexterity, or are exposed to significant health risks such as vascular injury when operating through the intricate and tortuous vascular system.

[0005] Particularly in neurovascular applications, the adage "time is brain" emphasizes the importance of rapid surgical intervention, which is essential to minimize the risk of irreversible brain damage. By providing more accurate and efficient navigation of the slender surgical device, shortening the time required for navigation and streamlining surgical intervention are of utmost importance for shortening the overall treatment time.

[0006] In particular, prior art lacks a system for navigating elongated surgical devices that would improve their operability and controllability, thereby achieving better treatment outcomes and reducing risks to patient safety.

[0007] WO 2007 / 008967 A2 discloses a system for controlling the position of an elongated medical device using a control handle, a robotic device, and a remote control mechanism that can remotely position the medical device within a patient's body. However, this system and the elongated medical device are complex and large, making it impossible to precisely and reliably reshape the distal end of the elongated medical device within the neurovascular system.

[0008] WO 2017 / 033182 A1 discloses a double concentric guidewire having a first guidewire, a second guidewire nested within the first guidewire, and an adjuster mechanism for displacing the second guidewire relative to the first guidewire by operating a manual control handle. However, because this system is manually operated, the efficiency and controllability of the guidewire are limited.

[0009] In general, there is no simple, compact system for navigating elongated surgical devices that can rapidly and precisely deflect the distal tip of such devices in a reliable and efficient manner. Furthermore, the prior art lacks a maneuverable system that does not deviate from common clinical practice and / or does not require a steep maneuvering learning curve.

[0010] The object of the present invention is to overcome these and other drawbacks of the prior art. [Overview of the project] [Problems that the invention aims to solve]

[0011] The present invention provides a powered, maneuverable system for navigating an elongated surgical device having an outer tubular body and an elongated actuating element nested within the outer tubular body, through a patient's lumen, particularly within the cerebrovascular system. The maneuverable system comprises an actuating unit configured to be coupled to the elongated actuating element in order to actuate the elongated actuating element, particularly to apply tension and / or compressive forces to the elongated actuating element. The maneuverable system comprises an input interface configured to receive inputs specifying the deformed geometric shape of a bendable section at the distal end of the outer tubular body, particularly a curved geometric shape, particularly user-generated inputs.

[0012] The deformed geometric shape may not necessarily be a single bend, but may include multiple bends or other shapes such as 3D shapes. Instead of user-generated input, it is also possible to provide input determined by an automated system based on partially or fully automated analytical imaging data.

[0013] The controllable system further includes a control unit operably coupled to an input interface and configured to generate control commands based on the input. The controllable system also includes an output interface operably coupled to the control unit and configured to transmit control commands to an actuator unit. The actuator unit is adapted to deflect the bendable section to a deformed geometric shape, particularly a curved geometric shape, based on the control commands.

[0014] The elongated surgical device may comprise a guidewire or catheter, preferably a guidewire having an outer diameter of 0.035″ / 0.89mm to 0.010″ / 0.25mm, and may comprise both a guidewire and / or catheter, or consist of both. Alternatively, the elongated surgical device may comprise an intervention device, an implantation device, or a diagnostic device, or consist of both. The tension and / or compression-responsive actuation element may comprise a pull wire, a tendon, or a push rod, or consist of both.

[0015] A responsive, elongated actuating element and a bendable section of an elongated surgical device may be configured such that the bendable section can be deformed into a first curved geometric shape by applying compression to the bendable section by retracting / extracting the responsive actuating element.

[0016] In addition to or instead of the above, the responsive elongated actuating element and the bendable section may be configured such that the bendable section can be deformed into a second curved geometric shape opposite to a first curved geometric shape by extending or pushing the responsive actuating element distally to the bendable section.

[0017] In a preferred embodiment, the actuation unit of the powered, maneuverable system is electrically powered. Alternatively, the actuation unit may be powered hydraulically, pneumatically, magnetically, ultrasonically, or chemically.

[0018] If the actuation unit is configured to be merely coupled to rather than permanently connected to an elongated surgical instrument, the actuation unit can be reused, resulting in an economically efficient solution by reducing long-term production costs.

[0019] The control unit may be configured to calculate at least a first and a second control command for deflecting a bendable section into two different curved geometric shapes based on a single input. The control unit may further be configured to send the first and second control commands to the actuator unit via an output interface at time intervals, particularly at predetermined time intervals. Specific geometric shapes and associated commands can also be stored in system memory or system-accessible memory. In this case, the user may simply select from several predetermined configurations, such as uncurved, partially curved, or fully curved.

[0020] This allows for the establishment of a deflection routine for the bendable section, such that the actuation unit is configured to sequentially deflect the bendable section into several, for example, two different curved geometric shapes, based on first and second control commands. This facilitates the manipulation of elongated surgical devices and enables more complex deflection routines without requiring clinicians to actively prompt for additional input. In addition, this improves the functionality and versatility of the maneuverable system by streamlining surgical procedures and reducing the cognitive and manual burden on clinicians.

[0021] The actuation unit may be configured to allow bidirectional movement of the elongated actuation element, thereby facilitating both proximal and distal linear motion of the elongated actuation element. The actuation unit may consist of a linear actuation unit or a rotary actuation unit with a conversion mechanism operably connected to or connectable to the elongated actuation element. The conversion mechanism is adapted to convert the rotational movement of the rotary actuation unit into linear movement of the elongated actuation element.

[0022] This actuation unit allows for precise and accurate control of the spatial position of elongated actuation elements based on input, enabling a compact design without compromising functionality.

[0023] The conversion mechanism of the rotary actuating unit may include a spool or roller for winding and unwinding an elongated actuating element, thereby ensuring a more compact structure while avoiding peak loads on the elongated actuating element.

[0024] The control unit and the actuating unit may be positioned within a common housing of the powered manipulable system.

[0025] This provides a space - efficient system for navigating an elongated surgical device while providing simplified wiring and protection for the control unit and the actuating unit.

[0026] The common housing may have a longitudinal dimension within the range of 0.1 cm to 25 cm, particularly within the range of 3 cm to 30 cm, preferably within the range of 5 cm to 10 cm, and a transverse dimension within the range of 0.036 cm to 10 cm, particularly within the range of 0.5 cm to 5 cm, preferably within the range of 0.7 cm to 1.75 cm. The common housing having the control unit and the actuating unit may have a weight of 1 g to 100 g, particularly 5 g to 50 g, preferably 10 g to 30 g.

[0027] These longitudinal and transverse dimensions and / or the low weight enable cost savings in terms of manufacturing and compact design. Thus, the dimensions of the manipulable system improve the space efficiency of the system without disturbing the clinician, which can be a valuable advantage in the limited space of an operating room / operating table. Further, this design improves the portability of the device and simplifies its ease of use by the clinician.

[0028] The powered manipulable system may be configured such that an elongated surgical device can be manually rotated and / or translated by a clinician, particularly together with the actuating unit. This simplifies the operation and design of the manipulable system.

[0029] The powered manipulable system may have a disconnect unit configured to receive an elongate surgical device, particularly an outer tubular body and an elongate actuating element, such that rotation and / or translational movement of the elongate surgical device is disconnected from the actuating unit. Thereby, the elongate surgical device can be made rotatable and / or translatable relative to the actuating unit. For this purpose, ball bearings may be provided. A first bearing may be provided on the outer tubular body connected to the housing, and a second bearing may be provided on the inner elongate actuating element or on the proximal mounting portion of the inner elongate actuating element connected to the actuating unit. The first and second bearings may be coupled such that the outer tubular body and the elongate actuating element can move together relative to the housing / actuating unit, particularly in the rotational and / or translational directions.

[0030] The powered manipulable system may have a positioning unit controllably coupled to a control unit. The positioning unit is configured to (a) rotate the elongate surgical device, particularly together with the actuating unit, around the central trajectory of the elongate surgical device and / or (b) translate the elongate surgical device, particularly together with the actuating unit, in the distal or proximal direction based on a movement input, preferably a movement input generated by the user.

[0031] This positioning unit enables precise and accurate orientation and spatial positioning of the elongate surgical device within the patient's vascular system while facilitating navigation independent of the dexterity of the clinician's hand.

[0032] The system may also be adapted to be integrated into a commercially available positioning unit, such as a robotic assistance system that enables a clinician to control percutaneous vascular interventions, such as CorPath GRX or Robocath R-One.

[0033] The powered, maneuverable system may have a driven unit. The driven unit is designed to compensate for the weight and / or torque acting on the actuating unit, in particular to avoid translational perturbations of elements connected to the proximal side of the elongated surgical device. The driven unit may have at least one bearing member, which is configured to support the actuating unit while moving the actuating unit distally, proximally, and / or rotationally around the central trajectory of the actuating unit as the elongated surgical device is moved. Alternatively or in addition thereto, the driven unit may have sensors, in particular force or position sensors, which are configured to generate force or position data by detecting rotational or translational movement of the elongated surgical device, and the driven unit may further have a driven drive unit, which is adapted to move the actuating unit, in particular a control unit, along the translational and / or rotational directions in real time and in synchronization with the elongated surgical device based on the force or position data.

[0034] This improves handling by minimizing / mitigating friction when manually moving elongated surgical devices or when moving them via a positioning unit. In addition, the driven unit effectively eliminates the weight of the device, freeing clinicians from the physical strain of handling elongated surgical devices, allowing them to perform long surgical procedures without fatigue.

[0035] The driven unit may have a biasing member, particularly a spring, adapted to provide a predetermined biasing force to the movement of the elongated surgical device together with the housing. This allows for more tactile feedback when moving the elongated surgical device, thus enabling more precise positioning.

[0036] At least one bearing member may be configured to support the entire common housing when moving an elongated surgical device.

[0037] At least one bearing member may include, or be composed of, linear and / or rotary ball bearings, roller / spherical bearings, sliding bearings, or pneumatic bearings to reduce friction when moving the operating unit and the elongated surgical device.

[0038] The force sensors and driven units enable adaptive force control to dynamically support the movement of elongated surgical devices and actuation units in real time, thereby achieving smoother and more precise synchronous rotational / translational movement of elongated devices and actuation units.

[0039] The driven unit may be connected to the actuating unit, or may even be formed by the actuating unit. Alternatively, the driven unit may be configured to be coupled to the actuating unit so that the actuating unit is movable relative to the driven unit.

[0040] The force sensor may be functionally connected to or connectable to the outer tubular body or elongated actuating element to detect rotational or translational action of the outer tubular body or elongated actuating element, such as action manually applied by a clinician.

[0041] The control unit may be configured to apply vibration to the elongated surgical device, particularly the elongated actuating element and / or outer tubular body, via an actuating unit or positioning unit, at a frequency of 1 Hz to 1000 Hz, preferably 20 Hz to 500 Hz, when deflecting the bendable section. The actuating unit, or particularly the positioning unit, is preferably adapted to apply vibration by repeatedly and alternately moving the elongated surgical device in the proximal and distal directions.

[0042] This can improve motion transmission to the outer tubular body and / or elongated actuarial element. Force transmission when deflecting a bendable section based on control commands can be impaired or delayed along elongated surgical devices that are subject to fluctuating stress and friction effects resulting from adapting to sharp curves in the vascular system. Resistance to static friction / motion of elongated surgical devices based on factors such as adhesion or static friction effects can be overcome by these vibrations, particularly by rapidly repeated forward and backward movements.

[0043] An input interface, particularly a user interface, may be electrically connected to a control unit to receive inputs directly, or it may be configured to receive inputs via wireless transmission from a remote control. The controllable system may include a wireless input transmission unit that can be coupled to the input interface. The wireless input transmission unit is configured to wirelessly transmit inputs to the input interface.

[0044] Wireless transmission simplifies the operation and treatment efficiency of powered maneuverable systems by enabling clinicians to wirelessly manipulate the deflection of bendable sections. This is particularly advantageous because a clinician operating a maneuverable system during a surgical procedure, for example by manually positioning / orienting an elongated device, can simultaneously receive wireless input to deflect the bendable section into a curved geometric shape.

[0045] A powered and maneuverable system may have at least one deflection sensor configured to generate deflection data by detecting the position of an elongated actuating element and / or the geometric shape of a bendable section. Deflection in this context refers to any type of deformation, i.e., simple bending, but also to more complex structures. The deflection sensor may be located on or adjacent to the bendable section to directly determine the deflection. It may also be located away from the bendable section and indirectly determine the deflection by measuring, for example, the position of an elongated element or the force acting on an elongated element. A control unit is configured to (a) receive deflection data from the deflection sensor, (b) determine, based on the deflection data, whether a desired geometric shape can be achieved, and (c) control the actuating unit in a closed feedback loop based on the detected deflection data to achieve the desired geometric shape of the bendable section in real time.

[0046] This ensures that the elongated actuation element is reliably positioned to achieve a specific deflection of the bendable section.

[0047] The deflection sensor may include an encoder configured to generate deflection data of the position of an elongated actuating element based on the motion of the actuating unit, particularly linear or rotational motion.

[0048] At least one deflection sensor may be selected from at least one of magnetic deflection sensors, optical deflection sensors, capacitive deflection sensors, or resistive deflection sensors. At least one deflection sensor is preferably located within the actuation unit or within the bendable section.

[0049] Magnetic deflection sensors may be formed by Hall effect-based position sensors. Optical deflection sensors may be formed by time-of-flight or reflection-based position sensors. Resistivity sensors may be formed by strain gauges or polymer film-based sensors.

[0050] The deflection sensors may be at least partially positioned on the actuation unit and / or elongated actuation elements to track their linear or angular position relative to each other.

[0051] When the deflection sensor is positioned within an elongated working element to detect the geometric shape of the bendable section, the deflection sensor may include or consist of an optical fiber with a strain gauge or Bragg grating.

[0052] The deflection sensor or imaging data allows for a more accurate determination of the geometric shape of the bendable section, and by adjusting the control of the actuation unit through the control unit in a closed feedback loop, the bendable section can be deflected more precisely to its curved geometric shape.

[0053] The system can also be equipped with sensors, such as position and / or force sensors, to determine the position of the actuating element or actuating unit, or the force acting on it. This allows the operation of the actuating unit to be controlled without necessarily having to determine the degree of deflection.

[0054] A powered, maneuverable system may include an energy storage device, particularly located within a common housing, for operating the maneuverable system.

[0055] This improves the portability of the controllable system and the flexibility in positioning the controllable system in the operating room / operating table.

[0056] The controllable system may include a graphical user interface configured to present visual information on a display. This information may indicate the curved geometric shape of a bendable section of an elongated surgical device, but more commonly, it may relate to the system's state, such as whether the system is "operating," "off," or "dead battery." The graphical user interface may also be configured to provide, in addition to or instead of, a movable control element having a spatial position, preferably a slider, on the display, which the user can adjust the degree of the curved geometric shape by adjusting the spatial position of this control element, particularly bidirectionally, and in particular, by continuously adjusting a uniform lateral bending angle across the entire bendable section.

[0057] A graphical user interface may be functionally coupled to a movable control element and configured to provide numerical and / or graphical indicators that display the degree of curvature of the geometric shape in real time.

[0058] The graphical user interface may be configured to transmit, in particular wirelessly, inputs based on the spatial position of movable control elements, specifying curved geometric shapes, to the input interface of the control unit in real time.

[0059] The controllable system may be adapted to use the system's radio input transmission unit as a display for a graphical user interface.

[0060] The graphical user interface enables simple, reliable, and easy-to-use control of the controllable system, visual feedback of curved geometric shapes, and simple reshaping / deflection of bendable sections by moving control elements with one hand.

[0061] Alternatively, the display or input may be formed by hardware components mounted on the system housing or on the remote control. In particular, a control display, such as an LED or LED display, can be used to indicate the degree of deflection or the system status.

[0062] Furthermore, physical means such as physical sliders, rotary knobs, or levers may be provided for controlling the system. Depending on the specific application, this may be preferred over graphical input because it provides direct tactile feedback to the user, eliminating the need for the user to constantly look at a display. However, it is also possible to enhance the graphical input interface with some form of feedback, such as vibration on the control device.

[0063] Another aspect of the present invention relates to a computer-implemented method for navigating an elongated surgical device having an outer tubular body and an elongated actuating element nested within the outer tubular body through a patient's internal lumen. The method includes (a) receiving, via an input interface, an input specifying a desired geometric shape, in particular a curved geometric shape, of a bendable section at the distal end of the outer tubular body, in particular a user-generated input; and (b) calculating a control command via a control unit based on the input. The method includes (c) transmitting the control command to an actuating unit via an output interface; and (d) deflecting the bendable section to the desired geometric shape based on the control command.

[0064] The above method optionally includes the step of applying vibration to an elongated surgical device, particularly to an elongated actuating element and / or outer tubular body, via an actuating unit or positioning unit, at a frequency of 1 Hz to 1000 Hz, preferably 20 Hz to 500 Hz.

[0065] The above method optionally includes the step of detecting position and / or force data and moving an actuating unit, particularly a control unit, along translational and / or rotational directions in real time, in synchronization with an elongated surgical device, based on the force and / or position data. This allows for compensation of the weight or torsion of the actuating unit.

[0066] Another aspect of the present invention relates to a computer program product that includes instructions causing the above-described powered, operable system to perform the above-described steps of a method implemented by a computer.

[0067] The powered and maneuverable system may comprise an elongated surgical device having an outer tubular body and an elongated tension and / or compression-responsive actuarial element nested within the outer tubular body. The distal end portion of the outer tubular body has a bendable section that can be deformed into a desired geometric shape.

[0068] The bendable section may be configured to have an essentially linear geometric shape when no external force, particularly tension, is applied to the bendable section.

[0069] Systems featuring elongated surgical devices optimize the interaction between often intricately arranged elongated working elements by, for example, enabling pre-connection between elongated working elements and working units, thereby promoting better reproducibility and reducing the risk of defects.

[0070] An elongated surgical device may have torsional rigidity such that a rotational force applied to the proximal end of the elongated surgical device is transmitted to the distal end of the elongated surgical device along the central trajectory of the elongated surgical device.

[0071] This allows for reliable rotation of the bendable section within the curved geometric shape while maintaining the curved geometric shape at the distal end, thereby enabling the bendable section to be positioned and directed within the patient's vascular system, particularly the intricate cerebrovascular system.

[0072] The bendable section may be uniformly deflectable laterally along its longitudinal length, and the curved geometric shape may be defined by a uniform lateral bending angle across the entire bendable section. The control unit and actuation unit may be configured to allow adjustment of the bending angle over the entire range of 0° to 540°, particularly over the entire range of 0° to 270°, preferably over the entire range of 0° to 180°.

[0073] The uniformity of the bending angle optimizes the ratio of load within the elongated surgical instrument to the maximum bend of the bendable section. This uniform stress distribution allows for structural integrity to be maintained even over the wide range of bending angles that may be required to advance through a meandering vascular system.

[0074] One side of the bendable section of an elongated surgical device may have a stress-relieving section, in particular, which may have at least one, preferably more, circumferential and / or helical notches, so that when tensile and / or compressive forces are applied to the elongated working element, the bendable section is deflected laterally to the stress-relieving section. The deflection may occur in two lateral directions within a plane, preferably in only one lateral direction.

[0075] This stress-relieving section allows for reliable and consistent deflection of the bendable section without plastic deformation.

[0076] One side of the bendable section of an elongated surgical device, particularly the side opposite the stress-relieving portion, may have a reinforcing portion, preferably a reinforcing structure. The reinforcing structure may be integrally formed with the outer tubular body and is longitudinally rigid, so that applying tension and / or compressive forces to the elongated working element does not essentially affect the length of the reinforcing portion in the longitudinal direction.

[0077] This improves the structural integrity of elongated surgical devices and allows for reliable deflection of the bendable sections.

[0078] The bendable section may comprise multiple stress-relieving sections and / or reinforcing sections located in different longitudinal subsections of the bendable section. This allows the bendable section to be deformed into more complex curved geometric shapes.

[0079] The distal end of the elongated actuarial element may be connected to the distal tip of the end of an elongated surgical device, which preferably has a rounded shape; the proximal end of the elongated actuarial element is connected to the actuarial unit so as to be longitudinally movable; and the proximal end of the outer tubular body is connected to the actuarial unit so as not to be longitudinally movable, and in particular to the housing of the actuarial unit. The connections may be configured such that each is rotatable.

[0080] This allows for the secure connection of slender surgical devices to actuators, providing an all-in-one solution that can be used right out of the box without the need to assemble a complex controllable system.

[0081] Elongated surgical devices may be sized and molded for use in peripheral interventions, interventional cardiology, or neurovascular surgical procedures. The outer tubular body may have a maximum cross-sectional dimension of less than 1 mm, particularly less than 0.6 mm, preferably less than 0.37 mm. Elongated surgical devices may have a length of 0.5 m to 4 m, particularly 1 m to 3.5 m, preferably 2 m to 3.15 m.

[0082] This small size allows for the manipulation of elongated surgical devices in tortuous and intricate vascular systems, such as those within the cerebrovascular system. Simultaneously, the cross-sectional dimensions of the outer tubular body enable the achievement of a smaller bending radius. Elongated surgical devices may also be used to deflect microcatheters, for example, by deflecting the bendable section into a curved geometric shape to propel the microcatheter backward.

[0083] The elongated surgical device may preferably include a radiopaque element located at the distal end of the elongated surgical device.

[0084] The radiopaque element enables real-time positioning of the distal tip of elongated surgical devices, particularly using fluorescence fluoroscopy.

[0085] The radiopaque elements may also extend along most or all of the bendable section so that the curved geometric shape can be verified by X-ray imaging techniques. The radiopaque elements may be configured to bend uniformly with the geometric shape of the bendable section, particularly by having a coil shape, for example, by radiopaque elements formed by platinum-iridium coils.

[0086] The outer tubular body may be formed by a single tubular element, and may contain or be made of stainless steel or nitinol, preferably formed by nitinol hypotubes, such as laser-cut hypotubes.

[0087] Nitinol exhibits superelastic properties that result in improved torqueability and allow it to reliably and repeatedly recover its original shape after being deformed into a curved geometric shape.

[0088] Next, the present invention will be described with reference to several embodiments and drawings. [Brief explanation of the drawing]

[0089] [Figure 1] This is a schematic plan view of a first embodiment of a powered, maneuverable system for navigating an elongated surgical device by deflecting a bendable section into a curved geometric shape. [Figure 2A] This is a diagram representing a second embodiment of a powered, maneuverable system, which includes a driven unit and is capable of translational and rotational movement by manual operation. [Figure 2B] This is a diagram representing a third embodiment of a powered, maneuverable system, which includes a driven unit and is capable of translational and rotational movement by a positioning unit. [Figure 3A] This is a diagram of a graphical user interface representation configured to provide movable control elements for adjusting curved geometric shapes based on user-generated input. [Figure 3B] This is a diagram of a remote control representation configured to provide a movable control element for adjusting a curved geometric shape based on user-generated input. [Figure 3C] This is a diagram of an elongated surgical device with a linear geometric shape. [Figure 3D] This is a diagram of an elongated surgical device having a first curved geometric shape. [Figure 3E] This is a diagram of a second, elongated surgical device having a curved geometric shape. [Figure 4] This is a cross-sectional view of a powered, maneuverable system having a detachment unit. [Figure 5] This is a schematic diagram of various components of the system according to the present invention. [Figure 6A] This is a schematic diagram of an embodiment of an elongated surgical device having a reconstructible tip shape, including a tip shape that can be reconstructed in three dimensions. [Figure 6B] This is a schematic diagram of different embodiments of an elongated surgical device having different reconstructible tip shapes, including a tip shape that can be reconstructed in three dimensions. [Figure 6C] This is a schematic diagram of different embodiments of an elongated surgical device having different reconstructible tip shapes, including a tip shape that can be reconstructed in three dimensions. [Figure 6D] This is a schematic diagram of different embodiments of an elongated surgical device having different reconstructible tip shapes, including a tip shape that can be reconstructed in three dimensions. [Figure 6E] This is a schematic diagram of different embodiments of an elongated surgical device having different reconstructible tip shapes, including a tip shape that can be reconstructed in three dimensions. [Figure 7A] This is a schematic diagram of an embodiment of the operating unit. [Figure 7B] These are schematic diagrams of different embodiments of the operating unit. [Figure 8A] This is a schematic diagram of an embodiment of the system's driven unit. [Figure 8B] These are schematic diagrams of different embodiments of the system's driven units. [Figure 8C] These are schematic diagrams of different embodiments of the system's driven units. [Figure 8D] These are schematic diagrams of different embodiments of the system's driven units. [Figure 9A] This is a schematic diagram of an embodiment of a driven unit in which the housing is suspended from a solid support. [Figure 9B] This is a schematic diagram of a different embodiment of a driven unit in which the housing is suspended from a solid support. [Figure 10A] This is a schematic diagram of an embodiment of a system having a deflection sensor. [Figure 10B] These are schematic diagrams of different embodiments of a system having different deflection sensors. [Figure 11] This is a diagram of a wireless input transmission unit according to the present invention, attached to a catheter valve connected to a catheter. [Modes for carrying out the invention]

[0090] Figure 1 shows a plan view of a powered, maneuverable system 101 for navigating an elongated surgical device 102 formed by a guidewire for neurovascular, peripheral, or cardiac indications.

[0091] The powered controllable system 101 includes an actuation unit, a control unit, an input interface, and an output interface, all located within a common housing 6 at the proximal end of the controllable system 101.

[0092] The elongated surgical device 102 comprises an outer tubular body 7 and at least one, in particular only one, tension- and / or compression-responsive elongated working element formed by a pull wire. The outer tubular body 7 is formed from a metal tube such as platinum, aluminum, magnesium, gold, stainless steel, or titanium, or from a metal alloy such as nitinol or cobalt-chromium. The tube may also consist of a collection of different tube subsections of different metals joined to each other via solid joints. Alternatively, the tube may be a single, integrated element, such as a nitinol hypotube with torsional rigidity. The outer tubular body 7 has a nominal diameter of 0.014″ / 0.36 mm and a length of 110 cm to 315 cm, particularly 250 cm. The distal end portion 71 of the outer tubular body 7 has a bendable section 4 that can be deflected into a curved geometric shape 41 based on user-generated input. The curved geometric shape 41 schematically shown in Figure 1 has a uniform lateral bending angle throughout the bendable section 4. The bendable section 4 in Figure 1 is configured to be deflected with a uniform lateral bending angle in the lateral direction 42, but may be deflectable in three dimensions. This allows the bendable section 4 to be deflected into a selected curved geometric shape 41 and directed forward / backward along the pathways of branched or tortuous vascular systems.

[0093] The input interface is configured to wirelessly receive user-generated input indicating a desired curved geometric shape 41 via a wireless transmitter 15. The control unit is configured to calculate control commands based on the user-generated input, and the output interface is configured to transmit the control commands from the control unit to the actuator unit. The actuator unit then moves the pull wires longitudinally back or forward based on the control commands so that the bendable section 4 is deflected into the desired curved geometric shape 41.

[0094] The control unit is further adapted to apply vibrations at a frequency of 10 Hz to the elongated actuating element of the elongated surgical device 102 via the actuating unit in the form of rapid forward and backward movement when deflecting the bendable section. This allows the bendable section to be deflected, however motion transmission subject to internal static friction may hinder or delay the deflection of the bendable section 4 into the curved geometric shape 41.

[0095] Figures 2A and 2B show representations of second and third embodiments of a powered maneuverable system 101, respectively, which includes a driven unit 8 and is capable of translational and rotational movement by manual operation (Figure 2A) or by a positioning unit 11 (Figure 2B). The powered maneuverable system 101 of Figures 2A and 2B includes all the elements described above in Figure 1 and further includes a wireless input transmitting unit 51 that can be coupled to the input interface to wirelessly transmit a user-generated input 52 indicating a desired curved geometric shape 41 of the bendable section 4 in the lateral direction 42. The input transmitting unit 51 has a graphical user interface 12 with a display 122 for displaying a movable control element, and the user can adjust the degree of the curved geometric shape 41 by directionally adjusting the spatial position of this control element. The control unit may be adapted to wirelessly transmit 15 status data of the actuating unit, driven unit, and / or elongated surgical device to the input transmitting unit 51, for example, to display the status data on the input transmitting unit 51.

[0096] The driven unit 8 in Figures 2A and 2B has bearing members that support the common housing 6 so that the common housing 6 can move simultaneously with the elongated surgical device 102 in the proximal direction P and distal direction D with minimal frictional resistance. Thus, the driven unit 8 enables more precise positioning of the elongated surgical device 102 by compensating for the weight / inertia of the common housing 6. The driven unit 8 is optionally further configured to support the common housing 6 so that the common housing 6 can move simultaneously with the elongated surgical device 102 in the rotational direction R with minimal frictional resistance. However, in a preferred embodiment, the rotational movement of the maneuverable system 101 may have a decoupling unit, which is adapted to decouple the rotational movement of the elongated surgical device 102 from the actuating unit / common housing 6, for example, via a circumferential ball bearing for connecting the proximal end of the elongated surgical device 102 to the actuating unit / common housing 6 (see Figure 4). This simplifies the design and eliminates the need for a rotary design of the operating unit / common housing 6, while still allowing for easy operation of the elongated surgical device 102.

[0097] The first embodiment of the controllable system 101 shown in Figure 2A is manually movable in the distal and proximal directions D, P, and rotational direction R. This allows for a simple design that enables longitudinal and rotational positioning of elongated surgical devices in the same way as established common practices for clinicians, without requiring a high learning curve.

[0098] A second embodiment of the operable system 101 in Figure 2B is translationally and rotationally movable via a positioning unit 11 having longitudinal and rotational actuators. The positioning unit can be formed by a commercially available device, such as a known device provided by, for example, CorPath GRX or Robocath R-One.

[0099] The wireless transmission unit 51 is further adapted to transmit user-generated movement inputs to the control unit via an input interface. The control unit is coupled to the positioning unit 11 so that the elongated surgical device can move rotationally around its longitudinal trajectory or translationally distally or proximally based on the user-generated movement inputs. The control unit may be connected to the positioning unit 11 by a rigid mechanical element 53 as shown in Figure 2B. Electrical or wireless connectivity between the positioning unit 11 and the positioning unit 11 contributes to increased compatibility with commercially available positioning units 11. By motorizing the movement of the elongated surgical device in this way, accuracy, safety, and procedure efficiency are improved.

[0100] Figure 3A shows a representation of a graphical user interface 12 configured to provide movable control elements on a display 122 for adjusting a curved geometric shape 141 based on user-generated input. The graphical user interface may be displayed on a wireless transmission unit 51 (see Figures 2A and 2B), or on an electronic device such as a smartphone or tablet. Alternatively, the graphical user interface 12 may be directly electronically connected to the control unit.

[0101] The graphical user interface has a slider 121 that is movable bidirectionally by the user to make small, even adjustments to the deflection of the bendable section 4 in real time (see Figures 3C and 3D). Different user-generated inputs specifying the curved geometric shape of the bendable section, based on the spatial position 123 of the slider 121, are sent to the input interface of the powered and maneuverable system. The graphical user interface 12 has a numerical indicator 124 that is functionally coupled to the movable slider 121 and displays an overall tip actuation / deflection ratio indicating the curved geometric shape. The display 122 may be configured to receive touch-sensor input commands from the user and / or may have control buttons 126, 127 that can be adapted to selectively fine-tune or coarse-tune the spatial position 123 of the slider 121, as shown in Figure 3A. This allows for not only rapid adjustment to the desired curved geometric shape but also intuitive, efficient, and precise adjustment of the deflection. In addition, the graphical user interface 12 has a second numerical indicator 128 that displays the battery status.

[0102] The graphical user interface 12 includes routine / macro buttons 125 that can be adapted to deflect a bendable section of an elongated surgical device to a specific, pre-stored curved geometric shape. In addition to or instead of this, the routine / macro buttons may be adapted to operate to send inputs to a control unit to deflect the bendable section to at least two different curved geometric shapes at time intervals. In this case, the control unit is adapted to send at least first and second control commands to the actuation unit to deflect the bendable section sequentially in time to two different curved geometric shapes. This simplifies the operation of the powered and maneuverable system by enabling the implementation of routine / macro functions that perform a series of predetermined commands / curved geometric shapes with a single input.

[0103] Figure 3B schematically shows a remote control unit 18 of the system, which is operable in a similar manner to the graphical user interface 12 of Figure 3A. The remote control unit 18 comprises a movable control element 181 formed by a slider, having a spatial position 183, and the user can receive haptic feedback by adjusting the spatial position 183 by manually, and especially mechanically, moving the movable control element 181. Alternatively or in addition to this, the control element 181 has control buttons 187 which can be used to adjust the spatial position 183 of the control element 181.

[0104] Figures 3C to 3E show elongated surgical devices 102 having a linear geometric shape, a first curved geometric shape 41, and a second curved geometric shape 43, respectively. The elongated surgical device 102 has a one-piece outer tubular body 7 formed of nitinol hypotubing, which has a distal end portion 71 with a bendable section 4. The bendable section 4 has a stress relief section 13 positioned laterally along the bendable section 4, and the stress relief section 13 has a plurality of notches, which are preferably laser-cut into the hypotubing. On the opposite side of the bendable section 4, a reinforcing section 14 of the outer tubular body 7 is formed continuously without notches and optionally has further reinforcing structures such as an increase in the material thickness of the hypotubing. Figure 3B shows that when tension is applied to the elongated actuating element 2 by an actuating unit (not shown in Figures 3A and 3B), the stress relief section 13 and reinforcing section 14 can deflect the bendable section 4 into a curved geometric shape 41. In Figures 3A and 3B, the bendable section can be deflected uniformly along the bendable section in a uniform manner, thereby achieving maximum angular deflection without compromising its structural integrity and durability by reducing local strain.

[0105] The bendable section is further provided with a deflection sensor 9 for determining the shape of the bendable section. In certain embodiments, the deflection sensor is formed as a fiber Bragg grating in a manner well known to those skilled in the art. The deflection sensor 9 is connected to a control unit of the system and enables measurement of parameters indicating first and / or second geometric shapes 41, 43. The control unit is adapted to determine the first and / or second geometric bend shapes 41, 43, compare them to a desired geometric bend shape, and determine the deviation from the desired geometric bend shape. The control unit is further adapted to adjust the geometric bend shape via operation of an actuator unit until the geometric bend shape 41, 43 approaches the desired geometric bend shape.

[0106] Figure 4 shows a cross-sectional view of a powered, maneuverable system 101 having a detachment unit 19 in the form of a pair of roller bearings 191, 192, and an elongated surgical device 102 having an outer tubular body 7 and an elongated actuation element 2. An actuation unit 3 is operably connected to a control unit 5, both of which are located within a common housing 6. The detachment unit 19 can detach the rotational movement of the elongated actuation element 2 from the actuation unit 3, to which the elongated actuation element 2 is attached, via a first ball bearing 191. The detachment unit 19 is further adapted to detach the rotational movement of the outer tubular body 7 of the elongated surgical device 102 from the common housing 6 of the powered, maneuverable system 101 via a second ball bearing 192 of the detachment unit 19.

[0107] Figure 4 shows that the disconnection unit 19 has a synchronous linkage 193 connected to both ball bearings 191 and 192, which couples the rotational movement of the elongated actuating element 2 and the outer tubular body 7. This allows the elongated actuating element 2 and the outer tubular body 7 to rotate simultaneously while reducing the frictional effect between them, enabling uniform alignment with respect to each other.

[0108] Figure 5 shows a schematic diagram of various components of system 101 according to the present invention. In particular, Figure 5 shows that an actuation unit, a processing unit for operating the actuation unit in communication with force and / or position sensors, an input interface, and an energy storage device are arranged within a common housing. The elongated actuation element is operable via the actuation unit for bending the bendable section of the elongated surgical device in the manner described above. The energy storage device powers the actuation unit, processing unit, and input interface so that the housing is portable and does not require an external power source.

[0109] In the embodiments described above in Figures 2A and 2B, a driven unit is connected to the housing of system 101 to facilitate the operation of the elongated surgical device.

[0110] The input interface of system 101 is a wirelessly or electrically connected transmitting unit. The transmitting unit may be powered by an energy storage device as shown in Figure 5, or it may be connected to an additional energy storage device. The transmitting unit in Figure 5 has a graphical user interface as described above in Figure 3A, so that it can transmit user-generated inputs to a processing unit and execute them via an actuation unit. As indicated by the dashed arrows, the transmitting unit may be located inside a housing and electrically connected to the energy storage and the input interface, or it may be located outside the housing and wirelessly connected to the input interface.

[0111] Figures 6A–6E illustrate different embodiments of the elongated surgical device 102 having different bendable sections 4. The distal end of the outer tubular body 7 can have different tubular designs that, when subjected to mechanical compression, spatially reconfigure from its original linear shape to various shapes. These different shapes allow the elongated surgical device 102 formed by the guidewire to help clinicians access complex anatomical structures that are typically nearly inaccessible with conventional, actively non-maneuverable guidewires. Other configurations bring new and untapped functions for the guidewire, such as gently anchoring the guidewire to specific locations within small arteries. For example, as illustrated in Figures 6A–6E, the elongated surgical device 102 of the present invention, based on the rational design of its distal end, allows for the acquisition of some of the most common tip configurations used in interventional neuroradiology, such as the so-called angle shape, J-shape, Simon shape, cobra shape, or anchor shape (Figures 6A–6E, respectively).

[0112] Commercially available devices are supplied with their tips pre-formed into these common configurations when removed from the package, to assist surgeons in treating particularly difficult cases. Alternatively, devices are supplied in a straight form, allowing surgeons to manually reshape the tip. Advantageously, the maneuverable guidewire of the present invention can actively change its geometric configuration as needed when activated.

[0113] In one embodiment, an elongated surgical device 102 can be designed such that its distal end, particularly its bendable section 4, acquires an "anchor shape" (Figure 6E) when activated. The anchor shape allows the flexible distal end of the elongated surgical device 102 to wrap around the inner wall of the artery in a three-dimensional spiral shape. To this end, an elongated reinforcing structure 14 is spirally positioned on the distal end, and therefore on the stress-relieving section 13, and wraps around (and defines) the spatially bendable section 4. Due to the flexibility of the bendable section 4, this rounded shape can accommodate almost any arterial tortuosity and curve. The primary use of this "anchor" is to fix the tip of a guidewire in a specific position, creating a so-called "fixation point," thereby facilitating the insertion of a catheter device onto an established guidewire and providing the surgeon with the ability to avoid undesirable movement (slipping) of the guidewire.

[0114] Figures 7A and 7B show schematic diagrams of two different embodiments of the operating unit 3 of system 101.

[0115] Figure 7A shows a schematic diagram of a rotary actuation unit 3 formed by a rotary motor and pulley. This rotary motor is connected to an elongated actuation element 2 to deflect the bendable section of the elongated surgical device 102 in the manner described above. The outer tubular body 7 of the elongated surgical device 102 is connected to the housing of the system 101. This allows the elongated actuation element 2 to be safely and non-twisted as it is wound onto / unwound from the pulley via the rotary motor, and further enables a particularly compact design of the maneuverable system.

[0116] Figure 7B shows a schematic diagram of the actuation unit formed by the linear motor. This linear motor enables a simple design with no backlash and a spatial position of the elongated actuation element 2 relative to the outer tubular body 7 / housing 6. The spatial position of the elongated actuation element 2 can be reliably determined by a position sensor, such as a Hall sensor (see Figures 10A and 10B).

[0117] Figures 8A to 8D show different embodiments of the driven unit 8 of system 101. The driven unit 8 is formed by a low-friction cylindrical sleeve having an inner conduit with lateral and distal openings, so that the housing 6 of system 101 is movable in the rotational direction R and longitudinal direction L within the conduit of the driven unit 8. The inner surface of the driven unit 8 may be formed or coated with a low coefficient of friction material such as polytetrafluoroethylene, polyoxymethylene, polyamide, or high molecular weight polyethylene. This allows the driven unit 8 to provide low and constant frictional resistance, facilitating the rotational direction R and longitudinal direction L movement of the elongated surgical instrument 102 relative to the driven unit 8.

[0118] The driven unit 8 in Figure 8B has a biasing member 83, particularly a spring, that connects the common housing 6 of the system 101 to the proximal end of the driven unit 8. The biasing member 83 may be adapted to provide predetermined frictional resistance and tactile feedback, enabling precise fine-tuning of the rotational and translational positions of the common housing 6 relative to the driven unit 8. In addition to or instead of this, the biasing member 83 may be adapted to bias the common housing 6 to a predetermined spatial position, so as to facilitate the operation of the elongated surgical instrument 102, particularly manual operation.

[0119] The driven unit 8 in Figure 8C has a driven drive unit 85 equipped with a translation actuator, which is adapted to move the common housing 6 relative to the driven unit 8, for example, by engaging a nut with a screw shaft connected to the housing 6 to cause a linear displacement of the common housing 6.

[0120] The driven drive unit 85 is decoupled from the rotational movement of the common housing 6 in the rotational direction R, for example, via a pivot coupling mechanism, so that the elongated surgical device 102 can still be manually rotated relative to the driven drive unit 85.

[0121] The driven unit 8 has a force / position sensor 82 adapted to detect force or position data indicating translational movement of the elongated surgical device 102 and the housing 6. The force / position sensor 82 is connected to a control unit (not shown in Figure 8C). The control unit is connected to a driven drive unit 85 of the driven unit 8 and is configured to process the force / position data in real time. The control unit is configured to operate the driven drive unit 85 based on the force / position data so that the housing 6 and the elongated surgical device 102 can be moved synchronously in the direction of the detected manual movement of the elongated surgical device 102. This facilitates manual movement of the elongated surgical device 102 by the user by supporting the translational movement of the elongated surgical device 102.

[0122] The control unit may further include a dynamic actuation adjustment mechanism adapted to interpret the user's actuation level and adjust the actuation of the driven drive unit 85 based on the user's actuation level. This may allow for slow and precise fine adjustment of the translational position of the elongated surgical device 102 and housing 6 when the user's actuation is weak, and rapid coarse adjustment when the measured actuation value is high.

[0123] The driven drive unit 85 may have an encoder for recording the elongated surgical device 102 and the common housing 6. The encoder and control unit may further be configured to provide the user with the precise rotation and / or translational spatial position of the housing 6, for example, by wireless communication to a wireless transmission unit (see Figures 2A and 2B).

[0124] In alternative embodiments (not shown in Figures 8A to 8D), the driven drive unit 85 may further be adapted to rotate the elongated surgical device 102 and the common housing 6 together with respect to the driven unit 8, as well as to perform translational movement.

[0125] Figure 8D shows a low-friction element 84 that is circumferentially arranged around the housing 6, enabling more precise and low-friction movement of the driven unit 8 within the cylindrical sleeve in the translational direction L and the rotational direction R.

[0126] Figures 9A and 9B show schematic diagrams of first and second embodiments of a powered, maneuverable system 101, having a housing 6 coupled to a driven unit 8 formed by a suspension unit 63 connected to a solid support 104 of system 101. The suspension unit 63 of the driven unit 8 is connected to the housing 6 and the solid support 104, respectively, at connection points, and is adjustable in length to allow translational movement of the housing, having the same effect as the driven unit described above (see Figures 8A to 8D). This allows for more controlled movement of the housing 6 by reducing / compensating for the frictional resistance / inertia of the housing 6, while simultaneously preventing unintended and unexpected movement of the housing 6 by the coupling of the suspension unit 63 to the solid support 104.

[0127] The housing 6 in Figures 9A and 9B is rotatably connected to the suspension unit 63 and solid support 104 of the driven unit 8, for example, at the connection point to the housing, via a pivot coupling mechanism 61, so that the housing 6 and the elongated surgical device 102 can rotate simultaneously in the rotational direction R, and in particular, can be rotated manually. In addition, the housing 6 and the elongated surgical device 102 are translationally movable in the longitudinal direction L by extending and retracting the suspension unit 63 of the driven unit 8. The suspension unit 63 in Figure 9A may be formed by a spring-loaded pulley so that it can be manually adjusted by a clinician and passively maintain its adjusted spatial position and orientation.

[0128] Figure 9B shows that the driven unit 8 of system 101 may have an off-axis rotation coupling 62 adapted so that the longitudinal axis of the housing 6 and the elongated surgical device 101 can rotate laterally relative to the solid support 104. This can be achieved by the suspension unit 63 of the driven unit 8 being rotatable around the connection point to the solid support 104 to adjust the off-axis rotation angle of the housing 6. This allows the clinician to adjust the position of the housing 6 and the elongated surgical device 101 with additional rotational degrees of freedom, facilitating the alignment and manipulation of system 101 according to clinical needs.

[0129] The driven unit 8 in Figures 9A and 9B may include at least one actuator, in particular an electric pulley, which may be configured to operate longitudinal translational movement, rotational movement of the elongated surgical device 102, in particular the housing 6, and / or off-axis rotation of the housing 6 / elongated surgical device 102.

[0130] Figures 10A and 10B show schematic diagrams of two embodiments of a powered, maneuverable system 101 having two different deflection sensors 9 for measuring the displacement of an elongated actuation element 2 formed by, for example, a bidirectional actuation rod of an elongated surgical device 102. The system 101 in Figures 10A and 10B comprises a control unit 5, an actuation unit 3, and deflection sensors 9, all located within a common housing 6.

[0131] The elongated surgical instrument 102 has an outer tubular body 7, which may be coupled to the elongated actuating element 2 via the aforementioned synchronous linkage 193 (see Figure 4), indicated by a dashed line, so that the outer tubular body 7 and the elongated actuating element 2 can move simultaneously in the rotational direction R. The rotational movement of the outer tubular body 7 and the elongated actuating element 2 is separated from the housing 6 and the actuating unit 3 by a separation unit 19, for example, having two annular ball bearings 191, 192.

[0132] The control unit 5 is adapted to operate the actuation unit 3 and receive deflection data from the deflection sensor 9 indicating the position of the proximal end of the elongated actuation element 2 along the longitudinal direction L. Based on the detected deflection data, the control unit is configured to determine the geometric shape of the bendable section of the elongated surgical instrument 102.

[0133] The deflection sensor 9 in Figure 10A is formed by a resistive deflection sensor located at the distal end of the shaft of the actuation unit 3, enabling a simple design.

[0134] The deflection sensor 9 in Figure 10B is formed by a Hall sensor that measures deflection data as the displacement of a magnetic field generator 91 connected to the shaft of the operating unit 3.

[0135] Figure 11 shows a remote control unit 18 according to the present invention attached to the catheter valve 201 of the catheter 20. The system 101 may comprise the catheter 20 and, preferably, a remote control unit 18 that can be attached to the catheter 20. By attaching the remote control unit 18 to the catheter 20, the clinician can make the remote control unit 18 readily available and visible when performing surgical interventions.

[0136] The remote control unit 18 is designed as described above in Figure 3B and is operable by a control button 187 for adjusting the spatial position 183 of the control element 181. The remote control unit 18 is further adapted to wirelessly transmit user input, such as the operation of the control button 187, to the system's control unit (not shown in Figure 11) so that the elongated surgical device 102 can be deflected to a desired geometric shape. Figure 11 shows that the elongated surgical device 102 is insertable through the system's catheter 20, which may be designed in particular to receive the elongated surgical device 102 into its inner lumen and facilitate seamless interaction.

Claims

1. A powered, maneuverable system (101) for navigating an elongated surgical device (102), which has an outer tubular body (7) and an elongated operating element (2) nested inside the outer tubular body (7), through a patient's internal lumen, particularly within the cerebrovascular system, wherein the maneuverable system (101) is (a) An actuation unit (3) configured to be coupled to the elongated actuation element (2) in order to actuate the elongated actuation element (2), in particular to apply tension and / or compression to the elongated actuation element, (b) An input interface configured to receive an input specifying the deformed geometric shape (41) of the bendable section (4) at the distal end portion (71) of the outer tubular body (7), in particular a user-generated input (52), (c) A control unit (5) operably coupled to the input interface and configured to generate control commands based on the input, (d) an output interface operably coupled to the control unit (5) and configured to transmit the control commands to the actuation unit (3), The actuation unit (3) is a powered, operable system (101) adapted to deform the bendable section (4) to the deformed geometric shape, particularly a curved geometric shape (41), based on the control command.

2. The actuation unit (3) is configured to generate movement of the elongated actuation element (2) in both proximal and distal linear movements. The aforementioned operating unit (3) is (i) Linear actuation unit (3), or (ii) A powered operable system (101) according to claim 1, comprising a rotary actuation unit (3) having a conversion mechanism operably connected to or connectable to the elongated actuation element (2), wherein the conversion mechanism is adapted to convert the rotational force of the rotary actuation unit (3) into linear motion of the elongated actuation element (2).

3. The powered controllable system (101) according to any one of the preceding claims, wherein the control unit (5) and the actuation unit (3) are positioned within a common housing (6) of the powered controllable system (101).

4. The aforementioned common housing (6) is A vertical dimension within the range of 0.1 cm to 25 cm, particularly within the range of 3 cm to 20 cm, preferably within the range of 5 cm to 10 cm, A powered, maneuverable system (101) according to claim 3, having a lateral dimension in the range of 0.036 cm to 10 cm, particularly in the range of 0.5 cm to 5 cm, preferably in the range of 0.8 cm to 1.75 cm.

5. The powered operable system (101) has a positioning unit (11) that is controllably coupled to the control unit (5), and the positioning unit (11) is (a) Rotating the elongated surgical device (102) in particular together with the actuation unit (3) around the central trajectory of the elongated surgical device (102), and / or (b) A powered, maneuverable system (101) according to any one of the preceding claims, configured to translate the elongated surgical device (102), particularly together with the actuation unit (3), in a distal or proximal direction (L) based on a movement input, preferably a user-generated movement input.

6. The powered operable system (101) has a driven unit (8), and the driven unit (8) is particularly, (a) Having at least one bearing member (81), the bearing member (81) is configured to support the actuation unit (3) as the elongated surgical device (102) is moved, while moving the actuation unit (3) in the distal direction, the proximal direction, and / or in the rotational direction around the central trajectory of the actuation unit (3), or (b) A sensor (82), in particular a force or position sensor, wherein the sensor (82) is configured to generate force or position data by detecting rotational or translational movement of the elongated surgical device (102), and further, A powered maneuverable system (101) according to any one of the preceding claims, having a driven drive unit (85), the driven drive unit (85) being adapted to move the actuation unit (3), in particular the control unit (5), along the translational and / or rotational directions in real time in synchronization with the elongated surgical device (102) based on the force or position data.

7. The powered maneuverable system (101) according to any one of the preceding claims, wherein the control unit (5) is configured to apply vibration to the elongated surgical device (102), particularly the elongated actuating element (2) and / or the outer tubular body (1), via the actuating unit (3) or the positioning unit (11) at a frequency of 1 Hz to 1000 Hz, preferably 20 Hz to 500 Hz, when deflecting the bendable section (4), and the actuating unit (3), or particularly the positioning unit (11), is preferably adapted to apply the vibration by repeatedly and alternately moving the elongated surgical device (102) in the proximal and distal directions of the elongated surgical device (102).

8. The aforementioned input interface, in particular the User input interface, (a) electrically connected to the control unit (5) to directly receive the input, or (b) configured to receive the input via wireless transmission, The operable system (101) preferably comprises a wireless input transmission unit (51) that can be coupled to the input interface and is configured to wirelessly transmit the input to the input interface, according to any one of the preceding claims.

9. The powered operable system (101) has at least one deflection sensor (9) configured to generate deflection data by detecting the position of the elongated actuation element (2) and / or the geometric shape of the bendable section (4), The control unit (5) is (a) Receiving the deflection data from the deflection sensor (9), (b) Based on the deflection data, determine whether the desired geometric shape is achieved, (c) A powered maneuverable system (101) according to any one of the preceding claims, configured to control the actuation unit (3) in a closed feedback loop based on the detected deflection data to achieve the desired geometric shape of the bendable section (4) in real time.

10. The powered maneuverable system (101) according to claim 9, wherein the at least one deflection sensor (9) is selected from at least one of magnetic deflection sensors, optical deflection sensors, capacitive deflection sensors, or resistive deflection sensors, and the at least one deflection sensor (9) is preferably located within the actuation unit (3) or within the bendable section (4).

11. The powered controllable system (101) according to any one of the preceding claims, further comprising an energy storage device (10) located in particular within the common housing (6) for operating the controllable system (101).

12. The system includes a graphical user interface (12), and the graphical user interface (12) is (a) Visual information, in particular information showing the curved geometric shape (41) of the bendable section (4) of the elongated surgical device (102), and / or information showing the state of the system, is displayed on the display (122). (b) A movable control element having a spatial position (123), preferably a slider (121), is provided on the display (122), and the user can adjust the degree of the curved geometric shape by adjusting the spatial position (123), in particular by adjusting it bidirectionally, in particular by continuously adjusting a uniform lateral bending angle across the entire bendable section (4), and / or (c) A numerical and / or graphical indicator (124) functionally coupled to the movable control element, which displays the degree of the curved geometric shape in real time, and / or (d) The powered maneuverable system (101) according to any one of the preceding claims, configured to transmit, in particular wirelessly, an input based on the spatial position (123) of the movable control element that specifies the curved geometric shape to the input interface of the control unit (5) in real time.

13. A computer-implemented method for navigating an elongated surgical device (102), which has an outer tubular body (7) and an elongated operating element (2) nested inside the outer tubular body (7), through a lumen in the patient's body, wherein the method is: (a) The step of receiving, via an input interface, an input specifying a desired geometric shape (41) of the bendable section (4) at the distal end portion (71) of the outer tubular body (7), in particular a user-generated input (52), (b) A step of calculating a control command based on the input via the control unit (5), (c) The step of transmitting the control command to the actuation unit (3) via the output interface, (d) A step of deflecting the bendable section (4) to the desired geometric shape (41) based on the control command, (e) optionally, applying vibration to the elongated surgical device (102), particularly to the elongated actuation element (2) and / or the outer tubular body (1), via the actuation unit (3) or positioning unit (11) at a frequency of 1 Hz to 1000 Hz, preferably at a frequency of 20 Hz to 500 Hz; (f) A method comprising optionally detecting force and / or position data and moving the actuation unit (3), in particular the control unit (5), along the translational and / or rotational directions in real time and in synchronization with the elongated surgical device (102) based on the force and / or position data.

14. A computer program product comprising instructions causing a powered, operable system (101) according to any one of claims 1 to 12 to perform the steps of the method according to claim 13.

15. The powered, controllable system (101) according to any one of claims 1 to 12, comprising the elongated surgical device (102) having the outer tubular body (7) and the tension and / or compression-responsive elongated actuation element (2) nested within the outer tubular body (7), wherein the distal end portion (71) of the outer tubular body (7) has the bendable section (4) which can be deformed into the curved geometric shape (41).

16. The powered maneuverable system (101) according to claim 15, wherein the elongated surgical device (102) has torsional rigidity such that a rotational force applied to the proximal end of the elongated surgical device (102) is transmitted to the distal end of the elongated surgical device (102) along the central trajectory of the elongated surgical device (102).

17. The powered maneuverable system (101) according to any one of claims 15 to 16, wherein the bendable section (4) is uniformly deflectable laterally along its longitudinal length, the curved geometric shape is defined by a uniform lateral bending angle across the entire bendable section (4), and the control unit (5) and the actuation unit (3) are configured to adjust the bending angle over the entire range of 0° to 540°, particularly over the entire range of 0° to 270°, preferably over the entire range of 0° to 180°.

18. A powered maneuverable system (101) according to any one of claims 15 to 17, wherein one side of the bendable section (4) of the elongated surgical device (102) has a stress-relieving section (13), and in particular comprises at least one, preferably a plurality of, circumferential and / or helical notches, so that when the tension and / or compressive force is applied to the elongated actuating element (2), the bendable section (4) is deflected laterally to the stress-relieving section (13).

19. A powered maneuverable system according to any one of claims 15 to 18, wherein one side of the bendable section (4) of the elongated surgical device (102), particularly the side opposite the stress-relieving section (13), has a reinforcing portion (14), preferably comprising a reinforcing structure, the reinforcing structure being integrally formed with the outer tubular body (7) and having longitudinal rigidity, so that applying the tension and / or compressive force to the elongated actuating element (2) does not essentially affect the length of the reinforcing portion (14) in the longitudinal direction.

20. The powered, maneuverable system (101) according to any one of claims 15 to 19, wherein the distal end (21) of the elongated actuation element (2) is connected to the distal tip (103) of the end of the elongated surgical device (102), which preferably has a rounded shape; the proximal end (22) of the elongated actuation element (2) is connected to the actuation unit (3) so as to be longitudinally movable; and the proximal end of the outer tubular body (7) is connected to the actuation unit (3) so as not to be longitudinally movable, and in particular to the housing of the actuation unit (3).

21. The elongated surgical device (102) is sized and molded for use in peripheral intervention, interventional cardiology, or neurovascular surgical procedures, and the outer tubular body (7) has a maximum cross-sectional dimension of less than 1 mm, particularly less than 0.6 mm, preferably less than 0.37 mm, according to any one of claims 15 to 20, the powered maneuverable system (101).

22. The powered, maneuverable system (101) according to any one of claims 15 to 21, wherein the elongated surgical device (102) preferably comprises a radiopaque element located at the distal end of the elongated surgical device (102).

23. The powered and maneuverable system (101) according to any one of claims 15 to 22, wherein the outer tubular body (7) is formed by an integral tubular element, and in particular contains or is made of stainless steel or nitinol, preferably formed by nitinol hypotube.

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