Power-steerable system, computer-implemented method and computer program product for guiding elongated surgical instrument through body lumen of patient

Abstract

The present invention relates to a powered steerable system (101) for guiding an elongate surgical instrument (102) having an outer tubular body (7) and an elongate drive element (2) nested within the outer tubular body (7) through a body lumen of a patient, in particular in the cerebrovascular system. The steerable system (101) comprises: a drive unit (3) configured to be coupled to the elongated drive element (2) for driving the elongated drive element (2); an input interface configured to receive an input, in particular a user-generated input (52), to specify a bending geometry (41) of the bendable area (4) at the distal end portion (71) of the outer tubular body (7); a control unit (5) operatively coupled to the input interface and configured to calculate a control command based on the input; and an output interface operatively coupled to the control unit (5) configured to transmit the control command to the drive unit (3). The drive unit (3) is adapted to deflect the bendable region (4) into the curved geometry (41) on the basis of the control command.

Description

Technical Field

[0001] According to the independent claims, the present invention relates to a power-controlled system, a computer-implemented method, and a computer program product for guiding an elongated surgical instrument having an outer tubular body and an elongated drive element through a patient's body cavity. The elongated drive element may be, for example, a tension-responsive element, a compression-responsive element, or a combination of both.

[0002] This invention is particularly suitable for neurovascular applications requiring precise and accurate operation in complex neurovascular systems. Background Technology

[0003] Existing slender surgical instruments for body cavities, such as intravascular guidewires / catheters, typically rely on manual manipulation to reshape the distal tip of the slender instrument, or even require the development of additional / different surgical instruments, such as guidewires with specially pre-shaped distal tips.

[0004] Various existing systems for guiding slender surgical instruments in vascular systems rely on the skills of clinicians, particularly manual skills, or pose considerable health risks such as vascular injury when manipulating complex and tortuous vascular systems.

[0005] In particular, in neurovascular applications, the adage "time is brain" underscores the importance of rapid surgical intervention, which is crucial for minimizing the risk of irreversible brain damage. Providing guidance with more precise and efficient slender surgical instruments, reducing the time required for guidance, and simplifying the surgical intervention are essential for reducing overall surgical time.

[0006] In particular, existing technologies lack systems for guiding slender surgical instruments to achieve better surgical outcomes and reduce patient safety risks by allowing for enhanced dexterity and controllability of slender surgical instruments.

[0007] WO 2007 / 008967 A2 discloses a system for controlling the position of a slender medical device using a control handle, robotic device, and remote control mechanism, which allows the medical device to be positioned within a patient's body in a remotely controlled manner. However, the system and the slender medical device are complex and bulky, and do not allow for precise and reliable reshaping of the distal tip of the slender medical device within the neurovascular system.

[0008] WO 2017 / 033182 A1 discloses a dual concentric guidewire having a first guidewire, a second guidewire nested within the first guidewire, and an adjustment mechanism for moving the second guidewire relative to the first guidewire by operating a manual control handle. However, this system is manually operated, which limits the efficiency and controllability of the guidewire.

[0009] Currently, there is a general lack of simple and compact systems for guiding slender surgical instruments, systems that allow for rapid and precise deflection of the distal tip of slender surgical instruments in a reliable and efficient manner. Furthermore, existing technologies lack manipulable systems that do not deviate from routine clinical practice and / or require a steep learning curve. Summary of the Invention

[0010] The purpose of this invention is to overcome these and other disadvantages of the prior art.

[0011] This invention provides a power-controlled system for guiding an elongated surgical instrument having an outer tubular body and an elongated drive element nested within the outer tubular body through a patient cavity, particularly in the cerebrovascular system. The controllable system includes a drive unit configured to couple to the elongated drive element for driving the elongated drive element, particularly for applying tension and / or compressive forces to the elongated drive element. The controllable system includes an input interface configured to receive input, particularly user-generated input, to specify the deformation geometry, particularly the bending geometry, of a bendable region at the distal portion of the outer tubular body.

[0012] The deformable geometry is not necessarily a single bend, but can also contain multiple bends or other shapes, such as 3D shapes. In addition to user-generated input, it is also conceivable to provide input determined by an automated system, such as imaging data based on partially fully automated analysis.

[0013] The controllable system also includes a control unit operatively coupled to the input interface and configured to generate control commands based on the input. The controllable system includes an output interface operatively coupled to the control unit configured to transmit the control commands to the drive unit. The drive unit is adapted to deflect the bendable region to the deformable geometry, particularly the bending geometry, based on the control commands.

[0014] The elongated surgical instrument may include or consist of a guidewire or catheter, preferably a guidewire having an outer diameter between 0.035 inches / 0.89 mm and 0.010 inches / 0.25 mm, particularly guidewires and catheters. Alternatively, the elongated surgical instrument may include or consist of interventional instruments, implantable instruments, or diagnostic instruments. Tension and / or compressive force responsive actuation elements may include or consist of drawstrings, chordae tendineae, or push rods.

[0015] The flexible region of the responsive elongated actuating element and the elongated surgical instrument can be configured such that compressive force is applied to the flexible region by retracting / pulling the responsive actuating element, so that the flexible region can be deformed into a first bending geometry.

[0016] Alternatively or alternatively, a responsive elongated actuating element and a bendable region can be configured such that the bendable region is extended by extending or pushing the responsive actuating element in the distal direction, such that the bendable region can be deformed to a second bending geometry, particularly a geometry opposite to the first bending geometry.

[0017] In a preferred embodiment, the drive unit of the power-controlled system is electrically driven. Alternatively, the drive unit may be driven by hydraulic, pneumatic, magnetic, ultrasonic, or chemical means.

[0018] If the drive unit is configured to be coupled only to a slender surgical instrument, rather than being fixedly connected to it, this allows the drive unit to be reused, thereby creating a cost-effective solution by reducing long-term production costs.

[0019] The control unit can be configured to calculate at least a first control command and a second control command based on an input, for deflecting the bendable region to two different bending geometries. The control unit can also be configured to transmit the first and second control commands to the drive unit via an output interface in a time-staggered manner (particularly at predetermined time intervals). Alternatively, certain geometries and associated commands can be stored in the system's internal memory or in system-accessible memory. In this case, the user can easily select between several predefined structures, such as, for example, unbent, partially bendable, or fully bendable.

[0020] This enables the establishment of deflection routines for the flexible region, allowing the drive unit to be configured to sequentially deflect the flexible region into multiple (e.g., two) different bending geometries based on first and second control commands. This facilitates the manipulation of slender surgical instruments and enables more complex deflection routines without requiring additional input commands from the clinician. Furthermore, this enhances the functionality and versatility of the controllable system by simplifying surgical procedures and reducing the clinician's cognitive and manual requirements.

[0021] The drive unit can be configured to enable bidirectional movement of the elongated drive element, thereby facilitating linear movement of the proximal and distal guides of the elongated drive element. The drive unit can be a linear drive unit or a rotary drive unit including a conversion mechanism operatively connected to or connectable to the elongated drive element. The conversion mechanism is adapted to convert the rotational motion of the rotary drive unit into linear motion of the elongated drive element.

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

[0023] The conversion mechanism of the rotary drive unit may include spools or rollers for winding and unwinding elongated drive elements, thereby ensuring a more compact structure while avoiding peak loads on the elongated drive elements.

[0024] The control unit and drive unit can be located within a common housing of the power-controlled system.

[0025] This allows for simplified wiring and protection for the control and drive units, while providing a space-efficient system for guiding slender surgical instruments.

[0026] The common housing can have a longitudinal dimension ranging from 0.1 cm to 25 cm, particularly from 3 cm to 30 cm, and preferably from 5 cm to 10 cm; and a lateral dimension ranging from 0.036 cm to 10 cm, particularly from 0.5 cm to 5 cm, and preferably from 0.7 cm to 1.75 cm. The common housing with the control unit and drive unit can have a weight ranging from 1 gram to 100 grams, particularly between 5 grams and 50 grams, and preferably between 10 grams and 30 grams.

[0027] These longitudinal and lateral dimensions and / or lightweight design allow for cost savings in manufacturing and enable a compact design. Therefore, the size of this operable system provides improved system space utilization without hindering clinicians, making it a valuable product within the limited space of the operating room / operating table. Furthermore, this design makes the instruments more portable and simplifies clinician use.

[0028] This power-controlled system can be configured to allow slender surgical instruments (particularly when used with a drive unit) to be manually rotated and / or translated by a clinician. This simplifies the operation and design of the controllable system.

[0029] The power-operable system may have a decoupling unit configured to receive an elongated surgical instrument, particularly its outer tubular body and an elongated drive element, thereby decoupling the rotational and / or translational motion of the elongated surgical instrument from the drive unit. This allows the elongated surgical instrument to be rotationally and / or translationally movable relative to the drive unit. For this purpose, ball bearings may be provided. A first bearing may be provided on the outer tubular body connected to the housing, while a second bearing may be provided on the inner elongated drive element or on a proximal mount of the inner elongated drive element connected to the drive unit. The first and second bearings may be coupled so that the outer tubular body and the elongated drive element can move synchronously, particularly synchronously relative to the housing / drive unit in the rotational and / or translational directions.

[0030] The power-controlled system may include a positioning unit controllably coupled to the control unit. The positioning unit is configured to: (a) rotate the elongated surgical instrument, particularly together with the drive unit, about the central trajectory of the elongated surgical instrument; and / or (b) translate the elongated surgical instrument, particularly together with the drive unit, in a distal or proximal direction based on motion input, preferably user-generated motion input.

[0031] This positioning unit enables precise orientation and spatial positioning of slender surgical instruments within the patient's vascular system, while facilitating guidance that does not rely on the manual skills of clinicians.

[0032] The system can also be adapted for integration into commercially available positioning units, such as robot-assisted systems that allow control of percutaneous vascular interventions, such as the CorPath GRX or Robocath R-One.

[0033] The power-controlled system may have a driven unit. This driven unit is designed to compensate for the weight and / or torque acting on the drive unit, and particularly to prevent translational disturbances of elements connected to the proximal side of the elongated surgical instrument. The driven unit may have at least one bearing member configured to support the drive unit as the elongated surgical instrument moves, while simultaneously allowing the drive unit to move in the distal, proximal, and / or rotational directions about the central track of the drive unit. Alternatively or additionally, the driven unit may include sensors, particularly force or position sensors, configured to generate force or position data by detecting rotational or translational actuation of the elongated surgical instrument; and a driven actuator adapted to cause the drive unit, and particularly the control unit, to move synchronously with the elongated surgical instrument in the translational and / or rotational directions based on real-time force or position data.

[0034] This enhances control while minimizing or reducing friction when moving slender surgical instruments manually or via a positioning unit. Furthermore, by effectively offsetting the weight of the instruments, the driven unit reduces the physical exertion required for clinicians to operate slender surgical instruments, allowing them to work fatigue-free during extended surgical procedures.

[0035] The driven unit may include a biasing member, particularly a spring, adapted to provide a predefined biasing force to the movement of the slender surgical instrument together with the housing. This allows for clearer tactile feedback when the slender surgical instrument is moved, enabling more precise positioning.

[0036] The at least one bearing member can be configured to support the entire common housing when moving a slender surgical instrument.

[0037] The at least one bearing component may include or consist of linear and / or rotary ball bearings, roller / spherical bearings, sliding bearings, or air bearings to reduce friction when the drive unit and slender surgical instruments are moved.

[0038] Force sensors and driven actuators enable adaptive force control, thereby dynamically supporting the movement of slender surgical instruments and drive units in real time, so as to achieve smoother and more precise rotational / translational movements of slender devices and drive units in a synchronized manner.

[0039] The driven driver can be connected to the drive unit, or even constitute the drive unit itself. Alternatively, the driven unit can be configured to be coupled to the drive unit such that the drive unit is movable relative to the driven unit.

[0040] Force sensors can be functionally connected to or can be connected to an outer tubular body or elongated drive element to detect rotational or translational actuation of the outer tubular body or elongated drive element, such as actuation manually applied by a clinician.

[0041] The control unit can be configured to apply vibrations, preferably between 20 Hz and 500 Hz, to the elongated surgical instrument, particularly the elongated drive element and / or the outer tubular body, via the drive unit or the positioning unit when the flexible region is deflected. The drive unit, particularly the positioning unit, is preferably adapted to apply the vibrations by repeatedly moving the elongated surgical instrument alternately in the proximal and distal directions of the elongated surgical instrument.

[0042] This enables the transmission of enhanced motion to the external tubular body and / or slender drive elements. When the flexible region is deflected based on control commands, the transmission of force along the slender surgical instrument may be impeded or delayed because the instrument may be subjected to various stresses and frictional effects caused by the tight bending of the instrument against the blood vessel. The viscous / resistance to the motion of the slender surgical instrument, based on factors such as adhesive or static friction effects, can be overcome by these vibrations, particularly rapid, repetitive reciprocating motions.

[0043] The input interface, particularly the user interface, can be electrically connected to the control unit to directly receive the input, or configured to receive the input from a remote controller via wireless transmission. 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 the input to the input interface.

[0044] By allowing clinicians to wirelessly manipulate the deflection of the flexible region, wireless transmission simplifies the operation of this powered and manipulable system, improving surgical efficiency. This is particularly advantageous because clinicians can simultaneously transmit input wirelessly to deflect the flexible region to a curved geometry while manipulating the steering system during surgery (e.g., by manually positioning / orienting slender instruments).

[0045] The power-controlled system may have at least one deflection sensor configured to generate deflection data by detecting the position of the elongated drive element and / or the geometry of the bendable region. In this context, deflection refers to any type of deformation, such as simple bending, or more complex structures. The deflection sensor may be positioned at or near the bendable region and directly determine the deflection. It may also be positioned away from the bendable region and indirectly determine the deflection, for example, by measuring the position of the elongated element or the force acting on the elongated element. The control unit is configured to: (a) receive the deflection data from the deflection sensor; (b) determine, based on the deflection data, whether a desired geometry has been achieved; and (c) control the drive unit based on the deflection data detected in a closed feedback loop to achieve the desired geometry of the bendable region in real time.

[0046] This allows for ensuring that slender drive elements are reliably positioned to achieve specific deflection in bendable regions.

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

[0048] The at least one deflection sensor may be selected from at least one of a self-magnetic deflection sensor, an optical deflection sensor, a capacitive deflection sensor, or a resistive deflection sensor. The at least one deflection sensor is preferably located in the drive unit or in the flexible region.

[0049] Magnetic deflection sensors can be constructed from position sensors based on the Hall effect. Optical deflection sensors can be constructed from position sensors based on time-of-flight or time-of-reflection. Resistive sensors can be constructed from sensors based on strain gauges or polymer thin films.

[0050] The deflection sensor may be arranged at least partially on the drive unit and / or elongated drive element to track linear or angular position relative to each other.

[0051] If the deflection sensor is arranged in an elongated actuating element to detect the geometry of a bendable region, the deflection sensor may include or consist of a strain gauge or an optical fiber with a Bragg grating.

[0052] Deflection sensor or imaging data allows for more precise determination of the geometry of the bendable region, and thus enables the bendable region to be more precisely deflected to the bending geometry by adjusting the control of the drive unit via the control unit in the closed feedback loop.

[0053] Sensors such as position and / or force sensors can also be provided to the system to determine the position of the drive element or drive unit, or the force acting on the drive element or drive unit. This allows control of the drive unit's operation without determining the deflection angle.

[0054] The power-controlled system may include an energy storage device, particularly arranged within the common housing, for operating the controllable system.

[0055] This improves the portability of the controllable system and increases the freedom of deployment of the controllable system in the operating room / on the operating table.

[0056] The controllable system may include a graphical user interface (GUI) configured to present visual information on a display. This information may indicate the bending geometry of the flexible region of the elongated surgical instrument, or it may generally indicate the system's status, such as whether the system is "operating," "off," or "battery depleted." Alternatively, the GUI may be configured to provide movable controls, preferably sliders, on the display. These controls have a spatial position adjustable by the user, particularly bidirectionally, to adjust the angle of the bending geometry, specifically to continuously adjust a uniform lateral bending angle over the entire flexible region.

[0057] The graphical user interface can be configured to provide a digital and / or graphical indicator that is functionally coupled to the movable control and displays the angle of the curved geometry in real time.

[0058] The graphical user interface can be configured to transmit input, particularly wirelessly, to the input interface of the control unit based on the spatial location of the movable control, in order to specify the bending geometry in real time.

[0059] The controllable system can be adapted to use the wireless input transmission unit of the system as a display for the graphical user interface.

[0060] This graphical user interface enables simple, reliable, and convenient control of the operable system, visual feedback on the curved geometry, and easy reshaping / deflection of the bendable area via single-handed movement of the controls.

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

[0062] In addition, physical methods (such as physical sliders, rotary knobs, or joysticks) can be provided to control the system. Depending on the specific application, this method may be superior to graphical input because it provides the user with direct tactile feedback. The user then does not need to constantly focus on the display. However, other feedback methods can be used to enhance the graphical input interface, such as vibration on the control device.

[0063] Another aspect of the invention relates to a computer-implemented method for guiding an elongated surgical instrument having an outer tubular body and an elongated actuating element nested within the outer tubular body through a patient's body cavity. The method includes: (a) receiving input, particularly user-generated input, via an input interface to specify a desired geometry, and particularly a bending geometry, of a flexible region at a distal portion of the outer tubular body; (b) calculating control commands via a control unit based on the input; (c) transmitting the control commands to the actuating unit via an output interface; and (d) deflecting the flexible region to the desired geometry based on the control commands.

[0064] The method may optionally include applying a vibration with a frequency between 1 Hz and 1000 Hz, preferably between 20 Hz and 500 Hz, to the elongated surgical instrument, particularly to the elongated drive element and / or the outer tubular body, via the drive unit or the positioning unit.

[0065] The method may optionally include: detecting position and / or force data, and based on real-time force and / or position data, causing the drive unit, and in particular the control unit, to move synchronously with the elongated surgical instrument in a translational and / or rotational direction. This allows for compensation for the weight or torsion of the drive unit.

[0066] Another aspect of the present invention relates to a computer program product comprising instructions for causing the aforementioned power-controlled system to perform the steps of the aforementioned computer implementation method.

[0067] The power-controlled system may include an elongated actuating element that is responsive to tension and / or compression within an outer tubular body. The distal portion of the outer tubular body has a bendable region that can deform to a desired geometry.

[0068] The flexible region can be configured to have a basically straight geometry when no external force (especially tension) is applied to it.

[0069] The system includes elongated surgical instruments, for example, capable of pre-connecting elongated actuating elements and actuating units, and optimizing the interaction between typically complex elongated actuating elements by improving reproducibility and reducing the risk of defects.

[0070] The elongated surgical instrument can be torsional rigid, such that rotational forces applied to the proximal end of the elongated surgical instrument are transmitted along the central track of the elongated surgical instrument to the distal end of the elongated surgical instrument.

[0071] This allows the flexible region with its curved geometry at the distal end to rotate reliably while maintaining the curved geometry, enabling the flexible region to be located and oriented within the patient's vascular system, particularly within the complex cerebrovascular system.

[0072] The bendable region can be uniformly laterally deflected along its longitudinal length, and the bending geometry can be defined by a uniform lateral bending angle over the entire bendable region. The control unit and the drive unit can be configured such that the bending angle is adjustable over the entire range from 0° to 540°, particularly over the entire range from 0° to 270°, and preferably over the entire range from 0° to 180°.

[0073] Uniformity of the bending angle optimizes the ratio of load to maximum bending in the flexible region within a slender surgical instrument. This uniform stress distribution ensures structural integrity is maintained even when navigating large bending angles that may be required when traversing tortuous blood vessels.

[0074] One side of the flexible region of the elongated surgical instrument may have a stress-relief area, particularly including at least one, preferably multiple, annular and / or helical incisions, such that when tension and / or compressive force is applied to the elongated drive element, the flexible region deflects in the transverse direction of the stress-relief area. This deflection may occur in two transverse directions within a single plane, preferably in exactly one transverse direction.

[0075] This stress-relieving section enables the flexible area to have reliable and continuous deflection capability without any plastic deformation.

[0076] One side of the flexible region of the elongated surgical instrument, particularly the side opposite the stress-relieving region, may have a reinforcing portion, preferably including a reinforcing structure. This reinforcing structure may be integrally formed by the outer tubular body and is longitudinally rigid, such that applying tension and / or compressive force to the elongated drive element will substantially not affect the length of the reinforcing portion in the longitudinal direction.

[0077] This improves the structural integrity of slender surgical instruments and enables reliable deflection of the flexible areas.

[0078] The flexible region may include multiple stress-relief areas and / or reinforcing portions arranged in different longitudinal sub-regions of the flexible region. This allows the flexible region to deform into more complex bending geometries.

[0079] The distal end of the elongated actuating element can be connected to the distal tip of the elongated surgical instrument (preferably, the distal tip has a rounded shape), and the proximal end of the elongated actuating element is longitudinally movably connected to the actuating unit, while the proximal end of the outer tubular body is longitudinally immovably connected relative to the actuating unit, particularly to the housing of the actuating unit. This connection can be made in a manner that allows for corresponding rotation.

[0080] This allows for the secure connection of slender surgical instruments and actuators, providing an integrated solution that ensures immediate use without the need for complex assembly of the controllable system.

[0081] The size and shape of this slender surgical instrument can be configured for use in peripheral interventional, interventional cardiology, or neurovascular surgery. The outer tubular body can have a maximum cross-sectional dimension of less than 1 mm, particularly less than 0.6 mm, and preferably less than 0.37 mm. The slender surgical instrument can have a length between 0.5 m and 4 m, particularly between 1 m and 3.5 m, and preferably between 2 m and 3.15 m.

[0082] This small size allows for manipulation in complex and tortuous vascular systems, such as those in the brain. Simultaneously, the cross-sectional dimensions of the outer tubular body enable a smaller bending radius. Furthermore, this slender surgical instrument can also be used to deflect microcatheters, for example, by deflecting the flexible region to a curved geometry, thereby extending the microcatheter posteriorly.

[0083] The elongated surgical instrument may include a non-transparent element, preferably located at the distal end of the elongated surgical instrument.

[0084] This non-transparent element allows for real-time positioning of the distal tip of slender surgical instruments, particularly through fluoroscopy.

[0085] The opaque element can also extend along most or all of the bendable region, allowing the bending geometry to be verified via X-ray imaging. The opaque element can be configured to bend uniformly with the geometry of the bendable region, particularly through opaque elements with a coil shape, such as those made of platinum-iridium coils.

[0086] The outer tubular body may be composed of an integral tubular element, particularly stainless steel or nitinol, preferably nitinol hyaluronic acid tube, such as a laser-cut hyaluronic acid tube.

[0087] Nickinol offers enhanced torsional capacity and exhibits superelastic properties, which allow it to reliably and repeatedly recover its original shape after being deformed to a bending geometry. Attached Figure Description

[0088] The invention will now be described with reference to certain embodiments and accompanying drawings, which illustrate:

[0089] Figure 1 : A schematic plan view of a first embodiment of a power-controlled system that guides a slender surgical instrument by deflecting a flexible region to a bending geometry;

[0090] Figure 2A and 2B The second and third embodiments of the power-controllable system are shown, the system including a driven unit, and the translational and rotational movements are respectively performed by manual operation or a positioning unit;

[0091] Figure 3A : A representation of a graphical user interface configured to provide movable controls for adjusting curved geometry based on user-generated input;

[0092] Figure 3B : Representation of a remote controller, which is configured to provide movable controls for adjusting the bending geometry based on user-generated input;

[0093] Figures 3C to 3E : Slender surgical instruments having linear geometry, a first curved geometry, and a second curved geometry, respectively;

[0094] Figure 4 : A cross-sectional view of a power-controllable system with a decoupling unit;

[0095] Figure 5 : A schematic diagram of the various components of the system according to the present invention;

[0096] Figures 6A to 6E : Schematic diagrams of different embodiments of elongated surgical instruments with different reconfigurable tip shapes, including tip shapes that are reconfigurable in three dimensions;

[0097] Figure 7A and 7B Schematic diagrams of two different embodiments of the drive unit;

[0098] Figures 8A to 8D Schematic diagrams of four different embodiments of the system's driven unit;

[0099] Figures 9A to 9B: Schematic diagram of different embodiments of the driven unit, wherein the housing is suspended on a solid support;

[0100] Figure 10A and 10B Schematic diagrams of two different embodiments of a system with two different deflection sensors;

[0101] Figure 11 The present invention relates to a wireless input transmission unit installed on a conduit valve connected to a conduit. Detailed Implementation

[0102] Figure 1 A plan view of a power-operable system 101 for guiding a slender surgical instrument 102, consisting of a guidewire, for neurovascular, peripheral, or cardiac indications is shown.

[0103] The power controllable system 101 has a drive unit, a control unit, an input interface, and an output interface arranged in a common housing 6 at the proximal end of the controllable system 101.

[0104] The elongated surgical instrument 102 has an outer tubular body 7 and at least one (particularly only one) elongated, tension- and / or compression-responsive actuation element made of a draw wire. The outer tubular body 7 is made of a metal tube (such as platinum, aluminum, magnesium, gold, stainless steel, titanium) or a metal alloy (such as nitinol, cobalt-chromium alloy). The tube may also be composed of components of sub-regions of different tubes of different metals connected together by robust connectors. Alternatively, the tube may be a single, monolithic element, such as a torsionally rigid nitinol hypo tube. The nominal diameter of the outer tubular body 7 is 0.014 inches / 0.36 millimeters, and it has a length between 110 cm and 315 cm (particularly 250 cm). The distal portion 71 of the outer tubular body 7 has a bendable region 4, deflectable to a bending geometry 41 based on user-generated input. Figure 1 The bending geometry 41, schematically shown, has a uniform lateral bending angle over the entire bendable region 4. Figure 1 The flexible region 4 is configured to deflect at a uniform lateral bending angle along the lateral direction 42, but it can also be deflectable in three dimensions. This allows the flexible region 4 to deflect to a selected bending geometry 41 and to orient and advance / retract along the path of a branching or tortuous vessel.

[0105] The input interface is configured to wirelessly receive user-generated input indicating the desired bending geometry 41 via wireless transmission 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 drive unit. The drive unit then retracts the drawwire longitudinally or advances the drawwire based on the control commands, thereby deflecting the bendable region 4 to the desired bending geometry 41.

[0106] The control unit is also adapted to apply vibrations in the form of rapid reciprocating motion to the elongated drive element of the elongated surgical instrument 102 at a frequency of 10 Hz via the drive unit when the bendable region is deflected. This allows the bendable region to be deflected, whereas motion transmission affected by internal static friction could impair or delay the deflection of the bendable region 4 to the bending geometry 41.

[0107] Figure 2A and Figure 2B The illustrations show representations of a second and third embodiment of a power-operable system 101, which includes a driven unit 8 and can be manually operated (…). Figure 2A ) or via positioning unit 11 ( Figure 2B It performs translational and rotational movements. Figure 2A and 2B The power controllable system 101 includes Figure 1 The control unit includes all the aforementioned components and also has a wireless input transmission unit 51, which is coupled to an input interface for wirelessly transmitting an input 52 that indicates a desired bending geometry 41 of the bendable region 4 in the lateral direction 42. The input transmission unit 51 has a graphical user interface 12 with a display 122 for displaying movable controls, the spatial position of which the user can directionally adjust to adjust the angle of the bending geometry 41. The control unit is adaptable for wireless transmission 15 of status data of the drive unit, driven unit, and / or slender surgical instruments to the input transmission unit 51, for example, displaying the status data on the input transmission unit 51.

[0108] Figure 2A and 2BThe driven unit 8 has a bearing member that supports the common housing 6, such that the common housing 6 and the elongated surgical instrument 102 are synchronously movable in the proximal direction P and the distal direction D, with minimal frictional resistance. Therefore, the driven unit 8 can more accurately position the elongated surgical instrument 102 by compensating for the weight / inertia of the common housing 6. The driven unit 8 may also optionally be configured to support the common housing 6, such that the common housing 6 and the elongated surgical instrument 102 are synchronously movable in the rotational direction R, with minimal frictional resistance. However, in a preferred embodiment, the rotational movement of the controllable system 101 may have a decoupling unit adapted to decouple the rotational movement of the elongated surgical instrument 102 from the drive unit / common housing 6, for example via an annular ball bearing for connecting the proximal end of the elongated surgical instrument 102 to the drive unit / common housing 6 (see [link to documentation]). Figure 4 This simplifies the design and eliminates the need for a rotating drive unit / common housing 6, while still allowing for easy manipulation of the slender surgical instrument 102.

[0109] Figure 2A The first embodiment of the controllable system 101 is manually movable in the distal direction D, the proximal direction P, and the rotational direction R. This enables longitudinal and rotational positioning of slender surgical instruments with a simple design, similar to established clinical practices, without a high learning curve.

[0110] Figure 2B A second embodiment of the controllable system 101 is capable of translational and rotational movement via a positioning unit 11, which has longitudinal and rotational actuators. The positioning unit can be made of commercially available equipment, such as known devices provided by companies like CorPath GRX or Robocath R-One.

[0111] The wireless transmission unit 51 is also adapted to transmit user-generated motion input to the control unit via an input interface. The control unit is coupled to the positioning unit 11, enabling the elongated surgical instrument to move in a rotational direction or translate in a distal or proximal direction based on user-generated motion input about its longitudinal trajectory. Figure 2B As shown, the control unit can be connected to the positioning unit 11 via a rigid mechanical component 53. Electrical or wireless connection between positioning units 11 facilitates compatibility with commercially available positioning units 11. This motorization of the movement of slender surgical instruments improves surgical precision, safety, and efficiency.

[0112] Figure 3AA representation of a graphical user interface 12 is shown, configured to provide movable controls on a display 122 for adjusting the curved geometry 141 based on user-generated input. The graphical user interface can also be displayed on a wireless transmission unit 51 (see [link]). Figure 2A and 2B (This can be displayed on an electronic device such as a smartphone or tablet.) Alternatively, the graphical user interface 12 can be directly electrically connected to the control unit.

[0113] The graphical user interface features a slider 121 that the user can move bidirectionally to adjust the deflection of the bendable region 4 in a uniform, real-time, and progressive manner (see [link]). Figure 3C and 3D Based on the spatial position 123 of slider 121, various inputs of the user-generated bending geometry for a specified bendable region are transmitted to the input interface of the power-controlled system. The graphical user interface 12 includes a digital indicator 124, functionally coupled to the movable slider 121, and displays the percentage of total tip drive / deflection indicating the bending geometry. The display 122 can be configured to receive touch-sensitive input commands from the user, and / or, as... Figure 3A Control buttons 126, 127 are shown, with a spatial position 123 that can be adapted to selectively fine-tune or coarsely adjust the slider 121. This allows for rapid adjustment of the desired bending geometry, while also allowing for precise adjustment of the deflection in an intuitive and efficient manner. Furthermore, the graphical user interface 12 includes a second digital indicator 128 that displays the battery status.

[0114] The graphical user interface 12 includes a routine / macro button 125 adapted to deflect a flexible region of a slender surgical instrument to a specific pre-stored bending geometry. Alternatively or concurrently, the routine / macro button may be adapted to operatively transmit input to a control unit for deflecting the flexible region to at least two different bending geometries in a time-staggered manner. In this case, the control unit is adapted to transmit at least a first control command and a second control command to a drive unit for sequentially deflecting the flexible region to the two different bending geometries in time. This allows routine / macro functions involving the execution of a series of predefined commands / bending geometries to be implemented with a single input, thereby simplifying the operation of the power-controlled system.

[0115] Figure 3B The remote control unit 18 of the system is schematically shown, which is connected to... Figure 3AThe graphical user interface 12 is similarly operable. The remote control unit 18 includes a movable control 181 consisting of a slider, having a spatial position 183 that can be adjusted by the user through manual (particularly mechanical tactile feedback) movement of the movable control 181. Alternatively or additionally, the control 181 has control buttons 187 for adjusting the spatial position 183 of the control 181.

[0116] Figures 3C to 3E Elongated surgical instruments 102 with linear geometry, a first curved geometry 41, and a second curved geometry 43 are shown. The elongated surgical instrument 102 has an integral outer tubular body 7 composed of a nitinol thiocyanate tube, having a distal portion 71 with a bendable region 4. The bendable region 4 has a stress-relief region 13 arranged along one side of the bendable region 4, the stress-relief region having multiple incisions, preferably laser-cut into the catheter. On the other side of the bendable region 4, a reinforcing portion 14 of the outer tubular body 7 is formed continuously without any incisions and optionally also has reinforcing structures, such as increased material thickness of the thiocyanate tube. Figure 3B It is shown that if the drive unit ( Figure 3A and 3B (Not shown) When tension is applied to the elongated drive element 2, the stress relief region 13 and the reinforcing portion 14 allow the bendable region 4 to deflect to the bending geometry 41. Figure 3A and 3B The flexible region deflects uniformly along the flexible region in a uniform manner, which allows for maximum angular deflection by reducing local strain without affecting its structural integrity and durability.

[0117] The bendable region is also provided with a deflection sensor 9 for determining the shape of the bendable region. In this specific embodiment, the deflection sensor is configured as a fiber Bragg grating in a manner known to those skilled in the art. The deflection sensor 9 is connected to the control unit of the system and allows measurement of parameters indicating the first geometry 41 and / or the second geometry 43. The control unit is adapted to determine the first bending geometry 41 and / or the second bending geometry 43, compare it with a desired bending geometry, and determine the deviation from the desired bending geometry. The control unit is also adapted to adjust the bending geometry via an operating drive unit until the bending geometry 41, 43 approaches the desired bending geometry.

[0118] Figure 4A cross-sectional view of a power-controlled system 101 is shown, comprising a decoupling unit 19 in the form of a pair of roller bearings 191 and 192, and an elongated surgical instrument 102 including an outer tubular body 7 and an elongated drive element 2. A drive unit 3 is operatively connected to a control unit 5, and both are arranged within a common housing 6. The decoupling unit 19 allows the rotational movement of the elongated drive element 2, which is attached to the elongated drive element 2 via a first ball bearing 191, to be decoupled from the drive unit 3. The decoupling unit 19 is also adapted to decouple the rotational movement of the outer tubular body 7 of the elongated surgical instrument 102 from the common housing 6 of the power-controlled system 101 via a second ball bearing 192 of the decoupling unit 19.

[0119] Figure 4 The decoupling unit 19 is shown to have a synchronizing link 193 connecting both ball bearings 191 and 192, which couples the rotational motion of the elongated drive element 2 and the outer tubular body 7. This allows the elongated drive element 2 and the outer tubular body 7 to rotate synchronously and achieve uniform alignment relative to each other, while reducing frictional effects between the elongated drive element 2 and the tubular body 7.

[0120] Figure 5 A schematic diagram of the various components of the system 101 according to the present invention is shown. Specifically, Figure 5 A drive unit, a processing unit for communicating with force and / or position sensors and for operating the drive unit, an input interface, and an energy storage device are shown, all arranged within a common housing. An elongated drive element can be operated via the drive unit to bend the flexible region of an elongated surgical instrument in the manner previously described. The energy storage device powers the drive unit, processing unit, and input interface, making the housing portable and eliminating the need for an external power source.

[0121] The driven unit is connected to the housing of system 101 so as to facilitate previously installed... Figure 2A and 2B The method described herein is used to operate slender surgical instruments.

[0122] The input interface of system 101 is a wireless or electrical connection transmission unit. For example... Figure 5 The transmission unit shown can be powered by an energy storage device or can be connected to an additional energy storage device. Figure 5 The transmission unit in the middle has the same characteristics as previously described. Figure 3A The graphical user interface described herein allows user-generated input to be transmitted to the processing unit and executed via the drive unit. As indicated by the dashed arrow, this transmission unit may be located inside the housing and electrically connected to the energy storage device and the input interface, or it may be located outside the housing and wirelessly connected to the input interface.

[0123] Figures 6A-6EDifferent embodiments of the elongated surgical instrument 102 with different flexible regions 4 are shown. The distal end of the outer tubular body 7 can have different tubular designs that, when subjected to mechanical compression, spatially reconstruct from a straight initial shape into various shapes. These different shapes allow the elongated surgical instrument 102, constructed of guidewires, to assist clinicians in accessing complex anatomical structures that are typically inaccessible using conventional non-actively manipulable guidewires. Other structures enable the guidewire to perform new, unexplored functions, such as, for example, gently anchoring the guidewire at specific locations within small arteries. For example, as... Figures 6A-6E As illustrated schematically, the elongated surgical instrument 102 of the present invention, based on the rational design of its distal end, can achieve some of the most commonly used tip structures in interventional neuroradiology, such as, for example, so-called angular, J-shaped, Simon-shaped, cobra-shaped, or anchor-shaped (respectively as...). Figures 6A-6E (As shown).

[0124] Commercially available devices are delivered with their tips pre-formed into these common configurations, which help surgeons handle specific, complex cases. Alternatively, these devices are delivered directly, allowing surgeons to manually readjust the tip shape. Advantageously, when actuated, the steerable guidewire of the present invention can actively and on-demand change its geometry.

[0125] In one embodiment, the elongated surgical instrument 102 may have its distal end, and particularly its flexible region 4, designed to acquire an "anchor shape" during actuation. Figure 6E The anchoring shape allows the flexible distal end of the elongated surgical instrument 102 to coil into a three-dimensional helical shape, closely adhering to the inner wall of the artery. For this purpose, the elongated reinforcing structure 14 is located distally in a helical manner, thus forming a stress-relief region 13 that coils around (and defines) the shape of the spatially flexible region 4. The flexibility of the flexible region 4 allows the coiled shape to adapt to virtually any degree of curvature and tortuosity of the artery. The primary application of this "anchoring" is to enable surgeons to fix the guidewire tip in a specific location and create a so-called "fixation point," which facilitates the insertion of catheter devices over an established guidewire and prevents unnecessary movement (slippage) of the guidewire.

[0126] Figure 7A and 7B Schematic diagrams of two different embodiments of the drive unit 3 of system 101 are shown.

[0127] Figure 7AA schematic diagram of a rotary drive unit 3 consisting of a rotary motor and pulleys is shown. The rotary motor is connected to an elongated drive element 2 for deflecting the flexible region of the elongated surgical instrument 102 in the manner previously described. The outer tubular body 7 of the elongated surgical instrument 102 is connected to the housing of the system 101. This allows for safe and kink-free storage of the elongated drive element 2 by winding / unwinding it on the pulleys via the rotary motor, and also enables a particularly compact design for the controllable system.

[0128] Figure 7B A schematic diagram of a drive unit consisting of a linear motor is shown. This linear motor allows for a simple, backlash-free design and enables the elongated drive element 2 to be spatially positioned relative to the outer tubular body 7 / housing 6. The spatial position of the elongated drive element 2 can be reliably determined by a position sensor (e.g., a Hall sensor) (see [reference]). Figure 10A and 10B ).

[0129] Figures 8A-8D Different embodiments of the driven unit 8 of system 101 are shown. The driven unit 8 is constructed of a low-friction cylindrical sleeve having an internal channel with lateral and distal openings, allowing the housing 6 of system 101 to move within the channel of the driven unit 8 in the rotational direction R and the longitudinal direction L. The inner surface of the driven unit 8 may be constructed of or coated with a material having a low coefficient of friction, such as polytetrafluoroethylene, polyoxymethylene, polyamide, or high molecular weight polyethylene. This allows the driven unit 8 to provide low and constant frictional resistance to facilitate the movement of the elongated surgical instrument 102 relative to the driven unit 8 in the rotational direction R and the longitudinal direction L.

[0130] Figure 8B The driven unit 8 has a biasing member 83 (particularly a spring) that connects the common housing 6 of system 101 to the proximal end of the driven unit 8. The biasing member 83 can be adapted to provide predefined frictional resistance and tactile feedback, thereby allowing precise fine-tuning of the rotational and translational position of the common housing 6 relative to the driven unit 8. Alternatively or additionally, the biasing member 83 can be adapted to bias the common housing 6 to a predefined spatial position, such that the restoring force of the biasing member 83 facilitates operation, particularly the manual operation of the slender surgical instrument 102.

[0131] Figure 8C The driven unit 8 has a driven driver 85, which includes a translation driver adapted to move the common housing 6 relative to the driven unit 8, for example by engaging a nut with a threaded shaft connected to the housing 6, thereby causing a linear displacement of the common housing 6.

[0132] The driven actuator 85, for example via a rotary coupling mechanism, is decoupled from the rotational motion of the common housing 6 in the rotational direction R, so that the slender surgical instrument 102 can still be manually rotated relative to the driven actuator 85.

[0133] The driven unit 8 has a force / position sensor 82, which is adapted to detect force or position data indicating the translational drive of the elongated surgical instrument 102 and the housing 6. The force / position sensor 82 is connected to the control unit ( Figure 8C (Not shown in the diagram). The control unit is connected to the driven driver 85 of the driven unit 8 and is configured to process force / position data in real time. The control unit is configured to operate the driven driver 85 based on the force / position data, such that the housing 6 and the elongated surgical instrument 102 can move synchronously in the direction of manual drive of the detected elongated surgical instrument 102. This facilitates manual movement of the elongated surgical instrument 102 by the user by supporting translational movement of the elongated surgical instrument 102.

[0134] The control unit may also include a dynamic drive modulation mechanism adapted to resolve the angle of the user drive and adjust the drive of the driven driver 85 based on the angle of the user drive. This allows for slower, more precise fine-tuning of the translational position of the slender surgical instrument 102 and housing 6 for weaker user drives, while allowing for faster coarse-tuning for higher measured drive values.

[0135] The driven actuator 85 may have an encoder that records the elongated surgical instrument 102 and the common housing 6. The encoder and control unit may also be configured to provide the user with the precise rotational and / or translational spatial position of the housing 6, for example, via wireless communication with a wireless transmission unit (see...). Figure 2A and 2B ).

[0136] In another embodiment ( Figures 8A-8D (Not shown in the image) The driven actuator 85 can be further adapted to rotate the elongated surgical instrument 102 and the common housing 6 together relative to the driven unit 8, similar to a translational motion.

[0137] Figure 8D Low-friction elements 84 are shown, which are arranged around the circumference of the housing 6 and allow for more precise and less frictional movement in the translational direction L and rotational direction R within the cylindrical sleeve of the driven unit 8.

[0138] Figure 9A and 9BSchematic diagrams of a first and second embodiment of a power-controlled system 101 are shown respectively. This system includes a housing 6 coupled to a driven unit 8, which is composed of a suspension unit 63 connected to a solid support 104 of the system 101. The suspension unit 63 of the driven unit 8 is connected to the housing 6 and the solid support 104 at connection points, and its length is adjustable to allow translational movement of the housing, which has a similar effect to the aforementioned driven unit (see [link to documentation]). Figures 8A-8D This allows for more controllable movement of the housing 6 by reducing / compensating for frictional resistance / inertia, while simultaneously preventing unintentional accidental movement of the housing 6 when the suspension unit 63 is coupled to the solid support 104.

[0139] Figure 9A and 9B The housing 6, for example via a rotary coupling mechanism 61, is rotatably connected to the suspension unit 63 and solid support 104 of the driven unit 8 at the connection point with the housing, such that the housing 6 and the elongated surgical instrument 102 are synchronously rotatable in the rotational direction R, and particularly manually rotatable. Furthermore, by extending / retracting the suspension unit 63 of the driven unit 8, the housing 6 and the elongated surgical instrument 102 can be translated in the longitudinal direction L. Figure 9A The suspension unit 63 can be composed of spring-loaded pulleys, allowing clinicians to manually adjust it and passively maintain its adjusted spatial position and orientation.

[0140] Figure 9B The driven unit 8 of system 101 is shown to have an off-axis rotary coupling 62 adapted to allow the longitudinal axis of the housing 6 and the elongated surgical instrument 101 to rotate laterally relative to the solid support 104. This can be achieved by rotatably adjusting the off-axis rotation angle of the housing 6 by means of a suspension unit 63 of the driven unit 8 about its connection point with the solid support 104. This allows clinicians to adjust the position of the housing 6 and the elongated surgical instrument 101 with additional rotational degrees of freedom to facilitate alignment and operation of system 101 according to clinical needs.

[0141] Figure 9A and 9B The driven unit 8 may include at least one driver, particularly an electric pulley, which may be configured to operate the elongated surgical instrument 102 (and particularly the housing 6) in longitudinal direction translational motion, rotational motion, and / or off-axis rotation of the housing 6 / elongated surgical instrument 102.

[0142] Figure 10A and 10BSchematic diagrams of two embodiments of a power-controlled system 101 are shown, which has two different deflection sensors 9 for measuring the displacement of the elongated drive element 2 of the elongated surgical instrument 102 (e.g., composed of a bidirectional drive rod). Figure 10A and 10B The system 101 has a control unit 5, a drive unit 3 and a deflection sensor 9 arranged in a common housing 6.

[0143] The elongated surgical instrument 102 has an outer tubular body 7, which is coupled to the elongated drive element 2 via a previously described synchronizing link 193 (shown in dashed lines), such that the two are synchronously movable in the rotational direction R (see [link to original document]). Figure 4 The rotational motion of the outer tubular body 7 and the elongated drive element 2 is decoupled from the housing 6 and the drive unit 3 by a decoupling unit 19 (e.g., by means of two annular ball bearings 191, 192).

[0144] The control unit 5 is adapted to operate the drive unit 3 and receives deflection data from the deflection sensor 9 indicating the position of the proximal end of the elongated drive element 2 along the longitudinal direction L. The control unit is configured to determine the geometry of the flexible region of the elongated surgical instrument 102 based on the detected deflection data.

[0145] Figure 10A The deflection sensor 9 in the drive unit 3 is a resistive deflection sensor arranged on the far end tip of the shaft, thus achieving a simple design.

[0146] Figure 10B The deflection sensor 9 in the drive unit 3 is composed of a Hall sensor, which measures the deflection data in the form of displacement from the magnetic field sensor 91 connected to the shaft of the drive unit 3.

[0147] Figure 11 A remote control unit 18 according to the invention is shown mounted on a catheter valve 201 of a catheter 20. The system 101 may include the catheter 20, and preferably includes a remote control unit 18 mountable to the catheter 20. Mounting the remote control unit 18 on the catheter 20 allows clinicians convenient access to and visibility of the remote control unit 18 during surgical intervention.

[0148] The remote control unit 18 is designed as described above. Figure 3B As described above, the spatial position 183 of the control 181 can be adjusted by operating the control button 187. The remote control unit 18 is also adapted to wirelessly transmit user input (e.g., operation of the control button 187) to the system's control unit (…). Figure 11 (not shown in the image), allowing the slender surgical instrument 102 to be deflected to the desired geometry. Figure 11The diagram shows that a slender surgical instrument 102 can be inserted through a system catheter 20, which is specifically designed to receive the slender surgical instrument 102 within its internal cavity to facilitate seamless interaction.

Claims

1. A power-controlled system (101) for guiding an elongated surgical instrument (102) having an outer tubular body (7) and an elongated drive element (2) nested within the outer tubular body (7) through a patient's body cavity, particularly in the cerebrovascular system, said controllable system (101) comprising: (a) A drive unit (3) configured to be coupled to the elongated drive element (2) for driving the elongated drive element (2), particularly for applying tension and / or compressive force to the elongated drive element; (b) An input interface configured to receive input, particularly user-generated input (52), to specify the deformable geometry (41) of the bendable region (4) at the distal portion (71) of the outer tubular body (7). (c) A control unit (5) operatively coupled to the input interface and configured to generate control commands based on the input; as well as (d) An output interface, operatively coupled to the control unit (5) configured to transmit the control commands to the drive unit (3), wherein The drive unit (3) is adapted to deform the bendable region (4) to the deformable geometry, particularly the bending geometry (41), based on the control command.

2. The power-controlled system (101) according to claim 1, wherein the drive unit (3) is configured to generate motion of the elongated drive element (2) in both proximal-oriented linear motion and distal-oriented linear motion, and the drive unit (3) is configured as follows (i) Linear drive unit (3); or (ii) A rotary drive unit (3) comprising a conversion mechanism operatively connected to or capable of being connected to the elongated drive element (2), wherein the conversion mechanism is adapted to convert the rotational force of the rotary drive unit (3) into linear motion of the elongated drive element (2).

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

4. The power-operable system (101) according to claim 3, wherein the common housing (6) has a longitudinal dimension in the range of 0.1 cm to 25 cm, particularly in the range of 3 cm to 20 cm, preferably in the range of 5 cm to 10 cm; and It has a lateral dimension in the range of 0.036 cm to 10 cm, particularly in the range of 0.5 cm to 5 cm, and preferably in the range of 0.8 cm to 1.75 cm.

5. The power-operable system (101) according to any one of the preceding claims, wherein the power-operable system (101) has a positioning unit (11) controllably coupled to the control unit (5) and configured to: (a) To rotate the elongated surgical instrument (102), in particular together with the drive unit (3), about the central track of the elongated surgical instrument (102); and / or (b) Based on motion input, preferably user-generated motion input, the elongated surgical instrument (102), in particular together with the drive unit (3), translates in the distal or proximal direction (L).

6. The power-operable system (101) according to any one of the preceding claims, wherein the power-operable system (101) has a driven unit (8), which in particular has (a) At least one bearing member (81) configured to support the drive unit (3) when the elongated surgical instrument (102) moves, while simultaneously moving the drive unit (3) in a distal direction, a proximal direction, and / or a rotational direction about the central track of the drive unit (3); or (b) A sensor (82), particularly a force or position sensor, configured to generate force or position data by detecting rotational or translational actuation of the elongated surgical instrument (102), and The driven actuator (85) is adapted to cause the drive unit (3), and in particular the control unit (5), to move synchronously with the elongated surgical instrument (102) in the translational and / or rotational directions based on real-time force or position data.

7. The power-operable system (101) according to any one of the preceding claims, wherein the control unit (5) is configured to apply vibrations at a frequency between 1 Hz and 1000 Hz, preferably between 20 Hz and 500 Hz, to the elongated surgical instrument (102), particularly to the elongated drive element (2) and / or the outer tubular body (1), via the drive unit (3) or the positioning unit (11), when the bendable region (4) is deflected, wherein the drive unit (3), particularly the positioning unit (11), is preferably adapted to apply the vibrations by causing the elongated surgical instrument (102) to move alternately and repeatedly in the proximal and distal directions of the elongated surgical instrument (102).

8. The power-controlled system (101) according to any one of the preceding claims, wherein the input interface, particularly the user input interface, is (a) Electrically connected to the control unit (5) for directly receiving the input; or (b) Configured to receive the input via wireless transmission, wherein The controllable system (101) preferably includes a wireless input transmission unit (51) that is coupled to the input interface and configured to wirelessly transmit the input to the input interface.

9. A power-operable system (101) according to any one of the preceding claims, wherein the power-operable system (101) has at least one deflection sensor (9) configured to generate deflection data by detecting the position of the elongated drive element (2) and / or the geometry of the bendable region (4), and The control unit (5) is configured to (a) Receive the deflection data from the deflection sensor (9), (b) Determine whether the desired geometry has been achieved based on the deflection data, and (c) Control the drive unit (3) based on the deflection data detected in the closed feedback loop to achieve the desired geometry of the bendable region (4) in real time.

10. The power-controlled system (101) according to claim 9, wherein the at least one deflection sensor (9) is selected from at least one of a self-magnetic deflection sensor, an optical deflection sensor, a capacitive deflection sensor or a resistive deflection sensor, wherein the at least one deflection sensor (9) is preferably located in the drive unit (3) or in the flexible region (4).

11. The power controllable system (101) according to any one of the preceding claims, wherein the power controllable system (101) includes an energy storage device (10), particularly disposed within the common housing (6), for operating the controllable system (101).

12. The power-controlled system (101) according to any one of the preceding claims, wherein the system includes a graphical user interface (12), wherein the graphical user interface (12) is configured to (a) Presenting visual information on the display (122), particularly information indicating the bending geometry (41) of the bendable region (4) of the elongated surgical instrument (102) and / or information on the state of the system; (b) A movable control, preferably a slider (121), is provided on the display (122), the movable control having a spatial position (123) adjustable by the user, particularly bidirectionally, to adjust the angle of the bending geometry, particularly to continuously adjust a uniform lateral bending angle over the entire bendable region (4); and / or (c) Providing a digital and / or graphical indicator (124) functionally coupled to the movable control to display the angle of the bending geometry in real time; and / or (d) Based on the spatial position (123) of the movable control, the input is transmitted, particularly wirelessly, to the input interface of the control unit (5) to specify the bending geometry in real time.

13. A computer-implemented method for guiding an elongated surgical instrument (102) having an outer tubular body (7) and an elongated drive element (2) nested within the outer tubular body (7) through a patient's body cavity, the method comprising the steps of: (a) Receive input via an input interface, particularly user-generated input (52), to specify the desired geometry (41) of the bendable region (4) at the distal portion (71) of the outer tubular body (7). (b) Based on the input, a control command is calculated via the control unit (5). (c) The control command is transmitted to the drive unit (3) via the output interface. (d) Based on the control command, the flexible region (4) is deflected to the desired geometry (41). (e) Optionally, a vibration with a frequency between 1 Hz and 1000 Hz, preferably between 20 Hz and 500 Hz, is applied to the elongated surgical instrument (102), particularly the elongated drive element (2) and / or the outer tubular body (1), via the drive unit (3) or the positioning unit (11). (f) Optionally, force and / or position data are detected, and based on real-time force and / or position data, the drive unit (3), and in particular the control unit (5), moves synchronously with the elongated surgical instrument (102) in the translational and / or rotational directions.

14. A computer program product comprising instructions for causing the powered controllable system (101) of any one of claims 1-12 to perform the method steps of any one of claims 13.

15. The power-controlled system (101) according to any one of claims 1-12, wherein the controllable system (101) comprises It has an outer tubular body (7) and an elongated drive element (2) that is responsive to tension and / or compression within the outer tubular body (7), wherein, The distal portion (71) of the outer tubular body (7) has a bendable region (4) that can be deformed to the bending geometry (41).

16. The power-controlled system (101) of claim 15, wherein the elongated surgical instrument (102) is torsional rigid, such that rotational forces applied to the proximal end of the elongated surgical instrument (102) are transmitted along the central track of the elongated surgical instrument (102) to the distal end of the elongated surgical instrument (102).

17. The power-operable system (101) according to any one of claims 15-16, wherein the bendable region (4) is capable of uniform lateral deflection along its longitudinal length, and the bending geometry is defined by a uniform lateral bending angle over the entire bendable region (4), wherein, The control unit (5) and the drive unit (3) are configured such that the bending angle is adjustable over the entire range from 0° to 540°, particularly over the entire range from 0° to 270°, and preferably over the entire range from 0° to 180°.

18. The power-controlled system (101) according to any one of claims 15-17, wherein The flexible region (4) of the elongated surgical instrument (102) has a stress relief region (13) on one side, particularly including at least one, preferably multiple, annular and / or spiral incisions, such that when tension and / or compressive force is applied to the elongated drive element (2), the flexible region (4) deflects in the lateral direction of the stress relief region (13).

19. The power-controlled system according to any one of claims 15-18, wherein One side of the flexible region (4) of the elongated surgical instrument (102), particularly the side opposite to the stress relief region (13), has a reinforcing portion (14), preferably including a reinforcing structure integrally formed by the outer tubular body (7) and being longitudinally rigid, such that applying tension and / or compressive force to the elongated drive element (2) does not substantially affect the length of the reinforcing portion (14) in the longitudinal direction.

20. The power-operable system (101) according to any one of claims 15-19, wherein the distal end (21) of the elongated drive element (2) is connected to the distal tip (103) of the elongated surgical instrument (102), preferably the distal tip having a rounded shape, and the proximal end (22) of the elongated drive element (2) is longitudinally movably connected to the drive unit (3), and the proximal end of the outer tubular body (7) is longitudinally immovably connected relative to the drive unit (3), particularly to the housing of the drive unit (3).

21. The power-operable system (101) according to any one of claims 15-20, wherein the elongated surgical instrument (102) is sized and shaped for peripheral interventional, interventional cardiology, or neurovascular surgery, wherein, The outer tubular body (7) has a maximum cross-sectional dimension of less than 1 mm, particularly less than 0.6 mm, and preferably less than 0.37 mm.

22. The power-operable system (101) according to any one of claims 15-21, wherein the elongated surgical instrument (102) includes a non-transparent element, preferably located at the distal end of the elongated surgical instrument (102).

23. The power-controlled system (101) according to any one of claims 15-22, wherein the outer tubular body (7) is composed of an integral tubular element, particularly comprising stainless steel or nitinol or made of stainless steel or nitinol, preferably made of nitinol hyaluronic acid tube.

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