SYSTEM AND METHOD FOR MOVING MEDICAL DEVICE TO TREAT OR DIAGNOSE A PATIENT - Patent application

Abstract

A system (10) for moving an intravascular medical device (85) within a vascular network (V) includes a magnetic actuator (40), a controller (50), and a control line driver (60). The control line driver (60) is adapted to hold and / or release a control line (70) attached to the medical device (85) at different speeds. The magnetic actuator is adapted to generate a magnetic field (41) at a predetermined location to pull the medical device (85) in a predetermined direction. The controller (50) is adapted to balance at least three forces applied to the medical device (85) and operate the magnetic actuator (40) and / or the control line driver (60).

Description

[Technical field]

[0001] The present invention relates to a system for displacing a medical device in a vascular network and to a method for treating or diagnosing a patient according to the preambles of the independent claims.

[0002] 2. Description of the Related Art It is generally known in the art to use devices inside the human body to deliver specific medical treatments.

[0003] For example, US Patent Application Publication No. 2009 / 0076536 discloses microrobots or devices that can be introduced into the human body to perform medical procedures, particularly to provide spatial support within cavities.

[0004] US Patent Application Publication No. 2013 / 0282173 discloses a remote-controlled surgical robot capable of moving within a patient's body and performing medical procedures therein.

[0005] WO 2020 / 064663 discloses a medical device having a recapture line. Pancaldi et al. (Nat. Commun. 11, 6356 (2020)) disclose a tethered intravascular microscopy probe for transport through a vascular network using fluid kinetic energy. Using magnetic actuation, the probe head can be deformed to achieve dynamic steering.

[0006] However, the known devices have several drawbacks. In particular, reliable navigation in a vascular network can be difficult to achieve, especially in tortuous vascular networks. Magnetic navigation of a medical device pushed by a flow through several branches is difficult because a magnetic field must be set for each branch. In case of high flow rates, the magnetic field of the system may not be strong enough to change the direction of the device. Furthermore, automatic magnetic navigation through successive branches requires control of the position of the medical device and the magnetic actuators.

[0007] It is therefore an object of the present invention to overcome the shortcomings of the prior art, in particular to provide a simple and reliable means of navigating medical devices within a vascular network. In particular, the present system and method aim to automate and / or optimize magnetic device guidance.

[0008] These and other objects are achieved by the system and method according to the features of the independent claims of the present invention.

[0009] The system according to the invention is particularly suitable for moving a medical device in a vascular network. The medical device may in particular be an implantable device. The medical device may comprise a head part having a magnetic portion and a back part having a control line. The medical device may be moved in the vascular network to treat or diagnose a patient. The system comprises a magnetic actuator, a controller and a control line driver. The control line may be attached to the control line driver. The control line driver is adapted to hold and / or release the control line at different speeds if it is a control line attached to the control line driver. The magnetic actuator is adapted to generate a magnetic field at a predefined location. Preferably, the magnetic field is predetermined. The magnetic field may exert a force on the medical device, in particular on the magnetic part of the medical device, such as to pull the medical device in a predefined direction. The controller is adapted to balance at least three forces applied to the medical device. Preferably, the controller balances the forces in real time. Preferably, the three forces include at least one of a drag force acting on the medical device by a fluid flow, e.g., blood in a blood vessel, a force by a control line, and a magnetic force by a magnetic actuator. The control line further operates the magnetic actuator and / or the control line driver.

[0010] The control lines can be useful for magnetic navigation. The present invention helps to find a good balance for various forces applied to the medical device, such as flow forces, gravity, control forces and magnetic or other potential forces acting on the medical device to navigate the medical device along a trajectory path. The system can automatically calculate the forces and the relationships between the forces and define the forces generated by the system, particularly the control line forces and magnetic forces, to ensure that the resulting forces move the medical device along a predefined trajectory.

[0011] This balance model also makes it possible to optimize the distribution of forces induced by the magnetic actuators and the control lines. The balance of forces can also be beneficial to optimize system requirements, such as lower magnetic fields and / or lower control line forces.

[0012] The control line drive may include, and preferably consist of, any one or combination of the following: pulleys, linear actuators, reels, electric motors, spindles, gears, screws and / or nuts, linear gear tracks, and continuous tracks. The control line drive may also comprise two or more of any one of these elements in combination with any one, two, or more of any other elements.

[0013] The control line driver may also additionally or alternatively comprise a control line connector adapted to provide an operable connection between the control line driver and the control line.

[0014] Preferably, the controller may comprise a processor and / or a memory. In a particularly preferred embodiment, the controller is operatively connected to the electric motor and adapted to control at least one of a speed, a power, and a torque of the electric motor.

[0015] The speed may be at least partially predetermined, automatically determined or manually selected. It is conceivable to use a combination of predetermined, automatically determined and manually selected speeds. For example, the control unit may calculate an appropriate speed profile based on the planned trajectory in the vessel, taking into account data on the flow of blood in the vessel, and store the speed profile in memory. Additionally or alternatively, the speed of the control line may be adapted automatically during the intervention, for example via a feedback loop taking into account the planned trajectory and the actual position data, and / or manually by the user. For this purpose, the system may preferably comprise an interface for the user, for example one or more touch screens, knobs, buttons, levers, adapted to allow the input of speed parameters. It is possible to use the same or additional interfaces to input further parameters related to the control of the position and speed of the medical device.

[0016] Preferably, the control unit is adapted to calculate the magnetic field at the device position in space and / or the force exerted by the magnetic field on the magnetic element when the magnetic element is placed at the device position in space. The control unit may take into account, in particular, at least one of the position, orientation and / or power of the magnetic actuator. Additionally or alternatively, the control unit may be adapted to receive data from a sensor at or near the device position, in particular data relating to the magnetic field and / or force at the device position.

[0017] Additionally or alternatively, the device may calculate at least one of a position, an orientation, and a power of a magnetic actuator suitable for achieving a magnetic field and / or a magnetic force at the device location. The magnetic field and / or magnetic force may be calculated qualitatively (e.g., direction only) or quantitatively.

[0018] It is contemplated that the control unit may be adapted to implement a closed feedback loop for the magnetic actuator, i.e. to calculate the position, orientation and / or power of the magnetic actuator based on a desired force and / or magnetic field, and to adapt or correct the position, orientation and / or power based, for example, on an actual measured magnetic field and / or force.

[0019] The control unit may further be adapted to calculate and / or determine the force acting on the medical device via the control line. To this end, the control unit may comprise and / or be operatively connected to a force sensor adapted to measure the force acting on the medical device. The control unit may control the control line driver to release the control line while keeping the force acting on the medical device via the control line constant. Additionally or alternatively, the control unit may be adapted to control the control line driver to release the control line at a constant speed. Additionally or alternatively, the control unit may further be adapted to control the control line driver to release the control line at a speed and / or pullback force determined based on the magnetic force acting on the medical device.

[0020] Particularly preferably, the control unit is able to control and / or limit one of the speed and the position of the medical device via the control line via the control line driver.

[0021] The control unit may further calculate and / or determine drag forces acting on the medical device due to the surrounding blood flow. The system may comprise a sensor, for example a Doppler ultrasound device, adapted to measure blood flow velocity at the device location. Additionally or alternatively, force data provided by a force sensor may be taken into account. Additionally or alternatively, the system may comprise a memory device containing flow data acquired before or during treatment depending on the location in the blood vessel.

[0022] The control unit is thus adapted to balance three forces that may act on the medical device. Balancing several forces may be understood in particular as adapting the force magnitude of at least one of several forces in response to and / or based on at least one other force, preferably all other forces.

[0023] The controller may be adapted to increase or decrease the magnetic force acting on the medical device by adapting at least one of the position, orientation and / or power of the magnetic actuator in response to forces exerted on the medical device by the blood flow and / or the control lines. For example, if the forces exerted on the medical device by the blood flow are too low to allow the medical device to move along the longitudinal axis of the blood vessel, the controller may adapt operation of the magnetic actuator to exert a force at least partially in a direction substantially parallel to the longitudinal axis to propel the medical device forward.

[0024] Additionally or alternatively, the controller may be adapted to increase or decrease the speed of the release of the control wire depending on the drag force exerted on the medical device by the blood flow and / or the magnetic force exerted on the medical device by the magnetic actuator. For example, the controller may determine that the available magnetic force may be limited due to spatial constraints or distance between the tissue and the magnetic actuator, and / or due to the drag force exerted by the blood flow that is strong enough that the available magnetic force is not sufficient to move the medical device in the intended direction. Thus, the controller may operate the control wire drive to slow down and / or stop the release of the control wire, such as to slow down and / or stop the medical device. As a result, a smaller magnetic force may be sufficient to move the medical device in the desired direction, especially since the medical device is slower, especially compared to the surrounding blood flow.

[0025] The system may comprise an orientation means for orienting the magnetic field. The orientation means may be operatively connected to the control unit. In case of a magnetic field generated by a permanent magnet, the orientation may be performed by moving the magnetic actuator, in particular using an orientation means having an arm, joint, telescope, wheel, gear, rail, etc., and combinations thereof. In particular, the orientation means may comprise a robot arm having six degrees of freedom for moving the permanent magnet.

[0026] In the case of magnetic fields generated by non-permanent magnets, directing the magnetic field can be achieved by varying the current in an electromagnet and / or by using the directing means described for permanent magnets.

[0027] In one embodiment according to the invention, the system is additionally or alternatively intended to treat or diagnose a patient by using a preferably implantable medical device having a magnetic portion and a shape, size and surface structure that defines the movement components of the medical device when dragged by a bodily fluid. The system comprises a magnetic actuator, a controller and a control line drive. The control line may be attached to the control line drive. The control line drive is or may be operatively connected to the controller such that at least one of the position, movement and velocity along the axis of the control line when attached to the control line drive is controllable by the controller via the control line drive. Additionally or alternatively, the controller may be adapted to at least partially control the position and / or velocity of the medical device within the blood vessel by at least one of the position, velocity and movement of the control line drive when operatively connected to the controller via a control line attached to the control line drive.

[0028] The control unit may further be adapted to control the position of the medical device in the blood vessel via the magnetic actuator, preferably in a plane perpendicular to and / or parallel to the longitudinal axis of the vessel. Preferably, the control unit is adapted to take into account a drag force exerted on the medical device by the blood flow to actuate the magnetic actuator and / or to control the movement or position of the control line. Additionally or alternatively, the control unit may further be adapted to actuate the magnetic actuator based on the velocity of the control line or to adapt the velocity of the control line based on the magnetic field generated by the magnetic actuator. Particularly preferably, the control unit is adapted to determine three force components exerted on the medical device by each of the blood flow, the magnetic force, and the control line, and to control the control line drive unit and the magnetic actuator to balance the three force components to achieve the intended movement of the medical device.

[0029] The system may preferably include a medical device having a magnetic portion and a shape, size, and surface structure that defines the moving components of the medical device when entrained by bodily fluids.

[0030] Preferably, the medical device is a microrobot adapted to perform a function within a patient, e.g., the microrobot can mechanically remove tissue, release drugs, provide heat or cold, induce thrombosis, and / or remove a thrombus.

[0031] Particularly preferably, the medical device comprises at least a first surface portion configured to maximize drag in an aqueous medium, in particular blood. The surface portion may be arranged at least partially circumferentially around the medical device, in particular in a plane perpendicular to the longitudinal axis defined by the line. Thus, the forward propulsion force by the blood, i.e. drag, can be maximized. Additionally or alternatively, it may be advantageous to include a second surface portion, in particular arranged at the tip intersecting the longitudinal axis defined by the control line, which minimizes frictional forces with the aqueous medium in order to reduce the magnetic force required for guidance.

[0032] Preferably, the density of the medical device head and / or control lines, particularly preferably the density of the entire medical device, is substantially the same as the density of water or blood, particularly water or blood, at physiological conditions (i.e., at 37° C. and physiological salt concentrations), and thus the medical device may be navigated within a blood vessel without having to consider gravity.

[0033] Additionally or alternatively, the system may further comprise a control line, which may be connected or connectable to a control line driver for operative connection with the controller.

[0034] Particularly preferably, the control lines are connected or connectable to a head portion of the medical device.

[0035] In some embodiments, the control line drive may be adapted for controlled release of the control line, in particular at a controlled speed and / or with a controlled force. Particularly preferably, the control line drive may be adapted for retracting the control line. For this purpose, the control line may be adapted, in particular by material selection and / or dimensions and / or construction, to have sufficient strength, in particular tensile strength or yield strength, to withstand the drag caused by the blood flow thereon when the medical device moves in the opposite direction to the blood flow.

[0036] A system according to any one of the preceding claims, the system having a detection component adapted to detect bifurcations in the vasculature. For example, the detection component may comprise image analysis software and / or an interface for receiving imaging data. Additionally or alternatively, the system may include data representative of the location and orientation of the bifurcations in a memory, the detection component being adapted to read such data via the interface.

[0037] Preferably, the system is configured to determine the minimum magnetic force required to displace the medical device, such as to guide the magnetic device at the branch, based on the current speed of the medical device and the distance between the medical device, particularly the medical device head, and the branch along the flow direction in the blood vessel.

[0038] Preferably, the magnetic actuator comprises at least one of an electromagnet and a permanent magnet. The magnetic actuator is capable of generating a magnetic field having a gradient. An electromagnet is particularly advantageous as it provides an electrically adjustable magnetic field.

[0039] Thus, the system according to the invention allows for easy and reliable navigation within a blood vessel. In particular, to guide, navigate or steer the medical device, the system does not necessarily require a shape change, such as bending, of the medical device (particularly its head portion) in response to magnetic actuation. Instead, the system allows for adjusting the magnetic actuation independently of the flow characteristics. For example, when the blood flow is substantially zero or very fast, the medical device can still be navigated within the blood vessel. Furthermore, the system can allow for greater flexibility in the magnetic actuation devices and their operation, since the resulting force exerted by the magnetic field is used without resorting to a shape change to achieve a change of direction by utilizing fluid kinetic energy. Thus, it may not be necessary to achieve a specific orientation of the magnetic field relative to the medical device, particularly the medical device head portion. However, it will be understood that a medical device adapted to change shape in response to magnetic actuation can be combined with the system according to the invention.

[0040] Furthermore, the system according to the invention is more reliable since the additional control of the position and velocity of the medical device by the control lines allows for longer reaction times and makes the procedure less prone to errors. Furthermore, the control lines can be used for at least partial retraction of the medical device, either manually or automatically, allowing for easy correction of the navigation path.

[0041] Due to the limitations of the speed of the medical device that can be achieved by the control wires, weaker magnetic forces / fields can be used for navigation. Thus, both space and energy requirements are reduced, resulting in cheaper and easier treatment options. Furthermore, the strong magnetic fields typically required by devices already known in the art may not be suitable for patients with certain types of implants, such as pacemakers.

[0042] In particular, the magnetic force, and therefore the weight, of a magnetic actuator required for actuation in a fluid typically increases with the flow rate of the fluid. In contrast, slowing and / or stopping the medical device allows a constant and / or lower magnetic force to be used to actuate the medical device independent of the fluid flow rate, thus reducing the total weight of the magnetic actuator and system.

[0043] Therefore, preferably, the magnetic actuator is configured to generate a magnetic force that is not sufficient to move the medical device against the blood flow. The magnetic actuator may in particular be a permanent magnet or an electromagnet, dimensioned accordingly. A magnetic actuator that provides only a limited magnetic field strength may be smaller, cheaper and safer for the patient.

[0044] Preferably, the control unit is adapted to balance at least four forces applied to the medical device, one of which may be gravity or a contact force of the medical device head and / or the control wire with the vessel wall.

[0045] For this purpose, the control unit may be further adapted to calculate the gravity from the characteristics and position of the medical device, and / or to detect, for example based on the imaging data, the direction of movement of the medical device, and / or whether the medical device head and / or the control wire are in contact with the vessel wall. Particularly preferably, the control unit may be adapted to quantitatively calculate at least one of the forces acting on the medical device due to the contact of the medical device head and / or the control wire with the vessel. Additionally or alternatively, the control unit may be adapted to receive data from a sensor measuring the contact force acting on the medical device.

[0046] Preferably, the control unit is adapted to take into account frictional forces between the control line and the vessel wall.

[0047] The control unit can determine the friction force in any of the above-mentioned ways, for example from imaging data, particularly three-dimensional imaging data. The control unit can also calculate the friction force based on data stored in the memory. For example, average or normalized friction force components can be stored and / or calculated and used alone or in combination with the imaging data. Additionally or alternatively, the system can include a sensor adapted to measure the friction force and an interface for providing the friction force data to the control unit, preferably via the memory.

[0048] Preferably, the control portion is adapted to balance the contact forces with the vessel wall caused by the head portion, in particular frictional, adhesive and penetration forces.

[0049] Preferably, data representative of at least one of the friction, adhesion and penetration forces are stored in the memory, and the control unit is adapted to access these data via the interface. The different forces of friction, adhesion and penetration can be calculated from numerical models, which can be stored in a storage device accessible by the system. These numerical models can use vascular geometric data extracted in particular from pre-operative and / or peri-operative images.

[0050] Preferably, the system comprises at least two magnetic actuators. The control unit is preferably adapted to control the at least two magnetic actuators.

[0051] Two or more magnetic actuators can provide more precise adjustment of the magnetic force, especially if only weak magnetic forces are used. Additionally, multiple magnetic actuators can allow for greater flexibility in guiding the medical device, enabling guidance in directions that may otherwise be inaccessible due to spatial constraints limiting the movement of the magnetic actuators.

[0052] Preferably, the control unit comprises at least one of an imaging system and an interface for receiving intraoperative data from the imaging system, preferably an input interface for receiving imaging data. The control unit may be adapted to determine the position of the medical device, in particular the medical device head.

[0053] The imaging system may be any imaging device known in the art, in particular an interventional system such as a Cath Lab, an ultrasound imaging system, a magnetic resonance device, fluoroscopy, an X-ray imaging device, and / or a computed tomography.

[0054] Preferably, the control unit detects the position of the medical device by a positioning element arranged relative to the medical device.

[0055] Additionally or alternatively, the control unit may comprise image analysis software adapted to detect the location of the medical device on the generated imaging data.

[0056] The controller may store the positioning data in memory, particularly for calculating magnetic and resistive forces as described above.

[0057] Preferably, the control unit is adapted to calculate at least one force, in particular any of the above-mentioned forces, based on trajectory data representative of a predetermined vascular path.

[0058] Preferably, the control unit includes an interface for a user to input the trajectory data, and the trajectory data is stored in the memory.

[0059] Preferably, the control unit is adapted to control the control line drive to slow down and / or stop the displacement of the medical device when moving the at least one magnetic actuator to a next position.

[0060] Slowing down and / or stopping the medical device can provide more time to accurately position the magnetic actuator, especially if subsequent branches are located close to each other.

[0061] Additionally, depending on the patient's anatomy and the location of the branch along the planned trajectory, it may not be possible to move the magnetic actuator directly to the next location without moving the medical device in an unintended direction. In such cases, stopping the medical device may allow the magnetic actuator to move without unintentionally propelling the medical device forward. Similarly, the additional time gained by slowing and / or stopping the medical device may allow the magnetic actuator to move away as needed, i.e., avoid a location where the medical device would be moved in an unintended direction.

[0062] Additionally or alternatively, the system may be configured to stop movement of the medical device relative to the bifurcation at a location upstream of the bifurcation.

[0063] Preferably, the control line drive comprises a force sensor, which may be adapted to measure a drag force exerted on the medical device by blood or another medium, and which may be operatively disposed between the control line and the control line drive and at least partially form an interface for connecting the control line drive and the control line.

[0064] The force sensor may be any force sensor known in the art, in particular a piezoelectric sensor, a spring sensor, a torque sensor, a capacitor, etc.

[0065] The force sensor can provide real-time force data of the force exerted on the control line by, for example, contact with a vessel wall or blood flow.

[0066] Additionally or alternatively, the system may include a further force sensor that is not part of the control line drive, for example the force sensor may be located on or form part of the medical device, the interface between the medical device head and the control line, or elsewhere.

[0067] Preferably, the control line driver comprises at least one interface for triggering and / or powering at least one function of the medical device.

[0068] The control line drive may include a power source, such as an electrical plug, a battery, or any other power source known in the art. Additionally or alternatively, the control line drive may be adapted to transmit power wirelessly to the medical device. For example, RFID technology may be used to power the medical device.

[0069] The control line drive preferably has a size, shape and material such that it can be connected at the patient side, In particular, the control line drive may be adapted for use in a sterile environment.

[0070] The control line may be embedded in a preferably sterile mechanism. The sterile mechanism is a physical element that protects the control line drive from contact with non-sterile elements. The sterile mechanism can be a bag, a box. In one embodiment, the control line support and the control line are embedded in a sterile mechanism.

[0071] The sterile mechanism of the control line drive may be filled with a sterile solution, particularly an isotonic solution. Preferably, the system comprises a plurality of control line drives, preferably two, three or four control line drives. The control unit can be adapted to operate the magnetic actuator and the plurality of control line drives to control the navigation of a plurality of medical devices, particularly preferably one medical device is attachable or attached to one control line drive each.

[0072] In a preferred embodiment, the system further comprises a flow member adapted to accelerate or decelerate blood flow at least in the vicinity of the medical device For example, the flow member can compress or expand a blood vessel mechanically or through the release of a drug to locally increase or decrease blood pressure or locally restrict or expand the cross-section of a blood vessel.

[0073] The system may preferably comprise means for controlling and / or decreasing and / or increasing the blood flow in the vessel. Particularly preferably, a delivery catheter and a balloon attached to a separate catheter are used. However, it is also conceivable to use an external device, for example a compression device.

[0074] It will be appreciated that a local change in flow may result in changes in flow direction and / or intensity in different, possibly remote and / or distal, regions.

[0075] It will be appreciated that the means for controlling and / or reducing blood flow may be attached or attachable to any portion of the medical device and / or delivery catheter, or the means may be configured as a separate device.

[0076] Reducing or increasing blood flow in certain vessels can be advantageous and provide better control over navigation.

[0077] The system may further comprise at least two control line drivers, each of which may be independently controllable by the controller. One control line may be attached or attachable to each control line driver and thus independently controlled.

[0078] Such a configuration allows for the control lines to be used to further steer and / or rotate the medical device when at least two control lines are attached to the same medical device.

[0079] However, it will be appreciated that at least two control line drives may be used to independently control the movement of at least two separate medical devices.

[0080] The present invention further relates to a method of treating or diagnosing a patient, preferably carried out using the system described herein. Introducing a medical device into a patient's vasculature; Calculating a balancing force to be applied to the medical device to generate a resultant force, the resultant force capable of moving the medical device along a predetermined path; operating at least one magnetic actuator, preferably via a controller, to generate at least one magnetic field at at least one predetermined location; Adapting the release rate of a control line attached to the medical device head. Includes.

[0081] Preferably, an optimum route to the target area is calculated by the control unit, or alternatively, data representing an optimum or desired route determined by a user may be entered into the memory via the interface.

[0082] Preferably, the method further comprises the step of moving the medical device along a predetermined path.

[0083] Preferably, the method includes the further step of shutting down the medical device prior to bifurcation. Additionally or alternatively, the method may further include any one of the following steps, or any combination thereof:

[0084] moving the medical device in a direction substantially the same as the direction of blood flow within the vessel, solely due to the drag exerted by the blood flow; controlling the speed of the medical device by applying a force to a control line connected to the medical device head, the force preferably being directed in a direction opposite to the direction of blood flow within the blood vessel; detecting a branch in a blood vessel; Slowing down the speed of the medical device by controlling the control line, preferably stopping the medical device at a position upstream of the branch; moving the medical device by the magnetic actuator in a direction perpendicular to the longitudinal axis of the blood vessel to guide the medical device towards the branch of the bifurcation; Preferably, releasing the line to accelerate the medical device by the drag force exerted by the blood flow.

[0085] The present invention further relates to a medical device, preferably a microrobot. The medical device is particularly suitable for use in such a system and / or in such a method. It will be understood that the medical device can have any of the features described in the context of the system herein. The medical device can include a magnetic portion that can be operatively connected to a magnetic actuator, and preferably at least a surface portion adapted to maximize drag in an aqueous medium, particularly blood. The medical device head is connected or connectable to a control line.

[0086] The invention will now be described in detail with reference to the following figures, in which: [Brief description of the drawings]

[0087] [Figure 1a]FIG. 2 illustrates a first embodiment of a control line driver in use. [Figure 1b] FIG. 2 illustrates a first embodiment of a control line driver in use. [Figure 1c] FIG. 2 illustrates a first embodiment of a control line driver in use. [Figure 1d] FIG. 2 illustrates a first embodiment of a control line driver in use. [Figure 2a] FIG. 13 is a diagram illustrating a third embodiment of a control line driver. [Figure 2b] FIG. 13 is a diagram illustrating a third embodiment of a control line driver. [Figure 3a] FIG. 13 is a diagram illustrating a fourth embodiment of a control line driver. [Figure 3b] FIG. 13 is a diagram illustrating a fourth embodiment of a control line driver. [Figure 4a] FIG. 13 is a diagram illustrating a fifth embodiment of a control line driver. [Figure 4b] FIG. 13 is a diagram illustrating a fifth embodiment of a control line driver. [Diagram 5] FIG. 4 is a diagram illustrating a user interface of the control unit. [Figure 6] FIG. 1 illustrates a medical device navigating within a patient's blood vessel. [Figure 7] 1 illustrates a medical device being navigated within a blood vessel by a system for moving the medical device. [Figure 8] FIG. 1 illustrates a first embodiment of a system for moving a medical device. [Figure 9] FIG. 1 illustrates a second embodiment of a system for moving a medical device. [Figure 10a] FIG. 2 is a schematic diagram of a magnetic actuator. [Figure 10b] FIG. 2 is a schematic diagram of a magnetic actuator. [Figure 10c] FIG. 2 is a schematic diagram of a magnetic actuator. [Figure 11] 1 is a schematic diagram of multiple medical devices being moved within a blood vessel by a system for moving the medical devices. [Figure 12]FIG. 2 is a schematic diagram of the operating principle of the actuator. [Figure 13] 1 is a schematic diagram of forces acting on a medical device. [Figure 14a] FIG. 1 shows a schematic diagram of a medical device having three control lines. [Figure 14b] FIG. 1 shows a schematic diagram of a medical device having three control lines. [Figure 14c] FIG. 1 shows a schematic diagram of a medical device having three control lines. [Figure 15a] FIG. 1 shows a schematic diagram of a medical device having two control lines. [Figure 15b] FIG. 1 shows a schematic diagram of a medical device having two control lines. [Figure 15c] FIG. 1 shows a schematic diagram of a medical device having two control lines. [Figure 16a] FIG. 1 illustrates a schematic diagram of a system including a medical device and an additional device for influencing blood flow in a blood vessel. [Figure 16b] FIG. 1 illustrates a schematic diagram of a system including a medical device and an additional device for influencing blood flow in a blood vessel. [Figure 17a] 1A-1C are schematic diagrams illustrating alternative systems including a medical device and a device for influencing blood flow in a blood vessel. [Figure 17b] 1A-1C are schematic diagrams illustrating alternative systems including a medical device and a device for influencing blood flow in a blood vessel. [Figure 18] 1 is a schematic diagram of an alternative device for affecting blood flow in a blood vessel. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0088] FIG. 1a shows one embodiment of a control line drive 60. The control line drive 60 comprises an electric motor 62. For clarity, the connection to the control (see FIG. 9) has been omitted. It will be understood that the control may be connected to the control line drive 60 by any means known in the art, such as a cable or a wireless connection (Bluetooth, WLAN, infrared port, etc.). The control line drive 60 further comprises an axel 61 operatively connected to the electric motor 62. The axel is adapted to receive a control line 70 that can be wound around the axel 61. Rotation of the axel 61 releases or pulls the control line 70. The control line drive 60 further comprises a clamp 63. Here, the clamp 63 is shown in an open configuration, allowing the control line 70 to move freely through the clamp. Thus, the release, stopping, or retraction of the control line 70 is controlled solely via the axel 61. Here, the control line 70 has a medical device head 80 attached to it. The position of the medical device is controllable by the control line driver 60 and accelerator 61 via movement of the control line 70 .

[0089] FIG. 1b illustrates the control line drive 60 of FIG. 1a, with the clamp 63 shown in a closed configuration. Thus, the control line 70 can be stopped and held independent of the movement of the axel 61. For example, the medical device 85 may be temporarily held and secured without using power to the electric motor 62. Closing the clamp 63 to hold the control line 70 may also be advantageous to secure the medical device 85 via the control line in the event of a malfunction of the control line drive 60. However, the clamp 64 may be used to stop and / or hold the control line 70 at any time and for any reason.

[0090] Figure 1c shows the control line drive 60 of Figures 1a and 1b, where the control line 70 is released by rotation of the axel while the clamp 63 is closed. Thus, a buildup of control line 71 is formed within the control line drive 60 between the axel 61 and the clamp 63. Now, the clamp 63 is closed and holds the medical device 85 (via the control line 70).

[0091] FIG. 1d illustrates the embodiment of FIGS. 1a-1c, where the clamp 63 is opened after the control line in the control line drive 70 is released and a control line build-up is formed as shown in FIG. 1c. Thus, the medical device 85 can flow substantially freely in a fluid, such as blood, until the control line 70 is extended as shown here. The method of operating the control line drive 60 as shown here is particularly advantageous for reducing tension in the control line 70 during navigation, for example, when no branches should be navigated for a particular path. It will be appreciated that when navigated as shown in FIGS. 1c and 1d, the force exerted by the control line 70 on the medical device 85 is temporarily substantially zero, and the control (see FIG. 9) can balance the magnetic and drag forces accordingly.

[0092] FIG. 2a shows a control line drive 60 substantially similar to the control line drive of FIG. 1a-1c. However, in this embodiment, no clamp (see FIG. 1a) is provided. Thus, the speed of the control line 70 can be directly controlled by the accelerator 61. Thus, when the medical device head 80 is attached to the control line 70, it moves at a maximum speed controlled by the speed of the control line 70 and the release speed of the control line drive 70. Typically, the user may decide to navigate the medical device 85 at a speed lower than the speed of the blood flow surrounding the medical device. In such a case, the speed of the medical device substantially corresponds to the release speed of the control line 70, which is determined by the accelerator and the rotation speed of the electric motor 62. Thus, the control unit (see, for example, FIG. 9) can be used to control the movement of the medical device 85 via the control of the electric motor 62. However, it will be understood that the user may also choose to release the control line 70 via the control unit at a speed higher than the speed of the blood flow in order to move the medical device head 80 substantially at the speed of the blood flow.

[0093] FIG. 2b shows the embodiment of FIG. 2a where the control line has been released further, causing the medical device 85 to move downstream in response.

[0094] FIG. 3a shows a further embodiment of the control line drive 60. The embodiment shown here is similar to the embodiment shown in FIGS. 1-1d and 2a-2b. In this embodiment, the control line drive further comprises a force sensor 64 adapted to detect a pulling force exerted on the control line 70 and / or the medical device head 80. When the medical device 85 is surrounded, for example, only by blood and does not encounter any obstacles, the medical device is typically substantially propelled by the drag force exerted by the blood, and the control line 70 can decelerate the medical device 85. Thus, the pulling force measured by the force sensor 64 can provide a correlation with the drag force due to the blood flow. Thus, based on the release speed of the control line 70 and the force measured by the force sensor 64, it may be possible to calculate the drag force.

[0095] Fig. 3b shows the embodiment of Fig. 3a, where the medical device 85 encounters an obstacle, here a thrombus 101. Thus, the movement of the medical device is slowed down and the tension in the control line 70 is reduced. Thus, the force sensor 64 measures a lower force. On the one hand, this allows to balance other forces as disclosed herein, for example to increase or decrease the magnetic force and / or the release speed of the control line 70 accordingly. On the other hand, it may also be possible to detect the obstacle 101 by analysis of the force data provided by the force sensor 164.

[0096] Additionally or alternatively, optical sensors can be used to monitor bending and / or changes in diameter and / or cross-sectional area or shape of the control line 70, which can be used to calculate forces acting on the control line 70 and / or medical device head portion 80.

[0097] Figure 4a shows a further embodiment of a control line driver 60 similar to the embodiments of Figures 1a-1d, 2a-2b, and 3a-3b, where the control line driver 60 further comprises a trigger 65 adapted to trigger a function of the medical device head 80 (and / or the medical device 85). In particular, the trigger 65 may include an optical fiber, a fluid transmission tube for liquid or gas, a conductive fiber or wire, or a wireless signal transmission means.

[0098] FIG. 4b shows that the control line drive after the trigger 65 stimulates the medical device 85 can perform an action 81, or for example, drug release, mechanical removal, cutting, occlusion, heating, cooling, adhesive release, and / or thrombosis induction.

[0099] FIG. 5 shows a user interface 90 for the control unit (see FIG. 9). The user interface 90 has multiple screens 91, 92, 93, 94 showing treatment and / or navigation characteristics. Here, the interface 90 comprises a first screen 91 showing the patient's vasculature V. The first screen 91 is configured as a touch screen and allows the user to define a target area G and / or a preferred trajectory T. Here, the target G is defined and the control unit automatically calculates the optimal trajectory T. The trajectory is stored as data in a memory (not shown). A second sub-screen 92 shows the vasculature with the position of the medical device 85. A third sub-screen 93 shows the control line driver parameters and provides an input interface by being configured as a touch screen. If automatically controlled, the third sub-screen can display actual values ​​such as rotation speed, device speed and / or stimulation activation (see FIG. 4a-4b). However, the user can also set a specific device speed and the control unit can automatically determine other parameters (e.g., control line release speed, magnetic force, etc.) to reach the desired value set by the user. The fourth sub-screen 94 displays the parameters of the magnetic actuator (see Figs. 10a-c and 11). As with the third sub-screen, the actual values ​​may be displayed so that the user can monitor them. If desired, the user may also set specific values. Preferred values ​​that may be displayed and / or set via the fourth sub-screen are the x-, y- and z-position and orientation in space, the displacement speed of the magnetic actuator, and / or the distance of the magnetic actuator to the patient. It will be appreciated that other parameters may additionally or alternatively be displayed or set.

[0100] 6 illustrates the concept of a medical device 85 moving within a blood vessel V to reach a target region G, where the medical device is subjected to a blood drag force F2 and a magnetic force F1. Thus, the medical device 85 moves generally in the direction of the magnetic force F1, but the drag force F2 is strong enough to move the medical device to a second position 82 and subsequently to a third position corresponding to a blood vessel branch away from the target.

[0101] 7 shows a medical device 85 navigated by a system according to the invention. The medical device head 80 is attached to a control line 70 that provides a third force F3 to the medical device in addition to the blood drag force F2 and the magnetic force F1. As the system detects the drag force F2 (see, e.g., Figs. 3a-3b), the system, via the control unit (see Fig. 9), can set the retraction force F3 and the magnetic force F1 in balance such that the total force acting on the medical device 85 moves the medical device to the second position 82 and subsequently to the third position 83 in the direction of the target area G.

[0102] 8 illustrates a system 10 according to the present invention. The system includes a controller 50 operatively connected to a magnetic actuator 40 and a control line driver 60, which may be, for example, any of the control line drivers 60 shown and described herein, and which is connected to a control line 70. The control line 70 is inserted into a blood vessel of a patient P and carries a medical device head 80, where a medical device 85 is guided to the patient's head to treat blood vessels in the brain.

[0103] Figure 9 shows a system 10 according to the invention similar to the system of Figure 8. In addition, the system shown further comprises an imaging system 11. The imaging system may be, inter alia, an ultrasound imaging system, a Doppler ultrasound imaging system, a fluoroscope, a PET scanner, a CT scanner, an MRI system or any other imaging system known in the art.

[0104] 10a-10c show schematic diagrams of different magnetic actuators 40 that can be used with any of the systems 10 described herein. The magnetic actuators 40 shown include electromagnets and magnetic field 41 controlled by a control unit (see Figs. 8 and 9) to generate a magnetic force that acts on the medical device at its location.

[0105] 10a shows a magnetic actuator 40, where the controller controls the power and electrical direction such that the magnetic field 41 is of medium strength, here indicated by the density and number of lines 41. The magnetic field is directed from top to bottom (represented by the arrows) and may have a strength of up to 75 millitesla. It will be understood that the magnetic field strength values ​​shown herein are exemplary in nature and may of course be configured to any value, particularly lower values ​​than those shown here.

[0106] Figure 10b shows the magnetic actuator 40 of Figure 10a, with the controller controlling the electromagnets such that the magnetic field strength is set to a higher value of 150 millitesla (as indicated by the higher density of lines 8) compared to the embodiment of Figure 10a, with the magnetic field direction set from bottom to top.

[0107] Figure 10c shows that the magnetic actuator 40 of Figures 10a and 10b is controlled by the control unit such that the magnetic field 41 has a strength of 75 millitesla and the direction of the magnetic field is directed from bottom to top, i.e., in the same direction compared to Figure 10b and in the opposite direction compared to Figure 10a.

[0108] FIG. 11 shows an exemplary embodiment of a system 10 according to the present invention. The system comprises a controller 50 operatively connected to three magnetic actuators 42, 43, 44 and four control line drivers 60, 60', 60'', 60'''. Each control line driver 60, 60', 60'', 60''' is connected to one control line 70, 70', 70'', 70''', respectively. Each control line 70, 70', 70'', 70''' is attached to a medical device head 80, 80', 80'', 80'''. The controller 50 is adapted to operate with several branches B1, B2. Here, the blood vessel V is the carotid artery and includes two branches B1, B2 which diverge into several branches V1, V1', V1'', V2', V2''. Each of the four medical device heads 80, 80', 80'', 80''' comprises magnetic microparticles 84 for interacting with the magnetic field 41', 41'', 41'''. The two magnetic actuators 42, 44 are arranged to generate a magnetic field 41'', 41''' each having predetermined characteristics in the first branch B1. Here, the magnetic actuator 41 generates a magnetic field 41'' that pushes the medical device into the branch V1'. In contrast, the magnetic actuator 44 generates a magnetic field 41''' that accelerates the movable element into the branch V1''. However, the magnetic actuators 42, 44 are configured to generate only a relatively weak magnetic field. By slowing down the medical device head portion 80, 80', 80'', 80''' by the control line drive 60, 60', 60'', 60''' and the control line 70, 70', 70'', 70''' to a speed lower than the blood flow speed, the magnetic field 41'', 41''' is nevertheless sufficient to guide the medical device towards the branch V1''. The control unit 50 calculates the maximum speed of the medical device head portion 80, 80', 80'', 80''' such that the control line is released at a corresponding speed such that the magnetic force exerted by the magnetic actuator 42, 44 is sufficient to guide and control the control line drive 70, 70', 70'', 70''' accordingly. In the second branch B2, another magnetic actuator 43 generates a magnetic field 41' adapted to move the medical device head portion 80, 80', 80'', 80''' towards and away from the branch V2''.The system 10 shown herein enables navigation of a medical device head 80, 80', 80'', 80''' along paths that are complex and inaccessible by two-force passive movement and / or magnetic guidance as known in the art.

[0109] Fig. 12 shows a schematic diagram of a possible operating principle of the control unit according to the invention when equipped with a feedback loop. A part of the body of the patient P is imaged by the imaging unit 11. The control unit 50 is adapted to analyze the image, for example to determine the position of the moving element relative to the branch. Based on that information, the control unit 50 controls the magnetic field and / or the control line, in particular by moving and / or powering the magnetic actuator and / or by controlling the control line drive, for example to guide the medical device according to a desired trajectory. This process can be repeated multiple times as necessary.

[0110] 13 is a schematic diagram of a force balance model that may be used in devices and systems according to the present invention. A medical device 85 is shown in a blood vessel containing a control line 70. The forces acting on the medical device 85 are as follows:

[0111] Hydrodynamic force F d gravity F g Adhesive force F adh Frictional force F f Surface F n Normal contact force on Magnetic force F ext The force F exerted by the control line 70 line Hydrodynamic force F d , gravity F g , and adhesion force F adh , frictional force F f , and surface F n The above normal contact force is the force that inherently occurs when the medical device 85 is immersed in the bloodstream.ext and force F line is artificially exerted and controlled by the system according to the invention.

[0112] The combination of the different forces mentioned above determines the velocity vector (direction and magnitude) and therefore the movement of the medical device 85 within the blood vessel V.

[0113] The motion of the medical device 85 can be described using the following equation, where m is the mass of the medical device and v r is its speed).

[0114]

number

[0115] The purpose of force balancing is to determine the necessary forces exerted by the system that, in combination with the naturally occurring forces, will produce a velocity vector suitable for moving the medical device 85 along a predetermined trajectory.

[0116] In particular, balancing the forces as described above allows for stopping, backing up, branching, and / or steering the medical device 85 within a vessel having reduced flow.

[0117] The different forces may be predetermined, estimated, directly measured, indirectly measured, or ignored.

[0118] To illustrate the above, two exemplary calculations using the above model are shown. Two sizes of medical devices (1.2 mm and 0.6 mm) are modeled for two different branches (internal carotid artery segment 1 (here ICA1-R) to internal carotid artery segment 2 (here ICA2) and ICA2 to anterior cerebral artery segment 1 (here ACA1).

[0119] The medical device head 80 having a size of 1.2 mm is 400 cm 3and placed at a distance of 45 cm to pass ICA1-R through the ICA2 branch, -6 To pass ICA2 through the ACA1 branch, a magnetic force of 8.9·10 -5 A force of N and a distance of 17 cm are required.

[0120] A similar calculation for a medical device head 80 having a size of 0.6 mm yields 3.7·10 -6 N (ICA1-R to ICA2) and 5.4·10 at 10 cm distance -5 Resulting in N(ICA2 to ACA1).

[0121] The above equation makes it possible to estimate the acceleration (ie, velocity fluctuations) of a medical device incorporating the various forces acting on it.

[0122] Typically, the force F of the control line 70 line All forces acting on device 80 are known except for . Therefore, the force balance equations can be solved in one of two ways:

[0123] The force exerted by the control line 70 is estimated and the acceleration of the medical device 85 is calculated. The acceleration of the medical device is determined and the resulting force exerted by the control line 70 is calculated.

[0124] There is an equivalence between the acceleration of the medical device head 80 and the force exerted by the control line force 70. It is possible to determine the force exerted by the control line 70 from the acceleration of the medical device 85 or to determine the acceleration of the medical device head 80 from the force exerted by the control line 70.

[0125] For example, in one configuration of the system, the velocity or acceleration of the medical device can be controlled by controlling the rate at which a control line driver (not shown) releases control line 70. The force exerted by control line 70 can be determined from the velocity / acceleration of the medical device.

[0126] 14a-15b show different embodiments of a medical device 85 having several control lines 70', 70'', 70'''.

[0127] FIG. 14a shows an embodiment of a medical device 85 having three control lines 70', 70'', 70'''. Each control line 70', 70'', 70''' is attached to a control line driver 60, 60', 60'', and can be independently controlled. The control line drivers may be separate or integrated into one unit.

[0128] Figure 14b shows the medical device 85 of Figure 14a in a fluid flow (e.g., blood), where the medical device 85 is intended to flow substantially straight with the fluid flow. Thus, all three control lines 70', 70'', 70''' exerted the same force on the medical device 80.

[0129] Figure 14b shows the medical device 85 of Figures 13a-13b during a steering operation, where control lines 70''' have been released, but control lines 70', 70'' still exert a force on the medical device head 80. As a result, the medical device 85 is steered in the direction of control lines 70', 70''.

[0130] In the illustrated embodiment, the medical device is attached to three control lines 70', 70'', 70''', which can be independently actuated by control line drives (not shown). By adjusting the tension in the different control lines, the system can change the position of the medical device in the bloodstream and vary the force acting on it.

[0131] This control helps to balance the forces acting on the medical device 85, for example, directing the medical device in the direction of flow leading to the target artery.

[0132] The tension or force on the different control lines 70', 70'', 70''' can be controlled by the release / unwind speed / movement of the different control lines.

[0133] Figure 15a shows an alternative embodiment of a medical device 85 similar to the embodiment of Figures 14a-14c, where only two control lines 70', 70'' are attached to the medical device head 80. Each control line 70', 70'' is attached to a control line driver 60, 60' and can be independently controlled.

[0134] 15b shows the medical device 85 in the bloodstream flowing substantially with the blood flow. Both control lines 70', 70'' exert substantially the same force on the medical device 85.

[0135] FIG. 15c shows the medical device 85 of 15b with the control lines 70'' loosened to steer the medical device 85 substantially as described in the context of FIG. 13c.

[0136] It will be appreciated that any number of control lines may be used depending on the intended application, and the embodiments shown in Figures 14 and 15, having three and two control lines, respectively, are exemplary in nature.

[0137] In general, a larger number of control lines may be advantageous because they allow for more versatile and precise steering. In contrast, fewer control lines may allow for easier and cheaper manufacture of the medical device and easier operation.

[0138] It is contemplated that one or more of the control lines may be configured to be rotatable, particularly to rotate the medical device. Preferably, some or all of the control lines are rotatable about the same axis.

[0139] Additionally or alternatively, the at least two control lines may be configured as helices, in particular elastic helices. Thus, rotation of the medical device may be caused by the control lines. Due to the helical shape, the control lines may exert a torque on the medical device. A release mechanism may be used to release the helical control lines.

[0140] It is also conceivable that one or more lines are adapted to pick up and / or release ballast. For example, a chamber may be adapted to be opened and closed via a control line. By opening a closed chamber, a ballast, for example saline, can be released. It is also conceivable that a closed chamber contains a gas or a vacuum, the opening of which allows blood to be withdrawn, thus increasing the weight of the medical device. In particular, a Nitinol spring may be used to open and close the chamber.

[0141] 16a shows a catheter device 100 used to deliver a medical device 85 to the general area to be treated. The medical device head 80 is attached to a control line 70 and can be navigated by any of the means described herein.

[0142] Figure 16b shows the catheter device of Figure 16a, where a balloon 101 attached to and located at the distal end of the catheter device 100 has been inflated to restrict blood flow through the blood vessel to be treated.

[0143] It will be understood that such balloons may optionally be used with any of the medical devices 85 disclosed herein. Furthermore, in addition or alternatively, any other means for controlling and / or restricting blood flow may be used, such as other inflatable means, drugs, patient orientation, and / or competition systems. The patient may be appropriately oriented and stabilized, for example, using pillows.

[0144] A competitive system may in particular be understood as a system adapted to apply pressure to the skin of a patient, the pressure being adapted to compress an artery in order to modify the blood flow, such as to reduce or stop the blood flow.

[0145] 17a shows a schematic of a medical device navigating the Circle of Willis through the internal carotid artery. In general, navigating a medical device from the internal carotid artery to the posterior communicating artery can be difficult because blood flow is typically low in the posterior communicating artery due to inflow from the posterior cerebral artery.

[0146] Figure 17b shows the medical device in substantially the same position as shown in Figure 17a. To reduce flow in the posterior cerebral artery and increase flow in the posterior communicating artery, a second medical device 100, now configured substantially as a medical device as described herein and further including an inflatable balloon 101, is introduced into the posterior cerebral artery to temporarily reduce blood flow. It will be appreciated that the second medical device may additionally or alternatively comprise or be formed by a catheter device.

[0147] By blocking or reducing blood flow in the posterior cerebral artery, blood flow from the carotid artery to the posterior communicating artery can be increased, facilitating navigation of medical devices.

[0148] It will therefore be appreciated that a system according to the present invention may include a device for reducing or controlling blood flow that is integrated into the medical device 85 and / or catheter device 100 for delivery or configured as a separate part of a system that can be deployed completely independently of the medical device 85.

[0149] FIG. 18 illustrates an alternative embodiment of a device 110 for reducing and / or controlling blood flow configured as a neck constriction device. The device 110 is configured to compress the carotid artery to reduce blood flow therein. Here, the compression device 110 is configured as a flexible ring that can be attached around the patient's neck. On the inside, the ring is divided into flexible portions that are actuatable to compress the tissue underneath. For example, mechanical compression can be achieved by inflating a balloon or by using a microactuator.

Claims

1. 1. A system (10) for moving an intravascular medical device (85) comprising a magnetic portion (84) in a head portion (80) and a control wire (70) in a back portion through a vascular network (V) to treat or diagnose a patient (P), the system (10) comprising: A magnetic actuator (40); A control unit (50); A control line driver (60) Equipped with the control line drive (60) is adapted to hold and / or release the control line (70) at different rates when the control line (70) is attached to the control line drive (60); said magnetic actuator (40) is adapted to generate a preferably predetermined magnetic field (41) at a preferably predetermined location to pull said medical device (85) in a preferably predetermined direction; The control unit (50) is adapted to balance, particularly in real time, at least three forces applied to the medical device (85), preferably including at least one of a flow drag force (F2), a force from the control line (F3), and a magnetic force (F1) by the magnetic actuator (40), and to operate the magnetic actuator (40) and / or the control line drive unit (60).

2. 2. The system of claim 1, wherein the control unit (50) is adapted to balance at least four forces applied to the medical device (85), preferably at least one of the at least four forces being one of gravity and a contact force with a blood vessel wall.

3. The system of claim 1 or 2, wherein the control unit (50) is adapted to take into account frictional forces caused by the control line (70) with the vessel wall.

4. The system according to any one of claims 1 to 3, wherein the control unit (50) is adapted to balance the contact forces, in particular frictional, adhesive and penetration forces, caused by the head unit with the vessel wall.

5. The system according to any one of claims 1 to 4, comprising at least two magnetic actuators (40, 42, 43, 44), the control unit (50) being adapted to control the at least two magnetic actuators (40, 42, 43, 44).

6. The system of any one of claims 1 to 5, wherein the control unit (50) has an interface for receiving intraoperative data from an imaging system (11), and the control unit (50) is adapted to determine the position of the medical device (85).

7. The system of any one of claims 1 to 6, wherein the control unit (50) is adapted to calculate the force based on trajectory data representative of a predetermined vascular path (T).

8. The system of claim 7, wherein the control unit has an interface (90) for a user to input the trajectory data.

9. The system of any one of claims 1 to 8, wherein the control unit (50) is adapted to control the control line drive unit (60) to slow down and / or stop the displacement of the medical device (85) when moving at least one magnetic actuator (40) to a next position.

10. The system of any one of claims 1 to 9, wherein the control line drive (60) comprises a force sensor (64).

11. The system of any one of claims 1 to 10, wherein the control line driver (60) has at least one interface (65) for triggering and / or powering at least one function (81) of the medical device (85).

12. The control line drive (60) and / or the control line (70) are embedded in a sterile mechanism. The system according to any one of claims 1 to 11,

13. 13. The system of claim 1, further comprising a plurality of control line drives (60, 60', 60'', 60'''), and the control unit (50) is adapted to operate the magnetic actuator (40) and the plurality of control line drives (60, 60', 60'', 60''') to control navigation of a plurality of medical devices (85).

14. The system according to any one of claims 1 to 13, further comprising means (110) for controlling and / or reducing blood flow in a blood vessel.

15. 15. The system of claim 1, comprising at least two control line drives (60, 60', 60''), the controller (50) adapted to independently control the at least two control line drives (60, 60', 60'').

16. A method for treating or diagnosing a patient (P) using a system (10) according to any one of claims 1 to 15, comprising the steps of: Introducing a medical device (85) into a blood vessel (V) of a patient (P); calculating a balancing force to be applied to the medical device (85) to generate a resultant force capable of moving the medical device (85) along a predetermined path (T); activating at least one magnetic actuator (40) to generate at least one magnetic field (41) at at least one predetermined location; Adapting the release rate of a control line (70) attached to the medical device (85); The method includes:

17. The method of claim 16, comprising the further step of stopping the medical device (85) before the branches (B1, B2).

Images