Robotic angioplasty

Abstract

A catheter system may be provided, wherein the catheter system may include a rolling film guide catheter and a docking unit. A docking unit may be provided for automatically inserting a plurality of devices into a rolling film guide catheter.

Description

Technical Field

[0001] The present invention relates to a catheter system and corresponding method and computer program, the catheter system comprising a docking unit for automatically inserting a plurality of devices into a rolling membrane guiding catheter. Background Art

[0002] Medical treatment of stenosis via percutaneous coronary intervention (PCI) may involve inserting a catheter into a blood vessel at the stenotic location. Usually, more than one member is introduced into the corresponding blood vessel to perform different steps of the treatment. In such a procedure, a guiding catheter may be introduced through which additional members / tools may be introduced into the blood vessel to the location of the treatment site (e.g., the stenotic site) in order to perform their respective functions there in a safe manner without directly interacting with the blood vessel wall during their insertion. Systems providing for automatic control of guiding catheters and / or other members introduced into the blood vessel may be particularly advantageous. However, there are problems in such automated catheter systems that need improvement.

[0003] Due to the insertion of a guide wire into the guide wire lumen, it is very difficult to automate a complete angioplasty procedure based on current rapid exchange and / or guide wire designs. Therefore, the insertion of new members, tools, and / or catheters into a guiding catheter that may already have been introduced requires manual labor by medical staff.

[0004] Furthermore, for hygienic reasons, any device of such a catheter system that may have come into contact with the catheter during treatment must be disposed of afterwards and replaced by a sterile substitute.

[0005] Using standard guiding catheters and / or introducer sheaths, when the guiding catheter enters an obstacle and the guiding catheter and / or introducer sheath are pushed back, it is further not guaranteed that the distal end of the guiding catheter and / or introducer sheath maintains its position. This is one of the reasons why current catheter placement is difficult to be precise.

[0006] Generally, non-automated catheter systems have various disadvantages, including for example that balloon selection (diameter and length) based on angiography is error-prone, and generally, procedures, especially those for removing and / or opening chronic total occlusions, are too time-consuming.

[0007] In summary, there is still a need to improve automated catheter systems. Summary of the Invention

[0008] The above need is at least partially met by the catheter system according to claim 1, the computer program according to claim 13, and the corresponding method.

[0009] According to one aspect of the present invention, a catheter system can be provided that includes a rolling membrane guiding catheter and a docking unit. The docking unit can be provided for automatically inserting a plurality of devices into the rolling membrane guiding catheter.

[0010] The combination of the rolling membrane catheter and the docking unit achieves various benefits: First, the insertion of the rolling membrane catheter can reduce the risk of damaging the blood vessel wall and provide a user-friendly and safe tool, thereby relaxing the requirements for automation precision. Second, using the rolling membrane catheter as a guiding catheter increases the safety during the insertion of any other device into the lumen to be treated, because the rolling membrane catheter can form a protective layer between at least one device and the blood vessel wall. Compared with other catheters, the flexibility of the rolling membrane can allow further operations to be performed by at least one device, which can rely on at least partially deformable guiding catheter to treat the blood vessel wall, for example, to widen a stenosis. In addition, the docking unit can have the advantage of being able to insert any device. This can be particularly advantageous because during treatment, it may not be obvious from the beginning which devices may be needed. Therefore, the docking unit can increase the flexibility in selecting the devices available during treatment. And due to the flexibility and additional degrees of freedom of the rolling membrane catheter, such as (partial) rolling in or out and / or (partial) inflation or deflation, the rolling membrane catheter can provide a particularly beneficial hub for automatic insertion.

[0011] In some examples, the rolling membrane catheter can include a rolling membrane, an outer shaft, and an inner shaft, wherein the rolling membrane can be connected to the distal end of the outer shaft and the distal end of the inner shaft. By providing pressure to the rolling membrane volume restricted by the inner shaft, the outer shaft, and the rolling membrane, and simultaneously moving the inner shaft distally relative to the outer shaft, the rolling membrane of the rolling membrane catheter can evert to the treatment site and beyond the treatment site in the lumen to be treated.

[0012] In an example, the docking unit can be connected to the inner shaft to allow any device introduced through the docking unit to advance unobstructed through the inner shaft to the treatment site with minimal or no interaction with the blood vessel wall, if desired. In some examples, the docking unit can receive multiple devices simultaneously, repeatedly, and / or continuously. This provides an extremely high degree of freedom in customizing treatment for the patient and / or in terms of (lack of) success in previous treatment steps. This can significantly increase the prospects of successful treatment and reduce the required treatment time and the risk of damaging the blood vessel wall and the devices used during treatment.

[0013] In some examples, the docking unit is configured as a funnel. The docking unit may include an outlet opening and an inlet opening, where the outlet opening is smaller than the inlet opening. For example, the outlet opening and the inlet opening are centered about a longitudinal axis of the docking unit, and a cross-sectional area of the outlet opening with respect to the longitudinal axis is smaller than a cross-sectional area of the inlet opening with respect to the longitudinal axis. Thus, the docking unit may be connected to the inner shaft of the rolling film guiding catheter via the outlet opening to allow at least one of the devices introduced through the inlet opening into the docking unit to be introduced into the inner shaft of the rolling film guiding catheter.

[0014] In some examples, the docking unit includes a wall between the outlet opening and the inlet opening. The wall is inclined with respect to the longitudinal axis, preferably inclined at less than 45°, more preferably inclined at less than 30°. This allows the device to easily and safely pass through the docking unit into the inner shaft of the rolling film guiding catheter.

[0015] In some additional examples, the docking unit includes a guiding channel for guiding the device from the inlet opening to the outlet opening. Preferably, each guiding channel is configured to guide a single device. For example, each guiding channel may be configured as a tunnel including tunnel walls. This allows the devices to be safely introduced into the inner shaft of the rolling film guiding catheter because the devices do not obstruct each other's movement within the docking unit due to the separation of the guiding channels.

[0016] In an example, each guiding channel includes a suitable connector to provide hydraulic and / or electrical power. Additionally, each guiding channel may include means for reading data (e.g., device identification data or data measured by the device) from the device inserted into the guiding channel.

[0017] In an example, the insertion may be automated such that no staff member is required to be present to, for example, exchange devices and / or insert new devices. This can reduce the cost per treatment, the risk associated with close contact with potentially infectious patients, the risk of staff error, etc.

[0018] In some examples, the plurality of devices to be inserted through the docking unit of the catheter system according to claim 1 includes at least one of the following: a guide wire, a dilator catheter, a balloon catheter, a stent, (another rolling film) catheter, a biopsy tool, an endoscope, an intravascular ultrasound IVUS tool, a fractional flow reserve FFR tool, and / or an optical coherence tomography OCT tool.

[0019] For example, a guidewire can be inserted via the docking unit. The guidewire can be inserted as a first guidewire, or the guidewire can already be placed within the rolling membrane guiding catheter in addition to at least one other guidewire. For example, a second guidewire can be inserted to direct another device along the second guidewire in a different direction than the first guidewire, e.g., to place an occlusion device to occlude a branch of the cardiovascular system that should not be entered by any other catheter and / or device.

[0020] In another example, a dilator catheter can be inserted via the docking unit. The dilator catheter can be used to radially expand the lumen to be treated, which can be achieved by expanding the dilator catheter and / or the conical tip of the dilator catheter to effectively increase the radius of the dilator at the treatment site as the dilator catheter is advanced distally beyond the treatment site. The dilator catheter can be made of any soft and / or at least partially compressible material to prevent damage to the blood vessel wall.

[0021] In some examples, at least one device inserted through the docking unit can be a balloon catheter. The balloon catheter can include a shaft having a balloon connected to a distal region of the balloon catheter shaft. The balloon can first be advanced through the rolling membrane guiding catheter to the treatment site and then expanded by applying pressure to the balloon, e.g., via the balloon catheter axially to the balloon, by a balloon fluid unit. The expansion can then apply a radial force to the blood vessel wall to widen the stenosis.

[0022] The device can also be, for example, a stent. Such a stent can include a mesh structure configured to expand at the treatment site to permanently stabilize and widen the stenosis. The stent can also include a medical agent continuously delivered to the surrounding tissue to inhibit, e.g., ingrowth, inflammation, and / or scar formation.

[0023] In some examples, an additional (another rolling membrane) catheter can be provided and inserted into the rolling membrane guiding catheter. The additional catheter can have a smaller diameter than the rolling membrane guiding catheter.

[0024] A biopsy tool can be any device configured to extract a tissue sample for evaluation. This can allow determination, e.g., of the texture of the stenosis to be treated to select an appropriate treatment strategy.

[0025] An endoscope can be any inspection instrument composed of, e.g., an image sensor, an optical lens, a light source, and / or a mechanical device. It can be configured to image lesions that cannot be detected by, e.g., X-ray-based imaging methods.

[0026] An IVUS tool can be any ultrasound-based device to be introduced into a patient's cardiovascular system for invasive imaging.

[0027] An FFR tool can be any diagnostic device configured to measure, e.g., the pressure difference across a stenosis.

[0028] OCT tools can be used for coronary artery imaging to visualize the lumen morphology and microstructure of the vessel wall with high resolution. Generally, a catheter based on optical fiber with a diameter of about 1 mm can be used. These can guide the catheter into the lumen to be treated via a rolling membrane.

[0029] Any additional device not described herein can be introduced through a docking unit.

[0030] In some examples, the catheter system may further include at least one fluid unit for determining the fluid state of the rolling membrane and / or at least one of the plurality of devices. Determining the fluid state of any component can provide useful control over various devices, which is compatible with the required flexibility of the catheter and / or devices used.

[0031] The fluid state can involve, for example, fluid pressure and / or fluid flow rate. The fluid can be any liquid fluid, gaseous fluid, and / or any mixture thereof. For example, the fluid unit can be a pressure pump for providing fluid pressure and / or fluid flow rate and / or a fluid sensor for sensing any parameter associated with the fluid state.

[0032] At least one fluid unit can contribute to and / or cause different modes in which, for example, the rolling membrane can be used to guide the catheter. For example, a constant fluid pressure and / or constant fluid flow rate can be provided to the rolling membrane during eversion and / or retraction of the rolling membrane to continuously maintain the rolling membrane in at least a partially inflated state, thus facilitating the rolling movement of the rolling membrane. In some examples, a closed-loop configuration can be achieved in which the fluid state is induced and sensed simultaneously.

[0033] In an example, the catheter system may further include at least one motion unit configured to determine the motion state of the rolling membrane-guided catheter, the rolling membrane, and / or at least one of the plurality of devices. At least one motion unit can provide the possibility of accurately determining the motion state of any device, possibly with a higher accuracy than that which a health professional may achieve. This can increase the chance of success and safety of the treatment.

[0034] As used herein, the term "determine" can involve initiating the corresponding state via, for example, an actuator and / or sensing the corresponding state via, for example, a sensor.

[0035] The motion state can involve, for example, the absolute and / or relative position, velocity, and / or acceleration of any catheter, device, and / or its components. For example, the motion unit can be a motion actuator for providing the motion state and / or a motion sensor for sensing any parameter associated with the motion state of any device described herein. In addition, the motion unit can supply power to the corresponding component to which it is operably coupled.

[0036] At least one motion unit may sense and / or cause motion of at least one of the catheters, devices, and / or their components used in different modes as described herein. In some examples, a closed-loop configuration may be implemented, where motion states are caused and sensed simultaneously.

[0037] For example, in a "preloading" mode, a rolling membrane of a rolling membrane-guided catheter may deliver a less performant product to and through a lesion, thereby expanding its scope and thus reducing damage to the vessel wall.

[0038] In another example, at least one motion unit of a catheter system is configured to determine a translational component of a motion state and / or a rotational component of the motion state. This may result in the necessary control of the catheter and / or device to accurately guide them through the cardiovascular system to a treatment site. This may provide the possibility of doing so without the need for manual intervention.

[0039] The translational and rotational components of the motion state may be fully isolated. For example, they may be controlled independently of each other. For example, two motion units may be provided that may be rotated 90° relative to each other. In such an exemplary configuration, one motion unit may be oriented parallel to the length axis of the controlled device and / or catheter to determine the translational component of the motion state of the controlled device and / or catheter, and a second motion unit may be oriented such that it determines the rotational component of the motion state of the controlled device and / or catheter, e.g., perpendicular to the length axis. However, the translational and rotational components may also be coupled. For example, both may be controlled by a motion unit that is not oriented at either a 0° angle or a 90° angle relative to the length axis of the controlled device and / or catheter, such that the same motion unit may cause rotation and translation simultaneously.

[0040] For example, a guidewire may have a curved tip that may be rotated towards a selected path at any bifurcation within the cardiovascular system to advance into a desired lumen via translational advancement. Additionally, any other device may be operated via translational and / or rotational operations to achieve a corresponding function. The increased degrees of freedom in operating different catheters, devices, and / or their components may increase the flexibility, accuracy, and success chances of treatment.

[0041] For example, two components may be associated with the safe and accurate advancement and / or retraction of corresponding catheters, devices, and / or their components.

[0042] In some examples, the motion unit includes a conveying roller configured to rotate about a rotation axis. The conveying roller is configured to move one of a plurality of devices into and out of the rolling film guiding conduit and / or the docking unit and / or rotate one of the plurality of devices (i.e., the controlled device) relative to the rolling film guiding conduit and / or the docking unit. If the rotation axis is perpendicular to the longitudinal axis of the controlled device, the conveying roller is configured to move the controlled device translationally. If the rotation axis is parallel to the longitudinal axis of the controlled device, the conveying roller is configured to rotate the controlled device. If the rotation axis is neither parallel nor perpendicular to the longitudinal axis of the device (i.e., the rotation axis and the longitudinal axis of the controlled device are inclined to each other at an angle greater than 0° and less than 90°), the conveying roller is configured to move and rotate the controlled device translationally.

[0043] In another example, the conveying roller is configured to rotate about a third rotation axis, where the third rotation axis is perpendicular to the first rotation axis. Rotating the conveying roller about the third rotation axis can determine whether the conveying roller is configured to move the controlled device translationally and / or rotate the controlled device. If the third rotation axis is perpendicular to the longitudinal axis of the controlled device, rotating the conveying roller about the third rotation axis determines the angle between the rotation axis of the conveying roller and the longitudinal axis of the controlled device. Thus, the ratio of translational movement and rotation of the controlled device can be adjusted: an angle of 0° between the rotation axis and the longitudinal axis of the controlled device (i.e., the rotation axis is parallel to the longitudinal axis) enables the controlled device to rotate, while an angle of 90° between the rotation axis and the longitudinal axis of the controlled device (i.e., the rotation axis is perpendicular to the longitudinal axis) enables the controlled device to move translationally along the longitudinal axis.

[0044] In some examples, at least one motion unit includes a first conveying roller configured to rotate about a first rotation axis and a second conveying roller configured to rotate about a second rotation axis, where the first conveying roller and the second conveying roller are arranged to form a gap between them along a third axis, and the first rotation axis lies in a first plane and the second rotation axis lies in a second plane, where the third axis is orthogonal to the first plane and the second plane.

[0045] In some examples, the gap is configured such that one of a plurality of devices can be arranged in the gap in a force-fitting manner along the third axis.

[0046] Thus, one of the plurality of devices can move translationally and / or rotate. Thus, the first conveying roller and the second conveying roller can move one of the plurality of devices into and out of the rolling film guiding conduit and / or the docking unit and / or rotate one of the plurality of devices relative to the rolling film guiding conduit and / or the docking unit.

[0047] In some examples, the first conveying roller and the second conveying roller are configured to be movable relative to each other along a third axis. Thus, the device can be placed between the first conveying roller and the second conveying roller in a force-fitting manner along the third axis.

[0048] In some examples, the first rotation axis and the second rotation axis are parallel. That is, if the length axis of the controlled device is orthogonal to the first rotation axis and the first conveying roller rotates about the first rotation axis in a direction opposite to the direction in which the second conveying roller rotates about the second rotation axis, the first conveying roller and the second conveying roller can translate the controlled device along the length axis. Alternatively, if the length axis is parallel to the first rotation axis and the first conveying roller and the second conveying roller rotate about the first rotation axis and the second rotation axis, respectively, in the same direction, the first conveying roller and the second conveying roller rotate the controlled device about the length axis of the controlled device.

[0049] In some examples, the projection of the first rotation axis on a plane orthogonal to the third axis and the projection of the second rotation axis on a plane orthogonal to the third axis enclose an angle between 0° and 180°. That is, the first conveying roller and the second conveying roller translate the controlled device (i.e., one of the plurality of devices) along the length axis of the controlled device and rotate the controlled device about the length axis. In the case where the first rotation axis rotates at the same speed as the second rotation axis, the projections of the co-rotating ends of the first rotation axis and the second rotation axis (i.e., the ends rotating in the same direction) in a plane orthogonal to the third axis are preferably mirror-symmetrical with the length axis of the controlled device to allow balanced and stable translation and rotation of the controlled device.

[0050] In some examples, the first conveying roller is configured to rotate about a fourth rotation axis and the second conveying roller is configured to rotate about a fifth rotation axis, where the fourth rotation axis is parallel to or the same as the third axis, and the fifth rotation axis is parallel to or the same as the third axis. By independently rotating the first conveying roller and the second conveying roller about the third axis or an axis parallel to the third axis, the arrangement of the first conveying roller and the second conveying roller can be adjusted such that one of the plurality of devices can be moved in different ways: only translation of the device, only rotation of the device, or translation and rotation.

[0051] In some examples, the first conveying roller and / or the second conveying roller includes a material (e.g., silicone) and / or a surface structure (e.g., knobs and / or grooves) configured to enhance the friction between the first conveying roller and / or the second conveying roller and one of the plurality of devices.

[0052] In some examples, at least one motion unit of the catheter system can be configured to be equipped with at least one replaceable and disposable conveyor belt. This can have the advantage that a sterile system can be provided relying on only a small number of replacements, which can reduce costs and physical labor. Providing a sterile working environment is generally required by medical standards and is thus essential for implementation.

[0053] In one example, the replaceable and disposable conveyor belt is placed around a conveyor roller. The replaceable and disposable conveyor belt can include materials (e.g., silicone) and / or surface structures (e.g., knobs and / or grooves) configured to enhance the friction between the conveyor roller and one of the plurality of devices.

[0054] As a supplement or alternative to the conveyor roller, at least one motion unit can include a conveyor belt for translationally moving and / or rotating one of the plurality of devices. The conveyor belt can be arranged as a conveyor roller. The conveyor belt can include a replaceable and disposable conveyor belt, which includes materials (e.g., silicone) and / or surface structures (e.g., knobs and / or grooves) configured to enhance the friction between the conveyor roller and one of the plurality of devices.

[0055] The catheter system can further include, for example, at least one device for identifying at least one of the plurality of devices. This can reduce the need for human intervention and even make it obsolete. This can improve efficiency and flexibility, thus allowing the introduction of the required devices.

[0056] For example, the component for identification can identify at least one of the plurality of devices by the shape of at least a part of the device to be introduced, a magnetic marker, an RFID tag, any visual code (such as a text code, a digital code, a symbol code, a QR code, a bar code, and / or a color code and / or an FTIR code). When the corresponding device is identified, it can be inserted via at least one motion unit through a docking unit. Otherwise, the operation can be stopped, for example, to increase safety.

[0057] For example, the device for identification can include at least one optical and / or mechanical sensor suitable for the corresponding code to be used, such as a bar code scanner.

[0058] In some examples, the docking unit of the catheter system can include a pressure-resistant seal. This can have the advantage of preventing any contamination of the patient's cardiovascular system while allowing the insertion of devices via the docking unit and providing pressure to the interior of the catheter (e.g., to the inner shaft of the rolling membrane catheter).

[0059] In another example, the catheter system includes a supply line that is fluidly connected to the inner shaft of the rolling membrane guiding catheter. In some examples, the docking unit may include a port that fluidly connects the supply line to the inner shaft of the rolling membrane guiding catheter. The supply line may be configured to carry a contrast agent. In some examples, the docking unit or the supply line may include a hemostatic valve for (automatically) opening or closing the port and, correspondingly, the supply line.

[0060] According to these embodiments, a fluid (e.g., a contrast agent) can be guided into the inner shaft of the rolling membrane guiding catheter. The distal end of the rolling membrane guiding catheter can be used to seal the inner shaft of the rolling membrane guiding catheter against a blood vessel.

[0061] In some examples, the catheter system may further include an imaging device and / or a device for image evaluation. The combination with the imaging device can further increase the degree of automation, such that the required manual input can be reduced, such that the image data can be directly processed by the catheter system. This can improve treatment accuracy, reliability, and speed.

[0062] The image data may include an image of the treatment site and may be acquired before and / or during the treatment, for example, by (actively) tracking the position of the vasculature and / or the catheter and / or tool used. The image evaluation device may also be configured to receive the acquired image data from the imaging device and / or image data acquired, for example, by a separate imaging device in a simultaneous and / or previous imaging session.

[0063] In some examples, the imaging unit may be at least partially based on (contrast-agent-based) X-ray angiography, computed tomography, optical coherence tomography, intravascular ultrasound imaging, and / or any combination thereof. The device for image evaluation may be adapted to evaluate any image data acquired by the imaging methods named herein and / or any other image data.

[0064] In an example, the catheter system may also be configured to determine at least one fluid and / or motion state of a component of the catheter system at least partially based on the image data. This may have the further advantage of adjusting the treatment to the precise geometry and / or texture of the treatment site to increase the chance of success and safety. Herein, a component may be a catheter, a device, and / or any of its sub-units.

[0065] Furthermore, when, for example, a balloon catheter can be used to palpate the lumen to be treated, the image data, the fluid state, and / or the motion state may also provide information regarding, for example, the geometry and / or texture of a stenosis. The corresponding feedback from the motion unit and / or the fluid unit of the palpation device may be evaluated by the control unit to extract information regarding the stenosis.

[0066] Image data can be provided by any of the imaging devices and / or imaging methods described herein. For example, the chiseling motion of the guide wire can be adjusted for the stenosis to be opened in terms of frequency, amplitude, duration, selection of the guide wire tip, and / or position relative to the stenosis. This can increase safety and reduce the time required for the procedure.

[0067] In another example, the catheter system can further include a control unit. The control unit can be operatively coupled to the catheter system for automatically and / or synchronously controlling at least one parameter associated with the motion state and / or fluid state of the rolling membrane guiding catheter and / or at least one of the plurality of devices. Any function described with reference to the control unit can also be implemented in at least one fluid unit and / or at least one motion unit, and vice versa. This can increase the likelihood of automating, for example, an action sequence that is caused via the control unit in a faster, more precise, and safer manner than a user might be able to achieve.

[0068] Any connection described herein can involve a time delay due to signal propagation time and / or processing time, and synchronization of one (sub)unit with any other (sub)unit can thus occur with a corresponding time delay. The signal can be direct and / or indirect, for example, via a control unit (such as a microprocessor, microcontroller, etc.) or provided separately.

[0069] The control unit can be adapted to implement at least one of the following functions. The catheter system can be capable of preparing all devices (e.g., via evacuation and / or flushing of the balloon lumen). For example, for checking the status of the devices (e.g., fluid state, motion state, calibration state, etc.). For performing the corresponding procedures as described herein, for monitoring critical parameters (e.g., the time the rolling membrane is in the inflated state, the fluid pressure provided to the rolling membrane, etc.) and, if an unexpected situation (deviation, such as reaching the rolling membrane burst pressure and / or encountering a completely closed stenosis) occurs, then proposing modifications (e.g., changing to a high-pressure balloon, scoring (moving a catheter with, for example, microblades through the stenotic plaque to relax the plaque, thus preparing for, e.g., using a balloon), applying lithotripsy by directly sending focused ultrasound energy or shock waves to the surrounding environment, etc.).

[0070] The control unit can be an integral part connected to the catheter system or a remote part configured to communicate with at least one fluid unit and / or at least one motion unit. The communication can, for example, include sending instructions based at least in part on at least one parameter associated with the fluid state and / or motion state of at least one component of the catheter system, and / or it can include receiving feedback / signals based at least in part on at least one parameter associated with the fluid state and / or motion state of at least one component of the catheter system.

[0071] This can be achieved, for example, in such a way that a parameter is measured by at least one fluid unit and / or motion unit, and in the adjustment of this parameter, at least one other parameter can be induced as indicated by the control unit. In a closed-loop configuration, this can relate to the same parameter, such that a parameter is continuously induced and monitored to be corrected if necessary.

[0072] Furthermore, this coupling of the units of the catheter system for synchronized operation allows the catheter system to be initiated to perform (predetermined) modes, some of which are described herein as examples. Any of the modes described herein can be automatically executed, for example, in response to a single command to initiate the corresponding mode. It can also be automatically stopped, for example, after a predetermined time or in response to at least one parameter measured by internal and / or external sensors of the catheter system, or by another command indicating the system to stop the corresponding mode.

[0073] In an exemplary constant fluid pressure mode, the control unit can maintain the fluid pressure inside the rolling membrane at a specified level for the flipping and reversion of the rolling membrane. The movement of the distal end of the rolling membrane can be controlled, for example, by moving the inner shaft of the rolling membrane catheter proximally via the corresponding motion unit. The controlled fluid pressure level can be achieved, for example, by a fluid container large enough connected to the hydraulic lumen. Furthermore, an electronic closed loop can monitor the fluid pressure level and correct the fluid pressure level via the fluid unit (including, for example, a motorized pump). In some examples, the inner shaft movement can be adjusted to increase or decrease the fluid pressure within the rolling membrane volume.

[0074] For example, in a constant fluid flow mode, the control unit can control the fluid flow entering the rolling membrane volume to be constant. The fluid unit connected to the rolling membrane volume can push hydraulic fluid into the lumen at a specific constant rate until the target volume or the maximum allowable fluid pressure is reached. The fluid pressure can be monitored simultaneously. When the maximum allowable fluid pressure level is reached, the control unit can stop the pump to avoid damaging the rolling membrane. In another example, the fluid pressure level can be controlled via the movement of the inner shaft of the rolling membrane catheter. Advancing it faster than the speed required for the corresponding fluid flow can reduce the fluid pressure. Advancing it more slowly may increase it. For a simpler solution, a simple mechanical device can be used, which can include an inflatable pump with an integrated gas pressure reservoir. For safety reasons, the fluid can be contained within a bag that can open into the rolling membrane volume. This can be done, for example, via a valve to achieve a fairly constant fluid pressure by allowing the fluid to expand when the membrane moves. To apply a higher pressure to the rolling membrane, the valve can be closed. The reversion of the rolling membrane can be performed at a reduced constant fluid pressure level while retracting the inner shaft of the rolling membrane catheter.

[0075] In another exemplary mode, the rolling membrane can be anchored to the vessel wall. If the diameter of the rolling membrane is smaller than the diameter of the blood vessel, the rolling membrane can be forced into a helical form against the vessel wall. When the inner shaft is under tension, the rolling membrane can take on a helical form. The helicity can be increased by selecting the fluid pressure level and at least partially impeding the movement of the inner shaft. The control unit can control the shape of the rolling membrane by applying a higher hydraulic fluid pressure to the rolling membrane than the hydraulic fluid pressure required for flipping. Additionally, the control unit can push the guide wire to assist in the passage of the rolling membrane. The movement of the guide wire can be used to pull the most distal end of the everted rolling membrane in the proximal direction. Thus, the guide wire and the rolling membrane can be designed to have a high frictional force between them.

[0076] In the exemplary "suction bell" mode, the control unit can control the generation of a controlled hydraulic pulse by means of the rolling membrane, which is "boosted" by pulling the guide wire and its sudden but controlled release. The rolling membrane, which can have a diameter larger than the dilated blood vessel, can be anchored to the vessel wall before narrowing. Then, the control unit can pull the proximal end of the inner shaft, thus "filling" the rolling membrane like a bow. Releasing the inner shaft may cause a sudden peak in hydraulic fluid pressure in the blood vessel directed towards the distal occlusion / treatment site.

[0077] In the exemplary chiseling mode, the control unit can increase the effectiveness of tunneling through an obstacle by concentrating the hydraulic pressure of the large balloon and / or the rolling membrane at the tip of the guide wire. The inner shaft of the rolling membrane catheter can allow the transport of a sharp tool without damaging the blood vessel. The diameter of the inflated rolling membrane can be larger than the blood vessel and can be anchored to the vessel wall before narrowing. The guide wire can have a rigid tip and can advance through the interior of the rolling membrane catheter towards the occlusion. The hydraulic fluid pressure within the volume of the rolling membrane can be reduced until the guide wire can move within the rolling membrane catheter towards the distal end of the rolling membrane and against the occlusion in the blood vessel. Then, the control unit can again increase the hydraulic fluid pressure provided to the volume of the rolling membrane to increase the friction against the guide wire. The control unit can instruct the corresponding movement unit to pull the proximal end of the guide wire. Due to the friction between the guide wire and the inflated but not yet everted rolling membrane, the membrane can "fill" like a bow. Releasing the guide wire, for example allowing it to move along a predetermined distance, may cause the tip of the guide wire to suddenly accelerate and move against the occlusion. Repeating this movement can cause a chiseling movement of the guide wire. The rolling membrane can follow the guide wire into the opening so created and can further open the fissure by applying hydraulic pressure to the vessel wall.

[0078] For example, the high-pressure inflation mode can include the control unit observing how far the rolling membrane is everted. When it may be only semi-everted, a high-pressure balloon can be placed inside, thus creating a super-high-pressure balloon. This assembly of a three-wall balloon at the treatment site can allow a combination of easy crossing, ultra-low profile, and ultra-high pressure.

[0079] For example, in the large-diameter spotting mode, the combination of an inner short balloon catheter and a larger and longer rolling membrane can allow for a more uniform movement and distribution of deformable fatty plaques. The rolling membrane and the inner balloon can be placed within the obstruction either by at least one corresponding fluid and / or motion unit or manually. The inner balloon can be inflated by applying a pressure close to the bursting pressure of the rolling membrane. The control unit (or the surgeon) can move the inflated balloon back and forth and / or forward inside the inflated rolling membrane to model the lumen. This can provide the advantage of a more uniform distribution of fatty plaques. The catheter system can be adapted to carry the required devices and automatically control / synchronize them.

[0080] For example, once any of the modes described herein may have at least partially opened the obstruction, a dedicated catheter, such as a high-pressure balloon, scoring, shock wave, IVUS, OCT, and / or FFR catheter, can be inserted through the inner shaft of the rolling membrane guiding catheter and through the lesion, which can resist further dilation. After positioning the corresponding device. The rolling membrane guiding catheter can be deflated and pulled back. The device to be inserted can be stored in a corresponding compartment near the docking unit to be available during the procedure and used as needed.

[0081] In some examples, the catheter system can also include a user interface. The control unit can also be configured to control at least one parameter associated with the motion state and / or fluid state of the rolling membrane guiding catheter and / or at least one device based at least in part on user input. This can have the advantage that patient treatment can be remotely controlled from different rooms and / or different healthcare institutions. This can reduce the amount of physical labor and increase safety, for example, when treating infectious patients. It can also allow the most suitable healthcare professional to perform the treatment independently of the geographical location where the treatment is being performed. However, the user interface can also be local, for example, allowing control to be initiated by an operator in the vicinity.

[0082] In an exemplary treatment, the catheter system may have been prepared based on, for example, CT scan analysis. Thus, the lesion to be treated is known and the intervention strategy can be clear. The necessary devices for percutaneous intervention can be provided by members of the medical staff into the corresponding compartments of the catheter system. This can include inserting and connecting all Luer connectors / connections. In an exemplary treatment, the catheters and devices used can include a rolling membrane guiding catheter and a guide wire, a dedicated dilator for accessing the right or left coronary artery, an optional high-pressure balloon for pre-dilation, an optional stent, and / or an optional post-dilation balloon. The femoral artery or the radial artery can be prepared for catheter system access for the patient. The catheter system can scan the RFID reader or barcode of the catheters in the storage rack via an identification device and can check each device against the PCI plan. It can also automatically vacuum and flush the lumen of the catheter. All sensors can be checked or calibrated if needed. The staff can finally manually attach the catheter system to the introducer sheath or guiding catheter. For example, from this point, the catheter system can be controlled by a health professional via a (remote) user interface. This can occur in different rooms and / or different health institutions. For example, using the fly-by-wire principle, the catheter system can execute the commands of the health professional input via the user interface. These commands can indicate a treatment as described herein:

[0083] The rolling membrane guiding catheter (or a rolling membrane guiding catheter with a dilator placed within the rolling membrane guiding catheter) and the guide wire can be pushed together by corresponding motion units towards the lumen to be treated. By rotation and pushing, the tip of the guide wire can be advanced into the target lumen. The rolling membrane can first expand after entering the (coronary) artery stem to be treated in an everted movement outside the guide wire. Once the rolling membrane may have entered the artery, it can be contracted and the guide wire can be retracted into the inner shaft of the rolling membrane guiding catheter. The guide wire can be controlled to remain stationary during the everted movement of the rolling membrane of the rolling membrane guiding catheter. Any other device to be introduced can be controlled and indicated accordingly.

[0084] In some examples, the catheter system may further include a primary platform and a secondary platform. The primary platform may include a guiding sheath that enters the patient's body. Additionally, the secondary platform may include a docking unit and may be configured to be movable relative to the primary platform.

[0085] For example, a catheter system can include two or more platforms. The main platform can serve as a connector between the patient and the secondary platform, which includes one or more, or substantially most or even all, of the catheters, devices, motion units, and / or fluid units described herein. The main platform can be connected to the patient via a guide sheath configured to receive a rolling membrane guiding catheter and / or any other device to be introduced into the patient's body. Additionally, an exemplary main platform can be configured to move the entire secondary platform relative to the patient, and corresponding devices can be mounted on the secondary platform. At the connection between the main platform and the secondary platform, there can be a connector with a variable length, such as a telescopic structure. Due to its variable length, the (telescopic) connector can be adapted to connect the secondary platform and the guide sheath at any time, such as when the rolling membrane guiding catheter has not been introduced, when the guiding catheter has been fully introduced into the patient's body, and / or at any point between these two states, regardless of the relative positions of the main platform and the secondary platform.

[0086] Furthermore, the connector can serve as a motion unit for determining the motion state of the outer shaft of the rolling membrane guiding catheter. The connector can also be configured to reduce its length as it moves forward to introduce, for example, the outer shaft of the rolling membrane guiding catheter into the patient's body. During this insertion, the entire secondary platform can move towards the patient and relative to the main platform together with the outer shaft. The secondary platform can include, for example, at least one motion unit operatively coupled to the inner shaft of the rolling membrane guiding catheter and / or multiple devices. It can also include at least one fluid unit configured to provide fluid pressure to the rolling membrane of the rolling membrane guiding catheter and / or multiple devices. It can also include a docking unit and a storage compartment for storing devices that may be needed during treatment and can be introduced through the docking unit. Other exemplary main platforms and secondary platforms can include any other devices described herein, and the functions described with reference to one platform can also be implemented in the other platform.

[0087] The secondary platform can be supported by the main platform, for example, such that the main platform is larger than the secondary platform, and the secondary platform can be movably mounted to the main platform, thereby allowing the secondary platform to move on the main platform. This can result in a closed and / or stable system with high flexibility.

[0088] According to another aspect of the present invention, a computer program including instructions can be provided. When the program is executed, it can cause the catheter system to automatically couple at least one fluid unit and at least one motion unit of the rolling membrane guiding catheter and / or at least one device for synchronous operation. The automatic coupling can be at least partially based on the motion state and / or fluid state of the rolling membrane guiding catheter and / or at least one device.

[0089] In one example, a computer program may cause a catheter system to perform any of the modes and / or any steps of the modes described herein. Any feature described with respect to a mode and / or feature of the catheter system may also be implemented in accordance with the instructions of the computer program and / or steps of the method, and vice versa.

[0090] In another example, the computer program may include additional instructions. When the program is executed, these may cause at least one motion unit and / or at least one fluid unit to determine the fluid state and / or motion state of a rolling membrane guide catheter and / or at least one device such that a predetermined function is performed. This may relate to any of the predetermined functions, modes, and / or functionalities described herein. This has the advantage of further automating the corresponding program to increase reliability, accuracy, treatment speed, and safety.

[0091] In some examples, the computer program may also include an interface for receiving image data of a treatment site. It may select at least one control parameter at least in part based on the image data, where the selection is at least in part based on a model that has been trained with a plurality of training data sets. Each training data set may include image data of the treatment site, at least one control parameter associated with a corresponding catheter operation, and optionally a performance value. This can be a beneficial application of artificial intelligence (e.g., machine learning) to select parameters for treatment based on the connection between the information available on the patient and the planned treatment that may not be understood by a health professional.

[0092] In an example, a computer program for causing a chiseling motion of a guide wire may be provided, further including an interface for receiving image data of a stenosis and selecting at least one control parameter at least in part based on the image data. Selecting at least one control parameter in an automated manner can improve safety, the applicability of the at least one control parameter, and reduce the risk of incorrect image assessment by a health professional operating the rolling membrane catheter.

[0093] Such image data may be evaluated, for example, by comparison with images of previously treated stenoses to adjust treatment parameters associated with the chiseling motion, such as frequency, amplitude, position relative to the stenosis and / or the catheter used, e.g., at least in part relative to the position, shape, and / or texture of the stenosis.

[0094] An exemplary computer program may also cause the selection of the at least one parameter to be at least in part based on a (machine learning) model that has been trained with a plurality of training data sets, each training data set including image data of a stenosis, at least one control parameter that has been used to remove the stenosis, and optionally a performance value. Similarly, a corresponding computer program may be provided to provide at least one parameter associated with any other action performed by the catheter.

[0095] The evaluation of the narrow image data and the corresponding parameter selection can be based on training via machine learning, for example, techniques such as linear regression, logistic regression, decision tree, support vector machine (SVM) algorithm, naive Bayes algorithm, k-nearest neighbor algorithm, k-means, random forest algorithm, dimensionality reduction algorithm, gradient boosting algorithm, and adaptive boosting algorithm. This can facilitate the selection of appropriate treatment parameters without the need for time-consuming and potentially error-prone image evaluation procedures.

[0096] On the other hand is a computer-implemented method for training an artificial intelligence model to predict at least one control parameter for treating stenosis (e.g., as outlined herein). The method can include: inputting a plurality of training data sets into the model to train the model, each training data set including narrow image data, at least one control parameter that has been used to remove the stenosis, and optionally a performance value.

[0097] The model can be based on techniques such as linear regression, logistic regression, decision tree, support vector machine (SVM) algorithm, naive Bayes algorithm, KNN algorithm, k-means, random forest algorithm, dimensionality reduction algorithm, gradient boosting algorithm, and AdaBoosting algorithm.

[0098] On the other hand is a computer-implemented method for predicting at least one control parameter for treating stenosis (e.g., as outlined herein). The method can include: using an artificial intelligence model that has been trained as outlined herein to predict at least one control parameter based on the narrow image data.

[0099] On the other hand can be training data for training an artificial intelligence model for predicting at least one control parameter for treating stenosis. The training data can include a plurality of training data sets, each training data set including narrow image data, at least one control parameter that has been used to remove the stenosis, and optionally a performance value. On the other hand relates to the use of such training data for training an artificial intelligence model for predicting at least one control parameter for treating stenosis.

[0100] A computer program as outlined herein can be executed by a corresponding catheter having a processing unit (e.g., a microcontroller, a microprocessor, etc.). In other examples, an external processing unit can execute the program, and the catheter as outlined herein can be coupled to the program, for example, wirelessly and / or in a wired manner.

[0101] Note that all functions described herein can be implemented as corresponding functions (devices) of the devices described herein, corresponding steps of the methods outlined herein, and / or corresponding instructions of the computer programs outlined herein. Even though described with reference to a device, a method, and / or a computer program, the aspects outlined herein can be applied to the corresponding other of a device, a method, and / or a computer program. BRIEF DESCRIPTION OF THE DRAWINGS

[0102] The drawings of the present disclosure illustrate the following:

[0103] Figure 1 Exemplary embodiments of a catheter system include a guiding catheter and a plurality of additional catheters.

[0104] Figure 2 Another exemplary embodiment of a catheter system includes a guiding catheter and a plurality of additional catheters.

[0105] Figure 3 An exemplary embodiment of a rolling membrane catheter as a guiding catheter of a catheter system.

[0106] Figure 4 Schematic diagram of an exemplary configuration of a catheter system and an operating device.

[0107] Figure 5A -The G-schematic diagram shows the introduction of a rolling membrane guiding catheter into the cardiovascular system, wire rotation, advancement of the rolling membrane guiding catheter and the wire into and beyond the treatment site, dilation of an exemplary stenosis by a dilator catheter, retraction of the dilator catheter and the wire, and flipping of the rolling membrane of the rolling membrane guiding catheter to widen the stenosis.

[0108] Figures 6A - 6C Exemplary arrangement of two delivery rollers for translational movement and / or rotation of a device. DETAILED DESCRIPTION

[0109] Figure 1 An exemplary embodiment of a catheter system 100 is shown. The exemplary catheter system 100 includes a main platform 110, and the main platform 110 includes a guiding sheath 111. It further includes a secondary platform 120, wherein the secondary platform 120 is configured to move relative to the main platform 110 such that the components of the secondary platform 120 are movable relative to the guiding sheath 111 and can thus be inserted into a patient.

[0110] A telescopic connection element 131 may be provided to allow for sealed insertion into a patient regardless of the relative distance between the main platform 110 and the secondary platform 120. The connection element 131 may be adapted as a motion unit, which may cause a corresponding relative movement, for example, when the guiding catheter is to be introduced into a blood vessel to be treated. However, in other examples, the connection element 131 may be implemented as a passive element adapted based on a relative movement that can be driven by a separate motion unit.

[0111] Figure 1The catheter system 100 includes a rolling membrane catheter as the guiding catheter 130. The guiding membrane catheter 130 can be controlled by several devices: The motion unit 131 can control the motion state of the outer shaft of the rolling membrane guiding catheter 130, and the devices (such as valves, openings, etc.) for connecting to the fluid unit 132 control the fluid state, for example, providing fluid pressure to the rolling membrane, and another motion unit 133 controls the motion state of the inner shaft of the rolling membrane guiding catheter 130. In an exemplary embodiment, the inner shaft of the rolling membrane guiding catheter 130 can be operably coupled to the docking unit 140.

[0112] Additional components can be introduced into the guiding catheter 130 via the docking unit 140. First, the guide wire 150 controlled by the guide wire motion unit 151 can guide the guiding catheter 130 and other wire-mounted components, such as the dilator catheter 160 controlled by the dilator motion unit 161 in this exemplary embodiment. In addition, Figure 1 The exemplary embodiment of shows additional exemplary catheters 170, 180 controlled by their respective motion units 171, 181. The additional catheters 170, 180 can be introduced parallel to and independently of the guide wire 150. All different catheters 130, 160, 170, 180 and the guide wire 150 can be controlled independently of each other and / or in a synchronized manner via Figure 1 an external or internal control unit not shown in. Generally, Figure 1 All the motion units 133, 151, 161, 171, 181 of the exemplary embodiment of can include belts or wheels via which the motion state of the corresponding components is determined. The used belts or wheels can be easily replaced by new sterile belts and wheels respectively.

[0113] Figure 2 shows another exemplary embodiment of the catheter system 100. In Figure 2 the example of, the docking unit 140 includes another port for fluidly connecting the supply line 141 to the inner shaft of the rolling membrane guiding catheter 130. The supply line 141 is configured to carry, for example, a contrast agent. The supply line 141 includes a valve 142 that is respectively used to (automatically) open and close the supply line 141.

[0114] Figure 3 shows an exemplary embodiment of the guiding catheter 130. In Figure 3In the example, the guide catheter 130 is a rolling membrane catheter having a rolling membrane 136 that is connected to the distal ends of the inner shaft 135 and the outer shaft 134. The exemplary guide catheter 130 includes a guide wire 150 controlled by a motion unit 151. The motion unit 151 can cause axial translation as well as rotation about the longitudinal axis to advance the guide wire 150 through the lumen to and / or beyond the treatment site. Accordingly, the introduction of any component of the guide catheter 130 must follow the path of the guide wire 150. The guide catheter 130 is introduced into the blood vessel via a motion unit 131 that drives the outer shaft 134 in the distal direction. In Figure 3 this example, the rolling membrane 136 is partially everted through the blood vessel and through the stenosis S. The fluid unit 132 provides sufficient pressure to the volume between the inner shaft 135 and the outer shaft 134, which volume is bounded by the rolling membrane 136 at the distal end. This holds the rolling membrane 136 in an inflated state such that when the inner shaft 135 moves distally relative to the outer shaft 134, the eversion of the rolling membrane 136 can occur in a rolling motion. The movement of the inner shaft 135 is caused by a motion unit 133. The pressure provided to the rolling membrane 136 can provide sufficient pressure via the inflated rolling membrane to the stenosis S to widen the stenosis. Other devices such as a stent, a balloon, etc. can be introduced into the site of the at least partially widened stenosis S to further widen the stenosis S. The rolling membrane 136 can be retracted in a reverse motion, where the rolling membrane 136 is in at least a partially inflated state and the inner shaft 135 is moved proximally by the motion unit 133. When the guide wire is retracted at the same speed as the inner shaft, the procedure can be interrupted when the distal tip of the rolling membrane has been retracted a few millimeters. The rolling membrane can be temporarily decompressed to be able to push the guide wire back to its initial position via the guide wire ribbon.

[0115] Figure 4 A schematic representation of an exemplary configuration of a catheter system 100 within an operating environment is shown. The operating environment can include a control unit 200, a user interface 300, artificial intelligence 400, and an imaging device 500. Wherein, the user interface 300, the optional artificial intelligence 400, and the optional imaging device 500 can be configured to exchange signals with each other to provide a common output that is provided to the control unit 200 and receive an input from the control unit 200. Then, the control unit can send signals to and / or receive signals from the catheter system 100 at least in part based on the output, as described herein. Any other configuration is also possible, where any one of these building blocks is not included or replaced by other devices, and / or where the signal conduction paths between the shown building blocks are changed, e.g., in terms of direction and which building blocks communicate directly.

[0116] Figures 5A - 5G is shown by according to Figure 1A plurality of schematic representations of snapshots of an exemplary treatment of a stenosis S by a catheter system, the catheter system including Figure 3 a rolling membrane guide catheter 130, a dilator catheter 160, and a guide wire 150.

[0117] Figure 5A A schematic diagram showing the introduction of the rolling membrane guide catheter 130 into the cardiovascular system. This can be caused by at least one motion unit 131 ( Figure 5A not shown in the figure).

[0118] Figure 5B A schematic diagram showing the rolling membrane guide catheter 130 being advanced into the cardiovascular system op to a position where the blood vessel divides into two vessels. The flexible tip of the guide wire 150 is pushed by the band 151 outside the dilator catheter 160 until it is necessary to engage the bifurcation.

[0119] Figure 5C A schematic diagram showing the rotation of the guide wire 150 to direct the bent tip of the guide wire 150 towards the treatment site (stenosis S). This can be caused by at least one guide wire motion unit 151 ( Figure 5C not shown in the figure). Thereby, the intended advancement of the guide wire 150 is prepared to guide the catheter 130 to the stenosis S. The dilator catheter 160 continuously creates a bending moment from the soft guide wire 150 to the stiffer distal end of the guide catheter 130 in the undeployed state, enabling the guide wire 150 to guide the guide catheter 130.

[0120] Figure 5D A schematic diagram showing the rolling membrane guide catheter 130 and the guide wire 150 advancing to and beyond the treatment site. During its advancement, the rolling membrane guide catheter 130 follows the guide wire 150, and the guide wire 150 can control its advancement by rotating the bent tip accordingly.

[0121] Figure 5E A schematic diagram showing the dilation of an exemplary stenosis S by the dilator catheter 160. The dilator catheter 160 has a tapered tip to create the bending moment as described above and can also be configured to widen the stenosis S when the tip advances into and beyond the stenosis. During the exemplary treatment, the dilation performed by the dilator catheter can be used as a pre - dilation to prepare for the following steps (the pre - dilation of the dilator catheter is optional).

[0122] Figure 5F A schematic diagram showing the retracted dilator catheter 160 and the guide wire 150. They can both be retracted into the rolling membrane guide catheter 130 or completely removed through a docking unit 140 ( Figure 5F not shown in the figure). If the guide wire has passed through the lesion, the guide wire can also be left in the stenosis for the next step.

[0123] Figure 5GShows a schematic diagram of the flipping of the rolling membrane 136 of the rolling membrane guiding catheter 130 to widen the stenosis S. The fluid unit 132 ( Figure 5F not shown in) can provide fluid pressure to the rolling membrane volume to evert the rolling membrane 136, thereby applying pressure to the stenosis S and widening the stenosis S. The catheter system 100 can be removed after this final step, or further measures can be taken, such as placing a stent.

[0124] Figures 6A - 6C Shows different arrangements of the first conveying roller 610 and the second conveying roller 620. The first conveying roller 610 and the second conveying roller 620 are part of a motion unit for controlling the motion state of the catheter 630 including the length axis 631. The first conveying roller 610 can rotate clockwise and counterclockwise about the first rotation axis 611. The second conveying roller 620 can rotate clockwise and counterclockwise about the second rotation axis 621. Each of the first conveying roller 610 and the second conveying roller 620 includes silicone sheaths 612, 622, which increase the friction between the catheter 630 and the first conveying roller 610 and the second conveying roller 620 and protect the catheter 630 from damage and contamination. The silicone sheaths 612, 622 are detachably connected to the first conveying roller 610, the second conveying roller 620 respectively, such that the silicone sheaths 612, 622 can slide into and out of the conveying rollers.

[0125] The first conveying roller 610 and the second conveying roller 620 can move along the z-axis to form a gap between the first conveying roller 610 and the second conveying roller 620, and the catheter 630 is fitted into the gap in a force-fitting manner. In addition, the first conveying roller 610 and the second conveying roller 620 can rotate about an axis parallel to the z-axis.

[0126] Figure 6A Shows a cross-sectional view of the first arrangement. The first conveying roller 610 rotates clockwise (as indicated by the arrow 613) about the first rotation axis 611 parallel to the y-axis. The second conveying roller 620 rotates counterclockwise (as indicated by the arrow 623) about the second rotation axis 621 parallel to the y-axis. Therefore, the catheter 630 moves translationally along its length axis 631, as indicated by the arrow 632.

[0127] Figure 6B Shows a cross-sectional view of the second arrangement. The first conveying roller 610 rotates clockwise (as indicated by the arrow 614) about the first rotation axis 611 parallel to the x-axis. The second conveying roller 620 rotates clockwise (as indicated by the arrow 624) about the second rotation axis 621 parallel to the x-axis. Therefore, the catheter 630 rotates about its length axis 631, as indicated by the arrow 633.

[0128] Figure 6CShows a top view of a third arrangement. The first rotation axis 611 and the longitudinal axis 631 of the conduit 630 enclose an angle α in the x-y plane, while the second rotation axis 621 and the longitudinal axis 631 of the conduit 630 enclose an angle -α in the x-y plane. In other words, the projection of the first rotation axis 611 in the x-y plane is mirror-symmetrical with respect to the longitudinal axis 631 of the conduit 603 as compared to the projection of the second rotation axis 621 in the x-y plane. The first rotation axis 611 rotates as indicated by the arrow 615. The second rotation axis 621 rotates as indicated by the arrow 625. Thus, the left end of the first conveying roller 616 rotates in the same direction as the left end of the second conveying roller 626, while the left end of the first conveying roller 616 rotates in the opposite direction to the right end of the second conveying roller 627. Consequently, the conduit 630 moves in a translational motion along its longitudinal axis 631, as indicated by the arrow 634, and rotates about its longitudinal axis 631, as indicated by the arrow 635.

Claims

1. A catheter system (100), comprising: A rolling membrane guiding catheter (130); A docking unit (140) for automatically inserting a plurality of devices (150, 160, 170, 180) into the rolling membrane guiding catheter (130).

2. The catheter system (100) according to claim 1, wherein the plurality of devices (150, 160, 170, 180) includes at least one of the following: a guide wire (150), a dilator catheter (160), a balloon catheter, a stent, another rolling membrane catheter, a biopsy tool, an endoscope, an intravascular ultrasound IVUS tool, a fractional flow reserve FFR tool, and / or an optical coherence tomography OCT tool.

3. The catheter system (100) according to claim 1 or 2, further comprising at least one fluid unit (132), the at least one fluid unit (132) being configured to determine the fluid state of at least one of the rolling membrane (136) and / or the plurality of devices (150, 160, 170, 180).

4. The catheter system (100) according to any one of claims 1 to 3, further comprising at least one motion unit (131, 133, 151, 161, 171, 181), the at least one motion unit being configured to determine the motion state of at least one of the rolling membrane guiding catheter (130), the rolling membrane (136), and / or the plurality of devices (150, 160, 170, 180).

5. The catheter system (100) according to claim 4, wherein the at least one motion unit (131, 133, 151, 161, 171, 181) is configured to determine the translational component of the motion state and / or the rotational component of the motion state.

6. The catheter system (100) according to claim 4 or 5, wherein the at least one motion unit (131, 133, 151, 161, 171, 181) is configured to be provided with a replaceable and / or disposable conveyor belt.

7. The catheter system (100) according to any one of claims 1 to 6, further comprising at least one device for identifying at least one of the plurality of devices (150, 160, 170, 180).

8. The catheter system (100) according to any one of claims 1 to 7, wherein the docking unit (140) includes a pressure-resistant seal.

9. The catheter system (100) according to any one of claims 1 to 8, further comprising an imaging device for providing image data (500) and / or a device for image evaluation of the image data.

10. The catheter system (100) according to claim 9, further being configured to determine the fluid state and / or the motion state at least partially based on the image data.

11. The catheter system (100) according to any one of claims 1 to 10 further comprises a control unit (200) operably coupled to the catheter system (100) for automatically and / or synchronously controlling at least one parameter associated with the motion state and / or fluid state of the guiding catheter and / or at least one of the plurality of devices (150, 160, 170, 180).

12. The catheter system (100) according to claim 11 further comprises a user interface (300), wherein the control unit (200) is further configured to control the at least one parameter at least in part based on user input.

13. The catheter system (100) according to any one of claims 1 to 12 further comprises a main platform (110) and a secondary platform (120), wherein the main platform (110) includes a guiding sheath (111) inserted into a patient's body, and the secondary platform (120) includes the docking unit (140) and is configured to be movable relative to the main platform (110).

14. A computer program comprising instructions which, when executed, cause the catheter system (100) according to any one of claims 3, 4 or 5 to 13, when claims 3 or 4 are cited, to automatically couple at least one fluid unit (132) and at least one motion unit (131, 133, 151, 161, 171, 181) of the rolling membrane guiding catheter (130) and / or the at least one device (150, 160, 170, 180) for synchronous operation.

15. The computer program according to claim 14 further comprises instructions which, when executed, cause the at least one motion unit (131, 133, 151, 161, 171, 181) and / or the at least one fluid unit (132) to determine the fluid state and / or motion state of the rolling membrane guiding catheter (130) and / or the at least one device (150, 160, 170, 180) such that at least one of a plurality of predetermined functions is executed.

Images