Scroll membrane catheter with at least partially automated scroll membrane pressure and guidewire retraction

Abstract

A scroll membrane catheter may be provided that includes a first scroll membrane. The scroll membrane catheter may also include a motion unit for determining a state of motion of the first scroll membrane. The scroll membrane conduit may be adapted to couple with a fluid unit for determining a fluid pressure and / or fluid flow of the first scroll membrane. The scroll membrane conduit may also be adapted such that the fluid unit and the motion unit are automatically coupled for synchronous operation based at least in part on the state of motion, fluid pressure, and / or fluid flow.

Description

Field of the Invention

[0001] The present invention relates to a rolling membrane catheter for automation comprising a fluid unit, a motion unit and / or a guide wire unit, and a corresponding method and computer program. 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. A rolling membrane catheter allows the catheter to be inserted into a stenotic cavity by flipping a rolling membrane during the unrolling process. Typically, in a first step, a guide wire is introduced into the blood vessel and guided to the treatment site, such as the stenotic location. The rolling membrane of the rolling membrane catheter can be flipped, for example, by providing pressure to the interior of the rolling membrane and moving one end of the rolling membrane distally. This may cause the rolling membrane to flip along the blood vessel wall, for example, without substantial friction. One end of the rolling membrane may be attached to, for example, an inner shaft, which moves distally when the rolling membrane attached to the distal end of the inner shaft flips. This causes the rolling membrane to flip towards the stenosis and possibly past the stenosis in the distal direction. The inserted rolling membrane can, for example, widen the stenosis or provide a guiding catheter for other devices to be introduced into the blood vessel at the location of the stenosis.

[0003] However, there are some issues to note when using a rolling membrane catheter.

[0004] Firstly, flipping the rolling membrane will be accompanied by a certain pressure applied to the rolling membrane. If the user (e.g., a health professional introducing the catheter) sets too high a pressure, the burst pressure of the rolling membrane may be exceeded, such that the rolling membrane may burst within the patient's cardiovascular system. Frictionless retraction of the rolling membrane is no longer possible, and if the friction exceeds the tensile strength of the catheter main body, this may lead to embolization of the device components.

[0005] Secondly, if used together with a guide wire, the rolling membrane generally clamps the guide wire when in the inflated state. Due to the flipping movement of the rolling membrane, the forward speed of the guide wire is twice that of the leading edge of the flipping rolling membrane. This requires special care to control the advancement of the guide wire in order to avoid the risk of perforating the patient's cardiovascular system.

[0006] Thirdly, during retraction of the rolling membrane through a container, a certain pressure is required inside the rolling membrane. In the case of too low a pressure during retraction of the rolling membrane or inside the rolling membrane, the rolling membrane may become unusable or damaged during retraction. Therefore, special care is needed to control the retraction of the rolling membrane.

[0007] Therefore, there is still a need to improve the rolling membrane catheter. Summary of the Invention

[0008] Aspects as described herein at least partially meet the above needs.

[0009] According to a first aspect, a scroll membrane catheter having a first scroll membrane can be provided. The scroll membrane catheter can further include a motion unit for determining a motion state of the first scroll membrane. The scroll membrane catheter can be adapted to be coupled to a fluid unit for determining a fluid pressure and / or a fluid flow rate of the first scroll membrane.

[0010] Since the volume to be inflated provided by the scroll membrane can increase during the flipping of the scroll membrane and decrease during the retraction of the scroll membrane, it may be advantageous to determine the fluid pressure and / or the fluid flow rate at least partially based on the motion state and vice versa. For example, when an overly high fluid pressure is provided, the scroll membrane may burst, and when an overly low pressure is provided, the scroll membrane may fold and / or be compressed and flip or retract in a non-ideal manner. Therefore, determining the motion state and / or the fluid pressure and / or the fluid flow rate of the first scroll membrane is beneficial because it allows for the safe operation of the scroll membrane catheter, such as the operation of the scroll membrane catheter in a non-critical motion state and / or fluid pressure and / or fluid flow rate, in which the scroll membrane does not burst or kink. Additionally, it can allow for user-friendly and flexible control of the scroll membrane catheter and a reduction in treatment time.

[0011] Generally speaking, as used herein, the term 'fluid state' can relate to the fluid pressure and / or the fluid flow rate provided to the volume encapsulated by the scroll membrane. The fluid can be a liquid and / or a gas. The term "motion state" can relate to one or more parameters, such as the position, velocity, acceleration characterizing the motion state of the scroll membrane (e.g., relative to the outer axis of the catheter), or any average value of these parameters over time. Additionally, the term "determine" (the state or the corresponding parameter) can relate to measuring and / or setting (the state or the corresponding parameter).

[0012] In one example, the fluid unit can include means configured to set the fluid state of the scroll membrane, for example, by providing a constant or varying fluid pressure and / or a constant or varying fluid flow rate. In another example, the fluid unit can include a sensor for sensing a parameter associated with the fluid state. The fluid unit can also include a plurality of sub-units, for example, at least one sensor for sensing a parameter associated with the fluid state and / or at least one means configured to set the fluid state, for example, a pressure pump and / or a pressure reservoir configured to provide a constant or varying fluid pressure and / or a constant or varying fluid flow rate. The fluid unit can be coupled to the scroll membrane catheter, for example, via a tube.

[0013] In one example, the motion unit may include a device configured to set a motion state, such as an actuator, which sets a specific position and causes motion with a constant or varying speed and / or a constant or varying acceleration. Additionally or alternatively, the motion unit may include a sensor that senses one or more parameters associated with the motion state, such as the position of the rolling film, for example, by measuring the relative displacement between the inner shaft and the outer shaft of the rolling film conduit, the speed of the rolling film or other components of the rolling film conduit, or the acceleration of the rolling film or other components of the rolling film conduit. Generally, the motion unit may also include a plurality of subunits, such as at least one sensor that senses parameters (such as position, speed, and / or acceleration) and / or at least one actuator that sets parameters (such as position, speed, and / or acceleration) and causes a corresponding motion of the rolling film.

[0014] In one example, the rolling film conduit and / or the motion unit may include a control unit, where the control unit is communicatively coupled to the motion unit or a subunit of the motion unit (e.g., an actuator or a sensor) and the fluid unit or a subunit of the fluid unit (e.g., a pressure pump or a sensor).

[0015] In some examples, the rolling film conduit is adapted to output a warning signal based on the motion state and / or the fluid pressure and / or the fluid flow rate.

[0016] The fluid state may be sensed by a sensor of the fluid unit, for example, in response to a specific motion state determined by the motion unit. Then, it may provide feedback to the operator, for example, to indicate whether the fluid state is within an acceptable range of the motion state (or vice versa). This may be done, for example, via a display, an acoustic signal, etc. For example, a warning signal may be output when any value exceeds a predetermined threshold. Such a threshold may depend on the motion state (fluid state).

[0017] The motion state may be sensed by a sensor of the motion unit, for example, in response to a certain fluid state determined by the fluid unit. Then, it may provide feedback to the operator, for example, to indicate whether the motion state is within an acceptable range of the fluid state (or vice versa). This may be done, for example, via a display, an acoustic signal, etc. For example, a warning signal may be output when any value exceeds a predetermined threshold. Such a threshold may depend on the fluid state (motion state).

[0018] In one example, the rolling film conduit may include a lamp and / or a display for showing a visual warning signal and / or a device for outputting an acoustic warning signal (e.g., a speaker) and / or a device for outputting a vibration that can be haptically sensed by the user as a warning signal.

[0019] In one example, the scroll membrane catheter and / or the motion unit may include a control unit, where the control unit is communicatively coupled to the motion unit or a subunit of the motion unit (e.g., an actuator or a sensor) and the fluid unit or a subunit of the fluid unit (e.g., a pressure pump or a sensor). The control unit is configured to trigger a warning signal. The warning signal is then output by means for outputting the warning signal (e.g., a light, a display, a speaker, and / or a means for outputting vibration, which can be tactilely sensed by the user as a warning signal). The control unit may be communicatively coupled, either wired or wirelessly, to the motion unit or a subunit of the motion unit, the fluid unit or a subunit of the fluid unit, and / or the means for outputting the warning signal.

[0020] Accordingly, once the scroll membrane catheter approaches a critical motion state and / or fluid pressure and / or fluid flow rate during operation, a warning signal can be output.

[0021] Any such configuration may allow for user-friendly operation of the scroll membrane catheter, as the motion state and / or fluid state are measured during operation and the motion state and / or fluid state are indicated, for example, on a display, or a warning signal is sent if a critical threshold is likely to be approached. Generally, any such automation can improve safety, for example, by preventing the scroll membrane from bursting or kinking, allow for user-friendly and flexible control of the scroll membrane catheter, and may reduce treatment time.

[0022] In some examples, the scroll membrane catheter is adapted to automatically couple the fluid unit and the motion unit for synchronous operation based at least in part on the motion state, fluid pressure, and / or fluid flow rate.

[0023] Since the desired fluid pressure and / or fluid flow rate of the scroll membrane may depend on the motion state of the scroll membrane, synchronizing the operation of the motion unit and the fluid unit based at least in part on the motion state, fluid pressure, and / or fluid flow rate can significantly improve the operation of the scroll membrane catheter. For example, the motion state of the scroll membrane can be automatically coupled to the fluid pressure provided to the scroll membrane. Since the volume to be inflated provided by the scroll membrane may increase during the flipping of the scroll membrane and decrease during the retraction of the scroll membrane, it may be advantageous to determine the fluid pressure and / or fluid flow rate based at least in part on the motion state, and vice versa. For example, when an overly high fluid pressure is provided, the scroll membrane may burst, and when an overly low pressure is provided, the scroll membrane may fold and / or be kinked and flip or retract in a non-ideal manner. Accordingly, it may be beneficial to automatically couple the fluid unit and the motion unit for synchronous operation based at least in part on the motion state, fluid pressure, and / or fluid flow.

[0024] In one example, a fluid unit and a motion unit, each of which may include one or more subunits, are coupled for synchronous operation. Synchronization of the fluid unit and the motion unit may depend on signaling between the two units and / or between subunits of the motion unit and / or the fluid unit. One or more individual subunits of each unit may also be further coupled for synchronous operation. In one example, the coupling may be achieved via means configured to transmit signaling between the fluid unit and the motion unit or between any of their subunits. Signal transmission may be directed in either way. Additionally, it is possible to signal simultaneously or alternately in both directions. The coupling may involve a time delay due to signal propagation time and / or processing time, and synchronization of one (sub)unit with any other (sub)unit may thus occur with a corresponding time delay. Signaling may be direct and / or indirect, e.g., via a control unit (such as a microprocessor, a microcontroller, etc.), which may be part of a wound film conduit (e.g., a subunit of the motion unit) or provided separately.

[0025] As an example, the control unit may be implemented as a "processing system" including one or more processors. Examples of processors include microprocessors, microcontrollers, graphics processing units (GPUs), central processing units (CPUs) application processors, digital signal processors (DSPs), reduced instruction set computing (RISC) processors, system on a chip (SoCs), baseband processors, field programmable gate arrays (FPGAs), programmable logic devices (PLDs), state machines, gated logic, discrete hardware circuits, and other suitable hardware configured to perform the various functions described throughout this disclosure. One or more processors in the processing system may execute software. Whether referred to as software, firmware, middleware, microcode, hardware description language, or other terms, software should be construed broadly to mean instructions, instruction sets, code, code segments, program code, programs, subprograms, software components, applications, software applications, software packages, routines, subroutines, objects, executable files, execution threads, processes, functions, etc.

[0026] Accordingly, in one or more example embodiments, the described functionality may be implemented in hardware, software, or any combination thereof. If implemented in software, the functionality may be stored on or encoded as one or more instructions or code on a computer-readable medium. Computer-readable media includes computer storage media. Storage media can be any available media that can be accessed by a computer. By way of example and not limitation, such computer-readable media can include random access memory (RAM), read only memory (ROM), electrically erasable programmable ROM (EEPROM), optical disk storage, magnetic disk storage, other magnetic storage devices, combinations of the aforementioned types of computer-readable media, or any other media that can be used to store computer-executable code in the form of instructions or data structures that can be accessed by a computer.

[0027] The transmitted signal can be at least partially based on parameters associated with the fluid state and / or the motion state. The parameters can be parameters set by an actuator and / or a device configured to set the fluid pressure and / or the fluid flow rate. Additionally, the parameters can be parameters measured by a sensor that senses parameters associated with the motion state and / or the fluid state.

[0028] In some examples, the fluid unit can automatically adjust the fluid pressure and / or the fluid flow provided to the rolling membrane at least partially based on the motion state such that the flipping and / or retraction of the rolling membrane occurs at any time during proper inflation of the rolling membrane. This can occur simultaneously with the sensing of the fluid state or without sensing the fluid state via a sensor.

[0029] In some examples, the rolling membrane conduit can be adapted to control the fluid unit at least partially based on the motion state to automatically determine the fluid pressure and / or the fluid flow rate of the rolling membrane. This can be done via signaling provided by the rolling membrane conduit and / or the motion unit. The signaling can be provided directly to the fluid unit, or it can be provided indirectly by a control unit (either of the conduit or external), optionally processed, and then provided to the fluid unit.

[0030] For example, the motion state of the rolling membrane can be determined by a motion unit as described herein. The determination of the motion state can occur, for example, by setting the motion state via a device configured to set the motion state sensed by a sensor, setting the motion state via a device configured to set the motion state and sensing the motion state by a sensor in a closed-loop configuration, and / or by a healthcare professional or any user operating the rolling membrane. This can apply to both the flipping and the retraction of the rolling membrane.

[0031] In one example, signaling that is at least partially determined based on a motion state and / or includes information regarding a parameter associated with the motion state, as determined herein, can be sent to a fluid unit. The signal transmission can occur mechanically, wirelessly, electronically, and / or in any other suitable manner.

[0032] For example, one or more subunits of the fluid unit can be automatically adjusted to the motion state, automatically sense the fluid state via sensors, and / or automatically adjust the fluid state via a device configured to set the fluid state.

[0033] Generally, various configurations are possible where a signal is sent from an actuator that causes the motion state and / or a sensor that senses the motion state to the fluid unit, which includes at least one sensor that senses a parameter associated with the fluid state and / or a device for setting the fluid state. Any such configuration can allow for user-friendly operation of a coiled membrane catheter, as the fluid state is automatically controlled or measured during operation and may be indicated, for example, on a display, or a warning signal is sent if it is approaching a critical threshold. Generally speaking, any such automation can improve safety, for example, by preventing the coiled membrane from bursting or kinking, allow for user-friendly and flexible control of the coiled membrane catheter, and can reduce treatment time.

[0034] The coiled membrane catheter can implement multiple of these operating modes based on user input via, for example, a user interface. The user can, for example, decide whether they want to enable automatic control of the fluid state, receive feedback via, for example, a display regarding the current fluid state, or only receive a warning signal if they are approaching a critical fluid pressure and / or fluid flow during operation. In an example, the fluid unit can be configured to control the fluid state such that at least one parameter associated with the fluid state remains within a given range. In this example, the user can, for example, determine the fluid state themselves, and the fluid unit will only switch to the automatic control mode if the user otherwise controls the fluid unit such that at least one parameter associated with the fluid state stays within the given range that can ensure safe operation.

[0035] It should be noted that the aspects described herein can be used with manual motion control (e.g., the motion unit only includes one or more sensors) or with (semi-)automatic motion control (e.g., the motion unit includes one or more actuators that can be motor-controlled, for example, based on corresponding commands from the user via, for example, one or more buttons, a touch screen, etc., the catheter can be provided with one or more buttons, a touch screen, etc., or one or more buttons, a touch screen, etc. can be operably connected to the catheter).

[0036] In some examples, the scroll membrane catheter may also include means for controlling the motion unit to automatically determine the motion state of the first scroll membrane based at least in part on fluid pressure and / or fluid flow rate. This can be done by signaling provided by the scroll membrane catheter and / or the fluid unit. The signaling can be provided directly to the motion unit, or it can be provided indirectly via a control unit (of the catheter or external), optionally processed, and then provided to the motion unit.

[0037] For example, the fluid state of the scroll membrane can be determined by the fluid unit as described herein. Determination of the fluid state can occur, for example, by setting the fluid state via means configured to set the fluid state sensed by a sensor, setting the fluid state via means configured to set the fluid state and sensing the fluid state by a sensor in a closed-loop configuration, and / or by a healthcare professional or any user operating the catheter. This can apply to both flipping of the scroll membrane and retraction of the scroll membrane.

[0038] In one example, a signal can be sent to the motion unit based at least in part on the fluid state determined as herein and / or signaling that includes information about parameters associated with the fluid state. The signal transmission can occur in a mechanical, wireless, electrical, and / or any other suitable manner.

[0039] For example, one or more subunits of the motion unit can be automatically adjusted to the fluid state, e.g., automatically sensing the motion state via a sensor and / or automatically adjusting the motion state via means configured to set the motion state. In one example, the motion state can be sensed by a sensor of the motion unit in response to a particular fluid state determined by the fluid unit. Then, it can, for example, provide feedback to the operator to indicate whether the motion state is within an acceptable range of the fluid state (or vice versa). This can be done, for example, via a display, an acoustic signal, etc. For example, a warning signal can be output when any value exceeds a predetermined threshold. Such a threshold can depend on the fluid state (motion state). In some examples, the motion unit can automatically adjust the motion state of the scroll membrane such that flipping and / or retraction of the scroll membrane occurs at any time during proper inflation of the scroll membrane. This can occur simultaneously with the sensing of the motion state as described herein, or it can occur without sensing the motion state via a sensor.

[0040] In general, any configuration is possible in which signals are sent from a device configured to set a fluid state and / or a sensor sensing a fluid state to a motion unit that includes at least one sensor sensing a parameter associated with a motion state and / or a device for setting a motion state. Any such configuration may allow for user-friendly operation of a coiled membrane catheter, since the motion state is automatically controlled or measured during operation and may be indicated, for example, on a display, or a warning signal may be sent if a critical threshold is approached. Generally speaking, any such automation may improve safety, for example, by preventing the coiled membrane from bursting or kinking, allow for user-friendly and flexible control of the coiled membrane catheter, and may reduce treatment time.

[0041] The coiled membrane catheter may implement multiple of these operating modes based on user input via, for example, a user interface. The user may, for example, decide whether they want to enable automatic control of the motion state, receive feedback regarding the current motion state, for example, via a display, or only receive a warning signal when they approach a critical motion state during operation. In an example, the motion unit may be configured to control the motion state such that at least one parameter associated with the motion state remains within a given range. In this example, the user may, for example, set the motion state themselves, and the motion unit will only switch to the automatic control mode if the user otherwise controls the fluid unit such that at least one parameter associated with the fluid state will leave the given range that can ensure safe operation.

[0042] It should be noted that aspects herein may be used with manual fluid control (e.g., the fluid unit includes only one or more sensors) or with (semi-)automatic fluid control (e.g., the fluid unit includes one or more devices for providing a fluid state that may be, for example, motor- or pump-controlled).

[0043] In some examples, the coiled membrane catheter may be adapted to control a fluid unit so as to automatically set the fluid pressure (and / or fluid flow rate) within a first range when the motion state includes motion in the distal direction, and / or control the fluid unit so as to automatically set the fluid pressure (and / or fluid flow rate) within a second range when the motion state includes motion in the proximal direction.

[0044] For example, the control may be provided by a device for controlling the fluid unit, which may be provided in the motion unit or via a separate control unit (of the catheter or possibly also external to the catheter).

[0045] For example, this may specifically optimize the fluid state for flipping of the coiled membrane, accompanying a motion state involving motion in the distal direction, and / or retraction of the coiled membrane, accompanying a motion state involving motion in the proximal direction. Different fluid states, especially different pressures, may be ideal for flipping and retraction, respectively.

[0046] Generally, there can be safety measures to prevent the fluid unit and / or the movement unit from exceeding a given threshold parameter, such as, maximum speed, maximum acceleration, maximum fluid pressure at which the rolling membrane may burst, maximum fluid flow rate, etc., and / or from falling below a given threshold parameter, such as, minimum speed, minimum acceleration, minimum fluid pressure, minimum fluid flow rate, etc. There can be a set of predetermined thresholds stored on the fluid unit and / or the movement unit and / or the control unit (of the catheter or a separate control unit). Such safety measures can allow for user-friendly, error-proof, and safe operation of the rolling membrane catheter.

[0047] In one example, this can be particularly advantageous when the inner shaft of the rolling membrane catheter is retracted. In this case, at least partial automated control of the fluid unit can prevent undesired kinking of the rolling membrane while it can prevent the rolling membrane from bursting when the pressure is too high.

[0048] In addition, a rolling membrane catheter assembly including a rolling membrane catheter and a fluid unit can be provided.

[0049] According to a second aspect, a rolling membrane catheter can include a first rolling membrane, a guide wire adapted to be disposed within the first rolling membrane, and a guide wire unit capable of being configured to grip and / or retract the guide wire when the first rolling membrane is in at least a partially inflated state.

[0050] This can allow for independent control of the guide wire position even when the rolling membrane is flipped and thus in at least a partially inflated state (e.g., fully inflated state). In some examples, this can be done by gripping the guide wire once or repeatedly gripping the guide wire, such that the distal ends of the rolling membrane and the guide wire advance the same or a similar distance in total.

[0051] In one example, such a guide wire unit can include an actuator to cause movement of the guide wire in the proximal direction and / or to hold the guide wire in a given position. This can counteract any other forces on the guide wire in the distal direction. Generally, the guide wire unit can provide a greater force than the force acting in the distal direction (e.g., caused by the at least partially inflated rolling membrane that grips the guide wire and moves distally if the guide wire unit is absent or turned off). This can be beneficial to prevent undesired advancement of the guide wire, which has a risk of perforating the patient's cardiovascular system. It can also be used to retract the guide wire before or during the flipping of the rolling membrane to increase safety during flipping.

[0052] In an exemplary embodiment, the rolling membrane catheter includes a first rolling membrane adapted such that when the guide wire is disposed within the first rolling membrane, the guide wire is gripped by the first rolling membrane when the first rolling membrane is in at least a partially inflated state.

[0053] In one example, when fluid pressure is applied to the first rolling membrane, the first rolling membrane of the rolling membrane catheter can be in at least a partially inflated state. In its at least partially inflated state, for example, when a pressure higher than a first threshold P clamp,1 is applied to the first rolling membrane, the first rolling membrane can clamp and advance a guide wire passing through the first rolling membrane centrally. The clamping force can be high enough such that during the flipping of the first rolling membrane, the guide wire moves with the first rolling membrane. When the first rolling membrane performs a flipping motion while the guide wire performs an axial translation, the distal end of the guide wire advances in the distal direction at twice the speed of the leading edge of the first rolling membrane. It may be advantageous to counteract the advancing guide wire by a guide wire unit. The guide wire unit can cause the guide wire to translate in the proximal direction and / or hold the guide wire in a constant position at any time. The retraction of the guide wire can occur when the first rolling membrane is in at least a partially collapsed state, where the clamping force of the first rolling membrane on the guide wire is at least partially reduced, or can occur when the first rolling membrane is in a (fully) inflated state, for example, during a conventional flip where the clamping force of the first rolling membrane on the guide wire is high. The guide wire unit can provide a force that exceeds the clamping force of the first rolling membrane on the guide wire to retract the guide wire or hold it in a constant position. That is, even when the first rolling membrane is in at least a partially inflated state or a fully inflated state, the position of the guide wire can be controlled independently of the movement of the first rolling membrane by the guide wire unit.

[0054] The rolling membrane catheter can include a guide wire unit, and the guide wire unit includes a second rolling membrane configured to clamp the guide wire when the second rolling membrane is in at least a partially inflated state.

[0055] The second rolling membrane can be controlled by a second fluid unit configured to apply pressure to the second rolling membrane. The second rolling membrane can be disposed around the guide wire, for example, at a proximal position of the catheter. When the second rolling membrane is in at least a partially inflated state and the second fluid unit applies a pressure higher than a second threshold P clamp,2 to the second rolling membrane, the second rolling membrane can clamp the guide wire. Applying fluid pressure to the second rolling membrane can cause the rolling membrane to inflate in order to clamp the guide wire and thus fix the position of the clamped guide wire. In some examples, the second rolling membrane can be adapted to flip in the proximal direction in order to not only clamp the guide wire but also retract it. The force applied by the guide wire unit can exceed the force applied by the first rolling membrane on the guide wire. This can be achieved by applying a higher fluid pressure to the second membrane than to the first rolling membrane. Using the second rolling membrane to counteract the effect of the first rolling membrane clamping the guide wire has various advantages. For example, similar or identical control devices can be used to control the fluid unit that determines the fluid state of the first rolling membrane and a similar fluid unit that determines the fluid state of the second rolling membrane. The two membranes can be controlled in a similar manner.

[0056] Note that the first aspect and the second aspect can also be combined. For example, a rolling membrane catheter (assembly) with a first rolling membrane can be provided. The rolling membrane catheter can further include a motion unit for determining the motion state of the first rolling membrane. The rolling membrane catheter can be adapted to be coupled to a fluid unit for determining the fluid pressure and / or fluid flow rate of the first rolling membrane. Additionally, the rolling membrane catheter can be adapted to automatically couple the fluid unit and the motion unit for synchronized operation, such as at least partially based on the motion state, fluid pressure, and / or fluid flow rate. It can also include a guide wire adapted to be disposed within the first rolling membrane and a guide wire unit configurable to retract the guide wire when the first rolling membrane is in at least a partially inflated state. The rolling membrane catheter can include any additional features described with respect to the first and second aspects herein.

[0057] When combining the first aspect and the second aspect, a particularly safe and easy-to-use operation of the catheter can be provided. It can be ensured that the motion states of the fluid and the membrane are synchronized, and at the same time, independent of the motion and pressure states of the membrane, the guide wire can be positioned in a predetermined manner.

[0058] In some examples, the rolling membrane catheter can be configured to automatically couple the guide wire unit to at least one of the fluid unit and the motion unit for synchronized operation.

[0059] The motion unit and / or fluid unit of one aspect and the guide wire unit of the other aspect can be operated, for example, in a (semi)-automated manner such that the fluid and / or motion unit and the guide wire unit engage alternately and / or simultaneously. This can result in an alternating advancement of the guide wire clamped by the flipped first rolling membrane and a retraction of the guide wire via the guide wire unit. Moreover, it can cause the flipping of the first rolling membrane without moving the guide wire. For example, the flipping of the rolling membrane can occur at a constant pressure or at a varying pressure above a given value to ensure that the rolling membrane is in a suitable inflated state at any time. Then, the retraction can occur intermittently, for example, by applying a retraction force that exceeds the clamping force of the first rolling membrane on the guide wire. In some examples, when the guide wire unit retracts the guide wire, the flipping of the rolling membrane can be (repeatedly) interrupted to minimize the friction that counteracts the retraction force between the guide wire and the first rolling membrane. This can result in a safe operation without accidentally advancing the guide wire, minimize the risk of perforating the vessel wall, and increase the speed at which the catheter can be introduced in a safe and user-friendly manner.

[0060] In another example, the guide wire unit is configured to send the position, velocity, and / or acceleration characterizing the motion state of the guide wire to a control unit or a motion unit, and the control unit or the motion unit is configured to monitor the position, velocity, and / or acceleration characterizing the motion state of the guide wire. This can further result in a safe operation of the guide wire within the blood vessel.

[0061] Additionally, other exemplary embodiments are possible, where for example a motion sensor indicates a motion state that indicates to the user that the guidewire unit can or should be engaged to retract the guidewire. In such a configuration, a warning signal can be sent when the guidewire has advanced beyond a predetermined threshold at the leading edge of the first rolling membrane. Additionally, examples are possible where the fluid unit of the first rolling membrane is coupled to the guidewire unit for synchronous operation such that when the guidewire unit retracts the guidewire, the pressure in the first rolling membrane decreases. The synchronization of the fluid unit, the motion unit, and / or the guidewire unit produces a number of advantageous technical effects: the guidewire can be controlled so that unwanted advancement does not occur, the pressure can be kept within an ideal range at any time, and the advancement of the catheter can occur in a well-controlled manner. All of these increase the overall safety of the treatment, can save time, and prevent typical user errors.

[0062] According to a third aspect, a computer program including instructions can be provided that, when the program is executed, cause a rolling membrane catheter as outlined herein (e.g., according to the first aspect) to automatically couple a fluid unit and a motion unit for synchronous operation based at least in part on a motion state, a fluid pressure, and / or a fluid flow rate.

[0063] Such a computer program can provide support to the user by automatically taking over the individual control of the rolling membrane catheter as outlined herein. This can increase safety during treatment and reduce the time required for treatment.

[0064] According to a fourth aspect, a computer program can include instructions that, when the program is executed, cause a rolling membrane catheter as outlined herein (e.g., according to the second aspect) to control a guidewire unit such that when the first rolling membrane flips, the guidewire remains within a predetermined range.

[0065] In one example, the computer program can instruct the guidewire unit to repeatedly retract the guidewire whenever the guidewire advances a predetermined length by flipping the first rolling membrane, and the guidewire can be clamped by the first rolling membrane. In possible computer programs, the frequency of retraction or the advancement length after the guidewire retracts can be set by predetermined parameters. Alternatively or additionally, it can be based at least in part on parameters determined by the fluid unit and / or the motion unit of the rolling membrane catheter. When introducing the rolling membrane catheter into a patient's cardiovascular system, the program can advantageously assist the user by controlling all parameters that the user may wish to automatically control. For example, it can ensure that the first rolling membrane flips at a constant average speed, where the intermittent phase of the guidewire retraction keeps its position fixed relative to the farthest tip of the rolling membrane. The program can be adapted to allow selection of such a flipping mode, and / or other flipping modes, such as: a mode where the guidewire position is fixed relative to the catheter (i.e., the rolling membrane flips but the guidewire remains stationary), or a mode where the guidewire moves at twice the speed of the rolling membrane.

[0066] Note that a procedure including the third and fourth aspects can be provided.

[0067] A computer program including instructions can be provided, which, when executed, control a motion unit, a fluid unit, and / or a guidewire unit according to at least one control parameter such that the guidewire moves alternately in the proximal and distal directions respectively to remove a stenosis (e.g., by performing a chiseling motion). Removing the stenosis includes opening a completely occluded path through the blood vessel.

[0068] This chiseling motion can be caused in various ways. All of the following operations can at least partially automatically adjust parameters such as frequency, amplitude, and / or relative position with respect to the stenosis and the catheter, and / or potential other information regarding the patient and / or the catheter used.

[0069] First, the chiseling motion can be caused by alternately expanding and collapsing a first rolling membrane via the fluid unit. This may result in the distal and proximal alternating motion of the guidewire clamped by the first rolling membrane.

[0070] Second, the repeated retraction of the inner shaft of the rolling membrane against the hydraulic forward force of the rolling membrane, and then the controlled sudden reduction of this retraction force, and / or retraction and then sudden release of the guidewire through the guidewire unit can cause this chiseling motion. In addition, the fluid pressure supplied to the first rolling membrane can be adjusted in a counter - circulation manner. In any case, due to the fluid pressure supplied to the first rolling membrane, when the guidewire is clamped by the first rolling membrane and retracted by the guidewire unit, the first rolling membrane is under increased tension. Then, when the guidewire is released by the proximal rolling membrane and advances rapidly towards the stenosis, this potential energy can be converted into kinetic energy.

[0071] Third, in some examples, the motion unit can move the inner shaft relative to the outer shaft in the proximal direction to set the first rolling membrane under tension, which can be, for example, in an expanded state and clamp the guidewire. Thus, the guidewire can also move in the proximal direction. When the inner shaft is released or moves rapidly in the distal direction, the guidewire advances rapidly towards the stenosis. Repeating these steps can result in the chiseling motion of the guidewire.

[0072] The above three examples can also be combined. Generally speaking, as described herein, any combination of automatic and / or non - automatic motions of any device included in the rolling membrane catheter can be utilized to perform such chiseling motion of the guidewire. The rolling membrane can also operate in a blunt mode, where the guidewire is partially retracted such that only the soft rolling membrane repeatedly presses against the occlusion.

[0073] It is particularly advantageous to at least partially automate this chiseling motion, as it can significantly reduce the treatment time required to open the stenosis, reduce the likelihood of errors due to user mistakes, and provide a simple way to adjust parameters associated with the chiseling motion, such as at least partially based on the location, shape, and texture of the stenosis.

[0074] In addition, it is particularly advantageous to perform an automatic ablation movement by means of a rolling membrane catheter, since the first rolling membrane that holds the guide wire centers the guide wire with respect to the vascular cross-section at the stenosis, so that the guide wire may hit the stenosis at the center away from the vessel wall. This is why using a rolling membrane catheter for ablation to open the stenosis is particularly safe and the risk of piercing the vessel wall is low. In addition, using the guide wire as a tool for opening the stenosis does not require any additional devices that the rolling membrane catheter may be equipped with.

[0075] In addition, with (semi-)automatic control, new parameter states can also be achieved that cannot be achieved by manual operation (e.g., high-frequency ablation operations that can significantly reduce the treatment time).

[0076] In one example, a computer program for causing an ablation movement of a guide wire can be provided, which also includes an interface for receiving image data of a stenosis and for selecting at least one control parameter at least partially based on the image data. Selecting at least one control parameter in an automated manner can improve safety, the applicability of at least one control parameter, and reduce the risk of incorrect image evaluation by the healthcare professional operating the rolling membrane catheter.

[0077] Such image data can be evaluated, for example, by comparison with images of previously treated stenoses in order to adjust treatment parameters associated with the ablation movement, such as frequency, amplitude, relative position to the stenosis, and / or the catheter used, for example, at least partially based on the location, shape, and / or texture of the stenosis.

[0078] The exemplary computer program can also cause the selection of parameters to be at least partially 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 (e.g., X-ray image data, angiography image data, intravascular ultrasound image data, or optical coherence tomography), at least one control parameter that has been used to remove the stenosis, and optionally a performance value. Similarly, a corresponding computer program can be provided to provide at least one parameter associated with any other action performed by the catheter.

[0079] The evaluation of the image data of the stenosis and the corresponding parameter selection can be based on training via machine learning, for example, techniques such as linear regression, logistic regression, decision trees, support vector machine (SVM) algorithms, naive Bayes algorithms, k-nearest neighbor algorithms, k-means, random forest algorithms, dimensionality reduction algorithms, gradient boosting algorithms, and adaptive boosting algorithms. This can facilitate the selection of appropriate treatment parameters without time-consuming and potentially error-prone image evaluation procedures.

[0080] 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 may include: inputting a plurality of training data sets into the model to train the model, each training data set including image data of stenosis, at least one control parameter that has been used to remove the stenosis, and optionally a performance value.

[0081] The model may be based on techniques such as linear regression, logistic regression, decision trees, support vector machine (SVM) algorithms, naive Bayes algorithms, KNN algorithms, K-means, random forest algorithms, dimensionality reduction algorithms, gradient boosting algorithms, and adaptive boosting algorithms.

[0082] 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 may include: using an artificial intelligence model that has been trained as outlined herein, based on image data of stenosis, to predict at least one control parameter.

[0083] On the other hand may be training data for training an artificial intelligence model for predicting at least one control parameter for treating stenosis. The training data may include a plurality of training data sets, each training data set including image data of stenosis, 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.

[0084] A computer program as outlined herein may be executed by a corresponding catheter having a processing unit (e.g., a microcontroller, a microprocessor, etc.). In other examples, an external processing unit may execute the program, and a catheter as outlined herein may be coupled to the program, for example, wirelessly and / or in a wired manner. Preferably, the catheter may be coupled to the external processing unit only fluidly.

[0085] Note that all functions described herein may be implemented as corresponding functions of the devices described herein (devices), corresponding steps of the methods outlined herein, and / or corresponding instructions of the computer programs outlined herein. Even though described with reference to devices, methods, and / or computer programs, the aspects outlined herein may be applied to the corresponding other of devices, methods, and / or computer programs. BRIEF DESCRIPTION OF THE DRAWINGS

[0086] The drawings of the present disclosure illustrate the following:

[0087] Figure 1A An exemplary embodiment of a scroll membrane catheter, which includes a motion unit and a guide wire unit including a scroll membrane;

[0088] Figure 1B Exemplary embodiments of a scroll membrane catheter, which includes means for coupling to a fluid unit, a motion unit, a guide wire unit including a scroll membrane, a catheter balloon, and a balloon fluid unit;

[0089] Figure 1C Overview of an exemplary embodiment of a scroll membrane catheter, which includes means for coupling to a fluid unit, a motion unit, a guide wire unit including a scroll membrane, a catheter balloon, and a balloon fluid unit, wherein exemplary dimensions are shown;

[0090] Figure 2 Exemplary scenarios of the chiseling motion of the guide wire of the scroll membrane catheter to open a stenosis.

[0091] Figure 3 An exemplary system, which includes a scroll membrane catheter, which is controlled by a control unit, which is controlled by a patient via a user interface and is operably coupled to an AI-assisted imaging evaluation device. Detailed Description

[0092] Possible embodiments of the present invention will be described below with reference to the above-mentioned drawings. For the sake of brevity, only a few embodiments may be described. Those skilled in the art will recognize that the specific features described with reference to these embodiments can be modified and combined differently, and they can also be omitted if the individual features are not necessary. The general explanations in the above part will also be valid for the following more detailed explanations.

[0093] Figure 1A An exemplary embodiment of a scroll membrane catheter 100 is shown, which includes means for coupling to a fluid unit 150, a motion unit 190, and a guide wire unit 170 including a second scroll membrane 180. It also includes an outer shaft 120 and an inner shaft 130 that can move axially therein.

[0094] The first scroll membrane 110 of the scroll membrane catheter 100 is attached to the distal ends of the outer shaft 120 and the inner shaft 130 in a pressure-sealed manner. When the inner shaft 130 moves in the distal direction relative to the outer shaft 120, when appropriate pressure is applied to the first scroll membrane 110, the scroll membrane 110 can be flipped. In an exemplary embodiment, only the optional third scroll membrane 160 is attached to the proximal ends of the outer shaft 120 and the inner shaft 130 in a pressure-sealed manner. The volume of the fluid pressure provided by the means 150 for coupling is defined by the inner shaft 130, the outer shaft 120, the first scroll membrane 110, and the third scroll membrane 160.

[0095] The motion unit 190 may include sensors and / or motion actuators, and in this exemplary embodiment, the sensors and / or motion actuators may respectively measure and / or cause the movement of the inner shaft 130 relative to the outer shaft 120. In some examples, the inner shaft 130 may be moved manually and / or under the control of the motion unit 190 in the distal and / or proximal directions.

[0096] Figure 1A The exemplary guide wire unit 170 of the shown coiled membrane catheter 100 is mounted to the proximal region of the coiled membrane catheter 100. It includes a second coiled membrane 180 which may be attached to a separate axially movable shaft 181 that remains pressed against the inner shaft 130, and the second coiled membrane 180 is configured to grip the guide wire 140 when sufficient fluid pressure is provided to the second coiled membrane 180, and the second coiled membrane 180 then expands and grips the guide wire 140. When the second coiled membrane 180 expands, the second coiled membrane 180 can thus lock the guide wire 140. Additionally or alternatively, for example when the separate shaft 181 moves proximally, when the force acting on the guide wire 140 via the second coiled membrane 180 exceeds the force acting on the guide wire 140 in the distal direction via the first coiled membrane 110, the second coiled membrane 180 can move the guide wire 140 proximally.

[0097] Figure 1B Another exemplary embodiment of a coiled membrane catheter 100' is shown, which coiled membrane catheter 100' includes means for coupling to a fluid unit 150, a motion unit 190, and a guide wire unit 170 including a second coiled membrane 180. It also includes an outer shaft 120 and an inner shaft 130 that is axially movable therein.

[0098] The first coiled membrane 110 of the coiled membrane catheter 100' is attached to the distal end of the outer shaft 120 and the distal end of the inner shaft 130 in a pressure-sealed manner. When the inner shaft 130 moves distally relative to the outer shaft 120, the coiled membrane 110 flips. The exemplary coiled membrane catheter 100' also includes a balloon 103 that is connected to the distal end of the inner shaft 130 and the distal end of an intermediate shaft 102. The intermediate shaft is further coupled to a balloon fluid unit 101 that is configured to provide fluid pressure to the balloon 103 to cause the balloon 103 to expand. The balloon 103 in the expanded state can widen a stenosis. In the exemplary embodiment, a third coiled membrane 160 is attached to the proximal end of the outer shaft 120 and the proximal end of the intermediate shaft 102 in a pressure-sealed manner. The volume for providing fluid pressure is defined by the intermediate shaft 102, the outer shaft 120, the first coiled membrane 110, the balloon 103, and the third coiled membrane 160.

[0099] The motion unit 190 may include sensors and / or motion actuators, and in this exemplary embodiment, the sensors and / or motion actuators may respectively measure and / or cause the movement of the inner shaft 130 and the intermediate shaft 102 relative to the outer shaft 120. The sensors of the motion unit 190 may measure the position, velocity, acceleration, or any average value of these parameters over time, which characterize the motion state of the rolling membrane 110 (e.g., relative to the outer shaft 120 of the catheter 100).

[0100] The fluid 150 may include a fluid pressure sensor and / or a fluid flow sensor. The rolling membrane catheter 100 may include a lamp and / or a display for showing a visual warning signal and / or a speaker for outputting an acoustic warning signal and / or a device for outputting vibrations that can be tactilely sensed by the user as a warning signal. If the motion state and / or the fluid pressure and / or the fluid flow respectively reach a threshold associated with a critical motion state (fluid pressure or fluid flow), the warning signal may be output.

[0101] Figure 1B The exemplary guide wire unit 170 of the shown rolling membrane catheter 100’ is mounted to the proximal region of the rolling membrane catheter 100. It includes a second rolling membrane 180, which may be attached to a separate axially movable shaft 181 and is configured to clamp the guide wire 140 when sufficient fluid pressure is provided to the second rolling membrane 180, and the second rolling membrane 180 then expands and clamps the guide wire 140. When the second rolling membrane 180 flips, it may retract the guide wire 140 in the proximal direction. This may be the case when the force acting on the guide wire 140 in the proximal direction via the second rolling membrane 180 exceeds the force acting on the guide wire 140 in the distal direction via the first rolling membrane 110. Additionally, in Figure 1B In the shown exemplary embodiment, the balloon fluid unit 101 is mounted to the proximal region of the rolling membrane catheter 100’.

[0102] Figure 1C A comprehensive overview of an exemplary embodiment of the rolling membrane catheter 100’ from Figure 1B is provided and typical dimensions are indicated: The outer shaft 120 may have a diameter of about 0.5 mm to 2.5 mm, e.g., 1.3 mm to 1.7 mm, and the intermediate shaft 102 may have a diameter of about 0.3 mm to 1.7 mm, e.g., 0.8 mm to 1.2 mm. The length of the first rolling membrane 110 may be about 50 mm to 250 mm or about 100 mm to 140 mm, and the balloon 103 may have an axial length of about 40 mm to 200 mm or about 80 mm to 120 mm. However, other embodiments may generally and / or relative to the individual components have different dimensions. For example, the length of the outer shaft 120 may be much longer than 300 mm and may typically be up to 1300 mm.

[0103] Figure 2 An exemplary scenario is shown where the guide wire 140 of the rolling membrane catheter 100 performs a chiseling motion to open the stenosis S. When the stenosis S is too narrow for the rolling membrane 110 of the rolling membrane catheter 100 to flip through it or is even completely occluded, it may be necessary to at least partially open the stenosis S to form an opening through which the rolling membrane catheter 100 can be introduced, for example, by flipping the rolling membrane 110 through the opening.

[0104] The guide wire 140 can be used as a tool to open such a stenotic stenosis S by performing repeated chiseling motions on the stenosis S. Parameters such as frequency, amplitude, and / or position relative to the stenosis S can be adjusted based at least in part on the position, shape, and texture of the stenosis S, the catheter 100 used, and / or other potential information about the patient and / or the catheter used.

[0105] It should be emphasized that the aspects regarding the device overview above can be provided as features or instructions of a computer program and / or method steps, and vice versa.

[0106] Figure 3 An exemplary embodiment including an exemplary rolling membrane catheter 100” is shown. The rolling membrane catheter 100” includes a rolling membrane 110, a guide wire 140, an outer shaft 120, and an inner shaft 130. The motion unit 190 can determine the motion state of the inner shaft 130, and the guide wire unit 170 can determine the motion state of the guide wire 140. Figure 3 The guide wire unit 170 in the illustrated embodiment can determine the translation and / or rotation of the guide wire 140 in the distal direction and the proximal direction. Thus, it can be regarded as another motion unit capable of performing more operations than simply retracting the guide wire 140. The rolling membrane catheter 100” also includes means configured as described herein for coupling to a fluid unit 150.

[0107] In Figure 3 In the illustrated exemplary embodiment, the means for coupling to the fluid unit 150, the fluid unit itself, the guide wire unit 170, and / or the motion unit 190 are operatively coupled to a control unit 200 as described herein. The control unit 200 can cause the fluid unit 150, the motion unit 190, and / or the guide wire unit 170 (the means for coupling to the fluid unit 150, the motion unit 190, and / or the guide wire unit 170) to perform the functions described herein by determining the corresponding motion states and / or the corresponding fluid states. This can occur automatically, and / or the control unit 200 can be controlled by the user via a user interface 500.

[0108] In some embodiments, the control unit 200 may be configured to receive input via, for example, the user interface 500 at least partially based on the mode the user desires to execute. Exemplary modes include advancing the rolling membrane in the distal direction, compensating for the advancement of the guide wire 140 at twice the speed of the leading edge of the rolling membrane 110, retracting the rolling membrane 110 without kinking, and / or the chiseling motion of the guide wire 140 for opening the stenosis S. It may also receive signaling at least partially based on the motion state and fluid state of the rolling membrane 110, the guide wire unit 170, and / or any other component that determines its fluid and / or motion state. Then, the control unit 200 may control any parameter associated with the fluid state and / or motion state via the corresponding unit, so that the catheter 100” executes the corresponding mode, such as the chiseling motion of the guide wire 140 at a suitable frequency, position, and / or amplitude. In a simple embodiment, the exemplary mode is executed according to the predetermined parameters associated with the corresponding mode.

[0109] In some examples, at least one parameter associated with at least one of the exemplary modes may be adjusted to a set of mode parameters according to which the corresponding mode may be executed. The set of exemplary mode parameters may be provided, for example, by a health professional or predetermined within at least one part of the system.

[0110] Additionally or alternatively, a set of input parameters may describe the treatment site, such as the stenosis S. The set of input parameters may relate to the location, size, texture, length, diameter, whether it is calcified and / or fibrotic, etc. of the stenosis S or any other treatment site. The set of exemplary input parameters may be at least partially based on, for example, the imaging data of the stenosis S, as described herein. For each set of input parameters, there may be an ideal set of mode parameters, which may be retrieved from a look-up table.

[0111] Additionally or alternatively, the control unit 200 may receive input from an optional AI assistant 400, which is configured to evaluate the imaging data 300 and thus provide a corresponding set of mode parameters. For example, the user may select via the user interface 500 that the chiseling mode should be executed to remove the stenosis S. Then, the AI assistant may provide a corresponding set of mode parameters based on the imaging data 300 of the stenosis S.

[0112] In some examples, the imaging data may be at least partially based on, for example, (contrast agent-based) X-ray angiography, computed tomography, optical coherence tomography, intravascular ultrasound imaging, and / or any combination thereof of the stenosis to be treated.

[0113] The AI assistant 400 may include a trained model that has been trained with a plurality of training data sets, each training data set including image data of a stenosis S, at least one control parameter that has been used to remove the stenosis S, and optionally a performance value.

[0114] The performance value may include a binary value indicating whether the treatment was successful, which may include the treatment duration, a measure of the size of the resulting opening, a measure of the damage caused to the vessel wall, etc.

[0115] The control parameter may be any one of a set of mode parameters for the treatment, e.g., the frequency and / or amplitude of the chiseling motion, and / or the distance from the stenosis S at which the chiseling motion is performed.

[0116] Based on the training data, the model can be trained to find the optimal parameters for treating the stenosis using the chiseling mode based on the imaging data of the stenosis.

[0117] In an exemplary application, a health professional can provide an image of the treatment site to the AI assistant 400. Then, it can provide predictions and / or suggestions, e.g., the appropriate mode parameters for the chiseling motion for that particular treatment site. These mode parameters can be constant or varying parameters as described herein and / or related to the motion state and / or fluid state of any component of the catheter 100. The catheter 100 and / or the corresponding unit can automatically execute the corresponding mode according to the mode parameters determined by the AI assistant 400 for the stenosis S known to the algorithm based on the image data provided to it. Alternatively or additionally, the user may have the freedom to set the mode parameters themselves at least partially based on the suggested mode parameters.

[0118] However, the AI - assistant 400 algorithm can also be applied to other modes described herein, including the flipping of the rolling membrane 110, the movement of the guide wire 140, and / or the retraction of the rolling membrane 110, e.g., in order to correctly position the catheter relative to the stenosis S before the treatment begins.

[0119] Generally, the AI assistant 400 may be able to identify relevant input parameters and put them into context in a way that a health professional may not be able to. Such an AI assistant 400 can be provided for all the modes described herein.

Claims

1. A rolling membrane catheter (100), comprising: A first rolling membrane (110); And A motion unit (190) for determining a motion state of the first rolling membrane (110); Wherein the rolling membrane catheter (100) is adapted to be coupled to a fluid unit (150) for determining a fluid pressure and / or a fluid flow rate of the first rolling membrane (110).

2. The scroll film catheter (100) according to claim 1, wherein, The rolling membrane catheter (100) is adapted to output a warning signal based on the motion state and / or the fluid pressure and / or the fluid flow rate.

3. The scroll film catheter (100) according to claim 1 or 2, wherein, The rolling membrane catheter (100) is adapted to automatically couple the fluid unit (150) and the motion unit (190) for synchronous operation at least partially based on the motion state, the fluid pressure, and / or the fluid flow rate.

4. The rolling membrane catheter (100) according to any one of claims 1 to 3, further comprising means for controlling the fluid unit (150) to automatically determine the fluid pressure and / or the fluid flow rate of the rolling membrane at least partially based on the motion state.

5. The rolling membrane catheter (100) according to any one of claims 1 to 4, further comprising means for controlling the motion unit (190) to automatically determine the motion state at least partially based on the fluid pressure and / or the fluid flow rate.

6. The scroll film catheter (100) according to any one of claims 4 or 4 and 5, wherein, The means for controlling the fluid unit (150) is adapted to control the fluid unit (150) to automatically set the fluid pressure within a first range when the motion state includes motion in a distal direction, and / or wherein, The means for controlling the fluid unit (150) is further adapted to control the fluid unit (150) to automatically set the fluid pressure within a second range when the motion state includes motion in a proximal direction.

7. A rolling membrane catheter assembly, comprising: The rolling membrane catheter (100) according to any one of claims 1 to 4; And The fluid unit (150).

8. A rolling membrane catheter (100), comprising: A first rolling membrane (110); A guide wire (140) adapted to be disposed within the first rolling membrane (110); And A guide wire unit configured to grip and / or retract the guide wire (140) when the first rolling membrane (110) is in at least a partially expanded state.

9. The scroll film catheter (100) according to claim 8, wherein, The first rolling membrane (110) is adapted such that when the guide wire (140) is disposed within the first rolling membrane (110), the guide wire (140) is gripped by the first rolling membrane (110) when the first rolling membrane (110) is in the at least partially expanded state.

10. The scroll film catheter (100) according to claim 8 or 9, wherein, The guide wire unit includes a second rolling membrane (180) configured to grip the guide wire (140) when the second rolling membrane (180) is in at least a partially expanded state.

11. The rolling membrane catheter (100) according to any one of claims 1 to 7, further comprising the features according to any one of claims 8 to 10.

12. The scroll membrane catheter (100) according to claim 11, wherein, The scroll membrane catheter (100) is configured such that the guide wire unit is automatically coupled to at least one of the fluid unit (150) and the motion unit (190) for synchronous operation.

13. A computer program comprising instructions which, when the program is executed, cause the scroll membrane catheter (100) according to any one of claims 1 to 7, 11 or 12 to automatically couple the fluid unit (150) and the motion unit (190) for synchronous operation based at least in part on the motion state, the fluid pressure and / or the fluid flow rate.

14. A computer program comprising instructions which, when the program is executed, cause the scroll membrane catheter (100) according to any one of claims 6 to 12 to control the guide wire unit such that the guide wire (140) remains within a predetermined range when the first scroll membrane (110) is flipped.

15. A computer program comprising instructions which, when the program is executed, cause the scroll membrane catheter (100) according to any one of claims 1 to 12 to control the motion unit (190), the fluid unit (150) and / or the guide wire unit according to at least one control parameter such that the guide wire (140) moves alternately in the proximal and distal directions for removing a stenosis (S).

16. The computer program according to claim 15, further comprising an interface for receiving image data of the stenosis (S) and selecting the at least one control parameter based at least in part on the image data.

17. The computer program according to claim 16, wherein, The selection is based at least in part on a model that has been trained with a plurality of training data sets, each training data set comprising image data of a stenosis (S), at least one control parameter that has been used to remove the stenosis (S), and optionally a performance value.

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