EP4633716A1

EP4633716A1 - Rolling membrane catheter

Info

Publication number: EP4633716A1
Application number: EP23813419.1A
Authority: EP
Inventors: Jeremy Wernli; Matthias Wesselmann; Azadeh MEHRABI
Original assignee: Biotronik AG
Current assignee: Biotronik AG
Priority date: 2022-12-12
Filing date: 2023-12-04
Publication date: 2025-10-22
Also published as: WO2024126128A1; CN120187484A

Abstract

A catheter comprises a rolling membrane and at least one locking means configured to lock a motion of the rolling membrane at least in part based on a fluid state of the catheter.

Description

Rolling membrane catheter

The present invention relates to a catheter comprising a rolling membrane and various means for facilitating practical use of such catheter. Further, corresponding systems comprising such catheter and at least one fluid unit are provided. The present invention further relates to the use of a tubular element comprising a friction-reducing element as a rolling membrane. It further relates to respective computer programs and methods.

Medical treatment of a stenosis via percutaneous coronary intervention (PCI) may involve the insertion of a catheter into a blood vessel at the position of the stenosis. Rolling membrane catheters may allow catheter insertion into narrow cavities by everting a rolling membrane during a roll-out process. Typically, in a first step, a guidewire is introduced into the blood vessel and guided to the treatment site, e.g., the location of a stenosis. The rolling membrane of the rolling membrane catheter may then be everted, e.g., by providing pressure to the inside of the rolling membrane by a fluid unit connected to the catheter via a fluid inlet and moving one end of the rolling membrane (e.g. a proximal and/or inner end) distally. This may cause an eversion of the rolling membrane along the vessel walls, for example, without substantive friction. The one end of the rolling membrane may be attached to, e.g., an inner shaft which moves distally when the rolling membrane, attached to a distal end of the inner shaft, is everted. This everts the rolling membrane in a distal direction towards and possibly past a stenosis. The as-inserted rolling membrane can for example widen the stenosis or works as a guide catheter for other means to be introduced to the blood vessel at the location of the stenosis.

However, there are a few issues that require care when using rolling membrane catheters. First, in conventional rolling membrane catheters, users may retract the rolling membrane when in an insufficiently inflated state such that the rolling membrane is clinched. Second, if used with a guidewire, the hydraulic pressure in the rolling membrane, when in an inflated state, typically clamps the guidewire and thus couples it with its motion. Due to the everting motion of the rolling membrane, the guidewire advances twice as fast as the leading edge of the everting rolling membrane. This requires particular care to control the advancement of the guidewire such as to avoid the risk to perforate the cardiovascular system of the patient. Further, the eversion and/or retraction of the rolling membrane is to be accompanied by a certain pressure applied to the rolling membrane. If a user, e.g., a health professional introducing the catheter, sets a pressure that is too high, the burst pressure of the rolling membrane may be exceeded, such that the rolling membrane might burst within the cardiovascular system of the patient. As a result, there is still a need for improving rolling membrane catheters.

According to a first aspect of the invention, a catheter comprising a rolling membrane may be provided. The catheter may further comprise at least one locking means configured to lock the rolling membrane at least in part based on a fluid state of the catheter. For example, the rolling membrane may be locked, e.g. such that it cannot be everted or retracted, when no sufficient fluid pressure is provided to the rolling membrane. Then it may be advantageous to lock the rolling membrane and to prevent, e.g., the retraction of the rolling membrane for example by retracting a member attached to one end of the rolling membrane as this might clinch the rolling membrane. Thus, such locking may not only prevent damage to the catheter but further reduces risks for the patient associated with removing the damaged catheter. In some examples, the locking means may additionally or alternatively be activated if the fluid pressure provided to the rolling membrane is too high. Hence, this may avoid that, e.g. by further retracting the rolling membrane, the membrane may burst.

In an example, locking may prevent an inner shaft of the catheter to move relative to an outer shaft of the catheter, wherein the rolling membrane may be connected to a distal end region of the inner shaft and a distal end region of the outer shaft. Thereby, the movement of the rolling membrane, i.e., the eversion and/or the retraction may be prevented.

The fluid state is to be understood as the state of a fluid within any volume of the catheter as described herein. The fluid state may relate, e.g., to a fluid pressure and/or a fluid flow. A fluid may be any liquid fluid, any gaseous fluid, and/or any combination thereof. The fluid state of the catheter may particularly relate to a fluid state of the membrane. For example, the locking means may be configured to lock the rolling membrane as long as a fluid pressure applied to a rolling membrane volume is below a predetermined threshold, such as to prevent movement of the membrane when in a not sufficiently inflated state. The locking means may be configured to release the rolling membrane when the fluid pressure applied to the rolling membrane volume reaches the predetermined threshold.

In some examples, the catheter comprises at least one locking means that may be at least in part connected to at least a portion of the outer shaft of the catheter. This may for example be achieved in an advantageous configuration wherein the locking means are an integral part of the outer shaft of the rolling membrane catheter, saving material and required space at the same time. This may improve the overall handling and safety.

In an example, one or more sections of the outer shaft may be formed by the locking means, e.g., interlocking and/or friction-locking means. To this end, a member may be provided on the outer shaft interacting with a member on an inner shaft to lock the motion of the rolling membrane. For example, the

22.173P-WO / 04.12.2023 locking means may further be shaped in such a way that interlocking and/or friction-locking is facilitated, e.g., by choosing rough and/or friction-increasing materials and/or by providing members and/or sites configured to interlock or otherwise engage with each other, like serrated sites. This may yield a compact, material-saving catheter design, reducing labor costs and material costs in production. The locking means may for example comprise one or more ring-shaped elements replacing a section of the outer shaft, which are biased to engage with the inner shaft unless pressure provided to a lumen between inner and outer shaft lifts them off the inner shaft and thus unlocking the rolling membrane. However, additionally or alternatively, other elements, e.g. with a circular or any other cross section, like, e.g., a knob, integrated into the surface of the outer shaft, etc., may be employed. Several such non-ring-shaped elements may be distributed around a circumference of the outer shaft. The catheter may comprise at least one locking means configured to be in a first configuration locking the motion of the rolling membrane when insufficient fluid pressure is provided to the catheter. Further, the locking means may be configured to be in a second configuration unlocking the motion of the rolling membrane when sufficient fluid pressure is provided to the catheter. Herein, the term ‘locking’ may be understood as preventing a motion of at least one member relative to at least one other member of the catheter and ‘unlocking’ may be understood as allowing the motion of at least one member relative to at least one other member if the catheter. A member can, for example, be any means/element/building block/(sub-)unit of the catheter. For example, when the locking means is connected to the outer shaft, the locking means may be in the second configuration when the locking means are in a lifted position in which, e.g., there is no contact between the locking means and the inner shaft and/or the respective counterpart connected to the inner shaft. The locking means may further be in contact with the inner shaft and/or the respective counterpart when it is the first configuration. In some examples, the locking means may be in constant contact with, e.g., the inner shaft but the force clamping the inner shaft, or any other member to be clamped for locking the rolling membrane, may be significantly different between the two configurations of the locking means. Thereby, the locking means provide a safetymechanism preventing damaging the catheter and/or vessel walls. This may yield a user-friendly, mechanical feedback to a user operating with the catheter on whether the inner member should be moved or not which may improve safety.

In a further example, the catheter may comprise at least one locking means comprising an elastic element configured to change its configuration based at least in part on the fluid state of the catheter. This may yield a low-cost locking means functioning, e.g., without any electrical means which may optimize reliability and/or safety. Further, the elastic element may be particularly suitable to maximize the area of contact with the surface of the member to be contacted and locked. The elastic element may be for example be a silicone, rubber, and/or any other elastic element in a shape configured to change its configuration in response to a change in the fluid state, e.g., a changing fluid pressure. It may be pre-tensioned, for example. Such element may for example be at least one elastic tubular member and/or ring that clamps the inner shaft of the catheter when a low fluid pressure is provided to the volume between the outer shaft and the inner shaft, locking the inner shaft relative to the outer shaft and thus the rolling membrane. The elastic element may be provided

22.173P-WO / 04.12.2023 to be under tension such that it clamps the inner shaft when no pressure or pressure below a predetermined threshold is provided. In an example, it may further be inflated at least partly, when a higher fluid pressure is provided to the volume between the outer shaft and the inner shaft such that it is lifted from the inner shaft (or pressure applied to the inner shaft is reduced), allowing for motion of the inner shaft relative to the outer shaft and thus the rolling membrane. In an example, the elastic element may be at least one knob configured to change its configuration such that it either locks or unlocks the rolling membrane depending on its fluid state-dependent configuration. In some examples, the elastic element may comprise at least one spring and/or spring-like element that may be configured to hold the locking element in the locking position unless sufficient fluid pressure is provided to the catheter counteracting the force of the spring and allowing for motion of the rolling membrane. In some examples, the elastic element may comprise an elastic layer with a finger-like element arranged to lock the inner shaft, unless sufficient pressure is applied to lift the elastic layer and thus the finger-like element from the inner shaft. Such elastic means may be robust, reliable, and safe solutions suitable to be integrated into a catheter.

In some examples, the catheter may further comprise a fluid state sensor. The at least one locking means may be in the locked and/or unlocked configuration based at least in part on measuring the fluid state provided to the catheter by the fluid state sensor. The fluid sensor may also be provided to the catheter in addition to any locking mechanism described herein.

According to a second aspect of the invention, a catheter comprising a rolling membrane is provided which prevents unintentional advancement of guidewire (i.e. the unwanted advancement of the guidewire at about twice the speed of the leading edge of the rolling membrane). This can be done by using either at least one decoupling means configured to decouple a motion of the rolling membrane from a motion of the guidewire or by using at least one motion compensation means configured to limit and compensate the motion of a guidewire advancement. Such a catheter comprises a rolling membrane, a guidewire, and at least one decoupling means configured to decouple a motion of the rolling membrane from a motion of the guidewire or at least one motion compensation means configured to limit and compensate the motion of a guidewire advancement. Decoupling the motion of the rolling membrane and the motion of the guidewire may solve some of the problems related to unwanted guidewire advancement described herein at least in part. It may further increase safety and provide a user-friendly catheter. The guidewire may be used as a tool to guide the rolling membrane such that the guidewire may be introduced into, e.g., a blood vessel to the treatment site like a stenosis. The tubular rolling membrane may be everted with the guidewire to and beyond the treatment site as it may envelop the guidewire such that its eversion is determined by the positioning of the guide wire. It may be advantageous to always be able to move the guidewire and the rolling membrane independently from each other. For this purpose, their motion may at least partially decoupled.

The at least one decoupling means may be any means providing any mechanism capable of decoupling the motion of the guidewire and the rolling membrane. This decoupling may allow for motion of the rolling

22.173P-WO / 04.12.2023 membrane when the guidewire is not moving and/or allow for motion of the guidewire when the rolling membrane is not moving. Further, the guidewire and the rolling membrane may move independently from each other simultaneously and/or consecutively, e.g., at different velocities, accelerations, and/or in different directions. The catheter may comprise at least one decoupling means comprising a clamping element configured to restrict the movement of the guidewire, preferably in a longitudinal direction. Clamping the guidewire may be an effective decoupling mechanism that is suitable to overcome the clamping force of the rolling membrane onto the guide wire. Thereby, it may increase safety.

The clamping element may for example be a mechanical clamp clamping the guidewire via an interlocking (e.g. in a form -fitting manner) and/or a friction-locking connection between the clamping element and the guidewire. For example, the clamping element may clamp the guidewire via at least two stamps configured to clamp the guide wire, a locking screw, and/or in a notch. Alternatively, the clamping element may be an elastic element (e.g. a silicone or rubber) and/or any other elastic element in a shape configured to change its configuration in response to a change in the fluid state (e.g. a changing fluid pressure). The clamping element may be tightened to clamp the guidewire once or the clamping force may be adjusted to the clamping force required at that moment. In an example, the clamping may be controlled by the user and/or it may be controlled (semi-) automatically. The user may further be instructed to clamp the guidewire by the clamping element based at least on part on the fluid state and/or the motion state of the rolling membrane, e.g., as sensed by a respective sensor.

The catheter may in some examples comprise decoupling means comprising at least one friction-reducing element on an outer side of the rolling membrane. This may have the advantage to reduce the friction between the rolling membrane and the guidewire. Thus, the guidewire may remain stationary while the rolling membrane is everted and/or retracted as a substantially weaker force may be applied by the rolling membrane onto the guidewire. This may further be advantageous as the rolling membrane may in this way be manipulated independently from any other member of the catheter.

The outer side of the rolling membrane is the side that is in contact with the vessel wall when the rolling membrane is fully everted and in contact with the guidewire when it is fully retracted.

In some examples, when the rolling membrane is in a (fully) retracted state and a fluid pressure is provided to the rolling membrane, the rolling membrane is inflated such that at least a part of the outer side of the rolling membrane may be brought into contact with at least a portion of the guidewire. The resulting clamping force onto the guidewire may depend on an area of contact and the fluid pressure provided to the rolling membrane. Due to the resulting clamping force and friction between the rolling membrane and the guidewire, the rolling membrane may drag the guidewire with it when it is everted or retracted. The force acting onto the guidewire generally depends on the area of contact, the normal force, i.e., the clamping force, and the coefficient of friction, which is an empirical property of the two materials in contact with

22.173P-WO / 04.12.2023 each other. The friction-reducing element may reduce the coefficient of friction. This may either reduce the force acting onto the guidewire such that either the force dragging the guidewire with the rolling membrane is simply reduced and/or the force may be reduced so much that the guidewire remains stationary when the rolling membrane is everted and/or retracted.

For example, the friction-reducing element may comprise a hydrophilic portion. The friction-reducing element may further, for example, comprise a film on the whole outer side of the rolling membrane or it may only cover a part of the outer side rolling membrane. The friction-reducing element may further be an integral part of the rolling membrane such that, e.g., the full rolling membrane consists of the friction reducing element and/or sections of the rolling membrane comprise the friction-reducing element. In some examples, the friction reducing element may cover a part of the outer side of the rolling membrane in form of any pattern which may be, e.g., striped, dotted, or a chessboard-pattern. Such pattern might further, e.g., vary along the length in axial direction of the rolling membrane, for example to provide a spatially altering coefficient of friction, adjusted to the respective area of contact between the guidewire and the rolling membrane depending on the respective state of eversion. For example, the portion of the rolling membrane that is everted first may be provided with a friction-reducing element as the area of contact is large when that portion is in contact with the guidewire. The last portion of the rolling membrane to be everted may be only covered in part by the friction-reducing element or may not be provided with the friction-reducing element. This may be sufficient as the contact area is small when the rolling membrane is almost fully everted. Thus, the friction force may be too small already to drag the guidewire with the rolling membrane. Hence, at that stage no friction reduction may be required anymore to decouple the motion of the rolling membrane and the guidewire. Generally, such pattern may be adjusted in any way tailoring the interaction between rolling membrane and guidewire. The friction-reducing element may, in some examples comprise one or more polymers, liquid films, etc. The friction-reducing element may further be adapted to be permanently applied to the rolling membrane such that no parts detach from the rolling membrane and contaminate the treated lumen.

The at least one motion compensation means may comprise a torque element (also denoted as guidewire torquer) and optionally an elastic object, preferably a spring (in which the load is an axial force) like a coil spring. This ensures that the guidewire advancement in the rolling membrane catheter is limited and (cyclically) compensated independently of the user, thereby increasing safety in a clinical setting. Optionally the motion compensation means can be provided with automatic pressure reduction. Therefore, the at least one motion compensation means may further comprise a sealing element, preferably a ball valve or a sliding seal.

The catheter may comprise a first fluid inlet configured to be connected to a first fluid unit. The first fluid inlet may be configured for pressurization of a pressure-controlled clamping element. The clamping element may be configured to clamp the guidewire when a fluid pressure is provided to the first fluid inlet

22.173P-WO / 04.12.2023 by the first fluid unit. For example, the clamping element may be inflated by the fluid pressure, upon which it clamps the guidewire. A fluid-state-based control may be an advantageous control system compatible with the necessary flexibility of the catheter. Further, it may provide a clamping force clamping the guidewire (semi-)automatically and/or only when required, therefore increasing safety, and improving the catheter handling in a user-friendly way.

The clamping element may be a mechanical clamp as described herein. Such mechanical clamp may be activated to clamp the guidewire in a (semi-)automatic way, e.g., as instructed by a control unit based at least in part on a fluid state sensed by a respective sensor. In some examples, the clamping element may be configured to directly respond to pressure provided to it. For example, the clamping element may comprise an element configured to be inflated and/or otherwise change its configuration depending on the pressure provided to it, e.g., by the fluid unit via the first fluid inlet. For example, when pressure below a predetermined threshold is provided to the clamping element it may not clamp the guidewire and/or when a fluid pressure above a predetermined threshold is provided to it, it may clamp the guidewire . The clamping element may, e.g., comprise an (elastic) ring with an inner diameter placed around the guidewire. When pressure is provided to the outer side of the ring, the inner diameter may be reduced such that the guide wire is clamped, the guidewire cannot move, and the motion of the rolling membrane and the guidewire is thus decoupled. The guidewire may be released at any time by adjusting the pressure provided to the clamping element. Any of the functionalities described with respect to the clamping element or any other function described herein may be implemented as steps of a method and/or instructions of a computer program.

The catheter may comprise a second fluid inlet configured to be connected to the first fluid unit and/or another fluid unit. The second fluid inlet may be configured for pressurization of the rolling membrane. The first fluid unit may further be configured to determine the fluid state of the rolling membrane of the catheter. Using the same fluid unit to determine the fluid state of the rolling membrane and to control the clamping element may simplify the system, make it more user-friendly, reduce material costs, and result in a suitable adjustment of the clamping force to the fluid state of the rolling membrane.

In some examples, different fluid units may be connected to the first and second inlet to control the two respective fluid states separately, possibly in mutual adjustment for synchronized operation. The same fluid unit may be connected to the first fluid inlet and the second fluid inlet providing the same fluid state to both. In particular, the guidewire may thus automatically (not) be clamped when the membrane is (not) inflated. The first fluid inlet may connect the fluid unit with the clamping element, activated by at least one parameter associated with the fluid state as described herein. The second fluid inlet may connect the fluid unit with the space between the outer shaft and the inner shaft of the catheter limited by the rolling membrane at the distal end of the catheter and by a sealing means at the proximal end of the catheter, which is referred to as the rolling membrane volume herein. The fluid state of the rolling membrane may be understood as the fluid state provided to the rolling membrane volume. In an example, the rolling membrane

22.173P-WO / 04.12.2023 may be considered in an inflated state, when the fluid pressure is above a minimum value (and below a burst pressure), wherein with a fluid pressure below the minimum value the rolling membrane is considered as only partly inflated.

In some examples, the at least one decoupling means or the at least one motion compensation means of the catheter is at least in part arranged at a portion of the catheter proximal to the rolling membrane. This may yield the advantage that the decoupling means may not interfere with the regular operation of the catheter, e.g., the insertion of the distal end of the catheter into the patient and/or the eversion of the rolling membrane. The decoupling means as described herein may be mounted directly to, e.g., a proximal end portion of the outer shaft and/or the inner shaft. In some examples, the decoupling means may be connected to the proximal end portion of the outer shaft and/or the inner shaft via a frame and/or a leg. The frame and/or a leg may extend from the proximal end region of the outer shaft further into the proximal direction to place the decoupling means proximally beyond the proximal end of the outer shaft. The frame and/or leg may have the shape of a bracket providing space for means to control the motion of the inner shaft, e.g., via a handle at the proximal end of the inner shaft.

In some examples, the catheter may comprise a third fluid inlet configured to be connected to a second fluid unit. The second fluid unit may be configured to provide a fluid pressure to the volume between the rolling membrane and the guidewire. This second fluid pressure may have an advantageous effect as it counteracts the fluid pressure provided to the other side of the rolling membrane (the rolling membrane volume) as described herein: For example, the additional pressure provided by the second fluid unit may at least partly lift the rolling membrane off the guidewire when the two pressures are adjusted to each other accordingly (and/or at least reduce the clamping force between the rolling membrane and the guidewire). This may reduce the friction force between rolling membrane and guidewire and thus decouple the motion of the rolling membrane and the guidewire. This may prevent the unwanted advancement of the guidewire at twice the speed of the leading edge of the rolling membrane. The third fluid inlet may be configured for pressurization of the volume between the inner shaft of the rolling membrane. In an example, the third fluid inlet may be located at the inner shaft, e.g., at a proximal end region of the inner shaft near the handle. This way it may not interfere with the operation of the catheter as described herein. The second fluid unit, like any other fluid unit, may be an external or an integral part of a catheter system. It may be controlled by a health professional or in a (semi-)automatic way, e.g., it may be adjusted based at least in part on the fluid state of the rolling membrane volume. In an example, the fluid pressure provided to the volume between the rolling membrane and the guidewire may be adjusted to the fluid pressure provided to the rolling membrane volume such that only a small portion of the rolling membrane is in contact with the guidewire, e.g., only along a ring at the distal end of the rolling membrane. This may reduce the friction enough to decouple the motion of the rolling membrane and the guidewire without necessarily opening an inner lumen of the rolling membrane. The fluid pressure provided to the volume between the rolling membrane and the guidewire may be adjusted at least in part automatically based at least in part on the fluid pressure provided

22.173P-WO / 04.12.2023 to the rolling membrane volume. This may, e.g., be realized by coupling the two respective fluid units for synchronized operation or even using one and the same fluid unit for the respective fluid inlets.

In one aspect, a system comprising a rolling membrane catheter as described herein and at least one fluid unit may be provided. The fluid unit may be configured to provide a fluid pressure to at least two of the following: the first fluid inlet, the second fluid inlet, and a third fluid inlet. Connecting one fluid unit to more than one inlet may provide a cost-effective and more user-friendly system. Further, it may be advantageous to provide the same fluid states to different means as their activation as described herein may be inherently coupled in an advantageously adjusted way. Further, this configuration provides a high flexibility and the possibility to adjust the use of at least one fluid unit to the planned treatment and/or other patient-related factors. The at least one fluid unit may be connected to the respective inlets via flexible hoses or any other connection means. The at least one fluid unit may be controlled by a health professional or in an automatic and/or semi-automatic way.

According to a third aspect of the invention, a catheter comprising a rolling membrane is provided. The catheter may comprise at least one pressure release valve and/or at least one friction-reducing element on an inner side of the rolling membrane. In some examples, the at least one pressure release valve may open when the fluid pressure exceeds a predetermined threshold. Thus, bursting of the rolling membrane may be prevented in a safe and user-friendly way. The at least one pressure release valve may for example be located at a proximal end portion of the outer shaft.

In an example, the friction-reducing element on the inner side of the rolling membrane may be present in addition or alternatively to a friction-reducing element on the outer side of the rolling membrane. Further, the friction-reducing element on the inner side of the rolling membrane may have any properties described herein in reference to the friction-reducing element on the outer side of the rolling membrane. The frictionreducing element on the inner side of the rolling membrane may reduce friction between two portions of the rolling membrane in contact with each other, as, e.g., when the rolling membrane is clamped in a stenosis such that it is not in its fully inflated state. When the portions in contact with each other can move relative to each other without substantial friction (or at least reduced friction) as afforded by the frictionreducing element, the rolling membrane may for example be retracted in a rolling motion without clinching/folding. The friction between two portions of the rolling membrane in contact with each other may be high, for example when no friction-reducing element is available. In such examples, the retraction of one end of the rolling membrane, e.g., via the retraction of the inner shaft, may drag the two contacting portions of the layer with it. This is incompatible with the intended rolling motion of the rolling membrane. Rather, the rolling membrane may be compressed along the axial direction and folded. By means of the friction-reducing element this issue may be avoided and a correct rolling-in of the membrane may be enabled even in difficult situations.

22.173P-WO / 04.12.2023 A fourth aspect of the invention is the use of a tubular element comprising a friction-reducing element applied to at least a part of an outer side of the tubular element and/or to at least a part of an inner side of the tubular element as a rolling membrane for a rolling membrane catheter. The tubular element used as a rolling membrane may have any feature described herein in relation to the rolling membrane, the frictionreducing elements, the catheter and/or any other members of the catheter.

According to a fifth aspect of the invention, a computer program comprising instructions may be provided, such that when the program is executed, it may cause a rolling membrane catheter to clamp a guidewire of the catheter by a clamping element to decouple a motion of a rolling membrane of the catheter from a motion of the guidewire. The computer program may comprise instructions implemented according to any feature described herein and further any such instruction of a computer program may be realized as a step of an according method. Such computer program may be advantageous for automatization, increasing reliability, reduce the risk of user errors and it may improve the over-all handling and/or performance of the respective catheter. Such computer program may in some examples be based at least in part on an artificial intelligence, Al, assistant as described herein. Such Al might suggest and/or determine at least one parameter associated with the operation of the catheter.

In a further example, a computer program comprising instructions may be provided, such that when the program is executed, it may cause the catheter (e.g. as described herein) to lock the rolling membrane at least in part based on a fluid state of the catheter. In some examples, it may cause the at least one locking means of a rolling membrane catheter to be in a first configuration locking the rolling membrane when insufficient fluid pressure is provided to the catheter. Further, it may cause the at least one locking means to be in a second configuration unlocking the motion of the rolling membrane when sufficient fluid pressure is provided to the catheter. This may for example involve signaling from a sensor sensing the fluid state of the rolling membrane volume, for example. Therein, the signaling may be based at least in part on at least one parameter associated with the fluid state of rolling membrane volume. This may bring the at least one locking means into contact with the inner shaft, e.g., in case the at least one locking means may be at least in part connected to at least a portion of an outer shaft of the catheter (as described herein). When the at least one locking means comprises an elastic element, the instructions of the computer program, when executed, may cause the elastic element to change its configuration based at least in part on the fluid state of the catheter.

Fig. 1A Schematic representation of a rolling membrane catheter with coupled rolling membrane and guidewire motion and with the rolling membrane in a partly everted state.

Fig. IB Schematic representation of a rolling membrane catheter with coupled rolling membrane and guidewire motion and with the rolling membrane in a further everted

22.173P-WO / 04.12.2023 state with the leading edge of the rolling membrane advanced by a distance x and the inner member and the guidewire advanced by a distance 2x.

Fig. 2 A Schematic representation of an outer shaft with an integrated locking means in the unlocking position.

Fig. 2B Schematic representation of an outer shaft with an integrated locking means in the locking position.

Fig. 3 A Schematic representation of a rolling membrane catheter with decoupled rolling membrane and guide wire motion via a mechanical clamp and with the rolling membrane in a partly everted state.

Fig. 3B Schematic representation of a rolling membrane catheter with decoupled rolling membrane and guide wire motion via a mechanical clamp and with the rolling membrane in a further everted state with the leading edge of the rolling membrane advanced by a distance x and a locked guidewire.

Fig. 4A Schematic representation of a rolling membrane catheter with decoupled rolling membrane and guidewire motion via a pressure-controlled clamp and with the rolling membrane in a partly everted state.

Fig. 4B Schematic representation of a rolling membrane catheter with decoupled rolling membrane and guidewire motion via a pressure-controlled clamp and with the rolling membrane in a further everted state with the leading edge of the rolling membrane advanced by a distance x and a locked guidewire.

Fig. 5 A Schematic representation of a rolling membrane catheter with decoupled rolling membrane and guidewire motion via a pressure-controlled clamp and with the rolling membrane in a partly everted state with a fluid pressure provided to the volume between the rolling membrane and the guidewire.

Fig. 5B Schematic representation of a rolling membrane catheter with decoupled rolling membrane and guidewire motion via a pressure-controlled clamp and with the rolling membrane in a further everted state with the leading edge of the rolling membrane advanced by a distance x and a locked guidewire with a fluid pressure provided to the volume between the rolling membrane and the guide wire.

Fig. 6A Schematic representation of the retraction of a pressurized rolling membrane,

Fig. 6B Schematic representation of the retraction of a non-pressurized rolling membrane ,

Fig. 7A to 7H Schematic representation of a rolling membrane catheter comprising a motion compensation means,

Fig. 8A/8B Schematic representation of a rolling membrane catheter comprising a motion compensation means with an automatic pressure reduction,

Fig. 9A/9B Schematic representation of another rolling membrane catheter comprising a motion compensation means with an automatic pressure reduction.

22.173P-WO / 04.12.2023 Herein, a distal direction and a proximal direction, whenever referred to, relates to a leftward and a rightward direction, respectively, in all figures described in the following.

Fig. 1A shows a schematic representation of a rolling membrane catheter 100 with coupled rolling membrane 120 and guidewire 110 motion and with the rolling membrane 120 in a partly everted state. The catheter comprises an outer shaft 130 and inner shaft 150. A second fluid inlet 140 is provided and configured to be connected to a fluid unit (not shown) determining the fluid state of the rolling membrane 120 by providing, e.g., a fluid pressure to the rolling membrane volume limited by the rolling membrane 120, the outer shaft 130, and the inner shaft 150. The exemplary embodiment of Fig. 1A further comprises a handle 160 at the proximal end of the inner shaft 150. A health professional may move the inner shaft 150 relative to the outer shaft 130 by this handle 160. They may move the inner shaft 150 in the distal direction to evert the rolling membrane 120 and in the proximal direction to retract the rolling membrane 120. During both, eversion and retraction, the rolling membrane 120 is ideally in an inflated state such that it is everted and/or retracted in a rolling motion.

Fig. IB shows the exemplary embodiment of the catheter 100 of Fig. 1 A wherein the rolling membrane 120 is in a further everted state, via movement of the inner shaft 150 in the distal direction, as the leading edge of the rolling membrane 120 is advanced by a distance x. The inner shaft 150 is in a different position, dislocated by a distance 2x compared to the situation of Fig. 1A. The guidewire 110, which is clamped by the rolling membrane 120 is also dislocated by a distance 2x in the distal direction compared to its position shown in Fig. 1A. Fig. IB thus shows an exemplary scenario for coupled motion of the guidewire 110 and the rolling membrane 120 bearing the risk of unwanted guidewire 110 advancement into, e.g., a blood vessel, one of the problems with rolling membrane catheters 100. Together, Fig. 1A and IB illustrate the basic working principle and the basic building blocks of a rolling membrane catheter 100.

Fig. 2A shows a schematic representation of an outer shaft 230 of a catheter 200 with an exemplary locking means 280 in the unlocking position. The exemplary locking means 280 is integrated in the outer shaft 230. The locking means 280 may comprise an elastic ring or tube. The locking means 280 of the shown exemplary may comprise an elastic tubular element which is integrated as one portion into the tubular outer shaft 230. In some examples, the elastic tubular element may abut around an outer surface of the outer shaft 230. The unlocking position of the exemplary embodiment shown in Fig. 2A is such that the elastic ring of the locking means is lifted off the inner shaft 250 due to sufficient pressure provided to the volume between the outer shaft 230 and the inner shaft 250. The section shown in Fig. 2A may only be a part of the full outer shaft 230 and there may be multiple such locking means 280 comprised in the outer shaft 230. The multiple locking means may be identical or different, e.g., differing in length in the axial direction, material, and/or shape.

22.173P-WO / 04.12.2023 Fig. 2B shows a schematic representation of the embodiment of Fig. 2A with an outer shaft 230 with an integrated locking means 280 in the locking position. The locking means 280 may be arranged around the outer shaft 230. The locking position of the exemplary embodiment shown in Fig. 2A is such that the elastic ring of the locking means is not lifted off the inner shaft 250 due to insufficient pressure provided to the volume between the outer shaft 230 and the inner shaft 250. Therefore, the locking means 180 clamps the inner shaft 250 and connects the outer shaft 230 and the inner shaft 250 such that they cannot move relative to each other. The locking means 280 may comprise a form other than tubular. For example, the locking means 280 may comprise at least one knob, piston, pin, and/or membrane. Any of these locking means 280 may be configured to be in the unlocking position when, e.g., sufficient fluid pressure is provided to the catheter 200. In the unlocking position, the locking means 280 are passive such that they do not lock any member of the catheter 200. Further, any locking means 280 may be configured to change its configuration as described herein, e.g., when insufficient fluid pressure is provided to the catheter 200, into their active locking position locking at least one member of the catheter 200.

Fig. 3A shows a schematic representation of a rolling membrane catheter 300 with decoupled rolling membrane 320 and guidewire 310 motion via a clamping element 37 and with the rolling membrane in a partly everted state. The clamping element 37 may extend from a proximal end of the outer shaft 330 and/or from a proximal end of a handpiece at the proximal end of the outer shaft 330 further proximally. The clamping element 37 shown in Fig. 3 A may be a mechanical clamp 370, wherein the guidewire 310 may be mechanically clamped via, e.g., a locking screw. Any other locking mechanism described herein is possible as well either alternatively or in addition to the shown locking screw. Further, the catheter 300 comprises the second fluid inlet 340 configured to be connected to a fluid unit (not shown) determining the fluid state of the rolling membrane 320. The catheter comprises further an inner shaft 350 and a handle 360.

Fig. 3B shows the exemplary embodiment of the catheter 300 of Fig. 3A wherein the rolling membrane 320 is in a further everted state as the leading edge of the rolling membrane 320 is advanced by a distance x. The inner shaft 350 is in a different position, dislocated, e.g. via the handle 360, by a distance 2x compared to the situation of Fig. 3A. The guidewire 310, which is clamped by the rolling membrane 320 is clamped by the clamping element 37 such that it is at the same position as in Fig. 3A, as the clamping force of the clamping element 37 exceeds the clamping force of the rolling membrane 320. Fig. 3B thus shows an exemplary scenario for decoupled motion of the guidewire 310 and the rolling membrane 320 reducing the risk of unwanted guidewire 310 advancement into, e.g., a blood vessel.

Fig. 4A, in analogy to Fig. 3A, shows a schematic representation of a rolling membrane catheter 400 with decoupled rolling membrane 420 and guidewire 410 motion via a clamping element 47 and with the rolling membrane in a partly everted state. The clamping element 47 shown in Fig. 4A is a pressure-controlled clamp 470, wherein the guidewire 410 is clamped via an elastic member brought into contact with the guidewire 410 to clamp the guidewire 410 when sufficient fluid pressure is provided to the clamp 470. The

22.173P-WO / 04.12.2023 clamping element 47 may be arranged similarly with respect to outer shaft 430 as outlined with reference to clamping element 37 and outer shaft 330 of Figs. 3A and 3B. Further, the catheter 400 comprises the second fluid inlet 440 configured to be connected to a fluid unit determining the fluid state of the rolling membrane 420. The catheter comprises further an inner shaft 450 and a handle 460.

Analogously to Fig. 3B, Fig. 4B shows the exemplary embodiment of the catheter 400 of Fig. 4A wherein the rolling membrane 420 is in a further everted state as the leading edge of the rolling membrane 420 is advanced by a distance x. The inner shaft 450 is in a different position, dislocated by a distance 2x compared to the situation of Fig. 4A. The guidewire 410, which is clamped by the rolling membrane 420 is also clamped by the clamping element 47 such that it is at the same position as in Fig. 4A, as the clamping force of the clamping element 47 exceeds the clamping force of the rolling membrane 420. Fig. 4B thus shows an exemplary scenario for decoupled motion of the guide wire 410 and the rolling membrane 420 reducing the risk of unwanted guidewire 410 advancement.

Fig. 5A shows a schematic representation of a rolling membrane catheter 500 with decoupled rolling membrane 520 and guidewire 510 motion via a clamping element 57, e.g. a pressure-controlled clamp 570, and with the rolling membrane 520 in a partly everted state, similarly as outlined with reference to rolling membrane catheter 500 of Fig. 4A. However, catheter 500 additionally comprises a fluid conduit to the inner shaft 550 via the handle 560. Thus, fluid pressure may be provided to the volume between the rolling membrane 520 and the guidewire 510. All three fluid inlets of the outer shaft 530, of the inner shaft 550, and of the pressure-controlled clamp 570 may be connected to the same fluid unit in this exemplary embodiment. The fluid pressure provided to the inner shaft 550 provides a fluid pressure to the volume between the rolling membrane 520 and the guidewire 510, lifting at least a part of the rolling membrane 520 off the guidewire 510. The fluid pressures provided to both sides of the rolling membrane 520 in Fig. 5A are adjusted such that the rolling membrane 520 is in contact with the guidewire 510 only with a small portion at the distal end of the rolling membrane 520. Further, the catheter 500 comprises the second fluid inlet 540 configured to be connected to a fluid unit determining the fluid state of the rolling membrane 520.

Analogously to Fig. 3B and 4B, Fig. 5B shows the exemplary embodiment of the catheter 500 of Fig. 5A wherein the rolling membrane 520 is in a further everted state as the leading edge of the rolling membrane 520 is advanced by a distance x. The inner shaft 550 is in a different position, dislocated, e.g., via the handle 560, by a distance 2x compared to the situation of Fig. 5A. The guidewire 510, which is clamped by the rolling membrane 520 is clamped by the clamping element 57 and further the friction between the rolling membrane 520 and the guidewire 510 is reduced such that it is at the same position as in Fig. 5A, as the clamping force of the clamping element 57 exceeds the clamping force of the rolling membrane 520. Fig. 5B thus shows an exemplary scenario for decoupled motion of the guide wire 510 and the rolling membrane 520 reducing the risk of unwanted guidewire 510 advancement.

22.173P-WO / 04.12.2023 Fig. 6A shows a schematic representation of the retraction of a pressurized rolling membrane (filled with fluid) 620 of a rolling membrane catheter 600 everted through a stenosis S. When the stenosis S is as wide as in Fig. 6A, the inner surfaces of the rolling membrane 620 are not in contact with each other and the rolling membrane 620 may be retracted by retracting the inner shaft 650 in the proximal direction as indicated by the straight dashed arrow. The rounded dashed arrows indicate the rolling motion of the retraction of the rolling membrane 620, essentially the reverse motion of the eversion. The at least one friction-reducing element 621 on the inner side of the rolling membrane does not contribute to the retraction process illustrated in Fig. 6A. The catheter further comprises an outer shaft 630.

Fig. 6B shows a schematic representation of the retraction of a rolling membrane 620 having a frictionreducing element 621 on the inner side everted through a narrow stenosis S. In case the rolling membrane 620 would burst, the stenosis S may collapse and become so narrow that the rolling membrane 620 would be clamped by the stenosis. The inner sides of the rolling membrane 620 provided with the at least one friction-reducing element 621, in Fig 6B in form of a coating and/or film, shown as dotted lines, are in contact. Without friction-reducing element 621, the friction between the portions of the rolling membrane 620 might be high enough to prevent a controlled retraction of the rolling membrane 620. It might potentially clinch or burst further. The at least one friction-reducing element 621, as present in the exemplary embodiment of Fig. 6B, however, may allow for the controlled retraction of the rolling membrane 620 in a rolling motion by retracting the inner shaft 650 in the proximal direction relative to the outer shaft 630 as indicated by the straight dashed arrow. Like in Fig. 6A, the rounded dashed arrows indicate the rolling motion of the retraction of the rolling membrane 620, essentially the reverse motion of the eversion. Therefore, the at least one friction-reducing element 621 provides a safety measure in case the burst of the rolling membrane 620 cannot be prevented such that the catheter 600 may still be retracted safely.

Both a guidewire advancement and a manual, repeated retraction of the guidewire are dependent on the user (physician). If not taken into account, there is a risk of uncontrolled advancement of the guidewire into distal vascular regions during rolling-out of the rolling membrane and thus a risk of vascular perforation in the patient. Under pressure, the rolling membrane of a rolling membrane catheter is ready for rolling-out and the guidewire is clamped by the rolling membrane. When the inner shaft is advanced and the rolling membrane is roll-outed without the use of a motion compensation means, the clamped guidewire is also advanced with twice the speed of the rolling membrane front. The guidewire tip can be pushed far beyond a maximum permissible distal position. This potentially poses a safety risk.

The problem that the rolling membrane and the guidewire movement are coupled can be solved by a rolling membrane shown in Fig. 7A to 7H comprising (at least) one motion compensation means 770 configured to limit and compensate the motion of a guidewire advancement. Fig. 7A to 71 show a schematic representation of a rolling membrane catheter 700 with coupled rolling membrane 720 and guidewire 710.

22.173P-WO / 04.12.2023 The rolling membrane catheter 700 comprises an outer shaft 730 and inner shaft 750. A fluid inlet 740 may be provided and configured to be connected to a fluid unit (not shown) determining the fluid state of the rolling membrane 720 and/or providing a fluid pressure to the rolling membrane volume limited by the rolling membrane 720, the outer shaft 730, and the inner shaft 750. The rolling membrane catheter 700 may further comprises a handle at the proximal end of the inner shaft 750. The (mechanical, cyclic) motion compensation means 770 may comprise a torque element 790 and optionally an elastic object 780, preferably a spring . It can be seen that the guidewire 710 is coupled relative to the rolling membrane catheter 700 or the outer shaft 730 by means of amotion compensation means 770 (here comprising a torque element and a coil spring). The motion compensation means 770 may be situated at a proximal region of the guidewire 710. D represents the maximal permissible distal position of the guidewire tip. By ensuring a distally limited guidewire advancement in a rolling membrane catheter 700 and thus decoupling this task from the user (physician), the solution significantly increases patient safety in clinical use.

Under pressure (see Fig. 7A), the rolling membrane 720 of a rolling membrane catheter 700 is ready for rolling-out. The guidewire 710 is clamped by the rolling membrane 720. When the rolling membrane is rolled out under pressure (see Fig. 7B), the maximum distal position of the guidewire is limited by the spring path. However, the rolling membrane's rolling path is also limited by the coupling with the guidewire 710. If the pressure in the rolling membrane is temporarily lowered (see Fig. 7C), the guidewire 710 can move freely again. The spring force pushes it back to the initial proximal position. Back under pressure (see Fig 7D), the rolling membrane 720 of the rolling membrane catheter 700 is ready for further rollingout. The guidewire 710 is again clamped by the rolling membrane 720. As the rolling membrane 720 continues to roll-out under pressure, the maximum distal position of the guidewire 710 is again limited by the spring path (see Fig. 7E). The rolling distance of the rolling membrane 720 is also limited again by the coupling with the guidewire 710. If the pressure in the rolling membrane 720 is temporarily lowered again (see Fig. 7F), the guidewire 710 can move freely again. It is pushed back into the initial proximal position by the spring force. As the rolling membrane 720 continues to roll-out under pressure (see Fig. 7G), the maximum distal position of the guidewire 710 is limited by the spring path. When the rolling membrane 720 is (almost) completely roll-outed (see Fig. 7H), the guidewire 710 can move freely again. The spring force pushes it back to the initial proximal position.

An alternative motion compensation means (not shown here) may comprise a torque element but may not comprise an elastic object such as a spring. This allows the physician maximum ease of control over what he wants to do. In such a case the physician can place the guidewire, then advance the rolling membrane catheter on the guidewire until it reaches the stenosis, the guidewire is advanced as distally as is possible and safe. The torque element is now advanced on the guidewire against a bow on the handle and is tightened/locked there. The physician can now pull the guidewire with the torque element back as far as possible without the guidewire losing the path already found. When the rolling membrane is rolled out, the torque element stops the guidewire in the most distal position previously determined by the physician as

22.173P-WO / 04.12.2023 safe. (The physician must visually monitor that the wire has not taken another branch). Optionally the (mechanical, cyclic) motion compensation means of the rolling membrane catheter of Fig. 7A to 7H may be provided with an automatic pressure reduction see (Fig. 8A/B and 9A/B).

Fig. 8A and 8B show a rolling membrane catheter 800 comprising a (mechanical, cyclic) motion compensation means 870 with an automatic pressure reduction. The rolling membrane catheter 800 further comprises an outer shaft 830 and inner shaft 850. A fluid inlet 840 may be provided and configured to be connected to a fluid unit (not shown) determining the fluid state of the rolling membrane 820 and/or providing a fluid pressure to the rolling membrane volume limited by the rolling membrane 820, the outer shaft 830, and the inner shaft 850. The rolling membrane catheter 800 may further comprises a handle at the proximal end of the inner shaft 850. The (mechanical, cyclic) motion compensation means 870 may comprise a torque element 890 and optionally an elastic object 880, preferably a spring. This variant of an automatic pressure reduction uses a ball valve 860. The ball valve seals as long as it does not experience any contact/force from the outside (see Fig 8A). When the rolling membrane 820 is rolled out under pressure, the maximum distal position of the guidewire 710 is limited by the spring path. The torque element 890 thereby pushes the ball valve 860 inward, causing a small leak and lowering the pressure inside (see Fig. 8A). This reduces the friction between the rolling membrane 820 and the guidewire until the spring force on the torque element 890 is sufficient to pull the guidewire back proximally. At the same time, the ball valve 860 seals and pressure can be built up again in the rolling membrane 820 for the next rolling cycle, where the whole process is repeated.

Fig. 9A and 9B show a rolling membrane catheter comprising a (mechanical, cyclic) motion compensation means with an alternative automatic pressure reduction. The rolling membrane catheter 900 further comprises an outer shaft 930 and inner shaft 950. A fluid inlet 940 may be provided and configured to be connected to a fluid unit (not shown) determining the fluid state of the rolling membrane 920 and/or providing a fluid pressure to the rolling membrane volume limited by the rolling membrane 920, the outer shaft 930, and the inner shaft 950. The rolling membrane catheter 900 may further comprises a handle at the proximal end of the inner shaft 950. The (mechanical, cyclic) motion compensation means 970 may comprise a torque element 990 and optionally an elastic object 980, preferably a spring. This variant of an automatic pressure reduction uses a tapered envelope as a sliding seal 960. The (hydrophilic) sliding seal 960 seals as long as the non-tapered part of the envelope is in the sliding seal 960 (see Fig. 9A). When the rolling membrane 920 is rolled out under pressure, the maximum distal position of the guidewire 910 is limited by the spring path. As a result, the tapered part of the envelope comes to rest in the area of the sliding seal, creating a small leak and lowering the pressure inside (see Fig. 9b). This reduces the friction between the rolling membrane 920 and the guidewire 910 until the spring force at the torque element 990 is sufficient to pull the guidewire 910 back proximally. At the same time, the sliding seal 960 seals and pressure can once more be built up in the rolling membrane 920 for the next rolling cycle, where the whole process is repeated.

22.173P-WO / 04.12.2023

Claims

1. A catheter (100, 200, 300, 400, 500, 600,700, 800, 900) comprising: a rolling membrane (120, 320, 420, 520, 620, 720, 820, 920); a guidewire (110, 310, 410, 510, (710); and at least one decoupling means configured to decouple a motion of the rolling membrane (120, 320, 420, 520, 620) from a motion of the guidewire (110, 310, 410, 510, 710, 810, 910) or at least one motion compensation means (770, 870) configured to limit and compensate the motion of a guidewire advancement.

2. The catheter (100, 200, 300, 400, 500, 600) of claim 1, wherein the at least one decoupling means comprises a clamping element (37, 47, 57) configured to restrict the movement of the guidewire (110, 310, 410, 510).

3. The catheter (100, 200, 300, 400, 500, 600) of claim 1 or 2, wherein the at least one decoupling means comprises at least one friction-reducing element on an outer side of the rolling membrane (120, 320, 420, 520, 620).

4. The catheter (100, 200, 300, 400, 500, 600) of claim 2 or 3 referred back to claim 2, further comprising a first fluid inlet configured to be connected to a first fluid unit, wherein the clamping element (37, 47, 57) is configured to restrict the movement of the guidewire (110, 310, 410, 510) when a fluid pressure is provided to the first fluid inlet by the first fluid unit.

5. The catheter (100, 200, 300, 400, 500, 600) of claim 4, further comprising a second fluid inlet (130, 340, 440 540) configured to be connected to the first fluid unit, wherein the first fluid unit is further configured to determine a fluid state ofthe rolling membrane (120, 320, 420, 520, 620) and optionally comprising a third fluid inlet configured to be connected to a second fluid unit configured to provide a fluid pressure to the volume between the inner shaft of the rolling membrane (120, 320, 420, 520, 620) and the guidewire (110, 310, 410, 510).

6. The catheter (100, 200, 300, 400, 500, 600) of any of claims 1 to 5, wherein the at least one decoupling means or the at least one motion compensation means (770, 870, 970) is at least in part arranged at a portion ofthe catheter (100, 200, 300, 400, 500, 600) proximal to the rolling membrane (120, 320, 420, 520, 620).

7. The catheter (100, 200, 300, 400, 500, 600) of 1, wherein the at least one motion compensation means (770, 870, 970) comprises a torque element (790, 890, 990) and optionally an elastic object (780, 880, 980), preferably a spring.

22.173P-WO / 04.12.2023 The catheter (100, 200, 300, 400, 500, 600) of any of claims 1 to 6, wherein the at least one motion compensation means (770, 870, 970) further comprises a sealing element, preferably a ball valve (860) or a sliding seal (960). A catheter (100, 200, 300, 400, 500, 600), preferably of any of claims 1 to 6, comprising a rolling membrane (120, 320, 420, 520, 620); and at least one pressure release valve configured to open when a pressure provided to a rolling membrane (120, 320, 420, 520, 620) volume exceeds a predetermined threshold and/or at least one friction-reducing element (621) on an inner side of the rolling membrane (120, 320, 420, 520, 620). A catheter (100, 200, 300, 400, 500, 600)), preferably of any of claims 1 to 6 or 9, comprising a rolling membrane (120, 320, 420, 520, 620); and at least one locking means (280) configured to lock the rolling membrane (120, 320, 420, 520, 620) at least in part based on a fluid state of the catheter (100, 200, 300, 400, 500, 600). The catheter (100, 200, 300, 400, 500, 600) of claim 10, wherein the at least one locking means (280) is at least in part connected to at least a portion of an outer shaft (130) of the catheter (100, 200, 300, 400, 500, 600) and/or wherein the at least one locking means (280) comprises an elastic element configured to change its configuration based at least in part on the fluid state of the catheter (100, 200, 300, 400, 500, 600). The catheter (100, 200, 300, 400, 500, 600) of claim 10 or 11, wherein the at least one locking means (280) is configured to be in a first configuration locking the rolling membrane (120, 320, 420, 520, 620) when insufficient fluid pressure is provided to the catheter (100, 200, 300, 400, 500, 600) and to be in a second configuration unlocking the rolling membrane (120, 320, 420, 520, 620) when sufficient fluid pressure is provided to the catheter (100, 200, 300, 400, 500, 600). A system comprising the catheter (100, 200, 300, 400, 500, 600) of claim 5 or claim 6 referred back to claim 5 and at least one fluid unit configured to provide a fluid pressure to at least two of the following: the first fluid inlet, the second fluid inlet, and the third fluid inlet. Tubular element comprising a friction-reducing element applied to at least a part of an outer side of the tubular element and/or to at least a part of an inner side of the tubular element for use as a rolling membrane (120, 320, 420, 520, 620) in a rolling membrane catheter (100, 200, 300, 400, 500, 600). A computer program comprising instructions which, when the program is executed, causes a rolling membrane catheter (100, 200, 300, 400, 500, 600) according to any of claims 5 to 6 or 12 to clamp

22.173P-WO / 04.12.2023 the guidewire (110, 310, 410, 510) to decouple a motion of the rolling membrane (120, 320, 420, 520, 620) from a motion of the guidewire (110, 310, 410, 510).

22.173P-WO / 04.12.2023