Hydraulically actuated catheters such as systems for treating vascular and non-vascular conditions

Abstract

The invention relates inter alia to a catheter comprising a membrane 1, which is adapted to be wound longitudinally along a patient's blood vessel.

Description

[Technical field]

[0001] The present invention relates to hydraulically actuated catheter such systems for treating vascular and non-vascular conditions and methods for operating hydraulically actuated catheter such systems. [Background technology]

[0002] In recent years, the number of vascular interventions required per year has increased. This can be at least partially explained by an aging population and adverse changes in people's lifestyle (e.g., high-fat nutrition), both of which can contribute to an increase in vascular diseases / vascular lesions, which may often require the above-mentioned vascular interventions. In addition to the increase in the number of vascular interventions required per year, the range of indications for the required vascular interventions (e.g., the number of different vascular diseases requiring intervention) and their complexity are also increasing, thereby increasing the burden on the related medical staff. In addition to regular vascular interventions, a well-known but not dominant representative vascular intervention can be the percutaneous coronary intervention (PCI). PCI can be based on percutaneously inserting a catheter into the patient's vascular system and extending the catheter forward through the patient's vascular system to the location of the vascular disease. However, during the above-mentioned conventional PCI, physicians may often encounter non-crossable lesions as part of the increasing complexity of vascular interventions, which cannot be crossed using a guidewire (the most common cause of technical failure) and / or cannot be crossed using a balloon catheter (the second most common cause of technical failure). The above-mentioned complications are commonly found in convoluted calcified arteries as well as chronic total occlusions (CTOs). Even in scenarios where it may be possible to cross a lesion using a guidewire (with a given technique and / or with a PCI intervention), it may happen that the lesion itself cannot be crossed using a balloon catheter. This may increase the complexity of the PCI and the associated time effort of medical staff.Another drawback of the technical failures mentioned above can be seen when the amount of radiation to which the patient may be exposed (e.g., to determine the current position of the catheter) increases, which increases the contrast volume but generally concomitantly reduces the likelihood of a successful procedure.

[0003] Another drawback is that in conventional angioplasty of complex coronary lesions, the coronary intervention is usually performed in a two-step process, including the insertion of a guidewire and / or a guiding catheter, followed by the insertion of a second balloon catheter and / or a stent delivery system that can be pushed along the guidewire. Thus, at least two catheters are required to be inserted into the patient's body in a two-step process, which increases the amount of medical equipment required for the vascular intervention, and also increases the procedural time required to perform the vascular intervention. Furthermore, the selection of the guidewire is usually considered a first priority prerequisite for successful angioplasty, and the requirements for the guidewire are very strict, the guidewire must have sufficient flexibility and sufficient stiffness for resistance to kinking and for pushability through the patient's arterial system. This additional task of properly selecting the guidewire is performed by the physician performing the conventional vascular intervention, and here there is an individual impact on the overall procedural time required to perform the vascular intervention. In percutaneous transluminal coronary angioplasty (PTCA), a guiding catheter is usually inserted into an access sheath together with a guidewire, and once the guiding catheter is in place, the guidewire is pushed out of the guiding catheter to enter the coronary artery and pass the stenosis, and then a guide extension catheter is introduced into the guiding catheter and advanced along the guidewire to reach the vessel. A typical guide extension catheter can be a monorail system. In a guide extension catheter (GEC) or guide catheter extension, a guide extension (e.g., having a length of 25 cm) can be passed over the guiding catheter in a rapid interchange manner and can extend beyond the distal end of the guiding catheter.The guide extension catheter may be thinner than the guiding catheter, for example, by 1 Fr, and may be designed to minimize trauma to the coronary artery. The proximal end of the guide extension catheter may be attached to a thin stainless steel push rod, which may be used to push and pull the guide extension catheter independently of the guiding catheter. However, even modern guide extension catheters still have difficulties crossing calcified arteries, specifically when there is a 180 degree bend due to excessive frictional forces. In this case, the physician may use a balloon catheter to assist the guide extension catheter in crossing such a bend. This procedure involves placing a balloon on the distal side of the guide extension catheter, then inflating the balloon, and then pushing the guiding catheter over the balloon catheter while deflating the balloon catheter. However, in some cases, the balloon catheter and the guiding catheter may move against the vessel wall, potentially damaging the intima due to excessive shear forces.

[0004] In light of these multiple shortcomings that physicians typically face during conventional vascular interventions known in the art, there is a need for improvements to conventional vascular interventions to at least partially overcome at least some of these shortcomings. Summary of the Invention [Means for solving the problem]

[0005] According to an embodiment, this need is met, at least in part, by a catheter comprising a rolling membrane (hereinafter also referred to as a rolling membrane catheter).

[0006] The membrane may be adapted to be longitudinally rolled along the patient's vessel, for example at least 5 centimeters. A membrane that may extend, for example at least 5 centimeters, may simplify steering of the catheter, since it may be able to unfold itself to a certain extent along the vessel, without any need for guidance provided by the physician and / or without the presence of a guiding catheter, which may be inserted into the patient's vessel in a previous step of the vascular intervention. Thus, the above-mentioned aspects of the invention may enable an "all-in-one" catheter solution, which may simplify the entire vascular intervention by reducing its complexity, in particular because the need for steering provided by the physician may be reduced and even procedural steps may be minimized (e.g., because no guiding catheter may be required). Furthermore, the use of a (long) membrane may provide a catheter with improved flexibility over a (long) longitudinal extent, while at the same time ensuring good deployability.

[0007] The winding may be understood as forming at least a part of a (flexible) hose that, in the rolled out state, can be placed substantially along the longitudinal direction of the blood vessel. The winding or hose preferably has a circular cross section (when viewed in a cut plane perpendicular to the longitudinal extension of the hose) and has a first end and an opposite second end (in the longitudinal / lengthwise extension of the hose). The second end may be attached to an external shaft or may extend to a position external to the patient. The first end may be sealed. Thus, in the rolled out state, the winding or hose may form an inner volume extending proximally from the first end, which may be surrounded by, for example, a cylindrical (flexible) wall of the hose's circumference. At least a part of the winding or hose (e.g. of the first end) may be able to fold back inwards, so that at least a part of the hose (e.g. of its outer wall) can be retracted into the catheter. By retracting (e.g. at the second end) and / or pushing forward and / or applying pressure to the inner volume portion formed by the winding membrane, the winding membrane can be retracted (proximally) and / or moved forward (distally) substantially without friction (with respect to the blood vessel). The winding of the winding membrane can thus be understood as a corresponding turning back (or inward) of at least a portion of the hose, e.g. in the longitudinal direction along the blood vessel of the patient. The winding membrane can be adapted to expand, e.g. along the ostium (measured from the ostium) by more than 10 cm, more than 20 cm, up to 30 cm, or even up to 40 cm or more in the longitudinal direction during an investigation and / or treatment, e.g. a vascular intervention. Thus, substantially friction-free deployment of the catheter can be achieved, optionally further without the use of an outer shaft (a long membrane can replace the shaft), and / or without the use of an inner shaft (a simple wire can be used to move the second end of the membrane), and / or without the use of a guidewire.

[0008] A wound membrane catheter may comprise an inner shaft and / or an outer shaft. However, wound membrane catheters may be provided with or without an inner shaft and / or an outer shaft.

[0009] The inner and / or outer shaft may preferably be reinforced with a metal, metal alloy, or polymer braid, and thus may be a braided inner and / or braided outer shaft or a fiber reinforced inner and / or outer shaft.

[0010] The concept of the volar membrane may not be limited to vascular interventions, but may also be used in neurological catheters (neurovascular fields), oncology, ear, nose, and throat medicine, endoscopy, urology, gastroenterology, gynecology, pulmonology, or nasolacrimal duct.

[0011] Another aspect of the invention relates to a catheter that may additionally or alternatively comprise: a wound membrane defining an inner volume portion that can be pressurized, and / or a guide element arranged in the inner volume portion to guide the wound membrane along the patient's blood vessel. The guide element may be any element that allows pushing the wound membrane. The guide element may be a guidewire, for example made of a (suitable) metal or metal alloy or a (suitable) polymer.

[0012] It may be possible that a second (distal) end of the membrane (e.g. of the hose forming the membrane) may be temporarily or permanently sealed so as to result in forming an inner volume of the hose. Thus, it may be facilitated to allow a fluid, e.g. a (pressurized) gas and / or a (pressurized) liquid, to be inserted into the inner volume of the membrane, e.g. via the first end of the membrane (or of the hose forming the membrane).

[0013] The inner volume of the wound membrane can additionally or alternatively have a guide element to allow additional steerability, which may be particularly beneficial in situations where the wound membrane needs to pass through one or more vessel bifurcations before reaching the lesion site to be treated. The guide element can exit the wound membrane through a first end (proximal end) of a hose associated with the wound membrane and can be adapted to be manipulated by the physician from outside the patient's body.

[0014] Thus, the catheter of the present invention allows for the avoidance of additional guide catheters, thus simplifying the vascular intervention and reducing the number of required medical instruments.

[0015] The guide element may be adapted to slide against the inside of the membrane, so that it remains at the distal portion of the membrane as the membrane unfolds. By adapting the guide element to slide against the inside of the membrane, it may be encouraged to keep the area of ​​the membrane that can be contacted by the guide element in a position on the membrane that maximizes the steering of the membrane by the guide element (e.g., at the distal portion of the membrane), regardless of the exact amount of unfolding of the membrane. Sliding the guide element backwards may be made possible by applying pulsatile fluid pressure. During the unpressurized or low-pressure phase of the membrane, the guide element under tension (e.g., locked with a spring-like element external to the patient) may automatically pull the guide element backwards.

[0016] The distal portion of the membrane may be understood as a portion of the membrane that is further away from the physician operating the catheter, as compared to the opposite proximal portion of the membrane in the longitudinal extension direction of the catheter, which may be closer to the physician operating the catheter. In a fully unfolded state, the distal portion includes the second end of the membrane. In a only partially unfolded state, the second end of the membrane will be retracted to some extent and therefore will generally be proximal to the distal portion of the membrane.

[0017] In some scenarios where the winding membrane is adapted to span only a short distance (e.g., less than 5 cm), it may alternatively be possible to adapt the guide element to be integrally connected to the inside of the winding membrane (instead of being slidably arranged).

[0018] The guide element can comprise a curved wire. Providing a guide element with a curved wire can facilitate easier steerability of the wound membrane because a physician manipulating the curved wire from outside the patient's body can transmit a constant force to a distal portion of the wound membrane, for example, by rotating the curved wire a constant angular amount about the longitudinal axis of the curved wire.

[0019] The force transmission can be optimized for each vascular intervention requirement by appropriately selecting the wire curvature, e.g., a larger curvature can be associated with a larger force transmission to the distal portion of the winding membrane compared to a wire having a smaller curvature. In some scenarios, the curvature can be non-uniform along the longitudinal extension of the curved wire, i.e., the effective bend radius can vary between adjacent infinitesimally small portions of the curved wire. The guide element can comprise a curved wire and can further comprise a sliding element in slidable contact with the winding membrane to facilitate force transmission of the curved wire and the guide element.

[0020] Another aspect of the invention relates to a catheter that may include a winding that may additionally or alternatively include a retraction element for retracting the winding from its expanded state. The retraction element may not include an inner lumen. The retraction element may be under tension at all times and does not have to be made of a pushable material. The retraction element may be any element that has sufficient tensile strength to prevent the winding from everting, and it must allow the winding to be pulled backwards into the shaft. Thus, the retraction wire may be a thread, a filament, or a rod (fine rod).

[0021] Providing a catheter winding with a retraction element can help allow the winding to be easily retracted (from outside the patient's body) if necessary. Potential decompression of the winding alone may not be sufficient to easily and / or completely retract the winding in all scenarios. By avoiding providing a retraction element with an inner lumen, the retraction element can be implemented as a single piece of solid wire, which can improve the flexibility of the retraction element and also reduce its weight.

[0022] In one embodiment, an end portion of the membrane may be adapted to form a distal tip of the catheter when the membrane is unfolded. The end portion may include a first end of the membrane. The end portion may be folded inwardly into the membrane such that in the folded-in state (i.e., when the membrane is unfolded), the overall dimensions of the catheter, and specifically the membrane, may be minimized. Thus, the compact design may avoid undue handling difficulties that may be encountered with long membranes.

[0023] The retraction element may be attached to an end portion of the membrane. By attaching the retraction element to the end portion of the membrane, an optimized retraction of the unfolded portion of the membrane may be facilitated. Preferably, the end portion of the membrane (which may be associated with the first end of the hose, as outlined above) may be the last portion of the membrane to be unfolded. The end portion is therefore the first portion of the membrane to be retracted. This makes it possible to completely avoid an undesired overlap of the side walls of the membrane when the membrane is folded inwards / retracted. This contributes to simplifying the handling of the catheter.

[0024] The retraction element may be adapted to steer the membrane along the vessel as it is unfolded. Adapting the retraction element to allow steering of the membrane further reduces the complexity of the catheter by also allowing the membrane to be (exclusively) steered by the retraction element as it is unfolded longitudinally along the vessel of the patient (e.g., without the need for a guidewire).

[0025] In some scenarios, the retraction element may comprise a curved wire, or at least a wire having a curved distal end, In such cases, the direction in which deployment of the wrap may occur may be determined by the physician from outside the patient's body.

[0026] In some scenarios, the retraction element may be adapted to additionally assist in guiding the membrane in addition to the (optional) guiding element. If the retraction element and the guiding element contact the membrane at two different locations, the membrane may have more freedom to steer. Thus, the flexibility and steerability of the catheter may be improved.

[0027] In some scenarios, the outer diameter of the catheter (and / or the membrane) may be smaller than the inner diameter of the patient's blood vessel.

[0028] Providing a catheter with a diameter that may be smaller than the inner diameter of the patient's blood vessel can ensure that blood can easily pass through the catheter as it extends, for example, to the lesion to be treated. Ensuring sufficient blood flow through the catheter can avoid tissue or patient trauma further distal to the most distal portion of the catheter, which may be particularly relevant in cases where time-consuming vascular interventions are required. Additionally, providing a catheter with a diameter smaller than the diameter of the patient's blood vessel can facilitate easier extension of the catheter along the patient's blood vessel.

[0029] The catheter may be adapted to establish a helix-like or helical shape along the length of the patient's blood vessel. For example, the helix radius and / or the helix pitch may be non-uniform.

[0030] If the catheter is adapted to assume a helical shape along the length of the patient's blood vessel, it may be facilitated to allow the catheter membrane to contact the inner wall of the patient's blood vessel at one or more different locations (e.g., to ensure that the catheter is at least locally immobilized) while still allowing sufficient blood to pass through the catheter. As outlined above, this may avoid tissue further distal to the catheter or sites of patient trauma.

[0031] A helix may be understood to include a corkscrew shape and a shape similar to a spiral staircase. The radius and / or pitch of the helix may vary smoothly along the longitudinal axis of the vessel. The radius of the helix may be understood as the inner diameter, e.g., the shortest distance from the longitudinal axis of the vessel, e.g., the center of the helix twisting, to the central longitudinal axis of the catheter, i.e., the central longitudinal axis of the wound membrane that forms the helix about the longitudinal axis. The pitch of the helix may be understood as the height of one turn of the complete helix, measured parallel to the longitudinal axis of the helix.

[0032] In an alternative scenario, it may be possible for at least one of the helix radius and / or the helix pitch to be uniform (ie, constant) along the longitudinal extension of the catheter.

[0033] In some scenarios, the wound membrane may have an inherent tendency to form the above-mentioned spiral-like shape, for example due to an inherent manufacturing process, and / or the spiral-like shape may be ensured (or reinforced) as a result of manipulation by the physician, preferably from outside the patient's body (e.g. twisting, rotating, and / or retracting the catheter). For example, if the longitudinal extension of the wound membrane is disturbed, the wound membrane is forced to assume a spiral shape. If tension on the retraction element increases during eversion, the shape of the wound membrane becomes more spiral-like. The spiral shape of the wound membrane may also be ensured by thermoforming the wound membrane into a spiral shape. The spiral shape of the wound membrane may also be ensured by intentionally making the wall thickness distribution non-uniform around the circumference, for example as induced during the extrusion process of the wound membrane. In addition, the tubing may be rotated as it is drawn, which causes the wound membrane to be thermoformed to obtain a spiral shape when it is released from the die.

[0034] Another aspect of the invention relates to a catheter, where the catheter can include a membrane that can define an interior volume that can be pressurized, the membrane being adapted to allow a stenosis in a patient's blood vessel to be dilated via expansion by the membrane by pressurizing the interior volume, in addition to or as an alternative to other aspects described herein.

[0035] Providing a catheter having a membrane that can define an inner volume that can be pressurized can facilitate enabling the membrane to apply a radial force against an inner wall of a patient's blood vessel at a location where the membrane contacts the blood vessel. Sufficient pressurization of the inner volume of the membrane can facilitate at least localized dilation of the blood vessel, thereby facilitating at least localized removal of a stenosis at the location of the dilation of the patient's blood vessel.

[0036] In general, the winding may be configured such that when pressurized, the winding extends to a greater extent in a longitudinal direction and to a lesser extent in a radial direction (e.g., perpendicular to the longitudinal direction along which the winding is unrolled). In some cases, the winding may be configured such that it is only allowed to extend (substantially) in a longitudinal direction when unrolled over a certain length of its maximum length (e.g., when the winding is unrolled over at least 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% of its total length).

[0037] However, in one embodiment, the winding may be further adapted to allow (at least) a portion of the expanded portion of the winding to expand primarily radially (perpendicular to the longitudinal direction along which the winding is expanded) (i.e., to a greater extent radially) and only to a lesser extent along the longitudinal direction. In some cases, the winding may be adapted to allow (at least) a portion to expand substantially only radially when the winding is expanded over a certain length of its maximum length (e.g., when the winding is expanded over at least 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% of its total length).

[0038] The outer diameter of the catheter (e.g., the membrane) may be adapted to substantially fill the patient's vessel in the radial direction. Providing the catheter to be able to substantially fill the patient's vessel may facilitate immobilization of the catheter relative to the vessel at a specific location. This may allow, for example, a predetermined pressure to be transmitted from the membrane in the radial direction to a specific location of the inner wall of the vessel, such as to at least locally dilate a stenosis. Furthermore, the local immobilization may ensure that a subsequent treatment step may be prepared and / or performed at the location of immobilization.

[0039] Substantially filling the patient's blood vessel may be understood as a scenario in which the catheter (at least at certain locations) has approximately the same diameter as the patient's blood vessel (ignoring small deviations caused by non-uniform blood vessel diameter relative to non-uniform catheter diameter, as may occur due to catheter manufacturing tolerances).

[0040] It may be possible for the catheter itself to substantially fill the patient's vessel (i.e., with the membrane not yet (fully) unfolded) and / or for the catheter to essentially fill the patient's vessel as a result of unfolding the membrane to a certain extent and then radially expanding.

[0041] The membrane may be adapted to allow a proximal end of the membrane to be located outside the patient's body when the membrane is deployed inside the patient's body. By providing the membrane such that it is capable of extending to the outside of the patient's body, the complexity of the catheter may be further reduced as the membrane may be the only portion of the catheter that extends along the patient's vasculature.

[0042] In such a scenario, the catheter may not have any additional catheter elements that can optionally deliver the wound membrane to a specific location within the patient's blood vessel where unfolding of the wound membrane can begin.

[0043] The winding may have, at least in part, a non-uniform outer surface. For example, the non-uniform outer surface may be adapted to at least locally increase friction against the patient's blood vessel and / or at least locally ablate a stenosis. By providing a winding with a non-uniform outer surface, the frictional properties of the winding may be locally enhanced or reduced when contacting the patient's blood vessel, thereby providing a tailored immobilization capability of the winding within the patient's blood vessel (e.g., designated areas on the winding may have a surface that may provide greater or lesser friction compared to adjacent designated areas). Furthermore, the non-uniform outer surface may also be used as a medical tool to at least locally remove a stenosis (similar to the concept of a scoring balloon or cutting balloon) caused by contact with the non-uniform outer surface of the winding or a stenosis when the winding is pressurized. By applying pressure against peaks or spikes of the winding located on the outer surface of the winding, a stenosis may be broken by a local maximum pressure. The non-uniform outer surface may also be used to adhere the wound membrane to the vessel wall, thereby aiding in the advancement of the wound membrane further into the vessel. The non-uniform outer surface may comprise a pattern, such as protrusions and / or recesses. The pattern may cover the entire outer surface of the wound membrane. Alternatively, the non-uniform outer surface may comprise one surface region, or may comprise two or more separate surface regions, each of which may have a different pattern. Additionally or alternatively, only a portion of the entire surface of the wound membrane may have a pattern.

[0044] Additionally or alternatively, the radius and / or diameter of the winding may vary along the length of the winding in the unfolded state. Providing a winding with a radius and / or diameter that may be non-uniform along the length of the winding may facilitate accessing a portion of a patient's vessel that is tapered. In such cases, a distal portion and / or end of the winding may have a smaller diameter compared to a portion of the winding that may be located at a more proximal position. Thus, the distal portion or end may be able to enter a narrower region of the vessel compared to a more proximal portion of the winding. A portion of the winding with a larger radius may be adapted to be used to locally immobilize the winding in front of a tapered region of the vessel. A winding with a non-uniform diameter along its length may reach any diameter at a particular location within the vessel when unwound or unfolded as well as when displaced axially. Thus, when the diameter of the membrane becomes too large for the vessel in a typical procedure, the membrane is stopped from expanding, the membrane is (at least partially) contracted, the catheter is pulled back, and the membrane is expanded again.

[0045] In some scenarios, it may be possible for the most distal portion of the winding to have a larger diameter compared to more proximally located regions of the winding.

[0046] Another aspect relates to a catheter that may additionally or alternatively include a wound membrane adapted to be expanded to form an elongated main portion and a distal end portion. The elongated main portion may be adapted to have a non-uniform cross-section. Providing an elongated main portion with a non-uniform cross-section allows the wound membrane to enter a tapered region of a patient's blood vessel. In some scenarios, the wound membrane may be adapted to allow for varying the degree of expansion of the wound membrane to vary the diameter associated with the non-uniform cross-section. In some scenarios, the diameter of the wound membrane may expand as the wound membrane is expanded further. In other scenarios, the diameter of the wound membrane may decrease as the wound membrane is expanded further.

[0047] Another aspect relates to a catheter, where the catheter may comprise a membrane, where additionally or alternatively at least a portion of the membrane may be folded inwards to form an inner wall, and the inner wall may comprise a drug layer. The drug layer may be adapted to be transported distally by unfolding the membrane (and thus form a portion of the outer surface of the membrane). Providing a membrane with a drug layer may facilitate delivery of a drug inside the membrane to a specific location in the human or animal body, for example in a blood vessel (protected by the membrane) of a patient. By folding the drug layer outwards, the drug may be released at a desired location in the human or animal body, for example in a blood vessel of a patient. Thus, targeted drug delivery in the human or animal body, for example inside a blood vessel of a patient, may be facilitated, and the medical effect of the respective drug may be realized only at the desired location. Furthermore, the length of the area in the human or animal body where the drug is applied, for example to a blood vessel, may be changed by unfolding the membrane to a greater or lesser extent. Furthermore, dilution of the drug as a result of the drug mixing with blood (which would reduce the drug's medical effectiveness) can be significantly reduced.

[0048] Another aspect of the invention relates to a catheter, where the catheter can include a membrane that can additionally or alternatively have a non-uniform outer surface.

[0049] Aspects relate to a catheter that can include a membrane that can be adapted to be spread to form an elongated main portion having a cross-section that can be smaller than the cross-section of a blood vessel. The membrane can be further adapted such that a centerline of the elongated main portion is adapted to be twined around a centerline of the blood vessel. This can allow the elongated main portion to substantially require a helical curvature about the centerline of the blood vessel, thereby improving anchoring of at least the elongated main portion of the membrane while allowing sufficient blood flow within the patient's blood vessel.

[0050] In some scenarios, it may be possible for the winding to further form a distal portion that is not twisted to the centerline of the vessel but instead can extend straight along the length of the patient's vessel.

[0051] Another aspect relates to a wound membrane catheter, where the catheter does not include an inner shaft. By providing a catheter without an inner shaft, the complexity of the catheter can be further reduced because an inner shaft (usually highly stiff / rigid) is not required. Thus, the flexibility and steerability of the catheter can be improved, and the handling of the catheter can be simplified.

[0052] Another aspect relates to a catheter that may comprise a membrane, where the membrane may additionally or alternatively be adapted to apply a force to a functional element disposed within a lumen formed at least in part by an inwardly folded portion of the membrane. By adapting the membrane to apply a force to a functional element disposed within its lumen, the functional element may be protected by the membrane, delivered to a specific location within the patient's blood vessel and released at the respective location, e.g. as a result of the force being applied to the functional element. The functional element may be a piece of (guide) wire, a stent, a microcatheter, etc.

[0053] The winding may further be adapted to allow this force to push the functional element distally of the catheter when the winding is at least partially unfolded distally.

[0054] Since the membrane may further be adapted to exert a force on the functional element, as a result of the additional supply of, for example, a holding or pushing force of the membrane on the functional element, an obstacle (e.g., a stenosis) in the patient's blood vessel may be overcome by the functional element. Thus, in this case, even a stenosis that cannot be penetrated by a catheter known in the prior art may be overcome. If the distal end of the membrane hits an obstacle, the functional element (e.g., a guidewire) can advance faster than the everted membrane and thus pull the everted membrane through friction into the gap already crossed by the functional element. This makes it possible to treat complex lesions. The force exerted by the membrane on the functional element may be oriented along the radial direction (holding force) and / or along the longitudinal direction (pushing force).

[0055] The winding may have a wall thickness of 10 μm to 90 μm, preferably 15 μm to 60 μm, 70-90 μm. The outer shaft may have a wall thickness of 100 μm to 500 μm.

[0056] The wrap may be made by blown film extrusion, blow molding of extruded tubing, or microextrusion. An elastomeric tube can be attached (e.g., by gluing or welding) to the inner and outer shafts and pulled back into the outer shaft, creating a conformable wrap.

[0057] Another aspect relates to a method for dilating a stenosis in a blood vessel. The method can include inserting a catheter having a membrane into a blood vessel. Additionally, the method can include at least partially unfolding the membrane to position the membrane proximate to the stenosis. Additionally, the method can include pressurizing the membrane to result in the stenosis being dilated. By at least partially unfolding the membrane to position the membrane proximate to the stenosis, the membrane can extend itself into the actual stenosis as a result of further unfolding and then pressurizing the membrane. Thus, the external pushing force required to guide the membrane to the location of the stenosis and the actual stenosis is reduced, and the primarily radial force that is increased as a result of pressurizing the membrane can be used to assist in dilating even very pronounced stenoses.

[0058] Another aspect relates to a method for forcing a guide element into a CTO region of a blood vessel. The method can include inserting a catheter having a membrane into the blood vessel, where at least a portion of the guide element is disposed within a lumen formed at least in part by an inwardly turned portion of the membrane. Pressurizing the membrane can provide a retention force that can keep the guide element in place (and potentially prevent the guide element from buckling). Additionally, the method can include spreading at least a portion of the membrane distally of the catheter, resulting in the guide element being forced distally into the CTO region.

[0059] The following figures are provided to aid in understanding the present invention. [Brief description of the drawings]

[0060] [Figure 1a] FIG. 1 shows a wound membrane catheter that does not have an inner shaft / outer shaft and has the same diameter as the patient's blood vessel. [Figure 1b]FIG. 1 shows a wound membrane catheter that does not have an inner shaft / outer shaft and has the same diameter as the patient's blood vessel. [Figure 1c] FIG. 1 shows a catheter that does not have an inner shaft / outer shaft and has the same diameter as the patient's blood vessel. [Figure 2a] FIG. 1 shows a wound membrane catheter that does not have an inner shaft / outer shaft and has a smaller diameter than the patient's blood vessel. [Figure 2b] FIG. 1 shows a wound membrane catheter that does not have an inner shaft / outer shaft and has a smaller diameter than the patient's blood vessel. [Figure 2c] FIG. 1 shows a wound membrane catheter that does not have an inner shaft / outer shaft and has a smaller diameter than the patient's blood vessel. [Figure 3a] FIG. 1 shows a wound membrane catheter having an inner shaft, no outer shaft, and the same diameter as the patient's blood vessel. [Figure 3b] FIG. 1 shows a wound membrane catheter having an inner shaft, no outer shaft, and the same diameter as the patient's blood vessel. [Figure 3c] FIG. 1 shows a wound membrane catheter having an inner shaft, no outer shaft, and the same diameter as the patient's blood vessel. [Figure 4a] FIG. 1 shows a wound membrane catheter having an inner shaft, no outer shaft, and a smaller diameter than the patient's blood vessel. [Figure 4b] FIG. 1 shows a wound membrane catheter having an inner shaft, no outer shaft, and a smaller diameter than the patient's blood vessel. [Figure 4c] FIG. 1 shows a wound membrane catheter having an inner shaft, no outer shaft, and a smaller diameter than the patient's blood vessel. [Figure 5a] FIG. 1 shows a wound membrane catheter having an outer shaft, no inner shaft, and the same diameter as the patient's blood vessel. [Figure 5b] FIG. 1 shows a wound membrane catheter having an outer shaft, no inner shaft, and the same diameter as the patient's blood vessel. [Figure 5c]FIG. 1 shows a wound membrane catheter having an outer shaft, no inner shaft, and the same diameter as the patient's blood vessel. [Figure 6a] FIG. 1 shows a wound membrane catheter having an outer shaft, no inner shaft, and a smaller diameter than the patient's blood vessel. [Figure 6b] FIG. 1 shows a wound membrane catheter having an outer shaft, no inner shaft, and a smaller diameter than the patient's blood vessel. [Figure 6c] FIG. 1 shows a wound membrane catheter having an outer shaft, no inner shaft, and a smaller diameter than the patient's blood vessel. [Figure 7a] FIG. 1 shows a wound membrane catheter having an outer shaft and an inner shaft having the same diameter as the patient's blood vessel. [Figure 7b] FIG. 1 shows a wound membrane catheter having an outer shaft and an inner shaft having the same diameter as the patient's blood vessel. [Figure 7c] FIG. 1 shows a wound membrane catheter having an outer shaft and an inner shaft having the same diameter as the patient's blood vessel. [Figure 8a] FIG. 1 shows a wound membrane catheter having an outer shaft, an inner shaft, and a diameter smaller than the patient's blood vessel. [Figure 8b] FIG. 1 shows a wound membrane catheter having an outer shaft, an inner shaft, and a diameter smaller than the patient's blood vessel. [Figure 8c] FIG. 1 shows a wound membrane catheter having an outer shaft, an inner shaft, and a diameter smaller than the patient's blood vessel. [Figure 9a] FIG. 1 illustrates an exemplary winding surface design. [Figure 9b] FIG. 1 illustrates an exemplary winding surface design. [Figure 9c] FIG. 1 illustrates an exemplary winding surface design. [Figure 10] FIG. 1 illustrates an exemplary spiral wound membrane design. [Figure 11a] FIG. 1 illustrates an exemplary tapered membrane design. [Figure 11b] FIG. 1 illustrates an exemplary tapered membrane design. [Figure 11c] FIG. 1 illustrates an exemplary tapered membrane design. [Figure 12a] FIG. 1 shows an exemplary stepped membrane design. [Figure 12b] FIG. 1 shows an exemplary stepped membrane design. [Figure 12c] FIG. 1 shows an exemplary stepped membrane design. [Figure 12d] FIG. 1 shows an exemplary stepped membrane design. [Figure 13a] FIG. 1 illustrates a wound membrane-based balloon angioplasty. [Figure 13b] FIG. 1 illustrates a wound membrane-based balloon angioplasty. [Figure 13c] FIG. 1 illustrates a wound membrane-based balloon angioplasty. [Figure 13d] FIG. 1 illustrates a wound membrane-based balloon angioplasty. [Figure 14a] Figure 2. Schematic diagram of wound membrane-based drug-coated balloon angioplasty. [Figure 14b] Figure 2. Schematic diagram of wound membrane-based drug-coated balloon angioplasty. [Figure 14c] Figure 2. Schematic diagram of wound membrane-based drug-coated balloon angioplasty. [Figure 14d] Figure 2. Schematic diagram of wound membrane-based drug-coated balloon angioplasty. [Figure 15a] FIG. 1 shows a membrane-based CTO crossing. [Figure 15b] FIG. 1 shows a membrane-based CTO crossing. [Figure 16a] FIG. 13 illustrates membrane-based localized drug release / object attraction. [Figure 16b] FIG. 13 illustrates membrane-based localized drug release / object attraction. [Figure 17a] FIG. 1 shows a membrane-based flexible balloon catheter delivery system. [Figure 17b]FIG. 1 shows a membrane-based flexible balloon catheter delivery system. [Figure 17c] FIG. 1 shows a membrane-based flexible balloon catheter delivery system. [Figure 17d] FIG. 1 shows a membrane-based flexible balloon catheter delivery system. [Figure 17e] FIG. 1 shows a membrane-based flexible balloon catheter delivery system. [Figure 18a] FIG. 1 shows a membrane-based pre-loaded balloon catheter delivery system. [Figure 18b] FIG. 1 shows a membrane-based pre-loaded balloon catheter delivery system. [Figure 18c] FIG. 1 shows a membrane-based pre-loaded balloon catheter delivery system. [Figure 18d] FIG. 1 shows a membrane-based pre-loaded balloon catheter delivery system. [Figure 19] FIG. 1 illustrates a membrane-based microcatheter delivery system. [Figure 20a] FIG. 1 shows a membrane-based SX stent delivery system. [Figure 20b] FIG. 1 shows a membrane-based SX stent delivery system. [Figure 20c] FIG. 1 shows a membrane-based SX stent delivery system. [Figure 20d] FIG. 1 shows a membrane-based SX stent delivery system. [Figure 20e] FIG. 1 shows a membrane-based SX stent delivery system. [Figure 21a] FIG. 1 shows a membrane-based flexible BE stent delivery system. [Figure 21b] FIG. 1 shows a membrane-based flexible BE stent delivery system. [Figure 21c] FIG. 1 shows a membrane-based flexible BE stent delivery system. [Figure 21d] FIG. 1 shows a membrane-based flexible BE stent delivery system. [Figure 21e] FIG. 1 shows a membrane-based flexible BE stent delivery system. [Figure 22a] FIG. 1 shows a membrane-based pre-loaded BE stent delivery system. [Figure 22b] FIG. 1 shows a membrane-based pre-loaded BE stent delivery system. [Figure 22c] FIG. 1 shows a membrane-based pre-loaded BE stent delivery system. [Fig. 22d] FIG. 1 shows a membrane-based pre-loaded BE stent delivery system. [Figure 23a] FIG. 1 shows a membrane-based dual lumen catheter for atherectomy. [Figure 23b] FIG. 1 shows a membrane-based dual lumen catheter for atherectomy. [Figure 24a] FIG. 1 illustrates a special guidewire steering concept for a wound membrane catheter. [Figure 24b] FIG. 1 illustrates a special guidewire steering concept for a wound membrane catheter. [Figure 24c] FIG. 1 illustrates a special guidewire steering concept for a wound membrane catheter. [Fig. 24d] FIG. 1 illustrates a special guidewire steering concept for a wound membrane catheter. [Figure 24e] FIG. 1 illustrates a special guidewire steering concept for a wound membrane catheter. [Figure 25a] FIG. 1 is a schematic diagram showing potential locations of lesion sites. [Figure 25b] FIG. 1 is a schematic diagram showing potential locations of lesion sites. [Figure 25c] FIG. 1 is a schematic diagram showing potential locations of lesion sites. [Figure 25d] FIG. 1 is a schematic diagram showing potential locations of lesion sites. [Figure 25e] FIG. 1 is a schematic diagram showing potential locations of lesion sites. [Fig. 25f] FIG. 1 is a schematic diagram showing potential locations of lesion sites. [Figure 25g] FIG. 1 is a schematic diagram showing potential locations of lesion sites. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0061] The following detailed description outlines possible example embodiments of the invention.

[0062] 1a-1c show a first possible embodiment of the catheter, in which the catheter may have a diameter having the same size as the patient's blood vessel into which it may be inserted.

[0063] FIG. 1a shows a catheter located in a patient's aorta with a membrane 1 in an initial state. In the illustrated initial state, the membrane 1 can be in such a state that at least a portion of the membrane can be folded inwards on itself to a certain extent (similar to a hose, in which at least a portion of one end of the hose is folded inwards on itself, as further explained above). Reference number 2 indicates a point at which a retraction element 4 is joined to a first end of the membrane 1. The membrane 1 can be implemented to form an inner volume portion 3. The membrane 1 can be expanded by applying pressure (hydraulic pressure), for example by gas or liquid, on the inner volume portion 3. As a result of applying pressure (pressure can be applied to the membrane 1 from the proximal direction P), the membrane 1 can expand on itself in the distal direction D. The physician can adjust the expansion (expansion) (and / or even the contraction, retraction) of the membrane 1 depending on the requirements of the intervention.

[0064] The catheter may further comprise a retraction element 4, for example comprising a wire (e.g. having no inner lumen). At the most inwardly folded position of the membrane 1, the membrane may be connected to the retraction element 4. The retraction element 4 may extend to the outside of the patient's body. As a result of pulling the retraction element 4 in the proximal direction P (e.g. from the outside of the patient's body), at least a part of the membrane 1 that may be unfolded in the distal direction D may be retracted again to an at least partially inwardly folded state. Similarly, the membrane may be further extended distally by pushing in the distal direction D, at least when a suitable pressure is applied. Thus, the physician may control, for example, the length of the unfolded membrane 1 by means of the retraction element 4 and / or by applying pressure. As outlined above, under some circumstances the retraction element 4 may also at least contribute to the steerability of the membrane 1. Under some circumstances it may be advantageous to at least partially contract the membrane 1. By pushing the retraction element 4 in the distal direction D, the winding 1 can be steered in the desired direction.

[0065] The catheter may further comprise a guide element 5 located within the inner volume portion 3 of the membrane 1, which may be used to guide the membrane 1 in a desired direction when the membrane 1 is unrolled in the distal direction D. The guide element 5 may comprise a curved wire that may extend to the outside of the patient and may be manipulated by the physician. The guide element 5 may be adapted to be in or be brought into slidable contact with the inner side of the membrane 1 at a sliding spot 6, which may be located at the distal part of the membrane. The sliding spot may be formed by the tip of the guide element. Thus, the physician may steer the membrane 1 by pushing the membrane 1 substantially in the desired direction with the guide element 5. The steerability may be enhanced by additionally (partially) expanding and / or contracting the membrane. The membrane 1 is exemplarily located in front of an ostium 7 into which the membrane 1 may be deployed when the membrane 1 is unrolled along the distal direction D.

[0066] Figure 1b shows the catheter of Figure 1a with the membrane 1 unfolded along the distal direction D to a certain extent less than that of Figure 1a (i.e., located distally from Figure 1a), so that the distal end of the membrane 1 extends into the ostium region 7 that is amenable to vascular intervention.

[0067] Similar to FIG. 1b, FIG. 1c shows the catheter of FIGS. 1a and 1b in a further expanded state in which the membrane 1 is further expanded into the stoma 7. FIG.

[0068] It is emphasized that regardless of the extent to which the winding 1 is unfolded, the sliding spot 6 associated with the guide element 5 can remain in the distal part (distal tip part) of the winding 1. Reference number 2 is the point at which the retraction element 4 is joined to the first end of the winding 1. The winding 1 can be adapted to be unfolded, for example, by at least 5 cm, at least 10 cm, at least 20 cm, or even at least 30 or 40 cm. For example, the winding 1 can be unfolded from the outside of the patient or from a position inside the patient close to the skin surface of the patient's body, up to the stoma 7.

[0069] Figures 2a-c show a second possible embodiment of the catheter. In this second embodiment, the catheter may have a diameter smaller than the diameter of the patient's blood vessel into which it is inserted. Except for the diameter of the catheter, the catheter may be implemented in the same way as the catheter described above with reference to Figures 1a-c. In particular, Figures 2a-c show the membrane 1 in various states when it is expanded in the distal direction D to enter the ostium 7.

[0070] 3a-3c show a third embodiment of the catheter, in which the catheter may have a diameter that is the same as the diameter of a patient's blood vessel into which the catheter may be inserted.

[0071] FIG. 3a shows a catheter located in the aorta of a patient with a membrane 1 in an initial state, where at least a portion of the membrane 1 may be folded inwardly into itself to a certain extent. The membrane 1 may further comprise an inner volume portion 3 in the same manner as outlined above with reference to FIGS. 1 and 2. Reference number 20 indicates the point where the inner shaft 8 is joined to the first end of the membrane 1. The portion of the membrane 1 that is folded inwardly may be attached to the inner shaft 8 accordingly. The inner shaft 8 may be preferably implemented to have a cylindrical shape and may preferably have an inner lumen. The inner lumen 8 may extend to the outside of the patient's body. In a preferred implementation, the inner shaft 8 may be made of a flexible material so that it may be bendable and may even be able to advance along the patient's blood vessel when it is pushed along the patient's blood vessel in the distal direction D.

[0072] The catheter according to this third embodiment may comprise a guidewire 9, which may be located in the central region of the membrane 1 and in the inner shaft 8 (e.g., if the membrane 1 provides sufficient stiffness and if the required guiding angle of the membrane 1 is not too large for the membrane). The guidewire 9 may extend to the outside of the patient's body and may preferably comprise a wire (e.g., with a curved tip). The guidewire 9 may be realized to guide the membrane 1 when it is unrolled along the distal direction D to, for example, enter the ostium 7. In general, the guidewire 9 can move faster than the membrane 1 (it can move twice as fast as the membrane) due to the movement mechanism of the membrane 1. Therefore, the guidewire 9 may need to be periodically retracted when the membrane 1 is unrolled. Under some circumstances, it may be necessary for the guidewire 9 to have a certain degree of stiffness so as to be able to withstand the bending forces arising from the membrane 1 when it is unrolled. If necessary, the guidewire 9 may be exchanged by the inner shaft 8.

[0073] Alternatively, the physician can eliminate the use of the guidewire 9 and use the inner shaft 8 for steering only in the unfolded state. In this case, the distal end of the inner shaft D can be (slightly) curved. In this case, the membrane 1 can be partially deflated and the inner shaft 8 can be pushed forward to the desired position to steer the membrane 1 before re-expanding the membrane 1 to unfold it further.

[0074] FIG. 3b shows the same catheter as in FIG. 3a, with the winding 1 at least partially unfolded along the distal direction D.

[0075] Figure 3c shows the same catheter as depicted in and described with reference to Figures 3a and 3b, with the membrane 1 being further unfolded to a nearly fully unfolded state. It is emphasized that as a result of unfolding the membrane 1, the inner shaft 8 is pulled to the distal end of the membrane 9, thereby forming an inner channel in the central region of the membrane 1 which can be accessed from outside the patient.

[0076] Figures 4a to 4c relate to a catheter according to a fourth embodiment. The catheter according to the fourth embodiment may be implemented in the same manner as the catheter according to the third embodiment described with reference to Figures 3a to 3c above. However, the difference is that the diameter of the catheter of the fourth embodiment may be smaller than the diameter of the patient's blood vessel.

[0077] Figures 5a to 5c depict a catheter according to a fifth embodiment. Figures 5a to 5c show a membrane according to the fifth embodiment in an initial state (Figure 5a) and in a state in which the membrane 1 is at least partially unfolded (Figures 5b and 5c). In the fifth embodiment, the catheter and in particular the membrane can have a diameter having the same size as the diameter of the patient's blood vessel.

[0078] Fig. 5a shows a catheter with a membrane 1 which may be generally similar to the membrane 1 according to any of the embodiments described with reference to Figs. 1 to 4 above. In the initial state, the membrane 1 may be folded inwards to a certain extent to form an inner volume portion 3. The membrane 1 according to the fifth embodiment may further comprise a retraction element 4 and a guide element 5 (located in the inner volume portion 3 of the membrane 1) which may be slidably arranged at a sliding spot 6 of the membrane 1. Reference number 2 indicates the point at which the retraction element 4 is joined to the first end of the membrane 1.

[0079] However, according to a fifth embodiment, the second end (distal end) of the membrane 1 can be attached to the outer shaft 10. The outer shaft 10 can preferably have a cylindrical shape with an inner lumen to receive the amount of the membrane 1 that is folded inward. The outer shaft 10 can further receive the retraction element 4 and the guide element 5. The outer shaft 10 can be made of a bendable flexible material and can be used to deliver the membrane 1 to the vicinity of the ostium 7, from which the membrane 1 can be unfolded along the distal direction D. As shown in FIG. 5, the membrane 1 is adapted to have a diameter larger than the diameter of the outer shaft 10, for example, approximately equal to the diameter of the blood vessel of the patient into which the membrane 1 is inserted, whereas the outer shaft 10 has a smaller diameter than the blood vessel. In an alternative embodiment, the outer shaft 10 has a diameter larger than the diameter of the membrane 1, for example, approximately equal to or smaller than the diameter of the blood vessel into which the membrane 1 is inserted. The distal end of the outer shaft D may be (slightly) curved.

[0080] 6a-6c show a catheter according to a sixth embodiment. The catheter according to the sixth embodiment can be implemented in the same way as the catheter according to the fifth embodiment described with reference to Figs. 5a-5c above. However, the membrane 1 according to the sixth embodiment can have a diameter smaller than the diameter of the patient's blood vessel into which the membrane 1 is inserted. Nevertheless, the diameter of the membrane can be, for example, about 5-500% or 10-50% larger than the diameter of the outer shaft 10, as shown in Figs. 6a-6c. In other examples, the membrane 1 can have approximately the same diameter as the outer shaft 10. In alternative embodiments, the outer shaft 10 has or is configured with a diameter larger than the diameter of the membrane 1, for example with or is configured with a diameter approximately equal to or smaller than the diameter of the blood vessel into which the membrane 1 is inserted. The distal end of the outer shaft D can be (slightly) curved.

[0081] Figures 6b and 6c show the catheter of Figure 6a with the membrane 1 in an at least partially (Figure 6b) or almost completely (Figure 6c) unfolded state.

[0082] Figures 7a-7c show a catheter according to a seventh embodiment, comprising a membrane in an initial state (Figure 7a) and in two alternative states (Figures 7b and 7c) in which the membrane 1 is at least partially or completely unfolded. In the seventh embodiment, the catheter, and in particular the membrane, can have a diameter the same size or comparable to the diameter of the patient's blood vessel. In general, in embodiments in which the diameter of the membrane 1 is comparable to the diameter of the patient's blood vessel, a better anchoring of the membrane 1 against the inner wall of the patient's blood vessel can be achieved.

[0083] The winding 1 according to the seventh embodiment may be implemented similarly to the winding 1 of the embodiment described above with reference to Figs. 1 to 5. The winding 1 may further be adapted to form an inner volume portion 3 and may be spread along a guide wire 9, which may be implemented similarly to the case outlined above in connection with the third embodiment (Fig. 3) and the fourth embodiment (Fig. 4). In the seventh embodiment, a first end of the winding 1 (which may for example be folded back inwards to a certain extent) may be connected to an inner shaft 8. A second end of the winding 1 may be connected to an outer shaft 10. Reference number 20 indicates the point at which the inner shaft 8 is joined to the first end of the winding 1.

[0084] 8a-8c show a catheter according to an eighth embodiment. The catheter according to the eighth embodiment may be implemented similarly to the catheter according to the seventh embodiment described with reference to FIGS. 7a-7c above. However, the membrane 1 according to the seventh embodiment may have a diameter smaller than the diameter of the patient's blood vessel. In cases where the diameter of the membrane 1 is smaller than the diameter of the patient's blood vessel, unhindered blood flow may be achieved during the vascular intervention. Nevertheless, the diameter of the membrane 1 may be larger (e.g., about 5-500% or 10-50%) than the diameter of the outer shaft 10, as shown in FIGS. 8a-8c. In other examples, the membrane 1 may have approximately the same diameter as the outer shaft 10.

[0085] 8b and 8c show the catheter of FIG. 8a, where the membrane 1 has been further unfolded. With regard to the eight embodiments mentioned above, it can be summarized that each of the embodiments combines the functionality of a guide catheter or guidewire (since the membrane 1 can be radially expandable) with that of a balloon catheter. Thus, the overall complexity of the catheter according to each of the above-mentioned embodiments can be reduced. Since each of the above-mentioned embodiments requires only a single catheter, the procedure time required to perform the vascular intervention can also be reduced, since only a single catheter needs to be inserted into the vasculature of the patient. The membrane 1 in each of the embodiments can preferably be implemented such that the unfolding takes place substantially without friction (even if the membrane 1 has a diameter equivalent to the respective blood vessel). Furthermore, considering the above-mentioned embodiments, it can be possible that the membrane 1 can be provided such that it can have a fixed diameter (smaller than or equal to the diameter of the blood vessel, which can be reached at full inflation). However, it may also be possible to make the diameter of the winding 1 somewhat variable (e.g., by providing an elastic winding having a relatively small Young's modulus) to allow the diameter of the winding 1 to be adapted to the specific requirements of the vascular intervention.

[0086] In any of the above mentioned embodiments in which the catheter comprises an outer shaft 10, the outer shaft 10 can be used to support the proximal catheter area as the catheter is pushed through the patient's vasculature, for example to the ostium 7. Additionally, the outer shaft can also protect the membrane 1 as it is folded inwardly into the outer shaft 10 as it is delivered to the ostium 7.

[0087] In any of the above mentioned embodiments, the membrane 1 can be filled with a radiopaque solution that can be visible in an angiogram. Visibility can be further improved by one or more x-ray markers that can be located either on the inner shaft 8 of the membrane 1 and / or on the surface of the membrane 1, intended to give the physician an indication of the distance of the extension of the membrane 1. The distance between the one or more x-ray markers can be predefined. Based on the CT image, the physician can determine the location of the stenosis and thus control the length of the membrane 1 that needs to be extended to reach the desired location in the patient's blood vessel. Furthermore, with the aid of the one or more x-ray markers, it can be ensured that the catheter is sufficiently extended.

[0088] Figures 9a-9c show potential embodiments of the winding 1 that can be used independently but also in conjunction with any of the other embodiments described herein. The winding 1 can have a generally uniform / smooth surface or, as shown in Figures 9a-9c, can have an at least partially non-uniform surface. The use of a non-uniform surface can provide the advantage, in particular, of at least locally increasing the friction of the winding 1 against the inside of the patient's blood vessel.

[0089] According to Fig. 9a, the winding membrane 1 may be provided with one or more (spike-like) protrusions 11 on its surface. The protrusions may be arranged according to a regular pattern and / or may be identical to one another. The protrusions may, for example, be made separately and attached to the membrane.

[0090] In another implementation, the winding 1 can be thermoformed such that the non-uniform surface of the winding 1 can have one or more circumferential grooves 12 (FIG. 9b) or one or more circumferential peaks 13 (FIG. 9c). The protrusions can vary in size and shape. However, it is also conceivable that the protrusions can be equal to one another. In either case, the protrusions can be arranged according to a regular pattern on the surface.

[0091] It should be noted that the non-uniform surface of the winding membrane 1 can advantageously be used as a scoring element to more quickly induce multiple cracks in the calcified stenosis that will widen as the fluid pressure inside the balloon is increased.

[0092] Fig. 10 shows another embodiment of a membrane 1 that can be used independently of, but also in conjunction with, any of the other embodiments described herein. The membrane 1 is located in a patient's blood vessel 14 and can have a diameter smaller than the diameter of the patient's blood vessel in at least some areas of the vessel. The membrane 1 can be adapted to ensure a helix-like shape, similar to a corkscrew and / or a twisted thread, for example, around a central axis 15 of the blood vessel 14. This implementation of the membrane 1 can allow unhindered blood flow while ensuring some anchoring of the membrane 1 against the inner wall of the patient's blood vessel.

[0093] 11a-11c show another implementation of the wound membrane 1 according to the above mentioned embodiment and implementation details, where the wound membrane 1 can be adapted to enter a blood vessel 14 that can narrow along the longitudinal extension of the blood vessel. The wound membrane can be adapted to have a tapered diameter when unfolded distally. For example, the wound membrane can have a diameter between 1.5 mm and 5.0 mm at its proximal end and a diameter that reduces to 1.33 mm at its distal end.

[0094] 11a, if the membrane 1 reaches a location 16 in the blood vessel 14 where the diameter of the blood vessel 14 is too small for the membrane 1 to extend further into the vessel (such location 16 may be visible on an angiogram), the membrane 1 may be allowed to be (at least partially) contracted, the catheter 17 (e.g., by the outer shaft) may be pulled back a certain distance (FIG. 11b), and the membrane 1 may be expanded again (FIG. 11c). This contraction / expansion step may allow the membrane 1 to move away from the catheter 17 (and / or the outer shaft 10) a larger distance, thus allowing a smaller radial expansion (but larger in the longitudinal direction) upon expansion. Thus, portions of the patient's blood vessel 14 that narrow over an increasing longitudinal distance may also be subjected to vascular intervention with a catheter according to an embodiment of the present application. Thus, a single catheter may be used to access vessels of various sizes. It should be noted that although in FIG. 11 the diameter changes continuously, it is also conceivable that the diameter could change in steps, such that portions of the winding 1 have an approximately constant diameter.

[0095] As an alternative to the embodiment described with reference to FIG. 11a above, it may also be possible to provide the winding 1 with a diameter that increases when the winding 1 is unfolded distally.

[0096] 12a-12d show corresponding examples with stepped diameters. As depicted in FIG. 12a, the membrane 1 can have a diameter that expands in steps from the position from which the membrane 1 is unrolled to the most distal position of the membrane 1. A continuous change is also possible as shown in FIGS. 11a-11c. When the membrane 1 reaches a position 16 in the patient's blood vessel 14 where the diameter of the blood vessel 14 is too small to extend the membrane 1 further along the distal direction D of the blood vessel, the membrane 1 can be at least partially contracted, the distance over which the membrane 1 is unrolled from the catheter 17 can be shortened, and the membrane 1 can be expanded again. The membrane 1 can thus have a smaller diameter because it is unrolled at a shorter distance from the catheter 17. The membrane 1 can therefore access even narrower sections of the patient's blood vessel 14. Similarly, it may be facilitated that only a single catheter is required to access sections of a patient's blood vessel 14 having various diameters.

[0097] Potential special design implementations of the membrane 1 as described with reference to Figures 11 and 12 above can further enable a physician to determine the anatomical structure of a blood vessel based at least in part on the contraction / expansion and retraction steps of at least a portion of the membrane 1.

[0098] In the following, potential application scenarios that can rely on one or more of the embodiments and aspects outlined above are described in further detail.

[0099] 13a-13d illustrate a balloon angioplasty process for dilating at least a localized stenosis S in a patient's blood vessel 14 with a catheter according to embodiments and / or aspects. It should be noted that the procedure described below may be performed with a catheter with or without an inner shaft 8 and / or an outer shaft 10.

[0100] FIG. 13a depicts a stenosis S in a patient's blood vessel 14. The membrane 1 (having a diameter equivalent to that of the patient's blood vessel 14) has already been spread close to the stenosis S with the aid of a guidewire 9 (which may be omitted). When the pressure in the inner volume portion 3 of the membrane 1 increases, the membrane 1 can be spread further and wound into the constriction or stenosis in the patient's blood vessel 14, either by itself without any further manipulation by the physician or through the interaction of pressurizing the membrane and / or moving the guidewire forward and backward. Because the pressure in the inner volume portion 3 of the membrane 1 can be adapted to the requirements of the vascular intervention, it may be possible for the membrane 1 to dilate the stenosis S even if only a small section of the membrane 1 can enter the stenosis. Thus, the membrane can literally be wound into the stenosis and at the same time gradually dilate the stenosis as the membrane is wound distally.

[0101] 13b shows an exemplary result of a catheter-based angioplasty according to an embodiment of the present invention, where the stenosis S has been dilated to a sufficient degree to allow the membrane 1 to now be wound through the blood vessel 14 without further obstruction (e.g., for further treatment). Because the stenosis S has been dilated to a sufficient degree, unobstructed blood flow within the blood vessel 14 may (also) be supported.

[0102] Figures 13c and 13d show an angioplasty of a stenosis S similar to the angioplasty described with reference to Figures 13a and 13b above. In the exemplary illustration according to Figures 13c and 13d, the diameter of the membrane 1 is chosen to be smaller than the diameter of the blood vessel 14. In such a scenario, the membrane 1 can be wound into a narrower lesion and at least partially dilate the stenosis S (Figure 13d). It may also be possible to use a membrane 1 having a diameter smaller than the diameter of the blood vessel 14 so that even very narrow lesions can be at least partially dilated. In a subsequent step, the membrane 1 can have a diameter equivalent to the diameter of the blood vessel 14 (e.g., with a membrane as outlined with reference to Figures 11 and 12) to completely dilate the stenosis S as described with reference to Figures 13a and 13b above.

[0103] In summary, the ability of the winding 1 to be rolled without hydraulic assistance and friction can facilitate expansion through very narrow lesions. Furthermore, the balloon length, i.e., the length of the radially expanding portion of the winding 1, can be varied depending on the requirements of the vascular intervention.

[0104] 14a and 14b show potential applications of a catheter, where a membrane 1 may be adapted to deliver a drug 15 to a distal-most spot of the membrane 1 according to any of the embodiments mentioned above. It should be noted that the procedures described below may be performed using a catheter with or without an inner shaft 8 and / or an outer shaft 10.

[0105] FIG. 14a depicts the membrane 1 unfolded, for example along a guidewire 9 (which may be omitted) to the vicinity of a stenosis S. The membrane 1 may be coated with a drug 15 at one or more locations. The locations at which the membrane 1 may be coated with the drug 15 may be preferably selected so that the location is protected by an inwardly folded portion of the membrane 1 and so that the drug 15 may be released only in the vicinity of a lesion, for example a stenosis S. Thus, the drug 15 may be delivered to a location where the drug 15 may be useful and may not be expanded by blood flow, for example as shown in FIG. 14b. FIG. 14b shows a situation where the membrane 1 has been unfolded so that the drug 15 is folded outward to be located adjacent to the side wall of a blood vessel 14 where a stenosis S is or may have been. Suitable drugs may be, for example, drugs capable of preventing restenosis or drugs capable of dissolving thrombi (i.e. antithrombotic drugs). A suitable drug may be an anti-proliferative drug, such as a paclitaxel drug or a sirolimus drug. In some applications, it may be possible that the lesion (e.g., stenosis S) may be treated with drug 15 before being treated by mechanical dilation with a catheter as described herein (e.g., drug may be delivered by the membrane 1 at low pressure and then the membrane 1 may be pressurized). In some applications, it may be possible that the lesion (e.g., stenosis S) may be mechanically dilated first and then further treated in a subsequent step with drug 15 that may be delivered directly to the location of the stenosis. The drug impact range may be adjustable because the length of the membrane 1 that is spread essentially determines the location at which the drug 15 can be folded back outward (and thus released). Thus, a drug-coated balloon catheter may be provided that may extend itself to a specific location within the patient's blood vessel 14. A knob / stop on the handle of the wound catheter can be used to limit the maximum longitudinal travel of the inner shaft, thereby also controlling the length over which the wound can be everted.

[0106] 15a-b show another application of a catheter according to embodiments described herein that may be used to cross a chronic total occlusion (CTO) in a blood vessel.

[0107] FIG. 15 a shows an exemplary situation in which the membrane 1 is deployed in the vicinity of a CTO, a total occlusion of a blood vessel 14 .

[0108] In some implementations, the winding 1 may have a surface that may be adapted to apply a force, for example, to the guidewire 9 (which may be located in the central portion of the winding 1). As a result of further folding the winding 1 outward (e.g., as a result of pressurizing the inner volume portion 3 of the winding 1), a potential force transfer from the winding 1 to at least a portion of the guidewire 9 located in the central region of the winding 1 may be facilitated. Thus, the guidewire 9 may be subjected to a longitudinal pushing force along the distal direction D. If the pressure applied to the inner volume portion 3 of the winding is sufficient and the friction between the guidewire 9 and the surface section of the winding is large enough, even a CTO may be crossed as a result of the hydraulically assisted pushing force F, and any buckling back of the guidewire 9 may be prevented. It is further noted that it may be preferable for the winding 1 to be sufficiently anchored against the inner wall of the patient's blood vessel 14 to enable it to apply sufficient force to the guidewire 9. This may be facilitated by another embodiment described herein.

[0109] FIG. 15b relates to FIG. 15a and shows the CTO at a subsequent stage after it has been successfully crossed by the guidewire 9.

[0110] 16a-16b show another application that can follow the respective embodiment related to the inner shaft as outlined above, where the catheter can comprise at least an inner shaft 8. By providing a catheter with an inner shaft 8 to which a membrane 1 can be connected in an initial inwardly folded degree (not depicted in FIG. 16), a fluid delivery system can be supported as depicted in FIG. 16a. The membrane 1 can be unfolded so that the distal end of the inner shaft 8 can be pulled to the most distal position of the membrane 1. In a preferred application, the membrane 1 can be placed (preferably locked) at the position where a particular fluid needs to be released. Because the inner shaft 8 can provide a lumen that extends to the outside of the patient's body, the physician can insert a particular fluid (e.g., a drug, a contrast agent) into the inner shaft, and then the fluid can be transported to the most distal position of the catheter (membrane 1) and released.

[0111] In applications where the membrane 1 has the same diameter as the patient's blood vessel 14, it may be possible to avoid any dilution of the released drug by the blood flow, which may increase the medical effect of the released drug. Another beneficial effect may be seen in that the drug may be released directly at the location of interest (e.g., near the site of the lesion so as to facilitate "local therapy"), thereby reducing the overall drug dosage. Potential applications of such drug delivery systems may also be found, for example, in cancer treatment, distal lysis treatment for ST-segment elevation myocardial infarction (STEMI), etc. The same applies to the exemplary use of contrast agents, which may reduce potential health risks for patients.

[0112] In some application scenarios, as depicted in Fig. 16b, the inner shaft 8 may also be used to aspirate certain objects (e.g., by applying negative pressure to the inner lumen of the inner shaft 8) located very close to the most distal part of the membrane 1. The objects to be aspirated may be, for example, (soft) thrombus and / or debris generated by an atherectomy procedure or any other type of procedure. The same may be true for residual objects such as drugs and contrast agents.

[0113] Although a guidewire 9 is shown in Figures 16a-16b, the guidewire 9 may be omitted.

[0114] 17a-17e show another application of a catheter according to any of the above mentioned embodiments, where the catheter may be used as a device delivery system.

[0115] FIG. 17a shows an exemplary application of the catheter, where the membrane 1 has been spread adjacent to the stenosis S, e.g., by an optional guidewire 9. The membrane 1 may be spread further into the stenosis S (FIG. 17b) and expanded, so that the stenosis S may be at least partially dilated (e.g., as described above with reference to FIG. 13). In some applications, it may be advantageous to fully spread the membrane 1 to allow the inner shaft 8 to be pulled up to the most distal portion of the membrane 1. Given the later delivery of a device (e.g., a functional device, such as a medical device) 16 (as will be further described below), this procedure may be understood as pre-dilatation, with the potential to subsequently fully dilate the stenosis, e.g., based at least in part on the device 16 being delivered.

[0116] In some applications, the device 16 may be inserted into the inner shaft 8 and pushed forward to the most distal part of the membrane 1, as depicted in FIG. 17c. The necessary pushing force may be applied from outside the patient's body by the physician. In some scenarios, the device 16 may be held in the middle of the membrane 1 as a result of pressurization of the inner volume portion 3 of the membrane 1. It may therefore be necessary to contract the membrane by such pressure difference (FIG. 17d) to allow the device 16 to be pushed further out of the membrane. It may also be necessary to retract the membrane 1 some distance to place the device 16 at the location of the stenosis S. As a result, the device 16 may be detached from the catheter and the membrane 1, and thus may be placed at a specific location, for example for a subsequent treatment (such as dilating the stenosis S as shown in FIG. 17e). As an example, the device 16 may be a simple balloon catheter (which may only comprise a tube and a balloon), which may, for example, fully dilate the stenosis S. In some cases, each balloon catheter may include its own shaft that may extend to the exterior of the patient's body to allow for (hydrodynamic) inflation of the balloon catheter. This procedure for delivering device 16 may also be referred to as flexible-type device delivery.

[0117] A variety of devices 16 can be delivered through the inner shaft 8 of the membrane 1. Some examples of devices 16 that can be delivered through the inner shaft 8 are any type of catheter, such as, for example, a simple balloon catheter, a standard balloon catheter, a high pressure balloon catheter, etc. The delivery of a balloon catheter may be particularly relevant in cases where a balloon catheter of a particular diameter is required. Additionally, bail-out devices, embolic protection devices, scoring or cutting elements, self-expanding stents, guidewires, coils, flow diverters, etc. may also be delivered. In some applications, it may be possible to deliver devices 16 such as a camera for endoscopy or to deliver a biopsy needle. The catheter according to the embodiments described herein may facilitate the delivery of a device 16 to a particular location in the patient's blood vessel 14 and / or the removal of the device 16 from a particular location in the patient's blood vessel 14 using only a single catheter. In some applications, it may be possible to deliver more than one device to a particular location in the patient's blood vessel 14, for example in a subsequent step. In some cases, such as when the device 16 unexpectedly dislodges during a vascular intervention and an additional high pressure balloon catheter is required, it may be possible to spontaneously deliver the device 16 to the lesion site, which may simplify and shorten the overall duration of a PCI or PVI (percutaneous ventricular intervention) or endovascular procedure.

[0118] 18a-18d show an alternative device delivery procedure in which the device 16 to be delivered may be preloaded into the inner shaft or central region of the membrane 1. The membrane 1 has an outer diameter smaller than the inner diameter of the patient's blood vessel 14. The delivery steps depicted in FIGS. 18a-18d may be understood to be similar to FIGS. 17a-17e described above. In particular, the device 16 may be equivalent to one or more of the devices exemplarily described above with reference to FIGS. 17a-17e.

[0119] However, deviating from the delivery process described with reference to Figures 17a-e above, it may be possible that the device 16 may be preloaded into the inner shaft 18. In other words, it may be possible that the device 16 may not be pushed through the inner shaft 8 to the most distal part of the membrane 1, but that the preloaded device 16 may be substantially pulled to the most distal part of the membrane 1 as a result of the membrane 1 being unfolded.

[0120] It may also be possible for the catheter to not include an inner shaft 8. In such a case, the device 16 may be preloaded into the central region of the membrane 1, so that the device 16 is surrounded by the inwardly turned portion of the membrane 1 in the center of the membrane. If sufficient friction occurs between the device 16 and the inwardly turned portion of the membrane 1, the device may be pulled to the most distal portion of the membrane 1 as a result of the membrane unfolding. This method of delivery may also be referred to as a preloaded mode. It is further noted that applications may also be possible where the membrane 1 is not attached to the inner shaft (since the catheter only has a membrane without an inner shaft). In such a case, the device 16 to be delivered is located in the central region of the membrane, which may be formed by the inwardly turned portion of the membrane.

[0121] FIG. 19 shows another application scenario for the catheter, where the catheter can be used to deliver a microcatheter 17 to a specific location during a vascular intervention. The catheter described below can be understood according to the implementation described herein, where the catheter has an inner shaft 8. FIG. 19 shows a scenario in which the membrane 1 is (fully) unfolded, so that the inner shaft 8 is pulled to the most distal end of the membrane 1. In this case, it can be possible to push a second, smaller catheter, such as a microcatheter 17, out of the membrane 1 at the most distal location of the membrane 1 through the inner shaft 8 (mother-and-child method). Such an application can enable the microcatheter 17 to be delivered to a branch of the patient's vascular system where a small vessel 18 branches off from the main vessel 14, where the small vessel 18 may not be accessible by the membrane 1. The microcatheter can be guided into the small vessel 18 by a guidewire 9, which can extend, for example, through both the microcatheter 17 and the membrane 1. Thus, the branching small vessel 18 can also be accessed by the catheter. Because the microcatheter 17 can be pushed through the inner shaft 8, it may only be necessary to use the "larger" main catheter (with the membrane 1) as a delivery system for the microcatheter 17, without the need to push another catheter through the patient's vasculature. Furthermore, the microcatheter 17 may be protected by the main catheter from being pushed through the inner shaft 8 up to the bifurcation location where the small blood vessels 18 branch off. The membrane may also provide support for the microcatheter 17 near its intended deployment location. In some other applications, it may also be possible to use the microcatheter 17 as a dedicated delivery system for drugs, so that drugs can be delivered to the small blood vessels 17. This may be advantageous, especially for STEMI patients.

[0122] 20a-20e show another application of the catheter according to an embodiment where the catheter is further used as a delivery system for a self-expanding stent (SX stent) 19. FIG.

[0123] FIG. 20a shows an initial situation that may be equivalent to the situation described with reference to FIG. 17a above, but the membrane 1 may have an outer diameter that is the same as or smaller than the inner diameter of the patient's blood vessel 14. The membrane 1 may be attached to the inner shaft 8. Furthermore, the SX stent 19 may be preloaded in a central region of the membrane 1 that may be formed as a result of the inwardly folded part of the membrane in a not yet fully deployed state of the membrane 1. The membrane 1 may be further wound into the stenosis S and deployed therein to at least partially dilate the stenosis S (FIG. 20b). As a result of further unfolding the membrane 1 (e.g. to dilate the stenosis S), the SX stent 19 may be pulled to the distal part of the membrane 1. As a result, it may be further necessary to contract the membrane with a certain amount of pressure (FIG. 20c) so that the SX stent 19 can be easily released and delivered to the most distal part of the membrane 1. As soon as the fluid pressure in the inner volume of the membrane 1 is reduced, the SX stent 19 will deploy the inside of the membrane 1 towards the outside of the membrane 1 and / or the vessel 14, and friction can completely prevent further movement. It may be necessary to retract the membrane 1 a certain distance to place the SX stent 19 in the patient's vessel 14 at the desired location. In this case, it is necessary to expand the membrane 1 beyond the pressure that would collapse the SX stent. In this case, the membrane 1 can be retracted. In this case, the SX stent 19 can be partially detached from the membrane and start to deploy itself (FIG. 20d). As soon as the SX stent 19 is fully deployed by further retraction of the membrane 1 (FIG. 20e), the patient's vessel 14 can be kept at least open / unoccluded by the SX stent 19. In some examples, the membrane 1 can be adapted to exert a compressive force on the portion of the SX stent 19 that is still surrounded by the membrane, so that sudden extrusion of the SX stent 19 in the distal direction upon deployment is avoided.

[0124] Additionally, it should be noted that applications may be possible where the SX stent 19 may be delivered by the membrane 1 without the presence of the inner shaft 8 .

[0125] This application example shows that the catheter according to the embodiment described above can be used to deliver the SX Stent 19 to the desired location with a single catheter and to minimize procedure time. Furthermore, this special frictionless design of the membrane 1 ensures the release of the SX Stent without friction.

[0126] 21a-21e show another application scenario of a catheter according to an embodiment, where the catheter may be used to deliver a balloon expandable stent (BE stent) to a desired location within a patient's blood vessel 14. The application scenario described below may be understood to be similar to the delivery procedure described with reference to FIG. 17 above, and therefore will be dealt with only briefly below.

[0127] FIG. 21a shows the same initial situation as described with reference to FIG. 20a above, but the BE stent 20 may not be preloaded. The membrane 1 may be wound into the stenosis S (FIG. 21b) and expanded, thus at least partially dilating the stenosis S. As a result of the (complete) unfolding of the membrane 1, the inner shaft 8 may be pulled to the most distal part of the membrane, so that a lumen through the catheter may be formed. In this case, it may be possible to push the BE stent 20 through the lumen until it reaches the most distal part of the membrane 1 (FIG. 21c). Under some circumstances, it may be necessary to retract and / or contract the membrane a certain distance in the proximal direction, so as to allow the BE stent 20 to be placed at the location of the stenosis (FIG. 21d). The BE stent 20 may then be expanded from outside the patient's body by the respective shaft providing a lumen from the BE stent 20 to the outside of the patient's body (FIG. 21e). The BE stent 20 can then fully dilate the underlying stenosis at the location where the BE stent 20 is deployed and expanded.

[0128] It should be noted that in alternative embodiments, the inner shaft 8 may not be necessary to deliver the BE stent 20. It may also be possible that the BE stent 20 can be pushed through the central lumen of the membrane when the membrane is fully open after eversion. Such a delivery system may provide similar advantages to those described with reference to FIG. 17 above.

[0129] Figures 22a-d relate to a use scenario of a catheter according to an embodiment, where the catheter may be preloaded with a BE stent 20. The procedure of loading a BE stent 20 in a preloading mode may include similar procedure steps as outlined above in relation to Figure 17, except that a preloaded BE stent 20 is delivered, as opposed to a (simple) balloon catheter 16. Thus, the advantages of such an application of a catheter according to an embodiment of the invention may be similar to those outlined above in relation to Figure 17.

[0130] 23a and 23b show another embodiment of a catheter in which a membrane 1 is attached to an inner shaft 8, which may be suitable for atherectomy.

[0131] FIG. 23a shows an exemplary situation in which the membrane 1 has been (fully) unfolded into the vicinity of the stenosis S. With the membrane fully unfolded, the inner shaft 8 is pulled to the most distal part of the membrane 1, thereby forming an inner lumen through the catheter. The inner lumen thus formed can extend to the outside of the patient, so that fluids can be inserted into the inner lumen, from which they can be delivered to the most distal part of the membrane 1 (as described above with reference to FIG. 16). In addition to the delivery capabilities described with reference to FIG. 16, it may also be possible to guide a water jet through the inner lumen of the membrane 1. A water jet may be understood as a pressurized "beam" of water, which may be limited to a given cross-sectional area. Such a water jet may enable atherectomy using the catheter. The water jet may make it possible to (fully) open the stenosis S by the impact of the water jet alone against the stenosis S. In some scenarios, it may be necessary to pre-deliver a specific drug to the stenosis S before applying the water jet. Additionally or alternatively, it may be possible to deliver a specific drug to the stenosis S after applying a water jet to the stenosis S. In some scenarios, the catheter may include a dual lumen, where the inner lumen of the membrane 1 may be split into two separate lumens, such that a portion of the inner lumen may be used to deliver a particular fluid to the stenosis S, while the remaining portion of each of the inner lumens may be used to aspirate fluids and / or solids (e.g., debris) from the vicinity of the stenosis S. In such implementations, it may be possible to deliver a particular drug to the stenosis S (to dissolve the stenosis S, for example). After drug delivery, it may be possible to aspirate the debris of the stenosis and / or potential remnants of the previously delivered drug.

[0132] Figure 23b shows three separate configurations of potential dual lumen embodiments. Thus, a major cross-sectional area of ​​the inner lumen may be provided for aspiration (i) (as thrombus and / or debris may be relatively large particles). In some circumstances, it may be preferred for the cross-sectional areas of the lumens of the dual lumen to have approximately equal cross-sectional areas (ii), while in other embodiments, the area provided for fluid delivery may be smaller compared to the cross-sectional area provided for aspiration and may not be located at the edge of the area provided for aspiration (iii).

[0133] Figures 24a-24e show alternative steering designs for steering the web 1 in a particular direction as it is unrolled.

[0134] 24a and 24b show an exemplary situation, where the membrane 1 can extend through a patient's blood vessel 14. Furthermore, it may be desirable for the membrane 1 to enter a branched blood vessel 21 (note that this application is not limited to branched blood vessels only, but may also be used in other applications requiring small bending radii), which may require, for example, a small bending radius (compared to typical bending radii in the aorta) to enter the branched blood vessel 21. Such a small bending radius may not always be possible with the guide element 5 or the guidewire 9, as explained above. In contrast, steering techniques are required that allow smaller bending radii to be possible.

[0135] FIG. 24c shows an example for a steering technique for the winding 1, which can allow even smaller bending radii. This steering can be based on a special curved wire 22, which can generally function as a guidewire, but which can have a surface that can generate high friction with the winding 1. Steering the winding in the desired direction can be based on the interaction of compressing the winding and / or moving the guidewire forward and backward. Additionally or alternatively, the curved wire 22 can have regions with different surface roughness or regions of different surface materials, with the aim of generating uneven / non-uniform friction in front of the winding 1. Additionally or alternatively, the tip part of the special guidewire 22 can have a shape with an enlarged diameter part (for example as depicted in FIG. 24e). It is considered that the central region of the curved section of the guidewire can be clearly visualized by the angiographic technique used, in order to interact with the winding in an optimized manner. This can be achieved by a localized amount of material or by using a stronger x-ray extenuating material, since the guidewire is allowed to have a higher stiffness in this area. For steering, the high friction part of the special curved wire 22 can be located in the distal part of the membrane 1, so that the curved design of the special guidewire 22 and / or the tip part creates a discrete radially uneven (e.g. one-sided) friction in front of the membrane 1. For steering of the tip part of the special guidewire 22 and for fine formation of sufficient friction, the membrane 1 can be fully contracted, which allows the special curved wire 22 to be manually guided in the desired direction. In a subsequent step, the membrane 1 can be expanded again, so that it comes into contact with the high friction part of the special curved wire 22 as it expands and unfolds again. By providing high friction, the membrane may have a tendency to spread more at the bottom of Fig. 24c), e.g., at location 23, compared to the top of Fig. 24c), thereby increasing the degree of bending of the curved wire 22. As a result, the winding 1 may be used to achieve smaller bending radii.Similar results can be achieved using a tip portion that contacts the membrane as it unfolds, as shown, for example, in Fig. 24e) In addition, it may be necessary to slow down the movement of the special guidewire 22 relative to the movement of the membrane 1 in order to create the necessary friction.

[0136] In addition, at least a part of the distal end of the membrane 1 may preferably be made of a viscoelastic material. The above-described radially uneven friction allows the membrane 1 to limit the radial tension of the balloon of the inflated and pressurized membrane 1 at the inside of the curve. The properties of the membrane 1, which relate to the pressure-dependent increase in length of the membrane 1 due to its favorable viscoelastic properties, may promote at least a partial plastic deformation of the distal part of the membrane 1 at high pressure at position 23. In addition to the above-mentioned deformations causing the membrane to move in a curve, the membrane 1 may also be plastically formed in the direction of the lesion. In other words, the application of non-uniform friction (and therefore non-uniform forces) to the inner viscoelastic part of the membrane 1 as it unfolds (i.e. as it is inflated) may prevent the part of the membrane 1 that is subjected to the non-uniform forces from further unfolding, for example in the longitudinal direction. However, the favorable viscoelastic properties of the membrane 1 may allow a viscoelastic deformation of the membrane 1, which may change the direction of further unfolding of the membrane 1. In this case, the areas that are not as strongly affected by the increased friction of the winding movement will expand (also plastically) to a greater extent, thus enhancing the curvature movement of the winding membrane 1. This allows easier steering for a particular lesion site and allows the desired force to be applied to the lesion site. This steering can be further improved by reducing the pressure within the winding membrane 1. Furthermore, under some circumstances, the special guidewire 22 can further have one or more x-ray markers to improve the visibility of the special guidewire during angiography.

[0137] 24d shows a detailed view of the special (guide) wire 22. The special guide wire 22 may comprise a region 24 which provides a highly enhanced friction with the winding 1.

[0138] FIG. 25 shows a schematic diagram of potential locations of lesions that may need to be accessible by a catheter according to the present invention. Usually, the membrane 1 is stiff enough to extend "straight". However, deviations from the straight extension direction may require additional steering concepts as described herein. It should be noted that the lesions may be located at a prebranch spot (FIG. 25a), a deep branch spot (FIG. 25b), the parent vessel only (FIG. 25c), the branch (FIG. 25d), the ostium (FIG. 25e), a prebranch location and ostium (FIG. 25f), or a deep branch location and ostium (FIG. 25g). It will be understood that the dashed and / or dotted lines associated with reference numbers 4, 5, 6, 8, 9, 10, 16, 19, 20 may be considered as solid lines in terms of drawing, and that the dashed and / or dotted lines are merely for better differentiation of the lines.

[0139] Throughout these figures, D means distal direction and P means proximal direction. Distal direction is understood as the direction in the longitudinal extension of the catheter that is further away from the physician operating the catheter. Proximal direction is understood as the direction in the longitudinal extension of the catheter that is closer to the physician operating the catheter. The distal direction can be the opposite of the proximal direction.

[0140] Further examples of the present disclosure are provided below.

[0141] 1. A catheter comprising a membrane, the membrane adapted to be wrapped longitudinally (eg, at least 1 mm, or 1 cm to 20 cm) along a patient's blood vessel.

[0142] 2. A catheter comprising: a membrane defining an inner volume portion that can be pressurized; and a guide element disposed within the inner volume portion (for guiding the membrane along a patient's blood vessel).

[0143] 3. The catheter of Example 2, wherein the guide element is adapted to be slidable against the inside of the membrane so that the guide element can remain in the distal portion of the membrane when the membrane is unfolded.

[0144] 4. The catheter of example 2 or 3, wherein the guide element comprises a curved wire.

[0145] 5. A catheter comprising a membrane and a retraction element having no inner lumen for retracting the membrane from its expanded condition.

[0146] 6. The catheter of any one of the above examples, wherein an end portion of the membrane is adapted to form a distal tip of the catheter when the membrane is unfolded.

[0147] 7. The catheter of Examples 5 and 6, wherein the retraction element is attached to an end portion of the membrane.

[0148] 8. The catheter of Example 7, wherein the guide element is adapted to steer the wound membrane along the blood vessel as the membrane is unfolded.

[0149] 9. The catheter of any one of Examples 1 to 8, wherein the outer diameter of the catheter is smaller than the diameter of the blood vessel.

[0150] 10. The catheter of Example 9, wherein the membrane is adapted to form a spiral-like shape along the length of the blood vessel.

[0151] 11. A catheter comprising a membrane defining an inner volume portion that can be pressurized, the membrane adapted to enable pressurization of the inner volume portion to dilate a stenosis in a patient's blood vessel via expansion by the membrane.

[0152] 12. The catheter of any one of the preceding examples, wherein an outer diameter of the catheter is adapted to substantially fill the patient's blood vessel in a radial direction.

[0153] 13. The catheter of any one of the above examples, wherein the membrane is adapted to enable a proximal end of the membrane to be located outside the patient's body when the membrane is unfolded inside the patient's body.

[0154] 14. The catheter of any one of the above examples, wherein the wound membrane has, at least in part, a non-uniform outer surface.

[0155] 15. The catheter of any one of the preceding examples, wherein the radius of the membrane varies along the length of the membrane in the unfolded state.

[0156] 16. A catheter comprising a membrane adapted to be expanded to form an elongated main portion and a distal end portion, the elongated main portion adapted to have a non-uniform cross-section.

[0157] 17. A catheter comprising a membrane, at least a portion of which can be folded inward to form an inner wall, the inner wall comprising a drug layer, such that unfolding the membrane delivers the drug layer distally.

[0158] 18. A catheter comprising a membrane, the membrane having, at least in part, a non-uniform outer surface.

[0159] 19. A catheter comprising a membrane adapted to be expanded to form an elongated main portion having a cross-section smaller than the cross-section of a blood vessel, the centerline of the elongated main portion adapted to be twisted to the centerline of the blood vessel.

[0160] 20. A catheter having a membrane, the catheter not having an inner shaft.

[0161] 21. A catheter comprising a membrane, the membrane adapted to apply a force to a functional element disposed within a lumen defined at least in part by an inwardly folded portion of the membrane.

[0162] 22. The catheter of example 21, wherein the membrane is adapted to push the functional element distally of the catheter with a force when the membrane is expanded distally.

[0163] 23. A method for dilating a stenosis in a blood vessel, the method comprising: inserting a catheter having a membrane into the blood vessel; spreading at least a portion of the membrane to position the membrane adjacent the stenosis; and pressurizing the membrane to result in the stenosis being dilated.

[0164] 24. A method for forcing a guide element into a stenosed region of a blood vessel, the method comprising: inserting a catheter having a membrane into the blood vessel, wherein at least a portion of the guide element is disposed within a lumen formed at least in part by an inwardly folded portion of the membrane; and spreading at least a portion of the membrane distally of the catheter, thereby forcing the guide element into the stenosed region in the distal direction.

[0165] 25. A catheter comprising or consisting of a wound membrane defining an inner volume portion that can be pressurized, a guide element, an optional outer shaft, and an optional retraction element, wherein the wound membrane is adapted to be spread longitudinally in the spread state, preferably along a patient's blood vessel, and the guide element is disposed within the inner volume portion for guiding the wound membrane along the patient's blood vessel.

[0166] 26. The catheter of example 25, wherein the catheter comprises a retraction element for retracting the membrane (from an expanded state of the membrane, preferably to an unexpanded or partially expanded state of the membrane).

[0167] 27. The catheter of example 25 or 26, wherein the guide element is attached to the membrane, preferably to the inner surface of the membrane.

[0168] 28. The catheter of any one of examples 25 to 27, wherein the guide element and / or the retraction element is attached to an end portion (distal end portion) of the membrane.

[0169] 29. A catheter of 28, in which guide and retraction elements are attached at various locations on the end portion (distal end portion) of the volar membrane.

[0170] 30. The catheter of any one of examples 25 to 29, wherein the catheter has an outer diameter the same as or smaller than the blood vessel into which it is inserted.

[0171] 31. The catheter of any one of examples 25 to 30, wherein the winding membrane is made of an organic polymer, preferably a thermoplastic or a thermoplastic elastomer.

[0172] 32. The catheter of any one of examples 25 to 31, wherein the winding membrane is made of polyamide, poly(dodecano-12-lactam), polyether block amide, or thermoplastic polyurethane.

[0173] 33. The catheter of any one of examples 25 to 32, wherein the guide element and / or the retraction element does not have an inner lumen.

[0174] 34. The catheter of any one of examples 25 to 33, wherein the guiding element is a guidewire, preferably a curved guidewire.

[0175] 35. The catheter of any one of examples 25 to 34, wherein the guide element and / or the retraction element do not penetrate or pierce the volar membrane.

[0176] 36. The catheter of any one of examples 25 to 35, wherein the winding membrane is pressure-tightly and / or liquid-tightly attached to the guiding element and / or the retraction element.

[0177] 37. The catheter of any one of examples 25 to 36, wherein the winding membrane is welded or glued to the guide element and / or the retraction element.

[0178] 38. The catheter of any one of Examples 25 to 37, wherein the guide element is adapted to be slidable against the inside of the membrane, such that the guide element can remain in the distal portion of the membrane when the membrane is in the expanded state.

[0179] 39. The catheter of any one of examples 25 to 28, wherein an end portion of the membrane is adapted to form a distal tip of the catheter when the membrane is in an unfolded state.

[0180] 40. The catheter of any one of examples 25 to 39, wherein the guide element and / or retraction element are adapted to steer the wound membrane along the blood vessel when the wound membrane is in the unfolded state.

[0181] 41. The catheter of any one of examples 25 to 40, wherein the membrane is adapted to form a spiral-like shape along the length of the blood vessel.

[0182] 42. The catheter of any one of examples 25 to 41, wherein the outer diameter of the catheter is adapted to radially fill the patient's blood vessel.

[0183] 43. The catheter of any one of examples 25 to 42, wherein the membrane is adapted to enable a proximal end of the membrane to be located outside the patient's body when the membrane is in the unfolded state.

[0184] 44. The catheter of any one of examples 25 to 43, wherein the membrane is adapted to enable a distal end of the membrane to be positioned inside the patient's body when the membrane is in the unfolded state.

[0185] 45. The catheter of any one of examples 25 to 44, wherein the wound membrane has, at least in part, a non-uniform outer surface.

[0186] 46. ​​The catheter of any one of examples 25 to 45, wherein the membrane has spikes on its outer surface.

[0187] 47. The catheter of any one of examples 25 to 45, wherein the wound membrane has a (thermoformed) circumferential groove, preferably a spirally arranged groove, on its outer surface.

[0188] 48. The catheter of any one of examples 25 to 45, wherein the wound membrane has (thermoformed) circumferential peaks, preferably helically arranged peaks, on its outer surface.

[0189] 49. The catheter of any one of examples 25 to 41 or 43 to 48, wherein the outer diameter of the membrane varies along the length of the membrane in the expanded state.

[0190] 50. The catheter of any one of examples 25 to 41 or 43 to 49, wherein the outer diameter of the membrane along the length of the membrane in the expanded state decreases from the proximal end of the membrane to the distal end of the membrane.

[0191] 51. The catheter of example 50, wherein the outer diameter of the membrane in the expanded state decreases continuously along the length of the membrane from the proximal end of the membrane to the distal end of the membrane.

[0192] 52. The catheter of example 50, wherein the outer diameter of the membrane in the expanded state along the longitudinal direction of the membrane decreases stepwise from the proximal end of the membrane to the distal end of the membrane.

[0193] 53. The catheter of any one of examples 25 to 41 or 43 to 49, wherein the outer diameter of the membrane along the longitudinal direction of the membrane in the expanded state expands from the proximal end of the membrane to the distal end of the membrane.

[0194] 54. The catheter of Example 53, wherein the outer diameter of the membrane along the longitudinal direction of the membrane in the expanded state increases continuously from the proximal end of the membrane to the distal end of the membrane.

[0195] 55. The catheter of Example 53, wherein the outer diameter of the membrane along the longitudinal direction of the membrane in the expanded state increases stepwise from the proximal end of the membrane to the distal end of the membrane.

[0196] 56. The catheter of any one of examples 25 to 55, wherein the outer diameter of the membrane in the expanded state is between 0.5 mm and 8.6 mm, between 0.66 mm and 3.3 mm, or between 0.99 mm and 1.98 mm.

[0197] 57. The catheter of any one of Examples 25 to 56, wherein the membrane is a drug-coated membrane.

[0198] 58. The catheter of any one of examples 25 to 57, wherein the membrane is a double-walled membrane.

[0199] 59. The catheter of any one of Examples 25 to 58, wherein the wound membrane is stretchable to a greater extent in the longitudinal direction than in the radial direction when pressurized.

[0200] 60. The catheter of any one of examples 25 to 69, wherein the catheter does not have an inner shaft.

[0201] 61. A catheter comprising or consisting of a winding membrane defining an inner volume portion that can be pressurized, a guide element, an inner shaft, an optional outer shaft, and an optional retraction element, (wherein the winding membrane is adapted to be in an expanded state in a longitudinal direction, preferably along a patient's blood vessel), the guide element being disposed within the inner shaft and the inner shaft being attached to the winding membrane.

[0202] 62. The catheter of example 61, wherein the inner shaft can be reinforced with a metal, metal alloy, or polymer braid.

[0203] 63. The catheter of example 61 or 62, wherein the guide element is attached to the membrane, preferably to the inner surface of the membrane.

[0204] 64. The catheter of any one of Examples 61 to 63, wherein the guide element and / or the retraction element is attached to an end portion (distal end portion) of the membrane.

[0205] 65. The catheter of example 64, wherein the guide element and the retraction element are attached at various positions on the end portions of the membrane.

[0206] 66. The catheter of any one of examples 61 to 65, wherein the catheter has an outer diameter the same as or smaller than the blood vessel into which it is inserted.

[0207] 67. The catheter of any one of examples 61 to 66, wherein the winding membrane is made of an organic polymer, preferably a thermoplastic or a thermoplastic elastomer.

[0208] 68. The catheter of any one of examples 61 to 67, wherein the winding membrane is made of polyamide, poly(dodecano-12-lactam), polyether block amide, or thermoplastic polyurethane.

[0209] 69. The catheter of any one of examples 61 to 68, wherein the guide element and / or the retraction element does not have an inner lumen.

[0210] 70. The catheter of any one of examples 61 to 69, wherein the guiding element is a guidewire, preferably a curved guidewire.

[0211] 71. The catheter of any one of examples 61 to 70, wherein the guide element and / or the retraction element do not penetrate or pierce the volar membrane.

[0212] 72. The catheter of any one of examples 61 to 71, wherein the winding membrane is pressure-tightly and / or liquid-tightly attached to the guiding element and / or the retraction element.

[0213] 73. The catheter of any one of examples 61 to 72, wherein the winding membrane is welded or glued to the guide element and / or the retraction element.

[0214] 74. The catheter of any one of Examples 61 to 73, wherein the guide elements (5, 6) are adapted to be slidable against the inside of the membrane, so that the guide elements can remain in the distal portion of the membrane when the membrane is in the expanded state.

[0215] 75. The catheter of any one of examples 61 to 74, wherein an end portion of the membrane is adapted to form a distal tip of the catheter when the membrane is in an unfolded state.

[0216] 76. The catheter of any one of Examples 61 to 75, wherein the guide elements (5, 6) and / or the retraction element (4) are adapted to steer the membrane along the blood vessel (14) when the membrane is in the expanded state.

[0217] 77. The catheter of any one of examples 61 to 76, wherein the membrane is adapted to form a spiral-like shape along the longitudinal direction of the blood vessel (14).

[0218] 78. The catheter of any one of examples 61 to 77, wherein the outer diameter of the catheter is adapted to radially fill the patient's blood vessel (14).

[0219] 79. The catheter of any one of examples 61 to 78, wherein the membrane is adapted to enable a proximal end of the membrane to be located outside the patient's body when the membrane is in the unfolded state.

[0220] 80. The catheter of any one of examples 61 to 79, wherein the membrane is adapted to enable a distal end of the membrane to be positioned inside the patient's body when the membrane is in the expanded state.

[0221] 81. The catheter of any one of Examples 61 to 80, wherein the wound membrane has, at least in part, a non-uniform outer surface.

[0222] 82. The catheter of any one of examples 61 to 81, wherein the membrane has spikes on its outer surface.

[0223] 83. The catheter of any one of Examples 61 to 82, wherein the wound membrane has a (thermoformed) circumferential groove, preferably a spirally arranged groove, on its outer surface.

[0224] 84. The catheter of any one of Examples 61 to 83, wherein the wound membrane has (thermoformed) circumferential peaks, preferably helically arranged peaks, on its outer surface.

[0225] 85. The catheter of any one of examples 61 to 77 or 79 to 84, wherein the outer diameter of the membrane changes along the longitudinal direction of the membrane in the expanded state.

[0226] 86. The catheter of any one of examples 61 to 77 or 79 to 85, wherein the outer diameter of the membrane along the length of the membrane in the expanded state decreases from the proximal end of the membrane to the distal end of the membrane.

[0227] 87. The catheter of example 86, wherein the outer diameter of the membrane in the expanded state along the longitudinal direction of the membrane decreases continuously from the proximal end of the membrane to the distal end of the membrane.

[0228] 88. The catheter of example 86, wherein the outer diameter of the membrane along the longitudinal direction of the membrane in the expanded state decreases gradually from the proximal end of the membrane to the distal end of the membrane.

[0229] 89. The catheter of any one of examples 61 to 77 or 79 to 85, wherein the outer diameter of the membrane along the longitudinal direction of the membrane in the expanded state expands from the proximal end of the membrane to the distal end of the membrane.

[0230] 90. The catheter of example 89, wherein the outer diameter of the membrane along the longitudinal direction of the membrane in the expanded state increases continuously from the proximal end of the membrane to the distal end of the membrane.

[0231] 91. The catheter of example 89, wherein the outer diameter of the membrane along the longitudinal direction of the membrane in the expanded state increases stepwise from the proximal end of the membrane to the distal end of the membrane.

[0232] 92. The catheter of any one of examples 61 to 91, wherein the outer diameter of the membrane in the expanded state is between 0.5 mm and 8.6 mm, between 0.66 mm and 3.3 mm, or between 0.99 mm and 1.98 mm.

[0233] 93. The catheter of any one of Examples 61 to 92, wherein the membrane is a drug-coated membrane.

[0234] 94. The catheter of any one of examples 61 to 93, wherein the membrane is a double-walled membrane.

[0235] 95. The catheter of any one of Examples 61 to 94, wherein the wound membrane is stretchable to a greater extent in the longitudinal direction than in the radial direction when pressurized.

[0236] 96. The catheter of any one of Examples 61 to 95, wherein the membrane is attached to the inner shaft.

[0237] 97. The catheter of any one of Examples 61 to 96, wherein the guiding element has regions of different stiffness and / or roughness.

[0238] 98. The catheter of any one of Examples 61 to 97, wherein the guide element has an atraumatic distal tip.

[0239] 99. The catheter of any one of Examples 61 to 98, wherein the membrane is attached to at least a distal end region of the inner shaft.

[0240] 100. The catheter of any one of examples 61 to 99, wherein the inner shaft is located (at least partially) within the inner volume portion of the volumic membrane.

[0241] 101. The catheter of any one of examples 61 to 100, wherein the membrane is pressurizable with a fluid that can be guided through the inner volume portion of the membrane but not up to the inner shaft.

[0242] 102. The catheter of any one of examples 25 to 101, wherein the catheter comprises an outer shaft.

[0243] 103. The catheter of example 102, wherein the membrane is attached to the outer shaft.

[0244] 104. The catheter of example 102 or 103, wherein the membrane is attached to at least the distal end region of the outer shaft.

[0245] 105. The catheter of any one of examples 102 to 104, wherein the membrane is more flexible than the outer shaft.

[0246] 106. The catheter of any one of examples 102 to 105, wherein the outer shaft can be reinforced with a metal, metal alloy, or polymer braid.

[0247] 107. The catheter of any one of examples 102 to 105, wherein the membrane has a smaller wall thickness than the outer shaft.

[0248] 108. The catheter of any one of examples 25 to 106, wherein the wound membrane has a wall thickness of 10 μm to 90 μm, preferably 15 μm to 60 μm, 70 μm to 90 μm.

[0249] 109. The catheter of any one of examples 102 to 108, wherein the outer shaft has a wall thickness of 100 μm to 500 μm.

[0250] 110. The catheter of any one of examples 25 to 109, wherein the catheter is a coronary catheter or a peripheral catheter.

[0251] 111. The catheter of example 110, wherein the catheter has a length between 20 cm and 200 cm.

[0252] 112. A catheter system comprising the catheter of any one of Examples 61 to 110 and a flushing unit for flushing with a fluid through the inner shaft, wherein the flushing unit is fluidly connected to the inner shaft.

[0253] 113. A catheter system comprising the catheter of any one of Examples 61 to 112 and a suction unit for sucking fluid, clots, or debris from around the catheter through the inner shaft, wherein the suction unit is fluidly connected to the inner shaft.

[0254] 114. A catheter system comprising the catheter of any one of Examples 61 to 113 and a drug delivery system for delivering at least one drug through the inner shaft, wherein the drug delivery system is fluidly connected to the inner shaft.

[0255] 115. A catheter system comprising the catheter of any one of Examples 61 to 114 and a stent delivery system for guiding a stent through the inner shaft.

[0256] 116. A catheter system comprising the catheter of any one of Examples 61 to 115 and a scoring element delivery system for guiding a scoring element through the inner shaft.

[0257] 117. A catheter system comprising the catheter of any one of Examples 61 to 116 and a microcatheter delivery system for guiding the microcatheter through the inner shaft.

[0258] 118. A catheter system comprising the catheter of any one of Examples 61 to 117 and a balloon catheter delivery system for guiding the balloon catheter through the inner shaft.

[0259] 119. A catheter system comprising the catheter of any one of Examples 61 to 118 and an embolic protection filter delivery system for guiding an embolic protection filter through the inner shaft.

[0260] 120. A method for operating the catheter of any one of Examples 25 to 111 or the catheter system of any one of Examples 112 to 119, wherein an inner volume portion of the membrane is pressurized with a fluid, preferably a biocompatible fluid, more preferably saline.

[0261] 121. A method for removing a stenosis using the catheter of any one of Examples 25 to 111 or the catheter system of any one of Examples 112 to 120, wherein an inner volume portion of the membrane is pressurized such that stretching of the membrane in the longitudinal direction dilates the stenosis in the patient's blood vessel.

[0262] 122. A method for manufacturing a catheter of any one of Examples 25 to 111, comprising the step of creating a wound membrane by blown film extrusion, blow molding of an extruded tube, microextrusion, or attaching an elastomeric tube to an inner shaft and an outer shaft and pulling the elastomeric tube back onto the outer shaft.

[0263] 123. A method for treating a narrow stenosis using a (crossing) catheter with or without an inner and / or outer shaft and equipped with a membrane, in which the catheter is inserted into a blood vessel and the membrane is pressurized with a fluid, so that the membrane is expanded in the longitudinal direction (D) and becomes expanded.

[0264] 124. The method of example 123, wherein the fluid is a biocompatible fluid, preferably saline or a contrast agent.

[0265] 125. The method of example 123 or 124, wherein the winding membrane is made of an organic polymer, preferably a thermoplastic or a thermoplastic elastomer.

[0266] 126. The process of any one of examples 123 to 125, wherein the wound membrane is made of polyamide, poly(dodecano-12-lactam), polyether block amide, or thermoplastic polyurethane.

[0267] 127. The method of any one of examples 123 to 126, wherein the wound membrane is a double-walled wound membrane.

[0268] 128. The method of any one of examples 123 to 127, wherein the outer diameter of the wound membrane in the unfolded state is between 0.5 mm and 2.7 mm, between 0.66 mm and 2.0 mm, or between 0.99 mm and 1.98 mm.

[0269] 129. The method of any one of examples 123 to 128, wherein the wound membrane has a wall thickness of 10 μm to 90 μm, preferably 15 μm to 60 μm, 70 μm to 90 μm.

[0270] 130. An example method, wherein the catheter has an outer shaft, the outer shaft having a wall thickness of 100 μm to 500 μm.

[0271] 131. A method in which an inner volume of a wound membrane is pressurized with a fluid at a pressure of 1000 kPa (10 bar) to 3000 kPa (30 bar).

[0272] 132. A catheter comprising a membrane (1) defining an inner volume portion (3) to be pressurized, the membrane being adapted to be expanded in a longitudinal direction (D) into an expanded state, characterized in that the catheter does not comprise an outer shaft, an inner shaft and a guiding element.

[0273] 133. A catheter comprising a membrane (1) defining an inner volume portion (3) that can be pressurized, the membrane being adapted to expand in a longitudinal direction (D) into an expanded state, the catheter further comprising an inner shaft (8) and / or an outer shaft, the inner shaft (8) and / or the outer shaft being reinforced by metal braid or reinforcing fabric.

[0274] 134. A catheter, preferably for crossing a stenosis or chronic total occlusion, comprising a membrane defining an inner volume portion (3) that can be pressurized, wherein the membrane is adapted to expand in a longitudinal direction (D) into an expanded state, the catheter further comprising an inner shaft (8) and / or an outer shaft, and optional guiding elements, the catheter having a catheter length of 80 cm to 200 cm, the membrane having an outer diameter between 1.5 mm and 5.0 mm, the membrane having a length between 4 cm and 60 cm, preferably between 4 cm and 20 cm.

[0275] 135. A catheter for medical applications (excluding intubation) with or without an inner and / or outer shaft, comprising a membrane (1) defining an inner volume portion (3) that can be pressurized, and optional guiding elements, wherein the membrane is adapted to expand in the longitudinal direction (D) into an expanded state, the catheter having a catheter length of up to 200 cm, the membrane having an outer diameter between 0.5 mm and 1.20 cm, preferably between 0.5 mm and 1.00 cm, more preferably between 1.0 mm and 5.0 mm, the membrane having a length of up to 100 cm, preferably between 4 cm and 60 cm.

[0276] 136. A catheter comprising a membrane (1) defining an inner volume portion (3) that can be pressurized, the membrane being adapted to be expanded in a longitudinal direction (D) into an expanded state, characterized in that the catheter further comprises an inner shaft (8) and an optional outer shaft (10), the inner shaft (8) being attached to the membrane (1), and a medical device, and / or a medical device delivery system, and / or a drug, and / or a drug delivery system, and / or a contrast fluid, and / or an aspiration system can be located / positioned within or guided through the inner shaft (8).

[0277] 137. The catheter of example 136, wherein the catheter does not include a stent, stent structure, guide element, or guidewire.

[0278] 138. The catheter of example 136 or 137, wherein the medical device or medical device delivery system comprises a sensor, an implantable cardioverter defibrillator electrode, an implantable cardioverter defibrillator lead, a neurostimulator device, an intravascular ultrasound (IVUS) system, an intravascular coil, a scoring element, a scoring balloon, an intravascular lithotripsy device, an aspiration device, an aneurysm embolization device, a needle, a camera, a catheter, preferably a microcatheter, an ablation catheter, a guiding catheter, or a balloon catheter.

[0279] 139. The catheter of any one of examples 136 to 138, wherein the catheter comprises an outer shaft.

[0280] 140. A catheter having a wound membrane, the catheter not having an inner shaft.

[0281] 141. The catheter of example 140, wherein the catheter does not have an outer shaft.

[0282] 142. The catheter of example 140 or 141, wherein the membrane (1) defines an inner volume portion (3) that can be pressurized, and the membrane is adapted to expand in the longitudinal direction (D) into an expanded state.

[0283] 143. A catheter having a membrane, the catheter not having an outer shaft.

[0284] 144. The catheter of example 143, wherein the catheter comprises an inner shaft.

[0285] 145. The catheter of example 143 or 144, wherein the membrane (1) defines an inner volume portion (3) that can be pressurized and the membrane is adapted to expand in the longitudinal direction (D) to assume the expanded state.

[0286] 146. The catheter of any one of examples 133 to 142, wherein the membrane is attached to the outer shaft.

[0287] 147. The catheter of any one of Examples 133 to 142, wherein the membrane is attached to at least a distal end region of the outer shaft.

[0288] 148. The catheter of any one of Examples 133 to 142, wherein the membrane is more flexible than the outer shaft.

[0289] 149. The catheter of any one of examples 133 to 142, wherein the membrane has a wall thickness smaller than the outer shaft.

[0290] 150. The catheter of any one of Examples 133 to 142, wherein the outer shaft is preferably reinforced with a metal braid, a metal alloy braid, a polymer braid, or a reinforcing fiber.

[0291] 151. The catheter of any one of Examples 133 to 150, wherein the membrane is attached to the inner shaft, preferably at least at a distal end region of the inner shaft.

[0292] 152. The catheter of any one of examples 133 to 151, wherein the membrane has a smaller wall thickness than the inner shaft.

[0293] 153. The catheter of any one of Examples 133 to 152, wherein the winding membrane is more flexible than the inner shaft.

[0294] 154. The catheter of any one of examples 176 to 195, wherein the inner shaft is preferably reinforced with a metal braid, a metal alloy braid, a polymer braid, or a reinforcing fiber.

[0295] 155. The catheter of any one of Examples 132 to 154, wherein the catheter further comprises a handle.

[0296] 156. The catheter of example 155, wherein the handle includes a stop or locking mechanism configured to prevent longitudinal advancement of the membrane and / or rotation of the membrane.

[0297] 157. The catheter of example 155 or 156, wherein the handle is provided with a marker or ruler.

[0298] 158. The catheter of any one of examples 155 to 157, wherein the catheter comprises a guide element.

[0299] 159. The catheter of any one of Examples 133 to 136 or 138 to 158, wherein the guide elements (5, 6) are arranged within the inner volume portion (3) of the membrane (1).

[0300] 160. The catheter of any one of examples 133 to 136 or 138 to 159, wherein the guiding element is a guidewire, preferably a curved guidewire.

[0301] 161. The catheter of any one of examples 133 to 136 or 138 to 160, wherein the guide elements (5, 6) are disposed within the inner shaft (8).

[0302] 162. The catheter of any one of examples 133 to 136 or 138 to 161, wherein the guiding element has regions of different stiffness and / or roughness.

[0303] 163. The catheter of any one of Examples 133 to 136 or 138 to 162, wherein the guide element has an atraumatic distal tip.

[0304] 164. The catheter of any one of Examples 132 to 163, wherein the outer diameter of the catheter is the same as or smaller than the inner diameter of the blood vessel (14) into which it is inserted.

[0305] 165. The catheter of any one of Examples 132 to 164, wherein the winding membrane (1) has, at least in part, a non-uniform outer surface.

[0306] 166. The catheter of any one of Examples 132 to 165, wherein the membrane has spikes on its outer surface.

[0307] 167. The catheter of any one of Examples 132 to 166, wherein the wound membrane has a circumferential groove, preferably a spirally arranged groove, on its outer surface.

[0308] 168. The catheter of any one of examples 132 to 167, wherein the winding membrane has circumferential peaks, preferably helically arranged peaks, on its outer surface.

[0309] 169. The catheter of any one of Examples 132 to 168, wherein the outer diameter of the membrane along the longitudinal direction of the membrane in the expanded state decreases continuously or stepwise from the proximal end of the membrane to the distal end of the membrane.

[0310] 170. The catheter of any one of Examples 132 to 169, wherein the outer diameter of the membrane along the longitudinal direction of the membrane in the expanded state increases continuously or stepwise from the proximal end of the membrane to the distal end of the membrane.

[0311] 171. The catheter of any one of examples 132 to 170, wherein the membrane comprises a drug or is at least partially covered by a drug coating layer.

[0312] 172. The catheter of any one of examples 132 to 171, wherein the winding membrane is made of an organic polymer, preferably a thermoplastic or a thermoplastic elastomer.

[0313] 173. The catheter of any one of examples 132 to 172, wherein the winding membrane is made of polyamide, poly(dodecano-12-lactam), polyether block amide, or thermoplastic polyurethane.

[0314] 174. The catheter of any one of Examples 132 to 173, wherein the wound membrane is stretchable to a greater extent in the longitudinal direction than in the radial direction when pressurized.

[0315] 175. The catheter of any one of Examples 133 to 174, wherein the inner shaft is located at least partially within the inner volume portion of the volumic membrane.

[0316] 176. The catheter of any one of Examples 132 to 175, wherein the membrane is a double-wall membrane.

[0317] 177. A catheter with or without an inner and / or outer shaft, comprising a membrane (1) and optional guiding elements, for use in drug delivery, crossing of chronic total occlusions, crossing of (narrow) stenoses, in gastrointestinal interventions, in interventional oncology, in intravascular lithotripsy, treatment of calcifications, in PVI procedures using sheaths, in thrombectomy, treatment of acute myocardial infarction, in renal denervation, treatment of venous occlusions, delivery of embolic protection devices, in reentry catheter procedures, delivery of implantable cardioverter defibrillator electrodes, in vascular interventions, preferably coronary or peripheral vascular interventions, or in urology, preferably treatment of urethra strictures, wherein the membrane (1) defines an inner volume portion (3) that can be pressurized and the membrane is adapted to be expanded in the longitudinal direction (D) to be in the expanded state.

[0318] 178. Use of a catheter with or without an inner and / or outer shaft, comprising a membrane (1) and optional guiding elements, for use in drug delivery, in crossing of chronic total occlusions, in crossing of (narrow) stenoses, in gastrointestinal interventions, in interventional oncology, in intravascular lithotripsy, in treatment of calcifications, in PVI procedures using sheaths, in thrombectomy, in treatment of acute myocardial infarction, in renal denervation, in treatment of venous occlusions, in delivery of embolic protection devices, in reentry catheter procedures, in delivery of implantable cardioverter defibrillator electrodes, in vascular interventions, preferably coronary interventions or peripheral vascular interventions, or in urology, preferably treatment of urethral strictures, wherein the membrane (1) defines an inner volume portion (3) that can be pressurized and the membrane is adapted to expand in the longitudinal direction (D) to expand.

[0319] 179. A catheter for use as an access catheter, support catheter, guiding catheter, guide extension catheter, reentry catheter, introducer sheath, or scoring balloon catheter, with or without an inner shaft and / or an outer shaft, comprising a membrane (1) and an optional guiding element, wherein the membrane (1) defines an inner volume portion (3) that can be pressurized, and wherein the membrane is adapted to expand in a longitudinal direction (D) to assume an expanded state.

[0320] 180. Use of a catheter with or without an inner and / or outer shaft, comprising a membrane (1) and an optional guiding element, for use as an access catheter, support catheter, guiding catheter, guide extension catheter, reentry catheter, introducer sheath, or scoring balloon catheter, wherein the membrane (1) defines an inner volume portion (3) that can be pressurized, and the membrane is adapted to expand in a longitudinal direction (D) to assume an expanded state.

[0321] 181. A catheter with or without an inner shaft and / or an outer shaft, comprising a membrane (1) and optional guiding elements, for use as an all-in-one device allowing for approaching, preparing, pre-dilating, dilating, crossing and treating a lesion site, wherein the membrane (1) defines an inner volume portion (3) that can be pressurized, and the membrane is adapted to expand in a longitudinal direction (D) to assume an expanded state.

[0322] 182. Use of a catheter with or without an inner and / or outer shaft, comprising a membrane (1) and optional guiding elements, for use as an all-in-one device allowing for approaching, preparing, pre-dilating, dilating, crossing and treating a lesion, wherein the membrane (1) defines an inner volume portion (3) that can be pressurized and the membrane is adapted to expand in a longitudinal direction (D) to assume an expanded state.

[0323] 183. A kit comprising a catheter according to any one of the above examples and instructions for use.

[0324] 184. A method for operating the catheter of any one of Examples 132 to 176, wherein an inner volume portion of the membrane is pressurized with a fluid.

[0325] 185. A method for treating a stenosis using the catheter of any one of Examples 132 to 176, wherein an inner volume of the membrane is pressurized with a fluid such that the membrane expands in a longitudinal direction (D) to an expanded state and dilates the stenosis in a blood vessel of a patient.

[0326] 186. A method for treating a narrow stenosis or chronic total occlusion using a catheter with or without an inner and / or outer shaft and comprising a membrane, wherein the catheter is inserted into a blood vessel and the membrane is pressurized with a fluid such that the membrane expands in a longitudinal direction (D) to an expanded state and dilates the stenosis in the patient's blood vessel.

[0327] 187. A method for re-entering the true arterial lumen by obtaining passage from the subintimal space along a chronic total occlusion using the catheter of any one of Examples 132 to 176.

[0328] 188. The method of any one of examples 184 to 186, wherein the fluid is a biocompatible fluid, preferably saline (which is an aqueous solution containing 0.9 wt % NaCl) or a contrast fluid.

[0329] 189. The catheter of any one of Examples 132 to 176, wherein the winding membrane (1) is transparent to electromagnetic radiation between 300 nm and 1000 nm, preferably between 380 nm and 780 nm.

[0330] 190. The catheter of any one of examples 132 to 176 or 189, wherein the spool does not have a side branch.

[0331] A stenosis in the context of this application is a narrowing or constriction of a hollow organ or body lumen, such as, for example, a blood vessel, a trachea, a ureter or urethra, or a bile duct. In some cases, such a narrowing is called a stricture, for example, in the case of a urethral stricture. In the case of a blood vessel, a stenosis may be due to arteriosclerosis, where an artery develops a lesion, thereby causing a narrowing of the artery due to the accumulation of atheromatous plaque. Atheromatous plaque usually contains macrophage cells or debris, lipids, calcium, and fibrous connective tissue. A stenosis has a certain length and severity (hardness), as well as a level of stenosis that is a certain percentage smaller than the diameter or volume of the original body lumen or hollow organ. A narrow stenosis is a stenosis that has a narrowing that is more than 50% but less than 100% of the diameter or volume of the original body lumen or hollow organ. In the case of blood vessels, a stenosis can be considered as occurring when it is greater than 50% of the cross-sectional area of ​​the blood vessel wall that is made up of atheromatous plaque.

[0332] A chronic total occlusion (CTO) is a complete obstruction of a coronary artery (a narrowing that is 100% of the diameter or volume of the coronary artery). A CTO that initially has a soft CTO cap may begin to age and over time may have a hard fibrous CTO cap.

[0333] An access catheter or crossing catheter is a catheter used to cross a lesion or stenosis. Access catheters do not have the ability to cross a CTO alone because they are not pushable.

[0334] A crossing total occlusion catheter is a catheter used to cross a CTO, preferably by recanalizing the CTO via the true lumen. A crossing total occlusion catheter has higher pushability than an access catheter. A crossing total occlusion catheter can be classified as an intraluminal device, a subintimal device, or a re-entry device. A re-entry crossing total occlusion catheter enters the true lumen from the subintimal space with or without a guidewire in chronic total occlusion.

[0335] A support catheter is a catheter (introducer) sheath. A support catheter can have a length of 6 cm to 8 cm and a diameter of 6 Fr to 9 Fr (1 Fr is defined as 1 / 3 mm). A support catheter can be a single lumen catheter (usually placed in a central vein). A combination of a volar catheter and a puncture needle is defined as an introducer sheath. A support catheter is a catheter used to support and even exchange a guidewire during a peripheral vascular intervention (PVI) procedure to allow crossing of the lesion site.

[0336] A guiding catheter is a catheter used to achieve access to the coronary ostium and to assist in the delivery of devices during coronary intervention. The selection of a guiding catheter for percutaneous coronary intervention (CVI) is based on the vessel diameter, tortuosity, degree of calcification, size of the ascending aorta, ostium orientation, and complexity of the planned intervention.

[0337] A guide extension catheter is a catheter used to extend the length of a guiding catheter. A guide extension catheter can have a diameter 1 Fr smaller than the diameter of the guiding catheter.

[0338] Intravascular lithotripsy devices are devices that modify calcified lesions through calcium fragmentation within the coronary and peripheral blood vessels.

Claims

1. 1. A catheter, preferably for crossing a stenosis or a chronic total occlusion, comprising a membrane (1) defining an inner volume portion (3) that can be pressurized, said membrane (1) being adapted to expand in a longitudinal direction (D) into an expanded state, said catheter further comprising an inner shaft (8) and / or an outer shaft (10) and optional guiding elements (5, 6), said catheter having a catheter length of 80 cm to 200 cm, said membrane (1) having an outer diameter between 1.5 mm and 5.0 mm, said membrane (1) having a length between 4 cm and 60 cm, preferably between 4 cm and 20 cm.

2. A catheter according to claim 1, wherein said catheter comprises said guide elements (5, 6).

3. 1. A catheter comprising a membrane (1) defining an inner volume portion (3) which can be pressurized, said membrane (1) adapted to be expanded in a longitudinal direction (D) into an expanded state, characterized in that said catheter further comprises an inner shaft (8) and an optional outer shaft (10), said inner shaft (8) being attached to said membrane (1) and a medical device and / or a medical device delivery system and / or a drug and / or a drug delivery system and / or a contrast fluid and / or an aspiration system being arranged within said inner shaft (8).

4. The catheter of claim 3, wherein the catheter does not comprise a stent, a stent structure, a guide element (5, 6), or a guidewire (9).

5. 5. The catheter of claim 3 or 4, wherein the medical device comprises a sensor, an implantable cardioverter defibrillator electrode, an implantable cardioverter defibrillator lead, a neurostimulator device, an intravascular coil, a scoring element, a scoring balloon, an intravascular lithotripsy device, an aspiration device, an aneurysm embolization device, a needle, an intravascular ultrasound (IVUS) system, a camera, a catheter, preferably a microcatheter, an ablation catheter, a guiding catheter, or a balloon catheter.

6. The catheter according to any one of claims 3 to 5, wherein the catheter comprises the outer shaft (10).

7. A catheter having a wound membrane, said catheter not comprising an inner shaft (8).

8. The catheter of claim 7, wherein the catheter does not include an outer shaft (10).

9. 9. The catheter according to claim 7 or 8, wherein the winding membrane (1) defines an inner volume portion (3) that can be pressurized, the winding membrane (1) being adapted to expand in a longitudinal direction (D) into an expanded state.

10. A catheter having a wound membrane, said catheter not comprising an outer shaft (10).

11. The catheter of claim 10, wherein the catheter comprises an inner shaft (8).

12. 12. The catheter according to claim 10 or 11, wherein the winding (1) defines an inner volume (3) that can be pressurized, the winding (1) being adapted to expand in a longitudinal direction (D) into an expanded state.

13. The catheter according to any one of claims 1 to 7, wherein the winding membrane (1) is attached to the outer shaft (10).

14. The catheter according to any one of claims 1 to 7, wherein the winding membrane (1) is attached to at least a distal end region of the outer shaft (10).

15. A catheter according to any one of claims 1 to 7 or 13 to 14, wherein the winding membrane (1) is more flexible than the outer shaft (10).

16. 16. The catheter of any one of claims 1 to 7 or 13 to 15, wherein the membrane (1) has a smaller wall thickness than the outer shaft (10).

17. The catheter of any one of claims 1 to 7 or 13 to 16, wherein the outer shaft (10) is reinforced, preferably by a metal braid, a metal alloy braid, a polymer braid, or a reinforcing fiber.

18. 18. The catheter of any one of claims 1 to 6 or 10 to 17, wherein the winding membrane (1) is attached to the inner shaft (8), preferably at least in the distal end region of the inner shaft (8).

19. 18. The catheter of any one of claims 1 to 6 or 10 to 17, wherein the membrane (1) has a smaller wall thickness than the inner shaft (8).

20. 20. The catheter of any one of claims 1 to 6 or 10 to 19, wherein the winding membrane (1) is more flexible than the inner shaft (8).

21. The catheter of any one of claims 1 to 6 or 10 to 20, wherein the inner shaft (8) is reinforced, preferably by a metal braid, a metal alloy braid, a polymer braid, or a reinforcing fiber.

22. The catheter of claim 1 , further comprising a handle.

23. 23. The catheter of claim 22, wherein the handle comprises a stop or locking mechanism configured to prevent the longitudinal advancement of the membrane (1) and / or rotation of the membrane (1).

24. 24. The catheter of claim 22 or 23, wherein the handle comprises a marker or ruler.

25. A catheter according to any one of claims 1 to 3 or 5 to 24, wherein the catheter comprises the guiding element (5, 6).

26. The catheter according to any one of claims 1 to 3 or 5 to 25, wherein the guide elements (5, 6) are arranged in the inner volume (3) of the winding membrane (1).

27. 27. A catheter according to any one of claims 1 to 3 or 5 to 26, wherein the guiding element (5, 6) is a guidewire (9), preferably a curved guidewire.

28. A catheter according to any one of claims 1 to 3 or 5 to 27, when rephrased as in any one of claims 10 to 24, wherein the guiding elements (5, 6) are arranged within the inner shaft (8).

29. 29. The catheter according to any one of claims 1 to 3 or 5 to 28, wherein the guiding elements (5, 6) have areas of different stiffness and / or roughness.

30. 30. The catheter of any one of claims 1 to 3 or 5 to 29, wherein the guide elements (5, 6) have an atraumatic distal tip.

31. 31. The catheter of any one of claims 1 to 30, wherein the outer diameter of the catheter is the same as or smaller than the inner diameter of the blood vessel (14) into which it is inserted.

32. 32. The catheter according to any one of claims 1 to 31, wherein the winding (1) has, at least in part, a non-uniform outer surface.

33. 33. The catheter according to any one of claims 1 to 32, wherein the membrane (1) has spikes on its outer surface.

34. 34. A catheter according to any one of claims 1 to 33, wherein the winding membrane (1) has a circumferential groove, preferably arranged helically, on its outer surface.

35. 35. A catheter according to any one of claims 1 to 34, wherein the winding membrane (1) has circumferential peaks on its outer surface, preferably helically arranged peaks.

36. 36. The catheter of claim 1, wherein the outer diameter of the membrane (1) along the longitudinal direction of the membrane (1) in the expanded state decreases continuously or stepwise from the proximal end of the membrane (1) to the distal end of the membrane (1).

37. 36. The catheter of claim 1, wherein the outer diameter of the membrane (1) along the longitudinal direction of the membrane (1) in the expanded state increases continuously or stepwise from the proximal end of the membrane (1) to the distal end of the membrane (1).

38. 38. The catheter according to any one of claims 1 to 37, wherein the winding (1) comprises a drug or is at least partially covered by a drug coating layer.

39. A catheter according to any one of the preceding claims, wherein the winding membrane (1) is made of an organic polymer, preferably a thermoplastic or a thermoplastic elastomer.

40. A catheter according to any one of claims 1 to 39, wherein the winding membrane (1) is made of polyamide, poly(dodecano-12-lactam), polyether block amide, or thermoplastic polyurethane.

41. 41. A catheter according to any one of claims 1 to 40, wherein the winding (1) is stretchable to a greater extent in the longitudinal direction than in the radial direction when pressurized.

42. 42. The catheter of claim 1, wherein the inner shaft (8) is at least partially located within the inner volume of the winding (1).

43. 43. The catheter according to any one of claims 1 to 42, wherein the winding (1) is a double-walled winding.

44. 1. A catheter with or without an inner shaft (8) and / or an outer shaft (10), comprising a membrane (1) and optional guiding elements, for use in drug delivery, in crossing of chronic total occlusions, in crossing of stenoses, in gastrointestinal interventions, in interventional oncology, in intravascular lithotripsy, in treatment of calcifications, in PVI procedures using sheaths, in thrombectomy, in treatment of acute myocardial infarction, in treatment of aneurysms, in renal denervation, in treatment of venous occlusions, in delivery of embolic protection devices, in reentry catheter procedures, in delivery of implantable cardioverter defibrillator electrodes, in vascular interventions, preferably coronary or peripheral vascular interventions, or in urology, preferably treatment of urethral strictures, wherein said membrane (1) defines an inner volume portion (3) that can be pressurized and wherein said membrane (1) is adapted to be expanded in a longitudinal direction (D) so as to be in an expanded state.

45. A catheter for use as an access catheter, a support catheter, a guiding catheter, a guide extension catheter, a reentry catheter, an introducer sheath or a scoring balloon catheter, with or without an inner shaft (8) and / or an outer shaft (10), comprising a membrane (1) and optional guide elements (5, 6), said membrane (1) defining an inner volume portion (3) that can be pressurized, said membrane (1) being adapted to expand in a longitudinal direction (D) to assume an expanded state.

46. 1. A catheter with or without an inner shaft (8) and / or an outer shaft (10), comprising a membrane (1) and optional guide elements (5, 6), for use as an all-in-one device allowing to approach a lesion, prepare the lesion, pre-dilate the lesion, dilate the lesion, cross the lesion and treat the lesion, wherein the membrane (1) defines an inner volume portion (3) that can be pressurized and is adapted to expand in a longitudinal direction (D) to assume an expanded state.

47. 47. A kit comprising a catheter according to any one of claims 1 to 46 and instructions for use.

48. 48. A method for operating a catheter according to any one of claims 1 to 47, wherein the inner volume of the membrane (1) is pressurised with a fluid.

49. 50. A method for treating a stenosis using a catheter according to any one of claims 1 to 48, wherein an inner volume of the membrane (1) is pressurized with a fluid, such that the membrane (1) expands in a longitudinal direction (D) to an expanded state and dilates the stenosis in a patient's blood vessel.

50. A method for treating a narrow stenosis or chronic total occlusion using a catheter with or without an inner and / or outer shaft (10) and comprising a membrane, wherein the catheter is inserted into a blood vessel and the membrane (1) is pressurized with a fluid, such that the membrane (1) expands in a longitudinal direction (D) to an expanded state and dilates the stenosis in the patient's blood vessel.

51. 51. The method according to any one of claims 49 to 50, wherein the fluid is a biocompatible fluid, preferably a saline solution or a contrast fluid.

52. 44. A method for re-entering the true arterial lumen by obtaining a passage from the subintimal space along a chronic total occlusion using a catheter according to any one of claims 1 to 43.

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