Catheter comprising a rolling membrane

Abstract

The present invention, inter alia, relates to a catheter, comprising a rolling membrane and a method for crossing a stenosis or a chronic total occlusion using a rolling membrane catheter.

Description

[0001] Catheter comprising a rolling membrane

[0002] The present application relates to rolling membrane catheter comprising a rolling membrane which is connected to an inner shaft and an outer shaft of the catheter. The application is further related to a method for crossing a stenosis or a chronic total occlusion using such a rolling membrane catheter.

[0003] A rolling membrane crossing catheter is used to cross lesions or occlusions in vessels with nearly no sliding friction and with hydraulically induced pushability. However, there is a need for improving existing rolling membrane catheter.

[0004] The catheter of claim 1 comprising a rolling membrane (hereinafter also referred to as a rolling membrane catheter) may contribute to overcome such drawbacks.

[0005] A catheter is described comprising a rolling membrane which is adapted to roll out in a longitudinal direction from a rolled-in state into a rolled-out state, the rolling membrane defines an inner volume that can be pressurized and / or depressurized; an outer shaft at least partially surrounding an inner shaft, wherein the inner shaft is slidably arranged within the outer shaft and wherein a first end of the rolling membrane is attached to a distal portion and / or a distal end of the inner shaft and a second end of the rolling membrane is attached to a distal portion and / or a distal end of the outer shaft; wherein the catheter further comprises at least one pushing element which is connected to a proximal portion and / or a proximal end of the inner shaft and partially surrounds the proximal portion and / or the proximal end of the inner shaft; and wherein the catheter optionally comprises a guidewire which is at least partially arranged within the inner shaft.

[0006] In a preferred embodiment a catheter comprises a rolling membrane which is adapted to roll out in a longitudinal direction from a rolled-in state into a rolled-out state, the rolling membrane defines an inner volume that can be pressurized and / or depressurized; an outer shaft at least partially surrounding an inner shaft, wherein the inner shaft is slidably arranged within the outer shaft and wherein a first end of the rolling membrane is attached to a distal portion and / or a distal end of the inner shaft and a second end of the rolling membrane is attached to a distal portion but not to the distal end of the outer shaft; wherein the catheter further comprises at least one pushing element which is connected to a proximal portion and a proximal end of the inner shaft and surrounds the proximal portion and the proximal end of the inner shaft; and wherein the catheter comprises a guidewire which is at least partially arranged within the inner shaft. The term “distal” throughout the application may be understood as more far away from a physician manipulating the catheter (than proximal). The term “proximal” throughout the application may be understood as being closer to the physician manipulating the catheter.

[0007] Contrary to the rolling membrane catheter described in EP 2 383 012 Bl the catheter according to the present application does not comprise a further dilatable balloon being connected to the inner shaft (which is not the distal portion or distal end of the inner shaft). This enables to obtain a catheter having a simplified and slimmer design. A slimmer design makes it easier to pass through narrow stenosis and crossing total occlusion. It is more flexible without inner balloon that could easily cross tortuous lesion. The simpler design reduces the complexity of handling the catheter, e.g. since there is a single dilatation pump to be connected, you cannot confound the balloons. A single balloon lumen improves flexibility and deliverability.

[0008] The first end of the rolling membrane may be attached to the distal portion of the inner shaft but not to the distal end of the inner shaft. This enables to reduce the risk of a damage of the rolling membrane with a guidewire guided through the inner shaft.

[0009] The second end of the rolling membrane may be attached to an outer side of the distal portion of the outer shaft but not to the distal end of the outer shaft. It is advantageous to mount the rolling membrane a few mm away from the distal end of the outer shaft so that the entire cross-sectional area of the rolling membrane is immediately available when inflating the rolling membrane from the rolled-in state into a rolled-out state. The higher the cross-section of the rolling membrane front (in a rolled-in state) on which the pressure acts is, the higher is the force that induces the roll-out of the rolling membrane into the rolled-out state.

[0010] In a preferred embodiment a catheter comprises a rolling membrane which is adapted to roll out in a longitudinal direction from a rolled-in state into a rolled-out state, the rolling membrane defines an inner volume that can be pressurized; an outer shaft at least partially surrounding an inner shaft, wherein the inner shaft is slidably arranged within the outer shaft and wherein a first end of the rolling membrane is attached to a distal portion and / or a distal end of the inner shaft and a second end of the rolling membrane is attached to a distal portion but not to the distal end of the outer shaft; wherein the catheter further comprises at least one pushing element which is connected to a proximal portion and a proximal end of the inner shaft and surrounds the proximal portion and the proximal end of the inner shaft; and wherein the catheter comprises a guidewire which is at least partially arranged within the inner shaft. The inner shaft may be more flexible than the pushing element. The pushing element may be a metal tube. The more rigid pushing element enables a higher pushability while at the same time the flexible inner shaft enables a flexible maneuvering at the patient’s side e.g. the blood vessel.

[0011] The pushing element may have at its proximal end a pushing handle which enables a better pushing of the pushing element. The pushing element may comprise a length measuring tool, preferably a ruler.

[0012] The pushing element may have at its proximal end a pressure port for pressurizing and depressurizing the rolling membrane. Preferably the pushing handle comprises at its proximal end the pressure port for pressurizing and depressurizing the rolling membrane. The pressure port may comprise a diaphragm.

[0013] A proximal portion and / or a proximal end of the outer shaft may be connected to a multi-port handle. The multi-port handle comprising a first port for injecting a contrast medium and / or for pressurizing and depressurizing the rolling membrane (shortly called pressure port) and a second port for receiving the pushing element (with the inner shaft and optionally the guidewire arranged therein. The pressure port may comprise a diaphragm.

[0014] The catheter may further comprise a sliding seal. The sliding seal may be connected to the pushing element and the multi-port handle. The multi-port (e.g. a Luer) handle may comprises at least one sliding seal being attached to the inner shaft, outer shaft and / or pushing element.

[0015] The pushing element can be slideably arranged at least partially within the outer shaft and the multi-port handle. The inner shaft which is partly fixed within the pushing element can be slideably arranged within the multi-port handle and / or the outer shaft.

[0016] The inner shaft may comprise at least one radiopaque marker which is attached to the distal portion and / or the distal end of the inner shaft and wherein the outer shaft comprises at least one radiopaque marker which is attached to the distal end of the outer shaft. Having radiopaque markers at least at the distal end of the inner shaft and at the distal end of the outer shaft enables a better visibility (under X-rays) of whether the rolling membrane is in the rolled-in or rolled-out state. Preferably, the inner shaft may comprise at least one first radiopaque marker which is attached to the distal portion and at least one second radiopaque marker which is attached to the distal end of the inner shaft and wherein the outer shaft comprises at least one radiopaque marker which is attached to the distal end of the outer shaft. The first radiopaque marker and the second radiopaque marker are spaced apart in the longitudinal direction of the catheter The radiopaque marker may be an annular radiopaque marker. The rolling membrane is connected pressure-tight with the outer shaft and inner shaft (e.g. by means of corresponding welds). The inner volume of the rolling membrane can be pressurized with a fluid. The fluid may be fed through a diaphragm pressure port. As the inner shaft has a smaller diameter it forms an annular space together with the outer shaft. The annular space is in fluid communication with the pressure port to be able to pressurize the rolling membrane with a fluid.

[0017] The fluid may be a contrast agent or a physiological saline solution or a mixture thereof. Using a contrast agent improves the visibility under X-rays and thus a better control of whether the rolling membrane is in the rolled-in or rolled-out state, especially in combination with the radiopaque markers described above. The fluid may be fed through a pressure port comprising a diaphragm.

[0018] The rolling membrane may be adapted to roll in and out in a longitudinal direction at the distal end of the catheter, preferably along a vessel of a patient, for example by at least one centimeter. A catheter with a rolling membrane to be rolled out in a distal direction along a blood vessel of a patient allows a friction reduced movement of a catheter along a blood vessel of a patient.

[0019] Further, the use of a (long) rolling membrane may provide the catheter with increased flexibility over a (long) longitudinal range while at the same time ensuring good deployability. A rolling-out or rolling-in of the rolling membrane may thus be understood as a corresponding folding outwards or folding inwards of at least a (main) portion of the rolling membrane, e.g., in a longitudinal direction along a vessel of the patient. The rolling membrane may be folded inwards into itself. It may be possible that the rolling membrane is adapted to roll out by more than 10 cm, more than 20 cm, up to 30 cm or even up to 40 cm or more in a longitudinal direction.

[0020] The rolling membrane may be configured such that, when in a rolled-out state, it comprises a smaller diameter at a distal portion of the rolling membrane as compared to a proximal portion of the rolling membrane.

[0021] The rolling membrane may be more flexible than the outer shaft. The rolling membrane may have a smaller wall thickness than the inner shaft and / or the outer shaft. The rolling membrane when being pressurized may be extendable in longitudinal direction at a higher extent than in the radial direction.

[0022] The rolling membrane may preferably be made from a flexible material for supporting a flexible folding of the rolling membrane inwards, thus supporting a rolling-in of the rolling membrane. The rolling membrane may be made of an organic polymer, preferably a (thermoplastic) elastomer. The rolling membrane may comprise a polyamide, preferably a polyamide-based elastomer (e.g. Pebax or PA 12); a polyether block amide, polyester (e.g., PET); a polyester-based elastomer (e.g., Hytrel); a polyurethane, preferably a thermoplastic polyurethane; a polyolefin-based elastomer (e.g., EPDM / EPDM-PP) and / or any other suitable material. Preferably, the rolling membrane is made of Polyamide 12 (PA12). Polyamide 12 (CAS- Nr.: 24937-16-4) is a thermoplastic, semi-crystalline and linear polymer. PA 12 is a homopolymer consisting of only one monomer component. Such polymers are based on aliphatic co-amino lauric acid or their lactams, the intramolecular acid amides formed by elimination of water. PA 12 is based on co-amino- lauric acid H2N-[CH2] 11-COOH with a total of 12 carbon atoms in the molecule. Thus, PA12 can be considered as Poly-laurylactam or poly(dodecano-12-lactam).

[0023] For example, the inner shaft and / or the outer shaft are made of a polyether ether keton (PEEK) and the rolling membrane and optionally the distal tip are made of PA 12. For example, the inner shaft and / or the outer shaft and the rolling membrane and optionally the distal tip are made of PA 12.

[0024] The rolling membrane may comprise a drug or is at least partially covered by a drug coating layer.

[0025] A first end of the rolling membrane is attached to a distal portion and / or a distal end of the inner shaft. The first end of the rolling membrane may be attached directly to (the material of) the distal portion and / or the distal end of the inner shaft. Alternatively, the first end of the rolling membrane may be attached indirectly to (the material of) the distal portion and / or the distal end of the inner shaft via a bonding material. For example, if the inner shaft is made of PEEK the rolling membrane may be attached to the distal portion and / or the distal end of the inner shaft via a polyamide (PA 12) as a bonding material (because PEEK is not weldable). The bonding material may at the same time serve as an auxiliary shaft or the distal tip of the inner shaft.

[0026] The guidewire may be adapted to be slidable with respect to an inner side of the rolling membrane. The guidewire may be made of a radiopaque material. The guide wire may extend from a proximal end of the catheter to a distal end of the catheter (and optionally further in the distal direction along the blood vessel of the patient).

[0027] The inner shaft and / or the outer shaft may be reinforced, preferably by a polymer braid or by reinforcing fibers.

[0028] An outer diameter of the catheter may be the same or smaller than an inner diameter of a vessel to be inserted.

[0029] The inner shaft may comprise a (cone shaped) distal tip or may be connected to a (cone shaped) distal tip at its distal end. The (cone shaped) distal tip may be made from a different material than the inner and / or outer shaft. Alternatively, the distal tip and the rolling membrane may be made from the same material. The (cone shaped) distal tip may be an atraumatic tip. The atraumatic tip may comprise an elastomer. The elastomer may, e.g., be a thermoplastic elastomer. In some cases, the elastomer may be a thermosetting polymer. In some exemplary implementations, the elastomer may comprise a polyamide -based elastomer, a polyester-based elastomer, a polyolefin-based elastomer and / or any other suitable type of elastomer or plastic / polymer material. In some exemplary implementations, the atraumatic tip may be made from a combination of one or more of the aforementioned materials. The atraumatic tip may comprise a compressible material, preferably a polymeric foam. By providing the atraumatic tip such that it comprises an elastomer, the atraumatic tip may possess increased failure strain and may be deformed under strain and tension without rupturing. Moreover, a simplified and cost-effective manufacturing procedure, e.g., by means of thermoforming, of the atraumatic tip may be supported as a simplified shaping of the atraumatic tip comprising the elastomer may be facilitated. Moreover, elastomers may provide increased biocompatibility thus avoiding allergic reactions of the patient.

[0030] The (cone shaped and / or atraumatic) distal tip may comprise at least on radiopaque marker. The at least one radiopaque marker at the distal tip of the inner shaft or at the distal end of the inner shaft allows an improved positioning of the guidewire’s distal end either inside the inner shaft or outside the inner shaft.

[0031] The atraumatic tip may advantageously contribute to a simplified movement of the rolling membrane catheter along the blood vessel of the patient by preventing damages / lesions caused to an inner wall of the blood vessel, even when the membrane is in a rolled-in state.

[0032] A cone shaped tip may support a simplified movement of the catheter along the distal direction (along the blood vessel of the patient). A cone shaped tip reduces the risk for complications arising from a rolling -in of the rolling membrane. This increases the safety of the usage of the catheter.

[0033] The atraumatic tip may be provided with a maximum diameter which is smaller than a diameter of the outer shaft. The atraumatic tip may be configured to receive a guidewire at a center region of the atraumatic tip. The rolling membrane may be adapted to move to a position distal to a position of the atraumatic tip when the rolling membrane is rolled out.

[0034] The atraumatic tip may be formed by a portion of the rolling membrane. In some exemplary implementations, at least a distal portion, as seen in a rolled-in state, of the rolling membrane, may be adapted to not being fully folded inwards into itself (e.g., into an inner lumen of the rolling membrane) and may instead be adapted to at partially form the atraumatic tip. By forming the atraumatic tip by a portion of the rolling membrane, a simplified catheter design may be facilitated (e.g., as less components need to be assembled) which may decrease manufacturing costs and recyclability of the catheter. In other examples, the rolling membrane may be adapted such that, in the fully retracted state, the distal portion of the rolling membrane is still rolled out. For example, the distal portion of the membrane may comprise an increased stiffness as compared to the remaining portion, e.g. as provided by thermoforming such as to form an atraumatic tip with a suitable resilience. Additionally or alternatively, a pressure in a predetermined range may be applied to the distal portion of the membrane such as to provide suitable resilience.

[0035] In some examples, the atraumatic tip may comprise a compressible material, preferably a plastic foam. Additionally or alternatively, the atraumatic tip may be adapted to be retractable via the inner lumen of the rolling membrane. For example, the atraumatic tip may be provided with an atraumatic tip shaft extending from the atraumatic tip to a proximal end of the catheter. The atraumatic tip shaft may be provided with a narrow inner lumen which may, e.g., encompass the guidewire. The atraumatic tip may then for example be retracted prior to rolling out the rolling membrane. Therefore, an obstacle free rolling -out of the rolling membrane may be ensured.

[0036] The rolling membrane may be adapted to move to a position distal to a position of the atraumatic tip when the rolling membrane is rolled out. Alternatively, the rolling membrane may be adapted not to move to a position distal to a position of the atraumatic tip when the rolling membrane is rolled out.

[0037] The multi-port handle may comprise a stopper and / or locking mechanism which is configured to avoid advancement of the rolling membrane in the longitudinal direction (further than a maximal permissible distal position) and / or rotation of the rolling membrane.

[0038] The use of the catheter as described above for crossing a stenosis or a chronic total occlusion is described. However, the rolling membrane may be used in any (neuro) vascular intervention, in neurology, in oncology, in ear, nose, and throat medicine, in endoscopy, in urology, gastroenterology, gynecology, pulmonology or in the nasolacrimal duct.

[0039] Als described herein are several methods for crossing a stenosis or a chronic total occlusion.

[0040] In general the catheter is moved to a desired position in the patient first, and at this desired position the rolling membrane may be rolled-out.

[0041] A method for crossing a stenosis or a chronic total occlusion, preferably using a catheter as described above, comprising the following steps in a consecutive order: a) advancing the catheter towards the stenosis or the chronic total occlusion, b) optionally penetrating or crossing through the stenosis or a chronic total occlusion with the guidewire, c) increasing the pressure in the inner volume of the rolling membrane, d) roll the rolling membrane out into a rolled out state, thereby penetrating or crossing through the stenosis or a chronic total occlusion with the rolling membrane, e) decreasing the pressure in the inner volume of the rolling membrane, such that the guidewire is not gripped by the rolling membrane, f) retracting the catheter in a proximal direction away from the penetrated or crossed stenosis or a chronic total occlusion.

[0042] After step f) the steps c) to f) may be repeated.

[0043] The retracting of the catheter in step f) may comprise the steps of retracting the guidewire into the inner shaft and moving the pushing element in the proximal direction to roll the rolling membrane in into a rolled- in state.

[0044] When penetrating or crossing through the stenosis or a chronic total occlusion the guidewire may be situated inside the inner shaft and has no contact to the rolling membrane

[0045] The following examples 1 to 10 refer to a rolling membrane catheter wherein the rolling membrane is attached to the distal end (and optionally to the distal portion) of the inner shaft:

[0046] Example 1: Crossing without guidewire

[0047] This method is primarily focused on crossing the lesion without the prior crossing of the lesion with a guidewire. It involves rolling out the rolling membrane, advancing the complete catheter, and then roll-in the membrane for subsequent crossings. The process does not involve complex maneuvers with the guidewire. By rolling out the membrane and moving the complete catheter to the target lesion, successful crossing can be achieved. Adjusting the pressure inside the inner volume of the rolling membrane facilitates controlled roll-out and roll-in maneuvers. In this method, the complete catheter is moved towards the lesion to perform the crossing. The proximal handle is moved to butt up against the multi-port handle, allowing the rolling membrane to roll out completely.

[0048] Example 2: Crossing without guidewire, inner shaft / guidewire stays in place during rolling

[0049] This method introduces the concept of crossing lesions without the prior crossing of the lesion with a guidewire by maintaining the guidewire position during the rolling membrane's roll-out and roll-in.

[0050] By retracting the catheter and guidewire, rolling in the membrane, and releasing the pressure inside the membrane, the guidewire can be kept in place while allowing controlled movements of the rolling membrane. This method ensures that the guidewire stays within the inner shaft during the procedure.

[0051] The inner shaft marker position serves as a reference point to maintain the guidewire position during the rolling membrane's roll-out and roll-in. Releasing the pressure inside the rolling membrane with a vacuum pump to deflate the rolling membrane. Similar to Example 1, the complete catheter is moved towards the lesion. However, in this method, after the initial crossing, the catheter is retracted up to approximately one rolling membrane length in front of the new proximal lesion end. Then, the rolling membrane is rolled in by advancing the outer shaft and the multi-port handle and / or pushing handle. Releasing the pressure inside the rolling membrane with a vacuum pump to deflate the rolling membrane.

[0052] However, the method steps could be carried out also with a prior crossing of the lesion with the guidewire.

[0053] Example 3: Crossing without guidewire, rolling membrane front stays in place during rolling

[0054] This method allows for crossing lesions without the prior crossing of the lesion with a guidewire while keeping the front of the rolling membrane in place during rolling. Similar to the methods of example 1 or 2, the complete catheter is moved towards the lesion initially. After crossing the lesion, the rolling membrane is rolled in by advancing the outer shaft and the multi-port handle and / or pushing handle, while the inner shaft is retracted to keep the front of the rolling membrane in place while allowing controlled rollout and roll-in movements. This method provides improved precision and control by preventing the front of the membrane from moving during the procedure. Adjusting the pressure inside the rolling membrane facilitates controlled roll-out and roll-in maneuvers while keeping the front of rolling membrane stable.

[0055] However, the method steps could be carried out also with a prior crossing of the lesion with the guidewire.

[0056] Example 4: Crossing over guidewire that has already been crossed previously through the lesion

[0057] This method addresses scenarios where the guidewire has already been crossed through the lesion before crossing the lesion with the rolling membrane. It involves steps such as decoupling of the guide guidewire, pulling it back to a proximal position, and then re-engaging it for further crossings. This method requires careful management of the guide guidewire position to prevent it from exiting the lesion during roll-out and roll-in maneuvers.

[0058] By decoupling and retracting the guide guidewire, the rolling membrane can be rolled in to the initial position for further crossing. Adjusting the pressure inside the rolling membrane facilitates guidewire decoupling and controlled roll-out and roll-in maneuvers. This method allows for multiple roll-outs of the rolling membrane while maintaining the guidewire's position within the lesion. In this method, the complete catheter is moved towards the lesion initially. After the initial crossing, if the lesion is short, the rolling membrane is rolled in by pulling back the pushing element. If the lesion is long, additional steps are involved, such as advancing the complete catheter over the guidewire, increasing the pressure (to p_high), and advancing the pushing element again to roll out the rolling membrane. The differences in crossing long and short lesions can be summarized as follows:

[0059] Method of Crossing a Short Lesions:

[0060] 1. Catheter Movement: For short lesions, the catheter is typically moved to the target lesion in one step.

[0061] 2. Roll-Out and Crossing: The rolling membrane is rolled out to the necessary extent, and the lesion is crossed by advancing the pushing handle until it butts up against the multi-port handle (Luer).

[0062] 3. Roll-in: After crossing the lesion, the rolling membrane is rolled in by pulling back the pushing element to its initial state for preparation to cross the next lesion, if required.

[0063] 4. Potential Deflation: If the procedure is complete or there are no more lesions to cross, the rolling membrane can be deflated (pressure reduced to zero) before removing the catheter from the patient.

[0064] Method of Crossing a Long Lesions:

[0065] 1. Catheter Movement: For long lesions, the catheter is typically moved to the target lesion in one step.

[0066] 2. Partial Crossing: After the initial roll-out and the partial crossing (penetration) of the lesion, the catheter is advanced further into the lesion, allowing for partial crossing.

[0067] 3. Roll-in and Further Crossing: The rolling membrane is rolled-in into its initial state to prepare for further crossing. The pushing element is pulled back, and the pressure is decreased to allow controlled roll-in. Subsequently, the rolling membrane is rolled out again, and the crossing process continues.

[0068] 4. Iterative Process: The roll-out, partial crossing, roll-in, and further crossing steps may be repeated until the entire long lesion is successfully crossed.

[0069] 5. Deflation and Completion: Once the entire long lesion is crossed, the rolling membrane can be deflated (pressure reduced to zero), and the catheter can be removed from the patient.

[0070] In summary, the main differences in crossing long and short lesions involve the need for iterative processes, partial crossings, and additional roll-out and roll-in steps to navigate the length of the long lesions effectively.

[0071] Crossing without guidewire

[0072] Moving the complete catheter to the target lesion.

[0073] Pulling back the guidewire to ensure it stays behind the rolling membrane front.

[0074] Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare a for roll-out).

[0075] Advancing the pushing element to allow the rolling membrane to roll out.

[0076] Crossing the lesion by moving the proximal handle until it butts up against the multi-port handle (Luer) Decreasing the pressure (to p_low) to prepare for roll-in.

[0077] Rolling-in the rolling membrane by pulling back the pushing element.

[0078] Ready to repeat the steps to cross another lesion if necessary.

[0079] For short lesions, the process ends with deflating the rolling membrane and pulling back the catheter. For long lesions, the process involves advancing the catheter to the rest of the lesion, then repeating the steps for further crossing.

[0080] Example 5: Crossing without guidewire, inner shaft / guidewire stavs in place during rolling

[0081] This method involves retracting the catheter and guidewire after the initial crossing, then rolling in the rolling membrane before continuing with the next steps. The methods steps are as follows:

[0082] Moving the complete catheter to the target lesion.

[0083] Pulling back the guidewire to the inner shaft marker position.

[0084] Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high).

[0085] Advancing the pushing element to allow the rolling membrane to roll out.

[0086] Crossing the lesion by moving the proximal handle until it butts up against the multi-port handle (Luer)

[0087] Decreasing the pressure (to p_low) to prepare for roll-in.

[0088] Retracting the catheter and the guide wire.

[0089] Rolling in the rolling membrane by advancing the outer shaft and pushing handle / multi-port handle (Luer).

[0090] Releasing the pressure inside the rolling membrane.

[0091] Pulling back the guide wire.

[0092] Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high).

[0093] Advancing the pushing element to allow the rolling membrane to roll out.

[0094] Crossing the lesion by moving the proximal handle until it butts up against the multi-port handle (Luer).

[0095] Example 6: Crossing without guidewire, rolling membrane front stavs in place during rolling

[0096] This method involves rolling in the rolling membrane while keeping the front in place, achieved by retracting the inner shaft while advancing the outer shaft / multi-port handle (Luer). The methods steps are as follows:

[0097] Moving the complete catheter to the target lesion.

[0098] Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high). Advancing the pushing element to allow the rolling membrane to roll out.

[0099] Crossing the lesion by moving the proximal handle until it butts up against the multi-port handle (Luer). Decreasing the pressure (to p_low) to prepare for roll-in.

[0100] Rolling in the rolling membrane by advancing the outer shaft and pushing handle / multi-port handle (Luer) while retracting the inner shaft.

[0101] Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high). Advancing the pushing element to allow the rolling membrane to roll out.

[0102] Crossing the lesion by moving the proximal handle until it butts up against the multi-port handle (Luer). that has alreadv been crossed the lesion

[0103] Moving the complete catheter to the target lesion. Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high). Advancing the pushing element to allow the rolling membrane to roll out.

[0104] Decreasing the pressure (to p=0) to allow guide guidewire decoupling.

[0105] Pulling back the guide guide wire.

[0106] Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high). Advancing the pushing element to allow the rolling membrane to roll out.

[0107] Decreasing the pressure (to p_low) to prepare for roll-in.

[0108] Rolling back the rolling membrane by pulling back the pushing element.

[0109] For short lesions, the process ends with repeating the steps for another lesion.

[0110] For long lesions, the process involves additional steps, such as advancing the catheter over the guidewire, increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high), and advancing the pushing element again before determining whether to deflate the rolling membrane and pull back the catheter.

[0111] Example 8: Differences in the handling of the catheter between the methods for rolling membrane with and without a tip

[0112] There are some differences in the handling of the catheter between the methods with and without a tip: Entry into the lesion: With a catheter without a tip, the initial entry into the lesion is done with the rolling membrane in a rolled-in state, and the pushing element is gradually advanced to allow the membrane to roll out. In contrast, with a catheter that has a tip, the membrane is already in a rolled-out state, and the pushing element is completely slid in at the beginning.

[0113] Rolling membrane position: In the methods without a tip, the rolling membrane starts in a rolled-in position and is gradually rolled out by advancing the pushing element. In contrast, in the methods with a tip, the rolling membrane is already in a rolled-out position at the beginning.

[0114] Pressure adjustments: The pressure inside the rolling membrane is adjusted during the procedure to facilitate roll-out and roll-in. In methods without a tip, the pressure is typically set to "p high" for roll-out and "p low" for roll-in. In methods with a tip, the pressure adjustments may follow a similar pattern, but the initial pressure setting may already be adjusted to accommodate the presence of the tip.

[0115] Guidewire management: When using a rolling membrane catheter without a tip, special attention is given to the guidewire position to ensure that it stays behind the rolling membrane front during crossing. The guidewire is either pulled back to a distal marker position or further, or it is held in place using the "inner shaft" technique. With a rolling membrane catheter that has a tip, the guidewire management may differ, as the tip itself can help guide the guidewire and prevent it from advancing beyond the desired position. Roll-in techniques: In the methods with a tip, there are specific roll-in techniques described, such as advancing the outer shaft and pushing handle / multi-port handle (Luer) while retracting the inner shaft to keep the front of the rolling membrane in place. These techniques may not be required or described in the methods without a tip.

[0116] Guidewire decoupling: When crossing over a guidewire that has already been passed through the lesion, decoupling the guidewire from the catheter is necessary to ensure its free movement. This step may involve decreasing the pressure in the rolling membrane to allow for guidewire decoupling and compensating for guidewire movement. The specific details of guidewire decoupling may vary depending on whether the catheter has a tip or not.

[0117] Example 8A: Rolling Membrane Catheter without a Tip:

[0118] When crossing without a guidewire, there are two methods described: (a) crossing short lesions with multiple roll-outs, and (b) crossing long lesions with multiple roll-outs.

[0119] In both cases, the rolling membrane is initially in a rolled-in state with zero pressure (p=0) inside the inner volume of the rolling membrane. The catheter is moved to the target lesion, and the pushing element is advanced to allow the rolling membrane to roll out. The lesion is crossed by moving the proximal handle until it butts up against the multi-port handle (Luer), with the rolling membrane fully rolled out and the pushing element completely slid in. After crossing, the rolling membrane is rolled in and the pushing element is pulled back to the initial state for the next lesion, or the rolling membrane is deflated, and the catheter is removed if no further lesions are present.

[0120] Example 8B: Rolling Membrane Catheter with a Tip:

[0121] When crossing without a guidewire, there is also a distinction between crossing short and long lesions with multiple roll-outs. The key difference is that the rolling membrane is initially in a rolled-out state, and the pushing element is completely slid-in. The methods for crossing short and long lesions involve similar steps as the method without a tip, but with the rolling membrane already in the rolled-out state. The same step- wise procedure is followed for crossing over a guidewire that has already been crossed previously through the lesion. In all cases, the rolling membrane is rolled in, and the pushing element is pulled back to the initial state to prepare for the next lesion or to remove the catheter if necessary. These methods provide different approaches for using rolling membrane catheters with and without a tip, depending on the presence or absence of a guidewire and the length of the lesion being crossed. Example 9: Rolling membrane catheter without a tip i) Crossing without guidewire: a) crossing short lesions with multiple roll outs:

[0122] 1. Moving the complete catheter to the target lesion while the rolling membrane in rolled- in state is (pressure inside the inner volume of rolling membrane is zero (p=0))

[0123] 2. Pullback guidewire to distal marker position or further to make sure that GW tip always stays behind rolling membrane front during crossing

[0124] 3. Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high). In order to prepare a roll-out.

[0125] 4. Start to advance the pushing element to allow the rolling membrane to roll out. The exact amount of rollout depends on the lesion length

[0126] 5. Start crossing the lesion by moving the proximal handle till it butts up against the multi-port handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slide-in)

[0127] 6. Decrease the pressure (to p_low) to prepare roll-in

[0128] 7. Roll-in the rolling membrane by pulling back the pushing element to have the initial state again to be prepared for the next lesion

[0129] 8. Ready to repeat the step 1 to 7 to cross another (short) lesion if necessary

[0130] 9. If not the rolling membrane could be deflated (p=0) and the catheter could be pulled back out of the patient. b) Crossing long lesion with a multiple roll-out

[0131] 1) Moving the complete catheter to the target lesion while the rolling membrane in rolled- in state is (pressure inside the inner volume of the rolling membrane is zero (p=0))

[0132] 2) Pullback guidewire to distal marker position or further to make sure that GW tip always stays behind rolling membrane front during crossing

[0133] 3) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out)

[0134] 4) Start to advance the pushing element to allow the rolling membrane to roll out. The exact amount of rollout depends on the lesion length

[0135] 5) Start crossing the lesion by moving the proximal handle (pushing element) till it butts up against the multi-port handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slide-in)

[0136] 6) Decrease the pressure (to p_low) to prepare roll-in

[0137] 7) Roll-in the rolling membrane by pulling back the pushing element to be ready to continue crossing of the lesion.

[0138] 8) Advance the complete catheter to rest of lesion. 9) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out)

[0139] 10) Start to advance the pushing element to allow the rolling membrane to roll out. The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slided-in)

[0140] 11) If crossed the lesion then deflated the rolling membrane (p=0) and the catheter could be pulled back out of the patient otherwise continue

[0141] 12) Decrease the pressure (to p_low) to prepare roll-in

[0142] 13) Roll-in the rolling membrane by pulling back the pushing element to have the initial state again to be prepared for the next lesion

[0143] 14) Ready to repeat the step 1 to 10 cross another (long) lesion if necessary c) Crossing without guidewire, inner shaft / guidewire stays in place during rolling

[0144] 1) Moving the complete catheter to the target lesion while the rolling membrane in rolled- in state is (pressure inside the inner volume of the rolling membrane is zero (p=0))

[0145] 2) Pullback guidewire to Inner Shaft Marker position or further

[0146] 3) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out)

[0147] 4) Start to advance the pushing element to allow the rolling membrane to roll out

[0148] 5) crossing the lesion by moving the proximal handle (pushing element) till it butts up against the multiport handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slided-in)

[0149] 6) Decrease the pressure (to p_low) to prepare roll-in

[0150] 7) Retract the catheter up to approx, one rolling membrane length in front of the new prox. lesion end.

[0151] 8) Roll-in the rolling membrane by advancing the outer shaft and pushing handle / multi-port handle (Luer) into the target lesion and holding the inner shaft with guide wire in place at the same time.

[0152] 9) Release the pressure inside the rolling membrane to p=0, ideally with vacuum

[0153] 10) Pullback guidewire to Inner Shaft Marker position or further

[0154] 11) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out)

[0155] 12) Start to advance the pushing element to allow the rolling membrane to roll out

[0156] 13) crossing the lesion by moving the proximal handle (pushing element) till it butts up against the multiport handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slided-in) d) Crossing without guidewire, rolling membrane front stays in place during rolling

[0157] 1) Moving the complete catheter to the target lesion while the rolling membrane in rolled- in state is (pressure inside the inner volume of the rolling membrane is zero (p=0)) 2) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out)

[0158] 3) Start to advance the pushing element to allow the rolling membrane to roll out

[0159] 4) crossing the lesion by moving the proximal handle (pushing element) till it butts up against the multiport handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slided-in)

[0160] 5) Decrease the pressure (to p_low) to prepare roll-in

[0161] 6) Roll-in the rolling membrane by advancing the outer shaft and pushing handle / multi-port handle (Luer) into the target lesion and retracting the inner shaft at the same time so that the front of the rolling membrane stays in place (check in Angiogram)

[0162] 7) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out)

[0163] 8) crossing the lesion by moving the proximal handle (pushing element) till it butts up against the multiport handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slide-in)

[0164] Example 10: Crossing over guidewire that has already been crossed previously through the lesion’ а) crossing short lesions with a multiple roll-out

[0165] 1) Moving the complete catheter to the target lesion while the rolling membrane in rolled- in state is (pressure inside the inner volume of the rolling membrane is zero (p=0))

[0166] 2) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out

[0167] 3) Advance the pushing element to allow the rolling membrane to roll out

[0168] 4) Decrease the pressure to p=0 to allow for guide guidewire decoupling.

[0169] 5) Pullback the guide guidewire to the most proximal position but it still stays in the lesion (to have some headroom for rolling out). б) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a further roll-out)

[0170] 7) Advance the pushing element to allow the rolling membrane to roll out

[0171] 8) Decrease the pressure (to p_low) to prepare roll-in

[0172] 9) Roll-in the rolling membrane by pulling back the pushing element to have the initial state again to be prepared for the next lesion if necessary

[0173] 10) Decrease the pressure in rolling membrane to p=0.

[0174] 11) Push the guidewire through the lesion again to have the initial state (guidewire is in lesion).

[0175] 12) Ready to repeat the step 1 to 10 to cross another (short) lesion b) Crossing long lesion with a multiple roll-out

[0176] 1) Moving the complete catheter to the target lesion while the rolling membrane in rolled- in state is (pressure inside the inner volume of the rolling membrane is zero (p=0))

[0177] 2) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out)

[0178] 3) Advance the pushing element to allow the rolling membrane to roll out

[0179] 4) Decrease the pressure to p=0 to decouple the guide guidewire.

[0180] 5) Pullback the guide guidewire to the most proximal position while still stays in the lesion (to have some headroom for rolling out).

[0181] 6) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out)

[0182] 7) Start crossing the lesion by moving the proximal handle (pushing element) till it butts up against the multi-port handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slide-in)

[0183] 8) Decrease the pressure to p=0.

[0184] 9) Advance the guide guidewire to the maximal permissible position to have some headroom for the further Roll-in (avoid guide guidewire exit from the lesion)

[0185] 10) Change the pressure in the rolling membrane (to p_low) in order to prepare for a roll-in

[0186] 11) Roll-in rolling membrane by pulling back the pushing element which also pulls the guidewire back (coupled). Complete roll-in not possible due to possible guidewire exit from the lesion.

[0187] 12) Decrease the pressure to p=0 to decouple the guide guidewire.

[0188] 13) Advance the guide guidewire to the maximal permissible position to have some headroom for the further Roll-in (avoid guide guidewire exit from the lesion)

[0189] 14) Change the pressure in the rolling membrane (to p low) in order to prepare for a roll-in

[0190] 15) Complete Roll-in rolling membrane by pulling back the pushing element which also pulls the guidewire back (coupled)

[0191] 16) Decrease the pressure to p=0 to decouple the guide guidewire.

[0192] 17) Advancement of the complete catheter over the guidewire into the lesion.

[0193] 18) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out)

[0194] 19) Start to advance the pushing element to allow the rolling membrane to roll out

[0195] 20) If cross then deflate the rolling membrane p=0 and pull back catheter out of patient otherwise continoue

[0196] 21) Set the pressure (to p_low) in order to prepare for a roll-in

[0197] 22) Roll-in the rolling membrane by pulling back the pushing element to have the initial state again to be prepared for advancing to the next lesion

[0198] 23) Decrease the pressure to p=0

[0199] 24) Ready to repeat the step 1 to 23 to cross another (long) lesion c) Crossing over guidewire, inner shaft / guidewire stays in place during rolling

[0200] 1) Advance the complete catheter up to approx, one rolling membrane length in front of the target lesion

[0201] 2) while the rolling membrane in rolled- in state is (pressure inside the inner volume of the rolling membrane is zero (p=0))

[0202] 3) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out)

[0203] 4) Start to advance the pushing element to allow the rolling membrane to roll out

[0204] 5) crossing the lesion by moving the proximal handle (pushing element) till it butts up against the multiport handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slide-in)

[0205] 6) Decrease the pressure (to p_low) to prepare roll-in

[0206] 7) Retract the complete catheter and the guidewire up to approx, one rolling membrane length in front of the new prox. lesion end.

[0207] 8) Roll-in the rolling membrane by advancing the outer shaft and pushing handle / multi-port handle (Luer) into the target lesion and holding the inner shaft with guide wire in place at the same time.

[0208] 9) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out)

[0209] 10) Start to advance the pushing element to allow the rolling membrane to roll out

[0210] 11) crossing the lesion by moving the proximal handle (pushing element) till it butts up against the multiport handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slide-in) d) Crossing over guidewire, rolling membrane front stays in place during rolling

[0211] 1) Moving the complete catheter to the target lesion while the rolling membrane in rolled- in state is (pressure inside the inner volume of the rolling membrane is zero (p=0))

[0212] 2) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out)

[0213] 3) Start to advance the pushing element to allow the rolling membrane to roll out

[0214] 4) crossing the lesion by moving the proximal handle (pushing element) till it butts up against the multiport handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slide-in)

[0215] 5) Decrease the pressure (to p_low) to prepare roll-in

[0216] 6) Roll-in the rolling membrane by advancing the outer shaft and handle / luer into the target lesion and retracting the inner shaft at the same time so that the front of the rolling membrane stays in place (check in Angiogram) 7) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out)

[0217] 8) Start to advance the pushing element to allow the rolling membrane to roll out

[0218] 9) crossing the lesion by moving the proximal handle (pushing element) till it butts up against the multiport handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slide-in)

[0219] The following examples refer to a rolling membrane catheter wherein the rolling membrane is attached to the distal portion but not to the distal end of the inner shaft:

[0220] Example 11: Crossing without guidewire: a) crossing short lesions with multiple roll outs

[0221] 1) Moving the complete catheter to the target lesion while the rolling membrane in rolled-out state is and pushing element is completely slided in (pressure inside the inner volume of the rolling membrane is zero (P=O))

[0222] 2) Change the pressure in the rolling membrane (to p_low) in order to prepare for a roll-in

[0223] 3) Roll-in the rolling membrane by pulling back the pushing element which also pulls the guidewire back (coupled) Depending on the initial guidewire position (see step 2), more or less of the guidewire tip gets clamped by the rolling membrane during rolling-in

[0224] 4) Advance the complete catheter to target lesion again (clamped guidewire is also pushed forward)

[0225] 5) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out)

[0226] 6) Start to advance the pushing element to allow the rolling membrane to roll out till Proximal handle butts up against the multi-port handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position.

[0227] 7) if crossed then deflate the rolling membrane and move the catheter out of patient otherwise continue

[0228] 8) Decrease the pressure to p=0

[0229] 9) Ready to repeat the step 1 to 7 to cross another (short) lesion b) Crossing long lesion with a multiple roll-out

[0230] 1) Moving the complete catheter to the target lesion while the rolling membrane in rolled-out state is and pushing element is completely slide in (pressure inside the inner volume of the rolling membrane is zero (P=O))

[0231] 2) Change the pressure in the rolling membrane (to p_low) in order to prepare for a roll-in

[0232] 3) Roll-in rolling membrane which also pulls the guidewire back (coupled). Depending on the initial guidewire position, more or less of the guide wire tip gets clamped by the rolling membrane during rollingin 4) Advance the complete catheter to target lesion again (clamped guidewire is also pushed forward)

[0233] 5) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out

[0234] 6) Start to advance the pushing element to allow the rolling membrane to roll out. Rolling membrane is not completely rolled out to avoid pushing the tip into the occlusion.

[0235] 7) Decrease the pressure (to p_low) in order to prepare for a roll-in

[0236] 8) Roll-in the rolling membrane by pulling back the pushing element to be ready to continue crossing of the lesion.

[0237] 9) Advance the complete catheter to rest of lesion

[0238] 10) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out

[0239] 11) Start to advance the pushing element to allow the rolling membrane to roll out

[0240] 12) Start crossing the lesion by moving the proximal handle (pushing element) till it butts up against the multi-port handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slide-in)

[0241] 13) Decrease the pressure to p=0.

[0242] 14) Ready to repeat the step 1 to 12 cross another (long) lesion c) Crossing without guidewire, inner shaft / guidewire stays in place during rolling

[0243] 1) Advance the complete catheter up to approx, one rolling membrane length in front of the target lesion while the rolling membrane in rolled-out state is and pushing element is completely slided in (pressure inside the inner volume of the rolling membrane is zero (p=0))

[0244] 2) Change the pressure in the rolling membrane (to p_low) in order to prepare for a roll-in

[0245] 3) Roll-in the rolling membrane by advancing the outer shaft and pushing handle / multi-port handle (Luer) to target lesion and holding the inner shaft with guidewire in place at the same time.

[0246] 4) Release the pressure in rolling membrane, p=0, ideally pull a vacuum.

[0247] 5) Pullback guide guidewire to Inner Shaft Marker position or further inside the inner shaft

[0248] 6) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out

[0249] 7) Start to advance the pushing element to allow the rolling membrane to roll out

[0250] 8) crossing the lesion by moving the proximal handle (pushing element) till it butts up against the multiport handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slide-in)

[0251] 9) Decrease the pressure (to p_low) in order to prepare for a roll-in

[0252] 10) Retract the catheter up to approx, one rolling membrane length in front of the new prox. lesion end.

[0253] 11) Roll-in the rolling membrane by advancing the outer shaft and pushing handle / multi-port handle (Luer) into the target lesion and holding the inner shaft with guide wire in place at the same time. 12) Release the pressure in rolling membrane, p=0, ideally pull a vacuum

[0254] 13) Pullback guide guidewire to Inner Shaft Marker position or further inside the inner shaft

[0255] 14) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out

[0256] 15) Start to advance the pushing element to allow the rolling membrane to roll out

[0257] 16) crossing the lesion by moving the proximal handle (pushing element) till it butts up against the multiport handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slide-in) d) Crossing without guidewire, rolling membrane front stays in place during rolling

[0258] 1) Advance the complete catheter up to approx, one rolling membrane length in front of the target lesion while the rolling membrane in rolled-out state is and pushing element is completely slide in (pressure inside the inner volume of the rolling membrane is zero (p=0))

[0259] 2) Change the pressure in the rolling membrane (to p_low) in order to prepare for a roll-in

[0260] 3) Roll-in the rolling membrane by advancing the outer shaft and pushing handle / multi-port handle (Luer) to the target lesion and retracting the inner shaft with at the same time so that the front of the rolling membrane stays in place (check in Angiogram)

[0261] 4) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out

[0262] 5) Start to advance the pushing element to allow the rolling membrane to roll out

[0263] 6) crossing the lesion by moving the proximal handle (pushing element) till it butts up against the multiport handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slide-in)

[0264] 7) Decrease the pressure (to p_low) in order to prepare for a roll-in

[0265] 8) Roll-in the rolling membrane by advancing the outer shaft and pushing handle / multi-port handle (Luer) into the target lesion and retracting the inner shaft at the same time so that the front of the rolling membrane stays in place (check in Angiogram)

[0266] 9) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out

[0267] 10) Start to advance the pushing element to allow the rolling membrane to roll out

[0268] 11) crossing the lesion by moving the proximal handle (pushing element) till it butts up against the multiport handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slide-in) Examole 12 crossing over guidewire that has already been crossed previously through the lesion а) crossing short lesions with a multiple roll-out

[0269] 1) Moving the complete catheter to the target lesion while the rolling membrane in rolled-out state is and pushing element is completely slide in (pressure inside the inner volume of the rolling membrane is zero (p=0)), guidewire has already crossed the lesion by physician.

[0270] 2) Advance the guide guidewire to the maximal permissible position to have some headroom for the Rollin (avoid guide guidewire exit from the lesion)

[0271] 3) Change the pressure in the rolling membrane (to p_low) in order to prepare for a roll-in

[0272] 4) Roll-in the rolling membrane by pulling back the pushing element which also pulls the guidewire back (coupled). Complete roll-in not possible due to possible guidewire exit from the lesion.

[0273] 5) Decrease the pressure to p=0 to decouple the guide guidewire. б) Advance the guide guidewire to the maximal permissible position to have some headroom for the further Roll-in (avoid guide guidewire exit from the lesion)

[0274] 7) Change the pressure in the rolling membrane (to p_low) in order to prepare for a roll-in

[0275] 8) Complete Roll-in of the rolling membrane by pulling back the pushing element which also pulls the guidewire back (coupled).

[0276] 9) Decrease the pressure to p=0 to prepare the advancement of the complete catheter to the target lesion

[0277] 10) Advancement of the complete catheter over the guidewire to the target lesion.

[0278] 11) Pullback the guidewire to the most proximal position while the guide guidewire still stays in the lesion (to have some headroom for rolling out).

[0279] 12) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out

[0280] 13) Advance the pushing element to allow the rolling membrane to roll out

[0281] 14) Decrease the pressure (to p=0) to allow for guidewire decoupling and compensation.

[0282] 15) Pullback the guidewire to the most proximal position while the guide guidewire still stays in the lesion (to have some headroom for rolling out).

[0283] 16) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a further roll-out

[0284] 17) cross the lesion by moving the proximal handle (pushing element) till it butts up against the multi-port handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slide-in)

[0285] 18) Decrease the pressure to p=0

[0286] 19) Ready to repeat the step 1 to 18 cross another (short) lesion b) Crossing long lesion with a multiple roll-out

[0287] 1) Moving the complete catheter to the target lesion while the rolling membrane in rolled-out state is and pushing element is completely slide in (pressure inside the inner volume of the rolling membrane is zero (p=0)), guidewire has already crossed the lesion by physician.

[0288] 2) Advance the guide guidewire to the maximal permissible position to have some headroom for the Rollin (avoid guide guidewire exit from the lesion)

[0289] 3) Change the pressure in the rolling membrane (to p_low) in order to prepare for a roll-in

[0290] 4) Roll-in the rolling membrane by pulling back the pushing element which also pulls the guidewire back (coupled). Complete roll-in not possible due to possible guidewire exit from the lesion

[0291] 5) Decrease the pressure to p=0 to decouple the guide guidewire.

[0292] 6) Advance the guide guidewire to the maximal permissible position to have some headroom for the further Roll-in (avoid guide guidewire exit from the lesion)

[0293] 7) Change the pressure in the rolling membrane (to p low) in order to prepare for a further roll-in

[0294] 8) Complete Roll-in of the rolling membrane by pulling back the pushing element which also pulls the guidewire back (coupled).

[0295] 9) Decrease the pressure to p=0 to decouple the guide guidewire

[0296] 10) Advancement of the complete catheter over the guidewire to the target lesion.

[0297] 11) Pullback the guidewire to the most proximal position while the guide guidewire still stays in the lesion (to have some headroom for rolling out).

[0298] 12) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out

[0299] 13) Advance the pushing element to allow the rolling membrane to roll out

[0300] 14) Decrease the pressure to p=0 to decouple the guide guidewire.

[0301] 15) Pullback the guidewire to the most proximal position while the guide guidewire still stays in the lesion (to have some headroom for rolling out).

[0302] 16) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out

[0303] 17) cross the lesion by moving the proximal handle (pushing element) till it butts up against the multi-port handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slide-in)

[0304] 18) Advance the guide guidewire to the maximal permissible position to have some headroom for the further Roll-in (avoid guide guidewire exit from the lesion)

[0305] 19) Change the pressure in the rolling membrane (to p low) in order to prepare for a roll-in

[0306] 20) Roll-in the rolling membrane by pulling back the pushing element which also pulls the guidewire back (coupled). Complete roll-in not possible due to possible guidewire exit from the lesion.

[0307] 21) Decrease the pressure to p=0 to decouple the guide guidewire. 22) Advance the guide guidewire to the maximal permissible position to have some headroom for the further Roll-in (avoid guide guidewire exit from the lesion)

[0308] 23) Change the pressure in the rolling membrane (to p_low) in order to prepare for a roll-in

[0309] 24) Complete Roll-in of the rolling membrane by pulling back the pushing element which also pulls the guidewire back (coupled).

[0310] 25) Decrease the pressure to p=0 to decouple the guide guidewire.

[0311] 26) Advancement of the complete catheter over the guidewire into the lesion.

[0312] 27) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out

[0313] 28) Start to advance the pushing element to allow the rolling membrane to roll out

[0314] 29) Advance the pushing element to allow the rolling membrane to roll out

[0315] 30) Decrease the pressure to p=0 to decouple the guide guidewire.

[0316] 31) Pullback the guidewire to the most proximal position while the guide guidewire still stays in the lesion (to have some headroom for rolling out).

[0317] 32) Set the pressure (to p_low or p_high in order to preparation for roll-out (p_low is sufficient in this case as the lesion is already crossed)

[0318] 33) Roll-out the rolling membrane completely by advancing the pushing element to have the initial state again to be prepared for advancing to the next lesion if necessary

[0319] 34) repeat the step 1 to 33 cross another (long) lesion c) Crossing over guidewire, inner shaft / guidewire stays in place during rolling

[0320] 1) Advance the complete catheter up to approx, one rolling membrane length in front of the target lesion while the rolling membrane in rolled-out state is and pushing element is completely slided in (pressure inside the inner volume of the rolling membrane is zero (p=0))

[0321] 2) change the pressure in the rolling membrane (to p_low) in order to prepare for a roll-in

[0322] 3) Roll-in the rolling membrane by advancing the outer shaft and pushing handle / multi-port handle (Luer) to target lesion and holding the inner shaft with guidewire in place at the same time.

[0323] 4) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out

[0324] 5) Start to advance the pushing element to allow the rolling membrane to roll out

[0325] 6) crossing the lesion by moving the proximal handle (pushing element) till it butts up against the multiport handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slide-in)

[0326] 7) Decrease the pressure (to p_low) in order to prepare for a roll-in

[0327] 8) Retract the complete catheter and the guidewire up to approx, one rolling membrane length in front of the new prox. lesion end. 9) Roll-in the rolling membrane by advancing the outer shaft and pushing handle / multi-port handle (Luer) into the target lesion and holding the inner shaft with guide wire in place at the same time.

[0328] 10) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out

[0329] 11) Start to advance the pushing element to allow the rolling membrane to roll out

[0330] 12) crossing the lesion by moving the proximal handle (pushing element) till it butts up against the multiport handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slide-in) d) Crossing over guidewire, rolling membrane front stays in place during rolling

[0331] 1) Moving the complete catheter to the target lesion while the rolling membrane in rolled-out state is and pushing element is completely slided in (pressure inside the inner volume of the rolling membrane is zero (p=0)), Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p high) in order to prepare for a roll-out

[0332] 2) Advance the guide guidewire to approx, one rolling membrane length distal of the target lesion

[0333] 3) Change the pressure in the rolling membrane (to p_low) in order to prepare for a roll-in

[0334] 4) Roll-in the rolling membrane by advancing the complete catheter to the target lesion and retracting the inner shaft at the same time so that the front of the rolling membrane stays in place (check in Angiogram)

[0335] 5) Increasing the pressure within the inner volume of the rolling membrane (Setting the pressure to p_high) in order to prepare for a roll-out

[0336] 6) Start to advance the pushing element to allow the rolling membrane to roll out

[0337] 7) crossing the lesion by moving the proximal handle (pushing element) till it butts up against the multiport handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slide-in)

[0338] 8) Decrease the pressure (to p_low) in order to prepare for a roll-in

[0339] 9) Roll-in the rolling membrane by advancing the outer shaft and pushing handle / multi-port handle (Luer) into the target lesion and retracting the inner shaft at the same time so that the front of the rolling membrane stays in place (check in Angiogram)

[0340] 10) Roll-in the rolling membrane by advancing the outer shaft and pushing handle / multi-port handle (Luer) into the target lesion and retracting the inner shaft at the same time so that the front of the rolling membrane stays in place (check in Angiogram)

[0341] 11) Start to advance the pushing element to allow the rolling membrane to roll out

[0342] 12) crossing the lesion by moving the proximal handle (pushing element) till it butts up against the multiport handle (Luer). The rolling membrane is therefore rolled out to the maximum in this position and pushing element completely slide-in) Example 13: Crossing and dilating of lesion without elongation of rolling membrane along its longitudinal axis while crossing and dilating the lesion

[0343] As the pressure within the rolling membrane is increased, the rolling membrane elongates or stretches along its longitudinal axis. Accordingly, a vessel wall may be stretched in its longitudinal direction if the pressure within the inner lumen of the rolling membrane is increased while the rolling membrane is in contact with the vessel wall or the lesion. This is the case, for example, during dilatation of the lesion after crossing by increasing the pressure within the inner lumen of the rolling membrane. A longitudinal stretch of the vessel may lead to a dissection of the vessel.

[0344] Apart from training, a special catheter handle design may be used to prevent the operator from increasing the balloon pressure while the balloon is in contact with the vessel wall by using a (check) valve connected to the pusher rod that shuts the dilatation pump of once the rolling membrane starts rolling out. The valve should have an override that allows the physician to increase / reduce the pressure if necessary.

[0345] The following methods yield to a dilatation of the lesion without transferring a longitudinal force on the vessel wall as the balloon pressure is not increased once the balloon is in contact with the vessel wall. a) Pressure within the inner lumen of the rolling membrane is increased to rated burst pressure prior crossing

[0346] A method for crossing a stenosis or a chronic total occlusion, preferably using a catheter as described above, comprising the following steps in a consecutive order: a) advancing the catheter towards the stenosis or the chronic total occlusion, b) optionally penetrating or crossing through the stenosis or a chronic total occlusion with the guidewire, c) increasing the pressure in the inner volume of the rolling membrane to a rated burst pressure, d) roll the rolling membrane out into a rolled out state, thereby penetrating or crossing through the stenosis or a chronic total occlusion with the rolling membrane, e) decreasing the pressure in the inner volume of the rolling membrane to allow rolling back of the rolling membrane and / or such that the guidewire is not gripped by the rolling membrane, f) retracting the catheter in a proximal direction away from the penetrated or crossed stenosis or a chronic total occlusion.

[0347] After step f) the steps c) to f) may be repeated.

[0348] The rated burst pressure is the pressure at which 99.9% of the rolling membranes will not burst at or below this value with at least 95% confidence. The rated burst pressure may be determined according to ISO 25539-2. Accordingly, the method leads to a maximum dilatation of the vessel with respect to the maximal inflated rolling membrane without transferring a longitudinal force on the vessel wall. Thus, a risk of dissection of a vessel wall may be reduced. b) Multiple crossing of the lesion with increasing pre-adjusted pressure

[0349] A method for crossing a stenosis or a chronic total occlusion, preferably using a catheter as described above, comprising the following steps in a consecutive order: a) advancing the catheter towards the stenosis or the chronic total occlusion, b) optionally penetrating or crossing through the stenosis or a chronic total occlusion with the guidewire, c) increasing the pressure in the inner volume of the rolling membrane, d) roll the rolling membrane out into a rolled out state, thereby penetrating or crossing through the stenosis or a chronic total occlusion with the rolling membrane, e) decreasing the pressure in the inner volume of the rolling membrane, to allow rolling back of the rolling membrane and / or such that the guidewire is not gripped by the rolling membrane, f) retracting the catheter in a proximal direction away from the penetrated or crossed stenosis or a chronic total occlusion, g) increasing the pressure in the inner volume of the rolling membrane further, h) roll the rolling membrane out into a rolled out state, thereby penetrating or crossing through the stenosis or a chronic total occlusion with the rolling membrane, i) decreasing the pressure in the inner volume of the rolling membrane, such that the guidewire is not gripped by the rolling membrane, j) retracting the catheter in a proximal direction away from the penetrated or crossed stenosis or a chronic total occlusion.

[0350] After step j) the steps c) to f) may be repeated.

[0351] Accordingly, instead of setting the pressure in the inner volume of the rolling membrane to the rated burst pressure prior to roll out of the rolling membrane, the rolling membrane may be rolled out into the rolled out state, thereby penetrating or crossing through the stenosis or a chronic total occlusion with the rolling membrane, a multiple times. Each time with a pre-adjusted increased pressure in the inner volume of the rolling membrane.

[0352] Additionally, prior to increasing the pressure in the inner volume of the rolling membrane to roll the rolling membrane out into a rolled out state, the method may comprise rolling out the rolling membrane into a proximal onset of the stenosis at a lower pressure. This may enable a better entering of the stenosis by the rolling membrane as the distal tip of the rolling membrane may get anchored at the proximal onset of the stenosis..

[0353] The above-described methods may not be limited to vascular interventions only but may also be used in neurological catheters (neurovascular field), in oncology, in ear, nose, and throat medicine, in endoscopy, in urology, gastroenterology, gynecology, pulmonology or in the nasolacrimal duct.

[0354] The following figures are provided to support the understanding of the present invention:

[0355] Figs. 1A-1B cross-sectional view of a rolling membrane catheter having a cone shaped distal tip;

[0356] Figs. 2A-2B cross-sectional view of another rolling membrane catheter having a straight distal tip;

[0357] Fig. 3 cross-sectional view of a rolling membrane catheter having radiopaque markers;

[0358] Fig. 4 cross-sectional view of another rolling membrane catheter having radiopaque markers;

[0359] Figs. 5A-5I Illustration of the method steps of a method for crossing a stenosis or a chronic total occlusion without prior crossing of the guidewire;

[0360] Figs. 6A-6J Illustration of the method steps of another method for crossing a stenosis or a chronic total occlusion without prior crossing of the guidewire;

[0361] Figs. 7A-7H Illustration of the method steps of a method for crossing a stenosis or a chronic total occlusion with prior crossing of the guidewire;

[0362] Figs. 8A-8H Illustration of the method steps of another method for crossing a stenosis or a chronic total occlusion with prior crossing of the guidewire;

[0363] Fig. 9 cross-sectional view of a rolling membrane catheter comprising a bonding material;

[0364] Fig. 10 cross-sectional view of another rolling membrane catheter comprising a bonding material;

[0365] Figs. 11A-11K Illustration of the method steps of another method for crossing a stenosis or a chronic total occlusion without prior crossing of the guidewire;

[0366] Figs. 12A-12R Illustration of the method steps of another method for crossing a stenosis or a chronic total occlusion without prior crossing of the guidewire;

[0367] Figs. 13A-13R Illustration of the method steps of another method for crossing a stenosis or a chronic total occlusion without prior crossing of the guidewire;

[0368] Figs. 14A-14L Illustration of the method steps of another method for crossing a stenosis or a chronic total occlusion without prior crossing of the guidewire;

[0369] Figs. 15A-15P Illustration of the method steps of another method for crossing a stenosis or a chronic total occlusion without prior crossing of the guidewire. Fig. 1A shows an example of a rolling membrane catheter 1 with a rolling membrane 2 in a rolled-in state, whereas Fig. IB shows the rolling membrane catheter 1 with a rolling membrane 2 in a rolled-out state (which has crossed a chronic total occlusion (CTO) / lesion)

[0370] The catheter 1 comprises an outer shaft 6 and an inner shaft 7. The outer shaft 6 at least partially surrounds the inner shaft 7. Thus, the outer shaft 6 has a larger diameter than an outer diameter of the inner shaft 7. As the inner shaft 7 has a smaller diameter it forms an annular space together with the outer shaft 6. The annular space is in fluid communication with the pressure port 13 to be able to pressurize the rolling membrane 2 with a fluid. The outer shaft 6 can be inserted into a patient’s vessel with its distal end whereas and its proximal end is always located outside the patient. Thus, the outer shaft 6 has an outer diameter which is smaller than the patient’s vessel.

[0371] The catheter 1 further comprises a pushing element 11, e.g. a metal rod, which is firmly connected to a proximal portion and / or proximal end of the inner shaft 7. The pushing element 11, e.g. a metal rod, partially surrounds the proximal portion and / or the proximal end of the inner shaft 7. The inner shaft 7 and the pushing element 11 are slidably arranged within the outer shaft 7. Thus, the pushing element 11 can be moved axially with the inner shaft in relation to the outer shaft 6. The pushing element 11 has at its proximal end a pushing handle 5. The pushing element 11 and / or the pushing handle 5 comprise at its proximal end a through hole for the guidewire 3. The inner shaft 7 is made from a more flexible material than the pushing element 11.

[0372] The rolling membrane 2 forms an inner volume 12 and comprises a first end and a second end. The first end of the rolling membrane 2 is attached to a distal portion and / or a distal end of the inner shaft 7 and the second end of the rolling membrane 2 is attached to an outer side of a distal portion of the outer shaft 6. The rolling membrane is adapted to roll out in a longitudinal direction from a rolled-in state into a rolled- out state when being pressurized and / or when the pushing element is moved in a distal direction. The rolling membrane therefore defines an inner volume that can be pressurized.

[0373] The catheter comprises a guidewire 3 which is at least partially and slidably arranged within the inner shaft 7. The catheter 1 can be pushed over the guidewire 3 to the therapy site in a patient’s body e.g. blood vessel. The max permissible distal position of the guidewire tip is defined by the length of the guidewire 3. Guidewires with different lengths and / or diameters may be used. Furthermore, the guidewire 3 can be used to roll the rolling membrane 2 out simply by transmission of the movement of the guidewire 3 to the surface of the rolling membrane 2 via friction and shear forces. This can especially be helpful in cases, where the hydraulic force acting on the distal end of the rolling membrane 2 is not sufficient to get the rolling membrane2 through very tight lesions or where the entry into the remaining stenosis / CTO is very small and at a straight angle to the guidewire 3 compared to the rolling membrane front. Here the guidewire helps to direct the rolling membrane 2 into the right direction. The pushing element is sealed against a multiport handle 4 via a sliding annular seal 15 in a pressure-tight manner, for example in the form of a so-called "Tuhoy Borst" seal.

[0374] A proximal portion and / or a proximal end of the outer shaft 6 is connected to a multi-port handle 4. The multi-port 4 handle comprises a first port for pressurizing and depressurizing the rolling membrane 2 and a second port for receiving the pushing element 11 with the inner shaft 7 and the guidewire 3 arranged therein.

[0375] The rolling membrane is connected pressure-tight with the outer shaft and inner shaft 7 (e.g. by means of corresponding welds) and the inner volume 12 of the rolling membrane 2 can be pressurized via a fluid. The fluid may be fed through a diaphragm pressure port 13.

[0376] In Figs. 1A and IB the inner shaft 7 comprise a cone shaped distal tip 8 whereas in Fig. 2A and 2 the inner shaft 7 has a tubular distal end or distal tip.

[0377] Fig. 2A shows an example of a rolling membrane catheter 1 with a rolling membrane 2 in a rolled-in state, whereas Fig. 2B shows the rolling membrane catheter 1 with a rolling membrane 2 in a rolled-out state (which has crossed a chronic total occlusion (CTO) / lesion).

[0378] Fig. 3 and 4 show the rolling membrane catheter of Fig. 2A, respectively whereas the catheters of Fig. 3 and 4 further comprises at least one radiopaque marker.

[0379] Fig. 3 shows a catheter wherein the inner shaft 7 comprises at least one radiopaque marker 8 which is attached to the distal end of the inner shaft 7) and wherein the outer shaft 6 comprises at least one radiopaque marker 8 which is attached to the distal end of the outer shaft 6.

[0380] Fig. 4 shows a catheter wherein the inner shaft 7 comprises at least one radiopaque marker 8 which is attached to the distal portion and to the distal end of the inner shaft 7 and wherein the outer shaft 6 comprises at least one radiopaque marker 8 which is attached to the distal end of the outer shaft 6.

[0381] Figs. 5A-5I illustrate the method steps of a method for crossing a stenosis or a chronic total occlusion without prior crossing of the guidewire 3. In this method the first end of the rolling membrane 2 is attached to the distal end of the inner shaft 7. First, the catheter 1 is advanced to target lesion in a rolled-in state. The inner pressure in the rolling membrane 2 is the same as atmospheric pressure. Then the guidewire 3 is pulled back to a distal marker position or further to make sure that guidewire tip always stays behind rolling membrane front during crossing the stenosis / CTO. The pressure in the inner volume 12 of the rolling membrane 2 is increased via the pressure port 13 to prepare for a roll-out. The pushing element is advanced in a distal direction to allow the rolling membrane 2 to roll-out. When the rolling membrane 2is completely rolled out the pushing handle 5butts up against proximal end of the multi-port handle 4 (e.g. a Luer). The rolling membrane 2 is therefore rolled out to the maximum position and the guidewire is not clamped by rolling membrane 2. The distal tip 9 of the inner shaft 7 is not in front of the rolling membrane 2 when the rolling membrane 2 is completely rolled out (means when the pushing element is completely slided into the outer shaft and the multi-port handle 4). If the lesion is short and thus was crossed already through the rolling membrane can be deflated and the catheter can be pulled back out of the patient. Therefore, the pressure is decreased to prepare a rolling-in. The rolling membrane 2is then pulled back by the pushing element 11. The rolling membrane catheter 1 is now ready to repeat the steps to cross another lesion or in case of a longer lesion to further advance the catheter to the long lesion or to cross it.

[0382] In case of a long lesion the catheter may be retracted up to approximately one rolling membrane length in front of the proximal not crossed lesion end. For example the rolling-in of the rolling membrane by advancing the outer shaft and the multi-port handle 4 and / or the pushing handle 5 into the target lesion and holding the inner shaft 7 with the guidewire 3 in place or retracting the inner shaft 7 at the same time so that the front of the rolling membrane 2 stays in place may occur at the same time.

[0383] Figs. 6A-6J illustrate the method steps of a method for crossing a stenosis or a chronic total occlusion without prior crossing of the guidewire 3. In this method the first end of the rolling membrane (2) is attached to the distal portion of the inner shaft 7 and not to the distal end. Thus, contrary to the method described in Fig. 5A-5I the distal tip 9 of the inner shaft 7 is in front of the rolling membrane 2 when the rolling membrane is completely rolled out (means when the pushing element is completely slided into the outer shaft and the multi-port handle). This lowers the risk of damaging the rolling membrane 2 with the guidewire 3 as the contact between guidewire 3 and rolling membrane 2 is avoided or at least reduced. However, the method steps are mutatis mutandis as described in Fig. 5A-5I

[0384] Figs. 7A-7H illustrate the method steps of a method for crossing a stenosis or a chronic total occlusion with prior crossing of the guidewire. The method steps are the same as described in Figs. 5A-5I except that after advancing the catheter 1 to target lesion and before increasing the pressure in the inner volume 12 of the rolling membrane 2 the guidewire 3 is advanced distally to penetrate or crossing through the lesion (stenosis or a chronic total occlusion).

[0385] Figs. 8A-8H illustrate the method steps of a method for crossing a stenosis or a chronic total occlusion with prior crossing of the guidewire. The method steps are the same as described in Fig. 6A-6J except that after advancing the catheter 1 to target lesion and before increasing the pressure in the inner volume 12 of the rolling membrane the guidewire is advanced distally to penetrate or crossing through the lesion (stenosis or a chronic total occlusion).

[0386] Fig. 9 shows a cross-sectional view of a rolling membrane catheter comprising a bonding material 10 being attached to the distal end and end portion of the inner shaft 7 and the first end of the rolling membrane 2.

[0387] Fig. 10 cross-sectional view of another rolling membrane catheter comprising a bonding material

[0388] 10 being attached to the distal end of the inner shaft 7 and the first end of the rolling membrane 2. The bonding material 10 may at the same time serve as the distal tip of the inner shaft 7.

[0389] For example, if the inner shaft 7 is made of PEEK the rolling membrane may be attached to the distal portion and / or the distal end of the inner shaft 7 via a polyamide (PA 12) as a bonding material 10 because PEEK is not weldable.

[0390] Figs. 9 and 10 show a conical transition from the rolling membrane 2 to the inner shaft 7.

[0391] Figs. 11A-1 IK illustrate the method steps of another method for crossing a stenosis or a chronic total occlusion without prior crossing of the guidewire 3. This method comprises a single roll-out of the rolling membrane 2 and is thus highly suitable for crossing of a rather short lesion. In a first step, illustrated in Fig.

[0392] 11 A, the catheter 1 is moved to the target lesion while the rolling membrane 2 is deflated, that is, the pressure within the rolling membrane 2 is equal or lower than the pressure outside of the rolling membrane 2. Said pressure is indicated as p=0 in the Figures and in the following. Such pressure may be equal or less than one atmosphere, i.e., 1013,15 hPa or equal or less than zero bar. Preferably, said pressure is between 0 bar and -1 bar. After that the guidewire 2 is pulled back to a position of the radiopaque marker 8 or even further backwards to make sure that the guidewire tip stays behind the rolling membrane 2 front during crossing as illustrated in Fig. 11C. In a next step, the pressure of the rolling membrane 2 is increased to p=high in preparation for roll-out of the rolling membrane 2, see Fig. HE, and the pushing handle 5 is advanced to allow the rolling membrane 2 to roll out, see Fig. 1 IF. The exact roll-out depends on the length of the lesion. In Fig. 11H, the pushing handle 5 butts against the multi-port handle 4, so that the rolling membrane 2 is rolled out to the maximum. Even in this maximum rolled-out position, the cone of the rolling membrane 2 remains hidden (rolled in) and only the cylindrical part is visible. That is, no tip is visible in front of the rolling membrane 2 when it is completely rolled-out (and the guide wire 3 is completely slidedin). When only one lesion needs to be crossed, the pressure of the rolling membrane 2 can be decreased to p=0 and the catheter 1 can be pulled out of the patient. In case that one or more further lesions shall be subsequently crossed, the pressure of the rolling membrane 2 is lowered to p=low, but not decreased to p=0, in preparation for rollback of the rolling membrane 2 as illustrated in Fig. 1 II. Said lowered pressure is indicated as p=low in the Figures and the following. The pressure p=low is higher than the pressure outside of the rolling membrane but lower than the pressure p=high. P=low may be higher than one atmosphere or higher than 0 bar. Then, the rolling membrane 2 is rolled back by pulling back the pushing handle 5, see Fig. 11 J. Subsequently, the pressure is decreased to p=0, see Fig. 1 IK, and the previous steps with regard to the crossing of the first lesion are repeated.

[0393] Figs. 12A-12R illustrate the method steps of another method for crossing a stenosis or a chronic total occlusion without prior crossing of the guidewire 3. This method comprises multiple rollouts of the rolling membrane 2 and is thus highly suitable for crossing of a rather long lesion. In a first step, illustrated in Fig. 12A, the catheter 1 is moved to the target lesion while the pressure within the rolling membrane 2 is p=0. After that the guidewire 3 is pulled back to a position of the radiopaque marker 8 or even further backwards to make sure that the guidewire tip stays behind the rolling membrane front during crossing as illustrated in Fig. 12B. In a next step, the pressure of the rolling membrane 2 is increased to p=high in preparation for roll-out of the rolling membrane 2, see Fig. 12C, and the pushing handle 5 is advanced to allow the rolling membrane 2 to roll out, see Fig. 12D. By that, the rolling membrane 2 starts to cross the lesion, see Fig. 12E. In Fig. 12F, the pushing handle 5 butts against the multi-port handle 4, so that the rolling membrane 2 is rolled out to the maximum. Even in this maximum rolled-out position, the cone of the rolling membrane 2 remains hidden (rolled in) and only the cylindrical part is visible. That is, no tip is visible in front of the rolling membrane 2 when it is completely rolled-out (and the guidewire 3 is completely slided-in). Subsequently, as shown in Fig. 12G, the pressure within the rolling membrane 2 is lowered in order to prepare for rollback of the rolling membrane 2. After that, the rolling membrane 2 is rolled back by pulling back the pushing handle 5, see Fig. 12H. Subsequently, as illustrated in Fig. 12K, the pressure remains low while the catheter is advanced into the lumen created into the lesion by the previous steps of the method. Once the distal end of the catheter 1 reaches the backplane of the lumen or fills out said lumen, the pressure within the rolling membrane 2 is increased, see Fig. 12M. After that, the guidewire 3 advances forward to allow the rolling membrane 2 to roll out, see Fig. 12N. After roll-out of the rolling membrane 2, the pressure within the rolling membrane 2 is lowered in order to prepare for rollback of the rolling membrane 2 again, see Fig. 12P. As before, the rolling membrane 2 is rolled back by pulling back the pushing handle 5, see Fig. 12Q, to be prepared for a further rollout of the rolling membrane 2 as described in the previous steps. Alternatively, the pressure of the rolling membrane 2 can be further decreased to p=0 so that the catheter 1 can be moved through the crossed lesion to advance to a next lesion, see Fig. 12R.

[0394] Figs. 13A-13R illustrate the method steps of another method for crossing a stenosis or a chronic total occlusion without prior crossing of the guidewire 3. This method comprises multiple rollouts of the rolling membrane 2 and is thus highly suitable for crossing of a rather long lesion. In comparison to the method illustrated in Figs. 12A-12R, the method illustrated in Figs. 13A-13R comprises an advancement of the guidewire 3 within the lumen generated into the lesion whereas the guidewire does not advance within the lumen generated into the lesion in the method illustrated in Figs. 12A-12R. The method illustrated in Figs. 13A-13R is different from the one illustrated in Figs. 12A-12R in so far, that the pressure within the rolling membrane 2 is further decreased, preferably to p=0, after the rolling membrane 2 is rolled back by pulling back the pushing handle 5, see Fig. 131. Subsequently, the guidewire 3 is advanced through the rolling membrane 2 into the lumen generated into the lesion, see Fig. 13J. After that, the catheter 1 is advanced into the lumen created into the lesion, see Fig. 13K, before the guidewire 3 is pulled back to a position of the radiopaque marker 8 or even further backwards.

[0395] Figs. 14 A- 14L illustrate the method steps of another method for crossing a stenosis or a chronic total occlusion without prior crossing of the guidewire 3. This method comprises multiple rollouts of the rolling membrane 2 and is thus particularly suitable for crossing of a rather long lesion. The method illustrated in Figs. 14A-14L deviates from the methods illustrated in Figs. 12A-12R and Figs. 13A-13R in so far, that after creating the lumen into the stenosis and the subsequent lowering of the pressure to p=low within the rolling membrane 2, the rolling membrane 2 is rolled-in by advancing the outer shaft 6 and the multi-port handle 4 towards the target lesion and retracting the inner shaft 7 at the same time, so that the front of the rolling membrane 2 stays in place, see Fig. 14G. The location of the front of the rolling membrane 2 can be checked by an angiogram . After that the pressure within the rolling membrane 2 is increased again to p=high in order to prepare for a next rollout of the rolling membrane 2. In case that the lesion is crossed after said next rollout of the rolling membrane 2 and no further lesion is to be crossed, the rolling membrane 2 may be deflated, that is, the pressure inside the rolling membrane 2 is set to p=0. In case further rollouts of the rolling membrane 2 shall be performed, the pressure inside the rolling membrane 2 is lowered to p=low in order to prepare the roll-in of the rolling membrane 2, see Figs. 14J-14L.

[0396] Figs. 15A-15P illustrate the method steps of another method for crossing a stenosis or a chronic total occlusion without prior crossing of the guidewire 3. This method comprises multiple rollouts of the rolling membrane 2 and is thus particularly suitable for crossing of a rather long lesion. The method illustrated in Figs. 15A-15P deviates from the methods illustrated in Figs. 13A-13R and Figs. 14A-14L in so far, that the catheter 1 is retracted to one rolling membrane length in front of the new proximal lesion end after lowering the pressure inside the rolling membrane 2 to p=low after the first roll-out the rolling membrane 2, see Fig. 15G. Subsequently, rolling membrane 2 is rolled-in by advancing the outer shaft 6 and multi-port handle 4 into the target lesion and holding the inner shaft 7 with the guidewire 3 in place at the same time, see Fig. 15H. After that, the rolling membrane 2 is deflated, that is, the pressure inside the rolling membrane 2 is set to p=0 and the guidewire 3 is pulled back, see Figs. 151 and 15J. In a next step the pressure inside the rolling membrane 2 is set to p=high in order to prepare for rollout of the rolling membrane 2, see Fig. 15K, and the pushing handle 5 is advanced to rollout the rolling membrane 2, see Fig. 15L. The subsequent method steps illustrated in Figs. 15M to 15P correspond to a roll-in of the rolling membrane 2 and potential further rollouts of the rolling membrane 2 as previously described, e.g., with respect to Figs. 12P-12R. List of reference si

[0397] 1 catheter

[0398] 2 rolling membrane

[0399] 3 guidewire

[0400] 4 multi-port handle

[0401] 5 pushing handle

[0402] 6 outer shaft

[0403] 7 inner shaft

[0404] 8 radiopaque marker

[0405] 9 distal tip of inner shaft

[0406] 10 bonding material

[0407] 11 pushing element

[0408] 12 inner volume of rolling membrane

[0409] 13 pressure port (inflation / deflation port)

[0410] 14 pushing element / guidewire port

[0411] 15 sliding seal

[0412] P Max. permissible distal position of the guidewire tip

Claims

Claims1. A catheter ( 1 ) comprising : a rolling membrane (2) being adapted to roll out in a longitudinal direction from a rolled-in state into a rolled-out state and vice versa and the rolling membrane defining an inner volume (12) that can be pressurized or depressurized; an outer shaft (6) at least partially surrounding an inner shaft (7), wherein the inner shaft (7) is slidably arranged within the outer shaft (7) and wherein a first end of the rolling membrane (2) is attached to a distal portion and / or a distal end of the inner shaft (7) and a second end of the rolling membrane (2) is attached to a distal portion and / or a distal end of the outer shaft (6); wherein the catheter (1) further comprises at least one pushing element (11) which is connected to a proximal portion and / or proximal end of the inner shaft (7) and surrounds the proximal portion and / or the proximal end of the inner shaft (7); wherein the catheter (1) does not comprise a further balloon being connected to the inner shaft (7); and wherein the catheter optionally comprises a guidewire (3) which is at least partially arranged within the inner shaft (7).

2. The catheter (1) according to claim 1, wherein the first end of the rolling membrane (2) is attached to the distal portion of the inner shaft (7) but not to the distal end of the inner shaft (7).

3. The catheter (1) according to claim 1 or 2, wherein the second end of the rolling membrane (2) is attached to an outer side of the distal portion of the outer shaft (6) but not to the distal end of the outer shaft (6).

4. The catheter (1) according to any one of the preceding claims, wherein the first end of the rolling membrane (2) is attached to the distal portion and / or the distal end of the inner shaft (7) via a bonding material (10).

5. The catheter (1) according to any one of the preceding claims, wherein the inner shaft (7) comprises an atraumatic distal tip (8) or is connected to the bonding material or an atraumatic distal tip (8) at its distal end, wherein preferably the atraumatic distal tip (8) is formed from the bonding material.

6. The catheter (1) according to claim 1, wherein the pushing element (11) is a metal tube.

7. The catheter (1) according to any one of the preceding claims, wherein the pushing element (11) has at its proximal end a pushing handle (5) which enables a pushing of the pushing element (11).

8. The catheter (1) according to any one of the preceding claims, wherein a proximal portion and / or a proximal end of the outer shaft (6) is connected to a multi-port handle (4) comprising a first port forpressurizing and depressurizing the rolling membrane (2) and / or for injecting a contrast agent and a second port for receiving the pushing element (11) with the inner shaft (7) and optionally the guide wire (3) arranged therein.

9. The catheter (1) according to claim 8, wherein the catheter (1) further comprises a sliding seal being connected to the pushing element (11) and the multi-port handle (4).

10. The catheter (1) according to any one of the preceding claims, wherein the inner shaft (7) comprises at least one radiopaque marker (8) which is attached to the distal portion and / or the distal end of the inner shaft (7) and wherein the outer shaft (6) comprises at least one radiopaque marker (8) which is attached to the distal end of the outer shaft (6).

11. The catheter (1) according to any one of the preceding claims, for use in crossing a stenosis or a chronic total occlusion.

12. A method for crossing a stenosis or a chronic total occlusion using the catheter of any of the claims 1 to 10, comprising the following steps in a consecutive order: i) advancing the catheter (1) towards the stenosis or the chronic total occlusion, ii) increasing the pressure in the inner volume (12) of the rolling membrane (2) to roll-out the rolling membrane into the rolled out state and advancing the catheter into or through the stenosis or the chronic total occlusion without a prior crossing of the lesion with a guide wire, iii) decreasing the pressure in the inner volume (12) of the rolling membrane (2), and iv) retracting the catheter (1) in a proximal direction away from the penetrated or crossed stenosis or a chronic total occlusion, optionally repeating the steps i) to iv).

13. A method for crossing a stenosis or a chronic total occlusion using the catheter of any of the claims 1 to 10, comprising the following steps in a consecutive order: v) advancing the catheter (1) towards the stenosis or the chronic total occlusion, w) increasing the pressure in the inner volume (12) of the rolling membrane (2) to roll-out the rolling membrane into the rolled out state and advancing the catheter (1) into or through the stenosis or the chronic total occlusion, while the guidewire (3) stays within the inner shaft (7) and maintains its position during a rolling membrane's roll-out and roll-in, x) advancing the outer shaft (6) and the multi-port handle (4) and / or pushing handle (5) to roll the rolling membrane (2) in, y) decreasing the pressure in the inner volume (12) of the rolling membrane (2) to deflate the rolling membrane (2), and z) retracting the catheter (1) in a proximal direction away from the penetrated or crossed stenosis or a chronic total occlusion, optionally repeating the steps w) to z).

14. A method for crossing a stenosis or a chronic total occlusion using the catheter of any of the claims1 to 10, comprising the following steps in a consecutive order: xi) advancing the catheter (1) towards the stenosis or the chronic total occlusion, xii) increasing the pressure in the inner volume ( 12) of the rolling membrane (2) to roll-out the rolling membrane (2) into the rolled out state and advancing the catheter (1) into or through the stenosis or the chronic total occlusion, xiii) advancing the outer shaft (6) and the multi-port handle (4) and / or pushing handle (5) to roll the rolling membrane (2) in, while retracting the inner shaft (7) to keep a front of the rolling membrane (7) in place while allowing controlled roll-out and roll-in movements, xiv) decreasing the pressure in the inner volume (12) of the rolling membrane (2), such that the guidewire (3) is not gripped by the rolling membrane (2), and xv) retracting the catheter (1) in a proximal direction away from the penetrated or crossed stenosis or a chronic total occlusion, optionally repeating the steps xii) to xiv).

15. A method for crossing a stenosis or a chronic total occlusion using the catheter of any of the claims 1 to 10, comprising the following steps in a consecutive order: j) penetrating or crossing through the stenosis or a chronic total occlusion with the guidewire (3), k) advancing the catheter (1) towards the stenosis or the chronic total occlusion, l) increasing the pressure in the inner volume (12) of the rolling membrane (2), m) advancing the pushing element (11) to roll the rolling membrane (2) out into a rolled out state, thereby penetrating or crossing through the stenosis or a chronic total occlusion with the rolling membrane (2), n) decreasing the pressure in the inner volume (12) of the rolling membrane (2), such that the guidewire (3) is not gripped by the rolling membrane (2), o) pulling the pushing element (11) in a proximal direction to roll the rolling membrane (2) in, and p) retracting the catheter (1) in a proximal direction away from the penetrated or crossed stenosis or a chronic total occlusion, optionally repeating the steps 1) to p).

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