Catheter comprising roll film

Abstract

The present invention relates, inter alia, to catheters comprising roll films and methods of using roll film catheters through stenosis or chronic total occlusion.

Description

Technical Field

[0001] This application relates to a roll-film catheter comprising a roll of membrane connected to an inner and outer shaft of the catheter. This application also relates to a method of using such a roll-film catheter to traverse stenosis or chronic total occlusion. Background Technology

[0002] Roller-type catheters are used to navigate lesions or occlusions in blood vessels with minimal sliding friction and hydraulically induced maneuverability. However, improvements to existing roller-type catheters are needed. Summary of the Invention

[0003] The conduit comprising a rolled membrane (hereinafter also referred to as a rolled membrane conduit) according to claim 1 can help overcome these disadvantages.

[0004] A catheter is described, comprising: a roll membrane adapted to unfold from a wound state to an unfolded state in a longitudinal direction, the roll membrane defining an internal volume that can be pressurized and / or depressurized; an outer shaft at least partially surrounding an inner shaft, wherein the inner shaft is slidably disposed within the outer shaft, and wherein a first end of the roll membrane is attached to a distal portion and / or distal end of the inner shaft, and a second end of the roll membrane is attached to a distal portion and / or distal end of the outer shaft; wherein the catheter further comprises at least one actuating element connected to and partially surrounding a proximal portion and / or proximal end of the inner shaft; and wherein the catheter optionally comprises a guidewire at least partially disposed within the inner shaft.

[0005] In a preferred embodiment, the catheter includes: a roll membrane adapted to unfold from a wound state to an unfolded state in a longitudinal direction, the roll membrane defining an internal volume that can be pressurized and / or depressurized; an outer shaft at least partially surrounding an inner shaft, wherein the inner shaft is slidably disposed within the outer shaft, and wherein a first end of the roll membrane is attached to a distal portion and / or distal end of the inner shaft, and a second end of the roll membrane is attached to a distal portion of the outer shaft but not to the distal end of the outer shaft; wherein the catheter further includes at least one actuating element connected to and surrounding a proximal portion and proximal end of the inner shaft; and wherein the catheter includes a guidewire at least partially disposed within the inner shaft.

[0006] Throughout this application, the term "distal" can be understood as being further away from the physician manipulating the catheter (compared to "proximal"). The term "proximal" throughout this application can be understood as being closer to the physician manipulating the catheter.

[0007] Unlike the roll-film catheter described in EP 2 383 012 B1, the catheter according to this application does not include an additional expandable balloon (which is not a distal portion or distal end of the inner axis) connected to the inner axis. This allows for a catheter with a simplified and slimmer design. The slimmer design makes it easier to pass through stenosis and complete occlusion. It is more flexible without the internal balloon, which can easily pass through tortuous lesions. The simpler design reduces the complexity of catheter handling, for example, because the single expansion pump to be connected prevents balloon confusion. The single balloon lumen improves flexibility and deliverability.

[0008] The first end of the diaphragm can be attached to the distal portion of the inner shaft, but not to the distal end of the inner shaft. This reduces the risk of the diaphragm being damaged by the guide wire guided through the inner shaft.

[0009] The second end of the film roll can be attached to the 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 film roll a few millimeters from the distal end of the outer shaft so that the entire cross-sectional area of ​​the film roll is immediately available when it is inflated from the wound state to the unfolded state. The larger the cross-section of the front portion of the film roll (in the wound state) to which pressure acts, the greater the force that causes the film roll to unfold into the unfolded state.

[0010] In a preferred embodiment, the catheter includes: a roll film adapted to unfold from a wound state to an unfolded state in a longitudinal direction, the roll film defining a pressurizable internal volume; an outer shaft at least partially surrounding an inner shaft, wherein the inner shaft is slidably disposed within the outer shaft, and wherein a first end of the roll film is attached to a distal portion and / or distal end of the inner shaft, and a second end of the roll film is attached to a distal portion of the outer shaft but not to the distal end of the outer shaft; wherein the catheter further includes at least one actuating element connected to and surrounding a proximal portion and proximal end of the inner shaft; and wherein the catheter includes a guidewire at least partially disposed within the inner shaft.

[0011] The inner shaft can be more flexible than the actuating element. The actuating element can be a metal tube. A more rigid actuating element can achieve greater actuation force, while a flexible inner shaft can allow for flexible manipulation on the patient side (e.g., a blood vessel).

[0012] The actuating element may have a actuating handle at its proximal end, which allows for better actuation of the actuating element. The actuating element may include a length measuring tool, preferably a ruler.

[0013] The actuating element may have a pressure port at its proximal end for pressurizing and depressurizing the film roll. Preferably, the actuating handle includes a pressure port at its proximal end for pressurizing and depressurizing the film roll. The pressure port may include a diaphragm.

[0014] The proximal portion and / or proximal end of the outer shaft can be connected to a multi-port handle. The multi-port handle includes a first port (referred to as the pressure port) for injecting contrast agents and / or for pressurizing and depressurizing the roll film, and a second port for receiving a push element (in which an inner shaft and optional guidewire are arranged). The pressure port may include a diaphragm.

[0015] The conduit may also include a sliding seal. The sliding seal may be connected to the actuating element and the multi-port handle. The multi-port (e.g., Luer connector) handle may include at least one sliding seal attached to the inner shaft, outer shaft, and / or actuating element.

[0016] The actuating element may be at least partially slidably arranged within the outer shaft and the multi-port handle. The inner shaft, partially fixed within the actuating element, may be slidably arranged within the multi-port handle and / or the outer shaft.

[0017] The inner shaft may include at least one radiopaque mark attached to the distal portion and / or distal end of the inner shaft, and the outer shaft includes at least one radiopaque mark attached to the distal end of the outer shaft. Having radiopaque marks at least at the distal ends of the inner and outer shafts allows for better (under X-ray) visualization of whether the film is in a wound or unwound state. Preferably, the inner shaft may include at least one first radiopaque mark attached to the distal portion and at least one second radiopaque mark attached to the distal end of the inner shaft, wherein the outer shaft includes at least one radiopaque mark attached to the distal end of the outer shaft. The first and second radiopaque marks are spaced apart in the longitudinal direction of the catheter. The radiopaque mark may be annular.

[0018] The diaphragm is pressure-sealed to the outer and inner shafts (e.g., by appropriate welding). The internal volume of the diaphragm can be pressurized with fluid. The fluid can be supplied through the diaphragm pressure port. Due to the smaller diameter of the inner shaft, it forms an annular space with the outer shaft. The annular space is in fluid communication with the pressure port so that the diaphragm can be pressurized with fluid.

[0019] The fluid can be a contrast agent, a saline solution, or a mixture thereof. The use of a contrast agent improves visibility under X-rays and thus provides better control over whether the membrane is wound up or unwound, especially when combined with the aforementioned radiopaque markers. The fluid can be supplied through a pressure port comprising a diaphragm.

[0020] The diaphragm can be adapted to be rolled in and unrolled longitudinally at the distal end of the catheter, preferably along the patient's blood vessels, for example, at least one centimeter. A catheter with a diaphragm to be unrolled distally along the patient's blood vessels allows the catheter to move along the patient's blood vessels in a manner that reduces friction.

[0021] Furthermore, the use of (long) roll membranes provides increased flexibility for the catheter along its (long) longitudinal direction while ensuring good deployability. Therefore, the unfolding or rolling of the roll membrane can be understood as a corresponding outward or inward folding of at least (primary) portions of the roll membrane, for example, along the longitudinal direction of the patient's blood vessel. The roll membrane can be folded inward into itself. It is possible that the roll membrane is adapted to unfold in the longitudinal direction to more than 10 cm, more than 20 cm, up to 30 cm, or even up to 40 cm or more.

[0022] The film roll can be configured such that, when in the unfolded state, the film roll includes a smaller diameter at the distal portion compared to the proximal portion.

[0023] The film roll can be more flexible than the outer shaft. The film roll can have a smaller wall thickness than the inner and / or outer shaft. When pressurized, the film roll can stretch to a greater extent in the longitudinal direction than in the radial direction.

[0024] The roll film can preferably be made of a flexible material to support the inward flexible folding of the roll film, thereby supporting the roll-up of the roll film. The roll film can be made of an organic polymer, preferably a (thermoplastic) elastomer. The roll film may include polyamides, preferably polyamide-based elastomers (e.g., Pebax or PA12); polyether block amides, polyesters (e.g., PET); polyester-based elastomers (e.g., Hytrel); polyurethanes, preferably thermoplastic polyurethanes; polyolefin-based elastomers (e.g., EPDM / EPDM-PP) and / or any other suitable material. Preferably, the roll film is made of polyamide 12 (PA12). Polyamide 12 (CAS-Nr.: 24937-16-4) is a thermoplastic, semi-crystalline, and linear polymer. PA12 is a homopolymer consisting of only one monomer component. Such polymers are based on aliphatic ω-aminolauric acid or its lactam, formed by eliminating water from the intramolecular acid amide. PA12 is based on ω-amino-lauric acid H2N-[CH2]11-COOH, which has a total of 12 carbon atoms in the molecule. Therefore, PA12 can be considered as polylauryl lactam or poly(dodecane-12-lactam).

[0025] For example, the inner and / or outer shafts are made of polyetheretherketone (PEEK), and the roll film and optionally the distal end are made of PA12. For example, the inner and / or outer shafts, the roll film, and optionally the distal end are made of PA12.

[0026] The film may contain a drug or be at least partially covered by a drug coating.

[0027] The first end of the roll film is attached to the distal portion and / or distal end of the inner shaft. The first end of the roll film can be directly attached to the distal portion and / or distal end (of the material) of the inner shaft. Alternatively, the first end of the roll film can be indirectly attached to the distal portion and / or distal end (of the material) of the inner shaft via a bonding material. For example, if the inner shaft is made of PEEK, the roll film can be attached to the distal portion and / or distal end of the inner shaft via polyamide (PA12) as a bonding material (because PEEK is not solderable). The bonding material can also serve as the distal end of either the auxiliary shaft or the inner shaft.

[0028] The guidewire can be adapted to slide relative to the inside of the diaphragm. The guidewire can be made of a radiopaque material. The guidewire can extend from the proximal end of the catheter to the distal end of the catheter (and optionally further extend distally along the patient's blood vessels).

[0029] The inner and / or outer shafts can preferably be reinforced by polymer braids or by reinforcing fibers.

[0030] The outer diameter of the catheter can be equal to or smaller than the inner diameter of the blood vessel to be inserted.

[0031] The inner shaft may include, or may be connected to, at its distal end, a (conical) distal end. The (conical) distal end may be made of a different material than the inner shaft and / or outer shaft. Alternatively, the distal end and the roll film may be made of the same material. The (conical) distal end may be an abrasion-free end. The abrasion-free end may include an elastomer. The elastomer may be, for example, a thermoplastic elastomer. In some cases, the elastomer may be a thermosetting polymer. In some exemplary embodiments, the elastomer may include 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 embodiments, the abrasion-free end may be made of one or more of the foregoing materials. The abrasion-free end may include a compressible material, preferably a polymer foam. By providing an abrasion-free end that includes an elastomer, the abrasion-free end can have increased failure strain and can deform under strain and tension without breaking. Furthermore, a simplified and cost-effective manufacturing process for the abrasion-free end can be supported, for example by thermoforming, as simplified forming of the abrasion-free end including the elastomer can be facilitated. In addition, elastomers can provide increased biocompatibility, thereby avoiding allergic reactions in patients.

[0032] The (conical and / or non-invasive) distal end may include at least one radiopaque marker. At least one radiopaque marker at the distal end of the inner shaft or at the distal end of the inner shaft allows for improved positioning of the distal end of the guidewire inside or outside the inner shaft.

[0033] The non-invasive end can advantageously help simplify the movement of the rolled-up catheter along the patient's blood vessels because it prevents damage / lesions to the inner wall of the blood vessel, even when the membrane is rolled up.

[0034] The tapered tip allows for easier distal movement of the catheter (along the patient's blood vessels). The tapered tip reduces the risk of complications caused by membrane entanglement. This increases the safety of catheter use.

[0035] The atraumatic tip can have a maximum diameter smaller than the outer axis diameter. The atraumatic tip can be configured to receive the guidewire at its central region. When the diaphragm unfolds, it can be adapted to move to a location away from the atraumatic tip.

[0036] The atraumatic tip can be formed from a portion of the roll membrane. In some exemplary embodiments, as seen in the wound state, at least the distal portion of the roll membrane can be adapted not to fold completely inward into itself (e.g., fold into the inner lumen of the roll membrane), but can be adapted to at least partially form the atraumatic tip. By forming the atraumatic tip from a portion of the roll membrane, simplified catheter design can be facilitated (e.g., because fewer components need to be assembled), which can reduce catheter manufacturing costs and recyclability. In other examples, the roll membrane can be adapted such that, in the fully retracted state, the distal portion of the roll membrane remains unfolded. For example, the distal portion of the membrane can include increased stiffness compared to the remaining portion, for example, as provided by thermoforming, to form an atraumatic tip with suitable elasticity. Additionally or alternatively, pressure within a predetermined range can be applied to the distal portion of the membrane to provide suitable elasticity.

[0037] In some examples, the atraumatic tip may comprise a compressible material, preferably foam. Additionally or alternatively, the atraumatic tip may be adapted to retract via an inner lumen through a roll-up membrane. For example, the atraumatic tip may be provided with an atraumatic tip shaft extending from the atraumatic tip to the proximal end of the catheter. The atraumatic tip shaft may be provided with a narrow inner lumen that may, for example, surround a guidewire. The atraumatic tip can then be retracted, for example, before the roll-up membrane is deployed. Thus, unobstructed deployment of the roll-up membrane can be ensured.

[0038] When the membrane is unrolled, it can be adapted to move to a position distal to the location of the non-invasive end. Alternatively, when the membrane is unrolled, it can be adapted not to move to a position distal to the location of the non-invasive end.

[0039] The multi-port handle may include a stop and / or a locking mechanism configured to prevent the film roll from advancing in the longitudinal direction (far beyond the maximum permissible distal position) and / or rotating.

[0040] The use of the catheter described above for traversing stenosis or chronic total occlusion is explained. However, the roll membrane can be used in any (neuro)vascular intervention, neurology, oncology, otolaryngology, endoscopy, urology, gastroenterology, gynecology, pulmonology, or nasolacrimal duct.

[0041] This article describes several methods for traversing narrow or chronic total occlusions.

[0042] Typically, the catheter is first moved to the desired location within the patient's body, and at that desired location, the membrane can be unrolled.

[0043] A method for traversing stenosis or chronic total occlusion, preferably using a catheter as described above, comprises the following steps in a sequential order:

[0044] a) Advance the catheter toward the narrow or chronically complete occlusion.

[0045] b) Optionally, a guidewire can be used to penetrate or pass through the stenosis or chronic total occlusion.

[0046] c) Increase the pressure within the internal volume of the rolled film.

[0047] d) Unwind the film to its unfolded state, thereby allowing the film to penetrate or pass through narrow or chronically complete occlusions.

[0048] e) Reduce the pressure within the internal volume of the roll film, so that the guide wire is not clamped by the roll film.

[0049] f) Retract the catheter proximally away from the stenosis or chronic complete occlusion that has been penetrated or crossed.

[0050] After step f), steps c) to f) can be repeated.

[0051] Step f) retraction of the catheter may include retracting the guidewire into the inner shaft and moving the push element in the proximal direction to wind the film into the wound state.

[0052] When penetrating or passing through a narrow or chronically complete occlusion, the guidewire can be located inside the inner shaft and not in contact with the diaphragm.

[0053] Examples 1 through 10 below relate to a roll-up membrane catheter, wherein the roll-up membrane is attached to the distal end of the inner shaft (and optionally to the distal portion):

[0054] Example 1: Passing through without a guidewire

[0055] This method focuses on lesion traversal without prior guidewire traversal. It involves unrolling the membrane, advancing the complete catheter, and then winding the membrane back in for subsequent traversal. The procedure does not involve complex guidewire manipulation. Successful traversal is achieved by unrolling the membrane and moving the complete catheter to the target lesion. Adjusting the pressure within the internal volume of the membrane facilitates controlled unrolling and winding manipulation. In this method, the complete catheter is moved toward the lesion to perform the traversal. Moving the proximal handle against the multiport handle allows the membrane to fully unroll.

[0056] Example 2: Passing without a guidewire, the inner shaft / guidewire remains in place during winding.

[0057] This method introduces the idea of ​​passing through the lesion without prior guidewire passage, by maintaining the guidewire position during the unfolding and winding of the film.

[0058] By retracting the catheter and guidewire, winding them within the membrane, and releasing the pressure within the membrane, the guidewire can be held in place while allowing controlled movement of the rolled membrane. This method ensures that the guidewire remains within the inner axis during the procedure.

[0059] The inner axis marker position is used as a reference point to maintain guidewire position during roll deployment and insertion. Pressure within the roll is released using a vacuum pump to deflate it. Similar to Example 1, the entire catheter is moved toward the lesion. However, in this method, after the initial pass, the catheter is retracted at most approximately one roll length in front of the new proximal lesion end. The roll is then wound in by advancing the outer axis and multiport handle and / or pushing the handle. Pressure within the roll is released using a vacuum pump to deflate it.

[0060] However, this procedure can also be performed if the guidewire has previously passed through the lesion.

[0061] Example 3: Passing through without a guide wire, the front of the roll film remains in place during roll-up.

[0062] This method allows passage through the lesion without prior guidewire insertion, while maintaining the front portion of the roll membrane in place during winding. Similar to the method in Examples 1 or 2, the entire catheter is initially moved toward the lesion. After passage through the lesion, the roll membrane is wound in by advancing the outer shaft and multiport handle and / or pushing the handle, while retracting the inner shaft to hold the front portion of the roll membrane in place, allowing for controlled winding-out and winding movements. This method provides improved precision and control by preventing movement of the front portion of the membrane during the procedure. Adjusting the pressure inside the roll membrane facilitates controlled unfolding and winding manipulation while keeping the front portion of the roll membrane stable.

[0063] However, this procedure can also be performed if the guidewire has previously passed through the lesion.

[0064] Example 4: Passing over a guidewire that has previously passed through a lesion

[0065] This method addresses situations where the guidewire has already passed through the lesion before it can be traversed with a roll-up. It involves steps such as dissociating the guidewire, pulling it back to its proximal position, and then re-engaging it for further traversal. This method requires careful management of the guidewire position to prevent it from leaving the lesion during the unfolding and roll-up maneuvers.

[0066] By disengaging and retracting the guidewire, the reel can be wound back into its initial position for further penetration. Adjusting the pressure inside the reel facilitates guidewire disengagement and controlled deployment and winding manipulation. This method allows for multiple deployments of the reel while maintaining the guidewire's position within the lesion. In this method, the entire catheter is initially moved toward the lesion. After the initial penetration, if the lesion is short, the reel is wound back by pulling back the push element. If the lesion is long, additional steps are involved, such as advancing the entire catheter over the guidewire, increasing pressure (to p_high), and advancing the push element again to deploy the reel.

[0067] The differences between long and short lesions can be summarized as follows:

[0068] Methods for traversing short lesions:

[0069] 1. Catheter movement: For short lesions, the catheter is usually moved to the target lesion in one step.

[0070] 2. Unfolding and Passing Through: Unfold the roll of film to the necessary extent and pass through the lesion by pushing the push handle until it abuts against the multi-port handle (Luer connector).

[0071] 3. Winding in: After passing through a lesion, if necessary, the film is wound in by pulling the push element back to its initial state to prepare for passing through the next lesion.

[0072] 4. Potential deflation: If the procedure is complete or there are no more lesions to pass through, the roll membrane can be deflated (pressure reduced to zero) before the catheter is removed from the patient.

[0073] Methods to penetrate long lesions:

[0074] 1. Catheter movement: For long lesions, the catheter is usually moved to the target lesion in one step.

[0075] 2. Partial penetration: After the initial unfolding and partial penetration (penetration) of the lesion, the catheter is further advanced into the lesion, thus allowing partial penetration.

[0076] 3. Winding in and further passing: The film is wound into its initial state in preparation for further passing. The actuating element is pulled back, and the pressure is reduced to allow controlled winding. The film is then unwound again, and the passing process continues.

[0077] 4. Iterative process: The steps of unfolding, partially crossing, entangling, and further crossing can be repeated until the entire long lesion is successfully crossed.

[0078] 5. Degassing and Completion: Once the entire long lesion has been traversed, the membrane can be degassed (pressure reduced to zero), and the catheter can be removed from the patient.

[0079] In summary, the main differences between traversing long and short lesions involve the need for iterative processes, partial traversal, and additional unfolding and entrainment steps to effectively navigate the length of long lesions.

[0080] Passing through without a guidewire

[0081] Move the intact catheter to the target lesion.

[0082] Pull back the guide wire to ensure it remains behind the front of the roll film.

[0083] Increase the pressure within the internal volume of the film roll (set the pressure to p_high) in preparation for unfolding.

[0084] The pusher element is advanced to allow the film roll to unfold.

[0085] Move the proximal handle through the lesion until it abuts against the multi-port handle (Luer connector).

[0086] Reduce the pressure (to p_low) to prepare for involvement.

[0087] The film is wound in by pulling back the push element.

[0088] If necessary, be prepared to repeat these steps to move through another lesion.

[0089] For short lesions, the procedure ends by degassing the membrane and pulling the catheter back.

[0090] For long lesions, the procedure involves advancing the catheter to the remainder of the lesion and then repeating the steps to penetrate further.

[0091] Example 5: Passing without a guidewire, the inner shaft / guidewire remains in place during winding.

[0092] This method involves retracting the catheter and guidewire after the initial insertion, and then winding them in a membrane roll before proceeding to the next step. The steps are as follows:

[0093] Move the intact catheter to the target lesion.

[0094] Pull the guidewire back to the inner axis mark position.

[0095] Increase the pressure within the internal volume of the film roll (set the pressure to p_high).

[0096] The pusher element is advanced to allow the film roll to unfold.

[0097] Pass through the lesion by moving the proximal handle until it comes into contact with the multi-port handle (Luer connector).

[0098] Reduce the pressure (to p_low) to prepare for involvement.

[0099] Retract the catheter and guidewire.

[0100] The film is wound in the roll by advancing the outer shaft and pushing the handle / multi-port handle (Luer connector).

[0101] Release the pressure inside the film roll.

[0102] Pull back the guidewire.

[0103] Increase the pressure within the internal volume of the film roll (set the pressure to p_high).

[0104] The pusher element is advanced to allow the film roll to unfold.

[0105] Pass through the lesion by moving the proximal handle until it comes into contact with the multi-port handle (Luer connector).

[0106] Example 6: Passing through without a guide wire, the front of the roll film remains in place during rolling.

[0107] This method involves winding the film while holding the front in place, which is achieved by retracting the inner shaft while advancing the outer shaft / multi-port handle (Luer joint). The method steps are as follows:

[0108] Move the intact catheter to the target lesion.

[0109] Increase the pressure within the internal volume of the film roll (set the pressure to p_high).

[0110] The pusher element is advanced to allow the film roll to unfold.

[0111] Pass through the lesion by moving the proximal handle until it comes into contact with the multi-port handle (Luer connector).

[0112] Reduce the pressure (to p_low) to prepare for involvement.

[0113] The film is wound in the roll by advancing the outer shaft and pushing the handle / multi-port handle (Luer connector) while retracting the inner shaft.

[0114] Increase the pressure within the internal volume of the film roll (set the pressure to p_high).

[0115] The pusher element is advanced to allow the film roll to unfold.

[0116] Pass through the lesion by moving the proximal handle until it comes into contact with the multi-port handle (Luer connector).

[0117] Example 7: Passing over a guidewire that has previously passed through a lesion

[0118] Move the intact catheter to the target lesion.

[0119] Increase the pressure within the internal volume of the film roll (set the pressure to p_high).

[0120] The pusher element is advanced to allow the film roll to unfold.

[0121] Reduce the pressure (to p=0) to allow the guidewire to dissociate.

[0122] Pull back the guidewire.

[0123] Increase the pressure within the internal volume of the film roll (set the pressure to p_high).

[0124] The pusher element is advanced to allow the film roll to unfold.

[0125] Reduce the pressure (to p_low) to prepare for involvement.

[0126] The film is rewound by pulling back the push element.

[0127] For short lesions, the process ends by repeating the steps for another lesion.

[0128] For long lesions, the procedure involves additional steps, such as advancing the catheter over the guidewire, increasing the pressure within the internal volume of the roll membrane (setting the pressure to p_high), and advancing the push element again before determining whether to deflate the roll membrane and pull the catheter back.

[0129] Example 8: Differences in catheter treatment between methods for using rolled films with and without ends.

[0130] There are some differences in catheter handling between methods with and without a distal end:

[0131] Entry into the lesion: For catheters without a distal end, initial entry into the lesion is accomplished with the membrane in a rolled-up state, and the actuating element is gradually advanced to allow the membrane to unfold. In contrast, for catheters with a distal end, the membrane is already unfolded, and the actuating element slides in fully at the beginning.

[0132] Film winding position: In methods without ends, the film winding begins in the winding position and is gradually unwound by advancing the pushing element. Conversely, in methods with ends, the film winding is already in the unwound position at the beginning.

[0133] Pressure regulation: During the procedure, the pressure inside the membrane is adjusted to facilitate unfolding and winding. In methods without ends, the pressure is typically set to "p_high" for unfolding and "p_low" for winding. In methods with ends, pressure regulation may follow a similar pattern, but the initial pressure setting may have been adjusted to accommodate the presence of the ends.

[0134] Guidewire management: When using a reel-in catheter without an end, pay special attention to guidewire positioning to ensure it remains behind the front of the reel during passage. The guidewire is pulled back to the distal marked position or further, or held in place using an "inner axis" technique. For reel-in catheters with an end, guidewire management may differ, as the end itself can help guide the guidewire and prevent it from advancing beyond the desired position.

[0135] Winding techniques: In methods with ends, specific winding techniques are described, such as advancing the outer shaft and pushing the handle / multi-port handle (Luer joint) while retracting the inner shaft to hold the front of the film in place. These techniques may not be required or described in methods without ends.

[0136] Guidewire dissociation: When a guidewire has passed over a lesion, it needs to be dissociated from the catheter to ensure its free movement. This step may include reducing the pressure in the reel to allow guidewire dissociation and compensating for guidewire movement. The specific details of guidewire dissociation may vary depending on whether the catheter has a distal end.

[0137] Example 8A: A capillary tube without a terminal end:

[0138] When passing through without a guidewire, two methods are described: (a) passing through short lesions via multiple deployments, and (b) passing through long lesions via multiple deployments.

[0139] In both cases, the membrane is initially rolled up with zero pressure (p=0) within its internal volume. The catheter is moved to the target lesion, and the pusher element is advanced to allow the membrane to roll out. The lesion is then traversed by moving the proximal handle until it abuts against the multi-port handle (Luer connector), where the membrane is fully unrolled and the pusher element has slid in completely. After traversal, the membrane is either rolled up and the pusher element is pulled back to its initial position for the next lesion, or the membrane is deflated, and the catheter is removed if no further lesions are found.

[0140] Example 8B: A spiral-shaped conduit with an end:

[0141] There are also differences between using multiple deployments to pass through short and long lesions when traversing without a guidewire. The key difference is that the reel is initially in the deployed state, and the pusher element is fully slid in. The methods used for passing through short and long lesions involve similar steps to the method without a tip, but the reel is already in the deployed state. The same step-by-step procedure is followed to pass over the guidewire that has previously passed through the lesion. In all cases, the reel is wound up, and the pusher 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 using reel catheters with and without tips, depending on the presence or absence of a guidewire and the length of the lesion being traversed.

[0142] Example 9: A capillary membrane catheter without an end

[0143] i) Passing through without a guidewire:

[0144] a) Utilizing multiple expansions to penetrate short lesions:

[0145] 1. Move the complete catheter to the target lesion while the membrane roll is in the rolled-up state (the pressure inside the membrane roll is zero (p=0)).

[0146] 2. Pull the guidewire back to the distal marked position or further to ensure that the GW end remains behind the front of the roll film throughout the pass.

[0147] 3. Increase the pressure within the internal volume of the roll film (set the pressure to p_high) to prepare for unfolding.

[0148] 4. Begin advancing the pushing element to allow the film to unwind. The exact unwinding amount depends on the length of the lesion.

[0149] 5. Begin traversing the lesion by moving the proximal handle until it abuts against the multi-port handle (Luer). The membrane then unfolds to its maximum extent at this position, propelling the element fully into place.

[0150] 6. Reduce pressure (to p_low) to prepare for entrainment.

[0151] 7. The film is wound up again by pulling back the push element to return it to its initial state, thus preparing it for the next lesion.

[0152] 8. If necessary, be prepared to repeat steps 1 through 7 to pass through another (short) lesion.

[0153] 9. If not, the membrane can be deflated (p=0), and the catheter can be pulled back from the patient.

[0154] b) Utilizing multiple unfolding methods to traverse long lesions

[0155] 1) Move the complete catheter to the target lesion while the membrane roll is in the rolled-up state (the pressure inside the membrane roll is zero (p=0)).

[0156] 2) Pull the guidewire back to the distal marked position or further to ensure that the GW end remains behind the front of the roll film throughout the pass.

[0157] 3) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) in preparation for unfolding.

[0158] 4) Begin advancing the pushing element to allow the film to unwind. The exact unwinding amount depends on the length of the lesion.

[0159] 5) Begin traversing the lesion by moving the proximal handle (push element) until it abuts against the multi-port handle (Luer connector). The membrane roll is then maximally unrolled at this position, and the push element slides in completely.

[0160] 6) Reduce pressure (to p_low) to prepare for entrainment.

[0161] 7) The film is wound up by pulling back the push element to prepare for continuing through the lesion.

[0162] 8) Advance the complete catheter to the remainder of the lesion.

[0163] 9) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) to prepare for unfolding.

[0164] 10) Begin advancing the push element to allow the film roll to unwind. Thus, the film roll is fully unwinding at this position, and the push element slides in completely.

[0165] 11) If the catheter passes through the lesion, deflate the membrane (p=0) and pull the catheter back out of the patient's body; otherwise, continue.

[0166] 12) Reduce pressure (to p_low) to prepare for entrainment.

[0167] 13) The film is wound up by pulling back the push element to return it to its initial state, thus preparing it for the next lesion.

[0168] 14) If necessary, be prepared to repeat steps 1 to 10 through another (long) lesion.

[0169] c) Passing without a guidewire, the inner shaft / guidewire remains in place during winding.

[0170] 1) Move the complete catheter to the target lesion while the membrane roll is in the rolled-up state (the pressure inside the membrane roll is zero (p=0)).

[0171] 2) Pull the guidewire back to the inner axis mark position or further.

[0172] 3) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) in preparation for unfolding.

[0173] 4) Begin advancing the driving element to allow the film roll to unfold.

[0174] 5) Pass the lesion through the proximal handle (push element) until it abuts against the multi-port handle (Luer connector). The membrane is thus maximally unfolded at this position, and the push element slides in completely.

[0175] 6) Reduce pressure (to p_low) to prepare for entrainment.

[0176] 7) Anterior to the proximal end of the lesion, retract the catheter by approximately one membrane roll length.

[0177] 8) Wrap the membrane by advancing the outer shaft and pushing the handle / multi-port handle (Luer connector) into the target lesion while simultaneously holding the inner shaft with the guidewire in place.

[0178] 9) Release the pressure inside the film roll to p=0, ideally a vacuum.

[0179] 10) Pull the guidewire back to the inner axis mark or further.

[0180] 11) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) to prepare for unfolding.

[0181] 12) Begin advancing the driving element to allow the film roll to unfold.

[0182] 13) Pass the lesion through the proximal handle (push element) until it abuts against the multi-port handle (Luer connector). The membrane is thus maximally unfolded at this position, and the push element slides in completely.

[0183] d) Passing through without a guide wire, the front of the roll film remains in place during winding.

[0184] 1) Move the complete catheter to the target lesion while the membrane roll is in the rolled-up state (the pressure inside the membrane roll is zero (p=0)).

[0185] 2) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) to prepare for unfolding.

[0186] 3) Begin advancing the driving element to allow the film roll to unfold.

[0187] 4) Move the proximal handle (push element) through the lesion until it abuts against the multi-port handle (Luer connector). The roll film will then be maximally unrolled at this position, and the push element will slide in completely.

[0188] 5) Reduce pressure (to p_low) to prepare for entrainment.

[0189] 6) Roll up the membrane by advancing the outer shaft and pushing the handle / multi-port handle (Luer connector) into the target lesion while simultaneously retracting the inner shaft to keep the front part of the membrane in the proper position (for angiography).

[0190] 7) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) to prepare for unfolding.

[0191] 8) Move the proximal handle (push element) through the lesion until it abuts against the multi-port handle (Luer connector). The roll film will then be maximally unrolled at this position, and the push element will slide in completely.

[0192] Example 10: Passing over a guidewire that has previously passed through a lesion

[0193] a) Through multiple unfoldings across short lesions

[0194] 1) Move the complete catheter to the target lesion while the membrane roll is in the rolled-up state (the pressure inside the membrane roll is zero (p=0)).

[0195] 2) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) to prepare for unfolding.

[0196] 3) Propel the driving element to allow the film roll to unfold.

[0197] 4) Reduce the pressure to p=0 to allow the guidewire to dissociate.

[0198] 5) Pull the guidewire back to the nearest side position, but leave it in the lesion (to have some clearance for deployment).

[0199] 6) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) to prepare for further unfolding.

[0200] 7) Advance the driving element to allow the film roll to unfold.

[0201] 8) Reduce pressure (to p_low) to prepare for entrainment.

[0202] 9) The film is wound up by pulling back the push element to return it to its initial state, in preparation for the next lesion if necessary.

[0203] 10) Reduce the pressure in the film roll to p=0

[0204] 11) Push the guidewire through the lesion again to achieve the initial state (guidewire in the lesion).

[0205] 12) Prepare to repeat steps 1 through 10 to pass through another (short) lesion.

[0206] b) Passing through long lesions via multiple unfoldings

[0207] 1) Move the complete catheter to the target lesion while the membrane roll is in the rolled-up state (the pressure inside the membrane roll is zero (p=0)).

[0208] 2) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) to prepare for unrolling.

[0209] 3) Propel the driving element to allow the film roll to unfold.

[0210] 4) Reduce the pressure to p=0 to disengage the guidewire.

[0211] 5) Pull the guidewire back to the nearest side while still remaining in the lesion (to have some clearance for deployment).

[0212] 6) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) to prepare for unfolding.

[0213] 7) Begin by moving the proximal handle (push element) through the lesion until it abuts against the multi-port handle (Luer connector). The membrane is then maximally unwound at this position, and the push element slides in completely.

[0214] 8) Reduce the pressure to p=0.

[0215] 9) Advance the guidewire to its maximum permissible position to have some clearance for further entrainment (to prevent the guidewire from exiting the lesion).

[0216] 10) Change the pressure in the film roll (to p_low) to prepare for winding.

[0217] 11) The guidewire is wound in by pulling back the push element, which also pulls the guidewire back (connects). Since the guidewire may come out of the lesion, complete winding is not possible.

[0218] 12) Reduce the pressure to p=0 to disengage the guidewire.

[0219] 13) Advance the guidewire to its maximum permissible position to have some clearance for further entrainment (to prevent the guidewire from exiting the lesion).

[0220] 14) Change the pressure in the film roll (to p low) to prepare for winding.

[0221] 15) The film is fully wound up by pulling back the push element, which also pulls back the guide wire (connection).

[0222] 16) Reduce the pressure to p=0 to disengage the guidewire.

[0223] 17) Advance the intact catheter along the guidewire into the lesion.

[0224] 18) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) to prepare for unfolding.

[0225] 19) Begin advancing the driving element to allow the film roll to unfold.

[0226] 20) If it passes through, deflate the membrane (p=0) and pull the catheter back from the patient; otherwise, continue.

[0227] 21) Set pressure (to p_low) to prepare for entrainment.

[0228] 22) The film is wound up by pulling back the push element to return it to its initial state, ready to be advanced to the next lesion.

[0229] 23) Reduce the pressure to p=0

[0230] 24) Prepare to repeat steps 1 through 23 to pass through another (long) lesion.

[0231] c) Passing over the guidewire, the inner shaft / guidewire remains in place during winding.

[0232] 1) Advance the complete catheter to approximately one membrane roll length in front of the target lesion.

[0233] 2) At the same time, the film is in the wound state (the pressure inside the internal volume of the film is zero (p=0)).

[0234] 3) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) in preparation for unfolding.

[0235] 4) Begin advancing the driving element to allow the film roll to unfold.

[0236] 5) Move the proximal handle (push element) through the lesion until it abuts against the multi-port handle (Luer connector). The membrane will then be maximally unfolded at this position, and the push element will slide in completely.

[0237] 6) Reduce pressure (to p_low) to prepare for entrainment.

[0238] 7) Retract the entire catheter and guidewire back to approximately one roll length in front of the proximal end of the lesion.

[0239] 8) Wrap the film by advancing the outer shaft and pushing the handle / multi-port handle (Luer connector) into the target lesion while simultaneously holding the inner shaft with the guidewire in place.

[0240] 9) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) to prepare for unfolding.

[0241] 10) Begin advancing the push element to allow the film roll to unfold.

[0242] 11) Move the proximal handle (push element) through the lesion until it abuts against the multi-port handle (Luer connector). The roll film is thus maximally unrolled at this position, and the push element slides in completely.

[0243] d) Passing over the guide wire, the front of the film is held in place during winding.

[0244] 1) Move the complete catheter to the target lesion while the membrane roll is in the rolled-up state (the pressure inside the membrane roll is zero (p=0)).

[0245] 2) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) to prepare for unrolling.

[0246] 3) Begin advancing the driving element to allow the film roll to unfold.

[0247] 4) Move the proximal handle (push element) through the lesion until it abuts against the multi-port handle (Luer connector). The roll film will then be maximally unrolled at this position, and the push element will slide in completely.

[0248] 5) Reduce pressure (to p_low) to prepare for entrainment.

[0249] 6) Roll up the membrane by advancing the outer shaft and handle / Luer connector into the target lesion while simultaneously retracting the inner shaft to keep the front of the membrane in the proper position (for angiography).

[0250] 7) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) to prepare for unfolding.

[0251] 8) Begin advancing the driving element to allow the film roll to unfold.

[0252] 9) Move the proximal handle (push element) through the lesion until it abuts against the multi-port handle (Luer connector). The roll film will then be maximally unfolded at this position, and the push element will slide in completely.

[0253] The following examples involve a roll-up catheter, where the roll-up membrane is attached to the distal portion but not to the distal end of the inner shaft:

[0254] Example 11: Passing through without a guidewire:

[0255] a) Utilizing multiple unfolding techniques to traverse short lesions

[0256] 1) Move the complete catheter to the target lesion while the roll membrane is in the unfolded state and the pusher element is fully slid in (the pressure inside the roll membrane is zero (P=0)).

[0257] 2) Change the pressure in the film roll (to p_low) to prepare for winding.

[0258] 3) The film is wound in by pulling back the push element, which also pulls back (connects) the guide wire according to the initial guide wire position (see step 2). During winding, the end of the guide wire is more or less clamped by the film.

[0259] 4) Advance the complete catheter to the target lesion again (the clamped guidewire is also pushed forward).

[0260] 5) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) in preparation for unfolding.

[0261] 6) Begin advancing the push element to allow the film roll to unfold until the proximal handle abuts against the multi-port handle (Luer connector). The film roll is thus unfolded to its maximum extent at this position.

[0262] 7) If it passes through, deflate the membrane and remove the catheter from the patient; otherwise, continue.

[0263] 8) Reduce the pressure to p=0

[0264] 9) Prepare to repeat steps 1 through 7 to pass through another (short) lesion.

[0265] b) Utilizing multiple unfolding methods to traverse long lesions

[0266] 1) Move the complete catheter to the target lesion while the roll membrane is in the unfolded state and the pusher element is fully slid in (the pressure inside the roll membrane is zero (P=0)).

[0267] 2) Change the pressure in the film roll (to p_low) to prepare for winding.

[0268] 3) Winding in the film, which also pulls the guidewire back (connects) according to the initial guidewire position. During rolling, the end of the guidewire is more or less clamped by the film.

[0269] 4) Advance the complete catheter to the target lesion again (the clamped guidewire is also pushed forward).

[0270] 5) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) in preparation for unfolding.

[0271] 6) Begin advancing the push element to allow the film roll to unfold. The film roll is not fully unfolded to avoid pushing the end into the occlusion.

[0272] 7) Reduce pressure (to p_low) to prepare for entrainment.

[0273] 8) The film is wound up by pulling back the push element in preparation to continue through the lesion.

[0274] 9) Advance the complete catheter to the remainder of the lesion.

[0275] 10) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) in preparation for unfolding.

[0276] 11) Begin advancing the driving element to allow the film roll to unfold.

[0277] 12) Begin by moving the proximal handle (push element) through the lesion until it abuts against the multi-port handle (Luer connector). The roll of membrane will then be maximally unrolled at this position, and the push element will slide in completely.

[0278] 13) Reduce the pressure to p=0.

[0279] 14) Prepare to repeat steps 1 to 12 through another (long) lesion.

[0280] c) Passing without a guidewire, the inner shaft / guidewire remains in place during winding.

[0281] 1) Advance the complete catheter to approximately one roll length in front of the target lesion, with the roll in the unfolded state and the pusher element fully slid in (the pressure within the internal volume of the roll is zero (p=0)).

[0282] 2) Change the pressure in the film roll (to p_low) to prepare for winding.

[0283] 3) Wrap the membrane by advancing the outer shaft and pushing the handle / multi-port handle (Luer connector) to the target lesion while simultaneously holding the inner shaft with the guidewire in place.

[0284] 4) Release the pressure in the film roll, p=0, ideally creating a vacuum.

[0285] 5) Pull the guidewire back to the inner shaft mark position or further back into the inner shaft.

[0286] 6) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) in preparation for unrolling.

[0287] 7) Begin advancing the driving element to allow the film roll to unfold.

[0288] 8) Move the proximal handle (push element) through the lesion until it abuts against the multi-port handle (Luer connector). The roll film will then be maximally unrolled at this position, and the push element will slide in completely.

[0289] 9) Reduce pressure (to p_low) to prepare for entrainment.

[0290] 10) Retract the catheter back to about one membrane length in front of the proximal end of the lesion.

[0291] 11) Wrap the membrane by advancing the outer shaft and pushing the handle / multi-port handle (Luer) into the target lesion while simultaneously holding the inner shaft with the guidewire in place.

[0292] 12) Release the pressure in the film roll, p=0, ideally creating a vacuum.

[0293] 13) Pull the guide wire back to the inner shaft mark position or pull it further back into the inner shaft.

[0294] 14) Increase the pressure within the internal volume of the roll film (set the pressure to p_high) in preparation for unfolding.

[0295] 15) Begin advancing the driving element to allow the film roll to unfold.

[0296] 16) Pass the lesion through the proximal handle (push element) until it abuts against the multi-port handle (Luer connector). The membrane is thus maximally unfolded at this position, and the push element slides in completely.

[0297] d) Passing through without a guide wire, the front of the roll film remains in place during winding.

[0298] 1) Advance the complete catheter to approximately one roll length in front of the target lesion, with the roll in the unfolded state and the moving element fully inserted (the pressure within the internal volume of the roll is zero (p=0)).

[0299] 2) Change the pressure in the film roll (to p_low) to prepare for winding.

[0300] 3) Roll up the membrane by advancing the outer axis and pushing the handle / multi-port handle (Luer) to the target lesion while simultaneously retracting the inner axis to keep the front part of the roll in the proper position (for angiography).

[0301] 4) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) in preparation for unfolding.

[0302] 5) Begin advancing the driving element to allow the film roll to unfold.

[0303] 6) Move the proximal handle (push element) through the lesion until it abuts against the multi-port handle (Luer connector). The membrane will then be maximally unfolded at this position, and the push element will slide in completely.

[0304] 7) Reduce pressure (to p_low) to prepare for entrainment.

[0305] 8) Roll up the membrane by advancing the outer axis and pushing the handle / multi-port handle (Luer) into the target lesion while simultaneously retracting the inner axis to keep the front of the membrane in place (for angiography).

[0306] 9) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) in preparation for unfolding.

[0307] 10) Begin advancing the push element to allow the film roll to unfold.

[0308] 11) Move the proximal handle (push element) through the lesion until it abuts against the multi-port handle (Luer connector). The roll of membrane will then be maximally unrolled at this position, and the push element will slide in completely.

[0309] Example 12: Passing over a guidewire that has previously passed through a lesion.

[0310] a) Through multiple unfoldings across short lesions

[0311] 1) Move the complete catheter to the target lesion while the roll membrane is in the unfolded state and the push element is fully slid in (the pressure inside the roll membrane is zero (p=0)), and the guidewire has been passed through the lesion by the physician.

[0312] 2) Advance the guidewire to its maximum permissible position to allow some clearance for roll-in (to prevent the guidewire from exiting the lesion).

[0313] 3) Change the pressure in the film roll (to p_low) to prepare for winding.

[0314] 4) The guidewire is wound in by pulling back the push element, which also pulls the guidewire back (connects). Since the guidewire may come out of the lesion site, it is impossible to completely wind it in.

[0315] 5) Reduce the pressure to p=0 to separate the guidewire.

[0316] 6) Advance the guidewire to its maximum permissible position to allow some clearance for further entanglement (to prevent the guidewire from exiting the lesion).

[0317] 7) Change the pressure in the film roll (to p_low) to prepare for winding.

[0318] 8) The film is fully wound up by pulling back the push element, which also pulls back the guide wire (connects).

[0319] 9) Reduce the pressure to p=0 to prepare for advancing the complete catheter to the target lesion.

[0320] 10) Advance the intact catheter along the guidewire to the target lesion.

[0321] 11) Pull the guidewire back to the nearest side position while keeping the guidewire still in the lesion (to have some clearance for deployment).

[0322] 12) Increase the pressure within the internal volume of the roll film (set the pressure to p_high) in preparation for unfolding.

[0323] 13) Propel the driving element to allow the film roll to unfold.

[0324] 14) Reduce pressure (to p=0) to allow guidewire dissociation and compensation.

[0325] 15) Pull the guidewire back to the nearest side position while keeping the guidewire still in the lesion (to have some clearance for deployment).

[0326] 16) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) to prepare for further unfolding.

[0327] 17) Move the proximal handle (push element) through the lesion until it abuts against the multi-port handle (Luer connector). The membrane is thus maximally unwound at this position, and the push element slides in completely.

[0328] 18) Reduce the pressure to p=0

[0329] 19) Prepare to repeat steps 1 to 18 through another (short) lesion.

[0330] b) Passing through long lesions via multiple unfoldings

[0331] 1) Move the complete catheter to the target lesion site while the roll membrane is in the unfolded state and the pusher element is fully slid in (the pressure inside the roll membrane is zero (p=0)), and the guidewire has been passed through the lesion by the physician.

[0332] 2) Advance the guidewire to its maximum permissible position to allow for some clearance for entanglement (to prevent the guidewire from exiting the lesion).

[0333] 3) Change the pressure in the film roll (to p_low) to prepare for winding.

[0334] 4) The guidewire is wound in by pulling back the push element, which also pulls the guidewire back (connects). Since the guidewire may come out of the lesion site, it is impossible to completely wind it in.

[0335] 5) Reduce the pressure to p=0 to separate the guidewire.

[0336] 6) Advance the guidewire to its maximum permissible position to allow some clearance for further entrainment (to prevent the guidewire from exiting the lesion).

[0337] 7) Change the pressure in the film roll (to p low) to prepare for further winding.

[0338] 8) The film is fully wound up by pulling back the push element, which also pulls back the guide wire (connects).

[0339] 9) Reduce the pressure to p=0 to disengage the guidewire.

[0340] 10) Advance the complete catheter to the target lesion along the guidewire.

[0341] 11) Pull the guidewire back to the nearest side position while keeping the guidewire still in the lesion (to have some clearance for deployment).

[0342] 12) Increase the pressure within the internal volume of the roll film (set the pressure to p_high) in preparation for unfolding.

[0343] 13) Propel the driving element to allow the film roll to unfold.

[0344] 14) Reduce the pressure to p=0 to separate the guidewire.

[0345] 15) Pull the guidewire back to the nearest side position while keeping the guidewire still in the lesion (to have some clearance for deployment).

[0346] 16) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) in preparation for unfolding.

[0347] 17) Move the proximal handle (push element) through the lesion until it abuts against the multi-port handle (Luer connector). The membrane is thus maximally unwound at this position, and the push element slides in completely.

[0348] 18) Advance the guidewire to its maximum permissible position to have some clearance for further entrainment (to prevent the guidewire from exiting the lesion).

[0349] 19) Change the pressure in the film roll (to p low) to prepare for winding.

[0350] 20) The guidewire is wound in by pulling back the push element, which also pulls the guidewire back (connects). Since the guidewire may come out of the lesion site, complete winding is not possible.

[0351] 21) Reduce the pressure to p=0 to separate the guidewire.

[0352] 22) Advance the guidewire to its maximum permissible position to have some clearance for further entrainment (to prevent the guidewire from exiting the lesion).

[0353] 23) Change the pressure in the film roll (to p_low) to prepare for winding.

[0354] 24) The film is fully wound up by pulling back the push element, which also pulls back the guide wire (connection).

[0355] 25) Reduce the pressure to p=0 to separate the guidewire.

[0356] 26) Advance the complete catheter into the lesion along the guidewire.

[0357] 27) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) in preparation for unfolding.

[0358] 28) Begin advancing the driving element to allow the film roll to unfold.

[0359] 29) Propel the actuating element to allow the film roll to unfold.

[0360] 30) Reduce the pressure to p=0 to separate the guidewire.

[0361] 31) Pull the guidewire back to the nearest side position while keeping the guidewire still in the lesion (to have some clearance for deployment).

[0362] 32) Set the pressure (to p_low or p_high) to prepare for deployment (in this case, p_low is sufficient because the lesion has already been penetrated).

[0363] 33) Fully unfold the film by advancing the actuating element to return it to its initial state, ready to advance to the next lesion if necessary.

[0364] 34) Repeat steps 1 to 33, passing through another (long) lesion.

[0365] c) Passing over the guidewire, the inner shaft / guidewire remains in place during winding.

[0366] 1) Advance the complete catheter to approximately one roll length in front of the target lesion, with the roll in the unfolded state and the pusher element fully slid in (the pressure within the internal volume of the roll is zero (p=0)).

[0367] 2) Change the pressure in the film roll (to p_low) to prepare for winding.

[0368] 3) Wrap the membrane by advancing the outer shaft and pushing the handle / multi-port handle (Luer connector) to the target lesion while simultaneously holding the inner shaft with the guidewire in place.

[0369] 4) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) in preparation for unfolding.

[0370] 5) Begin advancing the driving element to allow the film roll to unfold.

[0371] 6) Move the proximal handle (push element) through the lesion until it abuts against the multi-port handle (Luer connector). The membrane will then be maximally unfolded at this position, and the push element will slide in completely.

[0372] 7) Reduce pressure (to p_low) to prepare for entrainment.

[0373] 8) Retract the complete catheter and guidewire back to about one roll length in front of the proximal end of the lesion.

[0374] 9) Wrap the membrane by advancing the outer shaft and pushing the handle / multi-port handle (Luer connector) into the target lesion while simultaneously holding the inner shaft with the guidewire in place.

[0375] 10) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) in preparation for unfolding.

[0376] 11) Begin advancing the driving element to allow the film roll to unfold.

[0377] 12) Move the proximal handle (push element) through the lesion until it abuts against the multi-port handle (Luer connector). The membrane is thus maximally unwound at this position, and the push element slides in completely.

[0378] d) Passing over the guide wire, the front of the film is held in place during winding.

[0379] 1) Move the complete catheter to the target lesion while the membrane roll is in the deployed state and the pusher element is fully slid in (the pressure inside the membrane roll is zero (p=0)). Increase the pressure inside the membrane roll (set the pressure to p_high) to prepare for deployment.

[0380] 2) Advance the guidewire to approximately one roll of membrane length distal to the target lesion.

[0381] 3) Change the pressure in the film roll (to p_low) to prepare for winding.

[0382] 4) Roll up the membrane by advancing the complete catheter to the target lesion while simultaneously retracting it along the inner axis to keep the front part of the membrane in the proper position (as seen in angiography).

[0383] 5) Increase the pressure within the internal volume of the film roll (set the pressure to p_high) in preparation for unfolding.

[0384] 6) Begin advancing the driving element to allow the film roll to unfold.

[0385] 7) Move the proximal handle (push element) through the lesion until it abuts against the multi-port handle (Luer connector). The roll of membrane will then be maximally unrolled at this position, and the push element will slide in completely.

[0386] 8) Reduce pressure (to p_low) to prepare for entrainment.

[0387] 9) Roll up the membrane by advancing the outer shaft and pushing the handle / multi-port handle (Luer connector) into the target lesion while simultaneously retracting the inner shaft to keep the front of the membrane in place (for angiography).

[0388] 10) Roll up the membrane by advancing the outer axis and pushing the handle / multi-port handle (Luer) into the target lesion while simultaneously retracting the inner axis to keep the front of the membrane in place (for angiography).

[0389] 11) Begin advancing the driving element to allow the film roll to unfold.

[0390] 12) Move the proximal handle (push element) through the lesion until it abuts against the multi-port handle (Luer connector). The membrane is thus maximally unwound at this position, and the push element slides in completely.

[0391] Example 13: Passing through and expanding the lesion without elongating the roll membrane along its longitudinal axis.

[0392] As pressure within the membrane increases, the membrane elongates or stretches along its longitudinal axis. Therefore, if the pressure within the membrane's lumen increases when the membrane comes into contact with the vessel wall or lesion, the vessel wall may stretch in its longitudinal direction. This is, for example, during the dilation of a lesion after passage by increasing pressure within the membrane's lumen. This longitudinal stretching of the vessel can lead to its dissection.

[0393] In addition to training, a special catheter handle design can be used to employ a (check) valve connected to the plunger to prevent the operator from increasing balloon pressure when the balloon contacts the vessel wall. Once the membrane begins to unwind, the valve shuts off the dilation pump. The valve should have over-control functionality that allows the physician to increase / decrease the pressure as needed.

[0394] The following method causes the lesion to expand without transmitting longitudinal force to the vessel wall, because once the balloon comes into contact with the vessel wall, the balloon pressure will not increase.

[0395] a) Before passing through, the pressure inside the membrane roll cavity increases to the rated burst pressure.

[0396] A method for traversing stenosis or chronic total occlusion, preferably using a catheter as described above, comprises the following steps in a sequential order:

[0397] a) Advance the catheter toward the narrow or chronically complete occlusion.

[0398] b) Optionally, a guidewire can be used to penetrate or pass through the stenosis or chronic total occlusion.

[0399] c) Increase the pressure inside the roll film to the rated burst pressure.

[0400] d) Unwind the film to its unfolded state, thereby allowing the film to penetrate or pass through narrow or chronically complete occlusions.

[0401] e) Reduce the pressure within the internal volume of the diaphragm to allow the diaphragm to rewind and / or prevent the guidewire from being clamped by the diaphragm.

[0402] f) Retract the membrane in the proximal direction away from any stenosis or chronic total occlusion that has been penetrated or crossed.

[0403] After step f), steps c) to f) can be repeated.

[0404] The rated burst pressure is the pressure at which 99.9% of the film roll will not burst, with a confidence level of at least 95%. The rated burst pressure can be determined according to ISO 25539-2.

[0405] Therefore, this method results in maximum expansion of the blood vessel relative to the maximally expanded convoluted membrane without transmitting longitudinal forces on the vessel wall. This reduces the risk of vessel wall rupture.

[0406] b) Pass through the lesion multiple times with increased pre-regulation pressure.

[0407] A method for traversing stenosis or chronic total occlusion, preferably using a catheter as described above, comprises the following steps in a sequential order:

[0408] a) Advance the catheter toward the narrow or chronically complete occlusion.

[0409] b) Optionally, a guidewire can be used to penetrate or pass through the stenosis or chronic total occlusion.

[0410] c) Increase the pressure within the internal volume of the film roll.

[0411] d) Unwind the film to its unfolded state, thereby allowing the film to penetrate or pass through narrow or chronically complete occlusions.

[0412] e) Reduce the pressure within the internal volume of the diaphragm to allow the diaphragm to rewind and / or prevent the guidewire from being clamped by the diaphragm.

[0413] f) Retract the membrane proximally, away from any stenosis or chronic total occlusion that has been penetrated or crossed.

[0414] g) Further increase the pressure within the internal volume of the film roll.

[0415] h) Unwind the roll of film to its unfolded state, thereby allowing the roll of film to penetrate or pass through narrow or chronically complete occlusions.

[0416] i) Reduce the pressure within the internal volume of the film roll, so that the guide wire is not clamped by the film roll.

[0417] j) Retract the membrane in the proximal direction away from any stenosis or chronic total occlusion that has been penetrated or crossed.

[0418] After step j), steps c) through f) can be repeated.

[0419] Therefore, instead of setting the pressure within the internal volume of the film roll to the rated burst pressure before unrolling, the film roll can be unrolled to its unfolded state, allowing it to penetrate or pass through narrow or chronically complete occlusions multiple times. Each time, there is a pre-adjusted increase in pressure within the internal volume of the film roll.

[0420] Additionally, before increasing the pressure within the internal volume of the roll film to unfold it into its unfolded state, the method may include unfolding the roll film to the proximal initiation of the narrow section at a lower pressure. This allows the roll film to better enter the narrow section because the distal end of the roll film can be anchored at the proximal initiation of the narrow section.

[0421] The above methods are not limited to vascular interventions, but can also be used in nerve conduits (neurovascular field), oncology, otolaryngology, endoscopy, urology, gastroenterology, gynecology, pulmonology, or nasolacrimal duct. Attached Figure Description

[0422] The following figures are provided to support an understanding of the invention:

[0423] Figure 1A-1B It is a cross-sectional view of a spiral membrane duct with a tapered distal end;

[0424] Figure 2A-2B It is a cross-sectional view of another rolled membrane duct with a straight distal end;

[0425] Figure 3 It is a cross-sectional view of a spiral-wound catheter with radiopaque markings;

[0426] Figure 4 This is a cross-sectional view of another membrane conduit with radiopaque markings;

[0427] Figure 5A-5I The method steps for traversing stenosis or chronic total occlusion without prior guidewire crossing are shown;

[0428] Figure 6A-6J The method steps for another approach to traverse a stenotic or chronic total occlusion without prior guidewire crossing are shown;

[0429] Figures 7A-7H The method steps for traversing a stenotic or chronic total occlusion are shown, wherein the guidewire is first passed through;

[0430] Figures 8A-8H An illustration of the steps of another method for traversing a stenotic or chronic total occlusion is shown, in which the guidewire is passed first;

[0431] Figure 9It is a cross-sectional view of the film-coated conduit including the bonding materials;

[0432] Figure 10 It is a cross-sectional view of another roll-film conduit including the bonding material;

[0433] Figure 11A-11K The method steps for another approach to traverse a stenosis or chronic total occlusion without prior guidewire crossing are shown;

[0434] Figure 12A-12R The method steps for another approach to traverse a stenotic or chronic total occlusion without prior guidewire crossing are shown;

[0435] Figure 13A-13R The method steps for traversing a stenosis or chronic total occlusion without prior guidewire crossing are shown;

[0436] Figure 14A-14L The method steps for another approach to traverse a stenotic or chronic total occlusion without prior guidewire crossing are shown;

[0437] Figures 15A-15P The method steps for another approach to traverse a narrow or chronic total occlusion without prior guidewire crossing are shown. Detailed Implementation

[0438] Figure 1A An example of a roll-up catheter 1 is shown with the roll-up membrane 2 in the rolled-up state, while Figure 1B shows a roll-up catheter 1 with the roll-up membrane 2 in the unfolded state (it has passed through a chronic total occlusion (CTO) / lesion).

[0439] The catheter 1 includes an outer shaft 6 and an inner shaft 7. The outer shaft 6 at least partially surrounds the inner shaft 7. Therefore, the diameter of the outer shaft 6 is larger than the outer diameter of the inner shaft 7. Because 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 a pressure port 13 so that the membrane 2 can be pressurized with fluid. The outer shaft 6 can be inserted into the patient's blood vessel at its distal end, while its proximal end remains outside the patient's body. Therefore, the outer diameter of the outer shaft 6 is smaller than that of the patient's blood vessel.

[0440] The catheter 1 also includes an actuating element 11, such as a metal rod, which is securely connected to the proximal portion and / or proximal end of the inner shaft 7. The actuating element 11 (e.g., the metal rod) partially surrounds the proximal portion and / or proximal end of the inner shaft 7. The inner shaft 7 and the actuating element 11 are slidably arranged within the outer shaft 7. Thus, the actuating element 11 can move axially relative to the outer shaft 6 together with the inner shaft. The actuating element 11 has an actuating handle 5 at its proximal end. The actuating element 11 and / or the actuating handle 5 include a through-hole for the guidewire 3 at its proximal end. The inner shaft 7 is made of a more flexible material than the actuating element 11.

[0441] The film 2 forms an internal volume 12 and includes a first end and a second end. The first end of the film 2 is attached to the distal portion and / or distal end of the inner shaft 7, and the second end of the film 2 is attached to the outer side of the distal portion of the outer shaft 6. The film is adapted to unfold from a wound state to an unfolded state in the longitudinal direction when pressurized and / or when the actuating element moves in the distal direction. Therefore, the film defines an internal volume that can be pressurized.

[0442] The catheter includes a guidewire 3, which is at least partially and slidably arranged within the inner shaft 7. The catheter 1 can be pushed onto the guidewire 3 to the treatment site within the patient, such as a blood vessel. The maximum permissible distal position of the guidewire tip is defined by the length of the guidewire 3. Guidewires of different lengths and / or diameters can be used. Furthermore, the guidewire 3 can be used to simply transmit movement of the guidewire 3 to the surface of the roll membrane 2 via friction and shear forces, thereby unrolling the roll membrane 2. This is particularly useful when the fluid pressure acting on the distal end of the roll membrane 2 is insufficient to allow the roll membrane 2 to pass through very tight lesions or when the entrance to the residual stenosis / CTO is very small and perpendicular to the guidewire 3 compared to the anterior portion of the roll membrane. Here, the guidewire helps guide the roll membrane 2 in the correct direction. The actuating element is pressure-sealed onto the multi-port handle 4 by a sliding annular seal 15, for example, in the form of a so-called "TuhoyBorst" seal.

[0443] The proximal portion and / or proximal end of the outer shaft 6 is connected to the multiport handle 4. The multiport handle 4 includes a first port for pressurizing and depressurizing the roll 2 and a second port for receiving the push element 11, wherein the inner shaft 7 and the guide wire 3 are arranged in the push element 11.

[0444] The diaphragm is pressure-sealed to the outer and inner shafts 7 (e.g., by corresponding welding), and the internal volume 12 of the diaphragm 2 can be pressurized by fluid. The fluid can be supplied through the diaphragm pressure port 13.

[0445] exist Figure 1A and 1B In the middle, the inner shaft 7 includes a tapered distal end 8, while... Figure 2A In 2, the inner shaft 7 has a tubular distal end or distal end.

[0446] Figure 2A An example of a rolled-up membrane conduit 1 is shown, wherein the rolled-up membrane 2 is in the wound-up state, while Figure 2B The image shows a rolled membrane catheter 1 with the rolled membrane 2 in an unfolded state (it has passed through a chronic total occlusion (CTO) / lesion).

[0447] Figure 3 and Figure 4 They are shown respectively Figure 2A The rolled membrane catheter, and Figure 3 and Figure 4 The catheter also includes at least one non-transmissive marker.

[0448] Figure 3 A catheter is shown in which an inner shaft 7 includes at least one radiopaque mark 8 attached to the distal end of the inner shaft 7, and an outer shaft 6 includes at least one radiopaque mark 8 attached to the distal end of the outer shaft 6.

[0449] Figure 4 A catheter is shown in which an inner shaft 7 includes at least one radiopaque mark 8 attached to a distal portion and distal end of the inner shaft 7, and an outer shaft 6 includes at least one radiopaque mark 8 attached to the distal end of the outer shaft 6.

[0450] Figure 5A-5I The illustration depicts the steps of a method for traversing a stenosis or chronic total occlusion (CTO) without a guidewire 3 in the absence of a pre-existing guidewire. In this method, the first end of a roll-up membrane 2 is attached to the distal end of an inner shaft 7. First, the catheter 1 is advanced to the target lesion in a rolled-up state. The internal pressure within the roll-up membrane 2 is the same as atmospheric pressure. Then, the guidewire 3 is pulled back to the distal marked position or further to ensure that the guidewire tip remains behind the front of the roll-up membrane throughout the traversal of the stenosis / CTO. The pressure in the internal volume 12 of the roll-up membrane 2 is increased via a pressure port 13 in preparation for deployment. A push element is advanced distally to allow the roll-up membrane 2 to deploy. When the roll-up membrane 2 is fully deployed, the push handle 5 abuts against the proximal end of a multi-port handle 4 (e.g., a Luer connector). Thus, the roll-up membrane 2 is deployed to its maximum position, and the guidewire is not clamped by the roll-up membrane 2. When the roll-up membrane 2 is fully deployed (meaning when the push element is fully slid into the outer shaft and multi-port handle 4), the distal end 9 of the inner shaft 7 is no longer in front of the roll-up membrane 2. If the lesion is short and has therefore been crossed, the roll-up can be depressurized and the catheter can be pulled out of the patient. Thus, the pressure is reduced to prepare for roll-up. The roll-up 2 is then pulled back by the push element 11. The roll-up catheter 1 is now ready to repeat these steps to cross another lesion, or, in the case of a longer lesion, to further advance the catheter to or through the longer lesion.

[0451] In the case of long lesions, the catheter can be retracted to approximately one roll length proximal to the lesion end before it passes through. For example, the roll can be wound up by advancing the outer shaft and multi-port handle 4 and / or pushing handle 5 into the target lesion, and the inner shaft 7 with guidewire 3 can be held in place or the inner shaft 7 can be retracted simultaneously to hold the front of the roll 2 in place.

[0452] Figure 6A-6JThe method steps for traversing stenosis or chronic total occlusion without prior passage of guidewire 3 are shown. In this method, the first end of the roll membrane (2) is attached to the distal portion of the inner shaft 7 instead of the distal end. Therefore, with Figure 5A-5I In contrast to the method described herein, when the diaphragm is fully unwound (meaning when the push element is fully slid into the outer shaft and multi-port handle), the distal end 9 of the inner shaft 7 is positioned in front of the diaphragm 2. This reduces the risk of damage to both the diaphragm 2 and the guidewire 3 by avoiding or at least reducing contact between them. However, necessary modifications have been made to the method steps, such as… Figure 5A-5I As described in [the text].

[0453] Figures 7A-7H The method steps for traversing stenosis or chronic total occlusion after prior guidewire passage are shown. The method steps are similar to... Figure 5A-5I The same as described in the text, except that after the catheter 1 is advanced to the target lesion and before the pressure in the internal volume 12 of the roll membrane 2 is increased, the guidewire 3 is advanced distally to penetrate or pass through the lesion (stenosis or chronic total occlusion).

[0454] Figures 8A-8H The method steps for traversing stenosis or chronic total occlusion after prior guidewire passage are shown. The method steps are similar to... Figure 6A-6J The same as described in the text, except that after the catheter 1 is advanced to the target lesion and before the pressure in the internal volume 12 of the roll membrane is increased, the guidewire is advanced distally to penetrate or pass through the lesion (stenosis or chronic total occlusion).

[0455] Figure 9 A cross-sectional view of a roll-up conduit is shown, which includes a bonding material 10 attached to the distal and end portions of the inner shaft 7 and the first end of the roll-up membrane 2.

[0456] Figure 10 This is a cross-sectional view of another roll-on catheter, which includes a connecting material 10 attached to the distal end of the inner shaft 7 and the first end of the roll-on 2. The connecting material 10 can also serve as the distal end of the inner shaft 7.

[0457] For example, if the inner shaft 7 is made of PEEK, the roll film can be attached to the distal portion and / or distal end of the inner shaft 7 via polyamide (PA12) as the bonding material 10, since PEEK is not solderable.

[0458] Figure 9 and 10 The tapered transition from the roll film 2 to the inner shaft 7 is shown.

[0459] Figure 11A-11KThe method steps for another approach to traversing stenosis or chronic total occlusion without prior passage of guidewire 3 are shown. This method involves a single deployment of the roll membrane 2, making it well-suited for traversing relatively short lesions. In the first step shown in Figure 11A, catheter 1 is moved to the target lesion while the roll membrane 2 is deflated, i.e., the pressure inside the roll membrane 2 is equal to or less than the pressure outside the roll membrane 2. This pressure is indicated as p=0 in the figures and below. Such a pressure can be equal to or less than one atmosphere, i.e., 1013.15 hPa, or equal to or less than zero bar. Preferably, the pressure is between 0 bar and -1 bar. Afterward, guidewire 2 is pulled back to the position of the radiopaque marker 8 or even further back to ensure that the guidewire tip remains behind the front of the roll membrane 2 during traversal, as shown below. Figure 11C As shown. In the next step, the pressure of roll 2 is increased to p = high to prepare for the unwinding of roll 2, see [reference]. Figure 11E And push the handle 5 to allow the roll film 2 to unfold, see Figure 11F The exact extent of the development depends on the length of the lesion. Figure 11H In the middle, push handle 5 against multi-port handle 4 to maximize the unfolding of membrane 2. Even in this fully unfolded position, the cone of membrane 2 remains hidden (wound in), and only the cylindrical portion is visible. That is, when membrane 2 is fully unfolded (and guidewire 3 is fully slid in), the end is not visible in front of membrane 2. When only one lesion needs to be traversed, the pressure of membrane 2 can be reduced to p=0, and catheter 1 can be pulled out from the patient. In the case of subsequently traversing one or more other lesions, the pressure of membrane 2 is reduced to p=low, but not to p=0, to prepare for the rewinding of membrane 2, as... Figure 11I As shown. The reduced pressure is indicated as p=low in the accompanying drawings and below. The pressure p=low is higher than the pressure outside the film roll, but lower than the pressure p=high. p=low can be higher than one atmosphere or higher than 0 bar. Then, the film roll 2 is wound back by pulling back the push handle 5, see [reference]. Figure 11J Then, reduce the pressure to p=0, see [link / reference]. Figure 11K And repeat the previous steps regarding crossing the first lesion.

[0460] Figure 12A-12R The method steps for traversing stenosis or chronic total occlusion without prior passage of guidewire 3 are shown. This method involves multiple unfoldings of the roll membrane 2, making it well-suited for traversing relatively long lesions. In the first step, as... Figure 12A As shown, when the pressure within the membrane 2 is p=0, the catheter 1 moves to the target lesion. Afterwards, the guidewire 3 is pulled back to the position of the radiopaque marker 8 or even further back to ensure that the guidewire tip remains behind the front of the membrane during passage, as shown. Figure 12BAs shown. In the next step, the pressure of roll 2 is increased to p = high to prepare for the unwinding of roll 2, see [reference]. Figure 12C And push the handle 5 to allow the roll film 2 to unfold, see Figure 12D Thus, membrane 2 begins to penetrate the lesion, see... Figure 12E .exist Figure 12F In the middle, push handle 5 against multi-port handle 4 to maximize the unfolding of the diaphragm 2. Even in this fully unfolded position, the cone of the diaphragm 2 remains hidden (wound in), and only the cylindrical portion is visible. That is, when the diaphragm 2 is fully unfolded (and the guide wire 3 is fully slid in), the end is not visible from the front of the diaphragm 2. Subsequently, as... Figure 12G As shown, the pressure inside film roll 2 is reduced to prepare for rewinding. Then, film roll 2 is rewound by pulling back the push handle 5. See [link to relevant documentation]. Figure 12H Subsequently, as Figure 12K As shown, the pressure remains low as the catheter is advanced into the lumen created in the lesion by the previous steps of this method. Once the distal end of catheter 1 reaches the backplate of the lumen or fills the lumen, the pressure within the roll membrane 2 increases, see [link to diagram]. Figure 12M Then, guidewire 3 is advanced forward to allow membrane 2 to unwind, see [link to relevant documentation]. Figure 12N After roll 2 is unrolled, reduce the pressure inside roll 2 to prepare for rewinding. See [link to relevant documentation]. Figure 12P As previously stated, the film roll 2 is wound back by pulling back the push handle 5, see [link to previous text]. Figure 12Q This prepares for the further unfolding of membrane 2, as described in the previous steps. Alternatively, the pressure on membrane 2 can be further reduced to p=0, allowing catheter 1 to move through the lesion to advance to the next lesion, see [link to previous steps]. Figure 12R .

[0461] Figure 13A-13R The method steps for traversing stenosis or chronic total occlusion in the absence of prior passage of guidewire 3 are shown. This method involves multiple unfoldings of the roll membrane 2, making it well-suited for traversing relatively long lesions. (Compared to...) Figure 12A-12R Compared to the method shown, Figure 13A-13R The method shown involves advancing guidewire 3 within the lumen created in the lesion, while... Figure 12A-12R In the method shown, the guidewire is not advanced within the lumen created in the lesion. Figure 13A-13R The method shown is the same as Figure 12A-12R The difference in the method shown is that after the film 2 is wound back by pulling back the push handle 5, the pressure inside the film 2 is further reduced, preferably to p=0, see [link to relevant documentation]. Figure 13I Subsequently, guidewire 3 is advanced through the roll membrane 2 into the lumen created in the lesion, see [link to relevant documentation]. Figure 13JThen, before pulling guidewire 3 back to the position of radiopaque marker 8 or even further back, advance catheter 1 into the lumen formed in the lesion, see [link to relevant documentation]. Figure 13K .

[0462] Figure 14A-14L The method steps for traversing stenosis or chronic total occlusion in the absence of prior guidewire crossing are shown. This method involves multiple unfoldings of the roll membrane 2, making it particularly suitable for traversing relatively long lesions. Figure 14A-14L The method shown is the same as Figure 12A-12R and Figure 13A-13R The difference in the method shown is that, after forming the lumen into the stenosis and subsequently reducing the pressure within the roll membrane 2 to p=low, the roll membrane 2 is wound in by advancing the outer shaft 6 and the multi-port handle 4 toward the target lesion while simultaneously retracting the inner shaft 7, so that the front portion of the roll membrane 2 remains in place. See [link to relevant documentation]. Figure 14G The position of the anterior portion of membrane roll 2 can be examined via angiography. Afterward, the pressure within membrane roll 2 is increased again to p=high to prepare for the next unfolding of membrane roll 2. If, after the next roll-up of membrane roll 2, it passes through a lesion and does not pass through another lesion, membrane roll 2 can be deflated, i.e., the pressure within membrane roll 2 is set to p=0. When further unfolding of membrane roll 2 is to be performed, the pressure within membrane roll 2 is reduced to p=low to prepare for the roll-up of membrane roll 2, see [link to relevant documentation]. Figure 14J-14L .

[0463] Figures 15A-15P The method steps for another approach to traversing stenosis or chronic total occlusion without prior passage of guidewire 3 are shown. This method involves multiple unfoldings of the roll membrane 2, making it particularly suitable for traversing relatively long lesions. Figures 15A-15P The method shown is the same as Figure 13A-13R and Figure 14A-14L The difference in the method shown is that, after the initial unfolding of membrane 2, the pressure within membrane 2 is reduced to p=low, and then catheter 1 is retracted to one membrane length in front of the new proximal lesion end. See [link to relevant documentation]. Figure 15G Subsequently, the diaphragm 2 is wound in by advancing the outer shaft 6 and the multi-port handle 4 into the target lesion while simultaneously holding the inner shaft 7 with the guidewire 3 in place, see [link to relevant documentation]. Figure 15H Next, deflate membrane 2, that is, set the pressure inside membrane 2 to p=0 and pull back guide wire 3, see [link to relevant documentation]. Figure 15I and Figure 15J In the next step, the pressure inside roll 2 is set to p = high to prepare for the unwinding of roll 2. See [link to relevant documentation]. Figure 15K And push the push handle 5 to unfold the roll film 2, see Figure 15L . Figure 15M-15PThe subsequent method steps shown correspond to the winding of film 2 and possible further unfolding of film 2, as previously described, for example, regarding Figure 12P-12R As stated above.

[0464] List of reference numerals

[0465] 1. Catheter

[0466] 2. Roll film

[0467] 3. Guide wire

[0468] 4-port handle

[0469] 5. Push the handle

[0470] 6. Outer shaft

[0471] 7 Inner Shaft

[0472] 8. Non-transmissive markings

[0473] 9. The distal end of the inner shaft

[0474] 10. Combining materials

[0475] 11. Driving element

[0476] 12. Internal volume of the film roll

[0477] 13 Pressure port (inflation / deflation port)

[0478] 14. Drive element / guide wire port

[0479] 15 Sliding seal

[0480] P is the maximum permissible distal position of the guidewire tip.

Claims

1. A catheter (1) comprising: a roll membrane (2) adapted to be unrolled from a rolled-in state to an unrolled state in a longitudinal direction and vice versa, and defining an inner volume (12) which 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 roll membrane (2) is attached to a distal portion and / or distal end of the inner shaft (7) and a second end of the roll membrane (2) is attached to a distal portion and / or distal end of the outer shaft (6); wherein the catheter (1) further comprises at least one push element (11) connected to and surrounding a proximal portion and / or proximal end of the inner shaft (7); wherein the catheter (1) does not comprise a further balloon connected to the inner shaft (7); and wherein the catheter optionally comprises a guide wire (3) at least partially arranged within the inner shaft (7).

2. The catheter (1) according to claim 1, wherein The first end of the roll 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 roll membrane (2) is attached to the outside 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 roll membrane (2) is attached to the distal portion and / or 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 atraumatic distal tip (8) or is connected to the bonding material or atraumatic distal tip (8) at its distal end, wherein preferably the atraumatic distal tip (8) is formed by the bonding material.

6. The catheter (1) according to any one of the preceding claims, wherein The push element (11) is a metal tube.

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

8. The catheter (1) according to any one of the preceding claims, wherein A proximal portion and / or proximal end of the outer shaft (6) is connected to a multiport handle (4) comprising a first port for pressurizing and depressurizing the roll membrane (2) and / or for injecting contrast agent and a second port for receiving the push element (11), wherein the inner shaft (7) and optionally the guide wire (3) are arranged in the push element (11).

9. The catheter (1) according to claim 8, wherein The catheter (1) further comprises a sliding seal connected to the push element (11) and the multiport handle (4).

10. Catheter (1) according to any one of the preceding claims, wherein The inner shaft (7) comprises at least one radiopaque marker (8) attached to a distal portion and / or distal end of the inner shaft (7), and wherein the outer shaft (6) comprises at least one radiopaque marker (8) attached to a 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 chronic total occlusion using the catheter of any one of claims 1 to 10, the method comprising the following steps in consecutive order: i) advancing the catheter (1) towards the stenosis or chronic total occlusion, ii) increasing the pressure in the inner volume (12) of the bellows (2) to unfold the bellows to an unfolded state and advancing the catheter into or through the stenosis or chronic total occlusion without previously crossing the lesion with a guidewire, iii) reducing the pressure in the inner volume (12) of the bellows (2), and iv) retracting the catheter (1) in proximal direction away from the penetrated or crossed stenosis or chronic total occlusion, optionally repeating steps i) to iv).

13. A method for crossing a stenosis or chronic total occlusion using the catheter of any one of claims 1 to 10, the method comprising the following steps in consecutive order: v) advancing the catheter (1) towards the stenosis or chronic total occlusion, w) increasing the pressure in the inner volume (12) of the bellows (2) to unfold the bellows to an unfolded state and advancing the catheter (1) into or through the stenosis or chronic total occlusion while the guidewire (3) resides within the inner shaft (7) and maintains its position during unfolding and rolling up of the bellows, x) advancing the outer shaft (6) and the multiport handle (4) and / or the push handle (5) to roll up the bellows (2), y) reducing the pressure in the inner volume (12) of the bellows (2) to deflate the bellows (2), and z) retracting the catheter (1) in proximal direction away from the penetrated or crossed stenosis or chronic total occlusion, optionally repeating steps w) to z).

14. A method for crossing a stenosis or chronic total occlusion using the catheter of any one of claims 1 to 10, the method comprising the following steps in consecutive order: xi) advancing the catheter (1) towards the stenosis or chronic total occlusion, xii) increasing the pressure in the inner volume (12) of the bellows (2) to unfold the bellows (2) to an unfolded state and advancing the catheter (1) into or through the stenosis or chronic total occlusion, xiii) advancing the outer shaft (6) and the multiport handle (4) and / or the push handle (5) to roll up the bellows (2) while retracting the inner shaft (7) to keep the front of the bellows (7) in place while allowing controlled unfolding and rolling up movement, xiv) reducing the pressure in the inner volume (12) of the bellows (2) so that the guidewire (3) is not pinched by the bellows (2), and xv) retracting the catheter (1) in proximal direction away from the penetrated or crossed stenosis or chronic total occlusion, optionally repeating steps xii) to xiv).

15. A method for crossing a stenosis or chronic total occlusion using the catheter of any one of claims 1 to 10, the method comprising the following steps in consecutive order: j) penetrating or crossing the stenosis or chronic total occlusion with a guidewire (3), k) advancing the catheter (1) towards the stenosis or chronic total occlusion, l) increasing the pressure in the interior volume (12) of the balloon (2), m) advancing the push element (11) to unfold the balloon (2) into an unfolded state, thereby penetrating or crossing the stenosis or chronic total occlusion with the balloon (2), n) decreasing the pressure in the interior volume (12) of the balloon (2) such that the guidewire (3) is not clamped by the balloon (2), o) pulling the push element (11) in proximal direction to wind the balloon (2) in, and p) retracting the catheter (1) in proximal direction away from the penetrated or crossed stenosis or chronic total occlusion, optionally repeating steps 1) to p).

Images