Optimized design of rolling film and catheter of rolling film catheter

Abstract

The invention relates to a rolling film catheter and a method for manufacturing a rolling film catheter. A method for connecting an inner shaft and an outer shaft to a rolling film is also described. The rolling film may include a trauma resistant tip that forms a distal tip of the catheter when the rolling film is in a rolled state.

Description

Technical Field

[0001] The present invention relates to different catheters including rolling membranes and methods for manufacturing the same. Background Art

[0002] In the past few years, changing living environments (e.g., stressful daily life, unhealthy nutritional habits, lack of exercise, smoking, etc.) have led to an increase in coronary artery and / or artery-related diseases. These diseases may generally cause dangerous effects on the health status of patients (e.g., stenosis and / or occlusion of blood vessels), and may deteriorate in some cases, leading to an increased mortality rate of affected patients.

[0003] To avoid life-threatening situations, it may be crucial to diagnose corresponding diseases and / or allow the cure of diseases in the early stages of the diseases, where the risk to the patient should preferably be as low as possible. Preferred minimally invasive methods that support the early diagnosis and / or cure of such diseases are based on the use of catheters. In most cases, a catheter can be implemented as a hose-like device in a tubular shape, which can be inserted into a patient's body and can move along arteries and / or veins until an abnormality (e.g., stenosis) in the patient's blood vessels. Such a catheter can be adapted to deliver medical devices (e.g., cameras, stents, etc.) and / or drugs to the affected area of the patient's blood vessels to diagnose and / or cure the corresponding diseases. In some cases, the forward movement of the catheter (e.g., in the distal direction) and / or the backward movement of the catheter (e.g., in the proximal direction) may become difficult, especially in cases where the blood vessels are blocked (e.g., calcified) and / or curved.

[0004] The use of rolling membrane catheters can contribute to improving the operation of catheters under the above conditions. However, existing rolling membrane catheters still show disadvantages when used for diagnostic and / or therapeutic applications.

[0005] For example, when the rolling membrane is at least partially wound up, the rolling membrane may sometimes exhibit undesired folding, which in some exemplary cases may counteract the further winding up and / or movement of the rolling membrane in the proximal direction. In addition, rolling membrane catheters are generally deployed along a patient's blood vessel. However, it may not always be easy to insert a guide wire into the rolling membrane and it may cause damage to the rolling membrane. In addition, the movement of the rolling membrane catheter in the distal direction along the patient's blood vessel may be associated with an increased risk of causing lesions at the inner wall of the patient's blood vessel in some cases, especially if the rolling membrane is in a wound-up state. In addition, in such a wound-up state, the bending modulus of the distal end of the rolling membrane catheter should not be higher than that of the guide wire, otherwise the distal end will not be able to follow the path laid by the guide wire. Summary of the Invention

[0006] Therefore, there is a need to further improve existing rolling membrane catheters. This need can be satisfied at least in part by a first aspect of the present invention relating to a catheter. The catheter may include a rolling membrane and an atraumatic tip that forms the distal end of the catheter when the rolling membrane is in the rolled-up state. Even when the membrane is in the rolled-up state, the atraumatic tip can advantageously contribute to simplifying the movement of the rolling membrane catheter along the patient's blood vessel by preventing damage / injury to the inner wall of the blood vessel.

[0007] Generally, the catheter may be adapted to have a rolling membrane that unfolds in the distal direction along the patient's blood vessel to allow for friction-reduced movement of the catheter along the patient's blood vessel. However, in a typical scenario, the catheter is first moved to the desired location within the patient, and only at that point can the rolling membrane be unfolded. If the rolling membrane is in the rolled-up state, generally the outer shaft forms the distal end of the catheter, and the rolling membrane is disposed within the outer shaft for unfolding. This presents a potential risk of damage to the inner wall of the blood vessel. By having an atraumatic tip that forms the distal end of the catheter when the membrane is in the rolled-up state, this risk is reduced.

[0008] The rolling membrane may be adapted to unfold in the distal direction and along the patient's blood vessel. The atraumatic tip may preferably include a conical shape for supporting simplified movement of the catheter along the patient's blood vessel in the distal direction. The most distal end of the atraumatic tip may be set in a curved shape for further supporting the propagation of the atraumatic tip and the catheter connected thereto along the patient's blood vessel. The atraumatic tip may preferably be provided with a maximum diameter that is smaller than the diameter of the patient's blood vessel into which the catheter is to be inserted. The atraumatic tip may be configured to receive a guide wire at a central region of the atraumatic tip. The guide wire may extend from the proximal end of the catheter to the distal end of the catheter (and optionally further extend in the distal direction along the patient's blood vessel).

[0009] When the rolling membrane unfolds, the rolling membrane may be adapted to move to a position away from the position of the atraumatic tip.

[0010] When the rolling membrane is deployed in the distal direction, the atraumatic tip may be adapted to allow the rolling membrane to exit the catheter at least partially through the opening of the atraumatic tip. If the rolling membrane is in a rolled-up state, the rolling membrane may be entirely located in a position proximal to the atraumatic tip. The atraumatic tip may be adapted to form a transition zone when the membrane is deployed. The flexibility of the deployed (distal) membrane may be high, and the flexibility of the atraumatic tip may be slightly lower, but still higher than, for example, the flexibility of the outer shaft of the catheter, in which the rolling membrane may be located in the deployed state. At least the distal portion of the atraumatic tip may be adapted to be widened in a direction perpendicular to the axial direction of the catheter, preferably due to the deployment of the rolling membrane. The atraumatic tip may be at least partially connected to the outer shaft of the catheter, which at least partially surrounds the rolling membrane. The atraumatic tip may be configured to be in a first (closed) state when the rolling membrane is in a rolled-up state. The atraumatic tip may be configured to be widened to a second (open) state when the rolling membrane is at least partially deployed. For example, the pressure within the rolling membrane may apply a radial force to the atraumatic tip such that its inner diameter may be widened.

[0011] By providing an atraumatic tip that can be widened, the delivery of medical devices / instruments and / or medical drugs can be supported (e.g., by widening the atraumatic tip) without adversely affecting the atraumatic properties of the atraumatic tip when the catheter is moved in the distal direction along the patient's blood vessel (e.g., when the atraumatic tip is in a closed state). The atraumatic tip 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 polyamide-based elastomers, polyester-based elastomers, polyolefin-based elastomers, and / or any other suitable type of elastomer or plastic / polymer material. In some exemplary embodiments, the atraumatic tip may be made of a combination of one or more of the foregoing materials.

[0012] By providing a trauma - resistant tip that includes an elastomer, the trauma - resistant tip can have an increased failure strain and can deform under strain and tension without breaking. Additionally, since the simplification of forming the trauma - resistant tip including the elastomer can be facilitated, a simplified and cost - effective manufacturing process of the trauma - resistant tip can be supported, such as by thermoforming. Moreover, the elastomer can provide increased biocompatibility, thus avoiding allergic reactions in patients. The trauma - resistant tip can be formed from a portion of a rolling membrane. In some exemplary embodiments, as seen in the rolled - up state of the rolling membrane, at least the distal portion can be adapted to not fully fold inwards onto itself (e.g., fold into the inner lumen of the rolling membrane), and instead can be adapted to partially form the trauma - resistant tip. By forming the trauma - resistant tip from a portion of the rolling membrane, a simplified catheter design can be facilitated (e.g., because fewer components need to be assembled), which can reduce the manufacturing cost and recyclability of the catheter. In other examples, the rolling membrane can be adapted such that in the fully retracted state, the distal portion of the rolling membrane remains deployed. For example, the distal portion of the membrane can include increased stiffness compared to the rest, e.g., as provided by thermoforming, in order to form a trauma - resistant tip with suitable elasticity. Additionally or alternatively, a pressure within a predetermined range can be applied to the distal portion of the membrane in order to provide suitable elasticity.

[0013] The trauma - resistant tip can be permanently attached to the rolling membrane and / or the outer shaft of the catheter (e.g., the rolling membrane can be attached to the outer shaft). In some examples, the trauma - resistant tip can include a compressible material, preferably plastic foam. Additionally or alternatively, the trauma - resistant tip can be adapted to be retractable via the inner lumen of the rolling membrane. For example, the trauma - resistant tip can be provided with a trauma - resistant tip shaft that extends from the trauma - resistant tip to the proximal end of the catheter. The trauma - resistant tip shaft can be provided with a narrow inner lumen that can, for example, surround a guide wire. Then, the trauma - resistant tip can be retracted, for example, before the rolling membrane is deployed. Thus, an unobstructed deployment of the rolling membrane can be ensured.

[0014] A second aspect relates to a catheter that can include a rolling membrane and a protective element, wherein the protective element can be arranged within the inner lumen of the rolling membrane for protecting the rolling membrane when a guide wire is inserted into the rolling membrane from the distal end of the catheter.

[0015] The rolling membrane can include polyamide - based elastomers (e.g., PA12 or Pebax), polyesters (e.g., PET), polyester - based elastomers (e.g., Hytrel), polyurethanes, polyolefin - based elastomers (e.g., EPDM / EPDM - PP), and / or any other suitable materials.

[0016] When the rolling membrane is in the wound state, the protection element can be arranged in the inner lumen of the rolling membrane. By providing a protection element for the rolling membrane, it can facilitate the insertion of a guide wire into the inner shaft of the rolling membrane (especially if the rolling membrane is in the wound state) without damaging the rolling membrane. The damage may be caused, for example, by the sharp end of the guide wire and / or by the unwanted friction generated by the guide wire contacting the inner wall of the rolling membrane, such as when the guide wire is inserted distally into the rolling membrane. The distal end of the protection element may include a larger diameter compared to the proximal end of the protection element to facilitate the insertion of the guide wire. The protection element may include a funnel-shaped configuration. The distal end of the protection element may be provided with a diameter that is at least 1.5 times as large as the diameter of the proximal end of the protection element. Alternatively, the distal end may be provided with a diameter that is at least 2 times, 3 times, 4 times, 5 times, 6 times or even up to 10 times as large as the diameter of the proximal end. In some exemplary embodiments, the diameter of the distal end may differ from the diameter of the proximal end by at least 0.5 French, 1 French, 1.5 French, 2.0 French, 2.5 French, 3 French, 3.5 French, 4.0 French or more. 1 French is defined as 1 / 3 mm. The funnel-shaped configuration of the protection element can advantageously support the simplified insertion of the guide wire into the inner lumen of the rolling membrane because a larger opening cross-section of the distal end of the inner lumen of the rolling membrane can be artificially provided. The protection element may include one or more predetermined break points extending along the axial direction of the catheter.

[0017] The one or more predetermined break points may be provided as corresponding one or more perforations and / or notches in the protection element. For example, one or more dot-shaped perforations and / or indentations may be provided. Additionally or alternatively, one or more break points may be provided as corresponding one or more slits or grooves (each slit or groove preferably extending along the axial direction of the catheter). By providing one or more predetermined break points in the protection element, it can facilitate the removal of the protection element from the catheter after the guide wire is inserted and before the catheter is inserted into a patient's blood vessel.

[0018] The protective element may also be provided with a color and / or material different from that of the rolling membrane and / or the rest of the catheter (e.g., the outer shaft). The protective element may be provided with a signal color (e.g., a bright color such as yellow, green, etc.) and / or a different tactile sensation from the rest of the catheter. By providing the protective element with a color / different tactile sensation, it can be ensured that the protective element can be clearly visible to medical staff as a protector that needs to be removed after the guide wire is inserted. The protective element may include at least one distal portion. The protective element may be adapted to be removed from the catheter by pulling at least one distal portion and thus tearing the protective element along the axial direction of the catheter (preferably along one or more break points). As seen with respect to the axial direction of the catheter, the protective element may be provided with at least two break points that are arranged opposite to each other such that when the protective element is torn along two opposite directions with respect to the axial direction of the catheter, the protective element can be divided into two semi-cylindrical portions. Tearing the protective element may allow for the simple removal of the protective element before inserting the catheter into the patient's blood vessel.

[0019] A third aspect of the present invention relates to another catheter. The catheter may include a rolling membrane, wherein the rolling membrane may be provided with at least one reinforcing means adapted to support the winding of the rolling membrane. Providing at least one reinforcing means for the rolling membrane may, for example, counteract (and preferably prevent) the bulging of the rolling membrane when the rolling membrane is wound. In some cases, bulging may be understood as at least a partial overlap of at least two layers of the rolling membrane. In some (extreme cases), bulging may be understood as a bellows-like deformation of the rolling membrane along at least the cylindrical portion of the rolling membrane, as seen when the rolling membrane is fully unfolded. In some examples, the at least one reinforcing means may also counteract (and preferably prevent) the winding of the membrane at an undesired location (e.g., at the location where it is connected to the outer shaft of the catheter). Thus, the third aspect can advantageously contribute to the simplified handling of the catheter, especially by reducing the risk of complications caused by the winding of the rolling membrane. This can increase the safety of using the catheter and can avoid excessive time consumption by medical staff due to the undesired winding behavior of the rolling membrane.

[0020] The catheter may include, for example: an inner shaft, to which a first end portion of the rolling membrane is attached. The first end portion of the rolling membrane may be adapted to form an angle with the inner shaft that is less than 180° and greater than 30°, preferably less than 120° and greater than 60°, for supporting the winding-in of the rolling membrane. By providing a relatively large angle, the winding-in of the rolling membrane at the first end portion can be facilitated. Thus, the relatively large angle can be regarded as a strengthening means, as it counteracts the uncontrolled folding and / or bulging of the membrane at undesired positions, but facilitates the winding-in at the first position. In a preferred embodiment, when the rolling membrane is in the deployed state, the first end portion of the rolling membrane may be located at the distal end of the rolling membrane. At least the distal portion of the rolling membrane (e.g., arranged at the first position) may preferably be made of a flexible material for supporting the flexible inward folding of the rolling membrane, thus supporting the winding-in of the rolling membrane.

[0021] The catheter may further include an outer shaft, to which a second end portion of the rolling membrane may be attached, wherein the second end portion of the rolling membrane may be adapted to form an angle with the outer shaft that is greater than 0° and at most 30°, more preferably an angle of 1° to 20°, and most preferably 5° to 7°, for supporting the winding-in of the rolling membrane. By configuring the second end portion of the rolling membrane such that it can form the above-mentioned angle with the outer shaft, an undesired overlap of at least two layers of the rolling membrane at at least the second end portion of the rolling membrane can be avoided. This can ensure that the rolling membrane can, for example, fold inwardly into itself from the first end portion of the rolling membrane, and can inhibit / avoid an undesired bulging of the rolling membrane at its second end portion.

[0022] In a preferred embodiment, when the rolling membrane is in the deployed state, the second end portion of the rolling membrane may be located at the proximal end of the rolling membrane. The second end portion of the rolling membrane may preferably be made of a material that is less flexible than the material that can be used, for example, to form the distal portion (e.g., the first end portion) of the rolling membrane by thermoforming. In some embodiments, the second end may be made of a non-flexible (e.g., non-bendable) material.

[0023] The at least one reinforcement device may include at least one linear element that extends at least partially along the axial direction of the catheter and / or extends helically around the axial direction of the catheter and / or extends around the axial direction of the catheter in a zigzag pattern. In some exemplary embodiments, the at least one reinforcement device may be provided as at least one reinforcement wire. The at least one reinforcement wire may be made of nitinol and / or any other shape memory alloy and / or any other suitable material that can provide reinforcement capabilities. The at least one reinforcement device may be attached to the outer surface of the rolling membrane (e.g., intended for container contact in the deployed state) by, for example, welding and / or gluing and / or any other suitable procedure. Additionally or alternatively, the at least one reinforcement device may be incorporated into the rolling membrane such that the at least one reinforcement device may be located within the volume of the material of the rolling membrane (e.g., the at least one reinforcement device may not be visible at the surface of the rolling membrane). The at least one reinforcement device may additionally or alternatively be provided by the tapered shape of the rolling membrane such that when the rolling membrane is rolled up, the smaller diameter portion of the rolling membrane is inserted into the larger diameter portion of the rolling membrane.

[0024] The rolling membrane may be configured such that when in the deployed state, it includes a smaller diameter at the distal portion of the rolling membrane compared to the proximal portion of the rolling membrane. In some exemplary embodiments, the diameter of the rolling membrane may increase, for example, linearly (e.g., at least linearly in a certain portion). In some exemplary embodiments, the diameter of the rolling membrane may reach a maximum value between the distal portion and the proximal portion of the rolling membrane such that the diameter at the distal end of the rolling membrane and the diameter at the proximal end of the rolling membrane are both less than the maximum diameter. In some exemplary embodiments, the position of the maximum diameter of the rolling membrane (relative to the axial direction of the catheter) may be closer to the proximal end of the rolling membrane compared to the distal end of the rolling membrane (as seen in the deployed state).

[0025] A method for connecting an inner shaft and an outer shaft to a rolling membrane is further described, the method comprising the following steps or consisting of the following steps:

[0026] - Providing a rolling membrane having a first end / distal end and a second end / proximal end,

[0027] - Providing an inner shaft having an inner shaft wall surrounding an inner shaft lumen, a distal inner shaft end, a proximal inner shaft end, and the inner shaft having an outer diameter,

[0028] - Providing an outer shaft having an outer shaft wall surrounding an outer shaft lumen, a distal outer shaft end, a proximal outer shaft end, and the outer shaft having an outer diameter greater than the outer diameter of the inner shaft,

[0029] - Place the first end / distal end of the rolling membrane on the distal inner shaft end and weld the distal inner shaft end to the first end / distal end of the rolling membrane by using a welding wire inserted into the inner shaft lumen, optionally via an adhesive material placed between the first end / distal end of the rolling membrane and the distal inner shaft end.

[0030] - Subsequently, flip the rolling membrane and insert the flipped rolling membrane and the inner shaft into the outer shaft.

[0031] - Place the second end / proximal end of the rolling membrane on the distal outer shaft end and weld the distal outer shaft end to the second end / proximal end of the rolling membrane by using a welding tube inserted into the outer shaft lumen and between the outer shaft wall and the inner shaft wall.

[0032] Remove the welding wire from the inner shaft lumen and optionally remove the welding tube.

[0033] This welding process allows for the fabrication of a rolling membrane having a shallow angle between the rolling membrane and the outer shaft.

[0034] The welding can be plastic / polymer welding, in which at least one (thermoplastic) polymer is melted with the help of heat, thus achieving the bonding between two components (such as the inner shaft / outer shaft, balloon). Therefore, the adhesive material is a material that can achieve the connection between two or more components (such as the inner shaft / outer shaft and the balloon) due to heat fusion. The adhesive material may include or consist of at least one (thermoplastic) polymer.

[0035] Using a welding wire inserted into the inner shaft lumen avoids the accidental collapse of the rolling membrane during welding. This also applies to the welding tube inserted into the outer shaft lumen. The welding wire is usually solid, however it can also be a hollow tube. The second end / proximal end of the rolling membrane can be welded to the inner side or the outer side of the outer shaft wall, and the first end / distal end of the rolling membrane can be welded to the inner side or the outer side of the inner shaft wall, preferably to the outer side of the inner shaft wall.

[0036] Flipping the rolling membrane is accomplished by pulling the proximal end of the rolling membrane through the inner shaft in the proximal direction. Flipping the rolling membrane can be accomplished with or without (elevated) pressure applied through the inner shaft.

[0037] The rolling membrane in this method may be provided with at least one reinforcing device (suitable for supporting the winding and / or unwinding of the rolling membrane). The at least one reinforcing device may include at least one linear element that extends at least partially along the axial direction of the rolling membrane and / or extends helically around the axial direction of the rolling membrane and / or extends in a zigzag pattern around the axial direction of the rolling membrane.

[0038] The method may further include a step in which the distal region of the rolling membrane is thermoformed such that it forms an angle of less than 180° and greater than 30°, preferably less than 120° and greater than 60°, with the inner shaft, and / or a step in which the proximal region of the rolling membrane is thermoformed such that it forms an angle of greater than 0° and at most 30°, preferably an angle of 1° to 20°, with the outer shaft.

[0039] The welding of the distal inner shaft end to the first end / distal end of the rolling membrane can be accomplished by using a welding wire inserted into the lumen of the inner shaft or via an adhesive material placed between the first end / distal end of the rolling membrane and the distal inner shaft end. The adhesive material can be a suitable (thermoplastic) polymer. For example, if the inner shaft is made of a first material (e.g., a (thermoplastic) polymer) and the balloon is made of another material different from the first material of the inner shaft (e.g., a second (thermoplastic) material), the adhesive material can be made of the same material as the balloon (or of a different material).

[0040] The welding of the distal outer shaft end to the second end / proximal end of the rolling membrane can be accomplished with or without an adhesive material by using a welding tube inserted into the lumen of the outer shaft and between the outer shaft wall and the inner shaft wall or by using a welding wire inserted into the lumen of the rolling membrane. A method for manufacturing a rolling membrane catheter is also described, which method includes a method for connecting the inner shaft and the outer shaft to the rolling membrane. A rolling membrane catheter is a catheter that includes a rolling membrane.

[0041] Furthermore, a method for manufacturing a rolling membrane catheter is described, which method includes the following steps or consists of the following steps:

[0042] - Providing a rolling membrane having a first end / distal end and a second end / proximal end,

[0043] - Providing an inner shaft,

[0044] - Providing an outer shaft, wherein the outer diameter of the outer shaft is greater than the outer diameter of the inner shaft,

[0045] - Placing the first end / distal end of the rolling membrane on the distal inner shaft end and, optionally, connecting the distal inner shaft end to the first end / distal end of the rolling membrane via an adhesive material or adhesive placed between the first end / distal end of the rolling membrane and the distal inner shaft end,

[0046] - Subsequently flipping the rolling membrane and inserting the flipped rolling membrane and the inner shaft into the outer shaft,

[0047] - Placing the second end / proximal end of the rolling membrane on the distal outer shaft end and connecting the distal outer shaft end to the second end / proximal end of the rolling membrane.

[0048] An adhesive material is a material that can join two components (such as an inner shaft / outer shaft and a balloon) without the need for heating. The adhesive material can be glue.

[0049] Connecting the distal end of the inner shaft to the first end / distal end of the rolling membrane can be accomplished by welding the distal end of the inner shaft (plastic) to the first end / distal end of the rolling membrane using a welding wire inserted into the lumen of the inner shaft.

[0050] Welding the distal end of the inner shaft to the first end / distal end of the rolling membrane by using a welding wire inserted into the lumen of the inner shaft can be accomplished via an adhesive material placed between the first end / distal end of the rolling membrane and the distal end of the inner shaft. The adhesive material can be a suitable (thermoplastic) polymer. For example, if the inner shaft is made of a first material (such as a (thermoplastic) polymer), and the balloon is made of another material different from the first material of the inner shaft (such as a second (thermoplastic) material), then the adhesive material can be made of the same material as the balloon (or a different material).

[0051] Flipping the rolling membrane can be accomplished by pulling the second end / proximal end of the rolling membrane over the inner shaft in the proximal direction.

[0052] Connecting the distal end of the outer shaft to the second end / proximal end of the rolling membrane can be accomplished by using a welding tube inserted into the lumen of the outer shaft and positioned between the outer shaft wall and the inner shaft wall or by using a welding wire inserted into the lumen of the rolling membrane to weld the distal end of the outer shaft to the second end / proximal end of the rolling membrane. Welding the distal end of the outer shaft to the second end / proximal end of the rolling membrane by using a welding tube inserted into the lumen of the outer shaft and positioned between the outer shaft wall and the inner shaft wall or by using a welding tube inserted into the lumen of the rolling membrane can be accomplished with or without an adhesive material. In the case of using an adhesive material, the adhesive material can be placed between the second end / proximal end of the rolling membrane and the distal end of the outer shaft. The adhesive material can be a suitable (thermoplastic) polymer. For example, if the inner shaft is made of a first material (such as a (thermoplastic) polymer), and the balloon is made of another material different from the first material of the inner shaft (such as a second (thermoplastic) material), then the adhesive material can be made of the same material as the balloon (or a different material).

[0053] The method can also include the step of removing the welding wire from the lumen of the inner shaft. Alternatively, the method can include the step of removing the welding wire from the lumen of the inner shaft and removing the welding tube.

[0054] The method can also include the step of connecting the inner shaft and / or the outer shaft to a proximal shaft, preferably, the proximal shaft is made of metal or metal alloy.

[0055] The method can also include the step of connecting the inner shaft to a push rod, preferably, the push rod is made of a material harder than the material of the inner shaft.

[0056] Describes another method for manufacturing a rolling membrane catheter, the method comprising the following steps or consisting of the following steps:

[0057] - Provide a rolling membrane having a distal end and a proximal end,

[0058] - Provide an inner shaft,

[0059] - Provide an outer shaft, wherein the outer diameter of the outer shaft is greater than the outer diameter of the inner shaft,

[0060] - Place the first end / distal end of the rolling membrane on the distal inner shaft end and connect the distal inner shaft end to the first end / distal end of the rolling membrane, optionally via an adhesive material or bonding material placed between the first end / distal end of the rolling membrane and the distal inner shaft end,

[0061] - Subsequently insert the rolling membrane and the inner shaft into the outer shaft lumen and connect the distal outer shaft end to the second end / proximal end of the rolling membrane.

[0062] Connecting the distal inner shaft end to the first end / distal end of the rolling membrane can be accomplished by welding the distal inner shaft end to the first end / distal end of the rolling membrane using a welding wire or welding tube inserted into the inner shaft lumen. Connecting the distal inner shaft end to the first end / distal end of the rolling membrane via a welding wire inserted into the inner shaft lumen can be accomplished via an adhesive material placed between the first end / distal end of the rolling membrane and the distal inner shaft end. The adhesive material can be a suitable (thermoplastic) polymer. For example, if the inner shaft is made of a first material (e.g., a (thermoplastic) polymer) and the balloon is made of another material (e.g., a second (thermoplastic) material different from the first material of the inner shaft), the adhesive material can be made of the same material as the balloon or a different material.

[0063] Connecting the distal outer shaft end to the second end / proximal end of the rolling membrane can be accomplished by using a welding tube inserted into the outer shaft lumen and positioned between the outer shaft wall and the inner shaft wall or by using a welding wire inserted into the rolling membrane lumen to weld the distal outer shaft end to the second end / proximal end of the rolling membrane. Welding the distal outer shaft end to the second end / proximal end of the rolling membrane by using a welding tube inserted into the outer shaft lumen and between the outer shaft wall and the inner shaft wall or by using a welding tube inserted into the rolling membrane lumen can be accomplished with or without an adhesive material. The adhesive material can be placed between the second end / proximal end of the rolling membrane and the distal outer shaft end. The adhesive material can be a suitable (thermoplastic) polymer. For example, if the inner shaft is made of a first material (e.g., a (thermoplastic) polymer) and the balloon is made of another material (e.g., a second (thermoplastic) material different from the first material of the inner shaft), the adhesive material can be made of the same material as the balloon or a different material.

[0064] The method may further comprise the step of removing the welding wire and / or welding tube from the inner shaft lumen and the outer shaft lumen.

[0065] The method may further include the step of connecting the inner shaft and / or the outer shaft to the proximal shaft, preferably, the proximal shaft is made of metal or metal alloy.

[0066] The method may further include the step of connecting the inner shaft to the push rod, preferably, the push rod is made of a material harder than the material of the inner shaft. The push rod may be made of metal or metal alloy.

[0067] Throughout the method, the rolling membrane may be provided with at least one reinforcing device. The at least one reinforcing device may include at least one linear element, and the at least one linear element extends at least partially along the axial direction of the catheter and / or extends helically around the axial direction of the catheter and / or extends around the axial direction of the catheter in a zigzag pattern. BRIEF DESCRIPTION OF THE DRAWINGS

[0068] Figure 1 is an exemplary illustration of a rolling membrane catheter;

[0069] Figure 2 is an exemplary illustration of the use of a guiding element for supporting the insertion of a guide wire into the inner shaft of a rolling membrane catheter having at least partially wound rolling membrane;

[0070] Figures 3A - 3C is an illustration of an exemplary embodiment for providing a rolling membrane catheter with an atraumatic tip;

[0071] Figures 4A - 4C is an illustration of an exemplary problem that occurs during the winding of the rolling membrane;

[0072] Figures 5A - 5C is an illustration of an exemplary embodiment for at least partially resisting the undesired folding of the rolling membrane during winding;

[0073] Figures 6A - 6C is an illustration of an exemplary embodiment for providing a rolling membrane having at least one reinforcing device at the first end of the rolling membrane;

[0074] Figures 7A - 7C is an illustration of an exemplary embodiment for providing a rolling membrane having at least one reinforcing device at the first end and at the second end of the rolling membrane;

[0075] Figures 8A - 8B is an illustration of an exemplary embodiment for providing a rolling membrane having at least one reinforcing device at the first end and at the second end of the rolling membrane;

[0076] Figures 9A - 9C is an illustration of an exemplary embodiment for providing a rolling membrane having at least one reinforcing device at the first end of the rolling membrane;

[0077] Figures 10A - 10C is an illustration of an exemplary embodiment of a rolling membrane for providing at least one reinforcing device at a first end of the rolling membrane;

[0078] Figures 11A - 11C is an illustration of an exemplary embodiment of a rolling membrane having at least one reinforcing device extending from a distal portion of the rolling membrane to a proximal portion of the rolling membrane;

[0079] Figures 12A - 12B is an illustration of an exemplary embodiment of a rolling membrane having at least one reinforcing device extending from a distal portion of the rolling membrane to a proximal portion of the rolling membrane;

[0080] Figures 13A - 13B is an illustration of an exemplary embodiment of a rolling membrane having improved winding-in ability;

[0081] Figures 14A - 14B is an illustration of an exemplary rolling membrane catheter having a trauma - resistant end in non - pressurized and pressurized states. Detailed Description

[0082] Figure 1 Shows an example of the basic elements of the rolling membrane catheter 1. Figure 1 Exemplarily shows the rolling membrane catheter 1, where the rolling membrane 2 is fully deployed. The rolling membrane catheter 1 may include an outer shaft 6 and an inner shaft 7. The rolling membrane 2 forms an inner lumen 3 and includes a proximal end 4 and a distal end 5. The proximal end 4 of the rolling membrane 2 is connected to the outer shaft 6, while the distal end 5 of the rolling membrane 2 is connected to the inner shaft 7. The inner shaft 7 may be at least partially received within the inner lumen 3 of the rolling membrane 2. A guide wire G may be located within the inner lumen 3 of the rolling membrane 2 and / or within the inner shaft 7.

[0083] Figure 2 Shows an exemplary embodiment of a rolling membrane catheter according to a second aspect of the present invention, which relates to an improved and simplified insertion of a guide wire G into the inner lumen of the rolling membrane 2 when the rolling membrane 2 is in a wound - up state. The proximal end 4 of the rolling membrane 2 is connected to the outer shaft 6, while the distal end 5 of the rolling membrane 2 is connected to the inner shaft 7. Figure 2 Depicts an exemplary embodiment of the rolling membrane catheter 1, which is additionally provided with a protective element 15. Although not shown, it is conceivable that the protective element 15 can be provided to a catheter having a trauma - resistant end, as outlined in reference Figure 3A -C. More specifically, Figure 2Shows a rolling membrane catheter 1, in which a protection element 15 has been fully inserted into the inner lumen 3 of the rolling membrane 2, where the rolling membrane 2 is fully wound. The protection element 15 can be placed by medical staff in the inner lumen 3 of the rolling membrane 2 before inserting a guide wire G. Alternatively, the rolling membrane catheter 2 can be transported with the protection element 15 already inserted by the manufacturer. The protection element 15 can be configured to protect the entire inner lumen of the (wound) rolling membrane, for example, from the distal end of the outer shaft 6 to the distal end of the inner shaft 7. This can ensure that the entire length of the wound rolling membrane 2 is protected by the protection element 15, such that the risk of damaging the inner wall of the rolling membrane 2 when inserting the guide wire G (from the distal direction, i.e., from the left side in Figure 3) can be minimized. After inserting the guide wire G, the protection element 15 can be simply removed, for example, by pulling or sliding the protection element 15 in the distal direction. The enlarged opening 16 at the distal end of the protection element 15 (e.g., in the form of a funnel) can support the operator in pulling the protection element 15 out of the rolling membrane catheter 1. The protection element 15 can be adapted with one or more break points (not shown). One or more break points can be arranged, for example, along an axis parallel to the axial direction of the catheter (e.g., from the distal end of the protection element 15 to the proximal end of the protection element 15, such as edge to edge or extending at least 0.5 cm, 1 cm, 2 cm, 3 cm, 4 cm or at least 5 cm etc. in the proximal direction from the distal end of the protection element 15). In some embodiments, the protection element 15 can be provided with one or more break points of at least two lines extending in the proximal direction from the distal end of the protection element 15. Such an arrangement of at least two lines can allow the protection element 15 to be torn into at least two pieces along a predetermined axis (e.g., along the axial direction of the catheter 1). In other words, the protection element 15 can be arranged such that it can be effectively peeled off from the rolling membrane catheter 1.

[0084] It should be emphasized that the aspects outlined with respect to the second aspect can be combined with the aspects outlined with respect to the first aspect.

[0085] Figure 3A -C shows an exemplary embodiment of a rolling membrane catheter according to a first aspect of the present invention, which relates to providing a rolling membrane catheter with a trauma - resistant end (such as the distal end 9), preferably made of elastomer or polymer foam. The rolling membrane catheter includes a rolling membrane 2 having an inner lumen 3. The proximal end of the rolling membrane 2 is connected to an outer shaft 6, while the distal end 5 of the rolling membrane 2 is connected to an inner shaft 7. The same reference numerals generally denote the same elements as outlined. Figure 1 The trauma - resistant end 8 can preferably include a maximum radius that is less than the minimum radius of the patient's blood vessel to be examined by the rolling membrane catheter 1.

[0086] Figure 3AShows a first exemplary embodiment for providing a trauma - resistant tip 8 that forms the distal end 9 of the rolling - membrane catheter 1. In this first embodiment, the trauma - resistant tip is formed by the most distal portion of the rolling membrane 2. When the rolling membrane 2 is being wound, the rolling membrane is generally adapted to fold inwardly into the inner lumen 3. However, the most distal portion can be adapted not to fold inwardly but to form a conical shape that forms the trauma - resistant tip 8. In some exemplary embodiments, the trauma - resistant tip 8 can be formed from the rolling membrane 2 by one or more of, for example, heat - pressing, injection - molding, providing one or more reinforcing elements to the most distal portion of the rolling membrane (causing the curvature of the most distal portion of the rolling membrane), and / or any other suitable manufacturing method. Generally speaking, the rolling - membrane catheter 1 can be moved in the distal direction D along the patient's blood vessel guided by the guide wire G. With the trauma - resistant tip 8, even when the rolling membrane 2 is in the retracted state, the catheter 1 can be safely moved distally.

[0087] Figure 3B Shows a second exemplary embodiment for providing a trauma - resistant tip 10 as the distal end 9 of the rolling - membrane catheter 1. The trauma - resistant tip 10 can include a conical cross - section and can be formed integrally (e.g., as a cap) and / or formed by two half - shells 11, 12 (or a greater number of components) that can be configured to form a cone at the distal end of the outer shaft 6. The trauma - resistant tip 10 can be arranged around the outer side of the outer shaft 6 and optionally around the outer side of the rolling membrane 2, which can be attached to the distal end of the outer shaft 6. The trauma - resistant tip 10 can include a distal (e.g., central) opening for receiving the distal end of the guide wire G therein. In the closed state of the trauma - resistant tip 10 (as Figure 3B shown), the half - shells 11 and 12 (or, for example, four quarter - shells) can be arranged concentrically around the guide wire G. The trauma - resistant tip 10 can be made of an elastomeric material similar to an elastomer. Thus, the trauma - resistant tip 10 can be adapted to be widened (e.g., due to at least partial deployment of the rolling membrane 2 in the distal direction D). The widening can result in an increase in the spacing between the half - shells 11 and 12 (or, for example, four quarter - shells).

[0088] Figure 3CShows a third exemplary embodiment for providing a trauma - resistant tip 13 for the rolling - membrane catheter 1, which trauma - resistant tip is preferably made of polymeric foam. The trauma - resistant tip 13 can be retracted in the proximal direction P of the rolling - membrane catheter 1. The trauma - resistant tip 13 can be compressible and can be compressed due to the retraction of the trauma - resistant tip 13 in the proximal direction P. The trauma - resistant tip 13 can be connected to a trauma - resistant tip shaft 14, such as a dilator, for retracting the trauma - resistant tip 13 in the proximal direction P. The trauma - resistant tip 13 and / or the trauma - resistant tip shaft 14 can be coated. The trauma - resistant tip 13 and / or the trauma - resistant tip shaft 14 can preferably be coated with a hydrophilic coating for improving the retractability of the trauma - resistant tip shaft 14 (and the connected trauma - resistant tip 13) in the proximal direction P. The trauma - resistant tip shaft 14 can be at least partially disposed within the inner shaft 7. By providing at least one of the above - mentioned trauma - resistant tips 8, 10, and / or 13 for the rolling - membrane catheter 1, reliable tracking of the rolling - membrane catheter 1 along the patient's blood vessel can be facilitated even when the rolling membrane 2 is fully wound.

[0089] It should be understood that different concepts of the trauma - resistant tips as described above can also be combined.

[0090] Figures 4A through 4C Shows an exemplary problem of the rolling - membrane catheter 1 solved by the third aspect, which third aspect relates to supporting the desired winding behavior of the rolling membrane 2. The third aspect can also be combined with the first and / or second aspects.

[0091] If the rolling membrane is intended to be wound from the deployed state, the distal portion of the rolling membrane 2 needs to be folded inwardly into itself (e.g., folded into the inner lumen 3 of the rolling membrane 2) to allow the desired winding (e.g., as Figure 13B shown). However, in some cases, the desired folding of the rolling membrane 2 may not occur, and the rolling membrane 2 may fold and / or wind in an undesired manner. The proximal end 4 of the rolling membrane 2 is connected to the outer shaft 6, while the distal end 5 of the rolling membrane 2 is connected to the inner shaft 7.

[0092] Figure 4A Exemplarily depicts an undesired folding of the rolling membrane 2 at the proximal end 4 of the rolling membrane 4 (e.g., in the presence of internal pressure in the rolling membrane 2). Such an undesired folding of the rolling membrane 2 can cause the rolling membrane 2 to fold further from the proximal direction P towards the distal direction D at the proximal end 4, rather than the rolling membrane 2 folding from the distal direction D along the proximal direction P at the distal end 5. In some cases, the undesired folding of the rolling membrane 2 from the proximal direction P can counteract the desired folding of the rolling membrane 2 from the distal direction D.

[0093] Figure 4BAnother undesirable fold of the rolling membrane 2 is illustratively depicted, which may include an undesirable overlap 19 of at least one layer of the rolling membrane 2. Such an undesirable overlap may be caused, for example, by a kink in a certain part of the rolling membrane 2 (e.g., the cylindrical part of the rolling membrane 2 as seen when the rolling membrane 2 is deployed). Such a fold may prevent the conventional winding of the rolling membrane.

[0094] Figure 4C A further undesirable fold of the rolling membrane 2 is illustratively shown, which is at least partially based on the bulging of the rolling membrane 2, such that a certain part 20 of the rolling membrane is compressed along the longitudinal extension part of the rolling membrane conduit 1 (e.g., the cylindrical part of the rolling membrane 2 as seen when the rolling membrane 2 is deployed), similar to an accordion. In addition, such bulging may prevent the conventional winding of the rolling membrane.

[0095] Figures 5A through 5C Different embodiments of at least one reinforcing device 21 for providing the rolling membrane 2 with a means to counteract undesirable folds are illustratively shown (e.g., as described above with reference to Figures 4A through 4C ). In each embodiment, the rolling membrane 2 is connected to the outer side of the outer shaft 6 at the second end 40 of the rolling membrane 2, and is connected to the outer side of the inner shaft 7 at the first end 50 of the rolling membrane 2.

[0096] Figure 5A A first embodiment of providing at least one reinforcing device 21 for the rolling membrane 2 at the first end 50 of the rolling membrane 2 (e.g., at the distal end of the rolling membrane 2) is shown. At this first end 50, the rolling membrane 2 may be adapted to form an angle, for example, α = 90°, between the rolling membrane 2 and the outer side of the inner shaft 7, as Figure 5A shown. Compared with the second end 40 of the rolling membrane 2, the taper angle of the first end 50 of the rolling membrane 2 is steeper and / or the cone is more bendable, which can promote the flipping of the distal rolling membrane cone when the inner shaft 7 moves in the proximal direction P (causing the distal rolling movement of the rolling membrane 2). Therefore, the undesirable folds of the rolling membrane 2 can be counteracted.

[0097] Figure 5B A second embodiment of providing at least one reinforcing device 21 for the rolling membrane 2 at the second end 40 of the rolling membrane 2 (e.g., at the proximal end of the rolling membrane 2) is shown. In this second embodiment, the rolling membrane 2 may form a shallow angle of 30° with the outer shaft 6, as Figure 5B shown. A shallower angle and / or a more bend-resistant cone at the second end 40 of the rolling membrane 2 compared to the first end 50 of the rolling membrane 2 can counteract the undesirable folds of the rolling membrane 2 at its proximal end, and thus can contribute to the undisturbed folding of the rolling membrane 2 from the distal end of the rolling membrane 2.

[0098] Figure 5CA third embodiment is shown, which provides at least one strengthening device 21 extending in the axial direction of the rolling film conduit 1 for the rolling film 2, such that the rolling film 2 has axial anti-kinking property and can resist the bulging of the rolling film 2 when being wound.

[0099] Figures 6A through 6C Exemplary manufacturing steps of the rolling film 2 are shown. At least one strengthening device 21 can be provided at the distal end 5 of the rolling film 2. The proximal end 4 of the rolling film 2 is connected to the outer shaft 6, while the distal end 5 of the rolling film 2 is connected to the inner shaft 7.

[0100] Figure 6A A dedicated preform is exemplarily depicted, which can be adapted to form the rolling film, for example, by thermoforming, such that a steep angle of about 90° is formed at the distal end 5 of the rolling film. Additionally or alternatively, the shape of the preform of the rolling film can be provided such that the rolling film can inherently exhibit a shallow angle of about 30° or less at the proximal end 4 of the rolling film. Thus, at both ends of the rolling film, elements can be provided to facilitate the desired winding and counteract the undesired winding, bulging, etc.

[0101] Figure 6B An exemplary connection process for connecting the rolling film to the inner shaft is depicted. Two overlapping sections of the rolling film can be connected to the inner shaft, for example, by thermoforming, welding, heat bonding, adhesives, etc. This can help to automatically ensure an angle between 180° and 30° when starting the winding of the film.

[0102] Figure 6C Another method for providing the rolling film 2 with a steep angle relative to the inner shaft 7 at its distal end 5 is exemplarily shown. This can be achieved by placing a fixing element 22 (e.g., a ring) around the rolling film 2, which can (rigidly) fix the rolling film 2 to the inner shaft 7. Due to the associated shortening of the material of the rolling film 2 in the fixing element 22, a steep angle can be generated between the rolling film 2 and the inner shaft 7.

[0103] Figures 7A through 7C An exemplary method for providing the rolling film conduit 1 is shown, wherein the rolling film 2 is connected to the inner shaft 7 at its distal rolling film end 5, and the rolling film 2 is connected to the outer shaft 6 at its proximal rolling film end 4. The inner shaft has an inner shaft wall surrounding the inner shaft lumen, a distal inner shaft end, a proximal inner shaft end, and the inner shaft has an outer diameter. The outer shaft has an outer shaft wall surrounding the outer shaft lumen, a distal outer shaft end, a proximal outer shaft end. The outer diameter of the outer shaft 6 is greater than the outer diameter of the inner shaft 7.

[0104] Figure 7AShows a first exemplary embodiment for providing a first end of the rolling membrane 2, which first end is the distal end 5 of the rolling membrane 2 (when the rolling membrane 2 is in the deployed state) in the final rolling membrane conduit 1. The (first end) distal rolling membrane end 5 is connected (e.g., by welding) to the inner shaft 7. A welding wire 22 can be inserted into the inner shaft lumen of the inner shaft 7 to prevent the rolling membrane 2 from accidentally collapsing during welding. It should be understood that other techniques for connecting the rolling membrane 2 and the inner shaft 7 can also be used. Welding the distal inner shaft end to the first end / distal end of the rolling membrane by using a welding wire inserted into the inner shaft lumen can be accomplished via an adhesive material placed between the first end / distal end of the rolling membrane and the distal inner shaft end.

[0105] Figure 7B Exemplarily shows the flipping of the rolling membrane 2. The flipping of the rolling membrane can be accomplished such that the second end of the rolling membrane 2 (which is the proximal end 4 of the rolling membrane 2 in the final rolling membrane conduit 1 when the rolling membrane 2 is in the deployed state) is pulled in the proximal direction over the inner shaft 7, as Figure 7C shown. Then the flipped rolling membrane and the inner shaft 7 are inserted into the outer shaft (this process step is not shown).

[0106] Figure 7C Shows an exemplary step of connecting the rolling membrane 2 to the outer shaft 6 at the (second end) proximal end 4 of the rolling membrane. Figure 7C Further depicts an exemplary welding process for welding the rolling membrane 2 to the outer shaft 6 such that a shallow angle can be formed between the rolling membrane 2 and the outer shaft 6. A welding tube 23 can be inserted into the inner lumen of the outer shaft 6 (also referred to as the outer shaft lumen) to further support the welding process and prevent the rolling membrane 2 and / or the outer shaft 6 from accidentally collapsing at the welding area and due to the welding itself. The welding tube is inserted between the outer shaft wall and the inner shaft wall. After welding, the welding wire is removed from the inner shaft lumen, and optionally the welding tube is removed. Additionally, an adhesive material can be used.

[0107] Figure 8A and Figure 8B Shows an alternative method for providing at least one reinforcing device 21 for the rolling membrane 3.

[0108] Figure 8A Shows another embodiment of the rolling membrane 2 of the rolling membrane conduit 1, wherein the rolling membrane 2 has been configured to support the winding-in of the rolling membrane 2. Similarly, as outlined with reference to Figures 7A through 7C The rolling membrane 2 can be provided with a relatively large connection angle at its distal end 5. To also provide a reinforcing element at the proximal end 4 of the rolling membrane 2, an annular element 24 (e.g., a snap ring) can be used to connect the proximal end 4 of the rolling membrane 2 to the inner side of the outer shaft 6 such that a shallow angle of the rolling membrane 2 relative to the outer shaft 6 can be ensured.

[0109] Figure 8BAn exemplary manufacturing method for providing at least one reinforcing device 21 at the proximal end 4 for the rolling membrane 2 is shown (as seen when the rolling membrane 2 is in the deployed state). After welding the rolling membrane 2 to the inner shaft 7 (e.g., as outlined with reference to Figure 7A ), the outer shaft can be placed over the rolling membrane 2 and the inner shaft 7. Optionally, the proximal end 4 of the rolling membrane 2 can be connected (e.g., by welding) to the inner wall of the outer shaft 6. In some cases, a welding wire 22 can be inserted into the inner lumen 3 of the rolling membrane 2 to support the welding process. The welding wire 22 can be provided with a diameter slightly smaller (e.g., a fraction of a French smaller) than the inner diameter of the outer shaft 6, such that the outer shaft 6 and the rolling membrane 2 can be pressed against the outer side of the welding wire 22 to further support the connection of the outer shaft 6 and the rolling membrane 2 through the welding process.

[0110] The above welding process can result in the connection of the rolling membrane 2 to the inner wall of the outer shaft 6 (compared to the outer wall in Figure 7C ), and can additionally ensure a tight seal.

[0111] Before or after the optional connection step, an annular element 24 can be inserted into the inner lumen 3 of the rolling membrane 2 at a position close to (e.g., separated by 0.5 cm, 1 cm, 2 cm, 3 cm, 4 cm, 5 cm or any other suitable distance) the proximal most part 4 of the rolling membrane 2. By means of the annular element 24, the rolling membrane 2 can be sealed to the outer shaft 6 and the manufacturing steps for supporting the deployment (and / or winding in) of the rolling membrane 2 can be separated. For further support in understanding, when Figure 8B the inner shaft 7 of the catheter 1 moves distally D relative to the outer shaft 6, a portion 25 of the rolling membrane 2 is brought into the Figure 8A position shown.

[0112] Figures 9A through 1 Figure 2C depicts exemplary manufacturing steps for providing a rolling membrane 2 having a wall thickness gradient relative to the length of the rolling membrane 2. Due to the advantageous wall thickness profile of the rolling membrane 2, these manufacturing steps enable better rollability of the rolling membrane 2 and a lower risk of collapse when the rolling membrane is rolled back.

[0113] Figure 9AIllustrated is the formation of a rolling membrane 2 from a preform 26 (e.g., a balloon or a tube) by applying different temperatures T1, T2, and T3 to the preform 26 in different spatial segments and applying a pressure p to the inner lumen of the preform 26. The temperatures T1, T2, and T3 can be selected such that the highest temperature T3 can be applied to the preform 26 at the location of the preform 26, and the preform 26 can subsequently form the distal end 5 of the rolling membrane 2 (as seen when the rolling membrane is fully deployed). The preform 26 can generally be formed into a cylindrical shape with tapered cross-sections at both ends. A second temperature T2 can be applied to the preform 26, where the temperature T2 can be less than T3, and where, compared to the temperature T3, the temperature T2 can extend over a greater portion of the preform 26. The temperature T2 can be applied substantially in the region where the distal tapered section of the preform 26 will be formed. In the remaining portion of the preform 26, a temperature T1 lower than the temperature T2 can be applied.

[0114] Figure 9B Exemplarily illustrated is the formation of the rolling membrane 2 of the preform 26 (starting from the distal end) when the inner lumen 3 of the subsequently formed rolling membrane 2 is pressurized. By ensuring the highest temperature at the distal end 5 of the rolling membrane 2, when the preform 26 is bulged by pressurizing the preform 26, compared to the case where the preform 26 can be exposed to a uniform temperature when the preform 25 is inflated, a wall thickness of the rolling membrane 2 that can be thinner in this portion of the rolling membrane 2 can be obtained. Due to the thinner wall thickness of the rolling membrane 2, the rolling membrane 2 can be more flexible (e.g., foldable) in this region, such that when the rolling membrane 2 is at least partially rolled, the distal end 5 of the rolling membrane 2 can be more easily folded inward into the inner lumen 3 of the rolling membrane 2.

[0115] Figure 9C Illustrated is the final rolling membrane 2 after the preform 26 is fully inflated in the presence of the temperatures T1, T2, and T3.

[0116] Figures 10A through 10C Illustrated is another exemplary manufacturing method for providing at least one reinforcing device 21 to the rolling membrane 2 at a first end (e.g., the most distal end) of the rolling membrane 2.

[0117] Figure 10A Exemplarily illustrated is the preform 26, which can be similar to Figure 9A -C preform, and which is exposed to the temperature T1 at the distal end 5, and which can be exposed to a second temperature T2 at the proximal end 4 that can be lower than T1. Additionally, the distal end 5 can be exposed to a pressure p1 (referring to the pressure applied to the inner lumen of the preform 26), and the proximal end 4 can be exposed to a pressure p2, where p1 can be selected to be greater than p2, e.g., by dynamic flow.

[0118] Figure 10BSubsequent manufacturing steps are exemplarily shown, where the preform 26 can be inflated from the distal end 5 by ensuring the above temperature and pressure distribution. Thus, the preform can be inflated successively from the distal end to the proximal end.

[0119] Figure 10C Subsequent manufacturing steps are exemplarily shown while inflating the preform 26 and ensuring the temperature and pressure distribution as described above with reference to Figure 10A and Figure 10B The resulting rolled film 2 is shown. By means of the above temperature and pressure distribution, it can be ensured that the wall thickness of the rolled film 2 at its distal end 5 can be smaller than the wall thickness of the rolled film 2 at its proximal end 4. The thinner wall thickness at the distal end 5 can be obtained by a higher temperature T1 (compared to T2), while applying a higher pressure p1 in the part with the higher temperature T1. This combination can promote the expansion of the preform 26, especially in the said part, which can result in a thinner wall thickness and increased flexibility of the rolled film 2 in the corresponding part. Thus, a thinner wall thickness can be obtained at the distal end 5 compared to the proximal end 4, which can contribute to increasing the folding ability of the rolled film 2 (as described above) when the rolled film 2 is wound up. In the case of blow molding, even if the pressure is initially constant due to a large cross-section, a pressure gradient can be generated dynamically. When the balloon tube is separated from the pressure source by extrusion, for example, the pressure will drop during balloon formation, and a pressure drop will occur due to the expansion of the enclosed gas volume. Figures 11A through 11C Another embodiment is shown in which at least one strengthening device 21 is provided for the rolled film 2, where one or more linear elements (e.g., strengthening wires) are used to provide increased kink resistance for the rolled film 2.

[0120] Figure 11A Exemplarily shown are a plurality of linear elements 21 extending in the axial direction A of the rolled film 2 (where the exact number of linear elements can vary), specifically, extending in the cylindrical part of the rolled film 2 (as seen when the rolled film 2 is fully unfolded). In addition to the central cylindrical part, the rolled film 2 can include distal and proximal tapered end parts.

[0121] Figure 11B Exemplarily shown is a cross-section of the rolled film 2 (taken along a direction perpendicular to the axial direction A) and the embedding of at least one strengthening device 21 in the material of the rolled film 2. In other words, at least one strengthening device 21 (e.g., provided as a linear element) can be embedded in the material of the rolled film 2 and not only attached to the surface of the rolled film 2, which can provide additional kink resistance and can avoid ablation of at least one strengthening device 21 under the influence of the kinking forces acting on it.

[0122] Figure 11CAnother exemplary embodiment showing an implementation of at least one reinforcing device 21 is presented, where the at least one reinforcing device 21 is arranged in a zigzag pattern extending along and / or around the axial direction A on the rolling membrane 2. In some preferred implementations, the at least one reinforcing device 21 can be helically wound around the axial direction A of the rolling membrane conduit 1 ( Figure 11C not shown in the figure). This arrangement of the at least one reinforcing device 21 can prevent the rolling of the rolling membrane 2 from being hindered due to mechanical interference with the reinforcing device 21, because when the rolling membrane 2 is rolled up, the helical arrangement of the at least one reinforcing device can substantially form a cylindrical element.

[0123] Figures 12A through 12B Another embodiment showing the provision of at least one reinforcing device 21 for the rolling membrane 2 is presented, where the at least one reinforcing device 21 is provided as at least one predetermined fold in the rolling membrane 2.

[0124] Figure 12A The conduit with the rolling membrane 2 and the inner shaft 7 is shown in a cut-away cross-section. If the rolling membrane 2 expands (e.g., unfolds), the rolling membrane 2 can form a circular cross-section, and the predetermined creases may not be visible because they can be pressed radially outward relative to the inner shaft 7.

[0125] Figure 12B Shows Figure 12A the rolling membrane 2, where the pressure in the expandable volume of the rolling membrane 2 is low. In this case, the predetermined creases of the rolling membrane 2 can cause the rolling membrane 2 to be pre-folded at the positions of one or more predetermined folds. Thus, the rolling membrane 2 is sufficient to resist uncontrolled collapse. Additionally or alternatively, controlled collapse can be achieved by providing the rolling membrane 2 with corresponding reinforcing wires, as described above with reference to Figure 11A and Figure 11B stated.

[0126] Figure 13A and Figure 13B Another embodiment of the rolling membrane 2 is shown. More specifically, Figure 13A a possible embodiment of the rolling membrane 2 is depicted, where the rolling membrane 2 is arranged to be conical. The conical rolling membrane 2 can be adapted such that the conical rolling membrane 2 has a smaller diameter at the distal portion of the rolling membrane 2 (when unfolded) compared to the diameter at the position near the distal portion of the rolling membrane 2.

[0127] Figure 13B Exemplarily shows the rolling of the rolling membrane 2 adjusted according to Figure 13A . Since the distal portion of the rolling membrane 2 is provided with a smaller diameter compared to the proximal portion of the rolling membrane 2, the smaller diameter portion of the rolling membrane 2 can be folded into the larger diameter portion of the rolling membrane 2. When the rolling membrane is rolled up, this can counteract the undesired folding of the rolling membrane 2.

[0128] It should be emphasized that the embodiments described herein are mainly presented as separate and distinct aspects for the purpose of supporting the understanding of the present invention. However, the embodiments described herein and aspects of the embodiments may also be combined with each other and should not be understood only as different aspects of the present invention.

[0129] Figure 14A and Figure 14B shows another exemplary embodiment for providing a trauma - resistant tip 10 for the rolling - membrane catheter 1. Figure 14A shows the rolling membrane in a non - pressurized (rolled - up) state, and Figure 14B shows the rolling membrane in a pressurized (deployed) state. The rolling - membrane catheter 1 includes a rolling membrane 2 having an inner lumen. The proximal end of the rolling membrane 2 is connected to an outer shaft 6, while the distal end of the rolling membrane 2 is connected to an inner shaft 7. The trauma - resistant tip 10 may be made of an elastomeric material similar to an elastomer. In contrast to Figure 3B the elastomeric material in FIGS. 14a - 14b need not be elastic to the extent that it can assume the diameter of the inflated rolling membrane. The trauma - resistant tip 10 may include a tapered cross - section. The trauma - resistant tip 10 may be formed integrally (e.g., as a cap) or formed from two half - shells (or a greater number of components) that may be configured to form a taper at the distal end of the outer shaft 6. The trauma - resistant tip 10 may be disposed around the outside of the distal end of the outer shaft 6 and at least partially on the inside of the rolling membrane 2. The trauma - resistant tip 10 may include a distal (e.g., central) opening for accommodating the distal end of a guide wire G therein. In the closed state of the trauma - resistant tip 10, the half - shells and (or, e.g., four quarter - shells) may be concentrically disposed around the guide wire G.

Claims

1. A method for connecting an inner shaft (7) and an outer shaft (6) to a rolling membrane (2), comprising the following steps: - Provide a rolling membrane (2) having a distal end (5) and a proximal end (4), - Provide the inner shaft (7), which has an inner shaft wall surrounding the inner shaft lumen, a distal inner shaft end, a proximal inner shaft end, and the inner shaft has an outer diameter, - Provide the outer shaft (6), which has an outer shaft wall surrounding the outer shaft lumen, a distal outer shaft end, a proximal outer shaft end, and the outer diameter of the outer shaft is greater than the outer diameter of the inner shaft, - Place the distal end (5) of the rolling membrane (2) on the distal inner shaft end and weld the distal inner shaft end to the distal end (5) of the rolling membrane (2) by using a welding wire (22) inserted into the inner shaft lumen, optionally via an adhesive material placed between the distal end (5) of the rolling membrane (2) and the distal inner shaft end, - Subsequently flip the rolling membrane (2) and insert the flipped rolling membrane (2) and the inner shaft (7) into the outer shaft (6), - Place the proximal end (4) of the rolling membrane (2) on the distal outer shaft end and weld the distal outer shaft end to the proximal end (4) of the rolling membrane (2) by using a welding tube (23) inserted into the outer shaft lumen and between the outer shaft wall and the inner shaft wall, Remove the welding wire (22) from the inner shaft lumen and optionally remove the welding tube (23).

2. The method according to claim 1, wherein, The rolling membrane (2) is provided with at least one strengthening device (21).

3. The method according to claim 2, wherein, The at least one strengthening device (21) includes at least one linear element that extends at least partially along the axial direction (A) of the rolling membrane (2) and / or extends helically around the axial direction of the rolling membrane (2) and / or extends in a zigzag pattern around the axial direction (A) of the rolling membrane (2).

4. The method according to any one of the preceding claims, wherein, The method further includes a step in which the distal region of the rolling membrane (2) is thermoformed such that the rolling membrane (2) forms an angle of less than 180° and greater than 30°, preferably less than 120° and greater than 60°, with the inner shaft, and / or a step in which the proximal region of the rolling membrane (2) is thermoformed such that the rolling membrane (2) forms an angle of greater than 0° and at most 30°, preferably an angle of 1° to 20°, with the outer shaft (6).

5. The method according to any one of the preceding claims, wherein, The proximal end (4) of the rolling membrane (2) is welded to the inner side or the outer side of the outer shaft wall, and the distal end (5) of the rolling membrane (2) is welded to the inner side or the outer side of the inner shaft wall, preferably welded to the outer side of the inner shaft wall.

6. A method for manufacturing a rolling membrane catheter (1), comprising the method for connecting an inner shaft (7) and an outer shaft (6) to a rolling membrane (2) according to claims 1 to 5.

7. A catheter (1), comprising a rolling membrane (2); and anti-traumatic ends (8, 10, 13), when the rolling membrane (2) is in an unfolded state, the anti-traumatic ends (8, 10, 13) form the distal end (9) of the catheter (1).

8. The catheter (1) according to claim 7, wherein, When the rolling membrane (2) is deployed, the rolling membrane (2) is adapted to move to a position away from the anti-trauma ends (8, 10).

9. The catheter (1) according to claim 7 or 8, wherein, At least the distal part of the anti-trauma ends (8, 10) is adapted to be widened in a direction perpendicular to the axial direction of the catheter, preferably due to the deployment of the rolling membrane.

10. The catheter (1) according to any one of claims 7 to 9, wherein, The anti-trauma ends (8, 10, 13) include or consist of an elastomer or a polymer foam.

11. The catheter (1) according to any one of claims 7 to 10, wherein, The anti-trauma tip (8) is formed by a part of the rolling membrane (2).

12. A catheter (1), comprising a rolling membrane (2); and a protection element (15), wherein, The protection element (15) can be arranged within the inner lumen (3) of the rolling membrane (2) for protecting the rolling membrane (2) when inserting a guide wire (G) from the distal end of the catheter (1) into the rolling membrane (2).

13. The catheter (1) according to claim 12, wherein, The protection element (15) has a funnel-like shape; and wherein, the distal end of the protection element (15) has a larger diameter compared to the proximal end of the protection element (15) to facilitate the insertion of the guide wire (G).

14. The catheter (1) according to claim 12 or 13, wherein, The protection element (15) includes one or more predetermined breaking points extending along the axial direction of the catheter.

15. The catheter (1) according to any one of claims 12 to 14, wherein,The protection element (15) includes at least one distal portion, and wherein, the protection element (15) is adapted to be removable from the catheter (1) by pulling the at least one distal portion, thereby tearing the protection element (15) along the axial direction (A) of the catheter (1), preferably along the one or more breaking points.

16. A method for manufacturing a rolling film catheter (1), comprising the following steps: - Provide a rolling membrane (2) having a distal end (5) and a proximal end (4), - Provide an inner shaft (7), - Provide an outer shaft (6), wherein the outer diameter of the outer shaft (6) is greater than the outer diameter of the inner shaft (7), - Place the distal end (5) of the rolling membrane (2) on the distal inner shaft end, and optionally connect the distal inner shaft end to the distal end (5) of the rolling membrane (2) via an adhesive material or bonding material placed between the distal end (5) of the rolling membrane (2) and the distal inner shaft end - Subsequently turn over the rolling membrane (2) and insert the turned-over rolling membrane and the inner shaft (7) into the outer shaft (6), - Place the proximal end (4) of the rolling membrane (2) on the distal outer shaft end and connect the distal outer shaft end to the proximal end (4) of the rolling membrane (2).

17. The method according to claim 16, wherein, Connecting the distal inner shaft end to the distal end (5) of the rolling membrane (2) is accomplished by welding the distal inner shaft end to the distal end (5) of the rolling membrane (2).

18. The method according to claim 17, wherein, Connecting the distal inner shaft end to the distal end (5) of the rolling membrane (2) is accomplished by using a welding wire (22) inserted into the inner shaft lumen to weld the distal inner shaft end to the distal end (5) of the rolling membrane (2).

19. The method according to claim 17, wherein, Connecting the distal inner shaft end to the distal end (5) of the rolling membrane (2) is accomplished by laser welding the distal inner shaft end to the distal end (5) of the rolling membrane (2).

20. The method according to any one of claims 16 to 19, wherein, Turning over the rolling membrane (2) is accomplished by pulling the proximal end (4) of the rolling membrane (2) in the proximal direction over the inner shaft (7).

21. The method according to any one of claims 16 to 20, wherein, Connecting the distal outer shaft end to the proximal end (4) of the rolling membrane (2) is accomplished by using a welding tube (23) inserted into the outer shaft lumen and between the outer shaft wall and the inner shaft wall to weld the distal outer shaft end to the proximal end (4) of the rolling membrane (2).

22. The method according to any one of claims 18 to 21, wherein, The method further includes the step of removing the welding wire (22) from the inner shaft lumen.

23. The method according to any one of claims 16 to 22, wherein, The method further includes the step of connecting the inner shaft (7) and / or the outer shaft (6) to a proximal shaft.

24. The method according to any one of claims 16 to 23, wherein, The method further includes the step of connecting the inner shaft (7) to a push rod.

25. The method according to any one of claims 23 to 24, wherein, The proximal shaft and / or the push rod is made of metal or a metal alloy.

26. The method according to any one of claims 16 to 25, wherein, The rolling membrane (2) is provided with at least one reinforcing device (21).

27. The method according to any one of claims 16 to 26, wherein, The at least one reinforcing device (21) includes at least one linear element that extends at least partially along the axial direction of the catheter and / or extends helically around the axial direction of the catheter and / or extends in a zigzag pattern around the axial direction of the catheter.

28. The method according to any one of claims 17 to 27, wherein, Welding the distal inner shaft end to the distal end (5) of the rolling membrane (2) is accomplished via an adhesive material placed between the distal end (5) of the rolling membrane (2) and the distal inner shaft end.

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