Optimized design of rolling film as guide extension catheter

Abstract

The invention relates in particular to a guide extension catheter comprising a rolling film, an inner shaft, where a first portion of the rolling film is connected to the inner shaft, and where the catheter further comprises a connecting element for temporarily connecting a second portion of the rolling film to an outer shaft.

Description

Technical Field

[0001] The present invention relates to different types of guiding extension catheters and methods of using the same. Background Art

[0002] 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 over the past few years. 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 increase in the 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 at an early stage of the disease, where the risk to the patient should preferably be as low as possible.

[0004] Preferred minimally invasive methods for supporting 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 an artery and / or vein until a general abnormality (e.g., stenosis) in the patient's blood vessels.

[0005] Such a catheter can be adapted to deliver a medical device (e.g., a balloon, a stent, etc.) and / or a drug to an affected area of a patient's blood vessel for diagnosing and / or curing the corresponding disease.

[0006] 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 vessel is blocked (e.g., calcified) and / or tortuous.

[0007] For example, in complex percutaneous coronary interventions (PCIs), one of the greatest challenges is the inability to cross a lesion to a target lesion with a catheter and / or a medical device and / or a medical drug. In such cases, partner wire and / or anchor balloon techniques can help to successfully complete a coronary intervention.

[0008] The mother and child technique is another powerful method for delivering a medical device to a certain target lesion. Considering the mother and child zygote technique, inserting a 4-French (Fr) catheter (child catheter) into a 6-Fr guiding catheter (mother catheter) can greatly improve the success rate of crossing lesions that may fail with standard methods. Therefore, the "4-in-6" system is also becoming a viable alternative for highly calcified, angulated, or tortuous lesions.

[0009] In addition, in this regard, the rapid exchange of the guiding extension catheter (GEC) or guiding catheter extension has been evolving. Previous studies have proposed mechanisms for its efficiency, such as increasing backup support through deep intubation, serving as a conduit to reduce friction between the vessel wall and the catheter, or for improving coaxial alignment between the catheter and the lesion. It also aids in stent and balloon delivery in complex coronary lesions, complex anatomies, and / or left internal thoracic artery grafts.

[0010] For percutaneous transluminal coronary angioplasty (PTCA), the guiding catheter is typically inserted into a sheath together with a guide wire. Once the guiding catheter is in place, the guide wire is pushed out of the guiding catheter and into the coronary artery and through the stenosis. Then, the guiding extension catheter is introduced into the guiding catheter and finds its way into the vessel through the guide wire.

[0011] The guiding extension catheter can be a monorail system. The guiding extension portion has an average length of 25 cm, and it can pass through in a rapid exchange manner and can extend beyond the distal end of the guiding catheter. The guiding extension catheter can be thinner than the guiding catheter by, for example, 1 Fr, and it can be designed to minimize trauma to the coronary artery. The proximal end of the guiding extension catheter can be attached to a thin stainless steel pusher rod, which can be used to push and pull the guiding extension catheter independently of the guiding catheter.

[0012] However, even modern guiding extension catheters still have difficulty passing through calcified arteries, especially when there is a 180° bend, due to excessive friction. Then, the physician may use a balloon catheter to assist the guiding extension catheter in passing through such a bend. This procedure requires placing the balloon distal to the guiding extension catheter, then inflating the balloon, and subsequently pushing the guiding catheter over the balloon catheter while deflating the balloon catheter. However, in some cases, the balloon catheter and the guiding catheter may move relative to the vessel wall and may cause intimal injury due to excessive shear.

[0013] In summary, if a catheter is needed to study highly curved vessels, existing catheters may be limited in their application, may pose excessive risks to the patient's health status, and may unduly prolong catheter-based interventions.

[0014] Therefore, there is a need to improve currently available catheters, especially guiding extension catheters.

[0015] These disadvantages can be overcome at least in part by the guiding extension catheter according to claim 1, 15, or 20. Summary of the Invention

[0016] The (rolling membrane) guiding extension catheter according to the present invention includes a rolling membrane and an outer shaft (such as a guiding catheter).

[0017] According to a first aspect of the present invention, the guiding extension catheter comprises or consists of a rolling membrane; an outer shaft; an inner shaft, at least partially arranged or arrangeable within the outer shaft; and wherein the rolling membrane is connected to the inner shaft and optionally a connecting element for (at least temporarily) connecting the rolling membrane to the outer shaft.

[0018] A first part of the rolling membrane is connected to the inner shaft, and the catheter further comprises a connecting element for temporarily (e.g., releasably) connecting a second part of the rolling membrane to the outer shaft.

[0019] The rolling membrane may be adapted to unroll in the distal direction. The rolling membrane may be adapted to roll proximally. The rolling membrane may be configured such that the rolling membrane extends to a greater extent in the longitudinal direction than in the radial direction (i.e., the direction perpendicular to the longitudinal direction in which the rolling membrane unrolls).

[0020] In some embodiments, if the rolling membrane is fully unrolled, the first part of the rolling membrane may be the distal end of the rolling membrane. Thus, the rolling membrane may be configured to move away from the outer shaft in the distal direction. Additionally or alternatively, if the rolling membrane is fully rolled up, the second part of the rolling membrane may be the proximal part of the rolling membrane.

[0021] In some preferred embodiments, the outer shaft may be a guiding catheter.

[0022] The connecting element is connected to the proximal part of the rolling membrane and / or the connecting element is adapted such that the connecting element can be connected to the outer shaft.

[0023] By providing the catheter with a connecting element for temporarily connecting the proximal part of the rolling membrane to the outer shaft, the situational and non-permanent extension of the catheter can be facilitated. This can advantageously increase the fields of possible applications in which the catheter can be used. For example, if the catheter may not be able to pass through a lesion in a patient's blood vessel, the catheter can additionally be provided with a suitable extension (e.g., by means of the outer shaft and the connecting element to connect the rolling membrane) such that the lesion can be passed through without damaging the inner wall of the corresponding blood vessel of the patient. In combination with a rolling membrane that can be adapted to travel safely and non-invasively along the patient's blood vessel, the connected rolling membrane can be utilized to facilitate a guiding extension catheter that can be released when not needed. For example, in a situation where the membrane cannot be fully unrolled, it may be useful to implement a (releasable) connection at this (proximal) end of the membrane (which would be distal if the membrane were fully unrolled).

[0024] The connecting element may be adapted to be inserted into the outer shaft and adapted to establish a connection between the rolling membrane and the outer shaft. The connecting element may be connected to the rolling membrane by clamping. In some examples, welding, gluing, etc. may also be used. The connection between the rolling membrane and the outer shaft may be liquid and / or fluid tight.

[0025] The connecting element and the rolling membrane can be made of the same material (combination). Alternatively, the connecting element and the rolling membrane can differ in at least one constituent material.

[0026] The connection between the connecting element and the rolling membrane can be temporary. However, in some examples, the connection between the connecting element and the rolling membrane can be permanent.

[0027] The connecting element can include a first diameter at the proximal portion of the connecting element and a second diameter at the distal portion of the connecting element. The first diameter can be equal to or less than the inner diameter of the outer shaft, and the second diameter can be less than the first diameter at the proximal portion of the connecting element. This can achieve a force fit between the connecting element and the outer shaft.

[0028] If the first diameter of the proximal portion of the connecting element is adapted to be less than the inner diameter of the outer shaft, it can facilitate the convenient insertion and sliding characteristics of the connecting element into and within the outer shaft. This can contribute to the simplification of the catheter and its overall convenient usability.

[0029] Alternatively, the first diameter can be adapted to be greater than the inner diameter of the outer shaft. At least the proximal portion of the connecting element can be adapted to be flexible such that, before inserting the connecting element into the lumen of the outer shaft, the proximal portion of the connecting element can be slightly squeezed. Since at least the proximal portion of the connecting element may attempt to relax back to its original diameter, a thrust force can be exerted on the inner wall of the outer shaft, and the thrust force can be accompanied by frictional / shearing forces such that the connecting element can be locked within the outer shaft, preferably by clamping.

[0030] By making the diameter of the distal portion of the connecting element smaller than the corresponding proximal portion, it can facilitate the convenient insertion of the connecting element into the outer shaft.

[0031] The connecting element can be connected to the distal portion of the rolling membrane.

[0032] The connecting element, preferably the proximal portion of the connecting element, can be connected to the distal portion of the rolling membrane. The proximal portion of the rolling membrane can be connected to the inner shaft. Additionally or alternatively, the distal portion of the connecting element can be connected to the rolling membrane. The connecting element can generally be provided with a lumen.

[0033] By adapting the connecting element such that it can be connected to the distal portion of the rolling membrane, preferably at the proximal portion of the connecting element, it can facilitate at least partial accommodation of the rolling membrane within the lumen of the connecting element. This can help protect the rolling membrane if the catheter needs to exert a certain thrust force in the distal direction to pass through a (minor) occlusion without damaging the rolling membrane.

[0034] The connecting element can include an annular element for applying a radial force to the distal portion of the rolling membrane and to the outer side or the inner side of the outer shaft.

[0035] The annular element can be configured as a ring. The annular element can include a slideway. The annular element can include a diameter greater than the inner diameter of the outer shaft. By squeezing the annular element in the radial direction, the diameter of the annular element can be reduced.

[0036] By inserting the annular element into the inner cavity of the outer shaft and placing a part of the rolling membrane between the ring and the inner side of the outer shaft, the ring can exhibit a radial acting force on the rolling membrane and the inner side of the outer shaft, thereby locking the rolling membrane in the outer shaft.

[0037] The connecting element can be adapted to be placed on the outer shaft and adapted to establish a clamping connection between the rolling membrane and the outer shaft.

[0038] The annular element can include a diameter smaller than the outer diameter of the outer shaft. Therefore, when the annular element is placed on the outer shaft, it can tend to reduce its diameter and thus can exhibit a radial force on the outer side of the outer shaft, which can be advantageously used to clamp the rolling membrane to the outer side of the outer shaft.

[0039] By adapting the connecting element such that it can be placed on the outer shaft, the rolling membrane can be clamped to the outer side of the outer shaft. With this configuration, the insertion of a medical device (as will be further described below) from the inner cavity of the outer shaft into the rolling membrane can be supported.

[0040] The connecting element can include a hydrophilic coating and / or an expandable coating so as to expand if exposed to a liquid. If the connecting element is inserted into the inner cavity of the outer shaft, the coating can be located between the connecting element and the inner side of the outer shaft.

[0041] The hydrophilic coating can be a hydrogel (e.g., polyvinylpyrrolidone). The coating can exhibit a sealing ability at least when exposed to a liquid, such that if the coating contacts at least one other contact surface, it prevents, for example, the passage of a liquid.

[0042] By providing a hydrophilic coating for the connecting element, if the expandable liquid has been exposed to a liquid, the connecting element can move / slide to a desired target position without being affected by friction. Thus, a single coating can provide two beneficial effects: sealing ability while still supporting the mobility of the connecting element.

[0043] The rolling membrane can also include a sealing element, preferably a hemostatic valve, at its proximal portion.

[0044] By providing a rolling membrane with a hemostatic valve at its proximal portion, the firm and aseptic insertion of a medical device into the inner cavity of the rolling membrane can be facilitated. Alternatively, the fluid supply to the rolling membrane can be facilitated, thereby allowing the expansion of the rolling membrane.

[0045] The catheter can also include: a manipulation element for manipulating the sealing element. The manipulation element can be inserted into the inner cavity of the rolling membrane from the proximal direction.

[0046] The actuating element may be adapted to push the sealing element in a distal direction (from a proximal direction). Additionally or alternatively, the actuating element may be adapted to pull the sealing element in a proximal direction (from a proximal direction). Additionally or alternatively, the actuating element may be adapted to be rotatable about its longitudinal axis, for example in order to rotate the sealing element.

[0047] The actuating element may allow for manipulation of the sealing element from a remote location (e.g., from outside the patient's body), which may facilitate simplified manipulation of the catheter, especially when inserted into the patient's body.

[0048] The sealing element may be diametrically adjustable by means of the actuating element.

[0049] The sealing element may be provided with a variable diameter. The variable diameter of the sealing element may be mechanically manipulated. The sealing element may be remotely manipulated from outside the patient's body.

[0050] By providing the sealing element in an adaptable manner, the sealing element may be easily adapted to the situational requirements. For example, when the sealing element is to be inserted into an outer shaft, for example, the sealing element may be set to a small diameter so that the sealing element does not inadvertently impede the insertion. However, when the sealing element has been successfully inserted into an outer shaft, for example, and is pushed to a desired target location, the diameter of the sealing element may be increased so that the desired sealing performance is exhibited.

[0051] At least when the rolling membrane is in the unrolled state, the rolling membrane may be adapted to form a lumen.

[0052] If the rolling membrane is in at least a partially rolled-up state, the lumen of the rolling membrane may effectively be occupied by the rolling membrane folded therein. In some exemplary embodiments, when the rolling membrane is in the unrolled state, the inner shaft may not enter the lumen of the rolling membrane.

[0053] Forming a lumen in the rolling membrane may allow for delivery of a medical device (e.g., another catheter and / or stent, etc.) and / or a medical drug to a target location, which may preferably be distal to the most distal tip of the rolling membrane. The delivery may preferably be based on inserting the device and / or the drug to be delivered into the lumen of the rolling membrane from the proximal direction of the rolling membrane and pushing the device and / or the drug in the distal direction, as seen when the rolling membrane is fully unrolled.

[0054] The connecting element may be adapted to seal the inflatable volume of the rolling membrane in a pressure-tight manner.

[0055] A pressure-tight seal may be understood as a seal that may not allow fluid particles to penetrate from a volume located proximal to the connecting element, for example, to a volume located distal to the connecting element until a certain threshold pressure.

[0056] If the connection between the rolling membrane and the outer shaft is suitable for pressure sealing and / or fluid sealing, the rolling membrane can be expandable, for example, expanding from the proximal direction of the connecting element, for example, by supplying pressurized liquid and / or gas. By means of the connecting element, if the rolling membrane is combined with the outer shaft, the rolling membrane can be particularly expandable.

[0057] A second aspect of the present invention relates to a method for using a guiding extension catheter (preferably the catheter as described above). The method may include providing an outer shaft and providing a rolling membrane, the rolling membrane being connected to an inner shaft at a first portion of the rolling membrane. The method may further include releasably / temporarily connecting a second portion of the rolling membrane to the outer shaft, preferably via a connecting element, such that the rolling membrane can be unrolled along the longitudinal axis of the outer shaft.

[0058] By means of the above method, the catheter can be more simply adapted to the situational needs, even when partially inserted into a patient's blood vessel.

[0059] The method may further include inserting the distal end of the outer shaft into a blood vessel and at least partially unrolling the distal end of the rolling membrane along the blood vessel, such that a lumen can be formed in the rolling membrane to facilitate the delivery of a medical device and / or a medical drug from the proximal end of the rolling membrane to the distal end of the rolling membrane.

[0060] By operating the catheter according to the foregoing method, the synergistic effect of the extension catheter and the rolling membrane can be advantageously utilized. This can improve the user experience of the members of the medical staff and can reduce the risk to the patient, for example, caused by the movement of the catheter in the distal direction.

[0061] A third aspect of the present invention relates to a guiding extension catheter, which includes a rolling membrane, a proximal shaft, and an outer shaft or consists of a rolling membrane, a proximal shaft, and an outer shaft, preferably a guiding catheter. The proximal shaft can be considered as an inner shaft, which is partially disposed within the outer shaft, preferably disposed within the guiding catheter. The proximal shaft may include a lumen.

[0062] The rolling membrane includes a first portion and a second portion. The first portion can be disposed at the distal end of the rolling membrane, while the second portion can be disposed at the proximal end of the rolling membrane. The rolling membrane can be configured to form an inner rolling membrane lumen in the rolled-up state and / or the unrolled state of the rolling membrane. The inner rolling membrane lumen has a larger diameter than a conventional inner shaft. Therefore, the diameter of the rolling membrane lumen enables a (medical and / or sensing) device to be guided through the rolling membrane lumen (for example, whenever the rolling membrane function is not required).

[0063] The proximal shaft can be connected to the second part of the rolling membrane. Preferably, the proximal shaft can be connected to the rolling membrane such that the proximal shaft at least partially houses the second end of the rolling membrane within the lumen of the proximal shaft. In other words, the rolling membrane can be connected to the inner side of the proximal shaft. Thus, the proximal shaft may not limit the inner diameter of the inner rolling membrane cavity. The proximal shaft can have a push-pull function, i.e., pushing the rolling membrane in the distal direction (towards the patient) and pulling the rolling membrane in the proximal direction (towards the operator / doctor).

[0064] The outer shaft, preferably the guiding catheter, can be adapted to enter at least partially into the body of the patient using part I of the outer shaft. The outer shaft, preferably the guiding catheter, can be further adapted to remain at least partially outside the patient's body together with a part of the outer shaft.

[0065] The diameter of the outer shaft (preferably the guiding catheter) can increase at its proximal part (at part O staying outside the body) compared to its distal part. The diameter of the guiding catheter can increase at its proximal part such that the proximal shaft cannot enter the distal part of the guiding catheter. Since the outer shaft (preferably the guiding catheter) has a smaller diameter at its distal part than at its proximal part, it hinders the insertion of the proximal shaft into the distal part of the outer shaft. Thus, the length by which the rolling membrane exits the outer shaft (preferably the guiding catheter) in the unrolled state can be defined by the length of the distal part of the outer shaft (preferably the guiding catheter) that has a smaller diameter than the proximal part of the outer shaft. The proximal shaft can be adapted to remain outside the patient's body during use of the catheter with the patient. In other words, the proximal shaft can be adapted not to enter the patient's body.

[0066] The rolling membrane can be adapted to unroll in the distal direction. The rolling membrane can be adapted to roll in the proximal direction. The rolling membrane can be configured such that the rolling membrane extends to a greater extent in the longitudinal direction than in the radial direction. In some embodiments, if the rolling membrane is fully unrolled, the first part of the rolling membrane can be the distal end of the rolling membrane. Thus, the rolling membrane is configured to exit the outer shaft, preferably the guiding catheter, in the distal direction.

[0067] The outer shaft, preferably the guiding catheter, houses at least a part of the rolling membrane. At least the distal part of the outer shaft, preferably the guiding catheter, can be connected to the first part of the rolling membrane.

[0068] The proximal shaft can be adapted to push the rolling membrane in the distal direction D and / or pull the rolling membrane in the proximal direction P. The lumen of the proximal shaft can be connected to the lumen of the rolling membrane such that, for example, a medical device and / or a medical drug can be fed from the proximal part of the catheter to the distal part of the catheter.

[0069] The rolling membrane can have a smaller wall thickness than the inner shaft. Thus, it impairs the inner rolling membrane lumen less than a conventional inner shaft.

[0070] The proximal end of the rolling membrane can be connected to the inner side of the proximal shaft, and the distal end of the rolling membrane can be connected to the outer shaft, preferably to the guiding catheter. The outer shaft can accommodate at least a part of the rolling membrane.

[0071] At the proximal part of the outer shaft (preferably the guiding catheter), the outer shaft can terminate at a sealing element. The sealing element can preferably be a hemostatic valve. The proximal shaft can at least partially extend through the sealing element.

[0072] A fourth aspect of the present invention relates to a guiding extension catheter, which includes a rolling membrane or consists of a rolling membrane, an outer shaft (e.g., a guiding catheter), the rolling membrane partially extends through the outer shaft, and the proximal part of the rolling membrane is slidably connected to a sealing valve, and the distal part of the rolling membrane is connected to a connecting element.

[0073] The sealing valve and / or the connecting element can include a hydrophilic coating and / or an expandable coating so as to expand when exposed to liquid. The sealing valve can include at least one hemostatic valve, for example, the sealing valve can be a Tuohy Borst valve.

[0074] The sealing valve can have its distal movement restricted by the outer catheter. For example, the distal end of the sealing valve and the proximal end of the outer catheter can form a positive connection (form - fit connection). To connect the outer shaft to the valve 611, the valve can include a shaft - shaped part that points in the distal direction and has an outer diameter slightly smaller than the inner diameter of the outer shaft. The shaft - shaped part can be provided with an inner diameter of at least 4Fr.

[0075] The outer shaft can be movably arranged on the rolling membrane. The outer shaft can move in the proximal direction, wherein, due to the translation of the outer shaft, the connecting element can (further) move in the distal direction into the outer shaft. The sliding movement of the connecting element can be advantageously supported by a preferably hydrophilic coating of the connecting element, which can reduce the friction during the sliding translation.

[0076] The rolling membrane can extend through the sealing valve (e.g., Tuohy Borst valve). In some embodiments, the rolling membrane can be connected to the proximal shaft in the proximal part of the rolling membrane.

[0077] The connecting element can be adapted to seal the distal part of the catheter.

[0078] The guiding extension catheter according to the present invention can synergistically combine the advantages of the guiding extension catheter (as described above) and the rolling membrane for improving the catheter - based inventions as described above.

[0079] The catheter can further include an outer shaft that at least partially encloses the rolling membrane, wherein at least the proximal part of the outer shaft remains outside the patient's body during the use of the catheter with the patient. Description of the Drawings

[0080] The following drawings are provided to support the understanding of the present invention:

[0081] Figure 1A-1B : Illustration of an exemplary rolling membrane catheter without an inner shaft;

[0082] Figure 2A-2C : Illustration of an exemplary rolling membrane catheter with an inner shaft and additional connection elements;

[0083] Figure 3A-3B : Illustration of an exemplary rolling membrane catheter with an inner shaft and additional connection elements;

[0084] Figure 4 : Illustration of an exemplary component of a rolling membrane guiding extension catheter;

[0085] Figure 5 : Illustration of an exemplary combination of an outer shaft and a rolling membrane catheter;

[0086] Figure 6A-6B : Illustration of an assembled rolling membrane guiding extension catheter. Detailed Description

[0087] Figure 1A and Figure 1B depicts a first exemplary embodiment of a rolling membrane catheter according to one aspect of the present invention.

[0088] Figure 1A Shows an exemplary embodiment of a catheter 100, which includes a rolling membrane 101 (depicted in a wound state). The rolling membrane 101 includes a first portion 102 and a second portion 103. The first portion 102 may be disposed in the distal portion of the rolling membrane 101, while the second portion 103 may be disposed in the proximal portion of the rolling membrane 101. The rolling membrane 101 may be configured to form a lumen 104 in the wound state of the rolling membrane 101 and / or in the unwound state of the rolling membrane 101.

[0089] The catheter 100 may further include an outer shaft 105, which may accommodate at least a portion of the rolling membrane 101. The outer shaft 105 may be a guiding catheter. The outer shaft 105 may be adapted to enter at least partially into a patient's body using a portion I of the outer shaft 105. The outer shaft 105 may be further adapted to be at least partially retained outside the patient's body together with a portion O of the outer shaft 105. The diameter of the outer shaft 105 may increase at its proximal portion (at the portion O remaining outside the body) compared to its distal portion.

[0090] At least the distal portion of the outer shaft 105 may be connected to the first portion 102 of the rolling membrane 101. At the proximal portion of the outer shaft 105, the outer shaft 105 may terminate at a sealing element 106. The sealing element 106 may preferably be a hemostatic valve.

[0091] The catheter 100 may further include a proximal shaft 107. The proximal shaft 107 may extend at least partially through the sealing element 106. The proximal shaft 107 may include a lumen. The proximal shaft 107 may be connected to the second portion 103 of the rolling membrane 101. Preferably, the proximal shaft 107 may be connected to the rolling membrane 101 such that the proximal shaft 107 at least partially houses the second end 103 of the rolling membrane 101 within the lumen of the proximal shaft 107. In other words, the rolling membrane 101 may be connected to the inner side of the proximal shaft 107. Thus, the proximal shaft 107 may not limit the inner diameter of the lumen 104 of the rolling membrane 101 and thus may not limit the inner diameter of the outer shaft (guide catheter) 105 itself.

[0092] The proximal shaft 107 may be adapted to always remain outside the patient, preferably in portion O. The proximal shaft 107 may be adapted to push the rolling membrane 101 in the distal direction D and / or pull the rolling membrane 101 in the proximal direction P. The lumen of the proximal shaft 107 may be connected to the lumen 104 of the rolling membrane 101 such that, for example, a medical device and / or a medical drug may be fed from the proximal portion of the catheter 100 to the distal portion of the catheter 100.

[0093] Figure 1B is shown Figure 1A an exemplary embodiment of the catheter 100 in which the rolling membrane 101 has been fully unrolled along the distal direction D. The proximal shaft 107 may be held within the outer shaft 105, particularly within the portion of the outer shaft 105 that is outside the patient and may have an increased diameter.

[0094] Figure 2A -B shows another embodiment of the catheter 200 according to one aspect of the present invention.

[0095] It is noted that Figure 2A shows a combination of the outer shaft 205 and the rolling membrane 201 for forming a rolling membrane guided extension catheter (RMGCE). The rolling membrane 201 may be provided with a length between 1 cm and 30 cm (as seen in the fully unrolled state of the rolling membrane 201).

[0096] The rolling membrane 201 may be connected to the inner shaft 208. The rolling membrane 201 may be connected to the inner shaft 208 in the distal portion of the inner shaft 208. The rolling membrane 201 may be connected to the inner shaft 208 on the outer side of the inner shaft 208. The rolling membrane 201 may be connected to the inner shaft 208 by welding, gluing, clamping, and / or any other suitable method.

[0097] The catheter may further include a connecting element 209. The connecting element 209 may be provided as an annular element, for example, a ring such as the spring ring 210, as Figure 2CExemplarily depicted. In some exemplary embodiments, the connecting element 209 may be implemented as an elastic bracket-like structure. In some exemplary embodiments, the connecting element 209 may be provided as a spring seal element.

[0098] The connecting element 209 may be placed at a distance from the distal end of the outer shaft 205 to allow the rolling membrane 201 to self-seal against the inner side of the outer shaft 205. If the connecting element 209 is provided as a spring seal element, the spring seal element must ensure sufficient pressure loss for any liquid passing between the spring element and the outer shaft 205 (e.g., the guiding catheter) such that the pressure within the expandable volume of the rolling membrane 201 is higher than the pressure on the outer side of the rolling membrane 201.

[0099] The connecting element 209 may preferably be adapted to slide within the lumen of the outer shaft 205 and then be fixed therein. Alternatively, the connecting element 209 may also be adapted to be placed on the outer side of the outer shaft 205 and clamp the rolling membrane 201 to the outer shaft 205.

[0100] In an exemplary embodiment of the catheter 200, when the rolling membrane 201 is fully unrolled, the portion of the rolling membrane 201 in contact with the connecting element 209 may form the proximal end of the rolling membrane. The inner shaft 208 may bring the portion of the rolling membrane 201 connected to the inner shaft 208 to the most distal position.

[0101] Figure 2B The connected outer shaft 205 and the connecting element 209 are shown, where the connecting element 209 is adapted to be inserted into the lumen of the outer shaft 205. The connecting element is connected to the distal portion of the outer shaft.

[0102] The connecting element 209 may be provided as an annular element (as described above with reference to Figure 2A ), and may be provided with a diameter that may be larger than the inner diameter of the outer shaft 205. When the connecting element 209 is inserted into the lumen of the outer shaft 205, the connecting element 209 may exert a force on the rolling membrane 201 and the inner side of the outer shaft 205 such that the rolling membrane 201 is at least temporarily connected to the outer shaft 205.

[0103] Figure 3A and Figure 3B Another exemplary embodiment of the connecting element 309 is depicted. The connecting element 309 is attached to the distal portion of the rolling membrane 301, and the proximal portion of the rolling membrane is preferably attached to the inner shaft 308 at the proximal side.

[0104] Figure 3AAn exemplary illustration of the connection element 309 according to another aspect of the present invention is shown. In this exemplary embodiment, the connection element 309 may be provided as a funnel-shaped element, which may include a first diameter at the proximal portion of the connection element 309, and the first diameter may be less than or equal to (in a stationary state, i.e., in a state where the connection element 309 is not connected to the outer shaft 305) the inner diameter of the outer shaft 305.

[0105] Figure 3B An exemplary combination of the outer shaft 305 and the connection element 309 is shown, and the outer shaft 305 may be configured as described above. The connection element 309 may be inserted into the inner cavity of the outer shaft 305. The connection element is connected to the proximal portion of the outer shaft. The connection element 309 may be connected to the inner side of the outer shaft 305 and may be locked in the inner cavity of the outer shaft 305 through the proximal portion of the connection element 309, and the proximal portion may be compressed in diameter and thus radially pressed against the inner side of the outer shaft 305 at its proximal side. Thereby, the temporary connection between the connection element 309 and the outer shaft 305 can be promoted.

[0106] Relative to the proximal portion of the connection element 309, the diameter of the connection element 309 may generally be provided with a diameter that allows the connection element 309 to be inserted into the outer shaft 305. For example, if the rolling membrane 301 is provided as a 4Fr element and if the outer shaft is a 6Fr element, the proximal portion of the connection element 309 may be provided with a Fr of 6Fr or less to form a seal between the outer shaft 305 and the connection element 309.

[0107] Preferably, the outer shaft 305 may be provided with an inner diameter that is 1Fr larger than the diameter of the rolling membrane 301 to facilitate the application of the mother and child technique (e.g., a smaller catheter can be inserted into the inner volume of a larger catheter). In the most preferred embodiment, the outer shaft 305 may be provided as a 6Fr component, and the connection element may be provided as a 4Fr component.

[0108] As Figure 3A and Figure 3B shown, by inserting the connection element 309 into the outer shaft 305, a rolling membrane-guided extension catheter (RMGCE) can be formed by a member of the medical staff. In a preferred embodiment, the RMGCE can be formed by any guiding catheter serving as the outer shaft 305.

[0109] Figure 4 Another exemplary embodiment of the catheter 400 is depicted, particularly a rolling membrane catheter, which may include an inner shaft (not shown) having an additional tension lock for forming a rolling membrane-guided extension catheter (RMGCE), and the RMGCE needs to be inserted into a guiding catheter with the correct inner diameter. The catheter 400 may include a rolling membrane 401 axially extending from the distal direction D to the proximal direction P.

[0110] At the proximal end of the rolling membrane 401 (as seen when the rolling membrane 400 is fully unrolled), the rolling membrane 401 can be connected to a sealing and / or connecting element 409. The sealing element 409 can include a hydrophilic coating and / or an expandable coating. The sealing element 409 can preferably include a sealing element. The sealing element can be provided as a spring sealing element.

[0111] The rolling membrane 401 can pass through a valve 411, such as a Tuohy borst adapter. The valve 411 can preferably be placed outside the patient's body. The valve 411 can be provided with means 414 for supplying fluid (e.g., liquid and / or gas) to the expandable volume of the rolling membrane 401.

[0112] The catheter 400 can also include a manipulation element 412 disposed in the lumen 404 of the rolling membrane 401. The manipulation element 412 can be connected to the sealing element 409 and can extend or be operatively coupled to a location outside the patient's body. The manipulation element 412 can be adapted to prevent the sealing element 409 (and the rolling membrane 401) from inadvertently entering the patient's blood vessel too far (in particular, if the rolling membrane 401 expands, the hydraulic pressure applied to the rolling membrane 401 will pull the sealing element 409 out of the guiding catheter). The manipulation element 412 can allow the sealing element 409 to be placed, for example, within an outer shaft (not shown).

[0113] Figure 5 Exemplarily shown are the insertion of the rolling membrane 501 (e.g., the rolling membrane 401 described above with reference to Figure 4 into an outer shaft 505 (e.g., a guiding catheter in order to form an RMGCE) in five stages i)-v).

[0114] Stage i) shows the rolling membrane 501, which can be configured as described above with reference to Figure 4 as described.

[0115] Stage ii) shows the insertion of the rolling membrane 501 into the outer shaft 505. The maximum radius of the rolling membrane 501 can be configured to be less than the inner diameter of the outer shaft 505.

[0116] Stage iii) shows a scenario of the rolling membrane 501 inserted into the outer shaft 505. The connecting and / or sealing element 509 (preferably provided with a hydrophilic and expandable coating) may have been exposed to a liquid such that a seal of the lumen of the outer shaft 505 can be effected. The seal can cause a preferably airtight separation of the distal volume portion of the lumen of the outer shaft 505 from the proximal volume portion of the lumen of the outer shaft 505. It can releasably connect the rolling membrane 501 to the outer shaft 505 (e.g., the proximal portion of the rolling membrane).

[0117] Stage iii) further depicts a blocking element 513, which may include a volume element configured to have dimensions exceeding the diameter of the outer shaft 505, such that the blocking element may not be able to enter the outer shaft 505, for example, from the proximal direction P. This configuration can ensure that the manipulation element 512 does not accidentally enter the patient's blood vessel.

[0118] Stage iii) further depicts a rolling membrane 501 in at least a partially unrolled state.

[0119] Stage iv) depicts the rolling membrane 501 of stage iii), in which a medical device 514 has been inserted into the lumen 504 of the rolling membrane 501. The medical device 514 can be, for example, a catheter, which can be inserted from the proximal direction P through the lumen of the rolling membrane 501 to the distal direction D.

[0120] Stage v) depicts the rolling membrane 501 of stage iv), in which the medical device 514 has been delivered to a position distal to the farthest distal tip of the rolling membrane 501.

[0121] Generally, the rolling membrane 501 can preferably be everted into a narrow and tortuous blood vessel. When everting the rolling membrane 501 into the blood vessel (as shown in stage iii), the rolling membrane 501 can contract at least partially (stage iv), and can push any catheter smaller than 4Fr to the target position.

[0122] Figure 6A and Figure 6B Exemplarily shown as above with reference to Figure 4 and Figure 5 the catheter 600 described.

[0123] Figure 6A Shows a possible combination of the rolling membrane 601 with the outer shaft 605 (e.g., the outer shaft 505 as described above with reference to Figure 5 and the valve 611 (e.g., the valve 411 as described above with reference to Figure 4 ). In Figure 6A , the rolling membrane 601 has been at least partially inserted into the outer shaft 605. The outer shaft 605 can be moved in the proximal direction P, wherein, due to the translation of the outer shaft 605, the connecting element 609 can further enter the outer shaft 605 in the distal direction. The sliding movement of the connecting element 609 can be advantageously supported by a preferably hydrophilic coating of the connecting element 609, which can reduce the friction during the sliding translation.

[0124] Figure 6B Shows Figure 6A the catheter of Figure 6A , in which the outer shaft 605 of

[0125] Figure 6B The rolling membrane 601 is also shown in at least a partially everted state.

[0126] In a preferred embodiment, the rolling membrane 601 may include a diameter that is less than the diameter of the patient's blood vessel. Additionally, the diameter of the rolling membrane 601 may be greater than the inner diameter of the outer shaft 605 (at least in the unrolled state of the rolling membrane 601).

[0127] In some embodiments, the rolling membrane 601 may be connected to a proximal shaft in the proximal portion of the rolling membrane 601.

[0128] The connecting element 609 may also be adapted to seal the catheter 600 in the distal portion of the catheter 600.

[0129] To connect the outer shaft 605 to the valve 611, the valve 611 may include a shaft-shaped portion that is oriented in the distal direction D and includes an outer diameter that is slightly less than the inner diameter of the outer shaft 605. The shaft-shaped portion may be provided with an inner diameter of at least 4Fr.

[0130] In some exemplary embodiments, the catheter 600 may be provided with an additional tube inside the lumen of the rolling membrane 601 as an additional manipulation element 612 for manipulating the connecting element 609. The valve 611 may be configured to be pressure-sealed and may be adapted to seal the proximal portion of the catheter 600.

[0131] The volume element 613 may be similar to the volume element 513 outlined in the reference Figure 5 as outlined.

Claims

1. A guiding extension catheter (200; 300; 400), comprising: a rolling membrane (201; 301); an inner shaft (208; 308); wherein a first part of the rolling membrane (201; 301; 401) is connected to the inner shaft (208; 308); the catheter (200; 300; 400) further comprises connecting elements (209; 210; 309; 409) for temporarily connecting a second part of the rolling membrane (201; 301; 401) to an outer shaft.

2. The guiding extension catheter (200; 300; 400) according to claim 1, wherein the connecting element (209; 309; 409) is connected to the proximal portion of the rolling membrane (201; 301; 401), and the connecting element (209, 309, 409) is capable of being connected to the outer shaft (105; 205; 305).

3. The guiding extension catheter (200, 300, 400) according to claim 1 or 2, wherein the connecting element (209; 309; 409) is adapted to be inserted into the outer shaft (205; 305) and is adapted to establish a clamping connection between the rolling membrane (201; 301; 401) and the outer shaft (205; 305).

4. The guiding extension catheter (300) according to claim 1 or 2, wherein the connecting element (309) includes a first diameter at the proximal portion of the connecting element (309) and a second diameter at the distal portion of the connecting element (309), the first diameter being equal to or less than the inner diameter of the outer shaft (305), and the second diameter being less than the first diameter at the proximal portion of the connecting element (309).

5. The guiding extension catheter (200; 300; 400) according to claim 1, wherein the connecting element (209; 210; 309; 409) is capable of being connected to the distal portion of the rolling membrane (201; 301; 401).

6. The guiding extension catheter (200; 300; 400) according to claim 5, wherein the connecting element (209; 210; 309; 409) includes an annular element for applying a radial force to the distal portion of the rolling membrane (201; 210; 301; 401) and the outer side of the outer shaft (205; 305; 605) or the inner side of the outer shaft (205; 210; 305).

7. The guiding extension catheter (200) according to claim 5 or 6, wherein the connecting element (210) is adapted to be placed on the outer shaft (205) and is adapted to establish a clamping connection between the rolling membrane (201) and the outer shaft (205).

8. The guiding extension catheter (200; 300; 400) according to claim 5 or 6, wherein the connecting element (209; 210; 309; 409) comprises a hydrophilic coating and / or an expandable coating so as to be able to expand if exposed to liquid.

9. The guiding extension catheter (400) according to any one of the preceding claims, wherein the rolling membrane (401) further comprises a sealing element (411) at its proximal part, preferably a hemostatic valve.

10. The guiding extension catheter (400) according to claim 9, further comprising: a manipulation element (412) for manipulating the sealing element (411); wherein the manipulation element (412) can be inserted into the inner cavity (404) of the rolling membrane (401) from the proximal direction.

11. The guiding extension catheter (400) according to claim 10, wherein the diameter of the sealing element can be adjusted by the actuating element (412).

12. The guiding extension catheter (200; 300; 400) according to any one of the preceding claims, wherein the rolling membrane (201; 301; 401) is adapted to form a lumen (404) at least when the rolling membrane (201; 301; 401) is in the unrolled state.

13. The guiding extension catheter according to any one of the preceding claims, wherein the connecting element (209; 309; 409) is adapted to seal the expandable volume of the rolling membrane (201; 301; 401) in a pressure-tight manner.

14. A method for using a catheter (200; 300; 400), the catheter preferably being the catheter according to claims 1 to 13, the method comprising: providing an outer shaft (205; 305); providing a rolling membrane (201; 301; 401) connected to an inner shaft at a first part of the rolling membrane (201; 301; 401); releasably connecting a second part of the rolling membrane (201; 301; 401) to the outer shaft (205; 305) via a connecting element such that the rolling membrane (201; 301; 401) can be unrolled along the longitudinal axis of the outer shaft (105; 205; 305).

15. A guiding extension catheter (100) comprising or consisting of: a rolling membrane (101), a proximal shaft (107), and a guiding catheter (105), wherein the proximal end of the rolling membrane (101) is connected to the inside of the proximal shaft (107), and wherein the distal end of the rolling membrane (101) is connected to the guiding catheter (105).

16. The guiding extension catheter (100) according to claim 15, wherein the diameter of the guiding catheter (105) increases at its proximal part such that the proximal shaft (107) cannot enter the distal part of the guiding catheter (105).

17. The guiding extension catheter (100) according to claim 15 or 16, wherein the proximal part of the guiding catheter (105) is connected to a sealing element (106).

18. The guiding extension catheter (100) according to claim 17, wherein the sealing element (106) is a hemostatic valve.

19. The guiding extension catheter (100) according to claim 17 or 18, wherein the proximal shaft (107) extends at least partially through the sealing element (106).

20. A guiding extension catheter (500, 600), comprising or consisting of: rolling membranes (501, 601), outer shafts (505, 605), the rolling membranes (501, 601) partially extending through the outer shafts, and wherein the proximal parts of the rolling membranes (501, 601) are slidably connected to a sealing valve (611), and the distal parts of the rolling membranes (501, 601) are connected to connecting elements (509, 609).

21. The guiding extension catheter (500, 600) according to claim 20, wherein the outer shaft (505, 605) is a guiding catheter.

22. The guiding extension catheter (600) according to claim 20 or 21, wherein the sealing valve (611) and / or the connecting element (609) comprises a hydrophilic coating and / or an expandable coating so as to expand if exposed to liquid.

23. The guiding extension catheter (600) according to any one of claims 20 to 22, wherein the sealing valve (611) comprises at least one hemostatic valve.

24. The guiding extension catheter (600) according to any one of claims 20 to 23, wherein the sealing valve (611) is a Tuohy Borst valve.

25. The guiding extension catheter (600) according to any one of claims 20 to 24, wherein the rolling membrane (601) extends through the sealing valve (611).

26. The guiding extension catheter (600) according to any one of claims 20 to 25, wherein the distal movement of the sealing valve (611) is restricted by the outer catheter (605).

27. The guiding extension catheter (600) according to any one of claims 20 to 26, wherein the connecting element (609) is adapted to seal the distal portion of the catheter (600).

28. The guiding extension catheter (600) according to any one of claims 20 to 27, wherein the distal end of the sealing valve (611) and the proximal end of the outer catheter (605) can form a positive connection.

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