Method for forming a slit in an aortic isolation membrane and catheter assembly for forming a slit in an aortic isolation membrane ("Zi-Cat")

Abstract

The present invention relates to a catheter assembly for forming a slit in an isolation membrane (4) of a patient's aorta. The assembly includes a first catheter (2) configured to be inserted into a true lumen (6) located on a first side of the isolation membrane (4), a second catheter (8) configured to be inserted into a false lumen (10) located on a second side of the isolation membrane (4), and a conductive wire (12) configured to be disposed so as to be conductively connectable to the first catheter (2) and the second catheter (8). The wire (12) is further configured to be energized with an electric current so that the wire (12) can form a slit in the isolation membrane (4). Also described is a method for forming a slit in an isolation membrane (4) of a patient's aorta, the method comprising the steps of: (a) positioning a first catheter (2) so that it extends at least partially into a true lumen (6) of the aorta located on a first side of the isolation membrane (4); (b) positioning a second catheter (8) so that it extends at least partially into a false lumen (10) of the aorta located on a second side of the isolation membrane (4); (c) positioning a conductive wire (12) so that it is conductively connected to the first catheter (2) and the second catheter (8); (d) applying an electric current to the wire (12); and (e) moving the wire (12) relative to the isolation membrane (4) to form a slit in the isolation membrane (4).

Description

[Technical Field]

[0001] The present disclosure relates to a method for forming a slit in an aortic isolation membrane and a catheter assembly for forming a slit in an aortic isolation membrane. [Background technology]

[0002] Aortic dissection occurs when the innermost layer of the aorta is damaged, allowing blood to flow between the layers of the aortic wall and separating them. Aortic dissection can result in insufficient blood flow to the heart or complete rupture of the aorta, which can be rapidly fatal. There are two main types of aortic dissection: Stanford Type A, which involves the first part of the aorta (the part closest to the heart), and Type B, which does not involve the part closest to the heart.

[0003] The aorta is composed of three layers: the intima, media, and adventitia. The intima is in direct contact with the blood inside the vessel and is primarily composed of an endothelial cell layer on a basement membrane. The media contains connective tissue and muscle tissue. The adventitia contains connective tissue and protects the vessel from the outside. The initiating event in aortic dissection is the formation of a tear in the intima of the aorta. Due to high pressure inside the aorta, blood flows through the tear into the media. The pressure of the blood flowing into the media causes the tear to expand. The tear may expand proximally (closer to the heart), distally (farther from the heart), or even both. Blood passes through the media to form a "false lumen." The "true lumen" is the normal blood passageway of the aorta. The intimal tissue layer separating the false lumen from the true lumen is called an intimal flap or dissection flap. The majority of aortic dissections arise from a tear in the intima of the ascending aorta (65%), the aortic arch (10%), or just distal to the cordis arteriosum in the descending aorta (20%).

[0004] Aortic dissection is one of the most dreaded diseases of the aorta. Treatment of post-dissection aortic arch and thoracoabdominal aortic aneurysms presents significant therapeutic challenges. Despite advances in diagnostics, medical treatments, and surgical techniques, patient mortality and morbidity remain high.

[0005] Management of aortic dissection includes stenting of the aorta, particularly with a stent graft.

[0006] Replacement of the ascending aorta and resection of the ostial segment leaves the downstream dissected aorta intact. The remaining isolating membrane still contains a patent false lumen. The presence of a patent false lumen in the descending aorta leads to the development of a post-dissection aneurysm in some patients. According to a 2012 paper by Evangelista et al., 9% of patients require further treatment due to aortic dilatation during follow-up (Evangelista, A. et al.: Long-term outcome of aortic dissection with patent false lumen: predictive role of entry tear size and location. Circulation, 2012; 125(5): 3133-41).

[0007] The management of aortic arch and thoracoabdominal dissecting aortic aneurysms is complex, and the optimal treatment depends on many factors. In addition to patient-related factors, there are also technical and anatomical challenges. The proximal seal often involves the aortic arch. Specifically, there is a risk of true lumen collapse or aortic bifurcation detachment from the false lumen, making endograft alignment difficult or impossible. Open thoracoabdominal repair remains a significant surgical challenge.

[0008] More specifically, a very narrow true lumen, often slit-like, makes endograft positioning difficult, especially because of the risk of stent occlusion due to a thick chronic dissection flap. The aortic bifurcation is perfused by either a true lumen or a false lumen. These facts necessitate a patient-specific treatment concept. In particular, a narrow true lumen poses the risk of not being able to deploy the endograft to the required size.

[0009] Therefore, there is a need for additional methods of treating aortic dissection, specifically, techniques for creating a slit in a patient's aortic dissection membrane. There is also a need for a system for managing aortic dissection, specifically, a catheter assembly for creating a slit in a patient's aortic dissection membrane. Summary of the Invention

[0010] These objects are achieved by the independent claims. The dependent claims contemplate preferred embodiments. Additional and / or alternative aspects of the present disclosure are discussed herein and in each aspect.

[0011] According to the present disclosure, there is provided a method for forming a slit in an isolation membrane of a patient's aorta, the method comprising the steps of: (a) positioning a first catheter so that it extends at least partially into the true lumen of the aorta on a first side of the isolation membrane; (b) positioning a second catheter so that it extends at least partially into the false lumen of the aorta on a second side of the isolation membrane; (c) positioning a conductive wire so that it is conductively connected to the first catheter and the second catheter; (d) applying an electric current to the wire; and (e) moving the wire relative to the isolation membrane to form a slit in the isolation membrane.

[0012] This method can be performed using a catheter assembly for slitting a dissecting membrane in a patient's aorta, as described in the present disclosure. The catheter assembly for slitting a dissecting membrane in a patient's aorta according to the present disclosure includes a first catheter, a second catheter, and a conductive wire.

[0013] The first catheter is configured to be inserted into a true lumen located on a first side of the isolation membrane. The second catheter is configured to be inserted into a false lumen located on a second side of the isolation membrane. The conductive wire is configured to be disposed so as to be conductively connectable to the first catheter and the second catheter. The wire is further configured so as to be capable of forming a slit in the isolation membrane by passing an electric current through the wire.

[0014] By creating a slit in the anatomic membrane, the true lumen of the aorta can be enlarged, thereby enabling or facilitating the implantation of an endovascular stent graft. Specifically, this method allows for the creation of a common lumen for endovascular procedures, particularly for the placement of an endograft. That is, a large connection can be created between the true lumen and the false lumen. This so-called "neo-lumen" or "common lumen" allows for the implantation of an endograft, thereby ensuring blood flow to the patient's aortic bifurcation and organs.

[0015] The above-described method and assembly are particularly effective and safe in addressing the problem of narrow true lumens in post-dissection aneurysms, and generally allow for the creation of slits in the dissecting membrane from the aortic arch to the iliac bifurcation.

[0016] The present method and assembly constitute an effective approach to overcome traditional conflicts in thoracoabdominal endovascular repair, such as compression of the true lumen and avulsion of the aortic branch from the false lumen.

[0017] This procedure can be, but is not required to be, performed via a surgical thoracotomy, and can also be, but is not required to be, performed during aortic arch replacement surgery, such as with the frozen elephant trunk technique.

[0018] Various aspects can implement the following features.

[0019] The first catheter and the second catheter may be formed from an electrically insulating material.

[0020] The length of the first catheter can be, for example, 1 m to 2 m, preferably 1 m to 1.5 m. The length of the second catheter can be, for example, 1 m to 2 m, preferably 1 m to 1.5 m. The first catheter may have a first end configured to be positioned outside the patient's body and a second end opposite the first end configured to be positioned inside the patient's body. The second catheter may have a first end configured to be positioned outside the patient's body and a second end opposite the first end configured to be positioned inside the patient's body.

[0021] The first catheter may have a lumen extending between its first end and its second end. The second catheter may have a lumen extending between its first end and its second end. In step (c), the wire may be positioned to extend partially within the lumen of the first catheter and partially within the lumen of the second catheter. In step (c), the wire may be positioned such that a first end of the wire protrudes from the first end of the first catheter and a second end of the wire opposite the first end of the wire protrudes from the first end of the second catheter.

[0022] In step (a), the first catheter may be inserted through a first groin of the patient, and in step (b), the second catheter may be inserted through a second groin of the patient.

[0023] The catheter may be configured to allow a contrast agent to be delivered to the incision membrane, for example, by passing through the lumen of the catheter, thereby facilitating x-ray control of the method.

[0024] The length of the wire can be, for example, 1.5 m to 4 m, and preferably 2 m to 3.5 m.

[0025] The wire may include a central region configured to contact the separator to form a slit in the separator. The central region may be located, for example, less than 40 cm, preferably less than 30 cm, and more preferably less than 20 cm, from the geometric center of the wire. The length of the central region measured along the longitudinal extension of the wire may be, for example, 1 cm to 10 cm, preferably 2 cm to 5 cm.

[0026] In step (c), the central region may be disposed, for example, between the second end of the first catheter and the second end of the second catheter.

[0027] The wire may include an electrically insulating sheath and may have an electrically non-insulating region in its central region for forming a slit in the separator. The non-insulating region may be preferably directly surrounded by the insulating sheath. The non-insulating region may be the only non-insulating region in the central region of the wire. This allows the current applied to the wire in step (d) to be limited to the non-insulating region.

[0028] The non-insulated region may extend along a portion of the longitudinal extension of the wire. The non-insulated region may extend around only a portion of the circumference of the wire.

[0029] The central region may include a preformed twist. The preformed twist may be located between opposite ends of the non-insulating region. For example, the wire may be configured to form two legs through the twist, and when no other force (other than gravity) is acting on the wire, these legs may form an angle of 45° to 135°, preferably 60° to 120°, and more preferably 60° to 90°. This twist may facilitate proper positioning of the wire relative to the separator, particularly during step (e).

[0030] In step (e), the first catheter and the second catheter may be moved distally relative to each other, in particular while fixing the longitudinal position of the wire relative to the first and second catheters, and for this purpose the catheter arrangement may further comprise means for fixing the wire relative to the first catheter and / or the second catheter.

[0031] This prevents the wire, particularly its central region, from moving relative to the first and / or second catheter during step (e), thereby reducing the risk of causing unnecessary damage to the living tissue, particularly during step (e), and thus allowing the formation of the slit to be carried out in a particularly safe and controlled manner.

[0032] The wire may be heated by applying an electric current to the wire in step (d), and the slit may be formed by electrocautery in step (e). Thus, step (d) may be performed at least during step (e), for example, only during step (e).

[0033] The wire may have a first end and / or a second end configured to be coupled to a current source for applying an electric current to the wire, particularly to the uninsulated region of the wire. To this end, the catheter assembly may include a corresponding current source. The electric current may have a voltage between 100 V and 300 V. The electric current may be an alternating current having a frequency between 200 kHz and 600 kHz. The current source may include a high-frequency generator.

[0034] Step (d) may include coupling the wire to a current source by providing an electrical connection between the first end and / or second end of the wire configured to be coupled to the current source and the current source.

[0035] In step (d), the current source may be electrically connected to the wires via a connector, which may be mechanically and electrically connected to the corresponding first and / or second ends of the wires. The current source may be coupled to a handle, particularly an electrocautery handle, which may be electrically connected to the connector to supply the current generated by the current source to the wires.

[0036] Preferably, step (a) and / or step (b) and / or step (c) and / or step (e) may be carried out under X-ray control, which allows the method to be carried out in a particularly well-controlled manner.

[0037] The method may further include the step of (f) inserting the wire into one of the two catheters, particularly into a cavity of one of the two catheters, and advancing the wire until a distal end portion of the wire exits one of the two catheters, while inserting an auxiliary wire into the other of the two catheters, grasping the distal end portion of the wire with the auxiliary wire, and pulling the wire toward the other of the two catheters by the auxiliary wire. This allows the method to be appropriately performed without surgically opening the patient's thoracic cavity.

[0038] For this purpose, the wire may include a distal end portion with a hook. Accordingly, the catheter assembly may further include an auxiliary wire for gripping the distal end portion of the wire. The auxiliary wire may include a distal end portion with an eyelet configured to grip the hook of the distal end portion of the wire. This facilitates the implementation of step (f), and in particular the grasping or winding of the distal end portion of the wire by the auxiliary wire in step (f).

[0039] In particular, step (f) can be performed with the first catheter positioned in the true lumen and the second catheter positioned in the false lumen.

[0040] In step (f), inserting the wire into a lumen of one of the two catheters and advancing the wire until the distal portion of the wire exits one of the two catheters can be accomplished by inserting the wire into the first end of one of the two catheters and pushing the wire through the lumen of one of the two catheters until the distal portion of the wire protrudes from the second end of one of the two catheters.

[0041] Step (f) may further include using the auxiliary wire to insert a terminal portion of the wire into the cavity of the other of the two catheters through the second end of the other of the two catheters, and pushing the terminal portion of the wire until it protrudes from the first end of the other of the two catheters and can be grasped.

[0042] Step (f) may be carried out under X-ray control.

[0043] The first catheter and / or the second catheter may each include a protruding region that extends or is configured to be able to extend radially beyond the remainder and / or adjacent regions of the catheter. Such protruding regions, on the one hand, allow the wire to be positioned appropriately close to the incision membrane, thereby facilitating appropriate slitting, and, on the other hand, allow the wire to maintain a desired constant distance from the aortic wall region during the slitting, thereby significantly reducing the risk of undesired tissue damage. Furthermore, the desired distance from the wall can be maintained substantially constant when forming the slit in step (e).

[0044] The protruding region may be configured to be deformable from a first state to a second state, wherein the protruding region is configured to have a larger cross-sectional area in the second state than in the first state when viewed in a cross section perpendicular to the longitudinal extension of each catheter. In the second state, the protruding region extends at least partially radially beyond the remainder and / or adjacent regions of the catheter. In the first state, the protruding region may or may not extend beyond the remainder and / or adjacent regions of the catheter. For example, the protruding region may be configured to be expandable so as to be deformable from a first contracted state to a second expanded state, wherein the cross-sectional area of ​​the protruding region in the second expanded state is larger than the cross-sectional area of ​​the protruding region in the first contracted state.

[0045] The ratio of the second cross-sectional area to the first cross-sectional area may be, for example, at least 1.1, or 1.5, or 2, or 3, or 4, or 5.

[0046] The protrusion region may further be capable of transforming from the second state to the first state, and may further be capable of repeatedly transforming between the second state and the first state, e.g., multiple times.

[0047] The configuration may be such that, when the first catheter and the second catheter are inserted into a patient, the protrusion region can be transformed from a first state to a second state from a first end of the first catheter, i.e., from outside the patient's body. For example, a manipulation element can be provided at the first end of each catheter. The transformation can be achieved by injecting a fluid, such as a gas or liquid, into the protrusion region. For example, a contrast agent or medium can be used to transform between the first state and the second state, thereby enabling both the transformation and visualization during manipulation. The transformation of the protrusion region from the first state to the second state may be configured to occur from the first end of each catheter, i.e., from outside the patient's body, when the first and second catheters are inserted into the patient. For example, a handling element may be provided at the first end of each catheter. Such transformation may be caused by introducing a fluid, e.g., a gas or liquid, into the protrusion region. For example, a contrast agent or medium may be used to cause the transformation between the first and second states, thereby achieving both transformation and visibility during operation.

[0048] The raised regions may be adhered to the outer surface of each catheter, for example with an adhesive, and / or may be molded into part of the outer surface of each catheter.

[0049] The raised region may be formed to surround the outer periphery of each catheter, for example, to completely surround the outer periphery, or the raised region may not surround the outer periphery of each catheter, but may be located on only one side thereof, for example.

[0050] The protruding region can be formed by, for example, a balloon.

[0051] The protruding regions are preferably formed eccentrically relative to the remaining regions of the catheters. For example, the protruding regions may be configured such that the major axis defined by the protruding regions or the center of the protruding regions is positioned at a fixed distance from the major axis defined by the remaining regions of the catheters. This allows the desired distance from the aortic wall to be appropriately maintained during the formation of the slits.

[0052] The protruding region may be configured to be filled with a contrast agent, which allows for easier control of the catheter's movement, especially under X-ray control.

[0053] Each of the catheters may further include a second lumen configured to be filled with a contrast agent, for example configured to allow a filler agent to be forced from the second lumen into the protruding region.

[0054] The protrusion is preferably a three-dimensional structure that extends circumferentially around the catheter.

[0055] For example, the protruding region may be eccentric by configuring it to include two or more chambers.

[0056] The eccentricity can be, for example, such that the protrusions protrude less from the catheter on the side facing the isolation membrane than on the side away from the isolation membrane. The eccentricity ratio is not particularly limited and may vary depending on anatomical and / or spatial circumstances, but can be, for example, between one-third and one-half. Such eccentricity may be variable and / or individually adjustable. The eccentricity of the protrusion regions for each catheter can also be achieved by offsetting the protrusion regions with respect to the longitudinal axis of the catheter.

[0057] The raised region may be located on a portion of an individual catheter that is offset from the longitudinal axis of the catheter, or on a bifurcation of an individual catheter.

[0058] The balloon may be an inflatable balloon. That is, step (a) of the method may further include placing the first catheter in the true lumen with its balloon deflated, and then inflating the balloon. Correspondingly, step (b) of the method may further include placing the second catheter in the false lumen with its balloon deflated, and then inflating the balloon. It is preferable to perform step (e) with the balloons of both catheters inflated.

[0059] More generally, step (a) of the method may further comprise placing the first catheter in the true lumen with its protruding region in the first state, and then deforming the protruding region to the second state. Correspondingly, step (b) of the method may further comprise placing the second catheter in the false lumen with its protruding region in the first state, and then deforming the protruding region to the second state. It is preferable to perform step (e) with the protruding regions of both catheters in the second state.

[0060] The first catheter and / or the second catheter may each have a side opening for passing the wire therethrough.

[0061] The protruding region of each catheter may include a first inflatable balloon located proximal to the side opening of each catheter and / or a (second) inflatable balloon distal to the side opening of each catheter, which may improve positioning and guidance of a wire during slitting of an isolation membrane.

[0062] The protruding region of each catheter may include at least two inflatable balloons. The at least two balloons may be arranged adjacent to one another, for example, in corresponding planes perpendicular to the longitudinal axis of the catheter. The two balloons may be in contact with one another. The at least two balloons may be arranged to overlap one another along the longitudinal extension of each catheter. This may further improve positioning and guidance of the wire against the inner wall of the aorta, and may also increase safety.

[0063] When the protrusion region and a cross section through the catheter are viewed from the perspective of a plane perpendicular to the longitudinal axis of the catheter, the longitudinal axis of the catheter and the center of the protrusion region are offset from each other and are positioned to form the vertices of an imaginary triangle, preferably an isosceles or equilateral triangle.

[0064] Each of the catheters may comprise a plurality of separate catheter sections or branches, for example at least two side arm elements, in which case the at least two extension regions, preferably balloons, are each provided on one of the at least two side arm elements, which side arm elements in particular allow for safe and proper positioning of the balloon relative to the longitudinal axis of each of the catheters.

[0065] The at least two side arm elements may be provided on an outer surface of each catheter. The at least two side arm elements may be formed by side arm catheters, each extending longitudinally between the first end of the catheter and the second end of the catheter, preferably parallel to each other. The balloon may be inflatable through each side arm catheter. Each side arm catheter may include a separate lumen.

[0066] The at least two side arm elements may be configured to move upwardly away from the outer surface of each catheter within the region including the protrusion region. The at least two side arm elements may be configured to be biased away from the outer surface of each catheter within the region including the protrusion region. That is, the side arms may be configured to abut against the respective catheter in the first state and move away from the catheter when transformed from the first state to the second state, or vice versa. This allows the catheter to be inserted in a particularly suitable manner into the aorta, which has a particularly small cross-sectional area, especially when the balloons are deflated.

[0067] Each of the at least two side arm elements may be configured to allow a medium, such as a contrast agent, to be passed therethrough and injected into a respective balloon to inflate the respective balloon or to transform the respective balloon from a first state to a second state.

[0068] According to a further aspect of the present disclosure, there is provided a use of a catheter assembly as described herein for forming a slit in an isolation membrane of an aorta of a patient.

[0069] side In particular, the present disclosure includes the following aspects:

[0070] 1. A method for forming a slit in an isolation membrane (4) of a patient's aorta, comprising: (a) positioning a first catheter (2) so that it extends at least partially into the true lumen (6) of the aorta located on a first side of the isolation membrane (4); (b) positioning a second catheter (8) so that it extends at least partially into a false lumen (10) of the aorta located on a second side of the isolation membrane (4); (c) disposing a conductive wire (12) so as to be conductively connected to the first catheter (2) and the second catheter (8); (d) applying an electric current to the wire (12); and (e) forming a slit in the separator (4) by moving the wire (12) relative to the separator (4); A method comprising:

[0071] 2. The method of aspect 1, wherein in step (e), the wire (12) is maintained fixed relative to the first catheter (2) and / or the second catheter (8), particularly relative to the longitudinal extension line (12) of the wire.

[0072] 3. The method of aspect 1 or 2, wherein in step (d), a current source (52), e.g., a current source including a high-frequency generator, is electrically connected to the wire (12) via a connector (16) to apply a current to the wire (12).

[0073] 4. The method of aspect 3, wherein the current source (52) is electrically connected to a cautery handle (50) configured to be electrically connected (16) to the connector.

[0074] 5. The method of any preceding aspect, wherein the current has a voltage of 100V to 300V.

[0075] 6. The method of any preceding aspect, wherein the current is an alternating current having a frequency of 200 kHz to 600 kHz.

[0076] 7. The method of any preceding aspect, wherein in step (a), the first catheter (2) is inserted via a first groin of the patient, preferably percutaneously.

[0077] 8. The method of aspect 7, wherein in step (b), the second catheter (8) is inserted via a second groin of the patient, preferably percutaneously.

[0078] 9. The method of any of the preceding aspects, wherein in step (e), the first catheter (2) and the second catheter (4) are each moved distally.

[0079] 10. The method of any preceding aspect, wherein step (a) and / or step (b) and / or step (c) and / or step (e) are performed under X-ray control.

[0080] 11. The method of any preceding aspect, wherein a contrast agent is injected through the first catheter (2) and / or the second catheter (8) towards the isolation membrane (4).

[0081] 12. The method of any preceding aspect, further comprising the steps of: (f) inserting the wire (12) into one of the two catheters (2, 8) and advancing it until the distal end portion (122) of the wire (12) exits the one of the two catheters (2, 8); An auxiliary wire (14) is inserted into the other of the two catheters (8, 2); A step of grasping the distal end portion (122) of the wire (12) with the auxiliary wire (14) and pulling the wire (12) toward the other of the two catheters (8, 2) by the auxiliary wire (14).

[0082] 13. A catheter assembly for forming a slit in an isolation membrane of a patient's aorta, comprising: a first catheter (2) for insertion into a true lumen (6) located on a first side of the isolation membrane (4); a second catheter (8) for insertion into a false lumen (10) located on a second side of the isolation membrane (4); and a conductive wire (12) configured to be disposed so as to be conductively connectable to the first catheter (2) and the second catheter (8); Including, The catheter assembly is configured such that an electric current is further passed through the wire (12) so that the wire (12) can form a slit in the separator (4).

[0083] 14. The catheter assembly described in aspect 13, wherein the wire (12) includes a central region (128), and the central region (128) is configured to contact the isolation membrane (4) to form a slit in the isolation membrane (4).

[0084] 15. A catheter assembly as described in aspect 14, wherein the wire (12) includes an electrically insulating sheath (124) and an electrically non-insulating region (126) within the central region (128) for forming a slit in the isolation membrane (4).

[0085] 16. The catheter assembly of aspect 14 or 15, wherein the central region (128) includes a preformed twist.

[0086] 17. The catheter assembly described in aspects 13-16, wherein the first catheter (2) and / or the second catheter (8) each include a protruding region (30) that extends radially or is configured to be radially extendable beyond the remainder and / or adjacent regions (2, 8) of the catheter.

[0087] 18. The catheter assembly described in aspect 17, wherein the protrusion region (30) is configured to be deformable from a first state to a second state, and wherein the protrusion region (30) has a larger cross-sectional area in the second state than in the first state, particularly when viewed in a cross section perpendicular to the longitudinal extension line of each catheter (2, 8).

[0088] 19. The catheter assembly described in aspect 18, configured so that the protrusion region (30) can be transformed from the first state to the second state from outside the patient's body when the first catheter (2) and the second catheter (8) are inserted into the patient.

[0089] 20. A catheter assembly as described in any of aspects 17 to 19, wherein the protruding region (30) is disposed on and / or forms the outer surface (27) of each of the catheters (2, 8).

[0090] 21. A catheter assembly described in any one of aspects 17 to 20, wherein the protruding region (30) completely surrounds the outer circumference of the catheter.

[0091] 22. A catheter assembly described in any one of aspects 17 to 20, wherein the protruding region (30) partially surrounds the outer circumference of the catheter.

[0092] 23. A catheter assembly described in any of aspects 17 to 22, wherein the protrusion region (30) is formed by a balloon, preferably an inflatable balloon, and / or preferably the protrusion region is positioned eccentrically relative to the main axis (HK) of the catheter.

[0093] 24. A catheter assembly described in any of aspects 17 to 23, wherein the protrusion region (30) is configured such that the major axis (HB) defined by the protrusion region (30) or the center of the protrusion region (30) is positioned at a distance (δ) from the major axis (HK) defined by the remaining region of the catheter (2, 8).

[0094] 25. A catheter assembly described in any one of aspects 17 to 24, wherein the protrusion region (30) is configured to be able to be filled with a contrast agent.

[0095] 26. A catheter assembly described in any one of sides 17 to 25, wherein the wire (12) is electrically connected to a connector (16).

[0096] 27. The catheter assembly described in aspect 26, wherein the wire (12) is electrically connected to a power source (22) via the connector (16).

[0097] 28. The catheter assembly of any one of aspects 13 to 27, further comprising means for fixing the wire (12) to the first catheter (2) and / or the second catheter (8).

[0098] 29. A catheter assembly according to any one of aspects 13 to 28, wherein the wire (12) includes an end portion (122) having a hook.

[0099] 30. The catheter assembly described in aspect 29, further comprising an auxiliary wire (14) for gripping the terminal portion (122) of the wire (12), the auxiliary wire (14) preferably comprising a terminal portion (142) having an eyelet, the eyelet configured to grip the hook of the terminal portion (122) of the wire (12).

[0100] 31. A catheter assembly described in any of aspects 13 to 30, wherein the first catheter (2) and / or the second catheter (8) each have a side opening (21, 21') through which the wire (12) can pass.

[0101] 32. A catheter assembly as described in aspect 31, having the features of any of aspects 17 to 30, wherein the protruding region (301) of each catheter (2, 8) includes a first inflatable balloon (32, 32') located proximal to the side opening (21, 21') of each catheter (2, 8), and / or a second inflatable balloon (34, 34') located distal to the side opening (21, 21') of each catheter (2, 8).

[0102] 33. A catheter assembly according to any one of aspects 13 to 30, wherein the protruding region (302) of each catheter (2, 8) includes at least two inflatable balloons (35, 36).

[0103] 34. The catheter assembly of aspect 33, wherein the at least two balloons (35, 36) are positioned adjacent to each other.

[0104] 35. A catheter assembly as described in aspect 33 or 34, wherein the at least two balloons (35, 36) are arranged one above the other along the longitudinal extension of each catheter (2, 8).

[0105] 36. A catheter assembly described in any of aspects 33 to 35, wherein each catheter (2, 8) includes at least two side arm elements (65, 66), and each of the at least two balloons (35, 36) is provided on a respective one of the at least two side arm elements (65, 66).

[0106] 37. The catheter assembly described in aspect 36, wherein the at least two side arm elements (65, 66) are arranged on and / or form the outer surface (27) of each of the catheters (2, 8).

[0107] 38. The catheter assembly described in aspect 36 or 37, wherein the at least two side arm elements (65, 66) are formed by side arm catheters, each side arm catheter extending longitudinally between the first end (22, 82) of each catheter (2, 8) and the second end (24, 84) of each catheter (2, 8).

[0108] 39. A catheter assembly described in any of sides 36 to 38, wherein the at least two side arm elements (65, 66) are configured to rise from the outer surface (27) of each catheter (2, 8) within a region including the protrusion region (302).

[0109] 40. The catheter assembly of aspect 39, wherein the at least two side arm elements (65, 66) are configured to be biased away from the outer surface (27) of each catheter (2, 8) within the region (302) including the protrusion region.

[0110] 41. A catheter assembly described in any of aspects 38 to 40, wherein each of the at least two side arm elements (65, 66) is configured to allow a medium such as a contrast agent to be passed therethrough and injected into each of the balloons (35, 36).

[0111] 42. Use of the catheter assembly described in any of aspects 13 to 41 for forming a slit in an isolation membrane (4) of a patient's aorta. [Brief explanation of the drawings]

[0112] The subject matter of the present disclosure will now be described in more detail with reference to preferred exemplary embodiments thereof as illustrated in the accompanying drawings. [Figure 1] 1a-1c are schematic diagrams illustrating the steps of the method described herein for forming a slit in an isolation membrane in a patient's aorta. [Figure 2] FIG. 2 is a schematic cross-sectional view of a portion of the catheter and wire used in the method. [Figure 3]Figure 3a is a schematic cross-sectional view showing a cross section of the catheter in the protrusion region of the catheter, and Figure 3b is a schematic cross-sectional view showing the first catheter, the second catheter, and the wire in the step of forming a slit in the isolation membrane. [Figure 4] FIG. 4 is a schematic diagram showing a connector provided at one end of the wire, a cauterization handle connected to the connector, and a current source connected to the cauterization handle. [Figure 5] FIG. 5 is a schematic diagram showing a procedure for holding or winding the end portion of the wire with an auxiliary wire. [Figure 6] Figure 6a is a schematic diagram showing the distal end of a catheter having a side opening for passing the wire, Figure 6b is a schematic diagram showing the distal end of a catheter having a side opening for passing the wire and two inflatable balloons located distal and proximal to the side opening, with each balloon deflated, and Figure 6c is a schematic diagram showing the distal end of the catheter shown in Figure 6b, with each balloon inflated. [Figure 7] FIG. 7 is a schematic diagram showing a catheter assembly including a first catheter and a second catheter, each having a side opening and two balloons, and a wire disposed partially within the first catheter and partially within the second catheter. [Figure 8] FIG. 8 is a schematic diagram of a distal portion of a catheter configured to be placed outside a patient's body and including means for securing the wire to the catheter so that the wire is maintained relative to the longitudinal extension of the catheter. [Figure 9a] FIG. 9a is a schematic side view of a distal portion of a catheter having two balloons disposed adjacent to each other, each balloon in a deflated state. [Figure 9b] FIG. 9b shows the corresponding cross section along line IXb-IXb of FIG. 9a. [Figure 10a] FIG. 10a is a side view of the distal end portion shown in FIG. 9a with the balloons each inflated. [Figure 10b]FIG. 10b shows the corresponding cross section along line Xb-Xb of FIG. 10a. [Figure 11] FIG. 11 is a schematic side view showing the two catheters shown in FIGS. 9a to 10b, which further include a wire for electrically forming a slit in the isolation membrane. [Figure 12] FIG. 12 is a schematic cross-sectional view showing the state in which the two catheters of FIG. 10 are inserted into the aorta. DETAILED DESCRIPTION OF THE INVENTION

[0113] A method for treating aortic dissection is described below. The method preferably includes endovascular stenting of the aorta, such as by insertion of a stent graft. Prior to such endovascular stenting, a slit is formed in the aortic isolation membrane according to a corresponding method described herein. Formation of the slit in the isolation membrane is suitable for enlarging the true lumen of the aortic dissection membrane, thereby enabling or facilitating subsequent endovascular stent graft placement.

[0114] 1a-1c are schematic diagrams illustrating a method for forming a slit in a dissecting membrane of a patient's aorta, as described herein. FIG. 1a is a schematic diagram of a patient's aorta. The aorta has a dissecting membrane 4. A true lumen 6 is located on a first side of the dissecting membrane 4, and a false lumen 10 is located on a second side of the dissecting membrane 4. In the exemplary schematic diagram of FIG. 1a, the false lumen 10 extends distally beyond the aortic bifurcation 42. However, this is merely one example. In general, the dissecting membrane 4, the true lumen 6, and the false lumen 10 may have various configurations.

[0115] The method for forming a slit in an isolation membrane includes the following step (a): positioning a first catheter 2 so that it extends at least partially into a true lumen 6 of the aorta located on a first side 4 of the isolation membrane. The method further includes the following step (b): positioning a second catheter 8 so that it extends at least partially into a false lumen 10 of the aorta located on a second side 4 of the isolation membrane.

[0116] First catheter 2 has a first end 22 configured to be positioned outside the patient's body and an opposite second end 24 configured to be positioned within the patient's body. Second catheter 8 has a first end 82 configured to be positioned outside the patient's body and an opposite second end 84 configured to be positioned within the patient's body.

[0117] The first catheter 2 has a lumen extending between its first end 22 and its second end 24. The second catheter 8 has a lumen extending between its first end 82 and its second end 84. The first catheter 2 and the second catheter 8 are preferably formed from an electrically insulating material.

[0118] In step (a), the first catheter 2 may be percutaneously inserted into a first groin of the patient, and in step (b), the second catheter 8 may be percutaneously inserted into a second groin of the patient.

[0119] In step (a), the first catheter 2 may be positioned so that its second end 24 is located within the area of ​​the aorta where the false lumen 10 and the true lumen 6 are directly connected, i.e., the area where there is no membrane between the two lumen 6, 10.

[0120] In step (b), the second catheter 8 may be positioned so that its second end 84 is located within said region of the aorta.

[0121] The method further includes the following step (c): arranging a conductive wire 12 to be conductively connected to the first catheter 2 and the second catheter 8. Specifically, the wire 12 may be arranged to extend through the lumen 2 of the first catheter and the lumen 8 of the second catheter in step (c). The first end 22 of the first catheter 2 may have an axial and / or radial opening 23 (see FIG. 2 ) for passing the wire 12 therethrough. The axial opening 23 may have an open end extending around the longitudinal axis HK of the catheter 2. The second catheter 8 may be similarly shaped.

[0122] The method further includes the following step (d): applying a current to the wire 12. Specifically, as shown in FIG. 4 , in step (d), a current source 52 may be electrically connected to the wire 12 via the connector 16 to apply a current to the wire 12. For example, the connector 16 may be mechanically and electrically connected to an end or end portion 129 of the wire 12. The end portion 129 of the wire 12 may protrude from the first end 22 of the first catheter 2 or the first end 82 of the second catheter 8, for example, through axial and / or radial openings configured accordingly. The current source 52 may be electrically connected to a cauterization handle 50 configured to be electrically and mechanically coupled to the connector 16.

[0123] The current may have a voltage of 100 V to 300 V. The current may be an alternating current having a frequency of 200 kHz to 600 kHz.

[0124] The method further includes the following step (e): forming a slit in the separator 4 by moving the wire 12 to which the current has been applied in step (d) relative to the separator 4. The wire 12 and the current may be configured so that the formation of the slit in the separator 4 can be performed by electrocautery.

[0125] In step (e), the wire 12 is preferably maintained fixedly relative to the first catheter 2 and the second catheter 8. For example, first means, e.g., in the form of a clamp or the like, may be provided to secure the wire 12 at its first end 22 so as to maintain it relative to the longitudinal extension of the first catheter 2. Correspondingly, second means, e.g., in the form of another clamp or the like, may be provided to secure the wire 12 at its first end 82 so as to maintain it relative to the longitudinal extension of the second catheter 8.

[0126] 8 is a schematic diagram of an example of a corresponding first means 29 for fixing the wire 12 relative to the first end 22 of the first catheter 2 in the longitudinal extension thereof. For example, the means 29 may be provided at the first end 22 of the catheter 2 and be rotatable about the longitudinal axis of the catheter 2, such that the wire 12 can be moved from an unlocked position to a locked position by a first rotational movement, and from a locked position to an unlocked position by a second rotational movement opposite to the first rotational movement.

[0127] In step (e), the first catheter 2 and the second catheter 4 may each be moved distally, as illustrated by the arrows in Figure 1b, which allows the slit formation step to be carried out in a particularly well-controlled manner.

[0128] FIG. 1b is a schematic diagram showing the state in which the catheters 2, 8 have been moved a certain distance in the distal direction or withdrawn.

[0129] FIG. 1c is a schematic diagram of the aorta after an intravascular stent graft 90 has been inserted into the aorta to stabilize the blood vessel. Generally, a stent or stent graft is easier to insert into a blood vessel with a large lumen than into a blood vessel with a small lumen. By forming a slit in the isolation membrane 4, a relatively large lumen can be formed, particularly a lumen larger than both the true lumen and the false lumen. Therefore, after forming a slit in the isolation membrane 4, the stent graft 90 can be inserted in a particularly suitable manner.

[0130] Steps (a) and / or (b) and / or (c) and / or (e) are preferably performed under X-ray control. For example, the lumens of the catheters 2 and 8 can be used to apply a contrast agent to the isolation membrane 4. Therefore, the lumens of the catheters are preferably configured to allow filling with the contrast agent.

[0131] 2, wire 12 includes a central region 128 that contacts separator 4 and forms a slit in separator 4. Central region 128 preferably includes a preformed twist, which allows wire 12 to be properly positioned relative to separator 4 before and during step (e).

[0132] Through this twist, wire 12 may be configured to form two legs that preferably form an angle α of 60° to 120°, for example 80° to 100°, when no other forces (other than gravity) are acting on wire 12. Preferably, the twist is configured to allow wire 12 to be straightened so that wire 12 can be pulled or pushed through at least one of lumens 2, 8 of catheters 2, 8.

[0133] The wire 12 preferably includes an electrically insulating sheath 124 and, within a central region 128, an electrically non-insulating region 126 for forming a slit in the separator 4. The non-insulating region 126 may be an elongated region extending along the longitudinal extension of the wire 12. The length of the non-insulating region 126 may be, for example, 0.5 cm to 4 cm, and preferably 1 cm to 3 cm.

[0134] Preferably, the first catheter 2 and / or the second catheter 8 each include a raised region 30 that extends or is configured to be able to extend radially beyond the remainder and / or adjacent regions of the catheter 2, 8. An example of such a configuration is shown schematically in Figure 2 for the first catheter 2. The raised region 30 can be formed, for example, by a balloon, in particular by an inflatable balloon.

[0135] Preferably, the balloon 30 is configured to be inflatable via each catheter 2, 8. To this end, each catheter 2, 8 may include an additional lumen extending from its first end 22, 82 to the corresponding balloon 30.

[0136] The protruding region or balloon 30 is preferably configured to protrude radially eccentrically from the outer circumferential surface 26 of the remaining region or a portion thereof of each catheter 2, 8. For example, the protruding region 30 is configured such that the long axis HB defined by the protruding region 30 or the center of the protruding region 30 is a distance δ away from the long axis HK defined by the remaining region of each catheter 2, 8. The distance δ can be, for example, 0.5 cm to 1 cm.

[0137] The radial extension of the protrusion 30 may be, for example, 0.5 cm to 3 cm, for example 1 cm to 2.5 cm.

[0138] 3a is a schematic diagram showing a cross section of the catheter 2 in the region of the balloon 30. In this cross section, the radially opposing surfaces of the balloon 30 have a maximum distance δ1 and a minimum distance δ2 with respect to the outer circumferential surface 26 of the remaining region of each catheter 2, 8. The relationship δ1:δ2 can be, for example, 20:1 to 1.5:1, preferably 10:1 to 2:1.

[0139] The eccentric design of the protrusions or balloons 30 allows the wire 12 to be advantageously positioned relative to the isolation membrane 4 during the slit-forming step (e), reducing the risk of the wire 12 undesirably contacting tissue not being slit, such as portions of the aortic wall. Such a configuration is shown diagrammatically in FIG. 3b, which illustrates cross sections of the catheters 2, 8, the wire 12, and the isolation membrane 4. That is, the protrusions 30 ensure that the central region 128 of the wire 12, particularly the uninsulated region 126, maintains a certain minimum distance from the tissue region surrounded by the isolation membrane 4. The distance D from the second end 24, 84 of each catheter 2, 8 to the protrusions 30 can be, for example, 1 cm to 5 cm, preferably 1 cm to 3 cm. The protrusions 30 may have a maximum radial extension, and the distance between the maximum radial extension and each catheter end can be 1 cm to 4 cm. The maximum radial extension can be 0.5 cm to 3 cm.

[0140] The balloon 30 is preferably expandable and contractible. This configuration is preferably configured so that the catheters 2, 8 can be inserted into the patient's body with the balloon 30 in a contracted state, and the balloon 30 can be inflated when the catheters 2, 8 are positioned in the true lumen 6 and false lumen 10, respectively, and ready to begin step (e). This facilitates insertion of the catheters 2, 8.

[0141] The balloon 30 is preferably configured to be fillable with a contrast agent, which makes it easier to control its movement under X-ray.

[0142] More generally, the protruding region 30 of each catheter 2, 8 can be configured to be deformable from a first state to a second state, with the protruding region 30 having a larger cross-sectional area in the second state than in the first state when viewed in a cross section perpendicular to the longitudinal extension of each catheter 2, 8. For example, the cross-sectional area in the second state can be at least 1.1 times, preferably 1.5 times, and more preferably 2.0 times or more the cross-sectional area in the first state. Preferably, the transformation of each catheter 2, 8 from the first state to the second state is reversible.

[0143] Preferably, the first catheter 2 and the second catheter 8 are configured such that when inserted into the patient, for example via the above-mentioned further cavity, the protrusion region 30 can be transformed from the first state to the second state from outside the patient's body.

[0144] The raised areas may be disposed on or formed as part of the outer surface 27 of each catheter 2, 8, for example by means of gluing or co-molding. This is advantageous from a manufacturing standpoint.

[0145] The raised regions 30 may be disposed on or formed as part of the outer surface 27 of each catheter 2, 8 as a closed circumferential shape on the outer surface 27. This allows the raised regions 30 to be disposed at each level so as to extend in a closed manner circumferentially around the longitudinal axis HK of each catheter 2, 8 and the aortic wall when the catheter 2, 8 is inserted, thereby providing protection from all directions.

[0146] Alternatively, the protruding regions 30 may be circumferentially unclosed on or from a portion of the outer surface 27 of each catheter 2, 8. This allows the protruding regions 30 to be used to facilitate asymmetric positioning of the longitudinal axis HK of each catheter 2, 8 within the aorta, for example, near the isolation membrane 4, when the catheter 2, 8 is inserted. Such a configuration is particularly advantageous with respect to the cutting process.

[0147] As shown in Fig. 5, the method preferably further includes the following step: (f) inserting a wire 12 into one of the two catheters 2, 8 (first catheter 2 in the example shown in Fig. 5) and pushing the terminal portion 122 of the wire 12 out of one of the two catheters 2, 8, and then inserting an auxiliary wire 14 into the other of the two catheters 8, 2 (second catheter 8 in the example shown in Fig. 5), grasping the terminal portion 122 of the wire 12 with the auxiliary wire 14, and pulling the wire 12 toward the other of the two catheters 8, 2. Step (f) is preferably performed after steps (a) and (b) and before or simultaneously with step (c).

[0148] 4 and 5, the distal end portion 122 preferably includes a hook. The auxiliary wire 14 preferably includes a distal end portion 142 with an eyelet configured to grip or wrap around the hook of the distal end portion 122 of the wire 12. This configuration facilitates gripping the distal end portion 122 of the wire 12 with the auxiliary wire 14 in step (f).

[0149] Further according to the method, step (e) may be followed by step (g) of withdrawing wire 12 from catheter 2, 8. Catheter 2, 8 may then be removed from the patient's body.

[0150] 6a shows a variant of the catheter 2, for example a variant of each of the first catheter 2 and the second catheter 8. This catheter 2 differs from the previous catheters 2 in that it has a lateral opening 21 for the passage, i.e., entry and exit, of the wire 12. The lateral opening 21 is located at the second end of the catheter 2, i.e., the end configured to be placed inside the patient's body. The lateral opening 21 can be elongated with a major axis extending parallel to the major axis HK of the catheter 2.

[0151] The openings in Figure 6 and the catheters previously described and illustrated are interchangeable. The catheter examples described in this disclosure are not limited to the nature of the protruding elements and openings illustrated, and may vary based on this disclosure. For example, the protruding elements shown in Figures 6 through 12 need not be balloons but can be other protruding elements.

[0152] The catheter 2 may be provided with a guide surface for leading the wire 12 out of the side opening 21 in a direction having an axial component and a transverse component relative to the longitudinal axis HK of the catheter 2 .

[0153] To allow particularly low-risk insertion of the catheter 2 into the aortic lumens 6, 10, the distal end portion 25 of the end 24 of the catheter 2 may be rounded.

[0154] 6b and 6c show a variation in which the protrusion 301 of each catheter 2 includes a first inflatable balloon 32 and a second inflatable balloon 34. The first balloon 32 is located proximal to the side opening 21, and the second balloon 34 is located distal to the side opening 21. FIG. 7 shows two such catheters and the corresponding wire 12. The two balloons 32, 34 improve positioning and guidance of the wire 12 when cutting the isolation membrane 4. Alternatively, the catheters may each include only one balloon 32 or 34.

[0155] Figure 9a is a side view showing a schematic representation of the end of a further variant of each catheter 2. Here, the protruding region 302 includes two balloons 35, 36 arranged adjacent to each other in the vertical cross section shown in Figure 9b. The balloons 35, 36 are each in a deflated state. The two balloons 35, 36 are preferably arranged in the same axial region as the catheter 2. The two balloons 35, 36 may have the same shape.

[0156] The catheter 2 includes two side arm elements 65, 66. The first balloon 35 is provided on the first side arm element 65, and the second balloon 36 is provided on the second side arm element 66.

[0157] Figure 10a is a side view of the end of the catheter 2 shown in Figure 9a, showing the two balloons 35, 36 in an inflated state. As shown in Figure 10b, which shows a cross section taken along line Xb-Xb in Figure 10a, the cross-sectional area of ​​the protruding region 302 perpendicular to the longitudinal extension of the catheter 2 is configured to be larger in the second, i.e., inflated state, than in the first, i.e., deflated state.

[0158] 9a and 10a, the side arm members 65, 66 are configured to lift off the outer surface 27 of the catheter 2 in the region that includes the protruding region 302. The side arm members 65, 66 may be secured to the outer surface 27 of the catheter 2 distal and / or proximal to the region that includes the protruding region 302.

[0159] Within this region, the side arm elements 65, 66 are preferably configured to be offset relative to the outer surface 27 of the catheter 2. Therefore, in this case, the balloons 35, 36 and the side arm elements 65, 66 approach the longitudinal axis HK of the catheter 2 from the radially outer side when the balloons 35, 36 change from an inflated state to a deflated state. This makes the catheter 2 particularly suitable for insertion into the aorta with the balloons 35, 36 in a deflated state.

[0160] Figure 11 is a schematic side view of a first catheter 2 and a second catheter 8, each configured as shown in Figures 9a-10b, and further including a wire 12 for electrically forming a slit in the isolation membrane 4. Figure 12 is a corresponding cross-sectional view taken at the level of the balloons of the two catheters 2, 8 inserted into the aorta. As can be seen particularly from Figure 12, the two balloons of each catheter 2, 8 are particularly well suited to securely positioning the wire 12 on the membrane 4 while maintaining an appropriate distance from the inner wall of the aorta.

Claims

1. A method for forming a slit in an isolation membrane (4) of a patient's aorta, comprising: (a) positioning a first catheter (2) so that it extends at least partially into the true lumen (6) of the aorta on a first side of the isolation membrane (4); (b) positioning a second catheter (8) so that it extends at least partially into a false lumen (10) of the aorta located on a second side of the isolation membrane (4); (c) disposing a conductive wire (12) so as to be conductively connected to the first catheter (2) and the second catheter (8); (d) applying an electric current to the wire (12); and (e) forming a slit in the separator (4) by moving the wire (12) relative to the separator (4); A method comprising:

2. 2. The method of claim 1, wherein in step (e), the wire (12) is maintained fixed relative to the first catheter (2) and / or the second catheter (8).

3. In step (d), a current source (52) is electrically connected to the wire (12) via a connector (16) to apply a current to the wire (12); and / or the current has a voltage between 100V and 300V; and / or 3. The method according to claim 1, wherein the current is an alternating current having a frequency of 200 kHz to 600 kHz.

4. In step (a), the first catheter (2) is inserted via a first groin of the patient; and / or The method according to any one of claims 1 to 3, wherein in step (b), the second catheter (8) is inserted via a second groin of the patient.

5. In step (e), the first catheter (2) and the second catheter (4) are each moved distally; and / or 5. The method according to any one of claims 1 to 4, wherein step (a) and / or step (b) and / or step (c) and / or step (e) are carried out under X-ray control.

6. Furthermore (f) inserting the wire (12) into one of the two catheters (2, 8) and advancing it until the distal end portion (122) of the wire (12) exits the one of the two catheters (2, 8); Inserting an auxiliary wire (14) into the other of the two catheters (8, 2); The distal end portion (122) of the wire (12) is grasped by the auxiliary wire (14), and the wire (12) is pulled by the auxiliary wire (14) toward the other of the two catheters (8, 2). The method according to any one of claims 1 to 5, comprising:

7. 1. A catheter assembly for forming a slit in an isolation membrane of a patient's aorta, comprising: a first catheter (2) configured to be inserted into a true lumen (6) located on a first side of the isolation membrane (4); a second catheter (8) configured to be inserted into a false lumen (10) located on a second side of the isolation membrane (4); and a conductive wire (12) configured to be disposed so as to be conductively connectable to the first catheter (2) and the second catheter (8); Including, The wire (12) is further configured to be energized to form a slit in the separator (4) by the wire (12); the first catheter (2) and / or the second catheter (8) each include a protruding region (30) that extends or is configured to extend radially beyond the catheter (2, 8) or an adjacent region of the catheter; Preferably, the protrusion region (30) is configured to be deformable from a first state to a second state, the protrusion region (30) having a larger cross-sectional area in the second state than in the first state, and the protrusion region (30) is formed, for example, by at least one balloon.

8. the wire (12) includes a central region (128); the central region (128) is configured to contact the separator (4) to form a slit in the separator (4); and / or the wire (12) comprises an electrically insulating sheath (124) and an electrically non-insulating region (126) in the central region (128) for forming a slit in the separator (4); and / or The catheter assembly of claim 7, wherein the central region (128) includes a preformed kink.

9. the protruding region (30) is configured such that the major axis (HB) defined by the protruding region (30) or the center of the protruding region (30) is located at a distance (δ) from the major axis (HK) defined by the remaining region of the catheter (2, 8); and / or A catheter assembly according to claim 7 or 8, wherein the protruding region (30) is arranged eccentrically with respect to the main axis (HK) of the catheter.

10. The wire (12) is electrically connected to a connector (16); A catheter assembly according to any one of claims 7 to 9, wherein the wire (12) is preferably electrically connected to a power source (22) via the connector (16).

11. and / or means for fixing the wire (12) relative to the first catheter (2) and / or the second catheter (8). the wire (12) includes a distal end portion (122) with a hook; A catheter assembly according to any one of claims 7 to 10, wherein the catheter assembly preferably further comprises an auxiliary wire (14) for gripping the terminal portion (122) of the wire (12), the auxiliary wire (14) preferably comprising a terminal portion (142) having an eyelet, the eyelet being configured to grip the hook of the terminal portion (122) of the wire (12).

12. 12. A catheter assembly according to any one of claims 7 to 11, wherein the first catheter (2) and / or the second catheter (8) each have a side opening (21, 21') through which the wire (12) can pass, and preferably the protrusion region (301) of each of the catheters (2, 8) includes a first inflatable balloon (32, 32') located proximal to the side opening (21, 21') of each of the catheters (2, 8) and a second inflatable balloon (34, 34') located distal to the side opening (21, 21') of each of the catheters (2, 8).

13. 12. A catheter assembly according to any one of claims 7 to 11, wherein the protruding region (302) of each catheter (2, 8) comprises at least two inflatable balloons (35, 36), preferably arranged adjacent to each other and / or arranged one above the other along the longitudinal extension of each catheter (2, 8).

14. 14. The catheter assembly of claim 13, wherein each of the catheters includes at least two side arm elements, each of the at least two balloons being provided on a respective one of the at least two side arm elements, preferably the at least two side arm elements being formed by side arm catheters, each side arm catheter extending longitudinally between the first end of the respective catheter and the second end of the respective catheter, and the at least two side arm elements being configured to rise from the outer surface of the respective catheter within a region including the protrusion region.

15. Use of a catheter assembly according to any one of claims 7 to 14 for forming a slit in an isolation membrane (4) in the aorta of a patient.

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