Endovascular embolization catheter module having an electrothermal separation region

Abstract

The invention relates to an endovascular embolization catheter module having an electrothermal separation region.

Description

[0001] ENDOVASCULAR EMBOLIZATION CATHETER MODULE HAVING AN ELECTROTHERMAL SEPARATION REGION

[0002] Technical Field of the Invention

[0003] The invention relates to an endovascular embolization catheter module having an electrothermal separation region.

[0004] State of the Art

[0005] Endovascular embolization is a minimally invasive treatment method used to block or control blood flow within blood vessels. Generally, undesired blood flow is stopped by placing special materials such as metal coils, liquid embolic agents, or particles into the vessel by means of a catheter. This method is frequently applied in the treatment of ballooned vessels (aneurysms) in the brain, kidneys, or other organs, in reducing tumours by blocking the vessels supplying blood to the tumour or in reducing bleeding prior to surgical intervention, in controlling bleeding in conditions such as trauma, postpartum haemorrhages, or gastrointestinal bleeding, in the treatment of arteriovenous malformations (AVM), and in the treatment of varicose veins in the genital or pelvic region (varicocele or pelvic congestion syndrome). Since endovascular embolization is a minimally invasive method, it does not require surgical incisions, is performed via a catheter, and allows intervention only on problematic vessels without damaging healthy tissues. Patients can generally return to their daily lives in a short time, and since the procedure is target-oriented, the treatment is highly effective. During application, a catheter is placed into the vessel under local anaesthesia, when the target region is reached the embolic material that will stop blood flow is injected, and cessation of blood flow is confirmed after the procedure. Endovascular embolization is a modern interventional radiology method frequently used for both diagnostic and therapeutic purposes and stands out as an effective treatment method particularly in conditions posing vital risk such as aneurysms. The endovascular embolization catheter is generally designed specifically for minimally invasive interventions and is advanced within the vessel accompanied by a guidewireto be precisely positioned at the procedure site. During application, some disadvantages related to the catheter may arise. For example, difficulty may be experienced in correctly positioning the catheter, and this likelihood is high especially in cases with complex vascular structures or very narrow vessels. In addition, complications such as the risk of damaging the vessel wall by the catheter, the possibility of causing clot formation, or rarely the embolic material spreading to an incorrect region may also be observed. Furthermore, due to long-lasting procedures or technical difficulties in catheter placement, the procedure time may be prolonged, which may cause additional discomfort for the patient. These disadvantages can be largely reduced by the experience of the specialist physician performing the procedure and the quality of the catheter used.

[0006] In embolization procedures applied to neurovascular structures, after injection of the embolic agent into the target region or regions, it is required that the proximal remaining tube line be removed from the body by separating from the distal region of the catheter. However, in some procedures, due to reflux of the embolic agent filling into the separation region from the separation tip designed for separation of the material, or due to compact configurations in the design, separation may not occur. Failure of separation at the separation region of the embolization catheter may lead to various complications during or after the procedure. Some of these complications include catheter thrombosis, catheter damage, vessel damage, and embolic complications. Blockage of the catheter may obstruct blood flow during the procedure as a result of clotting or accumulation of embolic agent. The catheter may be subjected to damage such as bending or tearing during the procedure. This may impair the function of the catheter and lead to complications. Damage to the vessel wall by the catheter may lead to complications such as tearing or dissection. This may lead to problems such as bleeding, haematoma formation, or vessel occlusion. The embolic agent may be carried to undesired regions and may lead to complications such as tissue ischaemia, infarction, or stroke.

[0007] In the state of the art, a multi-point electrolytic separation system and a method for separating embolic materials are described in patent document number CN106725697B. In this system used for aneurysm embolization, it is aimed to fill the interior of the aneurysm with coil material to enable embolization and thus eliminate the risk of rupture. The embolic material mentioned in this document is a coil, and thecoil material is not a hollow cylindrical tube like a catheter but rather has a coiled wire structure and has application difficulties in terms of function. The coil catheter having an electrothermal separation region described in this document is functionally a thin coiled micro-level wire structure filling the aneurysm walls, and the separation regions are based on electrothermal separation of the wire’s own body.

[0008] In another state of the art, patent document number CN102186526A describes a microcatheter with a detachable tip. The main problem addressed in this document is certain deficiencies of existing endovascular medical devices. These deficiencies include situations such as potential damage to the vessel wall, risk of blockage, and complexity of the procedure. In particular, it is stated that existing devices used in embolization procedures are insufficient in matters such as advancing precisely toward the target and completing the procedure without damaging undesired tissues. The solution presented to these problems in this document is to develop a new type of detachable-tip miniature liquid-conducting capillary device. This device aims to perform embolization procedures in a more flexible, more precise, and safer manner compared to traditional methods. The detachable tip feature of the device allows easy removal of the device from the body after the procedure, while its flexible structure enables adaptation to different anatomical structures. The device described in this document is designed to be used for catheter-assisted embolization procedures. However, the separation region is not electrothermal in nature, and a mechanically featured separation region is provided.

[0009] Due to the limitations and inadequacies of solutions in the existing technique, the possibility of occurrence of various complications due to failure of separation at the separation region of the embolization catheter in endovascular embolization procedures, the risk of damaging the vessel wall by the catheter, the possibility of causing clot formation, the risk of complications such as spreading of the embolic material to an incorrect region, the occurrence of catheter thrombosis, catheter damage, vessel damage, and embolic complications when the catheter does not separate, and the need for an extra manoeuvre or material to separate the catheter from the vessel, it has been deemed necessary to make an improvement in this field.Brief Description and Aims of the Invention

[0010] The invention relates to an endovascular embolization catheter module having an electrothermal separation region.

[0011] An aim of the invention is to eliminate the problem of failure of catheter separation that may be encountered in endovascular embolization applications and to minimise the risk of occurrence of related complications. The endovascular embolization catheter that is the subject of the invention, by means of the electrothermal separation region and separation region it possesses, minimises the possibility of occurrence of a complication during the procedure while also ensuring clear separation of the catheter. Another aim of the invention is to develop an endovascular embolization catheter module capable of conveying injectable materials. The endovascular embolization catheter module that is the subject of the invention is a catheter capable of conveying injectable materials by means of the electrothermal separation point and hollow structure it possesses.

[0012] Another aim of the invention is to develop an endovascular embolization catheter module that performs separation of the catheter from the vessel without the need for an extra manoeuvre or material. The fact that the catheter module that is the subject of the invention has a hollow structure and is a catheter capable of conveying injectable materials enables separation to be performed without the need for an extra manoeuvre or material.

[0013] Description of the Drawings

[0014] Figure 1. External view of the endovascular embolization catheter module having an electrothermal separation region

[0015] Figure 2. Distal end portion view of the endovascular embolization catheter module having an electrothermal separation region (within protective sheath)

[0016] Figure 3. Detailed view of the distal end portion of the endovascular embolization catheter module having an electrothermal separation region

[0017] Figure 4. Distal end portion view of the endovascular embolization catheter module having an electrothermal separation region (outside protective sheath)Figure 5. Proximal end portion view of the endovascular embolization catheter module having an electrothermal separation region

[0018] Definitions of the Elements / Parts Constituting the Invention

[0019] 1. Embolization tube

[0020] 2. Separation tip

[0021] 3. Separation region

[0022] 4. Electrolytic catheter

[0023] 5. Protective sheath

[0024] 6. Inlet end

[0025] Detailed Description of the Invention

[0026] The invention relates to an endovascular embolization catheter module having an electrothermal separation region. The endovascular embolization catheter module that is the subject of the invention minimises the risk of occurrence of catheter thrombosis, catheter damage, vessel damage, and embolic complications while performing embolization procedures by means of the separation region it possesses. The endovascular embolization catheter module having an electrothermal separation region that is the subject of the invention is a catheter capable of conveying injectable embolization materials such as Onyx embolization to the target vascular structure. The endovascular embolization catheter module that is the subject of the invention is a catheter capable of conveying injectable materials by means of the electrothermal separation point and hollow structure it possesses. The endovascular embolization catheter module that is the subject of the invention exhibits the electrothermal separation point feature not on a coil, but on a microcatheter structure through which the embolic material is injected. The fact that the catheter module that is the subject of the invention has a hollow structure and is a catheter capable of conveying injectable materials enables separation to be performed without the need for an extra manoeuvre or material.The endovascular embolization catheter module that is the subject of the invention comprises;

[0027] • an embolization tube (1 ) that enables transmission of the embolic material into the vessel, is connected distally to the separation tip (2) by means of the separation region (3), and is connected proximally to the inlet end (6),

[0028] • a separation tip (2) that is the outlet region of the embolic material into the vessel, is connected to the end portion of the embolization tube (1 ) by means of the separation region (3), and has a conical diameter increase at the portion to be connected to the embolization tube (1),

[0029] • a separation region (3) that is the region where the embolization tube (1) and the separation tip (2) are separated by means of the electrolytic catheter (4), • an electrolytic catheter (4) that advances by being combined with the protective sheath (5) in a manner adjacent to the outer wall and parallel to the outer portion of the embolization tube (1),

[0030] • a protective sheath (5) that is a covering part advancing around the embolization tube (1) up to the separation region (3) such that the electrolytic catheter (4) remains on the outer side, and

[0031] • an inlet end (6) that is the region adjacent to the protective sheath (5) into which the embolic material will be sent into the embolization tube (1) by means of an injector by being fixed.

[0032] In the endovascular embolization catheter module that is the subject of the invention, said distal refers to the part of the catheter that is distant from the body centre or starting point. The end portion of the catheter is referred to as distal, and this is the portion that reaches the targeted region during the procedure. Proximal refers to the part of the catheter that is close to the body centre or starting point. This is the part controlled by the operator or connected to a device. For example, in an embolization catheter, the distal end is the end that contacts the target region where the embolization material is released, while the proximal end is the side controlled by the operator or where the device connection is located.

[0033] The embolization tube (1) is the element that enables transmission of the embolic material in the catheter and is connected distally to the separation tip (2) by means ofthe separation region (3). Proximally, it is connected to the inlet end (6). The embolization tube (1 ) is adjacent on the outer surface to the electrolytic catheter (4) by means of the protective sheath (5).

[0034] The separation tip (2) is the region where the embolic material exits into the vessel in the catheter module and is connected to the end portion of the embolization tube (1) by means of the separation region (3). The separation tip (2) is the part that will remain in the vessel when the embolization procedure is completed. There is a conical diameter increase at the portion of the separation tip (2) to be connected to the embolization tube (1). On the inner surface of this portion, the spiral end of the electrolytic catheter (4) passed around the embolization tube is tightly positioned. The separation region (3) is the region where the embolization tube (1) and the separation tip (2) are separated by means of the electrolytic catheter (4). The separation region (3) has a structure that can melt by the electrolysis mechanism of the electrolytic catheter. The spiral end of the electrolytic catheter (4) is wound around the separation region (3) in a manner that remains tightly positioned and is passed onto the conical enlarged portion of the separation tip (2).

[0035] The electrolytic catheter (4) advances by being combined with the protective sheath (5) in a manner adjacent to the outer wall and parallel to the outer portion of the embolization tube (1). It exits from the inner portion of the inlet end (6) proximally. This region is the region where transmission of electrolysis begins.

[0036] The protective sheath (5) is a covering part advancing around the embolization tube (1) up to the separation region (3) such that the electrolytic catheter (4) remains on the outer side. The protective sheath (5) ensures that the elements constituting the catheter module remain together while advancing within the vessel.

[0037] The inlet end (6) is adjacent to the protective sheath (5). The inlet end (6) is the region into which the embolic material will be sent into the embolization tube (1) by means of an injector by being fixed.

[0038] The basic operating mechanism of the endovascular embolization catheter module that is the subject of the invention is based on injecting the embolic material into the vessel after reaching the targeted position within the embolic vessel and performing sufficient filling within the vessel after being decided by the specialist of the procedure.The operating method of the endovascular embolization catheter module that is the subject of the invention comprises the process steps of;

[0039] i. contacting the electrolytic catheter (4) with the electrolysis point for electrolysis to occur,

[0040] ii. initiating electrolysis around the separation region (3) by the electrolytic catheter (4) advancing within the protective sheath (5) and separation of the separation tip (2) from the embolization tube (1), and

[0041] iii. after separation is performed, removing the embolization tube (1) and the electrolytic catheter (4) from within the vessel such that the separation tip (2) remains within the vessel.

Claims

CLAIMS1. An endovascular embolization catheter having an electrothermal separation region, comprising;- an embolization tube (1) that enables transmission of the embolic material into the vessel, is connected distally to the separation tip (2) by means of the separation region (3), and is connected proximally to the inlet end (6), - a separation tip (2) that is the outlet region of the embolic material into the vessel, is connected to the end portion of the embolization tube (1 ) by means of the separation region (3), and has a conical diameter increase at the portion to be connected to the embolization tube (1),- a separation region (3) that is the region where the embolization tube (1 ) and the separation tip (2) are separated by means of the electrolytic catheter (4), - an electrolytic catheter (4) that advances by being combined with the protective sheath (5) in a manner adjacent to the outer wall and parallel to the outer portion of the embolization tube (1),- a protective sheath (5) that is a covering part advancing around the embolization tube (1 ) up to the separation region (3) such that the electrolytic catheter (4) remains on the outer side, and- an inlet end (6) that is the region adjacent to the protective sheath (5) into which the embolic material will be sent into the embolization tube (1) by means of an injector by being fixed.

2. A method of operation of an endovascular embolization catheter according to claim 1 , comprising the process steps of;i. contacting the electrolytic catheter (4) with the electrolysis point for electrolysis to occur,ii. initiating electrolysis around the separation region (3) by the electrolytic catheter (4) advancing within the protective sheath (5) and separation of the separation tip (2) from the embolization tube (1), andiii. after separation is performed, removing the embolization tube (1) and the electrolytic catheter (4) from within the vessel such that the separation tip (2) remains within the vessel.

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