Vascular occlusion apparatus

Abstract

In particular, the invention relates to a vascular occlusion apparatus for the treatment of diseases such as fistulas, distal end perforations, LIMA side branches, tumors, arteriovenous malformations, etc., which allows the closure of vessel ends and vessel walls and vessel ruptures that allow blood flow in the pathological vascular structure, which allows the unwanted blood flow to be stopped by positioning it in the desired position within the vessel, and does not require the use of a different apparatus for positioning.

Description

[0001] VASCULAR OCCLUSION APPARATUS

[0002] Technical Area

[0003] The invention relates to a vascular occlusion apparatus that enables the closure of pathological vascular structures and the interruption of blood flow.

[0004] In particular, the invention relates to a vascular occlusion apparatus for the treatment of diseases such as fistulas, distal end perforations, LIMA side branches, tumors, arteriovenous malformations, etc., which allows the closure of vessel ends and vessel walls and vessel ruptures that allow blood flow in the pathological vascular structure, which allows the unwanted blood flow to be stopped by positioning it in the desired position within the vessel, and does not require the use of a different apparatus for positioning.

[0005] State of the Art

[0006] Minimally invasive interventions, which have fewer complications, more efficient results and lower costs compared to complex open surgery, are performed with the support of image guidance. For many minimally invasive interventions, blood vessels are a common route of entry into the body, and an endovascular approach can provide access to almost any organ in the body. In the embolization procedure, which is a frequently preferred indication for targeting a lesion from the endovascular approach, blood flow to the part of the body where the procedure is applied is reduced or cut off. In this context, embolization refers to the intentional occlusion of blood vessels in an intravascular manner, using embolic agents or devices through catheters for therapeutic purposes. Therapeutic endovascular embolization is used in a variety of clinical scenarios; from acute potentially fatal bleeding to aneurysms, vascular malformations (fistulas, etc.) and targeted oncological applications such as embolization of tumor-feeding blood vessels.

[0007] The first documented embolization procedure was performed by Robert Dawbain in 1904. Dawbain embolized patients by injecting molten paraffin-petroleum into the external carotid arteries before surgery to reduce head and neck lesions. In 1930, Barney Brooks first described vascular occlusion and suggested that the only satisfactory way to treat an arteriovenous malformation (AVM) was to close the fistula orifice. Later, a thin strip of muscle was used successfully to embolize a carotid-cavernous fistula. These and other pioneering studies have led to innovative methods for embolization using both natural and synthetic agents. In 1964, Charles Dotter, a radiologist at Oregon Health & Science University, performed the first percutaneous transluminal angioplasty for the treatment of atherosclerotic arterial stenosis, ushering in the era of catheter-based interventions for diagnosis and treatment. He was also a pioneer in balloon catheterization, coronary angiography (X-ray imaging for vessel visualization), percutaneous arterial stent placement and played an important role in the development of an entirely new medical specialty, interventional radiology.

[0008] In the early years, muscle fragments, blood clots, and stainless steel beads were used as embolic agents. Since the 1970s, however, advances in imaging and catheter technology have significantly advanced embolization methods. In response to the failure of natural analogs for embolization, researchers and clinicians have used advances in materials to create new embolic agents for specific clinical applications. Examples of these materials include metal coils, calibrated microspheres, and biocol adhesives. Materials and devices used for embolization in the literature are detailed below.

[0009] Mechanical occlusive devices:

[0010] Various mechanical occlusion devices such as coils, plugs, stents, and balloons are used in the clinic for embolization. Coils are most commonly used for aneurysm treatment and bleeding control and are often combined with other devices or agents by using more than one coil.

[0011] 1 ) Coils: Coil embolization is widely used to mechanically occlude aneurysms or block bleeding vessels. During the procedure, a catheter is guided through the bloodstream to reach the target vein. Once positioned, the coil is pushed through the catheter using a delivery system and compressed into the vessel lining or aneurysm sac, resulting in embolization. Among the many properties of coils, biocompatibility is an important factor and for long-term implantation, coil materials must be bioinert so as not to trigger a local or systemic adverse host response. Furthermore, the coils need to be formable for ease of manufacture, flexible enough for catheterization and visible under imaging methods. Another critical feature of coils is their surface thrombogenicity, thereby controlling fibrin formation and platelet adhesion. Coils consist primarily of bio-inert metal cores such as stainless steel, platinum or nitinol and also include a coating. Theoretically, the core should have relatively high longitudinal strength, but low radial forces to avoid excessive stress to the vessel wall.

[0012] 2) Shape memory polymer foam (SMP foam): Shape memory materials have emerged as an important class of stimulus-responsive materials in the medical field for minimally invasive procedures. Because of the inherent risks of inflammation and recalen (reopening and resumption of blood flow) associated with metal-based coils, shape memory polymer (SMP) is recommended as an alternative to foam-based occlusion devices. These devices have many favorable features that make them suitable as aneurysm filling materials, including adjustable pore sizes that allow for optimal adaptation of cellular infiltration and stable tissue integration within the foam. Biocompatibility, mechanical properties and contrast imaging have been improved for SMP foams. SMP foams can be made radiopaque with doped tantalum or tungsten. At the same time, SMP foams are coated in coils to facilitate delivery and packaging performance in aneurysm treatment.

[0013] Particles:

[0014] Particles were the first embolic agents developed and are currently the most widely used agents due to their versatile functionality. Particles may be irregularly shaped or calibrated, natural or synthetic, and persistent or biodegradable. Historically, uncalibrated particles were widely used and are still used clinically today (e.g., gelatin pledgets). However, in vivo the path of travel and level of obstruction are often unpredictable. Therefore, calibrated microspheres are generally preferred due to their controllable size distribution and spherical shape, which can improve embolization outcomes. The generally accepted lower limit for particulate embolic agents used for embolization is 40 pm. The particles used in the clinic are autologous (patient-owned) clots or tissues, Polyvinyl Alcohol (PVA) particles, gelatin, microspheres, and drug-eluting beads. embolic agents:

[0015] There is increasing interest in liquid / gel embolic agents for intravascular interventions because of their ability to penetrate targets that catheters and coils cannot reach. Liquid / gel embolic agents obstruct blood flow by creating permanent casts that are not dependent on the patient's clotting system for thrombus formation. For liquid / gel embolic agents, phase transformation of the material is often required between application (e.g., inside the syringe and inside the catheter) and operating conditions (e.g., in the body). While lower viscosity is desirable for passage through the delivery system (e.g., syringe and catheter), a harder, more solid structure after exiting the catheter is important for achieving vascular dispersion. Such liquid-to-solid (sol-gel) phase transition can be achieved through approaches categorized as physical crosslinking (e.g., precipitation and ionic crosslinking) and chemical crosslinking (e.g., polymerization). In particular, environmental differences between in vitro and in vivo conditions provide various triggering factors for certain physical mechanisms to occur (e.g. pH, ionic strength and temperature). The flow-induced shear thinning effect (decreasing viscosity as shear rate increases) also enables the development of new embolic agents regardless of environmental factors.

[0016] All available embolic materials have their advantages and shortcomings, and while there is no "one size fits all" material for embolization, general characteristics of an ideal embolic material include biocompatibility, easy applicability, resistance to fragmentation / migration, biodegradability (depending on the application), ability to be visible / traceable on common imaging modalities such as fluoroscopy, magnetic resonance imaging (MRI), computed tomography (CT) or ultrasound, and ability to be used for therapeutic purposes. Clinical scenarios may require temporary or permanent occlusion of blood vessels ranging in size from arterial (up to 1 -2 cm diameter) to capillary (up to 5-10 pm diameter). In this sense, the main challenge in the development of embolic agents is "the versatility of embolization as an intervention". Additionally, the material used for the procedure must be able to be placed via a catheter, but must maintain its structural integrity to withstand arterial blood pressure. Therefore, the efficacy of an embolic agent depends on its ability to adapt to the unique clinical scenarios presented by each patient and its ability to deliver an effective treatment while minimizing the occurrence of side effects in surrounding structures.

[0017] In a patent document numbered JP5885057B2, which is in the state of the art, a stent delivery catheter that allows easy placement of the guide wire is described. In the stent delivery catheter, an inner shaft pushes out a stent with a piston, and a guidewire is located along the inner shaft. The proximal end of the guidewire provided through the inner shaft is opened through the port portion of the outer shaft. The stent delivery catheter has a first shaft and a second shaft that is larger in diameter than the first shaft. The shaft of the stent delivery catheter expands while in use. A guidewire is inserted from the distal end of the stent delivery catheter into the guidewire opening and is removed outward from the near end of the outer shaft through the port connected to the near end of the inner shaft. The document does not mention a solution for closing the vessel ends that allow blood flow in the pathological vasculature, as well as the vessel walls, by positioning it inside the vessel without the need for a different positioning apparatus.

[0018] Another patent document US6019777A of the state of the art discloses an apparatus and method for inserting one or more stents into a body lumen. The apparatus includes a catheter with a removable part. It also has a tubular sheath, which contains a part that resists compressive forces and can thus be positioned anywhere within the body lumen. After stent placement, the first sheath can be slipped off the catheter shaft. A second sheath can be placed by sliding it over the catheter shaft. The apparatus contains a balloon catheter shaft and has a gap through which a guide wire can pass. The catheter shaft may include first catheter and second catheter elements coaxially adjacent. The document does not mention a solution for closing the vessel ends that allow blood flow in the pathological vasculature, as well as the vessel walls, by positioning it inside the vessel without the need for a different positioning apparatus.

[0019] As a result, there is a need to develop a vascular occlusion apparatus that allows the closure of the vessel ends and vessel walls that allow blood flow in the pathological vasculature, to stop the unwanted blood flow in the pathological vasculature and at the same time the bleeding caused by vascular rupture by positioning it in the desired position in the vessel and does not require the use of a different apparatus for positioning. Purpose of the Invention

[0020] The present invention relates to a vascular occlusion apparatus that meets the above- mentioned requirements, eliminates possible disadvantages and provides some additional advantages.

[0021] The main purpose of the vascular occlusion apparatus subject to the invention is to obtain a vascular occlusion apparatus that allows the closure of the vessel ends and vessel walls that allow blood flow in the pathological vascular structure and to prevent bleeding caused by vascular ruptures.

[0022] Another purpose of the invention is to obtain a functional vascular occlusion apparatus that allows stopping unwanted blood flow by positioning it in desired / different positions within the vessel.

[0023] Another purpose of the invention is to obtain a practical vascular occlusion apparatus that does not require the use of a different or customized apparatus or device during the insertion and positioning processes into the vessel and facilitates use.

[0024] Another purpose of the invention is to obtain an efficient vascular occlusion apparatus that reduces production and usage costs.

[0025] Another object of the invention is to provide an effective vascular occlusion apparatus that prevents the formation of folds and curlings in the vessel.

[0026] Another object of the invention is to provide a functional vascular occlusion apparatus that can be applied to vessels of different diameters to stop unwanted blood flow regardless of the width of the vessel.

[0027] Another object of the invention is to provide a functional vascular occluding apparatus, which allows the bleeding area to be closed with a single apparatus without the need to use a second apparatus to stop the blood flow in the vessel, especially when the vessel is bleeding as a result of rupture. In order to achieve the above objectives in the most general form, the vascular occlusion apparatus, which allows the closure of the vessel ends and vessel walls that allow blood flow in the pathological vascular structure and prevent bleeding caused by vascular rupture, includes at least one first carriage element including at least one channel; at least one first occlusion element; at least one second occlusion element; at least one second carriage element; at least one setting element; at least one gap.

[0028] The structural and characteristic features and all advantages of the invention will be more clearly understood by means of the figures given below and the detailed description written by making references to these figures, and therefore, the evaluation should be made by considering these figures and detailed description.

[0029] Figures to Help Understand the Invention

[0030] To best understand the structure and advantages of the present invention, it should be evaluated together with the figures described below.

[0031] Figure 1 : It is a sectional view of the vascular occlusion apparatus which is the subject of the invention.

[0032] Figure 2: Another cross-sectional view of the vascular occlusion apparatus which is the subject of the invention.

[0033] Part References

[0034] 1 . First carriage element

[0035] 2. First occlusion element

[0036] 2a. Stent body

[0037] 3. Second occlusion element

[0038] 4. Second carriage element

[0039] 5. Setting element

[0040] 6. Gap

[0041] A. Vascular occlusion device Detailed Description of the Invention

[0042] In this detailed description, preferred embodiments of the inventive vascular occluding apparatus are described solely for the purpose of a better understanding of the subject matter and without limitation.

[0043] A vascular occlusion apparatus (A), the exemplary view of which is shown in Figure 1 , developed with the present invention, which allows the closure of vessel ends and vessel walls that allow blood flow in pathological vasculature, the prevention of bleeding caused by vessel rupture, and the stopping of unwanted blood flow, suitable for positioning in different positions and independent of the width / diameter value of the vessel, is comprised of at least one first carriage element (1 ), preferably a shaft or preferably a hollow tube with an inner diameter of 0.014 inch (0.03556 cm) for the wire to pass through, preferably made of thermoplastic, polyamide (nylon) and / or polyester material, preferably made of thermoplastic, polyamide (nylon) and / or polyester material, containing at least one channel suitable for the passage of a wire suitable for use in coronary artery intervention, allowing the apparatus (A) to be slid on the wire passing through it and carried into and out of the vessel; in the form of a hollow cylinder with closed radial surfaces, including at least one first opening at the end close to the user and at least one second opening at the end distant from the user, positioned so as to allow the first carriage element (1 ) to pass through it, at least one first occlusion element, preferably in the form of a coated stent, preferably made of plastic, polyurethane, polytetrafluoroethylene and / or silicone material, which is preferably made of plastic, polyurethane, polytetrafluoroethylene and / or silicone material, which ensures the closure of the surfaces parallel to the extension axis of the vessel and the prevention of unwanted blood outflow outside the closed vascular structure by coagulation of the blood filling into it after its placement in the vessel (2); connected with the first occlusion element (2) in such a way as to close the second opening, suitable for comfortable advancement of the apparatus (A) in the vein, ensuring the closure of at least one surface or end of the vein that is not parallel to the axis of extension of the vein by coagulation of the blood filled into it after its placement in the vein and preventing unwanted blood outflow outside the closed vascular structure, at least one second occlusion element (3), preferably made of plastic, polyurethane, polytetrafluoroethylene and / or silicone material, preferably in the form of a tapered shape extending in a narrowing direction away from the first occlusion element (2); at the center of the second occlusion element (3), positioned at a distance from the first carriage element (1 ) beyond the end of the first carriage element (1 ) which is distal to the user, the second occlusion element (3) being supported, advanced in the vessel and prevented from folding during advancement, preferably having a shaft or at least one second carriage element (4) having a hollow tubular structure with an internal diameter of 0.014 inches (0.03556 cm) hollow tubular structure, preferably made of thermoplastic, polyamide (nylon) and / or polyester material (4); at least one setting element (5), preferably of a balloon structure, preferably made of polyurethane and / or silicone material, which is positioned in the first occlusion element (2) in fixed connection with the first carriage element (1 ), which is positioned in the first occlusion element (2), which is inflated after the apparatus (A) is inserted into the vessel and which allows the first occlusion element (2) to be installed against the inner wall of the vessel and the position of the first and second occlusion elements (2, 3) in the vessel to be fixed; at least one gap (6), for retraction of the apparatus (A) positioned between the first and the second carriage element (1 , 4) after insertion of the apparatus (A) into the vessel by maintaining a distance between the first and the second carriage element (1 , 4), preferably of a length of 1 millimeter along an axis parallel to the axis of extension of the vessel, preferably of a form suitable for convenient movement of the apparatus (A) within the vessel and to prevent folding of the apparatus (A), which allows the first carriage element (1 ) and the setting element (5) to be separated from the apparatus (A) and allows the first and second occlusion elements (2, 3) to remain fixed in the position in which they are inserted in the vessel.

[0044] In an exemplary embodiment of the vascular occlusion apparatus (A) developed with the present invention, a standard wire, preferably 0.014 inch thick and suitable for use in coronary artery intervention, is first passed into the vessel to be embolized / occluded. After the wire is passed through the channel in the first carriage element (1 ), the apparatus (A) is moved forward by sliding over the wire, again by means of the first carriage element (1 ). Meanwhile, the second occlusion element (3) is supported by the second carriage element (4) and is prevented from bending or folding within the vessel. After the apparatus (A) is positioned in the vessel in the desired position to cut off the unwanted blood flow, the first occlusion element (2) is expanded by inflating the setting element (5) and fixed in its position in the vessel by installing it against the inner walls of the vessel. After the fixing process, the setting element (5) is lowered / deflated and is pulled back and taken out of the vein by sliding it over the wire using the first carriage element (1 ). During the retraction process, the first carriage element (1 ) and the setting element (5) are separated from the apparatus (A) by the gap (6) and the first and second occlusion elements (2, 3) and the second carriage element (4) remain fixed in their position within the vessel. Afterwards, the blood transmitted through the vessel is filled into the first and second occlusion elements (2, 3) and coagulated. Thus, the first occlusion element (2) closes the vessel surfaces lying parallel to the vessel extension axis and the second occlusion element (3) closes the open end of the vessel distal to the user, thus completing the embolization process that closes all openings of the pathological and / or ruptured vessel that cause bleeding and stops the unwanted blood flow.

[0045] In a preferred embodiment of the invention, the vascular occlusion apparatus (A) comprises at least one stent body (2a) positioned within the first occlusion element (2), providing structural support for maintaining the physical form and increasing the strength of the first occlusion element (2), preferably in the form of a wireframe, preferably made of stainless steel, cobalt-chromium alloy, nickel-titanium alloy (nitinol), platinum and / or tantalum alloy.

[0046] In another preferred embodiment of the invention, the vascular occlusion apparatus (A) comprises at least one first channel opening positioned in the first carriage element (1 ) and having a lumen structure which allows the wire to pass therethrough.

[0047] In a further preferred embodiment of the invention, the vascular occlusion apparatus (A) comprises at least a second channel opening positioned in the first carriage element (1 ) and having a lumen structure which allows the delivery of a fluid for inflating the setting element (5).

[0048] The vascular occlusion apparatus (A) developed with the present invention is used to close the vessel ends and vessel walls that allow blood flow in the pathological vasculature and to stop the unwanted blood flow in the pathological vasculature as well as the bleeding caused by vessel rupture by positioning it in the desired position within the vessel. In this way, an efficient, effective and functional vessel occlusion apparatus (A) is obtained, which is suitable for use in vessels with different internal width / diameter values, does not require the use of a different apparatus for positioning, can be applied practically and quickly, and reduces procedure time and cost.

Claims

CLAIMS1. A vascular occlusion apparatus (A) which is suitable for locating in different positions, closes vessel walls and vessel ends that allow blood flow in pathological vasculature, prevents bleeding caused by vessel rupture and stops unwanted blood flow regardless of the width / diameter of the vessel, comprising: at least one first carriage element (1 ) which carries the apparatus (A) into and out of the vessel by sliding on a wire which is suitable for use in coronary artery intervention, wherein the first carriage element (1 ) comprises at least one channel which allows the wire pass through it; at least one first occlusion element (2) which ensures the closure of the surfaces parallel to the extension axis of the vessel by coagulation of the blood filling into it after its placement in the vessel and prevents unwanted blood outflow outside the closed vessel structure, wherein the first occlusion element (2) is in the form of a hollow cylinder with closed radial surfaces which has at least one first opening at the end close to the user and at least one second opening at the end far from the user, and is positioned in a way to allow the first carriage element (1 ) to pass through it; at least one second occlusion element (3) which ensures the closure of at least one surface or end of the vessel which is not parallel to the axis of extension of the vessel by coagulation of the blood filled into it after its placement in the vessel and prevents unwanted blood outflow outside the closed vessel structure, wherein the second occlusion element (3) has a structure suitable for comfortable advancement of the apparatus (A) in the vessel and it is connected to the first occlusion element (2) in such a way as to close the second opening; at least one second carriage element (4) which supports and advances the second occlusion element (3) within the vessel and prevents it from folding during advancement, wherein the second carriage element (4) is located at the center of the second occlusion element (3) and subsequently to the end of thefirst carriage element (1 ) distal to the user with a distance from the first carriage element (1 ); at least one setting element (5) which sets the first occlusion element (2) against the inner wall of the vessel and fixes the position of the first and the second occlusion elements (2, 3) in the vessel by inflating after the insertion of the apparatus (A) into the vessel, wherein the setting element (5) is located in the first occlusion element (2) in fixed connection with the first carriage element (1 ); at least one gap (6) which separates the first carriage element (1 ) and the setting element (5) from the apparatus (A) during retraction of the apparatus (A) after insertion into the vessel with allowing to maintain a distance between the first and second carriage element (1 , 4) and allows the first and second occlusion elements (2, 3) to remain fixed in the position in which they are inserted into the vessel, wherein the gap (6) is located between the first and second carriage element (1 , 4).

2. A vascular occlusion apparatus (A) according to claim 1 , wherein the first carriage element (1 ) is a hollow pipe structure with an inner diameter of 0.014 inches for the shaft or preferably the wire to pass through it.

3. A vascular occlusion apparatus (A) according to claim 1 , wherein the first carriage elements (1 ) are made of thermoplastic, polyamide and / or polyester material.

4. A vascular occlusion apparatus (A) according to claim 1 , wherein the first occlusion element (2) has a covered stent structure.

5. A vascular occlusion apparatus (A) according to claim 1 , wherein the first occlusion element (2) is made of plastic, polyurethane, polytetrafluoroethylene and / or silicone material.

6. A vascular occlusion apparatus (A) according to claim 1 , wherein the second occlusion element (3) is in a conical form which narrows as it moves away from the first occlusion element (2).

7. A vascular occlusion apparatus (A) according to claim 1 , wherein the second occlusion element (3) is made of plastic, polyurethane, polytetrafluoroethylene and / or silicone material.

8. A vascular occlusion apparatus (A) according to claim 4, wherein the second carriage element (4) is in the form of a shaft containing at least one channel suitable for the wire to pass through it or a hollow pipe with an inner diameter of 0.014 inches.

9. A vascular occlusion apparatus (A) according to claim 4, wherein the second carriage element (4) is made of thermoplastic, polyamide and / or polyester material.

10. A vascular occlusion apparatus (A) according to claim 1 , wherein the setting element (5) is the form a balloon.

11. A vascular occlusion apparatus (A) according to claim 1 , wherein the setting element (5) is made of polyurethane and / or silicone material.

12. A vascular occlusion apparatus (A) according to claim 1 , wherein the length value of the distance extending along the axis parallel to the extension axis of the vessel is 1 millimeter.

13. A vascular occlusion apparatus (A) according to claim 1 , wherein the gap (6) is in a form that is suitable for the apparatus (A) to be easily moved within the vessel and to prevent the apparatus (A) from folding.

14. A vascular occlusion apparatus (A) according to claim 1 , wherein the apparatus (A) comprises at least one stent body (2a) preferably in the form of a wire mesh, preferably made of stainless steel, cobalt-chromium alloy, nickel-titanium alloy (nitinol), platinum and / or tantalum alloy material, wherein the stent body (2a) is located within the first occlusion element (2) and provides structural support to protect the physical form of the first occlusion element (2) and to increase its strength.

15. A vascular occlusion apparatus (A) according to claim 1 , wherein the apparatus (A) comprises at least one first channel opening which is located in the first carriage element (1 ) and is in the form of a lumen that allows the wire to pass through it.

16. A vascular occlusion apparatus (A) according to claim 1 , wherein the apparatus (A) comprises at least one second channel opening which is located in the first carriage element (1 ) and is in the form of a lumen that allows the transmission of the fluid which provides inflation of the setting element (5) through it.

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