Transcarotid artery neurovascular catheter

Abstract

An intravascular catheter optimized for accessing the anterior cerebral vessels from a carotid access site is disclosed. An interventional catheter for arterial procedures includes an elongate body sized and shaped for transcervical introduction into the common carotid artery at an access site in the neck, the elongate body having a length such that, during use, a distal-most section can be positioned in an intracranial artery and at least a portion of a proximal-most section is positioned in the common carotid artery.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims priority to the following applications: (1) U.S. Provisional Application No. 62 / 029,799, filed July 28, 2014; (2) U.S. Provisional Application No. 62 / 075,101, filed November 4, 2014; (3) U.S. Provisional Application No. 62 / 046,112, filed September 4, 2014; (4) U.S. Provisional Application No. 62 / 075,169, filed November 4, 2014; and (5) U.S. Provisional Application No. 62 / 083,128, filed November 21, 2014. The entire disclosures of the provisional patent applications are hereby incorporated by reference herein in their entirety, and the priority of their filing dates is claimed.

Background Art

[0002] Intravascular catheters are used to access a target vascular region from a remote vascular access site for performing a procedure. The design, material, and structure of a particular catheter are primarily directed at enabling the catheter to reach the target vascular anatomy without causing vascular trauma and to perform the intended function of the catheter when it reaches the target anatomy. Catheters often have multiple requirements that can be conflicting. Thus, an excellent design optimally balances the goals of these requirements.

[0003] Many catheters are single-lumen catheters, in which the lumen functions as a conduit for the delivery of radiopaque or therapeutic agents, or for other intervention devices into the blood vessel, and / or for the extravascularization of blood, thrombi, or other occlusive materials. Such catheters have physical properties that allow them to advance from the proximal end through the vascular access site to the vascular biostructure (which is often highly curved, delicate, winding, and far from the vascular access site). These catheters are also designed to be used with auxiliary devices placed in the internal lumen, such as guidewires, and sometimes smaller catheters, and also to advance through a vascular access sheath, guide catheter, and sometimes subselective guide catheter (i.e., a catheter specifically designed to go to a position distal to a general guide catheter) toward the target biostructure. In other words, a catheter is often not a single catheter, but a system of catheter, guidewire, guide catheter, and sheath that allows the user to properly perform the procedure they intend.

[0004] Interventions in the cerebral vascular system often present unique access challenges. Most neurological interventions utilize transfemoral access through the carotid or vertebral arteries and from there to the target cerebral artery. However, this access route is often winding and may contain stenotic plaque material at the aortic arch and the origins of the carotid and brachiocephalic vessels, posing a risk of embolic complications during the access portion of the procedure. Furthermore, cerebral vessels are generally more delicate and prone to perforation than the coronary or other peripheral vascular systems. In recent years, intervention devices, such as wires, guide catheters, stents, and balloon catheters, have all been miniaturized and made more flexible to function better in neurovascular biostructures. However, many neurological interventions remain more difficult or impossible due to device access challenges. In some cases, the desired access site is the carotid artery. Procedures in the intracranial and cerebral arteries are considerably closer to this access site than to the femoral artery access site. Importantly, the risk of embolic complications during navigation of the aortic arch and proximal carotid and brachiocephalic arteries is avoided. However, since most catheters used in interventional procedures are designed for femoral access sites, current devices are not ideal for alternative carotid access sites in terms of both length and mechanical properties. This makes the procedure more difficult, and in some cases, more risky, when a device designed for femoral access is used for carotid access procedures.

[0005] U.S. Patent No. 5,496,294 ('294 patent) describes a single-lumen three-layer catheter design comprising: (1) an inner polytetrafluoroethylene (PTFE) liner for providing a low-friction inner surface; (2) a reinforcing layer formed from metal coil wire or metal coil ribbon; and (3) an outer jacket layer. Generally, the three layers are bonded together by heat and external pressure, for example, using heat-shrink tubing. The catheter has many sections of stiffness that change so that the flexibility increases toward the distal end of the catheter. This change in flexibility can be achieved by changing the durometer of the outer jacket layer along the length of the catheter. Another method of changing flexibility is to change the reinforcing structure and / or material along the length of the catheter.

[0006] One limitation of the '294 patent and other existing neurovascular catheter technologies is that the device is designed for femoral access approaches to the cerebral arteries. The route from the femoral artery to the common carotid artery, and from there to the internal carotid artery, is long and involves some extension and flexion. The dimensions provided in the '294 patent are consistent with this design objective. However, a catheter designed to navigate this route is not suitable for transcarotid access and has a length and flexible transition that actually impairs the performance of a transcarotid catheter. For example, the flexible section needs to have at least 40 cm of gradually increasing stiffness from the distal end to the nearest stiff section so that it can navigate both the internal carotid artery curve and the flexures required to go from the aortic arch to the common carotid artery and then to the internal carotid artery.

[0007] Another disadvantage of the catheter structure described in the '294 patent is the limited ability of the catheter to have a continuous and smooth transition of flexibility along the length of the catheter. There is a subtle difference in the flexibility of the catheter when one jacket material is adjacent to another jacket material, or when one reinforcing structure is adjacent to another reinforcing structure. Furthermore, the three-layer catheter structure of the '294 patent has limitations in wall thickness because the three layers of the catheter must be able to be handled and assembled during manufacturing. In addition, the catheter structure makes it difficult to have a relatively large internal lumen diameter while maintaining flexibility and / or resistance to very sharp bends in blood vessels. Generally, larger diameter catheters also tend to be more rigid in order to maintain kink resistance. [Prior art documents] [Patent Documents]

[0008] [Patent Document 1] U.S. Patent No. 5,496,294 [Patent Document 2] U.S. Patent Application Publication No. 12 / 834,869 [Patent Document 3] U.S. Patent Application Publication No. 14 / 537,316 [Overview of the Initiative]

[0009] A single catheter with dimensions and mechanical properties optimized for accessing the cerebral blood vessels from a carotid artery access site is required. A single catheter with a smooth, gradual transition along its length from a first flexibility to at least a second different flexibility is also required. Furthermore, a single catheter with a relatively large inner diameter compared to prior art catheters, while maintaining physical properties such as thin wall thickness, kink resistance, and flexibility, is also needed.

[0010] We disclose an intravascular catheter optimized for accessing the anterior cerebral vessels from a carotid artery access site.

[0011] Furthermore, we disclose a catheter which includes variations in flexibility or stiffness moving along the entire length of the catheter or a portion of the length of the catheter. Conveniently, the change in the flexibility of the catheter is indicated by a smooth, rather than abrupt, change. In other words, the flexibility of the catheter transitions gradually along the length of the catheter from one section of the catheter to an adjacent section without any abrupt or discontinuous change. Depending on how the catheter is used and to which particular section of the vascular biostructure the catheter is used, as detailed below, the catheter can be made to a specific size and shape.

[0012] Furthermore, a single intervention catheter for arterial procedures is disclosed, comprising an elongated body sized and shaped for transcervically introducing into the common carotid artery at a neck access position, and an elongated body sized and shaped for navigating distally through the common carotid artery to an intracranial artery via the neck access position, and an internal lumen in the elongated body, the internal lumen forming a proximal opening in the proximal region of the elongated body and a distal opening in the distal region of the elongated body, wherein the elongated body has a nearest-most section and a far-most section, the nearest-most section being the most rigid part of the elongated body, and the elongated body has a total length and far-most section length such that the far-most section can be positioned in an intracranial artery during use, and at the same time at least a portion of the nearest-most section is positioned in the common carotid artery.

[0013] Other features and advantages will become apparent from the following description of various embodiments illustrating the principles of this disclosure. [Brief explanation of the drawing]

[0014] [Figure 1A] Figure 1A shows a schematic diagram of an exemplary catheter. [Figure 1B] Figure 1B shows a schematic diagram of an alternative embodiment of a single catheter. [Figure 2] Figure 2 shows an example of a catheter with an oblique distal tip or distal edge. [Figure 3] Figure 3 shows an example of a catheter with an oblique distal tip or distal edge. [Figure 4] Figure 4 shows an example of a catheter with an oblique distal tip or distal edge. [Figure 5] Figure 5 shows an example of a catheter with an oblique distal tip or distal edge. [Figure 6] Figure 6 shows an embodiment of a catheter having a tapered coaxial internal component. [Figure 7] Figure 7 shows another embodiment of a catheter having a tapered coaxial internal component. [Modes for carrying out the invention]

[0015] [Detailed description of the invention] Figure 1A shows a schematic view of an exemplary catheter 105. The catheter 105 is an elongated body having outer dimensions sized and shaped for insertion into a blood vessel. In certain embodiments, the catheter 105 is sized and shaped for insertion into an access sheath of a carotid access system as described in U.S. Patent Application No. 12 / 834,869, entitled "SYSTEMS AND METHODS FOR TREATING A CAROTID ARTERY", which is incorporated herein by reference in its entirety. U.S. Patent Application No. 14 / 537,316, filed November 10, 2014, entitled "METHODS AND DEVICES FOR TRANSCAROTID ACCESS", is also incorporated herein by reference in its entirety. The proximal region of the catheter 105 may have one or more mechanical or electromechanical control mechanisms for controlling various components at or near the distal end of the catheter 105. For example, the control mechanism can be used to control the inflation of one or more balloons, the advancement / deployment of system components (such as stents), the flushing or aspiration of fluid through the catheter, and combinations thereof.

[0016] Referring again to Figure 1A, the catheter 105 is configured to be inserted into the carotid artery through an access sheath and navigated distally to the distal ICA or cerebral blood vessels. A proximal port 2035 having a hemostatic valve may be disposed at the proximal end of the catheter 105 to allow the introduction of devices, such as microcatheters, guidewires, stent delivery devices, aneurysm coil delivery devices, or thrombus removal devices, while preventing or minimizing blood loss during the procedure. The hemostatic valve can also be integral with the catheter proximal adapter or removably attached to the proximal end of the catheter via a proximal connector. In certain embodiments, the valve is an adjustable aperture valve, such as a Tuohy-Borst or rotating hemostatic valve (RHV). In other embodiments, the valve is a passive seal hemostatic valve.

[0017] The catheter 105 may be manufactured to have a structure of two or more layers. In one embodiment, the catheter has a PTFE inner liner, an outer jacket layer, and at least a portion of the catheter has a reinforcing structure, such as a tubular structure formed from a coiled, braided, or cut hypotube. Furthermore, the catheter may have a radiopaque marker at its distal tip to facilitate placement of a device using fluoroscopy.

[0018] Catheter 105 has an insertable portion (or working length) sized to be inserted through an access sheath into the carotid artery and through the arterial pathway (through the artery) into the distal ICA or cerebral blood vessels. In certain embodiments adapted to be used with an access sheath having a total length of about 15 - 20 cm including a sheath hemostasis valve, catheter 105 has a working length of 40 - 70 cm. The working length (or insertable portion) of the catheter is the portion of the catheter sized and shaped to be inserted into the artery, and at least a portion of the working length is actually inserted into the artery during the procedure. In certain embodiments, the catheter has a working length less than 70 cm, less than 60 cm or less than 50 cm. Similar catheters designed for transfemoral access sites can have a working length of 100 - 130 cm. Alternatively, the length of the catheter can be determined relative to the location of the access site and the target cerebral artery site. In certain embodiments, the catheter is configured to be introduced into the artery at an arterial location less than 40 cm, less than 30 cm or less than 20 cm from the location of the target site, measured through the arterial pathway. That distance can also be determined by the ratio of (working length) / (distance between the location where the catheter enters the arteriotomy and the target site). In certain embodiments, this ratio is less than 2x. In certain embodiments, the working length of the device can have a hydrophilic coating to improve the ease of advancement of the device through the vasculature. In certain embodiments, at least 40% of the working length of the catheter is coated with a hydrophilic substance. In other embodiments, at least 50% or at least 60% of the working length of the catheter is coated with a hydrophilic substance. In certain embodiments, the elongated body has a total length and a length of the most distal section or portion such that during use, the most distal section can be positioned in the intracranial artery while being inserted trans-cervically into the common carotid artery, and at least a portion of the proximal most section 115 (FIG. 1A) is positioned in the common carotid artery.

[0019] In one embodiment, the most distal section 111 (Figure 1A) is composed of one or more flexible sections to be more flexible than the proximal section in order to successfully navigate the internal carotid artery curvature and reach a target site in the distal (internal carotid artery) ICA or cerebral artery. The shaft may have one or more increasingly stiff transition or intermediate sections 113 toward the more proximal section of the shaft, with the most proximal section having the stiffest shaft section. Alternatively, the transition section is a section of stiffness that changes continuously from distal section stiffness to proximal section stiffness. In one embodiment, the most distal flexible section is 5–15 cm. In another embodiment, the most distal flexible section is 3–10 cm. In another embodiment, the distal section is 2–7 cm. In one embodiment, the transition section is 5–15 cm. In another embodiment, the transition section is 5–10 cm. In another embodiment, the transition section is 4–8 cm. In all of these embodiments, the nearest rigid section occupies the remainder of the working length. In one embodiment, where the catheter has a working length of 40 cm, the nearest rigid section is 10–30 cm. In one embodiment, where the catheter has a working length of 70 cm, the nearest rigid section is 40–60 cm. In one embodiment, the stiffest portion of the catheter is the nearest portion of the catheter. The catheter may have a length such that, when inserted into the common carotid artery via a transcarotid passage to the common carotid artery, the stiffest portion of the catheter is at least partially located in the common carotid artery or at least 2 cm into the common carotid artery. In one embodiment, the catheter has a length such that, when the distal section is in an intracranial artery during use, at least a portion of the nearest section is located in the common carotid artery. The relative lengths of the distal section, transitional section and nearest section are not necessarily shown to exact scale in Figure 1A.

[0020] Alternatively, the flexible distal section and the transition section may be described as part of the total catheter working length. In one embodiment, the most distal flexible section is 3–15% of the catheter's working length. In another embodiment, the most distal flexible section is 4–25% of the catheter's working length. Similarly, in one embodiment, the transition section is 7–35% of the catheter's working length. In another embodiment, the transition section is 6–20% of the catheter's working length.

[0021] In one embodiment, the flexibility of the most distal section is 3-10 N-mm 2 The flexibility of the nearest section is 100-500 N-mm 2 Therefore, the flexibility / multiple flexibility of the transition section is between these two values.

[0022] As described above, a catheter may have a section having a discreet and / or continuously variable stiffness shaft. This variable flexibility section can be achieved in many ways. For example, the outer jacket layer may consist of discreet sections of polymer having different durometers, compositions, and / or thicknesses. In other embodiments, the outer layer has one or more sections of continuously variable outer layer material with varying flexibility. The catheter may have the continuously variable outer layer material by dip coating the outer layer rather than laminating a jacket extrusion onto the catheter's PTFE liner and reinforcement assembly. The dip coating may be, for example, a polymer solution that polymerizes to form the outer jacket layer of the catheter. A smooth transition from one flexibility (e.g., durometer) to another along the length of the catheter can be achieved by dipping the catheter assembly into a multi-variable durometer material, thereby achieving a stepwise transition from one durometer to another, for example, by dipping one side of the catheter into one durometer that gradually decreases in the transition area, and then dipping the other side into another durometer that gradually decreases in the same transition area, thereby creating a gradual transition from one durometer to the other. In this embodiment, the dip coating can form a thinner outer jacket than the bonded assembly. In another embodiment, to give flexibility that varies along the length of the catheter, the catheter has an outer jacket layer that is extruded with durometers that vary along the length.

[0023] In some embodiments, at least a portion of the catheter has a reinforcing structure, for example, a wound coil or a tubular structure formed from a braid, consisting of a discreet or continuously changing structure (e.g., a changing coil pitch or braid pitch) for varying stiffness. In some embodiments, the reinforcing structure is a cut hypotube having a gradually changing cut pattern along its length, for example, a spiral pattern of cuts with a continuously changing pitch or an intermittently changing cut gap, or a repeating cut pattern that allows the tube to bend, thereby the repeating pattern having a continuously changing repeating distance or repeating size or both. Since a cut hypotube-reinforced catheter has a structure that is potentially more stable in the axial direction compared to a wound coil, it can also have better indentation than a coil-reinforced catheter. The material for the reinforcing structure can be stainless steel, e.g., 304 stainless steel, nitinol, cobalt-chromium alloy, or other metal alloys that impart a desired combination of strength, flexibility and crush resistance. In some embodiments, the reinforcing structure comprises multiple materials along various flexible sections.

[0024] In other embodiments, the catheter has a PTFE inner liner having one or more thicknesses along the flexible change section. In one embodiment, the PTFE inner liner is configured to be extremely thin, for example, 0.0005 to 0.0010 inches. This embodiment provides the ability to construct catheters with a high level of flexibility, as well as thinner-walled catheters. For example, the PTFE liner is constructed by drawing a mandrel through a liquid PTFE solution, rather than by conventional methods of manufacturing thin-walled PTFE tubes (i.e., extruding a PTFE paste, then drying and sintering it to form a PTFE tube). The drawing method allows for very thin, controlled wall thicknesses, for example, 0.0005 to 0.0010 inches.

[0025] Any combination of the aforementioned manufacturing methods can be used to achieve the desired flexibility and kink resistance requirements. Current three-layer catheters have a wall thickness of 0.005 to 0.008 inches. These manufacturing methods may produce catheters with higher catheter performance at the same wall thickness, or catheters with equivalent or higher catheter performance at thinner wall thicknesses, for example, 0.003 to 0.005 inches.

[0026] In one embodiment, the distal flexible section of the catheter may be constructed using one or more of the following layers: an immersion coating outer layer, an ultrathin drawn PTFE layer, and a cut hypotube reinforcement layer, having a gradual transition from the flexible section to a more rigid proximal section. In one embodiment, the entire catheter is constructed of one or more of these elements.

[0027] In some cases, it is necessary to reach anatomical targets using a catheter with the largest possible internal lumen size. For example, a catheter may be used to aspirate an occlusion within a blood vessel. Therefore, a highly flexible, kink-resistant, and disintegration-resistant catheter with thin walls and a large internal diameter is required. Catheters using the construction methods disclosed herein meet these requirements. For example, a catheter has an internal diameter of 0.068–0.095 inches and a working length of 40–60 cm. In other embodiments, the catheter may be sized to reach more distal cerebral arteries and may have an internal diameter of 0.035–0.062 inches and a working length of 50–70 cm. In one embodiment, the catheter is configured to navigate around a 180° bend around a radius as small as 0.050 or 0.100 inches without twisting, where the bend is measured through an artery and located within 5 cm, 10 cm, or 15 cm of the arterial incision. In one embodiment, the catheter can withstand collapsing up to a 180° x 0.050 inch radius bend while in a winding biological structure without collapsing when connected to a vacuum up to 20 inHg. In another embodiment, the catheter can withstand collapsing when connected to a vacuum up to 25 inHg under the same conditions.

[0028] In another embodiment shown in Figure 1B, the inner and outer diameters may be progressively increased in the proximal region 107 of the catheter. This progressive increase corresponds to an increase in diameter relative to the adjacent region of the catheter. This embodiment further optimizes the suction force of the catheter. For example, during a procedure, the portion of the catheter in a more proximal, larger blood vessel may have a larger diameter than the distal region 109 of the catheter (which can be the most distal region). In this embodiment, the catheter may have a certain diameter for the distal region 109 (e.g., the most distal 10-15 cm), and then a progressive increase in diameter of 10-25% of the most distal diameter for the proximal region 107 of the working length. This progressive increase occurs over a tapered transition section of 3-10 mm in length, depending on the magnitude of the progressive increase and the need to form a smooth transition. Alternatively, the catheter may be used with a stepped sheath having a proximal region with a larger diameter. In this case, the catheter may have progressively increased length and diameter to accommodate the stepped sheath. For example, if the sheath has a portion with a larger diameter at the proximal 20 cm, the catheter has a larger diameter at the proximal 25 cm to allow for additional length for the proximal adapter and valve (e.g., RHV). The remaining distal region has a smaller diameter and has a gradual increase over tapering transition sections of 3 to 10 mm in length, depending on the magnitude of the gradual increase and the need to form a smooth transition.

[0029] In some cases, neurovascular catheters are used to aspirate clots or other obstructions within cerebral or intracranial blood vessels. Figures 2–5 show examples of catheters with oblique distal tips or distal margins. Referring to Figure 2, the distal region of catheter 105 is shown. Catheter 105 has a distal tip or distal margin 210 that forms an opening 215 at the distal end of catheter 105. The distal margin 210 forms an angle that is not perpendicular to the longitudinal axis L. Such a tip defines an opening 215 of a different size than if the tip were perpendicular to the axis L. That is, the opening 215 is larger and provides a larger aspiration area compared to a distal tip cut perpendicular to the longitudinal axis. Thus, the catheter can provide a greater suction force to occlusions located near the tip. Furthermore, the larger area of ​​the opening 215 also facilitates aspirating the clot into the lumen of the catheter rather than simply capturing the clot with suction at the tip and drawing the captured clot out with the catheter. In Figure 2, the catheter 105 has an oblique, straight distal edge 210 that forms an elliptical opening 215. In Figures 3, 4, and 5, the distal edge 210 is curved or non-linear so that the distal opening 215 is non-planar, and can provide a larger opening without significantly extending the tip length, and the opening can further optimize the contact area with the occlusion. The distal edge 210 can be straight, curved, wavy, or irregular. In one embodiment of a cut hypotube reinforced catheter, the distal tip of the hypotube can be formed to be non-square. In one embodiment having a radiopaque marker band, the radiopaque marker band may have a non-square edge, which can then be used to form a non-square catheter tip shape. In one embodiment, the catheter may have an oblique distal tip; that is, the distal tip of the catheter is oblique or non-perpendicular to the longitudinal axis of the catheter.

[0030] The difficulty in advancing a catheter through severe bends and across side branches stems from a mismatch between the catheter and internal guide elements, such as smaller catheters, microcatheters, or guidewires. One method of catheter advancement is called triaxial, in which a smaller catheter or microcatheter is positioned between the catheter and the guidewire. However, in current systems, smaller catheters have a diameter mismatch with larger catheters, guidewires, or both, and this mismatch creates a step at the leading edge of the system as it advances through the vascular system. This step can cause difficulties when navigating highly curved vessels, particularly where side branches are present, such as in the ophthalmic artery. In one embodiment, as shown in Figure 6, the catheter 105 is provided with a tapered coaxial internal component 2652 that replaces a smaller catheter commonly used. The internal component 2652 is sized and shaped to be inserted through the internal lumen of the catheter. The internal component 2652 has a tapered region having a certain outer diameter, which forms a smooth transition from the inner diameter of the catheter 2030 to the outer diameter of the guidewire 2515 or microcatheter (which extends through the internal lumen of the internal component 2652). In one embodiment, when the tapered expander or internal component 2652 is placed inside the catheter, it forms a smooth transition from the most distal tip of the larger catheter 105 to the outer diameter of the guidewire 2515 (which may be, for example, 0.014 to 0.018 inches in diameter). For example, the internal lumen diameter may be 0.020 to 0.024 inches. In another embodiment, the internal diameter is made to accommodate a microcatheter having an outer diameter of 0.030 to 0.040 inches or a 0.035-inch guidewire in the internal lumen, for example, the lumen diameter may be 0.042 to 0.044 inches.

[0031] In the variation of this embodiment shown in Figure 7, the internal component 2652 includes, in addition to the tapered region, a distal region 2653 which is an extension formed with a uniform or single diameter, extending distally beyond the tapered portion of the internal component 2652. In this embodiment, the distal region 2653 of the internal component 2652 can perform some or all of the functions that a microcatheter would perform during an interventional procedure, for example, performing distal angiography across an occlusion, injecting intra-arterial drugs, or delivering devices such as aneurysm coils or stent retrievers. Thus, the microcatheter does not need to be replaced with a dilator to perform these procedures.

[0032] To create a smooth transition from the flexibility of the guidewire to the flexibility of the catheter, the material of the dilator (internal component 2652) is sufficiently flexible and the tapering is sufficiently long. This configuration facilitates the advancement of the catheter into the target cerebral vascular system through curved biostructures. In some embodiments, the dilator is configured to have varying stiffness, for example, the most distal section is made of a softer material and the material becomes progressively harder towards the more proximal section. In some embodiments, the distal end of the tapered dilator has a radiopaque marker, such as a platinum / iridium band, tungsten, platinum or tantalum-impregnated polymer, or other radiopaque marker.

[0033] While various methods and device embodiments are described in detail in this specification in terms of several versions, it should be understood that other versions, embodiments, uses, and combinations thereof are also possible. Therefore, the intent and scope of the appended claims should not be limited to the embodiments described herein. The disclosures in this specification may include the following aspects: (Aspect 1) An intervention catheter for arterial procedures, An elongated body sized and shaped to be introduced transcervically into the common carotid artery at an access point in the neck, and an elongated body sized and shaped to be navigated distally through the common carotid artery to the intracranial artery via the access point in the neck, An internal lumen in the elongated body, which forms a proximal opening in the proximal region of the elongated body and a distal opening in the distal region of the elongated body. Includes, The elongated body has a nearest section and a distal section, the nearest section being the most rigid part of the elongated body, and the elongated body has an overall length and distal section length such that the distal section can be positioned in an intracranial artery during use, and at the same time at least a portion of the nearest section can be positioned in a common carotid artery. An intervention catheter for arterial procedures. (Aspect 2) The catheter according to embodiment 1, wherein the elongated body includes a first transition section between the proximal section and the distal section, and the first transition section has a stiffness between the stiffness of the proximal section and the stiffness of the distal section. (Aspect 3) The catheter according to embodiment 1, wherein the elongated body has a working length, and the distal section is 3% to 15% of the working length of the elongated body. (Aspect 4) The catheter according to embodiment 1, wherein the elongated body has a working length, and the most distal section is 4% to 25% of the working length of the elongated body. (Aspect 5) The catheter according to embodiment 2, wherein the first transition section is 7% to 35% of the working length of the catheter. (Aspect 6) The catheter according to embodiment 2, wherein the first transition section is 6% to 20% of the working length of the catheter. (Aspect 7) The catheter according to embodiment 3, wherein the elongated body has an inner diameter of 0.068 to 0.095 inches and a working length of 40 to 60 cm. (Pattern 8) The catheter according to embodiment 3, wherein the elongated body has an inner diameter of 0.035 to 0.062 inches and a working length of 50 to 70 cm. (Aspect 9) The catheter according to embodiment 1, wherein the elongated body has a change in rigidity that transitions along at least a portion of the length of the catheter. (Aspect 10) The catheter according to embodiment 9, wherein the change in rigidity is indicated by a smooth change in flexibility without any sudden changes in flexibility. (Aspect 11) The catheter according to embodiment 9, wherein the flexibility of the elongated body gradually transitions along the length of the elongated body without any discontinuous change in the flexibility from one section of the elongated body to an adjacent section of the elongated body. (Aspect 12) The nearest section is 100-500 N-mm 2 A catheter according to embodiment 1, having the rigidity of [the specified value]. (Aspect 13) The aforementioned distal section is 3-10 N-mm 2 A catheter according to embodiment 1, having the rigidity of [the specified value]. (Aspect 14) The catheter according to embodiment 1, wherein the distal section is 5 to 15 cm in length. (Aspect 15) The catheter according to embodiment 1, wherein the distal section is 3 to 10 cm in length. (Aspect 16) The catheter according to embodiment 2, wherein the first transition section is 5 to 10 cm in length. (Aspect 17) The catheter according to embodiment 2, wherein the first transition section is 4 to 8 cm in length. (Aspect 18) The catheter according to embodiment 1, wherein the elongated body has a working length of 40 cm and the nearest section has a length of 10 to 30 cm. (Aspect 19) A catheter according to embodiment 1, The distal section of the catheter has an inner diameter of 0.035 to 0.062 inches. The catheter can navigate a 180° bend with a radius of 0.100 inches without twisting. The catheter withstands collapse when connected to a vacuum of up to 25 inHg while navigating a 180° bend with a radius of 0.100 inches. The catheter described in Embodiment 1. (Aspect 20) A catheter according to embodiment 1, The distal section of the catheter has an inner diameter of 0.068 to 0.095 inches. The catheter can navigate a 180° bend with a radius of 0.100 inches without twisting. The catheter withstands collapse when connected to a vacuum of up to 25 inHg while navigating a 180° bend with a radius of 0.100 inches. The catheter described in Embodiment 1.

Claims

1. An intervention catheter for arterial procedures, An elongated body sized and shaped to be introduced transcervically into the common carotid artery at a neck access point, and an elongated body sized and shaped to be navigated distally through the common carotid artery to the intracranial artery via the neck access point, An internal lumen in the elongated body, which forms a proximal opening in the proximal region of the elongated body and a distal opening in the distal region of the elongated body. Includes, The elongated body has a nearest section and a distal section, the nearest section being the most rigid part of the elongated body, and the elongated body has an overall length and distal section length such that the distal section can be positioned in an intracranial artery during use, and at the same time at least a portion of the nearest section can be positioned in a common carotid artery, The distal section of the catheter has an inner diameter of 0.889 mm to 1.574 mm (0.035 inches to 0.062 inches) and a tolerance of 3 to 10 N-mm. ２ It has rigidity, The catheter can navigate a 180° bend with a radius of 2.54 mm (0.100 inches) without twisting. The catheter is configured to withstand collapse when connected to a vacuum of up to 12.278 PSI (25 inHg) while navigating a 180° bend with a radius of 2.54 mm (0.100 inches). The catheter has a polytetrafluoroethylene (PTFE) inner liner with a thickness of 0.0127 mm to 0.0254 mm (0.0005 inches to 0.0010 inches). The distal end of the elongated body is provided with an angled opening that is positioned at an angle that changes along the length of the elongated body. An intervention catheter for arterial procedures.

2. The catheter according to claim 1, wherein the elongated body includes a first transition section between the nearest section and the most distal section, and the first transition section has a stiffness between the stiffness of the nearest section and the stiffness of the most distal section.

3. The catheter according to claim 1, wherein the elongated body has a working length, and the distal section is 3% to 15% of the working length of the elongated body.

4. The catheter according to claim 1, wherein the elongated body has a working length, and the distal section is 4% to 25% of the working length of the elongated body.

5. The catheter according to claim 2, wherein the first transition section is 7% to 35% of the working length of the catheter.

6. The aforementioned elongated body has an inner diameter of 1,727 mm to 2,413 mm (0.068 to 0.095 inches) and a working length of 40 to 60 cm, or The catheter according to claim 3, having an inner diameter of 0.889 mm to 1.574 mm (0.035 to 0.062 inches) and a working length of 50 to 70 cm.

7. The catheter according to claim 1, wherein the elongated body has a change in rigidity that transitions along at least a portion of the length of the catheter.

8. The catheter according to claim 7, wherein the change in rigidity is indicated by a smooth change in flexibility without any sudden changes in flexibility.

9. The catheter according to claim 7, wherein the flexibility of the elongated body gradually transitions along the length of the elongated body without any discontinuous change in the flexibility from one section of the elongated body to an adjacent section of the elongated body.

10. The nearest section is 100-500 N-mm ２ A catheter according to claim 1, having the rigidity of the following:

11. The catheter according to claim 1, wherein the distal section is 5 to 15 cm in length.

12. The catheter according to claim 2, wherein the first transition section is 5 to 10 cm in length.

13. The catheter according to claim 1, wherein the elongated body has a working length of 40 cm and the nearest section has a length of 10 to 30 cm.

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