Catheter and related systems

Abstract

The catheter tube (102) includes an inner tube (108) and a reinforcing structure (112). The reinforcing structure includes a winding filament (118) surrounding the inner tube and a braided filament assembly (120) surrounding the winding filament. The reinforcing structure is configured to resist radial deformation of the inner tube as a medical device moves through the inner tube. An exemplary medical intervention system includes an exemplary catheter and an exemplary medical device that can be deployed and implanted using the catheter (100).

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Application No. 18 / 956,826, filed November 22, 2024, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] This disclosure relates to catheters, such as catheters for delivering stents and other medical devices to target locations within a patient's body. This disclosure also relates to associated systems and methods for performing medical interventions using such catheters. Background Technology

[0004] Stents can be used to open or widen channels within the body to treat a variety of medical conditions. In some cases, catheters can be used to deploy such devices to the desired location within the body for treatment. Cerebral venous sinus stenosis is a condition that obstructs the outflow of venous blood from the dural venous sinuses and can benefit from the implantation of a stent to resolve the obstruction. In some cases, the catheters used to deploy such stents may have drawbacks, such as kinking, lack of flexibility when guided through curved areas within the body, and damage to the tubular wall caused by the stent as it advances through the catheter. Summary of the Invention

[0005] This disclosure relates to catheters, such as catheters for delivering stents and other medical devices to target locations within a patient's body. Such catheters include a catheter body designed to resist radial deformation as the medical device moves through the catheter to achieve optimal performance of the delivery process. This disclosure also relates to associated systems and methods for performing medical interventions using such catheters, such as deploying and implanting a braided stent at a portion of a blood vessel within a patient's neurovascular system to treat pulsatile tinnitus.

[0006] The catheters discussed in this article offer several advantages. For example, the exemplary catheter's body includes an inner tube with a relatively smooth inner surface, allowing the medical device to move substantially non-damagingly through the lumen of the body. The length of the body can be selected to accommodate variations in the patient's anatomy and can also be selected based on the physician's preference for using the catheter.

[0007] The catheter body also includes a double-layered reinforcement structure that provides resistance to radial deformation as the medical device moves axially through the inner tube and exerts an outward radial force on the inner surface of the inner tube. The coiled wire and braided wire assembly of the reinforcement structure together advantageously improve the performance of the method for delivering the medical device by minimizing the stretching and compression of the inner tube as the medical device advances through the catheter body's inner tube. For example, the coiled wire helps maintain the substantially circular cross-sectional shape of the inner tube as the medical device advances through the tube. During catheter body manufacturing, the braided wire assembly can be applied directly to the coiled wire via a braiding machine that applies a relatively strong internal tension to the braided wire assembly. This internal tension helps the coiled wire resist radial deformation.

[0008] The catheter body also includes multiple marker strips spaced along the central axis of the body at key axial locations and visible during medical imaging. Therefore, the marker strips facilitate accurate visual estimation of the distal and proximal ends of the medical device relative to the target location. For example, the marker strips improve the physician's ability to estimate the landing position of the medical device when it is fully deployed at the target location.

[0009] The conduit body also includes an outer layer formed as a hydrophilic coating. The outer layer is fused to the outer surfaces of the reinforcing structure, marking strip, and inner tube to encapsulate and seal these components to form the conduit body. Furthermore, the outer layer is formed of one or more relatively soft polymer materials that provide only minimal bending resistance. The combined properties of the inner tube, reinforcing structure, and outer layer provide the conduit body with a construction exhibiting very low buckling stiffness while maintaining strong resistance to radial deformation.

[0010] In one aspect, the catheter body includes an inner tube and a reinforcing structure. The reinforcing structure includes a winding thread surrounding the inner tube and a braided thread assembly surrounding the winding thread. The reinforcing structure is configured to resist radial deformation of the inner tube as the medical device moves through it.

[0011] In some implementations, the catheter body is a 5-French catheter body.

[0012] In some implementations, the hardness of the inner tube varies along its length.

[0013] In some embodiments, the winding wire has a pitch of about 0.15 mm to about 0.20 mm.

[0014] In some implementations, the braided filament assembly comprises multiple filaments overlapping each other in a regular pattern to form multiple openings.

[0015] In some implementations, the multiple filaments include 16 filaments.

[0016] In some implementations, the braided yarn assembly has a braiding density of 65 to 75 ppi.

[0017] In some embodiments, the catheter body also includes one or more marker strips configured to provide visualization of the catheter body when it is positioned within the patient.

[0018] In some implementations, one or more marking strips comprise three marking strips spaced equidistant from each other.

[0019] In some implementations, one or more marking strips overlap with the reinforcing structure.

[0020] In some embodiments, each of one or more marking strips comprises one or more radiopaque materials.

[0021] In some embodiments, the conduit body also includes an outer layer that encapsulates the reinforcing structure and the outer surface of the inner tube.

[0022] In some implementations, the outer layer includes a coating.

[0023] In some implementations, the inner tube defines a single lumen, the size of which is configured to accommodate a medical device.

[0024] On the other hand, a medical interventional system includes a medical device and a catheter body. The catheter body includes an inner tube and a reinforcing structure. The reinforcing structure includes a winding thread surrounding the inner tube and a braided thread assembly surrounding the winding thread. The reinforcing structure is configured to resist radial deformation of the inner tube when the medical device moves through it.

[0025] In some embodiments, the medical device includes a stent configured for implantation at a target location within the patient's body.

[0026] In some implementations, the target location includes a portion of a blood vessel within the patient's neurovascular system.

[0027] In some implementations, the medical intervention system also includes a delivery device sized to be positioned within the catheter body.

[0028] In some embodiments, the guiding device includes a main shaft and a non-transparent distal section.

[0029] In some embodiments, the radiopaque distal segment includes a generally cylindrical distal axis and a tapered distal end configured to extend from the distal end of the catheter body as the catheter body moves through the patient's body.

[0030] On the other hand, a method of performing a medical intervention includes moving a medical device through an inner tube of a catheter body, and as the medical device moves through the inner tube, causing the inner tube to resist radial deformation using a reinforcing structure of the catheter body, wherein the reinforcing structure includes a winding filament surrounding the inner tube and a braided filament assembly surrounding the winding filament.

[0031] In some embodiments, the method further includes moving the medical device through the distal end of the catheter body to implant the medical device at a target location within the patient's body.

[0032] In some implementations, the target location includes a portion of a blood vessel in the neurovascular system.

[0033] In some implementations, the medical device includes a stent.

[0034] In some implementations, the catheter body is a 5-French catheter body.

[0035] In some embodiments, the method also includes maintaining the substantially circular cross-sectional shape of the inner tube as the medical device moves through it.

[0036] In some implementations, the method also includes making the catheter body visible when it is in the patient’s body.

[0037] In some embodiments, the catheter body also includes one or more radiopaque marking strips.

[0038] In some embodiments, the method further includes, before moving the medical device through the inner cannula of the catheter body: placing the delivery device inside the catheter body and using the delivery device to guide the catheter body to a target location within the patient's body.

[0039] In some embodiments, the delivery device includes a main shaft and a nontransparent distal section, and the nontransparent distal section includes a generally cylindrical distal shaft and a tapered distal end configured to extend from the distal end of the catheter body when the catheter body is used.

[0040] Details of one or more embodiments are set forth in the accompanying drawings and description. Other features, aspects, and advantages of the embodiments will become apparent from the description, drawings, and claims. Attached Figure Description

[0041] Figure 1 This is a top view of an exemplary catheter system including a catheter and a delivery device, wherein the catheter includes a catheter body and an inlet hub.

[0042] Figure 2 yes Figure 1 A cross-sectional view of the conduit body.

[0043] Figure 3 yes Figure 1 A side view of the distal portion of the catheter body, which includes a reinforcing structure with winding and braiding filament assemblies.

[0044] Figure 4 yes Figure 1 A side view of a portion of the winding wire that reinforces the conduit body.

[0045] Figure 5 yes Figure 1 A side view of a portion of the braided wire assembly that reinforces the conduit body.

[0046] Figure 6 It can be used Figure 1 A stereoscopic side view of an exemplary medical device for delivering a catheter to a target location.

[0047] Figure 7 yes Figure 6 A three-dimensional front view of a medical device.

[0048] Figure 8 It is used for insertion Figure 6 A side view of an exemplary insertion device for a medical device.

[0049] Figure 9 It is shown Figure 6 Medical devices and Figure 8 The insertion device is loaded into Figure 1 The catheter body is shown in a side view for implantation.

[0050] Figure 10 It is shown Figure 6 Medical devices and Figure 8 A side view of the connection between the insertion devices.

[0051] Figure 11 This is a flowchart illustrating an exemplary method for implanting a medical device.

[0052] Figure 12 It is shown Figure 6 A diagram illustrating the implantation of a medical device.

[0053] Figure 13 Depicting implantation into the target blood vessel Figure 6 Example medical images of medical devices.

[0054] Figure 14 This is a flowchart illustrating an exemplary method for performing a medical intervention. Detailed Implementation

[0055] Figure 1An exemplary catheter 100 is shown, through which a medical device can be delivered to and deployed at a target location within a patient. The catheter 100 is insertable and can be guided through one or more vessels of the patient's vascular system to position the distal end of the catheter 100 at the target location, and the medical device is axially movable through the catheter 100 to be deployed externally to the distal end of the catheter 100 and implanted at the target location. In some examples, the target location is part of a vessel in the patient's neurovascular system (e.g., a vascular system located in the head and neck) or part of a vessel in the patient's peripheral vascular system. In some examples, the medical device is an interventional device, such as a microcatheter, guidewire, or braided stent, as will be discussed below. Figures 6 to 13 To be discussed in more detail.

[0056] The catheter 100 includes a body 102 and an access hub 104 that is coupled to the proximal end 106 of the body 102 at a mating interface. In some embodiments, the catheter 100 is a 5-French catheter. The access hub 104 of the catheter 100 may be a Luer fitting or other type of fitting that facilitates attachment or otherwise coupling of an accessory device to the body 102 at a connection feature 132 (e.g., a threaded profile or other type of connection mechanism). The access hub 104 includes an inlet port 134 through which fluid can be injected into the body 102, or through which a medical device can be inserted. Additionally, the access hub 102 includes a tapered grooved portion 136 extending on the proximal end 106 of the body 102. Strain relief is provided along the groove of the portion 136 to prevent the body 102 from kinking near the proximal end 106 of the body 102.

[0057] refer to Figure 2 and Figure 3 The tube body 102 includes an inner tube 108 (e.g., an inner tubular member) forming a single lumen 110 of the conduit 100. The tube body 102 also includes a reinforcing structure 112 surrounding the inner tube 108 along a central axis 114 of the tube body 102 and an outer layer 116 (e.g., a coating) surrounding both the inner tube 108 and the reinforcing structure 112. Thus, the reinforcing structure 112 is positioned between the inner tube 108 and the outer layer 116 (e.g., located in the middle therebetween).

[0058] In some embodiments, the inner tube 102 has an inner diameter of about 1.65 mm to about 1.70 mm (e.g., about 1.67 mm) and a wall thickness of about 0.027 mm to about 0.038 mm (e.g., about 0.033 mm). The inner surface of the inner tube 108 is relatively smooth, allowing the medical device to move substantially undamaged through the lumen 110. The length of the tube body 102 is the length of the inner tube 108 and is generally selected to allow it to be guided throughout the selected blood vessel to the target location within the patient's body. That is, the length is selected to accommodate variations in the patient's anatomy. The length may additionally be selected based on the physician's operational preferences for using the catheter 100. For example, operational preferences may involve the compatibility of the tube body 102 with other devices (e.g., guiding catheters or guidewires), preferred access locations (e.g., radial versus femoral access), or other parameters. In some embodiments, the length of the inner tube 108 ranges from about 85 cm to about 135 cm, depending on the target location within the body. For example, when the target location is within the neurovascular system, the length of the inner tube 108 can be in the range of approximately 105 cm to approximately 125 cm, while when the target location is within the peripheral vascular system, the length of the inner tube 108 can be in the range of approximately 85 cm to approximately 115 cm.

[0059] The material composition of the inner tube 108 results in relatively low surface friction, minimizing any resistance to the insertion and delivery of a medical device (e.g., a stent) within the inner tube 108. This reduced resistance during delivery minimizes the possibility of trauma to the vessel wall surrounding the tube body 102. In some embodiments, the inner tube 108 is made of polytetrafluoroethylene (PTFE). In some examples, PTFE is chosen as the material for the inner tube 108 due to its biocompatibility, chemical inertness, durability, and strength properties.

[0060] Additionally, in some embodiments, the hardness (e.g., and correspondingly, stiffness) of the inner tube 108 varies along its axial length. For example, the inner tube 108 may include multiple segments (e.g., eight segments or a different number of segments), each made of PTFE, and these segments each have a different discrete hardness measure (e.g., a durometer value). In some embodiments, the durometer value decreases (e.g., flexibility increases) for each consecutive segment of the inner tube 108 (e.g., from the proximal end 106 of the tube body 102 to the distal end 128 of the tube body 102).

[0061] The reinforcing structure 112 is a double-layered structure that provides resistance to radial deformation of the tube 102 as the medical device moves axially through the inner tube 108 and applies an outwardly pointing radial force to the inner surface of the inner tube 108. The reinforcing structure 112 includes two components that together provide this structural integrity to the tube 102. For example, the reinforcing structure 112 includes a winding filament 118 surrounding the inner tube 108 and a braided filament assembly 120 surrounding the winding filament 118. The winding filament 118 and the braided filament assembly 120 together advantageously improve the performance of the method for delivering the medical device by minimizing the stretching and compression of the inner tube 108 as the medical device advances through it. In some embodiments, the reinforcing structure 112 is spaced from the distal end 128 of the tube 102 by a distance of about 0.5 mm to about 1.5 mm (e.g., about 1.0 mm) and otherwise extends proximally along the remaining length of the inner tube 108.

[0062] Still referencing Figure 2 and Figure 3 The winding wire 118 is positioned directly on (e.g., in contact with) the inner tube 108, giving it an integral cylindrical shape. For example, during the manufacture of the tube body 102, the winding wire 118 can be applied directly to the inner tube 108 via a coil winding machine, resulting in relatively high strength compared to other similar winding wires that are formed separately and then placed on the inner tube 108. The winding wire 118 is a solid (e.g., non-hollow) component and is a key factor in imparting radial strength to the tube body 102. As the medical device advances through the tube body 102, the winding wire 118 serves to maintain the substantially circular cross-sectional shape of the inner tube 108.

[0063] refer to Figure 4 In some embodiments, the winding wire 118 has a pitch p (e.g., the gap between adjacent circumferential portions of the winding wire 118) of about 0.15 mm to about 0.20 mm (e.g., about 0.18 mm). The core of the winding wire 118 may have a circular cross-sectional shape 138, or the winding wire 118 may have a non-circular (e.g., rectangular or other) cross-sectional shape along its core. The winding wire 118 has a core width (e.g., diameter or other width) of about 0.025 mm to about 0.088 mm (e.g., about 0.063 mm). The winding wire 118 is made of one or more materials such as stainless steel or nitinol. In some examples, the winding wire 118 may be formed using a manufacturing process that utilizes tension or winding angle during the winding process to control the strength and / or stiffness of the winding wire 118.

[0064] refer to Figure 3 and Figure 5The braided filament assembly 120 is an interlocking mesh structure. Therefore, the braided filament assembly 120 comprises multiple filaments 122 overlapping each other in a regular pattern. The braided filament assembly 120 has an overall cylindrical shape and is positioned directly on (e.g., in contact with) the winding filament 118. For example, during the manufacture of the tube 102, the braided filament assembly 120 can be applied directly to the winding filament 118 via a braiding machine, resulting in a relatively strong internal tension in the braided filament assembly 120 compared to other similar braided filament assemblies that are formed on separate mandrels and then placed on the winding filament 118. This internal tension helps the winding filament 118 resist radial deformation.

[0065] In some embodiments, the spacing between the filaments 122 of the braided filament assembly 120 forms a plurality of openings 124 (e.g., quadrilateral openings). The openings 124 have a width w1 defined by adjacent portions of the filaments 122 along a first direction and a width w2 defined by adjacent portions of the filaments 122 along a second direction. In some embodiments, the first and second directions together define an acute angle θ. The widths w1 and w2 of the openings 124 may be different or substantially equal, such as... Figure 3 and Figure 5 As shown. In some examples, the pattern of the braided filament assembly 120 is defined by the number of filaments 122 (e.g., carriers) and by the weave density or weft per inch (PPI). In some examples, PPI is defined as the number of times the filaments 122 cross each other in a direction along each inch of length. In some embodiments, the braided filament assembly 120 includes 16 filaments and has a weave density of 65 to 75 PPI (e.g., 70 PPI). In some embodiments, the number of filaments 122 and the PPI determine the widths w1 and w2 of the opening 124 and the angle θ.

[0066] The size and shape of the opening 124 can affect the ease with which the tube 102 can be bent without affecting the inner tube 108's resistance to ellipticization or otherwise to collapse of its roundness. Correspondingly, as the number of filaments 122 (e.g., carriers) increases, the stiffness, torque response, and kink resistance (e.g., resistance to ellipticization or roundness collapse) of the inner tube 108 increase. In some examples, torque response refers to the ability of the inner tube 108 to transmit rotational forces applied to the proximal end 106 (e.g., near the operator) to the distal end 128 (e.g., placed within the patient). For example, a good torque response means that rotational motion of the distal end 128 closely reflects the corresponding rotational motion of the proximal end 106 with minimal hysteresis or loss of rotational accuracy. Additionally, as the PPI increases, the stiffness, torque response, and kink resistance of the inner tube 108 increase.

[0067] Still referencing Figure 3 and Figure 5The filaments 122 of the braided filament assembly 120 are solid (e.g., non-hollow), elongated, flat components with a substantially rectangular cross-sectional shape. In some embodiments, each filament 122 has a width of about 2.54 μm to about 127 μm (e.g., about 76.2 μm) and a thickness of about 12.7 μm to about 50.8 μm (e.g., about 25.4 μm). The filaments 122 are made of one or more materials, such as stainless steel or other materials.

[0068] refer to Figure 1 and Figure 3 The tube body 102 also includes a plurality of marker bands 130 spaced apart at key axial locations along the central axis 114 of the tube body 102. The marker bands 130 are visible during medical imaging (e.g., digital subtraction angiography or any other suitable medical imaging technique) to provide visualization of the tube body 102 as it moves through the blood vessel. The marker bands 130 can also aid in accurate visual estimation of the distal and proximal ends of the medical device relative to the target location. Therefore, the marker bands 130 improve the physician's ability to estimate the landing position of the medical device when it is fully deployed at the target location.

[0069] In some embodiments, the marking band 130 is located (e.g., overlaps) at the distal end 140 of the reinforcing structure 112. One or more additional marking bands 130 may be located proximal to the distal marking band 130 and thus overlap with the reinforcing structure 112. In some embodiments, the tube body 102 includes a total of three marking bands 130. In other embodiments, the tube body 102 may include a different number of marking bands 130. In some embodiments, each marking band 130 has a length of about 1 mm to about 3 mm (e.g., about 1.5 mm) (e.g., extending along the central axis 114 of the tube body 102) and a thickness of about 0.025 mm to about 0.064 mm (e.g., about 0.038 mm). In some embodiments, the marking bands 130 are spaced apart from each other by a distance of about 2 cm to about 6 cm (e.g., about 4 cm). The marking bands 130 may be made of one or more radiopaque materials capable of being visualized, such as platinum, iridium, and gold.

[0070] refer to Figure 1 and Figure 3 The outer layer 116 surrounds the aforementioned components of the tube body 102 and thus forms the surface of the tube body 102 that contacts the main body. For example, the outer layer 116 may be formed as a hydrophilic coating that is fused to the outer surface of the reinforcing structure 112, the marking strip 130 and the inner tube 108 to encapsulate and seal these components to form the tube body 102.

[0071] The outer layer 116 is formed of one or more relatively soft polymeric materials that provide only minimal flexural strength. Example materials that can be used to form the outer layer 116 include polyurethane, thermoplastic elastomers (e.g., polyamides and polyethers), and nylon. In some embodiments, the outer layer 116 is translucent or substantially transparent. In some embodiments, the outer layer 116 has a thickness in the range of about 0.33 mm to about 0.46 mm (e.g., about 0.38 mm). The thickness of the outer layer 116 may be minimized along the reinforcing structure 112 and / or the marking strip 130, and maximized along the portions of the tube 102 where the reinforcing structure 112 is not present. In this way, the outer layer 116 imparts a substantially constant outer diameter to the tube 102.

[0072] like Figure 2 and Figure 3 As shown, the inner tube 108, reinforcing structure 112, marking strip 130, and outer layer 116 are concentrically configured and held in place by the outer layer 116. The inner diameter of the tube body 102 is the inner diameter of the inner tube 108, and the outer diameter of the tube body 102 is defined by the concentric configuration of the inner tube 108, reinforcing structure 112, marking strip 130, and outer layer 116. In some embodiments, the outer diameter of the tube body 102 is in the range of about 1.80 mm to about 1.90 mm (e.g., about 1.85 mm), such that the catheter 100 is a 5-French catheter. In some embodiments, the outer diameter of the tube body 102 is maximum along the marking strip 130 and otherwise substantially constant along the remaining length of the tube body 102. The combined properties of the inner tube 108, reinforcing structure 112, and outer layer 116 provide the catheter body 102 with a configuration that has very low buckling stiffness while maintaining strong resistance to radial deformation (e.g., while maintaining the ability to minimize or substantially prevent radial deformation).

[0073] Refer again Figure 1 The catheter system 150 includes a catheter 100 and a delivery device 160 designed to cooperate with the catheter 100 to assist in guiding the catheter 100 to a target location within the body. The delivery device 160 includes a main shaft portion 162, a distal shaft portion 164, and a distal end 166 that together define a single lumen 168 of the delivery device 160. The lumen 168 extends from the proximal end of the delivery device 160 to an opening 174 at the distal end 170 of the delivery device 160. The main shaft portion 162 and the distal shaft portion 164 have a generally cylindrical shape, while the distal end 166 has a generally tapered shape that tapers from a maximum diameter (e.g., the diameter of the shaft portions 162, 164) to a minimum diameter at the distal end 170. The size of the delivery device 160 is set to be inserted into the catheter body 102 (e.g., through the inlet port 134 of the hub 104) to the extent that the entire distal end 166 is exposed from the distal end 128 of the tube body 102.

[0074] In some embodiments, the main shaft portion 162 and the distal shaft portion 164 have an inner diameter of about 0.48 mm to about 0.56 mm (e.g., about 0.51 mm) and an outer diameter of about 1.22 mm to about 1.32 mm (e.g., about 1.27 mm). In some embodiments, the minimum diameter of the distal end 166 is about 0.71 mm to about 0.81 mm (e.g., about 0.76 mm). Shaft portions 162 and 164 have a combined length substantially equal to the length of the tube body 102. In some embodiments, the distal end 166 has a length of about 19 mm to about 20 mm (e.g., about 20 mm).

[0075] The main shaft portion 162 of the delivery device 160 is made of one or more materials, such as polyurethane, thermoplastic elastomers (e.g., polyamide and polyether), and nylon. The distal shaft portion 164 and the distal end 166 together form the distal section 172 and are made of one or more ultra-soft materials that facilitate the delivery device 160's movement around sharp bends in the vascular system without resistance or kinking. For example, the distal section 172 may be made of one or more materials such as polyurethane.

[0076] Furthermore, in some embodiments, the distal segment 172 may be made of polyurethane mixed with one or more radiopaque materials (e.g., barium sulfate (BaSO4)), which allows the distal segment 172 to be visualized during imaging and as the guide device 160 is guided through the vascular system. Alternatively or additionally to utilize BaSO4, the distal segment 172 may be equipped with a radiopaque marker strip (e.g., similar to marker strip 130 and made of platinum and iridium) for visualization. The distal end 170 of the guide device 160 is a blunt end, which allows the guide device 160 to move through the vascular system without damaging (e.g., puncturing, tearing, or otherwise harming) the vascular system.

[0077] Figure 6 and Figure 7 An exemplary medical device is shown, which can be delivered to a target location using a catheter 100, such that the catheter 100, the delivery device 160, and the insertion device 500 (see below) Figures 8 to 10 (Discussion) Together with the medical device, it constitutes a medical interventional system. In this example, the medical device is implemented as a stent 200, which is designed to maintain a channel through a blood vessel that is part of a neurovascular system in order to treat pulsatile tinnitus. The stent 200 includes a single filament 202 wound to form a braid 204. The braid 204 extends between the proximal end 206 and the distal end 208 of the stent 200. In some embodiments, the filament 202 is a drawn-filled tube (DFT) filament.

[0078] In some embodiments, the length of the stent 200 prior to implantation (e.g., unconstrained length) ranges from about 20 mm to about 100 mm. The unconstrained length of the stent 200 can be selected based on the distance from the confluence of sinuses through the patient's transverse and sigmoid sinuses, allowing the stent 200 to be deployed within these vessels while minimizing the risk of stenosis development after stent placement. In some embodiments, the diameter of the stent body 204 prior to implantation (e.g., unconstrained diameter) ranges from about 6 mm to about 10 mm and can be selected based on the patient's anatomy. For example, the unconstrained diameter of the stent body 204 can be determined based on the diameter of the patient's dural venous sinuses.

[0079] The filament 202 may be radiopaque, allowing visualization of the stent 200 using any of the aforementioned medical imaging techniques. The intersecting portions of the filaments 202 in the braided stent body 204 are not connected to each other, allowing the crossing portions of the filaments 202 to slide past each other as the stent 200 moves along a curve or undergoes other forms of compression. Due to this structure of the movable picks along the braided stent body 204, the stent 200 remains patent (e.g., open and unobstructed) and resists kinking when positioned along a curved path. The stent 200 is also heat-treated to give it shape memory. Therefore, the stent 200 can be compressed during delivery to the target vessel (e.g., inside the catheter body 102) and can self-expand into the desired shape to contact the vessel wall once implanted.

[0080] During implantation, the stent 200 applies a chronic (e.g., continuous) force directed radially outward toward the vessel wall. This force keeps the vessel sufficiently open to change the blood flow through it from pulsatile or turbulent flow to laminar flow. As a result, the chronic force applied by the stent 200 after implantation in the dural venous sinus is sufficient to eliminate or significantly reduce pulsatile tinnitus experienced by the patient. In some embodiments, the chronic force applied by the stent 200 after implantation is in the range of about 0.020 N / mm to about 0.050 N / mm.

[0081] Still referencing Figure 6 and Figure 7The stent 200 includes flared coronals 210, 212 at each of its proximal end 206 and distal end 208. The flared coronals 210, 212 allow the stent 200 to be secured to a surrounding blood vessel. Therefore, the stent 200 can be deployed intravenously and held in place, such as within a patient's dura mater sinus. The unconstrained diameter of each of the coronals 210, 212 is typically in the range of about 1 mm to about 2 mm larger than the unconstrained diameter of the stent body 204. For example, in some embodiments, the unconstrained diameter of each of the coronals 210, 212 is in the range of about 7 mm to about 12 mm.

[0082] refer to Figure 8 and Figure 9 The stent 200 is configured to be implanted into the dura mater venous sinus of a patient using an insertion device 500 and a catheter 100. The insertion device 500 includes an actuator rod 502, a stent body coil 504 positioned at a distal end 508 of the actuator rod 502, a transmissive actuator body coil 510 positioned on a portion of the actuator rod 502, and a polymer tube 512 positioned on the actuator rod 502 between the stent body coil 504 and the transmissive actuator body coil 510. In some embodiments, the actuator rod 502 tapers between a proximal end 506 and a distal end 508 of the actuator rod 502.

[0083] The stent body coil 504 of the insertion device 500 is attached to the proximal end of the pusher rod 502. The stent body coil 504 is formed of a coil of wire and is flexible enough to prevent damage to the patient's blood vessels during stent implantation as the insertion device 500 advances through the patient's vascular system. The stent body coil 504 is configured to extend approximately half the length of the stent 200 when the stent 200 is loaded onto the insertion device 500 for implantation. The stent body coil 504 provides column strength and kink resistance to the pusher rod 502 and the stent 200 as the pusher rod 502 and the stent 200 advance through the catheter body 102 during stent delivery to the target vessel.

[0084] A pusher body coil 510 is attached to the pusher rod 502 between the proximal end 506 of the pusher rod 502 and the polymer tube 512. The pusher body coil 510 is formed of a coil of wire with sufficient flexibility to prevent kinking of the pusher rod 502 as it advances through the patient's vascular system during stent implantation. In some embodiments, the pusher body coil is formed of stainless steel (e.g., 304V stainless steel), nitinol (NiTi), platinum-tungsten alloy, platinum, or combinations thereof. In some embodiments, the pusher body coil 510 is formed of a radiopaque material such as platinum. As a result, the pusher body coil 510 can be used during the implantation procedure to track the position of the insertion device 500 within the patient's vascular system using medical imaging throughout the implantation process. Consequently, clinicians can monitor the position of the pusher body coil 510 within the patient's blood vessels in real time to ensure accurate placement of the stent 200.

[0085] refer to Figure 9 A polymer tubing 512 is attached to the actuator rod 502 along its length between the stent body coil 504 and the actuator body coil 510. In some embodiments, a platinum-tungsten (PtW) coil 514 is coupled to the actuator rod 502 below the polymer tubing 512, allowing medical imaging to be used to track the position of the polymer tubing 512 throughout the implantation process. The polymer tubing 512, together with the catheter body 200, is configured to releasably engage the proximal end 206 of the stent 200 to the actuator rod 502 during stent 200 implantation. Therefore, by tracking the position of the polymer tubing 512 during the implantation process, the position of the proximal end 206 of the stent 200 can be determined in real time throughout the implantation process.

[0086] refer to Figures 6 to 9The stent 200 includes two marking coils 320 and 322 positioned on the proximal end 206 of the stent body 204 and configured to interact with the polymer tubing 512 and the catheter tubing 102 to hold the stent 200 in position along the pusher rod 502 before implantation into a blood vessel. The marking coils 320 and 322 are both formed of wire of a certain length wound around opposing loops 324 and 326 of the stent body 204 at the proximal end 206. For example, the proximal end 206 of the stent body 204 includes four long loops 324, 326, 328, and 330 and four short loops 332, 334, 336, and 338, and the marking coils 320 and 322 are coupled to the stent body 204 along the two opposing long loops 324 and 326. In some embodiments, the marking coils 320 and 322 are welded to the stent body 204. In some embodiments, the marking coils 320, 322 are bonded to the stent body 204 using a UV-curable adhesive or epoxy resin. In some embodiments, the marking coils 320, 322 are formed of radiopaque filaments, which allows for real-time visualization of the marking coils 320, 322 using medical imaging during stent implantation. Therefore, the position of the proximal end 206 of the stent 200 can be determined by tracking the position of the marking coils 320, 322 using medical imaging during the implantation process. In some embodiments, the marking coils 320, 322 are formed of DFT filaments. For example, the marking coils 320, 322 may be formed of a nickel-titanium alloy (e.g., nitinol) tube filled with platinum, platinum-tungsten alloy, gold, barium sulfate, or combinations thereof.

[0087] refer to Figure 10When the stent 200 is loaded onto the insertion device 500 for implantation, marking coils 320, 322 are positioned above and frictionally engaged with the polymer body 512. During stent 200 implantation, the insertion device 500 (to which the stent 200 is releasably coupled) is inserted and passes through the catheter body 102. As the insertion device 500 and the stent 200 pass through the catheter body 102, marking coils 320, 322 contact and are positioned between the polymer body 512 and the body 102 (e.g., the inner surface of the inner tube 108). Marking coils 320, 322 extend proximally beyond the polymer body 512 and engage with the proximal surface of the polymer body 512. When the catheter body 102 is positioned over the marker coils 320, 322 and the polymer tube 512, friction generated by the contact between the marker coils 320, 322 and the polymer tube 512 and the catheter body 102 prevents the stent 200 from moving within the catheter body 102. Once the distal end 128 of the catheter body 102 is properly positioned within the blood vessel for stent 200 delivery, the catheter body 102 is retracted proximally while maintaining the position of the pusher rod 502. Once the catheter body 102 is retracted proximally over the polymer tube 512, such that the polymer tube 512 and the marker coils 320, 322 are positioned outside the catheter body 102, the proximal end 206 of the stent body 204 expands, disengaging the marker coils 320, 322 from the polymer tube 512. As a result, the stent 200 is released from the insertion device 500 and implanted into the blood vessel (e.g., at the target location).

[0088] Figure 11 This is a flowchart illustrating an exemplary method 600 for implanting a stent (e.g., stent 200) into a patient using a catheter (e.g., catheter 100). Reference Figure 11 and Figure 12 In some embodiments, method 600 includes step 602 of inserting a catheter body (e.g., catheter body 102) into a target vessel of the patient's dural venous sinus 400. The un-stenotic portion of the transverse sinus 444 has a generally wider lumen than the stenotic portion, which has a narrowed lumen. To implant the stent 200 into the transverse sinus 444, catheter body 102 passes through the jugular sac 406 and the sigmoid sinus 408 and enters the transverse sinus.

[0089] refer to Figure 13 In some embodiments, a short sheath is placed in the femoral vein of patient 402 by using a micro-puncture kit, and catheter 100 and delivery device 160 are used. Figure 13 (Not shown in the image) and guide wire 902 to guide catheter body 102 through a short sheath into the femoral vein to perform the insertion of catheter body 102 into target vessel 906. As mentioned above regarding Figure 1The use of the guide device 160 discussed involves inserting the device 160 through the access hub 102 and into the catheter body 102 until the distal end 166 of the guide device 160 protrudes from the distal end 128 of the catheter body 102. Once inserted into the femoral vein, the guidewire 902, the guide device 160, and the catheter body 102 can be tracked using medical imaging (e.g., fluoroscopy) and advanced through the body to the target vessel 906 (e.g., the transverse sinus 444).

[0090] In some embodiments, the catheter body 102 is inserted into the target blood vessel 906 without the insertion device 500 and / or without the stent 200. For example, the catheter body 102 may be placed in the target blood vessel 906 before the insertion device 500 or the stent 200 is inserted into the catheter body 102.

[0091] Once the catheter body 102 is inserted into the target blood vessel, the delivery device 160 is removed (e.g., withdrawn) from the catheter body 102. The insertion device (e.g., insertion device 500) and the stent releasably coupled to the insertion device are then inserted into the catheter (604), as... Figure 13 As shown.

[0092] Refer again Figure 8 The stent 200 is coupled to the insertion device 500 by inserting the pusher rod 502 through the lumen of the stent 200 up to the proximal end 206 of the stent 200, where the marking coils 320, 322 are in contact with and at least partially positioned on the polymer tube 512. Once the stent 200 is coupled to the pusher rod 502, with the marking coils 320, 322 positioned on the polymer tube 512, the pusher rod 502 is inserted into the proximal end 106 of the catheter body 102.

[0093] Once inserted into the catheter body, the insertion device, together with the stent, advances distally through the catheter body until the distal end of the stent is positioned near the distal end of the catheter body (606). (See above regarding...) Figure 3 As discussed, when the stent 200 moves axially through the tube 102 and applies an outward radial force to the inner surface of the tube 102, the double-layered construction of the reinforcing structure 112 of the catheter tube 102 resists radial deformation. When the pusher rod 502 advances distally through the catheter tube 102, the friction generated by the contact between the marking coils 320, 322 and the inner surface of the catheter tube 102 and the polymer tube 512 is sufficient to prevent the stent 200 from moving relative to the pusher rod 502 within the catheter tube 102 as the stent 200 advances through the catheter tube 102. As a result, the stent 200 can advance and retract within the catheter tube 102 via the movement of the pusher rod 502, provided that the marking coils 320, 322 remain in contact with the inner surface of the catheter tube 102 and the polymer tube 512.

[0094] Once the distal end of the catheter is properly positioned within the target vessel and the distal end of the stent is positioned near the distal end of the catheter body, the catheter body is withdrawn proximally to at least partially release the stent from the catheter (608). Figure 13 An example of real-time medical imaging of the stent 200 during implantation is depicted. As shown, when the catheter body 102 is withdrawn proximally, the portion 242 of the stent 200 that is no longer contained within the catheter body 102 self-expands to apply force to the target vessel 906. As previously described, the stent 200 is formed from a radiopaque DFT wire 102, and the position of the expanded stent 200 can be monitored in real time during the implantation process.

[0095] Additionally, the PtW coil 514 beneath the polymer body 512 is radiopaque, and since the proximal end 206 of the stent 200 is coupled to the polymer body 512 via marker coils 320, 322 during insertion, the position of the proximal end 206 of the stent 200 can be tracked during implantation by monitoring the position of the polymer body 512. Furthermore, in some embodiments, the marker coils 320, 322 are formed of a radiopaque material, such as radiopaque DFT wire, and the proximal end 206 of the stent 200 can be tracked during implantation by monitoring the position of the marker coils 320, 322 using medical imaging. By monitoring the position of the polymer body 512 and / or the proximal end 206 of the stent 200 within the catheter body 102, clinicians can determine how close the distal end 128 of the catheter body 102 is to the proximal end 206 of the stent 200. This involves how close the stent 200 is to complete deployment from the catheter body 102, and how close it is to being reinserted into the catheter body 102.

[0096] Before the stent is fully deployed from the catheter body, the clinician uses medical imaging to visualize the stent's position within the target vessel to determine if the stent is properly positioned (610). If the clinician determines that the stent 200 is not properly positioned within the target vessel 906, the clinician can advance the catheter body 102 distally to reinsert the stent 200 into the catheter body 102 (612), and the catheter body 102 can be repositioned within the target vessel 906 (614). Once the catheter body 102 is repositioned within the target vessel 906, the process of partially releasing the stent 200 from the catheter body 102 and checking the stent's positioning can be repeated.

[0097] Additionally, due to the self-expanding material (e.g., nitinol) used to form the stent 200, clinicians can apply forward (e.g., distally) pressure to the portion of the stent 200 already deployed from the catheter body 102 using the catheter body 102 without needing to reinsert the stent 200. By applying forward pressure to the deployed portion of the stent 200, the stent 200 can be positioned more closely appose to the wall of the target vessel 906 and better conform to the contour of the target vessel 906. Furthermore, by applying forward pressure to the stent 200 using the catheter body 102 during partial deployment, the stent 200 can be used to further open stenosis in the target vessel 905 during stent 200 deployment within the vessel 906.

[0098] As previously described, the friction generated by the contact between the marking coils 320, 322 and the inner surface of the catheter body 102 and the polymer body 512 is sufficient to prevent the stent 200 from moving relative to the actuator rod 502 as it advances through the catheter body 102. As a result, the stent 200 can be re-inserted into the catheter body 102 as long as the marking coils 320, 322 and the polymer body 512 are contained within the catheter body 102. In some embodiments, the stent 200 can be re-inserted into the catheter body 102 when up to 90% of the length of the stent body 204 has been deployed from the catheter body 102. Therefore, the stent 200 can be re-inserted into the catheter body 102 when 90% or less of the length of the stent body 204 has been deployed from the catheter body 102. The ability to reload the stent 200 into the catheter body 102 offers several advantages, including the ability for clinicians to reposition the stent 200 when the initial deployment location is inappropriately selected, when the stent 200 slides distally or proximally during deployment, or if the diameter or length of the selected stent 200 is determined to be inappropriate based on the patient's anatomy.

[0099] Once the clinician has confirmed that the stent is properly positioned within the target vessel, the clinician withdraws the catheter body proximally to release the stent from the insertion device and implant it into the target vessel (616). As previously described, the friction generated by the contact between the marking coils 320, 322 and the inner surface of the catheter body 102 and the polymer tube 512 is sufficient to prevent the stent 200 from moving relative to the actuator rod 502. To release the stent 200 from the insertion device 500, the catheter body 102 is withdrawn proximally while maintaining the position of the actuator rod 502 until the marking coils 320, 322 and the polymer tube 512 are deployed from the distal end 128 of the catheter body 102 and positioned outside the catheter body 102. Once the proximal end 206 of the stent 200 is outside the catheter body 102, the proximal end 206 expands so that the marking coils 320, 322 are no longer frictionally engaged with the polymer tube 512. Therefore, deploying the marking coils 320, 322 and the polymer tubing 512 outside the catheter body 102 releases the stent 200 from the insertion device 500 and implants the stent 200 into the target blood vessel 906. In some embodiments, the force required to deploy the stent 200 outside the catheter body 102 is in the range of about 1N to about 5N.

[0100] Once the stent 200 is deployed from the catheter body 102, it self-expands into an expanded state within the target vessel 906 in the patient's dural venous sinus. The stent 200 contacts the inner wall of the target vessel 906 and applies a force sufficient to change the blood flow within the vessel 906 from pulsatile or turbulent to laminar. For example, the stent 200 contacts the inner wall of the transverse sinus and applies a chronic outward force thereto to increase the lumen of the transverse sinus, thereby allowing increased blood flow through the transverse sinus 444. In some embodiments, after stent 200 implantation, the lumen of the transverse sinus 444 expands to a height of approximately 8 mm and a width of approximately 6 mm. As a result, the chronic outward force provided by the stent 200 after implantation in the target vessel 906 of the dural venous sinus is sufficient to eliminate or significantly reduce the pulsatile tinnitus experienced by the patient. Once the stent 200 is fully deployed from the catheter body 102 and expanded within the lumen of the target vessel 906 (i.e., once the stent 200 is implanted in the vessel), the contact between the stent 200 and the vessel wall, particularly the contact between the flared corollas 310, 312 of the stent 200 and the vessel, permanently fixes the stent 200 in place within the vessel. Therefore, once the stent 200 has been fully deployed from the catheter body 102 and implanted in the vessel, the stent 200 cannot be reinserted or removed from the vessel 906.

[0101] Once the stent 200 is released from the insertion device 500, the insertion device 500 can be withdrawn proximally through the catheter body 102 and removed from the patient. Once the stent 200 has been implanted in the target vessel 906 and the insertion device 500 has been removed, the catheter body 102 can be further withdrawn proximally and removed from the patient.

[0102] Figure 14 This is a flowchart illustrating an exemplary method 700 for performing a medical intervention. In some embodiments, method 700 includes step 702 for moving a medical device (e.g., stent 200) through an inner tube (e.g., inner tube 108) of a catheter body (e.g., tube body 102). In some embodiments, method 700 includes step 704 for resisting radial deformation of the inner tube by utilizing a reinforcing structure (e.g., reinforcing structure 112) of the catheter body as the medical device moves through the inner tube, wherein the reinforcing structure includes a winding thread (e.g., winding thread 118) surrounding the inner tube and a braided thread assembly (e.g., braided thread assembly 120) surrounding the winding thread.

[0103] While catheter 100, delivery device 160, and stent 200 have been described and illustrated with respect to certain dimensions, sizes, shapes, configurations, materials, and methods 600, in some embodiments, catheters, delivery devices, or stents that are similar in construction and / or function to catheter 100, delivery device 160, or stent 200 may include one or more different sizes, shapes, configurations, constructions, or materials, or operate according to different methods. For example, while catheter 100 has been described with respect to method 600 for delivering stent 200 to a neurovascular target location and to method 700 for performing a medical intervention, in some embodiments, catheter 100 may serve as a guiding or supporting catheter for other interventional neuroradiological procedures.

[0104] Therefore, other embodiments are within the scope of the appended claims.

Claims

1. A catheter body, comprising: Inner tube; as well as The reinforced structure includes: The winding wires surrounding the inner tube, and The braided yarn assembly surrounding the wound yarn, The reinforcement structure is configured to make the inner tube resist radial deformation when the medical device moves through it.

2. The catheter body according to claim 1, wherein the catheter body is a 5-French catheter body.

3. The conduit body according to any one of the preceding claims, wherein the hardness of the inner tube varies along the length of the inner tube.

4. The catheter body according to any one of the preceding claims, wherein the winding wire has a pitch of about 0.15 mm to about 0.20 mm.

5. The catheter body according to any one of the preceding claims, wherein the braided filament assembly comprises multiple filaments overlapping each other in a regular pattern to form a plurality of openings.

6. The catheter body according to claim 5, wherein the plurality of filaments comprises 16 filaments.

7. The conduit body according to any one of claims 5 to 6, wherein the braided filament assembly has a braid density of 65 to 75 ppi.

8. The catheter body according to any one of the preceding claims further includes one or more marking strips configured to provide visualization of the catheter body when it is disposed in a patient.

9. The catheter body according to claim 8, wherein the one or more marking bands comprise three marking bands spaced equidistant from each other.

10. The catheter body according to any one of claims 8 to 9, wherein the one or more marking bands overlap with the reinforcing structure.

11. The catheter body according to any one of claims 8 to 10, wherein each of the one or more marking bands comprises one or more radiopaque materials.

12. The conduit body according to any one of the preceding claims further includes an outer layer, the outer layer encapsulating the reinforcing structure and the outer surface of the inner tube.

13. The conduit body according to claim 12, wherein the outer layer comprises a coating.

14. The catheter body according to any one of the preceding claims, wherein the inner tube defines a single lumen, the lumen being sized to accommodate the medical device.

15. A medical intervention system, comprising: Medical devices; as well as The catheter body includes: Inner tube, and The reinforced structure includes: The winding wires surrounding the inner tube, and The braided yarn assembly surrounding the wound yarn, The reinforcing structure is configured to make the inner tube resist radial deformation as the medical device moves through it.

16. The medical intervention system of claim 15, wherein the medical device includes a stent configured to be implanted at a target location within the patient's body.

17. The medical intervention system of claim 16, wherein the target location comprises a portion of a blood vessel within the patient's neurovascular system.

18. The medical interventional system according to any one of claims 15 to 17, further comprising a delivery device, the dimensions of which are configured to be positioned within the catheter body.

19. The medical interventional system according to any one of claims 15 to 18, wherein the guiding device comprises a main shaft and a non-transmissive distal section.

20. The medical intervention system of claim 19, wherein the radiopaque distal segment comprises a substantially cylindrical distal axis and a tapered distal end, the tapered distal end being configured to extend from the distal end of the catheter body as the catheter body moves through the patient's body.

21. A method for performing a medical intervention, the method comprising: To move the medical device through the inner tube of the catheter body; as well as As the medical device moves through the inner tube, the inner tube utilizes the reinforcing structure of the catheter body to resist radial deformation, wherein the reinforcing structure includes: The winding wires surrounding the inner tube, and A braided yarn assembly surrounding the wound yarn.

22. The method of claim 21, further comprising moving the medical device past the distal end of the catheter body to implant the medical device at a target location within the patient's body.

23. The method of claim 22, wherein the target location comprises a portion of a blood vessel in the neurovascular system.

24. The method according to any one of claims 21 to 23, wherein the medical device comprises a stent.

25. The method according to any one of claims 21 to 24, wherein the catheter body is a 5-French catheter body.

26. The method according to any one of claims 21 to 25, further comprising maintaining the inner tube in a substantially circular cross-sectional shape as the medical device moves through the inner tube.

27. The method according to any one of claims 21 to 26, further comprising making the catheter body visible when it is in the patient's body.

28. The method of claim 27, wherein the catheter body further comprises one or more radiopaque marking strips.

29. The method according to any one of claims 21 to 28, further comprising, before moving the medical device through the inner tube of the catheter body: The delivery device is placed inside the catheter tube; and The catheter body is guided to the target location inside the patient's body using the delivery device.

30. The method of claim 29, wherein the guiding device includes a main shaft and a non-transparent distal section, and wherein the non-transparent distal section includes a substantially cylindrical distal shaft and a tapered distal end configured to extend from the distal end of the catheter body when the catheter body is used.

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