Intravascular delivery systems and devices

Abstract

Intravascular delivery systems, devices, and methods are disclosed herein. A typical delivery device may include an inner shaft defining a lumen extending along the length of the delivery device, an outer shaft enclosing the inner shaft along at least a portion of the length of the delivery device, and a distal tip portion of the outer shaft. The inner shaft may include a recess configured to receive a self-expandable implant. The outer shaft may include a functional member and a coil that are retractable relative to the inner shaft and provide increased tensile strength to the outer shaft. The tip portion may extend to the distal end of the delivery device and may have cross-sectional dimensions that are tapered distally.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 505,349, filed on May 31, 2023, entitled "IMPLANTS AND IMPLANT DELIVERY DEVICES", the disclosure of which is incorporated herein by reference in its entirety.

[0002] This technology relates to delivery systems, devices, and methods for delivering intravascular implants. In some embodiments, the implant is used to maintain the desired patency of a target vessel.

Summary of the Invention

Means for Solving the Problems

[0003] Detailed Description I. Overview Embodiments of this technology relate to intravascular implants ("implants") and associated implant delivery devices for the treatment of medical conditions arising from vascular problems. Vascular problems may include blockages or abnormalities in a patient's arteries, veins, or blood vessels. The implants used to treat these conditions depend on the anatomical location of the vascular problem or the target vessel. For example, multiple implants (e.g., stents) are used to treat medical conditions arising from problems in the cardiothoracic, neurovascular, abdominal-pelvic, and peripheral blood vessels, as these anatomical locations generally consist of longer, more highly branched networks. For example, excessive intracranial pressure, or more specifically, the pressure of cerebrospinal fluid against the vessel walls of neurovascular vessels, can cause the vessel walls to collapse and / or form arachnoid granules, which reduces blood flow. As cerebrospinal fluid is absorbed into neurovascular vessels through a pressure gradient, the cerebrospinal fluid pressure becomes higher than the intravascular pressure, reducing blood flow through the vessels. Reduced blood flow can lead to a further increase in intravascular pressure, requiring even higher intracranial pressure for cerebrospinal fluid absorption, creating a vicious cycle of reduced blood flow and higher intracranial pressure. One or more shorter, circular implants in cross-section can be implanted in blood vessels to restore cerebrospinal fluid drainage and relieve pressure. However, partly due to implant / vascular flow mismatch, these implants can create turbulent and low-pressure areas in the upstream or downstream areas adjacent to the implant and the blood vessel, potentially causing the vessel to collapse in these areas.

[0004] Techniques used to treat symptoms in more complex anatomical regions may also include combining multiple implants of different lengths, diameters, or cross-sections. While multiple implant structures increase the coverage area, the delivery of mismatched-sized implants using currently available delivery methods requires each implant to be delivered one at a time, increasing the likelihood of mismatch between implant size and anatomical location, and exposing patients to increased procedural risk. For example, delivery of an implant that is too small may lead to implant migration, and delivery of an implant that is too large may lead to an increased potential for vascular injury (e.g., tearing of the vessel wall) and / or collapse of a vessel adjacent to the implant.

[0005] Embodiments of this technology include a delivery device having an implant used to maintain the desired patency of a target vessel. The effect of the implant on the patency of the target vessel depends on various factors, including the implant length, diameter, cross-sectional shape, flexibility, and ability to withstand different radial forces at one or more anatomical locations. For example, the implant may have one or more regions covering one or more anatomical locations within the target vessel. One or more regions may have various parameters such as radial force along the length of the implant, diameter, cross-sectional shape, or flexibility. For example, the implant may have a patency region that is less flexible and can partially conform to the vessel, and an ostium region that is more flexible and conforms completely to the vessel (or at least more than that of the patency region). The inlet region is pre-formed or conformable to provide less stress to the healthy portion of the blood vessel, preventing the formation of turbulent and / or low-pressure regions at the implant inlet, thereby reducing and / or eliminating upstream vascular collapse and thus enabling better fluid flow through the implant. In some embodiments, the implant includes one or more additional regions. For example, the implant may include an outlet region distinct from one or both of the inlet and patency regions.

[0006] In some embodiments, individual implants, each comprising one or more regions, are joined together to create a longer implant. A longer implant can provide and / or resist radial forces along a longer length of the target vessel after a single implantation, reducing procedural complexity and increasing patient safety; therefore, implanting a single longer implant may be advantageous in contrast to multiple individual implants. However, longer implants and / or implants of varying flexibility are incompatible with current delivery devices. Thus, without compatible and complex delivery devices, the similar delivery complications described herein persist. Therefore, there is a need for safer and more efficient implant delivery devices configured to deliver and deploy one or more implants at various anatomical locations.

[0007] Embodiments of this technology further include associated implant delivery devices, systems, and methods that mitigate many of the problems described above and herein. An implant delivery system may include one or more implants and compatible implant delivery devices configured to retain and deploy the implants. The system may be used to deliver and deploy implants within the body of a patient (e.g., a human or animal subject) or more specifically, along the length of a target blood vessel. The delivery device may include an inner shaft and an outer shaft surrounding the inner shaft. The outer shaft may include a recess or depression configured to retain the implant as described above and herein. The delivery device may be customized to the target blood vessel and / or implant by varying the length, diameter, cross-sectional shape, or flexibility of the inner and outer shafts. For example, the flexibility of a delivery device adjacent to an area containing an implant may closely match that of the area containing the implant, increasing the maneuverability of the delivery device throughout the blood vessel. In addition, or alternatively, the flexibility of the delivery device can be variable along the length of the delivery device, allowing the implant delivery device to adapt to different anatomical regions encountered throughout the vascular system, from the insertion site to the target vascular system. In some embodiments, the delivery device is compatible with longer implants or multiple implants for treating portions of the vascular system, including longer lesions and / or stenotic areas.

[0008] In some embodiments, the delivery device includes a lumen along its entire length, configured to hold a guidewire. The delivery device may further include one or more vents to expel air from within the delivery device during procedural preparation (i.e., prior to insertion of the delivery device into the blood vessel). In some embodiments, the delivery device includes a deflectable and / or maneuverable distal tip portion. The distal portion is controllable by the user via a proximal handle and can further increase the maneuverability of the delivery device through the target blood vessel. In some embodiments, the delivery device may include one or more sensors or electrical components to monitor the navigation of the delivery device through the entire blood vessel and the deployment of the implant in the target anatomical region. For example, the delivery device may include sensors to monitor / measure physiological parameters such as blood pressure and flow rate prior to, during, and / or after implant deployment. The delivery device may further be configured to rotationally orient the implant within the target blood vessel. In some embodiments, the delivery device is configured to self-orient in the target anatomical region, allowing the implant to be deployed in a desired rotational orientation. In some embodiments, the handle is used to deploy or recapture the implant, and, if necessary, allows the user to adjust or reposition the implant.

[0009] In some embodiments, the system is used to deploy implants within venous sinuses to treat symptoms. For example, the delivery device can deliver and deploy implants into one or more of the transverse sinus, sigmoid sinus, and superior sagittal sinus while being nontraumatic to fragile cortical veins that are easily damaged. In some embodiments, the delivery device includes a distal tip suitable for nontraumatic navigation of the target vessel. The distal tip portion can have a high degree of flexibility so that the distal tip does not puncture or disturb surrounding anatomical structures throughout the navigation. For example, a delivery system used to deploy implants within venous sinuses may include a distal tip with the required flexibility to reduce the likelihood of damaging cortical veins throughout the navigation.

[0010] The delivery device may also include one or more functional members that reduce the possibility of delivery device elongation, provide compressive / longitudinal resistance within the delivery device, and increase the tensile strength of the outer shaft. For example, the functional member may be a coil positioned within the outer shaft to provide compressive force across the implant, thereby reducing the possibility of implant expansion and associated delivery risks. In addition, or alternatively, the functional member may be a braid positioned within the inner and / or outer shaft to increase the longitudinal stiffness of the delivery device and prevent elongation. In some embodiments, the delivery device includes one or more tensile members, such as one or more tensile fibers, comprising aramid (e.g., Kevlar) and / or liquid crystal fibers (e.g., Vectran), positioned within the outer shaft to increase the overall tensile strength of the outer shaft and prevent elongation. Tensile fibers may also be used in addition to one or more of the functional members described herein to increase the tensile strength of the delivery device and / or reduce its compression / elongation.

[0011] In some embodiments, the implants and associated delivery devices of the present technology relate to treating disorders associated with vascular stenosis. As previously stated, in some embodiments, the present technology described herein relates to delivering and positioning an implant within a venous sinus and maintaining the desired patency of the venous sinus. However, the disclosed embodiments are merely examples of various embodiments of the present technology, and therefore the disclosed embodiments can be used in other types of openings, passages, and / or vessels, such as cardiovascular, pulmonary, and / or peripheral vascular vessels. Accordingly, the specific structural and / or functional details disclosed herein are not to be construed as limitations, but merely as a basis for the claims and as representative grounds to teach those skilled in the art to construct and use the present system, apparatus, and method in appropriately detailed structures. Furthermore, the terms and phrases used herein are not intended to be limiting, but rather to provide an understandable description of the present system, apparatus, and method.

[0012] In the figures, the same reference numerals generally identify similar and / or identical elements. Many of the details, dimensions, and other features shown in the figures are merely illustrative of a particular embodiment of the present art. Therefore, other embodiments may have other details, dimensions, and features without departing from the spirit or scope of the disclosure. In addition, those skilled in the art will understand that various further embodiments of the disclosed art may be practiced without some of the details described below. [Brief explanation of the drawing]

[0013] The features, aspects, and advantages of the technology disclosed herein can be better understood with reference to the following drawings.

[0014] [Figure 1] Figure 1 shows an implant delivery device according to an embodiment of this technology.

[0015] [Figure 2A] Figures 2A-2C show cross-sectional views of the deployment of an implant from the implant delivery device of FIG. 1. [Figure 2B] Figures 2A-2C show cross-sectional views of the deployment of an implant from the implant delivery device of FIG. 1. [Figure 2C] Figures 2A-2C show cross-sectional views of the deployment of an implant from the implant delivery device of FIG. 1.

[0016] [Figure 3] Figures 3 and 4 show additional implant delivery devices according to embodiments of the present technology. [Figure 4] Figures 3 and 4 show additional implant delivery devices according to embodiments of the present technology.

[0017] [Figure 5A] Figures 5A-9C show endovascular implants according to embodiments of the present technology. [Figure 5B] Figures 5A-9C show endovascular implants according to embodiments of the present technology. [Figure 5C] Figures 5A-9C show endovascular implants according to embodiments of the present technology. [Figure 6A] Figures 5A-9C show endovascular implants according to embodiments of the present technology. [Figure 6B] Figures 5A-9C show endovascular implants according to embodiments of the present technology. [Figure 6C] Figures 5A-9C show endovascular implants according to embodiments of the present technology. [Figure 7A] Figures 5A-9C show endovascular implants according to embodiments of the present technology. [Figure 7B] Figures 5A-9C show endovascular implants according to embodiments of the present technology. [Figure 7C] Figures 5A-9C show endovascular implants according to embodiments of the present technology. [Figure 8A] Figures 5A-9C show endovascular implants according to embodiments of the present technology. [Figure 8B] Figures 5A-9C show an intravascular implant according to an embodiment of the present technology. [Figure 8C] Figures 5A-9C show an intravascular implant according to an embodiment of the present technology. [Figure 9A] Figures 5A-9C show an intravascular implant according to an embodiment of the present technology. [Figure 9B] Figures 5A-9C show an intravascular implant according to an embodiment of the present technology. [Figure 9C] Figures 5A-9C show an intravascular implant according to an embodiment of the present technology.

[0018] [Figure 10] Figure 10 shows the implant delivery device of FIG. 1 within a portion of the patient's coronary sinus.

[0019] [Figure 11] Figures 11-16 show cross-sectional views of the inner shaft of an implant delivery device according to an embodiment of the present technology. [Figure 12] Figures 11-16 show cross-sectional views of the inner shaft of an implant delivery device according to an embodiment of the present technology. [Figure 13] Figures 11-16 show cross-sectional views of the inner shaft of an implant delivery device according to an embodiment of the present technology. [Figure 14] Figures 11-16 show cross-sectional views of the inner shaft of an implant delivery device according to an embodiment of the present technology. [Figure 15] Figures 11-16 show cross-sectional views of the inner shaft of an implant delivery device according to an embodiment of the present technology. [Figure 16] Figures 11-16 show cross-sectional views of the inner shaft of an implant delivery device according to an embodiment of the present technology.

[0020] [Figure 17A] Figures 17A-17C show the inner shaft of an implant delivery device according to an embodiment of the present technology. [Figure 17B]Figures 17A-17C show the inner shaft of an implant delivery device according to an embodiment of this technology. [Figure 17C] Figures 17A-17C show the inner shaft of an implant delivery device according to an embodiment of this technology.

[0021] [Figure 18A] Figures 18A and 18B show an inner shaft with a biasing feature according to an embodiment of the present technology. [Figure 18B] Figures 18A and 18B show an inner shaft with a biasing feature according to an embodiment of the present technology.

[0022] [Figure 19] Figure 19-23 shows a cross-sectional view of the outer shaft of an implant delivery device according to an embodiment of this technology. [Figure 20] Figure 19-23 shows a cross-sectional view of the outer shaft of an implant delivery device according to an embodiment of this technology. [Figure 21] Figure 19-23 shows a cross-sectional view of the outer shaft of an implant delivery device according to an embodiment of this technology. [Figure 22] Figure 19-23 shows a cross-sectional view of the outer shaft of an implant delivery device according to an embodiment of this technology. [Figure 23] Figure 19-23 shows a cross-sectional view of the outer shaft of an implant delivery device according to an embodiment of this technology.

[0023] [Figure 24] Figures 24 and 25 show cross-sectional views of parts of an implant delivery device according to an embodiment of the present technology. [Figure 25] Figures 24 and 25 show cross-sectional views of parts of an implant delivery device according to an embodiment of the present technology.

[0024] [Figure 26] Figure 26-28 shows a cross-sectional view of the distal portion of the inner shaft of an implant delivery device according to an embodiment of this technology. [Figure 27] Figure 26-28 shows a cross-sectional view of the distal portion of the inner shaft of an implant delivery device according to an embodiment of this technology. [Figure 28] Figure 26-28 shows a cross-sectional view of the distal portion of the inner shaft of an implant delivery device according to an embodiment of this technology.

[0025] [Figure 29A] Figure 29A-31 shows the handle of an implant delivery device in various states according to an embodiment of this technology. [Figure 29B] Figure 29A-31 shows the handle of an implant delivery device in various states according to an embodiment of this technology. [Figure 29C] Figure 29A-31 shows the handle of an implant delivery device in various states according to an embodiment of this technology. [Figure 30A] Figure 29A-31 shows the handle of an implant delivery device in various states according to an embodiment of this technology. [Figure 30B] Figure 29A-31 shows the handle of an implant delivery device in various states according to an embodiment of this technology. [Figure 31] Figure 29A-31 shows the handle of an implant delivery device in various states according to an embodiment of this technology.

[0026] [Figure 32] Figure 32 shows a cross-sectional view of an implant delivery device configured to deploy two implants according to an embodiment of the present technology.

[0027] [Figure 33A] Figures 33A and 33B show cross-sectional views of an implant delivery device with a rail-type shaft in various states according to an embodiment of the present technology. [Figure 33B]Figures 33A and 33B show cross-sectional views of an implant delivery device with a rail-type shaft in various states according to an embodiment of the present technology.

[0028] [Figure 34] Figures 34 and 35 show cross-sectional views of a lumen-less implant delivery device according to an embodiment of this technology. [Figure 35] Figures 34 and 35 show cross-sectional views of a lumen-less implant delivery device according to an embodiment of this technology.

[0029] [Figure 36] Figure 36 shows a cross-sectional view of an implant delivery device with a steerable distal portion according to an embodiment of this technology. [Modes for carrying out the invention]

[0030] II. Devices, systems, and methods for implant delivery Figure 1 shows an implant delivery device 100 configured to deliver and deploy one or more implants (e.g., implants 1000 in Figures 5A-8B) to one or more target locations within a blood vessel. The delivery device 100 includes a handle region 80 used to maneuver the delivery device 100 throughout the blood vessel, a shaft region 50 distal to the handle region 80 and extending therefrom, and a distal tip region 20 distal to the shaft region 50 and extending therefrom. The handle region 80 may include a handle 800 having a handle base 820 and a rotor 810, and the shaft region 50 may include a proximal shaft region 51 and an implant region 60 distal to the proximal shaft region 50. The rotor 810 can be coupled to the distal end of the handle base 820 and the proximal end of the shaft region 50, which includes an inner shaft (e.g., the inner shaft 120 in Figures 11-18B, 24, and 25) and an outer shaft (e.g., the outer shaft 500 in Figure 19-25), as described herein. During operation, the rotor 810 can be actuated (e.g., rotated) to retract the outer shaft and deploy the implant, as described in more detail with reference to Figures 2A-2C. The proximal shaft region 51 and the implant region 60 may include one or more components (e.g., functional members) or configurations used to provide the delivery device with one or more of the desired flexibility, resistance to compression / extension / expansion, and / or other common delivery device properties. In some embodiments, the delivery device 100 can also recapture the implant 1000 using the handle region 80 following deployment, as described in more detail with reference to Figures 29A-31. The delivery device 100 may further include a lumen port 920 that extends into a lumen (e.g., lumen 205 in Figures 2A-2D) that straddles the entire length of the delivery device 100. In some embodiments, the lumen port 920 is used to deliver a guidewire and / or to flush air from within the lumen 205.

[0031] Figures 2A-2C show cross-sectional views of the deployment of the implant 1000 from the delivery device 100 in Figure 1. Referring first to Figure 2A, the delivery device 100 may include a lumen 205, an inner shaft 120 that is outward from the lumen 205 and at least partially defines it, and an outer shaft 500 that is outward from the inner shaft 120 and retractable proximal to the inner shaft 120. The lumen 205 is accessible via a lumen port 920 in Figure 1, which extends along the entire length of the inner shaft 120. As shown in Figure 2A, the implant 1000 can be maintained between the inner shaft 120 and the outer shaft 500 in the implant region 60.

[0032] The tip portion 20 is distal to the recess 270, is substantially tapered distally, and has decreasing cross-sectional dimensions. In some embodiments, the distal tip or distal inner shaft (DIS) 280 ("distal tip 280") can have a length of at least 1.5 centimeters (cm), 2.0 cm, 2.5 cm, 3.0 cm, 3.5 cm, or 4.0 cm. In addition, or alternatively, the proximal region of the distal tip 280 can have cross-sectional dimensions in the range of 1.2 to 2.5 millimeters (mm), and the distal region of the distal tip 280 can have cross-sectional dimensions in the range of 0.5 to 1.2 mm. In some embodiments, at least half of the distal tip 280 (e.g., a combination of the distal and proximal regions) includes a cross-sectional dimension of less than 2.5 mm. In some embodiments, the inner shaft 120 and the tip portion 20 are formed from a single material and / or have a continuous surface. In addition, or alternatively, the inner shaft 120 and the tip portion 20 are formed from different materials and have continuous and / or discontinuous surfaces.

[0033] The inner shaft 120 may have cross-sectional dimensions that vary along the length of the delivery device 100. For example, the inner shaft 120 may include a recess or recessed area 270 ("recess 270") configured to receive or maintain the implant 1000. The recess 270 may include a base recessed surface 272, a proximal recessed surface 274 that is proximal to and angled with respect to the base recessed surface 272, and a distal recessed surface 276 that is distal to and angled with respect to the base recessed surface 272. In some embodiments, the proximal recessed surface 274 may be normal to the base recessed surface 272 (i.e., angled 90° with respect to it). In addition, or alternatively, the distal recessed surface 276 may have an angle of at least 90°, 95°, 100°, 110°, 120°, 135°, or greater with respect to the base recessed surface 272, such that the distal recessed surface 276 is inclined distally. Advantageously, the angle of the distal recessed surface 276 with respect to the base recessed surface 272 can help prevent the implant 1000 from becoming entangled in that area of ​​the recess 270 once the implant 1000 is deployed and the delivery device is removed from the patient. The recess 270 may be defined by a first cross-sectional dimension (D1) and a second cross-sectional dimension (D2) adjacent to both sides of the implant 1000, which together form the recess 270 and receive the implant 1000. In some embodiments, D1 is generally large enough so that the portion of the inner shaft 120 adjacent to the implant 1000 acts as a backstop to maintain the implant 1000 within the implant area 60 during delivery and deployment. In some embodiments, D1 is 0.1 mm to 1.5 mm or any cross-sectional dimension in between, or at least 0.2 mm, 0.4 mm, 0.6 mm, or 0.8 mm, and D2 is 0.1 mm to 1.5 mm or any cross-sectional dimension in between, or at least 0.2 mm, 0.4 mm, 0.6 mm, or 0.8 mm.In some embodiments, the outer diameter of the outer shaft 500 is 0.75 mm to 3.0 mm, or any outer diameter in between, or a maximum of 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, 2 mm, 2.5 mm, or 3 mm. In some embodiments, the outer diameter of the inner shaft 120 is 0.5 mm to 2.5 mm, or any outer diameter in between, or a maximum of 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, 2 mm, or 2.5 mm. In some embodiments, the outer diameter of the recess 270 is 0.25 mm to 2.0 mm, or any outer diameter in between, or a maximum of 0.25 mm, 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2.0 mm. The recess 270 can maintain the position of the implant 1000 relative to the delivery device 100 during navigation to the target site and during the deployment of the implant 1000.

[0034] The delivery device 100, or more specifically, the inner shaft 120 or distal tip 280, may further include a shelf 278 distal to and extending from the recess 270. The shelf 278 may be angled with respect to the distal recess surface 276 (e.g., normal to it) and / or substantially parallel to the base recess surface 272. As shown in Figure 2A, the distal end of the outer shaft 500 may be positioned across the shelf 278 when the implant 1000 is constrained within the recess 270. In some embodiments, the recess 270 has a length of 2 centimeters (cm) to 15 cm, or at least 6 cm, 8 cm, 10 cm, or 15 cm.

[0035] In some embodiments, the implant 1000 can self-expand from a constrained state to an unconstrained state by applying a radially outward force on the outer shaft 500. The outer shaft 500 is configured to withstand the radially outward force applied by the implant 1000 so that the implant 1000 does not unfold until it reaches the target site, thereby reducing the possibility of unwanted unfolding and increasing patient safety. In some embodiments, the outer shaft 500 withstands radially outward forces applied by the implant 1000 of 0.1 N / mm to 10 N / mm, or at least 0.1 N / mm, 0.25 N / mm, 0.5 N / mm, 1 N / mm, 2 N / mm, 5 N / mm, or 8 N / mm. For example, when the outer shaft 500 is retracted (i.e., moved proximal to the inner shaft 120 within the implant region 60), the outer shaft 500 resists elongation, allowing for precise deployment of the implant 1000. In addition, or alternatively, the outer shaft 500 may be configured to prevent the implant 1000 from stretching and / or becoming pinched between the outer shaft 500 and the inner shaft 120 outside the implant region 60. In some embodiments, the inner shaft 120 is configured to maintain the longitudinal position of the implant 1000 while the outer shaft 500 is retracted. For example, the proximal portion of the inner shaft 120 of the implant 1000 may be configured to maintain the longitudinal position of the implant 1000 as the outer shaft 500 is retracted and the implant 1000 attempts to move proximal (i.e., by applying a radial force to the outer shaft 500).

[0036] Still referring to Figure 2A, the outer shaft 500 completely constrains the implant 1000 as it would be when delivered to the target site. The outer shaft 500 can be retracted to allow the implant 1000 to self-expand (e.g., to a specified diameter / cross-sectional shape). As shown in Figure 2B, the outer shaft 500 can be partially retracted in the implant region 60 so that the implant 1000 can expand from cross-sectional dimension (D3) to cross-sectional dimension (D4). In some embodiments, D3 is any cross-sectional dimension between 0.1 mm and 2 mm or in between, or at most 0.1 mm, 0.2 mm, 0.3 mm, 0.5 mm, or 1.0 mm, and D4 is any cross-sectional dimension between 1 mm and 5 mm or in between, or at least 1.5 mm, 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, or 4.0 mm. D3 can generally be small enough so that the delivery device 100 can navigate through the target vessel to the target site, and D4 can generally be large enough to occlude with the vessel wall at the target site. Figure 2C shows the outer shaft 500 retracted proximal beyond the implant region 60 so that the implant 1000 is fully deployed and has a cross-sectional dimension (D4) along the entire length of the implant 1000. It should be noted that although the illustrated implant 1000 appears to have the same cross-sectional dimension along its entire length, the delivery device 100 can be used to deploy one or more implants having one or more cross-sectional dimensions and / or other parameters, as will be described in more detail with reference to Figures 5A-9C.

[0037] Figures 3 and 4 show individual delivery devices 300 and 400. The devices 300 and 400 in Figures 3 and 4 may include the same or generally similar components as the delivery device 100. As shown in Figure 3, the delivery device 300 includes a thumbwheel 965 on a handle 800. The thumbwheel 965 can be used to retract the outer shaft 500 along the length of the implant area 60, in contrast to the rotor 810 in Figure 1.

[0038] As shown in Figure 4, the delivery device 400 can completely omit the handle (e.g., the handle 800 in Figure 1) and instead include a pullback retraction mechanism. For example, the pullback retraction mechanism may include a hub 930, a second lumen port 940, a port tube 950, and a lock 960. The second lumen port 940 may be the same as, or generally similar to, the lumen port 920. In some embodiments, the lumen port 920 is configured to hold the guidewire, and the second lumen port 940 and port tube 950 are used for flushing from within the delivery device 400, or vice versa. To retract the outer shaft 500 along the length of the implant region 60 and deploy the implant (e.g., implant 1000 in Figures 2A-2D), the hub 930 can be pulled proximal toward the lumen port 920. In addition, or alternatively, the hub 930 or another location on or within the delivery devices 100, 300, 400 may include a lock 960 to prevent unwanted movement of the inner shaft 120 relative to the outer shaft 500. For example, a pullback mechanism may be used to maintain the position of the inner shaft 120 relative to the outer shaft 500 prior to deployment (e.g., during transport, preparation, or navigation prior to reaching a target location). In some embodiments, the hub 930 has a fluid seal that allows the inner shaft (e.g., the inner shaft 120 in Figures 2A-2C) to move relative to the hub 930 and the outer shaft 500. The area between the inner shaft 120 and the outer shaft 500 may be flushed with a fluid (e.g., saline) via a second lumen port 940 (e.g., a Luer fitting) and a port tube 950.

[0039] III. Endovascular Implants Figures 5A–9C show various implants 1000 that can be delivered using a delivery device described herein (e.g., delivery device 100). As shown in Figure 5A, the implant 1000 may include one or more implant regions or areas. For example, the implant 1000 may include a first area 1050, a second area 1100 distal to the first area 1050, and a third area 1200 proximal to the first area 1050. As shown in Figure 5A, the first area 1050 may include one or more first area rings or structures 1060a–1060d (collectively referred to as “first area structures 1060”). The first area structures may be coupled to each other by couplings 1020a–1020f (collectively referred to as “couplings 1020”). In some embodiments, the first region 1050 is configured to have sufficient radial force to open the vessel under the highest expected forces (e.g., external forces from a collapsed vessel and / or internal forces from intravascular occlusion such as arachnoid granules) and to maintain that open state. In addition, or alternatively, the first region 1050 may be configured to have radial force that meets the expansion force requirements for, for example, opening a stenotic target and maintaining sufficient fluid and / or blood flow throughout the vessel. The first region structure 1060 may be consistent or varied in nature. Thus, the first region 1050 may be further divided into subregions with various parameters (e.g., various radial forces, diameters, etc.). In addition, the connectors 1020 may have consistent or varied parameters. The number of connectors 1020 connecting the first region structure 1060 may vary along the length of the implant 1000. For example, one or more of the mutually adjacent first area structures 1060 can be coupled with one or more of the couplers 1020.

[0040] The first region 1050 can generally cover at least a targeted therapeutic area of ​​a blood vessel (e.g., stenosis). Therefore, the radial force imparted by the first region 1050 may be sufficient to open the blood vessel and / or resist significant radial compression from forces, pressures (e.g., cerebrospinal fluid), occlusion, etc., applied thereto by the blood vessel. The length of the first region 1050 can be 5 mm to 200 mm in length, or at least 5 mm, 80 mm, 100 mm, 150 mm, or 200 mm, depending on the desired area of ​​coverage. The first region 1050 may further include one or more subregions with varying radial forces and / or flexibility. The first region structure 1060 may have a longitudinal dimension (D6) of 0.5 mm to 10 mm, or at least 0.5 mm, 2.5 mm, 5 mm, 7 mm, or 10 mm.

[0041] In some embodiments, the second region 1100 is coupled to the first region 1050 by couplers 1020g and 1020h (collectively referred to as "coupler 1020"). As shown in Figure 5A, the second region 1100 may include one or more second region end rings or structures 1110, and the second region 1100 may include one or more second region end structures 1110 ("second region end structures" 1110) and one or more second region transition rings or structures 1120a-1120c (collectively referred to as "second region transition structures 1120"). The second region transition structures 1120 may be coupled to each other and to the second region end structures 1110 by couplers 1020i-1020n (collectively referred to as "coupler 1020"). In some embodiments, the second regional end structure 1110 may have different radial forces and / or flexibility than the first regional structure 1060 and / or the second regional transition structure 1120, such as typically lower radial forces and / or higher flexibility, to conform to the vascular shape and more easily mitigate changes in the intrinsic shape of the vessel. This also allows the second regional end structure 1110 to conform, or substantially conform, to the cross-sectional shape of the vessel adjacent to the implant 1000 when deployed. In addition, or alternatively, the second regional end structure 1110 may be configured with a different cross-sectional shape (including a larger or smaller cross-sectional shape compared to that of the first regional structure 1060). The second regional transition structure 1120 may provide a transition between the first region 1050 and the second regional end structure 1110. The transitional region may include various radial forces, flexibility, and / or cross-sectional shapes, which may occur discretely (e.g., in one or more stages), continuously, or in combination thereof. The second region 1100 may be further divided into subregions with various properties. The second region 1100 may have various properties, which can help to match the cross-sectional shape along at least a portion of the target blood vessel, improve fluid flow adjacent to and within the implant, and optimize the forces applied to the blood vessel and adjacent tissue.The number of connectors 1020 is constant along the length of the implant 1000 or can vary. As shown in Figure 5A, connectors 1020d connect the “apex” on the first segmental structure 1060b to the “valley” on the first segmental structure 1060c. For example, there may be six apex on the first segmental structures 1060b and 1060c and three connectors 1020 connecting these two structures. Similarly, there may be nine apex and three connectors 1020, twelve apex and four connectors 1020, or any combination of apex and connectors 1020 between segmental structures 1060, 1110, and 1210.

[0042] In some embodiments, as shown in Figures 6A, 7A, and 8A, the structures between and within the first region 1050 and / or the second region 1100 (e.g., the first region structure 1060, the second region transition structure 1120, and / or the second region end structure 1110) are positioned directly adjacent to each other without the coupling 1020. In some embodiments, the second region transition structure 1120 and the second region end structure have longitudinal dimensions (D10 and D11) that are equivalent to, greater than, or less than the longitudinal dimension (D6) of the first region structure 1060. For example, the longitudinal dimensions (D10 and D11) may be 0.5 mm to 10 mm, or at least 0.5 mm, 2.5 mm, 5 mm, 7 mm, or 10 mm. In some embodiments, the length of the interconnected second regional end structures 1110 may be 2 mm to 25 mm, or at least 2 mm, 5 mm, 10 mm, or 15 mm. If included, the length of the interconnected second regional transition structures 1120 may similarly be 2 mm to 25 mm, or at least 2 mm, 5 mm, 10 mm, 15 mm, or 25 mm.

[0043] The second region 1100 may occupy the distal or upstream end (i.e., entrance) of the implant 1000 relative to the first region 1050. The length of the second region 1100 can extend from 0.5 mm to 40 mm, or at least 0.5 mm, 5 mm, 10 mm, 15 mm, 20 mm, or 40 mm, depending on the target placement of the implant 1000. The diameter or circumference of the second region 1100 is generally equivalent to or less than that of the first region 1050, as shown in Figures 5B and 5C, 6B and 6C, 7B and 7C, 8B and 8C, and 9A and 9B, respectively. In addition, at least a portion of the second region 1100 may take on a shape at least similar to the blood vessel into which it is implanted, and in some embodiments, it may take on a shape substantially similar to the blood vessel. The second region 1100 may include one or more subregions with varying radial forces, flexibility, and / or cross-sectional outlines. The radial force can vary, for example, within the second region transition structure 1120, over the length of the second region 1100, to adapt to a smooth transition from a specific vessel. In some embodiments, a single structure has a variable radial force along its longitudinal length to adapt to target vessel conditions. The radial force of the second region transition structure 1120 and / or the second region end structure 1110 may be 0.001 N / mm to 3 N / mm, or 0.001 N / mm, 0.25 N / mm, 0.5 N / mm, 0.75 N / mm, or 3 N / mm.

[0044] In some embodiments, the implant 1000 may include a third region 1200 coupled to the first region 1050, with or without a connector 1020. The third region 1200 may have different properties (e.g., radial force and / or flexibility) from the first region 1050 and / or the second region 1100, and the third region 1200 may potentially facilitate the transition from the first region 1050 to the blood vessel and / or, when deployed, more readily conform to the cross-sectional shape of the blood vessel adjacent to the implant 1000. In addition, or alternatively, the third region 1200 may provide a different cross-sectional shape (including a larger or smaller cross-sectional shape compared to the first region 1050). The third region 1200 may include a transition structure as described herein with reference to the second region 1100. Any transition structure or combination of transition structures can have various radial forces and / or flexibility, cross-sectional shapes, and can occur discretely (e.g., in one or more stages), continuously, or in combination thereof. The third region 1200 can be divided into subregions with various properties. The third region 1200 can provide various additional properties to the implant 1000, which can help improve blood flow adjacent to and within the implant 1000, and optimize the forces applied to the blood vessel and adjacent tissues, by conforming to the cross-sectional shape along at least a portion of the target blood vessel.

[0045] The third region 1200 generally extends from the first region 1050 to the downstream end of the implant 1000. The length of the third region 1200 may be 0.5 mm to 40 mm, or at least 0.5 mm, 5 mm, 10 mm, 15 mm, 20 mm, 22 mm, or 40 mm. The diameter or circumference of the third region 1200 may be larger than, equal to, or smaller than the first region 1050. In addition, at least a portion of the third region 1200 may have a shape that is at least similar with respect to the blood vessel into which it is implanted. The radial force may vary over the length of the third region 1200 to adapt to a smooth transition to the specific blood vessel. The radial force of the third region 1200 may be 0.001 N / mm to 4 N / mm, or 0.001 N / mm, 0.25 N / mm, 0.5 N / mm, 0.95 N / mm, or 4 N / mm. It should be noted that while a single third region structure is depicted in Figures 5A and 6A, the third region may include one or more third region structures 1210 to each other and to the first region structure 1060 using one or more couplings 1020, as described herein. Similar to the first region 1050 and the second region 1100, the third region 1200 may include one or more subregions with varying radial forces and / or flexibility due to the various properties of the third region structure 1210. In addition, or alternatively, the third area structure 1210 may have a longitudinal dimension (D6) of 0.5 mm to 10 mm, or at least 0.5 mm, 2.5 mm, 5 mm, 7 mm, or 10 mm.

[0046] In some embodiments, the implant 1000 may have more than three regions to optimize parameters / performance / safety depending on the target vessel and location / coverage of the implant 1000. For example, the implant 1000 may have a second region 1100, a first region 1050, another region similar to the second region 1100, another region similar to the first region 1050, and / or potentially a third region 1200. In some embodiments, the implant 1000 may be made from a self-expanding material such as NiTi or a NiTi alloy. In addition, or alternatively, the implant 1000 may be a balloon implant or made from other materials that are mechanically expandable and / or not self-expanding.

[0047] Referring collectively to Figures 5A-9C, the implant 1000 may also include one or more radiopaque markers 1300a-1300c (collectively referred to as “radiopaque markers 1300”). The radiopaque markers 1300 may be incorporated into one or more regions of the implant 1000 (e.g., a first region 1050, a second region 1100, and / or a third region 1200) to increase the visibility of the implant 1000 under imaging / fluoroscopy. The radiopaque markers 1300 may be continuous, discrete, or any combination thereof. In addition, or alternatively, the radiopaque markers 1300 may be positioned between one or more regions of the implant 1000 to identify distal or proximal end regions, transition regions, and / or other properties of the implant 1000.

[0048] Referring here to Figures 5A and 5B, the implant 1000 may be round in cross-section when confined within the delivery device 100. In addition, or alternatively, as shown in Figures 5C-6C, the implant 1000 may be non-round in cross-section when confined within the delivery device 100. The implant 1000 may also have a different shape when deployed within the target vessel. When the implant 1000 is confined within the delivery device 100 or expanded in free space, it may be substantially round in cross-sectional shape (as shown, for example, in Figure 5B). However, once the implant 1000 is deployed within the target vessel, the cross-sectional shape of the implant 1000 may expand or conform to and / or resemble that of the target vessel (as shown, for example, in Figure 5C), at least in part. The implant 1000 may have one or more regions (e.g., regions 1050, 1100, 1200) that vary in radial force, diameter / cross-sectional shape, flexibility, and structural properties, enabling the implant 1000 to conform to the target blood vessel.

[0049] In some embodiments, the implant 1000 includes an open-cell configuration (e.g., as shown in Figure 5A), a mixture of open and closed cells (e.g., as shown in Figure 6A), or a fully closed-cell design. As shown in Figure 5A, the open-cell design may include one longitudinal dimension (D5) between structures 1110, 1120, and / or 1210. The longitudinal dimension (D5) may be 0.01 mm to 2 mm, or at least 0.01 mm, 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, or 2 mm. As shown in Figure 6A, the closed-cell configuration may be formed by directly coupling structures 1110, 1120, and / or 1210 to adjacent structures without the use of a coupling device 1020. A mixed configuration of open and closed cells may generally include one or more longitudinal dimensions (D5, D12, and D13) between structures 1110, 1120, and / or 1210, which decrease in size and transition from an open-cell configuration to a closed-cell configuration. The longitudinal dimensions (D12 and D13) may be 0 mm to 2 mm, or at most 0.1 mm, 0.2 mm, 0.5 mm, or 2 mm.

[0050] In some embodiments, structures 1110, 1120, and / or 1210 are fabricated from filament fibers that are generally wound or folded to be more or less compact so that one or more regions of the implant 1000 conform to the target vascular duct. As shown in Figure 5A, the first region structure 1060 may have a cross-sectional dimension (D7) between wound filaments of 0.5 mm to 10 mm, or at most 0.5 mm, 1 mm, 2.5 mm, 5 mm, or 10 mm. The third region structure 1210 and the second region transition structure 1120 may have a cross-sectional dimension (D8) between wound filaments that is generally smaller than the cross-sectional dimension (D7) of the first region structure 1060. The cross-sectional dimension (D8) may be 0.5 mm to 4 mm, 0.5 mm, 1 mm, 2 mm, or 4 mm. In some embodiments, the second area end structure 1110 includes a cross-sectional dimension (D9) which varies from the cross-sectional dimension (D8) and is 0.1 mm to 4 mm, or at most 0.1 mm, 0.5 mm, 1 mm, 1.5 mm, 2 mm, or 4 mm.

[0051] The implant 1000 may have a braided structure either instead of, or in addition to, the structures described herein (e.g., structures 1060, 1120, and / or 1110). As shown in Figure 7A, the first region 1050 may include a single-pitch braid, a variable-pitch braid with various wires, strands, properties, parameters, or dimensions across the length of the first region 1050. For example, as the first region approaches the second region 1100, the pitch braid may become more conformal to the vessel. As shown in Figure 7C, the first region 1050 may generally have a more rounded horizontal cross-section in both free-unconstrained and / or constrained states. The first region 1050 may, at least partially, take the shape of the target vessel. The second region 1100 may also include a variable-pitch braid with transitional properties, particularly near the inlet side of the implant, to conform to the shape of the specific vessel. As shown in Figure 7B, the second region 1100 may have a horizontal cross-section that is more conformal to the blood vessel than the first region 1050. In some embodiments, the implant 1000 includes radiopaque markers 1300 (e.g., radiopaque filaments) that can be woven through closed cells to enable additional types of radiopaqueness. Since woven markers are generally more discrete, it may be advantageous for the radiopaque markers 1300 to be woven into the implant 1000, in contrast to individually positioned markers. The first region 1050 can transition from a more closed cell region to a less closed cell region. Closed cell regions (e.g., regions where filaments are generally woven together more closely) can enable partial deployment and retrieval of the implant 1000, if so desired.

[0052] As illustrated with reference to Figures 5A and 6A, the implant 1000 in Figures 7A, 8A, and 9A can also be constructed from one or more open cell regions, one or more closed cell regions, or any combination thereof. For example, as shown in Figure 8A, the first region 1050 may include an open cell structure, and the second region 1100 may include a closed cell structure. The implant 1000 can be constructed using one or more open cell regions, one or more closed cell regions, or any combination thereof. The first region 1050 can be round in both free-unconstrained and constrained states (for example, as shown in Figure 8C). In addition, or alternatively, the first region 1050 can take the shape of a blood vessel, at least partially (for example, as shown in Figure 8B). The second region 1100 is shown with a variable-pitch braid, forming a transition, which allows the region to conform more easily to the shape of an intrinsic blood vessel, particularly near the inlet side (for example, as shown in Figure 8B). In some embodiments, the first region 1050 may be more rounded or less conformal to blood vessels than the second region 1100.

[0053] As shown in Figures 9A-9C, the implant 1000 can be configured to be round in a free and unconstrained state with a length of 2 cm to 15 cm or any length in between, or with an overall length of 2 cm, 5 cm, 6 cm, 8 cm, 10 cm, or 15 cm. The first region 1050 of the implant 1000 may be 1 cm to 14 cm or any length in between, or at most 1 cm, 2.5 cm, 5 cm, 10 cm, or 14 cm. The diameter of the first region 1050 may be 0.5 mm to 10 mm or any diameter in between, or at least 0.5 mm, 2.5 mm, 5 mm, 6 mm, 8 mm, or 10 mm. The first region 1050 may include one or more first region structures 1060 configured with 4 to 100 structures, or any number in between, or with at least 4, 20, 40, 60, 80, or 100 structures. One or more first region structures 1060a-1060k (collectively referred to as "first region structures 1060") can be coupled to one or more couplers 1020a-1020x (collectively referred to as "couplers 1020"). In some embodiments, three of the couplers 1020 are used to couple any pair of first region structures 1060. The second region 1100 of the implant 1000 may include one or more second region transition structures 1120a-1120c (collectively referred to as "second region transition structures 1120") and one or more second region end structures 1110a-1110e (collectively referred to as "second region end structures 1110"), which are similarly coupled to one another by couplers 1020. The second region 1100 may be 5 mm to 50 mm in length or any length in between, or up to 5 mm, 10 mm, 15 mm, 20 mm, 25 mm, or 50 mm. The diameter of the second region 1100 may be 0.5 mm to 10 mm or any diameter in between, or at least 0.5 mm, 2.5 mm, 5 mm, 6 mm, 8 mm, or 10 mm. In some embodiments, the second region 1100 may be configured with various properties to adapt to variable radial forces of the target anatomical structure.The second segmental end structure 1110 may be 5 mm to 25 mm in length or any length in between, or up to 5 mm, 10 mm, 15 mm, 20 mm, or 25 mm. The second segmental end structure 1110 is configured to roughly conform to the shape of the intrinsic blood vessel and may take a substantially triangular shape in cross-section (as shown in Figure 9C) in order to navigate through tortuous anatomical structures. As shown in Figures 9B and 9C, the cross-sectional outline of the implant 1000 from the second segmental end structure 1110 to the second segmental transition structure 1120 and further to the first segment 1050 may gradually become more circular.

[0054] IV. Delivery devices for implant delivery Figure 10 shows the delivery device 100 described herein within a portion of the patient's venous sinuses (VS) and jugular veins (JV). The venous sinuses (VS) may include the transverse sinus (TS), the sigmoid sinus (SS), and the superior sagittal sinus (SSS). The delivery device 100 can be coupled to a guide catheter 1700 used to navigate the delivery device 100 to a target location within the venous sinuses (VS). As shown in Figure 10, the transverse sinus (TS), as well as the sigmoid sinus (SS) and the superior sagittal sinus (SSS), may be stenotic (e.g., transverse sinus stenosis (TSN)). Stenosis may be caused by external pressure and / or may include arachnoid granules within the venous sinuses (VS). The delivery device 100 can be used to deliver the implant described herein (e.g., implant 1000) into the venous sinuses (VS). For example, in the transverse sinus (TS) and sigmoid sinus (SS), the diameter (of the round portion of implant 1000) may be 3 mm to 12 mm, or at most 3 mm, 6 mm, 8 mm, or 12 mm. In addition, or alternatively, in the transverse sinus (TS) and sigmoid sinus (SS), the circumference (of the non-round portion of implant 1000) may be 9 mm to 38 mm, or at least 9 mm, 19 mm, 25 mm, or 38 mm. In some embodiments, implant 1000 used to treat the transverse sinus (TS) and sigmoid sinus (SS) may have a radial force range of 0.001 N / mm to 4 N / mm, or at least 0.001 N / mm, 0.25 N / mm, 0.5 N / mm, 1 N / mm, or 4 N / mm.

[0055] In addition, or alternatively, the delivery device 100 may be configured with properties tailored to the requirements of the venous sinus (VS). For example, the delivery device 100 may generally be more flexible to navigate the tortuous sections of the venous sinus (VS) (i.e., in contrast to the straighter sections of the anatomical structure). In some embodiments, the delivery device 100 is maneuverable and / or navigable through a variety of anatomical locations to deliver and deploy one or more implants 1000. In some embodiments, the delivery device 100 is preferably 8 French (F), 6F, or less in diameter with respect to cylindrical implants 1000, or other major cross-sectional dimensions with respect to non-cylindrical implants 1000. In some embodiments, the implant 1000 expands to a diameter / cross-sectional dimension of less than 5 mm, 10 mm, or 15 mm, or equal thereto, so that a delivery device 100 with generally similar cross-sectional dimensions is used to deliver the implant 1000. In addition, or as an alternative, a delivery device 100 having generally larger cross-sectional dimensions may be used to deliver and deploy one or more generally larger implants (e.g., grafts, valves, etc.).

[0056] The delivery device 100 can also be manufactured in various lengths to adapt to one or more access sites, including, but not limited to, the neck (e.g., jugular veins, carotid arteries, etc.), the arm (e.g., upper arm, radius, etc.), and / or the inguinal region (e.g., femoral veins, femoral arteries, etc.). In some embodiments, the entire delivery device 100 extends from the access site to the target site. In addition, or alternatively, the delivery device 100 may have a working length equivalent to the length of the delivery device 100 inserted into the patient and / or other devices (e.g., sheath, access catheter, etc.). For example, a delivery device 100 used at a cervical access site is typically shorter in overall working length, for example, 25 cm to 75 cm in length, or at most 25 cm, 50 cm, or 75 cm. A delivery device 100 used at an inguinal access site may have a working length of 90 cm to 150 cm, or at least 90 cm, 130 cm, and 150 cm. The working length of the delivery device 100 used at an arm access point may be approximately intermediate and / or at most similar to that of the delivery device 100 used at an inguinal access point, e.g., 75 cm to 150 cm, or at least 75 cm, 115 cm, or 150 cm. As long as sufficient working length is available, the delivery device 100 can be inserted from any location (for example, a delivery device that is 150 cm in length can be used in conjunction with a jugular vein approach). In some embodiments, the working length of the delivery device 100 is the length of the delivery device 100 excluding the handle 800. Exemplary procedural techniques for delivering the implant 1000 into the venous sinus (VS) using the delivery device 100 are described in detail herein.

[0057] Figures 11-16 show cross-sectional views of embodiments of the inner shaft 120 of a delivery device (e.g., delivery device 100 as described herein). The inner shaft 120 in Figure 11-16 may be the same as, or generally similar to, the inner shaft 120 described elsewhere in this specification (e.g., the inner shaft 120 in Figures 2A-2C). Referring collectively to Figure 11-16, the inner shaft 120 may include two or more regions, and in some embodiments, three or more regions. For example, the inner shaft 120 may include a proximal inner shaft (PIS) region 125, an implant inner shaft (IIS) region 220 distal to the PIS region 125, and a distal tip region 260 of the IIS region 220 (also referred to herein as the distal inner shaft (DIS) region). The PIS region 125 may be the portion of the medial shaft 120 proximal to the location where the implant (e.g., implant 1000 as described herein) is positioned (i.e., the location closest to the user, physician, healthcare professional, etc.). The IIS region 220 may be the region where the implant (e.g., implant 1000 as described herein) is positioned, as will be described in more detail with reference to Figures 17A-17C. The tip region 260 is distal to the IIS region 220 and thereby may be distal to the location where the implant 1000 is positioned.

[0058] The PIS region 125 may include two sub-regions or components: a proximal-internal shaft (PIS) 130 and an intermediate-internal shaft (MIS) 180. In some embodiments, the PIS 130 and MIS 180 are combined into a single region, simply referred to as the PIS 130 and / or PIS region 125. The PIS 130 may comprise a combination of the PIS jacket 140, the PIS functional member 150, the functional member 155 (as shown in Figure 12-15), the PIS liner 160, or any individual components or combinations thereof. The PIS 130 may be fabricated from PTFE-impregnated polyimide with or without braiding or coiling, and with or without the PIS jacket 140 and / or the PIS liner 160 and / or the PIS functional member 150 and / or the functional member 155. The PIS functional members 150 and / or functional members 155 can be used to provide the PIS 130 with column strength and / or resistance to compression. The PIS functional member 150 can be made from polymers, metals, polyimides, polyethylene, polyurethane, polyamides, compounding (e.g., Pebax), stainless steel, NiTi, hypotubes, braids, coils, thermosetting resins, and / or thermoplastics. The functional member 155 can be made from polymers, metals, polyimides, polyethylene, polyurethane, polyamides, compounding (e.g., Pebax), stainless steel, NiTi, thermosetting resins, and / or thermoplastics. The functional member 155 may be a hypotube, braided material, coil, or other suitable structure, with or without grooves, slots, or openings. The PIS liner 160 is preferably made of a lubricating / low-friction material, such as a fluorinated polymer (FEP, PTFE, etc.), high-density polyethylene, and equivalents, or constructed using such material, to facilitate easy tracking over the guide wire 1600. The PIS jacket 140 can be made of a lubricating / low-friction material or may include at least a lubricating / low-friction outer surface (e.g., an outer surface coated with a lubricating material).

[0059] The PIS jacket 140 is lubricating / low-frictional to the inner surface of the outer shaft (e.g., the outer shaft 500 as described herein) over the range of motion of the outer shaft 500 relative to the inner shaft 120, allowing the outer shaft 500 to be easily retracted relative to the inner shaft 120 during the deployment of the implant 1000. The PIS jacket 140 may include polyethylene (e.g., high density), fluorinated polymers or copolymers or impregnated polymers, polyurethane, nylon, nylon compound, block copolymer, metal, and / or coated materials. The PIS jacket 140 may also be made from materials that are generally similar in structure and composition to the functional member 155. For example, the PIS jacket 140 may be a hypotube with or without slots or windows, which is then coated to increase lubricity.

[0060] In some embodiments, the tip region 260, primarily used for navigating through more tortuous anatomical structures (e.g., sigmoid sinuses), can generally have a higher degree of flexibility than the PIS region 125 and / or IIS region 220. The flexibility of the delivery device 100 navigating within the venous sinus (VS) can have a minimum bending radius of at least 3 mm, 5 mm, 7 mm, 10 mm, or 15 mm, or 3 mm to 15 mm, or 5 mm to 10 mm, to prevent twisting of the delivery device 100 and thereby reduce the possibility of impairing the movement of the guidewire 1600 and / or the deployment of the implant 1000. For example, at a radius of 8 mm in a three-point bending test, the delivery device 100 can have a force of 0.1 N to 3 N, or up to 0.1 N, 0.5 N, 1 N, 2 N, or 3 N. When navigating a target area such as the chest, the delivery device 100 can have a generally larger minimum bending radius, such as 1 cm to 20 cm, or at least 1 cm, 5 cm, 10 cm, 15 cm, or 20 cm. Therefore, it may be desirable to change the flexibility along the length of the inner shaft 120 by changing, for example, the material and / or structure of the functional member 155 and / or PIS functional member 150. Such materials and / or structures may include coil pitch / diameter / material properties, braiding parameters / material properties, slotted, laser-cut, open-windowed hypotube, etc., each of which can be selected for the functional member 155 and / or PIS functional member 150. In addition, or alternatively, the inner shaft 120 may include or omit the MIS 180 so that the PIS region 125 includes only the PIS 130. For example, PIS130 may include PIS functional members 150 made from NiTi, NiTi alloy, hypo tubing, stainless steel, braids (e.g., flat or round wires), and / or coils.

[0061] The braiding can be consistent or varied along the length of the region. For example, the proximal end portion of the PIS functional member 150 can be constructed using a relatively high ppi (number of weft threads per inch) braiding pattern with decreasing ppi towards the distal end of the PIS functional member 150. For example, the proximal end portion of the PIS functional member 150 may include ppi of 60 to 70 ppi, while the distal end portion may include ppi of 30 to 40 ppi, thus providing greater flexibility to the tip region 260. Similarly, the PIS functional member 150 may be a coil with or without varying coil spacing and / or wire properties (e.g., diameter) along at least a portion of the length of the functional member 150.

[0062] In some embodiments, one or more MIS180s can be incorporated into an internal shaft 120. The internal shaft 120 can span a length from the thoracic location and / or within the jugular vein (JV) to within the sigmoid sinus (SS). Individual MIS180s can be made from materials similar or dissimilar to each other, with necessary modifications to increase flexibility. The MIS180s may include a functional member 200, which may be a coil (e.g., stainless steel) or structure (polyimide, braid, hypotube, etc.) that is relatively more flexible than the PIS functional member 150. The PIS functional member 150 or functional member 155 may extend distally into the MIS functional member 200, or may be an extension of the MIS functional member 200 with or without modification of properties. The MIS functional member 200 or functional member 155 can become an IIS functional member 240 that extends distally and with or without changes in properties (e.g., material, dimensions, etc.). For example, the braid pitch, wire dimensions, coil spacing and coil wire diameter, slots, or openings can be adjusted along the length of one or more of the PIS functional member 150, MIS functional member 200, and / or IIS functional member 240 to optimize the desired flexibility and resistance to compression of the inner shaft 120. In some embodiments, the PIS functional member 150 is constructed from, for example, polyimide, metal or polymer hypotube, coil, or braid, or a combination thereof, and the MIS functional member 200 has a relatively more flexible coil, braid, cut / uncut hypotube, or one or more polymers to reduce the stiffness of the MIS 180 compared to the PIS 130. The MIS 180 can also be made from a material completely different from the PIS 130 to provide desired properties. If included, MIS180 may have a length of 10 cm to 50 cm, or at least 10 cm, 35 cm, or 50 cm. PIS liner 160 and MIS liner 210 may be the same or separate components.It may be desirable that the liner provide a lubricating / low-friction inner surface, which can be constructed from, for example, a fluorinated polymer or copolymer or impregnated polymer (FEP, PTFE, etc.), polyethylene (e.g., high density), polyurethane, metal, coating, and / or equivalent, to facilitate easy following over the guide wire (e.g., guide wire 1600 as described herein).

[0063] The PIS jacket 140 and / or MIS jacket 190 can be made from a single material or from multiple materials (e.g., a laminate with a polyimide inner and polyethylene outer component). The PIS jacket 140 and / or MIS jacket 190 may have an outer surface that is lubricating / low friction with respect to the inner surface of the outer shaft 500 over the range of motion of the outer shaft 500 relative to the inner shaft 120. In some embodiments, the lubricating / low friction property is achieved through material selection and / or coating, which can assist in the retraction of the outer shaft 500 to deploy the implant 1000. For example, the MIS jacket 190 can be coated with and / or made from polyethylene (e.g., high density), fluorinated polymers or copolymers or impregnated polymers, polyurethane, nylon and nylon compound, block copolymers, or metals. The PIS jacket 140 and / or MIS jacket 190 can also be made from materials generally similar to the functional member 155 and / or MIS functional member 200. For example, the MIS jacket 190 may be a hypo tube with or without slots or windows, which is its natural state or is coated to increase lubricity. For example, the PIS jacket 140 may be a solid hypo tube, which is continuous and has windows or slots added as it becomes the MIS jacket 190, which can be coated to increase lubricity (as shown in Figure 14). The material may be, for example, stainless steel, NiTi, NiTi alloys, and / or polymers.

[0064] The IIS region 220 is located at least partially along the inner shaft 120 where the implant (e.g., implant 1000 as described herein) is positioned relative to the inner shaft 120. The IIS region 220 may have a thinner profile than at least a portion of the inner shaft 120 (e.g., PIS region 125) that is proximal to the IIS region in order to hold the implant 1000. It may be desirable that at least a portion of the IIS region 220 is loaded with the implant 1000 and that the outer shaft (e.g., outer shaft 500 as described herein) has flexibility similar to at least a portion of the delivery device 100 adjacent to the IIS region 220. This allows the delivery device 100 with the implant 1000 to smoothly follow the guidewire (e.g., guidewire 1600 as described herein) without abrupt transitions and / or potential twisting points, reducing potential trauma to the blood vessel and improving navigability. The IIS region 220 can be constructed using, but is not limited to, one or more of the IIS jacket 230, IIS functional member 240, functional member 155, and IIS liner 250. The cross-section of the IIS region 220 may be substantially round to deliver the implant 1000, which is round when crushed. In addition, or alternatively, the IIS region 220 may be non-round for the implant 1000, which is non-round when crushed.

[0065] Similar to the functional members described herein, the IIS functional member 240 and / or functional member 155 can provide resistance to compression while allowing the necessary flexibility for navigating through meandering anatomical structures. The IIS functional member 240 may consist of one or more tubular members, including open or fenestrated tubular members, solid tubular members, coils, braids, or combinations thereof. The IIS functional member 240 may be an extension of the PIS functional member 150 and / or MIS functional member 200. In these cases, the material, hypotube cutting pattern, braid, and / or coil properties, including wire or material properties (e.g., dimensions, heat treatment, tensile strength, etc.), can be modified to provide the desired functional characteristics. Embodiments relating to braids may include changing the braid pitch to increase flexibility, and / or, relating to coils, reducing the wire diameter, changing material properties, and / or changing the coil spacing. These modifications can be used to modify functional properties, such as the flexibility and / or compressive resistance of the IIS region 220. The IIS liner 250 may be an extension of the PIS liner 160 and / or the MIS liner 210, or it may be a separate component or a combination of components. The IIS liner 250 preferably has a lubricating / low-friction inner surface and may be made from and / or coated from, for example, polyethylene (e.g., high density), a fluorinated polymer or copolymer or impregnated polymer, polyurethane, or metal to facilitate tracking across the guide wire.

[0066] Similarly, the IIS jacket 230 may be coated with and / or fabricated from a lubricating / low-friction material to facilitate the deployment of the implant 1000. In some embodiments, the IIS jacket 230 may be fabricated from a material that is not relatively low-friction so that the IIS jacket 230 helps to maintain the implant 1000 in place (e.g., to prevent the implant 1000 from moving, shortening, or compressing / accumulating longitudinally) during the introduction and advancement of the delivery device 100 with the implant 1000 into, through, and to the target deployment site, and during the deployment of the implant 1000. In addition, or alternatively, the surface of the IIS jacket 230 may have one or more features, e.g., ridges, protrusions, dimples, coatings, textures, surface treatments, etc., or a combination thereof, to facilitate the maintenance of the position / shape of the implant 1000 relative to the delivery device 100 prior to and / or during the deployment of the implant 1000.

[0067] The IIS jacket 230 may include one or more IIS tapers 235a and 235b (collectively referred to as “IIS taper 235”) (as shown in Figure 16), such as regions with progressively smaller cross-sectional dimensions at one end and progressively larger cross-sectional dimensions at the other end. The IIS taper 235 may be used to assist in holding the implant in place and / or to adjust the flexibility of that portion of the delivery device 100 and / or to accommodate constrained changes in the diameter of the implant 1000. The IIS taper 235 may be located in one or more locations along the inner shaft 120. The IIS taper 235 may be located, for example, in the distal region of the IIS region 220, where the implant may be more flexible and / or have different dimensions from the more proximal region of the implant.

[0068] The IIS region 220 is at least partially radiopaque and / or may have one or more radiopaque markers 330 to help identify the location and / or features of the implant 1000, such as the region of the implant 1000, for example, one or more radiopaque markers 330 to identify the location where the first region 1050 is adjacent to the second region 1100. Radiopaque marker 330a may be located adjacent to the proximal (relative to the inner shaft 120) end of the implant 1000. In addition, radiopaque marker 330b may be located adjacent to the distal (relative to the inner shaft 120) end of the implant 1000. Radiopaque markers 330a, 330b may be located adjacent to or within the IIS region 220. In addition, or alternatively, the tip region 260 may include a radiopaque marker 330c that may indicate the location where the distal end of the delivery device 100 is located. In some embodiments, one or more components of the tip region 260 (e.g., the distal tip region 320) are fabricated, partially or entirely, from a radiopaque material to assist in positioning and / or navigation. The IIS functional member 240 or any part thereof may also be radiopaque, at least partially, by being fabricated using a radiopaque material, such as tungsten, platinum, tantalum, iridium, and alloys thereof, and / or by using a polymer (e.g., polyethylene, polyurethane, Pebax, nylon, compound) filled with a radiopaque material (e.g., tungsten, BaSO4). Examples include, but are not limited to, radiopaque coils, hypotubes with or without openings or cuts, and / or braids. In addition, or instead, a radiopaque wire wound along the length of the IIS functional member 240 can provide radiopaqueness. The IIS jacket 230 may be radiopaque, for example, by using a polymer filled with a radiopaque material as described above with respect to the IIS functional component 240.

[0069] The tip region 260 may include a distal tip region 320 at the inner shaft 120 and the most distal end ("distal end") of the delivery device 100. The tip region 260 may be configured to be flexible, enable non-traumatic and easy navigation, which is particularly useful in tortuous anatomical structures, and provide a transition to a more proximal region of the inner shaft 120 and / or outer shaft 500 (e.g., between the IIS region 220 and the distal end region 620 of the outer shaft). In some embodiments, the tip region 260 includes a distal tip 280. The distal tip 280 may include an outer shape or diameter similar to that of the distal end of the outer shaft 500. In addition, or alternatively, the distal tip 280 may include a distal tip taper 290 to make the tip region more non-traumatic. The tip region 260 and / or distal tip 280 include a proximal lateral shape or diameter that is generally similar to, or identical to, that of the distal end of the outer shaft 500, ensuring that there is no opportunity for the outer shaft 500 to have an exposed anterior edge when introducing and navigating the delivery device 100 with the implant 1000 through it into anatomical structures. In some embodiments, the distal tip taper 290 includes cross-sectional dimensions that decrease distally toward the distal tip region 320. The distal tip taper 290 serves primarily as a transition to a more proximal region of the inner shaft 120 in terms of flexibility and diameter. The length of the tip region 260 may be 0.5 cm to 8 cm, or at least 0.5, 4 cm, or 8 cm, or greater.

[0070] In some embodiments, the tip region 260 includes a distal tip extension region 305 which is 0.5 cm to 3 cm in length, or at least 0.5 cm, 1.75 cm, and 3 cm in length. The distal tip extension region 305 may have a relatively constant shape with respect to part of its length or diameter, or it may have some taper or steps and may have changes in flexibility along its length. The distal tip extension region 305 can assist the followability of the delivery device 100 with the implant 1000 by providing the tip region 260 to navigate through tortuous sections of the blood vessel before the IIS region 220 of the delivery device 100 is required to navigate through its section of the blood vessel. In some embodiments, the distal tip end region 320 is the tip of the delivery device 100. The distal tip region 320 is preferably rounded and / or tapered and / or chamfered, without sharp edges, to provide a non-traumatic tip when advancing the delivery device 100 with the implant 1000 through the blood vessel, and can be easily exposed to the blood vessel.

[0071] In some embodiments, one or more of the liner, functional members, and / or jacket may extend into, and / or through the tip region 260. As shown in Figure 12-15, the IIS functional member 240 and the IIS liner 250 extend partially or completely into the tip region 260. This may be done to optimize flexibility, mounting surface area, and improve transition along the region of the delivery device 100 with the implant 1000. In some embodiments, the tip region 260 has its own functional members, which are different from, similar to, or identical to those in other parts of the delivery device 100.

[0072] As shown in Figure 15, the tip region 260 may include one or more sensors 370. The sensors 370 may be coupled to a sensor lead 380 that connects the delivery device 100 to one or more external devices. The sensors 370 may include, but are not limited to, pressure, flow, and / or temperature measurements. By having sensors 370, data can be collected without the need to replace the delivery device 100 with another catheter with measuring capabilities, which in turn reduces procedure time, saves the cost of another catheter for making measurements, and increases safety by reducing the amount of devices (e.g., surgical tools, etc.) placed in the blood vessel. For example, the sensors 370 may be used to measure pre-deployment pressure and flow across the stenosis, throughout the delivery and / or after deployment of the implant 1000, assess improvements and / or changes, and provide indications of procedure success.

[0073] In some embodiments, the liner, functional members, and / or jacket can be combined in any or all of the PIS regions 125, IIS regions 220, or tip regions 260. For example, the PIS functional member 150 is a braid and / or coil partially or completely embedded in the polymer, and the polymer can effectively serve as the PIS jacket 140 (as shown in Figures 11 and 12) and / or PIS liner 160.

[0074] In some embodiments, the outer surface of the inner shaft 120 may be coated or layered to increase or decrease friction / movement against other surfaces of the delivery device 100 and / or the surface of the implant 1000, and / or against other devices used during the procedure, such as the guidewire 1600, target vessel, and / or guide catheter, introducer, and / or equivalent. Surface coatings may be hydrophilic, hydrophobic, fluoropolymer, silicone, polymer, etc., and lubricating materials for the outer layer or jacket as described herein may be used. In some embodiments, the inner shaft 120 provides a substantial amount of resistance to the overall compression of the delivery device 100. By allowing the inner shaft 120 to provide resistance to compression, the outer shaft 500 can provide a reduced level of compression resistance, potentially allowing the outer shaft 500 to be relatively thin-walled and configured for greater resistance to extension, and reducing the longitudinal compression resistance required by the implant 1000 within the delivery device 100.

[0075] Figures 17A–17C show the inner shaft 120 of a delivery device (e.g., delivery device 100 as described herein). As shown in Figures 17A–17C, the inner shaft 120 may be the same as, or generally similar to, the inner shaft 120 described in Figures 11–16. As shown in Figures 17B and 17C, the IIS region 220 may be triangular in cross-section to mimic the shape of a crushed implant 1000, which is triangular in cross-section. If the implant 1000 has more than one cross-sectional shape (e.g., round and triangular, triangular and rectangular, etc.), the IIS region 220 may have two (or more) similar cross-sections. In addition, if the IOS region (for example, IOS region 600 as described herein) has a non-round inner outer shape, the length of the inner shaft 120 adjacent to the IIS region 220 may be similar to or longer than the IIS region 220, and / or may have a similar non-round shape to allow the IOS region 600 to recede across the inner shaft 120.

[0076] In some embodiments, radiopaque markers 330 on the inner shaft 120 are used to rotationally orient the delivery device 100 relative to an implant that is non-round when crushed (e.g., implant 1000 in Figures 6A–6C). As shown in Figure 17B, the inner shaft 120 may include radiopaque markers 333 on the lower portion of the inner shaft 120 and radiopaque markers 336a and 336b (collectively referred to as “radiopaque markers 336”) on one or more side portions of the inner shaft. For example, radiopaque markers 333 may be positioned to identify the longer side of implant 1000 under fluoroscopy, and radiopaque markers 336 may be positioned to identify one or more shorter sides of implant 1000. If all sides of the implant 1000 are of the same length, one or more of the radiopaque markers 330, 333, and 336 within the delivery device 100 can be used to provide visibility regarding the rotational orientation of the flat / flatter side of the implant 1000. In some embodiments, the radiopaque markers 333 and 336 are radiopaque marker 330 in Figure 17A, positioned on both sides of the IIS region 220 to ensure that the implant 1000 is properly oriented when deployed in a blood vessel. Although not explicitly shown in Figures 17A-17C, one or more radiopaque markers can also be similarly incorporated into the outer shaft 500 as described herein. In some embodiments, typically, if the implant 1000 is non-round and a desired orientation within the vascular space exists, the delivery device 100 includes a side for providing self-orientation within the target location, allowing the implant 1000 to be deployed with the desired rotational orientation, whether or not it is necessary to intentionally rotate the delivery device 100 when it is at the target location for deployment.

[0077] Figures 18A and 18B show the internal shaft 120 with biasing features. As shown in Figure 18A, a portion of one or more of any segments of the MIS 180, IIS region 220, distal tip 280, and / or external shaft (e.g., external shaft 500 as described herein) can be biased to curve the delivery device (e.g., delivery device 100 as described herein) with a specific rotational orientation in order to position the desired side of the implant 1000 in a specific orientation. For example, as shown in Figures 18A and 18B, the IIS region 220 may include a cranial side 1540 outside the curve to adapt to positioning the generally longer side of the implant 1000 outside the curve, facing toward the skull, when it is located in the transverse sinus (TS) and / or sigmoid sinus (SS). In addition, or alternatively, the IIS region 220 may include cerebral sides 1550a and 1550b (collectively referred to as “cerebral side 1550”), which are generally shorter than the cranial side 1540 and positioned toward the brain. In some embodiments, the biasing feature is mounted within an eccentric tubular member. In addition, or alternatively, the biasing feature may be part of the outer shaft 500 and / or inner shaft 120. For example, the outer shaft 500 or inner shaft 120 may have a greater wall thickness on one or both sides of the shaft. In some embodiments, the biasing feature is one or more elements, such as a metal strip, positioned on or within the outer shaft 500 or inner shaft 120, made from pre-curved NiTi or stainless steel, with or without a radiopaque coating (e.g., the radiopaque marker 333 of the delivery device 100 in Figure 11). In addition, or as an alternative, one or more of the outer shaft 500 or the inner shaft 120 may be formed with a curved portion by thermoforming or molding.

[0078] Figures 19-23 show a cross-sectional view of the outer shaft 500 of a delivery device (e.g., delivery device 100 as described herein). The outer shaft 500 in Figure 19-23 may include the same or generally similar features as the outer shaft 500 as described herein. Referring collectively to Figure 19-23, the outer shaft 500 may include one or more regions, or in some embodiments, two or more regions. For example, the outer shaft 500 may include a proximal outer shaft (POS) region 510 proximal to the location where an implant (e.g., implant 1000 as described herein) is positioned within the delivery device 100. In addition, the outer shaft 500 may include an implant outer shaft (IOS) region 600 where the implant 1000 is maintained within the delivery device. In some embodiments, a distal region (not shown) distal to the IOS region 600 is present. For example, the distal region may be the extension of a depression within the medial shaft (for example, the extension of the depression 270 in the medial shaft 120 in Figure 11-18B).

[0079] The POS region 510 can be made from a single material or from multiple materials, such as a combination of a POS jacket 520 and a POS liner 540. As shown in Figures 19-23, the POS jacket 520 may generally be thicker than the POS liner 540. In addition, or alternatively, the POS jacket 520 may generally be the same thickness as or thinner than the POS liner 540. The POS region 510 may also include a POS functional member 550. The POS functional member 550 may have the same or generally similar features as the functional members described herein with respect to the inner shaft (e.g., functional members 200, 240 of the inner shaft 120 in Figures 11-17C). The POS region 510 and IOS region 600 may have variable diameters, as will be described in more detail with reference to Figure 2A. In addition, or alternatively, as shown in Figure 20, the outer shaft 500 may have a relatively constant inner diameter throughout its entire length.

[0080] The POS region 510 may comprise a polymer tube with or without variable stiffness (e.g., polymer variation) and functionality along its entire length. In some embodiments, the POS region 510 includes a single or multiple wall thicknesses along its entire length or wall thickness. In some embodiments, it is preferable that the POS region 510 is constructed such that elongation is sufficiently minimized when the POS region 510 is retracted relative to the inner shaft 120 to deploy the implant 1000. In this regard, one or more materials or structures with relatively high tensile strength, such as polyethylene, polyurethane, polyimide, nylon, nylon compound, block copolymer, metal, fiber, and / or braid, can be used in the construction of the POS region 510.

[0081] As shown in Figure 19, the POS region 510 may include a POS marker 530. The POS marker 530 may be a visual marker, for example, being a different color from the POS jacket 520 and / or being radiopaque. The POS marker 530 may be positioned at a specific distance from the IOS region 600 and / or the tip region 260 of the inner shaft 120 as described herein. In some embodiments, the POS marker 530 may be positioned at a distance of 75 cm to 115 cm, or at least 75 cm, 85 cm, 95 cm, or 115 cm, from the distal tip of the delivery device 100 (e.g., the distal tip region 320 in Figures 11-16). For example, the POS marker 530 may be used to position the distal tip region 320 at the distal end of a guide catheter (i.e., the guide catheter 1700 in Figure 10). The specific distance can also be used to include the length of any fittings or adapters that may be incorporated at the proximal end of the guide catheter 1700, etc. In some embodiments, multiple POS markers 530 may be used at distances of 90 cm to 135 cm, or at least 90 cm, 112 cm, or 135 cm, etc., from the distal tip region 320 to indicate a position above one within the guide catheter 1700.

[0082] In some embodiments, the POS region 510 has more than one region. As shown in Figures 22 and 23, the POS region 510 may include an intermediate-outer shaft (MOS) region 560. The MOS region 560 may be configured to extend through a more tortuous vessel than the POS region 510, such as from within the jugular vein (JV) into the sigmoid sinus (SS), and may also extend into the transverse sinus (TS), superior sagittal sinus (SSS), contralateral transverse sinus, and / or contralateral sigmoid sinus, as will be described in more detail with reference to Figure 10. The MOS region 560 may be more flexible than at least a portion of the POS region 510. The MOS region 560 may include a MOS jacket 570, which may be an extension of the POS jacket 520 or a separate component. In some embodiments, the entire outer shaft jacket of the outer shaft 500 may be a single component. The MOS region 560 may also include a MOS functional member 590, similar to the functional members described herein with respect to the inner shaft 120. The MOS region 560 may include a MOS liner 580. The MOS liner 580 is preferably a lubricating and / or low-friction material for the outer surface of the inner shaft 120, and can be constructed from, or using, a fluorinated polymer (FEP, PTFE, etc.), high-density polyethylene, and equivalents. The POS liner 540 and the MOS liner 580 may be composed of the same or different components.

[0083] The IOS region 600 in which the implant 1000 is positioned may be an extension of the POS region 510 or the MOS region 560, or it may be constructed using a combination of different diameters, wall thicknesses, flexibility, tensile strengths, coatings, and / or liners. In some embodiments, the IOS region 600 and the outer shaft 500 are constructed to sufficiently minimize elongation when the outer shaft 500 is retracted relative to the inner shaft 120 to deploy the implant 1000. The IOS region 600 may include an IOS liner 610, which may include a material that allows the retraction of the outer shaft 500 without causing excessive shortening, adhesion, or bouncing of the implant 1000 during deployment, and during the introduction and advancement of the delivery device 100 with the implant 1000 through it to the target deployment site within the anatomical structure. The IOS liner 610 may be a lubricating and / or low-friction material for the implant 1000 and can be made from a high-density material (e.g., polyethylene, fluorinated polymer, copolymer, impregnated polymer, polyurethane, metal). In addition, or alternatively, the IOS liner 610 may be a coating that increases lubricity. The IOS liner 610, POS liner 540, and MOS liner 580 may be identical or different components.

[0084] The distal end region 620 of the outer shaft can optionally extend beyond the location of the implant. In some embodiments, the distal end region 620 of the outer shaft is configured to extend beyond the implant and fit into the recess 270, allowing the outer shaft 500 to withstand relative movement to the inner shaft 120 without exposing the implant during the introduction and / or advancement of the delivery device 100 into the target anatomical structure. In addition, or alternatively, the distal end region 620 of the outer shaft can serve as a transition area to optimize the flexibility of the distal end region of the delivery device 100.

[0085] In some embodiments, one or more regions of the outer shaft 500 have functional members made from one or more functional members or elements. For example, the outer shaft 500 may have a POS functional member 550 which includes a braid and a coil extending over the braid. Similarly, the MOS functional member 590 and the IOS functional member 612 may include a braid and a coil extending over the braid. As described above, one or more of the functional members 550, 590, and 612 may extend into and / or be incorporated into one or more of the regions 510, 560, and 600 of the outer shaft 500. For example, the POS functional member 550 may extend into the MOS region 560 to form the MOS functional member 590 and / or extend into the IOS region 600 to form the IOS functional member 612.

[0086] In some embodiments, at least a portion of the outer shaft 500 is not round. For example, implant 1000 may be non-round (e.g., triangular) in a collapsed state, and the inner shape of the IOS region 600 may mimic the shape of implant 1000. In addition, or alternatively, if implant 1000 is triangular in shape in a collapsed state (e.g., implant 1000 in Figure 18A), the inner shape of the IOS region 600 may be triangular in shape and conform to the shape of implant 1000. The outer shape of the IOS region 600 may also be triangular, round, or of a different shape. Given that the inner shape of the IOS region 600 is not round, a portion of the inner shaft 120 proximal to the location of implant 1000 may be similarly shaped in cross-section, or smaller, as described in more detail with reference to Figure 8B, allowing the IOS region 600 to recede over that portion of the inner shaft 120.

[0087] As shown in Figure 19, the outer shaft 500 may include vents 325 extending from the lumen or the ring between the inner shaft 120 and the outer shaft 500 to an area outside the outer shaft 500, for example, to allow airflow or other fluids to be removed or flushed out of the lumen. In some embodiments, as shown in Figure 11, the inner shaft 120 may also include vents 325. The vents 325 can generally be aligned so that air can flow out of the ring between the outer shaft 500 and the inner shaft 120 during the preparation of the delivery device (i.e., to flush the delivery device with saline).

[0088] In some embodiments, the outer shaft 500 may include one or more of the radiopaque markers 330 described herein to indicate a location on the outer shaft 500. In some embodiments, the outer shaft 500 includes one of the radiopaque markers 330 at the distal end of the outer shaft distal end region 620 so that the user can visualize the distal end of the outer shaft distal end region 620 relative to the implant 1000 under fluoroscopy during the positioning and / or deployment of the implant 1000.

[0089] In some embodiments, part or all of one or more of the regions 510, 560, and 600 of the outer shaft 500 are radiopaque. For example, regions 510, 560, and 600 can be made from a radiopaque material or a polymer (e.g., polyethylene, polyurethane, Pebax, nylon, compound) filled with a radiopaque material (e.g., tungsten, BaSO4). In some embodiments, one or more of the regions 510, 560, and 600 of the outer shaft 500 are a single component such as a polymer tube, with or without variable properties (e.g., rigidity and flexibility) and with or without varying diameters and / or wall thicknesses.

[0090] Figures 24 and 25 show partial cross-sectional views of the delivery device 100, including an inner shaft 120, an outer shaft 500, and an implant 1000 in a constrained state prior to introduction or deployment at the target site. The inner shaft 120 may be the same as, or generally similar to, the inner shaft in Figure 11-18B or any of the inner shafts described herein. The outer shaft 500 may be the same as, or generally similar to, the outer shaft 500 in Figure 19-23 or any of the outer shafts 500 described herein. The implant 1000 may be the same as, or generally similar to, the implant 1000 in Figures 5A-9C or any of the implants 1000 described herein.

[0091] As described herein, the inner shaft 120 may have one or more (e.g., two, three, four, or five) regions with varying degrees of flexibility. In some embodiments, the regions may include a proximal PIS region (e.g., PIS region 125 as described herein) where the implant 1000 is positioned, an IIS region (e.g., IIS region 220 as described herein) where the implant 1000 is maintained, and a distal tip region 260 where the implant 1000 is positioned. The PIS region 125 may have two or more subregions, including a PIS 130 and one or more MIS 180. The PIS 130 may be 30 cm to 135 cm in length, or any length in between, or at least 30 cm, 75 cm, or 135 cm. The PIS 130 may include a PIS liner 160, a PIS functional member 150, and a PIS jacket 140. The PIS liner 160 can extend into the tip region 260 through one or more MIS 180s and IIS regions 220. The PIS functional member 150 may be, for example, a stainless steel braid. The PIS functional member 150 can extend into the tip region 260 through one or more MIS 180s and IIS regions 220. The PIS jacket 140 can be made from nylon and may have an outer diameter of 0.5 mm to 2.5 mm, or any in between, or up to 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, 2 mm, or 2.5 mm. The MIS 180 may include an MIS liner 210, an MIS functional member 200, and an MIS jacket 190. The MIS liner 210 may be an extension of the PIS liner 160. The MIS functional member 200 may be an extension of the PIS functional member 150. The proximal MIS jacket 190 and the distal MIS jacket 190 may be block copolymers with varying degrees of flexibility.

[0092] The inner shaft 120 may include an IIS region 220 that holds the implant 1000, as will be described in more detail with reference to Figure 11-17B. The IIS region 220 may generally be 2 cm to 15 cm in length, or any length in between, or long enough to accommodate an implant 1000 of at least 2 cm, 5 cm, 6 cm, 8 cm, 10 cm, or 15 cm in length. The IIS liner 250 may be an extension of the PIS liner 160 and / or the MIS liner 210. The IIS functional member 240 may be an extension of the PIS functional member 150 and / or the MIS functional member 200. In some embodiments, the IIS jacket 230 is made of urethane. The tip region 260 may be 1 cm to 6 cm in length, or any length in between, or at least 1 cm, 1.5 cm, 3.5 cm, 4 cm, or 6 cm in length. The MIS liner 210 may extend to the length of the tip region 260. The MIS functional member 200 may extend into the tip region 260. The tip region 260 may be made of urethane or other suitable polymer. The inner shaft 120 may have one or more additional functional members 155 extending from the POS region 510 to the IOS region 600. The functional members 155 may generally become more flexible as they approach the IOS region 600 from the POS region 510.

[0093] As described herein, the outer shaft 500 may have multiple regions, including a POS region 510 proximal to the location where the implant 1000 is positioned, and an IOS region 600 in which the implant 1000 is positioned and extends into the recess 270. The POS region 510 may be made from a fluoropolymer or other low coefficient of friction polymer (i.e., a polymer with a coefficient of friction of less than 0.3, or preferably less than 0.1), and may include a POS liner 540 that extends through the length of the outer shaft 500 and can form the MOS liner 580 and IOS liner 610. The POS functional member 550 may be a coil that extends along the length of the outer shaft 500 and forms the MOS functional member 590 and / or IOS functional member 612 (for example, as shown in Figure 25). The PIS jacket 520 may be made from nylon. The MOS region 560 may include a MOS jacket 570 made from a block copolymer that increases in flexibility toward the IOS jacket 614. The IOS jacket 614 can be made from urethane. The outer shaft 500 may also include a radiopaque marker 330 in the distal end region 620 of the outer shaft.

[0094] As described in more detail herein (see, for example, Figure 19-23), the outer surface of the outer shaft 500 may be coated or laminated to increase or decrease friction / movement against blood vessels and / or other devices used during the procedure, such as guide catheters, delivery devices, and equivalents. In addition, or alternatively, the inner surface of the outer shaft 500 may be coated or laminated to increase or decrease friction / movement against the surface of the inner shaft 120 and / or implant 1000. The surface coating may be hydrophilic, hydrophobic, fluoropolymer, silicone, and / or polymer, or may include them. In addition, one or more components may be made from an impregnating material such as PTFE-impregnated polyimide to increase or decrease friction / movement within the delivery device 100.

[0095] Collectively referring to Figures 24 and 25, the inner shaft 120 may include a PIS liner 160 extending from the proximal region of the delivery device 100 to the region adjacent to the distal tip region 320. The PIS functional member 150 may be a stainless steel braid adjacent to the radiopaque marker 330 and / or extending to the region adjacent to the distal tip region 320. The PIS jacket 140 may be a combination of block copolymers with different flexibility to optimize the bending stiffness along the length of the delivery device 100. The inner shaft 120 may include a functional member 155 made from a hypotube (e.g., stainless steel or NiTi) with various openings or cuts along part of its length to allow for reduced bending stiffness in the tip region 260 compared to the POS region 510. In addition, or alternatively, the functional member 155 may extend from the handle (e.g., the handle 800 in Figure 29A-31) to the POS region 510, to the IOS region 600 (i.e., adjacent to the implant 1000), and / or to the tip region 260.

[0096] In some embodiments, the radiopaque marker 330 can be incorporated into a functional member 155 adjacent to the tip region 260 to help identify the location of the implant 1000 (e.g., radiopaque marker 330b). The functional member 155 can be configured to act as a backstop to the IOS region 600 to prevent the implant 1000 from moving proximal during deployment while the outer shaft 500 is retracted. In some embodiments, the tip region 260 may be 20mm to 50mm in length, or 20mm, 30mm, 40mm, or 50mm, and the recess 270 may be 2.5cm to 15cm in length, or 2.5cm, 5cm, 6cm, 8cm, 10cm, or 15cm. The tip region 260 may be manufactured separately (e.g., molded) and then coupled to the rest of the inner shaft 120. In addition, or alternatively, the tip region 260 can be insert-molded into the remaining portion of the inner shaft 120.

[0097] The outer shaft 500 may include a POS liner 540 that extends to the region of the outer shaft 500 adjacent to the tip region 260. A POS functional member 550 may be present across the POS liner 540, comprising a stainless steel braid with a nitinol coil extending across the braid. For example, the braid can provide a longitudinal stiffness component, and the coil extending across the braid can prevent the braid from expanding due to long-term outward forces applied by the implant 1000 to the outer shaft 500. This POS functional member 550 structure may extend over the entire length of the delivery device 100 to the region of the outer shaft 500 adjacent to the tip region 260.

[0098] As shown in Figure 25, in addition to one or more outer shaft functional members 550, 590, 612, the outer shaft 500 may include one or more tensile members 615. One or more tensile members 615 can provide additional tensile strength to the outer shaft 500, and therefore to the delivery device 100. One or more tensile members 615 may be made from polyester fibers, aramid (e.g., Kevlar) fibers, liquid crystal fibers (e.g., Vectran), metal wires, polymer fibers, etc., which may be wound and / or in a braid. In some embodiments, the tensile members 615 are made from one or more strings that do not completely enclose the outer shaft 500, the recess 270, and / or the implant 1000. The tensile members 615 may have a total tensile strength of 0.5 to 5 pounds, or at least 0.5, 1.5, 2.5, or 5 pounds. One or more outer shaft functional members 550, 590, and / or 612 and one or more tensile members 615 can add tensile strength to the outer shaft 500 and can be positioned within the outer shaft 500 as described herein. One or more outer shaft functional members 550, 590, and / or 612 and one or more tensile members 615 may be in the form of fibers, wires, and / or braids. In some embodiments, one or more tensile members 615 are located below, above, and / or woven into one or more outer shaft functional members 550, 590, and / or 612. For example, one or more tensile members 615 may be located below, above, and / or woven into the braided portion of functional member 550. In addition, or alternatively, both one or more tensile members 615 and the braided portion of functional member 550 may be located below the coiled portion of functional member 550.

[0099] In addition, or alternatively, the tensile member 615 can be incorporated within or between the POS liner 540 and the POS jacket 520 and / or the IOS jacket 570. The POS jacket 520 and / or the IOS jacket 570 can be fabricated from multiple polymers along the length of the delivery device 100 to obtain desired flexibility and properties. In some embodiments, the POS jacket 520 generally has higher rigidity than the MOS jacket 570 and / or IOS jacket 614 when bending and moving. In some embodiments, one or more polymers are incorporated within the MOS jacket 570 and / or IOS jacket 614 to reduce the resistance of the delivery device 100 to bending, making the delivery device 100 more flexible and making it easier for it to navigate through more meandering anatomical structures. The outer shaft jackets 520, 570, and 614 can be fabricated primarily from nylon and / or block copolymers and can extend over at least a portion of the recess 270.

[0100] In some embodiments, one or more outer shaft functional members 550, 590, and / or 612 and one or more tension members 615 are located within the outer shaft 500 as one or more fibers, braids, and coils. From the inside out, the outer shaft 500 may include a liner (e.g., a POS liner 540), one or more fibers (e.g., one or more tension members 615), braids (e.g., braids of functional member 550), coils (e.g., coils of functional member 550), and jackets (e.g., outer shaft jackets 520, 570, 614). The outer shaft 500 and one or more components of the outer shaft 500 described herein may form the outer circumference around the recess 270 and / or implant 1000.

[0101] In some embodiments, the delivery device 100 has an overall working length of 140 cm to 150 cm or any length in between, or an overall working length of at least 140 cm, 145 cm, and 150 cm. The overall working length of the delivery device 100 can be any length that allows the delivery device 100 to approach and reach the target vessel from any typical access point. In some embodiments, the delivery device 100 with an implant 1000 is configured to reach the sinus venosus (VS). For example, using a femoral approach, the length of the delivery device 100 may be such that the second regional end structure 1110 is positioned adjacent to the sinus venosus confluence and the implant 1000 extends into the sigmoid sinus (SS).

[0102] Figures 26-28 show cross-sectional views of the distal portion of the inner shaft 120 of the delivery device 100 described herein. In some embodiments, the tip region 260 includes an enlarged distal tip region 340, which has a shape that makes it very difficult for any anterior edge of the tip region 260 to catch on or cause trauma to small blood vessels (e.g., cortical veins) and / or be non-traumatic when navigating around tight bends. As shown in Figure 26, the enlarged distal tip region 340 may resemble a sphere or an enlarged portion relative to an adjacent diameter / cross-sectional outline. Other shapes can also be used for the same effect of keeping the edge of the lumen 205 / distal tip region 320 of the tip region 260 away from the vessel wall throughout the navigation.

[0103] In some embodiments, the tip region 260 is generally longer to provide a very stepwise transition from the distal tip region 320 to a more proximal location of the delivery device 100. As shown in Figure 27, the distal tip 280 is generally longer in length (e.g., at least 1 mm, 2 mm, 4 mm, 6 mm, 10 mm, or 20 mm in length) and can provide a smooth transition to the IOS region 600. In some embodiments, the distal tip 280 and / or tip region 260 is generally longer in longitudinal length and can allow a flexible and thin portion (e.g., distal tip taper 290, distal tip extension region 305, part or all of the distal tip region 320) to navigate around a tortuous curve, such as the sigmoid sinus (SS) at the bifurcation from the jugular vein (JV), before the IOS region 600 enters the tortuous region. The tip region 260 is configured with flexibility to transition into the IOS region 600, enabling smooth and non-traumatic advancement of the delivery device 100 with the implant 1000 to the target site.

[0104] In some embodiments, the tip region 260 may have a distal tip extension lumen 310 that extends at least partially through the tip region 260, with or without an enlarged distal tip region 340. If incorporated, the distal tip extension lumen 310 may extend proximal to or adjacent to the distal end of the tip region 260. Having a smaller diameter in the lumen 205 reduces the gap between the guidewire 1600 and the distal tip extension lumen 310, minimizing any exposed edges of the distal end of the delivery device 100 to the blood vessel, for example, thereby reducing the potential for trauma to the blood vessel. For example, if the guidewire 1600 is a 0.014-inch diameter guidewire, the lumen 205 may nominally be 0.017 inches, and the distal tip extension lumen 310 may be less than 0.017 inches, or between 0.0145 inches and 0.016 inches. The distal tip-extended lumen 310, with or without the enlarged distal tip-end region 340, significantly reduces the likelihood of the tip region 260 becoming entangled in or causing injury to small blood vessels.

[0105] As shown in Figure 27, the tip region 260 may have a recess 270 formed by a shelf 278 that serves as a location for the distal end region 620 of the outer shaft. By allowing the distal end region 620 of the outer shaft to extend beyond the implant 1000 into the shelf 278 of the recess 270, this allows for some relative movement of the outer shaft 500 relative to the inner shaft 120 without exposing the implant 1000 during the introduction and advancement of the delivery device 100 with the implant 1000. The shelf 278 of the recess 270 can also allow for some initial retraction of the outer shaft 500 prior to the initiation of the release of the implant 1000 in order to help optimize the position of the implant 1000 during deployment. The shelf 278 of the recess 270 can also help create a stepwise transition in flexibility within the IOS region 600 of the delivery device 100. The shelf portion 278 of the recess 270 is typically 0.5 mm to 20 mm in length, or any length in between, or up to 0.5 mm, 5 mm, 10 mm, or 20 mm. The shelf portion 278 of the recess 270 thus allows for the maintenance of a non-traumatic outer surface of the delivery device 100 when the implant 1000 is positioned within the IOS region 600. The tip region 260 also has some overlapping material that extends proximal over the distal end of the outer shaft 500, which can reduce the likelihood of one or more edges of components of the delivery device 100 being exposed when the outer shaft 500 moves proximal to the inner shaft 120 at any point prior to initiating the deployment of the implant 1000.

[0106] The tip region 260 can also be made from one or more materials, for example, the tip region 260 can be made from a single polymer, e.g., polyethylene, polyurethane, nylon and nylon compound, block copolymer, compound, and / or from multiple polymers. For example, the distal tip 280 can be made from one or more materials (e.g., different polymers such as polyethylene and polyurethane) of different densities from the distal tip taper 290, the distal tip extension region 305, and / or the distal tip end region 320. In some embodiments, one or more of the distal tip 280, the distal tip extension region 305, and / or the distal tip end region 320 are made from one or more different polymers of different densities (e.g., a change from high-density polyethylene to lower-density polyethylene, or from polyurethane to nylon or Pebax). In addition, or alternatively, one or more components of the tip region 260 may be radiopaque and / or contain one or more radiopaque markers 330. For example, the distal tip extension region 305 may be radiopaque (for example, filled with a material such as a tungsten-filled polymer). In some embodiments, the distal tip extension region 305 extends from the distal tip end region 320 by 1 mm to 8 mm, or any distance in between, or up to 1 mm, 2 mm, 5 mm, or 8 mm.

[0107] Figures 29A-31 show the handle 800 of a delivery device (e.g., delivery device 100 as described herein) in various states. The handle 800 can be configured to allow a user to operate the delivery device 100 with an implant 1000, deploy the implant 1000, and remove the delivery device 100 from a blood vessel. As shown in Figures 29A and 29B, the outer shaft 500 can be retracted, and in Figure 29C, the outer shaft 500 can be advanced to cover the implant 1000. The handle 800 may include a handle base 820 and a rotor 810, which, when rotated, moves the outer shaft 500 relative to the inner shaft 120, or, in the case of delivery device 100 with a rail configuration, the proximal outer rail shaft 630 and the proximal inner rail shaft 360. When the rotor 810 is rotated, a ball 890 can be moved along the rotor outer shaft groove 850. The rotor outer shaft groove 850 is a variable-pitch helical groove that requires relatively more rotations to cause a slight movement in the outer shaft 500 at the start of implant 1000 deployment, followed by a coarser pitch that increases the rate of retraction of the outer shaft 500 per rotation.

[0108] When the implant 1000 is in the desired position within the blood vessel for deployment, the rotor 810 can be rotated, which moves the ball 890 along the rotor outer shaft groove 850. The rotor outer shaft groove 850 may be a helical groove with or without variable pitch. Variable pitch can be implemented using a fine-pitch rotor outer shaft groove 860, for example, at the beginning of the deployment of the implant 1000, requiring relatively more rotations to result in a small movement in the outer shaft 500, to help to precisely position and / or secure the initial length of the implant 1000 within the blood vessel. As the implant 1000 is further deployed, the pitch can become coarser, requiring relatively fewer rotations to deploy the rest of the implant 1000, reducing the force required to deploy the implant 1000 and thus reducing procedure time.

[0109] The ball 890 can also communicate with the outer shaft rail 870, which contains an outer shaft rail pocket 880, which holds the ball 890 in place relative to the outer shaft rail 870. The outer shaft rail 870 can be mounted on the outer shaft 500. The rotor 810 can be held in a longitudinal position relative to the handle base 820 by the handle base tongue 830 and the corresponding rotor positioning groove 840. As shown in Figure 29B, the outer shaft rail 870 can be constrained from significant rotation relative to the handle base locator 900 using a flat-to-flat surface or a mating / restraining surface arrangement. The handle base locator 900 may be part of and / or a separate component of the handle base 820. The inner shaft 120 can also extend inside the outer shaft 500, through or engaging with the handle base locator 900, and communicate with the lumen port 920. The lumen port 920 can be used to flush the lumen 205 and may contain fittings such as Luer fittings.

[0110] The handles 800 may include strain reducers 910 to help prevent twisting of the delivery device shafts as they withdraw from the handles. The surfaces of the rotor 810 and / or the handle base 820 may be grooved, slotted, engraved, textured, or modified to optimize tactile feel and grip with a gloved hand. The area formed between the inside of the outer shaft 500 and the outside of the inner shaft 120 and implant 1000 may have a fluid communication port (not shown) similar to the lumen port 920 (e.g., a Luer fitting) to allow fluid flushing of the area. In a rail configuration, the lumen port 920 is not required. The handles 800 may have strain reducers 910 to help prevent twisting of the delivery device shafts as they withdraw from the handles 800. The outer surface of the rotor 810 may be grooved, and the surface of the handle base 820 may be engraved.

[0111] Figures 30A and 30B show various diagrams of the handle of the delivery device 100, in which the outer shaft 500 is retracted. The delivery device 100 may be the same as, or generally similar to, the handle described in Figure 3, including the thumbwheel-activated retraction of the inner shaft 120. The handle 800 may be the same as, or generally similar to, the handle 800 in Figures 29A–29C. The handle 800 may further have a handle base 820, accompanied by a thumbwheel 965 positioned so that its operation is accessible from outside the handle base 820. The thumbwheel may be functionally coupled to one or more thumbwheel gears 970, which directly or indirectly result in the movement of the outer shaft rail engagement 985. The outer shaft rail engagement 985 may be functionally coupled to the inner shaft 120. Rotating the thumbwheel 965 can move the outer shaft 500 in relation to the inner shaft 120, allowing for the deployment or recapture of the implant 1000. Alignment of either the inner shaft 120 and the outer shaft 500 with respect to the handle 800 can be achieved by having a guide that limits the rotation of either shaft relative to the handle 800. For example, the outer shaft rail 870 may have one or more alignment tabs 975 that fit into alignment slots 980. In addition, or alternatively, the reverse configuration is also acceptable, in which the outer shaft rail 870 has one or more alignment slots 980 and the handle base 820 or other components have alignment tabs 975.

[0112] As shown in Figure 31, the handle 800 may include a handle body 822 coupled to the outer shaft 500 and containing a strain relief body 910. The handle body 822 has a second lumen port 940, which may be a Luer fitting flushing port, allowing flushing (typically with saline or heparinized saline) of the ring between the inner shaft 120 and the outer shaft 500. To seal the proximal end of the ring, there may be an actuator 826 (e.g., a seal actuator) having one or more threads 824 common to the handle body 822, allowing the actuator 826 to tighten an O-ring 828 or equivalent component to create a seal. The compression of the O-ring 828 also acts as a locking mechanism and may be sufficient force to prevent movement of the inner shaft 120 relative to the outer shaft 500 until it is released as part of the step of deploying the implant 1000. The inner shaft 120 may have a pin hub 932. To deploy the implant 1000, the actuator 826 is relaxed, allowing the pin hub 392 / inner shaft 120 to be held in place, while the handle body 822 and outer shaft 500 are retracted.

[0113] In one or more embodiments, the handle 800 or other location on or within the delivery device 100 may include a lock 960 to prevent unwanted movement of the inner shaft 120 relative to the outer shaft 500. In addition, or alternatively, the handle 800 may include a second lumen port 940 that allows the area between the inner shaft 120 and the outer shaft 500 to be flushed with a fluid (e.g., saline or heparinized saline) and a strain relief body 910 to reduce strain on the delivery device 100.

[0114] Figure 32 shows a cross-sectional view of a delivery device 100 (e.g., the delivery device 100 as described herein) configured to deploy two implants (e.g., implants 1000 as described herein). In some embodiments, the delivery device 100 is configured to deploy multiple implants 1000a and 1000b (collectively referred to as "multiple implants 1000") at multiple locations, enabling the deployment of generally longer implant lengths within one or more vessels. This is beneficial to avoid the need to introduce and navigate multiple catheters to the target location, which can reduce equipment costs, reduce procedure time, and improve safety. Examples include a delivery device 100 with a distally located implant 1000 for deployment in the transverse sinus (TS) and sigmoid sinus (SS) and a more proximal implant 1000 (on the delivery device 100) for delivery in the contralateral transverse sinus (only), or the reverse configuration. Any combination of implants 1000 can be configured, such as a transverse sinus (TS) implant 1000, a transverse sinus (TS)-sigmoid sinus (SS) implant 1000, and / or a superior sagittal sinus (SSS) dedicated implant 1000, along with a superior sagittal sinus (SSS)-sigmoid sinus (SS) implant 1000. In addition, three or more implants 1000, such as a transverse sinus (TS)-sigmoid sinus (SS) implant 1000, a superior sagittal sinus (SSS) dedicated implant 1000, and a contralateral transverse sinus dedicated implant 1000, can be placed in one of the delivery devices 100. These multiple implants 1000 can be in any desired order or configuration.

[0115] Multiple implants 1000 can be used to adjust the implantation area length by having transverse sinus (TS)-sigmoid sinus (SS) implants (e.g., 6-10 cm in longitudinal length, or any length in between) and one or more transverse sinus (TS)-dedicated and / or superior sagittal sinus (SSS)-dedicated implants on the same delivery device 100. Thus, the transverse sinus (TS)-sigmoid sinus (SS) implants 1000 can be deployed, and the patient can be tested for symptom relief and other visual and / or physiological indicators. If desired, additional transverse sinus (TS) and / or sigmoid sinus (SS) implants can then be deployed, with the ability to re-evaluate the patient each time without the need to remove the catheter and then introduce a new catheter. In addition, superior sagittal sinus (SSS)-dedicated implants 1000 can be deployed. Other embodiments include multiple relatively short implants 1000 (e.g., up to 8 cm in length) on the same delivery device 100, enabling the construction of an implantation area of ​​desired length at a desired location. Additional implants 1000, such as a transverse sinus (TS) dedicated implant 1000, a sigmoid sinus (SS) dedicated implant 1000, and a superior sagittal sinus (SSS) dedicated implant 1000, can be constructed as described herein with reference to Figures 5A-9C, although the implants 1000 can also generally be shorter in length (e.g., less than 2 cm in total length).

[0116] Figures 33A and 33B show cross-sectional views of a delivery device with a rail-type shaft in various configurations (e.g., the delivery device 100 described herein). As shown in Figures 33A and 33B, the delivery device 100 generally has a shorter lumen 205, allowing the use of the lumen 205 as a rail-type configuration in which the implant 1000 is confined within the outer shaft 500 and the outer shaft 500 is advanced (i.e., covering the implant 1000). As shown in Figure 33B, the outer shaft 500 can be retracted and the implant 1000 can be deployed. The lumen 205 is generally shorter in length, allowing a standard-length guidewire (e.g., the guidewire 1600 described herein) to be placed in the patient prior to introducing the delivery device 100 with the implant 1000. The MIS180 or PIS130 may include a guidewire exit port 350, which allows the guidewire 1600 to exit the delivery device 100 at a location in the patient or in a guide catheter (e.g., the guide catheter 1700 as described herein). As shown, the guidewire exit port 350 may be located adjacent to the junction of the MIS180 and PIS130, but may also be located at another location along the length of the delivery device 100. The proximal medial rail shaft 360 may preferably be less flexible than the MIS180 for most of its length. The proximal medial rail shaft 360 may be a solid structure (e.g., stainless steel or NiTi wire) or a tubular member (hypotube, polymer, etc.), which may include functional members 155 and / or jackets such as the PIS functional member 150 and PIS jacket 140 as described herein. The proximal medial rail shaft 360 is smaller in diameter and length than the guidewire 1600, which allows the guidewire 1600 to be outside the delivery device 100 while it is still inside the blood vessel and / or guide catheter 1700.

[0117] The proximal internal rail shaft 360 can be coupled to one or more of the MIS functional members 200, MIS jacket 190, and MIS liner 210, etc., by having at least a portion of the proximal internal rail shaft 360 straddle the guidewire exit port 350 and attaching it to the MIS 180. Alternatively, the guidewire exit port 350 may be entirely within the MIS 180 or PIS 130 using a similar coupling mechanism within the internal shaft 120.

[0118] The outer shaft 500 may include a guidewire exit port 350 to allow the guidewire 1600 to exit the delivery device 100. With the outer shaft 500 fully advanced and constraining the implant 1000, the guidewire exit port 350 in the inner shaft 120 and the outer shaft 500 can be sufficiently aligned to allow the guidewire 1600 to exit. The guidewire exit port 350 may be located in the POS region 510 or the MOS region 560 and may be configured to be located within the lumen 205.

[0119] The POS region 510 can be configured with a suitable gap for the proximal medial rail shaft 360. For example, the diameter of the gap in the POS region may be 0.001 inches to 0.020 inches, or any measurement in between, or at least 0.002 inches, 0.012 inches, or 0.020 inches. The POS region 510 may be the same as the POS region 510 described herein, but with generally smaller inner and outer diameters, given the dimensions of the proximal medial rail shaft 360 and the need for the guidewire 1600 to be outside the delivery device 100 while still being inside the vascular and / or guiding catheter 1700.

[0120] As further shown in Figures 33A and 33B, the MOS region 560 may have a sufficient inner diameter in the portion that will be retracted proximal to the guidewire exit port 350 in order to accommodate the outer diameters of the proximal outer rail shaft 630 and the guidewire 1600 within the retracted length of the MOS region 560, in a configuration in which the guidewire exit port 350 is located at least partially within the MOS region 560. In some embodiments, the configuration of the MOS region 560 allows for the movement of the guidewire 1600 and / or the delivery device 100 relative to each other when the outer shaft is retracted and the implant 1000 is deployed. The outer shaft 500 may generally include a rail outer shaft functional member 640 and / or rail outer shaft jacket 650 and / or rail outer shaft liner 660, which are identical or similar to the functional members, jackets and / or liners described herein.

[0121] Figures 34 and 35 show cross-sectional views of a delivery device (e.g., delivery device 100 as described herein) with the lumen (e.g., lumen 205 for the guidewire 1600 as described herein) omitted. Referring collectively to Figures 34 and 35, the delivery device 100 may include an inner shaft core 390 and a tip region 260 (i.e., an extended tip region). The inner shaft core 390 may provide additional support to one or more additional components of the inner shaft 120, including compression resistance. The inner shaft core 390 may have multiple sections with various properties such as diameter, flexibility, and compression resistance. This can be accomplished by changing the material, having multiple materials (e.g., polymer and metal) within the region, and / or changing the properties of the material. As shown in Figure 35, the delivery device 100 may include pre-formed shapes other than being straight longitudinally with respect to the more proximal region of the delivery device 100. In this embodiment, the tip region 260 has a curved portion suitable for navigating target anatomical structures, such as the sigmoid sinus (SS), transverse sinus (TS), and / or superior sagittal sinus (SSS). For example, the tip region 260 may have an angle α1 that is 5° to 90°, or in between, or at least 15°, 30°, 45°, 60°, or 90°, which is downward with respect to the longitudinal length of the delivery device 100.

[0122] Figure 36 shows a cross-sectional view of a delivery device 100 (e.g., the delivery device 100 described herein) with a steerable tip region 260. For example, the delivery device 100 may include separate components extending into or even more proximal to a steerable and / or deflectable distal region and / or IIS region 220 such as the tip region 260 (in contrast to including the guidewire 1600 in Figure 10). The delivery device 100 may include a deflection member 396 that can be pulled proximal or pushed distally to steer the tip region 260, and which can vary depending on an angle α1. The delivery device 100 may further include a support member 303 and one or more deflection members 396 along the length of the delivery device 100 to assist deflection in one or more directions and / or positions along the longitudinal length. The deflection member 396 may also be rotated or transitioned longitudinally within the inner shaft 120 to achieve desired deflection / steerability.

[0123] V. Techniques for implant delivery using delivery devices The following embodiment illustrates one procedure for treating sinus venous stenosis using the delivery device 100 and implant 1000 described herein. Vascular access is obtained by placing a sheath in the femoral, brachial, or jugular vein (JV). A guide catheter with an introducer (e.g., guide catheter 1700 in Figure 10) and an associated, typically 0.035-inch guidewire (e.g., guidewire 1600 in Figure 10) are inserted into the sheath and advanced to the jugular bulb. Optionally, the guide catheter 1700 can be positioned with its distal end medial to the sigmoid sinus (e.g., the sigmoid sinus (SS) in Figure 10), or the guide catheter 1700 can be further advanced into anatomical structures (e.g., the transverse sinus (TS), stenotic transverse sinus (TSN), or superior sagittal sinus (SSS) in Figure 10). Once vascular access is achieved, the guidewire 1600 (e.g., a 0.035-inch guidewire) and the guide catheter introducer are removed from the patient.

[0124] A ring located within the delivery device 100, including the implant 1000, positioned between the inner shaft 120 and the outer shaft 500, can be flushed with fluid (e.g., saline) via a flushing port and flushing port tube (e.g., the second lumen port 940 and port tube 950 in Figure 4), which may be a Luer fitting. If provided, air can be discharged through a vent in the delivery device (e.g., vent 325 in Figures 11 or 25). The lumen of the delivery device 100 (e.g., lumen 205) can be flushed with fluid (e.g., saline) via a lumen port (e.g., lumen port 920). The delivery device 100, including the implant 1000, is typically loaded with a 0.014-inch guidewire 1600 and inserted into the guide catheter 1700. The delivery device 100, including the implant 1000, is advanced near the distal end of the guide catheter 1700. A POS marker (e.g., POS marker 530 in Figure 19) can be used to allow advancement without the use of fluoroscopy. The guidewire 1600 is advanced until its distal end passes the desired location for deployment of the implant 1000. If the desired location is to have the distal end of the implant 1000 adjacent to a sinus junction, the guidewire 1600 can be advanced into either the superior sagittal sinus (SSS) or the contralateral transverse sinus (TS). The delivery device 100, including the implant 1000, is then advanced along the guidewire 1600 until the implant 1000 is in the desired location. Optionally, the delivery device 100, including the implant 1000 and the guidewire 1600, can be moved together or independently through the blood vessel in smaller increments. When the guide catheter 1700 is advanced / positioned to the location where the implant 1000 is to be deployed, the guide catheter 1700 can be retracted a sufficiently long distance so that the implant 1000 can be deployed without interference.

[0125] As determined by the radiopaque marker on the delivery device 100 (e.g., radiopaque marker 330 in Figures 11-16) and / or the radiopaque marker on the implant 1000 (e.g., radiopaque marker 1300 in Figures 5A-9A), once the implant 1000 is in the desired position, a handle (e.g., handle 800 in Figure 1) can be used to retract the outer shaft of the delivery device 100 (e.g., outer shaft 500 in Figure 1). More specifically, as the actuator (e.g., actuator 826 in Figure 31) is relaxed, the pin hub (e.g., pin hub 932 in Figure 31) can be held in place, and the handle body (e.g., handle body 822 in Figure 31) moves toward the pin hub 932, initiating the retraction of the outer shaft 500 and the deployment of the implant 1000 from the delivery device 100. The short length of the implant 1000 is initially deployed, allowing the implant 1000 to engage with the blood vessel wall. The position of the implant 1000 can be evaluated, and if the implant 1000 is in the desired position and / or at that time, further retraction of the handle body 822 is continued, retracting the outer shaft 500 until the implant 1000 is fully deployed.

[0126] When one or more additional implants 1000 are loaded onto the delivery device 100, the guidewire 1600 is moved until its distal end passes a desired location for the deployment of the additional implants 1000. The deployment of the implants 1000 at this location is carried out as described above. This can be repeated until coverage of a desired area of ​​the implants 1000 is achieved and / or all implants 1000 are deployed.

[0127] After the deployment of one or more implants 1000 is complete, the delivery device 100 is retracted into the guide catheter 1700, and the guidewire 1600 is retracted into the guide catheter 1700. Optionally, the delivery device 100 and the guidewire 1600 may be retracted together into the guide catheter 1700, or in any order or step. A diagnosis may be performed to assess the placement, physiological parameters, symptom relief, etc., provided by the initial delivery of the implants 1000. If the delivery device 100 includes a sensor 370, the diagnosis may be performed before, during, and / or after the deployment of the implants 1000, prior to the removal of the delivery device 100 from the patient. The guide catheter 1700 is then removed from the patient, and the access site is closed using known methodologies.

[0128] It is noteworthy that the delivery device 100 and / or any one of its individual components or any subset of its components, along with the implant 1000 described herein, can be used as a complete system, individually, in combination, and / or with other guidewires, catheters, or vascular and non-vascular devices. Various sizes and combinations can be selected and used depending on the intended clinical procedure.

[0129] VI. Conclusion It will be apparent to those skilled in the art that modifications may be made to the details of the embodiments described above without departing from the fundamental principles of the Art. In some cases, well-known structures and functions are not shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the Art. While steps of a method may be presented herein in a particular order, alternative embodiments may perform the steps in a different order. Similarly, certain aspects of the Art disclosed in the context of a particular embodiment may be combined with or excluded in other embodiments. Furthermore, while advantages associated with certain embodiments of the Art may be disclosed in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments must necessarily exhibit such advantages or other advantages disclosed herein in order to fall within the scope of the Art. Thus, the present disclosure and the associated Art may encompass other embodiments not expressly shown or described herein, and the present invention is not limited except by the appended claims.

[0130] Where the context allows, singular or plural terms may also contain plural or singular terms, respectively. In addition, unless the word “or” is explicitly limited to referring to a list of two or more items and meaning only a single item exclusively from the other items, the use of “or” in such a list shall be interpreted as including (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. Furthermore, as used herein, the phrase “and / or” as in “A and / or B” refers to A only, B only, or both A and B. In addition, the terms “comprising,” “including,” “having,” and “with” are used throughout to mean that any more than a number of identical features and / or other features of an additional type include at least the enumerated features, so as not to exclude them. Furthermore, as used herein, the phrases “based on,” “depends on,” “as a result of,” and “in response to” shall not be construed as references to a limited set of conditions. For example, an exemplary step described as “based on condition A” may be based on both condition A and condition B without departing from the scope of this disclosure. In other words, as used herein, the phrase “based on” shall be construed in the same manner as the phrase “based at least in part on” or “based at least partially on.”

[0131] Throughout this disclosure, the singular terms “a,” “an,” and “the” include plural referents unless the context explicitly indicates otherwise. In addition, the terms “comprising,” “including,” and “having” should be interpreted as meaning that any more than a number of identical features and / or other features of an additional type include at least the enumerated features, so as not to be excluded.

[0132] In this specification, references to “one embodiment,” “an embodiment,” “some embodiments,” or similar expressions mean that certain features, structures, operations, or characteristics described in relation to an embodiment may be included in at least one embodiment of the Art. Therefore, not all such expressions in this specification necessarily refer to the same embodiment. Furthermore, various specific features, structures, operations, or characteristics may be combined in any preferred manner in one or more embodiments.

[0133] Unless otherwise indicated, all numbers representing concentrations, shear strengths, and other numerical values ​​used in this specification and claims are understood to be modified in all cases by the term “about.” Therefore, unless otherwise indicated, the numerical parameters described in the following specification and the appended claims are approximations, which may vary depending on the desired properties to be obtained by the Art. Each numerical parameter should be interpreted, at least in light of the reported number of significant figures and by applying common rounding techniques, not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims. In addition, all ranges disclosed herein are understood to encompass all subranges incorporated therein. For example, the range “1 to 10” includes all subranges between (and including) the minimum value of 1 and the maximum value of 10, i.e., all subranges having a minimum value equal to or greater than 1 and a maximum value equal to or less than 10, e.g., 5.5 to 10.

[0134] The disclosures described above should not be construed as reflecting an intention that any claim requires features beyond those expressly enumerated in that claim. Rather, as reflected in the following claims, aspects of the invention lie in a combination of fewer features than all of any single aforementioned disclosed embodiment combined. Accordingly, the claims following this detailed description are expressly incorporated within the detailed description herein, and each claim stands alone as a separate embodiment. This disclosure includes all reordering of the independent claims with their dependent claims.

[0135] This technology is illustrated, for example, according to various aspects described below as numbered appendices (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the technology. Note that any of the dependent appendices may be combined in any combination and classified as individual independent appendices. Other appendices may also be presented in a similar format.

[0136] This technology is illustrated, for example, according to various aspects described below as numbered appendices (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the technology. Note that any of the dependent appendices may be combined in any combination and classified as individual independent appendices. Other appendices may also be presented in a similar format. 1. A delivery device configured to deliver an implant to a patient's target blood vessel, An internal shaft defining a lumen extending along the length of a delivery device, comprising an implant region including a recess, the recess configured to receive a self-expandable implant configured to expand from a constrained to an unconstrained state, An outer shaft encircling an inner shaft along at least a first portion of the length of the delivery device, the outer shaft being retractable proximal to the inner shaft, The distal tip portion of the outer shaft and / or recess, which extends to the distal end of the delivery device and includes a cross-sectional dimension that is tapered in the distal direction, A functional member extending along at least a second portion of the length of the delivery device, located within the outer shaft and / or radially between the recess and the outer shaft, wherein the functional member is configured to provide increased tensile strength to the outer shaft, A coil extending along at least a third portion of the length of the delivery device, located within the outer shaft and / or radially between the functional member and the outer shaft, A delivery device equipped with the following features. 2. The functional component is a delivery device as described in Appendix 1, comprising a braid. 3. The functional component is the delivery device described in Appendix 1, which forms the outer circumference around the recess. 4. The delivery device as described in Appendix 1, comprising fibers having a total tensile strength of at least 1.5 pounds. 5. The delivery device as described in Appendix 1, wherein the functional component comprises fibers, the fibers being strings and / or not completely enclosing the outer shaft. 6. The delivery device as described in Appendix 1, wherein the functional component comprises fibers, the fibers being strings and / or not completely enclosing the recess. 7. The delivery device according to Appendix 1, wherein the functional component comprises aramid and / or liquid crystal polymer fibers. 8. The delivery device as described in Appendix 1, wherein the functional component comprises fibers that do not completely enclose the outer shaft, and the delivery device further comprises a braid within the outer shaft. 9. The delivery device according to Appendix 1, wherein the functional component comprises fibers that do not completely enclose the recess, and the delivery device further comprises a braid that forms the outer perimeter around the recess. 10. The delivery device as described in Appendix 1, further comprising a hypotube radially inwardly oriented on the proximal and lateral shaft of the implant region, wherein the hypotube comprises stainless steel and / or nitinol. 11. The delivery device according to Appendix 1, further comprising a hypotube radially inwardly oriented proximal and functional member of the implant region, wherein the hypotube includes a variety of slots or windows along the length of the delivery device such that the flexibility of the hypotube increases distally. 12. The delivery device as described in Appendix 1, wherein the tip portion has a tip length of at least 1.5 centimeters. 13. The delivery device as described in Appendix 1, wherein the tip portion has a tip length of at least 1.5 centimeters and a proximal region having a cross-sectional dimension of 1.0 to 2.5 millimeters, and a distal region having a cross-sectional dimension of 0.5 to 1.5 millimeters. 14. The delivery device as described in Appendix 1, wherein the tip portion has a tip length of at least 1.5 centimeters, and the majority of the tip region has a cross-sectional dimension of less than 2.5 millimeters. 15. The delivery device according to Appendix 1, wherein the inner shaft is formed from a first material, and the tip portion is formed from a second material different from the first material. 16. The delivery device as described in Appendix 1, wherein the inner shaft and tip portion are formed from a single material and have a continuous surface. 17. The delivery device as described in Appendix 1, wherein the cross-sectional dimensions of the tip portion are tapered along most of the length of the tip portion. 18. The delivery device as described in Appendix 1, wherein the depression is partially defined by (i) a basal depression surface extending along a portion of the length of the delivery device, (ii) a proximal depression surface angled with respect to the basal depression surface, and (iii) a distal depression surface angled with respect to the basal depression surface. 19. The delivery device as described in Appendix 1, wherein the recess has a length of at least 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, or 10 cm. 20. The delivery device as described in Appendix 1, wherein the inner shaft or tip portion is distal to the recess and includes a shelf extending therefrom, and when the implant is restrained, the distal end of the outer shaft is above the shelf. 21. The delivery device as described in Appendix 1, wherein the inner shaft or tip portion is distal to the recess and includes a shelf extending therefrom, and when the implant is restrained, the distal end of the outer shaft overlaps the shelf by at least 2 or 3 millimeters. 22. The inner shaft or tip portion is distal to the recess and includes a shelf portion extending therefrom, When the implant is restrained, the distal end of the outer shaft is above the shelf. The outermost region of the outer shaft is longitudinally aligned with the outermost region of the tip portion and / or adjacent thereto. The delivery device described in Appendix 1. 23. The delivery device as described in Appendix 1, wherein the medial shaft comprises a proximal medial shaft region proximal to the implant region and a distal medial shaft region distal to the implant region, and the cross-sectional dimensions of the implant region are smaller than the cross-sectional dimensions of the proximal medial shaft region and the distal medial shaft region. 24. The delivery device according to Appendix 1, wherein the delivery device includes an annular region between an inner shaft and an outer shaft, and the delivery device further includes a vent extending from the annular region between a recess and a tip portion. 25. The delivery device according to Appendix 1, further comprising a vent extending outward from the ring through at least a portion of the inner shaft and / or outer shaft, wherein the vent is located in a recess of the inner shaft and / or distal thereto. 26. A delivery device configured to deliver an implant to a patient's target blood vessel, An internal shaft defining a lumen extending along the length of a delivery device, comprising an implant region including a recess configured to receive a self-expandable implant, wherein the recess is partially defined by (i) a basal recess surface extending along a portion of the length of the delivery device, (ii) a proximal recess surface angled with respect to the basal recess surface, and (iii) a distal recess surface angled at least 90° with respect to the basal recess surface, the internal shaft, An outer shaft encircling an inner shaft along at least a first portion of the length of the delivery device, the outer shaft being retractable relative to the inner shaft, The distal tip portion of the outer shaft and / or recess comprises a tip portion having a proximal region having a first cross-sectional tip dimension and a distal region having a second cross-sectional tip dimension less than the first cross-sectional tip dimension, A functional member located within and / or facing outward in a recess, configured to provide increased tensile strength to the outer shaft, A coil located within the outer shaft and / or facing outward in the radial direction of the recess, A delivery device equipped with the following features. 27. The delivery device according to Appendix 26, wherein the coil includes a first coil portion having a first rigidity and a second coil portion distal to the first coil portion having a second rigidity less than the first rigidity. 28. The delivery device according to Appendix 26, wherein the coil includes a first coil portion having a first degree of flexibility and a second coil portion distal to the first coil portion having a second degree of flexibility exceeding the first degree of flexibility. 29. The delivery device according to Appendix 26, wherein the functional component comprises a braid within an outer shaft, and the delivery device further comprises one or more fibers with a total tensile strength of at least 1.5 pounds. 30. The delivery device according to Appendix 26, wherein the functional component comprises a braid forming the outer circumference around the recess, and the delivery device further comprises fibers having a total tensile strength of at least 1.5 pounds. 31. The delivery device according to Appendix 26, wherein the functional component comprises aramid and / or liquid crystal polymer fibers. 32. The recess is at least 3 centimeters or 6 centimeters in length, and the functional member comprises fibers that do not completely surround the outer shaft and / or recess, and the delivery device further, Braids that face inward around the coil and / or form the outer circumference around the recess, The jacket that covers the coil, A hypotube for the proximal and functional member and / or outer shaft of the implant region, comprising a hypotube containing stainless steel and / or nitinol, A delivery device as described in Appendix 26, comprising the above. 33. A method for deploying an implant in a patient's target area, A step of inserting a delivery device into a patient, wherein the delivery device is A self-expanding implant configured to expand from a restrained state to an unrestrained state, Define the lumen extending along the length of the delivery device, including the recess, and the inner shaft, An outer shaft encircles an inner shaft along at least a first portion of the length of the delivery device, and the implant is located in an inward recess of the outer shaft, The outer shaft and the distal tapered tip portion of the recess, The coil inside the outer shaft, Functional components facing inward in the radial direction of the coil, It has steps, Steps include advancing the delivery device to the target area of ​​the patient, The procedure involves deploying the implant by retracting the outer shaft relative to the inner shaft, thereby allowing the implant to self-expand. After deploying the implant, the step of removing the delivery device from the patient, Methods that include... 34. The method according to Appendix 33, wherein the target region comprises a venous sinus, transverse sinus, sigmoid sinus, superior sagittal sinus, or jugular vein. 35. The method according to Appendix 33, wherein the coil includes a first coil portion having a first rigidity and a second coil portion distal to the first coil portion having a second rigidity less than the first rigidity. 36. The method according to Appendix 33, wherein the coil includes a first coil portion having a first degree of flexibility and a second coil portion distal to the first coil portion having a second degree of flexibility exceeding the first degree of flexibility. 37. The method according to Appendix 33, wherein the functional member comprises a braid forming the outer circumference around the recess and / or within the outer shaft, and the delivery device further comprises fibers having a total tensile strength of at least 1.5 pounds. 38. The recess is at least 3 centimeters or 6 centimeters in length, and the functional member comprises Vectran fibers that do not completely enclose the recess and / or the outer shaft, and the delivery device further, Braids that face inward around the coil and / or form the outer circumference around the recess, The jacket that covers the coil, A hypotube for the proximal and functional member and / or outer shaft of the implant region, comprising a hypotube containing stainless steel and / or nitinol, The method described in Appendix 33, comprising: 39. A delivery device configured to deliver an implant to a patient's target blood vessel, An inner shaft defining a lumen extending along the length of the delivery device, including a distal inner shaft tip portion having a tapered cross-sectional dimension distally, An outer shaft that surrounds an inner shaft along at least a portion of its length, and is retractable relative to the inner shaft, A self-expandable implant located radially between the lumen and the outer shaft, proximal to the distal tip of the inner shaft, wherein during operation, as the outer shaft retracts relative to the inner shaft, the implant expands from a constrained state to an unconstrained state. A delivery device equipped with the following features. 40. The delivery device according to Appendix 39, wherein the implant has a first shape in a restrained state and a second shape different from the first shape in an unrestrained state. 41. The delivery device as described in Appendix 39, wherein the implant has a circular or rounded square shape when constrained and a non-circular or rounded triangular shape when unconstrained. 42. The delivery device according to Appendix 39, comprising an implant, a first region, and a second region distal to the first region, wherein the first region includes a first shape, and the second region includes a second shape different from the first shape when expanded in free air or without an externally constraining surface. 43. The delivery device according to Appendix 39, comprising an implant, a first region, and a second region distal to the first region, wherein the first region includes a first radial force, and the second region includes a second radial force different from the first radial force. 44. The delivery device according to Appendix 39, comprising an implant, a first region, and a second region distal to the first region, wherein the first region includes a first radial force, and the second region includes a second radial force different from the first radial force. 45. The delivery device according to Appendix 39, further comprising a plurality of structures and a plurality of connectors, each extending between adjacent individual structures, wherein each individual structure comprises or consists of a continuous filament having a plurality of windings and forming a predetermined shape. 46. ​​The delivery device according to Appendix 39, further comprising multiple structures, each spaced apart from an adjacent structure and connected to an adjacent structure via one or more connectors. 47. The delivery device according to Appendix 39, the implant further comprising a first region comprising a plurality of first structures and a second region distal to the first region comprising a plurality of second structures, wherein the first structures are spaced apart from adjacent structures and connected to adjacent structures via one or more connectors, and the second structures are directly coupled to adjacent second structures. 48. The implant further comprises multiple structures connected to each other via one or more connectors, the individual structures having a length of at least 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm, or within the range of 0.5 to 10 mm, as described in Appendix 39. 49. The delivery device according to Appendix 39, the implant further comprising a first structure having a first number of turns and forming a first shape, and a second structure distal to the first structure, wherein the second structure has a second number of turns different from the first number of turns and / or a second shape different from the first shape. 50. The delivery device according to Appendix 39, the implant further comprises a first region including a plurality of first structures, each connected to an adjacent first structure via a first number of connectors, and a second region distal to the first region, each including a plurality of second structures, the second region being connected to an adjacent second structure via a second number of connectors exceeding the first number of connectors. 51. The delivery device according to Appendix 39, the implant further comprising a first region and a second region distal to the first region, each comprising a plurality of first structures having a first flexibility and a first radial outward force, the second region comprising a plurality of second structures having a second flexibility different from the first flexibility and / or a second radial outward force different from the first radial outward force. 52. The delivery device according to Appendix 39, the implant further comprising a first region each comprising a plurality of first structures defining a ring, wherein the first structures comprise a primary structure having a first width and a distal secondary structure of the primary structure having a second width different from the first width. 53. The delivery device according to Appendix 39, the implant further comprising a first region including a first structure and a second region distal to the first region including a second structure, wherein the first structure comprises a first number of turns and the second structure comprises a second number of turns different from the first number of turns, and the first structure is directly coupled to the second structure via one or more connectors. 54. The delivery device according to Appendix 39, the implant further comprising a first region comprising a plurality of first structures and a second region distal to the first region comprising a plurality of second structures, wherein each of the first structures comprises a first diameter and each of the second structures comprises a second diameter less than the first diameter. 55. The delivery device as described in Appendix 39, the implant comprising a braid, wherein the pitch of the braid varies or decreases along the length of the implant in the distal direction. 56. The delivery device according to Appendix 39, the implant comprising a first region including a structure having a filament, and a second region distal to the first region including a braid. 57. The delivery device according to Appendix 39, the implant comprising a first region including a structure having a filament, and a second region distal to the first region including a braid, wherein the first region in an unrestrained state has a first shape, and the second region in an unrestrained state has a second shape different from the first shape. 58. The implant is a delivery device as described in Appendix 39, comprising nitinol (NiTi), nitinol alloy, stainless steel, and / or a combination thereof. 59. The implant is a delivery device as described in Appendix 39, having a length of at least 2 centimeters (cm), 5 cm, 6 cm, 8 cm, 10 cm, 15 cm, 30 cm, or 15 cm, or within the range of 2 to 15 cm. 60. The delivery device as described in Appendix 39, which applies a radially outward force of at least 0.001 Newtons (N) / millimeter (mm), 0.005 N / mm, 0.01 N / mm, 0.02 N / mm, 0.05 N / mm, 0.1 N / mm, 0.5 N / mm, 1 N / mm, 2 N / mm, 3 N / mm, or 4 N / mm, or in the range of 0.001 to 40 N / mm, to the implant in a compressed and / or unrestrained state. 61. The implant is a delivery device as described in Appendix 39, having a radially outward force that decreases along the length of the implant in the distal direction. 62. The delivery device as described in Appendix 39, wherein the medial shaft and distal medial shaft tip region consist of and / or are fabricated from a single material. 63. The delivery device according to Appendix 39, wherein the medial shaft comprises a proximal medial shaft region having a first degree of flexibility and a distal medial shaft region having a second degree of flexibility exceeding the first degree of flexibility. 64. The delivery device as described in Appendix 39, wherein the medial shaft comprises a proximal medial shaft region proximal to the implant, an implant medial shaft region distal to the proximal medial shaft region, and a distal medial shaft region distal to the implant medial shaft region, wherein the cross-sectional dimensions or diameter of the implant medial shaft region are smaller than the cross-sectional dimensions or diameter of the proximal medial shaft region and / or the distal medial shaft region. 65. The delivery device as described in Appendix 39, wherein the target vessel comprises a venous sinus, transverse sinus, sigmoid sinus, superior sagittal sinus, or jugular vein.

Claims

1. A delivery device configured to deliver an implant to a patient's target blood vessel, wherein the delivery device is An inner shaft defining a lumen extending along the length of the delivery device, the inner shaft comprising an implant region including a recess, the recess configured to receive a self-expandable implant configured to expand from a constrained state to an unconstrained state, An outer shaft surrounding the inner shaft along at least a first portion of the length of the delivery device, the outer shaft comprising (i) a functional member extending along at least a second portion of the length of the delivery device and providing increased tensile strength to the outer shaft, and (ii) a coil extending along at least a third portion of the length of the delivery device, wherein the outer shaft is retractable in a proximal direction relative to the inner shaft, The distal tip portion of the outer shaft and / or the recess, the tip portion extending to the distal end of the delivery device and having a tapered cross-sectional dimension in the distal direction A delivery device equipped with the following features.

2. The delivery device according to claim 1, wherein the functional member comprises a braid that forms the outer circumference around the recess.

3. The delivery device according to claim 1, wherein the functional component comprises fibers having a total tensile strength of at least 1.5 pounds.

4. The delivery device according to claim 1, wherein the functional member comprises fibers, the fibers being strings and / or not completely enclosing the recess.

5. The delivery device according to claim 1, wherein the functional member comprises aramid and / or liquid crystal polymer fibers.

6. The delivery device according to claim 1, wherein the functional member comprises fibers that do not completely enclose the recess, and the outer shaft further comprises a braid that forms an outer circumference around the recess.

7. The delivery device according to claim 1, further comprising a hypotubule proximal to the implant region and radially inward of the functional member, wherein the hypotubule comprises stainless steel and / or nitinol.

8. The delivery device according to claim 1, further comprising a hypotube proximal to the implant region and radially inward of the functional member, wherein the hypotube includes a variety of slots or openings along the length of the delivery device such that the flexibility of the hypotube increases distally.

9. The delivery device according to claim 1, further comprising a vent extending outward from a ring between the inner shaft and the outer shaft through at least a portion of the inner shaft and / or the outer shaft, wherein the vent is located in the recess of the inner shaft and / or distal to the recess of the inner shaft.

10. The delivery device according to claim 1, wherein the tip portion has a tip length of at least 1.5 centimeters.

11. The delivery device according to claim 1, wherein the tip portion has a tip length of at least 1.5 centimeters, a proximal region having a cross-sectional dimension of 1.0 to 2.5 millimeters, and a distal region having a cross-sectional dimension of 0.5 to 1.5 millimeters.

12. The delivery device according to claim 1, wherein the tip portion has a tip length of at least 1.5 centimeters, and at least half of the tip region has a cross-sectional dimension of less than 1.5 millimeters.

13. The delivery device according to claim 1, further comprising a sensor configured to measure at least one of pressure, temperature, or flow, wherein the sensor is located on the outermost surface of the tip region.

14. The delivery device according to claim 1, wherein the functional member is a first functional member, and the delivery device further comprises a second functional member which faces inward into the recess and extends through at least a portion of the implant region and the tip portion.

15. The delivery device according to claim 1, wherein the recess is partially defined by (i) a base recess surface extending along a portion of the length of the delivery device, (ii) a proximal recess surface angled with respect to the base recess surface, and (iii) a distal recess surface angled at least 90 degrees with respect to the base recess surface.

16. The delivery device according to claim 1, wherein the recess has a length of at least 6 centimeters.

17. The delivery device according to claim 1, wherein the inner shaft or tip portion is distal to the recess and includes a shelf portion extending from the recess, and when the implant is in the restrained state, the distal end of the outer shaft overlaps with the shelf portion by at least 1 mm.

18. The inner shaft or tip portion is distal to the recess and includes a shelf portion extending from the recess. When the implant is in the restrained state, the distal end of the outer shaft is on the shelf portion. The delivery device according to claim 1, wherein the outermost region of the outer shaft is aligned longitudinally with the outermost region of the tip portion.

19. The delivery device according to claim 1, wherein the outer shaft is configured to withstand radially outward forces of 0.1 N / mm to 10 N / mm.

20. The delivery device according to claim 1, wherein the delivery device includes a minimum bending radius of at least 7 millimeters.

21. A delivery device configured to deliver an implant to a patient's target blood vessel, wherein the delivery device is An inner shaft defining a lumen extending along the length of the delivery device, the inner shaft comprising an implant region including a recess configured to receive a self-expandable implant, the recess being partially defined by (i) a base recess surface extending along a portion of the length of the delivery device, (ii) a proximal recess surface angled with respect to the base recess surface, and (iii) a distal recess surface angled at least 90 degrees with respect to the base recess surface, An outer shaft surrounding the inner shaft along at least a first portion of the length of the delivery device, wherein the outer shaft is retractable relative to the inner shaft, The distal tip portion of the outer shaft and / or the recess, wherein the tip portion comprises a proximal region having a first cross-sectional tip dimension and a distal region having a second cross-sectional tip dimension less than the first cross-sectional tip dimension, A functional member that faces outward into the recess and is configured to provide increased tensile strength to the outer shaft, The coil is radially outward of the functional member and extends across the recess. A delivery device equipped with the following features.

22. The delivery device according to claim 21, wherein the outer shaft includes the functional member and the coil such that the functional member and the coil can be retracted relative to the inner shaft.

23. The delivery device according to claim 21, wherein the functional member comprises a braid and is part of the outer shaft, and the delivery device further comprises fibers having a total tensile strength of at least 1.5 pounds.

24. The delivery device according to claim 21, wherein the functional member comprises aramid and / or liquid crystal polymer fibers.

25. The recess is at least 3 centimeters long, the functional member comprises fibers that do not completely surround the recess, and the delivery device further comprises The inward braiding of the aforementioned coil, The jacket extending over the aforementioned coil, A hypotube proximal to the implant region and inward of the outer shaft, wherein the hypotube comprises stainless steel and / or nitinol. The delivery device according to claim 21, comprising:

26. A method for deploying an implant in a target area of ​​a patient, wherein the method is The method involves inserting a delivery device into the patient, wherein the delivery device is A self-expanding implant configured to expand from a restrained state to an unrestrained state, A lumen extending along the length of the delivery device is defined, and an inner shaft including a recess is provided, An outer shaft surrounding the inner shaft along at least a first portion of the length of the delivery device, the outer shaft comprising (i) a coil and (ii) an inwardly facing functional member of the coil, the implant being positioned in the inwardly facing recess of the outer shaft, The outer shaft and the distal tapered tip portion of the recess To be equipped with, Advancing the delivery device to the target region of the patient, By retracting the outer shaft relative to the inner shaft, the implant is deployed, thereby enabling the implant to self-expand. After deploying the implant, the delivery device is removed from the patient. Methods that include...

27. The method according to claim 26, wherein the coil includes a first coil portion having a first rigidity and a second coil portion distal to the first coil portion having a second rigidity less than the first rigidity.

28. The method according to claim 26, wherein the functional member comprises a braid forming an outer circumference around the recess, and the delivery device further comprises fibers having a total tensile strength of at least 1.5 pounds.

29. The method according to claim 26, wherein the functional member comprises one or more aramid and / or liquid crystal polymer fibers having a total tensile strength of at least 1.5 pounds.

30. The recess is at least 6 centimeters long, the functional member comprises one or more fibers that do not completely enclose the recess, and the delivery device further The inward braiding of the aforementioned coil, The jacket extending over the aforementioned coil, A hypotube proximal to the implant region and inward of the outer shaft, wherein the hypotube comprises stainless steel and / or nitinol. The method according to claim 26, comprising:

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