Device and method for delivering non-balloon type expansion implants

Abstract

The present invention provides a device and method for delivering non-balloon type expansion implants. [Solution] The devices and methods described herein are for use with conventional catheters and guidewires. Access can be maintained by the catheter and / or guidewire, and the device can be retroloaded into the guidewire and catheter and advanced to the target. The device may include a tubular shaft having a lumen for housing the guidewire, at least one opening for housing the features of an implant positioned on the tubular shaft, and a plurality of relief cuts. The outer diameter of the tubular shaft is sized relative to the inner diameter of the catheter for housing the tubular shaft, so that a sheath cannot be positioned in the catheter lumen when the tubular shaft is in the catheter lumen. The tubular shaft can be displaced axially in the catheter lumen to advance or retract the implant positioned on the tubular shaft.

Description

Technical Field

[0001] (Cross - reference to related applications) This application claims the priority of U.S. Provisional Patent Application No. 63 / 491,128, filed on March 20, 2023, the entire content of which is incorporated herein by reference.

[0002] This disclosure generally relates to the field of interventional therapy, and more specifically to the field of intravascular stent placement. What is described herein are stent delivery devices and methods.

Background Art

[0003] Self - expanding stents are used in a variety of clinical applications, including interventions for coronary artery disease, congenital heart disease, gastrointestinal disorders, and peripheral vascular disease. Conventional systems for delivering self - expanding stents include "on - wire" systems that include a stent crimped onto a tube and stored within a sheath, where the entire system is pushed into, through, or along a delivery catheter. These systems can be very rigid. Alternatively, conventional systems for delivering self - expanding stents can include "bare catheter" systems that have a stent crimped onto a pusher wire and stored within a sheath. In that case, the stent is transferred from the sheath to the rear of the delivery catheter using the pusher wire and then pushed along the length of the delivery catheter in a sheath - removed configuration.

Summary of the Invention

Means for Solving the Problems

[0004] In some embodiments, the technology described herein relates to a system for delivering a vascular implant, the system comprising a tubular shaft including a proximal section defining a lumen, an implant-connecting section joined to the proximal section, the implant-connecting section defining at least one opening, the implant-connecting section configured to accommodate an implant feature located on the outer diameter of the tubular shaft, and a plurality of relief cuts of the tubular shaft to enhance the flexibility of the tubular shaft.

[0005] In some embodiments, the techniques described herein relate to a method for delivering a vascular implant, the method comprising advancing a guidewire and a catheter to a target site, wherein the guidewire is configured to be moved axially in parallel in the catheter, loading a tubular shaft onto the guidewire into the lumen of the catheter, wherein an implant is positioned on at least a portion of the tubular shaft, and moving the tubular shaft axially in parallel on the guidewire through the lumen of the catheter.

[0006] In some embodiments, the technology described herein relates to a system for delivering a vascular implant, the system comprising: a tubular shaft comprising a proximal section defining a lumen, an implant-connecting section defining at least one opening, and a plurality of relief cuts of the tubular shaft; an implant having a proximal end comprising at least one feature, which is positioned on the tubular shaft, which has at least one feature positioned on at least one opening of the tubular shaft; and a catheter defining a lumen having an inner diameter, wherein the inner diameter of the catheter is sized relative to the outer diameter of the tubular shaft such that a sheath cannot be positioned in the lumen of the catheter when the tubular shaft is in the lumen of the catheter, and the tubular shaft is configured to be axially displaced in the lumen of the catheter to advance or retract the implant positioned on the tubular shaft. [Effects of the Invention]

[0007] The above is a summary and therefore inevitably limits the details. The above-described aspects, along with other aspects, features, and advantages of the technology, are described below in relation to various embodiments with reference to the accompanying drawings. [Brief explanation of the drawing]

[0008] [Figure 1] This shows a catheter on a guidewire in a target vessel. [Figure 2A] This shows the distal portion of an embodiment of a self-expanding stent that is crimped onto a tubular shaft and positioned on a guidewire within the lumen of a catheter. [Figure 2B] This shows a schematic cross-sectional view of the guidewire inside the tubular shaft within the catheter. [Figure 2C] This diagram shows a schematic cross-section of the guide inside the tubular shaft within the catheter, with the implant positioned within the tubular shaft. [Figure 3] This shows the proximal portion of an embodiment of a self-expanding stent that is crimped onto a tubular shaft and positioned on a guidewire within the lumen of a catheter. [Figure 4] This shows an enlarged view of the distal portion of an embodiment of a stent crimped onto a tubular shaft. [Figure 5] This shows an enlarged view of the proximal portion of an embodiment of a stent crimped onto a tubular shaft. [Figure 6] The image shows an enlarged view of the opening defined by the proximal portion of the tubular shaft, where the size and shape of the opening are determined to accommodate the radiopaque marker in the proximal portion of the stent. [Figure 7A] A schematic diagram of an embodiment of a tubular shaft is shown. [Figure 7B] A schematic diagram of a portion of a tubular shaft is shown. [Figure 8] An embodiment of the proximal section of a tubular shaft is shown. [Figure 9] An embodiment of the distal section of a tubular shaft is shown. [Figure 10A] A perspective view of an embodiment of the implant connection section of a tubular shaft is shown. [Figure 10B] A perspective view of an embodiment of the implant connection section of a tubular shaft is shown. [Figure 11] Figure 10B shows a side view of the implant connection section. [Figure 12] A perspective view of an embodiment of the implant connection section of a tubular shaft is shown. [Figure 13] This image shows a magnified view of a portion of a tubular shaft to which an implantable radiopaque marker is attached. [Figure 14] This image shows a magnified view of a portion of the tubular shaft to which the implant is attached. [Figure 15] This shows the two-dimensional compression state of the implant embodiment. [Figure 16] Figure 15 shows a magnified view of the radiopaque marker on the implant. [Figure 17] This is a schematic diagram of an embodiment of a method for delivering an implant to a target site. [Figure 18] This is a schematic diagram of an embodiment of a method for delivering an implant to a target site. [Modes for carrying out the invention]

[0009] The illustrated embodiments are for illustrative purposes only and are not intended to limit the disclosure. The schematic diagrams are drawn to illustrate features and concepts and are not necessarily drawn to a specific scale.

[0010] The above is a summary and is therefore necessarily limited in detail. The above-described aspects, along with other aspects, features, and advantages of the Technology, will be described below in relation to various embodiments. The inclusion of the following embodiments is not intended to limit this disclosure to these embodiments, but rather to enable those skilled in the art to manufacture and use the invention under consideration. Other embodiments may be used and may be modified without departing from the spirit or scope of the subject matter presented herein. The aspects of the disclosure may be prepared, combined, modified, and designed in various different forms as described and illustrated herein, all of which are expressly considered and form part of this disclosure.

[0011] Generally, the systems, devices, and methods described herein can be used for coronary applications, peripheral applications, neurovascular applications, and / or pediatric applications. For example, the systems, devices, and methods described herein can provide improved techniques for implanting into or onto blood vessels where substantial changes between systolic and diastolic diameters, forces due to fluid patterns capable of moving an implant, changes in biological structures (e.g., the tendency of an arterial vessel to close), or other situations that cause substantial forces or diameter changes are seen.

[0012] In some embodiments, the systems, devices, and methods described herein can be used to treat and / or manage patient conditions associated with arterial vessels or other tortuous biological structures. These embodiments can provide technical solutions to address the challenges faced by treating physicians, including a delivery system specifically sized for a target population (e.g., pediatric), insertion, guidance, and deployment in a tortuous biological structure, and accurate implant placement that also ensures avoidance of additional procedures to adjust and correct the placement of the implant.

[0013] Generally, the implants used herein can refer to stents, self-expanding stents, stent retrievers, flow diverters, thrombus capture devices, septal catheters, flow occluders, and flow restrictors, among others.

[0014] More specifically, there are a variety of technical problems associated with conventional delivery systems for self-expanding stents. Conventional delivery systems for self-expanding stents are cumbersome and typically involve the use of multiple shafts, including at least a pusher wire to which the stent is positioned and a sheath positioned on the stent, all of which are located within a delivery catheter. The delivery system described herein provides a technical solution to the above technical problems. For example, to simplify and / or streamline setup and stent delivery, the delivery system described herein has fewer components than conventional systems. In addition, the delivery system described herein includes a tubular shaft to which the stent is positioned or crimped. The proximal portion of the tubular shaft includes one or more key-joint surfaces or notches (also known as openings or windows) that have a shape to accommodate one or more features of the stent (e.g., radiopaque markers). Thus, the tubular shaft also functions to advance and retract the stent in the catheter lumen before stent deployment.

[0015] A further technical problem with conventional delivery systems is that they generally limit the physician's ability to select an appropriate or desirable catheter type and / or size, as such selections are typically limited by the specifications of the delivery system. The delivery system described herein provides a technical solution to this technical problem. By providing a tubular shaft that can be delivered on a wire within a catheter already deployed or positioned (i.e., access maintained) at the target site, the physician may be able to select a desired catheter type and / or size, ensuring that the physician is not limited to a specific catheter packaged in (or assigned to) the delivery system. Accordingly, the stent delivery system and method described herein reduce the number of system components and allow the physician to select a catheter size appropriate for the patient and / or target biostructure.

[0016] Furthermore, the technical solutions provided by the systems, devices, and methods described herein offer one or more of the following: access to a target biostructure by some catheter and / or some guidewire; maintenance of the guidewire position so as not to impair access (e.g., based on procedure, physician, etc.); posterior loading of an implant on a guidewire with a tubular shaft; placement of a tubular shaft and implant in an empty catheter (e.g., without a sheath to restrain the implant) that is already in place (i.e., without needing to replace an existing catheter with a different delivery catheter); maintenance of the position of both the guidewire and catheter across or within a target vessel; the option of replacing an existing guidewire with a different guidewire using the systems described herein without removing the tubular shaft and / or implant from the catheter; and / or adjustment of the amount of leading guidewire and the location of guidewire access.

[0017] The technical solutions provided by the various embodiments of the tubular shaft described herein may include one or more of the following: openings or other features in the proximal and / or distal end portions of the tubular shaft that enable mating with an implant; openings or other features in the proximal and / or distal end portions of the tubular shaft that enable removal of the implant from the delivery system (at the proximal or operator end of the system); openings or other features in the proximal and / or distal end portions of the tubular shaft that provide redundancy to the mating mechanism while enabling the implant to be pushed in (advance) and pulled out (retract) even when the end or feature or opening is dismatted; maximization of the lumen for a guidewire defined by the tubular shaft by not providing a sheath surrounding the implant to save wall thickness; the ability to ensure guidewire access for implant deployment while using any catheter of appropriate inner diameter; implant stability and support provided while maintaining flexibility for delivery through tortuous vessels; and the ability to match the flexibility of the implant with the flexibility of the tubular shaft using cut patterns and / or materials.

[0018] Described herein are delivery systems comprising a non-balloon type expansion stent that can be positioned on or crimped onto a tubular shaft. The tubular shaft may include features used for fitting and pushing (e.g., advancing) or pulling (e.g., retracting) the stent within the lumen of a catheter.

[0019] Alternatively, the implant does not have to be crimped to the tubular shaft, but instead may be coupled to the distal end of the tubular shaft (using one or more features of the tubular shaft having a shape and / or arrangement that interacts with the implant) and be axially translated in the lumen of the catheter. For example, as described in more detail elsewhere herein, the tubular shaft may have a proximal section and an implant-connecting section, but not a distal section.

[0020] In general, the methods and devices described herein may be used in any application where a non-balloon dilating stent or implant is guided in a blood vessel and / or delivered to a target site. In some embodiments, guidewire access may be maintained separately from delivery so that the devices and methods described herein may be used in conjunction with a guidewire placed in the blood vessel before the introduction of the delivery system component. The systems described herein may be considered "on the wire" so that guidewire access may be maintained during the procedure. The tubular shaft defines a lumen for housing the guidewire. In other words, the tubular shaft may maintain or define the guidewire lumen so that the tubular shaft may be retroloaded on the guidewire.

[0021] The tubular shafts described herein include or may be formed from laser-cut metal shafts. For example, tubular shafts may be fabricated or formed from laser-cut metal hypotubes (e.g., nitinol, stainless steel, etc.) or polymers or shafts connected to each other to provide a desired flexible profile (i.e., a laser-cut nitinol distal end for flexibility, connected to a polymer or stainless steel end for the transmission of pressing forces). For example, when a tubular shaft contains a material such as nitinol, the cut pattern may be less pronounced due to the high flexibility of the material. For example, when a tubular shaft contains a material such as stainless steel, the cut pattern may be more pronounced due to the low flexibility of the material. The laser-cut tubular shafts described herein are designed for flexibility and the transmission of pressing and tensile forces. For example, the tubular shaft may include offset cuts to prevent the tube from stretching or shortening.

[0022] The systems and devices described herein may function to deliver implants to a target site on a wire within a blood vessel using an empty catheter (e.g., a catheter without a sheath to restrain the implant). Such systems and devices may be used in intravascular interventions, such as in the coronary arteries, neurovascular, peripheral arteries, arteries, and / or veins of adults and children.

[0023] Figure 1 shows the distal portion 100 of the catheter 120 on the guidewire 130 within the target vessel 110. The guidewire 130 advances through the vessel 110 to the target site or biostructure, and the catheter 120 advances on the guidewire 130 to the target site or biostructure. The catheter 120 has an outer diameter 132 and an inner diameter 134 (also shown in Figures 2B-2C). Figure 1 illustrates access to the target biostructure or target site within the vessel 110. The target biostructure or target site may be the ductus arteriosus. The target biostructure or target site may be the coronary artery. The target biostructure or target site may be an internal cranial location. The target biostructure or target site may be a peripheral vascular structure (vein or artery). The target biostructure or target site may be the pulmonary artery, which is fluidly connected to the ductus arteriosus. The target biostructure or target site may be the aorta, which is fluidly connected to the ductus arteriosus.

[0024] Figures 2A-2C are side and cross-sectional views of the distal portion 200 of the delivery system, respectively. For example, as shown in Figure 2A, the delivery system includes an implant 250 (e.g., a stent) positioned in at least a portion of the tubular shaft 240. The tubular shaft 240 can be positioned on the guidewire 230 within the lumen 222 of the catheter 220. For example, the tubular shaft 240 and the implant 250 can be retroloaded into the lumen 222 of the catheter 220 on the guidewire 230 and advanced through the lumen 222 of the catheter 220 to the target biostructure of the blood vessel 210. As shown in Figure 2B, the outer diameter 242 of at least a portion of the tubular shaft 240 (e.g., the distal portion of the tubular shaft) is smaller than the inner diameter 224 of the catheter 220, and the tubular shaft 240 is shown positioned in the lumen 222 of the catheter 220. In some embodiments, the outer diameter 242 of at least a portion (e.g., the proximal portion) of the tubular shaft 240 may be about 85% to about 98% of the inner diameter 224 of the catheter 220, about 85% to about 90% of the inner diameter 224 of the catheter 220, about 95% to about 98% of the inner diameter 224 of the catheter 220, about 88% to about 95% of the inner diameter 224 of the catheter 220, or about 90% to about 97% of the inner diameter 224 of the catheter 220. Furthermore, for example, the outer diameter 242 of at least a portion (e.g., the distal portion) of the tubular shaft 240 may be approximately 65% ​​to 95% of the inner diameter 224 of the catheter 220, approximately 70% to 80%, approximately 80% to 90%, approximately 70% to 75%, approximately 85% to 90%, or approximately 80% to 83%.

[0025] As shown in Figure 2B, the outer diameter 232 of the guidewire 230 is smaller than the inner diameter 246 of at least a portion of the tubular shaft 240. In this example, the guidewire 230 is shown as being positioned in the lumen 248 of at least a portion of the tubular shaft 240. For example, the outer diameter 323 of the guidewire 230 could be about 75% to about 85% of the inner diameter 246 of at least a portion of the tubular shaft 240 (e.g., the proximal section), about 75% to about 80% of the inner diameter 246 of at least a portion of the tubular shaft 240, about 76% to about 81% of the inner diameter 246 of at least a portion of the tubular shaft 240, or about 77% to about 80% of the inner diameter 246 of at least a portion of the tubular shaft 240.

[0026] Furthermore, for example, the outer diameter 323 of the guide wire 230 may be about 85% to about 95% of the inner diameter 246 of at least a portion of the tubular shaft 240 (e.g., the distal section), about 88% to about 93% of the inner diameter 246 of at least a portion of the tubular shaft 240, about 89% to about 91% of the inner diameter 246 of at least a portion of the tubular shaft 240, or about 90% to about 94% of the inner diameter 246 of at least a portion of the tubular shaft 240.

[0027] As shown in Figure 2C, the outer diameter 242 of at least a portion of the tubular shaft 240 (e.g., the distal portion of the tubular shaft, if present) is smaller than the inner diameter 252 of the crimping implant 250 or implant 250 that is positioned or coupled to the tubular shaft. For example, the diameter 242 of at least a portion of the tubular shaft 240 may be about 75% to about 98% of the inner diameter 252 of the crimping implant positioned on the tubular shaft. The diameter 242 of at least a portion of the tubular shaft 240 may be about 75% to about 85% of the inner diameter 252 of the crimping implant positioned on the tubular shaft. The diameter 242 of at least a portion of the tubular shaft 240 may be about 90% to about 98% of the inner diameter 252 of the crimping implant positioned on the tubular shaft. The diameter 242 of at least a portion of the tubular shaft 240 may be about 85% to about 97% of the inner diameter 252 of the crimping implant positioned on the tubular shaft. Furthermore, the outer diameter 256 of the implant 250 positioned around the tubular shaft 240 is smaller than the inner diameter 224 of the catheter 220. For example, the outer diameter 256 of the implant 250 may be approximately 90% to 99% of the inner diameter 224 of the catheter 220. The outer diameter 256 of the implant 250 may be approximately 90% to 95% of the inner diameter 224 of the catheter 220. The outer diameter 256 of the implant 250 may be approximately 93% to 98% of the inner diameter 224 of the catheter 220.

[0028] In some embodiments, the inner diameter of a tubular shaft may be covered with or include a coating of a lubricating material (e.g., silicone, PTFE, etc.) to reduce friction between the guide wire's access to or translation of the guide wire within the lumen of the tubular shaft.

[0029] Figure 3 shows the proximal portion 300 of the delivery system. For example, the delivery system includes an implant 350 positioned on a tubular shaft 340. The tubular shaft 340 can be positioned on a guidewire 330 within the lumen of the catheter 320. The proximal portion of the tubular shaft 340 defines one or more openings or windows 344, examples of which are described below with respect to Figures 10A-13. One or more openings or windows 344 have a size and / or shape such that they accommodate one or more features 349 of the implant 350 (e.g., radiopaque markers). Although one or more openings or windows 344 are shown in the proximal portion or section of the outer diameter of the tubular shaft 340, one or more openings or windows 344 may additionally or alternatively be located in the distal portion (e.g., distal section) or the intermediate portion (e.g., implant connection section) of the tubular shaft 340. For example, an implant 350 that interacts with a tubular shaft 340 may include one or more radiopaque markers 348 at its proximal and / or distal ends, such that the radiopaque markers 348 interact with one or more openings or windows 344 to allow the implant 350 to be pushed into or pulled out of the catheter 320 and / or guidewire 330.

[0030] Alternatively, one or more other features of the implant may engage with one or more elements of the tubular shaft to advance and retract the stent. For example, one or more elements of the tubular shaft may have a larger outer diameter than the crimp stent (or another part of the tubular shaft) to push the stent in. Furthermore, one or more elements of the tubular shaft may have a smaller outer diameter than the crimp stent, for example, to fit beneath the stent and engage with it to push or pull the stent through the lumen of the catheter.

[0031] In some embodiments, the implant may move parallel to the tubular shaft without the engagement of the implant's radiopaque marker or other features. This can occur if, when in the lumen of the catheter, the outer diameter of at least a portion of the tubular shaft matches or is substantially similar to the outer diameter of the implant. Thus, the implant may be pushed distally toward the tip of the catheter, but it may not be possible to pull the implant proximal within the catheter.

[0032] In some embodiments, the implant may be fitted to the proximal and / or distal portions of the tubular shaft by using one or more fixing features (e.g., complementary female and male connectors) between the implant and the tubular shaft.

[0033] Furthermore, as shown in Figure 3 and described above with reference to Figures 2B-2C, the catheter 320 defines a lumen 322 having an inner diameter 324 to accommodate the tubular shaft 340. The inner diameter 324 of the catheter 320 is sized relative to the outer diameter 342 of the tubular shaft 340 so that a sheath cannot be placed in the lumen 322 of the catheter 320 when the tubular shaft 340 is in the lumen 322 of the catheter 320.

[0034] Figure 4 shows an enlarged view of the distal portion 400 of one embodiment of an implant 450 crimped (or positioned) onto a tubular shaft 440. The implant 450 positioned on the tubular shaft 440 is shown positioned in the lumen of the catheter 420. The tubular shaft 440 includes one or more relief cuts 446 (e.g., cut patterns, optionally laser-cut) for flexibility. In some embodiments, one or more radiopaque markers (illustrated and described with reference to Figures 13-16) on the distal portion of the implant interact with one or more openings or windows in a portion of the outer diameter of the tubular shaft. For example, one or more windows or openings on the tubular shaft can engage with radiopaque markers on both sides of the implant (i.e., the distal and proximal sides of the stent) or on one side (i.e., the proximal side). Various openings or windows are described with reference to Figures 10A-12.

[0035] In some configurations of the system described herein, the tubular shaft may include a backstop 1010, bumper, ring, or raised shaft, as shown in Figure 10A, on the outer diameter of the tubular shaft at the proximal end of one or more windows or openings 1016, in order to press against the radiopaque marker (or other feature) of the implant and advance the implant through the lumen of the catheter.

[0036] Figure 5 shows an enlarged view of the proximal portion 500 of one embodiment of an implant 550 crimped or positioned on a tubular shaft 540. As shown in Figure 5, one or more radiopaque markers 548 (or other features) of the implant 550 engage with one or more windows or openings 544 of the tubular shaft 540. As further shown, the implant 550 positioned on the tubular shaft 540 is positioned in a catheter 520 and is axially translated (or axially displaced) within the inner diameter of the catheter 520. For example, at least a portion of the implant 550 is axially translated within the lumen of the catheter 520 through the interaction between one or more radiopaque markers 548 (or other features) of the implant 550 and one or more windows or openings 544 of the tubular shaft 540. The tubular shaft 540 includes one or more relief cuts 546 for flexibility.

[0037] Figure 6 shows a magnified view of an opening 644 defined by a portion of the tubular shaft 640. The opening 644 is sized and shaped to accommodate or connect to a radiopaque marker (or other feature) of the implant, so that the opening 644 may be used to advance or retract the implant relative to a catheter. Figure 6 also shows a magnified view of a relief cut 546 of the tubular shaft 640. The relief cut 546 is arranged in an intermittent helical cut pattern, but may alternatively be arranged in a brick-like cut pattern. For example, the tubular shaft 640 may include a spine (e.g., axial or helical) to allow both intrusion and traction without causing compression or extension of the tubular shaft 640.

[0038] Figure 7A shows one embodiment of the tubular shaft 700. The tubular shaft 700 includes a proximal section 710, an implant-connecting section 720, and a distal section 730. In some embodiments, the tubular shaft 700 includes the proximal section 710 and the implant-connecting section 720, but does not include the distal section 730. The proximal section 710 functions for the pushability of the tubular shaft. The implant-connecting section 720 (see, for example, Figures 10A-12) functions to be reversibly connected to the implant using one or more complementary shaped windows or openings 722 that connect, for example, to a radiopaque marker or other feature of the implant. The distal section 730 functions to guide the implant on the guidewire through the vascular structure. The distal section 730 includes an implant-receiving section 732. For example, at least a portion of the implant may cover the implant-receiving section 732. To improve delivery efficiency, the distal section 730 may have less flexibility than the implant in order to enhance the flexibility of the combination of the distal section 730 and the implant placed on top of it.

[0039] The distal end 712 of the proximal section 710 can be joined to the proximal end 724 of the implant connection section 720. In some embodiments, the proximal section 710 and the implant connection section 720 are a monolithic shaft or a continuous tube.

[0040] The distal end 726 of the implant connection section 720 may be joined to the proximal end 734 of the distal section 730. Joints between adjacent sections may be formed by welding, soldering, and brazing. In some embodiments, the joint between the proximal section 710 and the implant connection section 720 may use a first joining method (e.g., welding, soldering, brazing, etc.), and the joint between the implant connection section 720 and the distal section 730 may use a different joining method than the first joining method. In some embodiments, the joint between the proximal section 710 and the implant connection section 720 may use a first material, and the joint between the implant connection section 720 and the distal section 730 may use a different material than the first material. In some embodiments, the joint between the proximal section 710 and the implant connection section 720 and the joint between the implant connection section 720 and the distal section 730 may contain the same material and / or use the same process (e.g., welding, soldering, brazing, etc.).

[0041] The proximal section 710 may have a larger outer diameter than the distal section 730. For example, the outer diameter of the proximal section 710 may be approximately 110% to 135% larger, approximately 115% to 130% larger, approximately 115% to 120% larger, or approximately 125% to 130% larger than the outer diameter of the distal section 730. The implant connection section 720 may have a substantially similar outer diameter to the proximal section 710. The change from the outer diameter of the proximal section 710 or implant connection section 720 to the outer diameter of the distal section 730 may be a stepwise decrease (i.e., not a tapering or gently sloping transition). In some embodiments, the transition between the proximal section 710 or implant-connecting section 720 and the distal section 730 is gradual or tapered, based on tapering or making the joining process narrower in each section and / or in the joining process. For example, the joining process may be tapered so that the change in outer diameter is tapered from a large outer diameter to a small outer diameter by tapering the joining material.

[0042] In some embodiments, the tubular shaft has a monolithic structure, such as a laser-cut hypotube. In such embodiments, the outer diameter of the tubular shaft may be substantially uniform.

[0043] In some embodiments, each of the proximal section 710, the implant-connecting section 720, and the distal section 730 is formed from, encompasses, or includes, for example, stainless steel, titanium alloy, platinum, tantalum, palladium, or a combination thereof. For example, in some embodiments, each section is formed from stainless steel.

[0044] Figure 7B shows a schematic diagram of a portion of the tubular shaft 700, illustrating various parameters of the tubular shaft 700. For example, the cut pattern of the tubular shaft 700 may include parameters such as spine length 701, pitch 703, and columns per revolution 705. The spine length 701 may define the length (parallel to the longitudinal axis 707) of the solid region between adjacent cut ends 711a, 711b. The pitch 703 may define the length (parallel to the longitudinal axis 707 of the tubular shaft 700) between adjacent cuts 709a, 709b, and can determine the stiffness of the tube. The denser the pitch 703, the smaller the distance between adjacent cuts 709a, 709b, and the greater the flexibility of the tubular shaft. The columns per revolution 705 may define the number of columns 705 per 360 degrees of the tubular shaft 700. Column 705 can suppress the compression or extension of the tubular shaft 700 when the stent is inserted.

[0045] Figure 8 shows a schematic diagram of the proximal section 710 of the tubular shaft 700. The proximal section 710 may include one or more regions 812, 814, 816, 818, 820, and / or 822. In some embodiments, the proximal section 710 includes multiple regions (e.g., regions 812, 814, 816, 818, 820, 822). The proximal section 710 may include at least one region, e.g., region 812, region 814, region 816, region 818, region 820, or region 822.

[0046] In some embodiments, region 812 may have a length 830 that is about 80% to about 95% of the total length 828. Region 812 may have a length 830 that is about 85% to about 99% of the total length 828. Region 812 may have a length 830 that is about 85% to about 90% of the total length 828.

[0047] In some embodiments, region 814 may have a length 832 that is about 1% to about 10% of the total length 828, about 2% to about 8% of the total length 828, about 4% to about 6% of the total length 828, or about 5% to about 6% of the total length 828.

[0048] In some embodiments, region 816 may have a length 834 that is about 1% to about 10% of the total length 828, about 2% to about 6% of the total length 828, about 3% to about 6% of the total length 828, or about 4% to about 5% of the total length 828.

[0049] In some embodiments, region 818 may have a length 836 that is about 0.1 to about 2% of the total length 828, about 0.1% to about 1% of the total length 828, about 0.1% to about 0.5% of the total length 828, about 0.1% to about 1.5% of the total length 828, about 0.2% to about 0.3% of the total length 828, or about 0.2% to about 1% of the total length 828.

[0050] In some embodiments, regions 820, 822 may be raw hypotube. In other words, the distal end 824 and / or proximal end 826 of the proximal section 710 may be raw hypotube. For example, region 820 may be used for bonding to the implant bonding section 720 or the distal section 730. In some embodiments, region 820 may have a length 838 which is about 0.01% to about 1% of the total length 828, about 0.01% to about 0.08% of the total length 828, about 0.01% to about 0.08% of the total length 828, about 0.02% to about 0.06% of the total length 828, about 0.03% to about 0.05% of the total length 828, about 0.005% to about 0.05% of the total length 828, or about 0.008% to about 0.015% of the total length 828.

[0051] In some embodiments, the total length 828 of the proximal section 710 may be about 75 cm to about 100 cm, about 75 cm to about 90 cm, or about 80 cm to about 90 cm, for example, for pediatric use. The total length 828 of the proximal section 710 may be about 120 cm to about 150 cm, for example, for intracranial use. The total length 828 of the proximal section 710 may be about 80 cm to about 140 cm, for example, for vascular use.

[0052] Regions 812, 814, 816, 818, 820, or 822 may have a cut pattern with an increasing pitch. Regions 812, 814, 816, 818, 820, or 822 may have a cut pattern with a decreasing pitch. Regions 812, 814, 816, 818, 820, or 822 may have a cut pattern with a substantially constant pitch.

[0053] In some embodiments, a region having a cut pattern with a gradually decreasing pitch is adjacent to a region having a cut pattern with a substantially constant pitch. In some embodiments, a region having a cut pattern with a gradually increasing pitch is adjacent to a region having a cut pattern with a substantially constant pitch. In some embodiments, a region having a cut pattern with a substantially constant pitch lies between regions having a cut pattern with a gradually changing pitch (either increasing or decreasing pitch).

[0054] Any of regions 812, 814, 816, 818, 820, or 822 may have a cut pattern with gradually increasing spine length. Any of regions 812, 814, 816, 818, 820, or 822 may have a cut pattern with gradually decreasing spine length. Any of regions 812, 814, 816, 818, 820, or 822 may have a cut pattern with substantially constant spine length.

[0055] In some embodiments, a region having a cut pattern with a gradually decreasing spine length is adjacent to a region having a cut pattern with a substantially constant spine length. In some embodiments, a region having a cut pattern with a gradually increasing spine length is adjacent to a region having a cut pattern with a substantially constant spine length. In some embodiments, a region having a cut pattern with a substantially constant spine length lies between regions having a cut pattern with a gradually changing spine length (either increasing or decreasing spine length).

[0056] Regions 812, 814, 816, 818, 820, or 822 may be substantially unprocessed. Regions 812, 814, 816, 818, 820, or 822 may have an intermittent helical cut pattern. Regions 812, 814, 816, 818, 820, or 822 may have a brick-like cut pattern.

[0057] In some embodiments, a region having a cut pattern with a gradually decreasing pitch is adjacent to a substantially unprocessed region. In some embodiments, the substantially unprocessed region is adjacent to a region having a cut pattern with a substantially constant pitch. In some embodiments, the substantially unprocessed region is adjacent to a region having an intermittent helical cut pattern. In some embodiments, the substantially unprocessed region is adjacent to a region having a brick-like cut pattern. In some embodiments, the unprocessed region is located at the distal end 824 of the proximal section 710. In some embodiments, the unprocessed region is located at the proximal end 826 of the proximal section 710.

[0058] In some embodiments, the region having an intermittent helical cut pattern does not overlap with the region having a brick-like cut pattern. In some embodiments, the region having an intermittent helical cut pattern overlaps with the region having a brick-like cut pattern.

[0059] In some embodiments, at least one region has a cut pattern having a gradually increasing pitch that increases proximal toward the proximal end 826 of the proximal section 710. In some embodiments, one or more regions have a cut pattern having a gradually increasing pitch that increases proximal toward the proximal end 826 of the proximal section 710. The pitch may gradually increase from about 0.025 mm (0.001 in) to about 0.203 mm (0.008 in), from about 0.051 mm (0.002 in) to about 0.203 mm (0.008 in), from about 0.051 mm (0.002 in) to about 0.179 mm (0.007 in), from about 0.051 mm (0.002 in) to about 0.152 mm (0.006 in), or from about 0.076 mm (0.003 in) to about 0.152 mm (0.006 in). For example, any of regions 812, 814, 816, or 818 may have a gradually increasing pitch that increases proximal to the proximal end 826 of the proximal section 710. For example, region 814 may have a gradually increasing pitch that increases proximal to the proximal end 826 of the proximal section 710.

[0060] In some embodiments, at least one region has a cut pattern having a tapering pitch that decreases proximal toward the proximal end 826 of the proximal section 710. In some embodiments, one or more regions have a cut pattern having a tapering pitch that decreases proximal toward the proximal end 826 of the proximal section 710. The pitch may decrease from about 0.203 mm (0.008 in) to about 0.025 mm (0.001 in), from about 0.203 mm (0.008 in) to about 0.051 mm (0.002 in), from about 0.179 mm (0.007 in) to about 0.051 mm (0.002 in), from about 0.152 mm (0.006 in) to about 0.051 mm (0.002 in), or from about 0.152 mm (0.006 in) to about 0.076 mm (0.003 in). For example, any of regions 812, 814, 816, or 818 may have a tapering pitch that decreases in the proximal direction toward the proximal end 826 of the proximal section 710. For example, region 818 may have a tapering pitch that decreases in the proximal direction toward the proximal end 826 of the proximal section 710.

[0061] In some embodiments, at least one region has a cut pattern with a substantially constant pitch. In some embodiments, one or more regions have a cut pattern with a substantially constant pitch. In some embodiments, the substantially constant pitch is approximately 0.025 mm (0.001 in) to approximately 0.38 mm (0.015 in), approximately 0.025 mm (0.001 in) to approximately 0.152 mm (0.006 in), approximately 0.051 mm (0.002 in) to approximately 0.127 mm (0.005 in), approximately 0.051 mm (0.002 in) to approximately 0.102 mm (0.004 in), and approximately 0.051 mm m(0.002in) to approximately 0.076mm(0.003in), approximately 0.203mm(0.008in) to approximately 0.38mm(0.015in), approximately 0.203mm(0.008in) to approximately 0.305mm(0.012in), approximately 0.229mm(0.009in) to approximately 0.280mm(0.011in), or 0.229mm(0.009in) to approximately 0.254mm(0.010in). For example, any of regions 812, 814, 816, or 818 may have a substantially constant pitch. For example, either or both of region 812 or region 816 may have a substantially constant pitch. For example, one or both of region 812 or region 816 may have a substantially constant pitch of about 0.203 mm (0.008 in) to about 0.305 mm (0.012 in). For example, one or both of region 812 or region 816 may have a substantially constant pitch of about 0.229 mm (0.009 in) to about 0.280 mm (0.011 in).

[0062] In some embodiments, at least one region of the proximal section 710 has a plurality of relief cuts formed by an intermittent helical cut pattern. For example, about 5% to about 99% of the proximal section 710 may have an intermittent helical cut pattern. About 10% to about 95% of the proximal section 710 may have an intermittent helical cut pattern. About 50% to about 95% of the proximal section 710 may have an intermittent helical cut pattern. About 60% to about 95% of the proximal section 710 may have an intermittent helical cut pattern. About 80% to about 95% of the proximal section 710 may have an intermittent helical cut pattern. About 60% to about 99% of the proximal section 710 may have an intermittent helical cut pattern. About 70% to about 90% of the proximal section may have an intermittent helical cut pattern.

[0063] For example, one of the nearest regions has a discontinuous helical cut pattern. A region within approximately 60 cm to 80 cm of the proximal end 826 may have a discontinuous helical cut pattern. A region within approximately 70 cm to 80 cm of the proximal end 826 may have a discontinuous helical cut pattern. A region within approximately 75 cm to 85 cm of the proximal end 826 may have a discontinuous helical cut pattern. A region within approximately 75 cm to 80 cm of the proximal end 826 may have a discontinuous helical cut pattern. For example, any of regions 812, 814, 816, or 818 may have a discontinuous helical cut pattern. For example, region 812 may have a discontinuous helical cut pattern.

[0064] In some embodiments, a discontinuous helical cut pattern may have a column per revolution (CPR) of about 1.5 to about 4.5. A discontinuous helical cut pattern may have a CPR of about 2 to about 4. A discontinuous helical cut pattern may have a CPR of about 2 to about 3. A discontinuous helical cut pattern may have a CPR of about 2.5. The CPR may be substantially constant. The CPR may gradually increase from the distal end 824 of the proximal section 710 to the proximal end 826 of the proximal section 710. The CPR may gradually decrease from the distal end 824 of the proximal section 710 to the proximal end 826 of the proximal section 710.

[0065] In some embodiments, the intermittent helical cut pattern may have an uncut portion of about 40 to about 80 degrees (i.e., about 40 to about 80 degrees of the 360-degree rotation remain uncut). The intermittent helical cut pattern may have an uncut portion of about 50 to about 70 degrees. The intermittent helical cut pattern may have an uncut portion of about 55 to about 65 degrees.

[0066] In some embodiments, at least one region of the proximal section 710 has a plurality of relief cuts formed by a brick-like cut pattern. For example, about 5% to about 99% of the proximal section 710 may have a brick-like cut pattern. About 10% to about 95% of the proximal section 710 may have a brick-like cut pattern. About 5% to about 30% of the proximal section 710 may have a brick-like cut pattern. About 5% to about 20% of the proximal section 710 may have a brick-like cut pattern. About 3% to about 20% of the proximal section 710 may have a brick-like cut pattern. About 7% to about 15% of the proximal section 710 may have a brick-like cut pattern. About 8% to about 12% of the proximal section 710 may have a brick-like cut pattern. In some embodiments, one or more of the most distal regions of the proximal section 710 have a brick-like cut pattern. In some embodiments, a region within approximately 0.05 cm to approximately 8 cm of the distal end 824, or one or more regions, has a brick-like cut pattern. A region within approximately 2 cm to approximately 8 cm of the distal end 824 may have a brick-like cut pattern. A region within approximately 2 cm to approximately 4 cm of the distal end 824 may have a brick-like cut pattern. A region within approximately 4 cm to approximately 6 cm of the distal end 824 may have a brick-like cut pattern. A region within approximately 0.05 cm to approximately 2 cm of the distal end 824 may have a brick-like cut pattern. For example, any of regions 812, 814, 816, or 818 may have a brick-like cut pattern. For example, one or more of regions 814, 816, or 818 may have a brick-like cut pattern.

[0067] In some embodiments, at least one region has a cut pattern having a gradually increasing spine length that increases proximal toward the proximal end 826 of the proximal section 710. For example, the spine length may increase from about 0.051 mm (0.002 in) to about 0.254 mm (0.010 in). The spine length may increase from about 0.076 mm (0.003 in) to about 0.254 mm (0.010 in). The spine length may increase from about 0.101 mm (0.004 in) to about 0.254 mm (0.010 in). The spine length may increase from about 0.051 mm (0.002 in) to about 0.229 mm (0.009 in). The spine length may increase from about 0.127 mm (0.005 in) to about 0.203 mm (0.008 in). For example, any of regions 812, 814, 816, or 818 may have a gradually increasing spine length that increases proximal to the proximal end 826 of the proximal section 710. For example, region 814 may have a gradually increasing spine length that increases proximal to the proximal end 826 of the proximal section 710.

[0068] In some embodiments, at least one region has a cut pattern having a tapering spine length that decreases proximal toward the proximal end 826 of the proximal section 710. For example, the spine length may decrease from about 0.254 mm (0.010 in) to about 0.051 mm (0.002 in). The spine length may decrease from about 0.254 mm (0.010 in) to about 0.076 mm (0.003 in). The spine length may decrease from about 0.254 mm (0.010 in) to about 0.101 mm (0.004 in). The spine length may decrease from about 0.229 mm (0.009 in) to about 0.051 mm (0.002 in). The spine length may decrease from about 0.203 mm (0.008 in) to about 0.127 mm (0.005 in). For example, any of regions 812, 814, 816, or 818 may have a tapering spine length that decreases in the proximal direction toward the proximal end 826 of the proximal section 710. For example, region 818 may have a tapering spine length that decreases in the proximal direction toward the proximal end 826 of the proximal section 710.

[0069] In some embodiments, at least one region has a cut pattern with a substantially constant spine length. A substantially constant spine length may be about 0.051 mm (0.002 in) to about 0.203 mm (0.008 in). A substantially constant spine length may be about 0.051 mm (0.002 in) to about 0.178 mm (0.007 in). A substantially constant spine length may be about 0.076 mm (0.003 in) to about 0.178 mm (0.007 in). A substantially constant spine length may be about 0.102 mm (0.004 in) to about 0.152 mm (0.006 in). For example, any of regions 812, 814, 816, or 818 may have a substantially constant spine length. For example, region 816 may have a substantially constant spine length.

[0070] In some embodiments, any of the regions, for example, regions 812, 814, 816, and 818, may have a gradually decreasing pitch and a gradually decreasing spine length. For example, region 818 may have a gradually decreasing pitch and a gradually decreasing spine length. A combination of a gradually decreasing pitch and a gradually decreasing spine length that decreases proximally toward the proximal end 826 of the proximal section 710 may result in a decrease in flexibility toward the distal end 824 of the proximal section 710. This decrease in flexibility toward the distal end 824 of the proximal section 710 may preferably transition from the proximal section to the implant-connected section 720 and / or the distal section 730. In contrast, a substantially constant or increasing pitch toward the proximal end in at least some of the regions of the proximal section, for example, regions 816 and 814, may increase flexibility and therefore may be desirable for traversing the tubular shaft to the site of the vascular structure. A tubular shaft can be guided through tortuous biological structures, such as the ductus arteriosus or surrounding vascular structures, or within the cranial cavity. Furthermore, as will be described in more detail elsewhere in this specification, flexibility at the distal end of the tubular shaft, particularly in the implant housing section 732, may be desirable for following such tortuous biological structures.

[0071] In some embodiments, any of the regions, for example, regions 812, 814, 816, and 818, may have a substantially constant pitch. A substantially constant pitch can increase the column strength and / or intrusion of the tubular shaft. Intrusion and column strength may be desirable in the proximal portion of the proximal section 710, for example, region 812, to allow the system to be pushed through the catheter and through the vascular structure to the target site.

[0072] In some embodiments, any of the regions, for example, regions 812, 814, 816, and 818, may have a substantially constant pitch and an intermittent helical pattern. The combination of a substantially constant pitch and an intermittent helical pattern can enhance the column strength and / or intrusion properties of the tubular shaft. Intrusion properties and column strength may be desirable in the proximal portion of the proximal section 710, for example, region 812, to allow the system to be pushed through the catheter and through the vascular structure to the target site.

[0073] In some embodiments, any of the regions, for example, regions 812, 814, 816, and 818, may have a substantially constant pitch and a CPR of about 1.5 to about 4.5. The combination of a substantially constant pitch and a specific CPR can enhance the column strength and / or intrusion of the tubular shaft. Intrusion and column strength may be desirable in the proximal portion of the proximal section 710, for example, region 812, to allow the system to be pushed through the catheter and through the vascular structure to the target site.

[0074] In some embodiments, any of the regions, for example, regions 812, 814, 816, and 818, may have a substantially constant pitch and an uncut percentage of about 40% to about 60%. The combination of a substantially constant pitch and a specific uncut percentage can enhance the column strength and / or intrusion properties of the tubular shaft. Intrusion properties and column strength may be desirable in the proximal portion of the proximal section 710, for example, region 812, to allow the system to be pushed through the catheter and through the vascular structure to the target site.

[0075] In some embodiments, any of the regions, for example, regions 812, 814, 816, and 818, may have a CPR of about 1.5 to about 4.5 and an uncut percentage of about 40% to about 60%. A particular combination of CPR and a particular uncut percentage may enhance the column strength and / or intrusion properties of the tubular shaft. Intrusion properties and column strength may be desirable in the proximal portion of the proximal section 710, for example, region 812, to allow the system to penetrate the catheter and through the vascular structure to the target site.

[0076] In some embodiments, any of the regions, for example, regions 812, 814, 816, and 818, may have an intermittent helical cut pattern and an uncut percentage of about 40% to about 60%. The combination of the intermittent helical cut pattern and a specific uncut percentage may enhance the column strength and / or intrusion properties of the tubular shaft. Intrusion properties and column strength may be desirable in the proximal portion of the proximal section 710, for example, region 812, to allow the system to be pushed through the catheter and through the vascular structure to the target site.

[0077] In some embodiments, any of the regions, for example, regions 812, 814, 816, and 818, may have an intermittent helical cut pattern and a CPR of about 1.5 to about 4.5. The combination of the intermittent helical cut pattern and a specific CPR may enhance the column strength and / or intrusion of the tubular shaft. Intrusion and column strength may be desirable in the proximal portion of the proximal section 710, for example, region 812, to allow the system to be pushed through the catheter, through the vascular structure, to the target site.

[0078] In some embodiments, the outer diameter of the proximal section 710 is larger than the outer diameter of the distal section 730. For example, the implant is loaded into at least a portion of the distal section 730 so that the distal section 730 is positioned in the lumen of the implant. In contrast, the proximal section 710 may be used to press the implant into the tubular shaft. Therefore, the proximal section 710 may have substantially the same outer diameter as the implant in a crimped or unexpanded state. In embodiments without a distal section 730, the outer diameter of the proximal section 710 may be substantially similar to the outer diameter of the implant connection section 720.

[0079] In some embodiments, the outer diameter of the proximal section 710 is sized to accommodate within the lumen of a catheter, such as a microcatheter. In some embodiments, the outer diameter of the proximal section is approximately 0.055 cm (0.022 in) to approximately 0.085 cm (0.033 in). In some embodiments, the outer diameter of the proximal section is approximately 0.060 cm (0.024 in) to approximately 0.070 cm (0.028 in). In some embodiments, the inner diameter of the proximal section 710 is sized to accommodate a guidewire. In some embodiments, the inner diameter of the proximal section 710 may be at least approximately 0.038 cm. The inner diameter of the proximal section 710 may be approximately 0.038 cm (0.015 in) to approximately 0.050 cm (0.020 in). The inner diameter of the proximal section 710 can range from approximately 0.045 cm (0.018 in) to approximately 0.052 cm (0.020 in). The inner diameter of the proximal section 710 can range from approximately 0.046 cm (0.018 in) to approximately 0.050 cm (0.020 in).

[0080] In some embodiments, the wall thickness of the proximal section is approximately 0.127 mm (0.005 in) to approximately 0.254 mm (0.01 in). In some embodiments, the wall thickness of the proximal section is approximately 0.1524 mm (0.006 in) to approximately 0.229 mm (0.009 in). In some embodiments, the wall thickness of the proximal section is approximately 0.178 mm (0.007 in) to approximately 0.229 mm (0.009 in).

[0081] Figure 9 shows the distal section 730 of the tubular shaft 700. The distal section 730 includes one or more regions 938, 940, 942, and 944. In some embodiments, the distal section 730 includes multiple regions 938, 940, 942, and 944. In some embodiments, the distal section 730 includes at least one region, for example, region 938, region 940, region 942, or region 944.

[0082] In some embodiments, region 938 may have a length 934 that is about 60% to about 85% of the total length 946. Region 938 may have a length 934 that is about 65% to about 85% of the total length 946. Region 938 may have a length 934 that is about 70% to about 85% of the total length 946. Region 938 may have a length 934 that is about 75% to about 80% of the total length 946.

[0083] In some embodiments, region 940 may have a length 932 that is about 10% to about 30% of the total length 946. Region 940 may have a length 932 that is about 15% to about 30% of the total length 946. Region 940 may have a length 932 that is about 15% to about 25% of the total length 946. Region 940 may have a length 932 that is about 18% to about 22% of the total length 946.

[0084] In some embodiments, region 942 may have a length 930 that is about 0.5% to about 5% of the total length 946. Region 942 may have a length 930 that is about 1% to about 3% of the total length 946. Region 942 may have a length 930 that is about 1.5% to about 2.5% of the total length 946.

[0085] In some embodiments, region 944 may have a length 936 that is about 0.1% to about 1% of the total length 946. Region 944 may have a length 936 that is about 0.25% to about 1% of the total length 946. Region 944 may have a length 936 that is about 0.5% to about 0.8% of the total length 946. Region 944 may have a length 936 that is about 0.5% to about 0.75% of the total length 946.

[0086] The total length of distal section 730 (946) can be approximately 1 cm to 3 cm. The total length of distal section 730 (946) can be approximately 1.5 cm to 2.5 cm. The total length of distal section 730 (946) can be approximately 1.5 cm to 2 cm. The total length of distal section 730 (946) can be approximately 1.8 cm to 2 cm.

[0087] In some embodiments, one or both of regions 942 and 944 may be raw hypotube. For example, as shown in Figure 7A, the proximal end 926 of region 942 may be connected to or joined to the implant connection section 720.

[0088] In some embodiments, one or more regions, for example, regions 938, 940, 942, and 944, include a plurality of relief cuts formed by an intermittent helical cut pattern. The intermittent helical cut pattern may at least partially feature a tapering pitch that decreases proximal toward the proximal end 926 of the distal section 730. The pitch may decrease from about 0.152 mm (0.006 in) to about 0.025 mm (0.001 in). The pitch may decrease from about 0.127 mm (0.005 in) to about 0.051 mm (0.002 in). The pitch may decrease from about 0.102 mm (0.004 in) to about 0.076 mm (0.003 in). As shown in Figure 7A, it is desirable that the gradually decreasing pitch in the proximal direction transition from the low-flexibility implant connection section 720 to the high-flexibility distal section 730, which includes the implant housing section 732. In other words, one or more proximal regions of the distal section 730 (e.g., adjacent to the proximal end 926) and one or more distal regions of the proximal section 710 (e.g., adjacent to the distal end 824) may be less rigid than the implant connection section 720 but more rigid than one or more distal regions of the distal section 730 and one or more proximal regions of the proximal section 710. In some embodiments, any of regions 938, 940, 942, or 944 may have a gradually decreasing pitch. In some embodiments, region 940 may have a gradually decreasing pitch.

[0089] The intermittent helical cut pattern may feature, at least partially, a gradually increasing pitch that increases proximal toward the proximal end 926 of the distal section 730. The pitch may increase from approximately 0.025 mm (0.001 in) to approximately 0.152 mm (0.006 in). The pitch may increase from approximately 0.051 mm (0.002 in) to approximately 0.127 mm (0.005 in). The pitch may increase from approximately 0.076 mm (0.003 in) to approximately 0.102 mm (0.004 in).

[0090] The intermittent helical cut pattern may feature a substantially constant pitch, at least partially. A substantially constant pitch may range from about 0.025 mm (0.001 in) to about 0.127 mm (0.005 in). A substantially constant pitch may range from about 0.051 mm (0.002 in) to about 0.102 mm (0.004 in). A substantially constant pitch may be between about 0.076 mm. A substantially constant pitch may provide flexibility to the region while also providing column strength to follow or maintain support for implants positioned around the region. In some embodiments, any of regions 938, 940, 942, or 944 may have a substantially constant pitch. In some embodiments, region 938 may have a substantially constant pitch. The substantially constant pitch near the distal end 924 (e.g., region 944) of the distal section 730 provides flexibility for following tortuous vascular structures while maintaining support for implants positioned in or at least partially within a region, e.g., region 938.

[0091] In some embodiments, one or more regions, for example, regions 938, 940, 942, or 944, may contain a substantially constant CPR that increases (towards the proximal end 926) or decreases (towards the proximal end 926). For example, the CPR may be about 0.5 to about 4.5. The CPR may be about 1 to about 4. The CPR may be about 1.5 to about 2.5. The CPR may be substantially about 1.5. For example, one or both of regions 938 and 940 may contain a substantially constant CPR.

[0092] In some embodiments, one or more regions, for example, regions 938, 940, 942, or 944, may contain a substantially constant, increasing (towards the proximal end 926), or decreasing (towards the proximal end 926) degree of the uncut portion. For example, the degree of the uncut portion may be about 10 to about 40 degrees. The degree of the uncut portion may be about 10 to about 30 degrees. The degree of the uncut portion may be about 15 to about 30 degrees. The degree of the uncut portion may be about 15 to about 25 degrees. The degree of the uncut portion may be about 10 to about 20 degrees. The degree of the uncut portion may be about 15 to about 17 degrees. The degree of the uncut portion may be substantially about 16 degrees. For example, one or both of regions 938 and 940 may contain a substantially constant degree of the uncut portion.

[0093] In some embodiments, the degree of the uncut portion may decrease gradually (decreasing toward the proximal end 926 of the distal portion 730). For example, the degree of the uncut portion may decrease from about 40 degrees to about 10 degrees. The degree of the uncut portion may decrease from about 30 degrees to about 10 degrees. The degree of the uncut portion may decrease from about 25 degrees to about 10 degrees. The degree of the uncut portion may decrease from about 25 degrees to about 20 degrees. The degree of the uncut portion may decrease from about 30 degrees to about 15 degrees. The degree of the uncut portion may decrease from about 25 degrees to about 16 degrees. Any one of regions 938, 940, 942, or 944 may include a pattern in which the degree of the uncut portion decreases. For example, region 940 may have a pattern in which the degree of the uncut portion decreases.

[0094] In some embodiments, the degree of the uncut portion may increase gradually (increasing toward the proximal end 926 of the distal portion 730). For example, the degree of the uncut portion may increase gradually from about 10 degrees to about 40 degrees. The degree of the uncut portion may increase gradually from about 10 degrees to about 30 degrees. The degree of the uncut portion may increase gradually from about 10 degrees to about 25 degrees. The degree of the uncut portion may increase gradually from about 20 degrees to about 25 degrees. The degree of the uncut portion may increase gradually from about 15 degrees to about 30 degrees. The degree of the uncut portion may increase gradually from about 16 degrees to about 25 degrees. Any one of regions 938, 940, 942, or 944 may include a pattern in which the degree of the uncut portion increases gradually. For example, region 940 may have a pattern in which the degree of the uncut portion increases gradually.

[0095] Figures 10A-12 show various embodiments of the implant connection section. Each implant connection section 720 defines a lumen for housing a guidewire. The lumen of the implant connection section 720 may have an inner diameter similar to or larger than the outer diameter of the guidewire. For example, the lumen of the implant connection section 720 may have an inner diameter greater than approximately 0.0381 cm (0.015 in). For example, the inner diameter of the implant connection section 720 may range from approximately 0.0406 cm (0.016 in) to approximately 0.0508 cm (0.02 in).

[0096] Figure 10A shows one embodiment of the implant connection section 720a. The implant connection section 720a defines a lumen 1012 and optionally includes one or more bumpers or backstops 1010 for pushing in an implant that is at least partially supported by the tubular shaft. For example, one or more radiopaque markers or features of the implant may be coupled to or fitted into a window or opening 1016 defined by the implant connection section 720a. The bumpers or backstops 1010 may protrude from the surface 1018 of the implant connection section 720a, for example, on a vertical plane. As the implant is guided distally along the tubular shaft through the catheter, the implant may be pushed proximal along the tubular shaft by force. The bumpers or backstops 1010 interact with one or more radiopaque markers or features to restrict or prevent proximal movement of the implant along the implant connection section 720a, and therefore along the tubular shaft. As shown in Figure 7A, this can occur in a multi-section tubular shaft. Additionally or alternatively, this can occur in a tubular shaft that does not include a distal section 730. Additionally or alternatively, this can occur in a tubular shaft having a monolithic structure in which the outer diameter of the tubular shaft does not substantially change, and / or the outer diameter of the tubular shaft substantially matches the inner diameter of the implant on it, or the inner diameter of the catheter in which the implant moves. Each window or opening 1016 may include its respective backstop 1010 at the proximal end 1020 (opposite the distal end 1022) of the window or opening 1016. Alternatively, one or more openings 1016 or subsets thereof may include a backstop 1010, while subsets may not include a backstop 1010.

[0097] Figures 10B-12 show implant connection section 720b having a structure similar to that shown above in Figure 10A, except that the implant connection section 720b in Figures 10B-12 does not include a backstop 1010. Figures 10B-12 show implant housing section 720b defining multiple openings, namely opening 1024, opening 1026, and opening 1028. Each opening 1024, 1026, and 1028 includes a groove 1030 for housing the implant tab. For example, Figures 13-14 show an implant tab 1316 terminated by a radiopaque marker 1300. The radiopaque marker 1300 is press-fitted into opening 1314 defined by implant connection section 720d. The tab 1316 is press-fitted into groove 1312 or recess (described below in relation to Figure 12). The implant connection section 720d is joined to the proximal section 1310. The implant 1318 covers at least a portion of the distal section, which is joined to the implant connection section 720d at the end opposite to the proximal section 710. The groove 1030 extends from the distal end 1036 of the implant connection section 720b to the opening 1026. As shown in Figure 11, the length 1032 (longitudinal length from proximal to distal) of the opening, for example, the opening 1024, is about 40% to about 80% of the length 1014 of the implant connection section 720b. The length 1032 of the opening 1024 may be about 50% to about 70% of the length 1014 of the implant connection section 720b. In some embodiments, the opening of the tubular shaft may be about twice the length of the radiopaque marker to allow loading of the tubular shaft into the inner diameter of the implant after the implant has been crimped. In some configurations, the implant connection section 720 includes one or more openings, and the distal section 730 includes one or more openings. In such embodiments, one or more openings in the distal section 730 of the tubular shaft 700 may be longer than one or more proximal openings to allow for length tolerances of the implant. For example, for the three openings of the implant connection section 720, the width 1034 of the opening, for example, opening 1024, may extend circumferentially along the implant housing section 720b over an angle of about 45 degrees to about 110 degrees.

[0098] Figure 12 shows an implanting housing section 720c having a structure similar to that shown above in Figures 10B-11, except that Figure 12 shows a recess 1230 instead of a groove 1030. The recess 1230 is shaped to accommodate the implant tab, and the openings (any of the openings 1224, 1226, or 1228) are shaped to accommodate the radiopaque marker or other feature of the implant. For example, the radiopaque marker or other feature may be press-fitted into openings 1224, 1226, and / or 1228. The depth 1210 of the recess 1230 may be about 40% to about 70% of the thickness 1212 of the side wall 1218 of the implanting housing section 720c.

[0099] Figure 15 shows one embodiment of an implant, such as a stent (e.g., implant 1500), in a 2D crimping configuration. As shown, the implant 1500 has a first end section 1580 having a distal end 1592, a second end section 1590 having a proximal end 1594, and a body section 1540 between the first end section 1580 and the second end section 1590.

[0100] The first end section 1580 includes one ring, more than one ring, or multiple rings. As shown in this embodiment, the first end section 1580 includes a terminal ring 1510a containing a plurality of struts 1512a, each having a length of 1562; a second-to-last ring 1520a containing a plurality of struts 1514a, each having a length of 1564; and a third-to-last ring 1530a containing a plurality of struts 1516a, each having a length of 1566. The length 1562 of each strut 1512a may be substantially similar to the length 1564 of each strut 1514a and / or the length 1566 of each strut 1516a. Preferably, the length 1562 is greater than the length 1564, which is greater than the length 1566, so that the length of the struts increases as you move from the body section 1540 to the first end section 1580. In other embodiments, length 1566 is greater than length 1564, which is greater than length 1562, such that the strut length decreases as it moves from body section 1540 to first end section 1580. To reiterate, lengths 1564 and 1566 may be substantially the same, or lengths 1562 and 1564 may be substantially the same, or lengths 1562 and 1566 may be substantially the same. Each of the strut lengths 1562, 1564, and 1566 may be about 1.0 mm to about 2.5 mm. The length 1562 of each strut 1512a is about 1.5 mm to about 2.5 mm, or about 1.8 mm to about 2.2 mm. The length 1564 of each strut 1514a is about 1.5 mm to about 2.0 mm, or about 1.6 mm to about 1.9 mm. The length 1566 of each strut 1516a is approximately 1.0 mm to 2.0 mm, or approximately 1.3 mm to 1.7 mm. As shown in Figure 15, the distal end 1592 of the first end section 1580 includes one, one or more, or more radiopaque markers 1550a. Alternatively, the radiopaque markers 1550a may be replaced with connecting elements such as male or female connectors configured to connect to complementary features (e.g., female or male connectors, respectively) in the delivery system or implant connection section 720. The rings 1510a and 1520a and rings 1520a and 1530a are connected to each other via one or more bridges 1596.As shown in Figure 15, approximately 3 to 9 bridges may be provided.

[0101] The second end section 1590 includes one ring, more than one ring, or multiple rings. As shown in this embodiment, the second end section 1590 includes a terminal ring 1510b containing a plurality of struts 1516b, each having a length of 1574; a second-to-last ring 1520b containing a plurality of struts 1514b, each having a length of 1572; and a second-to-last ring 1530b containing a plurality of struts 1512b, each having a length of 1570. The length 1574 of each strut 1516b may be substantially similar to the length 1572 of each strut 1514b and / or the length 1570 of each strut 1512b. Preferably, the length 1574 is greater than the length 1572 which is greater than the length 1570 of each strut 1512b, so that the strut lengths increase as you move from the main section 1540 to the second end section 1590. In other embodiments, length 1570 is greater than length 1572, which is greater than length 1574, such that the strut length decreases when moving from body section 1540 to second end section 1590. In further variations, lengths 1574 and 1572 may be substantially the same, or lengths 1574 and 1570 may be substantially the same, or lengths 1572 and 1570 may be substantially the same. Each of the strut lengths 1572, 1574, and 1570 may be about 1.0 mm to about 2.5 mm. The length 1574 of each strut 1516b is about 1.5 mm to about 2.5 mm, or about 1.8 mm to about 2.2 mm. The length 1572 of each strut 1514b is about 1.5 mm to about 2.0 mm, or about 1.6 mm to about 1.9 mm. The length 1570 of each strut 1512b is approximately 1.0 mm to 2.0 mm, or approximately 1.3 mm to 1.7 mm. As shown in Figure 15, the proximal end 1594 includes one, one or more, or more radiopaque markers 1550b. Alternatively, the radiopaque markers 1550b may be replaced with connecting elements such as male or female connectors configured to connect to complementary features (e.g., female or male connectors, respectively) in the delivery system, tubular shaft, or implant connection section 720. The rings 1510b and 1520b and rings 1520b and 1530b are connected to each other via one or more bridges 1598.As shown in Figure 15, approximately 3 to 9 bridges can be provided between each pair of adjacent rings.

[0102] The main body section 1540 includes a plurality of rings 1542, each containing a plurality of struts 1544. The main body section 1540 may include one or more rings (for example, in an embodiment of septal defect) or more than one or more rings (for example, in an embodiment of patent ductus arteriosus). For example, there may be about one ring, about two to about six rings, or about three to about ten rings. Each of the plurality of struts 1544 of the main body section 1540 has a length 1568. As shown in Figure 15, the length 1568 of each strut 1544 may be about 1.0 mm to about 2.0 mm, preferably about 1.4 mm to about 1.7 mm. The rings 1542 of the main body section 1540 may be connected by a plurality of bridges 1546 between each pair of adjacent rings, for example, about three to about nine bridges. The implant may be a nitinol stent, a cobalt-chromium braided stent, a polymer stent, or another braided design. The implant may be used in a variety of cardiovascular non-balloon dilatable stent delivery applications, including peripheral vascular, coronary artery, and neurovascular applications.

[0103] Figure 16 shows an enlarged view of one embodiment of a radiopaque marker for an implant. The radiopaque marker 1550 includes a metal outer periphery 1600 that houses a radiopaque region 1610. The radiopaque region 1610 may be sized to exceed the threshold detection level of a measuring instrument (fluoroscope). For example, the radiopaque region 1610 may have a diameter of about 5 mm to about 10 mm. The metal outer periphery 1600 is coupled or joined to a tab 1620 that extends radially from the distal end 1592 and / or proximal end 1594 of the implant 1500. The tab 1620 may be press-fitted into the groove 1030 in Figure 10B or the recess 1230 in Figure 12. The metal outer periphery 1600 can be press-fitted into any of the openings 1024, 1026, 1028 (Figure 10B) or 1224, 1226, 1226 (Figure 12). In some examples, the implant may include three radiopaque markers at each end (e.g., three markers at the proximal end and three markers at the distal end). In some embodiments, approximately two radiopaque markers at each end of the implant can be fitted to a tubular shaft to allow substantially similar advancement and retraction of the implant within and / or relative to the catheter.

[0104] Refer to Figures 17-18 here. Generally, the methods described herein allow the operator to gain access to the treatment vessel with a guidewire and catheter of operator choice. In a pre-loaded tubular shaft-implant-transfer sheath complex, the guidewire may be "retroloaded" onto the tubular shaft. The tubular shaft may be used to push the implant onto the guidewire loaded from the transport sheath into the catheter. Thus, the operator can use a guidewire and a catheter of operator choice, rather than a fully equipped implant delivery system. The implant is delivered by pushing or advancing the tubular shaft-implant complex (through the catheter lumen) to the desired treatment site, and then pushing (biasing or advancing) the implant out of the catheter, or by pulling the catheter back (or retracting) to expose the implant. Once the implant is out of the catheter, the radiopaque marker disengages from the window of the tubular shaft during self-expansion.

[0105] Figure 17 is a flowchart of one embodiment of method 1700 for delivering an implant to a target site. Method 1700 includes, in block S1710, advancing a guidewire in a blood vessel to the target site; in block S1720, advancing a catheter on the guidewire; in block S1730, loading a tubular shaft having the implant on top into the lumen of the catheter at the proximal end of the catheter on the guidewire; and in block S1740, advancing the tubular shaft out of the lumen of the catheter at the distal end of the catheter so that one or more features of the implant are released from the tubular shaft and the implant self-expands. Method 1700 has the function of positioning the implant using existing guidewire and catheter access so that the implant delivery system can be retroloaded into the catheter (at the proximal end of the catheter or the user end) and on the guidewire. Alternatively, a guidewire may be deployed, and catheters of different sizes or shapes (based on, for example, physician preference) may be advanced on the guidewire, and the tubular shaft and implant may be retroloaded into the catheter and delivered to the target site. In method 1700 of Figure 17, the distal end of the catheter and / or guidewire can be substantially maintained (positioned) in a certain position while the tubular shaft and implant advance from the distal end to release the implant.

[0106] Figure 18 is a flowchart of one embodiment of method 1800 for delivering an implant to a target site. Method 1800 includes, in block S1810, advancing a guidewire into a blood vessel to the target site; in block S1820, advancing a catheter on the guidewire; in block S1830, loading a tubular shaft with the implant on top into the lumen of the catheter at the proximal end of the catheter on the guidewire; and in block S1840, retracting the distal end of the catheter from the tubular shaft so that one or more features of the implant are released from the tubular shaft and the implant self-expands. Method 1800 has the function of positioning the implant using existing guidewire and catheter access so that the implant delivery system can be retroloaded into the catheter on the guidewire (at the proximal end or user end of the catheter). Alternatively, the guidewire may be deployed, and catheters of different sizes or shapes (based on, for example, physician preference) may be advanced on the guidewire, after which the tubular shaft and implant may be retroloaded into the catheter and delivered to the target site. In method 1800 shown in Figure 18, the distal end of the tubular shaft (with the implant on top) can be substantially maintained in a certain position while the distal end of the catheter retracts to release the implant from the tubular shaft.

[0107] Examples Example 1. A system for delivering a vascular implant, comprising a proximal section defining a lumen, an implant connection section joined to the proximal section, the implant connection section defining at least one opening, the implant connection section having at least one opening configured to accommodate the features of an implant placed on the outer diameter of the tubular shaft, and a tubular shaft having a plurality of relief cuts in the tubular shaft to enhance the flexibility of the tubular shaft.

[0108] Example 2. Any one of the above examples, particularly the system of Example 1, further comprising a distal section, wherein the implant connection section is located between the proximal and distal sections, and the distal section comprises an implant housing section such that an implant is arranged around at least a portion of the distal section.

[0109] Example 3. Any one of the above embodiments, particularly the system of Example 1, wherein the tubular shaft is configured to be axially displaced on a guidewire in the lumen of the catheter to advance or retract an implant positioned on the tubular shaft.

[0110] Example 4. Any one of the above embodiments, particularly the system of Example 2, further comprising a catheter, wherein the catheter is configured to define an inner diameter and accommodate a tubular shaft therein, and the inner diameter of the catheter is sized relative to the outer diameter of the tubular shaft such that a sheath cannot be placed in the lumen of the catheter when the tubular shaft, on which the implant is positioned, is in the lumen of the catheter.

[0111] Example 5. Any one of the above embodiments, particularly the system of Example 2, further comprising a guide wire, the guide wire being positioned in the lumen of the tubular shaft and configured to be moved in parallel.

[0112] Example 6. Any one of the above examples, particularly the system of Example 1, wherein the implant is a self-expanding stent.

[0113] Example 7. Any one of the above examples, particularly the system of Example 2, wherein the distal section comprises multiple relief cuts, and the multiple relief cuts comprise an intermittent spiral cut pattern.

[0114] Example 8. Any one of the above examples, particularly the system of Example 1, wherein the proximal section comprises multiple relief cuts, and the multiple relief cuts comprise a combination of an intermittent spiral cut pattern and a brick-like cut pattern.

[0115] Example 9. Any one of the above examples, particularly the system of Example 8, wherein the intermittent spiral cut pattern and the brick-like cut pattern are in the non-overlapping region of the proximal section.

[0116] Example 10. Any one of the above examples, particularly the system of Example 1, wherein the outer diameter of the tubular shaft is sized relative to the inner diameter of a catheter configured to accommodate the tubular shaft, such that a sheath cannot be placed in the lumen of the catheter when the tubular shaft is in the lumen of the catheter.

[0117] Example 11. Any one of the above embodiments, in particular the system of Example 1, further comprising a backstop at the proximal end of at least one opening.

[0118] Example 12. Any one of the above examples, particularly the system of Example 2, wherein multiple relief cuts are configured to prevent shortening or elongation of the tubular shaft.

[0119] Example 13. Any one of the previously described examples, particularly the system of Example 2, in which the proximal section, implant connection section, and distal section are monolithic structures.

[0120] Example 14. Any one of the above examples, particularly the system of Example 1, wherein the implant is characterized by having a radiopaque marker extending radially from the proximal end of the implant.

[0121] Example 15. A method for delivering a vascular implant, comprising advancing a guidewire and a catheter to a target site, wherein the guidewire is configured to be moved axially by the catheter, loading a tubular shaft onto the guidewire and into the lumen of the catheter, with the implant positioned on at least a portion of the tubular shaft, and moving the tubular shaft axially along the guidewire and through the lumen of the catheter.

[0122] Example 16. Any one of the preceding examples, particularly the method of Example 16, further comprising deploying an implant at a target site by biasing a tubular shaft so that it exits from the distal end of the catheter lumen.

[0123] Example 17. Any one of the preceding examples, in particular the method of Example 16, wherein loading includes removing the sheath from the implant and the tubular shaft when the tubular shaft is loaded into the lumen of the catheter.

[0124] Example 18. Any one of the preceding embodiments, in particular the method of Example 16, wherein the axial translation of the tubular shaft comprises advancing the tubular shaft along the guidewire through the lumen of the catheter.

[0125] Example 19. Any one of the preceding embodiments, particularly the method of Example 16, wherein the axial parallel movement of the annular shaft includes retracting the tubular shaft on the guidewire in the lumen of the catheter.

[0126] Example 20. Any one of the previously described examples, particularly the method of Example 16, wherein the target site is the aorta, which is fluidly connected to the ductus arteriosus.

[0127] Example 21. Any one of the previously described examples, particularly the method of Example 16, wherein the target site is the pulmonary artery, which is fluidly connected to the ductus arteriosus.

[0128] Example 22. Any one of the previously described examples, particularly the method of Example 16, wherein the implant is a self-expanding stent.

[0129] Example 23. Any one of the preceding examples, in particular the method of Example 16, further encompassing the axial translation of a guidewire within the lumen of a tubular shaft.

[0130] Example 24. A system for delivering a vascular implant, comprising: a tubular shaft having a proximal section defining a lumen, an implant-connecting section defining at least one opening, and a plurality of relief cuts of the tubular shaft; an implant having a proximal end having at least one feature, the implant being positioned on the tubular shaft, the implant having at least one feature positioned at at least one opening of the tubular shaft; and a catheter defining a lumen having an inner diameter, wherein the inner diameter of the catheter is sized relative to the outer diameter of the tubular shaft such that a sheath cannot be positioned in the lumen of the catheter when the tubular shaft is in the lumen of the catheter, and the tubular shaft is configured to be displaced axially in the lumen of the catheter to advance or retract the implant positioned on the tubular shaft.

[0131] Example 25. Any one of the preceding examples, particularly the system of Example 24, wherein the tubular shaft further comprises a distal section, an implant connection section is located between the proximal and distal sections, and the distal section comprises an implant housing section such that an implant is arranged around at least a portion of the distal section.

[0132] Example 26. Any one of the above embodiments, in particular the system of Example 24, further comprising a guidewire, wherein the tubular shaft is configured to be axially displaced on the guidewire in the lumen of the catheter to advance or retract an implant positioned on the tubular shaft.

[0133] Example 27. Any one of the preceding examples, particularly the system of Example 24, wherein the implant is a self-expanding stent.

[0134] Example 28. Any one of the above examples, particularly the system of Example 25, wherein the distal section comprises multiple relief cuts, and the multiple relief cuts have an intermittent spiral cut pattern.

[0135] Example 29. Any one of the above examples, particularly the system of Example 24, wherein the proximal section comprises multiple relief cuts, and the multiple relief cuts comprise a combination of an intermittent spiral cut pattern and a brick-like cut pattern.

[0136] Example 30. Any one of the previously described examples, particularly the system of Example 29, wherein the intermittent spiral cut pattern and the brick-like cut pattern are in the non-overlapping region of the proximal section.

[0137] Example 31. Any one of the preceding embodiments, in particular the system of Example 24, further comprising a backstop at the proximal end of at least one opening.

[0138] Example 32. Any one of the above examples, particularly the system of Example 24, wherein multiple relief cuts are configured to prevent shortening or elongation of the tubular shaft.

[0139] Example 33. Any one of the previously described examples, particularly the system of Example 25, in which the proximal section, implant-connected section, and distal section are monolithic structures.

[0140] Example 34. Any one of the preceding examples, in particular the system of Example 25, wherein at least one feature of the implant comprises a radiopaque marker extending radially from the proximal end of the implant.

[0141] Example 35. A system for delivering an implant, comprising: a tubular shaft having a defined lumen and comprising a proximal and distal section; at least one opening defined by at least the distal section, configured to accommodate a radiopaque marker for an implant positioned on the outer diameter of the tubular shaft; and a plurality of relief cuts of the tubular shaft, the plurality of relief cuts having an intermittent pattern.

[0142] Example 36. Any one of the above embodiments, in particular the system of Example 35, further comprising a catheter configured to house a tubular shaft by defining an inner diameter, wherein the inner diameter of the catheter is sized relative to the outer diameter of the tubular shaft such that a sheath cannot be placed in the lumen of the catheter when the tubular shaft is in the lumen of the catheter, and the tubular shaft is configured to be displaced axially in the lumen of the catheter to advance or retract an implant placed on the tubular shaft.

[0143] Example 37. Any one of the preceding embodiments, in particular the system of Example 35, further comprising a guide wire positioned in the lumen of a tubular shaft and configured to be moved in parallel.

[0144] Example 38. A tubular shaft for delivering an implant, comprising a proximal section and a distal section, a lumen defined by the tubular shaft and configured to accommodate a guidewire, at least one opening defined by at least one distal section and configured to accommodate a radiopaque marker for an implant positioned on the outer diameter of the tubular shaft, and a plurality of relief cuts of the tubular shaft having an intermittent pattern.

[0145] Example 39. A tubular shaft according to any of the above embodiments, particularly the tubular shaft of Example 38, wherein the outer diameter of the tubular shaft is sized relative to the inner diameter of a catheter configured to accommodate the tubular shaft, such that a sheath cannot be placed in the lumen of the catheter when the tubular shaft is in the lumen of the catheter.

[0146] Example 40. Any one of the above embodiments, particularly the tubular shaft of Example 39, wherein the tubular shaft is configured to be displaced axially in the lumen of the catheter to advance or retract an implant positioned on the tubular shaft.

[0147] Example 41. Any one of the preceding embodiments, particularly the tubular shaft of Example 38, further comprising a bumper at the proximal end of at least one opening, the bumper configured to push in the radiopaque marker of the implant when the tubular shaft is axially displaced in the lumen of the catheter.

[0148] Example 42. A tubular shaft of any of the previous examples, particularly the one of Example 38, in which multiple relief cuts form a spine along the length of the tubular shaft.

[0149] Example 43. Any one of the above examples, particularly the tubular shaft of Example 38, wherein multiple relief cuts are configured to prevent shortening or elongation of the tubular shaft.

[0150] Example 44. A tubular shaft for delivering an implant, comprising a proximal section and a distal section, a lumen defined by the tubular shaft and configured to accommodate a guidewire, at least one opening defined by at least the distal section, and a plurality of relief cuts of the tubular shaft having an intermittent pattern.

[0151] Example 45. A tubular shaft according to any one of the above examples, particularly the tubular shaft of Example 44, wherein the outer diameter of the tubular shaft is sized relative to the inner diameter of a catheter configured to accommodate the tubular shaft, such that a sheath cannot be placed in the lumen of the catheter when the tubular shaft is in the lumen of the catheter.

[0152] Example 46. Any of the above embodiments, particularly the tubular shaft of Example 44, wherein the tubular shaft is configured to be displaced axially within the lumen of the catheter to advance or retract an implant positioned on the tubular shaft.

[0153] Example 47. A method for delivering an implant on a guidewire in an empty catheter system, comprising loading an implant onto a tubular shaft, loading a tubular shaft onto a guidewire, and advancing the tubular shaft through the lumen of a catheter, wherein the tubular shaft is configured to push the implant along the length of the lumen of the deployed catheter.

[0154] Example 48. A method for delivering an implant on a guidewire in an empty catheter system, comprising loading a tubular shaft on the guidewire and advancing or retracting the tubular shaft through the lumen of the catheter, wherein the tubular shaft is configured to push or pull an implant through the length of the lumen of the catheter.

[0155] In this specification, references such as “one embodiment,” “an embodiment,” “an illustrative embodiment,” and “some embodiments” indicate that the embodiments described may include certain features, structures, or properties, but not all embodiments may include or not include such features, structures, or properties. Furthermore, such phrases do not necessarily refer to the same embodiment. Moreover, when certain features, structures, or properties are described in relation to one embodiment, it is considered that the influence of such features, structures, or properties in relation to other embodiments, whether explicitly stated or not, is within the knowledge of those skilled in the art.

[0156] When used in the description and claims, the singular forms “a,” “an,” and “the” include both singular and plural references unless the context makes it clear otherwise. For example, the term “opening” may and may be considered to include multiple openings. Sometimes, claims and disclosures may include terms such as “a plurality,” “one or more,” or “at least one.” However, the absence of such terms is not intended to mean, and should not be interpreted as meaning, that plurals are not assumed.

[0157] The terms “about” or “approximately” refer to an approximate number that may vary by (+) or (-) 5%, 1%, or 0.1% when used before a numerical specification or range (for example, to specify length or pressure). All numerical ranges presented herein include the first and last digits indicated. The term “substantially” refers to almost (i.e., more than 50%) or essentially all of a device, substance, or composition.

[0158] As used herein, the terms “comprising” or “comprises” are intended to mean that a device, system, and method includes the elements described and may additionally include any other elements. “Consisting essentially of” means that a device, system, and method includes the elements described and excludes other elements that are essentially important to the combination for the purposes described. Therefore, a system or method consisting essentially of the elements specified herein does not exclude other materials, features, or steps that do not materially affect the fundamental and novel nature of the claimed disclosure. “Consisting of” means that a device, system, and method includes the elements described and excludes anything beyond trivial or insignificant elements or steps. Embodiments defined by each of these transitional terms are included within the scope of this disclosure.

[0159] The examples and illustrations included herein illustrate, not limit, specific embodiments in which the subject matter may be put into practice. Other embodiments may be used and derived from these so that structural, logical substitutions, and modifications may be made without departing from the scope of this disclosure. Such embodiments of the subject matter of the present invention may be referred to individually or collectively in this specification by the term “invention” for convenience only, and it is not intended to arbitrarily limit the scope of this application to any single invention or inventive concept when more than one is actually disclosed. Thus, while specific embodiments are illustrated and described herein, any mechanism expected to achieve the same objective may be substituted for the specific embodiments shown. This disclosure is intended to apply to any and all modifications or variations of the various embodiments. Considering the above description, combinations of the embodiments described above, and other embodiments not specifically described herein, will be obvious to those skilled in the art. [Explanation of Symbols]

[0160] 100, 200, 400 distal portion 110, 210 blood vessels 120, 220, 320, 420, 520 catheters 130, 230, 330 guide wires 132 Outer diameter of catheter 134, 224 Catheter inner diameter 222, 322 Catheter Lumen 232 Guide wire outer diameter 240, 340, 440, 540, 640, 700 tubular shafts 242, 342 Outer diameter of tubular shaft 246 Inner diameter of a tubular shaft 248, 1012 lumen 250, 350, 450, 550, 1318 implants 252 Inner diameter of the implant 256 Implant outer diameter 300, 500 Proximal portion 324 Inner diameter of the lumen 344, 544, 644, 722, 1016, 1024, 1026, 1028, 1224, 1226, 1228, 1314 Openings 348, 548, 1300, 1550, 1550a, 1550b Radiopaque markers 446, 546 relief cuts 701 Spine length 703 pitch 705 columns per revolution 707 Longitudinal axis 709a, 709b cut 710, 1310 Proximal division 711a, 711b Cut ends 712, 726, 824, 924, 1022, 1036, 1592 Distal end 720, 720a, 720b, 720c, 720d Implant connection classification 724, 734, 826, 926, 1020, 1594 Proximal end 730 Distal division 732 Implant housing category 812, 814, 816, 818, 820, 822, 938, 940, 942, 944 area 828, 946 total length 830, 832, 834, 836, 838, 840, 930, 932, 934, 936, 1562, 1564, 1566, 1568, 1570, 1572, 1574 Length 1010 Backstop 1014 Length of the implant connection portion 1018 Surface 1030 Groove 1032 Length of opening 1034 Width of the opening 1210 Depth 1212 Thickness 1218 Side wall 1230 recess 1312 channels 1316, 1620 tabs 1500 stents (implants) 1510a, 1510b Termination Rings 1512a, 1512b, 1514a, 1514b, 1516a, 1516b, 1544 strut 1520a, 1520b Second to last ring 1530a, 1530b The third to last ring 1540 Main Unit Classification 1542 Ring 1546, 1596, 1598 Bridge 1580 1st end section 1590 Second end division 1600 Metal outer periphery 1610 Radiopaque area 1700, 1800 method

Claims

1. A system for delivering vascular implants, Define the lumen, Proximal division and, An implant connection section joined to the proximal section, comprising an implant connection section defining at least one opening, wherein the at least one opening is configured to accommodate the features of an implant positioned on the outer diameter of a tubular shaft, Multiple relief cuts on the tubular shaft to increase the flexibility of the tubular shaft, A tubular shaft having, A system that is equipped with [the following].

2. The system according to claim 1, further comprising a distal section, wherein the implant connection section is located between the proximal section and the distal section, and the distal section comprises an implant housing section such that the implant is arranged around at least a portion of the distal section.

3. The system according to claim 1, wherein the tubular shaft is configured to be axially displaced on a guidewire in the lumen of a catheter so as to advance or retract the implant positioned on the tubular shaft.

4. The system according to claim 2, further comprising a catheter, wherein the catheter is configured to define an inner diameter and accommodate the tubular shaft therein, and the inner diameter of the catheter is sized relative to the outer diameter of the tubular shaft such that a sheath cannot be placed in the lumen of the catheter when the tubular shaft, on which the implant is positioned, is in the lumen of the catheter.

5. The system according to claim 2, further comprising a guide wire, wherein the guide wire is positioned in the lumen of the tubular shaft and is configured to move in parallel.

6. The system according to claim 1, wherein the implant is a self-expanding stent.

7. The system according to claim 2, wherein the distal section comprises the plurality of relief cuts, and the plurality of relief cuts comprises an intermittent spiral cut pattern.

8. The system according to claim 1, wherein the proximal section comprises the plurality of relief cuts, and the plurality of relief cuts comprises a combination of an intermittent spiral cut pattern and a brick-like cut pattern.

9. The system according to claim 8, wherein the intermittent spiral cut pattern and the brick-like cut pattern are located in the non-overlapping region of the proximal section.

10. The system according to claim 1, wherein the outer diameter of the tubular shaft is sized relative to the inner diameter of the catheter, which is configured to accommodate the tubular shaft, such that a sheath cannot be placed in the lumen of the catheter when the tubular shaft is in the lumen of the catheter.

11. The system according to claim 1, further comprising a backstop at the proximal end of at least one of the openings.

12. The system according to claim 2, wherein the plurality of relief cuts are configured to prevent shortening or elongation of the tubular shaft.

13. The system according to claim 2, wherein the proximal section, the implant connection section, and the distal section are monolithic structures.

14. The system according to claim 1, wherein the implant is characterized by having a radiopaque marker extending radially from the proximal end of the implant.

15. A method for delivering vascular implants, The method involves advancing a guidewire and a catheter to a target site, wherein the guidewire is configured to be moved parallel to the axial direction within the catheter. The process involves loading a tubular shaft into the lumen of the catheter on the guidewire, wherein an implant is positioned in at least a portion of the tubular shaft. The tubular shaft is moved axially parallel to the guide wire through the lumen of the catheter, A method that includes.

16. The method according to claim 16, further comprising deploying the implant at the target site by biasing the tubular shaft so that it exits from the distal end of the lumen of the catheter.

17. The method according to claim 16, wherein the loading includes removing the sheath from the implant and the tubular shaft when the tubular shaft is loaded into the lumen of the catheter.

18. The method according to claim 16, wherein the axial parallel movement of the tubular shaft includes advancing the tubular shaft on the guidewire through the lumen of the catheter.

19. The method according to claim 16, wherein the axial parallel movement of the tubular shaft includes retracting the tubular shaft on the guide wire in the lumen of the catheter.

20. The method according to claim 16, wherein the target site is the aorta, which is fluidly connected to the ductus arteriosus.

21. The method according to claim 16, wherein the target site is a pulmonary artery fluidly connected to a ductus arteriosus.

22. The method according to claim 16, wherein the implant is a self-expanding stent.

23. The method according to claim 16, further comprising moving the guide wire in the axial direction parallel within the lumen of the tubular shaft.

24. A system for delivering vascular implants, Define the lumen, Proximal division and, An implant connection section defining at least one opening, Multiple relief cuts on a tubular shaft, A tubular shaft having, An implant having a proximal end having at least one feature, an implant positioned on the tubular shaft, wherein the at least one feature is positioned at at least one opening of the tubular shaft, A catheter defining a lumen having an inner diameter, wherein the inner diameter of the catheter is sized relative to the outer diameter of the tubular shaft such that the sheath cannot be positioned in the lumen of the catheter when the tubular shaft is in the lumen of the catheter, Equipped with, The tubular shaft is configured to be displaced axially within the lumen of the catheter so as to advance and retract the implant positioned on the tubular shaft. system.

25. The system according to claim 24, wherein the tubular shaft further comprises a distal section, the implant connection section is located between the proximal section and the distal section, and the distal section comprises an implant housing section such that the implant is arranged around at least a portion of the distal section.

26. The system according to claim 24, further comprising a guidewire, wherein the tubular shaft is configured to be axially displaced on the guidewire within the lumen of the catheter to advance or retract the implant positioned on the tubular shaft.

27. The system according to claim 24, wherein the implant is a self-expanding stent.

28. The system according to claim 25, wherein the distal section comprises the plurality of relief cuts, and the plurality of relief cuts comprises an intermittent spiral cut pattern.

29. The system according to claim 24, wherein the proximal section comprises the plurality of relief cuts, and the plurality of relief cuts comprises a combination of an intermittent spiral cut pattern and a brick-like cut pattern.

30. The system according to claim 29, wherein the intermittent spiral cut pattern and the brick-like cut pattern are located in the non-overlapping region of the proximal section.

31. The system according to claim 24, further comprising a backstop at the proximal end of at least one of the openings.

32. The system according to claim 24, wherein the plurality of relief cuts are configured to prevent shortening or elongation of the tubular shaft.

33. The system according to claim 25, wherein the proximal section, the implant connection section, and the distal section are monolithic structures.

34. The system according to claim 25, wherein at least one feature of the implant comprises a radiopaque marker extending radially from the proximal end of the implant.

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