Medical device delivery member having a flexible, stretch-resistant distal portion

Abstract

The present invention is entitled "Medical device delivery member with flexible, stretch-resistant distal portion." The present invention provides a delivery member for delivering and deploying an intravascular medical device. The delivery member includes a flexible distal portion including a coiled wire coil surrounded by a flexible sleeve and inhibited from extending in length by a stretch-resistant member positioned through a lumen of the coil. The delivery member can include hypotubes positioned on either side (distal and proximal) of the coiled wire coil, to which the stretch-resistant member and the coiled wire coil can be attached. The distal hypotube can include an attachment slot for positioning and attaching a loop wire to the distal hypotube.

Description

Technical Field

[0001] This invention generally relates to endovascular medical device systems that can be navigated through the blood vessels of a human subject. More specifically, this invention relates to delivery systems and delivery components for delivering and deploying implantable medical devices to target locations in the body's blood vessels, and methods of using them. Background Technology

[0002] The use of catheter delivery systems to locate and deploy therapeutic devices such as inflatable balloons, stents, and embolic coils within the human vascular system has become standard procedure for treating endovascular diseases. These devices have been found particularly effective in treating areas where conventional procedures are impractical or pose significant risks to the patient, such as in the treatment of aneurysms in intracranial vessels. Surgical treatment of defects in intracranial vessels can be difficult and often risky due to the fragility of the tissues surrounding them (e.g., brain tissue). Advances in catheter-based implant delivery systems have provided alternative treatments in such cases. Some advantages of catheter delivery systems are that they offer methods for treating vessels by reducing the risk of trauma to surrounding tissues, and they also allow treatment of vessels previously considered inoperable.

[0003] Typically, these procedures involve inserting a delivery catheter into a patient's vascular system and guiding the catheter through the vascular system to a predetermined delivery site. Vascular occlusion devices, such as embolic coils, may be attached at the distal end of a delivery member (e.g., a microcatheter) to an implant engagement / deployment system (equivalently referred to herein as an "engagement system" or "deployment system") that pushes the coil through the delivery catheter and exits from the distal end of the delivery catheter into the delivery site. Exemplary delivery members and engagement / deployment systems are described in U.S. Patent Applications 15 / 850,993, 15 / 964,857, and 16 / 502,767, each of which is incorporated herein by reference.

[0004] Some challenges associated with the proper execution of this treatment protocol include ensuring that the delivery component and engagement system remain in a stable position throughout the treatment. For example, in some aneurysm treatment applications, as the aneurysm is increasingly filled with embolic material, the delivery component may tend to shift due to increased backlash from the implanted embolic material. If the delivery component shifts during treatment, the physician may not be able to accurately control the placement of the embolic material and may choose to stop embolizing the aneurysm. In such examples, the aneurysm may not be adequately embolized, which could lead to recanalization. Furthermore, excessive movement or stretching of the delivery component and / or the engagement system on it can cause premature dislodgement of the embolic coil.

[0005] Therefore, there is a need for improved methods, devices, and systems to provide implant delivery components and implant engagement systems with increased stability. Summary of the Invention

[0006] The object of this invention is to provide systems, apparatus, and methods that meet the aforementioned needs. Generally, the object of this invention is to provide a delivery member for delivering and deploying an implantable medical device having a flexible distal portion.

[0007] As the distal end of the delivery device is advanced through the tortuous distal anatomy, the stiffness of the distal portion of the delivery device can cause the microcatheter used to deliver the embolic material to be pulled back from the aneurysm. If the microcatheter is pulled back while advancing the embolic material, it may detach from the aneurysm, and the physician may lose control of the embolic coil and be unable to accurately control the placement of the embolic material, potentially preventing the completion of the treatment.

[0008] Flexibility can be provided by incorporating a wound coil of a certain length along the distal portion of the delivery member. The wound coil can be protected by a flexible polymer sheath located outside the coil. Elongation of the wound coil can be suppressed by a tensile-resistant tube attached to either end of the thiocyanate tube.

[0009] An exemplary delivery component for delivering an implantable medical device to a target location in a blood vessel of the body may include a proximal hypothalamus tube, a support coil segment, a distal hypothalamus tube, and a coupling system. The support coil segment may be attached to a distal end of the proximal hypothalamus tube. The distal hypothalamus tube, the support coil segment, and the proximal hypothalamus tube may form a continuous tubular structure having a lumen passing through it. The distal hypothalamus tube may include a distal end shaped to receive an implantable medical device. The distal hypothalamus tube may include a first attachment slot extending from the lumen to an outer surface of the distal hypothalamus tube. The distal hypothalamus tube may include a second attachment slot extending from the lumen to the outer surface of the distal hypothalamus tube. The coupling system is movable to engage and deploy the implantable medical device. The coupling system may include a loop and a traction wire. The loop may extend through an opening in the implantable medical device to engage the coupling system to the implantable medical device. The loop may have a first end and a second end. A first end may extend at least partially through a first attachment slot; a second end may extend at least partially through a second attachment slot. A traction wire may extend through the lumen and engage the engagement loop, thereby engaging the engagement system to the implantable medical device. The traction wire may be movable to retract proximally to disengage from the engagement loop for deployment of the implantable medical device.

[0010] The first attachment slot may have a distal end and a proximal end. The proximal end may have a first diameter, and the distal end may have a second diameter. The first diameter of the first attachment slot may be larger than the second diameter of the first attachment slot. Similarly, the second attachment slot may have a distal end and a proximal end. The proximal end may have a first diameter, and the distal end may have a second diameter. The first diameter of the second attachment slot may be larger than the second diameter of the second attachment slot.

[0011] The delivery member may include a first attachment member that connects a first end of the loop to a first attachment slot, and a second attachment member that connects a second end of the loop to a second attachment slot.

[0012] The loop may be made of metal, and the first attachment and / or the second attachment may be welded.

[0013] The first attachment and / or the second attachment may contain epoxy resin.

[0014] The first attachment may be a first knot in the loop, the diameter of which is approximately equal to the first diameter of the first attachment slot. The second attachment may be a second knot in the loop, the diameter of which is approximately equal to the first diameter of the second attachment slot.

[0015] The loop can be made of polymer material.

[0016] The distal submersible tube may include a helical groove along the longitudinal axis passing through the lumen.

[0017] The first attachment slot can be positioned opposite to the second attachment slot on the distal end of the submersible tube along a radial line passing through the longitudinal axis. The first attachment slot can be positioned proximal to the second attachment slot at a distance equal to half the pitch of the helical notch.

[0018] The first attachment slot may be located at a first position equidistant from two adjacent slots of the spiral cut. The second attachment slot may be located at a second position equidistant from two adjacent slots of the spiral cut.

[0019] The first and second attachment slots may be perpendicular to the longitudinal axis.

[0020] An exemplary distal hypochlorous tube for delivering a component may have a distal end shaped to receive an implantable medical device. The distal hypochlorous tube may have a lumen extending through it. The distal hypochlorous tube may include a first attachment slot extending from the lumen to an outer surface of the distal hypochlorous tube. The distal hypochlorous tube may include a second attachment slot extending from the lumen to the outer surface. The distal hypochlorous tube may have a loop. The loop may be attached to the first attachment slot at a first end and to the second attachment slot at a second end. The distal hypochlorous tube may have a helical notch in its outer surface. The helical notch may be cut along a longitudinal axis through the lumen.

[0021] The first attachment slot may have a distal end and a proximal end. The proximal end of the first attachment slot may have a diameter larger than that of the distal end of the first attachment slot. The second attachment slot may have a distal end and a proximal end. The proximal end of the second attachment slot may have a diameter larger than that of the distal end of the second attachment slot. A loop may be attached to the first attachment slot via a first attachment member. A loop may be attached to the second attachment slot via a second attachment member.

[0022] The loop may be made of metal, and the first attachment and / or the second attachment may be welded.

[0023] The first attachment and / or the second attachment may contain epoxy resin.

[0024] The first attachment may be a first knot in the loop, the diameter of which is approximately equal to the first diameter of the first attachment slot. The second attachment may be a second knot in the loop, the diameter of which is approximately equal to the first diameter of the second attachment slot.

[0025] The first attachment slot can be positioned opposite to the second attachment slot on the distal end of the submersible tube along a radial line passing through the longitudinal axis. The first attachment slot can be positioned proximal to the second attachment slot at a distance equal to half the pitch of the helical notch.

[0026] An exemplary method for attaching an implantable medical device to a delivery member includes providing the delivery member. The delivery member may include a flexible distal hypochlorous tube. The method may include passing a first end of a loop through a proximal end of a first attachment slot of the flexible distal hypochlorous tube. The method may include pulling the first end of the loop from the proximal end of the first attachment slot toward a distal end of the first attachment slot, the distal end having a smaller diameter than the proximal end. The method may include attaching the loop to the first attachment slot. The method may include passing a second end of the loop through a proximal end of a second attachment slot of the flexible distal hypochlorous tube. The method may include pulling the second end of the loop from the proximal end of the second attachment slot toward a distal end of the second attachment slot, the distal end having a smaller diameter than the proximal end. The method may include attaching the loop to the second attachment slot.

[0027] Attaching the loop to the first attachment slot may include welding the loop into the first attachment slot.

[0028] The method may include tying a first knot in the first end of the loop before pulling the first end of the loop from the proximal end of the first attachment slot toward the distal end of the first attachment slot. The method may include tying a second knot in the second end of the loop before pulling the second end of the loop from the proximal end of the second attachment slot toward the distal end of the second attachment slot. Attached Figure Description

[0029] The above and other aspects of the invention will be further discussed with reference to the following description and the accompanying drawings, in which similar numbers indicate similar structural elements and features in various figures. The drawings are not necessarily drawn to scale; rather, the emphasis is on illustrating the principles of the invention. The drawings depict one or more specific embodiments of the device of the invention by way of example only and not by way of limitation.

[0030] Figure 1 This is a cross-sectional view of a delivery member according to an aspect of the present invention;

[0031] Figure 2A This is a cross-sectional view of a flexible sleeve according to an aspect of the present invention;

[0032] Figure 2B This is a cross-sectional view of a tensile tube according to an aspect of the present invention;

[0033] Figure 2C This is a cross-sectional view of a wire coil attached to a distal and proximal submersible tube according to an aspect of the present invention.

[0034] Figures 2D-2H This is an illustration of a distal submersible tube having a first attachment slot and a second attachment slot according to an aspect of the present invention;

[0035] Figures 3A-3D This is an illustration of a joining system that shows the sequence for deploying an implant according to aspects of the invention;

[0036] Figure 4 This is a flowchart illustrating a method for designing or constructing a delivery component according to an aspect of the present invention;

[0037] Figure 5 This is a flowchart illustrating a method for using a delivery system including exemplary delivery components according to an aspect of the present invention; and

[0038] Figure 6 This is a flowchart illustrating a method for attaching an implantable medical device to a delivery component. Detailed Implementation

[0039] During endovascular treatment (e.g., aneurysm occlusion therapy), a lack of flexibility in the distal portion of the delivery component can cause the delivery component to pull back from the treatment site or otherwise displace when the implant or other medical device is placed in the aneurysm or other treatment site. Therefore, delivery components and engagement systems with more flexible distal portions can provide a stable system for delivering medical devices in neurovascular anatomy, in addition to other applications facing similar challenges. However, flexible structures may tend to deform, extend, or expand when navigating tortuous anatomy. Deformation of the delivery component can inhibit its ability to navigate to the treatment site and / or effectively deploy the medical device. Elongation of the delivery component can lead to premature deployment of the medical device.

[0040] The object of this invention is to provide a delivery member having a highly flexible distal portion that is tensile-resistant and structurally stable during the delivery and deployment of a medical therapeutic device. For ease of discussion, the medical therapeutic device is generally referred to herein as an "implant," but as will be understood and appreciated by those skilled in the art, aspects of this invention can be applied to the delivery and deployment of non-implanted medical devices.

[0041] According to the invention, in some examples, the highly flexible distal portion of the delivery member may include a coiled wire, an outer sheath, and an internal tensile-resistant member. The coiled wire may be formed from a substantially linear wire wound into a coil shape and / or from a thiocyanate tube laser-cut in a helical pattern. If the coiled wire is formed from a laser-cut thiocyanate tube, the helix may not have interference slots connecting the windings in the coil, in order to provide a more flexible coil. The outer sheath may suppress radial deformation of the coiled wire and / or provide a smooth surface against which the vessel wall can slide during implant delivery. The tensile-resistant member may suppress elongation of the coiled wire during implant delivery. Thus, the combination of the coiled wire, the outer sheath, and the tensile-resistant member can provide a distal portion of the delivery member with greater flexibility and stability than at least some known delivery members.

[0042] Switch to the attached image, as shown Figure 1As shown, the exemplary delivery member 10 may include a proximal tube 100, a coiled section 200, a distal tube 300, a cannula 500 surrounding the coiled section, and a tensile-resistant member 600 within the lumen of the coiled section 200. In this disclosure, the terms "proximal tube" and "proximal thiopancreatography (THP) tube" are used interchangeably; similarly, the terms "distal tube" and "distal thiopancreatography (THP) tube" are used interchangeably. The proximal tube 100 may extend a substantial portion of the length of the delivery member 10, wherein the coiled section 200 and the distal tube 300 form a length sufficient to absorb most of the pushback that may occur during implantation at the treatment site. In some examples, this length may be between about 30 cm and about 50 cm, or more specifically, about 40 cm. The proximal tube 100 may have a distal end 104 connected to the proximal end 202 of the coiled section 200, and the coiled section 200 may have a distal end 204 connected to the proximal end 302 of the distal tube 300. As will be described in more detail herein, the distal tube 300 may include a compressible portion 306. The compressible portion 306 may be formed by a helical notch 307 in the distal tube 300, a wound wire, a spiral strip, or other arrangements according to the invention that allow axial adjustment. A loop 400 for securing an implant or other medical treatment device to the delivery member 10 may be placed within the lumen 308 of the distal tube 300. The compressible portion 306 of the distal tube 300 may include attachment slots (e.g., a first attachment slot 310 and a second attachment slot 316) such that the loop 400 can pass from the lumen 308 through the distal tube 300 to the outer surface 309 of the distal sub-tube.

[0043] Figure 2A This is a sectional view of the 500mm sleeve. Figure 2B This is a sectional view of tensile member 600. Figure 2C It is a cross-sectional view of the assembled proximal tube 100, coiled section 200 and distal tube 300.

[0044] The coiled section 200 can be formed separately from the near-side sub-tube 100 and / or the far-side sub-tube 300. The separately formed coiled section 200 can be attached to the near-side tube 100 and / or the far-side tube 300 by welds 712, 714 or other suitable attachments. Alternatively or otherwise, at least a portion of the coiled section can be formed from a helical laser-cut portion of the sub-tube. By selecting a wire with a specific cross-section (e.g., circular) having a specific diameter D, or by selecting a wire with material properties that increase flexibility, the separately formed coiled section 200 can be made more flexible compared to a helical slotted tube. Conversely, by cutting individual sub-tubes to form the near-side tube 100, the coiled section 200, and the far-side sub-tube 300, reducing or eliminating welds 712, 714, or other attachments, the laser-cut portion can be manufactured more easily. In either case, the wire of coil 200 may have a diameter D in the range of about 0.8 mils to 5 mils (about 20 nm to about 130 nm).

[0045] The coiling section can be primarily formed of a non-transparent material (such as steel) and may include a translucent section 216 made of a translucent material (such as platinum and / or tungsten). The translucent section 216 can be positioned between the proximal, non-translucent section of coil 212 and the distal, non-translucent section of coil 214. The translucent section 216 can be positioned at a predetermined distance from the distal end 304 of the delivery member 10, allowing the physician to easily visualize the placement of the distal portion of the delivery member during the treatment procedure. The proximal section 212, the translucent section 216, and the distal section 214 can be concentrically welded.

[0046] The coiled section 200 may be surrounded by a flexible cannula or a fusion sheath 500 (collectively referred to herein as the "cannula"). The cannula 500 may inhibit radial expansion of the coil 200 during navigation and / or engagement with the vessel wall. The cannula 500 may include a polymer. The polymer may include additives to increase the lubricity of the cannula 500, thereby allowing the cannula to easily glide across the body's blood vessels. Figure 2A As shown, the cannula 500 may have a wall thickness T measured in the range of about 0.5 mils to about 2 mils (about 0.01 mm to about 0.05 mm). The cannula 500 may be further coated with a hydrophilic coating to further minimize friction during intravascular navigation. The cannula 500 may be fused or glued to the coil 200, the proximal hypotube 100, and / or the distal hypotube 300.

[0047] The tensile member 600 can be positioned to inhibit elongation of the coil 200 during intravascular navigation. The tensile member 600 may include a tube sized to fit within the lumen 208 of the coil 200. The tensile tube 600 may also be sized to extend through the entire length of the coil 200, within the lumen 108 of the proximal tube 100 and the lumen 308 of the distal tube 300. The tensile member 600 may be attached to the proximal tube 100 and the distal tube 300 at adhesive joints 702, 704 or other suitable attachments. The tensile member 600 may remain unattached to the coiled section 200, allowing the tensile member 600 and the coiled section 200 to move somewhat independently of each other.

[0048] The delivery member 10 may include a mechanical engagement system for engaging the medical device 12 during delivery to a treatment site, and the delivery member 10 may be mechanically actuated to deploy the medical device 12. The mechanically actuated engagement system may include one or more internal elongated members or traction wires extending through the delivery member, which a physician may manipulate at a proximal end to deploy the medical treatment device. Such wires or internal elongated members are generally referred to herein as “traction wires.” When reference is made herein to an engagement system, the engagement system may include a combination of a loop 400 and a traction wire 140.

[0049] Figures 2D-2H An exemplary distal submersible tube 300 is shown that can be used to secure the loop 400. The loop 400 can be positioned to secure an implant or other medical therapeutic device to the delivery member 10 and is movable to release the medical device 12 from the implant or other medical therapeutic device. This agreement will be referenced below. Figures 3A-3D To describe in more detail. In short, the loop 400 extends onto the locking portion 18 of the medical device 12. The pull cord 140 can then slide through an opening 405 at the distal end 404 of the loop 400. This allows the medical device 12 to remain in place until the pull cord 140 retracts to release the medical device 12.

[0050] Figure 2D This is a side view of a distal submersible tube 300 having a first attachment slot 310 and a second attachment slot 316 (the second attachment slot 316 is shown in the background of the drawing). The attachment slots 310, 316 may be openings in the outer surface 309 of the distal submersible tube 300, extending from the lumen 308 to the outer surface 309. The attachment slots 310, 316 may facilitate the attachment of a loop 400 to the distal submersible tube 300. The attachment slots 310, 316 may be laser-cut, for example, in the outer surface 309 of the distal submersible tube 300.

[0051] The first attachment slot 310 may have a distal end 312 and a proximal end 314. It can be seen that the diameter 313 of the distal end 312 may be smaller than the diameter 315 of the proximal end 314 of the first attachment slot 310. This tapered design facilitates the attachment of the loop 400 to the distal submersible tube 300. For example, if the diameter of the proximal end 314 is larger, the loop 400 can be fed through more easily. Once through the larger proximal diameter 315, the loop 400 can be pulled toward the distal end (312) of the first attachment slot (310). In some examples, the transition between the proximal end 314 and the distal end 312 may be slightly tapered, such that the loop 400 can wedge into the first attachment slot when pulled toward the distal end 312. The second attachment slot 316 may be similar to the first attachment slot 310 in all respects. For example, the second attachment slot 316 may have a distal end 322 and a proximal end 324, and the diameter 323 of the distal end 322 may be smaller than the diameter 325 of the proximal end 324 of the second attachment slot 316.

[0052] When the loop 400 is fed through the attachment slots 310, 316 and pulled toward the distal ends 312, 322, the loop 400 can be attached to the distal submersible tube 300 via attachments 409, 409. Figure 2E An exemplary first attachment 408 is shown (a second attachment 409 is shown in the background of this figure). Using a first attachment slot 310 as an example (a second attachment slot 316 can be similar), a loop 400 can be pulled toward the distal end 312 and positioned at a desired location within the length of the first attachment slot 310. The loop 400 can then be attached to the first attachment slot 310 at the first attachment 408. The first attachment 408 and / or the second attachment 409 can be located at the distal ends of their respective attachment slots 310, 316. However, it is not necessary to locate the first attachment 408 and / or the second attachment 409 at the farthest end of the slot; the first attachment 408 and / or the second attachment 409 can be placed in the middle section of the slot (i.e., closer to the side), such as... Figure 2E As shown.

[0053] The first attachment 408 may be a welded element that holds the loop 400 to the first attachment slot 310. In some examples, the loop 400 may comprise a metallic material such as stainless steel, cobalt-chromium alloy, titanium, nickel-titanium alloy (Nitinol), etc. Similarly, the distal submersible may comprise a metallic material such as stainless steel, cobalt-chromium alloy, titanium, Nitinol, etc. This allows the first attachment 408 to be a metallic welded element that attaches the loop 400 to the first attachment slot 310. In some examples, the loop 400 may comprise a polymeric material such as nylon, polypropylene, silk, polyester, etc. The loop may comprise braided or monofilament yarn. The first attachment 408 may be a thermoplastic welded element at the first attachment slot 310.

[0054] Alternatively, the first attachment 408 may be an epoxy resin that holds the end of the loop 400 to the first attachment slot 408. As described above, the second attachment slot 316 may include a second attachment 409 to attach the loop 400 to the second attachment slot 316. The second attachment 409 may be similar to the first attachment 408.

[0055] In some examples, the first attachment 408 may be a knot in the loop 400. As described above, the first attachment slot 310 may have a proximal end 314 with a diameter larger than the distal end 312. The loop 400 may be pulled through the first attachment slot 310, tied into a knot, and then pulled toward the distal end 312. The knot may be larger than the distal diameter 313, such that once a knot is tied in the loop 400, the loop 400 cannot be pulled back through the first attachment slot 310. In other examples, the loop 400 may first be tied into a knot, then the knot may be fed through the proximal end 314 of the first attachment slot 310, and subsequently the loop 400 may be pulled toward the distal end 312. In these examples, the knot diameter may be approximately equal to the first diameter 315 of the first attachment slot 310. This will allow the loop 400 to be fed through the proximal end 314, but prevent the loop 400 from being pulled through the distal end 312 of the first attachment slot 310. The second attachment 409 may similarly be a knot in the opposite end of the loop 400.

[0056] Figure 2FThis is a side view of an exemplary distal submersible tube 300. A first attachment slot 310 is in the foreground of the figure; a second attachment slot 316 is in the background. As described above, the distal submersible tube 300 may have a flexible and / or compressible portion 306. The compressible portion 306 may be formed by a helical notch 307 in the distal submersible tube 300, a wound wire, a helical strip, or other arrangements according to the invention that allow axial adjustment. In some examples, the placement of the first attachment slot 310 and / or the second attachment slot 316 may be selected based on the pitch of the helical notch 307. To improve the flexibility of the distal submersible tube 300, for example, the first attachment slot 310 may be offset relative to the second attachment slot 316 by a certain proportion of the pitch of the helical notch 307, as shown by slot offset 320. As shown in the figure, an example of the slot offset 320 is that the first attachment slot 310 can be positioned opposite to the second attachment slot 316, and the first attachment slot 310 can be offset proximally to the second attachment slot 316 by a distance approximately equal to half the pitch 318 of the spiral cutout 307. However, it is not necessary to position the first attachment slot 310 opposite to the second attachment slot 316. The first attachment slot 310 can be positioned at a first location equidistant from two adjacent cutouts of the spiral cutout 307, and the second attachment slot 316 can be positioned at a second location equidistant from two adjacent cutouts of the spiral cutout 307. This can be done at any location on the distal submersible 300, regardless of whether the attachment slots 310 and 316 are opposite to each other on another surface 309.

[0057] Figure 2G This is a perspective view of the distal submersible tube 300, showing an exemplary offset of the first attachment slot 310 and the second attachment slot 316. The offset of the first attachment slot 310 and the second attachment slot 316 relative to the pitch of the helical notch 307 can improve the flexibility of the distal submersible tube 300 without hindering the bending of the distal submersible tube around the helical notch 307.

[0058] Figure 2H This is a side cross-sectional view of an exemplary distal submersible tube 300. In some examples, the first attachment slot 310 and the second attachment slot 316 may be formed (e.g., by laser cutting, drilling, etc.) perpendicular to the longitudinal plane 326b passing through the lumen 308 of the distal submersible tube 300 in the distal submersible tube 300. The longitudinal plane 326b is a three-dimensional view of the longitudinal axis 326b passing through the lumen 308. The vertical slotting can help facilitate the attachment of the loop 400 to the first attachment slot 310 and the second attachment slot 316. For example, once the loop 400 is fed through the first attachment slot 310 and the second attachment slot 316, the vertical slotting can help ensure uniform surface contact between the loop 400 and the outer walls of the attachment slots 310, 316.

[0059] Figure 2HA good view is also provided of an exemplary slot offset 320 between the first attachment slot 310 and the second attachment slot 316. As described above, the first attachment slot 310 may be positioned opposite to the second attachment slot 316 on the distal submersible 300 along a radial line passing through the longitudinal axis 326a. The first attachment slot 310 and the second attachment slot 316 may be offset based on the pitch of the helical notch 307.

[0060] Figures 3A-3D A delivery member 10 is shown, comprising a mechanical engagement system including a traction wire 140 and a loop 400, which are positioned to secure an implant or other medical therapeutic device to the delivery member 10 and are movable to release the medical therapeutic device from the delivery member 10. The loop 400 may be attached to a distal tube 300 using a first attachment 408 and a second attachment 409. A tensile member 600 may be sized to allow the traction wire 140 to pass through the lumens 108, 208, and 308 of the proximal tube 100, the coiled section 200, and the distal tube 300. For example, the tensile member 600 may be tubular, having a lumen therethrough, and the traction wire 140 may extend through the lumen of the tubular tensile member 600. During the manufacture of the tensile member 600, the tensile member 600 may be extruded over the traction wire 140.

[0061] The combination of coil 200, cannula 500, and tensile member 600 can provide a highly flexible distal portion of delivery member 10, adapted for navigating tortuous anatomical structures (including neurovascular structures). Tensile member 600 can support coil 200 to prevent significant elongation of coil 200 during vascular navigation, thereby reducing tension on the traction wire 140 extending through it and minimizing the likelihood of premature deployment of attached medical therapeutic devices.

[0062] The proximal tube 100 may include a flexible segment 106, from which material has been removed to increase flexibility. The flexible segment 106 may be cut into a helical pattern. The helical pattern of the flexible segment 106 may be free of interference cutouts connecting the inner windings of the helix. A tensile member 600 may extend through the flexible segment 106 and be attached to the proximal tube 100 from the flexible segment 106 in a proximal direction. The tensile member 600 thereby inhibits elongation of the flexible segment 106 and the coiled segment 200 of the proximal tube 100. A cannula 500 may cover at least a portion of the flexible segment 106 to inhibit deformation of the flexible segment and / or reduce friction with the vascular system and the flexible segment 106 during intravascular navigation. In some examples, the cannula 500 may cover approximately 10 cm of the proximal tube 100, approaching and / or including the distal end 104 of the proximal tube 100.

[0063] The distal sub-thiospherical tube 300 may include a compressible portion 306. The compressible portion 306 is axially adjustable between an extended state and a compressed state. The distal sub-thiospherical tube 300 may also be flexible, enabling it to provide a stable system for delivering medical devices within neurovascular anatomy. The distal sub-thiospherical tube 300 may include, for example, a helical notch 307 formed by a laser cutting operation to create a compressible and / or flexible configuration. Alternatively or additionally, the compressible portion 306 may be formed from wound wire, a spiral ribbon, or other arrangements according to the invention that allow axial adjustment. Preferably, unless otherwise limited, the compressible portion 306 is in an extended state when at rest and automatically or elastically returns to an extended state from a compressed state.

[0064] Figures 3A-3D The use of a mechanical engagement / deployment system to detach the medical device 12 is shown. Figure 3A Engagement systems 140, 400 are shown that lock into the locking portion 18 of the medical device 12. A compressible portion 306 of the distal tube 300 is compressible, and an opening 405 in the loop 400 at the distal end 404 of the loop 400 can be placed through the locking portion 18. The medical device 12 is now secured when the traction wire 140 passes through the opening 405. Figure 3B The sequence of pulling the traction wire 140 toward the proximal side to initiate the release of the medical device 12 is shown. Figure 3C The moment the pull cord 140 leaves the opening 405 and is pulled out of the loop 400 is shown. The distal end 404 of the loop 400 disengages and leaves the locking portion 18. It can be seen that nothing is now holding the medical device 12 to the delivery member 10 (e.g., the distal hypotube 300). Figure 3D The end of the release sequence is shown. Here, the compressible portion 306 has extended / restored to its original shape and “popped” forward. The distal end 304 of the distal tube 300 applies a spring force E to the medical device 12 to “push it away,” thereby ensuring complete separation and delivery of the medical device 12.

[0065] The illustrations in the above figures depict generally hollow or tubular structures 100, 200, 300, 500, and 600 according to the invention. When used herein, the terms "tubular" and "tube" should be interpreted broadly and are not limited to structures that are perfectly cylindrical or have a perfectly circular cross-section or a uniform cross-section over their entire length. For example, tubular structures or systems are generally shown as substantially cylindrical structures. However, tubular systems may have tapered or curved outer surfaces without departing from the scope of the invention.

[0066] Figure 4 This is a flowchart including method steps for constructing or designing a delivery component, such as the exemplary delivery component described herein. References Figure 4In the method 800 outlined herein, in step 810, a first thallium tube, a second thallium tube, a flexible sheath, a wire coil, and a tensile member can be selected. The first thallium tube may be a proximal thallium tube 100 as described herein or known to those skilled in the art. The second thallium tube may be a distal thallium tube 300 as described herein or known to those skilled in the art. The flexible sheath may be a sheath or fusion sheath 500 as described herein or known to those skilled in the art. The wire coil may include a support coil or a winding section 200 as described herein or known to those skilled in the art. The tensile member may be a tensile member 600 as described herein or known to those skilled in the art.

[0067] In step 820, the tensile member can be positioned within the lumen of the wire coil. In step 820, the positioned tensile member can be substantially tubular. In step 830, the first thiocyanate tube, the wire coil, and the second thiocyanate tube can be attached to each other. In step 840, the tensile member is attached to the first and second thiocyanate tubes. The first thiocyanate tube, the wire coil, and the second thiocyanate tube can be attached as shown and described herein or in other ways that will be understood by those skilled in the art. Steps 820, 830, and 840 do not need to be performed in this order, but can be performed simultaneously. For example, as indicated in step 840, the tensile member can be attached to one of the first and second hyaluronic acid tubes, then as indicated in step 830, the hyaluronic acid tube to which the tensile member is attached can be attached to the wire coil, then as indicated in step 820, the tensile member can be positioned through the wire coil, then as indicated in step 830, the other hyaluronic acid tube can be attached to the wire coil, and then as indicated in step 840, the tensile member can be attached to the other hyaluronic acid tube.

[0068] In step 850, the wire coil may be covered by a flexible sleeve. The flexible sleeve may cover some or all of the outer surface of the wire coil. Step 850 may also include fusing the flexible sleeve to the wire coil and / or otherwise attaching the flexible sleeve to the delivery member. If the second thallium tube has a flexible section, in step 850, the flexible sleeve may also be positioned to cover at least a portion of the flexible section.

[0069] In step 860, the implant can be detachably attached to the distal end of the first thiastomach tube. In step 860, the implant can be attached by positioning a loop within the first thiastomach tube, positioning a traction wire to extend through the first thiastomach tube, coiling the wire around the second thiastomach tube, and securing the implant with the loop and traction wire. The traction wire can extend from the proximal end of the second thiastomach tube. If the first thiastomach tube has a compressible portion, in step 860, the compressible portion can be compressed, and the implant can be attached to the delivery member when the compressible portion is compressed.

[0070] Figure 5 This is a flowchart of method steps including the use of a system comprising a delivery component (such as the exemplary delivery component described herein) to administer endovascular treatment. Reference Figure 5 In the method 900 outlined herein, in step 910, a system may be selected comprising a distal hyposink, a proximal hyposink, a coiled section coaxially positioned between the hyposinks, a flexible sheath covering the coiled section, a tensile-resistant member positioned within the coiled section, and a medical treatment device attached to or near the distal hyposink. This system may be applicable to endovascular treatments as described and illustrated herein or known to those skilled in the art.

[0071] In step 920, the system can be moved through the catheter to the treatment site, such as an aneurysm or other abnormal site in the blood vessel. In step 930, the system is flexible as it moves through the catheter. In step 940, deformation of the coiled section of the system can be prevented by a flexible sheath and a tensile-resistant member; the flexible sheath inhibits radial deformation of the coiled section, while the tensile-resistant member inhibits longitudinal extension of the coil.

[0072] In step 950, a medical treatment device may be deployed. If the medical treatment device is an implant, the implant may be detached in step 950. In step 960, the distal tube may extend to push the medical treatment device away from the distal tube. If the medical treatment device is an implant that was detached in step 950, the detached implant may be ejected from the distal tube in response to the expansion of the distal tube in step 960.

[0073] Figure 6 This is a flowchart including method steps for attaching an implantable medical device to a delivery component. See also Figure 6 In the method 1000 outlined herein, in step 1010, a delivery member may be provided. The delivery member may include a flexible distal submersible tube as described herein. In step 1020, a first end of the loop may be passed through the proximal end of a first attachment slot of the distal submersible tube. In step 1030, the first end of the loop may be pulled from the proximal end toward the distal end of the first attachment slot. As described above, the distal end of the first attachment slot may have a smaller diameter than the proximal end.

[0074] In step 1040, the loop may be attached to the first attachment slot. This attachment can be performed in a variety of ways as described herein. The loop may be welded to the first attachment slot. In other examples, the loop may be attached to the first attachment slot via epoxy resin. In other examples, the loop may include a knot tied at a first end of the loop. This knot may be tied before the first end of the loop is pulled through the proximal end of the first attachment slot. In this case, the knot may be sized approximately the same as the diameter of the proximal end of the first attachment slot. This allows the knot to be fed through the proximal end but prevents the knot from being pulled back through the distal end. The knot may be tied after the first end of the loop has been pulled through the proximal end of the first attachment slot. This knot may be larger than one or both of the proximal and distal ends of the first attachment slot, such that the loop cannot be pulled back through the first attachment slot. The first end of the loop may be attached to the distal end of the first attachment slot, or the first end of the loop may be attached to any other location in the first attachment slot that is narrower than the proximal end (see example). Figure 2E ).

[0075] In steps 1050 to 1070, the method steps outlined above for steps 1020 to 1040 may be repeated for the second attachment slot. For example, the second end of the loop may be positioned in the second attachment slot, similar to the method described above for the first end of the loop and the first attachment slot.

[0076] The description contained herein is an example of embodiments of the invention and is not intended to limit the scope of the invention in any way. As described herein, the invention contemplates many variations and modifications of delivery systems, delivery components, and engagement systems, including alternative constructions of components, alternative materials, alternative medical therapeutic devices, alternative means for deploying medical therapeutic devices, alternative geometries of individual components, alternative means for attaching component parts, etc. These modifications will be apparent to those skilled in the art to which this invention pertains and are intended to fall within the scope of the appended claims.

Claims

1. A delivery member for delivering an implantable medical device to a target location in a blood vessel of the body, the delivery member comprising: Near-side submersible tube; A support coil section is attached to the distal end of the near-side submersible tube; The distal submersible tube includes: The distal end is shaped to receive the implantable medical device; A first attachment slot extends from the lumen of the distal submersible tube to the outer surface of the distal submersible tube; and A second attachment slot extends from the lumen to the outer surface; and A bonding system, movable to engage and deploy the implantable medical device bonded to the distal end of the distal submersible tube, the bonding system comprising: A loop extending through an opening in the implantable medical device to engage the fitting system to the implantable medical device, wherein a first end of the loop extends at least partially through a first attachment slot, and a second end of the loop extends at least partially through a second attachment slot; and A traction wire extends through the lumen, engages with the loop, thereby engaging the engagement system with the implantable medical device, and is movable to retract proximally to disengage from the engagement loop for deployment of the implantable medical device. The distal submersible tube further includes a helical groove along a longitudinal axis passing through the lumen; The first attachment slot is disposed on the distal submersible tube at a position opposite to the second attachment slot, along a diameter line passing through the longitudinal axis, and The first attachment slot is positioned near the second attachment slot at a distance equal to half the pitch of the spiral notch.

2. The delivery component according to claim 1, The first attachment slot includes a distal end and a proximal end, the proximal end having a first diameter and the distal end having a second diameter, wherein the first diameter of the first attachment slot is larger than the second diameter of the first attachment slot, and The second attachment slot includes a distal end and a proximal end, the proximal end having a first diameter and the distal end having a second diameter, wherein the first diameter of the second attachment slot is greater than the second diameter of the second attachment slot.

3. The delivery component according to claim 2, further comprising: A first attachment connects the first end of the loop to the first attachment slot. as well as The second attachment connects the second end of the loop to the second attachment slot.

4. The delivery component according to claim 3, The loop contains a metallic material. The first attachment is a welded part, and The second attachment is a welded component.

5. The delivery component according to claim 3, The first attachment comprises epoxy resin, and The second attachment comprises epoxy resin.

6. The delivery component according to claim 3, The first attachment is the first knot in the loop, and the knot has a knot diameter approximately equal to the first diameter of the first attachment slot. The second attachment is the second knot in the loop, and the diameter of the second knot is approximately equal to the first diameter of the second attachment slot.

7. The delivery member of claim 6, wherein the loop comprises a polymer material.

8. A distal submersible for delivering a component, the distal submersible comprising: The distal end is shaped to receive an implantable medical device; A lumen that extends through the distal subhose tube; A first attachment slot extends from the lumen to the outer surface of the distal subhole tube; A second attachment slot extends from the lumen to the outer surface; A loop, wherein the loop is attached to the first attachment slot at a first end and to the second attachment slot at a second end; as well as The outer surface has helical grooves that are cut along a longitudinal axis passing through the lumen. The first attachment slot is disposed on the distal submersible tube at a position opposite to the second attachment slot, along a diameter line passing through the longitudinal axis, and The first attachment slot is positioned near the second attachment slot at a distance equal to half the pitch of the spiral notch.

9. The distal submersible tube according to claim 8, The first attachment slot includes a distal end and a proximal end, the proximal end having a first diameter and the distal end having a second diameter, wherein the first diameter of the first attachment slot is larger than the second diameter of the first attachment slot, and The second attachment slot includes a distal end and a proximal end, the proximal end having a first diameter and the distal end having a second diameter, wherein the first diameter of the second attachment slot is larger than the second diameter of the second attachment slot. The loop is attached to the first attachment slot via a first attachment member, and The loop is attached to the second attachment slot via a second attachment member.

10. The distal submersible tube according to claim 9, The loop contains a metallic material. The first attachment is a welded part, and The second attachment is a welded component.

11. The distal submersible tube according to claim 9, The first attachment comprises epoxy resin, and The second attachment comprises epoxy resin.

12. The distal submersible tube according to claim 9, The first attachment is the first knot in the loop, and the first knot has a first knot diameter approximately equal to the first diameter of the first attachment slot. The second attachment is the second knot in the loop, and the second knot has a second knot diameter that is approximately equal to the first diameter of the second attachment slot.

13. A method of attaching an implantable medical device to a delivery component, the method comprising: The delivery component is provided, the delivery component comprising a flexible distal submersible tube; The first end of the loop passes through the proximal end of the first attachment slot of the flexible distal submersible tube; The first end of the loop is pulled from the proximal end of the first attachment slot toward the distal end of the first attachment slot, the distal end having a smaller diameter than the proximal end; Attach the loop to the first attachment slot; The second end of the loop passes through the proximal end of the second attachment slot of the flexible distal submersible tube; The second end of the loop is pulled from the proximal end of the second attachment slot toward the distal end of the second attachment slot, the distal end having a smaller diameter than the proximal end; and Attach the loop to the second attachment slot; The flexible distal subwave tube further includes a helical groove along the longitudinal axis of the lumen passing through the flexible distal subwave tube. The first attachment slot is disposed on the flexible distal submersible tube at a position opposite to the second attachment slot, along a diameter line passing through the longitudinal axis, and The first attachment slot is positioned near the second attachment slot at a distance equal to half the pitch of the spiral notch.

14. The method of claim 13, wherein attaching the loop to the first attachment slot includes welding the loop into the first attachment slot.

15. The method of claim 13, further comprising: Before pulling the first end of the loop from the proximal end of the first attachment slot toward the distal end of the first attachment slot, a first knot is tied in the first end of the loop; and Before pulling the second end of the loop from the proximal end of the second attachment slot toward the distal end of the second attachment slot, a second knot is tied in the second end of the loop.

Images