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

Abstract

To provide a delivery member for delivering and deploying an implantable medical device.SOLUTION: The delivery member includes: a distal hypotube; a flexible tubular section; a proximal hypotube; a lumen extending through the distal hypotube, the flexible tubular section and the proximal hypotube; a stretch resistant member; and a flexible sleeve. The stretch resistant tube can be positioned outside of the lumen, affixed to the proximal and distal hypotubes, and extending along at least a portion of an outer surface of the flexible tubular section. The flexible sleeve can comprise one or more stretch resistant fibers positioned within a wall of the flexible sleeve. The flexible sleeve can cover at least a majority of an outer surface of the flexible tubular section.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] (Cross - reference to Related Applications) This application is a continuation - in - part of U.S. Patent Application No. 17 / 218,801, filed Mar. 31, 2021, which is a continuation - in - part of U.S. Patent Application No. 16 / 502,767, filed Jul. 3, 2019, and this application is also a continuation - in - part of U.S. Patent Application No. 16 / 592,320, filed Oct. 3, 2019, and all of these are incorporated herein by reference as if fully set forth herein.

[0002] (Field of the Invention) The present invention generally relates to an intravascular medical device system that can be guided through the blood vessels of a human subject. More specifically, the present invention relates to a delivery system and a delivery member for delivering and deploying an implantable medical device to a target location in a blood vessel of the body, and methods of using the same.

Background Art

[0003] Using a catheter delivery system to position and deploy treatment devices such as inflatable balloons, stents, and embolization coils within the vascular structure of the human body has become a standard technique for treating intravascular diseases. Such devices have been found to be effective, particularly when conventional surgical techniques are not possible or when treating areas that pose a great risk to the patient, such as treating an aneurysm in the cerebral blood vessels. Due to the delicate tissues surrounding the cerebral blood vessels, such as brain tissue, performing surgical procedures to treat defects in the cerebral blood vessels is difficult and often risky. Advancements in catheter - based implant delivery systems have enabled alternative treatments in such cases. Some of the advantages of catheter delivery systems are to provide a method for treating blood vessels by an approach that has been found to reduce the risk of trauma to surrounding tissues, and further to enable the treatment of blood vessels that were previously considered inoperable.

[0004] Generally, these procedures involve inserting a delivery catheter into the patient's vascular structure and guiding it through the vascular structure to a designated delivery site. Vascular occlusion devices, such as embolization coils, can be attached to the implant engagement / delivery system at the distal end of a delivery member that pushes the coil through the delivery catheter from the distal end of the delivery catheter to the delivery site. Exemplary delivery members and engagement / deployment systems are described in U.S. Patent Application No. 15 / 850,993 (currently U.S. Patent No. 10,806,462 issued on October 20, 2020), published on June 27, 2019, as U.S. Patent Application Publication No. 2019 / 0192162(A1), and U.S. Patent Application No. 15 / 964,857 (currently U.S. Patent No. 10,806,461 issued on October 20, 2020), published on October 31, 2019, as U.S. Patent Application Publication No. 2019 / 0328398.

[0005] Some of the difficulties associated with properly performing such treatment procedures include ensuring that the delivery member and engagement system remain in a stable position throughout the treatment. For example, in some treatment applications for aneurysms, the delivery member may tend to move due to increased back-pushing from the implanted embolic material as the aneurysm is gradually filled with the embolic material. If the delivery member moves during treatment, the physician may not be able to precisely control the placement of the embolic material and may choose to stop filling the aneurysm. In such cases, the aneurysm may not be fully filled, which can lead to recanalization. Furthermore, excessive movement or stretching of the delivery member and / or the engagement system present thereon may lead to premature removal of the embolic coil. [Overview of the project] [Problems that the invention aims to solve]

[0006] Therefore, there is a need for improved methods, apparatus, and systems to provide implant delivery members and implant engagement systems with improved stability. [Means for solving the problem]

[0007] The object of the present invention is to provide systems, apparatus, and methods that satisfy the above-mentioned needs. Generally, the object of the present invention is to provide delivery members for delivering and deploying implantable medical devices having a flexible distal portion.

[0008] The rigidity of the distal portion of the delivery member may cause the microcatheter used to deliver the embolic material to be pulled back from the aneurysm as the distal end of the delivery member advances through tortuous distal anatomical structures. If the microcatheter is pulled back while the embolic material is advancing, the microcatheter may exit the aneurysm, potentially causing the physician to lose control of the embolic coil, resulting in an inability to precisely control the placement of the embolic material and potentially preventing the completion of the treatment.

[0009] Flexibility can be provided by incorporating a coil of a certain length wound along the distal portion of the delivery member. The wound coil may be protected by a flexible polymer sleeve positioned around the outside of the coil. The wound coil can prevent the stretch-resistant tube attached to the hypo tube at any end of the wound coil from stretching.

[0010] An exemplary delivery member for delivering an implantable medical device to a target location in the body's blood vessels may include a distal hypotubule, a flexible tubular section, a proximal hypotubule, a flexible sleeve covering the flexible tubular section, and a stretch-resistant member extending over the entire flexible section. The flexible tubular section may be configured to stretch longitudinally in the absence of the stretch-resistant member. The distal hypotubule, the flexible tubular section, and the proximal hypotubule may form a continuous tubular structure having a lumen running through it. The flexible sleeve may cover part or all of the flexible tubular section to prevent radial expansion of the flexible tubular section and to facilitate the flexible tubular section's ability to slide through the vascular structure. The stretch-resistant member may be attached to the proximal and distal hypotubules and thereby extend over the entire flexible tubular section. The stretch-resistant member may be positioned outside the lumen. The flexible sleeve may be attached to the flexible tubular section, or it may be fused to the stretch-resistant member through the opening of the flexible tubular section.

[0011] The delivery member may also include an engagement system that can engage with an implantable medical device and move to deploy it. The engagement system may include a loop wire and a pull wire. The loop wire may extend through an opening in the implantable medical device, and the pull wire may engage with the loop wire, thereby allowing the engagement system to engage with the implantable medical device. The pull wire may be positioned inside the lumen of the delivery member and may be retracted proximally to disengage the loop wire. Once disengaged from the pull wire, the loop wire is movable to retract from the opening in the implantable medical device, thereby allowing the implantable medical device to be deployed.

[0012] When the engagement system is moved to deploy the implantable medical device, at least a portion of the distal hypotubule may be compressed and may also be extended during the movement of the engagement system.

[0013] The flexible tubular section may include a radiopaque proximal coil, a radiopaque distal coil, and a radiopaque central coil positioned between the radiopaque coils.

[0014] A flexible tubular section can be fabricated from a wire wound to define a portion of the lumen of a delivery member. The wire from which the flexible tube is fabricated may have a cross-sectional diameter of approximately 0.8 mil to approximately 5 mil.

[0015] The flexible sleeve may contain a polymer. The flexible sleeve may contain additives to improve the lubricity of the polymer.

[0016] The flexible sleeve can be attached to the proximal hypotube and the distal hypotube. This allows the constructed flexible sleeve to cover the entire coil section and at least a portion of the proximal hypotube and / or at least a portion of the distal hypotube.

[0017] The stretch-resistant member may be an extruded tube.

[0018] The flexible tubular section and the distal hypotube may have a length of approximately 30 cm to approximately 50 cm, or more specifically approximately 40 cm, from the proximal end of the flexible tube to the distal end of the distal hypotube.

[0019] The proximal hypotube may include a spiral cut section near its distal end.

[0020] The delivery member may include a continuous hypotube comprising a distal hypotube, a proximal hypotube, and a flexible tubular section. The flexible tubular section may have a helical cut portion.

[0021] Exemplary methods for designing or constructing a delivery member such as the example above may include the steps of: selecting a first hypotube and a second hypotube; forming a wire coil section between the two hypotubes; extending a stretch-resistant member through the lumen of the wire coil section; attaching the stretch-resistant member to the first hypotube and the second hypotube; selecting a flexible sleeve; covering a flexible tubular section with the flexible sleeve; fusing the flexible sleeve to the stretch-resistant tube through the opening of the flexible tubular section; and attaching an implantable medical device to the distal end of the first hypotube so that the implantable medical device can be separated from the first hypotube during treatment.

[0022] Another exemplary method for designing or constructing a delivery member such as the example above may include: selecting a first hypotube having a first lumen; selecting a second hypotube having a second lumen; forming a flexible tubular section between the two hypotubes having a third lumen passing through it; extending a stretch-resistant member outside the first lumen, the second lumen, and the third lumen; attaching the distal portion of the stretch-resistant member to the first hypotube and the proximal portion of the stretch-resistant member to the second hypotube; selecting a flexible sleeve; covering the flexible tubular section with the flexible sleeve; fusing the flexible sleeve to the stretch-resistant tube through an opening in the flexible tubular section; and attaching an implantable medical device to the distal end of the first hypotube so that the implantable medical device can be separated from the first hypotube during treatment.

[0023] The step of forming the wire coil section can include forming a non-radiopaque proximal coil, forming a non-radiopaque distal coil, and forming a radiopaque central coil extending between the non-radiopaque proximal coil and the non-radiopaque distal coil. Alternatively, the wire coil section need not include a radiopaque section. The step of forming the wire coil section can additionally or alternatively include selecting a wire having a diameter of from about 0.8 mil to about 5 mils and winding the wire to form the wire coil section so as to define a lumen of the wire coil section.

[0024] The step of selecting the flexible sleeve can include selecting a polymeric sleeve having an additive for improving the lubricity of the polymer.

[0025] The step of extending the stretch-resistant member through the lumen of the wire coil can include extending a substantially tubular stretch-resistant member through the lumen of the wire coil.

[0026] The step of attaching the implantable medical device to the first hypodermic tube can include compressing the first hypodermic tube and attaching the implantable medical device to the distal end of the compressed first hypodermic tube.

[0027] An exemplary method for designing or constructing a delivery member may further include positioning a loop wire inside the lumen of a first hypodermic tube and positioning a pull wire to extend through the lumens of the first hypodermic tube, the wire coil section, and the second hypodermic tube. The step of attaching the implantable medical device may additionally or alternatively include extending the loop wire through an opening of the implantable medical device and engaging the pull wire with a portion of the loop wire extending through the opening of the implantable medical device. The step of attaching the implantable medical device may additionally or alternatively include positioning the pull wire to extend proximally from the proximal end of the second hypodermic tube.

[0028] Another exemplary method for designing or constructing a delivery member, such as the example above, includes helically cutting a hypodermic tube to form a coil section within the hypodermic tube such that a distal hypodermic tube section extends distally from the coil section and a proximal hypodermic tube section extends proximally from the coil section, extending a stretch-resistant tube through the lumen of the coil section, positioning a flexible sleeve to cover at least a majority of the outer surface of the coil section, fusing the flexible sleeve to the stretch-resistant tube between the windings of the coil section, and attaching an implantable medical device to the delivery member in proximity to the distal end of the distal hypodermic tube section.

[0029] This exemplary method may further include attaching the stretch-resistant tube to the proximal hypodermic tube portion within the lumen of the proximal hypodermic tube portion and attaching the stretch-resistant tube to the distal hypodermic tube portion within the lumen of the distal hypodermic tube portion.

[0030] This exemplary method may further include extending a pull wire through the lumen of the stretch-resistant tube such that the implantable medical device is released upon proximal translation of the pull wire. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The above and further aspects of the present invention are further discussed below with reference to the accompanying drawings, where similar figures in various drawings indicate similar structural elements and features. The drawings are not necessarily to scale and are primarily intended to illustrate the principles of the present invention. The figures depict one or more implementations of the apparatus of the present invention, not as limitations but merely as examples. [Figure 1] This is a cross-sectional view of a delivery member according to an embodiment of the present invention. [Figure 2A] This is a cross-sectional view of a flexible sleeve according to an aspect of the present invention. [Figure 2B] This is a cross-sectional view of an elongation-resistant tube according to an aspect of the present invention. [Figure 2C] This is a cross-sectional view of a wire coil attached to a distal hypotube and a proximal hypotube according to an aspect of the present invention. [Figure 3A] This is a diagram of an engagement system showing a sequence for deploying an implant according to an aspect of the present invention. [Figure 3B] This is a diagram of an engagement system showing a sequence for deploying an implant according to an aspect of the present invention. [Figure 3C] This is a diagram of an engagement system showing a sequence for deploying an implant according to an aspect of the present invention. [Figure 3D] This is a diagram of an engagement system showing a sequence for deploying an implant according to an aspect of the present invention. [Figure 4] This is a flowchart showing a method for designing and / or constructing a delivery member according to an aspect of the present invention. [Figure 5] This flowchart shows a method for using a delivery system that includes an exemplary delivery member according to an aspect of the present invention. [Figure 6A] This is a cross-sectional view of a distal hypotube and a stretch-resistant member attached to a proximal hypotube according to an aspect of the present invention. [Figure 6B]This is a cross-sectional view of a distal hypotube and a stretch-resistant member attached to a proximal hypotube according to an aspect of the present invention. [Figure 7A] This is a cross-sectional view of a flexible sleeve according to an aspect of the present invention. [Figure 7B] This is a cross-sectional view of a flexible sleeve according to an aspect of the present invention. [Figure 7C] This is a cross-sectional view of a delivery member according to an embodiment of the present invention. [Modes for carrying out the invention]

[0032] During endovascular procedures, such as aneurysm occlusion treatment, a lack of flexibility in the distal portion of the delivery member of a treatment device can pull the delivery member back from the treatment site or otherwise displace it while the implant or other medical device is positioned at the aneurysm or other treatment site. Therefore, delivery members and engagement systems with a more flexible distal portion can provide a stable system for delivering medical devices to neurovascular anatomical structures, in addition to other applications facing similar challenges. However, flexible structures may tend to deform, stretch, or expand when guiding tortuous anatomical structures. Deformation of the delivery member can hinder its ability to guide to the treatment site and / or effectively deploy the medical device. Stretching of the delivery member can result in premature deployment of the medical device.

[0033] The object of the present invention is to provide a delivery member having a highly flexible distal portion that is stretch-resistant and structurally stable throughout the delivery and deployment of a medical device. For ease of explanation, the medical device is generally referred to herein as “implant,” but as will be recognized and understood by those skilled in the art, aspects of the present invention may be applied to the delivery and deployment of non-implanted medical devices.

[0034] According to the present invention, in some examples, the highly flexible distal portion of the delivery member may include a coiled wire, an outer sleeve, and an inner stretch-resistant member. The coiled wire can be formed from a substantially linear wire wound into a coil shape and / or from a hypotube laser-cut in a helical pattern. When the coiled wire is formed from a laser-cut hypotube, the helix may lack interfering cuts connecting the windings within the coil, providing a more flexible coil. The outer sleeve can prevent the coiled wire from deforming radially and / or provide a smooth surface that allows the vessel wall to slide over it during implant delivery. The stretch-resistant member can prevent the coiled wire from stretching during implant delivery. Thus, the combination of the coiled wire, outer sleeve, and stretch-resistant member can provide a distal portion of a delivery member having higher flexibility and greater stability than at least some known delivery members.

[0035] Referring to the drawings, as shown in Figure 1, an exemplary delivery member 10 may include a proximal tube 100, a coil section 200, a distal tube 300, a sleeve 500 surrounding the coil section, and a stretch-resistant member 600 within the lumen of the coil section 200. The proximal tube 100 may extend for most of the length of the delivery member 10 having the coil section 200 and the distal tube 300, forming a length sufficient to absorb most of the pushback that may occur during implant placement at the treatment site. In some examples, the length may be about 30 cm to 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 coil section 200, and the coil section 200 may have a distal end 204 connected to the proximal end 302 of the distal coil 300.

[0036] Figure 2A is a cross-sectional view of the sleeve 500. Figure 2B is a cross-sectional view of the stretch-resistant member 600. Figure 2C is a cross-sectional view of the assembled proximal tube 100, coil section 200, and distal tube 300.

[0037] The coil section 200 may be formed separately from the proximal hypotube 100 and / or the distal hypotube 300. The separately formed coil section 200 can be attached by welds 712, 714, or other suitable attachments to the proximal tube 100 and / or the distal tube 300. Alternatively or additionally, at least a portion of the coil section may be formed from a helical laser-cut portion of the hypotube. The separately formed coil section 200 can be made more flexible than the helical-cut tube by selecting a wire having a specific cross-section with a specific diameter D, or by selecting a wire having material properties that increase flexibility. Conversely, the laser-cut portion can be more easily fabricated by cutting a single hypotube to form the proximal tube 100, the coil section 200, and the distal hypotube 300, reducing or eliminating welds 712, 714, or other attachments. In either case, the wire of coil 200 may have a diameter D within the range of approximately 0.8 mil and 5 mil.

[0038] The coil section can be formed primarily from a radiopaque material such as steel, and may include a radiopaque section 216 made from a radiopaque material such as platinum and / or tungsten. The radiopaque section 216 can be positioned between the proximal radiopaque section of coil 212 and the distal radiopaque section of coil 214. The radiopaque section 216 can be positioned at a predetermined distance from the distal end 304 of the delivery member 10 so that the physician can easily visualize the position of the distal portion of the delivery member during the treatment procedure. The proximal section 212, the radiopaque section 216, and the distal section 214 can be welded concentrically.

[0039] The coil section 200 may be surrounded by a flexible sleeve or molten jacket 500, collectively referred to herein as “sleeve”. The sleeve can prevent the coil 200 from expanding radially and / or engaging with the vessel wall during navigation. The sleeve 500 may contain a polymer. The polymer may contain additives to improve the lubricity of the sleeve 500, allowing the sleeve to slide easily through the body’s blood vessels. As shown in Figure 2A, the sleeve 500 may have a wall thickness T, ranging from about 0.5 mil to about 2 mil. The sleeve 500 may have a wall thickness of about 0.001 inch to about 0.003 inch. The sleeve 500 may be further coated with a hydrophilic coating to further minimize friction during intravascular navigation. The sleeve 500 may be fused or bonded to the coil 200, the proximal hypotube 100 and / or the distal hypotube 300. The flexible sleeve 500 can be fused to the stretch-resistant member 600 through the opening in the coil 200.

[0040] The stretch-resistant member 600 can be positioned to prevent the coil 200 from stretching during intravascular navigation. The stretch-resistant member 600 may include a tube sized to fit inside the lumen 208 of the coil 200. The stretch-resistant tube 600 may also be sized to extend through the entire length of the coil 200 and to extend into the lumen 308 of the distal coil 300, together with the lumen 108 of the proximal tube 100. The stretch-resistant member 600 can be attached to the proximal tube 100 and the distal tube 300 by adhesive joints 702, 704 or other suitable attachments. The stretch-resistant member 600 may remain detached from the coil section 200 so that the stretch-resistant member 600 and the coil section 200 can move to some extent independently of each other.

[0041] The delivery member 10 may include a mechanical engagement system for engaging the treatment device during delivery to the treatment site, which can be mechanically actuated to deploy the medical treatment device. The mechanically actuated engagement system often includes one or more internal elongated members or pull wires extending through the delivery member, which can be operated at the proximal end by a physician to deploy the medical treatment device. Such wires or internal elongated members are collectively referred to herein as “pull wires”.

[0042] Figures 3A to 3D show a delivery member 10 that includes a mechanical engagement system comprising a pull wire 140 and a loop wire 400 which can be positioned to secure an implant or other medical device to the delivery member 10 and can be moved to release the medical device from the delivery member 10. The loop wire 400 can be attached to the distal tube 300 by a weld 408 or by other or other suitable attachment. The stretch-resistant member 600 can be sized so that the pull wire 140 can pass through the proximal tube 100, the coil section 200, and the lumens 108, 208, and 308 of the distal tube 300. For example, the stretch-resistant member 600 may be tubular and have a lumen passing through the tube, and the pull wire 140 can extend through the lumen of the stretch-resistant member 600. During the manufacture of the stretch-resistant member 600, the stretch-resistant member 600 can be extruded onto the pull wire 140.

[0043] The combination of the coil 200, sleeve 500, and stretch-resistant member 600 can provide a highly flexible distal portion of the delivery member 10 suitable for guiding tortuous anatomical structures, including neurovascular structures. The stretch-resistant member 600 can support the coil 200 and prevent it from extending excessively during vascular navigation, thereby reducing the tension on the pull wire 140 extending through it and reducing the possibility of premature deployment of the attached medical device.

[0044] The proximal tube 100 may include a flexible section 106 from which material has been removed to increase the flexibility of the flexible section 106. The flexible section 106 may be cut in a helical pattern. The helical pattern of the flexible section 106 may lack interferential cuts connecting the windings within the helix. The stretch-resistant member 600 may extend through the flexible section 106 and be attached to the proximal tube 100 proximal to the flexible section 106. This allows the stretch-resistant member 600 to prevent the flexible section 106 of the proximal tube 100 and the coil section 200 from stretching. The sleeve 500 can cover at least a portion of the flexible section 106 to prevent deformation of the flexible section during intravascular navigation and / or reduce friction with the vascular structure and the flexible section 106. In some examples, the sleeve 500 can cover approximately 10 cm of the proximal tube 100 that approaches and / or includes the distal end 104 of the proximal tube 100.

[0045] The distal tube 300 may include a compressible portion 306. The compressible portion 306 may be axially adjustable between an elongated state and a compressed state. The compressed portion 306 may be formed from a helical cut portion of the tube 300 formed by a laser cutting operation. Additionally or alternatively, the compressible portion may be formed from a winding, a helical ribbon, or other configurations that allow for axial adjustment according to the present invention. Preferably, the compressible portion 306 is in an elongated state when at rest and, unless otherwise constrained, automatically or elastically returns from the compressed state to the elongated state.

[0046] Figures 3A to 3D illustrate the removal of the medical device 12 using a mechanical engagement / deployment system. Figure 3A shows the engagement systems 140, 400 engaged with the locking portion 18 of the medical device 12. The compressible portion 306 of the distal tube 300 can be compressed, and the opening 405 of the loop wire 400 at its distal end 404 can be positioned through the locking portion 18. Once the pull wire 140 is passed through the opening 405, the medical device 12 is secured at that point. Figure 3B shows the pull wire 140 being pulled proximal to initiate the release sequence of the medical device 12. Figure 3C illustrates the moment when the pull wire 140 exits the opening 405 and is detached from the loop wire 400. The distal end 404 of the loop wire 400 separates and exits the locking portion 18. As can be seen from the figures, there is now nothing holding the medical device 12 to the removal system 10. Figure 3D shows the end of the release sequence. Here, the compressible portion 306 expands / returns to its original shape and "snaps" forward. The distal end 304 of the distal tube 300 applies an elastic force E to the medical device 12, "pushing" it out and ensuring complete separation and delivery of the medical device 12.

[0047] The above description of the drawings illustrates substantially hollow or substantially tubular structures 100, 200, 300, 500, and 600 according to the present invention. As used herein, the terms “tubular” and “tube” are to be interpreted broadly and are not limited to structures having a right-circular or strictly circular cross-section, or a uniform cross-section along its entire length. For example, a tubular structure or tubular system is generally illustrated as a substantially right-circular structure. However, a tubular system may have a tapered or curved outer surface without departing from the scope of the present invention.

[0048] Figure 4 is a flowchart including method steps for constructing or designing a delivery member, such as an exemplary delivery member described herein. Referring to method 800 outlined in Figure 4, step 810 may involve selecting a first hypotube, a second hypotube, a flexible sleeve, a wire coil, and a stretch-resistant member. The first hypotube may be a proximal hypotube 100 as described herein, or otherwise known to those skilled in the art. The second hypotube may be a distal hypotube 300 as described herein, or otherwise known to those skilled in the art. The flexible sleeve may be a sleeve or molten jacket 500 as described herein, or otherwise known to those skilled in the art. The wire coil may include a support coil, a coil section 200 as described herein, or otherwise known to those skilled in the art. The stretch-resistant member may be a stretch-resistant member 600 as described herein, or otherwise known to those skilled in the art.

[0049] In step 820, the stretch-resistant member can be positioned within the lumen of the wire coil. In step 820, the positioned stretch-resistant member may be substantially tubular. In step 830, the first hypo tube, the wire coil, and the second hypo tube can be attached to each other. In step 840, the stretch-resistant member is attached to the first hypo tube and the second hypo tube. The first hypo tube, the wire coil, and the second hypo tube can be attached as illustrated and described herein, or by other means as understood by those skilled in the art. Steps 820, 830, and 840 do not need to be performed in that order and can be performed simultaneously. For example, the stretch-resistant member may be attached to one of the first hypo tube and the second hypo tube, as shown in step 840, and the hypo tube to which the stretch-resistant member is attached may then be attached to a wire coil, as shown in step 830, then the stretch-resistant member may be positioned through the wire coil, as shown in step 820, then the other end of the hypo tube may be attached to the wire coil, as shown in step 830, and then the stretch-resistant member may be attached to the other hypo tube, as shown in step 840.

[0050] In step 850, the wire coil can be covered with a flexible sleeve. The flexible sleeve can cover part or all of the outer surface of the wire coil. Step 850 may also include the steps of fusing the flexible sleeve to the wire coil and / or attaching the flexible sleeve to a delivery member by other means. Step 850 may also include the steps of fusing the flexible sleeve to a stretch-resistant member. If the second hypotube has a flexible section, in step 850 the flexible sleeve may also be positioned to cover at least a portion of the flexible section.

[0051] In step 860, the implant can be removably attached to the distal end of the first hypotube. In step 860, the implant can be attached by positioning the loop wire within the first hypotube, positioning the pull wire to extend through the first hypotube, the coil wire, and the second hypotube, and securing the implant with the loop wire and the pull wire. The pull wire can extend from the proximal end of the second hypotube. If the first hypotube has a compressible portion, the compressible portion can be compressed in step 860, and the implant can be attached to the delivery member while the compressible portion is compressed.

[0052] Figure 5 is a flowchart showing a method and steps for performing an intravascular procedure using a system including a delivery member, such as an exemplary delivery member described herein. Referring to method 900 outlined in Figure 5, step 910 may be a system comprising a distal hypotubule, a proximal hypotubule, a coil section coaxially positioned between the hypotubules, a flexible sleeve covering the coil section, a stretch-resistant member positioned inside the coil section, and a medical treatment device attached to or near the distal hypotubule. This system may be suitable for intravascular procedures such as those described and illustrated herein, or other intravascular procedures otherwise known to those skilled in the art.

[0053] In step 920, the system can be moved through the catheter to a treatment site such as the site of an aneurysm or other abnormality in the blood vessel. In step 930, the system can be bent as it moves through the catheter. In step 940, the coil section of the system can be prevented from deforming by the flexible sleeve and the stretch-resistant member, the stretch-resistant member can prevent the coil from extending longitudinally, while the flexible sleeve can prevent the coil section from deforming radially.

[0054] In step 950, the medical device may be deployed. If the medical device is an implant, in step 950, the implant may be removed. In step 960, the distal tube may extend to push the medical device out of the distal tube. If the medical device is an implant removed in step 950, in step 960, the removed implant may be released from the distal tube in response to the expansion of the distal tube.

[0055] Figure 6A is a cross-sectional view of a stretch-resistant member 600 attached to the distal hypotube 300 and the proximal hypotube 100 according to an aspect of the present invention. The stretch-resistant member 600 may be positioned to prevent the flexible tubular section 200 from stretching during intravascular navigation. The stretch-resistant member 600 may be positioned outside the lumen 208 of the flexible tubular section 200, and outside the lumens 108, 308 of either or both of the proximal hypotube 100 and the distal hypotube 100. The stretch-resistant member 600 may also be sized to extend along the entire length of the flexible tubular section 200, to the proximal hypotube 100, and to the distal hypotube 300. The stretch-resistant member 600 may be attached to the proximal tube 100 and the distal tube 300 by adhesive joints 722, 724 or other suitable attachments. The stretch-resistant member 600 can remain detached from the flexible tubular section 200 so that the stretch-resistant member 600 and the flexible tubular section 200 can move independently of each other to a certain extent.

[0056] Figure 6B is a cross-sectional view of a flexible sleeve 500 positioned over a stretch-resistant member 600 attached to a distal hypotube 300 and a proximal hypotube 100, according to an embodiment of the present invention. The flexible sleeve 500 may have a wall thickness T ranging from about 0.001 inches to about 0.003 inches. The flexible sleeve 500 may be further coated with a hydrophilic coating to further minimize friction during intravascular navigation. The flexible sleeve 500 may be fused or bonded to the flexible tubular section 200, the proximal hypotube 100, and / or the distal hypotube 300, so that the flexible sleeve 500 prevents the flexible tubular section 200 from stretching while the delivery member 10 is operated in the vascular system, and maintains the flexibility of the distal hypotube 300. The flexible sleeve 500 may be fused through an opening in the flexible tubular section 200.

[0057] As shown in Figures 7A and 7B, the sleeve 502 may have one or more stretch-resistant fibers 800 positioned within the wall of the sleeve 502. The stretch-resistant fibers 800 may include polymer fibers and / or metallic fibers. The stretch-resistant fibers 800 may be oriented within the wall of the sleeve 502 in a linear orientation as shown in Figure 7A, or in one or more helical orientations as shown in Figure 7B. The stretch-resistant fibers 800 may be incorporated into the wall of the sleeve 502 during the extrusion process of the fiber sleeve 502. The fiber sleeve 502 may have a wall thickness T ranging from about 0.001 inches to about 0.003 inches. The fiber sleeve 502 may be further coated with a hydrophilic coating to further minimize friction during intravascular navigation.

[0058] Figure 7C is a cross-sectional view of a delivery member 10 according to an aspect of the present invention. The fiber sleeve 502 may be fused or bonded to the flexible tubular section 200, the proximal hypotube 100, and / or the distal hypotube 300, so that the fiber sleeve 502 prevents the flexible tubular section 200 from stretching while the delivery member 10 is operated in the vascular system, and maintains the flexibility of the distal hypotube 300. The fiber sleeve 502 may also be fused through an opening in the flexible tubular section 200.

[0059] Where used herein, the terms “about” or “approximately” for any number or range indicate an appropriate dimensional tolerance that enables some or all of the components to function for the intended purposes described herein. More specifically, “about” or “approximately” may refer to a range of values ​​within ±20% of the listed values, for example, “about 90%” may refer to a range of values ​​between 71% and 99%.

[0060] The descriptions contained herein are examples of embodiments of the present invention and do not limit the scope of the invention in any way. As described herein, the present invention intends to provide many variations and modifications of delivery systems, delivery members, and engagement systems, including alternative component configurations, alternative materials, alternative medical treatment devices, alternative means for deploying medical treatment devices, alternative geometric shapes of individual components, alternative means for mounting components, etc. These modifications will be obvious to those skilled in the art to whom the present invention relates and are intended to be within the scope of the following claims.

[0061] [Implementation Method] (1) A delivery member for delivering an implantable medical device to a target location in the body's blood vessels, A distal hypotube having a distal end shaped to receive the implantable medical device, A flexible tubular section attached to the proximal end of the distal hypotube, having an opening that penetrates it, A proximal hypotube attached to the proximal end of the aforementioned flexible tubular section, The distal hypotube, the flexible tubular section, and the lumen extending through the proximal hypotube, A stretch-resistant member is positioned outside the lumen, attached to the proximal hypotube, attached to the distal hypotube, and extending along at least a portion of the outer surface of the flexible tubular section. A delivery member comprising: a flexible sleeve covering at least a large portion of the outer surface of the flexible tubular section and the stretch-resistant member. (2) The distal end of the distal hypotube is further equipped with a movable engagement system that engages with and deploys the implantable medical device, the engagement system A loop wire extending through an opening in the implantable medical device, thereby engaging the engagement system with the implantable medical device, the loop wire being movable to retract from the opening in the implantable medical device in order to deploy the implantable medical device, A delivery member according to Embodiment 1, comprising: a pull wire extending through the lumen, which is engaged with the loop wire, thereby engaging the engagement system with the implantable medical device, and is movable to retract proximally to disengage the loop wire in order to deploy the implantable medical device. (3) The distal hypotube has a compressible portion that can move from a compressed state to an extended state, The delivery member according to Embodiment 2, wherein the engagement system maintains the compressible portion in the compressed state when engaged with the implantable medical device. (4) The flexible tubular section is A radiopaque proximal coil extending from the proximal end of the flexible tubular section, A radiopaque distal coil extending from the distal end of the flexible tubular section, The delivery member according to Embodiment 1, comprising a radiopaque central coil extending between the radiopaque proximal coil and the radiopaque distal coil. (5) The flexible tubular section is The delivery member according to Embodiment 1, comprising a wire wound to form the flexible tubular section and defining a portion of the lumen, the wire having a diameter of approximately 20.32 μm (approximately 0.0008 inches) to approximately 127 μm (approximately 0.005 inches).

[0062] (6) The flexible sleeve contains a polymer, The delivery member according to Embodiment 1, wherein the flexible sleeve contains an additive effective in improving the lubricity of the polymer. (7) The delivery member according to Embodiment 1, wherein the flexible sleeve is attached to the proximal hypotube and the distal hypotube. (8) The delivery member according to Embodiment 1, wherein the flexible sleeve has a wall thickness of approximately 25.4 μm (approximately 0.001 inches) to approximately 76.2 μm (approximately 0.003 inches). (9) The delivery member according to Embodiment 1, wherein the delivery member has a measurable length from the proximal end of the flexible tubular section to the distal end of the distal hypotube, and the length is approximately 40 cm. (10) A delivery member for delivering an implantable medical device to a target location in a blood vessel of the body, A distal hypotube having a distal end shaped to receive the implantable medical device, A flexible tubular section attached to the proximal end of the distal hypotube, A proximal hypotube attached to the proximal end of the aforementioned flexible tubular section, The flexible sleeve covers at least a large portion of the outer surface of the flexible tubular section, The delivery member comprises a flexible sleeve having one or more stretch-resistant fibers positioned within the wall of the flexible sleeve.

[0063] (11) The flexible sleeve of the one or more stretch-resistant fibers comprises a polymer, The delivery member according to embodiment 10, wherein the flexible sleeve includes an additive effective in minimizing friction of the polymer. (12) The delivery member according to embodiment 10, wherein the flexible sleeve is further attached to the flexible tubular section. (13) The flexible sleeve comprises a polymer, The one or more stretch-resistant fibers include metal fibers. The delivery member according to embodiment 10, wherein the flexible sleeve includes an additive effective in minimizing friction of the polymer. (14) The delivery member according to embodiment 10, wherein one or more stretch-resistant fibers are positioned within the flexible sleeve in one or more linear orientations. (15) The delivery member according to embodiment 10, wherein one or more stretch-resistant fibers are positioned within the flexible sleeve in one or more spiral orientations.

[0064] (16) The delivery member according to Embodiment 10, wherein the flexible sleeve has a wall thickness of approximately 25.4 μm (approximately 0.001 inches) to approximately 76.2 μm (approximately 0.003 inches). (17) The distal hypotube, the flexible tubular section, and the lumen extending through the proximal hypotube, The system further comprises an engagement system that engages with the implantable medical device engaged at the distal end of the distal hypotube and is movable to deploy the device, the engagement system being A loop wire extending through an opening in the implantable medical device, thereby engaging the engagement system with the implantable medical device, the loop wire being movable to retract from the opening in the implantable medical device in order to deploy the implantable medical device, A delivery member according to embodiment 10, comprising: a pull wire extending through the lumen, which is engaged with the loop wire, thereby engaging the engagement system with the implantable medical device, and is movable to retract proximally to disengage the loop wire in order to deploy the implantable medical device. (18) A method for constructing a delivery member for delivering an implantable medical device, Select a first hypo tube having a first lumen passing through its interior, Select a second hypo tube that has a second lumen running through the inside, A flexible tubular section is formed extending from the distal end of the second hypotube to the proximal end of the first hypotube, and the flexible tubular section defines a third lumen through which it passes. The distal portion of the stretch-resistant member is attached to the first hypo tube, and the proximal portion of the stretch-resistant member is attached to the second hypo tube, The intermediate portion of the stretch-resistant member is positioned outside the first lumen, the second lumen, and the third lumen, and is attached to them. Choosing a flexible sleeve, The outer surface of the flexible tubular section is covered with the flexible sleeve, A method comprising attaching the implantable medical device to the delivery member in a manner that is close to the distal end of the first hypotube. (19) The step of selecting the flexible sleeve is: The further includes selecting the flexible sleeve containing a polymer, wherein the flexible sleeve is An additive effective in improving the lubricity of the aforementioned polymer, stretch-resistant fibers containing polymers, and The method according to Embodiment 18, further comprising at least one of metal-containing stretch-resistant fibers. (20) The step of detachably attaching the implantable medical device to the delivery member in close proximity to the distal end of the first hypotube is: Compressing the first hypo tube, The method according to Embodiment 18, further comprising attaching the implantable medical device to the delivery member in a manner that is close to the distal end of the compressed first hypotube.

Claims

1. A delivery member for delivering an implantable medical device to a target location in the body's blood vessels, wherein the delivery member extends along its longitudinal axis, and the delivery member is A distal hypotube having a distal end shaped to receive the implantable medical device, the distal hypotube extending along the longitudinal axis, A flexible tubular section attached to the proximal end of the distal hypotube, the flexible tubular section extending along the longitudinal axis and having an opening that penetrates its interior, A proximal hypotube attached to the proximal end of the aforementioned flexible tubular section, the proximal hypotube extending along the longitudinal axis, The distal hypotube, the flexible tubular section, and the lumen extending along the longitudinal axis through the proximal hypotube, A stretch-resistant member positioned outside the lumen, attached to the proximal hypotube, attached to the distal hypotube, extending along at least a portion of the outer surface of the flexible tubular section and along the longitudinal axis, and a stretch-resistant member not attached to the flexible tubular section, A delivery member comprising: a flexible sleeve covering at least a large portion of the outer surface of the flexible tubular section and the stretch-resistant member, the flexible sleeve positioned to cover the stretch-resistant member.

2. The distal end of the distal hypotubule further comprises an engagement system that engages with the implantable medical device and is movable to deploy it, the engagement system being A loop wire extending through an opening in the implantable medical device, thereby engaging the engagement system with the implantable medical device, the loop wire being movable to retract from the opening in the implantable medical device in order to deploy the implantable medical device, The delivery member according to claim 1, comprising: a pull wire extending through the lumen, which is engaged with the loop wire, thereby engaging the engagement system with the implantable medical device, and is movable to retract proximally to disengage the loop wire in order to deploy the implantable medical device.

3. The distal hypotube is provided with a compressible portion that can move from a compressed state to an extended state, The delivery member according to claim 2, wherein the engagement system maintains the compressible portion in the compressed state when engaged with the implantable medical device.

4. The aforementioned flexible tubular section is A radiopaque proximal coil extending from the proximal end of the flexible tubular section, A radiopaque distal coil extending from the distal end of the flexible tubular section, The delivery member according to claim 1, comprising a radiopaque central coil extending between the radiopaque proximal coil and the radiopaque distal coil.

5. The aforementioned flexible tubular section is The delivery member according to claim 1, comprising a wire wound to form the flexible tubular section and defining a portion of the lumen, the wire having a diameter of 20.32 μm to 127 μm.

6. The aforementioned flexible sleeve contains a polymer, The delivery member according to claim 1, wherein the flexible sleeve includes an additive effective in improving the lubricity of the polymer.

7. The delivery member according to claim 1, wherein the flexible sleeve is attached to the proximal hypotube and the distal hypotube.

8. The delivery member according to claim 1, wherein the flexible sleeve has a wall thickness of 25.4 μm to 76.2 μm.

9. The delivery member according to claim 1, wherein the delivery member has a length that can be measured from the proximal end of the flexible tubular section to the distal end of the distal hypotube, and the length is 40 cm.

10. A delivery member for delivering an implantable medical device to a target location in the body's blood vessels, A distal hypotube having a distal end shaped to receive the implantable medical device, A flexible tubular section attached to the proximal end of the distal hypotube, A proximal hypotube attached to the proximal end of the aforementioned flexible tubular section, The flexible sleeve covers at least a large portion of the outer surface of the flexible tubular section, A delivery member comprising a flexible sleeve having one stretch-resistant fiber positioned within the wall of the flexible sleeve in a helical orientation, and not having any stretch-resistant fibers positioned in a linear orientation.

11. The flexible sleeve of the one stretch-resistant fiber comprises a polymer. The delivery member according to claim 10, wherein the flexible sleeve includes an additive effective in minimizing friction of the polymer.

12. The delivery member according to claim 10, wherein the flexible sleeve is further attached to the flexible tubular section.

13. The aforementioned flexible sleeve contains a polymer, The aforementioned stretch-resistant fiber includes a metal fiber, The delivery member according to claim 10, wherein the flexible sleeve includes an additive effective in minimizing friction of the polymer.

14. The delivery member according to claim 10, wherein the flexible sleeve has a wall thickness of 25.4 μm to 76.2 μm.

15. The distal hypotube, the flexible tubular section, and the lumen extending through the proximal hypotube, The system further comprises an engagement system that engages with the implantable medical device engaged at the distal end of the distal hypotube and is movable to deploy the device, the engagement system being A loop wire extending through an opening in the implantable medical device, thereby engaging the engagement system with the implantable medical device, the loop wire being movable to retract from the opening in the implantable medical device in order to deploy the implantable medical device, The delivery member according to claim 10, comprising: a pull wire extending through the lumen, which is engaged with the loop wire, thereby engaging the engagement system with the implantable medical device, and is movable to retract proximally to disengage the loop wire in order to deploy the implantable medical device.

16. A method for constructing a delivery member for delivering an implantable medical device, wherein the delivery member extends along a longitudinal axis, and the method is The selection of a first hypotube having a first lumen passing through its interior, wherein the first hypotube extends along the longitudinal axis, The selection of a second hypotube having a second lumen passing through its interior, wherein the second hypotube extends along the longitudinal axis, A flexible tubular section is formed extending from the distal end of the second hypotube to the proximal end of the first hypotube, and along the longitudinal axis, so as to define a third lumen through which the flexible tubular section passes. The distal portion of the stretch-resistant member is attached to the first hypo tube, and the proximal portion of the stretch-resistant member is attached to the second hypo tube, wherein the intermediate portion of the stretch-resistant member is positioned outside the first lumen, the second lumen, and the third lumen, and the stretch-resistant member extends along the longitudinal axis and is not attached to the flexible tubular section. Choosing a flexible sleeve, Covering at least a large portion of the outer surface of the flexible tubular section with the flexible sleeve, wherein the flexible sleeve extends along the longitudinal axis and is positioned to cover the stretch-resistant member. A method comprising attaching the implantable medical device to the delivery member in a manner that is close to the distal end of the first hypotube.

17. The step of selecting the flexible sleeve is: The further includes selecting the flexible sleeve containing a polymer, wherein the flexible sleeve is An additive effective in improving the lubricity of the aforementioned polymer, stretch-resistant fibers containing polymers, and The method according to claim 16, further comprising at least one of metal-containing stretch-resistant fibers.

18. The step of detachably attaching the implantable medical device to the delivery member in proximity to the distal end of the first hypotube is: Compressing the first hypo tube, The method according to claim 16, further comprising attaching the implantable medical device to the delivery member in a manner that is close to the distal end of the compressed first hypotube.

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