KR20220136908A - Medical device delivery member with flexible stretch resistant distal portion - Google Patents

Abstract

Provided is a delivery member for delivering and deploying an implantable medical device. The delivery member comprises: 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. In addition, the stretch resistant tube may be positioned outside the lumen and attached to the proximal and distal hypotubes, and extend along at least a portion of an outer surface of the flexible tubular section. Moreover, the flexible sleeve may include one or more stretch resistant fibers positioned within a wall of the flexible sleeve, and the flexible sleeve can cover at least the majority of the outer surface of the flexible tubular section.

Description

MEDICAL DEVICE DELIVERY MEMBER WITH FLEXIBLE STRETCH RESISTANT DISTAL PORTION

Cross-reference to related applications

This application is a continuation-in-part of U.S. Patent Application Serial No. 17/218,801, filed March 31, 2021, which is a continuation-in-part of U.S. Patent Application Serial No. 16/502,767, filed on July 3, 2019 It is a continuation-in-part of U.S. Patent Application No. 16/592,320, filed on October 3, , all of which are hereby incorporated by reference as if fully set forth herein.

technical field

The present invention relates generally to an intravascular medical device system that is steerable through the blood vessels of a human patient's body. More particularly, the present invention relates to a delivery system and delivery member for delivering and deploying an implantable medical device to a target location in a blood vessel in the body and a method of using the same.

The use of a catheter delivery system to place and deploy therapeutic devices such as dilation balloons, stents, and embolic coils within the vasculature of the human body to treat vascular disease. It has become the standard procedure for Such devices have been found to be particularly useful for treating areas where traditional surgical procedures are not possible or pose a great risk to the patient, for example, for the treatment of aneurysm in cranial blood vessels. Due to the delicate tissue surrounding cranial blood vessels, such as brain tissue, performing surgical procedures to treat defects in cranial vessels can be difficult and often risky. Advances in catheter-based implant delivery systems have provided an alternative treatment in such cases. Some of the advantages of catheter delivery systems are that they provide a method for treating blood vessels by an approach that has been shown to reduce the risk of trauma to the surrounding tissue, and that they also treat blood vessels that would have previously been considered inoperable. is to make it possible

Typically, these procedures involve inserting a delivery catheter into the patient's vasculature, and guiding it through the vasculature to a predetermined delivery site. A vascular occlusion device, such as an embolic coil, may be attached to the implant engagement/deployment system at the distal end of the delivery member, which pushes the coil through the delivery catheter and from the distal end of the delivery catheter to the delivery site. An exemplary transfer member and engagement/deployment system is disclosed as U.S. Patent Application Publication No. 2019/0192162 A1 on June 27, 2019, and is now issued on October 20, 2020, each of which is incorporated herein by reference. U.S. Patent Application Serial No. 15/850,993, which is U.S. Patent No. 10,806,462; and U.S. Patent Application Serial No. 15/964,857, published as U.S. Patent Application Publication No. 2019/0328398 on October 31, 2019 and now issued October 20, 2020, U.S. Patent No. 10,806,461.

Some of the problems associated with properly performing such a therapeutic procedure include ensuring that the delivery member and engagement system remain in a stable position throughout the treatment. For example, in some aneurysm treatment applications, as the aneurysm is gradually packed with embolic material, the delivery member may tend to move due to increasing pushback from the implanted embolic material. If the delivery member moves during treatment, the surgeon may not be able to precisely control the placement of the embolic material and may choose to stop packing the aneurysm. In such instances, the aneurysm may not be sufficiently packed, which may lead to recanalization. In addition, excessive movement or stretching of the delivery member and/or the engagement system thereon may result in premature detachment of the embolic coil.

Accordingly, there is a need for improved methods, devices, and systems for providing implant delivery members and implant engagement systems with increased stability.

It is an object of the present invention to provide a system, apparatus and method for meeting the above-mentioned needs. In general, it is an object of the present invention to provide a delivery member for delivering and deploying an implantable medical device having a flexible distal portion.

The stiffness of the distal portion of the delivery member may allow the microcatheter used for delivery of the embolic material to be withdrawn from the aneurysm as the distal end of the delivery member is advanced through the tortuous distal anatomy. If the microcatheter retracts while advancing the embolic material, the microcatheter may emerge from the aneurysm, the physician may lose control of the embolic coil, and may not be able to accurately control the placement of the embolic material, may not be able to complete.

Flexibility may be provided by including a length of wound coil along the distal portion of the transfer member. The wound coil may be protected by a flexible polymer sleeve positioned around the outside of the coil. The wound coil may be restrained from elongating by a stretch resistant tube attached to a hypotube on both ends of the wound coil.

Exemplary delivery members for delivering an implantable medical device to a target location in a body vessel include a distal hypotube, a flexible tubular section, a proximal hypotube, a flexible sleeve covering the flexible tubular section, and extending across the flexible section. It may include a stretch-resistant member that becomes The flexible tubular section may be configured to longitudinally elongate the stretch-resistant member. The distal hypotube, the flexible tubular section, and the proximal hypotube may form an adjacent tubular structure having a through lumen. The flexible sleeve may cover some or all of the flexible tubular section, preventing radial expansion of the flexible tubular section, and promoting the ability of the flexible tubular section to slide through the vasculature. The stretch-resistant member may be attached to the proximal hypotube and the distal hypotube, thereby extending across the entirety of the flexible tubular section. The stretch-resistant member may be positioned external to the lumen. The flexible sleeve may be attached to the flexible tubular section and fused to the stretch resistant member through openings in the flexible tubular section.

The delivery member may also include an engagement system that is movable to engage and deploy the implantable medical device. The interlocking 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 the loop wire, thereby engaging the engagement system to the implantable medical device. The pull wire may be positioned within 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 deploying the implantable medical device.

At least a portion of the distal hypotube may be compressed and stretched upon movement of the engagement system when the engagement system is moved to deploy the implantable medical device.

The flexible tubular section may include a non-radiopaque proximal coil, a non-radiopaque distal coil, and a radiopaque central coil positioned between the non-radiopaque coils.

The flexible tubular section may be made from a wire wound to define a portion of the lumen of the delivery member. The wire from which the flexible tubular is made may have a cross-sectional diameter that measures from about 0.8 mils to about 5 mils.

The flexible sleeve may include a polymer. The flexible sleeve may include additives to increase the lubricity of the polymer.

The flexible sleeve may be attached to the proximal hypotube and the distal hypotube. Thereby, the flexible sleeve so configured may cover the entirety of the coiled section and at least a portion of the proximal hypotube and/or at least a portion of the distal hypotube.

The stretch-resistant member may be an extruded tube.

The flexible tubular section and the distal hypotube may have a length measured from the proximal end of the flexible tubular to the distal end of the distal hypotube, measuring from about 30 cm to about 50 cm, or more specifically about 40 cm. .

The proximal hypotube may include a helical cut portion near its distal end.

The delivery member may comprise a distal hypotube, a proximal hypotube, and a continuous hypotube comprising a flexible tubular section. The flexible tubular section may have a helical cut.

Exemplary methods for designing or constructing a transfer member such as the example above include selecting a first hypotube and a second hypotube, forming a wire coil section between the two hypotube, the wire coil section extending the stretch resistant member through the lumen, attaching the stretch resistant member to the first and second hypotubes, selecting the flexible sleeve, covering the flexible tubular section with the flexible sleeve, flexible fusing the sleeve to the stretch-resistant tube through openings in the flexible tubular section, and attaching the implantable medical device to the distal end of the first hypotube such that the implantable medical device can be detached from the first hypotube during treatment. may include steps.

Another exemplary method for designing or constructing a delivery member such as the example above includes selecting a first hypotube having a first lumen, selecting a second hypotube having a second lumen, and a third therethrough forming a flexible tubular section having a lumen between the two hypotubes, extending the extensible member outside of the first, second and third lumens; attaching to and attaching the proximal portion of the stretch-resistant member to the second hypotube, selecting the flexible sleeve, covering the flexible tubular section with the flexible sleeve, the flexible sleeve through openings in the flexible tubular section fusing to the stretch-resistant tube, and attaching the implantable medical device to the distal end of the first hypotube such that the implantable medical device can be detached from the first hypotube during treatment.

Forming the wire coil section includes forming a non-radiopaque proximal coil, forming a non-radiopaque distal coil, and between the non-radiopaque proximal coil and the non-radiopaque distal coil. and forming an elongated radiopaque central coil. Alternatively, the wire coil section need not include a radiopaque section. Forming the wire coil section may additionally or alternatively include selecting a wire having a diameter that measures from about 0.8 mil to about 5 mil, and winding the wire to form the wire coil section and defining a lumen of the wire coil section may include the step of

Selecting the flexible sleeve may include selecting the polymer sleeve having an additive to increase the lubricity of the polymer.

Extending the stretch-resistant member through the wire coil lumen may include extending the substantially tubular stretch-resistant member through the wire coil lumen.

Attaching the implantable medical device to the first hypotube may include compressing the first hypotube, and attaching the implantable medical device to a distal end of the compressed first hypotube.

An exemplary method for designing or constructing a transfer member includes positioning a loop wire within a lumen of a first hypotube, and drawing the pull wire to extend through the lumen of the first hypotube, the wire coil section, and the second hypotube. It may further include the step of positioning. Attaching the implantable medical device may additionally or alternatively include extending the loop wire through an opening in the implantable medical device, and engaging the pull wire to a portion of the loop wire extending through the opening in the implantable medical device. may include 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 hypotube.

Another exemplary method for designing or constructing a delivery member such as the example above is to spirally cut the hypotube to form a coiled section in the hypotube such that the distal hypotube section extends distally from the coiled section and the proximal hypotube allowing the tube section to extend proximally from the coiled section, extending the stretch resistant tube through a lumen of the coiled section, positioning the flexible sleeve over at least a majority of an outer surface of the coiled section, coiled fusing the flexible sleeve to the stretch-resistant tube between the windings of the section, and attaching the implantable medical device to the delivery member proximate the distal end of the distal hypotube section.

The exemplary method may further include attaching the stretch resistant tube to the proximal hypotube portion within the lumen of the proximal hypotube portion, and attaching the stretch resistant tube to the distal hypotube portion within the lumen of the distal hypotube portion. can

The exemplary method may further include extending the pull wire through the lumen of the stretch-resistant tube, such that upon proximal translation of the pull wire, the implantable medical device is released.

The above and additional aspects of the present invention are further discussed with reference to the following description in conjunction with the accompanying drawings in which like reference numerals indicate like structural elements and features in the various drawings. The drawings are not necessarily drawn to scale, emphasis instead being placed on illustrating the principles of the invention. The drawings illustrate one or more embodiments of an apparatus of the present invention by way of example only and not by way of limitation.
1 is an illustration of a cross-section of a transfer member in accordance with an aspect of the present invention;
2A is an illustration of a cross-section of a flexible sleeve in accordance with aspects of the present invention;
2B is an illustration of a cross-section of an extensible tube in accordance with an aspect of the present invention.
2C is an illustration of a cross-section of a wire coil attached to a distal hypotube and a proximal hypotube, in accordance with aspects of the present invention.
3A-3D are diagrams of an engagement system illustrating a sequence for deploying an implant, in accordance with aspects of the present invention;
4 is a flow diagram illustrating a method for designing or constructing a transfer member, in accordance with aspects of the present invention.
5 is a flow diagram illustrating a method for using a delivery system including an exemplary delivery member, in accordance with aspects of the present invention.
6A and 6B are illustrations of cross-sections of extensible members attached to a distal hypotube and a proximal hypotube, in accordance with aspects of the present invention.
7A and 7B are illustrations of cross-sections of flexible sleeves in accordance with aspects of the present invention.
7C is an illustration of a cross-section of a transfer member in accordance with aspects of the present invention.

During endovascular treatment, eg, aneurysmal occlusion treatment, the lack of flexibility of the distal portion of the treatment device delivery member may cause the delivery member to retract from the treatment site while the implant or other medical treatment device is being deployed within the aneurysm or other treatment site Otherwise, it can be moved out of place. Thus, a delivery member and an engagement system having a more flexible distal portion may provide a stable system for delivering a medical device in a neurovascular anatomy, in addition to other applications facing similar problems. However, flexible structures may tend to deform, extend, or expand when navigating through tortuous anatomy. Deformation of the delivery member may inhibit the ability of the delivery member to navigate to a treatment site and/or effectively deploy the medical device. Stretching of the delivery member may result in premature deployment of the medical device.

It is an object of the present invention to provide a delivery member having a highly flexible distal portion that is stretch resistant and structurally stable throughout delivery and deployment of a medical treatment device. For ease of discussion, medical treatment devices are generally referred to herein as “implants,” but as will be recognized and understood by those skilled in the art, aspects of the present invention deliver medical treatment devices that do not remain implanted. and deployment.

In accordance with 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 may be formed of a substantially linear wire wound into a coil shape and/or a hypotube laser cut into a helical pattern. When the coiled wire is formed from a laser cut hypotube, the helix may be free of interference cuts connecting the windings in the coil to provide a more flexible coil. The outer sleeve may inhibit radial deformation of the coiled wire and/or may provide a smooth surface against which the vessel wall may slide during delivery of the implant. The stretch-resistant member may inhibit elongation of the coiled wire during delivery of the implant. Thus, the combination of the coiled wire, the outer sleeve, and the stretch-resistant member can provide a distal portion of the delivery member with greater flexibility and greater stability than at least some known delivery members.

Referring to the drawings, as illustrated in FIG. 1 , an exemplary delivery member 10 includes a proximal tube 100 , a coiled section 200 , a distal tube 300 , and a sleeve 500 surrounding the coiled section. , and a stretch-resistant member 600 within the lumen of the coiled section 200 . The proximal tube 100 may extend over a majority of the length of the delivery member 10 , with the coiled section 200 and the distal tube 300 providing a sense of repulsion that may occur during placement of the implant at the treatment site. It forms a length sufficient to absorb most of it. In some examples, the length may measure from 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 coiled section 200 , the coiled section 200 being connected to the proximal end 302 of the distal coil 300 . It may have a distal end 204 connected thereto.

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

The coiled section 200 may be formed separately from the proximal hypotube 100 and/or the distal hypotube 300 . The separately formed coiled section 200 may be attached to the proximal tube 100 and/or the distal tube 300 by welds 712 , 714 or other suitable attachment. Alternatively or additionally, at least a portion of the coiled section may be formed from a helical laser-cut portion of the hypotube. A separately formed coiled section 200 can be made more flexible compared to a spirally cut tube by selecting a wire having a specific cross-section with a specific diameter D, or by selecting a wire with material properties to increase flexibility. can be manufactured. Conversely, laser-cut portions are readily fabricated by cutting a single hypotube to form proximal tube 100 , coiled section 200 , and distal hypotube 300 , such as welds 712 , 714 or other Attachments can be reduced or eliminated. In either case, the wire of coil 200 may have a diameter D that measures within a range that includes about 0.8 mils to 5 mils.

The coiled section may be formed primarily of a non-radiopaque material such as steel, and may include a radiopaque section 216 made of a radiopaque material such as platinum and/or tungsten. The radiopaque section 216 may be positioned between the proximal non-radiopaque section 212 of the coil and the distal non-radiopaque section 214 of the coil. The radiopaque section 216 may be positioned at a predetermined distance from the distal end 304 of the delivery member 10 to allow a surgeon to easily visualize the placement of the distal portion of the delivery member during a therapeutic procedure. The proximal section 212 , the radiopaque section 216 , and the distal section 214 may be concentrically welded.

The coiled section 200 may be surrounded by a flexible sleeve or fused jacket 500 collectively referred to herein as a “sleeve”. The sleeve may inhibit the coil 200 from expanding radially and/or engaging the vessel wall during navigation. Sleeve 500 may include a polymer. The polymer may include additives to increase the lubricity of the sleeve 500 so that the sleeve can easily glide through the body's blood vessels. As illustrated in FIG. 2A , sleeve 500 may have a wall thickness T measured within a range that includes from about 0.5 mils to about 2 mils. The sleeve 500 may have a wall thickness that measures from about 0.001 inches to about 0.003 inches. Sleeve 500 may be further coated with a hydrophilic coating to further minimize friction during intravascular navigation. Sleeve 500 may be fused or adhered to coil 200 , proximal hypotube 100 , and/or distal hypotube 300 . The flexible sleeve 500 may be fused to the stretch-resistant member 600 through openings in the coil 200 .

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

The delivery member 10 may include a mechanical engagement system for engaging the medical treatment device during delivery to the treatment site, which may be mechanically actuated to deploy the treatment device. Mechanically actuated engagement systems often include one or more inner elongate members or pull wires extending through a delivery member that can be manipulated at the proximal end by a physician to deploy the medical treatment device. Such wires or inner elongate members are collectively referred to herein as “pull wires”.

3A-3D show a pull wire 140 that can be positioned to secure an implant or other medical treatment device to the delivery member 10 and can be moved to release the medical treatment device from the delivery member 10 . and a mechanical engagement system including a loop wire 400 . The loop wire 400 may be attached to the distal tube 300 by a weld 408 or other suitable attachment. Stretch resistant member 600 can be sized to allow pull wire 140 to pass through proximal tube 100 , coiled section 200 , and lumens 108 , 208 , 308 of distal tube 300 . have. For example, the stretch-resistant member 600 may be tubular with a through lumen, and the pull wire 140 may extend through the lumen of the tubular stretch-resistant member 600 . During manufacture of the stretch-resistant member 600 , the stretch-resistant member 600 may be extruded over the pull wire 140 .

The combination of coil 200 , sleeve 500 , and extensible member 600 is a highly flexible distal of delivery member 10 suitable for navigating tortuous anatomy, including neurovascular vessels. part can be provided. The stretch-resistant member 600 supports the coil 200 to prevent the coil 200 from significantly elongating during navigation of the blood vessel, thereby reducing the tension on the pull wire 140 extending therethrough and to the attached medical treatment device. may reduce the likelihood of premature development of

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 spiral pattern. The spiral pattern of flexible section 106 may be free of interfering cuts connecting the windings within the spiral. The stretch-resistant member 600 may extend through the flexible section 106 and may be attached to the proximal tube 100 in a proximal direction from the flexible section 106 . Thereby, the stretch-resistant member 600 may inhibit elongation of the flexible section 106 and the coiled section 200 of the proximal tube 100 . The sleeve 500 may cover at least a portion of the flexible section 106 to inhibit deformation of the flexible section during endovascular navigation and/or reduce friction with the flexible section 106 and vasculature. In some examples, sleeve 500 may cover about 10 cm of proximal tube 100 proximate to and/or including distal end 104 of proximal tube 100 .

The distal tube 300 may include a compressible portion 306 . The compressible portion 306 may be axially adjustable between an elongated condition and a compressed condition. The compressible portion 306 may be formed from a helically cut portion of the tube 300 , which is formed by a laser cutting operation. Additionally or alternatively, the compressible portion may be formed of a wound wire, a helical ribbon, or other fixture that permits axial adjustment in accordance with the present invention. Preferably, the compressible portion 306 is in the stretched state at rest and automatically or resiliently returns from the compressed state to the stretched state unless otherwise constrained.

3A-3D illustrate separation of medical device 12 using a mechanical engagement/deployment system. 3A illustrates the engagement systems 140 , 400 locked within the locking portion 18 of the medical device 12 . The compressible portion 306 of the distal tube 300 may be compressed and the loop wire 400 opening 405 in the distal end 404 of the loop wire 400 may be disposed through the locking portion 18 . can When the pull wire 140 is placed through the opening 405 , the medical device 12 is now secured. 3B illustrates the pull wire 140 being pulled proximally to initiate a release sequence for the medical device 12 . 3C illustrates the moment when the pull wire 140 exits the opening 405 and is pulled free from the loop wire 400 . The distal end 404 of the loop wire 400 disengages from the locking portion 18 and exits. As can be seen, there is now nothing holding the medical device 12 in the separation system 10 . 3D illustrates the end of the unlock sequence. Here, the compressible portion 306 has extended/returned to its original shape and “protruded” forward. An elastic force E is imparted to the medical device 12 by the distal end 304 of the distal tube 300 to “push” the medical device away to ensure accurate separation and delivery of the medical device 12 .

The examples in the figures described above show generally hollow or tubular structures 100 , 200 , 300 , 500 , 600 according to the present invention. As used herein, the terms “tubular” and “tube” are to be interpreted broadly and are limited to structures that are right cylinders, strictly circumferential in cross-section, or have a uniform cross-section throughout their length. doesn't happen For example, a tubular structure or system is generally exemplified as a substantially columnar structure. However, the tubular system may have a tapered or curved outer surface without departing from the scope of the present invention.

4 is a flow diagram including method steps for constructing or designing a transmission member, such as an exemplary transmission member described herein. Referring to method 800 schematically illustrated in FIG. 4 , in step 810 , a first hypotube, a second hypotube, a flexible sleeve, a wire coil, and a stretch resistant member may be selected. The first hypotube may be the proximal hypotube 100 as described herein or otherwise as would be known to one of ordinary skill in the art. The second hypotube may be the distal hypotube 300 as described herein or otherwise as would be known to one of ordinary skill in the art. The flexible sleeve may be a sleeve or fused jacket 500 as described herein or otherwise known to one of ordinary skill in the art. The wire coil may include a support coil, ie coiled section 200 , as described herein or otherwise known to those skilled in the art. The stretch-resistant member may be the stretch-resistant member 600 as described herein or otherwise known to one of ordinary skill in the art.

In step 820, a stretch-resistant member may be positioned within the lumen of the wire coil. In step 820, the stretch-resistant member being positioned may be substantially tubular. In operation 830, the first hypotube, the wire coil, and the second hypotube may be attached to each other. In step 840, a stretch-resistant member is attached to the first hypotube and the second hypotube. The first hypotube, wire coil, and second hypotube may be attached as illustrated and described herein or by other means as will be understood by one of ordinary skill in the art. Steps 820 , 830 , and 840 need not be performed in that order, but may be performed simultaneously. For example, a stretch resistant member may be attached to one of the first and second hypotubes as shown in step 840 , followed by the hypotube to which the stretch resistant member is attached, as shown in step 830 . may be attached to the wire coil, and then a stretch resistant member may be positioned through the wire coil as shown in step 820 , and then the other of the hypotubes may be attached to the wire coil as shown in step 830 . and then the stretch resistant member may be attached to such other hypotube as shown in step 840 .

In step 850, the wire coil may be covered with 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 transfer member. Step 850 may also include fusing the flexible sleeve to the stretch-resistant member. If the second hypotube has a flexible section, at step 850, the flexible sleeve may also be positioned to cover at least a portion of the flexible section.

At step 860 , the implant may be removably attached to the distal end of the first hypotube. In step 860, the implant places the loop wire within the first hypotube, places the pull wire to extend through the first hypotube, the coiled wire, and the second hypotube, and places the implant with the loop wire and by fixing with a pull wire. A pull wire may extend from a proximal end of the second hypotube. If the first hypotube has a compressible portion, in step 860, the compressible portion may be compressed and the implant may be attached to the delivery member while the compressible portion is compressed.

5 is a flow diagram including method steps for performing endovascular treatment using a system comprising a delivery member, such as an exemplary delivery member described herein. Referring to method 900 schematically illustrated in FIG. 5 , in step 910 , a distal hypotube, a proximal hypotube, a coiled section coaxially positioned between the hypotubes, a flexible sleeve covering the coiled section , a stretch-resistant member positioned within the coiled section, and a medical treatment device attached to or near the distal hypotube may be selected. The system may be suitable for endovascular treatment as described and exemplified herein or otherwise known to those skilled in the art.

At step 920 , the system may be moved through the catheter to a treatment site, such as an aneurysm or other abnormal site in a blood vessel. At step 930 , the system may flex as it is moved through the catheter. In step 940, the coiled section of the system may be prevented from deforming by the flexible sleeve and the stretch-resistant member; The flexible sleeve may inhibit the coiled section from radially deforming, while the stretch-resistant member may inhibit the coil from extending longitudinally.

At 950 , the medical treatment device may be deployed. If the medical treatment device is an implant, at step 950 the implant may be detached. At step 960 , the distal tube may be extended to push the medical treatment device away from the distal tube. If the medical treatment device is the implant removed at step 950 , then at step 960 the detached implant may be ejected away from the distal tube in response to dilation of the distal tube.

6A is an illustration of a cross-section of an extensible member 600 attached to a distal hypotube 300 and a proximal hypotube 100, in accordance with aspects of the present invention. The stretch-resistant member 600 may be positioned to inhibit elongation of the flexible tubular section 200 during endovascular navigation. The stretch-resistant member 600 is external to the lumen 208 of the flexible tubular section 200 and of the lumens 108 , 308 of either or both the proximal hypotube 100 and the distal hypotube 100 . It may be located externally. The stretch-resistant member 600 may also be sized to extend along the entire length of the flexible tubular section 200 , extend into the proximal hypotube 100 , and extend into the distal hypotube 300 . Stretch-resistant member 600 may be attached to proximal tube 100 and distal tube 300 at adhesive joints 722 , 724 or other suitable attachments. The stretch-resistant member 600 may remain unattached to the flexible tubular section 200 such that the stretch-resistant member 600 and the flexible tubular section 200 can move somewhat independently of each other.

6B is an illustration of a cross-section of a flexible sleeve 500 positioned over an extensible member 600 attached to the distal hypotube 300 and the proximal hypotube 100, in accordance with aspects of the present invention. The flexible sleeve 500 may have a wall thickness T measured within a range including 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 is fused or bonded to the flexible tubular section 200 , the proximal hypotube 100 and/or the distal hypotube 300 so that the delivery member 10 is flexible while being manipulated within the vasculature. It allows the flexible sleeve 500 to prevent the sex tubular section 200 from elongating while also preserving the flexibility of the distal hypotube 300 . The flexible sleeve 500 may be fused through the openings of the flexible tubular section 200 .

7A and 7B , sleeve 502 may have one or more stretch-resistant fibers 800 positioned within a wall of sleeve 502 . Stretch-resistant fibers 800 may include polymer fibers and/or metal fibers. Stretch resistant fibers 800 may be oriented within the walls of sleeve 502 in a linear orientation as shown in FIG. 7A or in one or more helical orientations as shown in FIG. 7B . Stretch-resistant fibers 800 may be incorporated into the walls of the sleeve 502 during the extrusion process of the fibered sleeve 502 . The fiber-equipped sleeve 502 may have a wall thickness T measured within a range including from about 0.001 inches to about 0.003 inches. The fibrous sleeve 502 may be further coated with a hydrophilic coating to further minimize friction during intravascular navigation.

7C is an illustration of a cross-section of a transfer member 10 according to an aspect of the present invention. The fibrous sleeve 502 is fused or adhered to the flexible tubular section 200 , the proximal hypotube 100 and/or the distal hypotube 300 , such that the delivery member 10 is manipulated within the vasculature. It allows the fiber-beared sleeve 502 to prevent the flexible tubular section 200 from elongating while also preserving the flexibility of the distal hypotube 300 . The fiber-equipped sleeve 502 may also be fused through the openings of the flexible tubular section 200 .

As used herein, the term "about" or "approximately" for any numerical value or range means that some of the elements or a collection of elements function for their intended purpose as described herein. Adequate dimensional tolerances that allow More specifically, “about” or “approximately” may refer to a range of values ±20% of the recited value, such as “about 90%” may refer to a range of values from 71% to 99%.

The descriptions contained herein are examples of embodiments of the invention and are not intended to limit the scope of the invention in any way. As described herein, the present invention relates to alternative constructions of components, alternative materials, alternative medical treatment devices, alternative means for deploying medical treatment devices, alternative geometries and configurations of individual components. Many variations and modifications of the delivery system, the delivery member, and the engagement system are contemplated, including alternative means for attaching parts, and the like. These modifications will be apparent to those skilled in the art to which the invention pertains, and are intended to be within the scope of the following claims.

Claims (20)

A delivery member for delivering an implantable medical device to a target location in a body blood vessel, comprising:
a distal hypotube comprising a distal end configured to receive the implantable medical device;
a flexible tubular section attached to the proximal end of the distal hypotube, the flexible tubular section comprising openings therethrough;
a proximal hypotube attached to the proximal end of the flexible tubular section;
a lumen extending through the distal hypotube, the flexible tubular section, and the proximal hypotube;
a stretch resistant member positioned external to the lumen, attached to the proximal hypotube, attached to the distal hypotube, and extending along at least a portion of an outer surface of the flexible tubular section; and
and a flexible sleeve covering at least a majority of the outer surface of the stretch-resistant member and the flexible tubular section. According to claim 1,
an engagement system movable to engage and deploy the implantable medical device engaging the distal end of the distal hypotube;
The engagement system is
A loop that is movable to extend through an opening in the implantable medical device, thereby engaging the engagement system to the implantable medical device, and retracting from the opening in the implantable medical device to deploy the implantable medical device. wire (loop wire); and
extending through the lumen, engaging the loop wire to engage the engagement system with the implantable medical device, and movable to proximally retract to disengage the loop wire to deploy the implantable medical device. A transfer member comprising a pull wire. 3. The method of claim 2,
wherein the distal hypotube comprises a compressible portion movable from a compressed condition to an elongated condition;
and the engagement system maintains the compressible portion in the compressed state when engaged with the implantable medical device. The method of claim 1, wherein the flexible tubular section comprises:
a non-radiopaque proximal coil extending from the proximal end of the flexible tubular section;
a non-radiopaque distal coil extending from the distal end of the flexible tubular section; and
and a radiopaque central coil extending between the non-radiopaque proximal coil and the non-radiopaque distal coil. The method of claim 1, wherein the flexible tubular section comprises:
a wire wound to form the flexible tubular coil section and defining a portion of the lumen;
wherein the wire comprises a diameter measuring from about 0.0008 inches to about 0.005 inches. According to claim 1,
wherein the flexible sleeve comprises a polymer;
wherein the flexible sleeve includes an additive effective to increase the lubricity of the polymer. The delivery member of claim 1 , wherein the flexible sleeve is attached to the proximal hypotube and the distal hypotube. The transfer member of claim 1 , wherein the flexible sleeve comprises a wall thickness that measures from about 0.001 inches to about 0.003 inches. The delivery member of claim 1 , wherein the delivery member comprises a measurable length from the proximal end of the flexible tubular section to the distal end of the distal hypotube, the length measuring about 40 cm. A delivery member for delivering an implantable medical device to a target location in a body blood vessel, comprising:
a distal hypotube comprising a distal end configured 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 flexible tubular section; and
a flexible sleeve covering at least a majority of the outer surface of the flexible tubular section;
wherein the flexible sleeve comprises one or more stretch-resistant fibers positioned within a wall of the flexible sleeve. 11. The method of claim 10,
wherein said flexible sleeve of said at least one stretch-resistant fiber comprises a polymer;
wherein the flexible sleeve includes an additive effective to minimize friction of the polymer. 11. The transfer member of claim 10, wherein the flexible sleeve is further attached to the flexible tubular section. 11. The method of claim 10,
wherein the flexible sleeve comprises a polymer;
wherein the at least one stretch-resistant fiber comprises a metal fiber,
wherein the flexible sleeve includes an additive effective to minimize friction of the polymer. The delivery member of claim 10 , wherein the one or more stretch-resistant fibers are positioned within the flexible sleeve in one or more linear orientations. The transfer member of claim 10 , wherein the one or more stretch-resistant fibers are positioned within the flexible sleeve in one or more helical orientations. 11. The transfer member of claim 10, wherein the flexible sleeve comprises a wall thickness that measures from about 0.001 inches to about 0.003 inches. 11. The method of claim 10,
a lumen extending through the distal hypotube, the flexible tubular section, and the proximal hypotube; and
an engagement system movable to engage and deploy the implantable medical device engaging the distal end of the distal hypotube;
The engagement system is
A loop that is movable to extend through an opening in the implantable medical device, thereby engaging the engagement system to the implantable medical device, and retracting from the opening in the implantable medical device to deploy the implantable medical device. wire; and
extending through the lumen, engaging the loop wire to engage the engagement system with the implantable medical device, and movable to proximally retract to disengage the loop wire to deploy the implantable medical device. A transfer member comprising a pull wire. A method of constructing a delivery member for delivering an implantable medical device, comprising:
selecting a first hypotube comprising a first through lumen;
selecting a second hypotube comprising a second through lumen;
forming a flexible tubular section extending from the distal end of the second hypotube to the proximal end of the first hypotube, the flexible tubular section defining a third through lumen;
attaching a distal portion of an extensible member to the first hypotube and attaching a proximal portion of the extensible member to the second hypotube;
the attaching, wherein an intermediate portion of the stretch-resistant member is located outside the first, second and third lumens;
selecting a flexible sleeve;
covering at least a majority of an outer surface of the flexible tubular section with the flexible sleeve; and
and removably attaching the implantable medical device to the delivery member proximate the distal end of the first hypotube. 19. The method of claim 18, wherein selecting the flexible sleeve comprises:
selecting the flexible sleeve comprising a polymer, the flexible sleeve comprising:
an additive effective to increase the lubricity of the polymer;
stretch-resistant fibers comprising a polymer, and
and selecting the flexible sleeve further comprising at least one of stretch-resistant fibers comprising a metal. 19. The method of claim 18, wherein removably attaching the implantable medical device to the delivery member proximate the distal end of the first hypotube comprises:
compressing the first hypotube; and
and releasably attaching the implantable medical device to the delivery member proximate the distal end of the compressed first hypotube.

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