Low profile delivery system with locking wire lumen

Abstract

Aspects of the present disclosure relate to apparatuses, systems, and methods for medical device delivery. These apparatuses, systems, and methods may include at least one loop attached to a catheter shaft and extending through a medical device, and a release wire held in place by passing through the loop.

Description

This application is a divisional application of Chinese Patent Application No. 201880097434.4, which is the national phase application in China of the international application No. PCT / US2018 / 050773, titled "Low Profile Delivery System with Locked Wire Lumens", filed on March 11, 2021. Technical Field

[0001] The present invention relates to medical devices and methods for treating anatomical spaces (e.g., blood vessels) of the body. More specifically, the present invention relates to methods, devices, and systems including an implantable medical device prosthesis that allows for precise deployment in an anatomical space. Background Art

[0002] Diseases of the vasculature are becoming increasingly common. Due to the tortuous nature and complexity of the vasculature, treating the vasculature can be difficult. For example, aortic dissection typically begins at or near the aortic valve root and continues into the ascending aorta and aortic arch. Medical devices implanted in a diseased state can be used to treat aortic dissection, aneurysms, and other diseases of the vasculature or other luminal systems of the body such as, for example, the biliary, gastrointestinal, or respiratory systems.

[0003] There remains a desire to provide medical devices, systems, and methods for treating diseases along the aorta, and for treating diseases along the aorta and in the branch and luminal spaces extending therefrom. Summary of the Invention

[0004] In one example ("Example 1"), a medical device delivery system includes a catheter shaft; at least one loop attached to the catheter shaft; a medical device having an interior and an exterior; at least one opening through the medical device, the at least one opening configured to allow the loop to extend from the interior of the medical device to the exterior; and a release wire exterior to the medical device, the release wire being secured in place by passing through the loop.

[0005] In another example ("Example 2") further to the system of Example 1, the at least one loop is flexible and includes at least two flexible loops aligned with respect to the longitudinal axis of the medical device.

[0006] In another example ("Example 3") further to the system of any of Examples 1-2, the at least one flexible loop includes a fiber coupled to the catheter shaft.

[0007] In another example ("Example 4") further to the system of Example 3, the fiber is at least one of wrapped, glued, and bonded to the catheter shaft to form at least one flexible loop.

[0008] In yet another example (“Example 5”) further to the system of any one of Examples 1 - 4, the medical device is configured to collapse into a delivery configuration, and at least one flexible ring is configured to collapse towards the catheter shaft in response to the medical device collapsing into the delivery configuration.

[0009] In yet another example (“Example 6”) further to the system of Example 5, the system further includes at least one sheath configured to releasably hold the medical device in the delivery configuration.

[0010] In yet another example (“Example 7”) further to the system of any one of Examples 1 - 6, the medical device includes a stent and graft combination, and at least one opening is formed through the graft, and the at least one flexible ring includes graft material.

[0011] In yet another example (“Example 8”) further to the system of any one of Examples 1 - 7, at least one flexible ring is configured to hold at least a portion of a release wire in contact with the outer surface of the medical device.

[0012] In yet another example (“Example 9”) further to the system of any one of Examples 1 - 8, at least one flexible ring is configured to form a lumen for the release wire.

[0013] In yet another example (“Example 10”) further to the system of any one of Examples 1 - 9, the release wire terminates at an olive at one end of the catheter shaft.

[0014] In yet another example (“Example 11”) further to the system of Example 10, the release wire is configured to release from the olive in response to tension and retract through at least one flexible ring.

[0015] In yet another example (“Example 12”) further to the system of any one of Examples 1 - 11, the release wire and at least one ring are configured to hold the medical device coupled to the catheter shaft during orientation of the medical device.

[0016] In one example (“Example 13”), a method of manufacturing a delivery system for a medical device includes: coupling at least one flexible ring to a catheter shaft; disposing the at least one flexible ring to pass through an opening in the medical device; and disposing a release wire to pass through the at least one flexible ring to releasably couple the medical device to the catheter shaft.

[0017] In yet another example (“Example 14”) further to the method of Example 13, coupling at least one flexible ring to the catheter shaft includes at least one of wrapping, gluing, and bonding fibers to the catheter shaft to form at least one flexible ring.

[0018] In another example (“Example 15”) that is further to the method of any one of Examples 13 - 14, the method further includes collapsing the medical device relative to the catheter shaft into a delivery configuration and collapsing at least one flexible ring toward the catheter shaft in response to the medical device collapsing into the delivery configuration.

[0019] In another example (“Example 16”), a medical device delivery system includes: a catheter shaft; a medical device having an interior and an exterior; a flexible lumen attached to the catheter shaft and extending through at least one opening in the medical device, the flexible lumen configured to collapse in response to a decrease in the diameter of the medical device; and a release wire disposed to pass through the flexible lumen and configured to releasably couple the medical device to the catheter shaft.

[0020] In another example (“Example 17”) that is further to the system of Example 16, the flexible lumen includes a first flexible ring and a second flexible ring disposed at opposite ends of the medical device.

[0021] In another example (“Example 18”) that is further to the system of Example 17, the release wire is configured to be withdrawn through the first flexible ring and the second flexible ring in response to tension, and the first flexible ring and the second flexible ring remain coupled to the catheter shaft.

[0022] In another example (“Example 19”) that is further to the system of Example 18, the catheter shaft is configured to withdraw the first flexible ring and the second flexible ring after delivering the medical device.

[0023] In another example (“Example 20”) that is further to the system of Example 16, at least one flexible ring includes fibers coupled to the catheter shaft, and the fibers are at least one of wrapped, glued, and bonded to the catheter shaft to form at least one flexible ring. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The drawings are provided to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments, and together with the description are used to explain the principles of the present disclosure.

[0025] Figure 1 A side view of an exemplary delivery system having a medical device according to an embodiment is shown.

[0026] Figure 2 A perspective view of an exemplary delivery system having a medical device according to an embodiment is shown.

[0027] Figure 3 A perspective view of an exemplary release wire and a medical device according to an embodiment is shown.

[0028] Figure 4Shows a side view of an exemplary release wire and catheter shaft in accordance with one embodiment.

[0029] Figure 5 Shows an enlarged view of an exemplary flexible loop, medical device, and catheter shaft in accordance with one embodiment.

[0030] Figure 6 Shows an enlarged view of an exemplary flexible loop and catheter shaft in accordance with one embodiment.

[0031] Figure 7 Shows a side view of an exemplary release wire, flexible loop, and catheter shaft in accordance with one embodiment. Detailed Description

[0032] Those skilled in the art will readily appreciate that various aspects of the present disclosure may be implemented by any number of methods and devices constructed to perform the desired functions. It should also be noted that the figures referred to herein are not necessarily drawn to scale and may be enlarged to illustrate various aspects of the present disclosure, and in this regard, the figures should not be construed as limiting.

[0033] Aspects of the present disclosure relate to devices, systems, and methods including implantable medical devices that may be used to treat the vasculature or other luminal and non-luminal systems. In some examples, a delivery system such as a transcatheter delivery system is used to deliver the implantable medical device to the vasculature. In terms of the construction of the implantable medical device, various configurations may be envisioned, and the implantable medical device described herein may be substantially cylindrical, include bifurcations, or have any of a variety of features. Additionally, the implantable medical device may be configured to conform to the vasculature in which it is implanted and have a profile that facilitates the delivery of the implantable medical device using minimally invasive procedures (e.g., via transcatheter techniques) and that can withstand the forces and other stresses that occur once implanted in the vasculature.

[0034] The medical device may be collapsed into a delivery configuration for delivery and expanded at the target location. In some cases, the medical device may be partially expanded during deployment (e.g., for steering or orientation) or otherwise remain coupled to the catheter shaft. To maintain the coupling of the medical device to the catheter, the delivery system may include a release wire coupled to the medical device and the catheter.

[0035] In some cases, compared to a delivery system that does not releasably couple a medical device to a catheter shaft in terms of structure, a release wire may increase the overall delivery profile of the system, at least in part due to the catheter lumen for the release wire. To facilitate the delivery of a medical device using a release wire (or other similar device's coupling to a catheter), the systems discussed herein include a flexible loop or lumen through which the release wire is disposed. As discussed further in detail below, the flexible loop or lumen facilitates the delivery of the medical devices discussed herein.

[0036] Figure 1 A side view of an exemplary delivery system 100 with a medical device 106 is shown in accordance with one embodiment. The medical device 106 can be any intravascular device suitable for delivery to a treatment region of a patient's vasculature or other intravascular and non-intravascular systems (biliary, gastrointestinal, respiratory, or other desired systems) of the body. As Figure 1 shown, the delivery system 100 can also include a handle 108 at the proximal end of the system (the end of the system opposite the end where the medical device 106 is disposed). The handle 108 of the delivery system 100 is accessible to a user to assist in the delivery of the medical device 106. As further explained in detail below, the delivery system 100 can include one or more wires or wire materials that facilitate the delivery, orientation, or placement of the medical device 106.

[0037] In various embodiments, the medical device 106 can include a radially collapsed configuration that is adapted for delivery to a treatment region of a patient's vasculature. The medical device 106 can be constrained toward the radially collapsed configuration and is releasably mounted to a delivery device such as a catheter shaft 102. The diameter of the medical device 106 in the collapsed configuration is small enough such that the medical device 106 can be delivered through the vasculature to a target treatment location or region. In various embodiments, the diameter of the collapsed configuration is small enough to minimize the cross-sectional profile of the delivery system 100 and reduce or prevent tissue damage to the patient. In the collapsed configuration, the medical device 106 can be guided through the vasculature by the catheter shaft 102.

[0038] The medical device 106 can include a radially expanded configuration suitable for implanting the medical device 106 in a treatment region of a patient's vasculature. In the expanded configuration, the diameter of the medical device 106 can be substantially the same as the blood vessel or other body cavity in which the medical device 106 is to be placed. In other embodiments, the diameter of the medical device 106 in the expanded configuration can be slightly larger than the blood vessel to be treated to provide an intravascular friction or interference fit.

[0039] In various embodiments, the medical device 106 can include a self-expanding device such as a self-expanding stent graft. Such a device expands from a radially collapsed configuration to a radially expanded configuration when unconstrained. In other embodiments, the medical device 106 can include a device that is expanded by an assist device such as a balloon that applies an expansion force to the medical device 106. In still other embodiments, the delivery system 100 can include multiple medical devices 106. The use of a delivery system 100 having any number of medical devices 106 is within the scope of the present disclosure. The medical devices 106 discussed herein can include, for example, stents, grafts, stent grafts, heart valves, and other similar devices. Thus, the medical device 106 can include one or more stent components with one or more graft members disposed above and / or below the stent, and the medical device 106 can expand from a delivery diameter, through a range of larger intermediate diameters, and toward a maximum, pre-determined functional diameter. In some cases, the medical device 106 includes one or more stent components made of nitinol and graft members made of ePTFE. However, as discussed below, any suitable combination of (one or more) stent components and (one or more) graft members is within the scope of the present disclosure.

[0040] In some cases, the delivery system 100 can include one or more sleeves (and other restraint mechanisms) to restrain the medical device 106 in a collapsed configuration for intravascular delivery of the medical device 106 to a treatment site in a patient's vasculature or other body cavity. For the purposes of the present disclosure, the term "restrain" can mean (i) limiting the expansion of the diameter of the medical device 106 by self-expansion or by means of a device, or (ii) covering or surrounding the medical device 106 without otherwise limiting the medical device 106 (e.g., for storage or biocompatibility reasons and / or to provide protection to the medical device 106 and / or the vasculature). The delivery system 100 includes, for example, a sleeve 104 (or a pull-back sheath or other similar restraint structure) that surrounds the medical device 106 and restrains the medical device 106 toward a reduced diameter or collapsed configuration, as shown in further detail with reference to Figure 2 shown further below.

[0041] Figure 2 A perspective view of an exemplary delivery system 100 with a medical device 106 is shown in accordance with one embodiment. In various embodiments, the medical device 106 is restrained by a single sleeve 104 that circumferentially surrounds the medical device 106. In various embodiments, the sleeve 104 circumferentially surrounds the medical device 106 and restrains it toward a collapsed configuration, and the diameter of the medical device 106 in the collapsed configuration is less than the diameter of the medical device in an unconstrained or otherwise deployed state or configuration. For example, the sleeve 104 can restrain the medical device 106 toward a collapsed configuration for delivery within the vasculature.

[0042] In other embodiments, the medical device 106 is constrained by a plurality of sleeves (e.g., similar to sleeve 104) that circumferentially surround the medical device 106, which allows the medical device 106 to deploy to and maintain an intermediate configuration that is greater than the collapsed configuration and less than the deployed configuration. The plurality of sleeves can include at least two sleeves (e.g., both similar to sleeve 104) that circumferentially surround one another.

[0043] The (one or more) material sheets for forming the (one or more) sleeves can include a series of openings such that the openings extend from one edge of the sheet to the other edge. In such a configuration, the coupling member 224 can be woven or sewn through the series of openings in the (one or more) material sheets to thereby secure each of the two edges together and form a tubular member. For example, in Figure 2 , the coupling member 224 secures the edges of the sleeve 104 such that the sleeve 104 holds the medical device 106 towards a reduced diameter or outer peripheral dimension suitable for intravascular delivery.

[0044] In various embodiments, decoupling a single coupling member that closes a single sleeve from the sleeve allows the expandable device to expand towards a larger diameter or outer peripheral dimension. For example, referring to Figure 2 , a delivery system can be used to deliver the medical device 106 to a treatment region of the vasculature. The medical device 106 has a collapsed diameter for delivery, and the sleeve 104 circumferentially surrounds the medical device 106 and is held closed by the coupling member 224. As described in more detail below, the bending of the medical device 106 can be controlled (e.g., at an intermediate diameter) prior to full expansion to assist in facilitating delivery to the desired location. Once the medical device 106 is in position relative to the treatment region, the coupling member 224 is decoupled from the sleeve 104, and the sleeve 104 is released, thereby allowing the medical device 106 to expand towards a larger diameter.

[0045] In these embodiments, once the implant has been delivered near the treatment region of the patient's vasculature, the medical device 106 can expand from the collapsed configuration towards the intermediate configuration. The intermediate configuration can primarily assist in properly orienting and positioning the medical device 106 within the treatment region of the vasculature. In various embodiments, the medical device 106 can be concentrically surrounded by two sleeves having different diameters. In these configurations, the primary sleeve constrains the medical device 106 towards the collapsed configuration. Once the collapsed configuration sleeve is opened, the secondary sleeve then constrains the medical device 106 towards the intermediate configuration, and the secondary sleeve is similarly constructed and arranged as the sleeve 104 (e.g., the secondary sleeve can also be held together by a coupling member and released by the coupling member).

[0046] As described above, the medical device 106 can be oriented at a treatment region of the vasculature. To orient the medical device 106, the delivery system 100 includes a steering wire 220. Tension can be applied to the steering wire 220 to displace the steering wire 220 and bend the medical device 106. Bending the medical device 106 can primarily assist in traveling through curved or tortuous regions of the vasculature. Bending the medical device 106 can also allow the medical device 106 to conform to the curvature in a patient's vasculature or other body cavity.

[0047] In some cases, the delivery system 100 can include a handle 108 (as Figure 1 shown), to which a coupling member 224 and the steering wire 220 (or wires) are connected. The handle 108 can allow a user to manipulate the coupling member 224 and the steering wire 220 outside the patient's body.

[0048] Figure 3 A perspective view of an exemplary release wire 326 and the medical device 106 according to one embodiment is shown. The delivery system 100 can include a release wire 326 that (connects) the medical device 106 to the delivery system 100. Additionally, the release wire 326 can also be used to secure one steering wire 220 or multiple steering wires (e.g., similar to each other according to the desire) to the delivery system 100.

[0049] The release wire 326 can be disposed outside the medical device 106 (as shown), inside the medical device 106, or can be guided through the medical device 106 such that some portions of the release wire 326 are outside the medical device 106 and other portions of the release wire 326 are inside the medical device 106. Similar to the coupling member 224 and the steering wire 220 discussed above, the other end of the release wire 326 can be coupled to the handle 108 (not shown) of the delivery system 100. At the handle 108, the user can apply tension to the release wire 326 to remove the release wire 326 from the patient and separate the medical device 106 from the delivery system 100.

[0050] In various embodiments, the release wire 326 can be made of metal, polymer, or natural materials and can include materials of conventional medical grade, such as nylon, polyacrylamide, polycarbonate, polyethylene, polyoxymethylene, polymethyl methacrylate, polypropylene, polytetrafluoroethylene, polychlorotrifluoroethylene, polyvinyl chloride, polyurethane, elastomeric silicone polymer; metals such as stainless steel, cobalt-chromium alloy, and nitinol. The elongated member or locking wire can also be made of high-strength polymer fibers such as ultra-high molecular weight polyethylene fibers (e.g., Dyneema etc.) or aramid fibers (e.g., etc.).

[0051] Figure 4 A side view of an exemplary release wire 326 and catheter shaft 102 in accordance with one embodiment is shown. As Figure 4 shown, the delivery system 100 includes a catheter shaft 102, a medical device 106, a steering wire 220, and a release wire 326. The release wire 326 passes from outside the patient's body, through the catheter shaft 102 from a handle 108 (not shown), and exits near the distal or far end of the medical device 106. At this time, the release wire 326 can extend along the outer surface of the medical device 106.

[0052] In some cases, as Figure 4 shown, the release wire 326 interacts with the steering wire 220 and extends to the catheter tip 428. In this configuration, the release wire 326 releasably couples the steering wire 220 to the delivery system 100. The release wire 326 can be embedded, fixed, or attached to the catheter tip 428 and can be released from the catheter tip 428 in response to tension applied by the user to the release wire 326. Any way in which the release wire 326 can interact with one or more steering wires 220 to maintain a releasable coupling between the one or more steering wires 220 and the delivery system 100 is within the scope of the present disclosure. Although two steering wires 220 are shown, it should be understood that any number of steering wires 220 can be contemplated, including less than or more than Figure 4 the two shown.

[0053] Figure 5 An enlarged view of a flexible loop 530, a medical device 106, and a catheter shaft 102 (with the medical device 106 compressed or constrained onto the catheter shaft) in accordance with one embodiment is shown. As Figure 5 shown, the medical device 106 includes an opening 532. The opening 532 through the medical device 106 can be configured to allow the flexible loop 530 to extend from the interior of the medical device 106 (where the catheter shaft 102 is disposed to pass through the interior) to the exterior of the medical device 106, as Figure 5 shown. In some cases, the opening 532 through the medical device 106 can be configured to allow the flexible loop 530 to extend from the exterior of the medical device 106 to the interior of the medical device 106.

[0054] The medical device 106 can be collapsed into a delivery configuration for delivery and expanded at the target location. In some cases, the medical device 106 can be partially expanded during deployment (e.g., for steering or orientation) or otherwise maintained in connection with the catheter shaft. To maintain the connection between the medical device 106 and the catheter shaft 102, the delivery system can include a release wire 326 coupled to the medical device 106 and the catheter shaft 102 (as Figure 3-4 and Figure 7 shown).

[0055] In some cases, compared to a delivery system that does not have a structural aspect (e.g., a release wire, a locking wire, or other similar structure) that releasably couples the medical device 106 to the catheter shaft 102, the release wire 326 can increase the overall delivery profile of the system 100, in part due to the requirement to maintain the release wire within the catheter lumen. To facilitate the delivery of the medical device 106 using a release wire (or other similar means of coupling to the catheter), the flexible loop 530 can be used as a path for the release wire 326. In some cases, the delivery system 100 discussed herein can include multiple flexible loops 530. In some cases, the flexible loop 530 (or flexible loops 530) can form a flexible lumen through which the release wire 326 is disposed.

[0056] In some cases, the flexible loop 530 (flexible loops 530) can be attached to the catheter shaft 102 as Figure 6 shown. The flexible loop 530 (flexible loops 530 or lumen) can be configured to collapse in response to a decrease in the diameter of the medical device 106. In this way, the flexible loop 530 (flexible loops 530 or lumen) can facilitate delivery by forming a path or lumen for the release wire. Thus, the flexible loop 530 (flexible loops 530 or lumen) reduces the size or diameter of the catheter available for the delivery system discussed herein by forming a path for the release wire, whereas previously the catheter lumen would have been used as that path. As further shown in detail in Figure 7 , the flexible loop 530 (flexible loops 530 or lumen) can hold the release wire 326 or similar feature in place outside the medical device 106 by passing the release wire 326 through the flexible loop 530.

[0057] Figure 6 An enlarged view of an exemplary flexible loop 530 and catheter shaft 102 according to an embodiment is shown. As Figure 6 shown, the flexible loop 530 is coupled to the catheter shaft 102. The flexible loop 530 can be attached to the catheter shaft 102 along an extension of the catheter shaft through a portion of the lumen of a medical device, such as the medical device 106.

[0058] In some cases, the flexible loop 530 includes fibers 634 that are coupled to the catheter shaft 102. The fibers 634 can be wrapped, glued, bonded (adhered), sutured, stapled, interlocked, or otherwise coupled to the catheter shaft 102 to form the flexible loop 530. The medical device 106 discussed herein (as described above but not shown) can be a combination of a stent and a graft, or any configuration described in association with the medical device 106. The flexible loop 530 can be formed from the same or a similar material as the graft material of the medical device. Additionally, an opening can be provided through the graft portion of the medical device 106, and the flexible loop 530 is disposed through the opening.

[0059] To manufacture a delivery system that includes one or more flexible rings 530, the flexible ring 530 is coupled to the catheter shaft 102 (e.g., wrapping, gluing, bonding, suturing, stapling, interlocking, or otherwise coupling the fibers 634 to the catheter shaft 102 to form the flexible ring 530). After forming the flexible ring 530, the flexible ring 530 is configured to pass through an opening in the medical device 106 (e.g., as Figure 5 shown). Subsequently, a release wire can be configured to pass through the flexible ring 530 to releasably couple the medical device to the catheter shaft 102 (e.g., as Figure 7 shown). After the release wire is configured to pass through the flexible ring 530, the medical device can be collapsed relative to the catheter shaft 102 into a delivery configuration (the medical device can be collapsed against the catheter shaft 102 into a delivery configuration), and this delivery configuration can also include the collapse of the flexible ring 530 toward the catheter shaft 102 in response to the medical device collapsing into the delivery configuration.

[0060] Figure 7 A side view of an exemplary release wire 326, flexible ring 530, and catheter shaft 102 in accordance with an embodiment is shown. The release wire 326, flexible ring 530, and catheter shaft 102 form part of the delivery system 100. The medical device 106 has an interior and an exterior. As Figure 7 shown, a portion of the catheter shaft 102 is configured to pass through the interior of the medical device 106, and the release wire 326 is configured to pass through the exterior of the medical device 106.

[0061] As Figure 7 shown, the delivery system 100 includes two flexible rings 530. In some cases, the two flexible rings 530 are aligned relative to the longitudinal axis of the medical device 106, which can be aligned with the catheter shaft 102. Further, the medical device 106 is configured to collapse from the Figure 1 shown expanded / delivery configuration into a delivery configuration. In these cases, the flexible ring 530 or flexible rings 530 are configured to collapse toward the catheter shaft 102 in response to the medical device 106 collapsing into the delivery configuration. The delivery system 100 can include one or more sheaths / sleeves (e.g., as Figure 1-2 shown), which are configured to releasably hold the medical device 106 in the delivery configuration.

[0062] In some cases, the flexible ring 530 (or rings 530) is configured to keep at least a portion of the release wire 326 in contact with the outer surface of the medical device 106. Thus, in some cases, the flexible ring 530 is configured to form a lumen for the release wire 326. The flexible ring 530 (or as Figure 7A plurality of flexible rings 530 as shown are attached to the catheter shaft 102 and extend through openings 532 (or openings 532 for each respective flexible ring 530) that pass through the medical device 106. The flexible rings 530 (or lumens) are configured to collapse in response to a decrease in the diameter of the medical device 106. In some cases, the lumen is formed by a first ring 530 disposed at one end of the medical device 106 and a second ring 530 disposed at the other end of the medical device 106, wherein the release wire 326 is disposed to pass through the flexible lumen (formed by the plurality of rings 530). The release wire 326 is configured to releasably couple the medical device 106 to the catheter shaft 102.

[0063] In some cases, as Figure 4 shown, the release wire 326 can terminate at the catheter tip 428 (or olive) of the catheter shaft 102. The release wire 326 is configured to release from the catheter tip 428 (or olive) in response to tension and retract through the (plurality of) flexible rings 530. As described above, the medical device 106 can collapse into a delivery configuration for delivery and expand at the target location. In some cases, the medical device 106 can be partially expanded during deployment (e.g., for steering or orientation) or remain otherwise coupled to the catheter shaft. To maintain the coupling of the medical device 106 to the catheter shaft 102, the release wire 326 is coupled to the medical device 106 and to the catheter shaft 102 by being disposed to pass through the (plurality of) flexible rings 530 (or lumen). Thus, the medical device 106 can be partially expanded and remain in contact with the delivery system 100 and the catheter shaft 102 by means of the release wire 326. The release wire 326 and the (plurality of) rings 539 are configured to maintain the medical device 106 coupled to the catheter shaft 102 during orientation of the medical device 106.

[0064] In some cases, the (plurality of) flexible rings 530 contribute to the minimum delivery profile of the system 100, in part due to the elimination of the need for a lumen for the release wire 326 within the catheter lumen (which would increase the overall delivery size). In some cases, the flexible ring 530 (or plurality of flexible rings 530) can form a flexible lumen through which the release wire 326 is disposed to pass, and the flexible lumen can collapse with the medical device 106.

[0065] After the medical device 106 is oriented and deployed, the release wire 326 is configured to retract through the flexible loop(s) 530 in response to tension. The flexible loop(s) 530 are fixedly coupled to the catheter shaft 106. The catheter shaft 102 can be removed from the vasculature after the medical device 106 is deployed, leaving the medical device 106 at the target treatment location. The catheter shaft 102 can be retracted to remove the system 100 from the vasculature. By retracting the catheter shaft 102, since the flexible loop(s) 530 are fixedly attached to the catheter shaft 102, the flexible loop(s) 530 are also removed. The flexible loop(s) facilitate the use of the release wire 326 without increasing the size of the delivery system 100, which can promote the use of the system 100 by reaching smaller vasculatures compared to existing systems.

[0066] Possible materials for the graft member of the medical device discussed herein include, for example, expanded polytetrafluoroethylene (ePTFE), polyester, polyurethane, fluoropolymers such as perfluoroelastomers, polytetrafluoroethylene, silicone, polyurethane, ultra-high molecular weight polyethylene, aramid fibers, and combinations thereof. Other embodiments for the graft member material can include high-strength polymer fibers such as ultra-high molecular weight polyethylene fibers (e.g., Dyneema etc.) or aramid fibers (e.g., etc.). The graft member can include a bioactive agent. In one embodiment, the ePTFE graft includes a carbon component along its blood-contacting surface. Any graft member that can be delivered through a catheter is in accordance with the present disclosure.

[0067] In addition, the stent component of the medical device discussed herein can have various configurations such as, for example, rings, cut tubes, wound wires (or tapes), or flat patterned sheets rolled into tubes. The stent component can be made of metal, polymer, or natural materials and can include conventional medical-grade materials such as nylon, polyacrylamide, polycarbonate, polyethylene, polyoxymethylene, polymethyl methacrylate, polypropylene, polytetrafluoroethylene, polychlorotrifluoroethylene, polyvinyl chloride, polyurethane, elastomeric silicone polymers; metals such as stainless steel, cobalt-chromium alloy, and nitinol; and bioderived materials such as bovine artery / vein, pericardium, and collagen. The stent component can also include bioabsorbable materials such as poly(amino acids), poly(anhydrides), poly(caprolactone), poly(lactic / glycolic acid) polymers, poly(hydroxybutyrate), and poly(orthoesters). Any expandable stent component configuration that can be delivered through a catheter is in accordance with the present disclosure.

[0068] The invention of the present application has been generally and with reference to specific embodiments described above. It will be apparent to those skilled in the art that various modifications and changes can be made to the embodiments without departing from the scope of the present disclosure. Accordingly, the embodiments are intended to cover modifications and variations of the present invention as long as they fall within the scope of the appended claims and their equivalents.

Claims

1. A system, comprising: a catheter shaft having a loop extending from an outer surface of the catheter shaft; a release wire extending through the loop; a medical device coupled to the catheter shaft by the release wire, the medical device being expandable from a delivery configuration to a deployed configuration; and at least one restraint structure configured to releasably restrain the medical device in the delivery configuration.

2. The system according to claim 1, wherein the medical device has an interior, an exterior, and an opening therebetween, and the loop extends from the interior of the medical device to the exterior.

3. The system according to claim 1, wherein the at least one restraint structure includes a pull-back sheath.

4. The system according to claim 1, wherein the at least one restraint structure includes a sleeve releasably fixed around the medical device.

5. The system according to claim 4, wherein the sleeve is configured to transition between a tubular configuration and a sheet configuration around the medical device.

6. The system according to claim 5, wherein the sleeve is releasably fixed in the tubular configuration by a coupling member extending along a longitudinal axis of the sleeve.

7. The system according to claim 6, wherein the sleeve includes a series of openings along the longitudinal axis, and the coupling member weaves through the series of openings.

8. The system according to claim 5, wherein when the coupling member is removed from the sleeve, the sleeve transitions to the sheet configuration and the medical device expands.

9. The system according to claim 1, wherein the at least one restraint structure includes a main sleeve and a secondary sleeve, the main sleeve being releasably fixed to the medical device, and the secondary sleeve surrounding at least a portion of the main sleeve.

10. The system according to claim 1, wherein the diameter of the secondary sleeve is greater than the diameter of the main sleeve.

11. The system according to claim 10, wherein the main sleeve is configured to be released from the medical device, upon release, the medical device expands to an intermediate configuration between the delivery configuration and the deployed configuration, and the secondary sleeve releasably fixes the medical device in the intermediate configuration.

12. The system according to claim 11, wherein the secondary sleeve is configured to be released from the medical device, upon release, the medical device expands to the deployed configuration.

13. A system, comprising: a catheter shaft having a loop coupled to an outer surface of the catheter shaft; a release wire extending through the loop; a medical device expandable between a collapsed configuration and an expanded configuration, the medical device having an inner surface, an outer surface, and an opening therebetween, the loop configured to extend through the opening to releasably couple the catheter and the medical device; and At least one restraining structure configured to releasably hold the medical device in the collapsed configuration.

14. The system according to claim 13, wherein, when the medical device is in the delivery configuration, the ring is collapsible towards the catheter shaft.

15. The system according to claim 14, wherein, when the ring collapses, the projected distance of the ring to the catheter shaft decreases.

16. The system according to claim 13, wherein, the release wire is held in place along the outer surface of the medical device.

17. The system according to claim 13, wherein, the at least one restraining structure includes a pull-back sheath.

18. The system according to claim 13, wherein, the at least one restraining structure includes a sleeve releasably fixed around the medical device.

19. The system according to claim 13, wherein, the ring includes fibers that are at least one of wrapped, glued, bonded, sutured, stapled, or interlocked to the catheter shaft.

20. The system according to claim 13, wherein, the medical device includes a stent and a graft, wherein the opening is defined through the thickness of the graft.

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