Low-profile delivery system with lockwire lumen

Abstract

Various aspects of the present disclosure relate to devices, systems, and methods for delivery of a medical device, including at least one loop attached to a catheter shaft and extending through the medical device, and a release line held in place by passing through the loop.

Description

[Technical Field]

[0001] The present invention relates to medical devices and methods for treating anatomical spaces (e.g., vessels) in the body. In particular, the present invention relates to methods, instruments, and systems including implantable medical device prostheses that allow for precise deployment in anatomical spaces. [Background technology]

[0002] Diseases of the vascular system are becoming increasingly common. Treating the vessels can be difficult due to their tortuous and complex nature. For example, aortic dissections typically begin at or near the base of the aortic valve and progress to the ascending aorta and aortic arch. Medical devices implanted in diseased states can be used to treat aortic dissections, aneurysms, and other diseases of the vascular or other luminal systems, such as the biliary, gastrointestinal, or respiratory tracts.

[0003] It would further be desirable to provide medical devices, systems and methods for repairing disease along the aorta and for repairing disease along the aorta and the arterial branches and lumens extending therefrom. Summary of the Invention

[0004] In one embodiment (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 configured to allow the loop to extend from the interior to the exterior of the medical device, and a release line on the exterior of the medical device that is held in place by passing through the loop.

[0005] In another embodiment (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 embodiment (Example 3), further to the system of Examples 1 or 2, at least one flexible loop comprises a fiber coupled to the catheter shaft.

[0007] In another embodiment (Example 4), in addition to the system of Example 3, the fiber is at least one of wrapped, glued, and adhered to the catheter shaft to form at least one flexible loop.

[0008] In another embodiment (Example 5), in addition to the system of any one of Examples 1 to 4, the medical device is configured to collapse into a delivery configuration, and the at least one flexible loop is configured to collapse toward the catheter shaft in response to the medical device collapsing into the delivery configuration.

[0009] In another example (Example 6), in addition to the system of Example 5, the system also includes at least one sheath configured to releasably retain the medical device in the delivery configuration.

[0010] In another example (Example 7), further to any one of Examples 1-6, the medical device includes a stent and graft combination, wherein the at least one opening is configured through the graft, and the at least one flexible loop comprises graft material.

[0011] In another embodiment (Example 8), further to the system of any one of Examples 1-7, the at least one flexible loop is configured to maintain at least a portion of the release line in contact with an exterior surface of the medical device.

[0012] In another embodiment (Example 9), further to the system of any one of Examples 1-8, the at least one flexible loop is configured to form a lumen for a release line.

[0013] In another embodiment (Example 10), in addition to the system of any one of Examples 1-9, the release line terminates in an olive at one end of the catheter shaft.

[0014] In another embodiment (Example 11), further to the system of Example 10, the release line is configured to detach from the olive in response to pulling and retract through at least one flexible loop.

[0015] In another embodiment (Example 12), further to the system of any one of Examples 1-11, the release line and the at least one loop are configured to maintain the medical device coupled to the catheter shaft when the medical device is directed.

[0016] In one embodiment (Example 13), a method of manufacturing a delivery system for a medical device includes coupling at least one flexible loop to a catheter shaft, arranging the at least one flexible loop through an opening in the medical device, and arranging a release line through the at least one flexible loop to releasably couple the medical device to the catheter shaft.

[0017] In another example (Example 14), further to the method of Example 13, coupling the at least one flexible loop to the catheter shaft includes forming the at least one flexible loop by at least one of wrapping, gluing, and adhering the fiber to the catheter shaft.

[0018] In another embodiment (Example 15), in addition to the method of Examples 13 or 14, the method also includes folding the medical device against the catheter shaft into a delivery configuration, and folding at least one flexible loop toward the catheter shaft in response to the medical device folding 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 through the medical device, the flexible lumen configured to collapse in response to a reduction in diameter of the medical device, and a release line arranged through the flexible lumen and configured to releasably couple the medical device to the catheter shaft.

[0020] In another embodiment (Example 17), further to the system of Example 16, the flexible lumen includes a first flexible loop and a second flexible loop arranged on opposite ends of the medical device.

[0021] In another embodiment (Example 18), in addition to the system of Example 17, the release line is configured to retract through the first and second flexible loops in response to pulling, while the first and second flexible loops remain coupled to the catheter shaft.

[0022] In another embodiment (Example 19), in addition to the system of Example 18, the catheter shaft is configured to retract the first flexible loop and the second flexible loop after delivery of the medical device.

[0023] In another embodiment (Example 20), in addition to the system of Example 16, the at least one flexible loop includes a fiber coupled to the catheter shaft, and the fiber is at least one of wrapped, glued, and adhered to the catheter shaft to form the at least one flexible loop.

[0024] The accompanying drawings are included to provide a further understanding of the disclosure, and are incorporated into and constitute a part of this specification, illustrate embodiments, and together with the description, serve to explain the principles of the disclosure. [Brief explanation of the drawings]

[0025] [Figure 1] FIG. 1 is a side view of an example of a delivery system having a medical device according to one embodiment. [Figure 2] FIG. 2 is a perspective view of an example of a delivery system having a medical device according to one embodiment. [Figure 3] FIG. 3 is a perspective view of an example release line and medical device according to one embodiment. [Figure 4] FIG. 4 is a side view of an example release line and catheter shaft according to one embodiment. [Figure 5] FIG. 5 is an expanded view of an example of a flexible loop, medical device, and catheter shaft according to one embodiment. [Figure 6] FIG. 6 is a close-up view of an example of a flexible loop and catheter shaft according to one embodiment. [Figure 7] FIG. 7 is a side view of an example of a release line, flexible loop, and catheter shaft according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0026] Those skilled in the art will appreciate that the various aspects of the present disclosure may be realized by any number of methods and apparatus configured to perform the intended functions. It should also be understood that the accompanying drawings referred to herein are not necessarily to scale and may be exaggerated to illustrate the various aspects of the present disclosure, and in this regard the drawings should not be construed as limiting.

[0027] Various aspects of the present disclosure relate to instruments, systems, and methods, including implantable medical devices that can be used to treat vessels or other luminal and non-luminal systems of the body. In some embodiments, the implantable medical device is delivered to a vessel using a delivery system, such as a transcatheter delivery system. A variety of configurations are contemplated for the implantable medical device, and the implantable medical devices described herein can be substantially cylindrical, include branches, or have any of a variety of characteristics. Furthermore, the implantable medical device can be configured to conform to the vessel in which it is implanted, can have a profile that facilitates delivery of the implantable medical device using minimally invasive procedures (e.g., via transcatheterization), and can withstand forces and other stresses that occur after implantation in the vessel.

[0028] The medical device can be collapsed into a delivery configuration for delivery and expanded at the target location. In certain cases, the medical device can be partially expanded (e.g., for manipulation or orientation) or can remain coupled to the catheter shaft during deployment. To maintain the medical device coupled to the catheter, the delivery system can include a release line coupled to the medical device and the catheter.

[0029] Compared to delivery systems that do not have structural features for releasably coupling a medical device to a catheter shaft, a release line may, in certain cases, increase the overall delivery profile of the system due in part to the catheter lumen for the release line. To facilitate delivery of a medical device with a release line (or other similar device-catheter coupling), the systems disclosed herein include a flexible loop or lumen through which the release line is disposed. As discussed in more detail below, the flexible loop or lumen facilitates delivery of the medical devices discussed herein.

[0030] FIG. 1 shows a side view of an example delivery system 100 having a medical device 106 according to one embodiment. The medical device 106 can be any intraluminal device suitable for delivery to a treatment site in a vessel or other luminal and non-luminal systems of the body (such as the biliary tract, GI tract, respiratory system, or other). As shown in FIG. 1, the delivery system 100 can include a handle 108 at the proximal end of the system (the end of the system opposite to where the medical device 106 is positioned). The handle 108 of the delivery system 100 can be accessible to a user to aid in delivering the medical device 106. As described in more detail below, the delivery system 100 can include one or more lines or wires to facilitate delivery, direction, or placement of the medical device 106.

[0031] In various embodiments, the medical device 106 can include a radially collapsed configuration suitable for delivery to a treatment site in a patient's vessel. The medical device 106 can be constrained in the radially collapsed configuration and releasably attached to a delivery device, such as the catheter shaft 102. The diameter of the medical device 106 in the collapsed configuration is small enough to allow the medical device 106 to be delivered through the vessel to the target treatment location or site. 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 by the catheter shaft 102 through the vessel.

[0032] The medical device 106 can include a radially expanded configuration suitable for implanting the medical device 106 at a treatment site in a patient's vessel. In the expanded configuration, the diameter of the medical device 106 can be approximately the same as the diameter of the blood vessel or other body cavity in which the medical device 106 is placed. In other embodiments, the diameter of the medical device 106 in the expanded configuration can be slightly larger than the blood vessel to provide a frictional or interference fit within the blood vessel.

[0033] In various embodiments, the medical device 106 can include a self-expanding device, such as a self-expanding stent graft. This type of device expands from a radially collapsed configuration to a radially expanded configuration when unrestrained. In other embodiments, the medical device 106 comprises a device that is expanded with the aid of a secondary device, such as a balloon, that applies an expansion force to the medical device 106. In yet another embodiment, the delivery system 100 can include multiple medical devices 106. Use of the delivery system 100 with any number of medical devices 106 is within the scope of this 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. The stent can expand from a delivery diameter through larger intermediate diameters to a maximum set functional diameter. In certain instances, the medical device 106 includes one or more stent components made of Nitinol and a graft made of ePTFE, although, as discussed below, any suitable combination of stent components and graft members is within the scope of the present disclosure.

[0034] In certain cases, the delivery system 100 can include one or more sleeves (and other restraining mechanisms) to restrain the medical device 106 in a collapsed configuration for intraluminal delivery of the medical device 106 to a treatment portion of a patient's vessel or other body cavity. In this disclosure, "restraint" can mean (i) limiting the diameter of the medical device 106 from expanding, either by self-expansion or with the aid of a device, or (ii) covering or surrounding but not otherwise restraining the medical device 106 (e.g., for storage or biocompatibility purposes and / or to provide protection to the medical device 106 and / or vessel). The delivery system 100 can include, for example, a sleeve 104 (or pull-back sheath or other similar restraining structure) that surrounds the medical device 106 and restrains it toward a reduced or collapsed diameter, as shown in more detail below with reference to FIG. 2.

[0035] 2 is a perspective view of an example delivery system 100 having a medical device 106 according to one embodiment. In various embodiments, the medical device 106 is constrained by a single sleeve 104 that surrounds the circumference of the medical device 106. In various embodiments, the sleeve 104 surrounds the circumference of the medical device 106 to constrain the medical device toward a collapsed configuration, the collapsed configuration having a smaller diameter than the diameter of the medical device 106 in an unconstrained or deployed state or configuration. For example, the sleeve 104 constrains the medical device 106 toward a collapsed configuration for delivery within a vessel.

[0036] In other embodiments, medical device 106 is surrounded by multiple sleeves (e.g., similar to sleeve 104) that surround medical device 106. The sleeves enable medical device 106 to be deployed and held in an intermediate configuration that is larger than the collapsed configuration and smaller than the deployed configuration. The multiple sleeves can include at least two sleeves (e.g., each similar to sleeve 104) that circumferentially surround one another.

[0037] The sheet of material used to form the sleeve can include a series of openings such that the openings extend from one edge of the sheet to the other. In such a configuration, the connecting members 224 can be sewn or threaded through the series of openings to secure the two edges together to form a tube. For example, in FIG. 2, the connecting members 224 secure the edges of the sleeve 104 so that the sleeve 104 maintains the medical device 106 at a reduced diameter or circumferential size suitable for intraluminal delivery.

[0038] In various embodiments, a single coupling member that closes the single sleeve can be disengaged from the sleeve, allowing the expandable device to expand to a larger diameter or circumference. For example, with reference to FIG. 2 , a delivery system can be used to deliver a medical device 106 to a vascular treatment site. The medical device 106 has a collapsed diameter for delivery, and the sleeve 104 surrounds the circumference of the medical device 106 and is held closed by coupling members 224. As described in more detail below, the bending of the medical device 106 can be controlled prior to full expansion (e.g., at an intermediate diameter) to facilitate delivery to a desired location. Once the medical device 106 is in position relative to the treatment site, the coupling members 224 are disengaged from the sleeve 104, releasing the sleeve 104 and allowing the medical device 106 to expand to a larger diameter.

[0039] In such embodiments, once the implant is delivered near the treatment site in the patient's vessel, the medical device 106 can expand from the collapsed configuration to an intermediate configuration. The intermediate configuration can aid in, among other things, properly orienting and positioning the medical device 106 within the vascular treatment site. In various embodiments, the medical device 106 can be concentrically surrounded by two sleeves having different diameters. In such a configuration, the primary sleeve restrains the medical device 106 in the collapsed configuration. When the collapsed configuration sleeve is released, a secondary sleeve, similarly configured and arranged as sleeve 104, restrains the medical device 106 in the intermediate configuration (e.g., the secondary sleeves can also be released and held together by a connecting member).

[0040] As described above, the medical device 106 can be oriented at a treatment site in a vessel. To direct the medical device 106, the delivery system 100 includes a steering line 220. Tension can be applied to the steering line 220 to displace the steering line 220 and bend the medical device 106. Bending the medical device 106 aids in navigating curved or tortuous regions of a vessel. Bending the medical device 106 also allows the medical device 106 to conform to the curves of a vessel or other body lumen of a patient.

[0041] In certain instances, the delivery system 100 can include a handle 108 (FIG. 1) that connects the coupling member 224 and the steering line(s) 220. The handle 108 allows a user to manipulate the coupling member 224 and the steering line(s) 220 outside the patient's body.

[0042] 3 is a perspective view of an example release line 326 and medical device 106 according to one embodiment. The delivery system 100 can include a release line 326 for the medical device 106 of the delivery system 100. Additionally, the release line 326 can be used to secure the steering line 220 or multiple steering lines (e.g., each similar to one another) to the delivery system 100.

[0043] The release line 326 can be located external to the medical device 106, located internal to the medical device 106, or passed through the medical device 106 such that a portion of the release line 326 is external to the medical device 106 and another portion of the release line 326 is internal to the medical device 106. The other end of the release line 326 can be coupled to the handle 108 (not shown) of the delivery system 100, similar to the coupling member 224 and steering line 220 discussed above. At the handle 108, a user can apply tension to the release line 326 to remove the release line 326 from the patient and detach the medical device 106 from the delivery system 100.

[0044] In various embodiments, the release line 326 can be formed from metallic, polymeric, or natural materials, including conventional medical-grade materials such as nylon, polyacrylamide, polycarbonate, polyethylene, polyformaldehyde, polymethyl methacrylate, polypropylene, polytetrafluoroethylene, polytrifluorochloroethylene, polyvinyl chloride, polyurethane, elastomeric organosilicon polymers, and metals such as stainless steel, cobalt chromium alloys, and Nitinol. The elongate member or lockwire can also be formed from high-strength polymeric fibers, such as ultra-high molecular weight polyethylene fibers (e.g., Spectra®, Dyneema Purity®, etc.) or aramid fibers (e.g., Technora®, etc.).

[0045] Figure 4 is a side view of an example release line 326 and catheter shaft 102, according to one embodiment. As shown in Figure 4, the delivery system 100 includes the catheter shaft 102, the medical device 106, the steering line 220, and the release line 326. The release line 326 passes from outside the patient's body, from the handle 108 (not shown), through the catheter shaft 102, and exits distal to or near the distal end of the medical device 106. In this regard, the release line 326 may extend along the exterior surface of the medical device 106.

[0046] In certain instances, as shown in FIG. 4 , the release line 326 interacts with the steering line 220 and continues to the catheter tip 428. In such a configuration, the release line 326 releasably couples the steering line 220 to the delivery system 100. The release line 326 can be embedded in, attached to, or attached to the catheter tip 428 and can be released from the catheter tip 428 in response to a user applying a pull on the release line 326. Any manner in which the release line 326 can interact with the steering line(s) 220 to maintain a releasable coupling between the steering line 220 and the delivery system 100 is within the scope of the present disclosure. While two steering lines 220 are illustrated, it should be understood that any number of steering lines 220 less than or greater than the two shown in FIG. 4 are envisioned.

[0047] Figure 5 is an enlarged view of a flexible loop 530, a medical device 106, and a catheter shaft 102 (with the medical device 106 collapsed or folded), according to one embodiment. As shown in Figure 5, 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 (through which the catheter shaft 102 is disposed) to the exterior of the medical device 106, as shown in Figure 5. In certain 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.

[0048] The medical device 106 can be collapsed into a delivery configuration for delivery and expanded at the target location. In certain cases, the medical device 106 can be partially expanded upon deployment (e.g., for manipulation or orientation) or can remain coupled to the catheter shaft. To maintain the coupling of the medical device 106 to the catheter shaft 102, the delivery system can include a release line 326 (FIGS. 3-4 and 7) coupled to the medical device 106 and the catheter shaft 102.

[0049] Compared to delivery systems that do not have a structural feature (e.g., a release wire, lock wire, or other similar structure) for releasably coupling the medical device 106 to the catheter shaft 102, the release line 326 may, in certain cases, increase the overall delivery profile of the system 100, partially due to the need for a catheter lumen to maintain the release line. To facilitate delivery of a medical device 106 with a release line (or other similar device-catheter coupling), a flexible loop 530 can serve as a pathway for the release line 326. In certain cases, the delivery systems discussed herein can include multiple flexible loops 530. In certain cases, the flexible loop(s) 530 can form a flexible lumen through which the release line 326 is disposed.

[0050] In certain instances, the flexible loop(s) 530 are attached to the catheter shaft 102 (FIG. 6). The flexible loop(s) 530 or tools can be configured to collapse in response to a reduction in the diameter of the medical device 106. In this manner, the flexible loop(s) 530 or lumens can facilitate delivery by forming a pathway or lumen for a release wire. Thus, the flexible loop(s) 530 or lumens can reduce the size or diameter of a catheter useful for the delivery systems discussed herein by forming a pathway for a release wire (the catheter's lumen being previously used). As further shown in FIG. 7, the flexible loop(s) 530 or lumens can hold a release line 326 or similar feature in place outside the medical device 106 by passing it through the flexible loop 530.

[0051] Figure 6 is a close-up view of an example flexible loop 530 and catheter shaft 102, according to one embodiment. As shown in Figure 6, the flexible loop 530 is coupled to the catheter shaft 102. The flexible loop 530 can be attached to the catheter shaft 102 along a portion of the catheter shaft 102 that extends through the lumen of a medical device, such as medical device 106.

[0052] In certain instances, the flexible loop 530 includes a fiber 634 coupled to the catheter shaft 102. The fiber 634 can be wrapped, glued, adhered, sewn, tacked, interlocked, or otherwise coupled to the catheter shaft 102 to form the flexible loop 530. The medical device 106 discussed herein (discussed above but not shown) can be of any of the configurations described in connection with the stent and graft combination or medical device 106. The flexible loop 530 can be formed of a material that is the same as or similar to the graft material of the medical device. Additionally, the opening through which the flexible loop 530 is disposed can be arranged through the graft portion of the medical device 106.

[0053] To manufacture a delivery system including the flexible loop 530 or multiple flexible loops 530, the flexible loop 530 is coupled to the catheter shaft 102 (e.g., by wrapping the fiber 634 around the catheter shaft 102 and gluing, bonding, sewing, tacking, interlocking, or otherwise bonding to form the flexible loop 530). After the flexible loop 530 is formed, the flexible loop 530 is aligned through an opening in the medical device 106 (e.g., FIG. 5). A release line can then be aligned through the flexible loop 530 to releasably couple the medical device to the catheter shaft 102 (FIG. 7). After the release line is aligned through the flexible loop 530, the medical device can be collapsed against the catheter shaft 102 into a delivery configuration. This can also include collapsing the flexible loop 530 toward the catheter shaft 102 in response to the medical device collapsing into the delivery configuration.

[0054] 7 is a side view of an example of a release line 326, a flexible loop 530, and a catheter shaft 102 according to one embodiment. The release line 326, the flexible loop 530, and the catheter shaft 102 form part of the delivery system 100. The medical device 106 has an interior and an exterior. As shown in FIG. 7, a portion of the catheter shaft 102 is disposed through the interior of the medical device 106, and the release line 326 is disposed across the exterior of the medical device 106.

[0055] As shown in Figure 7, the delivery system 100 includes two flexible loops 530. In certain instances, the two flexible loops 530 are aligned with a longitudinal axis of the medical device 106, which is aligned with the catheter shaft 102. Additionally, the medical device 106 is configured to collapse from the expanded / delivery configuration shown in Figure 7 to a delivery configuration. In these instances, the flexible loop(s) 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 shown in Figures 1 or 2) configured to releasably retain the medical device 106 in the delivery configuration.

[0056] In certain cases, the flexible loop(s) 530 are configured to maintain at least a portion of the release line 326 in contact with the exterior surface of the medical device 106. Thus, the flexible loop 530 is configured to form a lumen for the release line 326 in certain cases. The flexible loop 530 (or loops, as shown in FIG. 7 ) is attached to the catheter shaft 102 and extends through an opening 532 (or opening 532 for each flexible loop 530) through the medical device 106. The flexible loop 530 (or lumen) is configured to collapse in response to a reduction in the diameter of the medical device 106. In certain cases, the lumen is formed by a first loop 530 arranged at one end of the medical device 106 and a second loop 530 arranged at another end of the medical device 106, and the release line 326 is arranged through the flexible lumen (formed by the loops 530). The release line 326 is configured to releasably couple the medical device 106 to the catheter shaft 102 .

[0057] In certain cases, as shown in FIG. 4 , the release line 326 can terminate at the catheter tip 428 (or olive) of the catheter shaft 102. The release line 326 is configured to release from the catheter tip 428 (or olive) in response to pulling and retract through the flexible loop 530. As described above, the medical device 106 can be collapsed into a delivery configuration for delivery and expanded at the target location. In certain cases, the medical device 106 can be partially expanded (e.g., for manipulation or orientation) or otherwise remain coupled to the catheter shaft during deployment. To maintain the coupling of the medical device 106 to the catheter shaft 102, the release line 326 is coupled to the medical device 106 by being routed through the flexible loop 530 (or lumen) and up to the catheter shaft 102. Thus, the medical device 106 can be partially expanded and maintain contact with the delivery system 100 and the catheter shaft 102 via the release line 326. The release line 326 and loop 539 are configured to maintain the medical device 106 coupled to the catheter shaft 102 when the medical device 106 is aimed.

[0058] The flexible loop 530, in certain cases, partially eliminates the need for a catheter lumen for the release line 326 (which may increase the overall delivery size), thereby facilitating a minimal delivery profile for the system 100. In certain cases, the flexible loop(s) 530 can form a flexible lumen through which the release line 326 is arranged and which can be folded along with the medical device 106.

[0059] After directing and deploying the medical device 106, the release line 326 is configured to retract in response to a pull through the flexible loop 530. The flexible loop 530 is fixedly coupled to the catheter shaft 106. The catheter shaft 102 can be removed from the vessel after deployment of the medical device 106, leaving the medical device 106 at the target treatment location. The catheter shaft 102 can be retracted to remove the system 100 from the vessel. By retracting the catheter shaft 102, the flexible loop 530 is also removed, as it is fixedly attached to the catheter shaft 102. The flexible loop facilitates use of the release line 326 without increasing the size of the delivery system 100 and can facilitate use of the system 100 by reaching into smaller vessels compared to prior systems.

[0060] Possible materials for the graft members of the medical devices discussed herein include, for example, expanded polytetrafluoroethylene (ePTFE), polyester, polyurethane, fluoropolymers such as perfluoroelastomers and the like, polytetrafluoroethylene, silicone, urethane, ultra-high molecular weight polyethylene, aramid fiber, and combinations thereof. Other embodiments of graft member materials include high-strength polymeric fibers such as ultra-high molecular weight polyethylene fibers (e.g., Spectra®, Dyneema Purity®, etc.) or aramid fibers (e.g., Technora®, etc.). The graft members can include bioactive agents. In one embodiment, the ePTFE graft includes a carbon component along with blood contacting surfaces. Any graft member that can be delivered by a catheter is in accordance with the present disclosure.

[0061] Furthermore, the stent components of the medical devices discussed herein can have a variety of configurations, such as rings, cut tubes, wound wire (or ribbons), or patterned sheets wound into a toroidal shape. Stent components can be formed from metals, polymers, or natural materials, including conventional medical-grade materials such as nylon, polyacrylamide, polycarbonate, polyethylene, polyformaldehyde, polymethyl methacrylate, polypropylene, polytetrafluoroethylene, polytrifluorochloroethylene, polyvinyl chloride, polyurethane, elastomeric organosilicon polymers, and metals such as stainless steel, cobalt-chromium alloys, and nitinol, as well as biologically derived materials such as bovine arteries / veins, pericardium, and collagen. Stent components 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 by a catheter is in accordance with the present disclosure.

[0062] The invention of this application has been described generally and with reference to specific embodiments. Those skilled in the art will recognize that various modifications and changes can be made to the embodiments without departing from the scope of the present disclosure. Therefore, the embodiments are intended to cover the modifications and changes of the present invention provided they come within the scope of the claims and their equivalents. The invention of the present application further includes the following aspects: <<Aspect 1>> 1. A medical device delivery system comprising: 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 configured to allow the loop to extend from the interior to the exterior of the medical device; a release line external to the medical device that is held in place by passing through the loop; A system comprising: <<Aspect 2>> 2. The system of aspect 1, wherein the at least one loop is flexible and includes at least two flexible loops aligned with respect to a longitudinal axis of the medical device. Aspect 3 3. The system of claim 1 or 2, wherein the at least one flexible loop comprises a fiber coupled to the catheter shaft. Aspect 4 4. The system of aspect 3, wherein the fiber is at least one of wrapped, glued, and adhered to the catheter shaft to form the at least one flexible loop. Aspect 5 A system described in any one of aspects 1 to 4, wherein the medical device is configured to be folded into a delivery configuration and the at least one flexible loop is configured to fold toward the catheter shaft in response to the medical device being folded into the delivery configuration. Aspect 6 Aspect 6. The system of aspect 5, further comprising at least one sheath configured to releasably hold the medical device in the delivery configuration. Aspect 7 A system described in any one of aspects 1 to 6, wherein the medical device comprises a stent and graft combination, the at least one opening is formed through the graft, and the at least one flexible loop comprises graft material. Aspect 8 Aspect 8. The system of any one of aspects 1-7, wherein the at least one flexible loop is configured to maintain at least a portion of the release line in contact with an exterior surface of the medical device. Aspect 9 Aspect 9. The system of any one of aspects 1-8, wherein the at least one flexible loop is configured to form a lumen for the release line. Aspect 10 Aspect 10. The system of any one of aspects 1-9, wherein the release line terminates in an olive at one end of the catheter shaft. Aspect 11 11. The system of claim 10, wherein the release line is configured to release from the olive in response to pulling and retract through the at least one flexible loop. Aspect 12 A system described in any one of aspects 1 to 11, wherein the release line and the at least one loop are configured to maintain the medical device coupled to the catheter shaft when the medical device is directed. Aspect 13 1. A method of manufacturing a delivery system for a medical device, comprising: coupling at least one flexible loop to a catheter shaft; disposing the at least one flexible loop through an opening in the medical device; Arranging a release line through the one flexible loop to releasably couple the medical device to the catheter shaft; A method comprising: Aspect 14 14. The method of claim 13, wherein coupling the at least one flexible loop to the catheter shaft comprises at least one of wrapping, gluing, and contacting a fiber to the catheter shaft to form the at least one flexible loop. Aspect 15 15. The method of claim 13 or 14, further comprising: folding the medical device against the catheter shaft into a delivery configuration; and folding the at least one flexible loop toward the catheter shaft in response to the medical device folding into the delivery configuration. Aspect 16 1. A medical device delivery system comprising: 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 through the medical device, the flexible lumen configured to collapse in response to a reduction in diameter of the medical device; a release line disposed through the flexible lumen and configured to releasably couple the medical device to the catheter shaft; A system comprising: Aspect 17 17. The system of aspect 16, wherein the flexible lumen includes a first flexible loop and a second flexible loop arranged on opposite ends of the medical device. Aspect 18 Aspect 18. The system of aspect 17, wherein the release line is configured to retract through the first and second flexible loops in response to pulling, and the first and second flexible loops remain coupled to the catheter shaft. Aspect 19 20. The system of claim 18, wherein the catheter shaft is configured to retract the first flexible loop and the second flexible loop after delivery of the medical device. Aspect 20 The system of aspect 16, wherein the at least one flexible loop comprises a fiber coupled to the catheter shaft, the fiber forming the at least one loop by at least one of being wrapped around, glued to, and adhered to the catheter shaft.

Claims

1. 1. A medical device delivery system comprising: A catheter shaft; at least one flexible loop attached to the catheter shaft, the at least one flexible loop comprising a flexible material and configured to form a lumen; and a medical device releasably coupled to the catheter shaft, the medical device having an interior and an exterior, the medical device defining at least one opening through a thickness of the medical device configured to allow the at least one flexible loop to extend from the interior to the exterior of the medical device; a release line that is held in place by passing through the lumen of the at least one flexible loop and is disposed on the exterior of the medical device and configured to release the medical device from the catheter shaft; Equipped with the release line extends linearly along the exterior of the medical device in the direction of a longitudinal axis of the medical device; The release line is configured to release from the distal end of the catheter shaft and retract through the flexible loop in response to an applied pull.

2. The system of claim 1 , wherein the at least one flexible loop comprises at least two flexible loops aligned with respect to a longitudinal axis of the medical device.

3. The system of claim 1 or 2, wherein the at least one flexible loop comprises a fiber coupled to the catheter shaft.

4. The system of claim 3 , wherein the fiber is at least one of wrapped, glued, and adhered to the catheter shaft to form the at least one flexible loop.

5. The system of any one of claims 1 to 4, wherein the medical device is configured to be folded into a delivery configuration, and the at least one flexible loop is configured to be folded toward the catheter shaft when the medical device is folded into the delivery configuration.

6. The system of claim 5 , further comprising at least one sheath configured to releasably retain the medical device in the delivery configuration.

7. 7. The system of claim 1, wherein the medical device comprises a stent and graft combination, the at least one opening formed through the graft, and the at least one flexible loop comprising graft material.

8. The system of any one of claims 1 to 7, wherein the at least one flexible loop is configured to maintain at least a portion of the release line in contact with an exterior surface of the medical device.

9. The system of any one of claims 1 to 8, wherein the at least one flexible loop is configured to form a lumen for the release line.

10. The system of any one of claims 1 to 9, wherein the release line terminates in an olive at one end of the catheter shaft.

11. The system of claim 10 , wherein the release line is configured to release from the olive in response to pulling and retract through the at least one flexible loop.

12. 12. The system of claim 1, wherein the release line and the at least one flexible loop are configured to maintain the medical device coupled to the catheter shaft when the medical device is directed.

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