Patent Description:
Disease of the vasculature is increasingly common. Treatment of the vasculature may be difficult because of the tortuous nature and complexity of the vasculature. Aortic dissections, for example, commonly begin at or near the aortic valve root and continue to the ascending aorta and the aortic arch. Medical devices implanted at a diseased state may be used for treatment of aortic dissections, aneurysms, and other diseases of the vasculature or other luminal systems of the body, such as the biliary tract, gastrointestinal tract, or respiratory system, for example. <CIT> is directed to a delivery device for deploying an expandable, endoluminal prosthesis within a body vessel. The delivery device may include one or more stent graft retention scaffolds having a plurality of arches, each arch encompassing an aperture forming a helical path and a trigger wire passing through at least two of the apertures following the helical path, wherein at least a portion of the stent graft is retained in a compressed configuration on the delivery device by the retention scaffold and trigger wire.

<CIT> is directed to a stent system comprising a stent body. At least one barb extends from the stent body and is configured such that a free end thereof is biased to extend radially outward from the stent body. A retaining mechanism is positioned to engage the at least one barb when the stent body is in a compressed state and retain the at least one barb in a tucked position relative to the stent body. A stent, a system for delivering a stent and a method of assembling a stent on a stent delivery shaft. The stent delivery system comprises a delivery shaft and a stent configured to be positioned about the delivery shaft. The stent includes an extension extending circumferentially from a portion of the stent to a free end, thereby defining a shoulder surface. The shoulder surface engages at least a portion of a belt to minimize axial movement of the belt during release of the release wire from engagement with the belt.

It remains desirable to provide medical devices, systems and methods for repairing disease along the aorta and also for repairing disease along the aorta and the branches extending and luminal spaces therefrom.

According to the invention, 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 exterior to the medical device held in place by passing through the loop.

The theat least one loop is flexible and includes at least two flexible loops aligned relative to a longitudinal axis of the medical device.

The at least one flexible loop is configured to form a lumen for the release line.

According to the invention, 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 as further disclosed in claim <NUM>.

Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting.

Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that include an implantable medical device that may be used in treatment of the vasculature or other luminal and non-luminal systems of the body. In some examples, the implantable medical device is delivered to the vasculature using a delivery system, such as a transcatheter delivery system. In terms of configurations for the implantable medical device, a variety of configurations are contemplated, and the implantable medical devices described herein may be substantially cylindrical, include a bifurcation, or have any of a variety of features. Further, the implantable medical devices may be configured to conform to the vasculature into which the implantable medical device is implanted, and have a profile that facilitates delivery of the implantable medical device using a minimally invasive procedure (e.g., via transcatheter techniques), and able to withstand forces and other stresses that occur once implanted in the vasculature.

The medical device may be collapsed to a delivery configuration for delivery and expanded at the target location. In certain instances, the medical device may be partially expanded (e.g., for steering or orienting) or remain otherwise coupled to the catheter shaft during deployment. To maintain coupling of the medical device to the catheter, the delivery system may include a release line coupled to the medical device and the catheter.

As compared to delivery systems without a structural aspect to releasably couple a medical device to a catheter shaft, the release line, in certain instances, can increase an overall delivery profile of the system due in part to a catheter lumen for the release line. To facilitate delivery of the medical device with a release line (or other similar device-to-catheter coupling), the systems discussed herein include a flexible loop or lumen through which the release line is arranged. As discussed in further detail below, the flexible loop or lumen facilitate delivery of the medical devices discussed herein.

<FIG> illustrates a side view of an example delivery system <NUM> having a medical device <NUM> in accordance with an embodiment. The medical device <NUM> may be any endoluminal device suitable for delivery to the treatment area of a vasculature, or other luminal and non-luminal systems of the body (biliary tract, GI tract, respiratory system, or other as desired). As shown in <FIG>, the delivery system <NUM> may also include a handle <NUM> at a proximal end of the system (the opposite end of the system at which the medical device <NUM> is arranged). The handle <NUM> of the delivery system <NUM> may be accessible to a user to assist in delivering the medical device <NUM>. As explained in further detail below, the delivery system <NUM> may include one or more lines or wires that facilitate delivery, orientation, or placement of the medical device <NUM>.

In various embodiments, the medical device <NUM> can include a radially collapsed configuration suitable for delivery to the treatment area of the vasculature of a patient. The medical device <NUM> can be constrained toward a radially collapsed configuration and releasably mounted onto a delivery device such as catheter shaft <NUM>. The diameter of the medical device <NUM> in the collapsed configuration is small enough for the medical device <NUM> to be delivered through the vasculature to a target treatment location or area. In various embodiments, the diameter of the collapsed configuration is small enough to minimize the crossing profile of the delivery system <NUM> and reduce or prevent tissue damage to the patient. In the collapsed configuration, the medical device <NUM> can be guided by a catheter shaft <NUM> through the vasculature.

The medical device <NUM> can comprise a radially expanded configuration suitable for implanting the medical device <NUM> in the treatment area of a patient's vasculature. In the expanded configuration, the diameter of the medical device <NUM> can be approximately the same as the vessel or other body lumen in which the medical device <NUM> is to be placed. In other embodiments, the diameter of the medical device <NUM> in the expanded configuration can be slightly larger than the vessel to be treated to provide a friction or interference fit within the vessel.

In various embodiments, medical device <NUM> can comprise a self-expandable device, such as a self-expandable stent graft. Such devices dilate from a radially collapsed configuration to a radially expanded configuration when unrestrained. In other embodiments, medical device <NUM> can comprise a device that is expanded with the assistance of a secondary device applying an expansion force on the medical device <NUM>, such as, for example, a balloon. In yet other embodiments, delivery system <NUM> can comprise a plurality of medical devices <NUM>. The use of the delivery system <NUM> with any number of medical devices <NUM> is within the scope of the present disclosure. The medical devices <NUM> discussed herein may include, for example, stents, grafts, stent grafts, heart valves, and other similar devices. Thus, medical device <NUM> can include one or more stent components with one or more graft members disposed over and/or under the stent, which can dilate from a delivery diameter, through a range of larger intermediary diameters, and toward a maximal, pre-determined functional diameter. In certain instances, the medical device <NUM> includes one or more stent components made of nitinol and a graft member made of ePTFE. However, and as discussed below, any suitable combination of stent component(s) and graft member(s) is within the scope of the present disclosure.

In certain instances, the delivery system <NUM> may include a sleeve or multiple sleeves (and other constrain mechanisms) to constrain the medical device <NUM> in a collapsed configuration for endoluminal delivery of the medical device <NUM> to a treatment portion of the vasculature or other body lumen of a patient. For the purposes of the disclosure, the term "constrain" may mean (i) to limit the expansion, either through self-expansion or assisted by a device, of the diameter of a medical device <NUM> or (ii) to cover or surround but not otherwise restrain a medical device <NUM> (e.g., for storage or biocompatibility reasons and/or to provide protection to the medical device <NUM> and/or the vasculature). The delivery system <NUM>, for example, comprises a sleeve <NUM> (or pull-back sheath or other similar constraining structure) which surrounds and constrains medical device <NUM> toward a reduced diameter or collapsed configuration as shown in further detail with reference to <FIG>.

<FIG> illustrates a perspective view of an example delivery system <NUM> having a medical device <NUM> in accordance with an embodiment. In various embodiments, the medical device <NUM> is constrained by a single sleeve <NUM> which circumferentially surrounds the medical device <NUM>. In various embodiments, the sleeve <NUM> circumferentially surrounds the medical device <NUM> and constrains it toward a collapsed configuration, in which the diameter is less than the diameter of the medical device <NUM> in an unconstrained or otherwise deployed state or configuration. For example, the sleeve <NUM> may constrain the medical device <NUM> toward a collapsed configuration for delivery within the vasculature.

In other embodiments, the medical device <NUM> is constrained by a plurality of sleeves (e.g., similar to the sleeve <NUM>) which circumferentially surround the medical device <NUM>, which allow the medical device <NUM> to be deployed and held at intermediate configurations larger than the collapsed configuration and smaller than the deployed configuration. The plurality of sleeves can comprise at least two sleeves (e.g., each similar to sleeve <NUM>) which circumferentially surround each other.

The sheet of material(s) used to form the sleeve(s) can comprise a series of openings, such that the openings extend from one edge of the sheet to the other. In such configurations, a coupling member <NUM> can be woven or stitched through the series of openings in the sheet of material(s), securing each of the two edges together and forming a tube. For example, in <FIG>, the coupling member <NUM> secures the edges of sleeve <NUM> such that sleeve <NUM> maintains medical device <NUM> toward a reduced diameter or outer peripheral dimension suitable for endoluminal delivery.

In various embodiments, disengaging a single coupling member which closes a single sleeve from the sleeve allows the expandable device to be expanded toward a larger diameter or outer peripheral dimension. For example, with reference to <FIG>, the delivery system can be used to deliver the medical device <NUM> to a treatment area of a vasculature. The medical device <NUM> has a collapsed diameter for delivery, and sleeve <NUM> circumferentially surrounds the medical device <NUM> and is held closed by the coupling member <NUM>. As described in more detail below, bending of the medical device <NUM> can be controlled prior to full expansion (e.g., at an intermediate diameter) to help facilitate delivery to the desired position. Once medical device <NUM> is in position relative to the treatment area, the coupling member <NUM> is disengaged from the sleeve <NUM> and the sleeve <NUM> is released, allowing medical device <NUM> to expand toward a larger diameter.

In such embodiments, the medical device <NUM> can be expanded from the collapsed configuration toward the intermediate configuration once the implant has been delivered near the treatment area of the vasculature of a patient. The intermediate configuration may, among other things, assist in properly orienting and locating the medical device <NUM> within the treatment area of the vasculature. In various embodiments, a medical device <NUM> can be concentrically surrounded by two sleeves having different diameters. In such configurations, a primary sleeve constrains the medical device <NUM> toward the collapsed configuration. Once the collapsed configuration sleeve is opened, a secondary sleeve constrains the medical device <NUM> toward the intermediate configuration similarly configured and arranged as the sleeve <NUM> (e.g., the secondary sleeve may also be held together released by a coupling member).

As noted above, the medical device <NUM> may be oriented at the treatment area of the vasculature. To orient the medical device <NUM>, the delivery system <NUM> includes a steering line <NUM>. Tension can be applied to the steering line <NUM> to displace the steering line <NUM> and bend the medical device <NUM>. Bending the medical device <NUM> may, among other things, assist in travelling through curved or tortuous regions of vasculature. Bending the medical device <NUM> may also allow the medical device <NUM> to conform to curvatures in the vasculature, or other body lumens of a patient.

In certain instances, the delivery system <NUM> may include a handle <NUM> (as shown in <FIG>) to which the coupling member <NUM> and the steering line <NUM> (or lines) are connected. The handle <NUM> may allow the user to manipulate the coupling member <NUM> and the steering line <NUM> outside of the patient.

<FIG> illustrates a perspective view of an example release line <NUM> and a medical device <NUM> in accordance with an embodiment. A delivery system <NUM> may include a release line <NUM> to the medical device <NUM> to the delivery system <NUM>. In addition, the release line <NUM> may also be used to secure a steering line <NUM> or multiple steering lines (e.g., each similar to another as desired) to the delivery system <NUM>.

The release line <NUM> may be arranged external to the medical device <NUM> (as shown), may be internal to the medical device <NUM>, or may be routed through the medical device <NUM> such that portions of the release line <NUM> are external to the medical device <NUM> and other portions of the release line <NUM> are internal to the medical device <NUM>. Another end of the release line <NUM>, similar to the coupling member <NUM> and steering line <NUM> discussed above, may be coupled to a handle <NUM> (not shown) of the delivery system <NUM>. At the handle <NUM>, tension may be applied to the release line <NUM> by a user to remove the release line <NUM> from the patient and uncouple the medical device <NUM> from the delivery system <NUM>.

In various embodiments, the release line <NUM> can be formed from metallic, polymeric or natural materials and can comprise conventional medical grade materials such as nylon, polyacrylamide, polycarbonate, polyethylene, polyformaldehyde, polymethylmethacrylate, polypropylene, polytetrafluoroethylene, polytrifluorochlorethylene, polyvinylchloride, polyurethane, elastomeric organosilicon polymers; metals such as stainless steels, cobalt-chromium alloys and nitinol. Elongated members or lock wires can also be formed from high strength polymer fibers such as ultra high molecular weight polyethylene fibers (e.g., Spectra®, Dyneema Purity®, etc.) or aramid fibers (e.g., Technora®, etc.).

<FIG> illustrates a side view of an example release line <NUM> and a catheter shaft <NUM> in accordance with an embodiment. As shown in <FIG>, a delivery system <NUM> incudes a catheter shaft <NUM>, medical device <NUM>, steering lines <NUM>, and a release line <NUM>. The release line <NUM> passes from outside of the body of the patient, from a handle <NUM> (not shown), through the catheter shaft <NUM>, and exits distal to or near a distal end of the medical device <NUM>. At this point, the release line <NUM> may extend along an exterior surface of the medical device <NUM>.

In certain instances and as shown in <FIG>, the release line <NUM> interacts with steering lines <NUM> continues to catheter tip <NUM>. In such a configuration, the release line <NUM> releasably couples steering lines <NUM> to the delivery system <NUM>. The release line <NUM> may be embedded, affixed, or attached to the catheter tip <NUM>, and may be released from the catheter tip <NUM> in response to tension applied to the release line <NUM> by a user. Any manner in which the release line <NUM> may interact with steering line or lines <NUM> to maintain a releasable coupling between steering line or lines <NUM> and the delivery system <NUM> is within the scope of the present disclosure. Although two steering lines <NUM> are shown, it should be understood any number of steering lines <NUM> is contemplated, including fewer or greater than the two shown in <FIG>.

<FIG> illustrates a close-up view of a flexible loop <NUM>, a medical device <NUM>, and a catheter shaft <NUM> (that the medical device <NUM> is crushed or constrained onto) in accordance with an embodiment. As shown in <FIG>, the medical device <NUM> includes an opening <NUM>. The opening <NUM> through the medical device <NUM> may be configured to allow the flexible loop <NUM> to extend from an interior of the medical device <NUM> (through which the catheter shaft <NUM> is arranged) to an exterior of the medical device <NUM> as shown in <FIG>. In certain instances, the opening <NUM> through the medical device <NUM> may be configured to allow the flexible loop <NUM> to extend from an exterior of the medical device <NUM> to an interior of the medical device <NUM>.

The medical device <NUM> may be collapsed to a delivery configuration for delivery and expanded at the target location. In certain instances, the medical device <NUM> may be partially expanded (e.g., for steering or orienting) or remain otherwise coupled to the catheter shaft during deployment. To maintain coupling of the medical device <NUM> to the catheter shaft <NUM>, the delivery system includes a release line <NUM> (as shown in <FIG> and <FIG>) coupled to the medical device <NUM> and the catheter shaft <NUM>.

As compared to delivery systems without a structural aspect (e.g., a release wire, lock wire, or other similar structure) to releasably couple the medical device <NUM> to the catheter shaft <NUM>, the release line <NUM>, in certain instances, can increase an overall delivery profile of the system <NUM> due in part to the requirement for a catheter lumen to maintain the release line. To facilitate delivery of the medical device <NUM> with a release line (or other similar device-to-catheter coupling), a flexible loop <NUM> serves as a pathway for the release line <NUM>. In certain instances, the delivery systems discussed herein may include multiple flexible loops <NUM>. In certain instances, the flexible loop <NUM> (or flexible loops <NUM>) may form a flexible lumen through which the release line <NUM> is arranged.

In certain instances, the flexible loop <NUM> (flexible loops <NUM>) may be attached to the catheter shaft <NUM> (as shown in <FIG>). The flexible loop <NUM> (flexible loops <NUM> or lumen) may be configured to collapse in response to reduction in diameter of the medical device <NUM>. In this manner, the flexible loop <NUM> (flexible loops <NUM> or lumen) may facilitate delivery by forming a pathway or lumen for a release wire. Thus, the flexible loop <NUM> (flexible loops <NUM> or lumen) lessen a size or diameter of a catheter usable for the delivery systems discussed herein by forming a pathway for a release wire where a lumen of a catheter would previously been used. As shown in further detail in <FIG>, the flexible loop <NUM> (flexible loops <NUM> or lumen) may hold the release line <NUM> or similar feature in place exterior to the medical device <NUM> by being passed through the flexible loop <NUM>.

<FIG> illustrates a close-up view of an example flexible loop <NUM> and a catheter shaft <NUM> in accordance with an embodiment. As shown in <FIG>, the flexible loop <NUM> is coupled to the catheter shaft <NUM>. The flexible loop <NUM> may be attached to the catheter shaft <NUM> along a portion of the catheter shaft <NUM> that extends through a lumen of a medical device, such as the medical device <NUM>.

In certain instances, the flexible loop <NUM> includes a fiber <NUM> coupled to the catheter shaft <NUM>. The fiber <NUM> may be wrapped, glued, bonded, sewn, tacked, interlocked or otherwise coupled to the catheter shaft <NUM> to form the flexible loop <NUM>. The medical device <NUM> (as discussed above but not shown) discussed herein may be a stent and graft combination, or any configuration described in association with the medical device <NUM>. The flexible loop <NUM> may be formed of the same or a similar material as the graft material of the medical device. In addition, the opening through which the flexible loop <NUM> is arranged may be arranged through the graft portion of the medical device <NUM>.

To manufacture a delivery system that includes the flexible loop <NUM> or more than one flexible loop <NUM>, the flexible loop <NUM> is coupled to the catheter shaft <NUM> (e.g., wrapping, gluing, bonding, sewing, tacking, interlocking, or otherwise coupling the fiber <NUM> to the catheter shaft <NUM> to form the flexible loop <NUM>). After the flexible loop <NUM> is formed, the flexible loop <NUM> is arranged through an opening (e.g., as shown in <FIG>) in the medical device <NUM>. Subsequently, a release line may be arranged through the flexible loop <NUM> to releasably couple the medical device to the catheter shaft <NUM> (e.g., as shown in <FIG>). After the release line is arranged through the flexible loop <NUM>, the medical device may be collapsed against the catheter shaft <NUM> to a delivery configuration, which can also include collapsing of the flexile loop <NUM> toward the catheter shaft <NUM> in response to the medical device being collapsed to the delivery configuration.

<FIG> illustrates a side view of an example release line <NUM>, flexible loop <NUM>, and a catheter shaft <NUM> in accordance with an embodiment. The release line <NUM>, flexible loop <NUM>, and catheter shaft <NUM> form portions of a delivery system <NUM>. The medical device <NUM> has an interior and an exterior. As shown in <FIG>, a portion of the catheter shaft <NUM> is arranged through the interior of the medical device <NUM>, and the release line <NUM> is arranged across the exterior of the medical device <NUM>.

As shown in <FIG>, the delivery system <NUM> includes two flexible loops <NUM>. According to the invention, the two flexible loops <NUM> are aligned relative to a longitudinal axis of the medical device <NUM>, which may be aligned with the catheter shaft <NUM>. Further, the medical device <NUM> is configured to collapse to a delivery configuration from an expanded/delivery configuration shown in <FIG>. In these instances, the flexible loop <NUM> or flexible loops <NUM> are configured to collapse toward the catheter shaft <NUM> in response to the medical device <NUM> being collapsed to the delivery configuration. The delivery system <NUM> may include one or more sheaths/sleeves (e.g., as shown in <FIG>) configured to releasably hold the medical device <NUM> in the delivery configuration.

In certain instances, the flexible loop <NUM> (or loops <NUM>) is configured to maintain at least a portion of the release line <NUM> in contact with an exterior surface of the medical device <NUM>. Thus, the flexible loop <NUM> is configured to form a lumen for the release line <NUM> according to the invention. The flexible loop <NUM> (or flexible loops <NUM> as shown in <FIG>) are attached to the catheter shaft <NUM> and extend through an opening <NUM> (or opening <NUM> for each respective flexible loop <NUM>) through the medical device <NUM>. The flexible loop <NUM> (or lumen) is configured to collapse in response to reduction in diameter of the medical device <NUM>. In certain instances, the lumen is formed by a first loop <NUM> arranged at one of the medical device <NUM> and a second loop <NUM> arranged at another end of the medical device <NUM>, with the release line <NUM> being arranged through the flexible lumen (formed by the loops <NUM>). The release line <NUM> is configured to releasably couple the medical device <NUM> to the catheter shaft <NUM>.

In certain instances and as shown in <FIG>, the release line <NUM> may terminate at a catheter tip <NUM> (or olive) of the catheter shaft <NUM>. The release line <NUM> is configured to release from the catheter tip <NUM> (or olive) in response to tension and withdraw through the flexible loop(s) <NUM>. As noted above, the medical device <NUM> may be collapsed to a delivery configuration for delivery and expanded at the target location. In certain instances, the medical device <NUM> may be partially expanded (e.g., for steering or orienting) or remain otherwise coupled to the catheter shaft during deployment. To maintain coupling of the medical device <NUM> to the catheter shaft <NUM>, the release line <NUM> is coupled to the medical device <NUM> by being arranged through the flexible loop(s) <NUM> (or lumen) and to the catheter shaft <NUM>. Thus, the medical device <NUM> may be partially expanded and maintained in contact with the delivery system <NUM> and the catheter shaft <NUM> by way of the release line <NUM>. The release line <NUM> and the loop(s) <NUM> are configured to maintain the medical device <NUM> coupled to the catheter shaft <NUM> during orientation of the medical device <NUM>.

The flexible loop(s) <NUM>, in certain instances, facilitate a minimal delivery profile of the system <NUM> due in part to removing the need for a lumen for the catheter lumen for the release line <NUM> (which can add to overall delivery size). In certain instances, the flexible loop <NUM> (or flexible loops <NUM>) may form a flexible lumen through which the release line <NUM> is arranged, and which may collapse along with the medical device <NUM>.

After orienting and deployment of the medical device <NUM>, the release line <NUM> is configured to withdrawn through the flexible loop(s) <NUM> in response to tension. The flexible loop(s) <NUM> are fixedly coupled to the catheter shaft <NUM>. The catheter shaft <NUM> may be removed from the vasculature after deployment of the medical device <NUM> and leave the medical device <NUM> at the target treatment location. The catheter shaft <NUM> may be withdrawn to remove the system <NUM> from the vasculature. By withdrawing the catheter shaft <NUM>, the flexible loop(s) <NUM> are also removed due to the flexible loop(s) <NUM> being fixedly attached to the catheter shaft <NUM>. The flexible loop(s) facilitate use of the release line <NUM> without increasing the size of the delivery system <NUM>, which may facilitate use of the system <NUM> through reach into smaller vasculature as compared to prior systems.

Potential materials for graft members of the medical devices discussed herein include, for example, expanded polytetrafluoroethylene (ePTFE), polyester, polyurethane, fluoropolymers, such as perflouorelastomers and the like, polytetrafluoroethylene, silicones, urethanes, ultra-high molecular weight polyethylene, aramid fibers, and combinations thereof. Other embodiments for a graft member material can include high strength polymer fibers such as ultra-high molecular weight polyethylene fibers (e.g., Spectra®, Dyneema Purity®, etc.) or aramid fibers (e.g., Technora®, etc.). The graft member may include a bioactive agent. In one embodiment, an ePTFE graft includes a carbon component along a blood contacting surface thereof. Any graft member which can be delivered by a catheter is in accordance with the present disclosure.

In addition, stent components of the medical devices discussed herein can have various configurations such as, for example, rings, cut tubes, wound wires (or ribbons) or flat patterned sheets rolled into a tubular form. Stent components can be formed from metallic, polymeric or natural materials and can comprise conventional medical grade materials such as nylon, polyacrylamide, polycarbonate, polyethylene, polyformaldehyde, polymethylmethacrylate, polypropylene, polytetrafluoroethylene, polytrifluorochlorethylene, polyvinylchloride, polyurethane, elastomeric organosilicon polymers; metals such as stainless steels, cobalt-chromium alloys and nitinol and biologically derived materials such as bovine arteries/veins, pericardium and collagen. Stent components can also comprise bioresorbable materials such as poly(amino acids), poly(anhydrides), poly(caprolactones), poly(lactic/glycolic acid) polymers, poly(hydroxybutyrates) and poly(orthoesters). Any expandable stent component configuration which can be delivered by a catheter is in accordance with the present disclosure.

Claim 1:
A medical device delivery system (<NUM>), the system (<NUM>) comprising:
a catheter shaft (<NUM>);
at least one loop (<NUM>) attached to the catheter shaft (<NUM>);
a medical device (<NUM>) having an interior and an exterior;
at least one opening (<NUM>) through the medical device (<NUM>) configured to allow the loop (<NUM>) to extend from the interior to the exterior of the medical device (<NUM>); and
a release line (<NUM>) exterior to the medical device (<NUM>) held in place by passing through the loop (<NUM>),
wherein the at least one loop (<NUM>) is flexible and includes at least two flexible loops (<NUM>) aligned relative to a longitudinal axis of the medical device (<NUM>); and
wherein the at least one flexible loop (<NUM>) is configured to form a lumen for the release line (<NUM>).