Medical device delivery systems and methods

Medical device delivery systems and methods are disclosed. In various examples, the medical device delivery system (1000) includes an elongate element (1100) including an olive (1200). The olive (1200) includes an opening that exposes a lockwire (1300) extending through a lumen of the olive (1200) such that a linking element (1500) can be coupled to the portion of the lockwire (1300) exposed by the opening, wherein the linking element (1500) provides a coupling to a medical device (1400).

BACKGROUND

Endovascular procedures address a broad array of medical needs, including endovascular access, diagnosis, and/or repair through minimally invasive or relatively less invasive means than surgical approaches. Generally, these procedures require the delivery of one or more medical device to a target site or region within a patient's vasculature. One common procedure is the delivery of an expandable endoluminal device within the vasculature for the treatment of an aneurysm. Expandable endoluminal devices can be designed to expand when a restraint is removed or to be balloon-expanded from their delivery diameter, through a range of intermediary diameters, up to a maximal, pre-determined functional diameter.

Generally, the endoluminal device is constrained in a suitable introductory size (or delivery diameter) and mounted onto a delivery device such as a catheter shaft to allow insertion into the vasculature. The endoluminal devices can be difficult to navigate through vasculature. In addition, navigation through tortuous and narrow body lumens may cause the endoluminal device to migrate or otherwise translate along the delivery device upon which it is mounted.

Some conventional endovascular delivery systems utilize atraumatic tips at the distal end of the delivery device to help facilitate navigation through the vasculature. Generally, such atraumatic tips are designed to help the device navigate the vasculature without causing damage or trauma to the vasculature.

SUMMARY

According to one example, (“Example 1”), a medical device delivery system includes an elongate element, and an olive coupled to the elongate element, the olive including a body having a proximal end, a distal end, the olive including a lockwire lumen and the body having an opening formed therein, the opening being formed in the body between the proximal and distal ends such that a portion of the lockwire lumen is exposed. The medical device delivery system of Example 1, further includes a lockwire removably coupled to the olive, the lockwire extending through the lockwire lumen such that a portion of the lockwire is exposed by the opening formed in the body of the olive, and a linking element removably coupled to the portion of the lockwire extending through the lockwire lumen and exposed by the opening formed in the body of the olive.

According to another example, (“Example 2”) further to Example 1, the linking element has a first end and a second end, the first end of the linking element being removably coupled to the portion of the lockwire extending through the lockwire lumen and exposed by the opening formed in the body of the olive such that the first end of the linking element is constrained against longitudinal translation along the lockwire beyond the proximal and distal ends of the olive.

According to another example, (“Example 3”) further to Example 2, the linking element operates to maintain a position of a medical device along the elongate element during a delivery and deployment of the medical device to a target region within a patient's vasculature.

According to another example, (“Example 4”) further to Example 3, the second end of the linking element is coupled to the medical device.

According to another example, (“Example 5”) further to Example 3, the second end of the linking element is coupled to the olive such that an intermediate portion of the linking element is routed through an aperture in the medical device.

According to another example, (“Example 6”) further to Example 3, the linking element includes an intermediate portion situated between the first and second ends of the linking element, the intermediate portion being coupled to the medical device and being operable to reduce a cross section of the medical device when tension is applied to the second end of the linking element.

According to another example, (“Example 7”) further to Example 6, the intermediate portion of the linking element is routed about a periphery of the medical device.

According to another example, (“Example 8”) further to Examples 3 to 7, the linking element is removable from the medical device.

According to another example, (“Example 9”) further to any of the preceding examples, the medical device delivery system further includes a first alignment mechanism coupled to the elongate element, the linking element being routed through the first alignment mechanism.

According to another example, (“Example 10”) further to Example 9, the first alignment mechanism is positioned along the elongate element such that a portion of the linking element proximal the intermediate portion is routed through the first alignment mechanism.

According to another example, (“Example 11”) further to Examples 9 to 10, the medical device delivery system further includes a second alignment mechanism coupled to the elongate element, the second alignment mechanism being positioned along the elongate element such that a portion of the linking element distal the intermediate portion is routed through the second alignment mechanism.

According to another example, (“Example 12”) further to Example 11, the first and second alignment mechanisms are positioned along the elongate element such that, as tension is applied to the linking element, a first longitudinally directed force exerted on medical device by the portion of the linking element extending between the first alignment mechanism and the medical device is counteracted by a second longitudinally directed force exerted on medical device by the portion of the linking element extending between the second alignment mechanism and the medical device.

According to another example, (“Example 13”) further to Examples 3 to 12, a tension can be applied to the linking element to reduce a cross section of the medical device without causing translation of the medical device.

According to another example, (“Example 14”) further to Examples 9 to 13, the first alignment mechanism is positioned along the elongate element such that a portion of the linking element distal the intermediate portion is routed through the first alignment mechanism.

According to another example, (“Example 15”) further to any of the preceding examples, the linking element is a steering element and is operable to deflect the olive when tension is applied to the second end of the linking element.

According to another example, (“Example 16”) further to any of the preceding examples, the opening formed in the body between the proximal and distal ends bisects the lockwire lumen such that the lockwire lumen includes a proximal portion and a distal portion.

According to another example, (“Example 17”) further to Example 16, the proximal and distal portions of the lockwire lumen are separated by a gap, and wherein the lockwire extends across the gap such that the lockwire is received within the proximal and distal portions of the lockwire lumen.

According to another example, (“Example 18”) further to any of the preceding examples, the olive further comprises a guidewire lumen, the lockwire lumen being laterally offset from the guidewire lumen.

According to another example, (“Example 19”) further to any of the preceding examples, the linking element is compressible.

According to another example, (“Example 20”), a method of releasably coupling a constraining element to an olive includes, providing an olive coupled to a distal end of an elongate element, the olive including a body having a proximal end and a distal end, the olive including a lumen and the body of the olive having an opening formed therein, the opening being formed in the body of the olive between the proximal and distal ends such that a portion of the lumen is exposed and such that the opening bisects the lumen such that lumen comprises a proximal portion and a distal portion. The method further includes routing a linking element to the olive such that a portion of the linking element is positioned within the lumen of the olive, positioning a distal end of the linking element in the opening formed in the olive such that the distal end of the linking element is situated between the proximal and distal portions of the lumen, inserting a lockwire into the proximal portion of the lumen, and advancing the lockwire through the proximal portion of the lumen and into the distal portion of the lumen such that the lockwire engages the linking element and constrains a distal end of the linking element from longitudinal translation along the lockwire beyond the proximal and distal ends of the olive.

According to another example, (“Example 21”), further to Example 20, the method further includes withdrawing the lockwire from the distal portion of the lumen such that a distal end of the lockwire is positioned within the proximal portion of the lumen operates to decouple the linking element from the lockwire.

While multiple embodiments are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

DETAILED DESCRIPTION

Persons skilled in the art will readily appreciate that the various embodiments of the inventive concepts provided in the present disclosure can be realized by any number of methods and apparatuses 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. In describing various examples, the term distal is used to denote a position along an exemplary device proximate to or alternatively nearest to the treatment region within a patient's body. The term proximal is used to denote a position along the exemplary device proximate to or alternatively nearest to the user or operator of the device.

Various aspects of the present disclosure are directed toward medical device delivery devices, systems, and methods that include an atraumatic tip or olive configured for a variety of purposes or functions. A medical device delivery system according to some embodiments is illustrated inFIG. 1. The medical device delivery system1000includes an elongate element1100and an atraumatic tip or olive1200coupled to the elongate element1100.

In some examples, the medical device delivery system1000further includes one or more lockwires1300that may be removably coupled to or otherwise received by the olive1200. As discussed in greater detail below, in some examples, the lockwire operates with the olive such that one or more medical devices1400are removably coupleable to the olive1200. In some such examples, one or more constraining elements (or linking elements), such as constraining fiber1500extend from the one or more medical devices1400to the one or more lockwires1300. As discussed in greater detail below, such configurations provide for the maintaining of a position of the one or more medical devices1400along the elongate element1100during delivery to or deployment at a target site or region within the vasculature. It should be appreciated that while the examples below refer to the constraining element as a constraining fiber1500, such reference should not be interpreted as limiting. For instance, it should be appreciated that the constraining element may be a structure that is suitable for being placed in tension, compression, or tension and compression. Likewise, those of skill in the art should appreciate that reference to the term constraining element should not be construed as being limited, but should rather be understood to include any linkage capable of structurally linking the lockwire to one or more other element of the system.

In some examples, the one or more lockwires1300may be additionally or alternatively removably coupleable to one or more steering lines to facilitate steering of the medical device delivery system1000. In some examples, the medical device delivery system1000is operable to be delivered to a target site by being advanced over a guidewire1600.

In various embodiments, the elongate element1100corresponds to a catheter shaft. In some examples, the elongate element1100is a flexible, elongated element having proximal and distal ends and is capable of being advanced through one or more vessels to a target site or region within the vasculature. The elongate element1100may be any device suitable for passage through the vasculature to a treatment region or target site. In some examples, the elongate element1100operates as a vehicle by which a medical device such as an endoluminal graft may be advanced to the treatment region. In some examples, the elongate element1100has a lumen extending through at least a portion of its length. In some examples, the lumen operates as a conduit such that the medical device delivery system1000can be delivered over a guide wire1600. In some examples, the lumen additionally or alternatively operates as a working lumen that provides a passageway through which one or more medical devices (e.g., medical devices, tools, lights, and/or any other suitable therapeutic devices) may be delivered to the treatment region.

The elongate element1100, or any portion thereof, can be comprised of any number of materials including silicone, latex, polyurethanes, polyvinyl chlorides, polyethylenes, polysiloxanes, polycarbonates, nylons, PTFE, ePTFE or other fluoropolymer, polyamides, stainless steel, nitinol, or any other biocompatible material, including combinations of the foregoing. Additionally, the elongate element1100, or any portion thereof, can be hydrophilic or hydrophobic. In various examples, the elongate element1100can have any cross-sectional shape including, for example, a circular shape, an oval shape, a triangular shape, a square shape, a polygon shape, a uniform shape, or a non-uniform shape.

In various embodiments, the medical device delivery system1000includes an olive1200coupled to the elongate element1100. In some examples, the olive is coupled at or proximate to a distal end1102of the elongate element1100. The olive1200includes a generally tapered or frustoconically-shaped distal portion, although in some examples the distal portion does not taper. In some examples, the olive1200includes a generally tapered or frustoconically-shaped proximal portion, although in some examples the proximal portion does not taper.

Turning now toFIGS. 1A-1C, an exemplary olive1200is illustrated. Olive1200includes a cylindrically shaped body1202having a proximal end1204, a distal end1206, and an intermediate portion1208situated between the proximal and distal ends1204and1206. In some examples, the body1202includes one or more tapered sections, such as proximal taper section1210and distal taper section1212. As shown, the distal taper section1212decreases in outer peripheral dimension longitudinally toward the distal end1206of the olive1200while the proximal taper section1210decreases in outer peripheral dimension longitudinally toward the proximal end1204of the olive1200. Those of skill will appreciate that the distal tapered section1212helps guide the atraumatic tip1200as it is being advanced through the vasculature and helps avoid surrounding tissue from being damaged in the event the atraumatic tip1200contacts the tissue as the medical device delivery system1000is advanced through the vasculature. The proximal tapered section1210helps navigation of the medical device delivery system1000as it is withdrawn through the medical device.

In some examples, the olive1200includes an inner lumen1214extending through at least a portion of its length. In some examples, the inner lumen1214extends from the proximal end1204to the distal end1206of the olive1200such that the lumen1214is exposed and accessible at both the proximal and distal ends1204and1206. In some examples, the lumen1214is sized such that a guide wire, such as guide wire1600(FIG. 1A), can be passed therethrough and the medical device delivery system1000can be delivered to a treatment region over the guide wire. In some examples, the lumen1214additionally or alternatively operates as a working lumen and provides a passageway through which one or more medical devices or therapeutics may be delivered to the treatment region.

In some examples, a longitudinal axis of the inner lumen1214is parallel to (or substantially parallel to) a longitudinal axis of the olive1200(i.e., coaxial). In some examples, the longitudinal axis of the inner lumen1214is parallel to (or substantially parallel to) but laterally offset from a longitudinal axis of the olive1200. In some examples, the olive1200is coupled to the elongate element1100such that the lumen1214of the olive1200is coaxial with the lumen of the elongate element1100.

In some embodiments, the olive1200includes one or more lockwire lumens extending through at least a portion of its length. For example, as shown inFIGS. 1A-2E, the olive1200includes a lockwire lumen1216extending through at least a portion of its length. As shown, the lockwire lumen1216is formed in the proximal taper section1210, projecting distally. However, in various examples, the lockwire lumen1216may be formed in the proximal end1204. Likewise, in some examples, the lockwire lumen may be formed in a distal taper portion1212or the distal end1206and may project proximally. In some examples, the lockwire lumen1216may extend entirely through the olive1200. In other examples, the lockwire lumen extends through only a portion of the length of the olive1200.

In some examples, a longitudinal axis of the lockwire lumen1216is parallel to (or substantially parallel to) but laterally offset from a longitudinal axis of the inner lumen1214of the olive1200. In some examples, a longitudinal axis of the lockwire lumen1216is nonparallel to (or not substantially parallel to) a longitudinal axis of the inner lumen1214. That is, in some examples, a longitudinal axis of the lockwire lumen1216is angled relative to the longitudinal axis of the inner lumen1214of the olive.

As discussed below, in some examples, the lockwire lumen1216may include a proximal portion1218and a distal portion1220that are separated by a gap as a result of a relief being formed in the olive1200.

The lockwire lumen1216is configured to receive the lockwire1300therein such that the lockwire may be selectively removed there-from. Such a configuration facilitates the removable coupling of the lockwire1300to the olive1200. That is, the lockwire1300may be selectively decoupled from the olive1200. In some examples, the lockwire lumen is formed in the olive1200such that its length exceeds a length of the portion of the lockwire received therein. Additionally, in some examples, a diameter of the lockwire lumen exceeds a diameter of the lockwire. For instance, in some examples, the lockwire lumen may be in the range of one (1) to three (3) thousandths of an inch larger than the lockwire. In some examples, however, the lockwire lumen may be less than one (1) thousandth of an inch larger than the lockwire, or alternatively larger than three (2) thousandths of an inch larger than the lockwire, depending on the application.

Generally, a diameter of the lockwire varies by application. For example, a lockwire utilized in association with a steering line may need to be larger in diameter than a lockwire utilized in association with a constraining fiber. However, a diameter of the lockwire need not be different for different applications. For example, as discussed below, a constraining fiber and a wire may simultaneously be coupled to a common lockwire. Exemplary diameters of lockwires are in the range of five (5) to fifteen (15) thousandths of an inch. For instance, in some examples a lockwire may be approximately nine (9) thousands of an inch in diameter. Those of skill should appreciate that the lockwire may be less than five (5) thousandths of an inch, or alternatively, larger than fifteen (15) thousandths of an inch in diameter, depending on the specific application, for example.

In some examples, the lockwire1300may be coupled to the olive1200by way of one or more threaded portions, friction or interference joints, welds, adhesives, or other suitable retention or coupling interfaces. In some such examples, the lockwire1300may be coupled to a first portion of the lockwire lumen1216while remaining uncoupled from a second portion of the lockwire lumen1216. In some examples, by having a lockwire lumen with a diameter that exceeds the diameter of the lockwire (i.e., oversized), a force required to insert and remove the lockwire from the lockwire lumen can be minimized.

In some examples, the diameter of the lockwire lumen may vary in diameter. For example, the distal portion of the lockwire lumen may be smaller in diameter than is the proximal portion of the lockwire lumen (or vice versa). In some such examples, the lockwire lumen may progressively decrease in diameter (e.g., continuous taper). In other such examples, the lockwire lumen may decrease in diameter in steps (e.g. a discontinuous taper wherein a first portion of a length of the lockwire lumen is first diameter while a second, different portion of the length of the lockwire lumen is a second, different diameter). Likewise, in some examples, the lockwire may additionally or alternatively decrease (or alternatively increase) in diameter (progressively or in steps) along its length. Those of skill should appreciate that such examples provide for a coupling between the lockwire and the lockwire lumen where only a portion of the lockwire inserted within the lockwire lumen contacts the lockwire lumen (e.g., a distal end, or a portion that contacts a proximal end of the proximal portion of the lockwire lumen). In some examples, the lockwire may be secured to one or more control mechanisms at its proximal end.

Moreover, while the lockwire lumen1216is illustrated as extending through only a portion of the olive1200, in some examples, one or more lockwire lumens may extend entirely though the olive1200. Likewise, in some examples, the olive may include a plurality of lockwire lumens and therefore may interface with or otherwise have a plurality of lockwires coupled therewith.

In some examples, one or more lockwire exposure features, such as lockwire exposure feature1222may be formed in the olive1200. In some examples, a lockwire exposure feature1222is formed as a relief, channel, trough, cavity, depression, or indentation in an outer surface of the olive1200. In some examples, the lockwire exposure feature1222is formed by skiving or otherwise removing material from the olive1200. While the lockwire exposure feature1222is illustrated as being formed in the intermediate portion1208, it should be appreciated that the lockwire exposure feature1222may be formed in any portion of the olive1200provided that a portion of the lockwire1300extending therethrough is exposable by the lockwire exposure feature1222. Generally, as discussed in greater detail below, the lockwire exposure feature1222facilitates a location for an attachment to the portion of the lockwire1300extending through the olive1200and exposed by the lockwire exposure feature1222.

Those of skill in the art should appreciate that while the examples illustrated and described herein include an olive with a skived portion (e.g., a lockwire exposure feature), in some examples, the system may include an olive with a plurality of independently formed skived portions (e.g., a plurality of independent lockwire exposure features). Thus, in some examples, the lockwire lumen may be sectioned into three or more portions. In such examples, the portions of the lockwire exposed by the multiple lockwire exposure features are each coupleable to one or more constraining elements (or linking elements) consistent with the other examples illustrated and described herein. Likewise, it should be appreciated that the system may include a plurality of olives, one or more of which may include one or more skived portions.

In various embodiments, the lockwire exposure feature1222is generally formed in the olive1200such that it bisects and otherwise exposes a portion of the lockwire lumen1216. This bisecting of the lockwire lumen1216operates to form the proximal and distal portions1218and1220of the lockwire lumen1216. It should be appreciated that the lockwire exposure feature1222bisection of the lockwire lumen1216need not divide the lockwire lumen1216into proximal and distal portions1218and1220having equal lengths, though equal lengths are desirable in some examples.

In addition, the lockwire exposure feature1222is formed in the olive1200such that the proximal and distal portions1218and1220of the lockwire lumen1216are separated by a gap. As explained in greater detail below, such a gap provides that one or more medical devices and/or one or more constraining fibers can be coupled to the portion of the lockwire exposed by the lockwire exposure feature1222that extends across the gap form the proximal to the distal (or vice versa) of the lockwire lumen.

As shown inFIG. 1C, the proximal and distal portions1218and1220of the lockwire lumen1216are separated by a gap1224. Those of skill in the art should appreciate that the relief forming the lockwire exposure feature1222may be of any shape or size provided that the relief exposes a portion of the lockwire lumen1216and does not sever or otherwise materially compromise the structural integrity of the olive1200. As shown inFIG. 1C, the relief forming the lockwire exposure feature1222is a triangular relief that converges to a point as the relief progresses radially inward from an exterior surface of the olive1200. As shown inFIGS. 1A and 1B, the triangular relief is circumferentially revolved around a portion of the olive1200to form the lockwire exposure feature1222. Those of skill in the art should appreciate that different applications may require different degrees to which the relief is revolved.

For instance, the relief forming the lockwire exposure feature1222ofFIGS. 1A-1Cis revolved approximately one-hundred-eighty (180) degrees about the olive1200. That is, as shown inFIGS. 1A-1C, the lockwire exposure feature1222extends around only a portion of the olive1200. In some examples, however, the lockwire exposure feature1222may extend around the olive1200entirely. That is, in some examples, the relief forming the lockwire exposure feature1222ofFIGS. 1A-1Bmay be revolved about the olive1200in excess of one-hundred-eighty (180) degrees, though the relief may also be revolved some amount between one-hundred-eighty (180) degrees and three-hundred-sixty (360) degrees. Likewise, in some other examples, a relief forming the lockwire exposure feature1222may be revolved less than one-hundred-eighty (180) degrees about the olive1200, provided that the degree to which the relief is revolved creates a void of sufficient size and depth to provide access to the lockwire extending within the lockwire lumen1216such that one or more medical devices may be coupled thereto.

In some other examples, the relief may alternatively be formed as a longitudinally extending groove or channel. That is, in some examples, as an alternative to (or in combination with) being revolved, the relief is projected longitudinally (see lockwire exposure feature2222illustrated inFIGS. 2A-2B, for example).

While the relief forming the lockwire exposure feature is illustrated in the accompanying figures as being generally triangular, it should be appreciated that virtually all shapes are contemplated and fall with the scope of the disclosure. Thus, while some relief shapes may include geometry that generally converges as it progresses radially inward, in some examples, the geometry of the relief may not converge or may alternatively diverge as it progresses radially inward.

Additional examples of relief shapes forming alternative lockwire exposure features are illustrated inFIGS. 2C-2E.FIG. 2Cillustrates a cross section of an exemplary olive having a lockwire exposure feature2222having a geometry that does not converge as it progresses radially inward. Such a configuration provides that the proximal and distal surfaces terminate in a base2232such that a gap2224is situated between the proximal and distal sections2218and2220of the lockwire lumen2216.FIG. 2Dillustrates a cross section of an exemplary olive having a lockwire exposure feature2222having a geometry that is curved or nonlinear as it progresses radially inward. Such a configuration provides that a gap2224is situated between the proximal and distal sections2218and2220of the lockwire lumen2216.FIG. 2Eillustrates a cross section of an exemplary olive having a lockwire exposure feature2222having a geometry that diverges as it progresses radially inward. Such a configuration provides that the proximal and distal surfaces terminate in a base2232such that a gap2224is situated between the proximal and distal sections2218and2220of the lockwire lumen2216. It should be appreciated that these configurations provide lockwire exposure features having gaps2224of significant width without severing or otherwise materially compromising the structural integrity of the olive2200.

Additionally, while not illustrated, in some examples, the lockwire exposure feature may be formed in the olive such that the guidewire lumen (and thus any guidewire extending therethrough) are exposed. In such configurations, the constraining element may be additionally or alternatively coupled to the portion of the guidewire extending through the guidewire lumen that is exposed by the lockwire exposure feature in a manner similar to the manner in which the constraining element is described as being coupled to the portion of the lockwire extending within the lockwire lumen and exposed by the lockwire exposure feature.

In some examples, the lockwire exposure feature is formed in the olive such that it includes a first or proximal surface and an opposing second or distal surface. In some examples, the proximal and distal surfaces converge and eventually intersect with one another, while in other examples the proximal and distal surfaces converge without intersecting with one another. Instead, the proximal and distal surfaces terminate into another surface prior to intersecting with one another. Likewise, in some examples, the proximal and distal surfaces diverge and terminate into another surface. In some examples, the proximal and distal surfaces terminate into a common surface. In some other examples, the proximal and distal surfaces terminate into different intermediate surfaces and those intermediate surfaces intersect with one another. In yet some other examples, the proximal and distal surfaces are one-and-the-same in that the relief is in the form of a semi-circle. In such examples, a transition between the proximal and distal surfaces is smooth or otherwise seamless. Thus, while some examples include the proximal and/or distal surfaces being linear, in other examples, the proximal and/or distal surfaces are nonlinear.

As discussed above, in various embodiments, the relief forming the lockwire exposure feature1222is formed in the olive1200such that a void of sufficient size and depth provides access to the lockwire lumen1216and the lockwire extending within the lockwire lumen1216. Thus, the lockwire exposure feature1222is generally formed to have a depth that extends more radially inward than (or at least as radially inward as) the lockwire lumen1216. Such a configuration provides that the lockwire lumen1216is exposed by the lockwire exposure feature1222. For example, as shown inFIG. 1C, the relief is formed in the olive1200such that the lockwire lumen1216is positioned more radially outward than is a base1232of the lockwire exposure feature1222. Such a configuration provides that a gap is situated between the base1232and any lockwire extending within the lockwire lumen1216. Accordingly, one or more constraining fibers can be lassoed around or otherwise coupled to the portion of the lockwire spanning the gap formed between the proximal and distal surfaces1228and1230, as discussed below.

While the examples discussed above include a relief revolved about a portion of the olive1200, in some examples, the lockwire exposure feature1222may be formed by simply boring into the olive1200an amount sufficient to expose the lockwire lumen1216and any lockwire extending within the lockwire lumen1216. While such a bore is traditionally circular and uniform, it should be appreciated that it need not be. Likewise, in some examples, the relief may be formed in the exterior surface1226along a longitudinal length of the olive1200(see e.g.,FIGS. 2A-2B).

Referring again toFIG. 1C, as shown, the lockwire exposure feature1222bisects the lockwire lumen1216such that the lockwire lumen1216includes a proximal section1218and a distal section1220. Generally, the proximal section1218of the lockwire lumen1216extends between the proximal surface1228and one of the proximal end1204and the proximal taper portion1210. The distal section1220of the lockwire lumen1216generally extends between the distal surface1230and one of the distal end1206and the distal taper portion1212. However, as mentioned above, the lockwire lumen may terminate at some point interior of the olive1200and thus not extend through the olive1200entirely.

In various examples, the lockwire1300is a longitudinally extending structure configured to engage the olive1200such that one or more medical devices can be coupled to the lockwire1300. In some examples, the lockwire1300can secure one or more steering lines to the olive1200. In other examples, the lockwire1300can additionally or alternatively secure one or more medical devices and/or one or more constraining fibers (or wires) to the olive1200.

In some examples, the lockwire1300extends from a treatment side inside a patient's vasculature to a proximal position outside of the body of the patient. In some examples, the lockwire1300extends adjacent the elongate element1100. In some examples, the lockwire1300extends through in interior lumen of the elongate element1100. For instance, in some examples, the lockwire1300extends through a lockwire lumen of the elongate element1100. That is, in some examples, the elongate element1100includes a lockwire lumen in addition to one or more other lumens, such as working lumens. In some examples, the lockwire extends through the one or more working lumens of the elongate element1100.

In some examples, as explained further below, the lockwire1300releasably couples one or more medical devices, constraining fibers (or wires), and/or steering lines to the olive1200. Any manner in which the lockwire1300can interact with such medical devices, constraining fibers (or wires), and/or steering lines to maintain a releasable coupling therebetween is within the scope of the present disclosure.

In various examples, the lockwire1300can 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. Further, the lockwire1300can 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.). Any material that can provide sufficient engagement with and secure the medical devices, constraining fibers, and/or steering lines to the olive1200is within the scope of the present disclosure.

In some examples, as mentioned above, the medical device delivery system1000operates to maintain a position of a medical device along the medical device delivery system1000during delivery and/or deployment of the medical device at a treatment region or site. It should be appreciated that minimizing or otherwise constraining the medical device against longitudinal movement along the medical device delivery system facilitates accurate and reliable deployment of the medical device at a treatment region or site.

Turning now toFIGS. 3A-3C, a medical device delivery system3000is illustrated as including an elongate element3100, an olive3200, and a lockwire3300. In some examples, the medical device delivery system3000further includes a control system (not illustrated). For example, a control system may be coupled to a proximal end of one or more of the elongate element3100and/or the lockwire3300. In some examples, the control system may operate to advance or retract the lockwire3300or deflect the olive1200as those of skill will appreciate.

As shown, a medical device3400and a deployment sheath3402are mounted on the medical device delivery system3000(FIGS. 3A and 3Bare illustrated with a portion of the deployment sheath3402removed such that a portion of the medical device3400is pictured). A constraining element, such as constraining fiber3500is illustrated as extending from a distal end of the medical device/sheath to the lockwire3300. As explained in greater detail below, the constraining fiber3500operates to couple the medical device3400and/or the deployment sheath3402to the medical device delivery system3000such that the medical device3400and/or the deployment sheath3402are constrained against longitudinal movement along the medical device delivery system during delivery and/or deployment of the medical device3400at the target site or region.

The elongate element3100, the olive3200, and the lockwire3300are consistent with the various elongate elements, olives, and lockwires discussed herein. It should be appreciated that while the examples below refer to the constraining element as a constraining fiber3500, such reference should not be interpreted as limiting. For instance, it should be appreciated that the constraining element may be a structure that is suitable for being placed in tension, compression, or tension and compression.

In various examples, the medical device3400is any suitable structure configured to provide treatment to the vasculature. For instance, the medical device can be any suitable medical device including, for example, a stent, a stent graft, a filter, a valve, a bifurcated stent, an occluder, a drug-delivering device, such as a drug-eluting balloon and/or stent, an oncology therapy, a pressure flow monitor, an energy transmission device, a spacer, an optical device, a marker, a sheath, and/or any other similar endoluminally deliverable device.

The medical device may be comprised of a shape-memory material, such as nitinol, or may be comprised of other materials, self-expandable or otherwise expandable (e.g., with a conventional balloon catheter or spring mechanism), such as various metals (e.g., stainless steel), alloys and polymers.

The deployment sheath generally covers the medical device and restrains the medical device toward an outer peripheral dimension or delivery configuration suitable for endoluminal delivery as those of skill in the art should appreciate. In various examples, the deployment sheath is any suitable sheath or sleeve that wraps around and constrains the medical device toward a delivery configuration for endoluminal delivery. The deployment sheath is flexible so that it generally conforms to the shape of the medical device and is sufficiently strong to restrain the medical device toward a delivery configuration during deployment to the treatment site. In various examples, a deployment sheath can be axially displaced or removed to reveal the medical device and allow expansion of the medical device at the treatment site.

In various examples, the deployment sheath can be made from a flexible film and comprise a series of holes, openings, passages, or eyelets defined along generally opposite sides of (or an entire periphery of) the sheath. In various examples, the sheath can be wrapped around and cover the medical device, and a release line, stitch, or constraining fiber can be threaded through the holes to compress and/or restrain the medical device toward a delivery configuration. During deployment, the release line, stitch, or constraining fiber, un-threads, or is otherwise released from the holes to release the deployment sheath and allow the medical device to expand. In some examples, the deployment sheath may be proximally withdrawn from the medical device after deployment of the medical device.

In various examples, the deployment sheath can be made of any suitable material, including for example, a fluoropolymer such as ePTFE. Alternatively, or in combination with a fluoropolymer, the deployment sheath can be formed of biocompatible materials, such as polymers, which can include fillers such as metals, carbon fibers, Dacron, glass fibers or ceramics. Such polymers can include olefin polymers, polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene which is not expanded, fluorinated ethylene propylene copolymer, polyvinyl acetate, polystyrene, poly(ethylene terephthalate), naphthalene dicarboxylate derivatives, such as polyethylene naphthalate, polybutylene naphthalate, polytrimethylene naphthalate and trimethylenediol naphthalate, polyurethane, polyurea, silicone rubbers, polyamides, polycarbonates, polyaldehydes, natural rubbers, polyester copolymers, styrene-butadiene copolymers, polyethers, such as fully or partially halogenated polyethers, copolymers, and combinations thereof. Also, polyesters, including polyethylene terephthalate (PET) polyesters, polypropylenes, polyethylenes, polyurethanes, polyolefins, polyvinyls, polymethylacetates, polyamides, naphthalane dicarboxylene derivatives, and natural silk can be included in the deployment sheath.

As shown inFIG. 3A, the medical device3400is covered or constrained by a deployment sheath3402such that the medical device3400and the deployment sheath3402are mounted on the medical device delivery system3000. In some examples, the medical device3400and/or the deployment sheath3402comprise one or more mechanisms that may serve as attachment points or vehicles for coupling the medical device3400and or deployment sheath3402to the medical device delivery system3000. As mentioned above, these attachment points or vehicles may be holes or stitches incorporated into the deployment sheath. For example, as illustrated inFIG. 3A, the deployment sheath3402includes a stitch portion3404, such as a chain stitch. As shown, a proximal end3502of the constraining fiber3500is coupled or otherwise incorporated into the deployment sheath3402. In some examples, the constraining fiber3500forms a portion of the stitch portion3404. In some examples, the constraining fiber3500is coupled to or otherwise woven through one or more of the stitches of the stitch portion3404. For instance, the constraining fiber3500may be routed through the top or distal-most stitch and then to the lockwire3300such that, until the constraining fiber3500is decoupled from the lockwire3300, the constraining fiber3500operates to prevent premature unlacing of the chain stitch (and thus premature deployment of the medical device3400). In some examples, after the constraining fiber3500is decoupled from the lockwire3300, the constraining fiber3500can be removed from the chain stitch such that the chain stitch can unlace and the medical device3400can be deployed. Thus, in such examples, the constraining fiber3500serves a dual purpose of maintaining a position of the medical device3400along the medical device delivery system3000(device fixation) and locking the stitch, although examples with one or the other feature are also contemplated.

It should be appreciated that device fixation provides for a consistent position and length of the medical device as it is collapsed and loaded onto the elongate element (crush) and during its deployment at the target region. Additionally, device fixation provides for a consistent position of the medical device relative to the elongate element and/or olive as the medical device delivery system is bent and/or manipulated as it is advanced through the vasculature.

In some examples, the constraining fiber3500is additionally or alternatively coupled to one or more of holes formed in the deployment sheath, such as one or more of the holes formed by the stitches of the stitch portion3404. However, the constraining fiber3500may be coupled to one or more holes formed in the deployment sheath3402that are not associated with the stitch portion3404. Likewise, the constraining fiber3500may be additionally or alternatively incorporated into the medical device.

In some examples, the distal end3504of the constraining fiber3500is configured to interface with the lockwire3300. In some such examples, the constraining fiber includes a knob, an eyelet, a hole, or any other suitable attachment mechanism3506at its distal end3504. The attachment mechanism3506is configured such that the lockwire3300can pass through or otherwise engage the attachment mechanism3506to releasably couple the constraining fiber3500to the lockwire3300.

In some examples, as discussed further below, the lockwire3300is configured to be advanced into the lockwire lumen (described above but not illustrated inFIGS. 3A-3C) and across the gap formed by the lockwire exposure feature3222. In the illustrated example ofFIG. 3A, the constraining fiber3500can be coupled with the lockwire3300by distally advancing the lockwire3300from its position proximal to the olive3200such that the lockwire3300is advanced through the proximal portion of the lockwire lumen, across the gap formed by the lockwire exposure feature3222, through the attachment mechanism3506of the constraining fiber3500an into the distal portion of the lockwire lumen.

As shown inFIG. 3A, the constraining fiber3500is configured to extend between the deployment sheath3402and/or the medical device3400and the lockwire exposure feature3222of the olive3200such that the constraining fiber3500can interface with the portion of the lockwire3300extending through the olive3200that is exposed by the lockwire exposure feature3222.FIG. 3Aillustrates the medical device3400and the deployment sheath3402mounted on the elongate element3100prior to the lockwire3300being inserted into the lockwire lumen (described above but not illustrated inFIGS. 3A-3C).

In various examples, coupling the constraining fiber3500to the lockwire3300includes positioning the attachment mechanism3506of the constraining fiber3500within the gap formed by3222such that, as the lockwire3300traverses the gap, the lockwire3300passes through the attachment mechanism3506of the constraining fiber3500. Specifically, in some examples, as the lockwire3300is distally advanced from the proximal portion of the lockwire lumen to the distal portion of the lockwire lumen (such as during a proximal-to-distal insertion and advancement of the lockwire into the olive3200), the lockwire3300exits the proximal portion of the lockwire lumen and traverses the gap separating the proximal portion of the lockwire lumen from the distal portion of the lockwire lumen. The attachment mechanism3506of the constraining fiber3500is situated such that during this traversal of the gap by the lockwire3300and before the lockwire3300enters the distal portion of the lockwire lumen, the distal end of the lockwire3300passes through the attachment mechanism3506. With the lockwire3300extending through the attachment mechanism3506, the constraining fiber3500is coupled to or otherwise restrained by the lockwire3300. As discussed in greater detail below, decoupling the constraining fiber3500from the lockwire3300is generally the reverse procedure of coupling the constraining fiber3500to the lockwire3300.

In some examples, the lockwire is recoupleable to the olive after it has been decoupled therefrom. That is, in some examples, the lockwire is reinsertable into the lockwire lumen. In some examples, the constraining fiber is reattachable to a reinserted lockwire. However, in some other examples, the lockwire is not recoupleable to the olive after it has been decoupled therefrom. Likewise, in some examples, after decoupling the constraining fiber from the lockwire, the constraining fiber is not recoupleable to the lockwire.

It should be appreciated that, whileFIGS. 3A-3Cillustrate the lockwire3300being inserted into the olive3200in a proximal-to-distal direction, other examples may include inserting the lockwire3300into the olive3200in a distal-to-proximal. During a distal-to-proximal insertion and advancement of the lockwire3300into the olive3200, after the lockwire3300exists the distal portion of the lockwire lumen and before the lockwire3300enters the proximal portion of the lockwire lumen, the distal end of the lockwire3300passes through the attachment mechanism3506. In such examples, decoupling the constraining fiber3500from the lockwire3300is generally the reverse procedure.

FIG. 3Billustrates the interface between the lockwire3300and the constraining fiber3500with the lockwire3300received in both the proximal and distal portions of the lockwire lumen after the lockwire3300has passed through the attachment mechanism3506of the constraining fiber3500. With the constraining fiber3500coupled to the lockwire3300as shown inFIG. 3B, the deployment sheath3402and the medical device3400are constrained against translating axially (and in particular, proximally) relative to the elongate element3100during delivery and deployment of the medical device3400.

In some examples, the constraining fiber3500is operable to apply a tensile force to the medical device3400and/or the deployment sheath3402should the medical device3400and/or the deployment sheath3402tend to translate proximally along the elongate element3100. Generally, such tensile force is operable to counteract proximal translation.

In some examples, with the distal end3504of the constraining fiber3500coupled with or otherwise retained by the portion of the lockwire exposed by the lockwire exposure feature3222, the distal end3504of the constraining fiber3500is constrained against axial translation along the lockwire3300and constrained against radial translation away from the olive3200. Specifically, in some examples, the of the attachment mechanism3506of the constraining fiber3500is constrained such that axial translation along the lockwire3300is limited to travel between a distal end of the proximal portion of the lockwire lumen and a proximal end of the distal portion of the lockwire lumen (i.e., between the proximal and distal surfaces3228and3230of the lockwire exposure feature3222). That is, the attachment mechanism3506of the constraining fiber3500is limited to translating along the portion of the lockwire3300that is exposed by the lockwire exposure feature3222. In addition, the extension of the lockwire3300through the attachment mechanism3506of the constraining fiber3500forms a hitch that prevents the constraining fiber3500from being radially withdrawn from the lockwire3300.

With a distal end3504of the constraining fiber3500coupled to the olive3200and a proximal end3502of the constraining fiber3500coupled to the deployment sheath3402, the constraining fiber3500operates to constrain the deployment sheath3402against longitudinal translation along the elongate element3100upon which the medical device3400and the deployment sheath3402are mounted, as mentioned above. Those of skill in the art should appreciate that while the constraining fiber3500in this illustrated example is not directly coupled to the medical device3400, the friction between the deployment sheath3402and the medical device3400operates to maintain a relative position between the medical device3400and the deployment sheath3402.

In some examples, decoupling the constraining fiber3500from the lockwire3300involves withdrawing the lockwire3300from at least a portion of the lockwire lumen, which, as mentioned above, generally involves the reverse process of inserting the lockwire3300into the lockwire lumen.FIG. 3Cillustrates the lockwire3300having been proximally withdrawn from the lockwire lumen of the olive3200and the attachment feature3506of the constraining fiber3500. It should be appreciated that while the lockwire3300is illustrated inFIG. 3Cas having been withdrawn from the lockwire lumen entirely, in some examples, the lockwire3300need not be withdrawn from the lockwire lumen entirely to facilitate decoupling of the constraining fiber3500. Instead, in some examples, the lockwire3300need only be withdrawn to the extent that the distal end of the lockwire3300clears the attachment mechanism3506of the constraining fiber3500.

Generally, where the lockwire3300is inserted into the lockwire lumen of the olive in a proximal-to-distal manner, the lockwire3300need only be withdrawn from the distal portion of the lockwire lumen and the attachment mechanism3506of the constraining fiber3500. Thus, in some examples, the constraining fiber3500may be decoupled from the lockwire3300while the lockwire remains inserted in (or even through) the proximal portion of the lockwire lumen. Likewise, where the lockwire3300is inserted into the lockwire lumen of the olive3200in a distal-to-proximal manner, the constraining fiber3500may be decoupled from the lockwire3300by distally withdrawing the lockwire3300from the proximal portion of the lockwire lumen and the attachment mechanism3506.

As shown inFIG. 3C, with the constraining fiber3500decoupled from the lockwire3300, the medical device3400and the deployment sheath3402are no longer constrained against axial translation along the elongate element3100by the constraining fiber3500. Accordingly, as shown inFIG. 3C, with the constraining fiber3500decoupled from the lockwire3300, the deployment sheath3402is removable from the medical device3400such that the medical device3400can be deployed. In some examples, as discussed above, the medical device is expanded as it is deployed.

While some of the above-discussed examples include coupling a proximal end of the constraining fiber to one or both of the deployment sheath and the medical device, in some examples, the proximal end of the constraining fiber is coupled to the olive of the medical device deployment system. Turning now toFIGS. 4A and 4B, a medical device delivery system4000is illustrated as including an elongate element4100, an olive4200, and a lockwire4300. As shown, a medical device4400and a deployment sheath4402are mounted on the medical device delivery system4000and releasably coupled thereto by a constraining element, such as constraining fiber4500(FIG. 4Ais illustrated with a portion of the deployment sheath4402removed such that a portion of the medical device4400is pictured). As explained in greater detail below, the constraining fiber4500operates to couple the medical device4400and/or the deployment sheath4402to the medical device delivery system4000such that the medical device4400and/or the deployment sheath4402are constrained against longitudinal movement along the medical device delivery system4000during delivery and/or deployment of the medical device4400at the target site or region.

The elongate element4100, the olive4200, the lockwire4300are consistent with the various elongate elements, olives, and lockwires discussed herein. It should be appreciated that while the examples below refer to the constraining element as a constraining fiber4500, such reference should not be interpreted as limiting. For instance, it should be appreciated that the constraining element may be a structure that is suitable for being placed in tension, compression, or tension and compression.

As shown inFIG. 4A, the medical device4400is covered or constrained by a deployment sheath4402such that the medical device4400and the deployment sheath4402are mounted on the medical device delivery system4000. In some examples, the medical device4400and/or the deployment sheath4402comprise one or more mechanisms that may serve as attachment points or vehicles for coupling the medical device4400and or deployment sheath4402to the medical device delivery system4000. As mentioned above, these attachment points or vehicles may be holes or stitches incorporated into the deployment sheath.

In the illustrated examples ofFIGS. 4A and 4B, the deployment sheath4402includes at least one constraining fiber aperture, such as constraining fiber aperture4406. In some examples, the constraining fiber aperture4406is configured to have the constraining fiber4500passed therethrough in a manner that couples the deployment sheath4402to the medical device delivery system4000, as explained in greater detail below.

As shown inFIGS. 4A and 4B, like the constraining fiber3500, the constraining fiber4500is configured to interface with the lockwire4300. Specifically, as shown, the constraining fiber includes attachment mechanism4506(e.g., a knob, an eyelet, a hole, or any other suitable attachment mechanism) at its distal end4504. Like the attachment mechanism3506, attachment mechanism4506is configured such that the lockwire4300can pass through the attachment mechanism4506to couple the constraining fiber4500to the lockwire4300. However, unlike the proximal end3502of the constraining fiber3500, the proximal end4502of the constraining fiber4500is coupled to the olive4200.

Accordingly, as illustrated inFIG. 4A, the constraining fiber4500is configured to extend from the olive4200and through the deployment sheath4402and/or the medical device4400such that a distal end4504and/or an attachment mechanism4506of the constraining fiber4500is operable to be coupled to a portion of the lockwire4300inserted into the lockwire lumen of the olive4200and exposed by the lockwire exposure feature4222. In various examples, the distal end4504and/or the attachment mechanism4506of the constraining fiber4500interfaces with the lockwire4300in a similar manner as discussed above with respect to the manner in which the distal end3504and/or the attachment mechanism3506of the constraining fiber3500interfaces with the lockwire3300. The proximal end4502of the constraining fiber4500is coupled to the olive4200as mentioned above. In various examples, the proximal end4502of the constraining fiber4500may by tied, adhered, welded, screwed or attached via one or more fasteners to the olive4200, as mentioned above.

FIG. 4Aillustrates the medical device4400and the deployment sheath4402mounted on the elongate element4100with the lockwire4300extending through the attachment mechanism4506of the constraining fiber4500and into the distal portion of the lockwire lumen (described above but not illustrated inFIGS. 4A and 4B). Accordingly, as shown, the constraining fiber4500is releasably coupled to the lockwire4300. Generally, with the proximal end4502of constraining fiber4500coupled to the olive4200and the distal end4504of the constraining fiber4500coupled to the lockwire4300, an intermediate portion4508of the constraining fiber4500engages the medical device4400and/or the deployment sheath4402. As illustrated inFIG. 4A, the intermediate portion of the constraining fiber4500passes through the constraining fiber aperture4406of the deployment sheath4402. In some examples, the intermediate portion4508may be looped around or looped through the constraining fiber aperture4406of the deployment sheath4402. In some examples, the intermediate portion of the constraining fiber4500additionally or alternatively similarly passes through (or is looped around and through) a constraining fiber aperture or some other engagement feature of the medical device4400.

Thus, the configuration illustrated inFIG. 4Aprovides that the deployment sheath4402and/or the medical device4400are constrained against translating axially (and in particular, proximally) relative to the elongate element4100upon which the deployment sheath4402and the medical device4400are mounted. For instance, as similarly discussed above with respect to constraining fiber3500, in some examples, the constraining fiber4500is operable to apply a tensile force to the medical device3400and/or the deployment sheath3402to counteract a tendency of the medical device3400and the deployment sheath3402to translate proximally along the elongate element3100.

In some examples, the constraining fiber4500is decoupleable from the lockwire4300in a manner similar to the manner in which the constraining fiber3500is decoupled from the lockwire3300.FIG. 4Billustrates the lockwire4300having been proximally withdrawn from the lockwire lumen of the olive4200such that the lockwire4300is withdrawn from the attachment feature4506of the constraining fiber4500. With the constraining fiber4500decoupled from the lockwire4300, the medical device4400and the deployment sheath4402are no longer constrained against axial translation along the elongate element4100by the constraining fiber4500. Accordingly, as shown inFIG. 4B, with the constraining fiber4500decoupled from the lockwire4300, the deployment sheath4402is removable from the medical device4400such that the medical device4400can be deployed.

Turning now toFIGS. 5A and 5B, a medical device delivery system5000is illustrated as including an elongate element5100, an olive5200, a lockwire5300, a constraining element or steering element, such as steering fiber5500, and a delivery catheter5600. The elongate element5100, the olive5200, and the lockwire5300are consistent with the various elongate elements, olives, and lockwires discussed herein. It should be appreciated that while the examples below refer to the constraining element as a constraining fiber5500, such reference should not be interpreted as limiting. For instance, it should be appreciated that the constraining element may be a structure that is suitable for being placed in tension, compression, or tension and compression. Thus, in some examples, the constraining element may be a constraining wire that is suitable to be placed in tension and/or compression. Likewise, in some examples, the lockwire may be a fiber and/or a wire in that may be placed in tension and compression, while in some other examples the lockwire may be placed only in tension.

Generally, the steering fiber5500allows for selective bending of the elongate element5100within the vasculature. In such configurations, tension can be applied to the steering fiber5500to cause the elongate element5100to bend as those of skill in the art should appreciate. Bending the elongate element5100can, among other things, help facilitate conformity of the medical device delivery system5000to curvatures in the vasculature of a patient which facilitates advancement of the medical device delivery system5000through curved regions of vasculature. Thus, such a configuration can be useful during delivery of the medical device delivery system5000to the target region or site.

In some examples, the steering fiber5500passes through the delivery catheter5600and is releasably coupled to the olive5200. In some examples, the steering fiber5500includes an attachment mechanism5506which is similar to the attachment mechanism3506of the constraining fiber3500described and illustrated herein. Thus, consistent with the examples discussed above, the steering fiber5500is configured to interface with the portion of the lockwire5300inserted within the lockwire lumen (described above but not illustrated inFIGS. 5A and 5B) of the olive5200that is exposed by the lockwire exposure feature5222.

In some examples, the steering fiber5500is of a similar material and construction as the constraining fibers discussed above. In some examples, the steering fiber5500can comprise 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. Further, the steering fiber5500can 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.). However, any material that can be used to bend and/or steer the elongate element or otherwise cause the olive5200to deflect is within the scope of the present disclosure.

FIG. 5Billustrates the medical device delivery system5000in a deflected configuration (FIG. 5Aillustrates the medical device delivery system5000in a nondeflected configuration). Thus, by configuring the constraining fiber as a steering fiber, the medical device delivery system5000is transitionable between deflected and nondeflected (or steered and nonsteered) states or configurations.

Similar to the various other examples illustrated and describe herein, the steering fiber5500is removably coupled to the olive5200. Such a configuration provides for a versatile medical device delivery system5000and interchangeability. For example, the illustrated example ofFIGS. 5A and 5Bmay be combinable with the other examples illustrated and discussed herein. For example, a medical device delivery system may include a plurality of constraining fibers coupled to the portion of the lockwire inserted within the lockwire lumen that is exposed by the lockwire exposure feature. In some such examples, a first of the constraining fibers may operate to maintain a position of a medical device and/or a deployment sheath along an elongate element, while a second constraining fiber operates as a steering fiber that facilitates delivery of the medical device delivery system to the treatment region within the vasculature.

Moreover, such a configuration provides for selective decoupling of one or more of the plurality of constraining fibers from the lockwire. In some examples, the steering fiber may be decoupleable from the lockwire without decoupling the constraining fiber from the lockwire. For instance, in some examples, the lockwire may be withdrawn through the lockwire lumen a degree sufficient to enable decoupling of the steering fiber but insufficient to enable decoupling of the constraining fiber. In some examples, the lockwire may be withdrawn through the lockwire lumen a degree sufficient to enable decoupling of both the steering fiber and the constraining fiber but only the steering fiber is decoupled from the lockwire, after which the lockwire is readvanced to a position within the lockwire lumen that prohibits decoupling of the constraining fiber that remains coupled to the lockwire. These and other examples are likewise combinable with the medical device delivery systems discussed below.

Turning now toFIGS. 6A and 6B, a medical device delivery system6000is illustrated as including an elongate element6100, an olive6200, a lockwire6300, and a constraining element, such as constraining fiber6500. The elongate element6100, the olive6200, the lockwire6300, and the constraining fiber6500are consistent with the various elongate elements, olives, lockwires, and constraining fibers discussed herein. It should be appreciated that while the examples below refer to the constraining element as a constraining fiber6500, such reference should not be interpreted as limiting. For instance, it should be appreciated that the constraining element may be a structure that is suitable for being placed in tension, compression, or tension and compression.

As illustrated, the constraining fiber6500is configured such that the distal portion6504and/or the attachment mechanism6506is coupled with the portion of the lockwire6300inserted within the lockwire lumen (discussed above but not illustrated inFIGS. 6A and 6B) and exposed by the lockwire exposure feature6222. The distal end6504of the constraining fiber6500extends from an intermediate portion6508of the lockwire6500that is coupled with the medical device6400. As discussed in greater detail below, the intermediate portion6508of the constraining fiber6500is coupled with the medical device6400such that the constraining fiber6500can operate to selectively reduce a cross section of a portion of the medical device6400. The intermediate portion6508of the constraining fiber6500extends from a proximal end of the constraining fiber6500(not illustrated inFIGS. 6A and 6B), such as outside the body, for example.

As illustrated inFIGS. 6A and 6B, the constraining fiber6500is coupled to the medical device6400. Specifically, the constraining fiber6500is laced around a periphery or circumference of the medical device6400. Generally, the constraining fiber6500is laced about the periphery of the medical device such that the constraining fiber6500can operate to selectively reduce a cross section (such as a diameter) or otherwise radially collapse a portion of the medical device6400in and around or proximate to where the constraining fiber6500is coupled to the medical device6400(e.g., the internal periphery of the inner lumen of the medical device6400). In some examples, the constraining fiber6500is laced on an internal periphery of the medical device6400. In some examples, the constraining fiber6500is additionally or alternatively laced about an external periphery of the medical device6400. In some examples, the constraining fiber6500extends within an integrated constraining lumen or other circumferentially extending lumen, as discussed in greater detail below. In some examples, the constraining fiber6500is routed or laced about an entire periphery of the medical device6400. In other examples, the constraining fiber6500is routed or laced about a portion of less than the entire periphery of the medical device6400.

In some examples, by coupling the distal end6504and/or the attachment mechanism6506of the constraining fiber6500to the lockwire6300, a tension can be applied to the constraining fiber6500without removing the constraining fiber6500from the medical device delivery system6000. Specifically, because the distal end6504of the constraining fiber6500is coupled to the lockwire6300at the olive6200, the distal end6504is constrained against axial translation (see discussion above) as tension is applied to the proximal end of the constraining fiber6500. Thus, the intermediate portion6508of the constraining fiber6500laced about the medical device6400constricts to reduce the cross section of the portion of the medical device6400about which the intermediate portion6508is laced.

Specifically, in some examples, as tension is applied to the constraining fiber6500(either from a proximal or distal end of the constraining fiber), a length of the constraining fiber6500routed about the periphery of the medical device6400is reduced such that the peripheral portion of the medical device6400about which the constraining fiber6500is routed is reduced. In some examples, the reduction in cross section of the medical device6400is proportional to the reduction in length of the portion of the constraining fiber6500that is routed about the periphery of the medical device6400. Thus, as the length of the portion of the constraining fiber6500that is routed about the periphery of the medical device6400decreases, so decreases the cross sectional area of the medical device6400in that region.

By providing a mechanism that allows for selectively reducing the cross section of the medical device, users can avoid premature anchoring of the medical device. In some examples, such versatility operates to avoid damaging a vessel where a medical device requires repositioning after initial deployment.

Because the constraining fiber6500is removably coupled to the lockwire6300, after the medical device6400is properly oriented and deployed, the constraining fiber6500can be decoupled from the lockwire6300(consistent with the examples discussed herein). In some examples, after properly aligning the medical device6400, the tension applied to the constraining fiber6500is released such that the medical device6400can adopt a natural configuration within the portion of the vasculature in which it is situated. In some examples, after releasing the tension on the constraining fiber6500the lockwire6300is withdrawn from the lockwire lumen of the olive6200such that the constraining fiber6500can be decoupled from the lockwire (see discussion above).

FIG. 6Billustrates a configuration wherein the constraining fiber6500is decoupled from the lockwire6300. As shown, the lockwire6300has been proximally withdrawn from the lockwire lumen of the olive6200and the distal end6504constraining fiber6500is free from the lockwire6300. In some examples, with the constraining fiber6500free (i.e., not coupled to the lockwire6300), the constraining fiber6500can be withdrawn from the medical device delivery system6000. In some examples, the constraining fiber6500can be withdrawn and decoupled from the medical device6400. In some such examples, as tension is applied to the proximal end of the constraining fiber6500, the free distal end6504is drawn away from the olive6200and through the medical device6400and out of the body. In some other examples, only a portion of the constraining fiber6500is removed from the body. For instance, in some examples, the constraining fiber6500is configured to bio-disintegrate and thus may remain in the body after deployment of the medical device6400and removal of the other components of the medical device delivery system6000.

Turning now toFIG. 7, a medical device delivery system7000is illustrated as including an elongate element7100, an olive7200, a lockwire7300, and a constraining element, such as constraining fiber7500. The elongate element7100, the olive7200, the lockwire7300, and the constraining fiber7500are consistent with the various elongate elements, olives, lockwires, and constraining fibers discussed herein. It should be appreciated that while the examples below refer to the constraining element as a constraining fiber7500, such reference should not be interpreted as limiting. For instance, it should be appreciated that the constraining element may be a structure that is suitable for being placed in tension, compression, or tension and compression.

As illustrated, the constraining fiber7500is configured such that the distal portion7504and/or the attachment mechanism7506are coupled with the portion of the lockwire7300inserted within the lockwire lumen (discussed above but not illustrated inFIG. 7) and exposed by the lockwire exposure feature7222. The distal end7504of the constraining fiber7500extends from an intermediate portion7508of the constraining fiber7500that is coupled with the medical device7400. In some examples, the intermediate portion7508of the constraining fiber7500is coupled with the medical device7400such that the constraining fiber7500can operate to selectively reduce a cross section of a portion of the medical device7400, as discussed above. In some examples, the intermediate portion7508of the constraining fiber7500extends from a proximal end of the constraining fiber7500(not illustrated inFIG. 7).

As mentioned above, in various examples, as tension is applied to the constraining fiber7500, a length of the constraining fiber7500routed about the periphery of the medical device7400is reduced such that the peripheral portion of the medical device7400about which the constraining fiber7500is route is reduced. Those of skill in the art will appreciate that the force applied to the medical device7400to induce such a tension is directed along the constraining fiber7500. Thus, in various examples, it is beneficial to route the constraining fiber7500such that the force exerted on the medical device7400operates to efficiently and effectively reduce a cross section of a portion of the medical device7400while maintaining a longitudinal position of the medical device7400relative to the elongate element7100.

As shown inFIG. 7, in some examples, the constraining fiber7500is routed through at least one alignment mechanism7700. In some examples, the alignment mechanism7700includes one or more apertures or lumens through which the constraining fiber7500is routed. In other examples, the alignment mechanism7700additionally or alternatively includes one or more channels (i.e., open channels) or grooves through which the constraining fiber7500is routed. By routing the constraining fiber7500though one or more alignment mechanisms7700, the constraining fiber7500can be routed such that the force exerted on the medical device7400by the constraining fiber7500is directed radially or semi-radially as opposed to longitudinally or substantially longitudinally. Directing the force radially or semi-radially has the effect of reducing the component of force that influences longitudinal translation of the medical device7400during delivery and deployment.

As shown inFIG. 7, the alignment mechanism7700is situated along the length of the constraining fiber7500between a proximal end of the constraining fiber7500and the intermediate portion of the constraining fiber7500that is coupled to or routed about the medical device7400. Thus, in some examples, the constraining fiber7500is routed such that a first intermediate portion of the constraining fiber7500is routed through the alignment mechanism7700and a second intermediate portion of the constraining fiber7500is routed through the medical device7400. In some examples, the first intermediate portion of the constraining fiber7500is proximal the second intermediate portion of the constraining fiber7500(see e.g.,FIG. 7). However, as discussed in greater detail below, an alignment mechanism may additionally or alternatively be situated along the length of the constraining fiber7500between a distal end7504of the constraining fiber7500and the intermediate portion of the constraining fiber7500that is coupled to the medical device7400.

In various examples, as tension is applied to the constraining fiber7500, the portion of the constraining fiber7500extending between the alignment mechanism7700and the medical device7400exerts a force on the medical device7400that is directed along the length of the constraining fiber7500toward the alignment mechanism7700. Thus, in some examples, applying tension to the constraining fiber7500causes the medical device7400to be drawn at least radially toward the alignment mechanism7700. In some examples, this force may operate to further facilitate the reduction in cross section of the portion of the medical device about which the constraining fiber is laced or routed, as well as correct any unwanted rotation of the medical device about a longitudinal axis of the medical device delivery system. In some examples, such a force may also operate to maintain a position of the medical device along the longitudinal length of the medical device delivery system during delivery and/or deployment.

In some examples, the alignment mechanism7700is positioned such that the portion of the constraining fiber7500extending between the alignment mechanism7700and the medical device extends normal to (or substantially normal to) an interior surface of the medical device7400. In some examples, the alignment mechanism7700is positioned such that the portion of the constraining fiber7500extending between the alignment mechanism7700and the medical device extends perpendicular to (or substantially perpendicular to) the longitudinal axis of the medical device delivery system7000.

In some examples, the alignment mechanism7700is positioned such that the portion of the constraining fiber7500extending between the alignment mechanism7700and the medical device7400extends at some angle offset from being perpendicular to (or substantially perpendicular to) the longitudinal axis of the medical device delivery system7000. In some examples, the constraining fiber7500extends from the alignment mechanism7700at an angle between forty-five (45) and ninety (90) degrees (or between ninety (90) and one-hundred-thirty-five (135) degrees) relative to the longitudinal axis of the medical device delivery system. However, it should be appreciated that an angle less than forty-five (45) degrees or greater than one-hundred-thirty-five (135) degrees may be selected without departing from the spirit or scope of the disclosure.

As shown inFIG. 7, the alignment mechanism7700is coupled to the elongate element7100. In other examples, the alignment mechanism7700may be coupled to the olive7200or some other component of the medical device delivery system7000. As shown, the alignment mechanism may be coupled to the olive or some other component of the medical device delivery system. The constraining fiber7500is routed such that a portion of the constraining fiber7500extends from a proximal end (not illustrated inFIG. 7) to the alignment mechanism7700. The constraining fiber7500is routed through the alignment mechanism7700and to the medical device7400such that a portion of the constraining fiber7500extends between the alignment mechanism7700and the medical device7400. As shown, the constraining fiber7500is routed through an aperture7406in the medical device7400and around a periphery of the medical device7400before extending to a position where the constraining fiber7500is coupled to the portion of the lockwire7300that is inserted in the lockwire lumen and exposed by the lockwire exposure feature7222.

As shown inFIG. 7, the constraining fiber7500is routed about the periphery of the medical device7400such that, after extending about the periphery of the medical device7400, the constraining fiber extends back through the aperture7406before extending to where it is coupled to the lockwire7300. In some examples, the portion of the constraining fiber7500that extends to the lockwire7300overlaps or otherwise loops around the portion of the constraining fiber7500extending from the alignment mechanism7700. For example, as shown inFIG. 7B, the portion7512of the constraining fiber7500that extends to the lockwire7300from the medical device7400passes beneath and around the portion7510of the constraining fiber7500extending to the medical device7400from the alignment mechanism7700. In some such examples, the constraining fiber7500is looped around itself such that as tension is applied to the constraining fiber7500, the portion of the constraining fiber7500that extends to the lockwire7300interferes with or otherwise entangles with the portion of the constraining fiber7500that extends from the alignment mechanism7700. In some examples, looping or entangling the constraining fiber7500with itself operates to avoid the portions of the constraining fiber passing through the aperture7406of the medical device from binding against and tearing the edge or periphery of the aperture7406or another portion of the medical device7400.

Turning back now toFIG. 7A, as discussed above, the distal end7504and/or the attachment mechanism7506are releasably coupled to the portion of the lockwire7300inserted into the lockwire lumen of the olive7200and exposed by the lockwire exposure feature7222. As discussed above, by coupling the distal end7504and/or the attachment mechanism7506of the constraining fiber7500, a tension can be applied to the constraining fiber7500. Specifically, because the distal end7504of the constraining fiber7500is coupled to the lockwire at the olive7200and therefore constrained against axial translation (see discussion above) as tension is applied to the proximal end of the constraining fiber7500, the intermediate portion7508of the constraining fiber7500laced about the medical device7400is operable to cause a constriction or reduction in the cross section of the portion of the medical device7400about which the intermediate portion7508is laced.

Likewise, as discussed above with respect to the medical device delivery system6000, because the constraining fiber7500is removably coupled to the lockwire7300, the constraining fiber7500can be decoupled from the lockwire7300after the medical device7400is properly oriented and deployed. Specifically, the lockwire7300may be withdrawn from the lockwire lumen of the olive7200such that the constraining fiber7500can be decoupled from the lockwire7300. Thereafter, the lockwire7300and the constraining fiber7500may be removed from the body, though removal may not be required (as discussed above).

While the above-discussed example includes a medical device delivery system including an alignment mechanism situated between the proximal end of the constraining fiber7500and the medical device7400, it should be appreciated that the constraining fiber7500may be situated between the distal end of the constraining fiber7500and the medical device7400. In such examples, after being routed about the periphery of the medical device7400and before extending to the lockwire7300, the constraining fiber7500is routed through the alignment mechanism7700.

Additionally, while the above-discussed example includes a medical device delivery system including a single alignment mechanism, in some examples, a plurality of alignment mechanisms may be incorporated. Turning now toFIG. 8, a medical device delivery system8000is illustrated as including an elongate element8100, an olive8200, a lockwire8300, and a constraining element, such as constraining fiber8500. The elongate element8100, the olive8200, the lockwire8300, and the constraining fiber8500are consistent with the various elongate elements, olives, lockwires, and constraining fibers discussed herein. It should be appreciated that while the examples below refer to the constraining element as a constraining fiber8500, such reference should not be interpreted as limiting. For instance, it should be appreciated that the constraining element may be a structure that is suitable for being placed in tension, compression, or tension and compression.

In addition, the medical device delivery system8000includes a first alignment mechanism8700and a second alignment mechanism8702. The alignment mechanism8700is similar to that alignment mechanism7700discussed above. The alignment mechanism8702is also similar to the alignment mechanism7700except that the constraining fiber8500is routed through the alignment mechanism8702after being routed about the periphery of the medical device8400. Thus, the alignment mechanism8702is situated along the elongate element8100between the distal end8504and the portion of the constraining fiber8500that is routed about the medical device8400.

As shown inFIG. 8, the constraining fiber8500is routed such that a portion of the constraining fiber8500extends from a proximal end (not illustrated inFIG. 8) to the first alignment mechanism8700. The constraining fiber8500is routed through the first alignment mechanism8700and to the medical device8400such that a portion of the constraining fiber8500extends between the first alignment mechanism8700and the medical device8400. As shown, the constraining fiber8500is routed through an aperture8406in the medical device8400and around a periphery of the medical device8400. Thereafter, the constraining fiber8500is routed to the second alignment mechanism8702. After being routed through the second alignment mechanism8702, the constraining fiber8500extends to a position where the constraining fiber8500is coupled to the portion of the lockwire8300that is inserted in the lockwire lumen and exposed by the lockwire exposure feature8222.

Like the constraining fiber7500illustrated inFIG. 7, the constraining fiber8500is routed about the periphery of the medical device8400such that, after extending about the periphery of the medical device8400, the constraining fiber extends back through the aperture8406before extending to where it is coupled to the lockwire8300. As shown, the portion of the constraining fiber8500that extends to the second alignment mechanism8702overlaps or otherwise loops around the portion of the constraining fiber8500extending from the alignment mechanism8700.

In some examples, the first and second alignment mechanisms8700and8702are coupled to the elongate element8100. In some such examples, the first and second alignment mechanisms8700and8702are positioned along a length of the elongate element8100such that, as tension is applied to the constraining fiber8500, the longitudinal forces exerted on the medical device8400by the portions of the constraining fiber extending between the first and second alignment mechanisms8700and8702cancel each other out.

Specifically, as tension is applied to the constraining fiber8500, a first force is exerted on the medical device8400by the portion of the constraining fiber8500extending between the first alignment mechanism8700and the medical device8400(i.e., constraining fiber portion8510). This first force is directed along the constraining fiber portion8510. Likewise, as the tension is applied to the constraining fiber8500, a second force is exerted on the medical device8400by the portion of the constraining fiber8500extending between the second alignment mechanism8702and the medical device8400(i.e., constraining fiber portion8512). This second force is directed along the constraining fiber portion8512. As mentioned above, in some examples, the alignment mechanism8700and8702are positioned such that the first and second forces cancel each other out. Such a configuration provides that the portion of the medical device8400about which the constraining fiber8500is routed can be reduced in cross section while maintaining a position of the medical device8400along the medical device delivery system8000.

In some other examples, the first and second alignment mechanisms8700and8702are positioned along a length of the elongate element8100such that, as tension is applied to the constraining fiber8500, the longitudinal forces exerted on the medical device8400by the portions of the constraining fiber extending between the medical device8400and the first and second alignment mechanisms8700and8702are non-equal. In some such examples, the first alignment mechanism8700is situated along the elongate element8100such that it is a first longitudinal distance from the portion of the medical device8400about which the constraining fiber8500is routed while the second alignment mechanism8702is situated along the elongate element8100such that it is a second, different longitudinal distance from the portion of the medical device8400about which the constraining fiber8500is routed.

In these examples, the component forces exerted on the medical device8400by the constraining fiber portions8510and8512do not cancel each other out. Instead, as those of skill in the art will appreciate, the constraining fiber portion extending to the alignment mechanisms that is more longitudinally offset will be associated with the larger component of force. However, even in such examples, the distance by which the medical device8400is offset relative to the first and second alignment mechanisms8700and8702can be limited such that a resulting longitudinal component force is insufficient to cause displacement of the medical device8400along the longitudinal axis of the medical device delivery system8000.

Accordingly, those of skill should appreciate that configurations incorporating such first and second alignment mechanisms can provide for medical device delivery systems that enable selective reduction of the cross sectional area of a medical device (e.g., for final positioning or reposition within the vasculature) without causing significant bias of the medical device along the longitudinal axis of the medical device delivery system

While certain of the examples discussed above include the constraining fiber being coupled to a deployment sheath, in some other examples, the constraining fiber is additionally or alternatively coupled to the medical device. That is, in some examples, the constraining fiber directly couples the medical device to the lockwire. In some such examples, the medical device may comprise apices, knobs, eyelets, holes, or any other mechanisms suitable for attachment to the constraining fiber. Generally, in such examples, the proximal end of the constraining fiber is coupled to one of the above-referenced mechanisms suitable for attachment (e.g., apices, knobs, eyelets, holes, etc. of the medical device) while the distal end of the constraining fiber is coupled to the portion of the lockwire exposed by the lockwire exposure feature of the olive, as discussed herein. As similarly discussed above, it should appreciate that while the constraining fiber3500in this example is not directly coupled to the deployment sheath, the friction between the deployment sheath and the medical device operates to maintain a relative position between the medical device and the deployment sheath. Thus, if the constraining fiber operates to constrain the medical device against longitudinal translation along the elongate element, the constraining fiber likewise operates to constrain the deployment sheath against longitudinal translation along the elongate element.

As mentioned above, in some examples, the constraining fiber is directly coupled to both the deployment sheath and the medical device. In some such examples, a distal end of the constraining fiber is coupled to both the deployment sheath and the medical device. In some examples, the constraining fiber is routed through an attachment feature of the deployment sheath (e.g., a stitch, a hole, etc.) and coupled to the medical device. In some examples, the constraining fiber is routed through an attachment feature of the medical device (e.g., a stitch, an apex, a hole, etc.) and coupled to the deployment sheath.

Additionally, as discussed above, in some examples, the constraining fiber extends within an integrated constraining lumen. A cross sectional view of an exemplary integrated constraining lumen is illustrated inFIG. 9. As shown, in some examples, a medical device9400may include a graft portion9408and a stent portion9410. The stent portion9410may be arranged on an exterior surface9412of the graft portion9408. The graft portion9408also includes an interior surface9414, which forms an internal lumen of the medical device9400. The constraining element conduit9416(e.g., integrated constraining lumen) may be arranged around a circumference of the medical device9400on the exterior surface9412of the graft portion9408with the stent portion9410being arranged between the exterior surface9412of the graft portion9408and the constraining element conduit9416. The constraining element conduit9416may include a discontinuity or gap at some point around the circumference of the medical device9400. The discontinuity or gap in the constraining element conduit9416may allow for a constraining fiber (or line or wire) to be arranged through the constraining element conduit9416.

The constraining element conduit9416may be formed by a graft portion9418that is attached to the exterior surface9412of the graft portion9408. In addition, the constraining element conduit9416may include a first boundary and a second boundary. As shown inFIG. 9, the first boundary of the constraining element conduit9416is the exterior surface9412of the graft portion9408, and the second boundary is formed by the graft portion9418. As a result, the constraining element conduit9416may provide a pathway through which a constraining fiber (or line or wire) (not shown) may be arranged. The constraining fiber (or line or wire) may constrain the medical device9400axially and/or radially in response to tension applied thereto.

FIG. 10Ais a cross-sectional view of the medical device10400and constraining element conduit10416. The medical device10400may include a graft portion10408and a stent portion10410. The stent portion10410may be arranged on an exterior surface of the graft portion10408. The constraining element conduit10416may be formed by a first graft portion10418that is attached to the exterior surface of the graft portion10408. The first graft portion10418may be bonded on the exterior surface of the graft portion10408. As shown inFIG. 10A, a wire (or alternatively a fiber)10422may be arranged between the exterior surface of the graft portion10408and the first graft portion10418. The wire10422may provide an obstruction during bonding of the first graft portion10418to the exterior surface of the graft portion10408such that end portions of the first graft portion10418is bonded to the exterior surface of the graft portion10408.

After the first graft portion10418is bonded to the exterior surface of the graft portion10408, the wire10422may be removed.FIG. 10Bis a cross-sectional view of the medical device10400and the constraining element conduit10416, as shown inFIG. 10A, that results from the wire10422providing an obstruction to bond the end portions of the first graft portion10418is bonded to the exterior surface of the graft portion10408. As shown inFIG. 10B, the wire10422leaves behind a passage of the constraining element conduit10416through which a constraining fiber10500may be arranged. As a result, the constraining element conduit10416may include a first boundary and a second boundary. As shown inFIG. 10B, the first boundary of the constraining element conduit10416is the exterior surface of the graft portion10408, and the second boundary is formed by the first graft portion10418.

In certain instances, a second graft portion10424may be arranged over the stent10410within the bounds of the first graft portion10418. The second graft portion10424may be bonded to the exterior surface of the graft portion similar to manner in which the first graft portion10418is bonded to the exterior surface of the graft portion10408(e.g., an FEP adhesive).FIG. 10Cis a cross-sectional view of the medical device10400, the constraining fiber conduit10416, and the constraining fiber10500, as shown inFIGS. 10A-B, with second (additional) graft portion10424in accordance with various aspects of the present disclosure. As a result, the second graft portion10424may form the first boundary of the constraining fiber conduit10416, with the first graft portion10418forming the second boundary. The constraining fiber conduit10416may include a discontinuity or gap at some point around the circumference of the medical device10400. The discontinuity or gap in the constraining fiber conduit10416may allow for the constraining fiber10500to be arranged through the constraining fiber conduit10416. More specifically, the circumference of the medical device10400may be between 25 mm and 50 mm. The discontinuity or gap in the constraining fiber conduit10416may be between 0.5 mm and 3 mm. The remaining portions of the constraining fiber conduit10416are continuous about the circumference of the medical device10400.

The constraining fiber10500may constrain the medical device10400axially and/or radially in response to tension applied thereto. In addition, the medical device10400may be constrained and unconstrained using the constraining fiber10500between a constrained configuration (e.g., for delivery of the medical device10400) and a deployed configuration (e.g., an operative state at a target therapy region). The implantable device10400may be constrained and unconstrained multiple times to allow for repositioning of the implantable device10400at the therapy location if the positioning is not desirable.

Though not explicitly illustrated or referred to in each of the above-discussed examples, those of skill should appreciate that the various medical device delivery systems described herein are deliverable though a delivery catheter (see for example the delivery catheter configuration illustrated and described inFIGS. 5A and 5B). Likewise, though not explicitly illustrated or referred to in each of the above-discussed examples, those of skill should appreciate that the various medical device delivery systems may include a control system coupled at a proximal end thereof, such as outside the patient's body or vasculature.

While the examples described and illustrated above include an elongate element having an olive coupled thereto, in some other examples, the elongate element may alternatively comprise a blunt, rounded, or tapered distal tip. That is, instead of coupling an olive to the elongate element, the distal end of the elongate element, itself, includes an integrally formed blunt, rounded, or tapered distal tip. In some examples, the distal tip of the elongate element can be characterized by varying degrees of rigidity or softness, which can further vary along the length of the elongate element.

Likewise, while the olive1200is illustrated and described as being generally cylindrical, it should be appreciated that the olive1200can be of any suitable size and can have any shape suitable for navigating the vasculature without departing from the spirit or scope of the present disclosure.

The inventive scope of this application has been described above both generically and with regard to various embodiments by way of example. It will be apparent to those skilled in the art that various modifications and variations can be made in to the embodiments, including combination of features from the various embodiments, without departing from the scope of invention. It is intended that the scope of invention include such modifications and variations.