The following relates generally to the stent arts, stent manufacturing arts, stent assembly arts, and related arts.
Stents constructed as self-expandable, metal support structures, delivered via intravascular devices, are commonly used in the treatment in intravascular disease, as well as in larger regions of the anatomy such as the esophagus. Self-expanding stents are typically made from a braided wire mesh or from laser cut tubes. Braided stents typically are made from a plurality of wires, spiral wound into a braided tubular structure. These stents are manufactured using a braiding machine (e.g., available from Steeger USA Inc., Inman, South Carolina, USA), and are manufactured in long lengths, then cut to size, leaving open wire ends. An example of a stent of this type is the WallStent Endoprosthesis Stent, available from Boston Scientific, Marlborough, Massachusetts, USA. Stents are placed in the vascular system or esophagus to expand the vessel or esophageal diameter to treat various disease states.
The following discloses certain improvements to overcome these problems and others.
In some embodiments disclosed herein, a stent includes a hollow tube comprising interlaced metal strands; and a reinforcement providing radial strength reinforcement at an end of the hollow tube.
In some embodiments disclosed herein, a method of assembling a stent includes braiding a plurality of metal strands to form a hollow tubular body; heat setting the hollow tubular body; and after the heat setting, forming a reinforcement providing radial strength reinforcement at one or both ends of the hollow tubular body.
One advantage resides in providing a stent with closed or fixed ends that provide greater radial strength at the open ends of the stent.
Another advantage resides providing in a stent with an optimal wire pitch or pic rate (per inch crossings) that provide improved conformability.
Another advantage resides in providing a stent made from Nitinol for improved durability.
Another advantage resides in providing a stent with an optimal braid angle at one or more ends of the stent.
Another advantage resides in providing a stent having enhanced radiopacity.
Another advantage resides in providing a stent with a variable radial strength along a length thereof.
A given embodiment may provide none, one, two, more, or all of the foregoing advantages, and/or may provide other advantages as will become apparent to one of ordinary skill in the art upon reading and understanding the present disclosure.
The invention may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention.
Braided stents by design tend to be more durable and flexible compared to laser cut stents. However, one limitation of braided stents is the radial strength at the open ends of the stent. The unrestricted movement of the wire ends results in lower radial strength/crush resistance at the ends of the stent, compared to the mid-section of the stent. This can result in poor outcomes due to reduced patency of the stent. In addition, commercially available braided stents tend to have lower radial force that equivalent laser cut stents.
The following relates to improvements in a braided stent. Such stents are typically manufactured by braiding wires made of Nitinol (a metal alloy of nickel and titanium where the Ni and Ti are present in roughly equal atomic percentages) on a mandrel and then heat setting the braided stent at typically 400-500° C. Other materials may also be used, such as platinum, titanium, gold, silver, stainless steel, or combination materials (e.g., a drawn-filled tube wire such as a Nitinol Drawn Filled Tube (available from DFT Wire, Fort Wayne Metals, Indiana, USA), which has an inner core of one or more radiopaque materials (i.e., platinum, tantalum, etc.). The resulting braided stent is self-expanding, so that it can be radially compressed to fit into a catheter tip or other delivery instrument and then expands into position in the vein when placed.
However, as noted, existing braided stents of this type suffer from reduced crush resistance and reduced radial strength at the ends of the stent. This is recognized herein to be due at least in part to loose wire ends at the ends of the stent. In view of this, the following discloses various approaches for increasing crush resistance and radial strength at the stent ends.
In some embodiments disclosed herein, the wire ends of a braided stent are bent over and connected to neighboring wire ends to form closed loops. In one approach, after the first heat set step, the Nitinol wire ends are bent to form the closed loops and a second heat set step is performed. Before or after the second heat set step, the formed wire ends of are secured together by welding (e.g., laser welding) or using crimp sleeves. This approach has an additional advantage of eliminating the loose wire ends, which reduces the possibility of the loose wire ends embedding into the blood vessel with potentially detrimental effects such as providing nucleation sites for thrombus or atherosclerosis.
In other embodiments disclosed herein, the wire crossings near the ends are welded together (e.g., by laser welding) to increase crush resistance and radial strength. This could be done alone, or in combination with the forming of closed loop ends as previously described.
In some embodiments disclosed herein, the wire ends are encapsulated with a polymer encapsulant by dip coating, spray coating, or another approach. Depending on the encapsulant material, a cure step may be added to cure the polymer. In some examples, the encapsulant covers the ends including filling in gaps in the braid. In another example, the braid gaps are not filled by the encapsulant. It is also contemplated to coat the entire stent rather than just the ends. This approach can optionally be combined with one or both of the previously described approaches.
In other embodiments disclosed herein, the braid density is increased at the ends. This can be measured by braid angle, or equivalently by the pics per inch (PPI). In one embodiment, the braid pitch or braid angle is increased by 25% or more at the ends compared with the central portion of the stent. In another (not necessarily mutually exclusive) embodiment, the braid has PPI=15 or higher at the ends. This approach can optionally be combined with one or more of the earlier-described approaches.
In some embodiments disclosed herein, the disclosed approaches can be deployed at both ends of the stent, or in a variant embodiment only at one end of the stent. The latter approach may be appropriate if, for example, the stent placement is known to lead to higher compression at one end of the stent as compared with the other end of the stent.
In other embodiments disclosed herein, a radiopaque marker can be placed at one or both ends of the stent. This may be gold or any other material that is absorbing for X-rays used in X-ray imaging. For example, a gold wire may be wrapped around each end. In the closed loop embodiment described previously, the crimp sleeves could be made of a radiopaque material to provide this imaging benefit as a secondary advantage. a
While described in the context of venous stents, the disclosed approaches are suitable for use in arterial stents and other types of stents such as esophageal stents. While Nitinol is the preferred material for these types of braided stents, braided stents of metal wires with high elasticity could be used instead.
With reference to
The stent 10 also include a reinforcement that provides radial strength reinforcement at one or more of the end portions 16, 18 of the hollow tube 12. For example, as shown in
Reinforcement by way of forming the loops 22 at one or both ends 16, 18 of the stent 10 advantageously provides radial strength reinforcement at the end(s). Additionally, the loops 22 eliminate unsecured ends of the wires 14 at the end(s) of the stent, by bonding ends of neighboring wires (e.g., the ends of illustrative wires 141, 142) together. This can be advantageous because the loops 22 are less likely to abrade or embed into the inner blood vessel wall. Such abrasion or embedding of the wire ends can provide potential nucleation sites for thrombus or atherosclerosis, and/or can weaken the blood vessel wall.
As shown in
With reference to
With reference to
It will be appreciated that the stent 10 can include multiple examples of the reinforcements described above. For example, the stent 10 can include both the loops 22 and the encapsulant 28, or the encapsulant 28 and the welds 26, and so forth. In addition, the first end portion 16 can include a first reinforcement (e.g., the loops 22), and the second end portion 18 can include a second reinforcement (e.g., the encapsulant 28), or both end portions 16, 18 can include the same reinforcement (e.g., loops 22 at both end portions 16, 18). These are merely illustrative examples and should not be construed as limiting.
The reinforcement operation 106 can be performed in a variety of manners. In one example, the forming of the reinforcement structure includes bending ends of the metal strands 14 at one or both end portions 16, 18 of the tubular hollow body 12 to form one or more loops 22. A second heat setting operation can be performed to heat set the loops 22. In another (non-mutually exclusive) example, one or more crimp sleeves 24 can be applied to the ends of the metal strands 14. In another (non-mutually exclusive) example, one or more welds 26 can be formed on the ends of the metal strands 14 to secure the loops 22 to neighboring metal strands 14. In another (non-mutually exclusive) example, an encapsulant 28 can be added to one or both end portions 16, 18 of the tubular structure 12. To do so, the encapsulant 28 can be applied to one or both end portions 16, 18 of the tubular structure 12 by dip coating or spray coating.
The disclosure has been described with reference to the preferred embodiments. Modifications and alterations may occur to others upon reading and understanding the preceding detailed description. It is intended that the exemplary embodiment be construed as including all such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.
Filing Document | Filing Date | Country | Kind |
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PCT/EP2021/085577 | 12/14/2021 | WO |
Number | Date | Country | |
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63126023 | Dec 2020 | US |