The present invention relates generally to stents for use in body vessels to treat medical conditions. In particular, this invention relates to an asymmetric stent having opposing sets of curved apices, where the curved section of one set of apices has a radius of curvature that is greater than the curved section of the other set of apices, and may present a lower profile, better compliance with irregular vascular geometry, and higher sealing forces than conventional stents.
Stents may be inserted into an anatomical vessel or duct for various purposes. Stents may maintain or restore patency in a formerly blocked or constricted passageway, for example, following a balloon angioplasty procedure. Other stents may be used for different procedures, for example, stents placed in or about a graft have been used to hold the graft in an open configuration to treat an aneurysm. Additionally, stents coupled to one or both ends of a graft may extend proximally or distally away from the graft to engage a healthy portion of a vessel wall away from a diseased portion of an aneurysm to provide endovascular graft fixation.
Stents may be either self-expanding or balloon-expandable, or they can have characteristics of both types of stents. Various existing self-expanding and balloon-expandable stent designs and configurations comprise generally symmetrical end regions including one or more apices formed of nitinol or another alloy wire formed into a ring. The apices commonly comprise relatively acute bends or present somewhat pointed surfaces, which may facilitate compression of the stent to a relatively small delivery profile due to the tight bend of the apices. Although having this advantage, in some situations, such relatively acute or pointed apices may be undesirable, in particular in vessel anatomies that are curved or tortuous such as, for example, the thoracic aorta.
The thoracic aorta presents a challenging anatomy for stent grafts used to treat thoracic aneurysms or dissections. The thoracic aorta comprises a curve known as the aortic arch, which extends between the ascending thoracic aorta (closet to the heart) and the descending thoracic aorta (which extends toward the abdominal aorta). Thoracic stent grafts are used to exclude thoracic aortic aneurysms. A stent graft's ability to conform to the tortuous anatomy of the aortic arch is a major concern. Current designs sometimes lack the desired sealing ability at the proximal end of the stent graft (closest to the heart). Also, current thoracic devices present a relatively large profile which, with some patients' anatomies may be problematic. Finally, many current stents have relatively acute points that may prevent them from being used in the aortic arch for fear of undesirable interaction with the artery wall after an extended amount of time in the patient.
Therefore, a generally nonsymmetrical stent having at least one relatively rounded apex that is less invasive in an expanded state than stents with more acute apices may alleviate the above problems, while providing an improved compliance to the aortic arch and increased radial force if used as a sealing and/or alignment stent, as well as a desirable ability to be crimped to a readily introducible diameter.
As one particular example, type-A thoracic aortic dissection (TAD-A) is a condition in which the intimal layer of the ascending thoracic aorta develops a tear, allowing blood to flow into the layers of the aortic wall, causing the development of a medial or subintimal hematoma. TAD-A is associated with a strikingly high mortality rate (about one-fourth to one-half of victims die within the first 24-48 hours). The only current treatment for TAD-A is open surgery, where the chest is opened, the aorta is clamped, and a vascular prosthesis is sewn in place. Operative mortality rate for this procedure may be around 10%. Endovascular treatment of TAD-B (which affects the descending thoracic aorta) has been effective in reducing short-term and longer term mortality. Therefore, it is desirable to provide an endovascular device configured to address the anatomic challenges of the thoracic aorta.
Various stents and stent-graft systems for treatment of medical conditions are disclosed. In one embodiment, an exemplary stent-graft system may be used for endovascular treatment of a thoracic aortic aneurysm.
The stent-graft system may comprise proximal and distal components, each comprising a graft having proximal and distal ends, where upon deployment the proximal and distal components at least partially overlap with one another to provide a fluid passageway therebetween. The proximal component may comprise a proximal stent having a plurality of proximal and distal apices connected by a plurality of generally straight portions, where a radius of curvature of at least one of the proximal apices may be greater than the radius of curvature of at least one of the distal apices.
The distal component may comprise a proximal z-stent coupled to the graft, where the proximal end of the graft comprises at least scallop formed therein that generally follows the shape of the proximal z-stent. Further, the distal component may comprise at least one z-stent coupled to the distal end of the graft and extending distally therefrom that reduces proximal migration of the distal component.
Advantageously, when the stent graft system is deployed, the proximal stent of the proximal component will maximize the efficacy of the proximal seal while reducing atraumatic contact with an artery wall, and further preventing distal migration of the proximal end of the proximal component. Further, the at least one scallop may advantageously reduce the potential for graft infolding, thereby reducing or eliminating the likelihood of impeded blood flow and/or endoleaks around the distal component.
Other systems, methods, features and advantages of the invention will be, or will become, apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be within the scope of the invention, and be encompassed by the following claims.
The invention can be better understood with reference to the following drawings and description. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. Moreover, in the figures, like referenced numerals designate corresponding parts throughout the different views.
The present invention relates generally to stents for use in body vessels to treat medical conditions. In particular, this invention relates to a novel asymmetric stent having opposing sets of curved apices, where the curved section of one set of apices has a radius of curvature that is greater than the curved section of the other set of apices, and may present a lower profile than conventional stents. The lower profile may present advantages for use in patients with particularly tortuous or small-diameter vessels.
In the present application, the term “proximal” refers to a direction that is generally closest to the heart during a medical procedure, while the term “distal” refers to a direction that is furthest from the heart during a medical procedure. Reference throughout is made to proximal and distal apices, but those of skill in the art will appreciate that the proximal-distal orientation of stents of the present invention may be reversed without exceeding the scope of the present invention.
As shown in
The asymmetric stent may be configured such that, when used with a graft, it will provide a sufficiently strong radial force at the graft's end openings to hold the graft material open against the artery wall. Also, the stent is intended to be short in length so that the graft will include flexibility sufficient to accommodate a patient's anatomy. This combination of flexibility and strong radial force provides an improved seal between the graft and artery wall. In addition, enhanced flexibility is provided as well, particularly when one or more stents are used to provide short segments and better accommodate curves.
In these and other examples, the ratio of the proximal apices' radius of curvature to the distal apices' radius of curvature may be about 2.6:1 to about 18:1, and desirably may be about 6:1. The outer circumference of the stent 200 preferably is generally consistent such that, in this configuration, a solid outer face around the stent 200 would form a cylinder, although the stent will most preferably provide compliance with a surface less smooth than a cylinder.
The rounded points on the stent may protrude from the graft material only a small amount as is shown in
As shown in the end view of
The proximal component 802 further comprises a series of z-stents 810a-810f disposed distally from the proximal stem 804. A proximal z-stent 810a may be attached to the inner circumference of the graft material 805, other z-stents 810b-810e may be attached to the outer diameter of the graft material 805, and a distal z-stent 810f may be attached to the inner circumference of the graft material 805, as depicted in
Moreover, in one embodiment, the proximal stent 804 extending from the graft material 805 may at least partially overlap with the most proximal z-stent 810a, as depicted in
The distal component 822 has a graft material 825 having proximal and distal ends 823a and 823b, and a series of z-stents 830a-830g. In the example shown, the proximal three z-stents 830a-830c are attached to the inner circumference of the graft material 805, three other z-stents 830d-830f are attached to the outer diameter of the graft material 805, and a distal z-stent 830g is attached to the inner circumference of the graft material 805. However, like the proximal component 802, the z-stents of the distal component 822 may be attached to either the inner circumference or the outer diameter of the graft material 805.
The proximal end 823a of the graft material 825 may comprise one or more scallops 845. Preferably, a plurality of scallops 845 are provided that closely follow the shape of the proximal z-stent 830a, such that portions of the graft material 825 are cut out just proximal to the z-stent 830a, as shown in
At the distal end 823b of the distal component 822, there is also a distally extending z-stent stent 834, which has a proximal end that may be fastened to the graft 825 using sutures, and then is exposed distal to the graft material, as shown in
The proximal and distal components 802 and 822 may be introduced and deployed using separate deployment systems. In one embodiment, the proximal component 802 is introduced using a delivery system having a curved tip, while the distal component 822 is introduced using a delivery system having a straight tip.
When the stent graft device 800 of
Advantageously, when the stent graft device 800 of
Stent examples of the present invention may be constructed of NiTi alloys or other materials presently known or yet to be developed, all within the scope of the present invention. The stents preferably are made from Nitinol wire and will therefore be MRI compatible. In another preferable embodiment, a stent may be made from a laser-cut Nitinol cannula, effectively rendering it a seamless or nearly-seamless wire-like construction. Nitinol's superelastic properties will facilitate the stents ability to be crimped down into a low profile delivery system.
While various embodiments of the invention have been described, the invention is not to be restricted except in light of the attached claims and their equivalents. Moreover, the advantages described herein are not necessarily the only advantages of the invention and it is not necessarily expected that every embodiment of the invention will achieve all of the advantages described.
The present patent document is a continuation application that claims the benefit of priority under 35 U.S.C. § 120 of U.S. patent application Ser. No. 14/952,498, filed Nov. 25, 2015, which is a continuation of U.S. patent application Ser. No. 12/904,452, filed Oct. 14, 2010 (now U.S. Pat. No. 9,226,813), which is a continuation-in-part of U.S. patent application Ser. No. 12/332,904, filed Dec. 11, 2008 (now U.S. Pat. No. 9,180,030), which claims priority to U.S. Provisional Application Ser. No. 61/016,753, filed Dec. 26, 2007, each of which is incorporated herein by reference in its entirety.
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Number | Date | Country | |
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20180263796 A1 | Sep 2018 | US |
Number | Date | Country | |
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61016753 | Dec 2007 | US |
Number | Date | Country | |
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Parent | 14952498 | Nov 2015 | US |
Child | 15982523 | US | |
Parent | 12904452 | Oct 2010 | US |
Child | 14952498 | US |
Number | Date | Country | |
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Parent | 12332904 | Dec 2008 | US |
Child | 12904452 | US |