Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Stent structure
Reexamination Certificate
1999-10-05
2001-10-16
Thaler, Michael H. (Department: 3731)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Stent structure
C623S001150
Reexamination Certificate
active
06302907
ABSTRACT:
TECHNICAL FIELD
The present invention relates generally to endoluminal grafts or “stents” and, more specifically, to a flexible stent advantageous for use in a curved or tortuous lumen.
BACKGROUND OF THE INVENTION
A stent is an elongated device used to support an intraluminal wall. In the case of a stenosis, a stent provides an unobstructed conduit for blood in the area of the stenosis. An intraluminal prosthesis may comprise a stent that carries a prosthetic graft layer of fabric. Such a prosthesis may be used, for example, to treat a vascular aneurysm by removing the pressure on a weakened part of an artery so as to reduce the risk of rupture. Typically, an intraluminal stent or prosthesis is implanted in a blood vessel at the site of a stenosis or aneurysm endoluminally, i.e. by so-called “minimally invasive techniques” in which the stent, restrained in a radially compressed configuration by a sheath or catheter, is delivered by a stent deployment system or “introducer” to the site where it is required. The introducer may enter the body through the patient's skin, or by a “cut down” technique in which the entry blood vessel is exposed by minor surgical means. When the introducer has been threaded into the body lumen to the stent deployment location, the introducer is manipulated to cause the stent to be ejected from the surrounding sheath or catheter in which it is restrained (or alternatively the surrounding sheath or catheter is retracted from the stent), whereupon the stent expands to a predetermined diameter at the deployment location, and the introducer is withdrawn. Stent expansion may be effected by spring elasticity, balloon expansion, or by the self-expansion of a thermally or stress-induced return of a memory material to a pre-conditioned expanded configuration.
Some locations in which stents may be implanted are tortuous in nature, such as the aortic arch for thoracic aneurysm treatment. Additionally, the aneurysm may gradually change in volume after implantation of the stent (known in the art as D3 and H3 shrinkage). Known stents may not be flexible enough to adjust to the tortuosity of the lumen along its length or to changes in the aneurysm after implantation. Thus, it would be useful to have a more flexible stent to accommodate such situations.
SUMMARY OF THE INVENTION
The present invention comprises a generally tubular intraluminal compound stent comprising a plurality of component stents, each component stent having a length and a plurality of individual hoops axially disposed along the length and connected by a connecting spine. The component stents are meshed with one another such that at least one hoop of one component stent is positioned between axially adjacent hoops of another component stent. Each component stent may comprise a single wire, each hoop comprising a circumferential winding of the wire, and the connecting spine comprising at least one connecting spine member comprising an extension of the wire between adjacent hoops. Each connecting spine may traverse each component stent circumferentially in a helical pattern, wherein the spine of at least one component stent is oriented in a different helical direction than the helical direction of the spine of another component stent in the compound stent. The compound stent may consist essentially of a first component stent having a first connecting spine and a second component stent having a second connecting spine. The hoops of the first component stent may be axially interspersed with the hoops of the second component stent in an alternating pattern, such as a single hoop alternating pattern. The first connecting spine may be helically oriented in a clockwise direction and the second connecting spine oriented in a counter-clockwise direction.
Each hoop may further have a periphery comprising a pattern of zig-zags having apices, wherein adjacent hoops of the meshed stents are aligned such that the apices of adjoining hoops abut or are interdigitated with one another. The compound stent may further comprise connectors, such as sutures, connecting at least some of the abutting or interdigitated apices.
The invention also comprises a process for manufacture of a compound stent having a length, the method comprising creating a plurality of component stents, each component stent having a length and a plurality of hoops axially disposed along the length and connected by a connecting spine. The process comprises meshing the plurality of component stents together such that at least one hoop of one component stent is positioned between axially adjacent hoops of another component stent. Each hoop of each stent may further comprise a pattern of zig-zags having apices in which case the method further comprises meshing the component stents so that the apices of adjacent hoops of the meshed component stents abut or are interdigitated with one another. The process may further comprise connecting at least some of the abutting or interdigitated apices with one another. Creating each component stent may comprise creating each component stent by winding a single wire circumferentially to form each hoop and extending connecting spine members between adjacent hoops, aligning the connecting spine members such that the connecting spine members collectively form a connecting spine oriented in a helical pattern. In such case, the process further comprises creating at least one of the component stents with a connecting spine that traverses the component stent in a helical orientation opposite the helical orientation of the connecting spines of the other component stents, so that meshing the component stents together comprises crossing the oppositely-oriented helical spines in at least one location along the compound stent.
It is to be understood that both the foregoing general description and the following detailed description are exemplary, but are not restrictive, of the invention.
REFERENCES:
patent: 5613981 (1997-03-01), Boyle et al.
patent: 5800515 (1998-09-01), Nadal et al.
patent: 5843158 (1998-12-01), Lenker et al.
patent: 5855596 (1999-01-01), Acciai et al.
patent: 6015432 (2000-01-01), Rakos et al.
patent: 6090127 (2000-07-01), Globerman
patent: 6117165 (2000-09-01), Becker
Ngo Lien
Ratner & Prestia
Sci-Med Life Systems, Inc.
Thaler Michael H.
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