Implantable endoprosthesis with patterned terminated ends...

Details Implantable endoprosthesis with patterned terminated ends... Implantable endoprosthesis with patterned terminated ends...

1998-06-30

2001-04-17

Millin, V. (Department: 3738)

Prosthesis (i.e., artificial body members), parts thereof, or ai

Arterial prosthesis

Stent structure

C623S001130

Reexamination Certificate

active

06217609

ABSTRACT:

1. Field of the Invention
This invention relates to a braided implantable endoprosthesis with patterned terminated ends and a method for making a braided implantable endoprosthesis using a trim-line to maximize elongated member end orientation and to aid member crossing control during constrainment. More particularly, the invention relates to a stent or stent-graft having ends or openings with a crown or saw-tooth shape to enable efficient deployment or recapture thereof in a delivery device.
2. Background of the Disclosure
U.S. Pat. No. 5,221,261, entitled,
Radiably Expandable Fixation Member,
discloses an open weave fixation device secured to a distal end of a catheter or other diagnostic or treatment device, for either temporarily or permanently fixing the device within a body cavity.
U.S. Pat. No. B1 4,655,771, entitled,
Prosthesis Comprising Expansible or Contractile Tubular Body,
discloses a prosthesis comprising a flexible tubular body for transluminal implantation.
U.S. Pat. No. 5,026,377, entitled,
Stent Placement Instrument and Method,
discloses an instrument for the deployment or retraction of a self-expanding stent in body canal.
U.S. Pat. No. 5,061,275, entitled,
Self
-
Expanding Prosthesis,
discloses a resilient, elastic self-expanding prosthesis comprising a flexible tubular body.
U.S. Pat. No. 5,064,435, entitled,
Self
-
Expanding Prosthesis Having Stable Axial Length,
discloses a body implantable stent that consists of two or more generally tubular coaxial and slidably connected stent segments. The axially outward and non-overlapping portions of the stent can be designed for secure fixation to the tissue wall segment, for example, as radially outward flares.
U.S. Pat. No. 5,607,466, entitled,
Catheter With a Stent,
discloses a catheter with a self-expanding stent of a permeable mesh of stiff intersecting fibers.
U.S. Pat. Nos. 5,628,787 and 5,630,840, entitled,
Clad Composite Stent,
discloses a body compatible stent formed of multiple filaments arranged in two sets of oppositely directed helical windings interwoven with one another in a braided configuration. Each of the filaments is a composite including a central core and a case surrounding the core.
U.S. Pat. No. 5,645,559, entitled,
Multiple Layer Stent,
discloses a radially self-expanding stent having multiple layers.
U.S. Pat. No. 5,653,684, entitled,
Catheter With Expandable Member Mesh Tip,
discloses a catheter with a flexible-member mesh tip movably attached at a distal end of the catheter.
U.S. Pat. No. 5,667,486, entitled,
Prostatic Stent,
discloses a prostatic stent. The proximal section has a shape conforming to the neck of the urinary bladder.
U.S. Pat. No. 5,718,159, entitled,
Process for Manufacturing Three
-
Dimensional Braided Covered Stent,
discloses a prosthesis having a flexible tubular three-dimensionally braided structure of metal or polymeric non-filaments, and polymeric multifilament yarns.
U.S. Pat. No. 5,741,333, entitled,
Self
-
Expanding Stent For A Medical
-
Device To Be Introduced Into A Cavity Of A Body,
discloses a self-expanding stent.
European published patent application EP 0 740 928 A2 discloses a self-expandable stent with paired members.
The referenced patents disclosed herein are incorporated by reference in their entireties and made a part hereof for all purposes.
SUMMARY OF THE INVENTION
The present invention optimizes elongated member orientation and control during the constrainment and expansion cycles of self-expanding braided stents and stent-grafts. Use of the crown trim method principles may be applied to a braided implantable endoprosthesis having braid pattern configurations greater than 1-over-1-under. The invention includes trimming elongated member ends at predetermined termini in order to provide an optimum trim length at a point on the elongated member where each predetermined terminus terminates control over another member, for example, a certain crossing point. When trimmed, a crown or saw-tooth-like pattern emerges as certain portions of the elongated members are removed from the endoprosthesis. The saw-tooth pattern is continued around the desired trim-line, for example, a circumference at one or more of the ends of the endoprosthesis.
The 1-over-1-under braid pattern configuration in a WALLSTENT® endoprosthesis works well for deployment/recapture. To achieve similar deployment and recapture performance for greater than 1-over-1-under braid configuration patterns, for example, 2-over-2-under; 2-over-1-under; 1-over-2-under; 3-over-3-under; 3-over-2-under; 2-over-3-under; 3-over-1-under; 1-over-3-under; 4-over-4-under; 4-over-3-under; 3-over-4-under; 4-over-2-under; 2-over-4-under; 4-over-1-under; 1-over-4-under; 5-over-5-under; 5-over-4-under; 4-over-5-under; 5-over-3-under; 3-over-5-under; 5-over-2-under; 2-over-5-under; 5-over-1-under; 1-over-5-under, treatment along a predetermined trim-line of at least one of the ends is preferred for smooth deployment and recapture. Other braid pattern configurations and combinations greater than 5-over-5-under are also envisioned.
The following definitions are used herein for reference and descriptive purposes in the application. Elongated members refers to wire, filaments, multistranded cables and yarns fashioned of synthetic or natural polymers including plastics, metals or composites having any generally cross-section or homogeneity including solid, cored, hollow or DFT sections. Resilient refers to any flexible material having a restoring capability if flexed less than required to permanently deform; for example, spring-like and self-supporting materials. Saw-toothed refers to generally triangular shaped teeth found on a saw and a pattern formed at the desired trim-line. Crown, crown-cut or crown-like refers to the saw-tooth-like shape of the termination patterns at the end portions or trim-line. Other configurations including corrugations, scallops, crenelations, serrations, notches and the like, whether repetitive or random, that provide the desired results are encompassed within the scope of saw-toothed or crown. Terminus refers to a certain point where an elongated member is cut. Termini refers to a series of more than one terminus.
For reference, a braid becomes a stent after annealing. Annealing of the braid relaxes the stresses in the members and sets the shape of the endoprosthesis. Braid angle refers to the included angle between interbraided members of the braid, in the axial orientation, prior to annealing. Filament crossing angle refers to the included angle of the stent after annealing.
The present invention provides a unique stepped layering of the elongated members, assuring that the terminus do not substantially contact the exterior tube wall when mounted, deployed or recaptured. Along a trim-line, the terminus distance to the applicable control point is minimized or optimized to ensure that each member is long enough to supply control or interaction to adjacent elongated members.
An advantage of the implantable endoprosthesis and the associated method described herein is generally reduced scraping and delivery system perforation and particulate generation.
In sum, the invention relates to a braided medical device such as an implantable endoprosthesis with patterned terminated ends including a first number of elongated members wound helically in a first common direction and crossing a second number of elongated members wound helically in a second common direction. The crossings of the first and second elongated members define an angle therebetween and a plurality of control points. The first and second elongated members are braided in a braid pattern greater than 1-over-1-under. A tubular body is formed of the first and second elongated members and has ends and a middle portion therebetween. The tubular body is constrainable to a reduced diameter size and is self-expandable to an increased diameter size. A passage at least partially through the tubular body extends in a longitudinal direction. At least a portion of a saw-tooth pattern is formed on at least one of the e

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