Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Stent combined with surgical delivery system
Reexamination Certificate
2001-06-27
2003-06-03
Hale, Gloria M. (Department: 3765)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Stent combined with surgical delivery system
C623S001150
Reexamination Certificate
active
06572644
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a stent mounting device and a method of coating a stent using the device.
2. Description of the Background
Blood vessel occlusions are commonly treated by mechanically enhancing blood flow in the affected vessels, such as by employing a stent. Stents act as scaffoldings, functioning to physically hold open and, if desired, to expand the wall of the passageway. Typically stents are capable of being compressed, so that they can be inserted through small lumens via catheters, and then expanded to a larger diameter once they are at the desired location. Examples in the patent literature disclosing stents include U.S. Pat. No. 4,733,665 issued to Palmaz, U.S. Pat. No. 4,800,882 issued to Gianturco, and U.S. Pat. No. 4,886,062 issued to Wiktor.
FIG. 1
illustrates a conventional stent
10
formed from a plurality of struts
12
. The plurality of struts
12
are radially expandable and interconnected by connecting elements
14
that are disposed between adjacent struts
12
, leaving lateral openings or gaps
16
between adjacent struts
12
. Struts
12
and connecting elements
14
define a tubular stent body having an outer, tissue-contacting surface and an inner surface. Struts
12
that are located at the respective ends of the tubular stent body are referred to herein as end rings
18
.
Stents are used not only for mechanical intervention but also as vehicles for providing biological therapy. Biological therapy can be achieved by medicating the stents. Medicated stents provide for the local administration of a therapeutic substance at the diseased site. Local delivery of a therapeutic substance is a preferred method of treatment because the substance is concentrated at a specific site and thus smaller total levels of medication can be administered in comparison to systemic dosages that often produce adverse or even toxic side effects for the patient.
One method of medicating a stent involves the use of a polymeric carrier coated onto the surface of the stent. A composition including a solvent, a polymer dissolved in the solvent, and a therapeutic substance dispersed in the blend is applied to the stent by immersing the stent in the composition or by spraying the composition onto the stent. The solvent is allowed to evaporate, leaving on the stent strut surfaces a coating of the polymer and the therapeutic substance impregnated in the polymer.
A shortcoming of the above-described method of medicating a stent is the potential for coating defects. While some coating defects can be minimized by adjusting the coating parameters, other defects occur due to the nature of the interface between the stent and the apparatus on which the stent is supported during the coating process. A high degree of surface contact between the stent and the supporting apparatus can provide regions in which the liquid composition can flow, wick, and collect as the composition is applied. As the solvent evaporates, the excess composition hardens to form excess coating on or between the stent struts. Upon the removal of the coated stent from the supporting apparatus, the excess coating may stick to the apparatus, thereby removing some of the coating from the stent and leaving bare areas. Alternatively, the excess coating may stick to the stent, thereby leaving excess coating as clumps or pools on the struts or webbing between the struts.
Thus, it is desirable to minimize the interface between the stent and the apparatus supporting the stent during the coating process to minimize coating defects. Accordingly, the present invention provides for a device for supporting a stent during the coating application process. The invention also provides for a method of coating the stent supported by the device.
SUMMARY OF THE INVENTION
The present invention provides a device for supporting a stent during the application of a coating to the stent. The method includes a body configured to penetrate at least partially into the stent and members protruding out from the body for preventing any contact between the inner surface of the stent and the outer surface of the body. The members can be arranged about the circumference of the body and can be circular in shape. In one embodiment, the device additionally includes slots in the outer surface of the body for receiving some of the coating material that comes into contact with the body.
Also provided is a mandrel for supporting a stent. The mandrel includes a body for being at least partially inserted in a hollow body of a stent. The mandrel also includes at least two members projecting out of the body and capable of being in contact with the inner surface of the stent. In one embodiment, the mandrel additionally includes grooves positioned in the body for receiving and containing excess coating substance applied to the stent.
The present invention also provides a method of coating a stent. The method includes positioning a stent over a mandrel having members projecting out of the mandrel, wherein at least one of the members is in contact with the inner surface of the stent. The method also includes applying a coating material to the stent.
REFERENCES:
patent: 4733665 (1988-03-01), Palmaz
patent: 4800882 (1989-01-01), Gianturco
patent: 4886062 (1989-12-01), Wiktor
patent: 5788626 (1998-08-01), Thompson
patent: 5895407 (1999-04-01), Jayaraman
patent: 5897911 (1999-04-01), Loeffler
patent: 5922393 (1999-07-01), Jayaraman
patent: 6010573 (2000-01-01), Bowlin
patent: 6120847 (2000-09-01), Yang et al.
patent: 6153252 (2000-11-01), Hossainy et al.
patent: 6258121 (2001-07-01), Yang et al.
patent: 6322847 (2001-11-01), Zhong et al.
patent: 6364903 (2002-04-01), Tseng et al.
patent: 6387118 (2002-05-01), Hanson
Plaridel K. Villareal, A Stent Mounting Device And A Method Of Using The Same To Coat A Stent, May 31, 2001, Ser. No. 09/873,020.
Inventor: Plaridel K. Villareal; Application Ser. No.: 09/873,020; Filed May 31, 2001; Title: A Stent Mounting Device And A Method Of Using The Same To Coat A Stent.
Advanced Cardiovascular Systems Inc.
Hale Gloria M.
Squire Sanders & Dempsey L.L.P.
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