Process for Coating a Surface of a Metallic Stent

The present invention relates to a process for coating a surface of a metallic stent. In the prior art, it is known to coat a stent to protect the outer surface thereof and to make the stent inert to various biological processes that can occur when the stent is placed in the vascular system of a person. U.S. Pat. No. 5,330,500 to Song discloses a self-expanding endovascular stent with silicone coating. The Song stent is made of stainless steel wire formed into a closed zig-zag configuration. The frame is then wrapped in a mesh having a silicone coating thereon. The Song stent is typical of coated stents in that care has not been taken to preclude the coating agent from covering openings that are formed in the stent structures. The present invention overcomes the deficiencies of Song by providing a coated stent wherein the coating agent does not intrude into openings in the stent body that have been created for specific reasons.

The present invention relates to a process for coating a surface of a metallic stent. The inventive process includes the following steps:

(1) In the preferred embodiment, a metallic stent is manufactured in any suitable process. For example, a stent may be made using a laser cutting machine, a chemical etching machine, an electron beam cutting machine or any other device that manufactures a generally tubular stent having a plurality of slots formed through the surface thereof.

(2) After the stent has been so manufactured, the stent is electro-polished to remove any burrs or other surface irregularities that could damage a patient in whom the stent is to be implanted.

(3) After electro-polishing the stent, cleaning procedures are undertaken to remove surface contaminants and carbon deposits resulting from the cutting operations and electro-polishing. The stent is first placed in a bath of deionized water and is heated to boiling temperature for approximately one-half hour. The stent is then removed from the bath and is dried in a chamber for about twelve hours with the chamber being purged of any nitrogen gas.

(4) Thereafter, the stent is placed in a bath containing a suitable surfactant such as, for example, a long chain alkyl quaternary salt such as those obtained by reacting dodecylchloride with tridodecylamine. Alternatively, other salts may be employed that are suitable for use with high carbon solvents. These surfactants remove all residual carbon present on the stent surfaces.

(5) After the steps described above have been completed, the stent may be coated with an agent that is either synthetic or biological, active or inactive. Active agents include heparin and other anticoagulants, EDGF (endothelium derived growth factor), VGFs (vascular growth factors) or inactive agents like silicone, polyurethane, PTFE (polytetrafluoroethylene) and/or other polymers. Inactive (or inert) agents may have active agents such as those listed above encapsulated there within.

(6) In the coating process, the coating agent, whichever one is chosen, is placed in a suitable container such as, for example, a glass beaker. The container is placed in an ultrasonic bath that is filled with a liquid such as, for example, water or alcohol. When the ultrasonic bath is activated, the container sonicates. When the stent is placed inside the beaker filled with the coating agent, the stent swirls within the coating agent in a continuous fashion with the swirling being attributable to the ultrasonic energy that is passed from the liquid in the ultrasonic bath onto the coating agent within the container and thereafter into the stent. This energy transfer enables the coating agent to fill the surface crevices of the stent and form a uniform layer of coating while preventing the coating agent from filling the slots of the stent. If desired, a plurality of stents may be simultaneously subjected to the inventive process including placement of a plurality of such stents within the container to be subjected to ultrasonic energy.

(7) Thereafter, the stent is removed from the container and is dried in a controlled atmosphere.

As such, it is a first object of the present invention to provide a process for coating a surface of a metallic stent.

It is a further object of the present invention to provide such a process wherein the stent is coated but slots thereof are left open.

It is a yet further object of the present invention to provide such a process wherein the coating agent may be active or inactive.

It is a yet further object of the present invention to provide such a process that employs the use of ultrasonic energy to assure a uniform and complete coating.

These and other objects, aspects and features of the present invention will be better understood from the following detailed description of the preferred embodiment when read in conjunction with the appended drawing figures.

FIG. 1 shows a stent coated in accordance with the teachings of the invention disclosed in U.S. Pat. No. 5,330,500 to Song.

FIG. 2 shows a schematic representation of an ultrasonic bath.

FIG. 3 shows the ultrasonic bath of FIG. 2 with a container filled with coating material and a stent therein being coated.

FIG. 4 shows a stent coated in accordance with the teachings of the present invention.

With reference, first, to FIG. 4, a stent is generally designated by the reference numeral 10 and is seen to include a tubular body 11 having a plurality of slots 13 formed completely through the body. A coating 15 is formed on the inner and outer surface of the body 11 and, as seen in FIG. 4, the coating does not cover the slots 13.

By comparison with FIG. 4, FIG. 1 shows a stent 20 having a body 21 including slots 23 and a coating 25 formed thereon in accordance with the teachings of U.S. Pat. No. 5,330,500 to Song. As seen in FIG. 1, the coating 25 covers the slots 23 and obstructs them.

As is well known, stents are provided with slots or other openings because such slots or other openings are instrumental in facilitating the retention of a stent in its position of placement within the vascular system of the human body. The slots or other openings allow tissues to grow and/or protrude therethrough to facilitate firm fixation of an implanted stent. Obscuring or covering of the slots or other openings of a stent during a coating process creates a great risk of failure of a stent implantation operation.

In accordance with the teachings of the inventive process, a stent may be reliably coated without obscuring of the slots or other openings thereof.

As is well known, stents may be made through fabrication of a tubular form that is then subjected to the process of a laser cutting machine, a chemical etching machine, an electron beam cutting machine or other device designed to cut slots or other openings therethrough such as the openings 13 seen in FIG. 4. After the process has been completed, the surfaces of the stent may have surface irregularities such as burrs, nicks, rough edges and the like that could damage body tissues during the implantation process and thereafter. Thus, after a stent has been manufactured in the manner described above, it is customary to electro-polish the stent or polish it using some other suitable procedure to remove any such surface irregularities.

In accordance with the teachings of the present invention, after the stent has been suitably polished, it is placed in a bath of deionized water. The water is then heated to boiling temperature and the stent is retained therein for from fifteen minutes to forty-five minutes. Thereafter, the stent is removed from the bath and placed in a sealed chamber in which nitrogen gas is purged. The chamber is kept at a temperature within the range of 40.degree. C. to 80.degree. C. and at a pressure in the range of 2 psi to 14 psi. This drying step is carried out for a period of eight to twelve hours.

Thereafter, the stent is removed from the sealed chamber and placed in a bath containing a suitable surfactant that is intended to remove all residual carbon that might still be present on the stent surfaces. Applicant has found that surfactants suitable for use in this process step consist of long chain alkyl quaternary salts such as tridodecylammonium chloride obtained by reacting dodecychloride with tridodecylamine. Other salts may suitably be employed that contain high carbon solvents. Again, this step is included to best facilitate removal of any and all residual carbon that might still be present on the stent surfaces.

With reference to FIG. 2, an ultrasonic bath is generally designated by the reference numeral 30 and is seen to include a housing 31 having a surface 33 on which a bath chamber 35 is mounted. A liquid 37 such as water or alcohol fills the container 35. Within the housing 31, an ultrasonic generator (not shown) is contained and is designed to impart ultrasonic energy to the liquid 37 within the container 35. Such an ultrasonic generator is well known to those skilled in the art.

The next process step in the inventive process involves coating the stent 10 by immersing it in a coating material exposed to ultrasonic energy. In this regard, reference is made to FIG. 3 that shows a container 39 filled with coating agent 41 and with the stent 10 immersed therein.

Various coating agents may be employed using the inventive process. Such coating agents may be synthetic or biological, active or inactive. Active agents include heparin and other anticoagulants, EDGF (endothelium derived growth factor) or VGFs (vascular growth factors). Inactive agents (inert agents) may include silicon, polyurethane, PTFE (polytetrafluoroethylene) and/or other polymers. If desired, such inactive or inert agents may have active agents such as those listed above encapsulated there within.

With reference to FIG. 3, the coating agent 41 is placed within the container 39. The stent 10 is placed within the container 39 immersed within the coating agent 41. The ultrasonic generator is activated and causes the container 39 to "sonicate". Sonication of the container 39 causes the stent 10 to swirl within the coating agent 41, which swirling action is attributable to ultrasonic energy that is passed from the liquid 37 within the container 35 and thence into the container 39 and the coating agent 41. This action causes molecules of the coating agent to fill any and all surface crevices within the surface of the stent 10 to form a uniform coating layer while also, concurrently, preventing the coating agent from covering the slots 13 formed through the surface thereof.

After a prescribed period of time, within the range of two to ten minutes, the stent 10 is removed from the container 39 and is suitably dried in a controlled atmosphere.

In this way, a stent may be coated in a manner that precludes covering of the slots or other surface openings thereof so that the stent 10 may be suitably implanted in the vascular system of a human being while retaining its full intended function.

Accordingly, an invention has been disclosed in terms of a preferred process for coating a surface of a metallic stent of great novelty and utility.

Of course, various changes, modifications and alterations in the teachings of the inventive method may be contemplated by those skilled in the art without departing from the intended spirit and scope thereof.

As such, it is intended that the present invention only be limited by the terms of the appended claims.