Patent Application
20120057813
The invention relates generally to improvements in the manufacture of expandable stents and, more particularly, to new and improved methods and apparatus for direct laser cutting of stents in providing stents of enhanced structural quality.
Stents are expandable endoprosthesis devices which are adapted to be implanted into a patient's body lumen, such as a blood vessel or coronary artery, to maintain the patency of the artery. These devices are typically used in the treatment of atherosclerotic stenosis in blood vessels, coronary arteries, and the like.
In the medical arts, stents are generally tubular-shaped devices which function to hold open a segment of a blood vessel or other anatomical lumen. Stents are very high precision, relatively fragile devices and, ideally, the most desirable stents incorporate a very fine precision structure cut from a very small diameter, thin-walled cylindrical tube. In this regard, it is extremely important to make precisely dimensioned, smooth, narrow cuts in the thin-walled tubing in extremely fine geometries without damaging the narrow struts that make up the stent structure. Prior art stents typically are cut by a laser and held by collet in a computer controlled machine that translates and rotates the stent as the laser cuts through the outer surface of the metal tubing. In order to stabilize the stent tubing, typically a bushing surrounds the stent tubing and is positioned between the laser and the collet holding the stent. Prior art bearings or bushings create a small amount of friction between the stent tubing and the bearing which can cause slight imperfections in the laser cutting process as the stent tubing is moved relative to the bearing.
Accordingly, the manufacturers of stents have long recognized the need for improved manufacturing processes and to reduce the amount of friction between the bearing and the stent tubing during the laser cutting process. The present invention fulfills these needs.
In general terms, the present invention provides a new and improved method and apparatus for direct laser cutting stents by enabling greater precision, reliability, structural integrity and overall quality.
The present invention provides an improved system for producing stents with a fine precision structure cut from a small diameter, thin-walled, cylindrical tube. The tubes are typically made of stainless steel, other biocompatible materials, or biodegradable materials, and are fixtured under a laser and positioned utilizing a CNC machine to generate a very intricate and precise pattern. Due to the thin wall and the small geometry of the stent pattern, it is necessary to have very precise control of the laser, its power level, the focus spot size, and, importantly, the precise positioning of the laser cutting path.
In keeping with the invention, a stent tubing is held in a collet in a CNC machine so that the stent tubing is able to rotate and translate relative to a fixed laser beam. In order to support the stent tubing, a bearing or bushing supports the stent tubing just proximal to the laser beam (between the collet and the laser beam). In this manner, the stent tubing is prevented from sagging or deflecting away from the laser beam, which would otherwise create inaccuracies in the cut stent pattern. In the present invention, a fluid bearing includes a housing having a gas inlet port and a fluid inlet port on its outer surface. A bearing is positioned within the housing and the bearing has multiple blades that are aligned with the gas inlet port on the housing. The bearing is free to rotate within the housing without touching the housing. The gas inlet port is positioned to inject a high pressure gas on the blades in order to impart a high speed rotation of the bearing within the housing. The fluid inlet port on the housing is positioned to inject fluid onto an inner surface of the bearing so that as the bearing rotates at high speed, a thin film of fluid adheres to the inner surface of the bearing. The stent tubing is inserted through an inner diameter of the bearing so that the bearing supports the stent tubing just proximal of the laser beam. As the bearing rotates at high speed, on the order of about 1,000 to 10,000 rpm (or higher), the film of fluid adheres to the inner surface of the bearing so that the film of fluid is between the inner surface of the bearing and the outer surface of the stent tubing. Since the bearing is rotating at high speed and a film of fluid is formed between the inner surface of the bearing and the outer surface of the stent tubing, the stent tubing is centered within the bearing thereby creating a near frictionless environment as the stent tubing translates and rotates relative to the laser beam. The fluid film has very low friction and will not place a significant resistive load on the stent tubing as the collet or CNC system rotates and translates the stent tubing relative to the laser beam.
The advantages of the present invention will be apparent from the following more detailed description when taken in conjunction with the accompanying drawings of exemplary embodiments.
Referring to
In keeping with the present invention, as shown in
In further keeping with the invention, a fluid bearing 20 is provided to support the stent tubing 18. More specifically, the fluid bearing includes a housing 22 that will be anchored at one end so that the housing is stationary and firmly supports the stent tubing. The housing has a gas inlet port 24 and a fluid inlet port 26 on its outer surface 28. Depending upon the specific requirements, more than one gas inlet port 24 and fluid inlet port 26 can be provided and spaced along the outer surface 28 of the housing 22. Typically, the multiple gas inlet ports or fluid inlet ports would extend in alignment circumferentially around the outer surface 28 of the housing 22. A bearing 30 is contained within the housing 22 so that the bearing can rotate at high speed within the housing without hitting or touching the walls of the housing. The bearing 30 has one or more blades 32 that are positioned in grooves 33 in the housing 22 which align with the gas inlet port 24. When high pressure gas is injected into gas inlet port 24, the gas will impinge on the blades 32 thereby causing the bearing 30 to rotate at high speeds. For example, it is contemplated that the bearing 30 will rotate at speeds between 1,000 rpm up to 10,000 rpm. In another embodiment, it may be appropriate for the bearing 30 to rotate at speeds between 10,000 rpm up to 100,000 rpm.
With reference in particular to
In use, the present invention provides a low friction fluid film between the bearing and the stent tubing so that the amount of friction between the bearing and the stent tubing is substantially reduced from the prior art devices. Again, referring to
In one embodiment, the space between the blades 32 and the grooves 33 in the housing 22 may be sufficient to allow the high pressure gas to be directed toward the stent tubing. This serves several purposes including allowing the gas to exhaust from the bearing 30, thereby allowing more gas to be injected to drive the bearing rotation. Further, as the gas exhausts, it may exert a pressure in the direction opposite to the flow of fluid along the stent tubing thereby forcing fluid out of the space between the bearing 30 and the stent tubing 18 in only one direction. This will prevent contamination of the region opposite to the exit location, namely where the laser is cutting the pattern in the stent tubing.
In an alternative embodiment, the blades 32 may be either flat fins or have a tilted configuration such as the blades found in a turbine (not shown). In either configuration, the grooves 33 that receive the blades 32 will be configured to accommodate the blades as the bearing 30 rotates. Further, the blades also can have a curved configuration and still provide the rotational forces on the bearing as described. In one embodiment, the blades have a rectangular shape and are substantially flat fins.
The fluid used with the present invention can be water, saline or any thin oil such as a mineral oil. Further, the high pressure gas typically will be air.
The housing 22 can be formed from any rigid material such as stainless steel, while the bearing 30 is formed from a low friction material such as a polymer, including such polymers such as PTFE.
It will be apparent from the foregoing that the present invention provides a new and improved method and apparatus for laser cutting stents thereby enabling greater precision, reliability and overall quality in forming precise stent patterns in stent tubing. Other modifications and improvements may be made without departing from the scope of the invention. Accordingly, it is not intended that the invention be limited, except by the appended claims.
