The treatment of coronary artery disease (CAD) dates back to the late 1920s, when cardiac catheterization was first implemented in the human body by Werner Forssmann. Building on the developments by various researchers, expandable meshed metallic scaffolding, called a stent, was introduced in the 1980s. The development of biodegradable materials has enabled the development of two major types of biodegradable stents, the polymer-based stent and the metal-based stent, which have increasingly attracted attention, especially in the last twenty years. The good balance of biocompatibility, biodegradability, and mechanical strength of magnesium alloys make them promising materials for metallic biodegradable stents.
Embodiments of the present disclosure are related to polishing techniques for tubular workpieces such as, e.g., stents and other flexible or rigid tubes.
In one embodiment, among others, a method comprises supporting a tubular workpiece on a rod that extends axially through the tubular workpiece; positioning an outer surface of a turning wheel against an external surface of the tubular workpiece, where the outer surface comprises abrasive particles and the external surface of the tubular workpiece is held against the outer surface by magnetic attraction between the rod and the turning wheel; and rotating the tubular workpiece by rotating the turning wheel, where the external surface of the tubular workpiece is polished by the abrasive particles during rotation of the tubular workpiece. In one or more aspects of these embodiments, the tubular workpiece can be axially oscillated on the rod during rotation. The turning wheel can have a cylindrical-shape or barrel-shape with a center diameter greater than an end diameter of the magnetic turning wheel. In one or more aspects of these embodiments, the method can comprise rocking the rod about a center of the turning wheel thereby producing an axial reciprocation of the tubular workpiece. An internal surface of the tubular workpiece can be polished during rotation of the tubular workpiece. The rod can be wrapped in a thread or fiber. The tubular workpiece can be a flexible tubular workpiece or a straight tubular workpiece. The flexible tubular workpiece can be a stent.
In another embodiment, a polishing system comprises a workpiece holder comprising a rod configured to axially support a tubular workpiece; a turning wheel comprising an internal magnet and abrasive particles distributed about an outer surface of the turning wheel; a wheel support assembly configured to position the outer surface of the turning wheel against the external surface of the tubular workpiece supported by the rod, where the external surface of the tubular workpiece is held against the outer surface by magnetic attraction between the rod and the internal magnet; and a turning wheel drive configured to turn the tubular workpiece on the rod by rotating the turning wheel, where the external surface of the tubular workpiece is polished by the abrasive particles during rotation of the tubular workpiece. In one or more aspects of these embodiments, the workpiece holder can be configured to axially oscillate the tubular workpiece on the rod during rotation by the turning wheel. The workpiece holder can be tilted in a rocking motion to cause the tubular workpiece to axially oscillate while rotating. The workpiece holder can be oscillated to axially reciprocate the tubular workpiece when rotated.
In one or more aspects of these embodiments, the turning wheel can have a cylindrical-shape or barrel-shape with a center diameter greater than an end diameter of the turning wheel. The outer surface of the turning wheel can include one or more layers of cushioning. The internal magnet can be a permanent magnet. The rod can be made of ferromagnetic materials. The rod can be coated with non-ferromagnetic materials. The rod can be wrapped in a thread or fiber. In one or more aspects of these embodiments, the abrasive particles can comprise abrasive particles having a mean diameter of less than or equal to 4 μm. The abrasive particles can have a mean diameter of less than or equal to 1 μm. The tubular workpiece can be a straight tubular workpiece or flexible tubular workpiece. The tubular workpiece can be a biodegradable stent.
Other systems, methods, features, and advantages of the present disclosure will be or become apparent to one with skill in the art upon examination of the following drawings and detailed description. It is intended that all such additional systems, methods, features, and advantages be included within this description, be within the scope of the present disclosure, and be protected by the accompanying claims. In addition, all optional and preferred features and modifications of the described embodiments are usable in all aspects of the disclosure taught herein. Furthermore, the individual features of the dependent claims, as well as all optional and preferred features and modifications of the described embodiments are combinable and interchangeable with one another.
Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present disclosure. Moreover, in the drawings, like reference numerals designate corresponding parts throughout the several views.
Disclosed herein are various embodiments of methods related to polishing of flexible tubes such as, e.g., stents. Polishing can be carried out on internal and/or external surfaces of the flexible tubes. Reference will now be made in detail to the description of the embodiments as illustrated in the drawings, wherein like reference numbers indicate like parts throughout the several views.
The development of biodegradable materials has enabled the development of two major types of biodegradable stents, the polymer-based stent and the metal-based stent, which have increasingly attracted attention. Magnesium alloys are promising materials for metallic biodegradable stent manufacturing because of their good balance of biocompatibility, biodegradability, and mechanical strength. In some implementations, magnesium alloy stents can be coated with biodegradable polymers (e.g., PLLA), and/or antiproliferative and antithrombosis drugs, to slow down the degradation rate. In order to achieve enhanced coatability and an effective rate of degradation, surface finishing can be used for smoothing the surface and removing burrs produced by the heat ablation of the laser-cutting operation used to produce the meshed stent. This disclosure presents a finishing processing principle for flexible tubes such as, e.g., magnesium alloy stents and describes an experimental setup designed to realize the principle. Finishing experiments were conducted using magnesium alloy tubes and stents to demonstrate the feasibility and finishing characteristics of the process.
Magnesium alloy stent manufacturing processes begin with cutting an ingot into cylindrical billets, and then hot-extruding the billets into tubes (e.g., with an outer diameter of about 3 mm, approximately 220 μm thick, and about 1 m long). The tubes are then annealed for the later cold drawing. The annealed thin-wall tubes can be repeatedly thinned by drawing and annealing processes until the tubes reach the thickness and outside diameter (e.g., about 150 μm thick and about 1.8 mm in diameter). A laser-cutting method can be used to generate the meshed tubular geometry through accurate and flexible cuts (e.g., with movement within 1-2 μm). Annealing can release the residual stresses created by the drawing and laser cutting, however burrs and surface defects from the heat ablation can remain on the outside surface of the stent.
Surface quality is important for biodegradable stents because it affects not only the coatability, but also eases the insertion and the rate of degradation in the human body. Research on magnesium alloy AZ91 showed that the surface roughness can generally influence the rate of corrosion. Increasing the surface roughness can affect the passivation tendency and increases the pitting susceptibility of the alloy. Therefore, an effective finishing process can prolong the life of the stent and prevent damage to the arterial vessel in which it is implanted.
This disclosure describes the processing principle and finishing equipment developed to realize surface finishing of stents. This disclosure also includes a description of the finishing characteristics and the identification of parameters that help to prove the concept.
Processing Principle and Finishing Equipment
Minimizing the creation of uneven stress in a stent during finishing can avoid impairing the stent's performance. Unlike workpieces finished with other mechanical machining processes, stents should not be rigidly clamped or chucked for finishing. Referring to
Referring next to
Surface Finishing of Stents
Modification of Experimental Setup.
Axial reciprocation of the workpiece 109 avoids repeatedly tracing the same paths on the surface, and can reduce or eliminate periodic scratches and ridges by creating a cross-hatch pattern on the workpiece surface. The axial reciprocation can be achieved by alternating the friction distribution between the turning wheel 106 and the ends of workpiece 109. By changing the tilt of the workpiece holder 203, the contact point with the workpiece 109 can be varied to linearly moves the workpiece 109 along the rod 112. Oscillation can be used to tilt the workpiece holder 203 up and down, and this up-and-down oscillation of the workpiece holder 203 can cause the workpiece 109 to oscillate axially while rotating.
Referring to
Referring to
Some finishing trials with tubes 109 showed that the lower friction between the workpiece 109 and wheel surface at the middle part of the workpiece 109 resulted in less finishing action in that area compared to the ends of workpiece 109. To overcome this issue, the wheel diameter was increased at the area corresponding to the middle of workpiece 109. An arc radius of 80 mm was empirically chosen for the wheel-surface geometry, resulting in a barrel-shaped wheel 106. The barrel shape was generated in this case by a clay mold. As the clay dried, cracks appeared in the surface, but they were covered by wool felt (1.59 mm thick), which replaced the surgical tape applied beneath the gaffer tape.
Polishing of the inner surface of the stent or workpiece 109 can be provided by the polishing system. Since the rod 112 exerts a force against the inner surface, it may be polished by the relative motion between the two. Due to the mesh-like geometry of a stent 109, abrasive 115 introduced to the stent 109 will travel between the two surfaces through the gaps. In addition to finishing the side-walls of the stent 109, the abrasive 115 can promote polishing of the inner surface of the stent 109. To improve the polishing results, the rod 112 can wrapped with, e.g., fiber or thread before mounting the workpiece 109 on the rod 112. The wrapping can create a buffer of one or more layers between the rod 112 and the inner surface of the workpiece 109 that prevents ionization, and may assist in holding the abrasive 115 in place.
Finishing Characteristics of Stents.
AZ61 alloy stents (Ø1.8×Ø1.5×17 mm) were prepared as workpieces 109 for the finishing trials. Each stent 109 was held with a Ø1×70 mm carbon steel rod 112 (
After finishing for four cycles of 5 minutes each (Test 1-Test 4), the external surface roughness was smoothed from 0.15-0.52 μm Sa to 0.02-0.14 μm Sa, and the internal surface roughness was smoothed from 0.27-0.54 μm Sa to 0.16-0.34 μm Sa.
The design of the workpiece 109 includes many holes to make it intrinsically deformable. This complicated the contact conditions between the wheel 106, workpiece 109, and rod 112; and raises difficulties in making stable contact between the wheel 106 and workpiece 109 while finishing. Although the external surface was well finished as illustrated in
Testing was also carried out with a rod 112 wrapped with 100% polyester thread 803. The polishing process was carried out for 5 minutes with an abrasive 115 including diamond powder (0-1 μm diameter), a rotational speed of the wheel 106 of 200 min−1, and a tilting angle of ±1.1°.
Applications of the disclosed finishing process and finishing system include:
It should be emphasized that the above-described embodiments of the present disclosure are merely possible examples of implementations set forth for a clear understanding of the principles of the disclosure. Many variations and modifications may be made to the above-described embodiment(s) without departing substantially from the spirit and principles of the disclosure. All such modifications and variations are intended to be included herein within the scope of this disclosure and protected by the following claims.
It should be noted that ratios, concentrations, amounts, and other numerical data may be expressed herein in a range format. It is to be understood that such a range format is used for convenience and brevity, and thus, should be interpreted in a flexible manner to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. To illustrate, a concentration range of “about 0.1% to about 5%” should be interpreted to include not only the explicitly recited concentration of about 0.1 wt % to about 5 wt %, but also include individual concentrations (e.g., 1%, 2%, 3%, and 4%) and the sub-ranges (e.g., 0.5%, 1.1%, 2.2%, 3.3%, and 4.4%) within the indicated range. The term “about” can include traditional rounding according to significant figures of numerical values. In addition, the phrase “about ‘x’ to ‘y’” includes “about ‘x’ to about ‘y’”.
This application is the 35 U.S.C. § 371 national stage application of PCT Application No. PCT/US2016/056800, filed Oct. 13, 2016, which claims priority to, and the benefit of U.S. provisional application entitled “Polishing Technique for Flexible Tubes” having Ser. No. 62/242,040, filed Oct. 15, 2015, both of which are which is hereby incorporated by reference in its entirety their entireties.
Filing Document | Filing Date | Country | Kind |
---|---|---|---|
PCT/US2016/056800 | 10/13/2016 | WO | 00 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2017/066420 | 4/20/2017 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
2818688 | Lennart | Jan 1958 | A |
2831296 | Griggs | Apr 1958 | A |
3594955 | Collin | Jul 1971 | A |
4580370 | Smith | Apr 1986 | A |
4656789 | Schwar | Apr 1987 | A |
8708778 | Greenslet | Apr 2014 | B2 |
8915769 | Kamikihara | Dec 2014 | B2 |
10632585 | Greenslet | Apr 2020 | B2 |
20030216109 | Riviere | Nov 2003 | A1 |
20060065518 | Aiura et al. | Mar 2006 | A1 |
20110301691 | Kamikihara | Dec 2011 | A1 |
20180311781 | Greenslet | Nov 2018 | A1 |
20190366501 | Greenslet | Dec 2019 | A1 |
Entry |
---|
International Search Report in co-pending, related PCT Application No. PCT/US16/56800, dated Jan. 12, 2017. |
Forssmann-Falck, R., 1997, Werner Forssmann: A Pioneer of Cardiology, The American Journal of Cardiology, vol. 79, No. 5, pp. 651-660. |
Htay, T., and Liu, M.W., 2005, Drug-eluting Stent: A Review and Update., Vascular Health and Risk Management, vol. 1, No. 4, pp. 263-276. |
Hermawan, H., Dubé, D., and Mantovani, D., 2010, Developments in Metallic Biodegradable Stents, Acta Biomaterialia, vol. 6, No. 5, pp. 1693-1697. |
Walter, R., and Kannan, M.B., 2011, Influence of Surface Roughness on the Corrosion Behaviour of Magnesium Alloy, Materials and Design, vol. 32, No. 4, pp. 2350-2354. |
Number | Date | Country | |
---|---|---|---|
20180311781 A1 | Nov 2018 | US |
Number | Date | Country | |
---|---|---|---|
62242040 | Oct 2015 | US |