U.S. patent application number 10/117484 was filed with the patent office on 2002-12-19 for method and apparatus for direct laser cutting of metal stents.
Invention is credited to Saunders, Richard J..
Application Number | 20020193866 10/117484 |
Document ID | / |
Family ID | 23355309 |
Filed Date | 2002-12-19 |
United States Patent
Application |
20020193866 |
Kind Code |
A1 |
Saunders, Richard J. |
December 19, 2002 |
Method and apparatus for direct laser cutting of metal stents
Abstract
An improved expandable stent for implantation in a body lumen,
such as an artery, and an improved method for making it from a
single length of tubing. The stent consists of a plurality of
radially expandable cut cylindrical elements generally aligned on a
common axis and interconnected by one or more interconnective
elements, the elements having a rectangular cross-section from
cut-to-cut. The individual radially expandable cylindrical elements
are disposed in an undulating pattern. The stent is manufactured by
direct laser cutting from a single metal tube using a finely
focused laser beam passing through a coaxial gas jet structure to
impinge on the working surface of the tube as the linear and rotary
velocity of the tube is precisely controlled.
Inventors: |
Saunders, Richard J.;
(Redwood City, CA) |
Correspondence
Address: |
FULWIDER PATTON LEE & UTECHT, LLP
HOWARD HUGHES CENTER
6060 CENTER DRIVE
TENTH FLOOR
LOS ANGELES
CA
90045
US
|
Family ID: |
23355309 |
Appl. No.: |
10/117484 |
Filed: |
April 5, 2002 |
Related U.S. Patent Documents
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Application
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Filing Date |
Patent Number |
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10117484 |
Apr 5, 2002 |
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09687313 |
Oct 13, 2000 |
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6369355 |
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09687313 |
Oct 13, 2000 |
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09114656 |
Jul 13, 1998 |
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6131266 |
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09114656 |
Jul 13, 1998 |
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08783698 |
Jan 15, 1997 |
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5780807 |
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08783698 |
Jan 15, 1997 |
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08345501 |
Nov 28, 1994 |
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Current U.S.
Class: |
623/1.15 ;
219/121.72 |
Current CPC
Class: |
A61F 2002/91533
20130101; B23K 26/1476 20130101; A61F 2230/0013 20130101; B23K
26/0823 20130101; B23K 2103/05 20180801; B23K 26/1435 20130101;
B23K 26/1438 20151001; G05B 2219/45171 20130101; G05B 2219/45041
20130101; G05B 19/182 20130101; B23K 26/1462 20151001; B23K 26/142
20151001; A61F 2/91 20130101; Y10T 29/49996 20150115; Y10T 29/49995
20150115; B23K 26/40 20130101; B23K 26/073 20130101; B23K 26/1436
20151001; B23K 26/18 20130101; B23K 2103/50 20180801; A61F 2/915
20130101; A61F 2002/91508 20130101 |
Class at
Publication: |
623/1.15 ;
219/121.72 |
International
Class: |
A61F 002/06; B23K
026/38 |
Claims
1. A longitudinal flexible stent for implanting in a body lumen,
comprising: a plurality of cut cylindrical elements which are
independently expandable in the radial direction and which are
interconnected so as to be generally aligned on a common
longitudinal axis, each cylindrical element having a rectangular
cross-section from one cut edge to another; and a plurality of
connecting elements for interconnecting said cut cylindrical
elements, said connecting elements configured to interconnect said
cylindrical elements that are adjacent to each other.
2. The stent of claim 1, wherein said plurality of cut cylindrical
elements include a plurality of peaks and valleys having a
serpentine pattern.
3. The stent of claim 2, wherein said plurality of peaks and
valleys include a plurality of U-shaped members, a plurality of
Y-shaped members, and a plurality of W-shaped members, some of said
U-shaped, Y-shaped, and W-shaped members being interconnected.
4. The stent of claim 1, wherein at least some of said plurality of
cut cylindrical elements tip radially outwardly to form outwardly
projecting edges upon radial expansion of said stent.
5. The stent of claim 1, wherein said cut cylindrical elements are
capable of retaining their expanded condition upon the expansion
thereof.
6. The stent of claim 1, wherein said stent is formed of stainless
steel.
7. The stent of claim 1, wherein said stent is formed from a single
piece of tubing.
8. A method of making an expandable metal stent, comprising the
steps of: supporting a metal tube for controlled linear and rotary
motion; impinging a finely focused laser beam upon the working
surface of said metal tube; and providing a protective mandrel
within said tube to protect the tube wall opposite the tube wall
being cut from being ablated by said laser beam, whereby a precise
pattern is cut into said tube to form said stent.
9. A method as set forth in claim 8, wherein said metal tube is
stainless steel.
10. A method as set forth in claim 8, wherein said protective
mandrel is stainless steel.
11. A method as set forth in claim 8, wherein said laser beam is
circularly polarized.
12. A method as set forth in claim 11, wherein said circular
polarization is accomplished by a quarter wave plate.
13. A method as set forth in claim 8, wherein said laser beam is
spatially filtered.
14. A method as set forth in claim 8, wherein the size of the
focused laser beam spot and depth of field is controlled by
selecting beam diameter.
15. A method as set forth in claim 8, wherein the size of the
focused laser beam spot and depth of field is controlled by
selecting focal length of the beam focusing lens.
16. A method as set forth in claim 8, wherein said laser beam
passes through a coaxial gas jet adjacent said tube.
17. A method as set forth in claim 16 wherein the gas is
oxygen.
18. A method as set forth in claim 8 and further including the
steps of: ultrasonically cleaning said stent after it is
formed.
19. A method as set forth in either of claim 1 or 18, and further
including the step of electro-polishing said stent after it is
formed.
Description
BACKGROUND OF THE INVENTION
[0001] This invention relates generally to improvements in the
manufacture of expandable metal stents and, more particularly, to
new and improved methods and apparatus for direct laser cutting of
metal stents and providing stents of enhanced structural
quality.
[0002] Stents are expandable endoprosthesis devices which are
adapted to be implanted into a patient's body lumen, such as a
blood vessel, to maintain the patency of the vessel. These devices
are typically used in the treatment of atherosclerotic stenosis in
blood vessels and the like.
[0003] 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. They are particularly suitable for use to
support and hold back a dissected arterial lining which can occlude
the fluid passageway.
[0004] Various means have been provided to deliver and implant
stents. One method frequently described for delivering a stent to a
desired intraluminal location includes mounting the expandable
stent on an expandable member, such as a balloon, provided on the
distal end of an intravascular catheter, advancing the catheter to
the desired location within the patient's body lumen, inflating the
balloon on the catheter to expand the stent into a permanent
expanded condition and then deflating the balloon and removing the
catheter.
[0005] One example of a particularly useful expandable stent is a
stent which is relatively flexible along its longitudinal axis to
facilitate delivery through tortuous body lumens, but which is
stiff and stable enough radially in an expanded condition to
maintain the patency of a body lumen such as an artery when
implanted within the lumen. Such a desirable stent typically
includes a plurality of radially expandable cylindrical elements
which are relatively independent in their ability to expand and to
flex relative to one another. The individual radially expandable
cylindrical elements of the stent are precisely dimensioned so as
to be longitudinally shorter than their own diameters.
Interconnecting elements or struts extending between adjacent
cylindrical elements provide increased stability and a preferable
position to prevent warping of the stent when it is expanded. The
resulting stent structure is a series of radially expandable
cylindrical elements which are spaced longitudinally close enough
so that small dissections in the wall of a body lumen may be
pressed back into position against the lumenal wall, but not so
close as to compromise the longitudinal flexibilities of the stent.
The individual cylindrical elements may rotate slightly relative to
adjacent cylindrical elements without significant deformation,
cumulatively giving a stent which is flexible along its length and
about its longitudinal axis, but is still very stiff in the radial
direction in order to resist collapse.
[0006] The aforedescribed stents generally have a precisely layed
out circumferential undulating pattern, e.g. serpentine. The
transverse cross-section of the undulating component of the
cylindrical element is relatively small and preferably has an apect
ratio of about two to one to about 0.5 to one. A one to one apect
ratio has been found particularly suitable. The open reticulated
structure of the stent allows for the perfusion of blood over a
large portion of the arterial wall which can improve the healing
and repair of a damaged arterial lining.
[0007] The radial expansion of the expandable cylinder deforms the
undulating pattern similar to changes in a waveform which result
from decreasing the waveform's amplitude and the frequency.
Preferably, the undulating patterns of the individual cylindrical
structures are in phase with each other in order to prevent the
contraction of the stent along its length when it is expanded. The
cylindrical structures of the stent are plastically deformed when
expanded so that the stent will remain in the expanded condition
and, therefore, they must be sufficiently rigid when expanded to
prevent their collapse in use. During expansion of the stent,
portions of the undulating pattern will tip outwardly resulting in
projecting members on the outer surface of the expanded stent.
These projecting members tip radially outwardly from the outer
surface of the stent and embed in the vessel wall and help secure
the expanded stent so that it does not move once it is
implanted.
[0008] The elongated elements which interconnect adjacent
cylindrical elements should have a precisely defined transverse
cross-section similar to the transverse dimensions of the
undulating components of the expandable cylindrical elements. The
interconnecting elements may be formed as a unitary structure with
the expandable cylindrical elements from the same intermediate
product, such as a tubular element, or they may be formed
independently and connected by suitable means, such as by welding
or by mechanically securing the ends of the interconnecting
elements to the ends of the expandable cylindrical elements.
Preferably, all of the interconnecting elements of a stent are
joined at either the peaks or the valleys of the undulating
structure of the cylindrical elements which form the stent. In this
manner, there is no shortening of the stent upon expansion.
[0009] The number and location of elements interconnecting adjacent
cylindrical elements can be varied in order to develop the desired
longitudinal flexibility in the stent structure both in the
unexpanded, as well as the expanded condition. These properties are
important to minimize alteration of the natural physiology of the
body lumen into which the stent is implanted and to maintain the
compliance of the body lumen which is internally supported by the
stent. Generally, the greater the longitudinal flexibility of the
stent, the easier and the more safely it can be delivered to the
implantation site.
[0010] It will be apparent from the foregoing that conventional
stents are very high precision, relatively fragile devices and,
ideally, the most desirable metal stents incorporate a 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 stainless tubes
in extremely fine geometries without damaging the narrow struts
that make up the stent structure. While the various cutting
processes, including chemical etching, heretofore utilized by the
prior art to form such expandable metal stents, have been adequate,
improvements have been sought to provide stents of enhanced
structural quality in terms of resolution, reliability and
yield.
[0011] Accordingly, those concerned with the development,
manufacture and use of metal stents have long recognized the need
for improved manufacturing processes for such stents. The present
invention fulfills these needs.
SUMMARY OF THE INVENTION
[0012] Briefly, and in general terms, the present invention
provides a new and improved method and apparatus for direct laser
cutting of metal stents enabling greater precision, reliability,
structural integrity and overall quality, without burrs, slag or
other imperfections which might otherwise hamper stent integrity
and performance.
[0013] Basically, the present invention provides an improved system
for producing metal stents with a fine precision structure cut from
a small diameter, thin-walled, cylindrical tube. The tubes are
typically made of stainless steel and are fixtured under a laser
and positioned utilizing a CNC 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 the precise
positioning of the laser cutting path.
[0014] In a presently preferred embodiment of the invention, in
order to minimize the heat input, which prevents thermal
distortion, uncontrolled burn out of the metal, and metallurgical
damage due to excessive heat, a Q-switched Nd/YAG laser that is
frequency doubled to produce a green beam at 532 nanometers is
utilized. Q-switching produces very short pulses (<100 nS) of
high peak powers (kilowatts), low energy per pulse (.ltoreq.3 mJ),
at high pulse rates (up to 40 kHz). The frequency doubling of the
beam from 1.06 microns to 0.532 microns allows the beam to be
focused to a spot size that is 2 times smaller and, therefore,
increases the power density by a factor of four. With all of these
parameters, it is possible to make smooth, narrow cuts in the
stainless tubes in very fine geometries without damaging the narrow
struts that make up to stent structure.
[0015] In addition to the laser and the CNC positioning equipment,
the optical delivery system utilized in the practice of the present
invention, includes a beam expander to increase the laser beam
diameter, a circular polarizer to eliminate polarization effects in
metal cutting, provisions for a spatial filter, a binocular viewing
head and focusing lens, and a coaxial gas jet that provides for the
introduction of a gas stream that surrounds the focused beam and is
directed along the beam axis. The coaxial gas jet nozzle is
centered around the focused beam with approximately 0.010" between
the tip of the nozzle and the tubing. The jet is pressurized with
oxygen at 20 psi and is directed at the tube with the focused laser
beam exiting the tip of the nozzle. The oxygen reacts with the
metal to assist in the cutting process very similar to oxyacetylene
cutting. The focused laser beam acts as an ignition source and
controls the reaction of the oxygen with the metal. In this manner,
it is possible to cut the material with a very fine kerf with
precision. In order to prevent burning by the beam and/or molten
slag on the far wall of the tube inside diameter, a stainless steel
mandrel is placed inside the tube and is allowed to toll on the
bottom of the tube as the pattern is cut. This acts as a
beam/debris block protecting the far wall inside diameter.
[0016] The cutting process utilizing oxygen with the finely focused
green beam results in a very narrow kerf (approx. 0.0005") with the
molten slag re-solidifying along the cut. This traps the cut out
scrap of the pattern and requires further processing. In order to
remove the slag debris from the cut allowing the scrap to be
removed from the remaining stent pattern, it is desirable to soak
the cut tube in a solution of HCL for a selected time and
temperature. Before it is soaked, the tube is placed in a bath of
alcohol/water solution and ultrasonically cleaned for approximately
1 minute to remove the loose debris left from the cutting
operation. After soaking, the tube is then ultrasonically cleaned
in the heated HCL for a period of time dependent upon the wall
thickness. To prevent cracking/breaking of the struts attached to
the material left at the two ends of the stent pattern due to
harmonic oscillations induced by the ultrasonic cleaner, a mandrel
is placed down the center of the tube during the cleaning/scrap
removal process. At completion of this process, the stent
structures are rinsed in water. They are then ready for
electropolishing.
[0017] Hence, the new and improved method and apparatus for direct
laser cutting of metal stents, in accordance with the present
invention, makes accurate, reliable, high resolution, expandable
stents with patterns having smooth, narrow cuts and very fine
geometries.
[0018] The above and other objects and advantages of this invention
will be apparent from the following more detailed description when
taken in conjunction with the accompanying drawings of exemplary
embodiments.
DESCRIPTION OF THE DRAWINGS
[0019] FIG. 1 is an elevational view, partially in section, of a
stent embodying features of the invention which is mounted on a
delivery catheter and disposed within a damaged artery;
[0020] FIG. 2 is an elevational view, partially in section, similar
to that shown in FIG. 1 wherein the stent is expanded within a
damaged artery, pressing the damaged lining against the arterial
wall;
[0021] FIG. 3 is an elevational view, partially in section showing
the expanded stent within the artery after withdrawal of the
delivery catheter;
[0022] FIG. 4 is a perspective view of a stent embodying in an
unexpanded state, with one end of the stent being shown in an
exploded view to illustrate the details thereof;
[0023] FIG. 5 is a plan view of a flattened section of a stent of
the invention which illustrates the undulating pattern of the stent
shown in FIG. 4;
[0024] FIG. 5a is a sectional view taken along the line 5a-5a in
FIG. 5;
[0025] FIG. 6 is a schematic representation of equipment for
selectively cutting the tubing in the manufacture of stents, in
accordance with the present invention;
[0026] FIG. 7 is an elevational view of a system for cutting an
appropriate pattern by laser in a metal tube to form a stent, in
accordance with the invention;
[0027] FIG. 8 is a plan view of the laser head and optical delivery
subsystem for the laser cutting system shown in FIG. 7;
[0028] FIG. 9 is an elevational view of a coaxial gas jet, rotary
collet, tube support and beam blocking apparatus for use in the
system of FIG. 7;
[0029] FIG. 10 is a sectional view taken along the line 10-10 in
FIG. 9;
[0030] FIG. 11 is an elevational and schematic drawing of laser
beam diameter vs. spot size and depth of focus; and
[0031] FIG. 12 is an elevational and schematic drawing of focal
length vs. spot size and depth of focus.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0032] Referring now to the drawings, and particularly FIG. 1
thereof, there is shown a stent 10 which is mounted onto a delivery
catheter 11. The stent 10 is a high precision patterned tubular
device. The stent 10 typically comprises a plurality of radially
expanded cylindrical elements 12 disposed generally coaxially and
interconnected by elements 13 disposed between adjacent cylindrical
elements. The delivery catheter 11 has an expandable portion or
balloon 14 for expanding of the stent 10 within an artery 15. The
artery 15, as shown in FIG. 1 has a dissected lining 16 which has
occluded a portion of the arterial passageway.
[0033] The typical delivery catheter 11 onto which the stent 10 is
mounted, is essentially the same as a conventional balloon
dilatation catheter for angioplasty procedures. The balloon 14 may
be formed of suitable materials such as polyethylene, polyethylene
terephthalate, polyvinyl chloride, nylon and ionomers such as
Surlyn.RTM. manufactured by the Polymer Products Division of the Du
Pont Company. Other polymers may also be used. In order for the
stent 10 to remain in place on the balloon 14 during delivery to
the site of the damage within the artery 15, the stent 10 is
compressed onto the balloon. A retractable protective delivery
sleeve 20 as described in copending application Ser. No. 07/647,464
filed on April 25, 1990 and entitled STENT DELIVERY SYSTEM may be
provided to further ensure that the stent stays in place on the
expandable portion of the delivery catheter 11 and prevent abrasion
of the body lumen by the open surface of the stent 20 during
delivery to the desired arterial location. Other means for securing
the stent 10 onto the balloon 14 may also be used, such as
providing collars or ridges on the ends of the working portion,
i.e. the cylindrical portion, of the balloon.
[0034] Each radially expandable cylindrical element 12 of the stent
10 may be independently expanded. Therefore, the balloon 14 may be
provided with an inflated shape other than cylindrical, e.g.
tapered, to facilitate implantation of the stent 10 in a variety of
body lumen shapes.
[0035] The delivery of the stent 10 is accomplished in the
following manner. The stent 10 is first mounted onto the inflatable
balloon 14 on the distal extremity of the delivery catheter 11. The
balloon 14 is slightly inflated to secure the stent 10 onto the
exterior of the balloon. The catheter-stent assembly is introduced
within the patient's vasculature in a conventional Seldinger
technique through a guiding catheter (not shown). A guidewire 18 is
disposed across the damaged arterial section with the detached or
dissected lining 16 and then the catheter-stent assembly is
advanced over a guidewire 18 within the artery 15 until the stent
10 is directly under the detached lining 16. The balloon 14 of the
catheter is expanded, expanding the stent 10 against the artery 15,
which is illustrated in FIG. 2. While not shown in the drawing, the
artery 15 is preferably expanded slightly by the expansion of the
stent 10 to seat or otherwise fix the stent 10 to prevent movement.
In some circumstances during the treatment of stenotic portions of
an artery, the artery may have to be expanded considerably in order
to facilitate passage of blood or other fluid therethrough.
[0036] The stent 10 serves to hold open the artery 15 after the
catheter 11 is withdrawn, as illustrated by FIG. 3. Due to the
formation of the stent 10 from elongated tubular member, the
undulating component of the cylindrical elements of the stent 10 is
relatively flat in transverse cross-section, so that when the stent
is expanded, the cylindrical elements are pressed into the wall of
the artery 15 and as a result do not interfere with the blood flow
through the artery 15. The cylindrical elements 12 of the stent 10
which are pressed into the wall of the artery 15 will eventually be
covered with endothelial cell growth which further minimizes blood
flow interference. The undulating portion of the cylindrical
sections 12 provide good tacking characteristics to prevent stent
movement within the artery. Furthermore, the closely spaced
cylindrical elements 12 at regular intervals provide uniform
support for the wall of the artery 15, and consequently are well
adapted to tack up and hold in place small flaps or dissections in
the wall of the artery 15, as illustrated in FIGS. 2 and 3.
[0037] FIG. 4 is an enlarged perspective view of the stent 10 shown
in FIG. 1 with one end of the stent shown in an exploded view to
illustrate in greater detail the placement of interconnecting
elements 13 between adjacent radially expandable cylindrical
elements 12. Each pair of the interconnecting elements 13 on one
side of a cylindrical element 12 are preferably placed to achieve
maximum flexibility for a stent. In the embodiment shown in FIG. 4,
the stent 10 has three interconnecting elements 13 between adjacent
radially expandable cylindrical elements 12 which are 120.degree.
apart. Each pair of interconnecting elements 13 on one side of a
cylindrical element 12 are offset radially 60.degree. from the pair
on the other side of the cylindrical element. The alternation of
the interconnecting elements results in a stent which is
longitudinally flexible in essentially all directions. Various
configurations for the placement of interconnecting elements are
possible. However, as previously mentioned, all of the
interconnecting elements of an individual stent should be secured
to either the peaks or valleys of the undulating structural
elements in order to prevent shortening of the stent during the
expansion thereof.
[0038] The number of undulations may also be varied to accommodate
placement of interconnecting elements 13, e.g. at the peaks of the
undulations or along the sides of the undulations as shown in FIG.
5.
[0039] As best observed in FIGS. 4 and 5, cylindrical elements 12
are in the form of a serpentine pattern 30. As previously
mentioned, each cylindrical element 12 is connected by
interconnecting elements 13. Serpentine pattern 30 is made up of a
plurality of U-shaped members 31, W-shaped members 32, and Y-shaped
members 33, each having a different radius so that expansion forces
are more evenly distributed over the various members.
[0040] The afordescribed illustrative stent 10 and similar stent
structures can be made in many ways. However, the preferred method
of making the stent is to cut a thin-walled tubular member, such as
stainless steel tubing to remove portions of the tubing in the
desired pattern for the stent, leaving relatively untouched the
portions of the metallic tubing which are to form the stent. In
accordance with the invention, it is preferred to cut the tubing in
the desired pattern by means of a machine-controlled laser as
illustrated schematically in FIG. 6.
[0041] The tubing may be made of suitable biocompatible material
such as stainless steel. The stainless steel tube may be Alloy
type: 316L SS, Special Chemistry per ASTM F138-92 or ASTM F139-92
grade 2. Special Chemistry of type 316L per ASTM F138-92 or ASTM
F139-92 Stainless Steel for Surgical Implants in weight
percent.
1 Carbon (C) 0.03% max. Manganese (Mn) 2.00% max. Phosphorous (P)
0.025% max. Sulphur (S) 0.010% max. Silicon (Si) 0.75% max.
Chromium (Cr) 17.00-19.00% Nickel (Ni) 13.00-15.50% Molybdenum (Mo)
2.00-3.00% Nitrogen (N) 0.10% max. Copper (Cu) 0.50% max. Iron (Fe)
Balance
[0042] The stent diameter is very small, so the tubing from which
it is made must necessarily also have a small diameter. Typically
the stent has an outer diameter on the order of about 0.06 inch in
the unexpanded condition, the same outer diameter of the tubing
from which it is made, and can be expanded to an outer diameter of
0.1 inch or more. The wall thickness of the tubing is about 0.003
inch.
[0043] Referring to FIG. 6, the tubing 21 is put in a rotatable
collet fixture 22 of a machine-controlled apparatus 23 for
positioning the tubing 21 relative to a laser 24. According to
machine-encoded instructions, the tubing 21 is rotated and moved
longitudinally relative to the laser 24 which is also
machine-controlled. The laser selectively removes the material from
the tubing by ablation and a pattern is cut into the tube. The tube
is therefore cut into the discrete pattern of the finished
stent.
[0044] The process of cutting a pattern for the stent into the
tubing is automated except for loading and unloading the length of
tubing. Referring again to FIG. 6 it may be done, for example,
using a CNC-opposing collet fixture 22 for axial rotation of the
length of tubing, in conjunction with a CNC X/Y table 25 to move
the length of tubing axially relatively to a machine-controlled
laser as described. The entire space between collets can be
patterned using the CO.sub.2 laser set-up of the foregoing example.
The program for control of the apparatus is dependent on the
particular configuration used and the pattern to be ablated in the
coating.
[0045] Referring now to FIGS. 7-10 of the drawings, there is shown
a process and apparatus, in accordance with the invention, for
producing metal stents with a fine precision structure cut from a
small diameter thin-walled cylindrical tube. Cutting a fine
structure (0.0035" web width) requires minimal heat input and the
ability to manipulate the tube with precision. It is also necessary
to support the tube yet not allow the stent structure to distort
during the cutting operation. In order to successfully achieve the
desired end results, the entire system must be configured very
carefully. The tubes are made of stainless steel with an outside
diameter of 0.060" to 0.066" and a wall thickness of 0.002" to
0.004". These tubes are fixtured under a laser and positioned
utilizing a CNC to generate a very intricate and precise pattern.
Due to the thin wall and the small geometry of the stent pattern
(0.0035" typical web width), it is necessary to have very precise
control of the laser, its power level, the focused spot size, and
the precise positioning of the laser cutting path.
[0046] In order to minimize the heat input into the stent
structure, which prevents thermal distortion, uncontrolled burn out
of the metal, and metallurgical damage due to excessive heat, and
thereby produce a smooth debris free cut, a Q-switched Nd/YAG,
typically available from Quantronix of Hauppauge, N.Y., that is
frequency doubled to produce a green beam at 532 nanometers is
utilized. Q-switching produces very short pulses (<100 nS) of
high peak powers (kilowatts), low energy per pulse (.ltoreq.3 mJ),
at high pulse rates (up to 40 kHz). The frequency doubling of the
beam from 1.06 microns to 0.532 microns allows the beam to be
focused to a spot size that is 2 times smaller, therefore
increasing the power density by a factor of 4 times. With all of
these parameters, it is possible to make smooth, narrow cuts in the
stainless tubes in very fine geometries without damaging the narrow
struts that make up to stent structure. Hence, the system of the
present invention makes it possible to adjust the laser parameters
to cut narrow kerf width which will minimize the heat input into
the material.
[0047] The positioning of the tubular structure requires the use of
precision CNC equipment such as that manufactured and sold by
Anorad Corporation. In addition, a unique rotary mechanism has been
provided that allows the computer program to be written as if the
pattern were being cut from a flat sheet. This allows both circular
and linear interpolation to be utilized in programming. Since the
finished structure of the stent is very small, a precision drive
mechanism is required that supports and drives both ends of the
tubular structure as it is cut. Since both ends are driven, they
must be aligned and precisely synchronized, otherwise the stent
structure would twist and distort as it is being cut. A suitable
computer program for controlling the CNC equipment is enclosed
herewith as Appendix A.
[0048] The optical system which expands the original laser beam,
delivers the beam through a viewing head and focuses the beam onto
the surface of the tube, incorporates a coaxial gas jet and nozzle
that helps to remove debris from the kerf and cools the region
where the beam interacts with the material as the beam cuts and
vaporizes the metal. It is also necessary to block the beam as it
cuts through the top surface of the tube and prevent the beam,
along with the molten metal and debris from the cut, from impinging
on the opposite surface of the tube.
[0049] In addition to the laser and the CNC positioning equipment,
the optical delivery system includes a beam expander to increase
the laser beam diameter, a circular polarizer, typically in the
form of a quarter wave plate, to eliminate polarization effects in
metal cutting, provisions for a spatial filter, a binocular viewing
head and focusing lens, and a coaxial gas jet that provides for the
introduction of a gas stream that surrounds the focused beam and is
directed along the beam axis. The coaxial gas jet nozzle (0.018"
I.D.) is centered around the focused beam with approximately 0.010"
between the tip of the nozzle and the tubing. The jet is
pressurized with oxygen at 20 psi and is directed at the tube with
the focused laser beam exiting the tip of the nozzle (0.018" dia.)
The oxygen reacts with the metal to assist in the cutting process
very similar to oxyacetylene cutting. The focused laser beam acts
as an ignition source and controls the reaction of the oxygen with
the metal. In this manner, it is possible to cut the material with
a very fine kerf with precision. In order to prevent burning by the
beam and/or molten slag on the far wall of the tube I.D., a
stainless steel mandrel (approx. 0.034" dia.) is placed inside the
tube and is allowed to roll on the bottom of the tube as the
pattern is cut. This acts as a beam/debris block protecting the far
wall I.D.
[0050] Alternatively, this may be accomplished by inserting a
second tube inside the stent tube which has an opening to trap the
excess energy in the beam which is transmitted through the kerf
along which collecting the debris that is ejected from the laser
cut kerf. A vacuum or positive pressure can be placed in this
shielding tube to remove the collection of debris.
[0051] Another technique that could be utilized to remove the
debris from the kerf and cool the surrounding material would be to
use the inner beam blocking tube as an internal gas jet. By sealing
one end of the tube and making a small hole in the side and placing
it directly under the focused laser beam, gas pressure could be
applied creating a small jet that would force the debris out of
the, laser cut kerf from the inside out. This would eliminate any
debris from forming or collecting on the inside of the stent
structure. It would place all the debris on the outside. With the
use of special protective coatings, the resultant debris can be
easily removed.
[0052] In most cases, the gas utilized in the jets may be reactive
or non-reactive (inert). In the case of reactive gas, oxygen or
compressed air is used. Compressed air is used in this application
since it offers more control of the material removed and reduces
the thermal effects of the material itself. Inert gas such as
argon, helium, or nitrogen can be used to eliminate any oxidation
of the cut material. The result is a cut edge with no oxidation,
but there is usually a tail of molten material that collects along
the exit side of the gas jet that must be mechanically or
chemically removed after the cutting operation.
[0053] The cutting process utilizing oxygen with the finely focused
green beam results in a very narrow kerf (approx. 0.0005") with the
molten slag re-solidifying along the cut. This traps the cut out
scrap of the pattern requiring further processing. In order to
remove the slag debris from the cut allowing the scrap to be
removed from the remaining stent pattern, it is necessary to soak
the cut tube in a solution of HCL for approximately 8 minutes at a
temperature of approximately 55.degree. C. Before it is soaked, the
tube is placed in a bath of alcohol/water solution and
ultrasonically cleaned for approximately 1 minute to remove the
loose debris left from the cutting operation. After soaking, the
tube is then ultrasonically cleaned in the heated HCL for 1-4
minutes depending upon the wall thickness. To prevent
cracking/breaking of the struts attached to the material left at
the two ends of the stent pattern due to harmonic oscillations
induced by the ultrasonic cleaner, a mandrel is placed down the
center of the tube during the cleaning/scrap removal process. At
completion of this process, the stent structures are rinsed in
water. They are now ready for electropolishing.
[0054] The stents are preferably electrochemically polished in an
acidic aqueous solution such as a solution of ELECTRO-GLO #300,
sold by the ELECTRO-GLO Co., Inc. in Chicago, Ill., which is a
mixture of sulfuric acid, carboxylic acids, phosphates, corrosion
inhibitors and a biodegradable surface active agent. The bath
temperature is maintained at about 110-135.degree. F. and the
current density is about 0.4 to about 1.5 amps per in..sup.2.
Cathode to anode area should be at least about two to one. The
stents may be further treated if desired, for example by applying a
biocompatible coating.
[0055] Referring now more particularly to FIGS. 11 and 12, it will
be apparent that both focused laser spot size and depth of focus
can be controlled by selecting beam diameter (FIG. 11) and focal
length for the focusing lens (FIG. 12). It will be apparent from
FIGS. 11 and 12 that increasing laser beam diameter, or reducing
lens focal length, reduces spot size at the cost of depth of
field.
[0056] Direct laser cutting produces edges which are essentially
perpendicular to the axis of the laser cutting beam, in contrast
with chemical etching and the like which produce pattern edges
which are angled. Hence, the laser cutting process of the present
invention essentially provides stent cross-sections, from
cut-to-cut, which are square or rectangular, rather than
trapezoidal; see FIG. 5a. The resulting stent structure provides
superior performance.
[0057] It will be apparent from the foregoing that the present
invention provides a new and improved method and apparatus for
direct laser cutting of metal stents enabling greater precision,
reliability, structural integrity and overall quality, without
burrs, slag or other imperfections which might otherwise hamper
stent integrity and performance. While the invention has been
illustrated and described herein in terms of its use as an
intravascular stent, it will be apparent to those skilled in the
art that the stent can be used in other instances such as to expand
prostatic urethras in cases of prostate hyperplasia. Other
modifications and improvements may be made without departing from
the scope of the invention.
[0058] It will be apparent from the foregoing that, while
particular forms of the invention have been illustrated and
described, various modifications can be made without departing from
the spirit and scope of the invention. Accordingly, it is not
intended that the invention be limited, except as by the appended
claims.
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