U.S. patent application number 13/847996 was filed with the patent office on 2013-10-31 for methods of making devices.
The applicant listed for this patent is Advanced Bio Prosthetic Surfaces, Ltd., a wholly owned subsidiary of Palmaz Scientific, Inc.. Invention is credited to Steven R. BAILEY, Christopher E. BANAS, Christopher T. BOYLE, Julio C. PALMAZ.
Application Number | 20130287931 13/847996 |
Document ID | / |
Family ID | 24842723 |
Filed Date | 2013-10-31 |
United States Patent
Application |
20130287931 |
Kind Code |
A1 |
PALMAZ; Julio C. ; et
al. |
October 31, 2013 |
METHODS OF MAKING DEVICES
Abstract
The method of making devices is disclosed herein. More
particularly, a method of manufacturing a device, comprises: vacuum
depositing a device-forming metal onto an unpatterned, exterior
surface of a generally cylindrical substrate to form a generally
tubular, unpatterned crystalline metal film under at least one
vacuum deposition process condition selected from at least one of
chamber pressure, deposition pressure, and partial pressure of a
process gas, said at least one process condition optimized to
substantially eliminate formation of chemical and intra- and
intergranular precipitates in the bulk material; and removing the
deposited generally tubular, unpatterned crystalline metal film
from the generally cylindrical substrate.
Inventors: |
PALMAZ; Julio C.; (Napa,
CA) ; BAILEY; Steven R.; (San Antonio, TX) ;
BOYLE; Christopher T.; (Flushing, NY) ; BANAS;
Christopher E.; (Breckenridge, CO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Advanced Bio Prosthetic Surfaces, Ltd., a wholly owned subsidiary
of Palmaz Scientific, Inc. |
Dallas |
TX |
US |
|
|
Family ID: |
24842723 |
Appl. No.: |
13/847996 |
Filed: |
March 20, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
09707685 |
Nov 7, 2000 |
|
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13847996 |
|
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Current U.S.
Class: |
427/2.25 ;
204/192.1 |
Current CPC
Class: |
A61F 2002/91558
20130101; A61F 2250/0014 20130101; A61F 2002/91516 20130101; A61F
2002/91575 20130101; A61F 2002/91566 20130101; A61F 2002/91583
20130101; A61F 2002/91533 20130101; A61F 2/91 20130101; C23C 14/042
20130101; C23C 14/34 20130101; A61F 2220/0058 20130101; A61F 2/915
20130101; A61F 2210/0076 20130101; C23C 14/0005 20130101; A61F
2002/072 20130101; C23C 14/221 20130101; A61F 2250/0026 20130101;
A61F 2002/9155 20130101; A61F 2002/91508 20130101; A61F 2002/30322
20130101 |
Class at
Publication: |
427/2.25 ;
204/192.1 |
International
Class: |
C23C 14/00 20060101
C23C014/00; C23C 14/22 20060101 C23C014/22; C23C 14/34 20060101
C23C014/34; C23C 14/04 20060101 C23C014/04 |
Claims
1. A method of manufacturing a device, comprising: a. vacuum
depositing a device-forming metal onto an unpatterned, exterior
surface of a generally cylindrical substrate to form a generally
tubular, unpatterned crystalline metal film under at least one
vacuum deposition process condition selected from at least one of
chamber pressure, deposition pressure, and partial pressure of a
process gas, said at least one process condition optimized to
substantially eliminate formation of chemical and intra- and
intergranular precipitates in the bulk material; and b. removing
the deposited generally tubular, unpatterned crystalline metal film
from the generally cylindrical substrate.
2. The method according to claim 1, further comprising a step of
depositing a sacrificial material layer onto the substrate prior to
step (a) and removing the sacrificial material layer in order to
remove the deposited generally tubular, unpatterned crystalline
metal film from the substrate in step (b), and wherein the process
condition controlled is a deposition rate and the deposition rate
is no less than about 20 nm/sec.
3. The method according to claim 1, wherein step (a) is conducted
by ion beam-assisted evaporative deposition.
4. The method according to claim 1, wherein step (a) is conducted
by sputtering.
5. The method according to claim 3, wherein the ion beam-assisted
evaporative deposition is conducted in the presence of an inert
gas.
6. A method of manufacturing a metal, comprising: a. vacuum
depositing a metal onto an unpatterned, exterior surface of a
generally cylindrical substrate to form a generally tubular,
unpatterned crystalline metal film under at least one vacuum
deposition process condition selected from at least one of chamber
pressure, deposition pressure, and partial pressure of a process
gas, said at least one process condition optimized to minimize
formation of chemical and intra- and intergranular precipitates in
the bulk material; b. defining the plurality of first and second
structural elements in the unpatterned metal film; and c. removing
the first and second structural elements from the generally
cylindrical substrate.
7. The method according to claim 6, further comprising a step of
depositing a sacrificial material layer onto the substrate prior to
step (a) and removing the sacrificial material layer in order to
remove the first and second structural elements from the substrate
in step (c).
8. The method according to claim 6, wherein step (a) is conducted
by ion beam-assisted evaporative deposition.
9. The method according to claim 6, wherein step (a) is conducted
by sputtering.
10. The method according to claim 8, wherein the ion beam-assisted
evaporative deposition is conducted in the presence of an inert
gas.
11. The method according to claim 10, wherein the inert gas is
selected from the group consisting of argon, xenon, nitrogen and
neon.
12. The method according to claim 6, wherein the process condition
controlled is a deposition rate and the deposition rate is no less
than about 20 nm/sec.
13. The method according to claim 6, wherein during the deposition
of the metal, the substrate is rotated.
14. A method of manufacturing a device, comprising: a. vacuum
depositing nickel and titanium onto an exterior surface of a
generally cylindrical substrate to form a deposited generally
tubular, crystalline nickel-titanium shape memory film having no
less than about 51.5 atomic percent nickel, the vacuum deposition
occurring under at least one vacuum deposition process condition
selected from at least one of chamber pressure, deposition
pressure, and partial pressure of a process gas, said at least one
process condition optimized to minimize formation of inter- and
intra-granular precipitates in the bulk material of the
nickel-titanium crystalline film; and b. removing the deposited
generally tubular, crystalline nickel-titanium shape memory film
from the generally cylindrical substrate.
15. The method according to claim 14, wherein the deposited
generally tubular film of nickel-titanium has a composition of
between about 51.5 and about 55.0 atomic percent nickel.
16. The method according to claim 14, wherein during the deposition
of the nickel and titanium, the substrate is rotated, and wherein
the process condition controlled is a deposition rate and the
deposition rate is no less than about 20 nm/sec.
17. The method according to claim 14, wherein a source of the
nickel and the titanium to be deposited is a nickel-titanium
alloy.
18. The method according to claim 14, wherein a source of the
nickel and the titanium to be deposited is a binary nickel-titanium
alloy.
19. The method according to claim 14, further comprising, prior to
step (a), a step of imparting a pattern defining the first and
second structural elements onto the exterior surface of the
substrate, and wherein the pattern is transferred to the tubular
film of nickel-titanium during step (a).
20. The method according to claim 14, further comprising a step of
imparting a pattern defining the first and second structural
elements onto the tubular film of nickel-titanium after step (a).
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation application of co-pending
U.S. patent application, Ser. No. 09/707,685, filed Nov. 7, 2000,
and is related to U.S. patent application, Ser. No. 11/327,795,
filed Jan. 6, 2006, herein incorporated by reference in their
entireties.
BACKGROUND
[0002] The present invention relates generally to a method of
making devices. More particularly, the present invention relates to
manufacturing metal devices with radial or hoop strength and
longitudinal flexibility, while maximizing fatigue life and
corrosion resistance.
[0003] Metal devices utilize inherent material mechanical
properties of the metal material. Typically, metal materials may
rebound when a positive pressure is exerted against the material.
Finally, shape-memory metals rely upon unique alloys that exhibit
shape memory under certain thermal conditions. Conventional
shape-memory is typically nickel-titanium alloys known generically
as nitinol, which have a transition phase at or near normal body
temperature, i.e., 37 degrees Centigrade.
[0004] One of the difficulties with many conventional metal designs
arises due to the conflicting criteria between the desired
properties of circumferential or hoop strength, longitudinal or
column strength, longitudinal flexibility, fish-scaling of
individual structural members, fatigue life, corrosion resistance,
corrosion fatigue, hemodynamics, radioopacity and biocompatibility.
Typically, metals that are designed to optimize for hoop strength
typically sacrifice either column strength and/or longitudinal
flexibility, while metals that are designed to optimize for column
strength often compromise longitudinal flexibility and/or hoop
strength.
[0005] Heretofore, however, the art has not devised a unibody metal
structural element geometry which achieves a balance between hoop
strength, column strength and longitudinal flexibility,
circumferential strength or hoop strength of the stent,
longitudinal strength or column strength, longitudinal flexibility,
fish-scaling of individual structural members of the stent, fatigue
life, corrosion resistance, corrosion fatigue, hemodynamics,
radioopacity, biocompatibility
SUMMARY OF THE INVENTION
[0006] Provided herein are systems and methods for making devices.
A method of manufacturing a metal, comprises: vacuum depositing a
metal onto an unpatterned, exterior surface of a generally
cylindrical substrate to form a generally tubular, unpatterned
crystalline metal film under at least one vacuum deposition process
condition selected from at least one of chamber pressure,
deposition pressure, and partial pressure of a process gas, said at
least one process condition optimized to minimize formation of
chemical and intra- and intergranular precipitates in the bulk
material; defining the plurality of first and second structural
elements in the unpatterned metal film; and removing the first and
second structural elements from the generally cylindrical
substrate.
[0007] A method of manufacturing a device, comprises: vacuum
depositing nickel and titanium onto an exterior surface of a
generally cylindrical substrate to form a deposited generally
tubular, crystalline nickel-titanium shape memory film having no
less than about 51.5 atomic percent nickel, the vacuum deposition
occurring under at least one vacuum deposition process condition
selected from at least one of chamber pressure, deposition
pressure, and partial pressure of a process gas, said at least one
process condition optimized to minimize formation of inter- and
intra-granular precipitates in the bulk material of the
nickel-titanium crystalline film; and removing the deposited
generally tubular, crystalline nickel-titanium shape memory film
from the generally cylindrical substrate.
[0008] A method of manufacturing a device, comprises: vacuum
depositing a device-forming metal onto an unpatterned, exterior
surface of a generally cylindrical substrate to form a generally
tubular, unpatterned crystalline metal film under at least one
vacuum deposition process condition selected from at least one of
chamber pressure, deposition pressure, and partial pressure of a
process gas, said at least one process condition optimized to
substantially eliminate formation of chemical and intra- and
intergranular precipitates in the bulk material; and removing the
deposited generally tubular, unpatterned crystalline metal film
from the generally cylindrical substrate.
[0009] The methods, systems, and apparatuses are set forth in part
in the description which follows, and in part will be obvious from
the description, or can be learned by practice of the methods,
apparatuses, and systems. The advantages of the methods,
apparatuses, and systems will be realized and attained by means of
the elements and combinations particularly pointed out in the
appended claims. It is to be understood that both the foregoing
general description and the following detailed description are
exemplary and explanatory only and are not restrictive of the
methods, apparatuses, and systems, as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] In the accompanying figures, like elements are identified by
like reference numerals among the several preferred embodiments of
the present invention.
[0011] FIG. 1 is a perspective view of the inventive endoluminal
stent.
[0012] FIG. 2A is a fragmentary side elevational view of a first
embodiment of the present invention depicting the inventive
endoluminal stent in its radially unexpanded configuration.
[0013] FIG. 2B is a fragmentary side elevational view of the first
embodiment of the present invention in its radially expanded
configuration.
[0014] FIG. 3A is a fragmentary side elevational view of a second
embodiment of the present invention in its radially unexpanded
configuration.
[0015] FIG. 3B is a fragmentary side elevational view of the first
embodiment of the present invention in its radially expanded
configuration.
[0016] FIG. 4A is a fragmentary side elevational view of a third
embodiment of the present invention in its radially unexpanded
configuration.
[0017] FIG. 4B is a fragmentary side elevational view of the third
embodiment of the present invention in its radially expanded
configuration.
[0018] FIG. 5 is a side elevational view of a portion of a fourth
embodiment of the present invention in its radially unexpanded
configuration.
[0019] FIG. 6A is a photomicrograph of section 6A in FIG. 5.
[0020] FIG. 6B is a photomicrograph of section 6B in FIG. 5.
[0021] FIG. 7 is a fragmentary side elevational view of a fifth
embodiment of the present invention in its radially unexpanded
configuration.
[0022] FIG. 8 is a fragmentary side elevational view of a sixth
embodiment of the present invention in its radially unexpanded
configuration.
[0023] FIG. 9 is a fragmentary side elevational view of a seventh
embodiment of the present invention in its radially unexpanded
configuration.
[0024] FIG. 10A is a diagrammatic cross-sectional view taken along
line 10A-10A of FIG. 7 illustrating a first construction of the
present invention.
[0025] FIG. 10B is a diagrammatic cross-sectional view taken along
line 10B-10B of FIG. 7 illustrating a second construction of the
present invention.
[0026] FIG. 10C is a diagrammatic cross-sectional view taken along
line 10C-10C of FIG. 7 illustrating the Z-axis profile of each of
the plurality of first structural elements of the present
invention.
[0027] FIG. 10D is a diagrammatic cross-sectional view taken along
line 10D-10D of FIG. 7 illustrating the Z-axis profile of each of
the plurality of second structural elements of the present
invention.
[0028] FIG. 11A is a fragmentary elevational view of an eighth
embodiment of the present invention in its radially unexpanded
state.
[0029] FIG. 11B is a fragmentary elevational view of the eighth
embodiment of the present invention in its radially expanded
state.
[0030] FIG. 11C is a side elevational view illustrating the eighth
embodiment of the inventive endoluminal stent.
[0031] FIG. 12 is a perspective view of a self-supporting graft in
accordance with the present invention.
[0032] FIG. 13 is a cross-sectional view taken along line 13-13 of
FIG. 12.
DETAILED DESCRIPTION OF THE INVENTION
[0033] The foregoing and other features and advantages of the
invention are apparent from the following detailed description of
exemplary embodiments, read in conjunction with the accompanying
drawings. The detailed description and drawings are merely
illustrative of the invention rather than limiting, the scope of
the invention being defined by the appended claims and equivalents
thereof.
[0034] Endoluminal stent and stent-graft design inherently attempts
to optimize the functional aspects of radial expandability, i.e.,
the ratio of delivery diameter to expanded diameter, hoop strength,
longitudinal flexibility, column strength, fish-scaling of
individual structural members of the stent, fatigue life, corrosion
resistance, corrosion fatigue, hemodynamics, biocompatibility and
the capability of stent-through-stent delivery. Conventional stent
designs have had to compromise one or more functional features of a
stent in order to maximize a particular functionality, e.g.,
longitudinal flexibility is minimized in order to achieve desirable
column strength or high hoop strengths are achieved at the expense
of small ratios of radial expandability. It is an objective of the
present invention to provide designs for endoluminal unibody stents
that achieve balances between the ratio of radial expandability,
hoop strength, longitudinal flexibility and column strength, with
biocompatibility, hemodynamics, radioopacity, minimal or no
fish-scaling and increased capacity for endothelialization.
[0035] An endoluminal stent and self-supporting endoluminal graft
is disclosed each of which is formed from generally two
interconnecting structural regions. First structural regions define
circumferential sections of the endoluminal stent, provide the
endoluminal stent with hoop strength, and are regions of relatively
higher stent pattern density. The first structural regions are
formed of a plurality of structural elements oriented
circumferentially about the stent and are arrayed in adjacent,
spaced-apart relationship with one another along the longitudinal
axis of the endoluminal stent. Second structural regions define
longitudinal support sections that interconnect adjacent
circumferential sections in adjacent pairs of first structural
regions and provide longitudinal or column strength to the
endoluminal stent. The second structural regions are formed of a
plurality of structural members oriented generally parallel to the
longitudinal axis of the endoluminal stent and generally
perpendicular to the orientation of the structural elements forming
the first structural regions and are arrayed about the
circumference of the endoluminal stent.
[0036] Two general embodiments of the stent of the present
invention are disclosed. A first embodiment consists of second
structural regions comprised of a plurality of longitudinal
structural members each of which has a generally sinusoidal
configuration along the longitudinal axis of the endoluminal stent,
and the first structural regions are comprised of a plurality of
sinusoidal structural elements that interconnect adjacent pairs of
the structural elements of the second structural regions. This
first embodiment is generally referred to herein as the
"longitudinally flexible stent". A second embodiment consists of
second structural regions comprised of a plurality of generally
linear second structural members which extend the entire
longitudinal axis of the endoluminal stent; the first structural
regions are comprised of a plurality of sinusoidal structural
elements which interconnect adjacent pairs of the plurality of
generally linear second structural elements in spaced apart
relationship. This second embodiment is generally referred to as
the "columnar stent". For purposes of the present application, an
individual structural element with a serpentine pattern or a
zig-zag configuration having either regular or irregular
periodicity or both in the some or all of the peaks and troughs is
referred to as being "sinusoidal" or having a "sine-wave
configuration."
[0037] In accordance with a first preferred embodiment of the
inventive endoluminal stent, there is provided endoluminal stent
that is comprised of a plurality of first structural elements that
together form the circumference of the stent and extending along
the longitudinal axis of the stent, and a plurality of second
structural elements that interconnect adjacent pairs of first
structural elements. Each of the plurality of first structural
elements has a generally sinusoidal configuration with a regular or
irregular periodicity or both between the peaks and troughs of the
pattern, with the peaks and troughs projecting from the first
structural elements in the circumferential axis. The plurality of
second structural elements are generally linear members which
interconnect an apex of a peak of one of the plurality of first
structural elements with an apex of a valley of a second and
adjacent one of the plurality of first structural elements. Each of
the plurality of second structural elements are generally oriented
parallel to the longitudinal axis of the stent.
[0038] The plurality of first structural elements is arrayed about
and forms the circumference of the stent, with individual first
structural elements extending parallel to the longitudinal axis of
the stent. Each of the plurality of first structural elements
preferably extends substantially the entire longitudinal axis of
the stent, however, it is contemplated that some or all of the
plurality of first structural elements may be oriented parallel to
the longitudinal axis of the stent without extending substantially
the entire longitudinal axis of the stent. Each of the plurality of
first structural elements generally has a sine-wave configuration
with the element being formed into successive peaks and troughs
extending along the longitudinal axis of the stent. Again, it will
be understood that the terms "sine-wave configuration" or
"sinusoidal" are intended to include elements which have peaks and
troughs with regular or irregular periodicity throughout the
longitudinal axis of the element or which have peaks and troughs
with regions of regular and regions of irregular periodicity along
the longitudinal axis of the element, the peaks and troughs and the
apices of the peaks and troughs may have many shapes, including,
without limitation, regular curves, irregular curves, Z-shaped,
U-shaped or the like. The plurality of first structural elements
are arrayed in phase with one another, such that the peaks and
troughs of one of the plurality of first structural elements in
circumferentially aligned with the peaks and troughs of an adjacent
first structural elements.
[0039] Each of the plurality of second structural elements
comprises generally linear members which interconnect adjacent
pairs of first structural elements. Each of the plurality of second
structural elements is either integral with or conjoined the first
structural elements with which it is associated. Each of the
plurality of second structural elements joins to a trough of one
first structural element with a peak of a second first structural
element, with successive troughs of one first structural element
being joined with successive peaks of the second first structural
element.
[0040] Alternatively, in accordance with a second preferred
embodiment of the present invention, the inventive endoluminal
stent may consist of a plurality of substantially linear first
structural elements oriented parallel to the longitudinal axis of
the stent and a plurality of generally sinusoidal second structural
elements which interconnect adjacent pairs of the first structural
elements and extend generally about the circumferential axis of the
stent. Each of the plurality of first structural elements
preferably extends substantially the entire longitudinal axis of
the stent, again, however, it is contemplated that some or all of
the plurality of first structural elements may be oriented parallel
to the longitudinal axis of the stent without extending
substantially the entire longitudinal axis of the stent. The
plurality of generally sinusoidal second structural elements form
the circumferential links of the stent, and permit radial
expansion, either by an applied radially outwardly directed force
which plastically deforms the second structural elements, under
inherent spring tension or as a result of shape memory properties
of the stent material, or combinations thereof.
[0041] In accordance with all embodiments of the present invention,
the plurality of first structural elements and the plurality of
second structural elements may be fabricated of like biocompatible
materials, preferably, biocompatible metals or metal alloys. In
this manner, both the plurality of first structural elements and
the plurality of second structural elements have like physical
material properties, e.g., tensile strength, modulus of elasticity,
plastic deformability, spring bias, shape memory or super-elastic
properties. Alternatively, the plurality of first structural
elements and the plurality of second structural elements may be
fabricated of biocompatible materials, preferably, biocompatible
metals or metal alloys which exhibit different physical or material
properties. In this latter case, the plurality of first structural
elements may, for example, be fabricated of a plastically
deformable material, such as stainless steel, while the plurality
of second structural elements are fabricated of a shape memory or
super-elastic material, such as nickel-titanium alloys, or of a
spring biased material, such as stainless steel.
[0042] Heretofore, joints between discrete sections of endoluminal
stents required welds in order to join sections of the stent. One
particular advantage of the present invention is that by forming
the stent using vapor deposition techniques, not only are discrete
sections atomically joined without the use of welds, but different
materials may be employed in different and discrete sections of the
stent in order to impart distinct material properties and,
therefore, functionality, to the discrete sections.
[0043] Finally, the present invention also includes a
self-supporting endoluminal graft. As used herein the term "graft"
is intended to indicate any type of tubular member that exhibits
integral columnar and circumferential strength and which has
openings that pass through the thickness of the tubular member. The
inventive self-supporting endoluminal graft preferably consists of
a member formed of at least one of a plurality of layers, each
layer being comprised of a plurality of first and second structural
elements which intersect one another, as described above, to define
a plurality of open regions between intersecting pairs of the first
and second structural elements. A web region subtends at least a
portion of the open region to at least partially enclose each of
the plurality of open regions. Successive adjacent layers of the
plurality of layers are positioned such that the open regions are
staggered in the Z-axis transverse through the wall of the
self-supporting endoluminal graft. By staggering the open regions,
interlamellar spaces are created to facilitate endothelialization
of the endoluminal graft.
[0044] The inventive endoluminal stent may be, but is not
necessarily, fabricated by vapor deposition techniques. Vapor
deposition fabrication of the inventive stents offers many
advantages, including, without limitation, the ability to fabricate
stents of complex geometries, the ability to control fatigue life,
corrosion resistance, corrosion fatigue, bulk and surface material
properties, and the ability to vary the transverse profiles, Z-axis
thickness and X-Y-axis surface area of the stent's structural
elements in manners that affect the longitudinal flexibility, hoop
strength of the stent and radial expansion profiles.
[0045] In accordance with the present invention there is provided
several preferred embodiments. In each of the preferred embodiments
of the present invention, the general configuration of the
inventive endoluminal stent is identical. With particular reference
to FIG. 1, the inventive endoluminal stent 10 consists generally of
a tubular cylindrical element having a stent wall 12 that defines a
central lumen 14 of the stent. A plurality of first structural
elements 16 are arrayed about the circumferential axis C' of the
stent 10 and extend parallel along the longitudinal axis of stent
10. A plurality of second structural elements 18 interconnects
adjacent pairs of the plurality of first structural elements 16.
Each of the plurality of first structural elements 16 have a
generally sinusoidal configuration with a plurality of peaks 16a
and a plurality of troughs 16b of each first structural element. As
noted above, the plurality of peaks 16a and the plurality of
troughs 16b may have either regular or irregular periodicity along
the longitudinal axis of each of the plurality of first structural
elements 16 or each of the plurality of first structural elements
may have regions of regular periodicity and regions of irregular
periodicity. Each of the plurality of second structural elements
preferably comprise linear elements which interconnect a peak 16a
of a first one of the first structural elements 16 with a trough
16b of a second one of the first structural elements adjacent the
first one of the first structural elements 16.
[0046] The plurality of first 16 and second 18 structural elements
are preferably made of materials selected from the group consisting
of elemental titanium, vanadium, aluminum, nickel, tantalum,
zirconium, chromium, silver, gold, silicon, magnesium, niobium,
scandium, platinum, cobalt, palladium, manganese, molybdenum and
alloys thereof, and nitinol and stainless steel. The plurality of
first structural elements 16 and the plurality of second structural
elements 18 may be made of the same material or of different
materials and have the same material properties or have different
material properties. The term "material properties" is intended to
encompass physical properties, including without limitation,
elasticity, tensile strength, mechanical properties, hardness, bulk
and/or surface grain size, grain composition, and grain boundary
size, intra and inter-granular precipitates. Similarly, the
materials selected for the plurality of first structural elements
16 and the plurality of second structural elements 18 may be
selected to have the same of different chemical properties. The
term "chemical properties" is intended to encompass both any
chemical reaction and change of state that the material may undergo
after being implanted into a body and the physiological response of
the body to the material after implantation.
[0047] The inventive stent 10, including the plurality of first
structural elements 16 and second structural elements 18, is
preferably made of a bulk material having controlled
heterogeneities on the luminal surface thereof. As is described in
co-pending, commonly assigned, U.S. patent application Ser. No.
09/443,929, filed Nov. 19, 1999, which is hereby incorporated by
reference, heterogeneities are controlled by fabricating the bulk
material of the stent to have defined grain sizes, chemical and
intra and intergranular precipitates and where the bulk and surface
morphology differ, yielding areas or sites along the surface of the
stent while maintaining acceptable or optimal protein binding
capability. The characteristically desirable properties of the
inventive stent are: (a) optimum mechanical properties consistent
with or exceeding regulatory approval criteria, (b) minimization of
defects, such as cracking or pin hole defects, (c) a fatigue life
of 400 MM cycles as measured by simulated accelerated testing, (d)
corrosion and/or corrosion-fatigue resistance, (e) biocompatibility
without having biologically significant impurities in the material,
(f) a substantially non-frictional abluminal surface to facilitate
atraumatic vascular crossing and tracking and compatible with
transcatheter techniques for stent introduction, (g) radiopaque at
selected sites and MRI compatible, (h) have a luminal surface which
is optimized for surface energy and microtopography, (i) minimal
manufacturing and material cost consistent with achieving the
desired material properties, and (j) high process yields.
[0048] In accordance with the present invention, the foregoing
properties are achieved by fabricating a stent by the metal
deposition methodologies used in the microelectronics and
nano-fabrication vacuum coating arts, and which are hereby
incorporated by reference. The preferred deposition methodologies
include ion-beam assisted evaporative deposition and sputtering
techniques. In ion beam-assisted evaporative deposition it is
preferable to employ dual and simultaneous thermal electron beam
evaporation with simultaneous ion bombardment of the substrate
using an inert gas, such as argon, xenon, nitrogen or neon.
Bombardment with an inert gas, such as argon ions serves to reduce
void content by increasing the atomic packing density in the
deposited material during deposition. The reduced void content in
the deposited material allows the mechanical properties of that
deposited material to be similar to the bulk material properties.
Deposition rates up to 20 nm/sec are achievable using ion
beam-assisted evaporative deposition techniques.
[0049] When sputtering techniques are employed, a 200-micron thick
stainless steel film may be deposited within about four hours of
deposition time. With the sputtering technique, it is preferable to
employ a cylindrical sputtering target, a single circumferential
source that concentrically surrounds the substrate that is held in
a coaxial position within the source.
[0050] Alternate deposition processes which may be employed to form
the stent in accordance with the present invention are cathodic
arc, laser ablation, and direct ion beam deposition. When employing
vacuum deposition methodologies, the crystalline structure of the
deposited film affects the mechanical properties of the deposited
film. These mechanical properties of the deposited film may be
modified by post-process treatment, such as by, for example,
annealing, high-pressure treatment or gas quenching.
[0051] Materials to make the inventive stents are chosen for their
biocompatibility, mechanical properties, i.e., tensile strength,
yield strength, and their ease of deposition include the following:
elemental titanium, vanadium, aluminum, nickel, tantalum,
zirconium, chromium, silver, gold, silicon, magnesium, niobium,
scandium, platinum, cobalt, palladium, manganese, molybdenum and
alloys thereof, such as zirconium-titanium-tantalum alloys,
nitinol, and stainless steel.
[0052] During deposition, the chamber pressure, the deposition
pressure and the partial pressure of the process gases are
controlled to optimize deposition of the desired species onto the
substrate. As is known in the microelectronic fabrication,
nano-fabrication and vacuum coating arts, both the reactive and
non-reactive gases are controlled and the inert or non-reactive
gaseous species introduced into the deposition chamber are
typically argon and nitrogen. The substrate may be either
stationary or moveable, either rotated about its longitudinal axis,
or moved in an X-Y plane within the reactor to facilitate
deposition or patterning of the deposited material onto the
substrate. The deposited material maybe deposited either as a
uniform solid film onto the substrate, or patterned by (a)
imparting either a positive or negative pattern onto the substrate,
such as by etching or photolithography techniques applied to the
substrate surface to create a positive or negative image of the
desired pattern or (b) using a mask or set of masks which are
either stationary or moveable relative to the substrate to define
the pattern applied to the substrate. Patterning may be employed to
achieve complex finished geometries of the resultant stent, both in
the context of spatial orientation of the pattern as well as the
material thickness at different regions of the deposited film, such
as by varying the wall thickness of the material over its length to
thicken sections at proximal and distal ends of the stent to
prevent flaring of the stent ends upon radial expansion of the
stent.
[0053] The stent may be removed from the substrate after stent
formation by any of a variety of methods. For example, the
substrate may be removed by chemical means, such as etching or
dissolution, by ablation, by machining or by ultrasonic energy.
Alternatively, a sacrificial layer of a material, such as carbon or
aluminum, may be deposited intermediate the substrate and the stent
and the sacrificial layer removed by melting, chemical means,
ablation, machining or other suitable means to free the stent from
the substrate.
[0054] The resulting stent may then be subjected to post-deposition
processing to modify the crystalline structure, such as by
annealing, or to modify the surface topography, such as by etching
to affect and control the heterogeneities on the blood flow surface
of the stent.
[0055] A plurality of microgrooves may be imparted onto the luminal
and/or abluminal surface of the stent 10, as is more fully
described in International Publication No. WO 99/23977, published
20 May 1999, which is commonly assigned with the present
application and is hereby incorporated by reference. The plurality
of microgrooves may be formed either as a post-deposition process
step, such as by etching, or during deposition, such as by
depositing the stent-forming material onto a mandrel which has a
microtopography on the surface thereof which causes the metal to
deposit with the microgroove pattern as part of the deposited
material.
[0056] Each of the preferred embodiments of the present invention
are preferably fabricated by employing a vapor deposition technique
which entails vapor depositing a stent-forming metal onto a
substrate. The substrate may be planar or cylindrical and is either
pre-patterned with one of the preferred geometries of first and
second structural elements, in either positive or negative image,
or the substrate may be un-patterned. Where the substrate is
un-patterned, the deposited stent-forming metal is subjected to
post-deposition patterning to pattern the deposited stent-forming
metal into one of the preferred geometries of the first and second
structural elements. In all embodiments of the present invention
fabricated by vapor deposition techniques, the need for
post-deposition processing of the patterned endoluminal stent,
e.g., modifying the surface of the stent by mechanical, electrical,
thermal or chemical machining or polishing, is eliminated or
minimized.
[0057] Vapor deposition fabrication of the inventive endoluminal
stents offers many advantages, including, for example, the ability
to fabricate stents of complex geometries, ultrafine dimensional
tolerances on the order of Angstroms, the ability to control
fatigue life, corrosion resistance, corrosion fatigue, inter- and
intra-granular precipitates and their effect on corrosion
resistance and corrosion fatigue, bulk material composition, bulk
and surface material properties, radioopacity, and the ability to
vary the transverse profiles, Z-axis thickness and X-Y-axis surface
area of the stent structural elements in manners that affect the
longitudinal flexibility, hoop strength, and radial expansion
behavior and profile of the stent. Bulk material composition may be
adjusted to employ elemental fractions in alloy compositions that
are not feasible when using conventionally formed metals. This
results in achieving the ability to tailor the alloy compositions
in a manner that optimizes the alloy composition for a desired
material or mechanical property. For example, nickel-titanium tubes
exhibiting shape memory and/or superelastic properties were made
employing in excess of 51.5 atomic percent nickel, which is not
achievable using conventional working techniques due to high
plateau stresses exhibited by the material. Specifically, the
present inventors have fabricated nickel-titanium alloy tubes
employing the method of the present invention that contain between
51.5 and 55 atomic percent nickel.
[0058] Vapor deposition of the inventive endoluminal stent, in
accordance with a preferred embodiment of the present invention,
significantly reduces or virtually eliminates inter- and
intra-granular precipitates in the bulk material. It is common
practice in the nickel-titanium endoluminal device industry to
control transition temperatures and resulting mechanical properties
by altering local granular nickel-titanium ratios by precipitation
regimens. In the present invention, the need to control
precipitates for mechanical properties is eliminated. Where
nickel-titanium is employed as the stent-forming metal in the
present invention, local nickel-titanium ratios will be the same or
virtually identical to the nickel-titanium ratios in the bulk
material, while still allowing for optimal morphology and
eliminating the need for employing precipitation heat treatment.
The resulting deposited stent-forming metal exhibits superior
corrosion resistance, and hence, resistance to corrosion fatigue,
when compared to conventional wrought nickel-titanium alloys.
[0059] The plurality of first structural elements 16 and the
plurality of second structural elements 18 are preferably
conformationally configured curing vapor deposition to impart a
generally ovular or elliptical transverse cross-sectional profile
and have chamfered or curved leading and trailing luminal and
abluminal surface edges in the longitudinal axis of the stent in
order to provide better blood flow surface profiles.
[0060] Turning to FIGS. 2-4, there are illustrated three preferred
embodiments of the present invention. Each embodiment is depicted
in its diametrically unexpanded state in the A Figure and in its
diametrically expanded state in the B Figure. Thus, FIG. 2A
represents a first embodiment of the inventive endoluminal stent in
its diametrically unexpanded state, while FIG. 2B represents the
first embodiment of the inventive endoluminal stent in its
diametrically expanded state.
[0061] With specific reference to FIGS. 2A and 2B, there is
illustrated stent 20 that consists of a plurality of first
structural elements 22 and a plurality of second structural
elements 24 which interconnect adjacent pairs of the plurality of
first structural elements 22. Each of the plurality of first
structural elements 22 extends parallel to the longitudinal axis L'
of the stent 20, while each of the plurality of second structural
elements 24 are arrayed in the circumferential axis C' of the stent
20. Each of the first structural elements 22 has a sinusoidal
configuration consisting of a plurality of successive peaks 26 and
troughs 28. The plurality of first structural elements 22 are
arrayed about the circumference of stent 20 such that the peaks 26
and the troughs 28 of each individual first structural element 22
are in phase with respect to adjacent peaks 26 and troughs 28 of
adjacent first structural elements 22.
[0062] The plurality of second structural elements 24 interconnect
adjacent pairs of first structural elements 22. Each second
structural element 24 has a first end 24a that connects with a
trough 28 of a first structural element 22 and a second end 24b
that connects with a peak 26 of an adjacent structural element 22.
The plurality of second structural elements 24 serve to maintain
the plurality of first structural elements in spaced-apart
relationship relative to one another about the circumference of the
stent 20. In accordance with a preferred embodiment of the
invention, the first end 24a of a second structural element 24
couples to a trough 28 such that it is generally tangential to a
downward slope 28s of the trough. Similarly, the second end 24b of
the second structural element 22 couples to a peak 26 of a first
structural element 22 such that the second structural element 24 is
generally tangential to a downward slope 26s of the peak 26.
[0063] In the unexpanded state depicted in FIG. 2A, each of the
plurality of second structural elements 24 have a generally S-shape
or sinusoidal shape, however, when the stent is in its
diametrically expanded state depicted in FIG. 2B, each of the
plurality of second structural elements 24 assumes a generally
linear configuration which serves to maintain an enlarged spacing
between adjacent pairs of first structural elements 22 than when
the stent 20 is in its unexpanded state.
[0064] Turning to FIGS. 3A and 3B, there is illustrated a second
preferred embodiment of the stent 30 present invention. Like stent
20 described above, stent 30 consists generally of a plurality of
first structural elements 32 and a plurality of second structural
elements 34 which interconnect adjacent pairs of the plurality of
first structural elements 32. Each of the plurality of first
structural elements 32 extends parallel to the longitudinal axis L'
of the stent 30, while each of the plurality of second structural
elements 34 are arrayed in the circumferential axis C' of the stent
30. Each of the first structural elements 32 has a generally
sinusoidal zigzag or Z-configuration consisting of a plurality of
successive peaks 36 and troughs 38. The plurality of first
structural elements 32 are arrayed about the circumference of stent
30 such that the peaks 36 and the troughs 38 of each individual
first structural element 32 are in phase with respect to adjacent
peaks 36 and troughs 38 of adjacent first structural elements
32.
[0065] The plurality of second structural elements 34 interconnect
adjacent pairs of first structural elements 32. Each second
structural element 24 has a first end 34a, which connects with a
trough 38 of a first structural element 32, and a second end 34b,
which connects with a peak 36 of an adjacent structural element 32.
The plurality of second structural elements 34 serve to maintain
the plurality of first structural elements in spaced-apart
relationship relative to one another about the circumference of the
stent 30.
[0066] In the unexpanded state depicted in FIG. 3A, each of the
plurality of second structural elements 34 have a generally linear
configuration which is positioned substantially parallel to the
longitudinal axis L' of the stent 30. However, when the stent 30 is
in its diametrically expanded state depicted in FIG. 3B, each of
the plurality of second structural elements 34 repositions to
assume a generally circumferential orientation relative to the
stent which, in turn, serves to maintain an enlarged spacing
between adjacent pairs of first structural elements 32 than when
the stent 30 is in its unexpanded state.
[0067] Turning to FIGS. 4A and 4B, there is illustrated a third
preferred embodiment of the stent 40 present invention. Like stents
20 and 30 described above, stent 40 consists generally of a
plurality of first structural elements 42 and a plurality of second
structural elements 44 which interconnect adjacent pairs of the
plurality of first structural elements 42. Each of the plurality of
first structural elements 42 extends parallel to the longitudinal
axis L' of the stent 40, while each of the plurality of second
structural elements 44 are arrayed in the circumferential axis C'
of the stent 40. Each of the first structural elements 42 has a
generally sinusoidal zig-zag or Z-configuration consisting of a
plurality of successive peaks 46 and troughs 48. Arcuate sections
45 are provided at apices of each of the peaks 46 and the troughs
48. The arcuate sections 45 act as springs for each first
structural element 42 to impart axial flexibility and longitudinal
compressibility and expandability to the stent 40. The plurality of
first structural elements 42 are arrayed about the circumference of
stent 40 such that the peaks 46 and the troughs 48 of each
individual first structural element 42 are in phase with respect to
adjacent peaks 46 and troughs 48 of adjacent first structural
elements 42.
[0068] The plurality of second structural elements 44 interconnect
adjacent pairs of first structural elements 32. Each second
structural element 44 has a first end 44a, which connects with an
arcuate section 45 of a trough 48 of a first structural element 42,
and a second end 44b, which connects with an arcuate section 45 of
a peak 46 of an adjacent structural element 42. The plurality of
second structural elements 44 serve to maintain the plurality of
first structural elements in spaced-apart relationship relative to
one another about the circumference of the stent 40.
[0069] In the unexpanded state depicted in FIG. 4A, each of the
plurality of second structural elements 44 have a generally linear
configuration and are oriented substantially parallel to adjacent
sections of the first structural elements 42 to which it is
attached. However, when the stent 40 is in its diametrically
expanded state depicted in FIG. 4B, each of the plurality of second
structural elements 44 repositions to assume an orientation which
is generally parallel to the longitudinal axis L' of the stent 40
and maintain an enlarged spacing between adjacent pairs of first
structural elements 42 than when the stent 40 is in its unexpanded
state.
[0070] FIGS. 5, 6A and 6B depict another preferred embodiment and
the best mode contemplated for the present invention. Like stents
20, 30 and 40 described above, stent 50 consists generally of a
plurality of first structural elements 52 and a plurality of second
structural elements 54 which interconnect adjacent pairs of the
plurality of first structural elements 52. Each of the plurality of
first structural elements 52 extends parallel to the longitudinal
axis L' of the stent 50, while each of the plurality of second
structural elements 54 are arrayed in the circumferential axis C'
of the stent 50. Each of the first structural elements 52 has a
generally sinusoidal zig-zag or Z-configuration consisting of a
plurality of successive peaks 56 and troughs 58. The plurality of
first structural elements 52 are arrayed about the circumference of
stent 50 such that the peaks 56 and the troughs 58 of each
individual first structural element 52 are in phase with respect to
adjacent peaks 56 and troughs 58 of adjacent first structural
elements 52.
[0071] The plurality of second structural elements 54 interconnect
adjacent pairs of first structural elements 52. Each second
structural element 54 has a first end 54a, which connects with a
trough 58 of a first structural element 52, and a second end 54b
that connects with a peak 56 of an adjacent structural element 52.
The plurality of second structural elements 54 serve to maintain
the plurality of first structural elements in spaced-apart
relationship relative to one another about the circumference of the
stent 50.
[0072] In the unexpanded state depicted in FIG. 5, each of the
plurality of second structural elements 54 have a generally linear
configuration which is positioned substantially parallel to the
longitudinal axis L' of the stent 50. For purposes of explanation
and illustration only, the stent 50 is also referenced with
proximal P and distal D orientations relative to the longitudinal
axis L' of the stent 50.
[0073] When the stent 50 is in its diametrically expanded state,
each of the plurality of second structural elements 54 repositions
to assume a generally circumferential orientation relative to the
stent which, in turn, serves to maintain an enlarged spacing
between adjacent pairs of first structural elements 52 than when
the stent 50 is in its unexpanded state.
[0074] Each of the plurality of first structural elements 52
further comprise alternating relatively narrower sections 52a and
relatively wider sections 52b which form each peak 56 and each
trough 58 of each first structural element 52. In accordance with
the best mode presently contemplated for the present invention, and
without limiting the scope of the invention, the preferred ratio of
surface area between the wider sections 52b and the narrower
sections 52a is about 2:1. Thus, for example, if the width W.sub.2
of the narrower section 52a is about 60i, the width W.sub.1 of the
wider section 52b will be about 1201. The apices of each peak 56
and each trough 58 are formed by a chamfer or taper between the
narrower section 52a and the wider section 52b of each peak 56 and
each trough 58 of each of the plurality of first structural
elements 52. The apex of a typical peak 56 and trough 58 and the
chamfered or tapered section, described above, is depicted in the
scanning electron photomicrograph at FIG. 6B
[0075] Each of the plurality of second structural elements 54 has a
generally elongate configuration that connects at a first end 54a
to a trough 58 and at a second end 54b to a peak 56. Each of the
first end 54a and the second end 54b connect to adjacent first
structural elements 52 and are formed by chamfered sections which
project generally at right angles relative to a central
longitudinal axis 57 of each of the plurality of second structural
elements 54 and connect to a terminal section of the narrower
section 52a of either each peak 56 or each trough 58 of each of the
plurality of the first structural elements 52. FIG. 6A depicts with
greater particularity a first end 54a and the chamfered section
integrally connecting a second structural element 54 with a first
structural element 52. The chamfered sections at first end 54a and
54b project in opposing directions relative to one another. Thus,
in one embodiment the chamfered section at the first end 54a
projects generally distally relative to the longitudinal axis L' of
stent 50, while the chamfered section at the second end 54b
projects generally proximally relative to the longitudinal axis L'
of stent 50. Those of ordinary skill in the art will understand
that the relative directional orientation of the first end 54a and
the second end 54b may be switched so that the first end 54a
projects generally proximally while the second end 54b projects
generally distally relative to the longitudinal axis L' of stent
50. Similarly, those of ordinary skill in the art will appreciate
that alternate configurations for the first end 54a and the second
end 54b are contemplated by the present invention. For example,
instead of a generally perpendicular orientation between the
chamfered section and the longitudinal axis 57 of the second
structural element 54, the first end 54a and the second end 54b
could have alternate angular orientations relative to the first
structural element 52 and the second structural element 54.
[0076] Turning to FIGS. 7-10, there are illustrated alternate
preferred embodiments of the present invention in which a plurality
of first structural elements are generally linear members which
extend parallel to a longitudinal axis L' of the stent and a
plurality of second structural elements which have a generally
sinusoidal shape form the circumferential axis C' of the stent and
permit radial expansion thereof. These alternate preferred
embodiments exhibit excellent column strength due to the linear
members of the plurality of first structural elements while the
configuration of the plurality of second structural elements
facilitate low device delivery profiles while allowing for large
ratios of radial expansion over the stent's unexpanded
diameter.
[0077] With particular reference to FIG. 7, there is illustrated a
stent 60 which includes a plurality of generally linear first
structural elements 62 which extend parallel to and substantially
the entire the longitudinal axis L' of the stent 60. The
circumferential axis C' of the stent 60 is comprises of a plurality
of second structural elements 64, each of which has a generally
U-shaped configuration. Individual second structural elements 64
interconnect adjacent pairs of first structural elements 62 and
maintain the first structural elements 62 in spaced apart
relationship from one another. Each individual second structural
element 64 is composed of an apex 66, which forms the peak of each
second structural element 64, a first connection section 63 and a
second connection section 65. The first connection section 63
connects the second structural element 64 to a single first
structural element 62, while the second connection section 65
connects the second structural element 64 to an adjacent first
structural element 62, thereby maintaining the first structural
elements 62 in spaced apart relationship relative to one another.
Each of the plurality of second structural elements 64 are either
integral with or connected to each of the plurality of first
structural elements 62 at intersection points 67 along the
circumferential axis C' of the stent 60. A plurality of second
structural elements 64 are aligned in end-to-end fashion, with the
first connection section 63 of one second structural element 64
being adjacent to a second connection section 65 of another second
structural element, thereby forming a continuous sinusoidal
circumferential element 69 which extends about the entire
circumferential axis C' of the stent 60. In the continuous
sinusoidal circumferential element 69, peaks of each sinusoidal
period are formed by the apices 66 of each generally U-shaped first
structural element 64, while troughs 65 of each sinusoidal period
are formed by the first connection section 63 of one second
structural element 64, the second connection section 65 of another
second structural element 64, and their connection point 67 on the
first structural element 62.
[0078] A plurality of continuous sinusoidal circumferential
elements 69 are arrayed in spaced apart relationship along the
longitudinal axis L' of the stent 60 and form the walls of the
stent 60. During radial expansion of the stent 60, each of the
plurality of second structural elements 64 extends
circumferentially along circumferential axis C' such that the
periodicity between successive peaks of each generally U-shaped
second structural element 64 increases.
[0079] In accordance with this preferred embodiment of stent 60,
the apices 66 of each first structural member 64, which forms the
peak of each sinusoidal period, have a common directional
orientation parallel to and directed either proximally or distally
relative to the longitudinal axis L' of the stent 60. In accordance
with a variation of the preferred embodiment of the stent 60, the
apices 66 of each first structural member 64 in a first continuous
sinusoidal circumferential element 69 are directionally oriented
opposite that of the apices 66 of each first structural member in a
second, adjacent, continuous sinusoidal circumferential element 69.
In this variation, adjacent continuous sinusoidal circumferential
elements 69 would be out-of-phase relative to one another, i.e.,
such as with a sine and cosine functions, with the apices 66 of
each sinusoidal element being adjacent one another and one apex 66
oriented proximally and a longitudinally adjacent apex 66 being
oriented distally relative to the longitudinal axis L' of the stent
60.
[0080] With particular reference to FIG. 8, there is illustrated an
alternate embodiment of the present invention in which stent 70 is
again comprised of a plurality of plurality of generally linear
first structural elements 72 which extend parallel to and
substantially the entire the longitudinal axis L' of the stent 70.
The circumferential axis C' of the stent 70 is comprises of a
plurality of second structural elements 74, each of which has a
generally U-shaped configuration.
[0081] Individual second structural elements 74 interconnect
adjacent pairs of first structural elements 72 and maintain the
first structural elements 72 in spaced apart relationship from one
another. Each individual second structural element 74 is composed
of an apex 76, which forms the peak of each second structural
element 74, a first connection section 73 and a second connection
section 75. As distinguished from stent 60, in which the apices 66
have a regular curve, each of the apices 76 of stent 70 are formed
by generally linear sections which are oriented parallel to the
circumferential axis C' of stent 70.
[0082] The first connection section 73 connects the second
structural element 74 to a single first structural element 72,
while the second connection section 75 connects the second
structural element 74 to an adjacent first structural element 72,
thereby maintaining the first structural elements 72 in spaced
apart relationship relative to one another. Each of the plurality
of second structural elements 74 are either integral with or
connected to each of the plurality of first structural elements 72
at intersection points 77 along the circumferential axis C' of the
stent 70.
[0083] A plurality of second structural elements 74 are aligned in
end-to-end fashion, with the first connection section 73 of one
second structural element 74 being adjacent to a second connection
section 75 of another second structural element, thereby forming a
continuous sinusoidal circumferential element 79 which extends
about the entire circumferential axis C' of the stent 70. In the
continuous sinusoidal circumferential element 79, peaks of each
sinusoidal period are formed by the apices 76 of each generally
U-shaped first structural element 74, while troughs 75 of each
sinusoidal period are formed by the first connection section 73 of
one second structural element 74, the second connection section 75
of another second structural element 74, and their connection point
77 on the first structural element 72.
[0084] A plurality of continuous sinusoidal circumferential
elements 79 are arrayed in spaced apart relationship along the
longitudinal axis L' of the stent 70 and form the walls of the
stent 70. During radial expansion of the stent 70, each of the
plurality of second structural elements 74 extends
circumferentially along circumferential axis C' such that the
periodicity between successive peaks of each generally U-shaped
second structural element 74 increases.
[0085] In accordance with this preferred embodiment of stent 70,
the continuous sinusoidal circumferential elements 79 are
categorized into a plurality of proximal sinusoidal circumferential
elements 79.sub.p and a plurality of distal sinusoidal
circumferential elements 79.sub.d. The sole difference between the
proximal 79.sub.p and the distal 79.sub.d sinusoidal
circumferential elements is the directional orientation of the
apices 76 of each second structural member 74 relative to the
longitudinal axis L' of the stent 70. That is, in the plurality of
proximal circumferential elements 79.sub.p, the apex 76 is oriented
toward the proximal end of the stent 70, while in the plurality of
distal circumferential elements 79.sub.d, the apex 76 is oriented
toward the distal end of the stent 70. Either at a medial line M'
of the stent 70 or at spaced apart longitudinal sections of the
stent 70, a proximal sinusoidal circumferential element 79.sub.p is
longitudinally adjacent a distal sinusoidal circumferential element
79.sub.d such that apices 76 of each of the proximal sinusoidal
circumferential element 79.sub.p are proximate the apices 76 of the
adjacent distal sinusoidal circumferential element 79.sub.d, i.e.,
as in a sine and cosine function. In this configuration, stent 70
will have added longitudinal flexibility either at the medial line
M' or at the spaced apart longitudinal sections of the stent 70
where the plurality of proximal sinusoidal circumferential elements
79.sub.p and a plurality of distal sinusoidal circumferential
elements 79.sub.d are out of phase relative to one another.
[0086] Turning now to FIG. 9, there is illustrated a stent 80 which
includes a plurality of generally linear first structural elements
82 which extend parallel to and substantially the entire the
longitudinal axis L' of the stent 80. The circumferential axis C'
of the stent 80 is comprises of a plurality of second structural
elements 84, each of which has a generally S-shaped or sine-wave
configuration. Individual second structural elements 84
interconnect adjacent pairs of first structural elements 82 and
maintain the first structural elements 82 in spaced apart
relationship from one another. Each individual second structural
element 84 is composed of at least two apices 66, 68, which project
in opposing directions relative to the longitudinal axis L' of the
stent 80, a first connection section 83 and a second connection
section 85. The first connection section 83 connects the second
structural element 84 to a single first structural element 82,
while the second connection section 85 connects the second
structural element 84 to an adjacent first structural element 82,
thereby maintaining the first structural elements 82 in spaced
apart relationship relative to one another. Each of the plurality
of second structural elements 84 are either integral with or
connected to each of the plurality of first structural elements 82
at intersection points 87 along the circumferential axis C' of the
stent 80. A plurality of second structural elements 84 are aligned
in end-to-end fashion, with the first connection section 83 of one
second structural element 84 being adjacent to a second connection
section 85 of another second structural element, thereby forming a
continuous circumferential element 89 which extends about the
entire circumferential axis C' of the stent 80. A plurality of
continuous circumferential elements 89 are arrayed in spaced apart
relationship along the longitudinal axis L' of the stent 80 and
form the walls of the stent 80.
[0087] In accordance with this preferred embodiment of stent 80,
the apices 86 of each second structural element 84 have a common
directional orientation parallel to and directed either proximally
or distally relative to the longitudinal axis L' of the stent 80.
Similarly, the apices 88 of each second structural element 84 have
a common directional orientation parallel to and directed either
proximally or distally relative to the longitudinal axis L' of the
stent 80. Thus, all apices 86 and all apices 88 are in phase
relative to like apices on longitudinally adjacent second
structural elements 84. In accordance with a variation of the
preferred embodiment of the stent 80, the apices 86 of each second
structural element 84 in a first continuous circumferential element
69 are directionally oriented opposite that of the apices 86 of
each second structural element 84 in a second, adjacent, continuous
circumferential element 89. In this variation, adjacent continuous
circumferential elements 89 would be out-of-phase relative to one
another, i.e., such as with a sine and cosine functions, with the
apices 86 of each second structural element 84 being longitudinally
adjacent one another and one apex 86 oriented proximally and a
longitudinally adjacent apex 86 being oriented distally relative to
the longitudinal axis L' of the stent 80.
[0088] FIGS. 10A and 10B illustrate alternate constructions of the
inventive stent. For purposes of the following discussion, it will
be noted that the particular stent geometry is a matter of choice
and includes, but is not limited to the inventive stents 10, 20,
30, 40, 50, 60 70 and 80 described above. As noted above, the stent
of the present invention may be fabricated of materials selected
from the group consisting of elemental titanium, vanadium,
aluminum, nickel, tantalum, zirconium, chromium, silver, gold,
silicon, magnesium, niobium, scandium, platinum, cobalt, palladium,
manganese, molybdenum, and alloys thereof, nitinol and stainless
steel.
[0089] Because the method of making the inventive stent involves
utilizing vacuum deposition technologies well known in the
microelectronics arts, either a single material may be employed or
plural materials may be employed to make either or both the
plurality of first structural elements 62 and the plurality of
second structural elements 64 or portions thereof. Where plural
materials are employed in the vacuum deposition fabrication of a
stent, such as, for example, inventive stents 10, 20, 30, 40, 50,
60, 70 or 80, intersection points 65, for example, between first
structural elements 62 and the first connection end 63 of one
second structural element 64 and a second connection end 68 of
another second structural element 64 may be either as a monolayer
of alloyed metals used to form the first structural element 62 and
the second structural element 64 as illustrated in FIG. 10A or as a
multiplayer of non-alloyed metals as illustrated in FIG. 10B. The
monolayer depicted in FIG. 10A is comprised of the metal used to
form the first structural element 62 that has been deposited first,
alloyed with the metal used to form the second structural element
64, which was deposited as a second step. The multi-layer depicted
in FIG. 10B is comprised of a layer of metal forming the first
structural element 62 which is deposited as a first step, then
depositing a layer of metal used to form the second structural
element 64 using non-alloying materials.
[0090] FIGS. 10C and 10D illustrate transverse cross-sectional
views through a second structural member 64 and a first structural
member 62, respectively for all embodiments of the inventive
endoluminal stent. Conventional stents typically have structural
elements with generally quadrilateral transverse shapes. Typically,
this is a result of using a hypotube as the starting material for
stent formation. The endoluminal stents in accordance with the
present invention present first and second structural elements 62,
64 which have radiused lateral surfaces 62a, 64a, respectively. In
addition, each of the first and second structural elements 62, 64
also have leading and trailing surfaces which are also radiused
(not shown). In this manner, all blood contact surfaces of the
inventive endoluminal stent present a curvilinear surface to the
blood flow thereby facilitating a more laminar blood flow over the
structural elements of the inventive endoluminal stent.
[0091] An alternative embodiment of the longitudinally flexible
stent of the present invention is illustrated in FIGS. 11A-11C.
Like the embodiments described above, longitudinally flexible stent
100 is comprised of a plurality of first structural elements 102
and a plurality of second structural elements 104. The first
structural elements 102 are positioned generally parallel to the
longitudinal axis L' of the endoluminal stent 100 and are arrayed
circumferentially about the circumferential axis C' of the
endoluminal stents 100. The plurality of second structural elements
104 are oriented generally parallel to the circumferential axis C'
of the endoluminal stent 100 and interconnect adjacent pairs of the
first structural elements 102 in spaced apart relationship about
the circumferential axis C' of the endoluminal stent 100. Each of
the plurality of second structural elements 104 preferably has a
sinusoidal configuration with at least one complete sine curve,
i.e., having both positive and negative amplitude in the proximal
and distal directions relative to the longitudinal axis L' of the
endoluminal stent 100, being subtended between adjacent pairs of
the first structural elements 102. A plurality of flex regions 110
is formed in each of the plurality of first structural members 102.
Each of the plurality of flex regions 110 are formed as narrowed
regions of the first structural member 102 and may be configured as
V-shaped projections which project circumferentially from each of
the plurality of first structural members 102. In accordance with
the best mode for the present invention, it is contemplated that
one of the plurality of flex regions 110 is positioned intermediate
adjacent pairs of the second structural elements 104 along the
first structural element 102. Alternative configurations are
additionally contemplated in which the flex regions 110 are
positioned between alternative pairs of second structural elements
104, are positioned only at proximal, distal or intermediate
regions of the endoluminal stent, or are positioned only on
selected first structural elements 102, or combinations thereof. In
this manner, the longitudinal flexibility of the endoluminal stent
100 may be tailored to impart greater coefficients of longitudinal
flexibility in different regions of the endoluminal stent 100.
[0092] In each of the foregoing embodiments, the, Z-axis thickness
and X-Y-axis surface area of the stent first and second structural
elements may be varied so as to affect the longitudinal
flexibility, hoop strength and radial expansion behavior and
profile of the stent. For example, a longitudinally intermediate
circumferential region of the endoluminal stent may have both first
and/or second structural elements which have a greater Z-axis wall
thickness than proximal and distal circumferential regions of the
stent. This configuration effectively reinforces the intermediate
circumferential region, with the result being that the proximal and
distal circumferential regions of the stent will radially dilate
before the intermediate circumferential region. Alternatively,
either or both of the proximal and distal circumferential regions
may have first and/or second structural elements which have greater
Z-axis wall thicknesses than those in a longitudinally intermediate
circumferential region. This configuration will result in the
longitudinally intermediate circumferential region radially
dilating prior to either or both of the proximal and distal
circumferential regions. Another alternative is to vary the Z-axis
wall thickness of the first and/or second structural elements in a
continuum along the longitudinal axis of the endoluminal stent such
that the stent radially expands into a conical configuration.
[0093] Finally, in accordance with the present invention there is
provided a self-supporting endoluminal graft 90 as depicted in FIG.
12. In accordance with a preferred embodiment of the invention, a
graft member is formed as a discrete thin sheet or tube of
biocompatible metals or metal-like material or as a laminated or
plied structure of a plurality of thin sheets or tubes in adjoining
relationship with one another. Like the inventive endoluminal
stent, described above, the thin sheet or tube includes a plurality
of first structural elements 94 that provide longitudinal or column
strength to the graft, and a plurality of second structural
elements 96 that provide circumferential or hoop strength to the
graft. The first and second structural elements 94, 96 form
integral and monolithic elements of the graft. A web 95 of the
material that forms the first and second structural elements
partially subtends interstitial openings 92 defined between
proximate first and second structural elements 94, 96. It is
preferable that the thin sheet or tube be comprised of pluralities
of openings 98, which pass transversely through the web 95 of the
graft member 90. The plurality of openings 98 may be random or may
be patterned. It is preferable that the size of each of the
plurality of openings be such as to permit cellular migration
through each opening, without permitting fluid flow there through.
In this manner, blood cannot flow through the plurality of
openings, but various cells or proteins may freely pass through the
plurality of openings to promote graft healing in vivo. The
inventive self-supported endoluminal graft 90 may be fabricated of
two or more discrete members each consisting of the inventive
endoluminal stent described above which are concentrically engaged
relative to one another, and positioned such that interstitial
openings 92 in each stent member are juxtaposed adjacent a first or
second structural element 94, 96 of an adjacent stent. In this
manner the interstitial openings 92 of each stent 90 are at least
partially occluded by the first and/or second structural elements
94, 96 of an adjacent endoluminal stent 90. Alternatively, the
inventive self-supported endoluminal graft 90 may be fabricated by
vacuum deposition techniques as described in co-pending, commonly
assigned, U.S. patent application Ser. No. 09/443,929, filed Nov.
19, 1999, which is hereby incorporated by reference. Where the
self-supported endoluminal graft is fabricated by vacuum deposition
techniques, the graft may be fabricated as a laminated or plied
structure in which the first and second structural elements 94, 96
of a first layer are integral and monolithic with one another, as
is the web 95 which subtends the interstitial space 92 between
adjacent first and second structural elements 94, 96.
[0094] With particular reference to FIG. 13 there is illustrated a
laminated self-supported graft 90 in accordance with the present
invention. Graft 90 is comprised of plural stent layers 90a, 90b,
90c, 90d which are successively deposited onto one another starting
with first stent layer 90a. First stent layer 90a is comprised of a
plurality of first structural elements 94 and second structural
elements 96, with a plurality of web regions 95, each of which
subtend a space 99 defined by the first and second structural
elements. At least one opening 98 is provided in at least a portion
of the web regions 95. A second stent layer 90b is deposited onto
the first stent layer 90a. Like the first stent layer 90a, second
stent layer 90b is comprised of a plurality of first structural
elements 94 and second structural elements 96, with a plurality of
web regions 95, each of which subtend a space 99 defined by the
first and second structural elements. Second stent layer 90b may be
of similar geometry or different geometry than first stent layer
90a, and is positioned out-of-phase relative to the geometric
pattern of first stent 90a. In being out-of-phase with first stent
layer 90a, the first structural element 94 of the second stent
layer 90b is adjacent and overlays both the second structural
elements 96, the plurality of web regions 95 and the openings 98 in
the first stent layer 90a. Successive stent layers 90c, 90d, and so
forth depending upon the particular desired graft construction, are
deposited upon one another such that adjacent stent layers form
interlamellar endothelial growth channels 97 between successive
stent layers 90a, 90b, 90c and 90d. The interlamellar endothelial
growth channels 97 promote endothelialization by providing tortuous
micropathways for cellular incorporation into the self-supporting
graft 90.
[0095] While the present inventions have been described with
reference to their preferred embodiments, those of ordinary skill
in the art will understand and appreciate that a multitude of
variations on the foregoing embodiments are possible and within the
skill of one of ordinary skill in the vapor deposition and stent
fabrication arts, and that the above-described embodiments are
illustrative only and are not limiting the scope of the present
invention which is limited only by the claims appended hereto.
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