U.S. patent application number 10/419280 was filed with the patent office on 2004-05-13 for intravascular stent with increasing coating retaining capacity.
Invention is credited to Jang, G. David.
Application Number | 20040093071 10/419280 |
Document ID | / |
Family ID | 25363552 |
Filed Date | 2004-05-13 |
United States Patent
Application |
20040093071 |
Kind Code |
A1 |
Jang, G. David |
May 13, 2004 |
Intravascular stent with increasing coating retaining capacity
Abstract
An expandable stent includes a tubular structure with an outer
surface positionable adjacent to a vessel wall and an inner surface
facing a lumen of a body passageway. The tubular structure further
includes a plurality of expansion struts, connector struts and
cells. The tubular structure has a first diameter which permits
intraluminal delivery of the tubular structure into the body
passageway, and a second expanded and deformed diameter which is
achieved upon the application of a radially, outwardly extending
force. A plurality of cavities are formed in the outer surface of
the stent.
Inventors: |
Jang, G. David; (Redlands,
CA) |
Correspondence
Address: |
JONES DAY
222 EAST 41ST STREET
NEW YORK
NY
10017
US
|
Family ID: |
25363552 |
Appl. No.: |
10/419280 |
Filed: |
April 17, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10419280 |
Apr 17, 2003 |
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09874349 |
Jun 4, 2001 |
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60209255 |
Jun 5, 2000 |
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60235164 |
Sep 23, 2000 |
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Current U.S.
Class: |
623/1.15 |
Current CPC
Class: |
A61F 2250/0067 20130101;
A61F 2/915 20130101; A61F 2002/91525 20130101; A61F 2250/0068
20130101; Y10T 83/04 20150401; A61F 2/91 20130101; A61F 2002/91558
20130101; A61F 2002/91533 20130101 |
Class at
Publication: |
623/001.15 |
International
Class: |
A61F 002/06 |
Claims
What is claimed is:
1. An expandable stent, comprising: a tubular structure including
an outer surface positionable adjacent to a vessel wall, an inner
surface facing a lumen of a body passageway, a plurality of
expansion struts, connector struts and cells, the tubular structure
having a first diameter which permits intraluminal delivery of the
tubular structure into the body passageway having a lumen, and a
second expanded and deformed diameter upon the application from the
interior of the tubular member of a radially, outwardly extending
force; and a plurality of cavities formed in the outer surface of
the stent.
2. The stent of claim 1, wherein the tubular structure is balloon
expandable.
3. The stent of claim 1, wherein the tubular structure is
self-expandable.
4. The stent of claim 1, wherein at least a portion of the tubular
structure is made of a shape memory alloy.
5. The stent of claim 1, wherein the plurality of cavities are
substantially evenly positioned on the tubular structure.
6. The stent of claim 1 wherein the plurality of cavities increase
a flexibility of the stent without substantially reducing a radial
strength of the stent in a deployed state.
7. The stent of claim 1, wherein the plurality of cavities are
micro-holes that extend from the outer surface.
8. The stent of claim 7, wherein the micro-holes have a
cross-section that is smaller than a cross section of a strut.
9. The stent of claim 7, wherein the micro-holes extend from the
outer surface through the inner surface.
10. The stent of claim 7, wherein the micro-holes extend from the
outer surface to an interior of the tubular structure without
extending through the inner surface.
11. The stent of claim 7, wherein at least a portion of the
micro-holes extend from the outer surface through the inner surface
and at least a portion extend from the outer surface to an interior
of the tubular structure without extending through the inner
surface.
12. The stent of claim 7, wherein at least a portion of the
micro-holes have geometry's that are configured to provide a
reservoir for a coating substance applied to the tubular
structure.
13. The stent of claim 7, wherein at least a portion of the
micro-holes have a diameter of at least 0.0007 inch.
14. The stent of claim 7, wherein at least a portion of the
micro-holes extend perpendicular from the outer surface to an
interior of the tubular structure.
15. The stent of claim 7, wherein at least a portion of the
micro-holes extend at a non-perpendicular slant angle from the
outer surface to an interior of the tubular structure.
16. The stent of claim 1, wherein the plurality of cavities are
micro-slits that extend from the outer surface.
17. The stent of claim 16, wherein the micro-slits have a
cross-section that is smaller than a cross section of a strut.
18. The stent of claim 16, wherein the micro-slits extend from the
outer surface through the inner surface.
19. The stent of claim 16, wherein the micro-slits extend from the
outer surface to an interior of the tubular structure without
extending through the inner surface.
20. The stent of claim 16, wherein at least a portion of the
micro-slits extend from the outer surface through the inner surface
and at least a portion extend from the outer surface to an interior
of the tubular structure without extending 4 through the inner
surface
21. The stent of claim 16, wherein at least a portion of the
micro-slits have geometry's that are configured to provide a
reservoir for a coating substance applied to the tubular
structure.
22. The stent of claim 16, wherein at least a portion of the
micro-slits have a width of at least 0.0007 inch.
23. The stent of claim 16, wherein at least a portion of the micro
slits have a width greater than 0.0007 inch.
24. The stent of claim 16, wherein at least a portion of the micro
slits have a length of at least 0.001 inch.
25. The stent of claim 16, wherein at least a portion of the micro
slits have a length greater than 0.001 inch.
26. The stent of claim 16, wherein at least a portion of the
micro-slits extend perpendicular from the outer surface to an
interior of the tubular structure.
27. The stent of claim 16, wherein at least a portion of the
micro-slits extend at a non-perpendicular slant angle from the
outer surface to an interior of the tubular structure.
28. The stent of claim 16, wherein at least a portion of the
micro-slits have a linear geometric shape.
29. The stent of claim 16, wherein at least a portion of the
micro-slits have a curved geometric shape.
30. The stent of claim 16, wherein at least a portion of the
micro-slits have a bottom surface formed in an interior of the
tubular structure.
31. The stent of claim 30, further including at least one aperture
that extends from the bottom surface of a micro-slit through the
inner surface.
32. The stent of claim 30, further including a plurality of
apertures that extend from the bottom surface of the micro-slit
through the inner surface.
33. The stent of claim 1, further comprising: a coating substance
on at least a portion of outer surface of the stent including at
least a portion of the plurality of cavities.
34. The stent of claim 33, wherein the coating substance is a
restenosis inhibiting agent.
35. The stent of claim 34, wherein the restenonis inhibiting agent
is selected from a drug, polymer and bio-engineered material.
36. The stent of claim 34, wherein the restenonis inhibiting agent
is a combination of two agents selected from a drug, polymer and
bio-engineered material.
37. The stent of claim 34, wherein each of a cavity of the
plurality of cavities is configured to have a shape adapted to
increase an amount of restenosis inhibiting agent coated on the
stent.
38. The stent of claim 33, wherein each of a cavity of the
plurality of cavities is configured to have a shape adapted to
provide reservoir of the coated substance on the stent.
39. An expandable stent, comprising: a tubular structure including
an outer surface positionable adjacent to a vessel wall, an inner
surface facing a lumen of a body passageway, a plurality of
expansion struts, connector struts and cells, the tubular structure
having a first diameter which permits intraluminal delivery of the
tubular structure into the body passageway having a lumen, and a
second expanded and deformed diameter upon the application from the
interior of the tubular member of a radially, outwardly extending
force; a plurality of cavities formed in the outer surface of the
stent; and a coating substance on at least a portion of outer
surface of the stent including and extending into at least a
portion of the cavities.
40. The stent of claim 39, wherein the coating substance is on at
least a portion of the inner surface of the stent.
41. The stent of claim 39, wherein the coating substance is a
restenosis inhibiting agent.
42. The stent of claim 41, wherein the restenonis inhibiting agent
is selected from a drug, polymer and bio-engineered material.
43. The stent of claim 34, wherein the restenonis inhibiting agent
is a combination of two agents selected from a drug, polymer and
bio-engineered material.
44. The stent of claim 40, wherein each of a cavity of the
plurality of cavities is configured to have a shape adapted to
increase an amount of restenosis inhibiting agent coated on the
stent.
45. The stent of claim 39, wherein each of a cavity of the
plurality of cavities is configured to have a shape adapted to
provide a reservoir of the coated substance on the stent.
46. The stent of claim 39, wherein the tubular structure is balloon
expandable.
47. The stent of claim 39, wherein the tubular structure is
self-expandable.
48. The stent of claim 39, wherein at least a portion of the
tubular structure is made of a shape memory alloy.
49. The stent of claim 39, wherein the plurality of cavities are
substantially evenly positioned on the tubular structure.
50. The stent of claim 39, wherein the plurality of cavities
increase a flexibility of the stent without substantially reducing
a radial strength of the stent in a deployed state.
51. The stent of claim 39, wherein the plurality of cavities are
micro-holes that extend from the outer surface.
52. The stent of claim 51, wherein the micro-holes have a
cross-section that is smaller than a cross section of a strut.
53. The stent of claim 39, wherein the plurality of cavities are
micro-slits that extend from the outer surface.
54. The stent of claim 55, wherein the micro-slits have a
cross-section that is smaller than a cross section of a strut.
55. A stent assembly, comprising: a balloon; and an expandable
stent positioned at an exterior of the balloon, the stent
including, a tubular structure including an outer surface
positionable adjacent to a vessel wall, an inner surface facing a
lumen of a body passageway, a plurality of expansion struts,
connector struts and cells, the tubular structure having a first
diameter which permits intraluminal delivery of the tubular
structure into the body passageway having a lumen, and a second
expanded and deformed diameter upon the application from the
interior of the tubular member of a radially, outwardly extending
force applied by the balloon; a plurality of cavities formed in the
outer surface of the stent; and a coating substance on at least a
portion of outer surface of the stent including and extending into
at least a portion of the cavities.
56. The stent of claim 55, wherein the coating substance is on at
least a portion of the inner surface of the stent.
57. The stent of claim 55, wherein the coating substance is a
restenosis inhibiting agent.
58. The stent of claim 55, wherein the restenonis inhibiting agent
is selected from a drug, polymer and bio-engineered material.
59. The stent of claim 55, wherein each of a cavity of the
plurality of cavities is configured to have a shape adapted to
increase an amount of restenosis inhibiting agent coated on the
stent.
60. The stent of claim 55, wherein each of a cavity of the
plurality of cavities is configured to have a shape adapted to
provide a reservoir of the coated substance on the stent.
61. A method of manufacturing an intravascular stent, comprising:
forming an intravascular stent having an inner surface and an outer
surface; and forming a plurality of cavities on the outer surface
of the intravascular stent; and disposing on at least a portion of
the outer surface and at least a portion of the plurality of
cavities a coating substance that inhibits restenosis.
62. The method of claim 61, wherein at least a portion of the
plurality of cavities is formed on the outer surface of the
intravascular stent by a laser.
63. The method of claim 61, wherein the at least a portion of the
plurality of cavities is formed on the outer surface of the
intravascular stent by EDM.
64. The method of claim 61, wherein the at least a portion of the
plurality of cavities is photochemically formed on the outer
surface of the intravascular stent.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of Provisional Patent
Application No. 60/235,164 filed Sep. 23, 2000, the disclosure of
which is incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of Invention
[0003] This invention relates generally to intravascular stents,
and more particularly to intravascular stents that include a
plurality of cavities formed on a surface of the stent and are
coated with a restenosis inhibiting agent.
[0004] 2. Description of the Related Art
[0005] By 1999, the percutaneous balloon angioplasty and stent
implant procedures have become the dominant non-surgical
revascularization method of the atherosclerotic stenosis, or
obstruction, of the vascular lumen, and particularly in the
coronary vascular system in the heart. With balloon angioplasty
alone, without use of stent, the restenosis rate after angioplasty
has been as high as 25-45% in the first lime clinical cases. With
use of stents after balloon angioplasty, the restenosis has been
reduced significantly. Even so, the restenosis rate after stent
implant is reported as 10-25% range depending on the condition of
the vessel stented or what specific stent was used, requiring a
need for further restenosis reducing measures after intravascular
stenting.
[0006] To further reduce the restenosis rate after stent implant,
numerous means has been fried, including laser, atherectomy, high
frequency ultrasound, radiation device, local drug delivery, etc.
Although the brachytherapy (radiation treatment) has proved to be
reasonably effective in further reducing restenosis after stent
implant, using brachytherpy is very cumbersome, inconvenient and
costly. Mainly because it is radioactive device and radiation
therapy specialist from another department has to be involved with
the interventional cardiologist in the cardiac catheterization
laboratory. The laser and atherectomy devices proved to be
marginally useful in this purpose with added costs.
[0007] The local drug therapy appears be a very promising method
for the future, as 5 better pharmaceutical, chemical or biogenetic
agents are developed and became available. Some research data, both
from animal tests and human clinical studies, indicate that there
are evidences of suppressing restenosis after stent implant when
certain growth blocking pharmaceutical agents available today are
used to coat the stent. In another instances, it has been
speculated that certain surface modifying materials coated on the
surface of the stent may be beneficial by it alone or in
combination wit growth suppressing agent, in reducing restenosis
rate. In either instance, the drug or substance should be locally
attached or coated on the stent and in sufficient amounts. However,
attaching or coating a sufficient amount of a substance or drug on
the coronary stent is not so easy a proposition.
[0008] Coating a drug or an agent on the surface of the stern has a
demanding problem of enough volume of such substance coated on the
small surface areas of stent struts, without increasing the
physical width or thickness of stent struts. This demand directly
conflicts with the metal fraction issue of the stent. If the width
(and lesser degree the thickness) of stent struts is increased in
order to widen drug coating surface areas, it would have an
elevated deleterious foreign body effect of the increased metal
fraction of the stent, which would promote restenosis.
[0009] Designing an ideal stent, particularly the coronary stent,
is a very demanding balance of a numerous conflicting factors. An
ideal stent requires an ideal balance of numerous different stent
features built into the stent. One of the many requirements of a
coronary, or any vascular stent, is to keep the metal fraction of
the stent low. This means that drug coating is a very demanding
task. Enough amounts of a drug or agent should be coated on the
miniscule surface areas of the stent struts, in order to have the
desired drug results of reducing restenosis. An average stent,
particularly a coronary stent, will have problem of providing
desired amount of drug-retaining capacity on the surface areas of
the stent struts.
[0010] The main invention of this application is not an invention
of the stent itself The present invention is the particular
measures designed to increase drug coating or attachment capacity
of a stent by adding exposed surface areas or reservoir capacity of
the stent, without increasing the width or thickness of the stent
struts or without increasing the metal fraction of the stent. These
special measures of present invention will enhance the coating
substances to a stent. Further, the present invention will enhance
the reservoir capacity of the stent for different forms of
restenosis reducing proteins, chemicals or drugs, and will prolong
the releasing time duration of the substances.
[0011] U.S. Pat. No. 6,190,404 discloses an intravascular stent
with an outer surface, an inner surface and grooves formed in the
inner surface of the stent. The grooves are positioned and provided
to increase the rate of migration of endothelial cells upon the
inner surface of the stent.
[0012] There is a need for a stent with a geometry that provides
for an increased amount of a coating substance. There is a further
need for a stent that includes reservoirs for retaining
coatings.
SUMMARY OF THE INVENTION
[0013] Accordingly, an object of the present invention is to
provide an intravascular stent with a geometry that provides for an
increased amount of a coating substance. Another object of the
present invention is to provide an intravascular stent with
cavities formed in the stent that serve as reservoirs of coatings
applied to the stent. Yet another object of the present invention
is to provide an intravascular stent with cavities formed in the
body of the stent and with a restenosis inhibiting agent applied to
the stent.
[0014] Another object of the present invention is to provide an
intravascular stent with micro-holes or micro-slits that provide
reservoirs for stent coatings. These and other objects of the
present invention are achieved in an expandable stent. A tubular
structure includes an outer surface positionable adjacent to a
vessel wall and an inner surface facing a lumen of a body
passageway. The tubular structure further includes a plurality of
expansion struts, connector struts and cells. The tubular structure
has a first diameter which permits intraluminal delivery of the
tubular structure into the body passageway, and a second expanded
and deformed diameter which is achieved upon the application of a
radially, outwardly extending force. A plurality of cavities are
formed in the outer surface of the stent.
[0015] In another embodiment of the present invention, an
expandable stent, includes a tubular structure with an outer
surface positionable adjacent to a vessel wall, an inner surface
facing a lumen of a body passageway, a plurality of expansion
struts, connector struts and cells. The tubular structure has a
first diameter which permits intraluminal delivery of the tubular
structure into the body passageway, and a second expanded and
deformed diameter that is achieved upon the application of a
radially, outwardly extending force. A plurality of cavities formed
in the outer surface of the stent. A coating substance is on at
least a portion of outer surface of the stent including and extends
into at least a portion of the cavities.
[0016] In another embodiment of the present invention, a stent
assembly includes a balloon and an expandable stent positioned at
an exterior of the balloon. The stent includes a tubular structure
with an outer surface positionable adjacent to a vessel wall, an
inner surface facing a lumen of a body passageway, a plurality of
expansion struts, connector struts and cells. The tubular structure
has a first diameter which permits intraluminal delivery of the
tubular structure into the body passageway, and a second expanded
and deformed diameter that is achieved upon the application of a
radially, outwardly extending force applied by the balloon. A
plurality of cavities are formed in the outer surface of the stent.
A coating substance is on at least a portion of outer surface of
the stent including and extending into at least a portion of the
cavities.
[0017] In another embodiment of the present invention, a method of
manufacturing an intravascular stent is provided. The intravascular
stent has an inner surface and an outer surface. A plurality of
cavities are formed on the outer surface. A coating substance that
inhibits restenosis is formed on at least a portion of the outer
surface and on at least a portion of the plurality of cavities
BRIEF DESCRIPTION OF DRAWINGS
[0018] FIG. 1 is a flat cut-open, two-dimensional, schematic view
of one embodiment of a stent of the present invention that includes
cavities formed in the body of the stent.
[0019] FIG. 2 is a close-up view of the stent from FIG. 1 with
cavities that extend from the outer surface of the stent into an
interior of the stent.
[0020] FIG. 3 is a cross-section, side view of a stent of the
present invention with cavities that extend from the outer surface
through the inner surface.
[0021] FIG. 3(b) is a cross-sectional, magnified, side view of one
embodiment of the stent of the present invention illustrating that
cavities can be closed and serve as reservoirs for coating
substance applied to the stent.
[0022] FIG. 3(c) is a cross-sectional, magnified view of another
embodiment of the present invention illustrating a stent that
includes cavities that extent at a slant angle from the outer
surface through the inner surface.
[0023] FIG. 3(d) is a cross-sectional, magnified, side view of one
embodiment of s the present invention with cavities that extend at
a slant, non-perpendicular angle from the outer surface to an
interior of the stent.
[0024] FIG. 4 is a flat cut-open, two-dimensional, schematic view
of a stent seen from the outer surface of the stent cavities
distributed in an even pattern.
[0025] FIG. 5 is a close-up, magnified, view of the expansion and
connector struts 10 from FIG. 4 with micro-slits and micro-holes
that extend from the outer surface of the stent struts.
[0026] FIG. 6(a) is a cross-sectional, magnified, side view of a
stent strut of the present invention illustrating micro slits that
extend through both the outer and inner surfaces and the entire
thickness of the stent strut.
[0027] FIG. 6(b) is a cross-sectional, magnified, side view of the
stent strut of the present invention illustrating perpendicularly
extending open micro slits on one side and closed micro-slits on
the opposite site of the strut.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0028] Referring now to FIG. 1, one embodiment of an expandable
stent 10 of the present invention is illustrated. A tubular
structure includes an outer surface positionable adjacent to a
vessel wall and an liner surface facing a lumen of a body
passageway. The tubular structure further includes a plurality of
expansion struts, connector struts and cells. The tubular structure
has a first diameter which permits intraluminal delivery of the
tubular structure into the body passageway, and a second expanded
and deformed diameter which is achieved upon the application of a
radially, outwardly extending force.
[0029] A plurality of cavities are formed in the outer surface of
the stent. The 30 cavities can be micro-holes or micro-slits and
extend from the outer surface to an interior of the struts, or
extend from the outer surface all the way through the inner
surface. An example of a stent design useful with the present
invention is disclosed in U.S. Pat. No. 5,954,743, incorporated
herein by reference. In FIG. 1, a two-dimensional view of the stent
10 is illustrated and is seen from the outer surface of the
cut-open, two-dimensional view.
[0030] Stent 10 includes expansion columns 12 and connector columns
14 in a continuous and alternating pattern to form a longitudinal
dimension and a vertical dimension. The vertical and longitudinal
dimensions determine the circumference and the length respectively
of stent 10. Expansion columns 12 have expansion struts 16 in a
vertical zigzag or corrugated pattern. One expansion column 12 is
linked to an adjacent expansion column 12 by connector column 14
between two adjacent expansion 12 columns. Connector columns 14
have connector struts 18 that serve as linking arms between
expansion struts 16 in two adjacent expansion columns 12. Stent 10
has a proximal end 20 and a truncated end 22 in the middle of stent
10.
[0031] In one embodiment, stent 10 is a tubular structure that
includes patterned expansion struts 16 and connectors struts 18
continuously linked circumferentially and longitudinally with a
predetermined length. The total surface areas of struts 16 and 18
are limited to a certain percent of the total cylindrical surface
area of tubular stent 10, particularly when stent 10 is expanded in
a vessel, with enlarged (by stent expansion) stent cells 24 that
make up the remainder of the total stent surface area.
[0032] The amount of a coating substance applied to and retained by
stent 10 is determined by the total surface area of stent struts 16
and 18. Coating substance is preferably a restenosis inhibiting
agent that is a drug, polymer and bio-engineered material and
combinations thereof. It will be appreciated that other types of
coating substances, well known to those skilled in the art, can be
applied to stent 10 of the present invention. Because the total
stent strut surface areas are limited in size, the amount of
coating substance applied to stent 10 is limited to a small volume.
When stent 10 is expanded in a vessel the relative surface area of
struts 16 and 18 decreases in relation to the areas of stent cells
24. The total cylindrical surface area of stent 10 when it is
implanted and expanded inside of a vessel is equal to the sum of
the strut surface areas, which do not change, and stent cells 24
areas. The size of stent cells 24 areas changes when stent 10 is
expanded. The present invention increases the amount of the coating
substance capacity of stent 10 without increase the metal fraction
of stent 10.
[0033] In various embodiments, the present invention increases the
coating substance retaining capacity of stent 10 by forming
cavities that can be micro holes 26 which are made, punched,
drilled or burned into the expansion and connector Struts 16. In
FIG. 1, micro holes 26 have openings 28 on outer surface of struts
16 and 18. Micro holes 26 are made and arranged in such a way so
that they can be evenly distributed in struts 16 and 18. In this
embodiment, micro holes 26 are evenly distributed through out the
entire body of stent 10. The number of micro holes 26 illustrated
in FIG. 1 is only by example.
[0034] The number of micro holes 26 created in stent 10 can vary by
increasing or decreasing the number according to the necessity and
requirements when such stents are fabricated for clinical use.
Additionally, the pattern of creating micro holes 26 in stent
struts 16 and 18 can be varied according to the clinical and
protocol needs. Although micro holes 26 in FIG. 1 are made in
straight lines it will be appreciated that micro holes 26 can be
made in any varied pattern or shape. Micro-holes 26 can be made to
form any suitable shape or pattern as necessary, if they meet the
structural or engineering requirements of stent 10. Micro holes 26
can be made in single line or in multiple lines in struts 16 and 18
and arranged in any pattern.
[0035] In the embodiment illustrated in FIG. 2, width 30 of
expansion strut 16 is shown as being larger than width 32 of
connector strut 18. It will be appreciated that the relative widths
can change and that width 32 can be greater than width 30.
[0036] The size of micro holes 26 can be based on the physical
dimensions of struts 16 and 18. Micro holes 26 cannot have
diameters or size as large as the width of struts 16 and 18. Micro
holes 26 can have substantially smaller widths or diameters than
widths 30 and 32 in order to maintain the structural integrity and
radial strength of stent 10. In one embodiment, micro holes 26 have
an effective size or diameter to provide an optimal retaining
capacity of substances or drugs that are coated or deposited on
stent 10. Similarly, the distance between micro holes 26 is
selected to maintain the integrity of stent 10 while providing an
optimal number of micro holes
[0037] 26 to provide a sufficient coating substance retaining
capacity. Micro holes 26 in struts 18 can be made smaller than
micro holes 26 in expansion struts 16 and visa versa.
[0038] Micro holes 26 and opening 28 can have more than one shape
including but not limited to circular, square, oval, oblong,
irregular, polygonal or a combination thereof, depending on the
method used to create micro holes 26. The tools to create micro
holes 26 can be mechanical, photochemical, laser, EDM and the like.
The shape or configuration of micro holes 26 and openings 28 in
stent struts 16 and 18 can be influenced by the size or diameter of
the micro hole 26 made, as well as by other manufacturing factors
such as a laser beam size, photochemical resolution or EDM cathode
and the like.
[0039] In the embodiment of FIG. 3(a), micro holes 26 penetrate the
entire widths 30 and 32 of struts 16 and 18 at a perpendicular
angle with opening 28 on both outer surface s 34 and inner surface
36. Shaded areas 38 show the cross-sectional cut surface of struts
16 and 18. Micro holes 26 are created in a regular interval with
the uninterrupted segment 28 between micro holes 26. Micro holes 26
communicate freely between outer surface 34 and inner surface 36.
As can be seen, micro holes 26 increase the contact surface areas
of stent struts 16 or 18 for the purpose of increasing the capacity
of retaining the intended coating substance added to stent 10. The
bore space of micro holes 26 also serve as micro reservoir chambers
for the substance to be added, attached or coated to stent 10. When
stent 10 is electropolished, the shape or dimension of micro holes
26 can be slightly changed.
[0040] FIG. 3(b) illustrates an embodiment where micro holes 36 are
blind and is extend from outer surface 34 but not do not continue
to inner surface 36. Shaded areas 38 indicate cross-sectioned stent
struts 16 and 18. In FIG. 3(b), micro holes 26 have cul de sac
geometry's 40 that terminate in an interior of struts 16 and 18.
Cul-de-sacs 40 serve as reservoirs for coating substances applied
to stent 10. Cul-desacs 40 can be created at regular or irregular
intervals with uninterrupted segments 42 between that are formed
between micro holes 26.
[0041] Referring now to FIG. 3(c), micro holes 26 are shown with
their axes at a slant angle relative to stent struts 16 and 18. In
this embodiment, micro holes 26 extend from outer surface 34 to
inner surface 36. Because micro holes 26 have a slant angle through
in this embodiment, the length and reservoir capacity of the 25
micro holes 26 is increased compared to the capacity of the FIG.
3(a) micro holes 26.
[0042] In the embodiment illustrated in FIG. 3(d), micro holes 26
have openings 28 on outer surface 34 and cul de sacs 40 on inner
surface 36, all formed at a slant angle. Outer surface 34 has
uninterrupted segments 42 between slant angled micro holes 26 and
inner surface 36 is smooth without openings 28. Again, cul-de-sac
40 provides a reservoir for a coating substance applied to stent
10. Because the bore space of micro holes is at a slant angle there
is an increased reservoir capacity.
[0043] In contrast to FIG. 1, the cavities formed in FIG. 4 are
micro slits, groves, and the like, collectively denoted as 40,
which have widths 44 that are larger than openings 36. Compared to
micro holes 26 of FIG. 1, the micro slits 40 shown in FIG. 4
provide a larger reservoir capacity for the coating substance.
Micro slits 40 can be evenly or unevenly distributed in struts 16
and 18. The number of micro slits 40 illustrated in FIG. 4 is only
by way of example. Increasing or decreasing the number of micro
slits 40 created in stent 10 may vary according to the clinical and
pharmcodynamic necessity and requirements. Additionally, the
pattern of creating micro slits 40 in struts 16 and 18 can vary
according to the clinical and engineering needs. Although micro
slits 40 illustrated in FIG. 4 are in straight lines, micro slits
40 can be made in curvilinear, square-angles, slant angled and the
like with or without radius of curvature. Micro slits 40 can be
made in any suitable pattern or shape as required, if they meet the
structural or engineering requirements of stent 10. Micro slits 40
can be made in single line or in multiple lines in struts 16 and 18
and arranged in any other pattern. The FIG. 4 embodiment
illustrates that micro holes 26 can also be included in the same
stent 10.
[0044] The magnified view of stent 10 illustrated in FIG. 5 shows
struts 16 and 18 with micro slits 40 and openings 46 on outer
surface 34 of stent 10. Width 34 of expansion strut 16 is larger
than width 32 of strut 18 in this embodiment. However, widths 34
and 32 can be the same in size or even reversed.
[0045] Width 44 of micro slit 40 is determined by the physical
dimensions and limits 20 of struts 16 and 18. Width 44 cannot be
made as large as widths 34 and 32. Width 44 is substantially
smaller than width 34 in order to maintain the structural integrity
and radial strength of stent 10. The length of micro slit 40 can be
made as long as stent struts 16 and 18. The length of micro slit 40
can be shorter or longer than the width of struts 16 and 18.
Similarly, the uninterrupted distance 42 between micro slits 40 is
selected so that the structural integrity of stent 10 is not
compromised. Within the allowable limits, micro slits 40 can be
made in different sizes or dimensions in same or differing
patterns. Micro slits 40 in struts 18 can be made smaller than, the
same as or greater than micro-slits 40 formed in struts 16.
[0046] The shape of micro slits 40 and opening 46 can be different
than that 30 illustrated in FIG. 5. The geometry of micro slits 40
can be straight linear, curvilinear, angled, squared or any other
shape, depending on the design of stent 10 and the method used to
make micro slits 40 during the manufacturing process. The tools to
create the micro slits 40 can be the same as those used for
micro-holes 26. Different shapes, sizes and positions of micro
slits 40 can be included in an individual stent 10.
[0047] Referring now to FIG. 6(a), micro slits 40 can extend
through struts 16 and 18 with openings 50 on both outer and inner
surfaces 34 and 36. Micro slits 40 can be created in a regular
interval with uninterrupted segment 42 between micro slits 40.
[0048] Additionally, in this embodiment micro slits 40 can
communicate freely between outer surface 34 inner surface 36. Micro
slits 40 increase coating substance contact surface areas of struts
16 and 18 for the purpose of increasing the reservoir capacity of
intended coating substances.
[0049] FIG. 6(b) illustrates that blind micro slits 40 partially
extend into struts 16 and 18 from outer surface 34. Blind micro
slits 40 end in cul-de-sacs 48 which can be of any desired
geometric configuration. Cul-de-sacs 48 create micro reservoirs 50
for coating substances and can be formed at regular or irregular
intervals with uninterrupted segments 42 between blind micro slits
48. Generally, the reservoir capacity of blind micro slits 40 is
greater than that of blind micro holes 26. Additionally, Micro
slits 40 can also be made in slant angles.
[0050] The foregoing description of a preferred embodiment of the
invention has been presented for purposes of illustration and
description. It is not intended to be exhaustive or to limit the
invention to the precise forms disclosed. Obviously, many
modifications and variations will be apparent to practitioners
skilled in this art. It is intended that the scope of the invention
be defined by the following claims and their equivalents.
[0051] What is claimed is:
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