U.S. patent application number 16/669019 was filed with the patent office on 2020-02-27 for deformable lumen support devices and methods of use.
This patent application is currently assigned to CELONOVA STENT, INC.. The applicant listed for this patent is CELONOVA STENT, INC.. Invention is credited to Andy Edward Denison, Kent C.B. Stalker.
Application Number | 20200060848 16/669019 |
Document ID | / |
Family ID | 39133800 |
Filed Date | 2020-02-27 |
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United States Patent
Application |
20200060848 |
Kind Code |
A1 |
Denison; Andy Edward ; et
al. |
February 27, 2020 |
DEFORMABLE LUMEN SUPPORT DEVICES AND METHODS OF USE
Abstract
Lumen support devices and methods of their use are provided. A
lumen support includes one or more plastically deformable cells
having two stable configurations with no stable configurations
between the two stable configurations. The lumen support device may
be plastically deformed to other stable configurations.
Inventors: |
Denison; Andy Edward;
(Temecula, CA) ; Stalker; Kent C.B.; (San Marcos,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CELONOVA STENT, INC. |
San Antonio |
TX |
US |
|
|
Assignee: |
CELONOVA STENT, INC.
San Antonio
TX
|
Family ID: |
39133800 |
Appl. No.: |
16/669019 |
Filed: |
October 30, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15338937 |
Oct 31, 2016 |
10500074 |
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16669019 |
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13595956 |
Aug 27, 2012 |
9510960 |
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15338937 |
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13347685 |
Jan 10, 2012 |
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13595956 |
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11875718 |
Oct 19, 2007 |
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13347685 |
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60853245 |
Oct 21, 2006 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/844 20130101;
A61F 2002/828 20130101; A61F 2/91 20130101; A61F 2/958 20130101;
A61F 2002/91566 20130101; Y10T 29/49925 20150115; A61F 2002/91558
20130101; A61F 2/915 20130101 |
International
Class: |
A61F 2/844 20060101
A61F002/844; A61F 2/915 20060101 A61F002/915; A61F 2/91 20060101
A61F002/91; A61F 2/958 20060101 A61F002/958 |
Claims
1-18. (canceled)
19. A balloon catheter comprising: a balloon; and a lumen support
device in a crimped configuration coupled to the balloon, the
device comprising one or more unit cells capable of transitioning
from a stable collapsed configuration to a stable expanded
configuration by application of a force through an inversion point
of decreased force, the one or more unit cells capable for
plastically deforming to an expanded plastically deformed
configuration; wherein the lumen support device comprises a
material having an elastic range between about 0.15 to about
1%.
20. The catheter of claim 19, wherein the material is a cobalt
alloy.
21. The catheter of claim 19, wherein an outer diameter of the
balloon is greater than a diameter of the lumen support device in
the stable collapsed configuration.
22. The catheter of claim 19, further comprising a guidewire.
23. The catheter of claim 19, further comprising an external
barrier around the lumen support device.
24. The catheter of claim 19, wherein the balloon is deflated.
25. The catheter of claim 19, wherein the lumen support device
includes a coating of one or more drugs, medications, or
polymers.
26. The catheter of claim 19, wherein the lumen support device
includes a plurality of cells, each of the plurality of cells
defined by at least a first segment and a second segment.
27. The catheter of claim 26, wherein the second segment is less
flexible than the first segment.
28. The catheter of claim 26, wherein the first segment
substantially conforms to a shape of the second segment in the
stable collapsed configuration.
29. The catheter of claim 26, wherein the plurality of cells is
arranged in a first column and a second column.
30. The catheter of claim 26, wherein the first column and the
second column are interconnected by at least one connector.
31. The catheter of claim 30, wherein the at least one connector is
flexible.
32. The catheter of claim 19, wherein the material has an
elongation of above 30%.
33. The catheter of claim 19, wherein the material has an ultimate
tensile strength greater than 500 MPa.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the priority benefit under 35 U.S.C.
.sctn. 119(e) of the provisional application 60/853,245, filed Oct.
21, 2006 which is hereby incorporated by reference in its
entirety.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] Embodiments described herein relate to lumen supports having
plastically deformable structures.
Description of Related Technology
[0003] Vascular prostheses, commonly referred to as stents, are now
widely used in interventional procedures for treating lesions of
the coronary arteries and other vessels. Such devices generally
have a tubular shape and are deployed in a vessel, and are intended
to restore and maintain the patency of a segment of a vessel.
Previously-known vascular prostheses are generally either
self-expanding or balloon expandable, and may vary in size, shape
or other characteristics depending on whether the use is for the
cardiac vasculature, carotid arteries, renal arteries, superficial
femoral arteries, or other vessels.
[0004] Self-expanding and balloon expandable stents often have
elasticities associated with a relatively large amount of recoil.
As such, the stent may be prone to recoil inward after being
expanded to its maximum outer diameter. If this recoil is
significant, the stent may not remain stationary relative to the
passageway, instead migrating to a point of lesser desirability. As
a result, serious or fatal injury to the patient may occur.
[0005] Another aspect of stents is the size to which they may be
compacted through crimping. Stents may be crimped onto a catheter
for delivery to a lesion location within a lumen. One manner of
crimping involves the application of a force directed in a radially
inward direction to force the stent into a compact profile.
However, the stent's diameter may tend to recoil to a diameter
greater than its minimum diameter. This recoil typically increases
as the material's elasticity increases. One disadvantage of this
phenomenon is that, with increased recoil after crimping, the
stent's delivery profile is increased, thereby limiting the stent's
applicability to small vessels that would otherwise be accessible
by a stent with a smaller delivery profile. Another disadvantage is
that a stent that is not tightly coupled to the delivery catheter
may become dislodged at an undesirable location during
delivery.
[0006] Different material choices for stents or other medical
devices offer different advantages and disadvantages. For example,
some highly elastic materials have increased strength and/or
increased radiopacity when compared to other materials with a lower
elasticity, yet suffer from greater recoil than materials with a
lesser elasticity. A balance is desired in which beneficial
features of such stent materials may be enjoyed while reducing
disadvantages such as recoil.
SUMMARY OF THE INVENTION
[0007] In view of the foregoing drawbacks of previously-know
vascular prostheses and other similar medical devices, one aspect
of certain embodiments described herein is to provide a lumen
support having one or more unit cells. In particular embodiments,
the one or more unit cells are capable of assuming multiple stable
configurations. In one aspect of certain embodiments, the lumen
support having the one or more multistable unit cells comprises
beneficial features of elastic materials. Another aspect of certain
embodiments is to provide a lumen support having one or more
multistable cells that do not significantly increase in diameter
due to recoil following crimping. Yet another object of certain
embodiments is to provide a lumen support that does not
significantly decrease in diameter due to recoil following
expansion.
[0008] These and other advantages are achieved by providing a
supportive structure having a body comprising a plurality of cells
capable of low recoil due to some reversal of elastic strain when
crimped. The cells further may undergo plastic deformation as the
medical device is deployed into an expanded configuration, and the
asymmetrical shape of the cells reduces the degree of recoil in
comparison to known stent designs. In certain embodiments, such a
supportive structure is well-adapted to be formed of certain
elastic materials such as cobalt alloys and stainless steel,
thereby being capable of enjoying the advantages of strength and/or
radiopacity, with a reduction in effects such as recoil.
[0009] In one embodiment, a lumen support is configured to be
expanded and contracted to a plurality of stable positions. In some
embodiments, the support includes a plurality of cells. In some
embodiments, each of the plurality of cells is defined by at least
a first segment and a second segment. In some embodiments, the cell
includes a first stable collapsed configuration, a second stable
collapsed configuration, a first stable expanded configuration, and
a second stable expanded configuration. In certain embodiments, the
first segment, is made of a material having an elastic range of
between about 0.15 to about 1% and an elongation of above 30% and
an ultimate tensile strength greater than 500 MPa. As discussed
further herein, the strut made of this material exhibits reduced
recoil to an applied force. In some embodiments, the second segment
is less flexible than the first segment. In certain embodiments,
the first segment may transition from a first stable contracted
position to a first stable expanded position relative to said
second segment. This transition causes the cell to transition from
the first stable collapsed configuration to the first stable
expanded configuration. In some embodiments, the first segment is
configured to plastically deform to a second stable contracted
position creating an area for each cell less than the area created
when said first segment is at said first stable contracted
position. In some embodiments, the first segment is configured to
plastically deform to a second stable expanded position creating an
area for each cell greater than the area created when said first
segment is at said first stable expanded position. In some
embodiments, the first segment is configured to transition between
contracted and expanded positions through an inversion point in
which force is reduced in order to complete the transition. In some
embodiments, the first segment has an elastic range of between
about 0.3 to about 0.8%. In some embodiments, the first segment
substantially conforms to the shape of the second segment in the
first stable collapsed configuration. In some embodiments, the
second segment comprises a plastically deformable segment made of
the material of the first segment.
[0010] In another embodiment, a lumen support includes a
plastically deformable structure made of a material having an
elastic range between about 0.15 to about 1% and an elongation of
above 30% and an ultimate tensile strength greater than 500 MPa.
Such structure is capable of assuming an original collapsed
configuration or a plastically deformed collapsed configuration and
an original expanded configuration or a plastically deformed
expanded configuration, wherein no stable configurations exist
between the original collapsed configurations or the original
expanded configuration. In certain embodiments, the structure is
defined in part by a first segment and a second segment, the first
segment being more flexible than the second segment. In certain
embodiments, the first segment is capable of transitioning between
a contracted position and an expanded position, relative to the
second segment, wherein the first segment passes a transition point
between the contracted position and the expanded position that
allows force to be decreased during the transition.
[0011] In another embodiment, a method of crimping a lumen support
on a delivery device is described. Such method may include
delivering a lumen support onto a delivery device. Lumen supports
are further discussed herein and can be used with any embodiment or
feature of any lumen support described herein. The method may
further include applying a radially inward force to the lumen
support, and deforming one or more unit cells of the lumen support
to a plastically deformed collapsed configuration. In certain
embodiments, the method may include transitioning the lumen support
to a stable collapsed configuration from a stable expanded
configuration by application of a force through an inversion point
of decreased force. In one embodiment, the lumen support has a
smaller diameter in the plastically deformed collapsed
configuration than in the stable collapsed configuration. In one
embodiment, the lumen support includes a first segment and a second
segment, the first segment being more pliable than the second
segment. In certain embodiments, the lumen support includes a
material having an elastic range between about 0.15 to about 1% and
an elongation of above 30% and an ultimate tensile strength greater
than 500 MPa.
[0012] In another embodiment, a lumen support includes a plurality
of unit cells arranged in a first column and a second column, the
first and second columns having a tubular shape and being
interconnected by at least one flexible connector. In some
embodiments, each unit cell in the first column of unit cells is
coupled by first flexible articulations. In some embodiments, each
unit cell in the second column of unit cells is coupled by second
flexible articulations. In some embodiments, at least some of the
unit cells of the plurality of unit cells are capable of
transitioning between a stable expanded configuration and a stable
collapsed configuration by application of a force through an
inversion point of decreased force. In some embodiments, the first
flexible articulations and the flexible connector are configured to
allow one or more unit cells of the first column to conform to a
lumen. In certain embodiments, the plurality of unit cells is made
of a material having an elastic range between about 0.15 to about
1% and an elongation of above 30% and an ultimate tensile strength
greater than 500 MPa. In some embodiments, the material is a cobalt
alloy or is stainless steel.
[0013] In another embodiment, a balloon catheter includes a balloon
and a lumen support device in a crimped configuration coupled to
the balloon. In one embodiment, the device includes one or more
unit cells capable of transitioning from a stable collapsed
configuration to a stable expanded configuration by application of
a force through an inversion point of decreased force. In some
embodiments, the one or more unit cells are capable of plastically
deforming to an expanded plastically deformed configuration. In
some embodiments, the lumen support device includes a material
having an elastic range between about 0.15 to about 1% and an
elongation of above 30% and an ultimate tensile strength greater
than 500 MPa. In some embodiments, the material is a cobalt
alloy.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The above and other objects and advantages of the present
invention will be apparent upon consideration of the following
detailed description, taken in conjunction with the accompanying
drawings, in which like reference characters refer to like parts
throughout, and in which:
[0015] FIG. 1 is a supportive structure in a stable expanded
configuration in accordance with one embodiment;
[0016] FIG. 2 is a supportive structure in a stable collapsed
configuration in accordance with one embodiment;
[0017] FIG. 3A is graph comparing the crimp force to the reduction
in diameter between a stent constructed in accordance with one
embodiment and another stent of a known design;
[0018] FIG. 3B is a drawing of various unit cell configurations as
correlated to points on the graph of FIG. 3A
[0019] FIG. 3C is a graph which shows crimping of unit cells shown
in FIG. 3B as well as expansion through an inversion point to a
plastically deformed configuration;
[0020] FIG. 4 is a section of a support structure in a first stable
expanded configuration that is displayed in a flattened profile in
accordance with one embodiment;
[0021] FIG. 5 is a section of a supportive structure in a first
stable collapsed configuration that is displayed in a flattened
profile in accordance with one embodiment;
[0022] FIG. 6A is a section of a supportive structure in a
plastically deformed expanded configuration that is displayed in a
flattened profile in accordance with one embodiment;
[0023] FIG. 6B is a section of a supportive structure is a
plastically deformed collapsed configuration that is displayed in a
flattened profile in accordance with one embodiment;
[0024] FIG. 7 is a section of a supportive structure that is
displayed in a flattened profile in accordance with one
embodiment;
[0025] FIG. 8 is a section of a supportive structure that is
displayed in a flattened profile in accordance with one
embodiment;
[0026] FIG. 9 is a section of a supportive structure that is
displayed in a flattened profile in accordance with one
embodiment;
[0027] FIGS. 10A-10E depict two cells from the embodiment of FIG. 7
in a flattened profile and in variety of configuration in
accordance with one embodiment;
[0028] FIGS. 11A-11E depict a column of cells from the embodiment
of FIG. 7 in a variety of configurations in accordance with one
embodiment.
[0029] FIGS. 12A-12B depict one embodiment of a supportive
structure according to one embodiment in an expanded and a
collapsed configuration;
[0030] FIG. 13 is a schematic drawing of a process of crimping a
unit cell from a stable expanded configuration through a stable
collapsed configuration to a plastically deformed collapsed
configuration;
[0031] FIGS. 14A-14B are schematic drawings comparing a
conventional crimping process for a stent to the crimping process
for the improved stent;
[0032] FIG. 15 is a schematic drawing comparing recoil of
plastically and elastically expanded stents;
[0033] FIG. 16 is a drawing of one embodiment of two cells of a
supportive structure having certain features;
[0034] FIG. 17 is a drawing of a crimped stent;
[0035] FIGS. 18A-18B are drawings of open cell embodiments having
expanded and collapsed configurations.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0036] Certain embodiments include a supportive structure that
comprises one or more cells having a stable collapsed configuration
and a stable expanded configuration. In particular embodiments, the
supportive structure may be at least a part of a medical device.
Unless otherwise indicated, the term "medical device" is a broad
term and is used in its ordinary sense and includes, without
limitation, wherein the context permits, stents, stent delivery
devices, valves, multi-stable valves, occlusion devices, expanders,
clips, loops, rings, and other devices including cells, whether
open or closed. In particular embodiments, the supportive structure
comprises one or more cells in a tubular form. In certain
embodiments, a tubular device is described in terms of "diameter"
of a portion of the tubular structure. While tubular embodiments
having circular cross-sections (e.g., of constant diameter along
its length) are sometimes preferred, other embodiments are not
limited to that geometry. As such devices within the scope of the
present invention may also include tapered portions, conical
flares, curved portions, branches, or have other similar
geometrical features known in the art.
[0037] An example of such a supportive structure is shown in U.S.
Pat. No. 6,488,702 (also referred to herein as "the Besselink
patent"), which is hereby incorporated by reference in its
entirety. Notably, the Besselink patent describes bistable and
multistable devices that have two or more stable configurations. In
particular, the Besselink patent describes a device having one or
more unit cells having a stable collapsed configuration and a
stable expanded configuration. As a cell transitions from the
stable collapsed configuration to the stable expanded
configuration, the cell transitions through a transition point at
which the force required to complete the transition is
decreased.
[0038] In contrast to the Besselink patent, a supportive structure
of certain embodiments described herein may be deformably collapsed
or expanded to a continuous range of discrete diameters less than
or greater than the diameter of the stable collapsed configuration
or the stable expanded configuration of the device. As such,
devices described herein may include one or more unit cells that
have stable collapsed and expanded configurations. Such
configurations elastically resist minor deformations. As noted, the
cell may transition from a stable collapsed configuration to a
stable expanded configuration through a transition point of
decreased force. The transition point allows the stent to assume
the opposite configuration without additional application of force.
Such expansion or contraction may be defined as isothermal in
certain embodiments. Once in a stable configuration, whether
collapsed or expanded, the cell may then be plastically deformed to
an expanded or reduced area. Following such plastic deformation,
some degree of recoil results in the unit cell assuming a
plastically deformed configuration.
[0039] As used herein, the phrase "predetermined stable state" or
"predetermined stable configuration" describes a configuration in
which one or more cells of the device are in a known configuration
that elastically resists change in a manner such that the cell
returns to the known configuration following minor deformations. As
an example, a bistable cell of the Besselink patent may have two
predetermined stable configurations, an open configuration and a
closed configuration. Such predetermined configurations may be
determined upon manufacture of the device. A cell may "snap" from
one configuration to the other in response to a threshold force
that displaces a portion of the cell beyond an intermediate or
transition point. These configurations are not only stable, but are
predetermined based on the design of the cell. In certain
embodiments, a predetermined stable configuration may also include
a plastically deformed configuration after recoil. As such, where
context permits, predetermined may also be used to describe a
plastically deformed configuration.
[0040] In certain embodiments, the plastically deformed state of
one or more cells may be described in terms of increased or
decreased area of the unit cell. In some embodiments, the one or
more unit cells may be plastically deformed from the original
stable collapsed configuration having a first area to a plastically
deformed stable collapsed configuration having a second area less
than the first area. Likewise, the one or more unit cells may be
plastically deformed from the original stable expanded
configuration having a first area to a plastically deformed stable
expanded configuration having a second area greater than the first
area.
[0041] Once plastically deformed in one configuration, the one or
more unit cells assume the plastically deformed configuration as
one of the two stable configurations of the unit cell. For example,
a cell that has been plastically deformed from the original stable
expanded configuration to a plastically deformed stable expanded
configuration will assume the plastically deformed stable
configuration of the cell. In some embodiments, such a cell may be
capable of transitioning back to a collapsed configuration by
applying requisite force to the cell. Likewise, according to some
embodiments, the one or more unit cells may be plastically deformed
to a plastically deformed collapsed position by crimping, and then
expanded to the predetermined stable expanded configuration or
beyond into a range of plastic deformation. In certain embodiments,
a plastically deformed cell may be further plastically deformed as
desired and where the structural integrity of the cell permits.
[0042] In certain embodiments, the medical device having the one or
more cells is made of an elastic material having certain mechanical
and physical properties. Applicants have unexpectedly discovered
that certain materials may resist recoil upon being compressed or
collapsed or expanded to a plastically deformed state when used in
combination with the geometry and structure of unit cells described
herein. In particular embodiments, optimal materials may include
materials having certain ultimate tensile strengths, elongation
percentages, and/or elastic ranges. In certain embodiments, one
material used in forming the medical device has an ultimate tensile
strength of greater than about 500 MPa, an elongation of greater
than about 30%, and an elastic range between about 0.15 and about
1%. In certain embodiments, one material used in forming the
medical device has an ultimate tensile strength between about 500
MPa and about 2000 MPa, an elongation of greater than about 25%,
and an elastic range between about 0.15% and about 0.8%. Other
potential ranges for materials are further described below.
[0043] In some embodiments, the material may have an elastic range
that is greater than or equal to about 0.20%. In certain
embodiments, the one or more cells are made of an elastic material
having an elastic range of between about 0.15% and about 0.8%. In
certain embodiments, the one or more cells are made of an elastic
material having an elastic range of between about 0.2% and about
0.7%. In certain embodiments, the one or more cells are made of an
elastic material having an elastic range of between about 0.3% and
about 0.9%. In certain embodiments, the one or more cells are made
of an elastic material having an elastic range of between about
0.2% and about 0.6%.
[0044] In some embodiments, the material may have an ultimate
tensile strength that is greater than or equal to about 500 MPa. In
certain embodiments, the one or more cells are made of a material
having an ultimate tensile strength of between about 450 MPa and
about 2000 MPa. In certain embodiments, the one or more cells are
made of a material having an ultimate tensile strength of between
about 600 MPa and about 1500 MPa. In certain embodiments, the one
or more cells are made of a material having an ultimate tensile
strength of between about 550 MPa and about 1200 MPa. In certain
embodiments, the one or more cells are made of a material having an
ultimate tensile strength between about 650 MPa and about 1000
MPa.
[0045] In some embodiments, the material may have an elongation
that is greater than or equal to about 30%. In certain embodiments,
the one or more cells are made of a material having an elongation
of between about 25 and about 75%. In certain embodiments, the one
or more cells are made of a material having an elongation of
between about 30% and about 60%. In certain embodiments, the one or
more cells are made of a material having an elongation of between
about 35% and about 55%.
[0046] It will be appreciated that examples of suitable materials
falling within these ranges include cobalt alloys. In some
embodiments, cobalt nickel chromium alloys may be used. In some
embodiments, cobalt chromium nickel alloys may be used. Nonlimiting
examples of such cobalt alloys include, but are not limited to
L-605 or MP35N. In certain embodiments, cobalt-chromium alloy is a
suitable material to use in forming stents or other medical
devices, as it has greater radiopacity than other materials
commonly used to form stents. As such, a smaller amount of
cobalt-chromium alloys may be used compared to other known
materials. While some embodiments include unit cells made in part
of cobalt-chromium alloy, embodiments may also be practiced with
materials having similar mechanical properties as described herein.
In one nonlimiting embodiments, a stainless steel alloy may be
used. In particular, a stainless steel alloy may include 316 SS.
Other suitable materials may include polymeric materials or
bioabsorbable materials. Physical and mechanical properties of the
above-mentioned suitable materials are found in Table 1, copied
from Poncin, P. et al., Stent Tubing: Understanding the Desired
Attributes, Materials & Processes for Medical Devices
Conference, September 2003, which is hereby incorporated by
reference in its entirety.
TABLE-US-00001 TABLE 1 Physical and mechanical properties of
selected materials. ULTIMATE ELASTIC TENSILE 0.2% YIELD UTS-
DENSITY MODULUS STRENGTH STRENGTH YIELD ELASTIC gr/cm.sup.3 GPa MPa
MPa MPa ELONG. % RANGE % STAINLESS STEELS Fe--18Cr--14Ni--2.5Mo
7.95 193 670 340 330 48 0.17 "316LVM" ASTM F138
Fe--21Cr--10Ni--3.5Mn--2.5Mo 7.90 195 740 430 310 35 0.22 ASTM F
1586 Fe--22Cr--13Ni--5Mn 7.88 193 827 448 379 45 0.23 ASTM F 1314
Fe--23Mn--21Cr--1Mo--1N 7.63 190 931 607 324 49 0.32 Nickel free SS
COBALT ALLOYS Co--20Cr--15W--10Ni 9.10 243 820-1200 380-780 420-600
35-55 0.16-0.32 "L605" ASTM F90 Co--20Cr--35Ni--10Mo 8.43 233 930
414 516 45 0.18 "MP35N" ASTM F 562 Co--20Cr--16Ni--16Fe--7Mo 8.30
221 950 450 500 45 0.20 "Phynox" ASTM F 1058 TITANIUM ALLOYS CP
Titanium 4.50 107 300 200 100 30 0.19 ASTM F 67, Grade 1
Ti--6Al--4V 4.43 105 860 795 65 10 0.72 Alpha/beta ASTM F 136
Ti--6Al--7Nb 4.74 106 1000 900 100 12 0.85 Alpha/beta ASTM F1295
Ti--15Mo 4.95 83 793 655 168 22 0.79 Beta grade ASTM F2066
REFRACTORY Tantalum 16.60 185 207 138 69 25 0.06 Niobium 8.57 103
195 105 90 25 0.10 Tungsten 19.3 411 3126 3000 126 3 0.73
Molybdenum 10.2 324 1540 1386 154 15 0.43 PRECIOUS Pt--10Ir 21.55
150 340 200 140 25 0.13 NITINOL Martensitic 6.45 40 1200 200-300
900-1000 25 1.9 Cold worked 40% 6.45 40 1450 NS NS 12 4-6
Superelastic 6.45 90 1400 NS NS 14 6-8 MAGNESIUM Mg 3Al--1Z 1.8 45
255 162 93 10-25 0.36
[0047] In one embodiment, a support structure is provided having
one or more cells defined by at least two sections, wherein one
section is more pliable than another section. Each unit cell may be
formed of at least two distinct, mechanically connected sections
with different mechanical behaviors. One section acts as a
relatively rigid support for the more flexible section. In certain
configurations, the more flexible section is responsible for most,
if not all, of the expansion of the stent. In some embodiments, a
cell includes two interconnected sections of unequal dimensions. In
one embodiment, a cell may include two struts having unequal
thicknesses, widths, and/or cross sections. For example, a first
strut may have a thickness less than the thickness of a second
strut.
[0048] In some embodiments, a first strut of the cell is configured
to be more flexible than a second strut of the cell. In certain
embodiments, the first and second struts are each concave in shape
in a collapsed configuration. In certain embodiments, the first
strut has substantially the same shape as the second strut in a
collapsed configuration. The more flexible or pliable first strut
may be transitioned from a first stable collapsed position having a
first distance from the second strut to a first stable expanded
position having a second distance from the second strut, the second
distance being greater than the first distance.
[0049] Based on the geometry of the struts, this transition of the
first strut from the first stable collapsed position to a first
stable expanded position requires the application of some amount of
force until the first strut passes through a transition point,
after which time the first strut may continue expanding to the
stable expanded configuration position without any additional force
being applied. Similarly, the first strut may move from the stable
expanded configuration position to the stable collapsed position,
requiring an amount of force required to reach a transition point,
after which time the first strut continues to move to the collapsed
configuration position without any additional force being
applied.
[0050] Additional force may be applied to the structure in either
the stable collapsed configuration or the stable expanded
configuration to achieve additional and useful expanded and/or
collapsed configurations. In certain embodiments, a unit cell in a
stable collapsed configuration may be deformed to have a second
stable collapsed configuration whereby the area of the unit cell is
decreased. In particular embodiments, the structure is plastically
deformed by crimping. Plastically deforming the unit cell to a
plastically deformed collapsed configuration can occur with
sufficient force to impart a desired reduced area of the unit cell.
Such plastic deformation causes the medical device comprising the
one or more unit cells to reach and substantially maintain a
compressed geometry. In certain embodiments, the compressed
geometry is suitable for delivery of the medical device within a
body lumen. Likewise, one or more cells of the medical device may
be plastically deformed beyond the original stable expanded
configuration to a plastically deformed stable expanded
configuration by the application of an outward force. Such plastic
deformation causes the medical device comprising the one or more
unit cells to reach and substantially maintain an expanded
geometry.
[0051] In certain embodiments, plastic deformation of the first,
more flexible strut is used to achieve plastically deformed stable
configurations. For example, an amount of force sufficient to
plastically deform the first strut may be applied when the first
strut is in a collapsed position. Such force is typically applied
at least in part in a direction toward the second less flexible
strut. The plastically deformed first strut attains a second
collapsed or contracted position having a distance closer to the
second strut. In some embodiment, the second, less flexible strut
may also experience plastic deformation or geometrical variance
with the deformation of the first strut.
[0052] Once plastic deformation has occurred to a plastically
deformed collapsed configuration, the cell does not return to
predetermined stable collapsed configuration. Likewise, once
plastic deformation has occurred to a plastically deformed expanded
configuration, the cell does not return to predetermined stable
expanded configuration. Instead, the cell substantially maintains
its collapsed or expanded configuration to which it was plastically
deformed. It will be appreciated that the size and shape of the
cell may be gradually decreased or increased by additional
plastically deforming force, thereby allowing the stent to be
collapsed or expanded through a continuum of diameters, perimeters,
cross-sectional areas and/or sizes.
[0053] Certain embodiments include the unit cells described herein.
In one embodiment, a one unit cell device may be used. For example,
one unit cell lumen support may be used. In certain embodiments,
unit cells of certain embodiments include one or more unit cells in
a column, such column being arranged in a tubular structure. In
certain embodiments, one or more columns may be connected together
as further described herein. In certain embodiments, rings of the
multistable unit cells having an inversion point between expanded
and collapsed configurations, may be used together with convention
unit cells that do not have the inversion geometry discussed
herein. For example, one ring of enhanced unit cells (i.e., having
an inversion point geometry) may be adjacent to a ring of
conventional unit cells that do not posses such inversion point
geometry.
[0054] Embodiments will now be described with reference to the
drawings provided. Although embodiments will be discussed in
connection with certain medical devices shown in the drawings, it
is understood that such discussion is to facilitate an
understanding of the preferred embodiments only, and is not
intended to limit the scope of the present application to the
embodiments shown in the figures.
[0055] As presently contemplated, one embodiment of a medical
device having one or more cells is a stent. Alternatively,
embodiments of the medical devices described herein could take the
form of a multistable valve, an expander, a clip, a loop, a ring,
or other like medical devices and/or lumen supports which use
expandable cells. For the sake of simplicity, embodiments relating
to stents are described below.
[0056] Referring now to FIGS. 1 and 2, an embodiment of a
supportive structure in the form of stent 10 is shown. Stent 10
includes a plurality of cells having at least bistable
configurations described in greater detail in the Besselink patent.
Stent 10 comprises a number of thick struts 12 interconnected to
thin struts 14 by connector members 16. Thick struts 12 typically
have different dimensions than thin struts 14. For example, thick
struts 12 may have a greater thickness, width, or cross-section
than thin strut 14. In a preferred embodiment in which the
thicknesses of struts 12 and 14 are different, thick struts 12 are
between about 1% to about 200% thicker than thin struts 14,
although it will be appreciated that the strut thicknesses may be
equal or may be different by some amount outside this range.
[0057] Stent 10 may comprise one or more materials. In particular
embodiments, stent 10 comprises a material having a certain elastic
range, elongation, and ultimate tensile strength as noted above. In
some embodiments, stent 10 is at least partially formed of such a
material. In some embodiments, stent 10 is fully formed of such a
material. In some embodiments, thin struts 14 are partially or
fully made of a cobalt-chromium alloy. In certain embodiments,
thick struts 12 are partially or fully made of a cobalt-chromium
alloy. Stent 10 may be formed of a uniform material or may be a
combination of one or more materials. For example, some embodiments
may include thin struts 14 formed of a first material and thick
struts 12 formed of a second material.
[0058] The construction of stent 10 includes a series of elements
with an arrangement of unit cells that enable stable expanded and
stable collapsed configurations. There are several ways to
manufacture a stent based upon this principle. In certain
embodiments, an arrangement of wire or strips may be welded
together at specific places. The particular pattern or arrangement
can also be made in a flat plate and then welded, brazed or crimped
to a more or less cylindrical shape or a cylindrical mid section
with two conical ends with larger diameters. Another possibility is
metal deposition in the desired pattern onto a substrate or the use
of sintering of prealloyed powder. A further method is making the
stent from a tubular shaped starting material, such as a hollow
tube of cobalt-chromium alloy, with a pattern of slits or slots
made in the wall by means of etching, grinding, cutting (e.g., with
a laser, water, etc.), spark erosion or any other suitable method.
In some embodiments, unit cells are manufactured in a collapsed
configuration such that the loss of material due to cutting is
reduced as compared to unit cells being formed in the expanded
configuration. One of skill in the art will appreciate other
methods of making the stents and other medical devices.
[0059] Thick struts 12 and thin struts 14 define openings 18 having
an area. The size of openings 18 varies in response to the relative
position of struts 12 and 14. In particular, as stent 10
transitions between an expanded configuration described in FIG. 1
to the collapsed configuration described in FIG. 2, the size of
openings 18 decreases. Likewise, the outer diameter of stent 10,
which is tubular with a circular cross-sectional profile, also
decreases. Stent 10 may also be transitioned from the expanded
configuration described in FIG. 1 to the collapsed configuration
described in FIG. 2 by the application of force in a
radially-inward direction. Such a transition is appropriate for
coupling stent 10 to a delivery device. For example, stent 10 may
be coupled onto a stent delivery device such as a balloon catheter.
In certain embodiments, stent 10 is placed over a balloon catheter
500 and crimped into place over the balloon.
[0060] When stent 10 is transitioned to the collapsed configuration
described in FIG. 2, thin struts 14 move from an expanded position
to a collapsed position closer to thick struts 12. Movement of the
thin struts 14 may be initiated by a radially inward force to stent
10. Thin struts 14 pass a critical point after which time thin
struts 14 "snap" to the stable collapsed position closer to thick
struts 12 without additional external force. Likewise, stent may be
transitioned to the expanded configuration described in FIG. 1.
Movement of thin struts 14 may be initiated by a radially outward
force being applied to stent 10, such as a radial outward force
from a balloon catheter. After application of an amount of
sufficient force to reach a transition point at which force is
reduced and the thin struts 14 "snap" to the expanded position
without additional application of outward force. Materials having
desired elasticities, such as the cobalt-chromium alloy, undergo
this "snapping" into place and resist recoil when further expanded
from the stable expanded state or further compressed from the
stable collapsed state.
[0061] As shown, stent 10 may be coupled to a balloon catheter 500.
In certain embodiments, the stent 10 is delivered to the balloon
catheter 500 in a stable expanded configuration. Application of a
compression force to stent 10 may result in the balloon catheter
500 collapsing through the transition point where no further force
is required for the stent 10 to assume the stable collapsed
configuration. In certain embodiments, the balloon catheter 500 has
a diameter greater than the diameter of the stent 10 in the stable
collapsed configuration. In such embodiments, the stent 10 may grip
the balloon catheter 500 because it exerts an elastic force (in the
inward direction toward the stable collapsed configuration) on the
balloon catheter. In certain embodiments, as further discussed
herein, stent 10 may be plastically deformed by a compressing
force, such that the stent 10 assumes a smaller diameter than in
its stable collapsed configuration.
[0062] In certain embodiments, stent 10, or other medical devices
having unit cells described herein, may be configured to have a
plurality of collapsed and expanded configurations. For example,
stent 10 may include two or more types of unit cells. In some
embodiments, the two or more types of unit cells may require
different amounts of forces for transitioning the cell from the
first stable position to the second stable position. For example, a
stent 10 may have a first unit cell type and a second unit cell
type. Each cell type may include a thick strut and a thin strut.
However, the thin struts may have different thicknesses and require
different amounts of force to transition the thin strut from the
collapsed position to the expanded position, or vice versa. In
particular embodiments, the diameter of a multi-stable medical
device may be adjusted through a series of stepwise configurations.
Accordingly, the device may be well suited for supporting a variety
of passageways.
[0063] FIG. 3A shows the amount of crimping or collapsing force on
the two unit cells shown in FIG. 3B. As shown in FIG. 3A, the
enhanced line shows crimping force versus diameter (mm). The
conventional plot represents a unit cell of a conventional balloon
expandable stent. In the (a) configuration shown in FIG. 3B, the
unit cells begin from a stable expanded configuration. While the
enhanced plot of FIG. 3A represents a crimp force being applied to
the cells in the stable expanded configuration, it is also
contemplated that a crimp force could also be applied from a
plastically deformed expanded configuration or a stable collapsed
configuration.
[0064] Upon application of a crimping force to the unit cells in
the (a) configuration, one unit cell begins to collapse. When
sufficient force has been applied to reach the inversion point
(denoted as (b) in FIG. 3A) of one of the unit cells, one unit cell
has a reduced area as shown on configuration (b) of FIG. 3B. It is
at this point that the thin strut of the unit cell moves to the
collapsed position without application of additional force.
[0065] After collapsing unit cell through inversion point (b), the
cell continues to close to the configuration shown in configuration
(c) of FIG. 3B upon application of the crimp force. The crimp force
is decreased as the strut transitions from configuration (b) to
configuration (c). At point (c) in FIG. 3A, the first unit cell has
passed through the inversion point and has reached a stable
collapsed configuration as shown in configuration (c) of FIG.
3B.
[0066] The second unit cell may also pass through an inversion
point upon application of a crimping force. Point (d) of FIG. 3A
shows the amount of force required to reach the inversion point of
the second unit cell. At this point, the two unit cell embodiments
adopt configuration (d) of FIG. 3B, which represents the geometry
at which the cell may transition to the collapsed position without
application of additional force.
[0067] As the second unit cell passes through the transition point,
it snaps closed to configuration (e). This configuration is
represented as point (e) in FIG. 3A. In this configuration, the
unit cell may elastically oppose an amount of force that is less
than the force required to transition the cell back to the stable
expanded configuration or the amount of force required to
plastically deform the cell to a plastically deformed collapsed
configuration.
[0068] It should be noted that the force required to collapse a
support structure that has a plurality of rows of different types
of cells may behave in a similar manner. It also should be note
that the diameter and application of force may vary depending on
the exact construction of the unit cells of the medical device. The
conventional designation of FIG. 3A shows the amount of force
required to crimp a conventional balloon expandable stent. Since
the unit cells of such stents do not have structures and geometries
like those described herein, the unit cells do not pass through the
same types of inversion points (points of decreasing force).
[0069] Referring to FIG. 3C, the designated enhanced plot shows the
applied force versus diameter curves for a stent comprising two
unit cell types as shown in FIG. 3B. The device having the two
cells types in the stable expanded configuration has an initial
diameter of about 1.8 mm. The device may then be crimped. This
external force to the device is represented as a negative force in
the graph. As demonstrated in FIG. 3A and discussed above, the
first unit cell type passes through a first inversion point where
the applied external force is reduced. The first cell then passes
through to a stable collapsed state, wherein the stent has a first
diameter of about 1.3 mm. The second unit cell may pass through a
second inversion point where the applied external force is reduced.
The second unit cell then passes through to a stable collapsed
state, such that the stent has a smaller diameter of about 1.1 mm.
This type of behavior may be seen with stents having two cell types
which require different amounts of forces to collapse the various
cell types. In certain embodiments, this type of behavior may be
observed when different portions of a stent are collapsed.
[0070] As can further be seen in FIG. 3C, additional external force
is applied to crimp the enhanced stent. Such external force
plastically deforms the stent to a reduced diameter. Upon ceasing
the external force, the stent comprising the two unit cells type
recoils. Notably, such recoil is less than the conventional balloon
expandable stent shown in the conventional plot in FIG. 3C. As can
be seen in the conventional plot, a conventional balloon expandable
stent may be crimped from a starting diameter of 1.8 mm to the same
minimum diameter as the enhanced stent. However, upon ceasing the
force to the conventional balloon expandable stent, the stent
recoils to a diameter greater than that of the enhanced stent.
[0071] Application of outward radial force to the enhanced stent in
the crimped configuration results in elastic expansion of the
stent. Such force may be delivered to the stent by a balloon. As
shown in the graph, the stent undergoes elastic and plastic
expansion as this outward radial force is applied. At about 0.3
units of force, the enhanced stent reaches an inversion point where
one or more cell types of the stent pass through the inversion
point. Thus, the amount of applied radial force decreases. Such
decrease in radial force may be seen as a small valley between 1.2
and 1.3 mm. As the enhanced stent is expanded through this stable
expanded configuration, applied force is continually in an elastic
and plastic regime through the stable expanded configuration. In
comparison, the conventional plastically deformable stent
experience no such release of energy as it does not have inversion
point geometry. Thus, no valley is seen for the conventional
stent.
[0072] The enhanced stent is then further expanded into a plastic
regime. Application of a force capable of deforming the stent
increases the stent diameter to about 2.8 mm. Upon removal of the
force, the stent recoils to a diameter of about 2.75 mm. As
compared to the conventional stent, the enhanced stent demonstrates
reduced recoil, resulting in a larger diameter plastically deformed
expanded configuration.
[0073] FIGS. 4-6A depict a section of a supportive structure that
is displayed in a flattened profile. This section 22 of device 20
may be obtained by severing a row of connector members 24 and
unrolling section 22 from a tubular shape into a flat shape. While
certain embodiments are described herein in terms of a flattened
profile of a tubular structure, it is understood that flattened
profiles may also be shown of devices not having a tubular
structure. Thick strut 26 is connected to thin strut 28 by
connector members 24. Openings 30 are defined by thick strut 26 and
thin strut 28.
[0074] FIG. 4 depicts section 22 with thick strut 26 and thin strut
28 in a first predetermined stable expanded configuration. In some
embodiments, this configuration may be appropriate for positioning
device 20 over a delivery device prior to crimping, as further
described herein. While device 20 has a predetermined expanded
diameter, the diameter of device 20 may be further expanded upon
plastic deformation of the unit cells.
[0075] FIG. 5 depicts section 22 having a first predetermined
stable collapsed configuration. In this configuration, thin strut
28 has been transitioned to a stable position toward the
corresponding thick strut 26 of the unit cell opening 30. This
collapsed configuration may be obtained by applying a radial inward
force to device 20 in an expanded configuration. For example,
device 20 having an expanded configuration as shown in FIG. 4 may
be transitioned to the collapsed configuration by applying a
compressive force, e.g., crimping. Likewise, device 20 may be
expanded from the collapsed configuration as shown in FIG. 5 to the
expanded configuration as shown in FIG. 6A by the application of a
radial outward force to device 20.
[0076] Advantageously, certain embodiments of devices, such as the
device shown in FIGS. 5 and 6, may include plastically deformable
unit cells. As such, one or more unit cells of device 20 may be
capable of assuming a plurality of plastically deformed
configurations, whether these configurations are plastically
deformed collapsed configurations or plastically deformed expanded
configurations.
[0077] In some embodiments, it may be desirable to plastically
deform device 20 to an expanded configuration wherein the device
has a greater diameter than the expanded configuration shown in
FIG. 4. FIG. 6A describes unit cells of section 22 of device 20
after plastic deformation has occurred. In this embodiment, thin
struts 28 have been plastically deformed away from thick struts 26.
Plastic deformation may reduce the recoil that may otherwise occur
when a material is elastically displaced. Moreover, plastic
deformation of the cells may alter their characteristics, so that
the cells no longer tend to "snap" back to a predetermined stable
expanded configuration.
[0078] In certain embodiments, device 20 may be configured to
obtain a plastically deformed diameter selected from a continual
range of diameters larger than the diameter of the predetermined
stable expanded configuration. The one or more unit cells of device
20 may be expanded from the predetermined stable expanded
configuration to a plastically deformed expanded configuration. To
accomplish this, an outward radial force may be applied to device
20. Such force may be greater than the total elastic strain limit
of the portion of the unit cells being plastically deformed. Once
the elastic strain limit is reached, the plastically deformed unit
cell may continue to be expanded and deformed in response to a
radially-outward force resulting in a larger diameter of device 20.
This diameter may be increased to any plastically deformed diameter
along a continuum as desired within the range of structural
integrity of device 20. Such plastic deformation can occur without
limitation to a select number of step-wise diameters.
[0079] In certain embodiments, device 20 may be configured to
obtain a plastically deformed diameter selected from a continual
range of diameter less than the diameter of the predetermined
stable collapsed configuration. With reference to FIG. 6B, device
20 is shown in a plastically deformed collapsed configuration. To
achieve such plastically deformed collapsed configuration, an
inward radial force may be applied device 20 in the predetermined
stable collapsed configuration, as shown in FIG. 4. Such inward
force should be greater than the elastic strain limit of the
portion of the unit cell being plastically deformed. Once the
elastic strain limit is reached, the plastically deformed unit cell
may continue to be collapsed and deformed in response to radial
inward force resulting in a smaller diameter of device 20.
[0080] FIGS. 7-9 demonstrate other flat profiles of supportive
structures in accordance with certain embodiments. FIG. 7 depicts
supportive structure 40 having five columns 42 of cells (columns
may also be referred to as rings). Thick struts 44 and thin struts
46 define openings 48 and are connected by articulations 50.
[0081] In some embodiments, articulations 50 are configured to
provide spacing between thick struts 44 and thin struts 46. In
certain embodiments, such spacing provides certain advantageous
properties to the unit cell. In some embodiments, the spacing is
configured to provide flexibility to the cell when in a collapsed
or an expanded configuration. As such, the spacing may be
configured such that one or more unit cells adapt to curvatures,
relief, or other particular architecture of the lumen passageway
when collapsed or expanded. In certain embodiments, the
articulations may be configured to geometrically change the amount
of force required to reach the inversion point of the cell.
[0082] Adjacent columns 42 of unit cells may be connected by row
interconnectors 52. Interconnectors 52 allow adjacent columns 42 to
be displaced relative to one another. Interconnectors 52 are
S-shaped bent connect bars having at least one peak and one trough.
In certain embodiments, interconnectors 52 may have two or more
bends. Interconnectors 52 connect adjacent cells which are
substantially lateral to each other. Interconnector 52 may be
spaced apart by a distance from other interconnects in same axis by
one or more unit cells. As shown, interconnectors 52 are spaced
apart by two unit cells. In certain embodiments, interconnectors 52
have substantially the same thickness as the thick strut 44 or the
thin strut 46. In certain embodiments, interconnectors 52 have a
thickness less than thick strut 44 or thin strut 46. In certain
embodiment, thickness or pliability of interconnector 52 may be
varied such that the supportive structure 40 is adapted to conform
to the deployment lumen. In certain embodiments, interconnectors 52
are configured for better nesting of the supportive structure 40 in
a collapsed or crimped configuration.
[0083] In certain embodiments, articulations 50 and interconnectors
52 provide supportive structure 40 with the ability to adapt to
certain lumen architectures. In some embodiments, the combination
of the articulations 50 and interconnectors 52 provide spacing
between unit cells such that one or more unit cells of device 40
may be displaced relative to its manufactured, crimped, or deployed
position. Off-axis displacement of a unit cell relative to the
longitudinal axis of the tubular supportive structure 40 unit cell
may be obtained within ranges of flexibility of the articulations
50 and interconnectors 52.
[0084] FIG. 8 depicts supportive structure 60 having six columns 62
of cells. Thick struts 64 and thin struts 66 define openings 68 and
are connected by articulations 70. Column interconnectors 72
connect adjacent columns 62, and allow adjacent columns 62 to be
displaced relative to one another. As shown, an interconnector 72
extends between an articulation 52 of one cell to an articulation
of another cell in an adjacent column 62. Interconnector 72 extends
along thin strut 62 and bends to a direction substantially parallel
to the axis of a column 62 of cells. Interconnector 72 extends in
the substantially parallel direction between adjacent columns 62 in
the axis of the columns 62. Interconnector 72 bends to extend along
the thick strut and joins articulation 70 of a cell in an adjacent
row. As shown, interconnector joins laterally displaced unit cells.
In certain embodiments, the displacement between interconnected
unit cells may be varied depending on the application.
[0085] FIG. 9 depicts supportive structure 80 having six columns 82
of cells. Thick struts 84 and thin struts 86 define openings 88 and
are connected by articulations 90. In some embodiments,
articulations 90 have a length which is approximately equal to half
the distance between the apices of thin strut 86 and thick struts
84 of the same unit cell. In some embodiments, the length (in the
axis of the columns) of the articulation can be about 5 to about 50
percent of the distance between the apices of the thin and thick
struts of the same unit cell. In certain embodiments, articulations
90 may have varying lengths. In the embodiment shown, adjacent
column interconnectors 92 extend between articulations 90. In such
articulations, the distance may be increased to accommodate the
thickness of interconnectors 92. Interconnectors 92 extend from
articulation 90 of a unit cell in a column 82 of unit cells to an
articulation 90 in an adjacent row. In this embodiment,
interconnector 92 has a similar shape to the interconnectors shown
in FIG. 8. However, interconnector 72 joins adjacent cells which
displaced to a lesser degree than that shown in FIG. 8.
[0086] In certain embodiments, unit cells may be configured such
that the thick struts and thin struts are arranged in a repeating
pattern that is consistent throughout the supportive structure. In
certain embodiments, the pattern may vary within the same column or
different columns of unit cells. For example, two adjacent unit
cells within the same column may be arranged such that the thick
struts of each cell are adjacent and are connected through joints
or articulations. Such a pattern may repeat such that the thin
struts are also adjacent to other thin struts and are connected to
each other by articulations. In certain embodiments, such a pattern
may repeat throughout the structural support or within certain
columns. In one embodiment, adjacent columns may oppositely
arranged unit cells (e.g., thick struts on top in the first column
and thick struts on bottom in the second, adjacent column, relative
to a planar arrangement).
[0087] While FIGS. 7-10 show certain types of cells structures,
cell interconnectors, and articulations, many different types of
these are known in the art and may be used. In certain embodiments,
other types of cell structures using principles described herein
may be used. In certain embodiments, various types of cell
interconnectors may be used including, but not limited to valley to
valley interconnectors, side to side interconnectors, valley to
side interconnectors, peak to side interconnectors, or peak to peak
connectors may be used in some embodiments. In certain embodiments,
interconnectors may have various thickness and configurations. In
certain embodiments, spacing between interconnectors may vary
depending on the application. Moreover, described in FIGS. 7-10 are
various features of structural supports. It is intended that one or
more of these features may be incorporated into any embodiment
described herein.
[0088] FIGS. 10A-10E depict two exemplar cells of the device 40 in
a flattened profile. FIGS. 11A-11E depict a single column 42 of
unit cells of device 40 arranged in a tubular structure. In one
embodiment, device 40 is formed such that openings 48 are spaced as
described in FIGS. 10A and 11A. As such, thick struts 44 are
separated from thin struts 46 and device 40 may be configured to
have a predetermined stable collapsed configuration and an expanded
configuration. As shown in FIGS. 10A & 11A, the unit cells are
shown in the expanded configuration.
[0089] Device 40 or a similar device may be coupled to a suitable
delivery device. For example, if the delivery device is a balloon
catheter, device 40 may be placed around the balloon catheter in
the vicinity of the balloon. Device 40 may then be transitioned
toward the collapsed state by crimping or otherwise applying a
radially-inward directed force. In some applications, it may be
desirable to collapse device 40 to the fully collapsed position. In
other applications it may be desirable to prevent the contraction
of device 40 to the fully collapsed state by interaction with the
delivery device. In such embodiments, the outer diameter of the
delivery device may be greater than the diameter of the device in
the stable collapsed configuration, but smaller than a diameter
where the force is reduced during compression or contraction of the
device, as discussed above. As such, the device 40 would apply an
inward force on the delivery device, e.g., on the balloon
catheter.
[0090] FIGS. 10B and 11B depict the respective portions of device
40 after crimping to a desired diameter. Such configuration is
achieved by applying a radially inward force to device 40
sufficient to transition the one or more cells of the device from
the stable expanded configuration to the stable collapsed
configuration and sufficient to plastically deform the unit cell to
a plastically deformed collapsed configuration. However, recoil of
stent may result in an increased diameter which is shown in FIGS.
10C and 11C. However, such recoil is less than that which may occur
when crimping of other plastically deformable designs formed of
similar materials.
[0091] Referring to FIGS. 10C and 11C, device 40 may be plastically
deformed to a collapsed diameter less than the predetermined stable
collapsed diameter. A radially inward force may be applied to the
device 40 in the predetermined stable collapsed configuration. Such
force must be sufficient to plastically deform the unit cell.
[0092] Referring to FIGS. 10D and 11D, device 40 is shown in an
expanded configuration achieved by applying sufficient radial
outward force to plastically deform the device from the
predetermined stable expanded configuration. As the outward force
is increased, device 40 may undergo expansion and may then begin to
plastically deform. As the difference in the sizes between thick
struts 44 and thin struts 46 is increased, a similar difference may
be seen in the amount of plastic deformation between those two
components. While the device 40 in this configuration may incur
some recoil resulting in the plastically deformed expanded
configuration shown in FIGS. 10E and 11E, the amount of recoil is
less than that of conventional balloon expandable supporting
structures or those structures which use a nonpreferred material
(e.g., highly elastic material).
[0093] While there are various states of plastically deformed
expansion, one example in the continuum of deformation is described
in FIGS. 10E and 11E. It will be appreciated that device 40 need
not be deformed to this degree, or alternatively, may be deformed
further to result in a still larger outer diameter. Because device
40 is expanded plastically, its diameter need not be limited to
discrete predetermined dimensions.
[0094] FIGS. 12A and 12B show one embodiment of a unit cell 110
incorporated into a portion of a medical device. The portion of the
medical device includes a repeating pattern 115. The medical device
incorporating the unit cell 110 can be a stent or other lumen
support or other medical device as discussed herein. Although the
unit cell 110 is incorporated into a repeating pattern, it can be
used in structures that do not repeat in a regular manner. In this
embodiment, the repeating pattern 115 includes a plurality of unit
cells 110 arranged in a plurality of rows of and in a plurality of
columns.
[0095] The orientation and position of the unit cells 110 can be
varied from row to row, within a row, from column to column, or
between columns. In the illustrated embodiment, the unit cells of
adjacent rows are arranged in opposite directions. In particular, a
row 100 is arranged in a manner so that a thick strut 102 of a
first unit cell in the row 100 is on the top and a thin strut 101
is on the bottom. In an adjacent row 105, the thick strut 102 of a
second unit cell in the adjacent row 105 is on the bottom and a
thin strut 101 is on the top. "Top" and "bottom" as used in this
paragraph is relative to the unit cells as shown in FIG. 12A. This
alternating configuration of unit cells in adjacent rows assists in
nesting of the device when in its collapsed configuration in some
embodiments.
[0096] The repeating pattern 115 also includes a plurality of
interconnectors 105 that interconnect different rows of the
pattern. For example, in the illustrated embodiment, the
interconnect 105 connects the adjacent rows 100 and 105. As with
other interconnects discussed herein, the interconnect 105 can
extend from a peak of a unit cell of one embodiment.
[0097] The interconnector 105 can have any suitable geometry and
configuration. For example, the interconnector 105 can have a first
end 116 configured to couple with a first row and a second end 117
configured to couple with a second row. In some embodiments, the
interconnector 105 has an elongate portion 118 between the first
and second ends 116, 117 that is selected to enhance a performance
characteristic of the pattern 115. For example, FIG. 12B
illustrates that the elongate portion 118 is shaped so that the
first and second ends 116, 117 extend away from lateral side of
unit cell to which they are coupled, e.g., generally perpendicular
to a longitudinal axis of the rows in which the unit cells are
located and so that the elongate portion extends generally parallel
to the longitudinal axis of the rows in which the unit cells are
located. This arrangement provides for a more compact geometry at
least in an unexpanded state.
[0098] The length of the interconnect 105, e.g. of the elongate
portion 118 thereof, can be selected to enhance a performance
characteristic of the pattern 115. For example, the interconnect
105 can be configured to couple peaks of unit cells that are
adjacent to each other in the collapsed state. Alternatively, the
interconnect 105 can be configured to couple peaks of unit cells
that separated by at least one intervening peak in the adjacent row
when the pattern 115 is in an unexpanded state. In the illustrated
embodiment, each interconnect 105 connects peaks of unit cells in
adjacent rows that are separated by at least one intervening unit
cell in the collapsed state. FIG. 12A shows that the pattern 115
permits the adjacent rows to shift such that no intervening peaks
separate the peaks to which the interconnect 105 is connected.
[0099] In some embodiments, interconnect 105 has a sinusoidal
geometry. However, the interconnect 105 may also have other
geometries described herein. In one embodiment, the interconnect
105 is spaced apart from adjacent interconnects such that the
interconnects do not contact each other when in the collapsed
configuration, shown in FIG. 12B.
[0100] As discussed above, each unit cell also preferably is
coupled to an adjacent unit cell along each row by an articulation
107. As discussed in more detail herein, articulations 107 enhance
the plastic deformability of the unit cells, e.g., from a stable
collapsed state to a crimped state, wherein the device or structure
has a reduced diameter. In some embodiments, the articulations 107
mechanically isolate adjacent unit cells so that the adjacent unit
cells are less rigid and are able to be plastically deformed to a
greater extent than if the unit cells were directly coupled
together. The articulations 107 can also enable the unit cells to
plastically deform under a lesser force or pressure to the same
extent than would be needed to expand unit cells that were directly
coupled together.
[0101] The articulations 107 can take any suitable configuration.
For example, in one embodiment, the articulation 107 includes a
first end 120 that is coupled with a first unit cell 125 and a
second end 121 that is coupled with a second unit cell 130. The
connection between the articulation 107 and the unit cells 125, 130
can be at any suitable location, for example, at adjacent valleys
of the two cells. In one arrangement, the articulation connects a
thin strut of one unit cell with a thick strut of an adjacent unit
cell. In some embodiments, the articulation 107 has a length
between the ends 120, 121 that can be varied based upon a desired
characteristic. For example, it may be desirable to elongate the
articulation 107 to provide greater mechanical isolation between
adjacent cells. On the other hand shortening the articulation 107
would provide a more compact arrangement. The articulation 107 is
at least at long as the thickness of the thin strut 101 in one
embodiment. In another embodiment, the articulation 50 is at least
at long as the thickness of the thick strut 102.
[0102] FIG. 13 shows a unit cell 150 undergoing a crimping
process.
[0103] In FIG. 13(a), the unit cell 150 is in a stable expanded
configuration. The unit cell 150 is similar to those hereinbefore
described and the descriptions of those cells are applicable to the
unit cell 150. In particular, the unit cell 150 has a thin strut
151 and a thick strut 152. The thick and thin struts 152, 151 can
be configured as elongated members extending between first and
second ends 160, 161. The first ends 160 can be coupled together
and the second ends at apices 165, 166. The apices 165, 166 are
described elsewhere herein as "peaks" of the unit cell 150.
[0104] The apices 165, 166 can take any suitable form. In one
embodiment, the apices 165, 166 have a portion which has localized
thinning. In certain embodiments, such thinning is configured to
promote flexibility of the thin strut from a collapsed position to
an expanded position. As such, the apices may be used to control
force required to reach the inversion point between the thick strut
152 and thin strut 151. In certain embodiments, the elongate member
175 of thick strut 152 may have varying thickness near apices 165.
In certain embodiment, the elongate member 175 of thick strut 152
has a thickness that ranges between about 150 to about 200 percent
compared to that of the apex 166 of the thin strut 151.
[0105] In some embodiments, the unit cell 150 is configured to
couple to other unit cells, for example to form a repeating pattern
suitable for forming all or a portion of a stent or other lumen
supporting medical device. In one embodiment, an articulation 170
is located along the length of the elongate member 175 of the thick
strut 152. In one embodiment, an articulation 170 is located along
the length of the elongate member 178 of the thin strut 151. In one
embodiment, the unit cell is configured such that at least in one
expanded configuration the elongate member 175, 178 of at least one
of the thick strut 152 and the thin strut 151 have a concave shape.
In one arrangement, both of the thin strut 151 and the thick strut
152 have a concave shape such that the unit cell 150 has a diamond
shape in at least one expanded configuration, as shown in FIG.
13(a).
[0106] FIG. 13(b) illustrates that application of an inward force
(e.g., a radially inwardly applied force) on the unit cell 150
causing the thin strut 151 to move toward the thick strut 152.
F.sub.1 represents an amount of force that unit cell 150
elastically opposes. Such amount of force may be applied, however,
cessation of the force would result in the cell expanding to the
expanded position shown in FIG. 13(a). This causes the distance
between the thick strut 152 and the thin strut 151 to be decreased
at least at a location spaced from the apices 166, 165, and causes
the unit cell to be compressed through the inversion point to a
predetermined stable collapsed configuration 125.
[0107] FIG. 13(c) further illustrates an inversion point
configuration 126 of unit cell 150. The designation e shows the
elastic regime from the inversion point to the predetermined stable
collapsed configuration. Each unit cell 150 is configured to have
an inversion configuration 126. Such configuration 126 is a
configuration in which the unit cell may move between stable
collapsed and expanded configurations without the application of
addition force. The inversion point configuration 126 is a
configuration at which a force suddenly decreases to complete the
transition to the collapsed or expanded configuration. In certain
embodiments, described herein the inversion point geometry is used
to minimize recoil in materials that would otherwise recoil beyond
an acceptable range. F.sub.2 represents a sufficient amount of
force to transition the unit cell 150 from the stable expanded
position shown in FIG. 13(a) to the inversion point at which no
additional force is required to complete the transition from the
expanded position to a collapsed position. Thus, F.sub.2 is greater
than F.sub.1.
[0108] FIG. 13(d) shows that further application of an inward force
to unit cell 150. Such inward force plastically deforms the stent.
F.sub.3 represents a plastically deformable amount of force. Such
amount of force must exceed the elastic strain limit of the thin
strut. In certain embodiments, F.sub.3 is be greater than the force
used to reach the inversion point F.sub.2, but this depends on the
exact configuration of the strut segments. In certain embodiments,
articulation 170 may be configuration to have a shape which allows
plastic deformation of the unit cell 150 to configuration 131
[0109] FIG. 13(e) illustrates the effect of recoil on the collapsed
state of the unit cell 150. Once a sufficient amount of crimping
force, F.sub.4, has been applied to unit cell 150, the thin strut
151 elastically recoils. Thus, designation f represents this amount
of elastic recoil, which can be measured as a distance. Thus, the
unit cell transitions from the fully deformed state 131 to the free
state 135 in which it has a plastically deformed collapsed
configuration.
[0110] Referring to FIG. 14A, a schematic drawing represents a
conventional balloon expandable stent without desired geometries
which allow the stent to pass through an inversion point. As such,
the conventional balloon expandable stents has a high degree of
recoil. Such stents are plastically deformable through a series of
configurations (1a), (2a) and to the collapsed diameter (4a).
However, such stents demonstrate a high degree of recoil denoted as
a.
[0111] Referring to FIG. 14B, a balloon expandable stent having the
geometries discussed herein and made of certain elastic materials
may pass through a series of expanded configurations (1b) and (2b)
and through an inversion point to reach configuration (3b) (also
designated as the predetermined stable collapsed configuration).
Upon application of a plastically deformable crimp force and then
release, the stent exhibits reduced recoil when compared to the
regular balloon expandable stent of FIG. 15.
[0112] FIG. 15 shows a comparison of a conventional balloon
expandable stents made of certain materials compared to stents
having bistable geometries that have an inversion point and which
are capable of undergoing plastic deformation. As discussed above,
the material and the geometry of the stent contributes to reduced
recoil when compared to other stents made of different materials or
having different geometries. Stents made of materials having
different elastic ranges are shown.
[0113] Referring to FIG. 15(a), stainless steel conventional
balloon expandable stents expand by means of elastic and plastic
deformation (E+P) from collapsed diameter (1) to desired expanded
diameter (4). However, this is followed by elastic recoil (-E) to a
diameter (6) within an acceptable range (5) that will provide good
clinical outcomes. In particular embodiments, described herein,
this acceptable range (5) is about 10% of the expanded diameter of
the stent. As shown, this stainless steel type stents recoil within
an accepted range, which has led to the common use of this type of
stent.
[0114] Referring to FIG. 15(b), a convention Cobalt-x-y alloy stent
is shown, such as stent made of L605 or MP35N. The elastic recoil
(-E) from expanded diameter (4) is greater, approximately twice
that of stainless steel shown in FIG. 15(a). Such recoil is outside
of the accepted range of recoil, leading to a smaller stable
diameter (6) that could lead to less desirable clinical outcomes.
This can only be overcome by expanding this stent beyond expanded
diameter (4), so that a clinically acceptable recoil diameter is
achieved. However, that type of expansion requires higher pressures
in the case of balloon expansion during angioplasty, and greater
diameter expansion. Such conditions may damage tissue at the edges
of the stent.
[0115] FIG. 15(c) shows one embodiment of the invention described
herein. Such a stent may be made with materials such as a cobalt
alloy, such as L605 or MP35N. During expansion, the stent passes
from predetermined stable collapsed configuration (2) to
predetermined expanded configuration (3) through an inversion point
in which elasticity is reversed and released by the stent. Thus,
less elastic recoil potential is built up during further
deformation from predetermined stable expanded configuration (3) to
plastically deformed expanded configuration (4). Hence, the stent
recoils to diameter (6). As shown, the recoil is less than that
experienced by example (a) or (b). Less elastic recoil provides a
wider lumen passageway, which is known to provide better clinical
outcomes. Such geometry overcomes one of the disadvantages
generally associated with higher elastic alloys, namely elastic
recoil outside of an acceptable range.
[0116] Referring to FIG. 15(c), an elastic range exceeding
preferred values results in recoil beyond an acceptable range of
recoil, even when the stent geometry allows the stent to pass
through the inversion point between a predetermined stable
collapsed configuration (2) and a predetermined stable expanded
configuration (3).
[0117] FIG. 15(e) illustrates a highly elastic stent, such as one
that uses Nitinol or other materials with greater than 1% and up to
about 8% or higher elastic range. As diagramed here, such stents
expand only by elastic energy from (2) to (3), with (3) being the
final dimension and can be achieved to similar diameters as shown
by position (4). However, such stents lack beneficial radial
strength and radiopacity properties.
[0118] Referring to FIG. 16, two unit cells 200, 201 of a device
are shown. Such unit cells are demonstrative of certain inventive
features of preferred unit cells having thick strut 207 and thin
strut 206. These features may also be seen in and are applicable to
other figures submitted herewith. One or more of the various
features of these unit cells 200, 201 may be used together with one
or more other features of units cells described herein (e.g.,
interconnectors, various width struts).
[0119] In this embodiment, thick strut 207 and thin strut 206 are
connected at the corners of the unit cell by hinges 210. Hinges 210
are shown as part of the thick strut 207 and thin strut 206. The
hinges can take any suitable form, so long as they permit or
enhance movement of one more both of the struts 207, 206 about the
hinge. In one embodiment, to form hinges 210, the thickness of
thick strut 207 is tapered to a thickness approximately equal to
the thickness of thin strut 206. In some embodiments, hinge 210 may
be formed by a gradual taper of thick strut 207 to a reduced
thickness greater than the average thickness of thin strut 206. In
certain embodiments, hinge 210 may also be formed by a thin portion
of thin strut 206. For example, the hinge portion 210 of thin strut
206 may have a reduced thickness as compared to the average
thickness of thin strut 206. As shown, the thickness of thin strut
206 is approximately equal to the thickness of hinge portion
210.
[0120] Further referring to FIG. 16, thick strut 206 may comprise a
base portion 211. Base portion 211 comprises several notable
features. In this embodiment, base portion 211 comprises two convex
portions 230, and concave portion 220. In certain embodiments, the
base portion is configured to allow substantial resistance to
plastic deformation of the thick strut 207. In some embodiments,
base portion 211 also includes articulation 215. Articulation 215
is geometrically configured to allow plastic deformation of the
individual cells. Articulation 215 creates spacing between thin
strut 206 of unit cell 200 and thick strut 207 of unit cell 201.
Such spacing provides an area between the thin and thick struts,
such that the unit cells may be plastically deformed beyond the
predetermined stable collapsed configurations.
[0121] Referring to FIG. 17, a stent 240 having a collapsed
configuration is shown. Between thin strut 206 and thick strut 207,
an articulation 215 is present which allows plastic deformation of
stent 240 to a crimped configuration. As shown, stent 240 may be
coupled to balloon catheter 501. In certain embodiments, a balloon
catheter 501 may be delivered over a guidewire to the body lumen
where the stent is to be deployed.
[0122] Referring to FIGS. 18A and 18B, one embodiment of a device
includes one or more open unit cells. Such devices may include only
open cells or a combination of open and closed cells. In certain
embodiments, such open unit cells may have a predetermined stable
expanded configuration (shown in FIG. 18A) and predetermined stable
collapsed configurations. In certain embodiments, such unit cells
may also be plastically deformed to collapsed or expanded
configurations. In certain embodiments, the various arms of the
thin and thick struts may have different stiffness or thicknesses
as desired. Designs of open unit cells may be taken to more
complicated patterns having various strut undulations and hinge
points. Such variables may provide various inversion points which
allow certain sections of the open cell to pass through various
collapsed or expanded configurations.
[0123] Embodiments also include methods of using a medical device
having one or more plastically deformable multistable cells. As
discussed above, stent 40 may be loaded onto a stent delivery
catheter. In some embodiments, the stent is crimped or collapsed
onto a stent delivery catheter. In certain embodiments, the stent
is collapsed to the predetermined stable collapsed configuration
thus decreasing the diameter of the stent.
[0124] In certain embodiments, the stent delivery catheter may have
a diameter greater than the diameter of the predetermined stable
collapsed configuration. If the inner diameter of the collapsed
stent is slightly smaller than the outer diameter of the balloon
catheter, then the stent would tend to apply radially-inward force
on the catheter. This phenomenon may occur as the cells, which have
passed the transition point, act under internal forces to attain
the predetermined stable configuration. As a result, the stent may
"squeeze" the catheter without the need for the further application
of an external force.
[0125] In some embodiments, the device having one or more unit
cells may be crimped further, resulting in some degree of plastic
deformation beyond the collapsed configuration. In certain
embodiments, a stent may be plastically deformed to a collapsed
configuration having a smaller diameter than the predetermined
stable collapsed configuration. Advantageously, such stent designs
allow for a smaller deployment diameter of the stent. Moreover, the
stent may substantially maintain its smaller diameter stent profile
upon plastic deformation, as the stent exhibits reduced recoil when
compared to stents of different designs.
[0126] Once coupled to the delivery device, a user may optionally
place a sheath or other external barrier around device 40. It will
be appreciated that in some embodiments of the present invention,
such a sheath is not desirable, as it may unnecessarily increase
the delivery profile.
[0127] Once positioned on the delivery device, the medical device
may then be inserted into a body lumen. The medical device may be
delivered to a desired deployment location within a blood vessel or
other passageway. Once in the desired location, the medical device
may be deployed.
[0128] Deployment of the medical device may occur in various
fashions depending on the medical device and the delivery device.
In certain embodiments, the delivery device provides a radial
outward force on the medical device. Such force is sufficient to
transition one or more unit cells to a stable expanded
configuration. In certain embodiments, the stable expanded
configuration is the predetermined stable expanded
configuration.
[0129] In some embodiments, the delivery device may disengage the
medical device once expanded to the predetermined stable expanded
configuration. A user optionally may adjust the position of device
40 in the passageway while in a predetermined stable collapsed or
expanded configuration, depending on the size of the
passageway.
[0130] In certain embodiments, a multistable medical device having
two or more stable expanded configurations, which are not
plastically deformed expanded configurations, may be used. The
medical device may be deployed in any of the stable expanded
configurations. In some embodiments, the medical device having one
or more cells may be expanded in a manner that results in a varied
diameter along its length. For example, the balloon may be deflated
and repositioned, or another balloon may be expanded at a location
within device 40, such that a force is applied to only a portion of
device. As such, an area of device 40 may be expanded to a larger
diameter than another area of device 40
[0131] In certain embodiments, the delivery device may be used to
apply a force sufficient to plastically deform the medical device
from a predetermined stable expanded configuration to a plastically
deformed stable expanded configuration. In certain embodiments, the
delivery device applies a force to the medical device through
mechanical means. In some embodiments, a balloon may be inflated to
apply a radially-outward force on device 40 and expand the diameter
of device 40. In certain embodiments, the stent may be plastically
deformed such that the stent contacts and/or supports the
passageway.
[0132] Once the device has been plastically deformed and expanded
into a desired configuration, the catheter may be removed from the
patient, leaving device 40 to support the passageway. Placement of
device 40 may be ascertained at this time, or earlier, by
radiography or other known methods.
[0133] The stents and other medical devices described herein may be
used together with other known options and methods. For example,
drugs optionally may be combined with a stent having the design
described herein by coating the stent or using other known methods.
One of skill in the art will appreciate that stents and other
medical devices may also comprise a coating, such as a coating of
one or more drugs, medications, or polymers. In particular
embodiments, the medical device (e.g., stent) including the unit
cells may be coated with a crosslinked collagen protein coating.
Such stent would possess the clinical benefits of being less
thrombogenic and provide a medium for endothelium cell migration
across the device. In certain embodiments, a tie layer may be used
to tie the coating to the unit cells.
[0134] As an example of the results obtainable by the present
invention, the following information is provided based in
experiments that have been conducted. A coronary stent constructed
in accordance with the present invention was formed having an outer
diameter of 1.8 mm when in the expanded predetermined stable
configuration. This stent was crimped to a collapsed configuration
having an outer diameter of 0.8 mm. Then, the stent was expanded to
a point in which plastic deformation occurred. The final diameter
of the stent was measured to be 3.0 mm. Thus, one of skill in the
art will appreciate the relationship between the compact delivery
profile and the attainable expanded diameter of this stent.
[0135] The various methods and techniques described above provide a
number of ways to carry out the invention. Of course, it is to be
understood that not necessarily all objectives or advantages
described may be achieved in accordance with any particular
embodiment described herein.
[0136] Furthermore, the skilled artisan will recognize the
interchangeability of various features from different embodiments.
Similarly, the various features and steps discussed above, as well
as other known equivalents for each such feature or step, can be
mixed and matched by one of ordinary skill in this art to perform
methods in accordance with principles described herein.
[0137] Although the invention has been disclosed in the context of
certain embodiments and examples, it will be understood by those
skilled in the art that the invention extends beyond the
specifically disclosed embodiments to other alternative embodiments
and/or uses and obvious modifications and equivalents thereof.
Accordingly, the invention is not intended to be limited by the
specific disclosures of preferred embodiments herein.
* * * * *