U.S. patent number RE35,988 [Application Number 08/630,696] was granted by the patent office on 1998-12-08 for stent construction of rolled configuration.
Invention is credited to John M. Neet, Thomas R. Winston.
United States Patent |
RE35,988 |
Winston , et al. |
December 8, 1998 |
Stent construction of rolled configuration
Abstract
A stent for reinforcing a damaged wall in a body passage such as
a vascular passage. The stent takes the form of a sheet or metal
foil wound tightly around a spool in a multiple layer roll and held
in a contracted state by a sheath sleeved around the roll. The
spool is inserted into the body passage until the stent is adjacent
to the area of the damaged wall. The spool and stent are then
advanced while the sheath is held stationary. This pushes the stent
out the end of the sheath and releases the stent such that the roll
unwinds and expands against the damaged vessel wall.
Inventors: |
Winston; Thomas R. (Leawood,
KS), Neet; John M. (Lawrence, KS) |
Family
ID: |
25452493 |
Appl.
No.: |
08/630,696 |
Filed: |
April 12, 1996 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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Reissue of: |
925959 |
Aug 5, 1992 |
05306294 |
Apr 26, 1994 |
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Current U.S.
Class: |
623/1.11;
606/108; 606/191; 606/195; 606/198; 623/1.22 |
Current CPC
Class: |
A61F
2/95 (20130101); A61F 2/92 (20130101); A61F
2/9662 (20200501); A61F 2002/9511 (20130101); A61B
5/14532 (20130101); A61F 2210/0076 (20130101) |
Current International
Class: |
A61F
2/06 (20060101); A61B 5/00 (20060101); A61F
002/06 () |
Field of
Search: |
;623/1,12
;606/151,153,155,108,191,198,195 ;604/104,281 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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678393 A5 |
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Sep 1991 |
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CH |
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WO 91/15254 |
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Oct 1991 |
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WO |
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WO 91/17789 |
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Nov 1991 |
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WO |
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WO 92/01425 |
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Feb 1992 |
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WO |
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Primary Examiner: Prebilic; Paul B.
Attorney, Agent or Firm: Knobbe, Martens, Olson & Bear,
LLP
Claims
We claim:
1. A stent assembly for placement in a body passage to reinforce a
damaged wall in the passage, comprising:
an elongated core;
an elongated, flexible sheet arranged on said core in a multiple
layer roll having expanded and contracted conditions and having a
spring force so that said sheet is urged toward the expanded
condition, said roll being tightly wound on the core in the
contracted condition and presenting in the expanded condition a
diameter at least equal to the diameter of the body passage.
said roll being spirally wound on said core and having a tendency
to radially expand, said roll presenting a plurality of adjacent,
arcuate layers of said sheet in a direction transverse to the
longitudinal axis of said core;
releasable means for retaining said roll in the contracted
condition on said core while the core is being inserted into the
passage to the location of the damaged walls; and
means for effecting release of said releasable means to permit the
roll to expand against the damaged wall in the expanded condition
of the roll,
said roll in the expanded condition thereof having at least two
overlapping layers which overlap and bear against one another over
a substantial portion of the circumference of .[.a.]. .Iadd.an
.Iaddend.inner layer, said expanded roll adapted for securely
contacting said damaged wall by virtue of said radial expansion
tendency.
2. The stent assembly of claim 1, including a first flange on said
core against which one end of said roll is engaged in the
contracted condition.
3. The stent assembly of claim 2, including a second flange on said
core, said roll being retained between the first flange and said
second flange in the contracted condition.
4. The stent assembly of claim 3, wherein said releasable means
comprises a pair of control cords having slip knot connections with
the respective first and second flanges arranged in a manner to
retain the roll in the contracted condition, said slip knot
connections being releasable upon pulling of said control cords to
thereby release said roll for expansion thereof to the expanded
condition.
5. The stent assembly of claim 4, wherein said core comprises a
tubular spool having an axial passage therethrough for receiving a
guide wire along which the spool may be guided to the location of
the damaged wall.
6. The stent assembly of claim 1, wherein said core comprises a
tubular spool having an axial passage therethrough for receiving a
guide wire along which the spool may be guided to the location of
the damaged wall.
7. The stent assembly of claim 1, wherein said sheet is constructed
or a metal foil.
8. The stent assembly of claim 1, wherein said sheet is constructed
or a stainless steel foil.
9. The stent assembly of claim 1, wherein said releasable means
comprises a sheath closely sleeved on said roll, said sheath being
movable axially relative to said core to release from the roll.
10. The stent assembly of claim 1, including:
a second flexible sheet arranged on said core in a second multiple
layer roll spaced from the first mentioned roll, said second roll
having a contracted condition wherein the second roll is tightly
wound on the core and an expanded condition wherein the second roll
presents a diameter substantially equal to the diameter of the body
passage, said second roll being urged toward the expanded
condition;
releasable means for retaining said second roll in the contracted
condition; and
means for effecting release of the releasable means for said second
roll.
11. The stent assembly of claim 10, wherein the releasable means
for the first and second rolls comprises a sheath closely sleeved
on the first and second rolls said sheath being movable axially
relative to said core to release from the first and second rolls in
succession.
12. Apparatus for reinforcing a damaged wall of a body passage,
comprising:
an elongated core;
an elongated stent in the form of a flexible sheet spirally wound
around the core in a multiple layer roll having contracted and
expanded conditions, said sheet being wound tightly on the core in
the contracted condition and having a spring force which tends to
radially expand toward the expanded condition thereof wherein the
sheet assumes a size to contact the damaged wall, and
said roll .[.presenting.]. .Iadd.having .Iaddend.a plurality of
adjacent, arcuate layers .[.of said sheet in a direction transverse
top the longitudinal axis of the core.].;
a sheath fitting closely around said roll to hold the sheet in the
contracted condition, said sheet being movable axially relative to
the roll to permit the sheath to release from the roll and thereby
allow expansion of the sheet against the damaged wall in the
expanded condition,
said roll in the expanded condition thereof having at least two
overlapping layers, which overlap and bear against one another over
a substantial portion of the circumference of the inner layer, said
expanded roll adapted for securely contracting said damaged wall by
virtue of said radial expansion tendency of the roll.
13. Apparatus as set forth in claim 12, including a flange on said
core against which one end of said roll is engaged in the
contracted condition.
14. Apparatus as set forth in claim 12, wherein said core comprises
a spool having an axial passage therethrough for receiving a guide
wire along which the spool may be guided to the location of the
damaged wall.
15. Apparatus as set forth in claim 12, wherein said sheet is
constructed of a thin metal foil.
16. Apparatus as set forth in claim 12, wherein said sheet is
constructed of a thin stainless steel foil.
17. Apparatus as set forth in claim 12, including second stent in
the form of a second flexible sheet wound around said core in a
second multiple layer roll having contracted and expanded
conditions, said second sheet being wound tightly on the core in
the contracted condition and being biased toward the expanded
condition wherein said second sheet assumes a size to contact the
passage wall, said sheath fitting closely on the second roll to
hold the second sheet in the contracted condition and being movable
axially to release from the second roll and thereby allow the
second roll to expand against the wall in the expanded condition.
.Iadd.
18. A stent for placement in a body passage to support a stricture
or reinforce a damaged wall in the passage, comprising:
an elongated flexible sheet arranged in a multiple layer roll
having expanded and contracted conditions and having a spring
force, so that when said sheet is in said contracted condition,
said spring force urges said sheet to expand toward the expanded
condition, said roll presenting in the expanded condition a
diameter at least equal to the diameter of the body passage;
said roll presenting in its contracted condition a plurality of
adjacent, arcuate layers;
said roll being retained in the contracted condition during an
insertion into said passage to the location of said damaged wall by
a retaining structure adapted to be inserted into said body
passage;
wherein upon release of said roll from said retaining structure at
the location of said damaged wall, said spring force urges
expansion of said roll into the expanded condition such that said
roll contacts said damaged wall, said roll further having in the
expanded condition a plurality of overlapping layers which overlap
and bear against one another over a substantial portion of the
circumference of an inner layer, said expanded roll further having
sufficient structural integrity to effect reinforcement or support
of said damaged wall. .Iaddend..Iadd.
19. The stent assembly of claim 18, wherein said sheet is
constructed of a metal foil. .Iaddend..Iadd.20. The stent assembly
of claim 19, wherein said metal foil is stainless steel.
.Iaddend..Iadd.21. The stent assembly of claim 19, wherein prior to
insertion into the body passage, said metal foil roll has been heat
treated while in said expanded condition to reduce internal
stresses within said roll. .Iaddend..Iadd.22. The stent assembly of
claim 18, wherein in said contracted condition, said roll has
approximately, six or seven adjacent arcuate layers of said
sheet.
.Iaddend..Iadd.23. The stent assembly of claim 18, wherein said
retaining structure comprises a sheath which closely overlaps said
roll in its contracted condition, said sheath being movable axially
with respect to said roll to effect ejection of said roll from said
sheath. .Iaddend..Iadd.24. The stent assembly of claim 23, further
comprising a flange slidably disposed within said overlapping
sheath at a point proximal to said roll, said flange being adapted
to provide a force on said roll to eject it from said sheath at a
desired location within the
body. .Iaddend..Iadd.25. A stent assembly for placement in a body
vessel for treatment of a vessel abnormality, the stent assembly
comprising:
a flexible sheet arranged in a multiple layer roll having expanded
and contracted conditions and having a spring force, so that when
said sheet is in said contracted condition, said spring force urges
said sheet to expand toward the expanded condition, said roll
presenting in the expanded condition a diameter at least equal to
the full diameter of the vessel;
said roll presenting in the contracted condition a plurality of
adjacent, arcuate layers;
wherein when said contracted roll is introduced within said vessel
at or near said abnormality and is not constrained so as to be
maintained in its contracted condition said spring force will urge
said stent into said expanded condition, said expanded condition
having multiple layers of said sheet that bear against one another
over a substantial portion of the circumference of an inner layer,
said multiple layers having a frictional force which resists stent
contraction thereby enhancing the structural integrity of said
stent such that said stent is able to firmly contact the vessel
wall to effect treatment of said abnormality. .Iaddend.
Description
FIELD OF THE INVENTION
This invention relates in general to the field of medical implants
and more particularly to a stent which is constructed in an
improved manner for simple and effective placement in a body
passage to reinforce a damaged area.
BACKGROUND OF THE INVENTION
Tubular prostheses commonly known as stents have been used to
reinforce and strengthen damaged blood vessels and other body
passages. For example, the blood vessels can collapse, dilate,
become partially occluded or otherwise damaged by disease or other
causes. The presence of an aneurysm or stricture in the blood
vessel often requires implantation of a stent to strengthen the
vascular wall in the area of the damage. Other passages in the body
can also sometimes benefit from stent implantation, including the
esophagus, the trachea, the gastro intestinal tract, the bile duct,
the ureter and the urethra.
The benefits or self-expanding stents have been recognized. A
self-expanding stent is held in a contracted state until it has
been positioned properly, typically with the aid of an instrument
such as a catheter. After the stent has been placed properly in the
damaged blood vessel, it is allowed to expand against the damaged
vessel will in order to reinforce the damaged area. Examples or
self-expanding stents are disclosed in Burton et al. U.S. Pat. Nos.
5,026,377 and 5,078,720, Hillstead U.S. Pat. No. 5,019,085, Wiktor
U.S. Pat. No. 4,969,458 and Gianturco U.S. Pat. No. 5,041,126. The
Wicktor and Gianturco stents are in the form of coiled or looped
wires that are unable to contact the entirety of the weakened
vessel wall. The same is true of the Hillstead stent which takes
the form of a multiple loop wire structure. The stents disclosed in
the two Burton patents are braided structures that are likewise
incapable of contacting the entirety of the damaged vessel wall.
All of the stents and particularly their placement means are
complicated to construct, and the stents are difficult to place
precisely in the damaged vessel.
SUMMARY OF THE INVENTION
The present invention is directed to an improved stent which is
particularly characterized by a stronger construction, the ability
to provide a solid and continuous wall that lines the entirety or
the damaged part of passage wall in which it is implanted, and by
ease and accuracy of placement. In accordance with the invention, a
stent is provided in the form of a flexible metal sheet which is
closely wound around a spool in a spiral roll. A sheath initially
surrounds the roll in order to retain it in a contracted state. The
spool, stent and sheath can be inserted together into the body with
the spool following a guide wire until it is located adjacent to
the damaged area. Then, the sheath is held stationary while the
spool is pushed out the end of the sheath, with a flange on the
spool making certain that the tightly coiled roll remains on the
spool. Once the spool has cleared the sheath, the roll is released
and allowed to expand against the damaged wall of the vessel. The
sheath and spool can then be withdrawn, leaving the stent in
place.
An alternative embodiment or the invention eliminates the sheath
and instead holds the stent in its retracted state by means of a
pair of control cords which are connected by slip knots to flanges
on the spool located adjacent to the opposite ends of the stent.
When the stent has been properly positioned, the cords can be
pulled to release the slip knots and allow the stent to expand
against the vessel wall. In both embodiments, multiple stents can
be carried on the some spool if it is necessary to strengthen the
vessel in more than one area.
Because the stent takes the form of a continuous sheet, the stent
essentially contacts the entirety of the damaged vessel wall area,
rather than simply reinforcing the damaged area as is the case with
looped or coiled wires or braided netting type structures. In
addition, the stent preferably has multiple layers that bear
against one another when the stent is in its expanded condition.
This further enhances the strength of the stent and provides
multiple layers that are held against one another by friction
resulting from the tendency for the stent to expand under the
influence of internal spring force.
The method by which the stent is placed in the proper position and
allowed to expand against the vessel wall is improved in a number
of respects compared to what has been proposed in the past. The
placement method is simple and accurate and does not involve
complexities such as the need to inflate a balloon catheter or
other mechanism.
DESCRIPTION OF THE DRAWINGS
In the accompanying drawings which form a part of the specification
and are to be read in conjunction therewith and in which like
reference numerals are used to indicate like parts in the various
views:
FIG. 1 is a fragmentary perspective view of a stent and placement
system for the stent, all constructed according to a preferred
embodiment of the present invention, with the stent in its
retracted condition and part of the sheath shown in section for
purposes of illustration;
FIG. 2 is a fragmentary sectional view illustrating the stent being
applied to a stricture in a blood vessel, with the broken lines
depicting the spool and stent pushed out the end of the sheath;
FIG. 3 is a fragmentary sectional view similar to FIG. 2, but
showing the stent expanded against the damaged vessel wall prior to
withdrawal of the sheath and spool;
FIG. 4 is a fragmentary sectional view showing an alternative
embodiment of the invention in which the spool is constructed to
carry multiple stents and to apply them to multiple damaged areas
are blood vessel;
FIG. 5 is a fragmentary sectional view or a stent arrangement
constructed according to an alternative embodiment of the
invention, with the stent in is retracted condition and positioned
properly for application to a damaged structure in a blood vessel;
and
FIG. 6 is a fragmentary sectional view similar to FIG. 5, but
showing the stent released and expanded against the damaged vessel
wall prior to withdrawal of the spool.
DETAILED DESCRIPTION OF THE INVENTION
Referring now to the drawings in more detail and initially to FIG.
1 in particular, numeral 10 generally designates a stent which is
constructed in accordance with a preferred embodiment of the
present invention. The stent 10 takes the form of an initially flat
metal sheet which is wound lightly around a core which is in the
form of a tubular spool 12. The stent 10 is preferably constructed
of a stainless steel foil which is commercially available under the
trade designation PH15-7. Condition CH900. The thickness of the
sheet 11 is preferably about 0.0005 inch. When the sheet 11 is
coiled around the spool 12, it is in the shape of a spiral roll 13,
and its outside diameter may be approximately 1.5 millimeter. The
sheet 11 is long enough that there are approximately six or seven
layers of the sheet which overlap one another when the roll 13 is
in the contracted position in FIGS. 1 and 2. The roll presents a
plurality of adjacent arcuate layers of the sheet in a direction
transverse to the longitudinal axis of the core.
The sheet 11 produces an inherent spring force which tends to
expand the sheet from the retracted condition of the roll 13. By
way or example, it is contemplated that the sheet will initially be
rolled to a diameter of approximately 5 millimeters and then heat
treated in that condition in order to relax the internal stresses
that arc induced by winding the sheet to a partially contracted
condition. Following the heat treatment, the material can be rolled
into the tighter roll 13 (approximately 1.5 millimeter in
diameter), and the roll will have fewer internal stresses than if
it were initially wound into the tight 1.5 millimeter cylinder. The
internal spring force of the roll 13 will tend to cause it to
unwind to an expanded condition in which its diameter is
approximately 5 millimeters (the diameter at which the heat
treatment takes place).
The sheet 11 is wound tightly on the spool 12 near one end of the
spool, and one end of the roll 13 butts against a flange 14 which
is formed on the spool 12 at a location spaced from the end of the
spool. The flange 14 projects radially from the spool 12 and has a
diameter approximately equal to the diameter of the stent 10 in its
fully contracted condition. The flange 14 is spaced from the end of
the spool a distance greater than the axial length of the stent 10.
The spool 12 is provided with a central axial passage 16 which
receives a guide wire 18. As will be explained more fully, the
spool 12 can be moved along the guide wire 18 in order to properly
position the stent 10.
The stent 10 is maintained in its fully contracted position by an
elongated sheath 20 having a tubular shape. The sheath 20 has an
inside diameter substantially equal to the outside diameter of the
stent 10 in its fully retracted condition. The spool 12 and stent
10 are located within the sheath 20, with the outer surface of the
stent 10 in contact with the inside surface of the sheath 20. The
sheath 20 has a tubular form in order to receive the stent 10 and
spool 12. The outside diameter of the sheath 20 is preferably
somewhat smaller than the body passage in which the stent 10 is to
be implanted. The spool 12 and sheath 20 are long enough that they
can be advanced into a vessel to the area which is to be treated
with the stent while the ends remain outside of the body.
In use, the sheath 20, with the stent 10 and spool 12 inside of it,
is inserted into the body and advanced until its end is adjacent to
an area of a body passage in which stent is to be implanted. For
example, with reference to FIG. 2, the sheath 20 may be inserted
through a blood vessel 22 until the leading end or the sheath is
adjacent to the damaged area such as the structure 24. The advance
of the sheath 20 is then stopped, and the tube 12 is advanced while
the sheath 20 remains stationary. As the tube is thus pushed out
through the end of the sheath 20, the spool carries the stent 10
with it because the flange 14 pushes the stent forwardly along with
the spool. Once the flange 14 and the entirety of the stent 10 have
cleared the end of the heath 20 in the position shown in broken
lines in FIG. 2, there is no longer anything restraining the stent
10 against expansion. At this time, the stent is aligned with the
structure 24.
Because the stent is no longer held against expansion, it expands
naturally under the influence or its inherent spring force to the
full diameter or the vessel 22. In the fully expanded condition of
the stent shown in FIG. 3, its outside surface contacts the inside
surface of the vessel wall and effects expansion of the structure
24.
It is noteworthy that the sheet construction of the stent 10 allows
it to line the entirety of the damaged surface of the vessel 22 at
the structure 24 and the adjacent areas of the vessel wall. In this
manner, the stent is able to remove the occlusion in the vessel
that is caused by the structure 24 and is also able to reinforce
and strengthen the damaged vessel area at and near the structure
24. Normal circulation through the vessel is thus restored. Rather
than holding the sheath 20 stationary and pushing the stent out
through its end, the sheath can be advanced until the stent is
aligned with the damaged area, and the sheath can then be retracted
while the spool 12 and stent 10 are held stationary. When the
sheath is withdrawn far enough to release the stent, the stent
expands in the manner previously indicated.
In the fully expanded condition of the stent, there are preferably
at least two overlapping layers which bear against one another over
a substantial portion of their circumference of an inner layer and
are held against one another by friction caused by the tendency of
the stent to expand to its undeformed condition. These overlapping
layers assure that the stent will be securely held in place and
provide enhanced structural integrity by reason of the multiple
layer structure that is implanted in the damaged area of the
vessel. Once the stent has fully expanded, the sheath 20 and the
tube 12 can be removed from the vessel, along with the guide wire
18. In its fully expanded condition, the diameter or the stent is
at least as great as the inside diameter of the vessel so that when
the stent expands into contact with the damaged vessel wall, it is
held securely against the roll under the influence or its inherent
spring force.
FIG. 4 depicts an arrangement which is for the most part identical
to that shown in FIGS. 1-3. The principal difference is that the
FIG. 4 construction has a spool 12 which is provided with a number
of spaced apart stents 10 carried adjacent to different flanges 14.
In use of the embodiment shown in FIG. 4, the stents 10 are applied
in series to different weakened or damaged areas of the vessel 22,
thereby strengthening the different damaged areas of the vessel to
which the stents are applied. Virtually any desired number of
stents can be carried on the spool 12.
FIGS. 5 and 6 depict an alternative embodiment of the invention In
which the sheath 20 is not present. In place of the sheath, the
function of holding the roll 13 in its contracted condition is
performed by a pair of control cords 26. One of the control cords
26 is fitted through the flange 14 and is provided with a slip knot
28 which is formed adjacent to the flange and which bears against
the outer layer or the stent 10 in a manner to prevent the stent
from expanding. The other control cord 26 is extended through a
second flange 30 which is spaced from flange 14 a distance slightly
greater than the length of the stent 10. The ends or the cords 26
opposite the slip knots 28 remain outside the vessel.
In use of the embodiment shown in FIGS. 5 and 6, the spool 12 is
extended into the vessel until the stent 10 is aligned with the
structure 24. Then, the control cords 26 are pulled to release the
slip knots 28, thereby releasing the stent 10 which then expands
naturally under the influence of the internal spring force to which
it is subjected. The stent expands to the fully expanded condition
shown in FIG. 6 in which it expands the stricture 24 and eliminates
the occlusion presented by the stricture. In addition, the stent 10
lines the vessel and strengthens and reinforces the damaged vessel
wall in the area or the structure in the same manner indicated
previously. Once the stent has been fully expanded, the spool 12
and guide wire 18 can be withdrawn from the vessel.
From the foregoing, it will be seen that this invention is one well
adapted to attain all the ends and objects hereinabove set forth
together with other advantages which are obvious and which are
inherent to the structure.
It will be understood that certain features and subcombinations are
of utility and may be employed without reference to other features
and subcombinations. This is contemplated by and is within the
scope of the claims.
Since many possible embodiments may be made of the invention
without departing from the scope thereof, it is to be understood
that all matter herein set forth or shown in the accompanying
drawings is to be interpreted as illustrative and not in a limiting
sense.
* * * * *