U.S. patent application number 13/957349 was filed with the patent office on 2013-11-28 for drug eluting stent for the treatment of dialysis graft stenoses.
This patent application is currently assigned to Abbott Cardiovascular Systems Inc.. The applicant listed for this patent is Abbott Cardiovascular Systems Inc.. Invention is credited to Paul Consigny, Tracey KRAUSA, Matthew C. MARKERT.
Application Number | 20130317591 13/957349 |
Document ID | / |
Family ID | 38006935 |
Filed Date | 2013-11-28 |
United States Patent
Application |
20130317591 |
Kind Code |
A1 |
Consigny; Paul ; et
al. |
November 28, 2013 |
DRUG ELUTING STENT FOR THE TREATMENT OF DIALYSIS GRAFT STENOSES
Abstract
A drug-eluting stent having a first cell pattern at one end and
a second cell pattern on an opposite end. The cells in the first
cell pattern have a smaller MCUSA than those in the second cell
pattern. An anti-restonic drug can be coated on the first cell
pattern and an anti-thrombotic drug on the second, with the
anti-thrombotic drug overlaying and covering both the first and
second cell patterns. The stent is operatively positionable at a
distal graft-vein anastomosis with the first cell pattern adjacent
the stenosis, and with the second cell pattern positioned adjacent
the vein or the graft.
Inventors: |
Consigny; Paul; (San Jose,
CA) ; KRAUSA; Tracey; (San Francisco, CA) ;
MARKERT; Matthew C.; (Redwood City, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Abbott Cardiovascular Systems Inc. |
Santa Clara |
CA |
US |
|
|
Assignee: |
Abbott Cardiovascular Systems
Inc.
Santa Clara
CA
|
Family ID: |
38006935 |
Appl. No.: |
13/957349 |
Filed: |
August 1, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11312159 |
Dec 19, 2005 |
8518100 |
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13957349 |
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Current U.S.
Class: |
623/1.11 ;
623/1.15; 623/1.42; 623/1.43 |
Current CPC
Class: |
A61F 2250/0023 20130101;
A61F 2/82 20130101; A61F 2/90 20130101; A61F 2250/0035 20130101;
A61F 2/86 20130101; A61F 2250/0036 20130101; A61F 2250/0067
20130101; A61F 2/91 20130101; A61M 1/3655 20130101 |
Class at
Publication: |
623/1.11 ;
623/1.42; 623/1.43; 623/1.15 |
International
Class: |
A61F 2/82 20060101
A61F002/82 |
Claims
1-33. (canceled)
34. A method, comprising: positioning a stent having a first stent
portion adjacent one end thereof and a second stent portion
adjacent an opposite end thereof at a stenosis at an anastamosis
with the first stent portion adjacent the stenosis; the first
portion defining a first maximum circular uncovered surface area
(MCUSA1); and the second stent portion defining a second maximum
circular uncovered surface area (MCUSA2); wherein MCUSA1 is less
than MCUSA2.
35. The method of claim 34, wherein the positioning includes
positioning the stent construction with the second stent portion
adjacent the vein.
36. The method of claim 34, wherein the positioning includes
positioning the stent construction with the second stent portion
adjacent a graft.
37-39. (canceled)
40. The method of claim 34, wherein the first stent portion has a
drug eluting coating on at least the abluminal surfaces
thereof.
41. The method of claim 34, wherein the second stent portion has an
anti-thrombotic coating on at least the luminal surfaces
thereof.
42. The method of claim 34, wherein the first stent portion has an
anti-restenotic drug eluting coating on luminal and abluminal
surfaces thereof.
43. The method of claim 34, wherein the second stent portion has an
anti-thrombotic coating on luminal and abluminal surfaces
thereof.
44. The method of claim 34, wherein the luminal and abluminal
surfaces of the entire stent has an anti-thrombotic coating.
45. The method of claim 34, wherein the positioning includes
delivering the stent using a catheter via puncture of a proximal
graft.
46. The method of claim 34, wherein the positioning includes
delivering the stent using a catheter via a central vein or
artery.
47. A stent, comprising: a stent having a first end and an opposite
second end; and the stent having a first stent zone extending from
the first end along a length thereof proximate to the first end and
spaced from the second end and a second stent zone extending from
the second end along a length thereof proximate to the second end
and spaced from the first end, wherein each one of the cells in the
first stent zone defines an open space that contains a first
maximum circular uncovered surface area (MCUSA1) and each one of
the cells in the second stem zone defines an open space that
contains a second first maximum circular uncovered surface area
(MCUSA2), wherein MCUSA1 is less than MCUSA2; wherein the stent has
a length measured as the distance between the first and second ends
and the first stent zone occupies from 20% up to about 50% of the
stent length and the second stent zone occupies the remaining 80%
to about 50%, respectively.
48. The stent of claim 47, wherein the first maximum circular area
is two to five mm.sup.2 and the second maximum circular area is six
to eighty mm.sup.2.
49. The stent of claim 47, wherein the first maximum circular area
is approximately 3.5 mm.sup.2 and the second maximum circular area
is approximately 19 mm.sup.2.
50. The stent of claim 47, wherein an anti-restenotic drug is on at
least an abluminal surface of the first zone, and an
anti-thrombotic drug is on at least a luminal surface of the second
zone.
51. The stent of claim 47, wherein the first zone has a length of
one to three cm, the second zone has a length of two to six cm and
the stent has a length of four to eight cm, or wherein the first
zone has a length of approximately two cm, the second zone has a
length of approximately four cm and the stent has a length of
approximately six cm.
52. A dialysis graft kit, comprising: a graft for being connected
to a vessel; and a stent for supporting the graft when the graft is
connected to the vessel, the stent comprising: a first end and an
opposite second end, the stent having a first stent zone extending
from the first end and spaced from the second end and a second
stent zone extending from the second end and spaced from the first
end. wherein when the stent is expanded within the graft and
supports the graft, each of the cells in the first stent zone
define an open space that contains first maximum circular uncovered
surface area (MCUSA1) and each of the cells in the second stent
zone define an open space that contains a second maximum circular
uncovered surface area (MCUSA2), wherein MCUSA1 is less than
MCUSA2, the first stent zone occupies about 33% of the stent
length, the second stent zone occupies about 66% of the stent
length, and a first drug or drug combination on the first zone but
not on the second zone, and a second drug or drug combination on
the second zone but not the first zone.
53. The dialysis graft kit of claim 52, further comprising: a third
stent zone occupying a portion of the length of the stent not
occupied by the first stent zone and the second stent zone, wherein
each of the cells in the third stent zone define an open space that
contains a third maximum circular area smaller than the second
maximum circular area and larger than the first maximum circular
area.
54. The stent of claim 47, further comprising: a third cell pattern
of the stent located between the first and second cell patterns,
wherein each of the cells in the third cell pattern contain a third
maximum circular area smaller than the second maximum circular area
and larger than the first maximum circular area.
55. The stent of claim 47, further comprising: a third cell pattern
of the stent located between the first and second cell patterns,
wherein the third cell pattern has a maximum circular area that
gradual increases for cells at the end adjacent the first cell
pattern to the opposite end adjacent the second cell pattern.
56. The stem of claim 47, wherein the first cell pattern occupies
about 33% of the total stent length and the second cell pattern
occupies about 66% of the total stent length.
Description
BACKGROUND OF THE INVENTION
[0001] In the late stages of kidney disease it is often necessary
for patients to repeatedly undergo dialysis where their blood is
removed, cleansed in a dialysis machine and then returned to their
bloodstream. Since arteries cannot be punctured numerous times
during a dialysis process and remain functional, grafts are used.
The grafts are implanted just below the patient's skin, typically
on the patient's arm, to give the physician easy access to the
artery and vein and the circulating blood. The graft can be easily
palpated and punctured easily with needles so that the dialysis
technician can access the patient's bloodstream.
[0002] Unfortunately, these grafts do not last long since they
develop thrombosis and restenosis, particularly at the distal
anastamosis. Wherever a graft is inserted, an injury repair process
occurs, typically at the distal anastamosis where there is
initially some thrombosis forming a matrix deposit. The cells
migrate into that area, and the patient ends up developing a
restenosis at the distal anastamosis. This stenosis developing in
the distal anastamosis restricts the flow of blood flow through the
graft. A blood clot will form proximal to that stenosis. The
physician will usually then remove the blood clot from the graft
with a balloon and then dilate the stenosis. The graft will stay
open for awhile but the restenosis and rethrombosis process will
reoccur, with the time interval between successive stenoses being
shorter and shorter. After a few stenoses, the graft is considered
a failure, requiring that the physician close the graft down and
create a new one. Unfortunately, patients only have a limited
number of sites where these grafts can be placed.
[0003] Stents have been used to maintain patency in stenosed
dialysis access grafts. These stents are typically plain biliary
stents. See, e.g., U.S. Pat. No. 5,591,226 (Trerotola et al.) U.S.
Pat. No. 5,755,775 (Trerotola et al.), US 2004/0015180 (Yencho et
al.) and George X. Zaleski, Brian Funaki, Jordan Rosenblum,
Jennifer Theoharis and Jeff Leef, "Metallic Stents Deployed in
Synthetic Arteriovenous Hemodialysis Grafts," American Journal of
Roentgenology 2001; 176:1515-1519. (The entire contents of these
publications and all other publications mentioned anywhere in this
disclosure are hereby incorporated by reference.) Examples of
self-expanding stents that have been used in dialysis grafts
include the Gianturco Z-stent (Cook) and the Wall Stent (Boston
Scientific).
[0004] When the dialysis needles are inserted into the graft
through the stent they will frequently impact the stent because the
stent cell openings are very small. If the needle impacts the
stent, it can dislodge it. It can also dull the needle, making it
impossible to enter so that the needle has to be removed and
reinserted, causing more trauma to the graft. Injury to stents
after needle puncture has been observed. See, e.g., Lane et al.,
"Puncture-Induced Deforming of a Metallic Stent Within a Dialysis
Access Graft Causing Thrombotic Failure: Case Report and
Description of Salvage," Journal of Vascular and Interventional
Radiology 1998; 9:837-839. Lane et al. at page 839, recommends that
one refrain from placing needle access in any dialysis graft
segment containing a stent. This recommendation is based upon their
observation that needle access deforms stents. See also, Rhodes and
Silas, "Dialysis Needle Puncture of Wallgrafts Placed in
Polytetrafluoroethylene Hemodialysis Grafts," Journal of Vascular
and Interventional Radiology 2005 16:1129-1134.
[0005] Accordingly, a new method and system for increasing the
lives of dialysis grafts are needed.
SUMMARY OF THE INVENTION
[0006] Directed to remedying disadvantages in the prior art,
disclosed herein is a drug eluting stent construction including a
stent having a first end, an opposite second end, a first stent
part along a length thereof proximate to the first end and spaced
from the second end, and a second stent part along a length thereof
proximate to the second end and spaced from the first end. Stent
cells in the second part have a Maximum Circular Uncovered Stent
Area (MCUSA) greater than stent cells in the first part. A first
drug or drug combination is on the first part but not on the second
part, and a second different drug or drug combination is on the
second part. The first drug or drug combination can include an
anti-restenotic drug, and the second different drug or drug
combination can include an overlaying anti-thrombotic drug covering
both the first part and the second part.
[0007] According to another definition of the invention, a stent
construction is provided which includes a stent having a first cell
pattern proximate to one end of the stent and a second cell pattern
proximate to an opposite end of the stent. The first cell pattern
has smaller cell dimensions than those of the second cell
pattern.
[0008] According to a further definition of the present invention,
a stent construction is provided which includes a stent having a
first end and an opposite second end. The stent has a first zone
along a length thereof proximate to the first end and spaced from
the second end and a second zone along a length thereof proximate
to the second end and spaced from the first end. A first drug or
drug combination is on the first zone but not on the second zone,
and a second different drug or drug combination is on the second
zone. The drugs can be applied to the stent by dip coating, roll
coating, electrostatic coating, vapor deposition coating or spray
coating.
[0009] Pursuant to another embodiment of the present invention, a
method is provided which includes positioning a stent construction
having a first stent portion adjacent one end thereof and a second
stent portion having a different construction than that of the
first stent portion adjacent an opposite end thereof at a stenosis
at a distal graft-vein anastamosis with the first stent portion
adjacent the stenosis. The stent construction can be positioned
with the second stent portion adjacent the vein as an arterial
venous anastomosis stent, or with the second stent portion adjacent
the graft or the vein as a dialysis graft stent.
[0010] Other objects and advantages of the present invention will
become more apparent to those persons having ordinary skill in the
art to which the present invention pertains from the foregoing
description taken in conjunction with the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is an enlarged schematic view of a stent of the
present invention having a small cell portion and a large cell
portion.
[0012] FIG. 2 is a view of a first alternative of the stent of FIG.
1.
[0013] FIG. 3 is a view of a second alternative of the stent of
FIG. 1.
[0014] FIG. 4 is an enlarged view taken on circle 4 of FIG. 1
showing the coating on the struts in the small cell portion.
[0015] FIG. 5 is an enlarged view taken on circle 5 of FIG. 1
showing the coating on the struts in the large cell portion.
[0016] FIG. 6 is an enlarged view taken on circle 6 of FIG. 1
showing a small open-cell layout with a dialysis needle
illustrated.
[0017] FIG. 7 is an enlarged view taken on circle 7 of FIG. 1
showing a large open-cell layout with a dialysis needle
illustrated.
[0018] FIG. 8 is an enlarged view taken on circle 8 of FIG. 2
showing a small closed-cell layout with a dialysis needle
illustrated.
[0019] FIG. 9 is an enlarged view taken on circle 9 of FIG. 2
showing a large closed-cell layout with a dialysis needle
illustrated.
[0020] FIG. 10 is an enlarged view taken at the intersection of the
small cell portion and the large cell portion of the stent of FIG.
1 showing the maximum circular unsupported surface areas (MCUSA)
for both portions.
[0021] FIG. 11 is a schematic view of a stenosis at a distal
graft-vein anastomosis.
[0022] FIG. 12 shows a stent of the present invention in an
operative position in the view of FIG. 11.
[0023] FIG. 13 shows a stent of the present invention in an
alternative operative position in the view of FIG. 11.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION
[0024] A stent of the present invention is illustrated
schematically in FIG. 1, generally at 100, and can be
balloon-expandable or self-expandable. As discussed in detail later
and with reference to FIGS. 12 and 13, it can be a dialysis graft
stent or an arterial venous anastomosis stent. Stent 100, which is
preferably formed as a single unitary construction, includes two
zones or portions, and can be formed by laser cutting a hypo tube
as would be apparent to those skilled in the art from this
disclosure. The first portion is shown on the left side of FIG. 1
generally at 110 and a (longer) second portion is shown on the
right side generally at 120. The stent 100 can be formed with
generally any strut and link configuration as is known. The stent
100, when expanded, can have an internal diameter of between four
and eight mm and a length between fifteen and seventy mm, or more
particularly, a diameter of approximately six mm and a length of
approximately thirty mm.
[0025] The first portion 110 has a tighter cell dimension than that
of the second portion 120, where the cell dimension is defined by
the Maximum Circular Unsupported Surface Area ("MCUSA"). For
example, cells in the first portion 110 can have an MCUSA of 2.0 to
5.0 mm.sup.2 or approximately 3.5 mm.sup.2, while the MCUSA of
cells in the second portion 120 can be 6.0 to 80 mm.sup.2 or
approximately 19.0 mm.sup.2. The cells in the second portion 120
are large enough to easily accommodate dialysis needles
therethrough such as "14" and "16" Gauge needles, having respective
diameters of 1.63 mm and 1.29 mm, and respective cross-sectional
areas of 2.09 mm.sup.2 and 1.31 mm.sup.2. Dialysis needles are
shown in FIGS. 12 (and 13) at 130 and 136.
[0026] Today's coronary artery drug eluting stents have maximal
circular uncovered surface areas (MCUSA) for individual cells
ranging from one to five mm.sup.2, which indicates that these cell
sizes are acceptable in the drug eluting stent area of the subject
stent 100. Areas greater than 2.1 mm.sup.2 permit a 14 Gauge needle
to penetrate with only a low probability of touching the stent. The
probability of introducing a 14 Gauge needle without touching the
stent increases as the areas of the individual cells increase, with
areas of at least five mm.sup.2 being acceptable.
[0027] The first portion 110 has cells 140 having a smaller MCUSA
than that of the cells 142 of the second portion 120 so that the
first portion can hold and effectively transmit drugs from a
coating 148 to the anastomotic stenosis, as shown in FIG. 12 for
example. These drugs are lipophilic so the cell size needs to be
small to provide drug to the entire area to prevent hyperplasia
from occurring, which creates restenosis. The second portion 120
can have a different drug coating 150 for transmitting drugs into
the bloodstream. Blood clot formation in grafts is a problem and
can be exacerbated by the presence of the stent, a foreign body.
Accordingly, an anti-thrombotic drug can be provided throughout the
entire length of the stent 100 or at least in the non-drug eluting
stent area 120. A purpose of the anti-thrombotic coating is thus to
reduce the likelihood of thrombosis being initiated by the stent
100. This is especially true for metallic stents made of materials
such as stainless steel, cobalt chrome, and nitinol. Furthermore,
thrombosis is exacerbated by stents damaged by needle penetration,
suggesting that an anti-thrombotic coating can retard that
thrombosis.
[0028] The drug of the first portion 110 is shown coated on struts
160 of the first portion in FIG. 4. FIG. 5 shows struts 170 in the
cell pattern of the second portion 120 coated with a different
second drug 150. While the struts 160, 170 are illustrated as
having rectangular cross-sections, other shapes as would be
apparent to those skilled in the art can be used. Further, the
struts within the same stent can have different widths.
[0029] The first stent portion 110 can have an anti-restenotic drug
coating 148. The drug of this coating can be eluted from a
nonabsorbable or absorbable polymer placed on a metallic stent or
eluted from a stent composed of a mixture of a bioabsorbable
polymer and drug or drugs. Biocompatible, nonabsorbable polymers
include alkylene vinyl alcohol copolymers such as ethylene vinyl
acetate (EVA), alkylene vinyl alcohol copolymers such as ethylene
vinyl alcohol (EVAL), poly (n-butyl methacrylate (PMBA), SOLEF
polymers such as poly (vinylidene fluoride-co-hexafluoropropene
(PVDF-co-HFP and poly (vinylidene fluoride) (PVDF) and combinations
thereof. Biocompatible, bioabsorbable polymers include blends of
polyesters, poly (D,L-lactide), poly (L-lactide), polyglycolide,
and poly (D,L-lactide-co-glycolide). See U.S. Pat. No. 6,673,385
(Ding et al.) and US 2004/0086542 (Hossainy et al.).
[0030] The anti-restenotic drug can be a single drug or a
combination of drugs that are eluted at similar or different rates.
The drugs include but are not limited to: (1) antiproliferative
drugs such as everolimus, sirolimus, ABT-578, and paclitaxel; (2)
anti-inflammatory drugs such as corticosteroids (e.g., clobetasol,
dexamethasone, and momentasone), inhibitors of the NFkB and p38
pathways; (3) immunosuppressants such as tacrolimus and
pimecrolimus; and (4) pro-healing drugs such as 17-beta estradiol,
nitric oxide donors, and nitric oxide generators (e.g., chelated
copper catalysts).
[0031] The struts 170 of the second stent portion 120 can have an
anti-thrombotic coating 150 as mentioned above especially on the
luminal surfaces thereof. This coating 150 can include: (1)
anti-thrombotics including heparan or heparin; and (2) antiplatelet
drugs including nitric oxide donors or nitric oxide generators
(chelated copper catalysts).
[0032] More particularly, the first drug or drug combination can
include an anti-restenotic drug and the second different drug or
drug combination can include an overlaying anti-thrombotic drug
covering both the first zone or portion 110 and the second zone or
portion 120. See U.S. 2005/0192662 (Ward). The drugs can be applied
by techniques known in the art including spray coating, dip coating
and roll coating. Another coating application technique uses
"depot" technology (see, e.g., US 2005/0234544 (Shanley)), or
applies the coating in channels or grooves on the stent
surfaces.
[0033] To assist in the placement of the strut in the body,
radiopaque markers 180, 184 are provided at opposite ends of the
first portion. These (metal) radiopaque markers can have a
construction as is known in the prior art, for biodegradable
stents. The markers can also be provided at the opposite end of the
stent 110, that is, at the right end of FIGS. 1 (and 2 and 3).
[0034] It may be to reduce the effect of bending stresses at the
juncture of the first and second portions 110, 120, that a
transitional portion 200 can be provided therebetween as shown in
FIG. 2 for the first alternative stent 210. The transitional
portion 200 can have a cell pattern with cells having an MCUSA
greater than those of the first portion 110 but smaller than those
of the second portion 120. Alternatively, the second portion 120
can have a gradually increasing MCUSA for cells at the end adjacent
the first portion 110 to the opposite end 220, as illustrated in
FIG. 3 by the second alternative stent 230.
[0035] The patterns of the cells 140 of the first stent portion 110
and/or the cells 142 of the second stent portion 120 can have an
"open" cell construction such as illustrated in FIG. 6 as well as
in FIG. 7. Examples of open cell designs are those. of the RX
Herculink Plus stent and the Multi-Link Zeta stent. While FIG. 6
shows at 240 a small open cell construction with a small MCUSA,
FIG. 7 shows at 250 a large open cell construction with a large
MCUSA. The relative sizes can be understood from the cross-section
of the dialysis needle 260 drawn in these figures. Alternatively,
the first portion 110 and/or the second portion 120 can have a
closed cell construction, such as illustrated in FIGS. 8 and 9.
FIG. 8 shows at 270 a small closed cell layout, and FIG. 9 shows a
large closed cell layout at 280 with a larger MCUSA than that of
the layout 270. Examples of closed cell designs are the Palmax
Genesis stent and the Cypher Sirolimus-Eluting Coronary stent.
[0036] The stent cell size can be increased by increasing the
distance between the struts, as can be seen from comparing FIG. 6
with FIG. 7, and FIG. 8 with FIG. 9. Alternatively, it can be
increased by switching from a closed cell design to an open cell
design by eliminating a link, as can be understood from comparing
FIGS. 8 and 9 with FIGS. 6 and 7. See, e.g., Garasic, J Metal.,
Circulation 101: 812-818, 2000. To increase the MCUSA of the open
and/or closed cell configurations, the length of the strut links
300 can be increased. If the links 300 have undulations 310, one
way of increasing the lengths of the links is to increase the
lengths of the undulations 310. Another way is to increase the
number of undulations 310 per link 300. A third way is to increase
the lengths of the straight portions 320, 330 on one or both sides
of the undulations 310 as can be seen by comparing FIGS. 6 and 7
and by comparing FIGS. 8 and 9.
[0037] The stent 100, for example, can have a strut and link
configuration as disclosed in U.S. Pat. No. 6,616,689 (Ainsworth et
al). The links 300 of the second portion 120 can each be
approximately two to six mm long, and the links 300 of the first
portion 110 can each be approximately one to three mm long.
Alternatively, the links 300 of the second portion 120 can be
approximately one to five mm longer than the links of the first
portion 110. Another definition of the invention is for the links
100 in the first cell portion 110 to have lengths which provide
MCUSA's of two to five mm.sup.2 of the cells 140 in the first
portion 100, when expanded. Links 300 in the second cell portion
120 can have lengths which provide MCUSA's of six to eighty
mm.sup.2 of cells 142 in the second portion of the stent 100 when
expanded. Alternatively, the links 300 can have lengths which
provide MCUSA's of approximately 3.5 mm.sup.2 in the first portion
110 of the stent 100 when expanded and the links in the second
portion 120 can have lengths which provide MCUSA's of approximately
19 mm.sup.2 in the second portion of the stent when the stent is
expanded. In other words, the short links (as on the left portion
of FIG. 1, for example) would be in the area of the stent that
would contain the drug and would be placed at the graft vein
anastamoses, as depicted in FIGS. 12 and 13.
[0038] The underlying stent 100 itself can be made of a
biodegradable metal or polymer. Examples of biocompatible,
bioabsorbable polymers include blends of polyesters, poly
(D,L-lactide), poly (L-Iactide), polyglycolide, poly
(D,L-lactide-co-glycolide), poly(hydroxyvalerate),
poly(lactide-co-glycolide), poly(hydroxybutyrate),
poly(hydroxybutyrate-co-valerate), polyorthoester, polyanhydride,
poly(glycolic acid), poly(glycolide), poly(L-lactic acid),
poly(L-lactide), poly(D,L-lactic acid), poly(D,L-lactide),
poly(caprolactone), poly(trimethylene carbonate), polyester amide,
poly(glycolic acid-co-trimethylene carbonate),
co-poly(ether-esters) (e.g., PEO/PLA), polyphosphazenes,
biomolecules (such as fibrin, fibrinogen, cellulose, starch,
collagen and hyaluronic acid), polyphosphoester, polyphosphoester
urethane, poly(amino acids), cyanoacrylates, and
poly(iminocarbonate) polydioxanone. Examples of usable
biodegradable metals for the stent 100 include magnesium alloys
such as an alloy of magnesium, yttrium and rare earth, and usable
bioerodible metals include magnesium, zinc, and iron. The
underlying stents can be metal stents or polymer stents; they can
be bioabsorbable, bioerodable, and/or biodegradable polymeric
stents with or without metallic components. Metals including cobalt
chromium alloy (Elgiloy), stainless steel (316L), Nitinol,
tantalum, and nickel-titanium alloy can be used as the stent
material.
[0039] The first portion 110 of the stent 100 can be shorter than
the second portion 120. It can be approximately one-third of the
length of the total stent 100, while the second portion can be
two-thirds of the length. Alternatively, the first portion 110 can
have a stent length approximately between twenty and fifty percent
of the length of the stent 100, and the second portion 120 can have
a length approximately between fifty and eighty percent of the
length of the stent. As an example, the stent 100, when expanded,
can have an internal diameter of between four and eight mm and a
length between fifteen and seventy mm, or more specifically a
diameter of approximately six mm and a length of approximately
thirty mm.
[0040] FIG. 11 shows a stenosis at a distal graft-vein anastomosis.
Referring to the reference numerals in that figure, disclosed
therein are proximal artery 410, blood flow 420, distal artery 430,
stenosis 440, distal anastomosis 450, central vein 460, distal vein
470, and (PTFE) graft 480.
[0041] The stent 100 can be used as a dialysis graft stent as shown
in FIG. 12. The catheter for inserting the stent 100 in position as
shown in FIG. 12 is illustrated in phantom lines at 510 on the
right side of the drawing. A first dialysis needle 130 can be
inserted through the graft 480 and a first stent cell in the second
stent portion 120 and into the blood channel 530 in the graft; and
a second dialysis needle 136 can be inserted through the graft 520
and a second stent cell in the second stent portion 120, or through
the graft 520 directly into the blood channel 530 in the graft.
Blood from the blood channel 530 at a proximal area is withdrawn
through the inserted first dialysis needle 136, processed in a
dialysis machine 540, and returned through the inserted second
dialysis needle into the blood channel at a distal area
thereof.
[0042] Alternatively, the stent 100 can be used as an arterial
venous anastomosis stent as shown in FIG. 13. The catheter for
inserting the stent in the position of FIG. 13 is illustrated in
the upper left portion of that figure in phantom lines at 560. Both
of the dialysis needles 136, 130 pass directly in the graft 480,
and not through the stent 110, and into the blood channel 530. The
open cell design is useful in this alternative placement of the
stent even though the dialysis needles 130, 136 will not be
inserted through the cells in this embodiment for two reasons.
First, venous flow can go through more easily because it is less
restricted. Second, because of the anti-thrombotic coating, there
is reduced likelihood of thrombosis in the venous segment.
[0043] In summary, the present invention can include a
self-expanding or balloon-expandable stent comprised of nitinol or
biodegradable polymer and having two cell patterns. An open cell
pattern in the area proximal to the anastamosis is provided in
order to facilitate needle punctures of the (PTFE) graft. The
performance of this area can be further enhanced by rounding the
edges of the stent struts to better deflect needles that strike the
strut. The stent has a less open pattern in the area that would be
opposed to the anastamotic area. This tighter cell design enhances
drug delivery by providing additional surface onto or into which
drugs can be placed. In addition, it decreases diffusion distances
and thereby decreases the likelihood that there would be areas
unaffected by the drug.
[0044] Another definition of the invention is a drug coated stent
in which the area in contact with the PTFE graft is coated with a
polymer that is nonfouling or anti-thrombotic or has affixed to it
or elutes a drug that prevents/inhibits thrombosis. An example is a
hydrogel to which is tethered a heparin or nitric oxide
donor/generator. The closed cell area of the stent that is in
contact with the stenotic vein-graft anastamosis elutes a drug that
inhibits restenosis. The drug can be a single drug such as
everolimus of paclitaxel, or a drug combination such as everolimus
with a anticoagulant/antithrombotic; everolimus with a nitric oxide
donor/generator; everolimus with an anti-inflammatory; or
everolimus with an immunosuppressant. This area may also be coated
with an antifouling coating that prevents clot formation.
[0045] The stent is designed to be deployed via a catheter inserted
directly through the dialysis graft material or via an artery or
vein that leads to or from the graft. The small cell region of the
stent can be positioned at the site of the anastamotic stenosis.
The large cell region of the stent can be positioned in the graft
area. The biodegradable polymer can be one that has a property to
self-expand to bring the drug eluting portion of the device in
contact with the anastamotic stenosis and then degrade faster than
the graft is expected to fail. This advantageously permits another
such stent to be inserted before the graft occludes.
[0046] From the foregoing detailed description, it will be evident
that there are a number of changes, adaptations and modifications
of the present invention which come within the province of those
skilled in the art. The scope of the invention includes any
combination of the elements from the different species or
embodiments disclosed herein, as well as subassemblies, assemblies,
and methods thereof. However, it is intended that all such
variations not departing from the spirit of the invention be
considered as within the scope thereof.
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