Stent fabrication method
First Claim
Patent Images
1. Apparatus for fabricating a stent, comprising:
- a) a platform adapted to receive a flat sheet of metal to be formed into said stent, said flat sheet of metal having a longitudinal axis, a first major surface, a second major surface, a first long side, and a second long side, said first and said second long sides substantially parallel to said longitudinal axis of said sheet;
b) a mandrel having a substantially cylindrical external surface and having a first end and a second end defining a longitudinal axis, said mandrel sized to have a cross-sectional diameter substantially equal to or less than the internal diameter of said stent to be fabricated;
c) means for securing said mandrel against a major surface of said flat sheet of metal; and
d) means for deforming said flat sheet of metal against said external surface of said mandrel so that said flat sheet of metal is deformed into a substantially tubular shape, said means for deforming adapted so that said first long side and said second long side remain substantially parallel to each other when said flat sheet of metal is deformed into said tubular shape.
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Accused Products
Abstract
A stent and a method for fabricating the stent are disclosed. The stent has an originally flat pattern and connection points where the sides of the flat pattern are joined. The method includes the steps of a) cutting a stent pattern into a flat piece of metal thereby to produce a metal pattern, b) deforming the metal pattern so as to cause two opposing sides to meet, and c) joining the two opposing sides at least at one point. Substantially no portion of the stent projects into the lumen of the stent when the stent is expanded against the internal wall of a blood vessel.
69 Citations
137 Claims
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1. Apparatus for fabricating a stent, comprising:
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a) a platform adapted to receive a flat sheet of metal to be formed into said stent, said flat sheet of metal having a longitudinal axis, a first major surface, a second major surface, a first long side, and a second long side, said first and said second long sides substantially parallel to said longitudinal axis of said sheet;
b) a mandrel having a substantially cylindrical external surface and having a first end and a second end defining a longitudinal axis, said mandrel sized to have a cross-sectional diameter substantially equal to or less than the internal diameter of said stent to be fabricated;
c) means for securing said mandrel against a major surface of said flat sheet of metal; and
d) means for deforming said flat sheet of metal against said external surface of said mandrel so that said flat sheet of metal is deformed into a substantially tubular shape, said means for deforming adapted so that said first long side and said second long side remain substantially parallel to each other when said flat sheet of metal is deformed into said tubular shape. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. Apparatus for fabricating a stent, comprising:
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a) a base having a platform adapted to receive a flat sheet of metal to be formed into said stent, said flat sheet of metal having a longitudinal axis, a first major surface, a second major surface, a first long side, and a second long side, said first and said second long sides substantially parallel to said longitudinal axis of said stent;
b) a mandrel having a substantially cylindrical external surface and having a first end and a second end defining a longitudinal axis, said mandrel sized to have a cross-sectional diameter substantially equal to or less than the internal diameter of said stent to be fabricated;
c) means for securing said mandrel against a major surface of said flat sheet of metal;
d) a plurality of deforming blades disposed around the periphery of said mandrel for deforming said flat sheet of metal against said external surface of said mandrel so that said flat sheet of metal is deformed into a substantially tubular shape, said blades disposed between said first end and said second end of said mandrel, each of said deforming blades adapted for independent and selective movement in a first direction toward said mandrel and a second direction away from said mandrel so as to selectively impinge upon said mandrel or upon a portion of said sheet disposed between said mandrel and each of said deforming blades, each of said deforming blades further adapted so that said first long side and said second long side of said sheet remain substantially parallel to each other when said stent is deformed into said tubular shape;
e) means for selectively moving each of said deforming blades in a first direction toward said mandrel and in a second direction away from said mandrel; and
f) means for securing said first long side of said sheet to said second long side of said sheet. - View Dependent Claims (9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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20. Apparatus for fabricating a stent, comprising:
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a) a laser housing;
b) a laser disposed within and selectively movable within said housing;
c) a movable table having a first end and a second end and adapted for selective movement into and out of said laser housing, said table adapted so that when said first end of said table is disposed within said laser housing said second end of said table is disposed outside of said housing and when said second end of said table is disposed within said laser housing said first end of said table is disposed outside of said laser housing;
d) a plurality of stent folders disposed at said first end of said table and a plurality of stent folders disposed at said second end of said table, each of said stent folders comprising;
a) a base having a platform adapted to receive a flat sheet of metal to be formed into said stent, said flat sheet of metal having a longitudinal axis, a first major surface, a second major surface, a first long side, and a second long side, said first and said second long sides substantially parallel to said longitudinal axis, said sheet provided with a plurality of alignment of apertures;
b) a plurality of alignment pins projecting from each of said platforms, said pins sized to engage said alignment apertures and align said sheet on said platform;
c) a mandrel having a substantially cylindrical external surface and having a first end, a second end, and a longitudinal axis, said mandrel sized to have a cross-sectional diameter substantially equal to or less than the internal diameter of said stent to be fabricated, said platform provided with a first concave recess adapted to receive said first end of said mandrel and a second concave recess adapted to receive said second end of said mandrel;
d) a hingedly connected arm adapted for movement in a first direction toward said platform and in a second direction away from said platform for securing said mandrel against a major surface of said flat sheet of metal;
e) a first deforming blade provided with a first deforming blade tip;
a second deforming blade provided with a second deforming blade tip;
a third deforming blade provided with a third deforming blade tip;
a fourth deforming blade provided with a fourth deforming blade tip;
a fifth deforming blade provided with a fifth deforming blade tip; and
a sixth deforming blade provided with a sixth deforming blade tip, said blades disposed around said external surface of said mandrel, said deforming blade tips adapted to deform said flat sheet of metal against said external surface of said mandrel so that said flat sheet of metal is deformed into a substantially tubular shape substantially conforming to said external surface, said deforming blades disposed between said first end and said second end of said mandrel, each of said deforming blades adapted for independent and selective movement in a first direction toward said mandrel and a second direction away from said mandrel so as to selectively impinge said deforming blade tips against said mandrel or upon a portion of said sheet disposed between said mandrel and each of said deforming blade tips, each of said deforming blades further adapted so that said first long side and said second long side of said sheet remain substantially parallel to each other when said stent is deformed into said tubular shape, said third and said sixth deforming blade tips provided with a plurality of scalloped laser apertures, said apertures sized and disposed to permit said third and said sixth deforming blade tips to secure said first long side and said second long side against said external surface of said mandrel while providing said laser access to predetermined portions of said first long side and said second long side in order to weld said first long side to said second long side;
f) a first motor connected to said first deforming blade;
a second motor connected to said second deforming blade;
a third motor connected to said third deforming blade;
a fourth motor connected to said fourth deforming blade;
a fifth motor connected to said fifth deforming blade; and
a sixth motor connected to said sixth deforming blade, each of said motors adapted for selectively moving each of said deforming blades to which it is connected in a first direction toward said mandrel and in a second direction away from said mandrel; and
g) a computer for controlling;
the sequence which said first end of said table and said second end of said table are disposed within said laser housing;
for controlling the sequence and degree to which each of said plurality of deforming blade tips impinges upon said mandrel or a portion of said sheet disposed between said mandrel and each of said deforming blade tips; and
for controlling the sequence, pattern, location, and amount of energy said laser applies to each of said first and second long sides of each of said sheets disposed on each of said plurality of stent folders. - View Dependent Claims (21, 22, 23)
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24. Apparatus for fabricating a stent, comprising:
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a) a base;
b) a sheet receiving area disposed on said base, said area adapted to receive a flat sheet of metal to be formed into said stent, said flat sheet of metal having a longitudinal axis, a first major surface, a second major surface, a first long side, and a second long side, said first and said second long sides substantially parallel to said longitudinal axis;
c) an arm having a first end and a second end, said first end of said arm adapted to selectively retain a mandrel having a substantially cylindrical external surface, said second end of said arm hingedly connected to said base and adapted for movement in a first direction toward said base and in a second direction away from said base and further adapted to secure said mandrel against a major surface of said flat sheet of metal disposed on said stent receiving area disposed on said base, said mandrel sized to have a cross-sectional diameter substantially equal to or less than the internal cross-sectional diameter of said stent to be fabricated;
d) means for deforming said flat piece of metal against said external surface of said mandrel so that said flat sheet of metal is deformed into a substantially tubular shape substantially conforming to said external surface of said mandrel with said first long side and said second long side substantially parallel to each other. - View Dependent Claims (25, 26)
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27. A stent aligning and welding jig comprising:
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a) a base having a first end and a second end, a first wall having a first end and a second end and a first major surface and a second major surface;
a second wall having a first end and a second end and a first major surface and a second major surface, said second major surface of said first wall and said first major surface of said second wall defining a longitudinal U-shaped channel having a longitudinal axis in said base, said first wall provided with a plurality of slots defining a plurality of first clamping portions having a top end and a bottom end and a first major surface and a second major surface, each of said first clamping portions provided with a first concave channel disposed at said top end of said second major surface of said first clamping portion and a second concave channel disposed at said bottom end of said second major surface of said first clamping portion, said first and said second concave channels substantially parallel to said longitudinal axis of said U-shaped channel;
said first wall of each of said plurality of first clamping portions provided with a compensation slit disposed between said first concave channel and said second concave channel, said compensation slit substantially parallel to said longitudinal axis of said U-shaped channel;
b) a plurality of second clamping portions disposed in said U-shaped channel between said second major surface of said first wall and said first major surface of said second wall, each of said second clamping portions disposed in registry with one of said first clamping portions, each of said second clamping portions having a top end, a bottom end, a first major surface, a second major surface, a first minor surface disposed at said top end, a second minor surface disposed at said bottom end, a third minor surface disposed between said top end and said bottom end, and a fourth minor surface disposed opposite said third minor surface between said top end and said bottom end, each of said second clamping portions provided with a first concave channel disposed at said top end of said first major surface of said second clamping portion and a second concave channel disposed at said bottom end of said first major surface of said second clamping portion, said first and said second concave channels substantially parallel to said longitudinal axis of said U-shaped channel;
c) a biasing means disposed between said first major surface of said second wall and said second major surface of each of said plurality of second clamping portions for biasing said first major surface of each of said second clamping portions against said second major surface of each of said first clamping portions which are in registry with each other;
d) a first mandrel support lever positioning pin projecting from said third minor surface and a second mandrel support lever positioning pin projecting from said fourth minor surface of each of said second clamping portions, said mandrel support lever positioning pins substantially parallel to said longitudinal axis of said U-shaped channel;
e) a biasing control means for selectively controlling the distance between said second major surface of each of said first clamping portions and said first major surface of each of said second clamping portions;
f) a retaining mandrel disposed in said second concave channel of said first wall and said second concave channel in each of said second clamping portions; and
g) a mandrel support lever for supporting said stent during the alignment of said first long side of said sheet with said second long side of said sheet, said lever provided with a first mandrel support notch for supporting said first end of said mandrel, a second mandrel support notch for supporting said second end of said mandrel, a first mandrel support lever positioning pin engagement surface for engaging said first mandrel support lever positioning pin and a second mandrel support lever positioning pin engagement surface for engaging said second mandrel support lever positioning pin when said mandrel support lever is disposed on said second wall. - View Dependent Claims (28, 29, 30, 31)
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32. A method of fabricating a stent comprising the steps of:
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a) providing a plurality of stent patterns into a flat piece of metal, each of said patterns having a first long side and a second long side, said first long side provided with a plurality of pairs of engagement points, said second long side provided with a plurality of pairs of engagement points, said plurality of pairs of engagement points disposed substantially opposite each other, said engagement points sized and disposed to communicate when said pattern is deformed and rolled into a tubular shape, each pair of said first long side engagement points provided with a bridge disposed between each first long side engagement point comprising the pair, said bridge having a width that is less than the width of the other portions of said stent;
b) disposing a mandrel having a substantially cylindrical external surface and a longitudinal axis between said first long side and said second long side of said sheet, said longitudinal axis substantially parallel to said first long side and said second long side;
c) deforming said pattern into a tubular shape so that said first long side pairs of engagement points contact said second long side pairs of engagement points;
d) cutting said bridge; and
e) attaching each of said engagement points to the engagement point with which it is in contact to form said expandable stent. - View Dependent Claims (33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56)
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- 57. The method of step 34, further comprising the step of inspecting both sides of said sheet after step a) and before step b).
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59. A jig for electropolishing a tubular stent, comprising:
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a rack having a first end and a second end, said rack provided with a plurality of stent electropolishing mounts, each of said mounts having a) a base;
b) an electrically conductive first member having a first end connected to said base and a second end adapted to selectively contact the external surface of said tubular stent without damaging said external surface;
c) an electrically non-conductive second member having a first end connected to said base and a second end adapted to be selectively disposed within the longitudinal bore of said stent without damaging said longitudinal bore, said first member and said second member further adapted so as to bias said second end of said second member towards said second end of said first member in an amount sufficient to secure said stent between said first and said second members.
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60. A method of electropolishing a stent, comprising the steps of:
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a) mounting a stent on a rack, said rack having a first end and a second end provided with a plurality of stent electropolishing mounts, each of said mounts having a base;
an electrically conductive first member having a first end connected to said base and a second end adapted to selectively contact the external surface of said tubular stent without damaging said external surface;
an electrically non-conductive second member having a first end connected to said base and a second end adapted to be selectively disposed within the longitudinal bore of said stent without damaging said longitudinal bore, said first member and said second member further adapted so as to bias said second end of said second member towards said second end of said first member in an amount sufficient to secure said stent between said first and said second members;
b) immersing said stent in an electropolishing bath and applying electrical current to said first member for a predetermined period of time; and
c) changing the point where said second end of said first member contacts said external surface of said stent prior to the expiration of said predetermined period of time. - View Dependent Claims (61, 62, 63, 64, 65, 66)
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67. A method of fabricating a stent having a longitudinal lumen comprising the steps of:
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a) providing a plurality of stent patterns in a flat sheet of metal;
each of said patterns having a first long side and a second long side, said first long side provided with a plurality of pairs of engagement points, said second long side provided with a plurality of pairs of engagement points, said plurality of pairs of engagement points disposed substantially opposite each other, said engagement points sized and disposed to communicate when said pattern is deformed and rolled into a tubular shape, each pair of said first long side engagement points provided with a bridge disposed between each first long side engagement point comprising said pair, said bridge having a width that is less than the width of the other portions of said stent;
b) disposing a mandrel having a substantially cylindrical external surface and a longitudinal axis between said first long side and said second long side of said sheet, said longitudinal axis substantially parallel to said first and said second long sides;
c) deforming said pattern into a tubular shape so that said first long side pairs of engagement points contact said second long side pairs of engagement points and allowing a portion of said stent to remain attached to said sheet of metal;
d) cutting said bridge;
e) attaching each of said engagement points to the engagement point with which it is in contact to form said stent;
f) attaching an electrode to said sheet of metal;
g) electropolishing said stent; and
f) disconnecting said stent from said sheet. - View Dependent Claims (68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93)
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94. A sheet for fabricating a stent having a longitudinal lumen comprising:
a) a flat piece of sheet metal provided with a plurality of stent patterns, each of said patterns having a first long side and a second long side, said first long side provided with a plurality of pairs of engagement points, said second long side provided with a plurality of pairs of engagement points, said plurality of pairs of engagement points disposed substantially opposite each other, said engagement points sized and disposed to communicate when said pattern is deformed and rolled into a tubular shape, each pair of said first long side engagement points provided with a bridge disposed between each first long side engagement point comprising said pair, said bridge having a width that is less than the width of the other portions of the stent. - View Dependent Claims (95, 96, 97, 98, 99, 100)
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101. A method for fabricating a stent having a longitudinal lumen, comprising the steps of:
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a.) constructing an apparatus comprising;
a) a laser housing;
b) a laser disposed within and selectively movable within said housing;
c) a movable table having a first end and a second end and adapted for selective movement into and out of said laser housing said table adapted so that when said first end of said table is disposed within said laser housing said second end of said table is disposed outside of said housing and when said second end of said table is disposed within said laser housing said first end of said table is disposed outside of said laser housing;
d) a plurality of stent folders disposed at said first end of said table and a plurality of stent folders disposed at said second end of said table, each of said stent folders comprising;
a) a base having a platform adapted to receive a flat sheet of metal to be formed into said stent, said flat sheet of metal having a longitudinal axis, a first major surface, a second major surface, a first long side, and a second long side, said first and said second long sides substantially parallel to said longitudinal axis, said sheet provided with a plurality of alignment of apertures;
b) a plurality of alignment pins projecting from each of said platforms, said pins sized to engage said alignment apertures and align said sheet on said platform;
c) a mandrel having a substantially cylindrical external surface and having a first end, a second end, and a longitudinal axis, said mandrel sized to have a cross-sectional diameter substantially equal to or less than the internal diameter of said stent to be fabricated, said platform provided with a first concave recess adapted to receive said first end of said mandrel and a second concave recess adapted to receive said second end of said mandrel;
d) a hingedly connected arm adapted for movement in a first direction toward said platform and in a second direction away from said platform for securing said mandrel against a major surface of said flat sheet of metal;
e) a first deforming blade provided with a first deforming blade tip;
a second deforming blade provided with a second deforming blade tip;
a third deforming blade provided with a third deforming blade tip;
a fourth deforming blade provided with a fourth deforming blade tip;
a fifth deforming blade provided with a fifth deforming blade tip; and
a sixth deforming blade provided with a sixth deforming blade tip, said blades disposed around said external surface of said mandrel, said deforming blade tips adapted to deform said flat sheet of metal against said external surface of said mandrel so that said flat sheet of metal is deformed into a substantially tubular shape substantially conforming to said external surface, said deforming blades disposed between said first end and said second end of said mandrel, each of said deforming blades adapted for independent and selective movement in a first direction toward said mandrel and a second direction away from said mandrel so as to selectively impinge said deforming blade tips against said mandrel or against a portion of said sheet disposed between said mandrel and each of said deforming blade tips, each of said deforming blades further adapted so that said first long side and said second long side of said sheet remain substantially parallel to each other when said stent is deformed into said tubular shape, said third and said sixth deforming blade tips provided with a plurality of scalloped laser apertures, said apertures sized and disposed to permit said third and said sixth deforming blade tips to secure said first long side and said second long side against said external surface of said mandrel while providing said laser access to predetermined portions of said first long side and said second long side of said sheet in order to weld said first long side to said second long side;
f) a first motor connected to said first deforming blade;
a second motor connected to said second deforming blade;
a third motor connected to said third deforming blade;
a fourth motor connected to said fourth deforming blade;
a fifth motor connected to said fifth deforming blade; and
a sixth motor connected to said sixth deforming blade, each of said motors adapted for selectively moving each of said deforming blades to which it is connected in a first direction toward said mandrel and in a second direction away from said mandrel; and
g) a computer for controlling;
the sequence which said first end of said table and said second end of said table are disposed within said laser housing;
for controlling the sequence and degree to which each of said plurality of deforming blade tips impinges upon said mandrel or a portion of said sheet disposed between said mandrel and each of said deforming blade tips; and
for controlling the sequence, pattern, location, and amount of energy said laser applies to each of said first and said second long sides of each of said sheets disposed on each of said plurality of stent folders;
b.) cutting a plurality of stent patterns into a flat piece of metal, each of said patterns having a first major surface and a second major surface, a first long side and a second long side, said first long side provided with a plurality of pairs of engagement points, said second long side provided with a plurality of pairs of engagement points, said plurality of pairs of engagement points disposed substantially opposite each other, said engagement points sized and disposed to communicate when said pattern is deformed and rolled into a tubular shape, each pair of said first long side engagement points provided with a bridge disposed between each first long side engagement point comprising the pair, said bridge having a width that is less than the width of the other portions of the stent, said sheet provided with a plurality of alignment apertures sized and disposed to engage said alignment pins on said base;
c.) disposing said sheet on said base so that said first major surface of said sheet is in contact with said base;
d.) disposing a mandrel having a substantially cylindrical external surface and a longitudinal axis against said second major surface of said sheet between said first long side and said second long side of said sheet, said longitudinal axis substantially parallel to said first long side and said second long side;
e.) deforming said pattern into a tubular shape so that said first long side pairs of engagement points contact said second long side pairs of engagement points said deforming step comprising the steps of;
a) actuating said sixth deforming blade motor so that said sixth deforming blade motor moves said sixth deforming blade in said first direction in an amount sufficient for said sixth deforming blade tip to contact said external surface of said mandrel so as to secure said mandrel against said sheet;
b) actuating said first deforming blade motor so that said first blade deforming motor moves said first deforming blade in said first direction in an amount sufficient for said first blade deforming tip to contact said first major surface of said sheet and deform said sheet against said external surface of said mandrel;
c) actuating said second deforming blade motor so that said second deforming blade motor moves said second deforming blade in said first direction in an amount sufficient for said second deforming blade tip to contact said first major surface of said sheet and deform said sheet against said external surface of said mandrel;
d) actuating said third deforming blade motor so that said third deforming blade motor moves said second deforming blade in said first direction in an amount sufficient for said third deforming blade tip to contact said first major surface of said sheet and deform said sheet against said external surface of said mandrel while actuating said sixth deforming blade motor so that said sixth deforming blade moves in said second direction away from said mandrel;
e) actuating said fourth deforming blade motor so that said fourth deforming blade motor moves said fourth deforming blade tip in said first direction in an amount sufficient for said fourth deforming blade tip to contact said first major surface of said sheet and deform said sheet against said external surface of said mandrel;
f) actuating said fifth deforming blade motor so that said fifth deforming blade motor moves said fifth deforming blade in said first direction in an amount sufficient for said fifth deforming blade tip to contact said first major surface of said sheet and deform said sheet against said external surface of said mandrel;
g) actuating said sixth deforming blade motor so that said sixth deforming blade motor moves said second deforming blade in said first direction in an amount sufficient for said second deforming blade tip to contact said first major surface of said sheet and deform said sheet against said external surface of said mandrel;
h) simultaneously actuating said third and sixth deforming blade motors so that said third and sixth deforming blade motors move said third and sixth deforming blades in said first direction in an amount sufficient for said third and sixth deforming blade tips to contact said first major surface of said sheet and deform said sheet against said external surface of said mandrel;
d) utilizing said laser in cutting said bridge; and
e) utilizing said laser in welding each of said engagement points to the engagement point with which it is in contact to form said expandable stent. - View Dependent Claims (102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 127)
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- 125. The method of step 101, further comprising the step of inspecting both sides of said sheet after step a) and before step b).
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128. A stent having a longitudinal lumen comprising:
a first long side and a second long side, said first long side provided with a plurality of pairs of engagement points, said second long side provided with a plurality of pairs of engagement points, said plurality of pairs of first long side engagement points and said plurality of pairs of second long side engagement points disposed substantially opposite each other and connected to each other via a weld, said weld wider than the other portions of said stent. - View Dependent Claims (129, 130, 131, 132, 133, 134, 135, 136, 137)
Specification