US6500203B1
Expired / Lapsed
US
⏱️ 0.0 years remaining
Process for making stent graft with braided polymeric sleeve
Assignee: Boston Scientific Scimed Inc
•
Filing: 1999-05-27
•
Granted: 2002-12-31
•
Expires: 2019-05-27
Abstract
Abstract A stent graft for transluminal implantation includes a resilient tubular interbraided latticework of metal or polymeric monofilaments, a tubular interbraided sleeve of polymeric multifilament yarns, and an adhesive layer between the sleeve and latticework for bonding them together. The monofilaments and multifilament yarns are arranged in respective sets of axially spaced apart and oppositely directed helices, concentric on a common axis of the stent graft. The respective braid angles of the monofilaments and multifilament yarns are carefully matched to ensure that the latticework and sleeve behave according to substantially the same relationship governing the amount of radial reduction that accompanies a given axial elongation. According to a process for fabricating the stent graft, the latticework and sleeve are braided and thermally set independently, then bonded to one another by a silicone polymer adhesive applied evenly to the latticework in a liquid spray that also incorporates an organic solvent. Especially preferred yarns are composed of essentially untwisted filaments that define non-circular yarn cross sections. Alternative stent graft constructions feature exterior and interior sleeves on opposite sides of the latticework, two or more sleeves axially spaced from one another on the same latticework, a latticework formed of a recovery metal, and a plastically deformable latticework.
Inventors
- 👤 Paul J. Thompson
- 👤 George W. Du
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-01 20:34
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/82; A61F2/86; A61F2/90; A61F2/02; A61F2/04; A61F2/06; A61F2/07; B; B29; B29D; B29D23/00; B29D23/001; D; D04; D04C; D04C1/00; D04C1/06; A61F2/0077; A61F2002/072; A61F2002/075; A61F2/30; A61F2002/30001; A61F2002/30003; A61F2002/3006; A61F2002/3008; A61F2002/30316; A61F2002/30329; A61F2002/30448; A61F2210/00; A61F2210/0076; A61F2220/00; A61F2220/0025; A61F2220/005; A61F2220/0075; A61F2240/00; A61F2240/001; A61F2250/00; A61F2250/0058; A61F2250/0096; A61F2250/0098; B29C; B29C35/00; B29C35/02; B29C53/00; B29C53/56; B29C53/58; B29C63/00; B29C63/18; B29K; B29K2105/00; B29K2105/06; B29K2105/08; B29K2105/0809; B29K2105/0827; B29K2105/0845; B29K2223/00; B29K2223/04; B29K2223/06; B29K2223/0608; B29K2223/065; B29K2223/10; B29K2223/12; B29K2227/00; B29K2227/12; B29K2227/18; B29K2267/00; B29K2271/00; B29K2275/00; B29K2281/00; B29K2281/06; B29L; B29L2023/00; B29L2023/005; B29L2023/007; D10; D10B; D10B2509/00; D10B2509/06
Claims Analysis
Total Claims: 50
Claim 1
Independent Claim
211 words
A process for making a medical device, including: braiding a plurality of structural strands into a tubular open latticework in which the strands form multiple first intersections and define a first braid angle when in a nominal state, wherein the structural strands along the length of the tubular open latticework are free of bonding to one another at the first intersections, said tubular open latticework being adjustable between the nominal state and a radially-reduced axially-elongated state according to a first relationship of radial reduction versus axial elongation; braiding a plurality of compliant textile strands into a tubular sleeve in which the textile strands form multiple second intersections and define a second braid angle substantially the same as said first braid angle when in a nominal state, wherein the textile strands along the length of the tubular sleeve are free of bonding to one another at the second intersections, said tubular sleeve being adjustable between the nominal state and a radially-reduced axially-elongated state according to a second relationship of radial reduction versus axial elongation substantially equivalent to said first relationship; and attaching a selected one of the latticework and sleeve within and in an axial alignment with the other of said latticework and sleeve so that said other surrounds the selected one.
Claim 2
Dependent Claim
211 words
A process for making a medical device, including: braiding a plurality of structural strands into a tubular open latticework in which the strands form multiple first intersections and define a first braid angle when in a nominal state, wherein the structural strands along the length of the tubular open latticework are free of bonding to one another at the first intersections, said tubular open latticework being adjustable between the nominal state and a radially-reduced axially-elongated state according to a first relationship of radial reduction versus axial elongation; braiding a plurality of compliant textile strands into a tubular sleeve in which the textile strands form multiple second intersections and define a second braid angle substantially the same as said first braid angle when in a nominal state, wherein the textile strands along the length of the tubular sleeve are free of bonding to one another at the second intersections, said tubular sleeve being adjustable between the nominal state and a radially-reduced axially-elongated state according to a second relationship of radial reduction versus axial elongation substantially equivalent to said first relationship; and attaching a selected one of the latticework and sleeve within and in an axial alignment with the other of said latticework and sleeve so that said other surrounds the selected one.
Claim 3
Dependent Claim
40 words
The process of claim 1 wherein: said forming of structural strands includes arranging the structural strands as first and second sets of helices wound in opposite directions about a common longitudinal axis, thereby forming rhombic interstices between adjacent structural strands.
Claim 4
Dependent Claim
40 words
The process of claim 2 wherein: said forming of textile strands includes arranging the textile strands as third and fourth sets of helices wound in opposite directions at the second braid angle when the sleeve is in its nominal state.
Claim 5
Dependent Claim
34 words
The process of claim 3 wherein said second braid angle is between 100.91 and 105.45 percent of said first braid angle and the sleeve is attached about and in axial alignment with the latticework.
Claim 6
Dependent Claim
34 words
The process of claim 3 wherein said second braid angle is between 97.72 and 102.27 percent of said first braid angle and the sleeve is attached within and in axial alignment with the latticework.
Claim 7
Dependent Claim
116 words
The process of claim 2 wherein: said structural material is thermally formable, and said forming of structural strands further includes winding the structural strands around a selectively sized first mandrel, then heating the strands while so wound to a heat forming temperature sufficient to thermally impart a nominal size and shape for the latticework when in its nominal state; and wherein said textile strands are thermally formable, and said forming of textile strands further includes winding the textile strands around a selectively sized second mandrel, then heating the textile strands while so wound to a second heat forming temperature sufficient to thermally impart a nominal size and shape to the sleeve when in the nominal state.
Claim 8
Dependent Claim
30 words
The process of claim 6 wherein: said selected one of the latticework and sleeve is the latticework, and said disposing includes positioning the latticework within and surrounded by the sleeve.
Claim 9
Dependent Claim
19 words
The process of claim 7 wherein: said first mandrel has a diameter less than that of said second mandrel.
Claim 10
Dependent Claim
71 words
The process of claim 2 wherein: said forming of structural strands further includes heat setting the structural strands when they are wound about a first mandrel at a first braid angle to determine a nominal latticework size and shape, said forming of textile strands includes thermally setting the textile strands when they are wound about a second mandrel at a second braid angle to determine a nominal sleeve size and shape.
Claim 11
Dependent Claim
33 words
The process of claim 9 wherein: the second mandrel has a diameter greater than that of the first mandrel, and said first and second braid angles are within one degree of one another.
Claim 12
Dependent Claim
28 words
The process of claim 9 wherein: said first and second mandrels have substantially the same diameters, and the first braid angle is larger than the second braid angle.
Claim 13
Dependent Claim
68 words
The process of claim 1 further including: prior to said disposing, applying an adhesive to at least one of the latticework and the sleeve over at least a portion of its axial length, wherein said forming an attachment includes maintaining the latticework and the sleeve in said engagement for a time sufficient for the adhesive to bond the latticework and the sleeve to form the composite stent graft.
Claim 14
Dependent Claim
50 words
The process of claim 12 wherein: said applying includes dissolving the adhesive in a liquid solvent, spraying the combined solvent and adhesive onto the at least one of the latticework and sleeve, and then evaporating the solvent whereby said coating is formed of a residue consisting essentially of the adhesive.
Claim 15
Dependent Claim
37 words
The process of claim 13 wherein: said applying further includes providing the adhesive in the form of a siloxane polymer and dissolving the siloxane polymer in an organic solvent at about 6 percent siloxane polymer by weight.
Claim 16
Dependent Claim
37 words
The process of claim 13 wherein: said adhesive is heat curable, and said forming an attachment includes maintaining the composite stent graft at a temperature of about 125-200 degrees C. for about 20 minutes to one hour.
Claim 17
Dependent Claim
39 words
The process of claim 12 wherein: said adhesive is curable, and applied uncured to said at least one of the latticework and sleeve; and said forming of the attachment includes curing said adhesive to bond the latticework and sleeve.
Claim 18
Dependent Claim
23 words
The process of claim 16 wherein: said applying includes electrostatically depositing an adhesive onto the at least one of said latticework and sleeve.
Claim 19
Dependent Claim
28 words
The process of claim 16 further including: after said curing, plastically deforming the latticework to reduce the radii of the latticework and the sleeve to their respective states.
Claim 20
Dependent Claim
57 words
The process of claim 1 wherein: said disposing includes adjusting the selected one of the latticework and sleeve to reduce its radius below that in its nominal state, axially aligning the selected one with the other while the other remains in its nominal state, and then radially expanding the selected one toward said engagement with the other.
Claim 21
Dependent Claim
12 words
A stent graft formed according to the process of claim 1 .
Claim 22
Dependent Claim
44 words
The process of claim 1 wherein: the forming of the compliant textile strands into a tubular sleeve comprises imparting to the sleeve in the nominal state a diameter substantially the same as a corresponding diameter of the tubular open latticework in the nominal state.
Claim 23
Dependent Claim
196 words
A process for making a medical device, including: providing a tubular stent comprised of a plurality of structural strands and adjustable between a nominal state and a radially-reduced axially-elongated state according to a first relationship of radial reduction vs. axial elongation; winding a plurality of complaint and thermally formable textile strands, to form a tubular sleeve having substantially the same size and shape as the stent in its nominal statem and heating the sleeve to a heat forming temperature sufficient to thermally impart said size and shape to the sleeveas the nominal size and shape of the sleeve when in a nominal state, wherein the sleeve is adjustable between said nominal state and a radially-reduced axially-elongated state according to a second relationship of radial reduction vs. axial elongation substantially equivalent to said first relationship, and provides a graft; disposing a selected one of the stent and the sleeve within and in an axial alignment with the other of the stent and sleeve, so that said other surrounds the selected one, then bringing the stent and sleeve into an engagement; and while maintaining the stent and sleeve in said engagement, binding the latticework and the sleeve together.
Claim 24
Dependent Claim
196 words
A process for making a medical device, including: providing a tubular stent comprised of a plurality of structural strands and adjustable between a nominal state and a radially-reduced axially-elongated state according to a first relationship of radial reduction vs. axial elongation; winding a plurality of complaint and thermally formable textile strands, to form a tubular sleeve having substantially the same size and shape as the stent in its nominal statem and heating the sleeve to a heat forming temperature sufficient to thermally impart said size and shape to the sleeveas the nominal size and shape of the sleeve when in a nominal state, wherein the sleeve is adjustable between said nominal state and a radially-reduced axially-elongated state according to a second relationship of radial reduction vs. axial elongation substantially equivalent to said first relationship, and provides a graft; disposing a selected one of the stent and the sleeve within and in an axial alignment with the other of the stent and sleeve, so that said other surrounds the selected one, then bringing the stent and sleeve into an engagement; and while maintaining the stent and sleeve in said engagement, binding the latticework and the sleeve together.
Claim 25
Dependent Claim
57 words
The process of claim 22 further including: applying an adhesive to at least one of the stent and the sleeve over at least a portion of its axial length; and wherein said binding includes maintaining the sleeve and the stent in said engagement for a time sufficient for the adhesive to bond the sleeve and the stent.
Claim 26
Dependent Claim
38 words
The process of claim 23 wherein: said adhesive is a curable adhesive, and is applied uncured to the at least one of said stent and sleeve; and said binding of the stent and sleeve includes curing the adhesive.
Claim 27
Dependent Claim
64 words
The process of claim 22 wherein: said disposing includes adjusting said selected one of the stent and sleeve to reduce its radius below that in its nominal state, axially aligning the selected one while radially reduced with the other of said stent and sleeve while said other remains in its nominal state, then radially expanding said selected one toward said engagement with the other.
Claim 28
Dependent Claim
17 words
The process of claim 22 wherein: said disposing places the stent within and surrounded by the sleeve.
Claim 29
Dependent Claim
59 words
The process of claim 22 wherein: said structural strands are thermally formable, and said providing a tubular stent comprises winding the structural strands around a selectively sized first mandrel, then heating the strands while so wound to a first heat forming temperature sufficient to thermally impart a nominal size and shape for the stent when in its nominal state.
Claim 30
Dependent Claim
24 words
The process of claim 27 wherein: said winding a plurality of textile strands comprises winding the textile strands around a selectively sized second mandrel.
Claim 31
Dependent Claim
40 words
The process of claim 22 wherein: said providing a tubular stent comprises arranging the structural strands as first and second sets of helices wound in opposite directions about a common longitudinal axis, thereby forming rhombic interstices between adjacent structural strands.
Claim 32
Dependent Claim
40 words
The process of claim 29 wherein: said arranging of the structural strands further includes heat setting the structural strands when they are wound about a first mandrel at a first braid angle to determine a nominal stent size and shape.
Claim 33
Dependent Claim
75 words
The process of claim 30 wherein: said winding a plurality of textile strands comprises arranging the textile strands as third and fourth sets of helices wound in opposite directions at a second braid angle when the sleeve is in its nominal state; and said heating the tubular sleeve includes thermally setting the textile strands when they are wound about a second mandrel at a second braid angle to determine the nominal sleeve size and shape.
Claim 34
Dependent Claim
33 words
The process of claim 31 wherein: the second mandrel has a diameter greater than that of the first mandrel, and the first and second braid angles are within one degree of one another.
Claim 35
Dependent Claim
28 words
The process of claim 31 wherein: said first and second mandrels have substantially the same diameters, and the first braid angle is larger than the second braid angle.
Claim 36
Dependent Claim
12 words
A stent graft formed according to the process of claim 22 .
Claim 37
Dependent Claim
24 words
The process of claim 22 wherein: said winding a plurality of textile strands further includes winding the textile strands around a selectively sized mandrel.
Claim 38
Dependent Claim
211 words
A process for making a medical device, including: braiding a tubular stent of open construction including a plurality of structural strands forming multiple first intersections and defining a first braid angle with the tubular stent in a nominal state, wherein the structural strands along the length of the tubular stent are free of bonding to one another at the first intersections, the tubular stent being adjustable between the nominal state and a radially-reduced axially-elongated state according to a first relationship of radial reduction versus axial elongation; braiding a compliant tubular sleeve including a plurality of compliant textile strands forming multiple second intersections and defining a second braid angle substantially the same as said first braid angle with the tubular sleeve in a nominal state, wherein the textile strands along the length of the tubular sleeve are free of bonding to one another at the second intersections, the tubular sleeve being adjustable between said nominal state and a radially-reduced axially elongated state according to a second relationship of radial reduction versus axial elongation substantially equivalent to said first relationship; and attaching a selected one of the stent and the sleeve within and in an axial alignment with the other of said stent and sleeve so that said other surrounds the selected one.
Claim 39
Dependent Claim
211 words
A process for making a medical device, including: braiding a tubular stent of open construction including a plurality of structural strands forming multiple first intersections and defining a first braid angle with the tubular stent in a nominal state, wherein the structural strands along the length of the tubular stent are free of bonding to one another at the first intersections, the tubular stent being adjustable between the nominal state and a radially-reduced axially-elongated state according to a first relationship of radial reduction versus axial elongation; braiding a compliant tubular sleeve including a plurality of compliant textile strands forming multiple second intersections and defining a second braid angle substantially the same as said first braid angle with the tubular sleeve in a nominal state, wherein the textile strands along the length of the tubular sleeve are free of bonding to one another at the second intersections, the tubular sleeve being adjustable between said nominal state and a radially-reduced axially elongated state according to a second relationship of radial reduction versus axial elongation substantially equivalent to said first relationship; and attaching a selected one of the stent and the sleeve within and in an axial alignment with the other of said stent and sleeve so that said other surrounds the selected one.
Claim 40
Dependent Claim
61 words
The process of claim 36 further including: prior to said attaching, applying an adhesive to at least one of the stent and the sleeve over at least a portion of its axial length, wherein said attaching includes maintaining the stent and the sleeve engaged with one another for a time sufficient for the adhesive to bond the stent and the sleeve.
Claim 41
Dependent Claim
30 words
The process of claim 36 wherein: the selected one of the stent and sleeve is the stent, and said attaching includes positioning the stent within and surrounded by the sleeve.
Claim 42
Dependent Claim
63 words
The process of claim 36 wherein: said forming of a tubular stent comprises arranging the structural strands as first and second sets of helices wound in opposite directions to form rhombic interstices between adjacent structural strands; and said forming the tubular sleeve comprises arranging the textile strands as third and fourth sets of helices wound in opposite directions about a common longitudinal axis.
Claim 43
Dependent Claim
70 words
The process of claim 36 wherein: said forming the stent includes heat setting the structural strands when they are wound about a first mandrel at the first braid angle to determine the nominal stent size and shape, and said forming the tubular sleeve includes thermally setting the textile strands when they are wound about a second mandrel at the second braid angle to determine the nominal sleeve size and shape.
Claim 44
Dependent Claim
42 words
The process of claim 36 wherein: said forming a compliant tubular sleeve comprises imparting to the sleeve in the nominal state a diameter and shape substantially the same as a corresponding diameter and shape of the tubular stent in the nominal state.
Claim 45
Dependent Claim
188 words
A process for making a medical device, including: providing a tubular stent adjustable between a nominal state and a radially-reduced axially-elongated state according to a first relationship of radial reduction versus axial elongation; forming a compliant tubular sleeve of a thermally formable material having substantially the same shape and diameter as the stent in its nominal state, heating the tubular sleeve while it is maintained in said shape and diameter to a heat forming temperature sufficient to thermally impart said shape and diameter to the sleeve when the sleeve is in a nominal state, wherein the sleeve is adjustable between said nominal state and a radially-reduced axially-elongated state according to a second relationship of radial reduction versus axial elongation substantially equivalent to said first relationship, and provides a graft; disposing a selected one of the stent and the compliant sleeve within and in an axial alignment with the other of the stent and sleeve, so that said other surrounds the selected one, then bringing the stent and sleeve into an engagement; and while maintaining the stent and compliant sleeve in said engagement, binding the stent and sleeve together.
Claim 46
Dependent Claim
188 words
A process for making a medical device, including: providing a tubular stent adjustable between a nominal state and a radially-reduced axially-elongated state according to a first relationship of radial reduction versus axial elongation; forming a compliant tubular sleeve of a thermally formable material having substantially the same shape and diameter as the stent in its nominal state, heating the tubular sleeve while it is maintained in said shape and diameter to a heat forming temperature sufficient to thermally impart said shape and diameter to the sleeve when the sleeve is in a nominal state, wherein the sleeve is adjustable between said nominal state and a radially-reduced axially-elongated state according to a second relationship of radial reduction versus axial elongation substantially equivalent to said first relationship, and provides a graft; disposing a selected one of the stent and the compliant sleeve within and in an axial alignment with the other of the stent and sleeve, so that said other surrounds the selected one, then bringing the stent and sleeve into an engagement; and while maintaining the stent and compliant sleeve in said engagement, binding the stent and sleeve together.
Claim 47
Dependent Claim
57 words
The process of claim 42 further including: applying an adhesive to at least one of the stent and the sleeve over at least a portion of its axial length; and wherein said binding includes maintaining the sleeve and the stent in said engagement for a time sufficient for the adhesive to bond the sleeve and the stent.
Claim 48
Dependent Claim
17 words
The process of claim 42 wherein: said disposing places the stent within and surrounded by the sleeve.
Claim 49
Dependent Claim
65 words
The process of claim 42 wherein: said providing a tubular stent comprises arranging a plurality of structural strands into first and second sets of helices wound in opposite directions about a common longitudinal stent axis, and said forming a tubular sleeve comprises arranging a plurality of textile strands into third and fourth sets of helices wound in opposite directions about a common longitudinal sleeve axis.
Claim 50
Dependent Claim
78 words
The process of claim 45 wherein: said structural strands are thermally formable, and said providing a tubular stent further comprises winding the structural strands around a selectively sized first mandrel, then heating the strands while so wound to a first heat forming temperature sufficient to thermally impart a nominal size and shape for the stent when in its nominal state; and said forming a compliant tubular sleeve comprises winding the textile strands around a selectively sized second mandrel.
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