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US5837008A Expired / Lapsed US ⏱️ 0.0 years remaining

Intravascular stent and method

Assignee: Medtronic Inc
•
Filing: 1995-04-27
•
Granted: 1998-11-17
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Expires: 2015-04-27
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Abstract

Abstract A method for making an intravascular stent by applying to the body of a stent a solution which includes a solvent, a polymer dissolved in the solvent and a therapeutic substance dispersed in the solvent and then evaporating the solvent. The inclusion of a polymer in intimate contact with a drug on the stent allows the drug to be retained on the stent during expansion of the stent and also controls the administration of drug following implantation. The adhesion of the coating and the rate at which the drug is delivered can be controlled by the selection of an appropriate bioabsorbable or biostable polymer and the ratio of drug to polymer in the solution. By this method, drugs such as dexamethasone can be applied to a stent, retained on a stent during expansion of the stent and elute at a controlled rate.

Inventors

  • 👤 Eric P. Berg
  • 👤 Ronald J. Tuch
  • 👤 Michael Dror
  • 👤 Rodney G. Wolff

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 14:06
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/82; A61L; A61L31/00; A61L31/08; A61L31/10; A61L31/14; A61L31/146; A61L31/16; A61F2/95; A61F2/958; A61F2210/00; A61F2210/0004; A61F2240/00; A61F2240/001; A61F2250/00; A61F2250/0058; A61F2250/0067; A61L2300/00; A61L2300/20; A61L2300/22; A61L2300/222; A61L2300/40; A61L2300/416; A61L2300/42; A61L2300/60; A61L2300/602; A61L2300/606; A61L2300/608

Claims Analysis

Total Claims: 39
Claim 1
Independent Claim 155 words
A method for delivery of a therapeutic substance to the interior of a body lumen comprising the steps of: (a) providing a generally cylindrical, radially expandable stent body having a surface; (b) applying to the surface a solution which includes a solvent, a polymer dissolved in the solvent and a therapeutic substance dispersed in the solvent; (c) evaporating the solvent to provide a coat of therapeutic substance and polymer on the surface; (d) repeating steps (b) and (c) until a plurality of coats of therapeutic substance and polymer are on the surface; (e) introducing the stent body and the plurality of coats of therapeutic substance and polymer transluminally into a selected portion of the body lumen; and (f) radially expanding the stent body and the plurality of coats of therapeutic substance and polymer into contact with the body lumen such that the plurality of coats of therapeutic substance and polymer are retained on the surface.
Claim 2
Independent Claim 155 words
A method for delivery of a therapeutic substance to the interior of a body lumen comprising the steps of: (a) providing a generally cylindrical, radially expandable stent body having a surface; (b) applying to the surface a solution which includes a solvent, a polymer dissolved in the solvent and a therapeutic substance dispersed in the solvent; (c) evaporating the solvent to provide a coat of therapeutic substance and polymer on the surface; (d) repeating steps (b) and (c) until a plurality of coats of therapeutic substance and polymer are on the surface; (e) introducing the stent body and the plurality of coats of therapeutic substance and polymer transluminally into a selected portion of the body lumen; and (f) radially expanding the stent body and the plurality of coats of therapeutic substance and polymer into contact with the body lumen such that the plurality of coats of therapeutic substance and polymer are retained on the surface.
Claim 3
Dependent Claim 13 words
A method according to claim 1 wherein the surface is a polymeric surface.
Claim 4
Dependent Claim 13 words
A method according to claim 1 wherein the solution is applied by spraying.
Claim 5
Dependent Claim 13 words
A method according to claim 1 wherein the solution is applied by immersion.
Claim 6
Dependent Claim 13 words
A method according to claim 1 wherein the polymer is a bioabsorbable polymer.
Claim 7
Dependent Claim 21 words
A method according to claim 5 wherein the polymer is selected from the group consisting of poly(L-lactic acid), poly(lactide-co-glycolide) and poly(hydroxybutyrate-co-valerate).
Claim 8
Dependent Claim 13 words
A method according to claim 1 wherein the polymer is a biostable polymer.
Claim 9
Dependent Claim 30 words
A method according to claim 7 wherein the polymer is selected from the group consisting of silicones, polyurethanes, polyesters, vinyl homopolymers and copolymers, acrylate homopolymers and copolymers, polyethers and cellulosics.
Claim 10
Dependent Claim 27 words
A method according to claim 1 wherein the ratio of therapeutic substance to dissolved polymer in the solution is in the range of about 10:1 to 1:100.
Claim 11
Dependent Claim 33 words
A method according to claim 1 wherein the therapeutic substance is selected from the group consisting of glucocorticoids, dexamethasone, dexamethasone sodium phosphate, anticoagulants, heparin, hirudin, tick anticoagulant peptide, angiopeptin, antimitotic agents, and oligonucleotides.
Claim 12
Independent Claim 160 words
A method for delivery of a therapeutic substance to the interior of a body lumen comprising the steps of: (a) providing a generally cylindrical, radially expandable stent body having a metal surface; (b) applying to the metal surface a solution which includes a solvent, a polymer dissolved in the solvent and a therapeutic substance dispersed in the solvent; (c) evaporating the solvent to provide a coat of therapeutic substance and polymer on the metal surface; (d) repeating steps (b) and (c) until a plurality of coats of therapeutic substance and polymer are on the metal surface; (e) introducing the stent body and the plurality of coats of therapeutic substance and polymer transluminally into a selected portion of the body lumen; and (f) radially expanding the stent body and the plurality of coats of therapeutic substance and polymer into contact with the body lumen such that the plurality of coats of therapeutic substance and polymer are retained on the metal surface.
Claim 13
Independent Claim 160 words
A method for delivery of a therapeutic substance to the interior of a body lumen comprising the steps of: (a) providing a generally cylindrical, radially expandable stent body having a metal surface; (b) applying to the metal surface a solution which includes a solvent, a polymer dissolved in the solvent and a therapeutic substance dispersed in the solvent; (c) evaporating the solvent to provide a coat of therapeutic substance and polymer on the metal surface; (d) repeating steps (b) and (c) until a plurality of coats of therapeutic substance and polymer are on the metal surface; (e) introducing the stent body and the plurality of coats of therapeutic substance and polymer transluminally into a selected portion of the body lumen; and (f) radially expanding the stent body and the plurality of coats of therapeutic substance and polymer into contact with the body lumen such that the plurality of coats of therapeutic substance and polymer are retained on the metal surface.
Claim 14
Dependent Claim 16 words
A method according to claim 11 wherein the metal surface is a low memory metal surface.
Claim 15
Dependent Claim 15 words
A method according to claim 11 wherein the metal surface is a stainless steel surface.
Claim 16
Dependent Claim 14 words
A method according to claim 11 wherein the metal surface is a tantalum surface.
Claim 17
Dependent Claim 15 words
A method according to claim 11 wherein the metal surface is a metal wire surface.
Claim 18
Dependent Claim 33 words
A method according to claim 11 wherein the metal surface comprises a plurality of reversing bends which permits the stent body to be expanded from a first diameter to a second, expanded diameter.
Claim 19
Dependent Claim 19 words
A method according to claim 11 wherein the metal surface is on an interior portion of the stent body.
Claim 20
Dependent Claim 19 words
A method according to claim 11 wherein the metal surface is on an exterior portion of the stent body.
Claim 21
Dependent Claim 13 words
A method according to claim 11 wherein the solution is applied by spraying.
Claim 22
Dependent Claim 13 words
A method according to claim 11 wherein the solution is applied by immersion.
Claim 23
Dependent Claim 13 words
A method according to claim 11 wherein the polymer is a bioabsorbable polymer.
Claim 24
Dependent Claim 21 words
A method according to claim 21 wherein the polymer is selected from the group consisting of poly(L-lactic acid), poly(lactide-co-glycolide) and poly(hydroxybutyrate-co-valerate).
Claim 25
Dependent Claim 13 words
A method according to claim 11 wherein the polymer is a biostable polymer.
Claim 26
Dependent Claim 30 words
A method according to claim 23 wherein the polymer is selected from the group consisting of silicones, polyurethanes, polyesters, vinyl homopolymers and copolymers, acrylate homopolymers and copolymers, polyethers and cellulosics.
Claim 27
Dependent Claim 27 words
A method according to claim 11 wherein the ratio of therapeutic substance to dissolved polymer in the solution is in the range of about 10:1 to 1:100.
Claim 28
Dependent Claim 33 words
A method according to claim 11 wherein the therapeutic substance is selected from the group consisting of glucocorticoids, dexamethasone, dexamethasone sodium phosphate, anticoagulants, heparin, hirudin, tick anticoagulant peptide, angiopeptin, antimitotic agents, and oligonucleotides.
Claim 29
Independent Claim 173 words
A method for delivery of a therapeutic substance to the interior of a body lumen comprising the steps of: (a) providing a generally cylindrical, radially expandable stent body having a surface; (b) applying to the surface a solution which includes a solvent, a polymer dissolved in the solvent and a therapeutic substance dispersed in the solvent; (c) evaporating the solvent to provide a coat of therapeutic substance and polymer on the surface; (d) repeating steps (b) and (c) until a plurality of coats of therapeutic substance and polymer are on the surface such that the ratio of therapeutic substance to dissolved polymer is varied in the plurality of coats; (e) introducing the stent body and the plurality of coats of therapeutic substance and polymer transluminally into a selected portion of the body lumen; and (f) radially expanding the stent body and the plurality of coats of therapeutic substance and polymer into contact with the body lumen such that the plurality of coats of therapeutic substance and polymer are retained on the metal surface.
Claim 30
Independent Claim 173 words
A method for delivery of a therapeutic substance to the interior of a body lumen comprising the steps of: (a) providing a generally cylindrical, radially expandable stent body having a surface; (b) applying to the surface a solution which includes a solvent, a polymer dissolved in the solvent and a therapeutic substance dispersed in the solvent; (c) evaporating the solvent to provide a coat of therapeutic substance and polymer on the surface; (d) repeating steps (b) and (c) until a plurality of coats of therapeutic substance and polymer are on the surface such that the ratio of therapeutic substance to dissolved polymer is varied in the plurality of coats; (e) introducing the stent body and the plurality of coats of therapeutic substance and polymer transluminally into a selected portion of the body lumen; and (f) radially expanding the stent body and the plurality of coats of therapeutic substance and polymer into contact with the body lumen such that the plurality of coats of therapeutic substance and polymer are retained on the metal surface.
Claim 31
Dependent Claim 26 words
A method according to claim 27 wherein the ratio of therapeutic substance to dissolved polymer is higher in an outer coat than in an inner coat.
Claim 32
Dependent Claim 13 words
A method according to claim 27 wherein the solution is applied by spraying.
Claim 33
Dependent Claim 13 words
A method according to claim 27 wherein the solution is applied by immersion.
Claim 34
Dependent Claim 13 words
A method according to claim 27 wherein the polymer is a bioabsorbable polymer.
Claim 35
Dependent Claim 21 words
A method according to claim 31 wherein the polymer is selected from the group consisting of poly(L-lactic acid), poly(lactide-co-glycolide) and poly(hydroxybutyrate-co-valerate).
Claim 36
Dependent Claim 13 words
A method according to claim 27 wherein the polymer is a biostable polymer.
Claim 37
Dependent Claim 30 words
A method according to claim 33 wherein the polymer is selected from the group consisting of silicones, polyurethanes, polyesters, vinyl homopolymers and copolymers, acrylate homopolymers and copolymers polyethers and cellulosics.
Claim 38
Dependent Claim 27 words
A method according to claim 27 wherein the ratio of therapeutic substance to dissolved polymer in the solution is in the range of about 10:1 to 1:100.
Claim 39
Dependent Claim 33 words
A method according to claim 27 wherein the therapeutic substance is selected from the group consisting of glucocorticoids, dexamethasone, dexamethasone sodium phosphate, anticoagulants, heparin, hirudin, tick anticoagulant peptide, angiopeptin, antimitotic agents, and oligonucleotides.

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3.5 Years (Year 4) 2001-11-16 2002-05-18 2002-11-17 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2005-11-16 2006-05-18 2006-11-17 $3760.00 Window Closed / Lapsed
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