Intravascular stent and method

• US 5,679,400 A
• Filed: 06/07/1995
• Issued: 10/21/1997
• Est. Priority Date: 04/26/1993
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Tuch, Ronald J.
• Primary Examiner(s): DUDASH, DIANA L
• Application Number:
  US08/482,346
• Time in Patent Office: 867 Days
• Field of Search: 427/2.24, 427/2.25, 427/2.28, 427/2.21, 427/352, 427/353, 427/2.14
• US Class Current: 427/2.14
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/222 Steroids, e.g. corticosteroids
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

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.

Claims

1. A method for providing a therapeutic substance into a body lumen comprising the steps of:

(a) providing a cylindrical, radially expandable stent body;

(b) applying to the stent body a solution which includes a solvent, a polymer dissolved in the solvent and a therapeutic substance dispersed in the solvent;

(c) evaporating the solvent;

(d) repeating application and evaporating steps (b) and (c) to provide an amount of polymer and a specified dose of therapeutic substance on the stent body;

(e) applying to the polymer and therapeutic substance on the stent body an overlayer of the polymer by the steps of;

(1) applying to the stent body a solution which includes the solvent and the polymer dissolved in the solvent while maintaining the specified dose of therapeutic substance applied in steps (a) to (d) on the stent;

(2) evaporating the solvent; and

(3) repeating application and evaporating steps (1) and (2) to provide a thickness of polymer on the stent body; and

(f) radially expanding the stent body, applied polymer and therapeutic substance such that the polymer and therapeutic substance are retained on the stent body.

2. A method according to claim 1 wherein the overlayer is applied by spraying.

3. A method according to claim 1 wherein the overlayer is applied by immersion.

4. A method according to claim 1 wherein the polymer is a bioabsorbable polymer.

5. A method according to claim 4 wherein the polymer is selected from the group consisting of poly(lactic acid), poly(lactide-co-glycolide) and poly(hydroxybutyrate-co-valerate).

6. A method according to claim 1 wherein the polymer is a biostable polymer.

7. A method according to claim 6 wherein the polymer is selected from the group consisting of silicones, polyurethanes, polyesters, vinyl homopolymers and copolymers, acrylate homopolymers and copolymers, polyethers and cellulosics.

8. A method according to claim 1 wherein the solution for applying the overlayer further includes a second solvent in which the polymer has a lesser solubility.

9. A method according to claim 1 wherein the drug is selected from the group consisting of glucocorticoids, dexamethasone, dexamethasone sodium phosphate, anticoagulants, heparin, hirudin, tick anticoagulant peptide, angiopeptin, antimitotic agents, and oligonucleotides.

10. A method for making an intravascular stent comprising the steps of:

(a) providing a cylindrical, radially expandable stent body;

(b) applying to the stent body a solution which includes a solvent, a polymer dissolved in the solvent and a therapeutic substance dispersed in the solvent;

(c) evaporating the solvent;

(d) repeating application and evaporating steps (b) and (c) to provide an amount of polymer and therapeutic substance on the stent body;

(e) eluting a known portion of the therapeutic substance from the polymer in an aqueous solution until a specified dose of the therapeutic substance is present on the stent; and

(f) radially expanding the stent body, applied polymer and therapeutic substance after elution such that the polymer and therapeutic substance are retained on the stent body.

11. A method according to claim 10 wherein the polymer is selected from the group consisting of poly(L-lactic acid), poly(lactide-co-glycolide), fibrin, silicone, polyurethane, and poly(phosphoester urethane).