Methods for making implantable medical devices

• US 8,945,206 B2
• Filed: 06/23/2009
• Issued: 02/03/2015
• Est. Priority Date: 06/07/1995
• Status: Expired due to Fees

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Bates, Brian L., Ragheb, Anthony O., Fearnot, Neal E., Kozma, Thomas G., Voorhees, William D. III
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US12/490,162
• Publication Number:
  US 20090285975A1
• Time in Patent Office: 2,051 Days
• Field of Search: 427/2.25, 623/1.42
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2/885 comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61K 51/1282 Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents
• CPC Class Codes: A61L 2300/256 Antibodies, e.g. immunoglobulins, vaccines
• 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 2300/602 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 27/306 Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/106 Inorganic materials other than carbon
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/088 Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 33/022 : Metal or alloys
• CPC Class Codes: A61N 5/1002 : Intraluminal radiation therapy
• CPC Class Codes: C08L 65/04 : Polyxylenes

Abstract

A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16, wherein the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 can be posited over the bioactive material layer 18, wherein the porous layer includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, and merely by condensation of a monomer vapor.

Claims

1. A method for preparing a medical device, comprising:

providing a vascular stent comprised of metal and having a plurality of discrete wells located in the metal and a surface between said wells, with each well of the plurality of discrete wells having a perimeter defined by sidewalls extending downwardly from said surface to a bottom wall extending transversely to and terminating at the sidewalls and providing a closed bottom to the well; and

depositing a material comprising at least one therapeutic agent into wells of said plurality of wells.

2. The method of claim 1, also comprising:

laser drilling said wells into said stent.

3. The method of claim 1, wherein the at least one therapeutic agent comprises an immunosuppressive agent.

4. The method of claim 1, wherein the at least one therapeutic agent comprises an antiproliferative agent.

5. The method of claim 1, also comprising depositing a porous polymeric layer over said material.

6. The method of claim 5, wherein the porous polymeric layer comprises a bioabsorbable polymer.

7. The method of claim 5, wherein the porous polymeric layer comprises a bioabsorbable polymer selected from the group consisting of poly(L-lactic acid), polycaprolactone, poly(lactide-co-glycolide), poly(hydroxybutyrate), poly (hydroxybutyrate-co-valerate), polydioxanone, polyorthoester, polyanhydride, poly(glycolic acid), poly(D,L-lactic acid), poly(glycolic acid-co-trimethylene carbonate), polyphosphoester, polyphosphoester urethane, poly(amino acids), cyanoacrylates, poly(trimethylene carbonate), poly(iminocarbonate), copoly(ether-esters), polyalkylene oxalates, and polyphosphazenes.

8. The method of claim 7, wherein the bioabsorbable polymer is poly(L-lactic acid) or poly(D,L-lactic acid).

9. The method of claim 7, wherein the bioabsorbable polymer is poly(lactide-co-glycolide).

10. A method for preparing a medical device, comprising:

providing a vascular stent comprised of a plurality of arms comprised of metal with said arms converging and meeting at a plurality of bends and having a plurality of discrete wells in the metal of said arms, with each well of the plurality of discrete wells having a perimeter defined by sidewalls extending downwardly from a surface of the stent to a bottom wall extending transversely to and terminating at the sidewalls and providing a closed bottom to the well; and

depositing a material comprising at least one therapeutic agent into wells of said plurality of wells.

11. The method of claim 10, wherein the at least one therapeutic agent comprises an immunosuppressive agent.

12. The method of claim 10, wherein the at least one therapeutic agent comprises an antiproliferative agent.