Coated stent

• US 5,779,729 A
• Filed: 02/08/1996
• Issued: 07/14/1998
• Est. Priority Date: 06/04/1993
• Status: Expired due to Fees

• Current Assignee: Istituto Nazionale Per LO Studio E La CURA DEI Tumori
• Original Assignee: Istituto Nazionale Per LO Studio E La CURA DEI Tumori
• Inventors: Severini, Aldo
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US08/597,379
• Time in Patent Office: 887 Days
• Field of Search: 606/191, 606/194, 606/195, 606/198, 623/1, 623/11, 623/12, 128/898
• US Class Current: 623/1.15
• 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 2002/30067 Coating or prosthesis-covering structure made of thermoplastic material
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: B29C 37/0017 by stripping articles from mould cores
• CPC Class Codes: B29C 41/08 Coating a former, core or other substrate by spraying or fluidisation, e.g. spraying powder spray-up of reinforcing fibres B29C70/305
• CPC Class Codes: B29C 41/20 incorporating preformed parts or layers, e.g. moulding inserts or for coating articles
• CPC Class Codes: B29K 2075/00 Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2101/12 Thermoplastic materials
• CPC Class Codes: B29K 2105/0073 Solution
• CPC Class Codes: B29K 2827/18 PTFE, i.e. polytetrafluorethene, e.g. ePTFE, i.e. expanded polytetrafluorethene
• CPC Class Codes: B29K 2995/0056 Biocompatible, e.g. biopolymers or bioelastomers
• CPC Class Codes: B29L 2031/7532 Artificial members, protheses
• CPC Class Codes: C08G 18/44 Polycarbonates
• CPC Class Codes: C08L 75/04 Polyurethanes

Abstract

A coated stent, particularly a biocompatible polymeric material coated stent, and a coating process are herein described.

Claims

1. In a prosthetic polymer coated stent selected from the group consisting of a Gianturco stent, a Gianturco-Roubin stent and a Gianturco-Rosch stent for implantation within an animal duct comprising an elongated metal mesh stent structure having a lumen, an inner lumen surface and an outer surface and a polymer coating extending completely over the elongated metal mesh stent structure, the improvement comprising:

the polymer coating being a thermoplastic polycarbonate urethane polymer coating and said coating having;

a smooth inner lumen surface to provide improved fluid hydrodynamics within the lumen; and

an outer surface configured to the outer surface of the elongated metal mesh stent structure to promote interaction of the coated stent with and non-migration thereof within the animal duct.

2. A stent according to claim 1, wherein the polycarbonate urethane polymer is substantially completely devoid of ether linkages.

3. A stent according to claim 1, wherein a Gianturco-Rosch stent is a metal mesh stent structure.

4. A stent according to claim 1, wherein said stent is coated with a monolayer of said polymer.

5. A stent according to claim 1, wherein said metal mesh stent structure is coated with a multilayer of said polymer.

6. A stent according to claim 1, wherein said coated polymer is an evaporated solution coating.

7. A stent according to claim 6, wherein an organic solvent is used in said solution.

8. A stent according to claim 7, wherein dimethylacetamide is said solvent.

9. A stent according to claim 6, wherein the concentration of said polymer in the solution is between 10 to 40 w/w %.

10. A process for coating an elongated metal mesh expandable stent selected from the group consisting of a Gianturco stent, a Gianturco-Roubin stent and a Gianturco-Rosch stent for use as a prosthetic for implantation within an animal duct, said stent having a lumen, an inner lumen surface and an outer surface, comprising:

(A) positioning the stent in an expanded configuration on a horizontal rotatable support means;

(B) rotating the support means;

(C) depositing a polymer on said stent and support means while the support means and stent are being rotated, so as to coat the stent and support means, wherein a polymer coating extends completely over the elongated metal mesh stent, a smooth inner lumen surface of the polymer coating is provided to improve hydrodynamics within the lumen and an outer surface of the polymer coating is configured to the outer surface of the elongated metal mesh stent to promote interaction of the coated stent with and non-migration thereof within an animal duct; and

(D) removing the so-coated stent from the support means.

11. The process of claim 10, wherein the stent is coated with a monolayer of the polymer.

12. The process of claim 10, wherein the stent is coated with a multilayer of the polymer.

13. The process of claim 10, wherein the support means has an outer surface of TEFLON.

14. The process of claim 10, wherein the support means is rotated at a speed of up to 20 rpm.

15. The process of claim 10, wherein the polymer is deposited on the stent and support means from a solution of the polymer and the solution is evaporated to produce the coating.

16. The process of claim 15, wherein the solution has an organic solvent.

17. The process of claim 16, wherein the organic solvent is dimethylacetamide.

18. The process of claim 15, wherein the concentration of the polymer in the solution is between 10 and 40 w/w%.