Method of making an intraluminal stent

• US 5,510,077 A
• Filed: 09/15/1994
• Issued: 04/23/1996
• Est. Priority Date: 03/19/1992
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Dror, Michael, Tuch, Ronald J., Dinh, Thomas Q.
• Primary Examiner(s): Tentoni, Leo B.
• Application Number:
  US08/306,806
• Time in Patent Office: 586 Days
• Field of Search: 264/22, 264/279, 264/279.1, 264/314, 264/316, 264/320, 264/330, 264/485, 264/488
• US Class Current: 264/485
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• 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 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 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• 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 31/041 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 31/046 Fibrin; Fibrinogen
• CPC Class Codes: A61L 31/047 Other specific proteins or polypeptides not covered by A61L31/044 - A61L31/046
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/128 containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C08L 89/00 Compositions of proteins; Compositions of derivatives thereof foodstuff preparations A23J3/00

Abstract

An intraluminal stent comprising fibrin treatment of restenosis is provided by a two stage molding process.

Claims

1. A method for making an intraluminal stem comprising the steps of:

(a) polymerizing fibrinogen into a fibrin stent preform in a first mold cavity;

(b) placing the fibrin stent preform into a second mold cavity having a molding surface; and

(c) compressing the fibrin stent preform against the molding surface of the second mold cavity to form the intraluminal stent.

2. The method of claim 1 wherein the polymerizing step comprises placing a mixture of fibrinogen and a fibrinogen-coagulating protein into the mold cavity and curing the mixture.

3. The method of claim 2 wherein the curing step comprises the application of water to the stent preform as it cures.

4. The method of claim 1 further comprising applying a buffer solution to the fibrin stent preform.

5. The method of claim 4 wherein the buffer solution includes a crosslinking agent.

6. The method of claim 1 further comprising applying heparin to the fibrin stent preform.

7. The method of claim 1 wherein the compressing step also includes an outward expansion of the fibrin stent preform.

8. A method for making an intraluminal stent comprising the steps of:

(a) polymerizing fibrinogen into a fibrin stent preform in a first mold cavity;

(b) placing a balloon into the fibrin stent preform;

(c) placing the balloon and fibrin stent preform into a second mold cavity having a molding surface; and

(c) compressing the fibrin stent preform against the molding surface of the second mold cavity by expanding the balloon to form the intraluminal stent.

9. The method of claim 8 wherein the polymerizing step comprises placing a mixture of fibrinogen and a fibrinogen-coagulating protein into the mold cavity and curing the mixture.

10. The method of claim 9 wherein the curing step comprises the application of water to the stent preform as it cures.

11. The method of claim 8 further comprising applying a buffer solution to the fibrin stent preform.

12. The method of claim 11 wherein the buffer solution includes a crosslinking agent.

13. The method of claim 8 further comprising applying heparin to the fibrin stent preform.

14. The method of claim 8 wherein the compressing step also includes an outward expansion of the balloon and fibrin stent preform.

15. A method for making an intraluminal stem comprising the steps of:

(a) placing a stent framework into a first mold cavity;

(b) injecting fibrinogen and a fibrinogen-coagulating protein into the first mold cavity around the stem framework and allowing the fibrinogen to cure in the mold cavity, thereby producing a fibrin stent preform comprising fibrin and the stent framework;

(c) placing the fibrin stent preform into a second mold cavity having a molding surface; and

(d) compressing the fibrin stent preform against the molding surface of the second mold cavity to form the intraluminal stent.

16. The method of claim 15 wherein the curing step comprises the application of water to the stent preform as it cures.

17. The method of claim 15 further comprising applying a buffer solution to the fibrin stent preform.

18. The method of claim 17 wherein the buffer solution includes a crosslinking agent.

19. The method of claim 15 further comprising applying heparin to the fibrin stent preform.

20. The method of claim 15 wherein the compressing step also includes an outward expansion of the fibrin stent preform.

21. The method of claim 15 also comprising the step of mounting the compressed preform onto a balloon catheter balloon.

22. The method of claim 15 also comprising the step of applying a sterilizing dose of radiation to the compressed preform.