Method of making an intraluminal stent

• US 5,571,166 A
• Filed: 09/15/1994
• Issued: 11/05/1996
• Est. Priority Date: 03/19/1992
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Schwartz, Robert S., Dror, Michael, Dinh, Thomas Q.
• Primary Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US08/306,781
• Time in Patent Office: 782 Days
• Field of Search: 623/1, 623/11, 623/12, 600/36, 606/151-158, 606/191-200, 604/8, 604/104
• US Class Current: 128/898
• 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 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 2300/622 Microcapsules
• 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
• CPC Class Codes: Y10S 623/921 Blood vessel

Abstract

An intraluminal stent comprising fibrin and heparin is capable of providing a treatment of restenosis.

Claims

1. A method for making an intraluminal stent for implantation in a body lumen comprising the steps of:

(a) providing a stent body;

(b) applying to the stent body a composition of fibrinogen and thrombin to effect polymerization of the fibrinogen to fibrin; and

(c) applying heparin to the fibrinogen and thrombin as the fibrinogen is being polymerized to fibrin.

6. The method of claim 1 wherein the heparin is in particulate form.

7. The method of claim 1 wherein the heparin is in the form of particles also comprising fibrin.

8. The method of claim 7 wherein the particles are in flake form.

9. The method of claim 1 wherein the composition of fibrinogen and thrombin applied to the stent body includes heparin at a concentration of heparin to fibrin in the range of about 10-200 units of heparin per milligram of fibrin.

2. A method for making an intraluminal stent for implantation in a body lumen comprising the steps of:

(a) providing a stent body;

(b) applying to the stent body a composition of fibrinogen and thrombin to effect polymerization of the fibrinogen to fibrin;

(c) applying heparin to the fibrinogen and thrombin as the fibrinogen is being polymerized to fibrin; and

(d) applying a second layer of fibrin over the heparin.

3. The method of claim 2 also comprising the step of immersing the fibrin stent with second layer of fibrin in a concentrated heparin solution.

4. The method of claim 3 wherein the immersion step takes place within two hours of the commencement of polymerization of the second fibrin layer.

5. The method of claim 3 wherein the immersion step takes place within thirty minutes of the commencement of polymerization of the second fibrin layer.

10. A method for making an intraluminal stent for implantation in a body lumen comprising the steps of:

(a) providing a stent body;

(b) applying to the stent body a composition of fibrinogen and thrombin to effect polymerization of fibrin on the stent body;

(c) immersing the stent body with fibrin in a solution of heparin within two hours after the commencement of polymerization of the fibrin.

11. The method of claim 10 wherein the heparin solution has a concentration of at least about 1000 units/ml.

12. The method of claim 10 wherein the heparin solution has a concentration in the range of about 10,000 to 20,000 units.

13. The method of claim 12 wherein the stent body is immersed in the heparin solution for about 12-24 hours.

14. The method of claim 10 wherein the stent body is immersed in the heparin solution within 30 minutes of commencement of polymerization of the fibrin.