Medical device for delivering a water-insoluble therapeutic salt or substance

• US 6,013,099 A
• Filed: 04/29/1998
• Issued: 01/11/2000
• Est. Priority Date: 04/29/1998
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Dinh, Thomas Q., Berg, Eric P., Wolff, Rodney G.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US09/069,659
• Time in Patent Office: 622 Days
• Field of Search: 623/1, 623/12
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

A device useful for localized delivery of a therapeutic material is provided. The device includes a structure including a porous material; and a water-insoluble salt of a therapeutic material dispersed in the porous material. The water-insoluble salt is formed by contacting an aqueous solution of a therapeutic salt with a heavy metal water-soluble salt dispersed throughout a substantial portion of the porous material. The porous material can be made of a polymer other than fibrin with fibrin incorporated into the pores, which can be the only layer of polymeric material on the medical device (e.g., stent). A new method for preparing a porous polymer material on a medical device.

Claims

1. A medical device having at least one blood-contacting surface comprising:

a non-fibrin porous material having fibrin incorporated therein; and

a water-insoluble therapeutic salt dispersed in at least a portion of the porous material.

2. The medical device of claim 1 wherein the non-fibrin porous material comprises a film.

3. The medical device of claim 2 wherein the non-fibrin porous material is selected from the group consisting of silicone, polyurethane, polysulfone, cellulose, polyethylene, polypropylene, polyamide, polyester, polytetrafluoroethylene, and a combination of two or more of these materials.

4. The medical device of claim 2 wherein the water-insoluble salt comprises a salt of an antithrombotic material.

5. The medical device of claim 4 wherein the antithrombotic material is heparin.

6. The medical device of claim 5 wherein the water-insoluble salt is selected from the group consisting of barium, calcium and silver salts of the antithrombotic material.

13. The medical device of claim 1 which is in the form of a generally cylindrical stent.

7. An intravascular stent comprising:

a generally cylindrical stent body;

a single layer of a polymeric film comprising a non-fibrin porous polymer with fibrin incorporated therein; and

a water-insoluble therapeutic salt dispersed in at least a portion of the porous polymeric film.

8. The stent of claim 7 wherein the non-fibrin porous polymer film comprises a material selected from the group of silicone, polyurethane, polysulfone, cellulose, polyethylene, polypropylene, polyamide, polyester, polytetrafluoroethylene, and a combination of two or more of these materials.

9. The stent of claim 8 wherein the non-fibrin porous polymer film comprises a polyurethane.

10. The stent of claim 7 wherein the water-insoluble therapeutic salt is an antithrombotic salt.

11. The stent of claim 10 wherein the antithrombotic salt is a salt of heparin.

12. The stent of claim 11 wherein the water-insoluble heparin salt is selected from the group consisting of silver, barium and calcium salts.