Stent and method of varying amounts of heparin coated thereon to control treatment

• US 5,876,433 A
• Filed: 05/29/1996
• Issued: 03/02/1999
• Est. Priority Date: 05/29/1996
• Status: Expired due to Term

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Lunn, Anthony C.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US08/654,948
• Time in Patent Office: 1,007 Days
• Field of Search: 606/198, 606/191, 623/1, 623/12
• US Class Current: 623/1.15
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 33/0011 Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
• CPC Class Codes: C08L 5/10 Heparin; Derivatives thereof

Abstract

The present invention addresses two previously unresolved problems simultaneously. First, the question concerning the amount of heparin applied to a stent is resolved. That is, the invention set forth herein will demonstrate that by varying the amount of heparin, the practitioner can actually more adequately determine whether in fact the patient will receive the correct dosage to address the problem, and at the right time in which to address the problem. Second, the problem of applying the heparin coating to a stent is addressed. There, specifically, the invention turns to the fashion in which to apply multiple layers of heparin coating to the stent, and to thereby variably adjust the dosage applied to the patient at the lesion site. The present invention does so by providing a method and device for coating a stent with multiple layers of heparin coating. By so doing, the heparin coating is absorbed by the body in a degree which varies with the amount of heparin applied. Thus, contrary to formerly popular belief, the present method allows for the significant adjustment of heparin therapy. And, the stent so coated allows for the variable application of such heparin therapy at the lesion site.

Claims

1. A stent for placement in a lumen of the body, and said stent placed into said lumen so as to contact said lumen, said stent coated with heparin wherein the stent is coated with enough heparin to insure above 0.7 pmol/cm² antithrombin III is absorbed by the body when the lumen contacts said stent.

2. A stent according to claim 1 wherein the stent is coated with a plurality of layers of variable density of said heparin coating.

3. A method of placing the stent of claim 1 comprising the steps of:

determining the lesion site in said lumen to which the stent is to be employed;

predetermining the amount of heparin needed on a said stent at said lesion site in order to insure above 0.7 pmol/cm² of antithrombin II is absorbed by the body with where the lesion contacts said stent;

coating said stent with the predetermined amount of said heparin; and

emplacing said stent into the body at said lesion site.

4. A stent of claim 1 wherein the stent is coated with enough heparin to insure the uptake of at least 10 pmol per cm² of antithrombin III.

5. A method of placing a stent coated with heparin wherein the amount of heparin is variably adjusted depending on the desired use of the said stent comprising the steps of:

determining the lesion site to which the stent is to be employed;

predetermining the amount of heparin needed on a said stent at said lesion site;

coating said stent with the predetermined amount of said heparin wherein the stent is coated with enough heparin to insure at least 0.7 pmol/cm² uptake of antithrombin III is absorbed by the body at said lesion site.

6. A method according to claim 5 wherein the stent is coated with a plurality of layers of variable density of said heparin coating.

7. A method according to claim 5 wherein the stent is useful for a particular lesion site in the body, said lesion site affecting the level of heparin coated on said stent.

8. A method according to claim 5 wherein the stent is coated with enough heparin to insure the uptake of at least 10 pmol per cm² of antithrombin III.