MEDICAL IMPLANT, COATING METHOD AND IMPLANTATION METHOD

• US 20110153005A1
• Filed: 12/17/2010
• Published: 06/23/2011
• Est. Priority Date: 12/21/2009
• Status: Abandoned Application

• Current Assignee: Biotronik VI Patent AG (Biotronik SE & Company KG)
• Original Assignee: Biotronik VI Patent AG (Biotronik SE & Company KG)
• Inventors: Harder, Claus
• Application Number:
  US12/972,102
• Publication Number:
  US 20110153005A1
• Time in Patent Office: Days
• US Class Current: 623/1.46
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

One example of the invention relates to a medical implant having a base body comprising a first end and a second end, which are arranged at opposite ends of the base body in a main direction of the extent of the base body, and a coating, such that the coating has at least one active substance with an active substance gradient. It is proposed that the quantity of active substance shall decrease from the first end to the second end, at least in the main direction of extent of the base body.

Claims

1. A medical implant comprising a base body which has a first end and a second end arranged opposite one another in a main direction of the extent of the base body, and a coating such that the coating has at least one active substance with an active substance gradient, characterized in that the quantity of active substance decreases from the first end to the second end at least in the main direction of extent of the base body.

2. The medical implant according to claim 1, characterized in that the active substance gradient varies with the thickness of the coating.

3. The medical implant according to claim 1, characterized in that the active substance gradient varies through changing active substance concentrations along the coating length from first to second end.

4. The medical implant according to claim 1, characterized in that at least one active substance is selected from a group consisting of:

lipid regulators (fibrates),

immunosuppressants,

immunomodulators,

vasodilators (sartans),

calcium channel blockers,

calcineurin inhibitors (tacrolimus),

antiphlogistics (glucocorticoids, cortisone, diclofenac),

anti-inflammatories (imidazoles),

anti-allergics,

oligonucleotides (dODN),

estrogens (genistein),

endothelializers (fibrin),

steroids,

proteins/peptides,

proliferation inhibitors,

analgesics,

antirheumatics,

cytostatics.

5. The medical implant according to claim 1, characterized in that the at least one active substance has a narrow therapeutic window.

6. The medical implant according to claim 1, characterized in that the first end is configured to be arranged in a cavity at an upstream end in an axial direction of flow in an implanted state.

7. The medical implant according to claim 1, characterized in that it is embodied as a stent.

8. The medical implant according to claim 1, characterized in that the base body comprises at least one of cobalt and chromium.

9. The medical implant according to claim 1, characterized in that the coating contains at least one polylactide.

10. The medical implant according to claim 1, characterized in that it is designed to elute at least one active substance in a human or animal body, at least one active substance being elutable, such that a desired local concentration distribution in an adjacent cavity wall is achieved.

11. The medical implant according to claim 1 made through a method comprising the steps of applying a coating stream with a polymer/active substance mixture at a variable velocity from the first end to the second end.

12. The medical implant according to claim 11, characterized in that the coating stream is moved at an increasing velocity from the first end to the second end.

13. The medical implant according to claim 11, characterized in that the coating stream is moved in at least one of the circumferential direction and in the axial direction relative to the medical implant.

14. A method for implanting the medical implant of claim 1 in an animal or human body, characterized in that the first end is arranged in a cavity in the animal or human body at an upstream end in an axial direction of flow.

15. A medical implant as defined by claim 1 wherein the active substance loading is at least 4 times greater at the first end than it is at the second end.

16. A medical implant as defined by claim 1 wherein the active substance loading varies linearly along the main direction of the implant.

17. A medical implant comprising:

a base body having a first end and an opposing distal second end in a main direction of the base body, the base body comprising at least one of cobalt and chromium; and

,

a coating covering at least a portion of the base body and comprising at least one active substance, the coating active substance present in a quantitative gradient along the base body main direction and decreasing from the first end to the second end, the at least one active substance being elutable wherein a eluted active substance gradient concentration is achieved in an adjacent cavity wall when the implant is implanted in a cavity corresponding generally to the gradient concentration in the coating along the base body main direction.

18. A medical implant as defined by claim 17 wherein the at least one active substance is provided in a constant concentration in the coating and the coating thickness varies between the first and second ends to achieve the quantitative active substance gradient between first and second ends, and wherein the coating contains at least one polylactide.

19. An implant as defined by claim 17 wherein the coating is provided in a substantially constant thickness between the first and second ends and the concentration of the at least one active substance in the coating varies between the first and second ends to achieve the quantitative gradient.

20. An implant as defined by claim 17 wherein:

the at least one active substance has a narrow therapeutic window and comprises at least one of;

lipid regulators (fibrates), immunosuppressants, immunomodulators, vasodilators (sartans), calcium channel blockers, calcineurin inhibitors (tacrolimus), antiphlogistics (glucocorticoids, cortisone, diclofenac), anti-inflammatories (imidazoles), anti-allergics, oligonucleotides (dODN), estrogens (genistein), endothelializers (fibrin), steroids, proteins/peptides, proliferation inhibitors, analgesics, antirheumatics, cytostatics; and

,

the active substance loading at the first end is at least 4 times greater than the active substance loading at the second end.