A coating for a medical device having an anti-thrombotic conjugate

A conjugate and antithrombotic technology, applied in the field of preparing heparin-bioabsorbable polymer conjugates

Inactive Publication Date: 2008-08-27
CORDIS CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

A potential disadvantage of this approach is that the incorporated drug can be adversely affected by high-energy UV light during cross-linking, or worse, the drug may polymerize with the matrix if they possess functional groups that can be activated by UV light energy cross-linking

Method used

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  • A coating for a medical device having an anti-thrombotic conjugate
  • A coating for a medical device having an anti-thrombotic conjugate
  • A coating for a medical device having an anti-thrombotic conjugate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Preparation of bioabsorbable polymers with carboxyl-terminated polymers

[0047] A predetermined amount of d,l-lactide (from Purac USA) was transferred to a dry round bottom glass reactor equipped with a magnetic stir bar. A predetermined amount of water and a toluene solution containing stannous octoate were added to the glass reactor. The glass reactor was then sealed with a stopper and cycled between argon and vacuum three times to remove air and oxygen from the reactor. The sealed reactor was then gradually heated to 140°C under vacuum and kept stirring with a magnetic stir bar. Until the reaction was complete, the polymer was dissolved in dichloromethane and precipitated in ethanol and dried under vacuum and low temperature heating. The process is figure 1 Illustrated with a schematic diagram.

Embodiment 2

[0049] Preparation of Antithrombotic Heparin-Bioabsorbable Polymer Conjugates

[0050] The bioabsorbable polymer prepared in Example 1 was dissolved in dimethylformamide (DMF), followed by N-hydroxysuccinimide (NHS) and dicyclohexylcarbodiimide (DCC). The molar ratio of PLA, NHS and DCC was 1:1.6:1.6. The resulting solution was kept under vacuum at room temperature for 5 hours. By-product dicyclohexylurea (DCU) and unreacted DCC and NHS were removed by filtration and extraction with water. Then, the activated bioabsorbable polymer was dissolved in DMF and reacted with heparin at room temperature for 4 hours. The final heparin-PLGA conjugate was then precipitated and lyophilized. The process is figure 2 Illustrated with a schematic diagram.

Embodiment 3

[0052] Coating of a drug-eluting stent having an outermost layer comprising a heparin bioabsorbable polymer conjugate

[0053] A medical device 50 coated in accordance with the present invention is attached image 3 Illustrated with a schematic diagram. The surface 10 of the cobalt chromium stent is sprayed with a drug-containing polymeric solution 20 which may include, for example, ethyl acetate (EA) containing PLGA and rapamycin. The weight ratio of PLGA and rapamycin was 2:1. After the drug-containing layer 20 is dried, a coating solution 30 containing a heparin absorbable polymer conjugate is sprayed on the first drug-containing layer 20 . After drying of the coating solution 30, a thin film with heparin 40 substantially on the outermost surface is obtained. While the invention has been described above with particularly preferred embodiments, it will be apparent to those skilled in the art that many modifications and variations can be made without departing from the spi...

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PUM

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Abstract

A conjugate between an anti-thrombotic agent and a bioabsorbable polymer is provided. In addition, a method is provided for applying a coating comprising an anti-thrombotic agent and a bioabsorbable polymer conjugate to at least a portion of an implantable device to prevent or reduce the formation of thrombosis on the surface of the device. A first or sub-layer of the coating is prepared by mixing a polymeric material and a biologically active agent with a solvent, thereby forming a homogeneous solution. A second or outer layer comprises an anti-thrombotic heparin-bioabsorbable polymer conjugate. This coating may be applied over the inner drug-containing layers using, for example, a dip coating or spray coating process. After drying, the anti-thrombotic heparin bioabsorbable polymer conjugate remains in the outer layer of the coating, allowing agent from the inner layer to be eluted there through. In addition, the outmost layer prevents the formation of thrombosis, and also serves to modulate the release kinetics of the agent(s) contained within an inner layer(s) of the coating.

Description

technical field [0001] The present invention relates to coating materials applied to at least a portion of one surface of an article. In particular, the present invention relates to an antithrombotic and antirestenotic coating composition having a multilayer coating wherein a first or inner layer is formed from a polymer and one or more bioactive agents, and a second layer Or the outer layer comprises an antithrombotic heparin-bioabsorbable polymer conjugate. The present invention also relates to the preparation of heparin-bioabsorbable polymer conjugates and methods of applying such antithrombotic heparin-bioabsorbable polymer conjugates to at least a portion of the surface of an implantable medical device. Background technique [0002] Atherogenic narrowing of arteries (stenosis), as well as progressive narrowing of blood vessels after angioplasty or stent implantation (restenosis), are currently commonly encountered vascular diseases. Stenosis is narrowing or constricti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/10A61L31/12A61L31/16A61F2/82
CPCA61L31/10A61L31/148A61L31/16A61L33/0029A61L2300/42A61P7/02A61P41/00
Inventor 赵中R·法洛蒂科
Owner CORDIS CORP
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