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Medical device that is coated with endothelial ligands

A technology of medical devices and ligands, which is applied in the direction of devices, prostheses, and coatings of human tubular structures, and can solve problems such as reducing the incidence of thrombus or restenosis, and cracking of coatings

Active Publication Date: 2015-07-29
ORBUSNEICH MEDICAL PTE LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0024] None of the above approaches significantly reduced the incidence of thrombosis or restenosis over time
Additionally, it has been shown that the coatings of prior art medical devices may crumble after device implantation

Method used

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  • Medical device that is coated with endothelial ligands
  • Medical device that is coated with endothelial ligands
  • Medical device that is coated with endothelial ligands

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0130] Preparation of coating composition

[0131] The polymer polyDL-lactide-co-glycolide (DLPLG, Birmingham Polymers) used was in the form of pellets. To prepare the polymer matrix composition to coat the stents, small pellets of these polymers were weighed and dissolved in ketone or dichloromethane solvents to form a solution. The drug is dissolved in the same solvent and added to the polymer solution to the desired concentration to form a uniform coating solution. To improve the ductility of the coating matrix and alter its release kinetics, the ratio of lactide to glycolide can be varied. Then, the solution is used to coat the scaffold to form as Figure 11 Uniform coating shown. Figure 12 A cross-section of an inventive coated stent is shown. The polymer / drug composition can be deposited on the surface of the stent by various standard methods.

Embodiment 2

[0133] Polymer / Drug Evaluation and Concentration

[0134] Method of spraying brackets:

[0135] Pellets of DLPLG polymer that have been dissolved in a solvent are mixed with one or more drugs. Alternatively, one or more polymers may be dissolved in a solvent, one or more drugs added, and mixed. The resulting mixture was evenly applied to the stent using standard methods. After coating and drying, the scaffolds were evaluated. Listed below are various examples of coating compositions that were investigated with various drugs and DLPLG and / or combinations thereof. Additionally, the formulation can consist of base coat DLPLG and top coat DLPLG or other polymers such as DLPLA or EVAC 25. Abbreviations for drugs and polymers used in coatings are as follows:

[0136] MPA: Mycophenolic Acid, RA: Retinoic Acid; CSA: Cyclosporin A; LOV: Rovastatin.TM. (Lovastatin); PCT: Paclitaxel; PBMA: Polybutylmethacrylate, EVAC: Ethylene Vinyl acetate copolymer; DLPLA: poly(DL-lactide), DLPLG...

Embodiment 3

[0161] The following experiments were performed to examine the drug efflux characteristics of the coating on stents coated using the method described in Example 2. The coating on the stent consisted of 4% paclitaxel and 96% of a 50:50 poly(DL-lactide-co-glycolide) polymer. Each scaffold was coated with 500 μg of the coating composition and incubated in 3 ml of bovine serum at 37° C. for 21 days. During the incubation period, paclitaxel released into the serum was measured on each day using standard techniques. Experimental results such as Figure 13 As shown, only about 4 μg of paclitaxel was released from the stent over a 21 day period, so the efflux profile of paclitaxel release was very slow and controlled.

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Abstract

A medical device for implantation into vessels or luminal structures within the body is provided. The medical device, such as a stent (100) and a synthetic graft, is coated with a pharmaceutical composition consisting of a controlled-release matrix and one or more pharmaceutical substances (110) for direct delivery of drugs to surrounding tissues. The coating on the medical device further comprises a ligand (120) such as an antibody or a small molecule for capturing progenitor endothelial cells in the blood contacting surface of the device for restoring an endothelium at the site of injury. In particular, the drug- coated stents are for use, for example, in balloon angioplasty procedures for preventing or inhibiting restenosis.

Description

[0001] This application claims priority to US Provisional Application 60 / 551,978, filed March 10,2004. technical field [0002] The present invention relates to a medical device for implantation into blood vessels and lumen structures in the body. More specifically, the present invention relates to stents or synthetic grafts coated with a controlled-release matrix containing a drug that can be delivered directly into surrounding tissue, and a ligand attached thereto for the capture Endothelial progenitor cells in the blood that come into contact with the surface of the device to form mature endothelium at the site of injury. Specifically, such polymer matrix / drug / ligand-coated stents are used, for example, in the treatment of restenosis, atherosclerosis and other diseases and in vascular lumen reconstruction therapy. Background of the invention [0003] Atherosclerosis is one of the leading causes of death and lost workforce in the world. Atherosclerosis is associated with...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61F2/82A61F2/06A61F2/00A61F2/852A61F2/86
CPCA61L2300/256A61L2300/416A61L2300/428A61F2/852A61L2300/602A61F2250/0035A61F2250/0067A61L31/16A61L31/10A61F2/86A61L31/148A61F2250/0063A61L2300/414A61L29/085C08L67/04A61F2/82A61F2/07A61L27/58A61L27/04
Inventor R·J·小科顿S·M·罗兰H·R·戴维斯M·J·B·库特里克
Owner ORBUSNEICH MEDICAL PTE LTD