Coated implantable medical device
AssigneesMED Institute, Inc., Cook Incorporated
InventorsAnthony Ragheb, Brian Bates, Neal Fearnot, Thomas Kozma, William Voorhees
Life of this patent
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Abstract
Methods of making coated implantable medical devices are provided. The methods include positioning a first layer comprising a bioactive on at least a portion of a structure, and positioning at least one porous layer over the first layer. The at least one porous layer has a thickness adequate to provide a controlled release of the bioactive.
Claims21
1-26. (canceled)
An implantable medical device, comprising:
- a structure configured as a stent graft comprising:
- an expandable stent in combination with a graft formed of a base material sized and shaped for introduction into a vascular system of a patient, the graft having at least one surface;
- a coating layer comprising a first polymer posited between the at least one surface of the graft and at least one bioactive layer;
- the at least one bioactive layer comprising a bioactive agent posited over the at least one surface of the graft and under a porous layer;
- the porous layer comprising a second polymer posited over the bioactive agent and controlling the release of the bioactive agent, the first polymer and the second polymer being the same or different.
The implantable medical device of claim 1, where the first polymer is parylene.
A method of delivering a bioactive material to a body vessel comprising the steps of:
- a. providing a structure configured as a stent graft comprising:
- an expandable stent in combination with a graft formed of a base material sized and shaped for introduction into a vascular system of a patient, the graft having at least one surface;
- the stent graft shaped for introduction into a vascular system of a patient, the graft having a vessel surface and a lumen surface;
- b. depositing a coating layer having a thickness of about 50 to 500,000 angstroms on the vascular surface of the graft, the coating layer consisting of one or more materials selected from the group consisting of:
- silane, polyimide, poly(ethylene oxide), poly(ethylene glycol), poly(propylene oxide), silicone, polytetrafluoroethylene, polytetramethyldisiloxane, parylene and a polymer of methane;
- c. depositing a bioactive layer having a thickness of about 5,000 to about 250,000 angstroms over the coating layer, the bioactive layer comprising 1 to 4 mg of bioactive per cm2 of gross surface area of the graft;
- d. depositing a porous layer over the bioactive layer, the porous layer comprising a biostable polymer and having a thickness of about 5,000 to 250,000 angstroms, to form a coated stent graft;
- e. inserting the coated stent graft into a body vessel using a catheter;
- and
- f. deploying the coated stent graft within a body vessel by placing the vessel surface of the expandable stent in contact with at least a portion of the body vessel.
A method of treating a human or veterinary patient, comprising implanting a coated stent graft at a point of treatment within the vascular system of a human or veterinary patient, the coated stent graft comprising:
- a. an expandable stent in combination with a graft formed of a base material sized and shaped for introduction into a vascular system of a patient, the graft having at least one surface;
- b. a coating layer comprising a first polymer posited between the at least one surface of the graft and at least one bioactive layer;
- c. the at least one bioactive layer comprising a bioactive agent posited over the at least one surface of the graft and under a porous layer;
- d. the porous layer comprising a second polymer posited over the bioactive agent and controlling the release of the bioactive agent, the first polymer and the second polymer being the same or different.
Dependencies are inferred from the claim text.