Method and system for coating insertable medical devices
Inventors
Doshi, Manish • Sherdiwala, Divyesh • Sojitra, Prakash • Vyas, Ashwin • Gandhi, Pankaj • Chevli, Bhavesh • Pothiawala, Yavar
Assignees
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Publication Number
US-8529983-B2
Publication Date
2013-09-10
Expiration Date
Abstract
A coating system for coating an Insertable Medical Device (IMD) with one or more drugs is disclosed. The coating system includes a spray nozzle unit for coating the IMD with one or more drugs. The IMD includes a guiding member, a coating member and a supporting member. The IMD is passed through a protection tube such that the guiding member is located within the protection tube and an end of the supporting member is connected to a holder to expose the coating member of the IMD to the spray nozzle unit. The protection tube is received by a mandrel fixture which includes a circular disc for holding and rotating the protection tube and the IMD within the protection tube. When the protection tube along with the IMD is rotated, the spray nozzle unit coats the coating member of the IMD with the one or more drugs.
Core Innovation
A spray-based coating system and process are disclosed for drug-coating Insertable Medical Devices (IMDs), particularly pre-crimped stent assemblies. The system includes a protection tube and a mandrel fixture for handling the IMD while coating, and the IMD has a guiding member, a coating member, and a supporting member.
The guiding member is kept within the protection tube while the coating member and supporting member protrude to receive spray from a spray nozzle unit. The protection tube holding the IMD is passed through the mandrel fixture, and an end of the supporting member is connected with a holder to expose the coating member to the spray nozzle unit for coating the at least one drug on the coating member of the IMD.
The mandrel fixture includes a circular disc, and an end of the protection tube is coupled to the circular disc to install and hold the IMD. For coating uniformity and efficiency, the mandrel fixture rotates the protection tube/IMD while the spray nozzle unit is controlled, and CNC synchronizes nozzle movement.
Solvent evaporation can be enhanced using an air blower and an exhaust fan. An atomizer unit uses inert gas, and an optional nanomizing capability is described for forming nanoparticles in connection with the drug solution and spray.
Claims Coverage
The independent claim clm-00001 sets out the method of installing an IMD on a coating system configured for spray coating at least one drug. The inventive features are centered on the protection tube and mandrel fixture arrangement that positions the IMD components for exposure to the spray nozzle unit, together with coupling to a circular disc of the mandrel fixture.
Protection tube positions guiding member within and exposes coating member for spray
Mounting the IMD comprises passing the protection tube holding the IMD through the mandrel fixture, wherein the guiding member of the IMD is located within the protection tube and the coating member along with the supporting member protrudes out from the protection tube.
Holder connection exposes coating member to spray nozzle unit
Connecting an end of the supporting member with a holder thereby exposing the coating member to the spray nozzle unit for coating the at least one drug on the coating member of the IMD.
Mandrel fixture circular disc coupling installs the IMD
Coupling an end of the protection tube to a circular disc of the mandrel fixture for installing the IMD.
Overall claim coverage focuses on installing an IMD so that the guiding member remains within the protection tube while the coating member protrudes and is exposed to spray coating, and on coupling the protection tube to a circular disc of the mandrel fixture to support installation during coating.
Stated Advantages
Improves uniform drug coating by rotating the protection tube/IMD during spray coating.
Enhances solvent evaporation using an air blower and an exhaust fan.
Improves coating uniformity and efficiency by synchronizing nozzle movement with CNC.
Documented Applications
Drug-coating Insertable Medical Devices (IMDs), particularly pre-crimped stent assemblies, using a spray-based coating system.
Coating stent assemblies using pre-crimped stent members including a balloon with a stent crimped onto the balloon, or coating a balloon.
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