Abstract: Gastric residence systems and methods of delivering a drug to an individual using a gastric residence system are described herein. The gastric residence system may include a time-dependent and/or enteric, or dual time-dependent and enteric polymeric linker. In some embodiments, the time-dependent polymeric linker includes PLGA, and optionally PLA or a carrier polymer. The enteric polymeric linker includes an enteric polymeric, and optionally a carrier polymer such as PCL or TPU. The time-dependent polymeric linker may degrade in the stomach of the individual according to a degradation (or flexural modulus loss) profile described herein, and the enteric polymeric linker may degrade in the intestine of the individual another degradation profile described herein (or flexural modulus loss).

Abstract: Gastric residence systems for administration of agents, such as drugs, are disclosed. Features which enhance gastric retention during the desired residence time and which allow for more precise control over residence time are disclosed, including circumferential filaments connecting the arms of a stellate gastric residence system; flexible arms for a gastric residence system; improved time-dependent and enteric disintegrating matrices (linkers); and release rate-modulating polymer coatings which are resistant to change in release rate properties during heat-assisted assembly or thermal cycling. Combinations of these features are also disclosed.

Abstract: The medical device of the invention comprises a surface comprising at least one outermost portion and a plurality of depressions. The depressions occupy at least about 80% of the surface area of the surface. The depressions contain a coating material that preferably comprises a biologically active material and/or polymer, and the outermost portion is substantially free of any coating material. The invention is also directed to a method for manufacturing a medical device. The method comprises applying a coating material to the surface of the medical device by using at least one roller.

Abstract: The medical device of the invention comprises a surface comprising at least one outermost portion and a plurality of depressions. The depressions occupy at least about 80% of the surface area of the surface. The depressions contain a coating material that preferably comprises a biologically active material and/or polymer, and the outermost portion is substantially free of any coating material. The invention is also directed to a method for manufacturing a medical device. The method comprises applying a coating material to the surface of the medical device by using at least one roller.

Abstract: The present invention is directed to methods, processes, and systems for coating portions of a workpiece as well as to workpieces that have themselves been coated in accord with the invention. Under these methods and processes of the invention, a means to repel may be positioned on a mandrel prior to applying a coating to the workpiece. The means to repel may prevent the coating of a target surface of the workpiece.

Abstract: Coated medical devices are disclosed. In certain embodiments of the invention, the coating materials include therapeutic agents, polymers, sugars, waxes, or fats. In certain embodiments of the invention, a medical device is coated on at least a portion of its surface with a first coating comprising a therapeutic agent and a wax or fat. The coated medical device may be a stent or catheter.

Abstract: The present invention is directed to methods, processes, and systems for coating portions of a workpiece as well as to workpieces that have themselves been coated in accord with the invention. Under these methods and processes of the invention, a means to repel may be positioned on a mandrel prior to applying a coating to the workpiece. The means to repel may prevent the coating of a target surface of the workpiece.

Abstract: The present invention is directed to novel implantable or insertable medical devices that provide controlled release of a therapeutic agent. According to an embodiment of the present invention, a therapeutic-agent-releasing medical device is provided, which comprises: (a) an implantable or insertable medical device; (b) a release layer disposed over at least a portion of the implantable or insertable medical device; and (c) a therapeutic agent. The release layer comprises a styrene copolymer and at least one additional polymer. The release layer regulates the rate of release of the therapeutic agent from the medical device upon implantation or insertion of the device into a patient. The present invention is also directed to methods of forming the above implantable or insertable medical devices, methods of administering a therapeutic agent to a patient using such devices, and methods of modulating the release of therapeutic agent from such devices.

Abstract: The present invention relates to phase separated polymeric regions and to their use in conjunction with implantable or insertable medical devices. In some aspects of the invention, phase separated polymeric regions are provided that include (a) at least one biostable polymeric phase and (b) at least one biodisintegrable polymeric phase, which is of nanoscale dimensions and which undergoes biodisintegration such that the phase separated polymeric region becomes a nanoporous polymeric region in vivo. Other aspects of the invention are directed to methods of making implantable or insertable medical devices having at least one nanoporous polymeric region. These methods include (a) providing a phase separated polymeric region comprising a stable polymeric phase and a disintegrable polymeric phase of nanoscale dimensions, (b) selectively removing the disintegrable polymeric phase thereby producing the nanoporous polymeric region.

Abstract: According to an aspect of the present invention, implantable or insertable medical devices are provided, which contain one or more polymeric regions. These polymeric regions, in turn, contain one or more polymers, at least one of which is a copolymer that includes the following: (a) one or more unsaturated hydrocarbon monomer species and (b) one or more heteroatom-containing monomer species.

Abstract: Therapeutic-agent-releasing medical devices are provided herein, which contain a rate controlling release region that includes a biodisintegrable agent and a biostable low glass transition temperature polymer. Upon contact (e.g., implantation or insertion) of the medical device with a subject, at least the surface of the release region becomes depleted of the biodisintegrable agent, and the low glass transition temperature polymer migrates to occupy at least a portion of the volume that is created by the departure of the biodisintegrable agent, thereby forming a barrier layer for therapeutic agent remaining within the device.

Abstract: Medical articles, such as drug-releasing patches or implantable or insertable medical devices, which are made up of a medical article substrate and a therapeutic-agent-containing region. The therapeutic-agent-containing region is made up of (i) a water-dispersible therapeutic agent therapeutic agent and (ii) coalesced polymer particles supplied by an aqueous dispersion. Also described are methods of forming such medical articles, and methods of releasing a therapeutic agent within a patient using such medical articles.

Abstract: Methods and apparatuses for coating surface of medical devices using coating heads are disclosed. In one embodiment, the invention includes a coating method using a coating head, wherein the coating head comprises at least one outlet orifice from which flows a coating material, to deposit at least one layer of coating material dispelled through the outlet orifice onto the surface of the medical device. In another embodiment, a slide coating head is used to deposit multiple layers of superposed coating materials. These methods are used to apply one or more coating materials, simultaneously or in sequence. In certain embodiments of the invention, the coating materials include therapeutic agents, polymers, sugars, waxes, or fats.

Abstract: A composition for delivery of a therapeutic agent is provided. The composition comprises: (a) a biocompatible block copolymer comprising one or more elastomeric blocks and one or more thermoplastic blocks and (b) a therapeutic agent, wherein the block copolymer is loaded with the therapeutic agent. The block copolymer is preferably of the formula X—(AB)n, where A is an elastomeric block, B is a thermoplastic block, n is a positive whole number and X is a seed molecule. The elastomeric blocks are preferably polyolefin blocks, and the thermoplastic blocks are preferably selected from vinyl aromatic blocks and methacrylate blocks. According to another aspect of the invention, a medical device is provided, at least a portion of which is insertable or implantable into the body of a patient. The medical device comprises (a) the above biocompatible block copolymer and (b) a therapeutic agent, wherein the block copolymer is loaded with the therapeutic agent.

Abstract: A composition for delivery of a therapeutic agent is provided. The composition comprises: (a) a biocompatible block copolymer comprising one or more elastomeric blocks and one or more thermoplastic blocks and (b) a therapeutic agent, wherein the block copolymer is loaded with the therapeutic agent. The block copolymer is preferably of the formula X—(AB)n, where A is an elastomeric block, B is a thermoplastic block, n is a positive whole number and X is a seed molecule. The elastomeric blocks are preferably polyolefin blocks, and the thermoplastic blocks are preferably selected from vinyl aromatic blocks and methacrylate blocks. According to another aspect of the invention, a medical device is provided, at least a portion of which is insertable or implantable into the body of a patient. The medical device comprises (a) the above biocompatible block copolymer and (b) a therapeutic agent, wherein the block copolymer is loaded with the therapeutic agent.

Abstract: Implantable or insertable medical devices are described. The medical devices comprise (a) a therapeutic agent and (b) a polymeric release region, which controls the release of the therapeutic agent upon administration to a patient. The polymeric release region further comprises an acrylic copolymer, which comprises (i) a plurality of rubbery acrylic units and (ii) a plurality of hard units. Also described are methods for administering a therapeutic agent to a patient using the above implantable or insertable medical devices as well as methods of making the above devices.

Abstract: An implantable or insertable medical device which comprises (a) a therapeutic agent and (b) a polymeric release region comprising a polymer. The polymeric release region is treated with a radiation dose that is effective to substantially increase the cumulative release of the therapeutic agent subsequent to administration to a patient. The polymeric release region can be, for example, (a) a carrier region that comprises the therapeutic agent or (b) a barrier region that is disposed over a therapeutic-agent-containing region that comprises the therapeutic agent. The present invention is further directed to methods of forming such medical devices, methods of releasing a therapeutic agent within a patient using such medical devices, and methods of modulating the release of a therapeutic agent from such medical devices.

Abstract: Implantable or insertable medical devices are described. The medical devices comprise (a) a therapeutic agent and (b) a polymeric release region, which controls the release of the therapeutic agent upon administration to a patient. The polymeric release region further comprises a silicone copolymer that contains a plurality of siloxane units and a plurality of non-siloxane units. Also described are methods for administering a therapeutic agent to a patient using the above implantable or insertable medical devices as well as methods of making the above devices.

Abstract: The medical device of the invention comprises a surface comprising at least one outermost portion and a plurality of depressions. The depressions occupy at least about 80% of the surface area of the surface. The depressions contain a coating material that preferably comprises a biologically active material and/or polymer, and the outermost portion is substantially free of any coating material. The invention is also directed to a method for manufacturing a medical device. The method comprises applying a coating material to the surface of the medical device by using at least one roller.

Abstract: A composition for delivery of a therapeutic agent is provided. The composition comprises: (a) a biocompatible block copolymer comprising one or more elastomeric blocks and one or more thermoplastic blocks and (b) a therapeutic agent, wherein the block copolymer is loaded with the therapeutic agent. The block copolymer is preferably of the formula X-(AB)n, where A is an elastomeric block, B is a thermoplastic block, n is a positive whole number and X is a seed molecule. The elastomeric blocks are preferably polyolefin blocks, and the thermoplastic blocks are preferably selected from vinyl aromatic blocks and methacrylate blocks. According to another aspect of the invention, a medical device is provided, at least a portion of which is insertable or implantable into the body of a patient. The medical device comprises (a) the above biocompatible block copolymer and (b) a therapeutic agent, wherein the block copolymer is loaded with the therapeutic agent.