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1. WO2011008896 - THERAPEUTIC METHODS USING CONTROLLED DELIVERY DEVICES HAVING ZERO ORDER KINETICS

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[ EN ]

CLAIMS

What is claimed is:

1. A device for delivery of one or more active agents comprising:

an impermeable, biocompatible housing matrix enclosing a supply of one or more active agents, wherein the matrix comprises one or more passageways that extend from a surface of the housing to the supply of the one or more active agents wherein the passageways provide for release of the active agents with zero order release kinetics.

2. The device of claim 1, wherein the matrix is at least one of nonbiodegradable, biodegradable, nonbioresorbable, bioresorbable or a combination or modification thereof.

3. The device of claim 1, wherein the one or more active agents is in a dosage form selected from the group consisting of a solid dosage form, a liquid dosage form, a semi-solid dosage, a powder, or a hydrogel with or without the use of a polymer.

4. The device of claim 3, wherein the polymer is a natural polymer, a synthetic polymer or a combination thereof.

5. The method of claim 4, wherein the natural polymer is selected from the group consisting of anionic polymers, alginic acid, pectin, carrageenan, chondroitin sulfate, dextran sulfate, cationic polymers, chitosan, polylysine, amphipathic polymers, collagen, carboxymethyl chitin, fibrin, and neutral polymers, dextran, agarose, pullulan, and combinations and modifications thereof.

6. The method of claim 4, wherein the synthetic polymer is selected from the group consisting of poly (vinyl alcohol), poly (ethylene oxide), poly (vinyl pyrrolidone), poly (N-isopropylacrylamide), poly- (caprolactone), poly(hydroxybutyrate), HEMA (hydroxyethylmethacrylate), PMMA (poly(methyl methacrylate), PEMA (poly(ethyl methacrylate), PAAm (polyacrylamide), cyclodextrin, and

combinations and modifications thereof.

7. The device of claim 1, wherein the housing matrix is selected from the group consisting of a polymer, a rubber, a metal, a mineral, a ceramic or a glass.

8. The device of claim 1, wherein the passageway is selected from the group consisting of a hole, a perforation, a channel, an orifice, an aperture, a bore or combinations thereof.

9. The device of claim 1, wherein the active agent is selected from the group consisting of a therapeutic drug, a vitamin, a mineral, a saccharide, a lipid, a nucleic acid, a protein, a peptide, and combinations thereof.

10. The device of claim 9, wherein the therapeutic drug is selected from the group consisting of an analgesic agent, an antiinflammatory agent, an antihistaminic agent, an antiallergic agent, a central nervous system drug, an antipyretic agent, a respiratory agent, a steroid, a local anesthetic, a

sympathomimetic agent, an antihypertensive agent, an antipsychotic agent, a calcium antagonist, a

muscle relaxant, a vitamin, a cholinergic agonist, an antidepressant, an antispasmodic agent, a mydriatic agent, an anti-diabetic agent, an anorectic agent, an antiulcerative agent, an anti-tumor agent or combinations modifications thereof.

11. The device of claim 9, wherein the proteins are selected from the group consisting of an immunoglobulin or fragments thereof, a hormone, an enzyme, a cytokine, a biomolecule, and

combinations and modifications thereof.

12. The device of claim 1, wherein the device comprises a geometrical shape selected from the group consisting of a cuboid, a cube, a sphere, a cone, an oval, and a cylinder.

13. The device of claim 1, wherein the device may optionally be attached to a medical device or a microelectronic circuit, wherein the microelectronic circuit comprises at least one of a sensor, a transmitter, a receiver, a transceiver, a switch, a power supply or a light.

14. The device of claim 13, wherein the medical device is selected from the group consisting of a stent, an urinary catheter, an intravascular catheter, a dialysis shunt, a wound drain tube, a skin suture, a vascular graft, an implantable mesh, an intraocular device, an eye buckle, a heart valve, and combinations and modifications thereof.

15. The device of claim 1, wherein the passageways range from 5 nanometers - 1 centimeter, 100 nanometers - 100 microns, 1 micron - 50 microns, 10 - 30 microns, 15 - 25 microns or 20 microns.

16. The device of claim 1, wherein the device is coated with a coating that prevents release of the one or more active agents until the coating is removed, which then causes release of the one or more active agents at a substantially constant rate.

17. A controlled release delivery system for providing a unidirectional release one or more active agents, comprising:

an impermeable housing matrix comprising an outlet port and encompassing an active agent supply, wherein the housing matrix is selected from the group consisting of a polymer, a metal, a mineral, a ceramic, or a glass, and the active agent supply comprises the one or more active agents selected from the group consisting of a diagnostic agent, a therapeutic agent, a prophylactic agent, a nutritional agent, or combinations thereof;

a polymer coating encapsulating the impermeable housing matrix, wherein the polymer coating is at least one of biocompatible, biodegradable, bioresorbable or a combination thereof; and

one or more passageways selected to provide zero order release kinetics that comprise at least one of a hole, a perforation, a channel, an orifice, an aperture, a bore, or combinations thereof, wherein the passageway extends from a surface of the polymer coating to the active agent supply.

18. The delivery system of claim 17, wherein the polymer coating is selected from the group consisting of polysaccharides, proteins, poly(ethylene glycol), poly(methacrylates), poly(ethylene-co-vinyl acetate), poly(DL-lactide), poly(glycolide), copolymers of lactide and glycolide, polyanhydride copolymers, and combinations and modifications thereof.

19. The delivery system of claim 17, wherein the passageways range from 5 nanometers - 1 centimeter, 100 nanometers - 100 microns, 1 micron - 50 microns, 10 - 30 microns, 15 - 25 microns or 20 microns.

20. The delivery system of claim 17, wherein the therapeutic agent or the prophylactic agent is selected from the group consisting of a drug, a protein, a peptide, a biomarker, a bioanalyte, a genetic material, and combinations and modifications thereof.

21. The delivery system of claim 20, wherein the drug is selected from the group consisting of an analgesic agent, an antiinflammatory agent, an antihistaminic agent, an antiallergic agent, a central nervous system drug, an antipyretic agent, a respiratory agent, a steroid, a local anesthetic, a

sympathomimetic agent, an antihypertensive agent, an antipsychotic agent, a calcium antagonist, a muscle relaxant, a vitamin, a cholinergic agonist, an antidepressant, an antispasmodic agent, a mydriatic agent, an antidiabetic agent, an anorectic agent, an antiulcerative agent, an antitumor agent, and combinations or modifications thereof.

22. The delivery system of claim 20, wherein the proteins are selected from the group consisting of an immunoglobulin, an antibody, a hormone, an enzyme, a cytokine, a biomolecule, and combinations and modifications thereof.

23. The delivery system of claim 17, wherein the system comprises a geometrical shape, wherein the said geometrical shape is selected from the group consisting of a cuboid, a cube, a sphere, a cone, an oval, and a cylinder.

24. The delivery system of claim 17, wherein the system may optionally be attached to a stent or a microelectronic sensor circuit, wherein the sensor comprises a transmitter.

25. A drug delivery device comprising a surface configured for a controlled release of a drug supply to a body organ, a tissue, a lumen, a blood vessel, wherein the drug release is maintained at a substantially constant rate, thereby resulting in zero order release kinetics, wherein the device encompasses the drug supply.

26. The device of claim 25, wherein the surface comprises one or more passageways comprising a hole, a perforation, a channel, an orifice, an aperture, a bore, or combinations thereof, wherein the passageway extends from the surface of the device to the drug supply.

27. The device of claim 25, wherein the device has a geometrical shape selected from the group consisting of a cuboid, a cube, a sphere, a cone, an oval, and a cylinder.

28. The device of claim 25, wherein the device may optionally be coated by a polymer, wherein the polymer is selected from the group consisting of polysaccharides, proteins, poly(ethylene glycol), poly(methacrylates), poly(ethylene-co-vinyl acetate), poly(DL-lactide), poly(glycolide), copolymers of lactide and glycolide, polyanhydride copolymers, and combinations and modifications thereof.

29. The device of claim 25, wherein the device comprises a biocompatible material selected from the group consisting of a polymer, a metal, a mineral, a ceramic, a glass, and combinations and modifications thereof.

30. The device of claim 25, wherein the drug supply is loaded by a method selected from the group consisting of capillary action, dipping, injecting, and pressure loading using positive or negative pressures.

31. The device of claim 25, wherein the device further comprises a housing impermeable to the drug supply and bodily fluids.

32. The device of claim 25, wherein said device further comprises at least one end having an outlet port, wherein the drug release occurs through said outlet port.

33. The device of claim 25, wherein a number and a size of at least one passageway modulates a rate and an extent of release of the drug.

34. The device of claim 25, wherein the device releases the drug supply into the body lumen for a time period ranging from days to several years.

35. The device of claim 25, wherein the rate and the extent of drug release is dependent on one or more parameters selected from the group consisting of drug solubility, device dimensions, passageway dimensions, and drug density.

36. The device of claim 25, wherein the drug release rate is manipulated by changing a parameter selected from the group consisting of one or more holes on the surface, diameter of the holes, distance between the holes, diameter of the tube, length of the tube, solubility of the drug, and the amount of drug supply.

37. The device of claim 25, wherein the passageway has a diameter ranging approximately between 5 nanometers - 1 centimeter, 100 nanometers - 100 microns, 1 micron - 50 microns, 10 - 30 microns, 15 -25 microns or 20 microns.

38. The device of claim 25, wherein the drug supply is selected from a drug depot or a drug reservoir comprising a solid, a liquid, a semi-solid, and a suspension.

39. The device of claim 25, wherein the drug is a member of a biopharmaceutical classification system (BCS) class selected from the group consisting of Class I (High permeability, High solubility); Class II (Low solubility, Low Permeability); Class III (High Solubility, Low Permeability), and Class IV (Low solubility, Low permeability).

40. The device of claim 25, wherein the device is configured for long-term administration in a biological organism by a method selected from the group consisting of implantation, insertion, and injection.

41. The device of claim 25, wherein the device comprises one or more units.

42. The device of claim 25, wherein the device is attached to a medical device, wherein the medical device is a stent.

43. A method for fabricating a controlled release delivery system for providing a unidirectional release one or more active agents with zero order release kinetics, wherein the active agents are selected from the group consisting of a drug, a diagnostic agent, a therapeutic agent, a prophylactic agent or combinations thereof comprising the steps of:

providing a silicon-wafer substrate comprising a trench;

placing a non-planar polyimide housing comprising a hollow core within the trench;

etching one or more passageways extending from the housing surface into the hollow core, wherein the etching is done by reactive ion etching, laser ablation or any other suitable technique; and loading an active agent supply comprising a drug depot or reservoir by a method selected from the group consisting of capillary action, dipping, injecting, and pressure loading using positive or negative pressures.

44. The method of claim 43, further comprising the optional step of coating the housing with a polymer, wherein the polymer is selected from the group consisting of polysaccharides, proteins, poly(ethylene glycol), poly(methacrylates), poly(ethylene-co-vinyl acetate), poly(DL-lactide), poly(glycolide), copolymers of lactide and glycolide, polyanhydride copolymers, and combinations and modifications thereof.

45. The method of claim 43, wherein the passageways comprise micro-holes having diameters ranging from 5 nanometers - 1 centimeter, 100 nanometers - 100 microns, 1 micron - 50 microns, 10 -30 microns, 15 - 25 microns or 20 microns.