초록

A medical device that includes at least one surface structure and/or micro-structure that is at least partially coated with a protective coating.

대표청구항 ▼

1. A medical device having a body portion that includes a plurality of micro-structures connected to said body portion, said medical device is a stent, sheath, or balloon, at least a portion of said micro-structures includes a plurality of micro-needles that extend upwardly from an outer surface of

1. A medical device having a body portion that includes a plurality of micro-structures connected to said body portion, said medical device is a stent, sheath, or balloon, at least a portion of said micro-structures includes a plurality of micro-needles that extend upwardly from an outer surface of said body portion, said protective material coated on said outer surface of said medical device and said plurality of micro-needles, said protective coating at least partially embedding said plurality of micro-needles in said protective coating so as to protect said plurality of micro-needles from damage prior to positioning said medical device at a treatment location, said protective material formed of a biodegradable material, said protective material formed of a different material composition than said plurality of micro-needles and said outer surface of said medical device, said plurality of micro-needles having a shape and size designed to penetrate into a treatment location of a body passageway when said body portion is expanded to an expanded cross-sectional area. 2. The medical device as defined in claim 1, wherein at least a portion of said medical device is formed by MEMS technology. 3. The medical device as defined in claim 1, wherein at least one region of said medical device includes at least one biological agent. 4. The medical device as defined in claim 3, wherein said at least one biological agent includes one or more compounds selected from the group consisting of trapidil, trapidil derivatives, taxol, taxol derivatives, cytochalasin, cytochalasin derivatives, paclitaxel, paclitaxel derivatives, rapamycin, rapamycin derivatives, GM-CSF, and GM-CSF derivatives. 5. The medical device as defined in claim 3, wherein at least one region of said medical device includes at least one polymer to at least partially coat said at least biological agent, at least partially encapsulate said at least biological agent, or at least partially coat and encapsulate said at least biological agent. 6. The medical device as defined in claim 5, wherein said at least one polymer is designed to controllably release at least one of said biological agents when said medical device is positioned in the body passageway. 7. The medical device as defined in claim 5, wherein said at least one polymer includes one or more polymers selected from the group consisting of parylene, a parylene derivative, chitosan, a chitosan derivative, PLGA, a PLGA derivative, PLA, a PLA derivative, PEVA, a PEVA derivative, PBMA, a PBMA derivative, POE, a POE derivative, PGA, a PGA derivative, PLLA, a PLLA derivative, PAA, a PAA derivative, PEG, and a PEG derivative. 8. The medical device as defined in claim 1, wherein said at least one micro-structure is at least partially formed by MEMS technology. 9. The medical device as defined in claim 1, wherein said plurality of micro-needles is at least partially formed of one or more materials, at least partially includes one or more materials, or at least partially includes and is at least partially formed of one or more materials, said one or more materials selected from the group consisting of a polymer, and a biological agent. 10. The medical device as defined in claim 1, wherein said medical device includes at least one internal structure, said internal structure including one or more materials selected from the group consisting of a polymer, and a biological agent. 11. The medical device as defined in claim 1, wherein said protective material at least partially controls a release rate of one or more materials from a plurality of said micro-needles. 12. A medical device that includes a body potion, said body portion includes a plurality of micro-structures, said medical device being a stent or a sheath, at least one region of said medical device includes biological agent, at least one region of said medical device includes polymer to a) at least partially coat said biological agent, b) at least partially encapsulate said biological agent, or c) at least partially coat and encapsulate said biological agent, at least a portion of said micro-structures connected to and extending upwardly from an outer surface of said body portion, said micro-structures extending upwardly from said outer surface of said body portion a distance of no more than 2 mm, said protective material formed of a different material composition than said outer surface of said medical device and said plurality of micro-structures extending upwardly from said outer surface of said body portion, said protective material coated on said outer surface of said medical device and said plurality of micro-structures extending upwardly from said outer surface of said body portion, said protective coating at least partially embedding said plurality of micro-structures extending upwardly from said outer surface of said body portion in said protective coating so as to at least partially protect said plurality of micro-structures from damage prior to positioning said medical device at a treatment location, said plurality of said micro-structures that extends upwardly from said outer surface of said body portion is i) at least partially formed of one or more materials, ii) at least partially includes one or more materials, or iii) at least partially includes and is at least partially formed of one or more materials, said one or more materials selected from the group consisting of said polymer and said biological agent, said plurality of said micro-structures that extends upwardly from said outer surface of said body portion coated with or including said biological agent, said plurality of micro-structures that extends upwardly from said outer surface of said body portion having a shape and size designed to penetrate into a treatment location of a body passageway when said body portion is expanded to an expanded cross-sectional area and to deliver said biological agent in said penetrated region of said body passageway, said biological agent including one or more compounds selected from the group consisting of trapidil, trapidil derivatives, taxol, taxol derivatives, cytochalasin, cytochalasin derivatives, paclitaxel, paclitaxel derivatives, rapamycin, rapamycin derivatives, GM-CSF, and GM-CSF derivatives, said polymer including one or more polymers selected from the group consisting of parylene, a parylene derivative, chitosan, a chitosan derivative, PLGA, a PLGA derivative, PLA, a PLA derivative, PEVA, a PEVA derivative, PBMA, a PBMA derivative, POE, a POE derivative, PGA, a PGA derivative, PLLA, a PLLA derivative, PAA, a PAA derivative, PEG, and a PEG derivative. 13. The medical device as defined in claim 12, wherein said plurality of said micro-structures that extends upwardly from said outer surface of said body portion includes micro-needles. 14. The medical device as defined in claim 12, wherein said protective material at least partially controls a release rate of one or more materials from at least one of said micro-structures. 15. The medical device as defined in claim 13, wherein said protective material at least partially controls a release rate of one or more materials from at least one of said micro-needles. 16. The medical device as defined in claim 12, wherein said biological agent is included in or coated on said plurality of said micro-structures that extends upwardly from said outer surface of said body portion, said biological agent includes rapamycin or rapamycin derivatives. 17. The medical device as defined in claim 15, wherein said biological agent is included in or coated on said plurality of said micro-structures that extends upwardly from said outer surface of said body portion, said biological agent includes rapamycin or rapamycin derivatives. 18. The medical device as defined in claim 12, wherein said at least one polymer includes poly(lactic acid) or poly(lactic acid) derivatives. 19. The medical device as defined in claim 17, wherein said at least one polymer includes poly(lactic acid) or poly(lactic acid) derivatives. 20. The medical device as defined in claim 12, wherein said protective material is biodegradable. 21. The medical device as defined in claim 19, wherein said protective material is biodegradable. 22. A medical device for use in a body passageway, said medical device including a stent having a body potion, an outer surface of said body portion including a plurality of micro-structures, at least a portion of micro-structures extending upwardly from said outer surface of said body portion, said micro-structures that extend upwardly from said outer surface of said body portion extending no more than about 2 mm upwardly from said outer surface of said body portion, said protective material also coated on said outer surface of said body portion, said protective material at least partially embedding said plurality of micro-structures extending upwardly from said outer surface of said body portion in said protective coating so as to protect said plurality of micro-structures that extend upwardly from said outer surface of said body portion from damage prior to positioning said medical device at a treatment location of the body passageway, said protective material designed and formulated to enable said plurality of micro-structures to at least partially breaks from or penetrates through said protective coating when said stent is expanded, said protective material is a biodegradable material, said protective material formed of a different material composition than outer surface of said medical device and said plurality of micro-structures extending upwardly from said outer surface of said body portion, said protective material including one or more materials selected from the group consisting of a first biological agent, adhesive, sugar, carbohydrate compound, paraffin, starch and salt, said plurality of micro-structures that extend upwardly from said outer surface of said body portion are fully formed of one or more materials selected from the group consisting of said polymer and biological agent, said plurality of said micro-structures that extend upwardly from said outer surface of said body portion coated with or including said biological agent, said plurality of micro-structures that extend upwardly from said outer surface of said body portion having a shape and size designed to penetrate into said treatment location of said body passageway when said body portion is expanded to an expanded cross-sectional area and to deliver said biological agent in said penetrated region of said body passageway, said biological agent including one or more compounds selected from the group consisting of trapidil, trapidil derivatives, taxol, taxol derivatives, cytochalasin, cytochalasin derivatives, paclitaxel, paclitaxel derivatives, rapamycin, rapamycin derivatives, GM-CSF, and GM-CSF derivatives, said polymer including one or more polymers selected from the group consisting of parylene, a parylene derivative, chitosan, a chitosan derivative, PLGA, a PLGA derivative, PLA, a PLA derivative, PEVA, a PEVA derivative, PBMA, a PBMA derivative, POE, a POE derivative, PGA, a PGA derivative, PLLA, a PLLA derivative, PAA, a PAA derivative, PEG, and a PEG derivative. 23. The medical device as defined in claim 22, wherein said plurality of said micro-structures extending upwardly from said outer surface of said body portion are micro-needles, a plurality of said micro-needles includes polymer and biological agent. 24. The medical device as defined in claim 22, wherein said plurality of said micro-structures extend upwardly from said outer surface of said body portion a distance of at least about 15 μm and no more than about 400 μm. 25. The medical device as defined in claim 23, wherein a plurality of said micro-structures extend upwardly from said outer surface of said body portion a distance of at least about 15 μm and no more than about 400 μm. 26. The medical device as defined in claim 22, wherein said plurality of said micro-structures include trapidil, trapidil derivatives, GM-CSF, GM-CSF derivatives, or combinations thereof. 27. The medical device as defined in claim 25, wherein said plurality of said micro-structures include trapidil, trapidil derivatives, GM-CSF, GM-CSF derivatives, or combinations thereof. 28. The medical device as defined in claim 27, wherein said plurality of said micro-structures extend upwardly from said outer surface of said body portion a distance of about 15-250 μm. 29. The medical device as defined in claim 22, wherein said protective material controls a release rate of said biological agent from said plurality of said micro-structures that extend upwardly from said outer surface of said body portion. 30. The medical device as defined in claim 23, wherein said protective material controls a release rate of said biological agent from said plurality of said micro-needles. 31. The medical device as defined in claim 28, wherein said protective material controls a release rate of said biological agent from said plurality of said micro-needles. 32. The medical device as defined in claim 1, wherein said protective material having a coating thickness that is generally uniform on said outer surface of said body portion, said coating thickness of said protective material on said various regions of said plurality of micro-needles being non-uniform. 33. The medical device as defined in claim 32, wherein said coating thickness of protective material is a thickness that results in said plurality of micro-needles being fully embedded in said protective material. 34. The medical device as defined in claim 12, wherein said protective material having a coating thickness that is generally uniform on said outer surface of said body portion, said coating thickness of said protective material on said various regions of said plurality of micro-structures extending upwardly from said outer surface of said body portion being non-uniform. 35. The medical device as defined in claim 21, wherein said protective material having a coating thickness that is generally uniform on said outer surface of said body portion, said coating thickness of said protective material on said various regions of said plurality of micro-structures extending upwardly from said outer surface of said body portion being non-uniform. 36. The medical device as defined in claim 34, wherein said coating thickness of protective material is a thickness that results in said plurality of micro-structures extending upwardly from said outer surface of said body portion being fully embedded in said protective material. 37. The medical device as defined in claim 35, wherein said coating thickness of protective material is a thickness that results in said plurality of micro-structures extending upwardly from said outer surface of said body portion being fully embedded in said protective material. 38. The medical device as defined in claim 22, wherein said protective material having a coating thickness that is generally uniform on said outer surface of said body portion, said coating thickness of said protective material on said various regions of said plurality of micro-structures extending upwardly from said outer surface of said body portion being non-uniform. 39. The medical device as defined in claim 31, wherein said protective material having a coating thickness that is generally uniform on said outer surface of said body portion, said coating thickness of said protective material on said various regions of said plurality of micro-structures extending upwardly from said outer surface of said body portion being non-uniform. 40. The medical device as defined in claim 38, wherein said coating thickness of protective material is a thickness that results in said plurality of micro-structures extending upwardly from said outer surface of said body portion being fully embedded in said protective material. 41. The medical device as defined in claim 39, wherein said coating thickness of protective material is a thickness that results in said plurality of micro-structures extending upwardly from said outer surface of said body portion being fully embedded in said protective material. 42. The medical device as defined in claim 1, wherein said protective material is designed and formulated to enable said plurality of micro-structures to at least partially break from or penetrate through said protective coating when said stent is expanded, said protective material including one or more materials selected from the group consisting of a first biological agent, adhesive, sugar, carbohydrate compound, paraffin, starch and salt. 43. The medical device as defined in claim 12, wherein said protective material is designed and formulated to enable said plurality of micro-structures to at least partially break from or penetrate through said protective coating when said stent is expanded, said protective material including one or more materials selected from the group consisting of a first biological agent, adhesive, sugar, carbohydrate compound, paraffin, starch and salt. 44. The medical device as defined in claim 38, wherein said protective material is designed and formulated to enable said plurality of micro-structures to at least partially break from or penetrate through said protective coating when said stent is expanded, said protective material including one or more materials selected from the group consisting of a first biological agent, adhesive, sugar, carbohydrate compound, paraffin, starch and salt.