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Kafe 바로가기국가/구분 | United States(US) Patent 등록 |
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국제특허분류(IPC7판) |
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출원번호 | US-0646333 (2003-08-22) |
발명자 / 주소 |
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출원인 / 주소 |
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대리인 / 주소 |
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인용정보 | 피인용 횟수 : 790 인용 특허 : 197 |
An implantable sensor for use in measuring a concentration of an analyte such as glucose in a bodily fluid, including a body with a sensing region adapted for transport of analytes between the sensor and the bodily fluid, wherein the sensing region is located on a curved portion of the body such tha
An implantable sensor for use in measuring a concentration of an analyte such as glucose in a bodily fluid, including a body with a sensing region adapted for transport of analytes between the sensor and the bodily fluid, wherein the sensing region is located on a curved portion of the body such that when a foreign body capsule forms around the sensor, a contractile force is exerted by the foreign body capsule toward the sensing region. The body is partially or entirely curved, partially or entirely covered with an anchoring material for supporting tissue ingrowth, and designed for subcutaneous tissue implantation. The geometric design, including curvature, shape, and other factors minimize chronic inflammatory response at the sensing region and contribute to improved performance of the sensor in vivo.
What is claimed is: 1. An implantable sensor for use in measuring a concentration of an analyte in a bodily fluid, the sensor comprising: a sensor body comprising a sensing region adapted for transport of an analyte thereto, and a porous biointerface material that covers at least a portion of the s
What is claimed is: 1. An implantable sensor for use in measuring a concentration of an analyte in a bodily fluid, the sensor comprising: a sensor body comprising a sensing region adapted for transport of an analyte thereto, and a porous biointerface material that covers at least a portion of the sensing region, wherein the porous biointerface material covering the portion of the sensing region supports tissue ingrowth, wherein the sensing region is located on a curved portion of the body such that when a foreign body capsule forms around the sensor, a contractile force is exerted by the foreign body capsule toward the sensing region, wherein the body comprises a first surface on which the sensing region is located and a second surface, and wherein said first surface comprises an anchoring material thereon for supporting tissue ingrowth and wherein said second surface is located opposite said first surface, and wherein said second surface is substantially smooth and comprises a biocompatible material that is non-adhesive to tissues. 2. The sensor of claim 1, wherein said second surface is curved. 3. The sensor of claim 1, wherein the sensor is a subcutaneous sensor. 4. The sensor of claim 1, wherein the sensor is configured for implantation in a soft tissue of a body. 5. The sensor of claim 1, wherein the sensor is a glucose sensor. 6. The sensor of claim 1, comprising a mechanical anchoring mechanism formed on the body. 7. The sensor of claim 6, wherein the mechanical anchoring mechanism is selected from the group consisting of prongs, spines, barbs, wings, hooks, a helical surface topography, and a gradually changing diameter. 8. The sensor of claim 1, wherein the biointerface material comprises interconnected cavities dimensioned and arranged to create contractile forces that counteract a generally uniform downward fibrous tissue contracture caused by the foreign body capsule in vivo and thereby interfere with formation of occlusive cells. 9. The sensor of claim 1, wherein said first surface, when viewed from a direction perpendicular to a center of said first surface, has a substantially rectangular profile with rounded corners. 10. The sensor of claim 1, wherein the anchoring material is selected from the group consisting of polyester, polypropylene cloth, polytetrafluoroethylene felts, expanded polytetrafluoroethylene, and porous silicone. 11. The sensor of claim 1, wherein the body comprises at least one of metal, ceramic, plastic, and glass. 12. The sensor of claim 11, wherein the body comprises a plastic. 13. The sensor of claim 12, wherein the plastic is selected from the group consisting of thermoplastic and thermoset plastic. 14. The sensor of claim 13, wherein the thermoset plastic is an epoxy. 15. The sensor of claim 1, wherein the sensing region is situated approximately at an apex of a surface of the body. 16. The sensor of claim 1, wherein the body is substantially cylindrical. 17. The sensor of claim 16, wherein a radius of curvature of the body is from about 0.5 mm to about 10 cm. 18. The sensor of claim 1, wherein the sensor further comprises an electronics body, and wherein the sensor body is tethered to the electronics body. 19. The sensor body of claim 18, wherein the electronics body is substantially cylindrical. 20. An implantable sensor for use in measuring a concentration of an analyte in a bodily fluid, the sensor comprising: a sensor body comprising a sensing region adapted for transport of an analyte thereto, and a porous biointerface material that covers at least a portion of the sensing region, wherein the porous biointerface material covering the portion of the sensing region supports tissue ingrowth, wherein the sensing region is located on a curved portion of the body such that when a foreign body capsule forms around the sensor, a contractile force is exerted by the foreign body capsule toward the sensing region, and wherein the body comprises a first major surface on which said sensing region is located and a second major surface, wherein the first major surface has edges between which a width of the first major surface can be measured, and wherein the sensing region is spaced away from the edges by a distance that is at least about 10% of the width of the first major surface. 21. The sensor of 20, wherein the sensing region is spaced away from the edges by a distance that is at least about 15% of the width of the first major surface. 22. The sensor of claim 20, wherein the sensing region is spaced away from the edges by a distance that is at least about 20% of the width of the first major surface. 23. The sensor of claim 20, wherein the sensing region is spaced away from the edges by a distance that is at least about 25% of the width of the first major surface. 24. The sensor of claim 20, wherein the sensing region is spaced away from the edges by a distance that is at least about 30% of the width of the first major surface. 25. The sensor of claim 20, wherein the spacing of the sensing region from the edges is true for at least two width measurements, which measurements are taken generally transverse to each other. 26. The sensor of claim 20, wherein the sensor is a subcutaneous sensor. 27. The sensor of claim 20, wherein the sensor is configured for implantation in a soft tissue of a body. 28. The sensor of claim 20, wherein the sensor is a glucose sensor. 29. The sensor of claim 20, further comprising a mechanical anchoring mechanism formed on the body. 30. The sensor of claim 29, wherein the mechanical anchoring mechanism is selected from the group consisting of prongs, spines, barbs, wings, hooks, a helical surface topography, and a gradually changing diameter. 31. The sensor of claim 20, wherein the biointerface material comprises interconnected cavities dimensioned and arranged to create contractile forces that counteract a generally uniform downward fibrous tissue contracture caused by the foreign body capsule in vivo and thereby interfere with formation of occlusive cells. 32. The sensor of claim 20, wherein said first major surface, when viewed from a direction perpendicular to a center of said first major surface, has a substantially rectangular profile with rounded corners. 33. The sensor of claim 20, further comprising an anchoring material connected to the body and selected from the group consisting of polyester, polypropylene cloth, polytetrafluoroethylene felts, expanded polytetrafluoroethylene, and porous silicone. 34. The sensor of claim 20, wherein the body comprises at least one of metal, ceramic, plastic, and glass. 35. The sensor of claim 34, wherein the body comprises a plastic. 36. The sensor of claim 35, wherein the plastic is selected from the group consisting of thermoplastic and thermoset plastic. 37. The sensor of claim 36, wherein the thermoset plastic is an epoxy. 38. The sensor of claim 20, wherein the sensing region is situated approximately at an apex of a surface of the body. 39. The sensor of claim 20, wherein the body is substantially cylindrical. 40. The sensor of claim 39, wherein a radius of curvature of the body is from about 0.5 mm to about 10 cm. 41. The sensor of claim 20, wherein the sensor further comprises an electronics body, and wherein the sensor body is tethered to the electronics body. 42. The sensor of claim 41, further comprising an anchoring material on the sensing body. 43. The sensor body of claim 41, wherein the electronics body is substantially cylindrical. 44. An implantable sensor for use in measuring a concentration of an analyte in a bodily fluid, the sensor comprising: a sensor body comprising a sensing region adapted for transport of an analyte thereto, and a porous biointerface material that covers at least a portion of the sensing region, wherein the porous biointerface material covering the portion of the sensing region supports tissue ingrowth, wherein the sensing region is located on a curved portion of the body such that when a foreign body capsule forms around the sensor, a contractile force is exerted by the foreign body capsule toward the sensing region, wherein the sensor comprises a major surface and wherein said curved portion is located on at least a portion of the major surface, and wherein the body comprises a first major surface on which said sensing region is located and a second major surface, wherein the first major surface is at least slightly convex. 45. The sensor of claim 44, wherein a reference plane may be defined that touches the first major surface at a point spaced in from edges of the first major surface, and is generally parallel to the first major surface, and is spaced away from opposite edges of the first major surface due to convexity of the first major surface, and wherein a location of an edge is the point at which a congruent line or a normal line is angled 45 degrees with respect to the reference plane. 46. The sensor of claim 44, wherein the reference plane is spaced from the edges a distance that is at least about 3% from the edges, and not more than 50% of the width. 47. The sensor of claim 44, wherein the reference plane is spaced from the edges a distance that is at least about 3% from the edges, and not more than 25% of the width. 48. The sensor of claim 44, wherein the reference plane is spaced from the edges a distance that is at least about 3% from the edges, and not more tan 15% of the width. 49. The sensor of claim 44, wherein the sensor is a subcutaneous sensor. 50. The sensor of claim 44, wherein the sensor is configured for implantation in a soft tissue of a body. 51. The sensor of claim 44, wherein the sensor is a glucose sensor. 52. The sensor of claim 44, further comprising a mechanical anchoring mechanism formed on the body. 53. The sensor of claim 52, wherein the mechanical anchoring mechanism is selected from the group consisting of prongs, spines, barbs, wings, hooks, a helical surface topography, and a gradually changing diameter. 54. The sensor of claim 44, wherein the biointerface material comprises interconnected cavities dimensioned and arranged to create contractile forces that counteract a generally uniform downward fibrous tissue contracture caused by the foreign body capsule in vivo and thereby interfere with formation of occlusive cells. 55. The sensor of claim 44, wherein said first major surface, when viewed from a direction perpendicular to a center of said first major surface, has a substantially rectangular profile with rounded corners. 56. The sensor of claim 44, further comprising an anchoring material connected to the body and selected from the group consisting of polyester, polypropylene cloth, polytetrafluoroethylene felts, expanded polytetrafluoroethylene, and porous silicone. 57. The sensor of claim 44, wherein the body comprises at least one of metal, ceramic, plastic, and glass. 58. The sensor of claim 44, wherein the body comprises a plastic. 59. The sensor of claim 58, wherein the plastic is selected from the group consisting of thermoplastic and thermoset plastic. 60. The sensor of claim 59, wherein the thermoset plastic is an epoxy. 61. The sensor of claim 44, wherein the sensing region is situated approximately at an apex of a surface of the body. 62. The sensor of claim 44, wherein the body is substantially cylindrical. 63. The sensor of claim 62, wherein a radius of curvature of the body is from about 0.5 mm to about 10 cm. 64. The sensor of claim 44, wherein the sensor further comprises an electronics body, and wherein the sensor body is tethered to the electronics body. 65. The sensor of claim 64, further comprising an anchoring material on the sensing body. 66. The sensor body of claim 64, wherein the electronics body is substantially cylindrical. 67. An implantable sensor for use in measuring a concentration of an analyte in a bodily fluid, the sensor comprising: a sensor body comprising a sensing region adapted for transport of an analyte thereto, and a porous biointerface material that covers at least a portion of the sensing region, wherein the porous biointerface material covering the portion of the sensing region supports tissue ingrowth, wherein the sensing region is located on a curved portion of the body such that when a foreign body capsule forms around the sensor, a contractile force is exerted by the foreign body capsule toward the sensing region, and wherein the body defines a surface area, and wherein between 10% and 100% of the surface area is convexly curved. 68. The sensor of claim 67, wherein the sensor is a subcutaneous sensor. 69. The sensor of claim 67, wherein the sensor is configured for implantation in a soft tissue of a body. 70. The sensor of claim 67, wherein the sensor is a glucose sensor. 71. The sensor of claim 67, further comprising a mechanical anchoring mechanism formed on the body. 72. The sensor of claim 71, wherein the mechanical anchoring mechanism is selected from the group consisting of prongs, spines, barbs, wings, hooks, a helical surface topography, and a gradually changing diameter. 73. The sensor of claim 67, wherein the biointerface material comprises interconnected cavities dimensioned and arranged to create contractile forces that counteract a generally uniform downward fibrous tissue contracture caused by the foreign body capsule in vivo and thereby interfere with formation of occlusive cells. 74. The sensor of claim 67, wherein the body comprises a first surface and a second surface, and wherein said first surface, when viewed from a direction perpendicular to a center of said first surface, has a substantially rectangular profile with rounded corners. 75. The sensor of claim 67, further comprising an anchoring material connected to the body and selected from the group consisting of polyester, polypropylene cloth, polytetrafluoroethylene felts, expanded polytetrafluoroethylene, and porous silicone. 76. The sensor of claim 67, wherein the body comprises at least one of metal, ceramic, plastic, and glass. 77. The sensor of claim 67, wherein the body comprises a plastic. 78. The sensor of claim 77, wherein the plastic is selected from the group consisting of thermoplastic and thermoset plastic. 79. The sensor of claim 78 wherein the thermoset plastic is an epoxy. 80. The sensor of claim 67, wherein the sensing region is situated approximately at an apex of a surface of the body. 81. The sensor of claim 67, wherein the body is substantially cylindrical. 82. The sensor of claim 81, wherein a radius of curvature of the body is from about 0.5 mm to about 10 cm. 83. The sensor of claim 67, wherein the sensor further comprises an electronics body, and wherein the sensor body is tethered to the electronics body. 84. The sensor of claim 83, further comprising an anchoring material on the sensing body. 85. The sensor body of claim 83, wherein the electronics body is substantially cylindrical. 86. An implantable sensor for use in measuring a concentration of an analyte in a bodily fluid, the sensor comprising: a sensor body comprising a sensing region adapted for transport of an analyte thereto, and a porous biointerface material that covers at least a portion of the sensing region, wherein the porous biointerface material covering the portion of the sensing region supports tissue ingrowth, wherein the sensing region is located on a curved portion of the body such that when a foreign body capsule forms around the sensor, a contractile force is exerted by the foreign body capsule toward the sensing region, and wherein the body defines a surface area, and wherein a substantial portion of the surface area is convexly curved. 87. The sensor of claim 86, wherein the sensor is a subcutaneous sensor. 88. The sensor of claim 86, wherein the sensor is configured for implantation in a soft tissue of a body. 89. The sensor of claim 86, wherein the sensor is a glucose sensor. 90. The sensor of claim 86, further comprising a mechanical anchoring mechanism formed on the body. 91. The sensor of claim 90, wherein the mechanical anchoring mechanism is selected from the group consisting of prongs, spines, barbs, wings, hooks, a helical surface topography, and a gradually changing diameter. 92. The sensor of claim 86, wherein the biointerface material comprises interconnected cavities dimensioned and arranged to create contractile forces that counteract a generally uniform downward fibrous tissue contracture caused by the foreign body capsule in vivo and thereby interfere with formation of occlusive cells. 93. The sensor of claim 86, wherein the body comprises a first surface and a second surface, and wherein said first surface, when viewed from a direction perpendicular to a center of said first surface, has a substantially rectangular profile with rounded corners. 94. The sensor of claim 86, further comprising an anchoring material connected to the body and selected from the group consisting of polyester, polypropylene cloth, polytetrafluoroethylene felts, expanded polytetrafluoroethylene, and porous silicone. 95. The sensor of claim 86, wherein the body comprises at least one of metal, ceramic, plastic, and glass. 96. The sensor of claim 86, wherein the body comprises a plastic. 97. The sensor of claim 96, wherein the plastic is selected from the group consisting of thermoplastic and thermoset plastic. 98. The sensor of claim 97, wherein the thermoset plastic is an epoxy. 99. The sensor of claim 86, wherein the sensing region is situated approximately at an apex of a surface of the body. 100. The sensor of claim 86, wherein the body is substantially cylindrical. 101. The sensor of claim 100, wherein a radius of curvature of the body is from about 0.5 mm to about 10 cm. 102. The sensor of claim 86, wherein the sensor further comprises an electronics body, and wherein the sensor body is tethered to the electronics body. 103. The sensor of claim 102, further comprising an anchoring material on the sensing body. 104. The sensor body of claim 102, wherein the electronics body is substantially cylindrical. 105. An implantable sensor for use in measuring a concentration of an analyte in a bodily fluid, the sensor comprising: a sensor body comprising a sensing region adapted for transport of an analyte thereto, and a porous biointerface material that covers at least a portion of the sensing region, wherein the porous biointerface material covering the portion of the sensing region supports tissue ingrowth, wherein the sensing region is located on a curved portion of the body such that when a foreign body capsule forms around the sensor, a contractile force is exerted by the foreign body capsule toward the sensing region, and wherein the body defines a surface area, and where at least about 90% of the surface area is convexly curved. 106. The sensor of claim 105, wherein the sensor is a subcutaneous sensor. 107. The sensor of claim 105, wherein the sensor is configured for implantation in a soft tissue of a body. 108. The sensor of claim 105, wherein the sensor is a glucose sensor. 109. The sensor of claim 105, further comprising a mechanical anchoring mechanism formed on the body. 110. The sensor of claim 109, wherein the mechanical anchoring mechanism is selected from the group consisting of prongs, spines, barbs, wings, hooks, a helical surface topography, and a gradually changing diameter. 111. The sensor of claim 105, wherein the biointerface material comprises interconnected cavities dimensioned and arranged to create contractile forces that counteract a generally uniform downward fibrous tissue contracture caused by the foreign body capsule in vivo and thereby interfere with formation of occlusive cells. 112. The sensor of claim 105, wherein the body comprises a first surface and a second surface, and wherein said first surface, when viewed from a direction perpendicular to a center of said first surface, has a substantially rectangular profile with rounded corners. 113. The sensor of claim 105, further comprising an anchoring material connected to the body and selected from the group consisting of polyester, polypropylene cloth, polytetrafluoroethylene felts, expanded polytetrafluoroethylene, and porous silicone. 114. The sensor of claim 105, wherein the body comprises at least one of metal, ceramic, plastic, and glass. 115. The sensor of claim 105, wherein the body comprises a plastic. 116. The sensor of claim 115, wherein the plastic is selected from the group consisting of thermoplastic and thermoset plastic. 117. The sensor of claim 116, wherein the thermoset plastic is an epoxy. 118. The sensor of claim 105, wherein the sensing region is situated approximately at an apex of a surface of the body. 119. The sensor of claim 105, wherein the body is substantially cylindrical. 120. The sensor of claim 119, wherein a radius of curvature of the body is from about 0.5 mm to about 10 cm. 121. The sensor of claim 105, wherein the sensor further comprises an electronics body, and wherein the sensor body is tethered to the electronics body. 122. The sensor of claim 121, further comprising an anchoring material on the sensing body. 123. The sensor body of claim 121, wherein the electronics body is substantially cylindrical. 124. An implantable sensor adapted to measure a concentration of an analyte in a bodily fluid, comprising: a body having a first major surface and, opposite thereto, a second major surface, wherein the first major surface is generally planar, slightly convex, and has rounded edges, with an electrochemical sensing region located on the first major surface that is spaced away from the rounded edges and a porous biointerface material covering at least a portion of the sensing region, wherein the porous biointerface material covering the portion of the sensing region supports tissue ingrowth, wherein the first major surface is sufficiently convex that when a foreign body capsule forms around the sensor, contractile forces are exerted thereby generally uniformly towards the sensing region. 125. The sensor of claim 124, wherein the sensor is a subcutaneous sensor. 126. The sensor of claim 124, wherein the sensor is configured for implantation in a soft tissue of a body. 127. The sensor of claim 124, wherein the sensor is a glucose sensor. 128. The sensor of claim 124, further comprising a mechanical anchoring mechanism formed on the body. 129. The sensor of claim 128, wherein the mechanical anchoring mechanism is selected from the group consisting of prongs, spines, barbs, wings, hooks, a helical surface topography, and a gradually changing diameter. 130. The sensor of claim 124, wherein the biointerface material comprises interconnected cavities dimensioned and arranged to create contractile forces that counteract a generally uniform downward fibrous tissue contracture caused by the foreign body capsule in vivo and thereby interfere with formation of occlusive cells. 131. The sensor of claim 124, wherein said first major surface, when viewed from a direction perpendicular to a center of said first major surface, has a substantially rectangular profile with rounded corners. 132. The sensor of claim 124, further comprising an anchoring material connected to the body and selected from the group consisting of polyester, polypropylene cloth, polytetrafluoroethylene felts, expanded polytetrafluoroethylene, and porous silicone. 133. The sensor of claim 124, wherein the body comprises at least one of metal, ceramic, plastic, and glass. 134. The sensor of claim 124, wherein the body comprises a plastic. 135. The sensor of claim 134, wherein the plastic is selected from the group consisting of thermoplastic and thermoset plastic. 136. The sensor of claim 135, wherein the thermoset plastic is an epoxy. 137. The sensor of claim 124, wherein the sensing region is situated approximately at an apex of a surface of the body. 138. The sensor of claim 124, wherein the body is substantially cylindrical. 139. The sensor of claim 138, wherein a radius of curvature of the body is from about 0.5 mm to about 10 cm. 140. The sensor of claim 124, wherein the sensor further comprises an electronics body, and wherein the body is tethered to the electronics body. 141. The sensor of claim 140, further comprising an anchoring material on the sensing body. 142. The sensor body of claim 140, wherein the electronics body is substantially cylindrical. 143. An implantable sensor for use in measuring a concentration of an analyte in a bodily fluid, the sensor comprising: a body, the body comprising a sensing region adapted for transport of analytes thereto, and a porous blointerface material covering at least a portion of the sensing region, wherein the porous biointerface material covering the portion of the sensing region supports tissue ingrowth, wherein the sensing region is located on a major surface of the body, wherein said major surface comprises a continuous curvature substantially across the entire surface of the body, and wherein a thermoset plastic material substantially encapsulates the body outside the sensing region. 144. The sensor of claim 143, wherein the sensor is a subcutaneous sensor. 145. The sensor of claim 143, wherein the sensor is configured for implantation in a soft tissue of a body. 146. The sensor of claim 143, wherein the sensor is a glucose sensor. 147. The sensor of claim 143, further comprising a mechanical anchoring mechanism formed on the body. 148. The sensor of claim 147, wherein the mechanical anchoring mechanism is selected from the group consisting of prongs, spines, barbs, wings, hooks, a helical surface topography, and a gradually changing diameter. 149. The sensor of claim 143, wherein the biointerface material comprises interconnected cavities dimensioned and arranged to create contractile forces that counteract a generally uniform downward fibrous tissue contracture caused by the foreign body capsule in vivo and thereby interfere with formation of occlusive cells. 150. The sensor of claim 143, wherein said major surface, when viewed from a direction perpendicular to a center of said major surface, has a substantially rectangular profile with rounded corners. 151. The sensor of claim 143, further comprising an anchoring material connected to the body and selected from the group consisting of polyester, polypropylene cloth, polytetrafluoroethylene felts, expanded polytetrafluoroethylene, and porous silicone. 152. The sensor of claim 143, wherein the body comprises at least one of metal, ceramic, plastic, and glass. 153. The sensor of claim 143, wherein the body comprises a plastic. 154. The sensor of claim 153, wherein the plastic is selected from the group consisting of thermoplastic and thermoset plastic. 155. The sensor of claim 154, wherein the thermoset plastic is an epoxy. 156. The sensor of claim 143, wherein the sensing region is situated approximately at an apex of a surface of the body. 157. The sensor of claim 143, wherein the body is substantially cylindrical. 158. The sensor of claim 157, wherein a radius of curvature of the body is from about 0.5 mm to about 10 cm. 159. The sensor of claim 143, wherein the sensor further comprises an electronics body, and wherein the body is tethered to the electronics body. 160. The sensor of claim 159, further comprising an anchoring material on the sensing body. 161. The sensor body of claim 159, wherein the electronics body is substantially cylindrical.
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