CN1644157A - 皮下植入式生物传感器 - Google Patents
皮下植入式生物传感器 Download PDFInfo
- Publication number
- CN1644157A CN1644157A CNA2004101010806A CN200410101080A CN1644157A CN 1644157 A CN1644157 A CN 1644157A CN A2004101010806 A CNA2004101010806 A CN A2004101010806A CN 200410101080 A CN200410101080 A CN 200410101080A CN 1644157 A CN1644157 A CN 1644157A
- Authority
- CN
- China
- Prior art keywords
- pin type
- closing member
- nook closing
- biological sensors
- layer
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 229910052751 metal Inorganic materials 0.000 claims description 38
- 239000002184 metal Substances 0.000 claims description 38
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 claims description 22
- NJPPVKZQTLUDBO-UHFFFAOYSA-N novaluron Chemical compound C1=C(Cl)C(OC(F)(F)C(OC(F)(F)F)F)=CC=C1NC(=O)NC(=O)C1=C(F)C=CC=C1F NJPPVKZQTLUDBO-UHFFFAOYSA-N 0.000 claims description 21
- 230000008595 infiltration Effects 0.000 claims description 13
- 238000001764 infiltration Methods 0.000 claims description 13
- 229920002521 macromolecule Polymers 0.000 claims description 11
- 108090000790 Enzymes Proteins 0.000 claims description 10
- 102000004190 Enzymes Human genes 0.000 claims description 10
- BQCADISMDOOEFD-UHFFFAOYSA-N Silver Chemical compound [Ag] BQCADISMDOOEFD-UHFFFAOYSA-N 0.000 claims description 8
- 229920000249 biocompatible polymer Polymers 0.000 claims description 8
- 230000005611 electricity Effects 0.000 claims description 8
- 229910052709 silver Inorganic materials 0.000 claims description 8
- 239000004332 silver Substances 0.000 claims description 8
- 229910021607 Silver chloride Inorganic materials 0.000 claims description 7
- HKZLPVFGJNLROG-UHFFFAOYSA-M silver monochloride Chemical compound [Cl-].[Ag+] HKZLPVFGJNLROG-UHFFFAOYSA-M 0.000 claims description 7
- 239000011248 coating agent Substances 0.000 claims description 6
- 238000000576 coating method Methods 0.000 claims description 6
- 229910052697 platinum Inorganic materials 0.000 claims description 5
- 239000002131 composite material Substances 0.000 claims description 4
- 239000012466 permeate Substances 0.000 claims description 4
- 238000007747 plating Methods 0.000 claims description 3
- 239000000126 substance Substances 0.000 abstract description 8
- 238000002513 implantation Methods 0.000 abstract description 3
- 210000001519 tissue Anatomy 0.000 description 18
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 13
- 239000008103 glucose Substances 0.000 description 13
- 238000000034 method Methods 0.000 description 13
- MHAJPDPJQMAIIY-UHFFFAOYSA-N Hydrogen peroxide Chemical compound OO MHAJPDPJQMAIIY-UHFFFAOYSA-N 0.000 description 12
- 229940088598 enzyme Drugs 0.000 description 9
- 239000007943 implant Substances 0.000 description 9
- 238000006243 chemical reaction Methods 0.000 description 7
- 230000004044 response Effects 0.000 description 6
- 238000005516 engineering process Methods 0.000 description 5
- 239000012530 fluid Substances 0.000 description 5
- 230000008569 process Effects 0.000 description 5
- 239000000047 product Substances 0.000 description 5
- 230000035945 sensitivity Effects 0.000 description 5
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 4
- 230000015572 biosynthetic process Effects 0.000 description 4
- 230000006378 damage Effects 0.000 description 4
- 239000001301 oxygen Substances 0.000 description 4
- 229910052760 oxygen Inorganic materials 0.000 description 4
- 230000035479 physiological effects, processes and functions Effects 0.000 description 4
- 238000007920 subcutaneous administration Methods 0.000 description 4
- 238000006056 electrooxidation reaction Methods 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 108010015776 Glucose oxidase Proteins 0.000 description 2
- 239000004366 Glucose oxidase Substances 0.000 description 2
- 229910019142 PO4 Inorganic materials 0.000 description 2
- 229910001069 Ti alloy Inorganic materials 0.000 description 2
- 239000008366 buffered solution Substances 0.000 description 2
- 230000007797 corrosion Effects 0.000 description 2
- 238000005260 corrosion Methods 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 238000003745 diagnosis Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 230000002255 enzymatic effect Effects 0.000 description 2
- 229940116332 glucose oxidase Drugs 0.000 description 2
- 235000019420 glucose oxidase Nutrition 0.000 description 2
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 2
- 229910052737 gold Inorganic materials 0.000 description 2
- 239000010931 gold Substances 0.000 description 2
- 230000000774 hypoallergenic effect Effects 0.000 description 2
- 238000003780 insertion Methods 0.000 description 2
- 230000037431 insertion Effects 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 2
- 230000007246 mechanism Effects 0.000 description 2
- 229920002529 medical grade silicone Polymers 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 2
- 239000010452 phosphate Substances 0.000 description 2
- 230000001766 physiological effect Effects 0.000 description 2
- 238000006722 reduction reaction Methods 0.000 description 2
- 231100000241 scar Toxicity 0.000 description 2
- 238000007789 sealing Methods 0.000 description 2
- 239000004945 silicone rubber Substances 0.000 description 2
- LJCNDNBULVLKSG-UHFFFAOYSA-N 2-aminoacetic acid;butane Chemical compound CCCC.CCCC.NCC(O)=O LJCNDNBULVLKSG-UHFFFAOYSA-N 0.000 description 1
- 229910001316 Ag alloy Inorganic materials 0.000 description 1
- 108010025188 Alcohol oxidase Proteins 0.000 description 1
- 206010002198 Anaphylactic reaction Diseases 0.000 description 1
- 108010089254 Cholesterol oxidase Proteins 0.000 description 1
- RGHNJXZEOKUKBD-UHFFFAOYSA-N D-gluconic acid Natural products OCC(O)C(O)C(O)C(O)C(O)=O RGHNJXZEOKUKBD-UHFFFAOYSA-N 0.000 description 1
- RGHNJXZEOKUKBD-SQOUGZDYSA-N Gluconic acid Natural products OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O RGHNJXZEOKUKBD-SQOUGZDYSA-N 0.000 description 1
- SXRSQZLOMIGNAQ-UHFFFAOYSA-N Glutaraldehyde Chemical compound O=CCCCC=O SXRSQZLOMIGNAQ-UHFFFAOYSA-N 0.000 description 1
- 229910021578 Iron(III) chloride Inorganic materials 0.000 description 1
- 108010073450 Lactate 2-monooxygenase Proteins 0.000 description 1
- 108090000854 Oxidoreductases Proteins 0.000 description 1
- 102000004316 Oxidoreductases Human genes 0.000 description 1
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 1
- 229910000831 Steel Inorganic materials 0.000 description 1
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 229910045601 alloy Inorganic materials 0.000 description 1
- 239000000956 alloy Substances 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 239000012491 analyte Substances 0.000 description 1
- 230000036783 anaphylactic response Effects 0.000 description 1
- 208000003455 anaphylaxis Diseases 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- -1 beraloy Inorganic materials 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000010382 chemical cross-linking Methods 0.000 description 1
- 239000007795 chemical reaction product Substances 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 238000005660 chlorination reaction Methods 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 239000003431 cross linking reagent Substances 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 230000000378 dietary effect Effects 0.000 description 1
- 238000009792 diffusion process Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000003487 electrochemical reaction Methods 0.000 description 1
- 230000005518 electrochemistry Effects 0.000 description 1
- 238000003411 electrode reaction Methods 0.000 description 1
- 230000008451 emotion Effects 0.000 description 1
- 238000006911 enzymatic reaction Methods 0.000 description 1
- 239000000174 gluconic acid Substances 0.000 description 1
- 235000012208 gluconic acid Nutrition 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000009413 insulation Methods 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- RBTARNINKXHZNM-UHFFFAOYSA-K iron trichloride Chemical compound Cl[Fe](Cl)Cl RBTARNINKXHZNM-UHFFFAOYSA-K 0.000 description 1
- 235000014655 lactic acid Nutrition 0.000 description 1
- 239000004310 lactic acid Substances 0.000 description 1
- 238000011031 large-scale manufacturing process Methods 0.000 description 1
- 210000003041 ligament Anatomy 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 230000005226 mechanical processes and functions Effects 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 206010033675 panniculitis Diseases 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 230000035790 physiological processes and functions Effects 0.000 description 1
- 239000011505 plaster Substances 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 239000000376 reactant Substances 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010959 steel Substances 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 210000004304 subcutaneous tissue Anatomy 0.000 description 1
- 230000003746 surface roughness Effects 0.000 description 1
- 230000036962 time dependent Effects 0.000 description 1
- 239000010936 titanium Substances 0.000 description 1
- 229910052719 titanium Inorganic materials 0.000 description 1
- 230000001052 transient effect Effects 0.000 description 1
- 229910052720 vanadium Inorganic materials 0.000 description 1
- GPPXJZIENCGNKB-UHFFFAOYSA-N vanadium Chemical compound [V]#[V] GPPXJZIENCGNKB-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
- A61B5/14865—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
- A61B5/6848—Needles
- A61B5/6849—Needles in combination with a needle set
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14542—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring blood gases
Abstract
对周围组织损伤小，检测灵敏度高，受检者不产生痛感，制备工艺相对简单，制备重复性好并易于质量控制的皮下植入式生物传感器，设有一基座(1)，在基座(1)下面与之垂直地固定有针型正电极(4)和针型负电极，所述针型正电极和针型负电极的上端连接有导电片。本发明适用于生物体内物质浓度的实时检测。
Description
技术领域
本发明涉及一种医学检测仪器的信号采集组件，特别是埋置于生物组织的电化学传感器。
背景技术
生物传感器或化学传感器技术一般指在不需要外加试剂和不需预先分离的条件下对复杂成份样品中的被分析物分子直接测定的方法和仪器技术。电化学生物传感器指以电极上的电化学氧化或还原反应将分子的性质转换为电信号的方式来实现检测。所产生的电信号与被测物的某种性质有可换算的关系。如伏安方法测得的电流或电压法测得的电压信号与被测分子的浓度有确切的相关关系，可以由此计算其浓度值。
植入式生物传感器的关键优点是连续测定体内某些随时间变化的重要生理或病理参数，例如氧、葡萄糖、乳酸的浓度等，从而获得更直接、更准确的诊断或治疗的效果。另外它是直接检测体液内的实时浓度，能真实反映被试对象的生理环境的变化。例如糖尿病患者体内葡萄糖浓度的变化受诸多因素的影响，其瞬时浓度在环境温度、饮食种类、情绪变化、体力活动、及个人的生理代谢速度等各种因素影响下是不可预见的，所以某一时刻的单次测量值不能反映其所处时间段内不同时刻的实时值，也不能代表其所处时间段的平均值，因此就不能提供有足够价值的治疗依据。在这种情况下，连续检测数据信息就能为疾病的诊断和治疗提供根本性的改进。
植入式电化学生物传感器的概念自二十世纪六十年代初Leland Clark博士提出用葡萄糖氧化酶转化血液或组织液内葡萄糖并用铂电极测定过氧化氢的方法以来，已有数千计的科研论文和数百计的专利发表，涵盖众多的化学方法、工作原理和多种多样的设计。然而在过去四十多年的时间里，在植入式传感器领域的发展上却相对缓慢，至今市场上仍无满意的可靠产品。这个事实本身说明了现代科学对植入体内的生物化学检测仪器与微观生物环境的相互反应的理解尚不够深入，也说明了开发此类产品的难度。
植入式传感器与组织间的相互作用代表了体内化学传感技术的主要特点和主要困难，它一般包括两个方面的内容：一是在分子生物学和细胞生物学水平上的生物体对异物的排斥反应机制；二是植入过程本身对组织造成的损伤及生理修复过程。二者都在不同程度上使周围组织对植入体的外表层形成隔离层(如伤疤的形成)。这种现象对一般用于机械功能的植入体(例如人工骨骼、韧带、瓣膜等)来说不一定影响其功能，但对生物传感器来说则完全不同，隔离层的形成使传感器与周围组织环境脱离接触，当传感器与组织液的分子渗透交换被阻碍或隔绝后，传感器所测到的就不是组织液正常成分从而失去了准确性。
组织与植入物间排斥(或相容)反应的程度用“生物相容性”来描述，生物相容性一方面是生物化学的因素：代表植入物本身表面的化学成分以及释放出来的添加剂和降解反应产物分子所引起的相应免疫反应、过敏反应等系列生理化学反应机制。生物相容性的另一方面是机械的因素：植入物的物理性质如表面粗糙程度、几何形状、尺寸大小等造成的不同程度的刺激以及植入过程形成的损伤等。目前大多植入式传感器要求使用辅助器具如套管针或内管针进行植入，这是将传感件事先装入管径相对大的套管针，连同套管针一起插入皮下，然后拔去套管针，传感件埋留于皮下，如此不仅引起被测人体痛感，且其所造成的额外创伤引起的伤疤对传感器功能的影响往往是主要因素。
还有一个常常被忽略的重要因素，即传感器检测反应本身对分子的消耗或反应产物分子释放到组织中对周围的正常生理环境造成的扰动。所检测的分子往往具有生理功能，传感器反应所消耗生物分子的量越多，则对周围组织的生理活动的干扰就越大。除前述的生物相容性诸因素之外，单位面积传感器检测反应本身所消耗被测分子的速度(或其释放到组织中的反应产物分子的速度)越低，则对组织正常生理活动的扰动就越小，就越可能测得真实生理浓度信号。目前大多传感器将传感面积限制在一个极小的部分表面上，而整个传感器主要作为支撑的载体。这就要求在极小的面积上产生很高的物流密度以获得足够的信号电流，因此存在传感器所处的局部对组织生理扰动大而整体灵敏度又不高的缺点。
能够用于规模生产的微型化传感器设计常因受其工艺复杂的限制而存在重复性差的问题，因此简单而可靠的生产工艺也是使传感器商品化的极重要因素。
发明内容
本发明要解决已知植入式传感器需要借助诸如套管针那样的辅助器具植入传感件所造成的创伤大、使传感功能受到不利影响以及传感面过小所致传感灵敏度低、生理扰动大等问题，为此提供本发明的一种皮下植入式生物传感器，这种皮下植入式生物传感器无需借助辅助器具就可将传感件植入皮下，对受检者无痛感，且传感面大，检测灵敏度高，所受扰动小。
为解决上述问题，本发明的皮下植入式生物传器采用的技术方案是设有一基座，其特殊之处是在基座下面与之垂直地固定有针型正电极和针型负电极，针型正、负电极的上端连接有导电片。
本发明所述的针型正电极、针型负电极可以各为一枚。
本发明也可以在所述的基座下面与之垂直地固定有一枚对电极。
本发明还可以是：针型正电极为一枚，针型负电极为相互并联的二枚、三枚或四枚；或者所述的针型负电极为一枚，针型正电极为相互并联的二枚、三枚或四枚。
所述针型正电极具有一金属针芯，金属针芯外面依次复合有惰性金属镀层、铂黑层和生物传感层；所述的针型负电极具有一金属针芯，金属针芯外面依次复合有银/氯化银层和生物相容性高分子渗透膜层。此传感器适用于过氧化氢的电化学氧化检测。
所述的生物传感层为复合层，其内层为酶层，外层为生物相容高分子渗透膜层。
所述的针型正电极具有一金属针芯，金属针芯外面依次复合有镀银层、铂黑层和生物传感层；所述的针型负电极具有一金属针芯，金属针芯外面依次复合有镀铂层和生物相容高分子渗透膜层。此传感器适用于氧的电化学还原检测。
可以在所述的基座其下面贴附有一胶布层。胶布层宜采用医用低敏胶布。
可以在所述的基座上面联有一顶盖，顶盖一侧开口，用于插接导线将信号输出供相应检仪检测；所述的导电片位于顶盖内。
本发明所述的金属针芯其直径可以是0.1～0.2毫米。
下面对本发明作进一步说明。
本发明所述针型正、负电极上端所连的导电片用于与外接导线电连接，将针型正、负电极采集的信号输出供相应检测仪检测。
针型正、负电极具有金属针芯，金属针芯可以由具足够钢性且耐腐蚀的金属，如不锈钢、铍青铜合金、钛合金制成，钛合金有如含90％以上的钛及余量的铝、钒形成的高强度耐腐蚀合金。
具有一枚针型正电极和一枚针型负电极的本发明为双电极型，针型正、负电极分别为指示电极及参比电极，此皮下植入式生物传感器适合于短期使用。在此基础上增设有一枚对电极即辅助电极的本发明为三电极型，它适合于长期使用，其中辅助电极用于负载电流，参比电极只提供电压参比而不负载电流，这种结构在电化学反应过程中不消耗参比电极，具有长期稳定的工作寿命。
本发明可以是具有一枚针型正电极，两枚以上相互电串联的针型负电极，它们共同与一枚针型正电极配对使用；或者是，具有一枚针型负电极，两枚以上相互电串联的针型正电极，它们共同与一枚针型负电极配对使用。
本发明在针型正电极的金属针芯外面依次复合有惰性金属镀层、铂黑层和生物传感层。铂黑层本身致密性差，不能防止层内金属被腐蚀，故在铂黑层与金属针芯表面之间镀以惰性金属如金、铂层。针型负电极具有一金属针芯，金属针芯外面依次复合有银/氯化银层和生物相容性高分子渗透膜层。针型负电极的金属针芯外面复合银/氯化银层，也可以二者合一采用富含银的刚性银合金针形物，将其表面在氯化钾溶液中电化学氧化或在氯化铁溶液中化学氯化形成具足量氯化银的表面。
所述的生物传感层为复合层，其内层为酶层，外层为生物相容高分子渗透膜层。酶层中的酶一般以氧为反应物或过氧化氢为产物的酶，如葡萄糖氧化酶、乳酸氧化酶、乙醇氧化酶、胆固醇氧化酶等。酶层可以经化学交联方法固定于铂黑层表面，如将酶溶液涂于铂黑层表面，再用戊二醛或其它带有双活性基团的交联剂反应使酶蛋白分子间形成化学键成为半固体状膜结合于铂黑层。酶层外为生物相容高分子渗透膜层，形成此层，例如在酶层外涂以医用级硅橡胶为骨架的混合高分子或共聚高分子溶液并使溶剂挥发而形成此渗透膜层。
生物传感层的总厚度可以不大于10微米，其中酶层不大于1微米，高分子渗透层不大于9微米。
使用时将本发明的传感器的针型正、负电极插入皮下组织，基座下面具有胶布层的将胶布层贴于皮肤表面。组织液中的氧和葡萄糖以扩散的方式通过所述的高分子渗透膜层进入酶反应层，葡萄糖在氧化酶的作用下被氧化为葡萄糖酸，同时生成过氧化氢，生成的过氧化氢与参加反应的葡萄糖有等当量关系。当本传感器系统与电化学恒压伏安仪电极电路连接时，过氧化氢在镀铂电极上0.55V(VS Ag/AgCl)条件下氧化，在电极回路中产生电极电流，该电流的强度与被测葡萄糖浓度成正比，由外接仪器的微电流检测电路记录后可以转化成葡萄糖浓度数据，并进一步存储和显示。
本发明的皮下植入式生物传感器由于在基座上固定有针型正电极和针型负电极，针型正、负电极上端连有导电片，故本传感器可以将传感件即针型正、负电极直接植皮下组织，无需借助辅助器具植入，对植入后周围组织造成的损伤小，克服了辅助器具植入对组织造成的额外损伤；本发明中的针型电极植入皮下，电极表面全部成为有效传感面，可最大限度地利用传感件与组织液的接触面，在尽量降低传感件与组织相间分子物质传递密度的条件下能获得最高灵敏度，因此既不牺牲灵敏度又不因过度消耗反应分子而扰动周围组织的正常生理平衡；本发明中的针型正、负电极其直径可以制成足够小，如针芯直径为0.1～0.2毫米，外层生物传感层厚度不大于10微米，如此小直径的针型电极插入皮下不会产生痛感，克服了已有植入式传感器因借助直径较大辅助器具的插入所引起的不同程度疼痛的缺陷；本发明的传感器还可以使复杂的结构和生产过程分解、独立，采用了传感器的正、负电极各自独立的原理，在生产过程中可分别制备，工艺相对简单，制备重复性好，易于质量控制。
附图说明
图1是本发明之一例外形结构示意图；
图2是本发明中的一例针型正电极结构示意图；
图3是本发明在磷酸盐缓冲溶液中对葡萄糖浓度的响应电流信号图。
具体实施方式
实施例1
皮下植入式生物传感器，具有一注塑成型的电绝缘基座(1)，基座(1)下面与之垂直地固定有一针型正电极(4)和一针型负电极，针型正、负电极的上端连接有导电片位于基座1上表面，基座1下面贴附有医用低敏胶布层(3)，基座1上面联有一顶盖(2)，顶盖(2)一侧开口用于外接插头插入与所述的导电片电连接。针型正电极具有一直径为0.16毫米的不锈钢金属针芯(41)，此金属针芯(41)外面依次复合有镀金层(42)、铂黑层(43)和生物传感层(44)；针型负电极具有如同上述的一金属针芯，金属针芯外面依次复合有银/氯化银层和生物相容性高分子渗透膜层。生物传感层(44)为复合层，其内层为氧化酶层，厚度0.5±0.3微米，外层为生物相容高分子渗透膜层，厚度为5±3微米。所述的生物相容高分子渗透膜层为医用级硅橡胶为骨架的混合高分子或共聚高分子导离子渗透膜层。
本传感器对葡萄糖浓度瞬时变化的响应时间不大于3分钟，对葡萄糖浓度检测的线性范围不低于15毫摩尔/升。图3示出本传感器在磷酸盐缓冲溶液中对葡萄糖浓度的响应电流信号特性曲线。图中向右方每一阶梯葡萄糖浓度依次升高3毫摩尔/升。图中纵座标表示传感器测得的响应电流强度值。
实施例2
本例皮下植入式生物传感器，在上例基础上于基座下面固定有一枚针型对电极。其它构造与上例的相同。
实施例3
本例传感器，具有三枚相互电串联的针型负电极替代例1的一枚针型负电极，针型正电极的金属针芯外面依次复合有镀银层(42)、铂黑层(43)和生物传感层(44)；针型负电极具有如同上述的一金属针芯，金属针芯外面依次复合有镀铂层和生物相容性高分子渗透膜层。其它构造与例1的相同。
Claims (10)
1、皮下植入式生物传感器，设有一基座(1)，其特征是在基座(1)下面与之垂直地固定有针型正电极(4)和针型负电极，所述针型正电极和针型负电极的上端连接有导电片。
2、如权利要求1所述的皮下植入式生物传感器，其特征是所述的针型正电极、针型负电极各为一枚。
3、如权利要求2所述的皮下植入式生物传感器，其特征是在基座(1)下面与之垂直地固定有一枚对电极。
4、如权利要求1所述的皮下植入式生物传感器，其特征是所述的针型正电极为一枚，针型负电极为相互并联的二枚、三枚或四枚；或者所述的针型负电极为一枚，针型正电极为相互并联的二枚、三枚或四枚。
5、如权利要求1、2、3或4所述的皮下植入式生物传感器，其特征是所述针型正电极具有一金属针芯(41)，金属针芯(41)外面依次复合有惰性金属镀层(42)、铂黑层(43)和生物传感层(44)；所述的针型负电极具有一金属针芯，金属针芯外面依次复合有银/氯化银层和生物相容性高分子渗透膜层。
6、如权利要求5所述的皮下植入式生物传感器，其特征是所述的生物传感层(44)为复合层，其内层为酶层，外层为生物相容高分子渗透膜层。
7、如权利要求1、2、3或4所述的皮下植入式生物传感器，其特征是所述的针型正电极具有一金属针芯，金属针芯外面依次复合有镀银层、铂黑层和生物传感层；所述的针型负电极具有一金属针芯，金属针芯外面依次复合有镀铂层和生物相容高分子渗透膜层。
8、如权利要求1、2、3或4所述的皮下植入式生物传感器，其特征是所述的基座其下面贴附有一胶布层(3)。
9、如权利要求9所述的皮下植入式生物传感器，其特征是所述的基座其上面联有一顶盖(2)，顶盖(2)一侧开口，所述的导电片位于顶盖(2)内。
10、如权利要求5所述的皮下植入式生物传感器，其特征是所述的金属针芯其直径为0.1～0.2毫米。
Priority Applications (9)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004101010806A CN100367906C (zh) | 2004-12-08 | 2004-12-08 | 皮下植入式生物传感器 |
| US11/262,373 US7979103B2 (en) | 2004-12-08 | 2005-10-29 | Catheter-free implantable needle biosensor |
| AU2005314502A AU2005314502B2 (en) | 2004-12-08 | 2005-11-09 | Catheter-free implantable needle biosensor |
| EP05819013A EP1841363B1 (en) | 2004-12-08 | 2005-11-09 | Catheter-free implantable needle biosensor |
| PCT/US2005/040749 WO2006062668A2 (en) | 2004-12-08 | 2005-11-09 | Catheter-free implantable needle biosensor |
| PL05819013T PL1841363T3 (pl) | 2004-12-08 | 2005-11-09 | Bezcewnikowy wszczepialny igłowy czujnik biologiczny |
| JP2007545484A JP4797024B2 (ja) | 2004-12-08 | 2005-11-09 | 導管なし埋め込み式針状生物センサー |
| ES05819013T ES2371766T3 (es) | 2004-12-08 | 2005-11-09 | Biosensor de aguja implantable sin catéter. |
| US13/032,500 US20110144466A1 (en) | 2004-12-08 | 2011-02-22 | Catheter-Free Implantable Needle Biosensor |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004101010806A CN100367906C (zh) | 2004-12-08 | 2004-12-08 | 皮下植入式生物传感器 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1644157A true CN1644157A (zh) | 2005-07-27 |
| CN100367906C CN100367906C (zh) | 2008-02-13 |
Family
ID=34869612
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2004101010806A Active CN100367906C (zh) | 2004-12-08 | 2004-12-08 | 皮下植入式生物传感器 |
Country Status (8)
| Country | Link |
|---|---|
| US (2) | US7979103B2 (zh) |
| EP (1) | EP1841363B1 (zh) |
| JP (1) | JP4797024B2 (zh) |
| CN (1) | CN100367906C (zh) |
| AU (1) | AU2005314502B2 (zh) |
| ES (1) | ES2371766T3 (zh) |
| PL (1) | PL1841363T3 (zh) |
| WO (1) | WO2006062668A2 (zh) |
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101716073B (zh) * | 2009-12-09 | 2011-07-20 | 中国科学院半导体研究所 | 长期记录生理电信号的侵入式斜针无痛皮肤干电极器件 |
| CN102247148A (zh) * | 2010-05-19 | 2011-11-23 | 爱科来株式会社 | 电化学传感器 |
| CN101530327B (zh) * | 2009-04-20 | 2012-09-05 | 湖州美奇医疗器械有限公司 | 皮下组织实时监测用针状电流测定式葡萄糖传感器及其制作方法 |
| CN101530328B (zh) * | 2009-04-20 | 2013-06-19 | 湖州美奇医疗器械有限公司 | 皮下植入式的葡萄糖传感器及其制作方法 |
| CN105411607A (zh) * | 2015-11-16 | 2016-03-23 | 杭州亿信网络科技有限公司 | 皮下组织介入式葡萄糖微型传感器及其制备方法 |
| WO2016141596A1 (zh) * | 2015-03-12 | 2016-09-15 | 深圳市光聚通讯技术开发有限公司 | 微型动态血糖仪 |
| CN107405116A (zh) * | 2015-03-06 | 2017-11-28 | 三星电子株式会社 | 生物计量信息测量设备 |
| CN107814865A (zh) * | 2017-10-27 | 2018-03-20 | 浙江大学 | 用于低温植埋的侵入式脑机接口 |
| CN108652646A (zh) * | 2018-03-15 | 2018-10-16 | 戴兵 | 一种皮下植入式生物传感器装置及系统 |
| CN108931568A (zh) * | 2018-05-25 | 2018-12-04 | 南京佳乐净膜科技有限公司 | 生物传感器及其制备方法 |
| CN111896587A (zh) * | 2020-08-12 | 2020-11-06 | 湖州美奇医疗器械有限公司 | 一种血糖监测传感器测试工装 |
| WO2022016639A1 (zh) * | 2020-07-24 | 2022-01-27 | 湖州美奇医疗器械有限公司 | 一种三电极皮下植入式葡萄糖传感器及其制作方法 |
Families Citing this family (72)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6001067A (en) | 1997-03-04 | 1999-12-14 | Shults; Mark C. | Device and method for determining analyte levels |
| US8527026B2 (en) | 1997-03-04 | 2013-09-03 | Dexcom, Inc. | Device and method for determining analyte levels |
| US20030032874A1 (en) | 2001-07-27 | 2003-02-13 | Dexcom, Inc. | Sensor head for use with implantable devices |
| US7613491B2 (en) | 2002-05-22 | 2009-11-03 | Dexcom, Inc. | Silicone based membranes for use in implantable glucose sensors |
| US8364229B2 (en) | 2003-07-25 | 2013-01-29 | Dexcom, Inc. | Analyte sensors having a signal-to-noise ratio substantially unaffected by non-constant noise |
| US7226978B2 (en) * | 2002-05-22 | 2007-06-05 | Dexcom, Inc. | Techniques to improve polyurethane membranes for implantable glucose sensors |
| WO2007120442A2 (en) | 2003-07-25 | 2007-10-25 | Dexcom, Inc. | Dual electrode system for a continuous analyte sensor |
| JP2007500336A (ja) | 2003-07-25 | 2007-01-11 | デックスコム・インコーポレーテッド | 電気化学センサーに用いる電極システム |
| US9763609B2 (en) | 2003-07-25 | 2017-09-19 | Dexcom, Inc. | Analyte sensors having a signal-to-noise ratio substantially unaffected by non-constant noise |
| EP1648298A4 (en) | 2003-07-25 | 2010-01-13 | Dexcom Inc | OXYGEN-IMPROVED MEMBRANE SYSTEMS FOR IMPLANTABLE DEVICES |
| US7920906B2 (en) | 2005-03-10 | 2011-04-05 | Dexcom, Inc. | System and methods for processing analyte sensor data for sensor calibration |
| US20050090607A1 (en) * | 2003-10-28 | 2005-04-28 | Dexcom, Inc. | Silicone composition for biocompatible membrane |
| US9247900B2 (en) | 2004-07-13 | 2016-02-02 | Dexcom, Inc. | Analyte sensor |
| US11633133B2 (en) | 2003-12-05 | 2023-04-25 | Dexcom, Inc. | Dual electrode system for a continuous analyte sensor |
| EP2239567B1 (en) | 2003-12-05 | 2015-09-02 | DexCom, Inc. | Calibration techniques for a continuous analyte sensor |
| US8423114B2 (en) | 2006-10-04 | 2013-04-16 | Dexcom, Inc. | Dual electrode system for a continuous analyte sensor |
| US8277713B2 (en) | 2004-05-03 | 2012-10-02 | Dexcom, Inc. | Implantable analyte sensor |
| US20060020192A1 (en) | 2004-07-13 | 2006-01-26 | Dexcom, Inc. | Transcutaneous analyte sensor |
| CN100367906C (zh) * | 2004-12-08 | 2008-02-13 | 圣美迪诺医疗科技(湖州)有限公司 | 皮下植入式生物传感器 |
| US8133178B2 (en) | 2006-02-22 | 2012-03-13 | Dexcom, Inc. | Analyte sensor |
| US8744546B2 (en) * | 2005-05-05 | 2014-06-03 | Dexcom, Inc. | Cellulosic-based resistance domain for an analyte sensor |
| WO2007120381A2 (en) * | 2006-04-14 | 2007-10-25 | Dexcom, Inc. | Analyte sensor |
| DK2302376T3 (da) * | 2006-08-08 | 2019-12-09 | Hoffmann La Roche | Elektrokemisk sensor til bestemmelse af en analytkoncentration |
| US7871456B2 (en) * | 2006-08-10 | 2011-01-18 | The Regents Of The University Of California | Membranes with controlled permeability to polar and apolar molecules in solution and methods of making same |
| EP1892877B1 (en) * | 2006-08-25 | 2008-12-03 | Alcatel Lucent | Digital signal receiver with Q-monitor |
| CA2680841A1 (en) | 2007-04-04 | 2008-10-16 | Isense Corporation | Analyte sensing device having one or more sensing electrodes |
| US8444566B2 (en) | 2007-05-14 | 2013-05-21 | Arnon AGMON | Guide for placement of catheter into brain and a method of utilizing the same |
| US20200037875A1 (en) | 2007-05-18 | 2020-02-06 | Dexcom, Inc. | Analyte sensors having a signal-to-noise ratio substantially unaffected by non-constant noise |
| EP2055369A1 (en) * | 2007-10-30 | 2009-05-06 | Sensile Pat AG | Sensitively permeable coated membrane |
| US20090247856A1 (en) * | 2008-03-28 | 2009-10-01 | Dexcom, Inc. | Polymer membranes for continuous analyte sensors |
| US11730407B2 (en) | 2008-03-28 | 2023-08-22 | Dexcom, Inc. | Polymer membranes for continuous analyte sensors |
| US8583204B2 (en) | 2008-03-28 | 2013-11-12 | Dexcom, Inc. | Polymer membranes for continuous analyte sensors |
| US8682408B2 (en) | 2008-03-28 | 2014-03-25 | Dexcom, Inc. | Polymer membranes for continuous analyte sensors |
| US8700114B2 (en) | 2008-07-31 | 2014-04-15 | Medtronic Minmed, Inc. | Analyte sensor apparatuses comprising multiple implantable sensor elements and methods for making and using them |
| EP2326944B1 (en) | 2008-09-19 | 2020-08-19 | Dexcom, Inc. | Particle-containing membrane and particulate electrode for analyte sensors |
| EP2448485B1 (en) * | 2009-07-02 | 2021-08-25 | Dexcom, Inc. | Analyte sensor |
| US9351677B2 (en) | 2009-07-02 | 2016-05-31 | Dexcom, Inc. | Analyte sensor with increased reference capacity |
| EP2482724A2 (en) * | 2009-09-30 | 2012-08-08 | Dexcom, Inc. | Transcutaneous analyte sensor |
| WO2011156095A2 (en) | 2010-06-10 | 2011-12-15 | The Regents Of The University Of California | Textile-based printable electrodes for electrochemical sensing |
| US9215995B2 (en) * | 2010-06-23 | 2015-12-22 | Medtronic Minimed, Inc. | Sensor systems having multiple probes and electrode arrays |
| WO2012019083A2 (en) | 2010-08-06 | 2012-02-09 | Microchips, Inc. | Biosensor membrane composition, biosensor, and methods for making same |
| WO2012150528A1 (en) * | 2011-05-03 | 2012-11-08 | Koninklijke Philips Electronics N.V. | Electrode assembly for contacting skin |
| CN102178513B (zh) * | 2011-05-05 | 2013-02-27 | 长沙三诺生物传感技术股份有限公司 | 夹心式生物传感器 |
| KR20140082642A (ko) | 2011-07-26 | 2014-07-02 | 글리젠스 인코포레이티드 | 용봉한 하우징을 포함하는 조직 이식 가능한 센서 |
| JP2014533523A (ja) | 2011-09-02 | 2014-12-15 | ザ レジェンツ オブ ザ ユニヴァーシティー オブ カリフォルニア | バイオセンシングおよび薬剤供給のためのマイクロ針アレイ |
| US10561353B2 (en) | 2016-06-01 | 2020-02-18 | Glysens Incorporated | Biocompatible implantable sensor apparatus and methods |
| US10660550B2 (en) | 2015-12-29 | 2020-05-26 | Glysens Incorporated | Implantable sensor apparatus and methods |
| US20140213866A1 (en) | 2012-10-12 | 2014-07-31 | Dexcom, Inc. | Sensors for continuous analyte monitoring, and related methods |
| CN104055526A (zh) * | 2013-12-05 | 2014-09-24 | 庞德兴 | 一种无源微创皮下生化参数检测芯片 |
| US20150289788A1 (en) | 2014-04-10 | 2015-10-15 | Dexcom, Inc. | Sensors for continuous analyte monitoring, and related methods |
| US10383558B2 (en) * | 2015-03-06 | 2019-08-20 | Samsung Electronics Co., Ltd. | Device for measuring bio information and method for manufacturing the same |
| KR102469144B1 (ko) | 2015-04-17 | 2022-11-21 | 삼성전자주식회사 | 생체 정보 측정 센서, 생체 정보 시스템 및 이를 이용한 생체 정보 측정 방법 |
| US11298039B2 (en) * | 2015-04-17 | 2022-04-12 | Samsung Electronics Co., Ltd | Biometric information measuring sensor, biometric information measuring system, and method of measuring biometric information using the sensor |
| WO2016182315A1 (en) * | 2015-05-11 | 2016-11-17 | Samsung Electronics Co., Ltd. | Biosensor electrode structure and biosensor including the same |
| KR20160132750A (ko) * | 2015-05-11 | 2016-11-21 | 삼성전자주식회사 | 바이오 센서용 전극 구조 및 상기한 전극 구조를 포함하는 바이오 센서 |
| KR20170040918A (ko) * | 2015-10-06 | 2017-04-14 | 삼성전자주식회사 | 바이오 센서 및 그의 센싱 방법 |
| US20170325725A1 (en) * | 2016-05-13 | 2017-11-16 | Percusense, LLC | Vivo sensing and infusion devices |
| US10638962B2 (en) | 2016-06-29 | 2020-05-05 | Glysens Incorporated | Bio-adaptable implantable sensor apparatus and methods |
| EP3515295A1 (en) * | 2016-09-21 | 2019-07-31 | University of Cincinnati | Accurate enzymatic sensing of sweat analytes |
| US10638979B2 (en) | 2017-07-10 | 2020-05-05 | Glysens Incorporated | Analyte sensor data evaluation and error reduction apparatus and methods |
| US11278668B2 (en) | 2017-12-22 | 2022-03-22 | Glysens Incorporated | Analyte sensor and medicant delivery data evaluation and error reduction apparatus and methods |
| US11255839B2 (en) | 2018-01-04 | 2022-02-22 | Glysens Incorporated | Apparatus and methods for analyte sensor mismatch correction |
| TWI682766B (zh) * | 2018-07-27 | 2020-01-21 | 華廣生技股份有限公司 | 彈性生理貼片 |
| CN110680343A (zh) * | 2019-09-11 | 2020-01-14 | 杭州瀚科医疗科技有限公司 | 新型皮下葡萄糖传感器电路导通方法 |
| US11478194B2 (en) | 2020-07-29 | 2022-10-25 | Biolinq Incorporated | Continuous analyte monitoring system with microneedle array |
| SE545874C2 (en) | 2021-05-08 | 2024-02-27 | Biolinq Incorporated | Fault detection for microneedle array based continuous analyte monitoring device |
| CA3223896A1 (en) * | 2021-07-06 | 2023-01-12 | Kirill Sliozberg | Analyte sensor and method for manufacturing an analyte sensor |
| EP4115806A1 (en) * | 2021-07-06 | 2023-01-11 | Roche Diabetes Care GmbH | Analyte sensor and method for manufacturing an analyte sensor |
| CA3232846A1 (en) * | 2021-09-22 | 2023-03-30 | Embecta Corp. | Glucose monitor injection port |
| CN113916954A (zh) * | 2021-09-30 | 2022-01-11 | 上海交通大学 | 一种片上原位微型银氯化银参比电极及其制备方法 |
| US20230408437A1 (en) * | 2022-05-18 | 2023-12-21 | Apex Biotechnology Corp. | Electrochemical system and implantable biochemical test chip |
| PL441669A1 (pl) * | 2022-07-07 | 2024-01-08 | Heart Guard Spółka Z Ograniczoną Odpowiedzialnością | Układ elektrod do mierzenia pH tkanek zwierzęcych, sonda zawierająca taki układ oraz zestaw zawierający wymienioną sondę |
Family Cites Families (39)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3957613A (en) * | 1974-11-01 | 1976-05-18 | General Electric Company | Miniature probe having multifunctional electrodes for sensing ions and gases |
| JPS5680107U (zh) * | 1979-11-20 | 1981-06-29 | ||
| DE3502913C1 (de) * | 1985-01-29 | 1986-07-03 | Günter Prof. Dr.rer.nat. 5100 Aachen Rau | Messaufnehmer zur nichtinvasiven Erfassung elektrophysiologischer Groessen |
| DE3700119A1 (de) * | 1987-01-03 | 1988-07-14 | Inst Diabetestechnologie Gemei | Implantierbarer elektrochemischer sensor |
| GB8725936D0 (en) * | 1987-11-05 | 1987-12-09 | Genetics Int Inc | Sensing system |
| US5094242A (en) * | 1988-11-07 | 1992-03-10 | Regents Of The University Of California | Implantable nerve stimulation device |
| US5211175A (en) * | 1988-11-07 | 1993-05-18 | Regents Of The University Of California | Method for implanting electra-acupuncture needle |
| JP2536780B2 (ja) * | 1988-11-10 | 1996-09-18 | 株式会社エー・アンド・デイ | 使い拾て型酵素電極 |
| US5200051A (en) * | 1988-11-14 | 1993-04-06 | I-Stat Corporation | Wholly microfabricated biosensors and process for the manufacture and use thereof |
| US5063081A (en) * | 1988-11-14 | 1991-11-05 | I-Stat Corporation | Method of manufacturing a plurality of uniform microfabricated sensing devices having an immobilized ligand receptor |
| US4953552A (en) * | 1989-04-21 | 1990-09-04 | Demarzo Arthur P | Blood glucose monitoring system |
| US5205286A (en) * | 1991-07-24 | 1993-04-27 | Intermedics, Inc. | Subcutaneous electrical data port |
| DK0637323T3 (da) * | 1992-04-24 | 1999-05-25 | Polymer Technology Group Inc | Copolymerer og ikke-porøs, semipermeabel membran deraf og dens anvendelse til permeering af molekyler med et forudbestemt m |
| CA2132277C (en) * | 1993-10-22 | 2005-05-10 | Giorgio Cirelli | Injection device |
| JP3465370B2 (ja) * | 1994-09-20 | 2003-11-10 | 凸版印刷株式会社 | 酵素電極 |
| IE72524B1 (en) * | 1994-11-04 | 1997-04-23 | Elan Med Tech | Analyte-controlled liquid delivery device and analyte monitor |
| ATE234129T1 (de) * | 1996-06-18 | 2003-03-15 | Alza Corp | Vorrichtung zur verbesserung der transdermalen verabreichung von medikamenten oder der abnahme von körperflüssigkeiten |
| CA2285959A1 (en) * | 1997-04-11 | 1998-10-22 | Alza Corporation | Minimally invasive detecting device |
| US6091975A (en) * | 1998-04-01 | 2000-07-18 | Alza Corporation | Minimally invasive detecting device |
| US6360888B1 (en) * | 1999-02-25 | 2002-03-26 | Minimed Inc. | Glucose sensor package system |
| US6256533B1 (en) * | 1999-06-09 | 2001-07-03 | The Procter & Gamble Company | Apparatus and method for using an intracutaneous microneedle array |
| US6379324B1 (en) * | 1999-06-09 | 2002-04-30 | The Procter & Gamble Company | Intracutaneous microneedle array apparatus |
| US6549797B1 (en) * | 1999-12-01 | 2003-04-15 | Vertis Neuroscience, Inc. | Electrode remover for a percutaneous electrical therapy system |
| JP2001208721A (ja) * | 2000-01-28 | 2001-08-03 | Natl Inst Of Advanced Industrial Science & Technology Meti | 酸素電極 |
| EP1162453A1 (fr) * | 2000-06-07 | 2001-12-12 | Asulab S.A. | Capteur électrochimique à reproductibilité accrue |
| JP3460020B2 (ja) * | 2000-08-04 | 2003-10-27 | 株式会社ニシトモ | 血糖値計 |
| MXPA03001694A (es) * | 2000-08-24 | 2004-11-01 | Johnson & Johnson | Metodo para toma de muestra transdermal de acido nucleico. |
| US6591133B1 (en) * | 2000-11-27 | 2003-07-08 | Microlin Llc | Apparatus and methods for fluid delivery using electroactive needles and implantable electrochemical delivery devices |
| US6837988B2 (en) * | 2001-06-12 | 2005-01-04 | Lifescan, Inc. | Biological fluid sampling and analyte measurement devices and methods |
| US7429258B2 (en) * | 2001-10-26 | 2008-09-30 | Massachusetts Institute Of Technology | Microneedle transport device |
| US6952604B2 (en) * | 2001-12-21 | 2005-10-04 | Becton, Dickinson And Company | Minimally-invasive system and method for monitoring analyte levels |
| US7245963B2 (en) * | 2002-03-07 | 2007-07-17 | Advisys, Inc. | Electrode assembly for constant-current electroporation and use |
| US7153265B2 (en) * | 2002-04-22 | 2006-12-26 | Medtronic Minimed, Inc. | Anti-inflammatory biosensor for reduced biofouling and enhanced sensor performance |
| US7120483B2 (en) | 2003-01-13 | 2006-10-10 | Isense Corporation | Methods for analyte sensing and measurement |
| US7228162B2 (en) * | 2003-01-13 | 2007-06-05 | Isense Corporation | Analyte sensor |
| US7146202B2 (en) * | 2003-06-16 | 2006-12-05 | Isense Corporation | Compound material analyte sensor |
| JP4359595B2 (ja) * | 2003-09-02 | 2009-11-04 | 広司 早出 | グルコースセンサおよびグルコース濃度測定装置 |
| CN2782015Y (zh) * | 2004-12-08 | 2006-05-24 | 圣美迪诺医疗科技(湖州)有限公司 | 皮下植入式生物传感器 |
| CN100367906C (zh) * | 2004-12-08 | 2008-02-13 | 圣美迪诺医疗科技(湖州)有限公司 | 皮下植入式生物传感器 |
-
2004
- 2004-12-08 CN CNB2004101010806A patent/CN100367906C/zh active Active
-
2005
- 2005-10-29 US US11/262,373 patent/US7979103B2/en active Active - Reinstated
- 2005-11-09 AU AU2005314502A patent/AU2005314502B2/en not_active Ceased
- 2005-11-09 PL PL05819013T patent/PL1841363T3/pl unknown
- 2005-11-09 ES ES05819013T patent/ES2371766T3/es active Active
- 2005-11-09 EP EP05819013A patent/EP1841363B1/en active Active
- 2005-11-09 JP JP2007545484A patent/JP4797024B2/ja not_active Expired - Fee Related
- 2005-11-09 WO PCT/US2005/040749 patent/WO2006062668A2/en active Application Filing
-
2011
- 2011-02-22 US US13/032,500 patent/US20110144466A1/en not_active Abandoned
Cited By (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101530327B (zh) * | 2009-04-20 | 2012-09-05 | 湖州美奇医疗器械有限公司 | 皮下组织实时监测用针状电流测定式葡萄糖传感器及其制作方法 |
| CN101530328B (zh) * | 2009-04-20 | 2013-06-19 | 湖州美奇医疗器械有限公司 | 皮下植入式的葡萄糖传感器及其制作方法 |
| CN101716073B (zh) * | 2009-12-09 | 2011-07-20 | 中国科学院半导体研究所 | 长期记录生理电信号的侵入式斜针无痛皮肤干电极器件 |
| CN102247148A (zh) * | 2010-05-19 | 2011-11-23 | 爱科来株式会社 | 电化学传感器 |
| CN102247148B (zh) * | 2010-05-19 | 2013-12-25 | 爱科来株式会社 | 电化学传感器 |
| CN107405116A (zh) * | 2015-03-06 | 2017-11-28 | 三星电子株式会社 | 生物计量信息测量设备 |
| CN107405116B (zh) * | 2015-03-06 | 2020-07-17 | 三星电子株式会社 | 生物计量信息测量设备 |
| WO2016141596A1 (zh) * | 2015-03-12 | 2016-09-15 | 深圳市光聚通讯技术开发有限公司 | 微型动态血糖仪 |
| CN105411607B (zh) * | 2015-11-16 | 2017-03-01 | 杭州亿信网络科技有限公司 | 皮下组织介入式葡萄糖微型传感器及其制备方法 |
| CN105411607A (zh) * | 2015-11-16 | 2016-03-23 | 杭州亿信网络科技有限公司 | 皮下组织介入式葡萄糖微型传感器及其制备方法 |
| CN107814865A (zh) * | 2017-10-27 | 2018-03-20 | 浙江大学 | 用于低温植埋的侵入式脑机接口 |
| CN108652646A (zh) * | 2018-03-15 | 2018-10-16 | 戴兵 | 一种皮下植入式生物传感器装置及系统 |
| CN108931568A (zh) * | 2018-05-25 | 2018-12-04 | 南京佳乐净膜科技有限公司 | 生物传感器及其制备方法 |
| CN108931568B (zh) * | 2018-05-25 | 2020-09-01 | 南京佳乐净膜科技有限公司 | 生物传感器及其制备方法 |
| WO2022016639A1 (zh) * | 2020-07-24 | 2022-01-27 | 湖州美奇医疗器械有限公司 | 一种三电极皮下植入式葡萄糖传感器及其制作方法 |
| CN111896587A (zh) * | 2020-08-12 | 2020-11-06 | 湖州美奇医疗器械有限公司 | 一种血糖监测传感器测试工装 |
Also Published As
| Publication number | Publication date |
|---|---|
| US20110144466A1 (en) | 2011-06-16 |
| AU2005314502B2 (en) | 2012-02-16 |
| PL1841363T3 (pl) | 2012-03-30 |
| US7979103B2 (en) | 2011-07-12 |
| EP1841363B1 (en) | 2011-10-05 |
| US20080033269A1 (en) | 2008-02-07 |
| WO2006062668A3 (en) | 2006-10-12 |
| ES2371766T3 (es) | 2012-01-09 |
| WO2006062668A2 (en) | 2006-06-15 |
| CN100367906C (zh) | 2008-02-13 |
| EP1841363A4 (en) | 2008-10-08 |
| JP2008544763A (ja) | 2008-12-11 |
| AU2005314502A1 (en) | 2006-06-15 |
| EP1841363A2 (en) | 2007-10-10 |
| JP4797024B2 (ja) | 2011-10-19 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN100367906C (zh) | 皮下植入式生物传感器 | |
| Jaffari et al. | Recent advances in amperometric glucose biosensors for in vivo monitoring | |
| Wilkins et al. | Integrated implantable device for long-term glucose monitoring | |
| Buerk | Biosensors: theory and applications | |
| Harrison et al. | Characterization of perfluorosulfonic acid polymer coated enzyme electrodes and a miniaturized integrated potentiostat for glucose analysis in whole blood | |
| US6893552B1 (en) | Microsensors for glucose and insulin monitoring | |
| RU2745479C1 (ru) | Способ и блок электроники для определения свойств биосенсора в условиях in vivo | |
| US20070299617A1 (en) | Biofouling self-compensating biosensor | |
| US20180233761A1 (en) | Self-charging implantable power source with biosensor functionality | |
| Wang et al. | One-step electropolymeric co-immobilization of glucose oxidase and heparin for amperometric biosensing of glucose | |
| CN106725470A (zh) | 一种连续或非连续的生理参数分析系统 | |
| CN113008966B (zh) | 一种可用于同时检测葡萄糖和尿酸的非酶电化学传感器 | |
| CN2782015Y (zh) | 皮下植入式生物传感器 | |
| CN207202871U (zh) | 一种连续或非连续的生理参数分析系统 | |
| Ward et al. | A wire-based dual-analyte sensor for glucose and lactate: in vitro and in vivo evaluation | |
| Ahmad et al. | Minimizing tissue–material interaction in microsensor for subcutaneous glucose monitoring | |
| CN108652646A (zh) | 一种皮下植入式生物传感器装置及系统 | |
| Preidel et al. | A new principle for an electrochemical oxygen sensor | |
| CN1296705C (zh) | 可调式生物传感器的控制电路 | |
| Lee et al. | Flexible enzyme free glucose micro-sensor for continuous monitoring applications | |
| Lemke et al. | Electrocatalytic glucose sensor for subcutaneous application | |
| EP3928697A1 (en) | Analyte sensor and a method for producing an analyte sensor | |
| CN113820368A (zh) | 一种基于聚吡咯薄膜的自支撑葡萄糖传感器及其构建方法 | |
| Yang et al. | Glucose biosensor based on oxygen electrode Part IV: In vivo evaluation of the rechargeable glucose sensor | |
| KR100464141B1 (ko) | 바이오 센서 |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| PP01 | Preservation of patent right |
Effective date of registration: 20161124 Granted publication date: 20080213 |
|
| RINS | Preservation of patent right or utility model and its discharge | ||
| PD01 | Discharge of preservation of patent |
Date of cancellation: 20170524 Granted publication date: 20080213 |
|
| PP01 | Preservation of patent right |
Effective date of registration: 20170524 Granted publication date: 20080213 |
|
| PD01 | Discharge of preservation of patent |
Date of cancellation: 20171124 Granted publication date: 20080213 |
|
| PD01 | Discharge of preservation of patent | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20190118 Address after: 100176 Building No. 1 Kangding Street, Beijing Economic and Technological Development Zone, 7 storeys 701 Patentee after: BEIJING SAN MEDITECH TECHNOLOGY CO.,LTD. Address before: No. 699, Bronze Road, Huzhou City, Zhejiang Province, 313000 Patentee before: San Meditech (Huzhou) Co.,Ltd. |
|
| TR01 | Transfer of patent right | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Endermic implantating biological sensors Effective date of registration: 20190730 Granted publication date: 20080213 Pledgee: Ji Xiaoyu Pledgor: BEIJING SAN MEDITECH TECHNOLOGY CO.,LTD. Registration number: 2019990000801 |
|
| PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
| PP01 | Preservation of patent right |
Effective date of registration: 20190819 Granted publication date: 20080213 |
|
| PP01 | Preservation of patent right | ||
| PD01 | Discharge of preservation of patent | ||
| PD01 | Discharge of preservation of patent |
Date of cancellation: 20230819 Granted publication date: 20080213 |
|
| TR01 | Transfer of patent right |
Effective date of registration: 20231007 Address after: 505-1, 5 / F, block C, building 6, No. 1366, Hongfeng Road, Huzhou City, Zhejiang Province, 313000 Patentee after: Demei medical technology (Huzhou) Co.,Ltd. Address before: 100176 Building No. 1 Kangding Street, Beijing Economic and Technological Development Zone, 7 storeys 701 Patentee before: BEIJING SAN MEDITECH TECHNOLOGY CO.,LTD. |
|
| TR01 | Transfer of patent right |