CN102740778A - 诊断口腔装置 - Google Patents
诊断口腔装置 Download PDFInfo
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- CN102740778A CN102740778A CN2010800592752A CN201080059275A CN102740778A CN 102740778 A CN102740778 A CN 102740778A CN 2010800592752 A CN2010800592752 A CN 2010800592752A CN 201080059275 A CN201080059275 A CN 201080059275A CN 102740778 A CN102740778 A CN 102740778A
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Abstract
本文描述了用于鉴定受试者存在口腔病况的装置和方法。
Description
相关申请交叉引用
本申请权利要求2009年12月23日提交的美国临时专利申请第61/289,425号的优先权，其通过引用结合到本文中。
背景
口腔健康问题可以采取许多形式，比如蛀牙、牙周疾病和口臭。细菌在许多口腔健康问题中起主要作用。例如，蛀牙和牙周疾病通常由口腔中不期望的细菌引起。细菌也与存在于唾液中的蛋白质相互作用形成覆盖牙齿的膜，称为牙菌斑。如果不将该牙菌斑去除，由细菌产生的酸可侵蚀牙齿导致蛀牙。牙菌斑也可侵蚀口腔的软牙龈组织导致成年人牙齿损失。
之前尝试的口腔保健检测系统已被广泛采用并具有有限的功能性。例如，采用用于诊断龋齿风险的常规方法的测试条尚未取得商业成功或被公众广泛采纳，所述测试条使用抗体来检测口腔细菌的存在。另外，使用颜色作为具体细菌或酶存在的指示剂的系统背负着对另外的显色处理或设备的需要，例如色度计或荧光计。除了不便实施多个步骤，使用另外的试剂和设备可增大风险和增大成本。
概述
本发明的一些实施方案提供了用于鉴定存在口腔病况(condition)的装置，所述装置包含：用于自口腔收集样品的容器；能够检测在所述样品内存在标志物的检测器；和能够由来自检测器的信号驱动的指示剂。
其它实施方案提供了用于鉴定受试者存在口腔病况的方法，所述方法包含：使用容器自受试者的口腔收集样品；检测样品中存在一种或多种标志物；并对受试者表明存在一种或多种标志物中的至少一种。
附图简述
图1为本发明实施方案的牙刷结构的示意性片段截面说明。
详述
本发明的一些实施方案提供了用于鉴定存在口腔病况的装置，所述装置包含：用于自口腔收集样品的容器；能够检测在所述样品内存在标志物的检测器；和能够由来自检测器的信号驱动的指示剂。在其它的实施方案中，容器可拆卸地固定于口腔护理器具。在其它的实施方案中，容器包含生物粘合剂。
在一些实施方案中，容器包含收集元件和储存器。在一些实施方案中，收集元件收集来自口腔的样品。在一些实施方案中，储存器储存来自口腔的样品。在一些实施方案中，容器含有流体连接收集元件和储存器以向储存器提供口腔流体的流体通路。在一些实施方案中，检测器配置在容器中。在某些实施方案中，指示剂配置在容器中。
在一些实施方案中，检测器配置在储存器中。在一些实施方案中，指示剂配置在储存器中。
图1示意性说明牙刷100，其具有收集元件200和和储存器155，储存器155提供用于储存口腔流体介质比如唾液和/或唾液与洁牙剂的混合物。在一些实施方案中，储存器155可提供于牙刷100的颈部105或在牙刷柄103的远端。
在一些实施方案中，流体通道140比如毛细管道在牙刷100的纵向延伸用于从至少一个入口150自口腔向储存器155递送样品。在一些实施方案中，通道140使用毛细管作用自入口150向储存器155吸取样品。在一些实施方案中，毛细管道140具有毛细结构。在某些实施方案中，通道140以多孔材料的形式存在。多孔材料的实例包括纤维材料、陶瓷和多孔塑料比如可得自Porex Technologies, Atlanta, Georgia的那些材料。纤维材料的一个实例为称为型号C10010，可得自Teibow Hanbai Co., Ltd., Tokyo, Japan的丙烯酸材料。在一些实施方案中，可提供具有较大和较小毛细管分布的多孔和/或纤维材料的混合物。在一些实施方案中，通道140可自许多相互连接的小毛细管形成，或者作为较大的单个毛细管。
在一些实施方案中，对储存器155中的样品的可经口腔检查而检测的口腔疾病、病症或病况进行分析。
在一些实施方案中，储存器包含可更换的盒。在一些实施方案中，容器进一步包含连接于收集元件的接收器，其适合于自口腔接受样品。
在一些实施方案中，流体通路包括纤维材料、陶瓷、多孔塑料或其组合，用于提供来自口腔的样品的毛细管回收。
在一些实施方案中，样品为唾液、牙龈沟液或组织。在一些实施方案中，标志物表明口腔护理不良。在其它的实施方案中，标志物选自IL-1β、PGE2、精氨酸和牙龈菌蛋白酶。
在一些实施方案中，指示剂为染料。在一些实施方案中，指示剂在单次检测事件后被耗尽。在一些实施方案中，指示剂为结构指示剂(structural indicator)。
在一些实施方案中，口腔护理器具为牙刷。在其它的实施方案中，口腔护理器具为牙线。
在一些实施方案中，容器、检测器和指示剂配置在贴片(patch)中。在其它的实施方案中，贴片能够固定于口腔的表面。
本发明的一些实施方案提供了用于鉴定受试者存在口腔病况的方法，所述方法包含：使用容器自受试者的口腔收集样品；检测所述样品中存在一种或多种标志物；并对所述受试者表明存在所述一种或多种标志物中的至少一种。
在一些实施方案中，样品为唾液、牙龈沟液或组织。
在一些实施方案中，容器包含过滤器。在一些实施方案中，容器可拆卸地固定于口腔护理器具。在其它的实施方案中，容器包含生物粘合剂。
在仍然其它的实施方案中，所述一种或多种标志物中的至少一种表明口腔护理不良。在其它的实施方案中，所述一种或多种标志物中的至少一种选自IL-1β、PGE2、精氨酸和牙龈菌蛋白酶。
在一些实施方案中，指示剂为染料。在其它的实施方案中，指示剂在单次检测事件后被耗尽。在一些实施方案中，指示剂为结构指示剂。在一些实施方案中，指示剂将在暴露于标志物之后立即证实存在具体标志物。在一些实施方案中，指示剂将在暴露于标志物之后约2天证实存在具体标志物。在其它的实施方案中，指示剂将在检测到阈值量的标志物之后证实存在具体标志物。
在其它的实施方案中，口腔护理器具为牙刷。在某些实施方案中，口腔护理器具为牙线。在一些实施方案中，口腔护理器具为锐口牙刮匙(dental pick)。在一些实施方案中，口腔护理器具为刮舌器。
在一些实施方案中，容器、检测器和指示剂储藏在单一结构中。在一些实施方案中，容器、检测器和指示剂储藏其中的结构为沸石或贴片。在一些实施方案中，容器、检测器和指示剂配置于贴片中。在一些实施方案中，贴片能够固定于口腔的表面。
在一些实施方案中，装置为与口腔护理器具分开使用的‘独立’装置。在一些实施方案中，装置可嵌入到安在一个或多个牙齿上的较大结构中。在一些实施方案中，装置加入到牙套、护口器、假牙或设计用于放置在口中或者一个或多个牙齿上延长的时间期间的其它装置中。
在其它的实施方案中，指示剂包含调味剂。在其它的实施方案中，指示剂包含结构指示剂。在一些实施方案中，结构指示剂向受试者提供口腔中存在具体标志物的指示。在一些实施方案中，标志物对具体疾病、病况或病症为特异性的。在一些实施方案中，结构指示剂可被受试者触知察觉。在一些实施方案中，结构指示剂对受试者可视觉察觉。在某些实施方案中，结构指示剂为凹陷(pit)。在其它的实施方案中，结构指示剂为脊。
在一些实施方案中，检测器包含一种或多种聚合物。合适的聚合物为本领域已知的，包括在Etienne O等. (Polyelectrolyte multilayer film coating and stability at the surfaces of oral prosthesis base polymers: an in vitro and in vivo study(聚电解质多层膜涂层和在口腔假体基底聚合物表面的稳定性：体外和体内研究). J Dent Res. 2006年1月, 85(1): 44-8)中描述的那些聚合物，其通过引用全文结合到本文中。
在一些实施方案中，指示剂与口腔流体和/或空气隔离。在一些实施方案中，指示剂在标志物检测之后可能不是立即可见。在一些实施方案中，指示剂需要标志物连续存在以变为可见。
在一些实施方案中，由本文描述的装置鉴定的口腔病况包括但不限于与口腔护理不良相关的病况、可通过口腔检查诊断的病况、和经美国牙科协会识别或另外鉴定与口腔护理不良相关的全身病况。
在一些实施方案中，病况选自：龋齿、牙龈炎、牙周炎、口臭和口干。在一些实施方案中，IL-1β、PGE2、精氨酸和牙龈菌蛋白酶为牙龈炎的标志物。在其它的实施方案中，牙龈炎用牙龈卟啉单胞菌(P. gingivalis)、牙龈二氧化碳噬纤维菌(C. gingivalis)、产黑色普雷沃菌(P. melaninogenica)、齿垢密螺旋体(Treponema denticola)、福氏拟杆菌(Bacterioides forsythus)和缓症链球菌(S. mitis)中的一种或多种水平升高来指示。在一些实施方案中，口臭用口腔中存在挥发性硫化合物包括甲硫醇、二甲基硫醚和硫化氢来指示。
在某些实施方案中，牙周炎用口腔中存在弹性蛋白酶、二肽基肽酶、β-葡萄糖醛酸酶、乳铁蛋白、血小板活化因子(PAF)、ICPT (吡啶啉交联羧基端终肽)、组织蛋白酶B (半胱氨酸蛋白酶)、半胱氨酸蛋白酶抑制剂、MMP-1、胶原酶-2 (基质金属蛋白酶, MMP-8)、MMP-13 (胶原酶-3)、明胶酶(MMP-9)、羟基-脱氧鸟苷和免疫球蛋白比如IgA、IgG和IgM来指示。
在其它的实施方案中，骨相关的生物标志物比如钙卫蛋白、骨钙蛋白、骨连蛋白(ostenocetin)和骨桥蛋白的存在与牙周疾病相关。在一些实施方案中，龋齿用低唾液pH、局部pH (即硬组织的具体位点)和用产酸口腔细菌(具体地讲为乳酸菌(Lactobacillus)种、变异链球菌(Streptococcus mutans)和放线菌(Actinomyces)种)来指示。
在一些实施方案中，非口腔基全身性疾病与口腔恶臭相关。在一些实施方案中，与口腔恶臭相关的非口腔基全身性疾病为：慢性肝衰竭、下呼吸道感染(支气管和肺感染)、肾脏感染和肾衰竭及三甲基胺尿症(“鱼腥味综合症”) (参见参考文献：Tangerman A. Halitosis in medicine: a review.(医学中的口臭：综述) Int Dent J. 2002年6月; 52 Suppl 3:201-6)。在一些实施方案中，标志物可在呼出气体中检测到。在一些实施方案中，受试者的呼吸中高浓度丙酮(称为“丙酮味口臭”)指示糖尿病酮症酸中毒。
在一些实施方案中，全身性疾病、病症或病况可为人病理状态、炎症或癌症。在一些实施方案中，标志物为细菌代谢物标志物，比如在PCT/US2009/039184中描述的那些标志物，其通过引用全文结合到本文中。
在一些实施方案中，指示剂显示的颜色强度与疾病或病症的严重性或流行程度相关联。在一些实施方案中，染料选自柠檬黄、苋菜红、诱惑红、赤藓红B、靛蓝胭脂红、亮蓝FCF、β-胡萝卜素、固绿FCF、罂红二钠盐、姜黄素、铬变素FB、新胭脂红、核黄素5’单-磷酸钠盐、核黄素、甜菜苷、番茄红素、巧克力棕色HT、亮黑BN、绿S、indogtine、红木素、亮猩红色4R、苋菜红、红色酸性染料偶氮玉红、胭脂虫红和日落黄FCF。
应该理解，尽管本发明连同其具体实施方案已经得到描述，上述描述旨在说明，但不限制本发明的范围。其它方面、优势和修改对于本发明所属领域的技术人员将是显而易见的，并且这些方面和修改处于本文描述和请求保护的本发明范围内。
Claims (32)
1.一种用于鉴定受试者存在口腔病况的装置，所述装置包含：
用于自口腔收集样品的容器；
能够检测所述样品内存在标志物的检测器；
能够由来自检测器的信号驱动的指示剂。
2.权利要求1的装置，其中所述容器包含：
用于自口腔收集样品的收集元件；和
用于储存所述样品的储存器；和
流体连接收集元件和储存器以向储存器提供样品的流体通路。
3.权利要求1的装置，其中所述容器可拆卸地固定于口腔护理器具。
4.权利要求1的装置，其中所述容器包含生物粘合剂。
5.权利要求2的装置，其中所述检测器配置在所述储存器中。
6.权利要求5的装置，其中所述指示剂配置在所述储存器中。
7.权利要求1的装置，其中所述样品为唾液、牙龈沟液或组织。
8.权利要求1的装置，其中所述标志物表明口腔护理不良。
9.权利要求1的装置，其中所述标志物选自IL-1β、PGE2、精氨酸和牙龈菌蛋白酶。
10.权利要求1的装置，其中所述指示剂为染料。
11.权利要求1的装置，其中所述指示剂在单次检测事件后被耗尽。
12.权利要求1的装置，其中所述指示剂为物理指示剂。
13.权利要求3的装置，其中所述口腔护理器具为牙刷。
14.权利要求3的装置，其中所述口腔护理器具为牙线。
15.权利要求1的装置，其中所述容器、检测器和指示剂配置在贴片中。
16.权利要求15的装置，其中所述贴片能够固定于口腔的表面。
17.一种用于鉴定受试者存在口腔病况的方法，所述方法包含：
使用容器自受试者的口腔收集样品；
检测所述样品中存在一种或多种标志物；和
对所述受试者表明存在所述一种或多种标志物中的至少一种。
18.权利要求17的方法，其中所述容器包含：
用于自口腔收集样品的收集元件；和
用于储存所述样品的储存器；和
流体连接收集元件和储存器以向储存器提供样品的流体通路。
19.权利要求17的方法，其中所述容器可拆卸地固定于口腔护理器具。
20.权利要求17的方法，其中所述容器包含生物粘合剂。
21.权利要求18的方法，其中所述检测器配置在所述储存器中。
22.权利要求18的方法，其中所述指示剂配置在所述储存器中。
23.权利要求17的方法，其中所述样品为唾液、牙龈沟液或组织。
24.权利要求17的方法，其中所述一种或多种标志物中的至少一种表明口腔护理不良。
25.权利要求24的方法，其中所述一种或多种标志物中的至少一种选自IL-1β、PGE2、精氨酸和牙龈菌蛋白酶。
26.权利要求17的方法，其中所述指示剂为染料。
27.权利要求17的方法，其中所述指示剂在单次检测事件后被耗尽。
28.权利要求17的方法，其中所述指示剂为结构指示剂。
29.权利要求19的方法，其中所述口腔护理器具为牙刷。
31.权利要求19的方法，其中所述口腔护理器具为牙线。
32.权利要求20的方法，其中所述容器、检测器和指示剂配置在贴片中。
33.权利要求32的方法，其中所述贴片能够固定于口腔的表面。
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| US61/289,425 | 2009-12-23 | ||
| PCT/US2010/061704 WO2011079164A1 (en) | 2009-12-23 | 2010-12-22 | Diagnostic oral device |
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| CN102740778A true CN102740778A (zh) | 2012-10-17 |
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Also Published As
| Publication number | Publication date |
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| US9606110B2 (en) | 2017-03-28 |
| KR101426632B1 (ko) | 2014-08-05 |
| CN102740778B (zh) | 2015-06-17 |
| US20150087074A1 (en) | 2015-03-26 |
| CO6541624A2 (es) | 2012-10-16 |
| WO2011079164A1 (en) | 2011-06-30 |
| MX2012006288A (es) | 2012-07-03 |
| RU2534519C2 (ru) | 2014-11-27 |
| AU2010336464B2 (en) | 2014-01-16 |
| EP2515766A1 (en) | 2012-10-31 |
| US8920340B2 (en) | 2014-12-30 |
| MY162827A (en) | 2017-07-31 |
| EP2515766B1 (en) | 2018-04-18 |
| RU2012131412A (ru) | 2014-02-20 |
| KR20120091456A (ko) | 2012-08-17 |
| CA2785055A1 (en) | 2011-06-30 |
| AU2010336464A1 (en) | 2012-06-21 |
| US20120309042A1 (en) | 2012-12-06 |
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