CN104970898B - 用于鉴定口腔状况的装置 - Google Patents
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Abstract
本发明涉及用于鉴定口腔状况的装置，并涉及用于检测口腔状况存在的装置和系统。所述装置包括：能够检测口腔状况标志物的检测器；自含式指示剂，其中所述指示剂由所述检测器暴露，其中所述指示剂为适合于经历触觉上可察觉的物理变化的结构指示剂；基部，其包括所述指示剂，其中所述指示剂是结构指示剂，并且所述结构指示剂为以下中的一种：(1)自所述基部延伸的突起；和(2)形成于基部中的坑；其中所述检测器形成为位于基部顶上的层；并且其中所述装置能够可拆卸地固定于口腔护理器具。
Description
本申请是申请日为2010年12月22日，申请号为201080059235.8(国际申请号为PCT/US2010/061708)，发明名称为“用于鉴定口腔状况的装置”的发明专利申请的分案申请。
相关申请的交叉引用
该申请要求2009年12月23日递交的美国临时专利申请第61/289422号的优先权，其通过引用结合到本文中。
背景
口腔卫生问题可呈多种形式，比如蛀牙、牙周疾病和口臭。细菌在许多口腔卫生问题中起主要作用。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，形成覆盖牙齿的薄膜(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缺失。
口腔护理剂比如冲洗剂和漱口剂用于去除细菌和供给呼吸清新剂。然而，当使用这些液体时人们不总是实施有效的口腔护理程序。因此，甚至在人已经完成他/她的口腔护理常规之后，大量有害细菌可仍然保留在口中，侵蚀牙齿和牙龈。
之前尝试的口腔保健检测系统还未被广泛采用并具有有限的功能。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，测试条使用抗体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的负担是需要用于显色的另外处理或设备，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。
因此，合乎需要的是提供能够至少在某种程度上克服本文所描述缺点的方法和设备。
概述
在一些实施方案中，本发明提供口腔装置，所述装置包括：能够检测口腔状况标志物的检测器；能够表明口腔状况存在的试剂，其中所述试剂配置在释放器中；和释放器，其配置为响应所述检测器检测的标志物而释放所述试剂。
一些实施方案提供口腔装置，所述装置包括：能够检测口腔状况标志物的检测器；在口腔装置的头部配置的自含式指示剂，其中所述指示剂由来自检测器的信号驱动。
进一步的实施方案提供口腔系统，所述系统包括：被配置用于引入到使用者口腔中的口腔装置；能够检测口腔状况标志物的检测器；能够表明口腔状况存在的试剂，其中所述试剂配置在释放器中；和释放器，其配置为响应所述检测器检测的标志物而释放所述试剂。
本发明的其它实施方案提供口腔系统，所述系统包括：口腔装置，其中所述口腔装置包括：能够检测口腔状况标志物的检测器；在口腔装置的头部配置的自含式指示剂，其中所述指示剂由来自检测器的信号驱动。
附图简述
图1为本发明一些实施方案装置的透视图。
图2为本文所描述装置的框图。
图3为本发明一些实施方案的检测标志物并响应检测事件而释放试剂的装置示意图。
详细描述
本文使用的术语“自含式”指在自身中具有实施所需功能所必要的一切，而不需要另外的处理、器材或设备的结构或组件。
本文使用的术语“结构指示剂”指其物理变化为视觉上和/或触觉上可察觉的指示剂。
一些实施方案提供检测使用者口腔状况的口腔装置。在一些实施方案中，装置响应检测状况而释放试剂。在一些实施方案中，状况可为有害状况，而在其它的实施方案中装置表明使用者良好的口腔卫生。在一些实施方案中，所释放的试剂为染料或其它指示剂，其可释放至口中或使用者感觉到(例如看见、触觉上感觉到、闻到或听到)的组件中。在其它的实施方案中，所释放的试剂为在治疗有害状况中有效的治疗剂。
在一些实施方案中，本发明提供口腔装置，所述装置包括：能够检测口腔状况标志物的检测器；能够表明口腔状况存在的试剂，其中所述试剂配置在释放器中；和释放器，其配置为响应所述检测器检测的标志物而释放所述试剂。
在一些实施方案中，检测器为配置在释放器上的涂层。在其它的实施方案中，配置检测器响应检测标志物而溶解；和检测器的溶解引起释放器释放其中所配置的试剂。在其它的实施方案中，检测器的溶解引起释放器的物理变化。在一些实施方案中，物理变化为释放器中产生孔。在其它的实施方案中，物理变化为释放器的形状变化。
在一些实施方案中，检测器的溶解引起释放器的化学变化。在一些实施方案中，化学变化为释放器的部分或完全溶解。
其它实施方案提供口腔装置，所述装置包括：能够检测口腔状况标志物的检测器；在口腔装置的头部配置的自含式指示剂，其中所述指示剂由来自检测器的信号驱动。
在一些实施方案中，标志物的检测表明良好的口腔卫生。在一些实施方案中，标志物选自：三氯生、磷酸盐、氨基酸、钾盐和亚锡盐。
在其它的实施方案中，标志物的检测表明存在适合经口腔检查检测的疾病、病症或状况。在一些实施方案中，标志物为细菌、真菌或病毒。在一些实施方案中，标志物选自：C-反应蛋白、葡萄糖、皮质醇、PSA、c-erbB-2-蛋白、激素、IL-1β、PGE2、精氨酸、牙龈菌蛋白酶、弹性蛋白酶、二肽基肽酶、β-葡糖醛酸酶、乳铁蛋白、血小板活化因子、ICPT、组织蛋白酶B、半胱氨酸蛋白酶抑制剂、MMP-1、胶原酶-2、MMP-8、MMP-13、MMP-9、羟基-脱氧鸟苷、免疫球蛋白、钙防卫蛋白、骨钙蛋白、ostenocetin和骨桥蛋白。
一些实施方案提供装置，其中指示剂为染料。其它的实施方案提供装置，其中指示剂为结构指示剂。
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，口腔护理器具为牙签(interdental pick)。
在一些实施方案中，装置进一步包括可更换芯，其中可更换芯可拆卸地固定于口腔装置；并且其中可更换芯包括检测器、试剂和释放器。在一些实施方案中，装置进一步包括配置在口腔装置上以查看可更换芯的窗口。
在一些实施方案中，试剂在单个检测事件后被耗尽。在一些实施方案中，试剂存在于释放器中的量足够用于多个检测事件。
在一些实施方案中，装置进一步包括多个检测器，其中配置至少两个检测器以检测不同的标志物。在其它的实施方案中，装置进一步包括多种试剂，其中至少两种试剂能够表明存在不同的口腔状况。
一些实施方案提供装置，其进一步包括：多个释放器，每种试剂配置在多个释放器中的相应释放器内，配置每个释放器以响应经相应检测器检测的相应标志物而释放相应试剂。在一些实施方案中，多种试剂中的第一种试剂在检测相应标志物时立即可用；和多种试剂中的第二种试剂在检测相应标志物之后延时可用。
本发明的一些实施方案提供口腔系统，所述系统包括：被配置用于引入到使用者口腔中的口腔装置；能够检测口腔状况标志物的检测器；能够表明口腔状况存在的试剂，其中所述试剂配置在释放器中；和释放器，其配置为响应所述检测器检测的标志物而释放试剂。
在一些实施方案中，口腔系统包括口腔装置，能够检测口腔状况标志物的检测器；在口腔装置的头部配置的自含式指示剂，其中所述指示剂由来自检测器的信号驱动。
如图1所示，装置12可配置在口腔护理器具上。装置12可配置在口腔护理器具10上的任何合适位置。在所显示的具体实例中，口腔护理器具10为牙刷，装置12配置在口腔护理器具10的头部14上。在一些实施方案中，牙刷为手动牙刷。在一些实施方案中，牙刷为电动牙刷。在一些实施方案中，牙刷为动力牙刷。在一些实施方案中，牙刷为压电牙刷。在一些实施方案中，牙刷为振动牙刷。在一些实施方案中，牙刷为一次性牙刷。其它的实施方案提供非牙刷口腔护理器具。合适的非牙刷口腔护理器具的实例包括但不限于牙间隙牙签或锐口牙刮匙、牙线、牙线夹持装置、刮舌器等。在一些实施方案中，装置12为可更换芯。本发明实施方案的优点是，通过如在图1中描绘的那样在口腔护理器具10上加入装置12，本发明的实施方案可在不给个人口腔护理方案增加步骤或程序的条件下使用。
或者，口腔护理器具10可为条带，比如牙齿增白带。在一些实施方案中，装置12可嵌入到适合使用者牙齿的结构中。例如，矫正支架、护口器、托牙或其它装置，其被设计用于长期放置在口中或者一个或多个牙齿上。
尽管装置12图解说明为自口腔护理器具10的头部一侧可见，但是本发明不限于这样的实施方案。例如，口腔护理器具10可在其背面、侧面、柄和/或肩部上具有窗口用于查看装置12的指示剂。因此，经装置12显示的疾病、诊断或治疗进展的色彩特征或“指纹”可通过口腔护理器具10上的这种窗口查看。
图2为在图1中描绘的装置12的框图。如图2所示，装置12包括检测器24、释放器26和试剂28。在一些实施方案中，配置检测器24以响应可存在于口腔中的特定标志物、引发物或刺激，其方式使得引起自释放器26释放试剂28。如本文描述的那样，检测器24、释放器26和试剂28的一些或全部功能可包括在检测器24中。
在一些实施方案中，配置检测器24以检测唾液或空气中任何合适的标志物或引发物。引发物可为口腔卫生或口腔状况的阴性或阳性指示剂。合适标志物/引发物的实例包括pH、原子、分子、蛋白质、有机体、口腔活动，比如三氯生等。更具体地讲，合适的标志物包括磷酸盐、氨基酸、钾盐和亚锡盐等。在一些实施方案中，配置检测器24以检测具体pH或pH范围。
在一些实施方案中，配置释放器26以用任何合适的方式释放试剂28。在一些实施方案中，试剂28释放在装置12中。在其它的实施方案中，试剂28释放至口腔中。在一些实施方案中，试剂28结合在释放器26的基质中，并随着释放器26在唾液存在下溶解时释放至口腔环境中。任选地，释放器26和检测器24可为单一材料，其被配置以结合试剂28并响应存在的预先确定的标志物而释放试剂28。
在一些实施方案中，试剂28可在与标志物接触之后立即释放。在一些实施方案中，试剂28在检测器24和标志物接触之后于预定时间释放。在一些实施方案中，试剂28在检测器24和标志物接触之后两(2)天释放。更具体地讲，合适的释放期包括例如在1、2、5、10、20或30秒内，在1、5、10、15、20或30分钟内，在1、2、3、5或10小时内，或在1或2天内。这些时间期间仅为实例并且其它时间期间也为合适的。
在一些实施方案中，试剂28治疗口腔状况。在一些实施方案中，试剂28对于存在状况的使用者用作指示剂。本文描述的试剂28可包括任何合适的药物或治疗剂、增白剂或其它活性剂、染料或其它指示剂。
如图3所示，显示在暴露于标志物32之前和之后的装置12。在暴露于标志物32之前，装置12包括检测器24和配置在基部34上的释放器/试剂26/28。如在该实例中图解说明的那样，检测器24和释放器/试剂26/28可配置为层或膜。当配置于口腔护理器具10中(例如图1)中时，边缘可被覆盖，并且至少在最初阶段，仅有上表面(例如检测器24)可暴露于口腔环境。任选地，装置12可包括保护膜或盖36。在一些实施方案中，盖36可由使用者在使用之前除去。在一些实施方案中，配置盖36以提供对下层的另外保护。例如盖36可使得使用者能够决定采用装置12的所需时间。另外，盖36可在运输和/或存储期间保护装置12。例如，盖36可防止被空气或空气中的水分激活。
在一些实施方案中，配置检测器24以响应标志物32而溶解，并使释放器/试剂26/28暴露于口腔环境。配置释放器26以响应暴露于口腔环境而溶解并释放试剂28。
在一些实施方案中，装置12任选地包括一个或多个结构指示剂38。通常，结构指示剂38为存在特定标志物的使用者提供视觉或物理指示。在一些实施方案中，使用者可察觉的指示为光、声音、气味、味道、纹理变化或振动。在其它的实施方案中，指示剂38为自底座34延伸的突起。在一些实施方案中，指示剂38为坑或脊。
在一些实施方案中，检测器24与标志物32之间的接触引起检测器24的物理或化学结构变化。在一些实施方案中，该变化经活性功能传递给释放器26。在一些实施方案中，释放器26经历化学或物理变化，其影响释放器26的形状和/或大小。在一些实施方案中，释放器26的变化使试剂28暴露于空气和/或唾液。在一些实施方案中，释放器26部分或完全溶解，或者形状变化可在释放器26中产生孔。在其它的实施方案中，释放器26的变化可引起试剂28作为蒸汽被排出到使用者的口腔中。
释放器26可为起涂层或包含材料作用的任何合适的材料。例如材料可为聚合物，比如聚合物薄膜。聚合物可为尼龙、聚乙烯、聚丙烯、羟丙基纤维素、聚羧乙烯、二氧化硅、弹性聚合物、聚合物的混合物、凝胶和薄膜或其组合。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 thesurfaces of oral prosthesis base polymers：an in vitro and in vivo study(在口腔修复基质聚合物表面的聚电解质多层薄膜涂层和稳定性：体外和体内研究).JDent.Res.2006年1月；85(1)：44-8)中描述的那些聚合物，其通过引用以其整体结合到本文中。在一些实施方案中，材料为抗菌可食性薄膜、蛋白质或多肽序列、病毒胶囊外衣、胶束、囊泡、珠、条带、脂质体、水溶性食品级聚合物、乳清蛋白薄膜、聚丙烯膜上的乳清蛋白分离涂层、转谷氨酰胺酶交联的明胶薄膜、食用纤维素薄膜和胶原。
试剂28可或不可在自装置12释放时立即被使用者察觉到。在一些实施方案中，试剂28包含在第二保护涂层比如盖36中。可选择盖36以具有任何所需性质。例如，第二涂层的溶解可需要标志物的持续存在和第二形状变化。盖36也可响应于唾液而缓慢溶解于口中。试剂28可在第二涂层溶解期间或之后被释放。对试剂28于口腔中变为活性的阶段的控制使得能够将试剂28靶向释放至身体的特定部分。例如，如果使用者具有牙龈炎，其标志为胶原酶的量增大，那么活性化合物比如十六烷基氯化吡啶、氯己啶或其它活性化合物形式的试剂28被配置为随着盖36溶解而释放，以治疗口腔疾病或小病。自然地其它活性物质/药物可以类似的方式使用。装置12可含有不同试剂，使得可自相同的装置12递送特定试剂的即释和延长释放制剂。
任何合适的活性功能可用于将检测器24连接至释放器26。在一些实施方案中，经本文所描述装置鉴定的口腔状况包括但不限于与口腔护理差相关的状况、可经口腔检查诊断的状况和其已被美国牙科协会(American Dental Association)识别或以其它方式鉴定为与口腔护理差相关的全身性状况。
适合于检测的口腔疾病包括龋齿、牙龈炎、牙周炎、口臭和口干。牙龈炎可通过标志物IL-1β、PGE2、精氨酸和牙龈菌蛋白酶指示。牙龈炎也可通过牙龈卟啉单胞菌(P.gingivalis)、牙龈二氧化碳嗜纤维菌(C.gingivalis)、产黑素普雷沃氏菌(P.melaninogenica)、齿垢密螺旋体(Treponema denticola)、福赛斯拟杆菌(Bacterioides forsythus)和缓症链球菌(S.mitis)中的一种或多种的水平升高指示。口臭可通过挥发性硫化合物(包括甲硫醇、二甲基硫醚和硫化氢)指示。牙周炎可通过弹性蛋白酶、二肽基肽酶、β-葡糖醛酸酶、乳铁蛋白、血小板活化因子(PAF)、ICPT(吡啶啉交联羧基端端肽)、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指示。来自与牙周疾病相关的口液的骨相关生物标志物也包括钙防卫蛋白、骨钙蛋白、ostenocetin和骨桥蛋白。
龋可通过低唾液pH、局部pH(即硬组织的具体位点)和通过产酸口腔细菌(具体地讲为乳酸杆菌种、变形链球菌和放线菌种)指示。也用口腔恶臭指示的几种非基于口腔的全身性疾病为：肝病性口臭，由慢性肝衰竭引起的罕见类型口臭的实例；下呼吸道感染(支气管和肺感染)；肾脏感染和肾功能衰竭及三甲基胺尿症(“鱼腥味症候群(fish odorsyndrome)”)(Tangerman A.Halitosis in medicine：a review(医学中的口臭).Int DentJ.2002年6月；52增刊3：201-6)，其通过引用以其整体结合到本文中。呼吸中高浓度丙酮(称为“丙酮味口臭”)可指示糖尿病酮症酸中毒。
标志物32也可为蛋白质、脂质、糖蛋白或碳水化合物。例如，炎症标志物可为细胞因子、金属蛋白酶或前列腺素比如PGE2。可用于诊断的细胞因子包括：IL-6、IL-1β、IL-8、IL-10、IL-12、TNF-α、RANKL。
在一些方面，可在呼出气体中检测标志物32。例如，细菌的代谢物标志物可用于指示细菌的存在，作为口臭的指示。细菌的代谢物标志物包括含有胺的化合物比如三甲胺和通过术语挥发性硫化合物(VSC)以及β-半乳糖苷酶活性鉴定的含硫化合物。有助于口臭的其它挥发性化合物包括挥发性短链脂肪酸、聚胺、醇、苯基化合物、链烷、酮和含氮化合物。
在一些实施方案中，试剂28响应一种或多种检测的标志物而被释放。在一些实施方案中，试剂28为研磨剂、口腔清新剂、牙齿增白剂、维生素、抗氧化剂、缓冲剂、益生素、抗菌剂/抗微生物剂、用于口腔和牙齿的脱敏剂、防龋剂(anti-cavity agent)或抗炎剂。
在一些实施方案中，装置12能够检测口中液体的缺乏并释放唾液腺的刺激物。试剂28的递送量和速率将取决于所需要的量和施用的试剂28。
抗牙菌斑剂28也可响应牙菌斑和/或牙菌斑形成状况的检测而被释放。可使用任何合适的抗牙菌斑剂。例如，试剂28可为酶比如蛋白酶(中性、酸性和碱性蛋白酶)、粘蛋白酶、胰酶制剂、真菌酶、淀粉酶、葡聚糖酶、moimnase、淀粉葡糖苷酶、葡萄糖氧化酶、纤维素酶、α-葡聚糖酶、α-淀粉酶、角质酶、淀粉葡糖苷酶、葡糖苷酶、乳过氧化物酶及其混合物。
试剂28可包含染料。理想地，染料以提供视觉可见颜色变化的足够量使用。颜色强度的程度与疾病或病症的严重性或流行程度相关。
染料可包括例如偶氮染料、卟啉、卟吩、靛蓝、三芳基甲烷、荧光素、叶绿素及其金属(比如铜)复合物、铁盐、多酚类、酞菁、花青苷、维生素、红麴(beni-koji)、姜黄及其提取物、无机基染料和荧光染料或phosphorant染料比如量子点。合适的染料也可包括柠檬黄、苋菜红、诱惑红(allura red)、赤藓红B、靛蓝胭脂红、亮蓝FCF、β-胡萝卜素、固绿FCF、羊毛婴红二钠盐、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4R、苋莱红、酸性红、偶氮玉红、胭脂虫红和日落黄FCF。
在分析物或标志物检测或释放器26裂解或降解之后约1秒-约36小时显示疾病或病症的检测。更具体地讲，在使用之后约1秒-约120秒显示疾病或病症的检测。
具有在设定时间(例如4周)内磨损的保护涂层比如盖36的本发明实施方案的优点是，使得装置12能够具有第二个功能。可配置盖36以在使用预定的时间之后缓慢溶解，以暴露检测器24和/或释放器/试剂26/28。在某些实施方案中，使用者能够评价其口腔护理方案的改进。
实施例
实施例1
释放器26包括含有与赤藓红B共价结合的可裂解酯键的聚合物。将聚合物成形并使用食品级胶粘剂牢固地固定到牙刷头的背面。在刷牙时和在口腔中诊断性酯酶存在下，酯键裂解，将染料释放至膜中，其在口腔护理器具10上显示颜色变化。在具体实例中，该颜色变化在头部14的背面可见，如图1所示。
或者，试剂28可释放至头部14的背面中。试剂28的释放可助于释放器26的分解，这将对使用者显示形状变化。诊断性酯可通过羟基封端的聚合物与具有酸性官能团的染料比如赤藓红B反应形成。在检测酯酶时，酯被裂解，释放有色染料。酯可通过本领域技术人员已知的任何手段形成。为了将检测的信号强度增大至至少4倍，可经生物素或链霉抗生物素蛋白部分连接染料。
实施例2
可将试剂28与释放器26连接。例如，可经其酚基之一将三氯生与酸封端的聚合物膜连接。该偶联将形成必要的诊断性可裂解酯。在检测口腔中酯酶活性时，配置三氯生以释放至口腔中。三氯生的量任选地为试剂28的约0.3％重量：体积(w/v)。释放器26也可含有与一种或多种染料连接的聚合物。例如，将三氯生和染料两者与释放器26连接。以这种方式，配置相同的牙刷以通过牙刷背面上的颜色或形状变化显示酶活性的存在，但是也可通过将三氯生释放至口腔中来治疗病况。
在一个实施方案中，释放器26具有检测器或酶裂解基团的离散部分。例如，释放器26的外缘具有很少检测器，而释放器26的中心具有可达十(10)倍多。识别和裂解释放器26中心的酶底物将在酶的检测时提供不同的视觉形状改变。线性或径向排列的聚合物可在标志物32的检测时提供不同的形状改变。
实施例3
在该实施例中，将试剂28包埋入或截留在附着于牙签顶端的诊断性释放器26的网格中。释放器26由胶原制成并在释放器26内含有高度浓缩的矫味剂和/或染料。在于龈线附近使用牙签时，配置装置12以检测牙龈炎的存在。响应检测牙龈炎，配置装置12以将基质金属蛋白酶8(MMP-8)释放至龈袋和口腔中。这使释放器26的胶原基质分解，从而减少释放诊断矫味剂。染料本身可在基质中可视化或者可被释放至口腔中用于使用者的进一步口腔反馈。释放器26的分解和染料的释放也可以以释放器26的形状变化方式查看。口腔护理器具10可具有手柄和头部，头部被设计用于沿着牙龈区域暂时放置于口腔中。或者，口腔护理器具10可以以用于延长放置于口腔中的形式比如条带存在。含有胶原的膜的实例在图1(以下)中举例说明：
表1
| 成分名称 | 实例 |
| 胶原 | 90.0％ |
| 矫味剂 | 9.0％ |
| FD&C No.1 | 1.0％ |
| 总材料 | 100％ |
实施例4
β-半乳糖苷酶活性与整个口腔和舌头恶臭的感官评分有关。在该实施例中，口腔护理器具10比如一次性使用牙刷的末端含有其可指示口臭的释放器26。可首先使用口腔护理器具10的末端测试人是否有口臭，并且如果检测到口臭，配置口腔护理器具10以提供口臭的视觉指示剂来告知使用者。作为响应，使用者可选择采用存在于口腔护理器具10中的口气清新珠以清新其口气。在该实施方案中，释放器26可包括与β-D-半乳糖连接的染料比如荧光素或令人不愉快的矫味剂。在检测唾液或牙龈沟液中的β-半乳糖苷酶时，在膜与荧光素或令人不愉快的矫味剂之间的糖苷键被配置为使结构完整性松散-向口腔中释放染料或令人不愉快的矫味剂。被如此告知的使用者然后可选择通过例如刷牙清新或处理其气息。
实施例5
口腔护理器具10的末端被配置为包括牙签尖(interdental tip)形状。牙签尖包括诊断性酸敏感聚合物。在使用和存在有害的酸性环境时，配置尖端以改变颜色。用Enamel Strengthening牙膏刷牙将减少酸性环境并从而保护牙齿免于进一步的侵蚀。新的牙签尖可插入到口腔护理器具10的末端上以验证新的无酸口腔环境。
低的唾液pH或局部pH(例如在硬组织上的具体位点)可使用pH敏感的释放器26检测。检测器24的酸敏感性可调整到位于pH 3-14之间。为了检测牙釉质侵蚀，其中低的局部pH为致病因子和其中如果未治疗可导致蛀牙和牙周炎，释放器26可对低于5.5的pH敏感，pH5.5为牙齿脱矿质的关键pH。释放器26的快速分解可发生于较低的pH值比如2-4。
存在许多可利用的酸敏感官能团，其可加入到释放器26中并校正至所需pH。酸保护基包括缩醛或缩酮。另外的实例可见于T.W.Green，P.G.M.Wuts，Protective Groups inOrganic Synthesis，Wiley-Interscience，New York，1999，67-74，708-711。
在一个实例中，偶氮染料的酚基可用酸不稳定的保护基比如叔丁基或四氢吡喃基保护。在酸检测时，保护基可裂解恢复偶氮染料与其初始可见颜色之间的共轭体系。
在另一个实施方案中，pH敏感的交联基团(例如碳酸酯)可连接在染料和/或治疗活性物质与释放器26之间。基团在要求的局部或唾液pH下裂解使染料和/或治疗活性物质与释放器26分离。试剂28可通过本领域技术人员已知的方法与释放器26连接。它们可例如经肽、聚氨酯、碳酸酯、酰肼或基于碳-碳的键连接。
在另一个实施方案中，检测器24可包括pH敏感部分比如可滴定聚合物。酸敏感性聚合物可为基于烷基丙烯酸的，比如聚甲基丙烯酸、聚乙基丙烯酸、聚丙基丙烯酸和聚丁基丙烯酸。聚合物可依存在的染料或试剂28的量而定以0.01-100％之间的mol％存在。在另一个实施例中，释放器26可包括截留或掺杂到不同的酸敏感性材料中的染料，其可在酸敏感性材料降解时释放。
在另一个实施方案中，酸敏感性染料例如赤藓红B或Oregon Green 488可通过羟基、羧基、胺、硫醇、酰肼、异硫氰酸酯或任何其它合适的交联基团与释放器26连接。配置这些染料以在酸检测时变化颜色。整个释放器26不需要由这些染料连接的聚合物组成。染料可掺杂至在释放器26上提供视觉上可观察到的颜色变化的重量％。染料与释放器26的重量％可在释放器26的0.0001-100％范围内，任选地为0.001％和至多为20重量％。
在另一个实施方案中，酸敏感性分子分解并与包埋的分子反应产生可视觉检测的颜色。
实施例6
口腔细菌齿垢密螺旋体、牙龈卟啉单胞菌和福赛斯拟杆菌为与成人牙周炎和恶臭高度相关的3种厌氧细菌。所有3种细菌释放独特的酶，其可分解合成肽苯甲酰基-DL-精氨酸-萘酰胺(称为BANA)为β-萘酰胺。配置检测器24为包括含有例如苯甲酰基-DL-精氨酸-萘酰胺基团的聚合物。检测和随后破坏诊断键将拆散和分解释放器26，释放其中包埋的染料或试剂28。不像BANA试验，在本发明中不需要在50℃下用偶氮染料温育副产物β-萘酰胺5分钟以观察产色反应，因为存在高浓度的诊断性可裂解肽序列与染料直接结合。高浓度的染料为消费者所易于可见。而且，酶在口腔内部的温度37℃下是非常有效的并且最佳地起作用。
含有诊断合成肽序列的释放器26或聚合物可与诊断染料赤藓红B共价结合。聚合物可成形并使用食品胶粘剂牢固地固定到存在于刮舌器上的条带中。使用时，存在引起口腔恶臭的3种细菌，将通过向条带中释放颜色和存在可使条带进一步分解的试剂28来显示，因此以形状变化显现给消费者。
实施例7
激素比如皮质醇、黄体酮、男性荷尔蒙(testerone)和内啡肽的受体可共价或非共价结合释放器26，其形成弹簧负载释放捕获机制的一部分。使激素与其在弹簧上的受体结合，释放弹簧，开启孔或门以快速释放有色染料用于激素检测。弹簧负载释放机制确保染料自膜快速排出。弹簧负载/悬臂方法可广泛应用于所有标志物。受体不需共价结合有色染料。在该实施例中，弹簧负载和释放方法为无标记方法，因为无论分析物还是受体都不需要被标记以检测标志物32。
本发明的许多特征和优点根据上述公开为显而易见的，并且因此旨在通过附加的权利要求覆盖落入本发明的真实精神和范围内的所有这样的本发明特征和优点。此外，因为许多修改和变化对本领域技术人员而言易于想到，所以不期望将本发明限制于举例说明和描述的精确结构和操作，并且因此，所有合适的修改和等价物必然落入本文所描述的本发明范围内。
Claims (12)
1.一种用于鉴定口腔状况的装置，所述装置包括：
能够检测口腔状况标志物的检测器；
自含式指示剂，其中所述指示剂由所述检测器暴露，其中所述指示剂为适合于经历触觉上可察觉的物理变化的结构指示剂；
基部，其包括所述指示剂，其中所述指示剂是结构指示剂，并且所述结构指示剂为以下中的一种：(1)自所述基部延伸的突起；和(2)形成于基部中的坑；
其中所述检测器形成为位于基部顶上的层；并且
其中所述装置能够可拆卸地固定于口腔护理器具。
2.根据权利要求1所述的装置，其中所述标志物的检测表明良好的口腔卫生。
3.根据权利要求2所述的装置，其中所述标志物选自三氯生、磷酸盐、氨基酸、钾盐和亚锡盐。
4.根据权利要求1所述的装置，其中所述标志物的检测表明存在适合经口腔检查检测的状况。
5.根据权利要求4所述的装置，其中所述标志物为细菌、真菌、酵母或病毒。
6.根据权利要求4所述的装置，其中所述标志物选自：C-反应蛋白、葡萄糖、皮质醇、PSA、c-erbB-2蛋白、激素、IL-1β、PGE2、精氨酸、牙龈菌蛋白酶、弹性蛋白酶、二肽基肽酶、β-葡糖醛酸酶、乳铁蛋白、血小板活化因子、ICPT、组织蛋白酶B、半胱氨酸蛋白酶抑制剂、MMP-1、胶原酶-2、MMP-8、MMP-13、MMP-9、羟基-脱氧鸟苷、免疫球蛋白、钙防卫蛋白、骨钙蛋白、ostenocetin和骨桥蛋白。
7.根据权利要求1所述的装置，其中所述口腔护理器具为包括柄和头的牙刷，所述头具有前表面和相对的后表面。
8.根据权利要求7所述的装置，还包括自所述头的前表面延伸的多个牙齿清洁元件，并且其中所述装置与所述头的后表面连接。
9.根据权利要求1所述的装置，其中配置所述检测器以响应检测所述标志物而溶解；和其中所述检测器的溶解暴露所述结构指示剂。
10.根据权利要求1所述的装置，其中所述口腔护理器具为包括柄和头的牙刷，所述头具有前表面和相对的后表面；
其中所述牙刷包括自所述头的前表面延伸的多个牙齿清洁元件；并且
其中所述基部和所述检测器共同形成整体结构，该整体结构与所述头的后表面连接。
11.根据权利要求9所述的装置，还包括：
释放器，其中放置有试剂，且
其中所述释放器和所述试剂一起形成为第二层，所述第二层位于所述基部和检测器之间。
12.根据权利要求11所述的装置，还包括形成第三层的盖，所述盖位于检测器顶部。
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| EP3111800B1 (en) | 2018-11-21 |
| WO2011079166A3 (en) | 2011-08-25 |
| KR101558124B1 (ko) | 2015-10-19 |
| KR20140143420A (ko) | 2014-12-16 |
| US9700395B2 (en) | 2017-07-11 |
| CN104970898A (zh) | 2015-10-14 |
| WO2011079166A2 (en) | 2011-06-30 |
| BR112012015431A2 (pt) | 2016-03-15 |
| EP2515707B1 (en) | 2016-09-07 |
| US8920746B2 (en) | 2014-12-30 |
| MX370962B (es) | 2020-01-10 |
| AU2010336466A1 (en) | 2012-06-21 |
| MX2012006291A (es) | 2012-07-03 |
| CA2783618C (en) | 2015-11-03 |
| CO6551725A2 (es) | 2012-10-31 |
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