CN114929096A - 下颌前移装置的附件 - Google Patents
下颌前移装置的附件 Download PDFInfo
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Abstract
披露了下颌前移装置(MAD)，其包括上夹板、下夹板和至少一个传感器，其中该传感器测量患者的生物或生物物理方面的参数。还披露了使用该装置的方法。
Description
相关申请
本申请要求KIM等人于2019年12月12日申请的名称为“下颌前移装置的附件”的美国临时申请序列号62/947,398的优先权，其全文包括所有附图通过引用并入于此。
技术领域
本发明属于口腔装置的领域。特别地，本发明属于用于制备设计和制造口腔装置的计算机辅助设计程序的领域。
背景技术
下颌前移装置(mandibular advancement devices，MAD)在患者口中存留时间长，即患者的全部睡眠时间。在该时间内，患者体内会发生许多影响MAD有效性和患者健康的生理和身体上的变化。使MAD能够对患者的这些变化进行实时响应以便于在特定时间为患者提供最有效的下颌位置调整是有用的。此外，内科医生想要知道在使用MAD时患者身体的变化历史以便于提供更好的治疗方案。
发明内容
所披露的下颌前移装置(MAD)包括上夹板、下夹板和至少一个传感器，其中该传感器测量患者的生物或生物物理方面的参数。还披露了使用该装置的方法。
具体实施方式
这里所披露的传感器在与下颌前移装置(MAD)结合时能够测量关于患者的某些生物或生物物理方面的参数。
之前已经描述了可以与本申请披露的传感器组合使用的一种MAD。例如参见USP9,820,882、USP 9,808,327、US专利申请公开号2018/0024530和2019/0105191、国际公开号WO 2019/018309 A1和国际专利申请号PCT/US2019/029471。该段中列举的所有公报披露的内容(“上面并入的公报”)，包括所有附图，尤其是披露了MAD、其设计方法、其制造方法或者其附件的这些方面，通过引用并入于此。
这里披露的MAD-传感器组合的优点有许多。装置整体是100％独立的(self-contained)并且完全可靠地位于患者口腔内部，能够实现完全的唇部密封。该装置是定制生产的(通过将患者的解剖学数据输入和医疗服务提供方(health care provider，HCP)的处方与元件的制造资源库进行结合而实现)，以将传感器和装置机构进行无缝整合并考虑患者的舒适度。
在一些实施方式中，HCP的处方包括起始咬合位置和可选的一个或多个定制治疗特征，比如前分离器(anterior discluder)、夹板选择、滴定机构、以及上面并入的公报中列举的其他特征。
在一些实施方式中，如果MAD包括一个以上的传感器，那么MAD被设计和制造成使得这些传感器在MAD的一个夹板上，上夹板或者下夹板。在其他实施方式中，这些传感器在不同的夹板上。在本申请全文中，将支承传感器的夹板称作“技术夹板”，而没有任何传感器的夹板称作“自由夹板”。
在一些实施方式中，这些夹板设计成保护最关键的元件，例如传感器。如果会由于例如患者咬牙、咀嚼或者咬该装置而导致装置故障，那么将自由夹板设计成先于技术夹板发生故障。这是通过将自由夹板制造的比技术夹板更薄或者通过由不同材料来制造这两个夹板实现的。自由夹板容易比技术夹板以更低成本和更方便的方式进行再造。
传感器
多种传感器可以与所披露的MAD一起使用。一般来说，可以将这些传感器分成以下几类：生理传感器、物理传感器、化学传感器和位置传感器。
在一些实施方式中，生理传感器测量和传递诸如体温、呼吸率、心率之类的生理数据，或者其他相关的生理数据，和/或上述值得任何变化。
在一些实施方式中，物理传感器是检测呼吸模式那些传感器，例如呼吸波动、空气流速、吸入空气的氧气浓度等等，并且将其与空气阻力进行相关。在一些实施方式中，传感器选自测量吸入空气的氧气浓度的氧气传感器、测量呼出气体的二氧化碳浓度的二氧化碳传感器、测量大气压力或口腔内部空气压力的压力传感器、空气流动传感器、噪声检测器或者活动检测传感器。传感器还可以检测鼾声和/或实施气道流特征分析。在一些实施方式中，传感器测量患者牙齿施加在MAD上的压力以便于测量牙齿表面的紧咬和/或研磨程度。
在一些实施方式中，化学传感器用于测量身体对呼吸的生理响应。例如，可以实时测量唾液pH值、唾液糖含量、唾液电导率、诸如唾液皮质醇之类的应力标志值、血氧饱和度值、血液pH值、血糖值、胰岛素值、炎症标志物等并经由基站向HCP发报告。细菌生物传感器可以在睡眠期间基于口腔中的细菌活性水平向HCP提供信息。
在一些实施方式中，位置传感器用于记录MAD在口腔中相对于预定参考位置的位置。这些传感器可以选择性跟踪下颌在前后、竖直和/或横向方向上的移动。
在一些实施方式中，传感器是感测块的元件，感测块包括除了传感器之外的其他元件。在某些实施方式中，感测块元件包括电池(可再充电的或可替换的)、与工业标准兼容的电池再充电电路、(如果适用)板载存储器、通讯模块、将传感器电压输入信号转换成数字信号的模拟/数字转换器、用于启动步进电机的控制模块和连接到外部传感器和电机的I/O总线中的一个或多个。
在一些实施方式中，在具有至少一个传感器的MAD的设计过程中，传感器和放置有该传感器的匣是计算机辅助设计(CAD)程序中的设计库元件。设计人员选择相关的库元件和传感器应该放置在MAD上的位置并且CAD程序据此提供设计。对于使用库元件设计MAD的讨论，参加上面并入的公报2018/0024530。
通讯
当前公开的传感器与基站进行无线通讯，传输它们获得的数据。本领域中已知各种模式的无线通讯。当前，最流行的模式似乎是
通讯。还可以使用其他模式，比如无线电、红外线、磁或类似模式等。可以想到现在已知的或者未来开发的所有无线通讯模式均可以与当前披露的传感器一起使用。
在一些实施方式中，基站是包含在物理支架内的软件。支架配置为与嵌入在MAD中的传感器进行无线通讯。在一些实施方式中，使用之后，患者将MAD放置在支架中，其可以选择性地对传感器的电池进行再充电。在一些实施方式中，支架配置成对MAD进行清洁，例如通过向可以放置MAD的地方提供喷淋或者通过为MAD提供将其很好容纳的腔室以使用清洁剂或蒸汽或类似物对其进行清洁。在其他实施方式中，基站是智能电话(例如
)、智能平板(例如
)或者笔记本电脑或台式电脑(统称为“装置”)上的软件。
在一些实施方式中，基站实时记录下颌的位置。HCP然后可以将某一时间点的生理响应与该时间点的下颌位置进行相关并据此作出治疗决策。
在一些实施方式中，基站和MAD在反馈系统中操作。当传感器获得的数据与基站通讯时，基站分析该数据并基于预先编译好的程序(pre-scripted routine)向MAD传递命令以作为响应而采取动作。在一些实施方式中，预先编译好的程序是基于HCP开出的处方。
在一些实施方式中，该响应是机械响应。在这些实施方式中，MAD包括步进电机，例如背式(dorsal style)，其能够使下颌对称或非对称地前移或回退0.1mm，或者其任何其它倍数。
在一些实施方式中，如果诸如血氧水平或气流扰动之类的生理数据表明患者继续睡眠会呈现非健康状态，基站会发出足以将患者唤醒的警报音频。在其他实施方式中，基站向MAD传递命令以在口腔中释放令人难以接受的化学物质来将患者唤醒，比如苦味物质。
在一些实施方式中，如果生理数据恶化并且患者没有醒来的迹象，比如将警报关掉，对基站进行编程以发出紧急医疗服务的警报。
在一些实施方式中，当前披露的MAD和传感器的组合用于以受控方式向患者提供药物。在一些这样的实施方式中，MAD包括可以用处方药物填充的嵌入式可再装填腔体。在其他实施方式中，MAD包括用于放置预装填药物容器的位置。在任何情况下，具有药物分配元件的MAD的设计使得患者不会感觉到大量的药物分配元件并且MAD就像其没有药物分配元件那样佩戴舒适。
相应于时间暗示或嵌入式传感器的输入，基站向MAD和药物分配元件传递命令以在脸颊与牙龈之间释放预定量的药物用于颊部给药或者释放到患者口中用于药物吸入。示例包括压力减小剂、镇静剂、葡萄糖、胰岛素、硝酸甘油或者其他用于心房颤动或不稳定型心绞痛的心脏病药物等。
在一些实施方式中，比如那些在上面并入的国际专利申请号PCT/US2019/029471中描述的，MAD包括内部机构以将下颌向前推进，例如通过转动螺钉。在一些这样的实施方式中，小的步进电机与前移机构连接。在一些实施方式中，响应于从传感器获得的数据，例如关于鼾声、通过口腔的空气流是层流还是紊流、心率变化、血氧饱和度值等的数据，基站向MAD步进电机发送命令以使下颌前移或回退小的增量，直到情形得以矫正，例如空气流变为层流、或者鼾声平息、或者血氧水平升高。传感器提供的生物反馈使得基站能够控制实时治疗。
在一些实施方式中，基站还与由医疗服务提供方(HCP)操纵的装置上的软件进行通讯。在这些实施方式中，基站直接向HCP装置传送收集的数据，其中HCP可以监视患者的进展而无需患者来诊所看医生。这个特征对于经常旅行的人，比如销售人员、长途司机、航空公司飞行员等，是相当有用的。通过利用该特征，HCP可以持续监视患者并且提出是否符合患者最佳利益的建议。这样，问题得以在其发生时被检测到并且校正。
在一些实施方式中，基站通过互联网、电话线、卫星、无线电、微波或者目前已知的或者随后开发的其他形式的长距离通讯形式与HCP软件进行通讯。
在一些实施方式中，基站可以分析数据并根据规定方案使MAD改变下颌关于上颌的位置以在使用MAD过程中使有效结果最大化。
在一些实施方式中，多个传感器连接到相同的感测块，而在其他实施方式中，每个传感器拥有其自身的感测块。
为了在需要前移的时候调整MAD来使下颌前移，当前市场上的MAD需要患者转动螺钉多次来达到合适的调整。当转动螺钉时，MAD的移动单元关于其固定单元移动。在许多情况下，每次调整需要转动螺钉两次。患者并不总是100％遵循这种指导，因为一些患者会分心且忘记了他们将螺钉转动了多少次，或者没有一直在转动螺钉，以及其他类似的问题。
在一些实施方式中，MAD包括可以由条形码读取器(比如智能电话)读取的条形码。QR码、标准条形码和其他类似的可读图形可以用于该目的。一部分条形码印在移动单元上，其余部分的条形码印在固定单元上。在每个单位增量上，比如0.1mm，两个半个条形码对准以形成与移动单元相对于固定单元的位置对应的码。当装置没有被合适调整时，得到的条形码是错乱的，不会导致任何信息被接收。当装置被合适调整时，两个半个条形码的对准与用于装置的位置的码对应。
Claims (14)
1.一种下颌前移装置(MAD)，包括上夹板、下夹板和至少一个传感器，其中所述传感器测量患者的生物或生物物理方面的参数。
2.根据权利要求1所述的装置，其中所述传感器测量处方中的医疗保健专业人员所需求的参数。
3.根据权利要求2所述的装置，其中所述处方包括起始咬合位置以及可选的一个或多个定制治疗特征。
4.根据权利要求3所述的装置，其中所述定制治疗特征是前分离器、夹板选择和滴定机构中的一个。
5.根据权利要求1所述的装置，其中所述装置包括两个或多个传感器，其中所有的传感器在所述MAD的一个夹板上，上夹板上或下夹板上。
6.根据权利要求1所述的装置，其中所述装置包括两个或更多个传感器，其中这些传感器在所述MAD的不同夹板上。
7.根据权利要求1所述的装置，其中所述传感器是生理传感器、物理传感器、化学传感器或位置传感器。
8.根据权利要求7所述的装置，其中所述生理传感器测量的患者数据包括体温、呼吸率、或心率、或者从一个时刻到另一个时刻的任何数据变化。
9.根据权利要求7所述的装置，其中所述物理传感器检测呼吸波动、空气流速、吸入空气的氧气浓度、呼出气体的二氧化碳浓度、大气压力、口腔内部空气压力、噪声、患者牙齿施加在MAD上的压力或者活动记录数据。
10.根据权利要求7所述的装置，其中所述化学传感器检测唾液pH值、唾液糖含量、唾液电导率、应力标志值、唾液皮质醇、血氧饱和度值、血液pH值、血糖值、胰岛素值或炎症标志物。
11.根据权利要求7所述的装置，其中所述位置传感器检测记录所述MAD在口中相对于预定参考位置的位置。
12.根据权利要求1所述的装置，其中所述传感器是感测块的元件，所述感测块包括至少一个另外的元件，所述另外的元件是可再充电的或可替换的电池、与工业标准可兼容的电池再充电电路、板载存储器、通讯模块、模/数转换器、用于启动步进电机的控制模块、和连接到外部元件的I/O总线。
13.根据权利要求1所述的装置，其中所述传感器包括配置用于与基站进行无线通讯的通讯部件。
14.根据权利要求13所述的装置，其中所述无线通讯是
无线电、红外线、或者磁通讯的形式。
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