CN106660793B - 施加一氧化氮至治疗部位的装置 - Google Patents
施加一氧化氮至治疗部位的装置 Download PDFInfo
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Abstract
一种用于产生且输送一氧化氮(NO)至治疗部位的器件包含主单元、施配器、连接器软管及移动支架。该主单元经由该连接器软管提供电力及气体至该施配器。该施配器包含用于产生呈等离子体状态的NO的等离子体产生器。该主单元包含用户接口以使用户能够控制该器件的至少一个操作方面。该施配器包含:枪握柄;触发器,用于致动该等离子体产生器;软管连接件,用于耦合至该连接器软管;及通风罩部分,用于使该等离子体产生器的尖端以预先确定的距离与治疗部位隔开。传感器具有施配器,以发送回馈且监测靠近施加的施加部位温度、施配器运动等。
Description
相关申请的交叉引用
本申请是2014年6月30日提交的、标题为「Apparatus for Applying NitricOxide to a Treatment Site」的申请中美国临时专利申请62/019,037,该临时申请的全文以引用的方式并入本文中。
技术领域
本发明大体上是关于医学治疗的领域,且更特定言之是关于一种用于在医学症状及疾病的治疗时有效地给予氧化氮的装置。
背景技术
一氧化氮(NO)气体是通常发现于人体内部及外部的呈气体状态的短寿命分子。NO是已知具有诸多调节、保护及治疗性质的传讯分子。通过刺激而使内生NO的产生增加或将外源产生的NO引入至人体中而增强人体NO的自然产生可改良人体对损伤、疼痛及入侵生物体的回应。然而,难以将NO输送至活组织,且在NO气体状态下,NO不穿透真皮层。为临床有用,NO必须以足够量存在于作用部位中。
为治疗目的输送NO的现有技术包含给予化学化合物以将NO以化学方法释放至人体中。其他方法采用NO路径促效剂及NO拮抗剂。其他方法采用高压NO气体及喷雾。另一方法涉及用气体NO引入至其中的密封真空容器包围人体。亦已尝试迫使加压一氧化氮通过组织及皮肤。因各种原因,此等方法已产出有限结果。例如,气体NO在组织介质中具高度反应性,具有低扩散常数且具有极短寿命。
未达成临床成功的另一方法涉及给予分子供体,已证实此是有问题的,此是因为无法调节对有效载荷的释放的控制,亦无法可靠地调节供体的穿透/饱和。
存在目标特定临床结果涉及NO的数种解决方案。例如,西地那非柠檬酸(Sildenafil citrate,以VIAGRA商标名售卖)干扰勃起功能障碍征候群中NO的渐减调节(down regulation)。例如,依那西普(Etanercept,以ENBRIL商标名售卖)使用抗-TNFα抗体来进行NO在关节炎症性疾病中将进行的事项。归因于难以在作用部位处直接刺激NO的产生,大部分解决方案涉及影响NO路径。由于缺乏此等NO路径药理学的部位特性,故负面副作用可为严重的。
发明内容
鉴于前述,提供一种用于以促进治疗效益的方式在作用部位处给予NO的装置及方法将为有利的。
根据本发明,公开一种用于产生NO且将其输送至治疗部位的器件。该器件可包含主单元、施配器、连接器软管及移动支架(mobile stand)。该主单元可经由该连接器软管提供电力及气体至该施配器。该施配器可包含用于产生呈等离子体状态的一氧化氮(NO)的等离子体产生器。该主单元可包含用户接口,以使用户能够控制该器件的至少操作方面。该用户接口可为触摸屏幕。
该施配器可包含:枪握柄(pistol grip handle);触发器,用于致动该等离子体产生器;软管连接件,用于耦合至该连接器软管;及通风罩(cowl)部分,用于使该等离子体产生器的尖端以预先确定距离与治疗部位隔开。该通风罩部分可包含沿该通风罩部分的长度的多个通风孔,以促进该器件的冷却。
安全传感器可经布置而邻近于该施配器的前端,以提供安全监测信号。该安全传感器可包括无源红外皮肤温度传感器。该安全传感器可包括接近传感器,以使使用者能够监测该施配器与治疗区域之间的距离。该接近传感器可经组态以在该施配器经放置而距该治疗区域比预先确定距离更接近的情况中撤销启动该器件。该器件可包含彩色照明器,该彩色照明器被布置在邻近于该施配器的前端,以将可改变的色彩投射于该治疗区域上,以指示适当使用、警报及错误中的至少一者。该器件可包含被布置于该施配器中或上的运动传感器,该运动传感器包括用于测量该施配器的运动的多轴加速度计。该运动传感器可用以在该施配器未移动达足够时间量的情况中取消启动该器件,以防止过度治疗病人上的目标部位。
附图说明
图1绘示根据本公开的用于产生NO的例示性器件;
图2是图1的器件的侧视图;
图3是图1的器件的后视图;
图4是图1的器件的一部分的详细视图;
图5是图1的器件的另一部分的详细视图;
图6是图1的器件的施配器部分的等角视图;
图7是图6的施配器的侧视图;
图8是图6的施配器的端视图;及
图9是图6的施配器的通用产生部分的电路设计。
具体实施方式
现将参考附图在下文中更全面地描述所公开的器件,附图中显示出各项实施例。然而,所公开的器件可以许多不同形式体现,且不应解释为限于本文中阐述的实施例。实情是,提供实施例使得本发明将是透彻的且完整的,且将本发明的范畴全面地传达给本领域技术人员。在整个图式中,相似符号指代相似组件。
根据本发明,公开一种用于产生呈等离子体状态的离散物质流的器件,其中该流已将NO作为其内容物的部分。在各项实施例中,可将流给予至生物体以获得治疗结果。在一些实施例中,据信于表层处(亦即,引导至皮肤或开放性伤口处)的NO施加刺激人体自身的NO产生,使得在适应症处及周围可获得治疗效果。或者,所公开的器件可利用呈等离子体状态的NO的能量及速度足够高使得其可穿透且围绕细胞膜的事实。在一些情况中,NO可通过生物膜及角质层以在关联组织中产生治疗结果。
可经由数种方法产生含有NO的呈等离子体状态的物质。大气含有氮及氧,且因此呈正确几何形状的足够能量可自气体混合物产生一氧化氮。可添加能量以将气体N2及O2转变为等离子体状态。在非限制性例示性实施例中,N2-O2混合物中预先形成的气体可被产生且通过传送足够能量的等离子体能量弧以产生呈等离子体状态的NO。
参考图1至图3,展示器件1,其用于产生呈等离子体状态的NO且用于施加此NO至治疗部位。一般而言,器件1可包含主单元2、施配器及连接器软管装配4及移动支架6。主单元2可包含触摸面板显示器8、功能按钮面板10及电源控制按钮12。施配器外壳14定位于主单元2的前侧上以使能够容易处置施配器及连接器软管装配4的施配器16。软管管理支撑件18可提供于移动支架6的侧部分上,以在器件1未在使用中时容纳施配器及连接器软管装配4的连接器软管20。移动支架6在第一端22处可连接至主单元2。在第二端24处,行动支架6可包含多个轮26以使器件1能够轮转至治疗设施内的期望地点。轮26可具有锁定特征部,且可布置于扩展平衡轮距部分28以在其在地板或另一表面上滚动时最大化器件1的稳定性。
如图2中可见,主单元2可包含适当通风口30以使电力供应组件维持在期望操作温度。柄32可提供于主单元2的侧表面上以容许器件1经由轮26沿表面移动。
如图3中所示,主单元2可包含隔离的远程通信电路及组件34。在一些实施例中,远程通信电路及组件34经由多种适当硬布线通信协议(包含以太网络、USB主机及客户端等)的任一者来实现器件1与远程运算系统(未示出)之间的通信。主单元2亦可包含一个或多个无线远程通信模块36,以经由多种适当无线通信协议(包含WiFi、cellular、Bluetooth等)的任一者来实现器件1与远程运算系统之间的无线通信。
主单元2进一步可容置快速改变过滤器外壳38、内部电源供应器40、电力输入模块42、电力输出模块44及冷却剂匣接近板46。如将明白,快速改变过滤器外壳38及冷却剂匣接近板46可以使得便于接近容纳于主单元中的可更换过滤器介质及冷却剂匣。
行动支架6可包含电力输入模块48及经隔离的90至240VAC 50/60Hz输入端50。
图4示出主单元2,其可容置器件1的主电力系统,且可用以藉由将空气吸入、冷却及电力供应至其而供电给施配器及连接器软管装配4。主单元2可包含触摸显示器8,其在一些实施例中,触摸显示器8可为彩色平板触摸显示器。触摸显示器8可包含电源按钮12及功能按钮面板10。为启动器件1,可于触摸显示器8上键入操作员键码以防止未经授权使用。如先前提及,施配器外壳14可提供于主单元2的前侧上,以使能够由使用者容易抓取且再套入(re-holster)施配器16。一个或多个柄32可被布置在主单元2的任一侧上,以容许轮26上的器件1容易移动。
图5示出其中连接器软管20的第一端52被耦合至主单元2以及连接器软管的第二端54耦合至施配器16的施配器及连接器软管装配4。连接器软管20可包括将施配器16连接至主单元2的挠性管。在一些实施例中,连接器软管20将冷却液体、电力、传感器数据及大气空气流的组合供应给施配器16,以产生利用施配器16施加的治疗作用。软管管理支撑件18被定位于行动支架6的侧表面上。在所绘示的实施例中,此软管管理支撑件18是凸起条,其大小被设计且经定位以使能够将连接器软管的回路56捕获于行动支架6与条之间。
图6至图8更详细示出施配器16。施配器16产生NO气体作为由器件1提供的NO治疗的部分。如可见,施配器16包括枪型配置,包含枪握柄部分56、触发器部分58、触发器护圈60、保护通风罩部分62及用于耦合至连接器软管20的第二端54的连接部分64。
如图7中可见,施配器特征为保护通风罩部分62内的凹入尖端66,此在治疗给予期间提供自动距离控制。此确保NO产生器部分68(图9)的尖端66相对于施加部位始终保持在期望预先确定的偏移距离“OD”处。在所绘示的实施例中,此预先确定的偏移距离“OD”是从等离子体产生器部分68的尖端66至施配器16的前端70而测量。
保护通风罩部分62确保以期望温度将NO提供至治疗部位,因此消除对使用者或病人的伤害的可能性。保护通风罩部分62可包含沿其的长度的多个通风孔72,以在使用期间及之后促进施配器16的冷却。
如图8中所示,安全传感器及投射器阵列74可被提供在邻近于施配器16的前端70,以提供多个安全监测及警示。例如,安全传感器及投射器阵列74可包含皮肤温度传感器。皮肤温度传感器可包含无源红外传感器,其在治疗期间不断地监测皮肤表面温度以确保其保持在期望的预先确定的范围内。
安全传感器及投射器阵列74亦可包含接近传感器,以使使用者能够确定施配器16与治疗区域之间的最佳距离以进行最安全及最有效治疗。接近传感器在放置过近情况中可撤销启动器件。
安全传感器及投射器阵列74亦可包含彩色照明器,其将可改变的色彩投射于治疗区域上以指示适当使用、警报及错误。
安全传感器及投射器阵列74进一步可包含运动传感器,诸如三轴加速度计。运动传感器可不断地测量施配器的运动。若施配器停止运动达长于预先确定时间量,则主单元在未充分移动情况中将撤销启动,以免过度治疗病人上的特定目标部位。
各等离子体产生器部分68可针对NO水平而被工厂测试,且校准数据可包含于等离子体产生器部分上。在一些实施例中,等离子体产生器部分68可由使用者移除以进行修复及/或更换。
图9示出施配器16的例示性NO产生器部分68。如可见,空气在产生器部分68的第一端处引入,且引导于对电极对之间,即与彼此隔离的阴极76及阳极78。固定DC弧放电被产生且维持在电极76、78之间。在弧放电的效应下,自电极76、78之间的区域中的空气形成含NO的气体流,且透过冷却通道(由冷却剂回路80冷却)抽出改含NO的气体流,使能够将NO固定在流82中。可将流及NO内容物的温度引至期望值以提供对治疗部位的治疗效益。关于所绘示的例示性NO产生器部分68的进一步细节可发现于例如Pekshev的美国专利第7,498,000号中,该案的全文以引用的方式并入本文中。
由对呈等离子体状态的空气的热力学平衡的组成分析确认的经典热力学示出,在低于2000℃的温度下,气体中NO的浓度不超过1%。增加等离子体温度增加NO浓度,在3500℃至4000℃的温度下达到其最大值(~5%)。略小于4000℃是所绘示的器件1的等离子体弧中放电的温度。导致形成NO的等离子体化学反应可由以下化学式表达:
N2+O2→2NO–180.9千焦/摩尔(kJ/mol.)
由于重组(2NO+O2=2NO2)的快速反应,在高温下NO分子的寿命相当于其合成的时间。为防止重组且针对医学应用保持NO的治疗浓度,期望实现反应混合物的快速冷却,亦即,骤冷。在制动周围冷空气(亦即,来自冷却剂回路80)的逸出流的情况下发生NO的骤冷。所绘示的器件1使能够在大气压力下使用周围空气产生直流等离子体弧。器件1产生具有含有医学上显著量的NO的等离子体种类组合物的热空气流8,在一项例示性实施例中,该量是约百万分之2,500(parts per million,ppm)NO。在其他实施例中,器件1可产生具有含有高达约3,500ppm NO的等离子体种类组合物的热空气流8,然而其不受限,且在进一步实施例中可提供更大浓度的NO。
图9中所示的器件1并非穷举的,且亦可使用等离子体产生NO的替代源搭配所公开的施配器16。
实际上,呈等离子体状态的NO可直接施加至活组织或邻近于活组织以产生期望效果。NO可有效地作用以维持心血管及呼吸系统中的稳态。NO作为传讯分子可引起血管舒张,此提升血管柔软性、舒缓血压、清洁血液、逆转动脉硬化且有效地防止心血管疾病且帮助其恢复。NO的另一重要功能在于减缓血管壁上的动脉硬化斑沉积。NO亦扮演免疫系统中的主动防御角色。NO是强抗氧化剂,且可抑制细菌感染、病毒及寄生攻击。NO甚至可阻止一些类型的癌细胞生长。在具有中度至重度糖尿病的病人中,NO可防止许多常见的且严重的并发症。NO亦可显著降低与关节炎中的关节肿胀相关联的疼痛。NO可有效地减低癌症、糖尿病、心肌梗塞及中风的风险。
在神经及内分泌系统中,NO可诱发各种人体器官发挥正常功能。NO可自由地渗透细胞膜以进行生物传讯,调整细胞活性且导致每一器官正确地完成其功能,包含肺、肝、肾、胃、头、脑及生殖器。NO可增加至生殖器官的血液流动以维持正常性功能。脑经由其周围神经将信号传输至会阴区域以提供给其以足够NO,以引起血管扩张,增加血液流动以增强勃起功能。在一些状况下,勃起无力是藉由神经末梢产生不足NO的结果。
NO亦可减缓老化过程且改良记忆力。由免疫系统产生的NO分子不仅能够破坏入侵微生物体,而且有助于活化且滋养脑细胞,而显著减缓老化且改良记忆力。
如本文中使用,以单数叙述及以字词“一”或“一个”进行的组件或步骤应理解为不排除多个组件或步骤,除非明确叙述此排除。此外,对本发明的“一项实施例”的引用并非意欲解释为排除亦并入有所叙述特征的额外实施例的存在。
虽然已参考某些实施例公开本发明,但在不脱离如由(若干)权利要求中界定的本发明的范围及范畴的情况下,可对所描述的实施例进行数种修改、变更及改变。因此,期望本发明不限于所描述的实施例,而是其具有由以下权利要求及其等效物的预言界定的全范畴。
Claims (10)
1.一种用于产生且输送一氧化氮NO至治疗部位的器件,包括:
主单元;
施配器;
连接器软管;及
移动支架;
其中主单元经由连接器软管提供电力及气体至施配器,施配器包含用于产生一氧化氮NO的等离子体产生器,所述施配器包含使得使用者能够监测施配器与治疗部位之间的相对距离的传感器以及用于将可改变的色彩投射于治疗区域上以指示警报及错误中的至少一个的彩色照明器。
2.如权利要求1所述的器件,主单元包含用户接口,以使用户能够控制器件的至少一个操作方面。
3.如权利要求2所述的器件,用户接口包括触摸屏幕。
4.如权利要求1所述的器件,施配器包括:
枪握柄;
触发器,用于致动等离子体产生器;
软管连接件,用于耦合至连接器软管;及
通风罩部分,用于使等离子体产生器的尖端以预先确定的距离与治疗部位间隔开。
5.如权利要求4所述的器件,通风罩部分包含沿通风罩部分的长度的多个通风孔,以促进器件的冷却。
6.如权利要求1所述的器件,进一步包括无源红外皮肤温度传感器,以监测治疗部位的温度使得该温度能够维持在预先确定的范围以内。
7.如权利要求1所述的器件,其中传感器是接近传感器。
8.如权利要求7所述的器件,其中接近传感器被配置为如果施配器被放置为距治疗部位比预先确定的距离更接近,则撤销启动器件。
9.如权利要求1所述的器件,进一步包括被布置于施配器中或施配器上的运动传感器,运动传感器包括用于测量施配器的运动的多轴加速度计。
10.如权利要求9所述的器件,其中运动传感器被配置为如果施配器未充分移动则撤销启动器件,以防止过度治疗治疗部位。
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-
2015
- 2015-06-23 CN CN201580035725.7A patent/CN106660793B/zh active Active
- 2015-06-23 US US15/321,520 patent/US10406375B2/en active Active
- 2015-06-23 EP EP15815265.2A patent/EP3160902B1/en active Active
- 2015-06-23 JP JP2017521072A patent/JP2017529193A/ja active Pending
- 2015-06-23 ES ES15815265T patent/ES2773679T3/es active Active
- 2015-06-23 MX MX2016017143A patent/MX2016017143A/es active IP Right Grant
- 2015-06-23 WO PCT/US2015/037179 patent/WO2016003705A1/en active Application Filing
- 2015-06-23 RU RU2017102681A patent/RU2017102681A/ru not_active Application Discontinuation
- 2015-06-23 CA CA2952246A patent/CA2952246A1/en not_active Abandoned
- 2015-06-23 KR KR1020167036112A patent/KR102079852B1/ko active IP Right Grant
- 2015-06-23 AU AU2015284596A patent/AU2015284596A1/en not_active Abandoned
- 2015-06-29 TW TW104120987A patent/TW201609210A/zh unknown
- 2015-06-30 AR ARP150102092A patent/AR101033A1/es unknown
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2016
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EP3160902A1 (en) | 2017-05-03 |
US20170203115A1 (en) | 2017-07-20 |
CA2952246A1 (en) | 2016-01-07 |
US10406375B2 (en) | 2019-09-10 |
TW201609210A (zh) | 2016-03-16 |
JP2017529193A (ja) | 2017-10-05 |
RU2017102681A (ru) | 2018-07-30 |
ES2773679T3 (es) | 2020-07-14 |
MX2016017143A (es) | 2017-05-12 |
KR102079852B1 (ko) | 2020-02-20 |
SA516380635B1 (ar) | 2020-10-29 |
EP3160902A4 (en) | 2017-12-20 |
KR20170023846A (ko) | 2017-03-06 |
RU2017102681A3 (zh) | 2018-12-24 |
WO2016003705A1 (en) | 2016-01-07 |
AU2015284596A1 (en) | 2017-01-12 |
EP3160902B1 (en) | 2019-11-27 |
AR101033A1 (es) | 2016-11-16 |
IL249559A0 (en) | 2017-02-28 |
CN106660793A (zh) | 2017-05-10 |
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