CN100431633C - 用于清醒性镇静的药物输送*** - Google Patents
用于清醒性镇静的药物输送*** Download PDFInfo
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Abstract
开发的吸入性麻醉剂有许多特性,包括快速起效和恢复,可控制性和理想的宽的安全范围。这些制剂的效力以在所需的其他特性范围内产生的麻醉的能力来确定。本发明涉及能发生麻醉但不产生记忆缺失或意识丧失的剂量水平。而且确定了能快速减低痛觉和消除痛觉但保留意识的剂量水平,描述了安全和有效地输送制剂的输送***。
Description
相关申请书的参考
申请人特此要求基于美国临时专利申请书60/330,063的优先权,该申请于2001年10月17日提出,题目为“用于清醒性镇静的药物输送***”,本文引用为参考。
技术领域
本发明涉及镇痛和清醒性镇静领域。特别的是,本发明涉及输送使患者产生镇痛的卤化醚的设备和方法。
相关领域的讨论(发明背景)
自从十九世纪中叶,清醒性镇静/镇痛被应用于医院和准医疗机构以缓解疼痛。氧化亚氮(N2O)自此成为最初的吸入性制剂。镇静催眠剂如安定和咪达***已经作为许多巴比妥盐(barbitutes),阿片样物质(opiods)和激动剂/拮抗剂制剂的替代品。
牙科和口腔外科首次使用了氧化亚氮清醒性镇静,并在成功应用于QueenVictoria后获得广泛接受。随后,意识镇静剂的使用扩展到医院、急诊室、救护车,和其他医疗单位。
清醒性镇静是一种疼痛阻滞技术,允许患者在侵入性操作中保持部分清醒。痛觉丧失与麻醉不同,它使患者保持意识并能回忆。特别的是,该方法是特别的,因为患者不感知疼痛,但保留了他们的保护性反射,保持自主呼吸,对刺激有反应。因此减轻了麻醉所带来的减少或抑制呼吸的风险。
清醒性镇静有许多优点。特别是,清醒性镇静减少了患者的焦虑,特别是儿童。因此,由于清醒性镇静降低了患者对治疗的紧张和抵抗,使医疗操作对患者和医疗保健从业人员都容易了。而且,该技术还有扩大应用的潜力。对患者控制痛觉丧失的研究已有成功。
吸入性卤化醚与使用氧化亚氮清醒性镇静和使用镇静催眠剂的清醒性镇静相比在重要类别上有许多优点。关于这些制剂的比较的离子如表1所示。
镇静催眠剂
特性 | 卤化醚 | 氧化亚氮 | 静脉用安定 | 静脉用咪达*** |
起效 | 快 | 快 | 适中 | 适中 |
安全范围 | 高 | 致畸和血液紊乱 | 适中 | 适中 |
与高浓度氧气使用 | 可 | 不可 | 任选 | 任选 |
滥用可能 | 无 | 可供娱乐 | 控制物质 | 控制物质 |
容易使用和撤消 | 是 | 是 | 需要撤消制剂 | 需要撤消制剂 |
可预知性 | 有 | 有 | 适度的 | 适度的 |
快速恢复至易于上路 | 可 | 可 | 长半衰期回跃可能 | 长半衰期回跃可能 |
表1
集合了这些特性的卤化醚使它成为吸引人的清醒性镇静的候选药物。但是,仍然需要安全、准确和性价比好的输送***。
近年来氧化亚氮清醒性镇静的使用有所下降主要反映了有关包括上述所列项目气体的安全范围问题,而且由于长期接触带来的对甲硫氨酸合成的干扰。特别这些因素涉及育龄的女性医疗保健专业人员,她们面对氧化亚氮的致畸情况带来的自发性流产所增加的风险。
氧化亚氮相对来说效果不佳。在下文本发明的描述中,氧化亚氮效果不佳,需要限制N2O的吸入百分比以保证患者得到足够的氧气。大气中的氧浓度是大约21%。所以,大多数国际法规机构,包括美国食品和药品监督管理局(“FDA”)为防止缺氧而制订的氧气输送指导。最常见的比率是70%N2O/30%氧气,虽然一些输送***维持50%氧气。在混合物中含70%N2O的情况下,大多数患者可发生清醒性镇静。70%N2O/30%氧气混合物,在输送水平上维持持续的基础上,达到0.636的最小肺泡容积(“MAC”)。
现今使用的六个吸入性醚:氟烷、甲氧氟烷、***、异氟烷、七氟烷和地氟烷。(Terrell,Airco,Inc.,合成***、异氟烷和地氟烷)。这些化合物的开发着重于非易燃性、非成瘾性、效果好、有快速诱导特性和心血管稳定性。传统上这些产品被包装于100ml和250ml的棕色玻璃瓶中,在使用特定的工具,温度补偿***被汽化。
这些药物被开发用于麻醉。没有用于吸入性镇痛剂的吸入性醚。这反映出工业上的理解,或是没有吸入性镇痛剂的需求,或是没有性价比好的特定设备以使用这些制剂镇痛剂作为在医院机构中开发麻醉使用的设备既复杂又昂贵,常常花费超过100,000美圆。综合这些因素实际上排除了使用这些药物作为清醒性镇静制剂,特别是在准医疗机构。
发明内容
开发的吸入性麻醉剂有许多特性,包括快速起效和恢复,可控制性和理想的宽的安全范围。这些制剂的效力以在所需的其他特性范围内产生的麻醉的能力来确定(痛觉丧失、记忆缺失和意识丧失)。本发明涉及能发生麻醉但不产生记忆缺失或意识丧失的剂量水平。而且确定了能快速减低痛觉和消除痛觉但保留意识的剂量水平,描述了安全和有效地输送制剂的输送***。
附图的简要描述
图1显示了本发明的一个实施方案的结构图。
图2显示了本发明的另一个实施方案的概略的透视图。
图3是与图2相似的概略的透视图,但旋转了180°。
本发明的详细描述
现代吸入制剂是卤化醚。通常它们特征是比重在1.0到2.0,低分子量(165.0-200.0),低沸点(22℃到104℃),明显的效力-0.16%-7.8%的制剂在氧气中会使99%成人被麻醉。这些特殊变量在本发明的特征中很重要,当药物从液体转化成气体并随载体气体输送-载体气体通常是氧气但有时是氧气和其他气体或包括氧气、氧化亚氮和/或空气的组合物。
但是,制剂在许多重要方面有变化。一些制剂包括甲氧氟烷、氟烷和七氟烷已知能与金属反应。在某种程度上,这些制剂在有“碱石灰”(氢氧化钙)和/或紫外线的存在下会分解。在或多或少的程度上,所有的卤化制剂是可溶解的。用于清醒性镇静的输送***必须与使用的制剂相容。
实施例1
麻醉制剂的效力是以麻醉剂导致50%的患者不动的最小肺泡浓度来测量的,范围定在经历了外科手术的39岁的男性(“MAC”)。有效力的吸入制剂的MAC变化很大。氧化亚氮-主要的吸入性清醒性镇静药物-的MAC,,只能在不一般的温度和压力条件下确定,如在高气压室,增加的剂量不产生氧缺乏时。研究建议氧化亚氮的MAC为110%。这样,为产生麻醉,大多数患者会窒息。相反,甲氧氟烷-一种早期卤化的醚-的MAC,只是0.16%。在本吸入性清醒性镇静***中,氧化亚氮与最少30%的氧气一起输送以保证患者维持足够水平的氧气。在美国,食品和药品监督管理局(“FDA”)制定70%氧化亚氮作为清醒性镇静单元中输送的限制。为此,70%氧化亚氮的MAC同等物可被用于与其他吸入剂的比较,如表2所示。
*MAC是在100%氧气用于中年男子的情况下。MAC随年龄和个人习惯包括酒精和药物摄取而变化。
表2
受益于较高水平的氧气输送的患者包括,但不限于,那些冠状动脉疾病(冠心病,CAD)的患者,用吸入性镇痛剂代替氧化亚氮能改善心肌氧供。
实施例2
为了输送一定浓度的相关制剂以产生镇痛但不丧失意识(或是记忆缺失或是意识丧失)需要精细校准的设备,通过该设备制剂可以剂量过高或输送低氧混合物最小的风险流动(图1)。为了在门诊机构中应用,该设备必须是性价比好的,花费少于现在价值100,000美圆或更多的麻醉机则较佳。与可用于镇静的镇静催眠药、巴比妥盐,阿片样物质和激动剂/拮抗剂相比,本发明提供更快的启动和恢复,较低的可能滥用风险。因此本发明包括氧气输送结构,或是一个或多个氧气气罐和/或氧气储藏器(“氧气源”)16的集气***和镇痛制剂储藏器12,例如但不限于一个制剂相容性气罐,附在镇痛剂储藏器12上的加热元件14,例如但不限于加热盘,连接在周围温度传感器以对环境温度和压力进行补偿。通过加热元件14加热镇痛剂储藏器12可以控制储藏器中制剂的压力,这样不管周围温度的变化,制剂的流动可被适当调控。该储藏***包括配对的指示***10以保证只有特定制剂才能被充入储藏器,一旦充满,只能与该制剂特定的输送***配对。氧气源16的氧气流经输送集气***22包括敏感压力调节器18到流量计20,或是类似物或是电子流量计,氧气按照严格的比例与储藏器12的制剂混合并精确计量出制剂的剂量达气体流量的+/-0.1%或更少。当制剂可被直接发送到流量计20,它还可以被安排流经输送集气***22以调节流量和保证设备安全性包括但不限于在氧气流被关闭或被确定为不足时自动制剂关闭***。氧冲洗***24使执业人员可以快速充满患者的肺部和强制排出残余制剂。该***的安排使氧冲洗***24启动时镇静剂流动被自动中止,因为氧冲洗***24通过三向阀门25连接到镇静剂储藏器12,当氧冲洗***24开,镇静剂储藏器12关,反之亦然。混合头和/或流量计***使使用者可以调节气流和制剂浓度达到由合适管理机构制订的清醒性镇静的限度,在校准上足够精确使制剂流接近所需的CS水平。而且,控制加热***14和流量计20可以协同操作以调节镇静制剂的流动。
如图2和3所示,本发明的一个实施方案是一个独立的医师工作单元。图2显示了加热器14;混合头28;氧气压力控制42;蒸汽压力控制44;氧气冲洗控制46;鼻套管出端口48;吸入器出端口50;氧压力测量器52;蒸气压力测量器54;可选的监测器56;流动速度控制58;麻醉剂浓度控制60;鼻/关/吸入选择开关62;和开/关控制64。
图3显示氧气源10;麻醉剂源12;加热器14;混合头28;电插座30;可选的空气气罐32;和电源线40。这些特点可以与其他能力组合,包括但不限于:改进该单元使之便携以用于急诊或军事应用;改进该单元用于患者有控制的镇痛(“PCA”);配置清除***以收回呼出的制剂并从环境中移除;组合该单元或允许该单元与生理检测仪相容,这些生理检测仪包括但不限于血氧仪、心电图、血压、二氧化碳监测仪和意识深度监测仪;以一种或多种结构使设备与诊断影像设备相容,诊断影像设备包括但不限于核磁共振设备(MRI’s),对在MRI影像(诊断)时需要镇静或减轻疼痛的患者提供镇痛。
清醒性镇静***可应用于临床上广泛的操作包括但不限于牙科和口腔外科操作、烧伤扩伤术、紧急情况或损伤情况下的减轻疼痛、重症监护室、心脏监护室或危重病监护室的使用、四肢检查和操作包括足部医疗操作、分娩、减少个体对针刺的恐惧,和没有镇静制剂就难以长时间固定的情况。
而且,本发明有下列特性。本发明增加血氧,对于心肌或脑氧不足的个体来说是重要的。本发明增加了职业安全,当本文的镇痛剂取代了氧化亚氮时,对育龄妇女是重要的特性。本发明可以减少与幽闭恐怖症有关的焦虑和减轻了面对长时间固定患者的疼痛,如在核磁共振影像检查(MRI)时使用MR-安全性(1.5tesla)的输送***。类似的,本发明可用于重症监护室(ICU)、危重病监护室(CCU),或在心脏导管***(术),植入式心脏除颤器或心脏起搏器调节期间,和通常的减轻疼痛时镇静作用。该设备可以改变结构,如架子或方法支持患者监测器的,包括把监测器整合到***中。而且,该设备可以有调节***来感知患者吸入的深度以安全控制患者的镇痛用法。
虽然本文描述了本发明的实施方案,本发明不限于这些实施方案。下列权利要求指向本发明,意在描述本发明,但它们的字面语言并不意味着限制本发明的范围。
Claims (30)
1.用于对患者释放气体以使患者不丧失意志地产生镇痛的***,包括:
a)氧气源;
b)储藏器,其适于储存产生镇痛的液态制剂,所述制剂为选自卤化醚的化合物;
c)释放集气***,其包含一对输入元件分别连接到氧气源和储藏器,和输出元件,集气***通过将液态化合物计量入氧气来提供氧气和产生镇痛的制剂的混合物,所述集气***具有如下的能力:提供所述混合物以使化合物不多于约0.636MAC,从而不丧失意识地产生镇痛作用;和
d)把混合物从释放集气***的输出元件输送到患者的装置,从而使所述患者在医疗或牙科干预或操作中,不丧失意志地产生镇痛。
2.权利要求1所述的***,其特征在于释放集气***包括连接在流体传送上的压力调节器和流量计,流量计是释放集气***输出元件的流体传送上。
3.权利要求2所述的***,其特征在于压力调节器是在释放集气***的输入元件连结与氧气源的流体传送上,流量计是在释放集气***的输入元件连结与储藏器的流体传送上。
4.权利要求1所述的***,还包括在操作上与包含产生镇痛的制剂的储藏器有关的加热装置,和控制有关的加热装置以对环境温度情况变化提供补偿的周围温度传感装置。
5.权利要求1所述的***,还包括氧气冲洗装置,在操作上连结在氧气源与患者之间。
6.权利要求1所述的***,其特征在于氧气源包含气罐。
7.权利要求1所述的***,其特征在于储藏器包含气罐。
8.权利要求1所述的***,其特征在于储藏器有配对的指示器。
9.权利要求2所述的***,其特征在于压力调节器是数字式的。
10.权利要求2所述的***,其特征在于压力调节器是模拟式的。
11.权利要求1所述的***,其特征在于所述***具有气体清除***。
12.如权利要求1所述的***,其特征在于,所述卤化醚是***。
13.如权利要求1所述的***,其特征在于,所述卤化醚是异氟烷。
14.如权利要求1所述的***,其特征在于,所述卤化醚是七氟烷。
15.如权利要求1所述的***,其特征在于,所述卤化醚是地氟烷。
16.如权利要求1所述的***,其特征在于,所述卤化醚是氟烷。
17.一种药物释放***,其具有:提供化合物的储藏器,所述化合物选自:氟烷、***、异氟烷、七氟烷和地氟烷,其中所述储藏器适于储存液态的所述化合物;和计量所述液态化合物用的流量计,其用于提供不多于约0.636MAC的液态化合物浓度,并具有有效用于心肌或脑氧供不足或冠心病的患者氧递送浓度,以使所述患者不丧失意识地产生镇痛作用,其中所述在镇痛过程中经受医疗或牙科干预或操作并是清醒的。
18.一种药物释放***,其具有:提供化合物的储藏器,所述化合物选自氟烷、***、异氟烷、七氟烷和地氟烷,其中所述储藏器适于储存液态的所述化合物;计量所述液态化合物用的流量计,其用于提供不多于约0.636MAC的化合物浓度,且以不用氧化亚氮为特征,提高了职业安全性,以使患者不丧失意识地产生镇痛作用,其中所述患者经受医疗或牙科干预或操作并是清醒的。
19.一种药物释放***,其具有:提供化合物的储藏器,所述化合物选自氟烷、***、异氟烷、七氟烷和地氟烷,其中所述储藏器适于储存液态的所述化合物;计量所述液态化合物用的流量计,其用于提供不多于约0.636MAC的化合物浓度,且具有MR安全性/1.5忒斯拉,减少了患者与医疗或牙科操作相关的焦虑、幽闭恐怖症和精神障碍,使面对长时间固定的患者不丧失意识地产生镇痛作用,其中所述患者在镇痛过程中经受操作并是清醒的。
20.一种药物释放***,其具有:提供化合物的储藏器,所述化合物选自氟烷、***、异氟烷、七氟烷和地氟烷,其中所述储藏器适于储存液态的所述化合物;计量所述液态化合物用的流量计,其用于提供不多于约0.636MAC的化合物浓度,且用于重症监护室(ICU)、危重病监护室(CCU)或心脏导管***术实验室以及通常的减轻疼痛中,以使患者不丧失意识地产生镇痛作用,其中所述患者在镇痛过程中经受医疗或牙科干预或操作并是清醒的。
21.权利要求1所述的***,其特征在于,其外形选自用于军事使用的便携式、挂壁式外形、落地式外形和作为气体释放***中一部分的外形。
22.权利要求1所述的***,其特征在于,该***还包括清除***,用于收回呼出的制剂并从环境中移除。
23.权利要求17所述的药物释放***,其特征在于,该***还包括清除***,用于收回呼出的制剂并从环境中移除。
24.一种药物释放***,其具有:提供化合物的储藏器,所述化合物选自氟烷、***、异氟烷、七氟烷和地氟烷,其中所述储藏器适于储存液态的所述化合物;计量所述液态化合物用的流量计,其用于提供不多于约0.636MAC的化合物浓度以使患者不丧失意识地产生镇痛作用,且操作上可回收患者呼出气体,其中所述患者在镇痛过程中经受医疗或牙科干预或操作并是清醒的。
25.一种药物释放***,其具有:提供化合物的储藏器,所述化合物选自氟烷、***、异氟烷、七氟烷和地氟烷,其中所述储藏器适于储存液态的所述化合物;计量所述液态化合物用的流量计,其用于提供不多于约0.636MAC的化合物浓度以使患者不丧失意识地产生镇痛作用,且操作上可不回收患者呼出气体,其中所述患者在镇痛过程中经受医疗或牙科干预或操作并是清醒的。
26.权利要求1所述的***,其特征在于,该***在操作上与支持对患者的监测仪相联系的装置有关,监测仪选自氧监测仪、血氧仪、心电图监测仪、血压监测仪、二氧化碳监测仪和意识深度监测仪。
27.权利要求1所述的***,其特征在于,该***与对患者的监测仪成为一体,监测仪选自氧监测仪、血氧仪、心电图监测仪、血压监测仪、二氧化碳监测仪和意识深度监测仪。
28.权利要求1所述的***,其特征在于,该***还包括感知患者吸入深度的调节器***,测量单位选自每平方英寸压力(PSI)和毫米汞柱。
29.一种药物释放***,其具有:提供化合物的储藏器,所述化合物选自氟烷、***、异氟烷、七氟烷和地氟烷,其中所述储藏器适于储存液态的所述化合物;计量所述液态化合物用的流量计,其用于提供不多于约0.636MAC的化合物浓度以使患者不丧失意识地产生镇痛作用,且还包括感知患者吸入深度的调节器***,测量单位选自每平方英寸压力(PSI)和毫米汞柱,其中所述患者在镇痛过程中经受医疗或牙科干预或操作并是清醒的。
30.一种药物释放***,其具有:提供化合物的储藏器,所述化合物选自氟烷、***、异氟烷、七氟烷和地氟烷,其中所述储藏器适于储存液态的所述化合物;计量所述液态化合物用的流量计,其用于提供不多于约0.636MAC的化合物浓度以使患者不丧失意识地产生镇痛作用,且以不用氧化亚氮为特征,提高了职业安全性,其中在经受医疗或牙科干预或操作患者中不丧失意志地产生镇痛作用。
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ES (2) | ES2475241T3 (zh) |
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