CN103841933A - 用于将负压提供至负压伤口治疗绷带的方法 - Google Patents
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Abstract
一种用于提供负压的方法,其中泵被循环开启和关闭以达到目标负压,所述目标负压被设定为略微低于治疗负压。一种装置通过将可能以与泵循环不同的速率发生的样本求平均值来确定实际压力。
Description
相关申请的交叉引用
本申请要求2011年11月18日提交的美国专利申请No. 13/299,783和2011年5月26日提交的美国临时申请No. 61/490,118的优先权,这两份申请以引用方式并入本文中。
技术领域
本发明涉及一种用于将负压提供至负压伤口治疗绷带的方法。
背景技术
负压伤口治疗是用来处理人们的某些伤口或溃疡的一种方法。通常,处理包括将绷带放置在伤口部位上方并连接到泵送装置。泵送装置提供吸力,从而在伤口部位处的绷带下面形成负压。渗出物和其它物质被从伤口部分移除,从而允许伤口比在环境压力下更快地愈合。
泵送装置主要包括泵。通常,使用者在泵送装置上选择(或以其它方式输入)合适的治疗压力,该压力与针对该患者的具体的负压处理有关。重要的是,泵和泵送装置快速且正确地达到将与负压伤口治疗结合使用的治疗压力。
泵可达到治疗压力的速率是重要的,因为该速率可不利地影响处理。此外,泵认识到已达到治疗压力的能力是重要的,以避免施加太少或太多的负压。因此,对于泵装置来说,泵装置获得治疗压力的速率和准确度是重要特性。
为了准确且快速地达到治疗压力,一些泵保持连续地开启。在一些装置中,这可能是有问题的。例如,一些泵可迅速地达到治疗压力;然而,泵和系统趋于超出治疗压力值。这需要额外的阀门和其它部件,其允许泵送装置释放负压,直到获得合适的负压。
此外,让泵连续地开启可起到电源泄漏的作用,并且对于依靠电池或其它便携式电源操作的泵送装置来说,这会负面地影响电源的使用寿命。
本发明涉及解决这些和其它问题。
发明内容
在本发明的一个实施例中,本发明涉及一种用于通过提供具有泵的泵送装置和在泵送装置上设置治疗负压而将负压提供至负压伤口治疗绷带的方法。泵送装置确定与治疗负压相关联的目标负压,并且目标负压小于治疗负压(如本文所讨论的,“小于”意味着其为较小负值,或者更低量的负压,换言之,更接近零)。泵送装置连接到负压伤口治疗绷带。目标负压通过以下方式达到:循环开启和关闭泵以在负压伤口治疗绷带中形成负压;获得负压伤口治疗绷带中的负压的多个样本,每个样本以第一设定时间间隔获得;计算预定数量的连续样本的平均值;比较平均值与目标负压;以及,继续循环开启和关闭泵,直到平均值大于目标压力。
该方法还可包括:在循环开启和关闭泵直到在完全关闭循环之后样本的平均值大于目标压力之后,以大于第一设定时间间隔的第二设定时间间隔对负压伤口治疗绷带中的负压取样。
在本发明的另一个实施例中,以第二设定时间间隔对负压伤口治疗绷带中的负压取样在泵已关闭预定时间量时开始。
预定时间量可以是300毫秒。
第二设定时间间隔可以是1000毫秒,并且第一设定时间间隔为100毫秒。
在一个实施例中,循环开启和关闭泵以在负压伤口治疗绷带中形成负压通过将泵开启80毫秒且然后将泵关闭80毫秒来执行。
在本发明的一些实施例中,治疗负压为125mmHg,并且目标负压为大约115mmHg。
在本发明的一些实施例中,治疗负压为90mmHg,并且目标负压为大约85mmHg。
在本发明的一些实施例中,治疗负压为60mmHg,并且目标负压为大约54mmHg。
在本发明的一些实施例中,治疗负压为40mmHg,并且目标负压为大约34mmHg。
在本发明的另一个实施例中,本发明是一种用于通过提供具有泵的泵送装置和在泵送装置上设置治疗负压而将负压提供至负压伤口治疗绷带的方法。泵送装置确定与治疗负压相关联的目标负压,并且目标负压小于治疗负压。泵送装置连接到负压伤口治疗绷带。目标负压通过以下方式达到:循环开启和关闭泵达第一预定时间量,以在负压伤口治疗绷带中形成负压;获得负压伤口治疗绷带中的负压的多个样本,每个样本以第一设定时间间隔获得;计算预定数量的连续样本的平均值;比较平均值与目标负压;以及,如果平均值不大于目标负压,则重复循环开启和关闭泵的步骤,获得多个样本,计算平均值并比较平均值,直到平均值大于目标负压。
在一些实施例中,平均值的比较以比计算平均值的速率更快的速率发生。
在一些实施例中,如果平均值大于目标负压,则通过以下方式维持目标负压:以大于第一时间间隔的第二设定时间间隔获得负压伤口治疗绷带中的负压的多个第二样本;以及比较每个第二样本与目标负压;并且,如果第二样本大于目标负压,则重复获得和比较的步骤。
在一些实施例中,如果第二样本不大于目标负压,则重复通过下列方式达到目标负压的步骤:循环开启和关闭泵;获得多个样本;计算平均值;以及比较平均值,直到平均值大于目标负压。
在本发明的各种实施例中,治疗负压可以选自由下列组成的集合:40mmHg;60mmHg;90mmHg;以及125mmHg。
根据所公开的实施例中的一个或多个的本发明允许泵合理迅速地达到治疗负压/目标负压并且尽可能可行地限制超出治疗负压/目标负压。
此外,实施例中的至少一个还提供了一种可靠的方法,以检测绷带压力何时由于泄漏而太频繁地“充满(topped-up)”(即,经常恢复循环开启和关闭泵以增加负压)。可预料,系统将例如由于系统中的不完美的管件连接而随时间推移少量泄漏。每分钟“充满”一次的泄漏速率是正常的。然而,四倍于该速率的泄漏速率是宣布微小泄漏的原因。这样的泄漏速率仍然在系统长期操纵的边界内,但应当让使用者知晓,以便加以纠正并延长系统电池寿命。一旦发现泄漏已恢复到正常水平就清除故障也是可取的。
应当理解,以上所述的本发明的方面和目的可以是可结合的,并且在阅读以下附图说明和本发明的具体实施方式之后,本发明的其它优点和方面将变得显而易见。
附图说明
根据结合附图的以下描述和所附权利要求,本发明将变得更加显而易见。在理解附图仅描绘典型实施例并且因此不应视为限制本公开的范围的情况下,将参照下面提供的附图具体而详细地描述和解释各实施例。
图1是结合本发明的一个或多个实施例使用的装置的前透视图。
图2是根据本发明的一个或多个实施例提供的装置的前侧剖开图。
图3是根据本发明的一个或多个实施例的方法的流程图。
具体实施方式
虽然本发明容许具有许多不同形式的实施例,但基于以下理解在附图中示出并在本文中详细描述一个或多个实施例:本公开将被视为本发明的原理的范例,而并非意图将本发明限制为图示的实施例。
在本说明书全文中对特征、优点、目的或类似语言的引用并不暗示可用本发明实现的所有特征和优点应当在或在本发明的任何单个实施例中。相反,涉及特征和优点的语言应理解为表示结合一个实施例描述的具体特征、优点或特性包括在本发明的至少一个实施例中。因此,在本说明书全文中对特征和优点的讨论以及类似语言可以但未必是指相同实施例。
如在附图1和2中所示,本发明涉及一种使用具有泵20的泵送装置10的方法。泵送装置10通常包括压力传感器22、止回阀24、控制电路26(具有微控制器)、内部管件28、LED 30和电源32。
为了将负压提供至伤口,泵送装置10通常用管14连接到负压伤口治疗绷带12。
为了达到目标负压,当压力低于目标压力时,泵送装置10将泵20开启少量时间。
泵装置10通常操作如下:微控制器通过数字输出开启泵20;泵20开始产生真空;真空被压力传感器22转换为电压;电压被模数转换器(“A/D”)转换为标准的、认可的压力工程单位;并且,微控制器比较监测压力与目标压力。
为了在短时间内达到目标负压并且避免超出目标负压,泵20被循环。在检查运转中的若干泵之后,工作循环(duty cycle),泵开启时间相对于泵关闭时间的百分比,对于各种泵20来说可以是恒定的。泵20在短时间内可抽出多少真空将影响泵开启时间。此外,绷带14和管件28的弹性以及压力传感器22和A/D可多么迅速地进行测量将影响泵关闭时间。
在一个实施例中,压力传感器22测量时间为20毫秒;而A/D测量时间为16微秒。因此,由于压力中的变化必须首先由压力传感器22、然后由A/D转换,所以最小测量时间为20.016毫秒。
据信,在使用读数之前将其平均化以用来缓解偶然性测量系统异常是有利的。一方面,平均化的样本的数量,在其趋于较少时,实现了一些异常缓解,但也保持对这些样本所测量的参数中的快速变化的最佳响应能力。当样本的数量较高时,看起来出现最佳异常缓解,但此时平均化对这些样本所测量的参数中的快速变化的响应能力较差。
经确定,使用5样本滑动平均值是有利的。如果压力被连续地取样,则将在5×20.016=100.090毫秒内获得完全平均值。然而,在基于值做出泵控制决策之前,没必要等待所有5个样本都被采集到,因为仅少量样本仍会充分地缓解系统异常。然而,对压力连续地取样(尤其是由于压力传感器22对系统施加在任何部件(除泵20之外)中的最大mA负载将在过少的泵控制增益的情况下不必要地缩短电池寿命。
因此,使用与泵开启/关闭循环异步的测量过程,其中压力样本每100毫秒贡献于平均值一次,并且如果泵开启/关闭控制逻辑每80毫秒比较一次平均值,其将足够频繁地比较平均值,以确定由对该平均值所做的最后一次贡献影响的平均值。这可以通过以下方式实现:每100毫秒启动一次过程;等待20毫秒压力传感器测量时间;然后,利用A/D测量压力。
可构思到将A/D测量的完成与泵开启/关闭控制逻辑严格地同步化,但软件设计最佳实践认为,应尽量避免软件模块之间的依赖性,并且同步化在这里是不必要的—泵开启/关闭控制逻辑(循环)将看到任何贡献对平均值所做的每一点改变。
当泵20已达到其目标压力时,以上详述的A/D取样和比较过程从例如100毫秒的重复速率改变为当泵已关闭达足够的时间量时1000毫秒的重复速率。这在压力不可能大幅变化时进一步保存了电池寿命。为切换至较慢重复速率泵20必须关闭的时间段可以为例如300毫秒;然而,该时间段可以是大于泵开启/关闭工作循环中的关闭时间的任何值(在工作循环中的更后者)。此外,应当至少这样长,以区分因泵20已达到目标压力所导致的“关闭”和泵控制工作循环的“关闭”。(使用300毫秒是因为该时间对于在泵关闭之后对于A/D对电池电压取样之前的等待来说是足够的时间量。电池仅在泵20关闭时被取样,因为泵对系统施加的mA负载与当泵关闭时显著不同,并且当泵不对系统加载时,更容易预测电池寿命。)
泵控制开启/关闭工作循环为优选地开启80毫秒和关闭80毫秒。经确定,40或80毫秒的“开启”时间对于限制各种绷带12的超压(over-shoot)来说是足够的。40毫秒值更好地限制超压,产生更接近目标压力的最终压力,但花费更长时间来获得目标压力。长于80毫秒的“开启”时间对于一些绷带来说产生超出范围的超压,而不论“关闭”时间是多少。如上所述,“关闭”时间对控制/测量算法的测量部分有影响。此外,管件和绷带弹性(虽然很小)可在短时间内扭曲平均或“稳定”压力。据信,有利的是在测量之前让这样的压力扭曲稳定下来。此外,也如上文所指出那样,压力传感器22和A/D测量需要时间。
大约30毫秒的“关闭”时间将涵盖两者,但便利的是使用相同的80毫秒定时器来控制开启时间和关闭时间。此外,让系统稳定更长时间(80毫秒的一倍或多倍)将提高测量的质量,因为它将让滑动平均值更彻底地填充—以花费更长时间获得最终压力为代价。虽然已讨论了这些时间,但本文中的任何内容都不应理解为将本发明限制为这些时间。
在使用中,使用者将治疗负压输入到泵送装置中。当然,这可利用具有预设治疗负压的泵送装置来实现,并且使用者仅仅选择一种。
在本发明的一个或多个实施例中,目标负压设定为略小于由使用者输入到泵送装置中的治疗负压。在本发明的实施例的工作示例中,使用了下列参数,目的是在15秒内获得40/60/90/125mmHg的治疗负压并且将超压限制到治疗负压的+/-10%。然而,对于40mmHg的治疗负压来说,公差优选地为+/-10mmHg (而不是+/-10%)。
使用设定为略小于40/60/90/125治疗负压的目标负压使得可补偿系统低估绷带内的实际负压的趋势。因此,构思到与先前提及的治疗负压值一起使用的目标压力分别为34、54、85和115mmHg。在不脱离本发明的精神的情况下,可根据以上讨论的各种参数(泵、绷带、弹性等)使用其它目标压力。
在根据本发明的一个或多个实施例的装置中,泵20将合理地迅速达到目标负压,停止,在若干秒之后“充满”一次或两次,并且转变到其中泵仅仅大约每分钟充满一次以补偿系统泄漏的状态。初始的一次或两次充满是由于压力完全稳定下来。
总之,在本发明的一个或多个实施例中,压力被每100ms取样一次;其中由压力传感器和A/D进行的取样花费20.016毫秒的时间。将样本加入到5元素滑动平均值中。泵送装置10每80毫秒异步地比较一次平均值(略快于压力取样的频率)。如果压力低于目标压力,则泵送装置10开启泵20不超过一个循环(80毫秒)。在等待一个关闭循环(80毫秒)之后,如果压力仍低于目标压力,则再次开启泵20。最后这两个步骤重复进行,直到压力大于目标压力,此时,泵20保持关闭,直到系统中的正常泄漏将压力减小至目标压力以下。在压力高于目标压力的时期内,当泵20已连续关闭300毫秒时开始,取样可减小至1000毫秒速率(以延长电池寿命)。
图3中示出了用于执行一些实施例的步骤的流程图。如图3中所示,并且如上文所讨论地,根据本发明的一个或多个实施例的方法可始于治疗负压的设定100。响应于这种设定,泵送装置将确定目标负压102。如先前所讨论地,目标负压小于治疗负压。
此时,泵送装置将开始循环开启和关闭泵104。此外,泵送装置还将开始对在绷带处的压力取样106。这种取样优选地在设定时间进行。在图3中,该取样示出为以“定时A”开始。泵送装置确定是否存在至少五个测量的样本108。如果收集了少于五个样本100,泵送装置继续对绷带处的压力取样106。
然而,如果收集了多于五个样本112,泵送装置将计算所采集的最后五个样本的平均值114。泵送装置接着将比较最后五个样本的平均值与目标负压116。如果最后五个样本的平均值小于目标负压118,泵送装置将继续对在绷带处的压力取样106。
如果最后五个样本的平均值大于目标压力120,泵送装置将停止泵循环。可构思到(虽然不需要),如果泵处于循环的中间,则该具体循环应在泵送循环停止之前完成。备选地,当确定平均值大于目标负压时,泵循环可立即停止。
在泵循环停止之后,装置开始对在绷带处的压力取样124。该取样优选地以预定的时间间隔进行,并且如图所示以“定时B”发生。如先前所提及的,为了增加可正对泵送装置供电的电池的寿命,优选的是定时B大于定时A。
最后,装置继续比较压力的样本(在步骤124中获得)与目标负压126。如果最近的样本大于目标负压128,则装置继续对在绷带处的压力取样124。
如果最近的样本小于目标压力130,则装置可将泵开启一个循环132,并且继续对绷带下面的压力取样124。备选地,装置可返回至循环开启和关闭泵送104以及先前为达到目标负压而采取的后续步骤。
除了达到和维持负压之外,本发明的一个或多个实施例也包括用于检测泄漏的方法。例如,如果已达到目标负压并且在目标负压下已进行至少20次充满,并且最后N(=3)次充满的时间间隔的平均值小于15秒,则可由泵装置宣布泄漏。如果泵被使用者禁用或者充满间隔大于或等于15秒,则可排除检测到微量泄漏。
15秒时间值与确定为最佳的不可接受的泄漏速率(每分钟充满4次)有关。泵送装置将每次充满的时间(自单元复位起)记录在N个元件的环形阵列中,并且在每次充满时或每80毫秒(不论哪个首先出现)检查一次充满间隔。(“或80毫秒”方面对于排除故障而不是宣布故障更有用。)
将阵列元件中最早的时间从当前时间减去,且然后除以N以产生最后N次充满的平均值(或者当80毫秒的定时器发信号(tick)以提示检查结果为充满时应有的平均值)。设定故障和排除故障的示例给出如下:
表1:
设定故障(假设为该压力已进行17次充满):
由于80毫秒定时器到时而要求的检查在上表中未示出,因为它们没有影响,并且这种省略使得更容易理解仅由于充满导致的检查如何发生。
表2:
排除故障(假设为上表1的继续)
在以上示例中,在最后充满的25秒内排除故障,15秒阈值(用来宣布故障的阈值)的三倍的一部分。这与当看起来故障似乎已修正时快速排除故障的目标一致。如果将系统时间与最新纪录的充满而不是最早的充满相比较,甚至可在快至15秒内更早地排除可能—但使用不止一个充满时间提供了对实际上已排除故障可能的更大的置信度。
应当理解,本文所述的本发明的附加实施例可由本领域的普通技术人员构思到,并且本发明的范围不限于所公开的实施例。虽然已示出和描述了本发明的具体实施例,但在不显著脱离本发明的精神的情况下可想到许多修改形式,并且保护范围仅受所附权利要求的范围限制。
Claims (19)
1. 一种用于将负压提供至负压伤口治疗绷带的方法,包括下列步骤:
提供具有泵的泵送装置;
设定在所述泵送装置上的治疗负压,其中,所述泵送装置确定与所述治疗负压相关联的目标负压,所述目标负压小于所述治疗负压;
将所述泵送装置连接到负压伤口治疗绷带;以及,
通过下列方式达到所述目标负压:
循环开启和关闭所述泵以在所述负压伤口治疗绷带中形成负压;
获得所述负压伤口治疗绷带中的所述负压的多个样本,每个样本以第一设定时间间隔获得;
计算预定数量的连续样本的平均值;
比较所述平均值与所述目标负压;以及
继续循环开启和关闭所述泵,直到所述平均值大于所述目标压力。
2. 根据权利要求1所述的方法,其特征在于,还包括下列步骤:
在循环开启和关闭所述泵直到在完全关闭循环之后样本的所述平均值大于所述目标压力的所述步骤之后,以大于所述第一设定时间间隔的第二设定时间间隔对所述负压伤口治疗绷带中的所述负压取样。
3. 根据权利要求2所述的方法,其特征在于,以所述第二设定时间间隔对所述负压伤口治疗绷带中的所述负压取样的步骤在所述泵已关闭预定时间量时开始。
4. 根据权利要求3所述的方法,其特征在于,所述预定时间量为300毫秒。
5. 根据权利要求2所述的方法,其特征在于,所述第二设定时间间隔为1000毫秒。
6. 根据权利要求5所述的方法,其特征在于,所述第一设定时间间隔为100毫秒。
7. 根据权利要求1所述的方法,其特征在于,循环开启和关闭所述泵以在所述负压伤口治疗绷带中形成负压的步骤通过将所述泵开启80毫秒且然后将所述泵关闭80毫秒来执行。
8. 根据权利要求7所述的方法,其特征在于,所述第一设定时间间隔为100毫秒。
9. 根据权利要求1所述的方法,其特征在于,所述治疗负压为125mmHg,并且所述目标负压为大约115mmHg。
10. 根据权利要求1所述的方法,其特征在于,所述治疗负压为90mmHg,并且所述目标负压为大约85mmHg。
11. 根据权利要求1所述的方法,其特征在于,所述治疗负压为60mmHg,并且所述目标负压为大约54mmHg。
12. 根据权利要求1所述的方法,其特征在于,所述治疗负压为40mmHg,并且所述目标负压为大约34mmHg。
13. 一种用于将负压提供至负压伤口治疗绷带的方法,包括下列步骤:
提供具有泵的泵送装置;
设定在所述泵送装置上的治疗负压,其中,所述泵送装置确定与所述治疗负压相关联的目标负压,所述目标负压小于所述治疗负压;
将所述泵送装置连接到负压伤口治疗绷带;以及,
通过下列方式达到所述目标负压:
循环开启和关闭所述泵达第一预定时间量,以在所述负压伤口治疗绷带中形成负压;
获得所述负压伤口治疗绷带中的所述负压的多个样本,每个样本以第一设定时间间隔获得;
计算预定数量的连续样本的平均值;
比较所述平均值与所述目标负压;以及
如果所述平均值不大于所述目标负压,则重复循环开启和关闭所述泵的所述步骤,获得多个样本,计算平均值并且比较所述平均值,直到所述平均值大于所述目标负压。
14. 根据权利要求13所述的方法,其特征在于,比较所述平均值的所述步骤以比计算所述平均值的速率更快的速率发生。
15. 根据权利要求13所述的方法,其特征在于,还包括下列步骤:
如果所述平均值大于所述目标负压,则通过以下方式维持所述目标负压:
以大于所述第一时间间隔的第二设定时间间隔获得所述负压伤口治疗绷带中的所述负压的多个第二样本;以及
比较每个第二样本与所述目标负压;以及,
如果第二样本大于所述目标负压,则重复获得和比较的所述步骤。
16. 根据权利要求15所述的方法,其特征在于,还包括下列步骤:
如果第二样本不大于所述目标负压,则重复通过下列方式达到所述目标负压的所述步骤:循环开启和关闭所述泵;获得多个样本;计算平均值;以及比较所述平均值,直到所述平均值大于所述目标负压。
17. 根据权利要求13所述的方法,其特征在于,所述治疗负压选自包括下列的集合:40mmHg;60mmHg;90mmHg;以及125mmHg。
18. 一种如本文所述的方法。
19. 一种具有来自本文中所述实施例的一个或多个步骤的方法。
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2011
- 2011-11-18 US US13/299,783 patent/US9067003B2/en active Active
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2012
- 2012-05-23 EP EP12789546.4A patent/EP2713971B1/en active Active
- 2012-05-23 MX MX2013013807A patent/MX2013013807A/es unknown
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- 2012-05-23 BR BR112013030198A patent/BR112013030198A2/pt not_active IP Right Cessation
- 2012-05-23 CN CN201280036812.0A patent/CN103841933B/zh active Active
- 2012-05-23 RU RU2013157032A patent/RU2608618C2/ru not_active IP Right Cessation
- 2012-05-23 AU AU2012258822A patent/AU2012258822B2/en active Active
- 2012-05-23 JP JP2014512071A patent/JP6162103B2/ja active Active
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- 2013-11-21 ZA ZA2013/08758A patent/ZA201308758B/en unknown
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2015
- 2015-06-11 US US14/737,387 patent/US10300178B2/en active Active
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2018
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- 2021-12-17 US US17/555,195 patent/US20220105255A1/en active Pending
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US20110008179A1 (en) * | 2007-07-02 | 2011-01-13 | Smith & Nephew Plc | Pressure control |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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TWI641397B (zh) * | 2015-12-15 | 2018-11-21 | 雃博股份有限公司 | 壓力控制方法及其系統 |
CN112604042A (zh) * | 2020-12-31 | 2021-04-06 | 广东普门生物医疗科技有限公司 | 减压引流系统及其控制方法和计算机可读存储介质 |
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ZA201308758B (en) | 2014-08-27 |
EP2713971A4 (en) | 2015-01-07 |
EP2713971A1 (en) | 2014-04-09 |
MX2013013807A (es) | 2014-05-28 |
CN103841933B (zh) | 2017-02-15 |
JP2014519905A (ja) | 2014-08-21 |
WO2012162370A1 (en) | 2012-11-29 |
US20120302977A1 (en) | 2012-11-29 |
JP6162103B2 (ja) | 2017-07-12 |
RU2013157032A (ru) | 2015-07-10 |
AU2012258822B2 (en) | 2016-09-08 |
US20190192746A1 (en) | 2019-06-27 |
CA2837296C (en) | 2020-03-10 |
AU2012258822A1 (en) | 2013-12-12 |
EP2713971B1 (en) | 2019-08-14 |
RU2608618C2 (ru) | 2017-01-23 |
US20150352267A1 (en) | 2015-12-10 |
US10300178B2 (en) | 2019-05-28 |
CA2837296A1 (en) | 2012-11-29 |
US20220105255A1 (en) | 2022-04-07 |
BR112013030198A2 (pt) | 2016-11-29 |
US9067003B2 (en) | 2015-06-30 |
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