CN103221077A - 压力控制设备 - Google Patents

压力控制设备 Download PDF

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CN103221077A
CN103221077A CN2011800557310A CN201180055731A CN103221077A CN 103221077 A CN103221077 A CN 103221077A CN 2011800557310 A CN2011800557310 A CN 2011800557310A CN 201180055731 A CN201180055731 A CN 201180055731A CN 103221077 A CN103221077 A CN 103221077A
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negative pressure
equipment
pressure source
desired negative
wound site
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CN103221077B (zh
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D.尼科利尼
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Smith and Nephew PLC
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    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
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    • A61M1/984—Containers specifically adapted for negative pressure wound therapy portable on the body
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Abstract

本发明公开了一种用于将负压施加至伤口部位的方法及设备。该设备包括负压源、处理元件和存储器，存储器包括指令，指令构造成用以当在处理器上执行时，引起设备经由负压源执行以下步骤：尝试在伤口部位处生成所期望的负压，如果在第一预定时间周期之后还未生成所期望的负压，则在第二预定时间周期内停用负压源，且随后在伤口部位处尝试生成所期望的负压。

Description

压力控制设备
技术领域
本发明涉及一种用于施加负压的方法及设备。具体而言但非排他地，本发明涉及在将局部负压施加在伤口部位处时将负压施加至伤口部位。
背景技术
关于提供设备和方法将其用于对伤口应用结合旨在提高TNP疗法的效果的其它治疗过程的局部负压(TNP)疗法，存在很多可用的现有技术。此类现有技术的实例包括下文列举和简要描述的那些。
TNP疗法(有时称为真空协助闭合或负压伤口疗法)通过以下来协助伤口的闭合和愈合：减少组织水肿；激励血液流动和组织的肉芽化；除去过多的分泌液，且可减少细菌接种量，且因此减少对伤口的感染。此外，TNP疗法允许伤口的较少外界干扰，且促进了更迅速的愈合。
在通过引用并入本文中的国际专利申请WO 2004 / 037334中，描述了用于对伤口抽吸、冲洗和清洁的设备、伤口敷料和方法。以很普通的用语，本申请描述了通过应用TNP疗法来治疗伤口，TNP疗法用于对伤口抽吸以及进一步提供附加流体来用于冲洗和/或清洁伤口，包括伤口分泌液和冲洗流体两者的该流体然后通过抽吸器件抽出，且通过用于将其中的有益材料与有害材料分离的器件来循环。有益于伤口愈合的材料经由伤口敷料再循环，而对伤口愈合有害的那些材料被丢弃到废物收集袋或容器中。
在通过引用并入本文中的国际专利申请WO2005/04670中，描述了使用抽吸、冲洗和清洁来清洁伤口的设备、伤口敷料和方法。又以很普通的用语，在该文献中描述的发明使用了在伤口的抽吸、冲洗和清洁方面与WO2004/037334中的设备类似的设备，然而其还包括重要的附加步骤：提供加热器件来控制回到伤口部位/敷料的有益材料的温度，以便其处于最佳温度，例如，为了具有对伤口的最有效的治疗效果。
然而，上文描述的设备和方法大体上仅适用于住院时的患者，因为使用的设备很复杂，需要具有如何操作和维护设备的专业知识的人，且还相对笨重且庞大，例如，不适于由患者在医院环境外容易移动。
例如，不需要连续住院但他们将仍想得益于延长的TNP疗法应用的具有相对较不严重的伤口的一些患者可以以容易便携且可维护的TNP疗法设备的可用性为条件来在家或在工作中进行治疗。为此，GB-A-2 307180描述了一种便携式TNP疗法单元，其可由患者携带且夹在皮带或背带上。因此，负压可施加在伤口部位处。
然而，这种便携式设备仍相对庞大，且可能需要由训练有素的护理员监护患者。此外，此类便携式疗法单元处理由泄漏造成进入伤口腔的流体流量的能力一般已有所下降。这导致由于不能在存在泄漏时保持伤口部位处所期望的负压而引起更多数目的报警。
与便携式设备相关联的另一个问题在于，有时使用机上电源如电池组，而非与电源如电力网(mains power source）连续连接。将会认识到的是，此类电池组仅具有有限的电力资源，且因此TNP疗法可能有时会由于电力故障而在所期望的时间阶段之前停止。
与可由患者单独使用而不需要技术熟练的助理的疗法单元相关联的另一个问题在于，当不可保持或启动所期望的疗法时，有时可启动警示灯或警示警报。这对于可能不理解此提示的意义的患者可能很痛苦。
与用于提供TNP疗法的设备相关联的又一个问题在于，与生成负压的泵相关联的马达将不时地启动或停止。来自于疗法单元的音量的变化可能引起患者焦虑。
发明内容
本发明的某些实施例的目的在于至少部分地减轻一个或多个上述问题。 
本发明的某些实施例的目的在于提供一种用于控制在伤口部位处提供的所期望的负压来协助伤口的闭合和愈合的方法。 
本发明的某些实施例的目的在于提供一种压力控制设备，其避免了在存在暂时泄漏时生成不必要的警报。
本发明的某些实施例的目的在于提供一种有助于延长电池电源寿命的压力控制设备。
本发明的某些实施例的目的在于提供一种减少泵用马达的启动或停机操作的数目的压力控制设备。
根据本发明的第一方面，提供了一种用于敷料伤口的设备，其用于在伤口部位处施加局部负压，该设备包括：
负压源；
处理元件；
包括指令的存储器，指令构造成在处理器上执行时引起设备执行以下步骤：
通过负压源，尝试在伤口部位处生成所期望的负压；
如果在第一预定时间周期之后还未生成所期望的负压，则在第二预定时间周期内停用负压源；以及
随后尝试在伤口部位处生成所期望的负压。
根据本发明的第二方面，提供给了一种在伤口部位处施加局部负压(TNP)的方法，包括以下步骤：
通过负压源，尝试在伤口部位处生成所期望的负压；
如果在第一预定时间周期之后还未生成所期望的负压，则在第二预定时间周期内停用负压源；以及
随后尝试在伤口部位处生成所期望的负压。
根据本发明的第三方面，提供了一种用于将负压施加至伤口的设备，包括：
联接到敷料上的负压源；以及
控制器，其构造成用以：
启动负压源以在敷料下生成第一所期望的负压；
如果在第一时间间隔的抽吸时，敷料下的负压还未达到第一所期望的负压，则在第二时间间隔内停用负压源；以及
在第二时间间隔的抽吸时，启动负压源来在敷料下生成第一所期望的负压。
在一些实施例中，控制器进一步构造成用以：在超过第一阈值的第一时间量内启动负压源之后敷料下还未生成第一所期望的负压时，停用负压源。
在一些实施例中，控制器进一步构造用以：当第一时间量超过第一阈值时，在第三时间间隔内停用负压源。
在一些实施例中，该设备还包括：开关，其构造成用以向控制器发信号来启动或停用负压源；以及控制器，其进一步构造成在第三时间间隔的抽吸时或在接收到来自于开关的信号以启动负压源时，启动负压源来在敷料下生成第一所期望的负压。
在一些实施例中，该设备还包括：指示器，其中控制器进一步构造成在第一时间量超过第一阈值时启动指示器。
在一些实施例中，控制器进一步构造用以：在第三时间间隔的抽吸时或接收到来自于开关的信号以启动负压源时，停用指示器。
在一些实施例中，指示器指出了密封中的泄漏。
在一些实施例中，控制器进一步构造用以：
当敷料下的负压已经达到第一所期望的负压时，停用负压源且监测敷料下的负压；以及
如果敷料下的负压降低到负压阈值以下，则启动负压源来在敷料下生成第二所期望的负压。
在一些实施例中，第一所期望的负压和第二所期望的负压是相同的。
在一些实施例中，第二所期望的负压小于第一所期望的负压。
在一些实施例中，控制器进一步构造成：如果敷料下的负压达到第二所期望的负压，或如果敷料下的负压还未在第四时间间隔的抽吸时达到第二所期望的负压，则停用负压源。
在一些实施例中，如果敷料下的负压在第四时间间隔的抽吸时还未达到第二所期望的负压，则控制器进一步构造成在第二时间间隔的抽吸时，启动负压源来在敷料下生成第一所期望的负压。
在一些实施例中，控制器进一步构造用以：如果控制器在小于第二阈值的第二时间量内已经启动负压源来达到第二所期望的负压，则启动负压源来在敷料下生成第一所期望的负压。
在一些实施例中，控制器进一步构造用以：如果控制器在超过第二阈值的第二时间量内已经启动负压源来达到第二所期望的负压，则停用负压源；以及
在第三时间间隔的抽吸时或在接收到来自于开关的信号以启动负压源时，启动负压源来在敷料下生成第一所期望的负压。
在一些实施例中，控制器进一步构造用以：
监测负压源的工作循环；以及
如果工作循环超过第一工作循环阈值而负压未达到敷料下的第一所期望的负压或第二所期望的负压，则停用负压源。
在一些实施例中，工作循环包括负压源在一定时间周期内起效的时间量、时间比例或时间百分比。
在一些实施例中，控制器进一步构造用以：计算超过第一工作循环阈值的工作循环数，且当超过第一工作循环阈值的工作循环数超过第二工作循环阈值时停用负压源。
在一些实施例中，控制器进一步构造成用以计算超过第一工作循环阈值的连续工作循环数。
在一些实施例中，第二工作循环阈值包括30分钟。
在一些实施例中，控制器进一步构造成：在第三时间间隔的抽吸时或在接收到来自于开关的信号以启动负压源时，启动负压源来在敷料下生成第一所期望的负压。
在一些实施例中，负压源包括泵。
在一些实施例中，该设备还包括：压力传感器，其构造成用以感测敷料下的压力，且将感测到的压力传输至控制器。
在一些实施例中，该设备还包括：联接在入口与负压源之间的单向阀，其中入口与敷料流体连通。
在一些实施例中，负压源包括：构造成用以将端口连接到外部负压源上的阀。
在一些实施例中，控制器进一步构造用以：通过操作阀来启动或停用负压源。
根据本发明的第四方面，提供了一种将负压施加至伤口的方法，包括：
将敷料定位在伤口上来在伤口上产生大致不透流体的密封；
将负压源联接到敷料上；
启动负压源以在敷料下生成第一所期望的负压；
如果在第一时间间隔的抽吸时，敷料下的负压还未达到第一所期望的负压，则在第二时间间隔内停用负压源；以及
在第二时间间隔的抽吸时，启动负压源来在敷料下生成第一所期望的负压。
在一些实施例中，该方法还包括：在超过第一阈值的第一时间量内启动负压源之后敷料下还未生成第一所期望的负压时，停用负压源。
在一些实施例中，该方法还包括：当第一时间量超过第一阈值时，在第三时间间隔内停用负压源。
在一些实施例中，该方法还包括：在第三时间间隔的抽吸时或在接收到来自于开关的信号以启动负压源时，启动负压源来在敷料下生成第一所期望的负压。
在一些实施例中，该方法还包括：向使用者指出第一时间量何时超过第一阈值。
在一些实施例中，该方法还包括：在第三时间间隔的抽吸时或接收到来自于开关的信号以启动负压源时，停止指示。
在一些实施例中，指示指出密封中的泄漏。
在一些实施例中，该方法还包括：
当敷料下的负压已经达到第一所期望的负压时，停用负压源且监测敷料下的负压；以及
如果敷料下的负压降到负压阈值以下，则启动负压源来在敷料下生成第二所期望的负压。
在一些实施例中，第一所期望的负压和第二所期望的负压是相同的。
在一些实施例中，第二所期望的负压小于第一所期望的负压。
在一些实施例中，该方法还包括：如果敷料下的负压已经达到第二所期望的负压，或如果敷料下的负压在第四时间间隔的抽吸时还未达到第二所期望的负压，则停用负压源。
在一些实施例中，该方法还包括：如果敷料下的负压在第四时间间隔的抽吸时还未达到第二所期望的负压，则在第二时间间隔的抽吸时，启动负压源来在敷料下生成第一所期望的负压。
在一些实施例中，该方法还包括：如果在小于第二阈值的第二时间量内已经启动负压源来达到第二所期望的负压，则启动负压源来在敷料下生成第一所期望的负压。
在一些实施例中，该方法还包括：
如果在超过第二阈值的第二时间量内已经启动负压源来达到第二所期望的负压，则停用负压源；以及
在第三时间间隔的抽吸时或在接收到来自于开关的信号以启动负压源时，启动负压源来在敷料下生成第一所期望的负压。
在一些实施例中，该方法还包括：
监测负压源的工作循环；以及
如果工作循环超过第一工作循环阈值而负压未达到敷料下的第一所期望的负压或第二所期望的负压，则停用负压源。
在一些实施例中，工作循环包括负压源在一定时间周期内起效的时间量、时间比例或时间百分比。
在一些实施例中，该方法还包括：计算超过第一工作循环阈值的工作循环数，且当超过第一工作循环阈值的工作循环数超过第二工作循环阈值时停用负压源。
在一些实施例中，该方法还包括：计算超过第一工作循环阈值的连续工作循环数。
在一些实施例中，第二工作循环阈值包括30分钟。
在一些实施例中，该方法还包括：在第三时间间隔的抽吸时或在接收到来自于开关的信号以启动负压源时，启动负压源来在敷料下生成第一所期望的负压。
在一些实施例中，负压源包括泵。
在一些实施例中，该方法还包括感测敷料下的压力。
在一些实施例中，该方法还包括：通过操作阀来启动或停用负压源。
本发明的某些实施例提供的优点在于：可避免由于伤口室中的暂时泄漏引起的报警，同时还减小了通过伤口室中的泄漏将污染物吸入伤口部位中的潜在可能。
本发明的某些实施例提供了延长用于向伤口部位提供所期望的负压的负压电池电源的可用寿命的优点。
附图说明
现在将仅通过举例的方式参照附图来在下文中描述本发明的实施例，在附图中：
图1示出了将负压伤口疗法应用于伤口部位的布置；
图2示出了压力控制设备的简图；
图3示出了另一个压力控制设备的简图；
图4示出了控制器的状态图；以及
图5示出了控制器。
在附图中，相似的参考标号表示相似的部分。
具体实施方式
图1示出了将负压伤口疗法应用于伤口部位10的布置。填塞材料12置于伤口腔内，且然后盖布14围绕伤口部位10密封到皮肤的表面上，以围绕伤口室的周边形成不透流体的密封。负压源如压力控制设备100经由管16联接到伤口腔上。流体收集罐(未示出)可联接在压力控制设备100与伤口室之间，以收集从伤口部位10抽出的任何伤口分泌液。填塞材料12的使用是可选的，且其可在某些布置中视情况省略。
作为备选，独立的伤口敷料可用于替换盖布，此类伤口敷料吸收敷料层内的伤口分泌液，以除去对单独的流体收集罐的需要。
2011年4月21日提交的美国申请第13/092,042号中找到了可组合本文所述的实施例使用的有关伤口敷料的更多细节，该申请的全部内容通过引用并入本文中。
本发明的某些实施例中构想的用于设备的负压范围可在大约-50mmHg至-200mmHg之间(注意这些压力是相对于正常环境大气压力的，因此-200mmHg实际上为大约560mmHg)。适当地，压力范围可在大约-75mmHg至-150mmHg之间。作为备选，可使用达到-75mmHg、达到-80mmHg或-80mmHg以上的压力范围。还适当地，可使用低于-75mmHg的压力范围。作为备选，可使用-100mmHg以上或-150mmHg以上的压力范围。
图2示出了根据本发明的实施例的压力控制设备100的简图，压力控制设备100可用于将负压施加于伤口部位10。压力控制设备包括联接到压力传感器116上的入口102，且入口102还经由单向止回阀104联接到泵106的入口上。泵由电动马达108操作，电动马达108从电池114吸收电力。控制器112联接到压力传感器116，且提供控制信号来用于控制电动马达108的操作。指示器110联接到控制器112上，以允许对使用者的状态信号的音频反馈和/或视觉反馈。泵106的出口联接到压力控制设备的出口118上。使用者可使用电源按钮120来启动或终止操作。
示出的泵106为隔膜泵，隔膜泵可为高效的，且能够提供所需的负压。将认识到的是，可使用其它类型的泵，如蠕动泵等。在一些布置中，单向止回阀104可形成泵106的一部分，且可不作为设备的单独元件存在。
尽管已经将设备描述为电池供能的，但将理解的是，设备作为备选可从电力网吸收电力，且除去电池电源单元。在一些布置中，设备可能够从电力网或可从电力网再充电的可再充电池供能。
在操作中，入口102联接到形成在伤口部位10上的伤口室上，例如，经由管16的长度。电动马达108在控制器112的控制下驱动泵106，以在入口102处提供负压。然后，负压可传输至伤口室，以便在伤口部位处提供所期望的负压。当泵106未起效时，止回阀104保持入口102处的负压水平，且协助避免泄漏。
在最初将压力控制设备100连接到伤口室上时，伤口部位处的压力将等于大气压力，且必须执行初始排空来在伤口部位处建立所期望的负压。该可需要泵106在延长的时间周期内操作，直到实现所期望的负压。
入口102处的压力代表伤口部位处经历的压力，且该压力由压力传感器116测量。控制器112接收压力传感器116处测量到的压力值，且一旦测量的压力达到所期望的负压，则控制器停用泵106。然后，控制器112继续监测压力传感器处的压力。
如果在初始排空阶段期间，控制器112确定在某一时间(例如，10分钟或20分钟或30分钟或40分钟等)内已经不能实现所期望的负压，则泄漏可存在于伤口室中，且通过指示器110发出该状态的信号，以示出伤口室已是未正确地密封，或存在一些其它错误或故障。
一旦已经建立所期望的负压，则控制器112监测压力控制设备的入口处的压力。有时，流体的泄漏可出现在伤口室中，降低了伤口部位处经历的负压的水平，或换言之，增大了伤口部位处的绝对压力。因此，在压力传感器116处测量到且提供给控制器112的压力值将随流体泄漏到伤口室而增大。当测量负压值降低到某一限定的压力水平以下时，控制器112将再启动泵106，以便在伤口部位处再建立所期望的负压。控制器再启动泵所处的所期望的负压和限定的压力水平提供了滞后限制，为了将局部负压施加到伤口部位上而应当保持该压力应在滞后限制之间。
然而，如果形成的泄漏允许流体(例如，空气)以大于最大泵能力106的流速泄漏到伤口室中，则压力控制设备100将不可能在伤口部位处保持所期望的负压。如果压力控制设备100在存在这种泄漏时继续尝试再建立所期望的负压，则电池电源单元114将变得耗尽。此外，在存在较大泄漏时继续操作泵可将污染物吸入伤口部位，且导致伤口部位过度干燥，这是非期望的。因此，如果在泵106操作了预定时间周期之后未再建立所期望的负压，则控制器112构造成用以停用泵106。例如，有时在大约30分钟至4小时之间。
伤口室中的泄漏的形成可由于很多因素而出现。此类泄漏的一个常见原因为用压力控制设备100治疗的患者的移动。例如，当患者从平躺移动至坐姿时，或在走路时的正常移动范围期间，可形成泄漏。此类泄漏可为暂时的，且已经发现当患者继续移动或回到其先前位置时将有规则地再密封。因此，存在的风险在于泵106可由于探测到随后将再密封的泄漏而停用。然而，一旦泄漏再密封，则压力控制设备的操作将能够在伤口室内再建立所期望的负压。
根据本发明的实施例，控制器112构造成用以在泵已经操作了一定时间周期而在伤口室中未达到所期望的负压水平之后停用泵106。这是出现了超时事件。然后，在进行重新尝试以使用泵106在伤口部位再建立所期望的负压之前，控制器将等待另一时间周期。如果泄漏已经再密封同时泵已经暂时停用，则重新尝试再建立所期望的负压将成功，且压力控制设备100的操作可按正常继续。然而，如果泄漏仍存在，则另一个超时事件将出现，且泵将停用另一个时间周期。
停用泵106且然后尝试再建立所期望的负压的该循环可重复多次，以便提供任何泄漏至再密封的机会。然而，一旦超时事件出现，则伤口部位处的负压将开始退化，且因此应用于伤口部位处的负压伤口疗法中将存在中断。尽管疗法中的短暂中断可能不是问题，但应当优选避免其中未施加负压的周期的延长。此外，如果伤口室中的泄漏通路存在延长的时间周期，则污染物到达伤口部位的潜在可能增大。因此，如果进行了N多次不成功的尝试来再建立所期望的负压，则可假定泄漏是持久的而不是暂时的，且控制器112停止压力控制设备100的操作，且通过音频和/或视觉提示来向使用者提供需要注意的信号。这允许患者或护理员布置待更换的任何敷料或盖布，从而重整伤口室，且允许继续负压伤口疗法。适当地，N为1至5(包括性的)之间的整数。
作为备选，可省略泵106和马达108，且可通过外部负压源来提供负压，如，通过连接至真空管线或真空罐。图3提供了结合外部负压源使用的另一个压力控制设备200的简图，且该设备可用于向伤口部位10提供负压。压力控制设备200包括联接在入口102与出口118之间的可控制的阀202。出口118联接到外部负压源上。控制器212向阀202提供控制信号，以控制外部负压源与入口102且从而与伤口室的联接。入口102处的压力由联接到入口上的压力传感器116监测，且这种监测的压力供应给控制器212。
图3中的压力控制设备200的操作类似于压力控制设备100的操作，只是压力通过操作阀202来将伤口室联接到外部负压源上来控制。控制器112能够通过控制阀202来控制入口102处的负压水平。通过经由压力传感器116监测入口处的压力，控制器212可控制阀来在伤口部位处提供所期望的负压。
不同于图2的压力控制设备，在存在泄漏时延长尝试提供所期望的负压将不会导致电池电源单元的耗尽。然而，长期来看，由于可能将污染物吸入伤口室且由于空气流过室会造成伤口部位的干燥而仍不期望在存在泄漏时继续施加负压。因此，图3中的控制器212执行了与上文参照压力控制设备100描述的相同的控制流。即，如果在预定时间周期内未在伤口部位处建立所期望的负压，则控制器212构造成用于通过闭合阀来使入口102与外部负压源脱离。然后，可进行多次尝试来再建立负压，以便提供伤口室中的暂时泄漏再密封的机会。
因此，图2和图3中的压力控制设备能够控制负压施加至伤口部位，且有利地减少了流体暂时泄漏到伤口室中造成的报警数。当形成的泄漏允许空气以高于某一水平的流速进入伤口室时，压力控制设备构造成在预定时间周期内停止向伤口室提供负压，以提供泄漏再密封的机会。然后，如果泄漏是暂时的且进行再密封，则然后可在随后的尝试中再建立所期望的负压。这避免了指示针对暂时泄漏的报警状态的需要，且还避免了吸入污染物和过量空气进入伤口室中的问题。这还避免了泵用马达反复地通电和断电，这又避免了相关的噪音水平变化，且有助于改善泵用马达的寿命。
控制器112,212可实现为微控制器或专用集成电路等，且可执行指令来提供上文所述的控制功能。例如，适合的微控制器将为来自于ST Microelectronics的STM8L MCU系列的一个，例如ST Microelectronics STM8L151G4U6，或来自于Freescale的MC9S08QE4/ 8的一个，如Freescale MC9S08QE4CWJ。
控制器112的操作可描述为有限状态机。下文参照图4描述了控制器的操作，图4示出了状态图300，该图描述了用于图1中所示的压力控制设备的控制器112的操作。
图5示出了控制器112的一个实施例。控制器包括存储器502，存储器502可存有用于执行控制功能的程序代码。存储器联接到能够执行指令的微控制器504上。微控制器联接到输入端506和输出端508上，通过输入端506和输出端508，微控制器能够监测系统的操作和向压力控制设备的其它部分提供控制信号。
又参看图4，可在第一次推动启动条时或压下使用者按钮等时可出现的压力控制设备100的启动310时，控制器112执行通电自测试(POST)302以确保压力控制设备正确地操作。如果通电自测试失败，则将不会使用压力控制设备。因此，在POST失败之后，控制器过渡至非可恢复错误状态304，且经由指示器110向使用者发出错误信号。 如果通过POST，则控制器112经由待机状态过渡至操作状态308，且在使用者经由按钮指示时执行初始排空312，其中将操作泵106，直到在伤口室中建立所期望的负压。作为备选，控制器可在状态312中执行初始排空之前等待使用者的输入。
一旦已经成功地建立所期望的负压，则控制器过渡至监测压力状态316。然而，如果在预定时间周期之后还未建立所期望的压力且初始排空状态312不能建立所期望的负压(表现出泄漏)，则超时出现。在第一超时时，控制器将过渡至等待状态314，其中控制器在过渡回到初始排空状态312之前等待一定时间周期。其它超时可从初始排空状态312出现，且控制器保持进行的重新尝试的数目的计数。一旦已经建立所期望的负压，则可重置重新尝试的数目。
如果超时出现且重试循环的数目大于允许的重新尝试的预定最大数目，则控制器过渡至暂停状态306。在暂停状态306中时，控制器将响应于使用者的输入或在最大暂停时间之后从暂停状态306过渡至初始排空状态312
在监测压力状态316中，控制器监测压力传感器116处测量的压力，且如果压力下降至所期望的压力范围以外，则控制器过渡至保持排空状态318。在保持排空状态318中，在预定的时间周期内启动吸出泵，例如，在大约10秒至60秒之间，或直到在伤口室中再建立所期望的负压，以先发生的为准。
将注意到，一些滞后将进入所期望的压力范围中，使得触发从监测压力状态316过渡至保持排空状态318的压力值(最低所期望负压)低于保持排空状态318期间由泵的操作在伤口室中建立的所期望的负压。例如，采用上文所述的操作压力范围，所期望的负压可为-150mmHg，且最低所期望的负压可为-75mmHg。作为备选，控制器可用于将压力保持在所期望的负压的某一百分比范围内，例如，可使用5%的滞后。
如果在吸出泵已经操作预定时间周期之前达到所期望的负压，则控制器过渡回到监测压力状态316。
然而，如果泵操作预定的时间周期而一般由于伤口室中的泄漏而在伤口室中未再建立所期望的负压，则压力控制设备将发出存在泄漏的信号。如果压力在滞后限制内，即，在最低所期望的负压与所期望的负压之间，则这表示存在高泄漏，其具有的流速与泵的能力类似。在此情形中，泵继续操作，直到再建立所期望的负压，或直到伤口部位处的压力不再保持在滞后限制内。
如果存在较大的泄漏，所期望的负压在达到最大保持时间之前恢复，则控制器将过渡回到监测压力状态316，但将发出存在泄漏的信号。然而，如果吸出泵操作成大于最大保持时间以恢复所期望的负压，则控制器将过渡至暂停状态306，同时发出存在泄漏的信号。
如果在保护排空状态318期间，伤口室中的压力未保持在滞后限制内，则已经出现灾难性的泄漏，且控制器过渡至等待状态314。
在一些实施例中，如果在预定时间周期之后，还未建立所期望的压力且保持排空状态318不能在达到最大保持时间之前建立所期望的负压，则超时出现。在第一超时时，控制器将过渡至等待状态314，其中控制器在过渡回到初始排空状态312之前等待一定时间周期。其它超时可从保持排空状态318出现，且控制器保持进行的重新尝试的数目的计数。一旦在保持排空状态318中已经建立所期望的负压，则可重置重新尝试的数目。如果超时出现且重新尝试的数目大于允许的重新尝试的预定最大数目，则如上文所述，控制器过渡至暂停状态306。
因此，如果泄漏使得其超过如限定的预定限制和泵工作循环(DC)，则在一些实施例中，在泵入时间除以泵出时间超过预定限制时，则泵将继续在滞后限制内操作特定的持续时间。例如，如图4中所示的大约30分钟。因此，在监测压力循环中，如果工作循环小于预定限制，则所有都良好。如果工作循环大于特定限制但小于超时时间，则泵继续运行达到30分钟。如果DC大于超时，则进入暂停状态306。
在处于操作状态308时的任何时间，控制器可响应于使用者的输入而置于暂停状态306中。一旦电池电压达到低电压终止水平或已经达到压力控制设备的寿命，则控制器停用压力控制设备且达到寿命终止状态。
相对于图3中的压力控制设备200描述的控制器212以与上文所述的相似的方式操作，只是初始排空和保持排空状态由阀启动状态替换，在阀启动状态中，入口102联接到外部负压源上，外部负压源经由可控制的阀元件202连接到出口118上。
作为备选，可省略POST状态302。
压力控制设备可构造成可再使用，且设有开关以允许设备按要求开启和关闭。此类可再使用的设备可包括可再充电的电源单元，且可提供低功率指示以便允许将电源单元更换/再充电。
在一次性的单次使用的压力控制设备中，可通过拉动启动条来提供启动，且一旦启动就不可能停用设备，直到将设备丢弃。
在本说明书的描述和权利要求的各处，词语"包括"和"包含"和词语的变型，例如"包括(comprising)"和"包括(comprises)"意指"包括但不限于"，且并非旨在(且不会)排除其它部分、添加物、构件、整体或步骤。
在本说明书的描述和权利要求的各处，单数涵盖复数，除非上下文另作要求。具体而言，在使用不定冠词的情况下，说明书将理解为构想出了复数以及单数，除非上下文另作要求。
结合本发明的特定方面、实施例或实例描述的特征、整体、特点、组合部分、化学部分或集合将理解为也适于本文描述的任何其它方面、实施例或实例，除非与其不相容。

Claims (38)

1.一种用于在将局部负压施加至伤口部位时将负压施加于伤口部位的设备，所述设备包括：
负压源；
处理元件；以及
包括指令的存储器，所述指令构造成在所述处理器上执行时引起所述设备执行以下步骤：
通过所述负压源，尝试在所述伤口部位处生成所期望的负压；
如果在第一预定时间周期之后还未生成所述所期望的负压，则在第二预定时间周期内停用所述负压源；以及
随后尝试在所述伤口部位处生成所述所期望的负压。
2.根据权利要求1所述的设备，其特征在于，所述指令进一步构造用以引起所述设备执行以下步骤：
如果在另一个预定时间周期之后还未生成所述所期望的负压，则在所述第二预定时间周期内停用所述负压源。
3.根据权利要求2所述的设备，其特征在于，所述指令进一步构造成用以引起所述设备执行以下步骤：
在所述另一个预定时间周期之后还未生成所期望的负压时，以N次循环重复在所述第二预定时间周期内停用所述负压源且随后尝试在所述伤口部位处生成所述所期望的负压的步骤。
4.根据权利要求3所述的设备，其特征在于，所述指令进一步构造成用以引起所述设备执行以下步骤：
当所述N次循环之后未生成所述所期望的负压时，引起所述设备停机。
5.根据权利要求4所述的设备，其特征在于，所述设备构造成用以在所述设备停机时提供警示信号。
6.根据任何前述权利要求所述的设备，其特征在于，所述指令进一步构造成用以引起所述设备执行以下步骤：
监测所述伤口部位处的负压；以及
如果所述监测到的负压小于阈值负压，则尝试在所述伤口部位处生成所述所期望的负压。
7.根据任何前述权利要求所述的设备，其特征在于，所述负压源包括泵。
8.根据权利要求7所述的设备，其特征在于，在所述伤口部位处尝试生成所述所期望的负压包括启动所述泵。
9.根据权利要求7或权利要求8所述的设备，其特征在于，停用所述负压源包括停用所述泵。
10.根据权利要求7至权利要求9中任一项所述的设备，其特征在于，所述设备还包括：
联接到所述设备的入口上的压力传感器；以及
其中在所述伤口部位处尝试生成所述所期望的负压包括取决于所述压力传感器处测量的压力来控制所述泵。
11.根据权利要求10所述的设备，其特征在于，所述指令进一步构造成用以引起所述设备执行以下步骤：
取决于所述压力传感器处测量的所述压力来控制所述泵，以在所述伤口部位保持所述所期望的负压。
12.根据权利要求10或权利要求11所述的设备，其特征在于，所述设备还包括联接在所述设备的入口与泵入口之间的单向阀。
13.根据权利要求1至权利要求5中任一项所述的设备，其特征在于，所述负压源包括布置成用以将所述设备联接到所述外部负压源上的阀元件。
14.根据权利要求13所述的设备，其特征在于，停用所述负压源包括闭合所述阀元件。
15.根据权利要求13或权利要求14所述的设备，其特征在于，在所述伤口部位处尝试生成所述所期望的负压包括调节从所述设备的入口经由所述阀元件的流体流。
16.根据权利要求15所述的设备，其特征在于，所述设备还包括：
联接到所述设备的入口上的压力传感器；以及
其中在所述伤口部位处尝试生成所述所期望的负压还包括取决于所述压力传感器处测量的压力来控制所述阀元件。
17.根据任何前述权利要求所述的设备，其特征在于，所述指令进一步构造成用以引起所述设备执行以下步骤：
如果成功地生成所述负压所花费的时间大于阈值时间限制，则在所述第二预定时间周期内停用所述负压源；以及
随后尝试在所述伤口部位处生成所述所期望的负压。
18.根据任何前述权利要求所述的设备，其特征在于，所述指令进一步构造成用以引起所述设备执行以下步骤：
监测所述负压源的工作循环；以及
如果所述工作循环超过工作循环阈值而没有在所述伤口部位处成功地生成所述所期望的负压，则停用所述负压源。
19.根据权利要求18所述的设备，其特征在于，所述工作循环包括所述负压源在时间限制内起效的时间量。
20.根据权利要求18或权利要求19所述的设备，其特征在于，所述指令进一步构造成用以引起所述设备执行以下步骤：
如果所述工作循环超过了所述工作循环阈值一定的持续时间，则停用所述负压源。
21.根据权利要求20所述的设备，其特征在于，所述持续时间包括30分钟。
22.一种用于在伤口部位处施加局部负压的伤口敷料，包括：
用于在伤口部位上密封的不透气的覆盖层，所述覆盖层包括孔口；
联接到所述孔口上的根据任何前述权利要求所述的设备。
23.一种提供负压来用于在伤口部位处施加局部负压的方法，包括以下步骤：
通过负压源，尝试在伤口部位处生成所期望的负压；
如果在第一预定时间周期之后还未生成所述所期望的负压，则在第二预定时间周期内停用所述负压源；以及
随后尝试在所述伤口部位处生成所述所期望的负压。
24.根据权利要求23所述的方法，其特征在于，所述方法还包括以下步骤：
如果在另一个预定时间周期之后还未生成所述所期望的负压，则在所述第二预定时间周期内停用所述负压源，且然后随后在所述伤口部位处尝试生成所述所期望的负压。
25.根据权利要求24所述的方法，其特征在于，所述方法还包括以下步骤：
在所述另一个预定时间周期之后仍未生成所期望的负压时，以N次循环重复在所述第二预定时间周期内停用所述负压源且随后尝试在所述伤口部位处生成所述所期望的负压的步骤。
26.根据权利要求25所述的方法，其特征在于，所述方法还包括以下步骤：
当所述N次循环之后未生成所述所期望的负压时，引起所述设备停机。
27.根据权利要求26所述的方法，其特征在于，所述方法还包括当所述设备停机时提供警示信号的步骤。
28.根据权利要求23至权利要求27中任一项所述的方法，其特征在于，所述负压源包括泵，以及尝试在所述伤口部位处生成所述所期望的负压的步骤包括启动所述泵。
29.根据权利要求28所述的方法，其特征在于，停用所述负压源的所述步骤包括停用所述泵。
30.根据权利要求23至权利要求27中任一项所述的方法，其特征在于，所述负压源包括布置成用以将所述设备联接到所述外部负压源上的阀元件；以及
其中尝试在所述伤口部位生成所述所期望的负压的所述步骤包括调节从所述设备的入口经由所述阀元件的流体流。
31.根据权利要求30所述的方法，其特征在于，停用所述负压源包括闭合所述阀元件。
32.根据权利要求23至权利要求31中任一项所述的方法，其特征在于，所述方法还包括以下步骤：
监测所述负压源的工作循环；以及
如果所述工作循环超过工作循环阈值而未在所述伤口部位处成功地生成所述所期望的负压，则停用所述负压源。
33.根据权利要求32所述的方法，其特征在于，所述工作循环包括所述负压源在时间限制内起效的时间量。
34.根据权利要求32或权利要求33所述的方法，其特征在于，所述方法还包括以下步骤； 
如果所述工作循环超过了所述工作循环阈值一定的持续时间，则停用所述负压源。
35.根据权利要求34所述的方法，其特征在于，所述持续时间包括30分钟。
36.一种计算机程序，包括用于引起计算机执行根据权利要求23至权利要求35中任一项所述的方法的计算机指令。
37.一种大致如前文参照附图描述的方法。
38.一种大致如前文参照附图描述那样构造和布置的设备。
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US11623039B2 (en) 2010-09-20 2023-04-11 Smith & Nephew Plc Systems and methods for controlling operation of a reduced pressure therapy system
US10058644B2 (en) 2010-09-20 2018-08-28 Smith & Nephew Plc Pressure control apparatus
US10105473B2 (en) 2010-09-20 2018-10-23 Smith & Nephew Plc Pressure control apparatus
US11534540B2 (en) 2010-09-20 2022-12-27 Smith & Nephew Plc Pressure control apparatus
US11027051B2 (en) 2010-09-20 2021-06-08 Smith & Nephew Plc Pressure control apparatus
US10307517B2 (en) 2010-09-20 2019-06-04 Smith & Nephew Plc Systems and methods for controlling operation of a reduced pressure therapy system
CN103987410A (zh) * 2011-07-26 2014-08-13 史密夫及内修公开有限公司 用于控制减压治疗系统的操作的系统和方法
CN105749363A (zh) * 2011-07-26 2016-07-13 史密夫及内修公开有限公司 用于控制减压治疗系统的操作的系统和方法
CN106687154B (zh) * 2014-07-31 2021-02-09 史密夫和内修有限公司 用于施用减压治疗的系统和方法
CN106687154A (zh) * 2014-07-31 2017-05-17 史密夫和内修有限公司 用于施用减压治疗的系统和方法
CN109789037A (zh) * 2016-08-19 2019-05-21 T.J.史密夫及内修有限公司 用于监测患者移动的减压治疗系统和方法
CN109640902B (zh) * 2016-08-31 2022-02-22 史密夫及内修公开有限公司 用于控制减压治疗系统的操作以检测泄漏的系统和方法
CN109640902A (zh) * 2016-08-31 2019-04-16 史密夫及内修公开有限公司 用于控制减压治疗系统的操作以检测泄漏的系统和方法
WO2023011475A1 (zh) * 2021-08-05 2023-02-09 江苏苏中药业集团医疗器械有限公司 一种用于医用真空负压机的单向阀系统

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