CN1973916B - 利用真空帮助组织愈合的治疗系统 - Google Patents
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Abstract
一种刺激组织愈合的系统,包括:多孔垫、气密的裹伤巾、导管、连接导管远端到所述裹伤巾的机构、能够取下地连接到导管近端的滤筒、用于向伤口部位施加负压的电泵、位于所述滤筒和所述电泵之间的第一疏水性过滤器、位于所述第一疏水性过滤器和所述电泵之间的第二疏水性过滤器和位于所述第一疏水性过滤器和所述第二疏水性过滤器之间或者位于所述第二疏水性过滤器和所述电泵之间的气味过滤器。
Description
技术领域
本发明总体上涉及组织的治疗系统。具体地,本发明涉及利用真空帮助开口创伤愈合的治疗系统。
背景技术
通过位于德克萨斯州Antonio镇的Kinetic Concepts公司及其市场可买到的生产线,真空帮助开口创伤愈合疗法近来已得到广泛应用。共同转让的1990年11月13日授予Zamierowski的美国专利4,969,880,以及其继续和部分继续的于1992年3月31日授权的美国专利5,100,396、1993年11月16日授权的美国专利5,261,893、和1996年6月18日授权的美国专利5,527,293,对真空帮助伤口愈合法进行了介绍,其中公开的内容在本文中引用参考。对真空帮助伤口愈合方法的进一步改进和提高在于2000年6月6日授予Zamierowski的美国专利6,071267和分别于1997年6月10日和1997年7月8日授予Argenta等人的美国专利5,636,643和5,645,081中进行了介绍,其中公开的内容在本文中参考引用。1998年5月13日授予Hunt等人的美国专利6,142,982公开了其他的改进。实际上,由受让人及其父母通过“真空帮助愈合”(或)实现商业化的伤口负压疗法的应用一般会涉及到伤口的机械似收缩和同时清除过多流体。疗法通过这种方式促进身体的自然发炎过程,同时减少了许多已知的固有副作用,比如不断增加的血流缺少适当的静脉血回流所必需的血管结构造成的浮肿。其结果是,疗法在促进伤口愈合上取得高度成功,治好了许多以前认为难以医治的创伤。
负压施加到伤口的频率以及压力随时间变化的频率直接影响到伤口愈合的速度。目前的真空治疗装置尚未能提供的随时间变化压力则被认为能够极大地提高伤口愈合速度。同样地,接受伤口治疗的患者快速恢复正常活动能力也可以提高伤口愈合速度,因为身体活动能力的提高通常伴随血脉循环增加,这可导致伤口处血液流动改善。恢复正常活动能力的阻碍之一是有限的电池寿命,这是现有真空帮助伤口愈合的治疗系统的电源带来的问题。此外,伤口还要求经常进行检查以保证伤口不感染。而且,快速恢复正常活动能力还不得不面对真空疗法必须采用的预防措施,设置装置以防止伤口流出物从滤筒无意中溢出或伤口流出物进入泵。
使用现有技术的固定频率摆动泵还要受到另外的限制。为了伤口处保持希望的负压所要求的泵尺寸和/或操作摆动泵所需功率造成的电池寿命降低导致了这些限制。现有技术的摆动泵一般设计成在限定的操作条件下工作,例如,固定频率下低压流量最大化。一般地,改变设计条件下的泵的共振频率要对各部件的质量和/或刚度进行变化。如果泵的压力增加,系统的刚度由于摆动泵膜片的背压增加而提高。泵的共振频率改变和固定频率驱动不能以最佳频率驱动泵。结果是,流量快速下降,泵在高压下驱动空气的能力受到限制。因此,当使用固定频率摆动泵时,为了提供高压下较高的流量,不是牺牲低压下的流量,就是使泵具有更大的尺寸。
出于上述原因,需要有一种真空帮助伤口愈合治疗系统,该系统能够随时间自动进行压力变化。此外,需要有更加有效的真空帮助伤口愈合的治疗系统,可使患者有更大的活动能力,同时减少流出物溢出或造成泵污染的危险。
发明内容
因此,本发明的目的是提供一种真空帮助伤口愈合治疗系统,该系统设置了提供随时间变化压力来提高组织生长刺激的装置。
本发明的另一目的是提出一种系统,能够在缺少交流电源的情况下长时间操作。
本发明的另外的目的是提供一种滤筒,以及无须卸下滤筒或干扰伤口就可对从伤口处抽出流体取样的具有成本效率的装置。
本发明还有一个目的是,提供一种真空帮助伤口愈合的治疗装置,其可固定到物体上,以减少干扰装置的可能,同时具有操作方便的设置。
根据上述目的,本发明总体上包括一种基本上可插入伤口处的多孔垫,和可气密密封伤口处的多孔垫的裹伤巾。导管的远端连接到所述裹伤巾以便向伤口处提供负压。流体取样端口设置在导管上,可对从伤口处通过导管抽出的伤口流出物取样。负压源与导管的近端连通。收集滤筒可取下地连接到导管,以便当施加负压时收集从伤口抽出的流出物。第一过滤器设置到滤筒的开口中,第二过滤器位于滤筒和负压源之间。由于负压源可以是通过交流或直流电供电的电泵,电源管理装置配合与其相关的电源管理程序,当单元由直流供电时可使电池寿命最大化。夹固机构用来将系统固定到静止的物体上,如床头栏杆或用来悬挂静脉点滴容器的支杆。
多孔垫包括泡沫体,在需要与促进细胞生长区接触的部分开孔很少以避免不必要的粘连,但多孔垫具有足够多的开口以便排放和负压治疗不被削弱地连续进行。多孔垫设置成与真空源流体连通以促进流体排出,如从现有技术已知道的。本发明的多孔垫可以是聚乙烯醇泡沫。如名为“创伤治疗所用手术巾和抽吸压头”的国际专利申请WO 99/13973所公开的,流体连通可通过导管连接到裹伤巾来建立,其中的内容在本文参考引用。
当放好多孔垫后,在伤口处形成气密密封以防止真空丧失。这样的密封可通过在伤口上设置裹伤巾来形成,使裹伤巾黏附到围绕伤处的健康皮肤上,同时保持伤口气体密封。
导管或管路设置成与泡沫垫流体连通,其远端与流体排放滤筒相连通,滤筒与真空源流体连通。恒定或间断的负压疗法如现有技术所介绍的那样进行。或者,负压随时间变化可进一步刺激细胞生长,这样可缩短治愈过程。对引入伤口的负压进行调节,以满足不同的目标压力,目标压力在最大目标压力和最小目标压力之间波动。
本发明所使用的变量泵的流量通过变化泵驱动频率可在一定压力范围内最大化。最佳的驱动频率可通过本系统连续调节,可对泵的压力周期性或连续地监控,以确定该压力下的最佳驱动频率。因此可提高现有技术的变量泵的性能,且不会增加泵的尺寸或重量。类似地,典型的变量泵的性能可通过较小的泵实现,这样就减小了整个系统的尺寸和重量,提高了患者使用的方便性和便携性。另一种负压源,如有时称作正排量泵的固定排量泵,也可以使用。
设置了电源管理系统,以便当本发明采用直流电源时,能够使电池寿命最大化。电源管理装置包括在预定时间间隔后去激活显示器或接触屏液晶显示控制屏的背光。当电源管理系统停止向电马达供电,直至目标能量设定值实际已足够大来驱动马达,可使电池寿命进一步延长。在这种情况下,马达用来驱动电泵以提供负压,如从现有技术已知道的。
根据本发明的另一方面,提供了一种刺激组织愈合的系统,包括:多孔垫;气密的裹伤巾;连接排放管远端到裹伤巾的机构;可取下地连接到排放管近端的滤筒;可向伤口处提供负压的独立泵送装置;以及管理独立泵送装置的电源的装置。
根据本发明的又一方面,提供了一种刺激组织愈合的系统,包括:多孔垫;气密的裹伤巾;可向伤口处提供负压的电泵;可取下地连接到提供负压装置的滤筒;可容纳滤筒和提供负压装置的壳体;固定壳体到静止物体的机构;以及管理电泵的电源的装置。
根据本发明的再一方面,提供了一种刺激组织愈合的系统,包括:多孔垫;气密的裹伤巾;可向伤口处提供负压的装置;管理提供负压装置的电源的装置;以及在一定时间间隔变化所述负压的装置。
根据本发明的另外一个方面,提供了一种刺激组织愈合的系统,包括:多孔垫;气密的裹伤巾;可向伤口处提供负压的摆动泵;在一定压力范围使泵送流量最大化的装置;以及管理摆动泵的电源的装置。
前面已经介绍了本发明一些相关的目的,这些目的只是用来说明本发明的重要特征和本发明的应用。许多其他具有优越性的结果可通过以不同方式应用本发明或通过改进本发明来实现,如下面所作介绍。因此,对本发明的完全了解和其他目的可通过参考下面对本发明的详细介绍来实现,其中包括优选实施例。
附图说明
下面,通过参考一些优选实施例的附图,对本发明的这些或其他的特征和优点进行介绍,通过这些介绍来说明本发明,而不是去限制本发明,图中相同的数字代表相似部件,附图中:
图1是根据本发明的组织治疗系统的示意性方块图;
图2a是根据本发明的流体取样端口的透视图;
图2b是根据本发明的流体取样端口的另一实施例的透视图;
图3a是根据本发明的泵壳体的后部的透视图;
图3b是根据本发明的泵壳体的前部的透视图;
图4a和4b是根据本发明的电源管理系统进行的优选步骤的流程图;
图5是显示实施根据本发明的脉冲治疗的优选步骤的流程图。
具体实施方式
尽管所属领域的普通技术人员可容易地看出存在许多不同的实施例,特别是理解了本文所提供的说明后,这些详细的介绍只是对本发明优选实施例的说明,本发明的范围只由所附权利要求限定。
本发明是一种真空帮助愈合的治疗系统,可用于刺激组织愈合。
现在具体参考图1,图中显示了系统的主要部件,其可根据本发明进行操作。本发明10包括基本上可插入伤口处12的泡沫垫11,和裹伤巾13,其可密封伤口处12的泡沫垫11。泡沫垫11可以是聚乙烯醇(PVA)开口聚合物材料,或其他具有能够帮助伤口愈合孔径的类似材料。孔密度优选为每直线长1英寸有多于38个孔。孔密度在40到50之间更好。最好是每直线长1英寸有45个孔。这样的孔密度换算成孔的尺寸为大约400微米。
添加显示剂,如结晶紫、亚甲蓝、或现有技术已知的类似试剂,当存在细菌作用时可造成泡沫垫11颜色改变。这样,使用者或健康保健人员可容易和方便地确定伤口处12是否存在感染。可以理解,显示剂还可沿导管线16布置在伤口处12和滤筒18之间。通过这样布置(未显示),可容易和方便地确定伤口处12存在细菌污染,而无须扰动伤口,因为当应用负压时伤口的细菌感染流出物从伤口处12通过导管16抽出时几乎马上出现颜色变化。
可以想到泡沫垫11还可涂复细菌抑制剂。添加这种抑制剂可限制和减少伤口处12的细菌密度。这种抑制剂可在插入伤口之前涂复或粘结到泡沫垫11,比如在消毒包装过程中。或者,抑制剂可在插入伤口处12之后注射到泡沫垫11中。
在插入伤口处12和与裹伤巾13密封之后,泡沫垫11设置成与真空源14流体连通,以促进流体排出和伤口愈合,如所属领域的普通技术人员所知道的。真空源14可以是便携式电泵,或如普通的健康护理设备中的壁式抽吸机。
根据本发明的优选实施例,泡沫垫11,裹伤巾13和真空源14按所属领域已知的方式提供,除了下面将详细介绍的改进部分。
泡沫垫11最好包括高度网状的和带有开口的聚亚安酯或聚醚泡沫,以通过抽吸更有效地渗透伤口流体。垫11最好设置成通过塑料或类似材料的导管16与滤筒18和真空源14流体连通。第一疏水性的膜式过滤器20插入滤筒18和真空源14之间,以防止伤口流出物污染真空源14。第一过滤器20还可以用作滤筒18的充满传感器。当流体接触第一过滤器20,产生的信号将发送到真空源14,使真空源关闭。裹伤巾13最好包括弹性材料,至少周边覆盖有压敏粘结剂,以便可密封地覆盖到伤口处12。在伤口处12保持真空密封。导管16设置成可通过粘结到裹伤巾13的附件17与泡沫11流体连通。
根据本发明的优选实施例,第二疏水性的过滤器22设置在第一过滤器20和真空源14之间。当第一过滤器20也用作滤筒18的充满传感器时,设置第二过滤器22是有优点的。这种情况下,第一过滤器20可用作充满传感器,而第二过滤器22可阻止伤口流出物污染真空源14。这样将根据功能分成安全装置和控制(或限制)装置,可使各装置独立工作。气味过滤器23可以是活性炭过滤器,设置在第一过滤器20和第二过滤器22之间,以消除伤口流出物带来的恶臭气体。在另一未显示的实施例中,气味过滤器23设置在第二疏水性的过滤器23和真空源14之间。第二气味过滤器15可设置在真空源14和外排出口25之间,以便进一步减少恶臭气体从本系统逸出。在另一实施例中,允许第一和第二过滤器20,22与滤筒18设置成一体,以保证过滤器20,22自动设置,减少系统暴露于过滤器20和22捕捉的污染物,因其中至少一个过滤器可能在正常使用时受污染。
通过在导管16设置可重复密封的进入口24,对流体取样的装置可进行操作。进入口24位于导管16远端16a和导管16近端16b之间。图2a和图2b详细介绍的进入口24可用于对从伤口处12吸出的流体取样。尽管显示出进入口24是从导管16突出的附件,应当了解,埋入式固定端口(未显示)可用于相同目的。进入口24包括可重复密封的膜片26,在用皮下注射针头刺穿后仍可保持密封。现有技术中已知的各种可在刺穿后保持密封的橡胶类材料也可使用。
本发明的从伤口流体取样的过程包括用流体取样器28,比如皮下注射针头或注射器,刺穿膜片26。取样器28穿过膜片26进入端口24,直至接触在导管16内腔30中流动的伤口流出物。1998年5月13日授予Hunt等人的美国专利6,142,982公开了一种实施例,其内容在本文中参考引用,如图2B所示,内腔30可由一个或多个外腔31围绕。外腔31可用作压力检测通道以感应伤口处12的压力变化。在另一未显示的实施例中,一个或多个外腔31可用作负压通道,而内腔30可用作压力检测通道。在本发明中,流体取样端口24只与内腔30连通,所以不会干涉在外腔31进行的压力检测。在另外的实施例(未显示)中,外腔31用作负压通道,而流体取样端口24与外腔31连通。
真空源14可包括位于壳体32中的便携泵,如图3a和3b所示。把手33可形成或连接于壳体32,令使用者容易把握和移动壳体32。
根据本发明的优选实施例,可将壳体32固定到静止物体,如静脉点滴支杆,的机构设置成夹具34的形式。可以是现有技术中已有的G形夹具的夹具34是可收回的,所以当不使用时可放回壳体32中凹进部分36的存放位置。通过铰链机构38可使夹具34从壳体32向外伸出,与存放位置形成90度角。在一未显示的实施例中,允许夹具34位于与存放位置形成180度的位置。铰链机构38可在夹具34完全延伸后锁定到适当位置,使壳体32通过夹具30进行悬挂。固定机构40,如螺栓,穿过夹具34上的孔42,使夹具34可调节地固定到各种静止的不同厚度的物体上。
或者,固定机构40包括弹簧促动的螺栓或销,可自动调节长度以适应各种具有不同截面厚度的物体,比如静脉点滴支杆。
本发明还允许对真空源14的电源进行管理,以便当本发明使用直流电源时可尽量延长电池寿命。在优选实施例中,如图4a的流程图所示,马达控制器44在步骤46确定实际压力是否小于或等于目标压力。如果实际压力小于目标压力,在步骤48对到达目标压力所需的尝试性马达驱动功率进行计算。在步骤49如果尝试性的马达驱动功率大于或等于制动功率,就在步骤50将尝试性的马达驱动功率实际施加到马达。如果实际压力大于目标压力,在步骤52将尝试性的马达驱动功率减小,并确定是否需要额外功率来克服制动功率。如果确定尝试性的功率不足以克服制动功率,在步骤54该尝试性的功率就不施加到马达。如果尝试性的功率足以克服制动功率,就在步骤50将尝试性的功率实际施加到马达。马达控制器44的功能如同闭环系统,可连续地测量实际压力并与预定的目标压力比较。该系统的优点是,当没有必要保持V.A.C.疗法规定的目标压力时,可防止向马达施加功率。由于不施加功率时不会无谓地向马达提供能量,因此电池寿命得到延长。
电池寿命可进一步延长,如图4b的流程图所示,通过在计算机处理器中设置一体的软件程序的方式,可自动停止本发明的系统10的可见显示器19的背光(见图3b)。在步骤55使用者输入信息,比如所需的目标压力或治疗持续时间,在步骤57激活图3b所示的可见显示器19的背光。在步骤55进行输入的使用者可以简单地触动可见显示器19,这种显示器可通过触动来激活,或是压力敏感屏幕,如现有技术已知道的。在步骤55促动警报也可能在步骤57激活显示器19的背光。如果发现在伤口处12有空气泄漏,警报可以自动促动。这样的泄漏可通过在伤口处12检测到压力下降或减少来显示。将保持激活背光,直到在步骤58确定事先设置的时间间隔是否结束。如果时间间隔未结束,将保持步骤57激活的背光。如果时间间隔已结束,背光将在步骤59自动消失,直到使用者输入另外的时间信息,或步骤55响起警报。
现在回头参考图1,当本发明使用的泵14是摆动泵时,通过变频泵驱动系统80可进一步延长电池的寿命。泵驱动系统80包括压力传感器82,控制系统84和变频驱动电路86。在优选实施例中,压力传感器82可探测泵的压力,压力传递到系统84。控制系统84决定泵14的最佳驱动频率,泵14产生压力传感器82测定和传送的压力。泵14的最佳驱动频率可通过控制系统重复地或连续地进行测定。控制系统84调节变频驱动电路86以便通过控制系统84确定的最佳频率来驱动泵。
使用变频泵驱动系统80还可使泵14的压力最大化。在对样品摆动泵进行的测试中,只改变30%的驱动频率可得到双倍的最大压力。此外,系统80可在更大的频率范围使流量最大化。结果是,泵的性能得到极大的改进,超过现有的固定频率驱动系统泵,且无须增加泵的尺寸或重量。接下来,电池寿命得到进一步延长,令使用者具有更大的活动能力,且不必限于不动的电源。或者,通过较小的泵就可以达到与现有技术的固定频率驱动系统泵类似的水平。结果是,通过提高单元的便携性,病人的活动能力得到提高。
该优选实施例还通过随时间变化的压力提高了对细胞生长的刺激,如图5的流程图所示。这种压力变化是通过与控制真空源或泵功能的计算机处理单元结合的软件程序进行的一系列计算实现的。当使用者,或如健康护理人员,在步骤60促动泵的脉冲模式,启动该程序。然后在步骤62使用者设定目标压力最大峰值和目标压力最小峰值。在步骤63软件设定压力方向进行“加压”。软件然后进入软件控制环路。在控制环路中,软件在步骤64首先确定是否压力正在增加。
如果在测试步骤64实际压力在增加,就要在步骤70确定是否变化的目标压力仍小于最大目标压力。如果变化的目标压力仍小于最大目标压力,软件接下来在步骤66确定是否实际压力已经等于(上升到)上升的目标压力。如果实际压力已经达到上升的目标压力,软件在步骤68对变化的目标压力增加一个间隔。或者克制不动作直到实际压力已经等于上升的目标压力。如果在测试步骤70变化的目标压力已经达到最大目标压力,软件在步骤69设定压力方向为“降压”,变化的目标压力开始向摆动循环的下部移动。
间隔可以用mmHg来测量或用其他的压力测量单位来表示。根据使用者的选择,间隔的幅度最好是在大约1到10mmHg的范围。
如果实际压力在测试步骤64是下降的,就要在步骤74确定是否变化的目标压力仍大于最小目标压力。如果变化的目标压力仍大于最小目标压力,软件在步骤76确定是否实际压力已经达到(下降到)下降目标压力。如果实际压力已经等于下降目标压力,软件在步骤72对变化的目标压力增加一个间隔。或者克制不动作直到实际压力已等于下降目标压力。如果在测试步骤74变化的目标压力已经达到最小目标压力,软件在步骤73将设定压力方向为“升压”,然后变化的目标压力开始向摆动循环的上部移动。这个摆动过程继续进行直到使用者不选择脉冲模式。
尽管已经通过参考一些优选的实施例对本发明进行了介绍,这些实施例只是以示例的方式提出,并非用来对本发明的范围加以限定。因此,本发明的范围只由所附权利要求来限定。
Claims (15)
1.一种刺激组织愈合的系统,包括:
多孔垫;
气密的裹伤巾;
导管;
连接导管远端到所述裹伤巾的机构;
能够取下地连接到导管近端的滤筒;
用于向伤口部位施加负压的电泵;
位于所述滤筒和所述电泵之间的第一疏水性过滤器;
位于所述第一疏水性过滤器和所述电泵之间的第二疏水性过滤器;和
位于所述第一疏水性过滤器和所述第二疏水性过滤器之间或者位于所述第二疏水性过滤器和所述电泵之间的气味过滤器。
2.根据权利要求1所述的系统,其特征在于,所述第一、第二疏水性过滤器和所述气味过滤器构成为所述滤筒的一体式部分。
3.根据权利要求1所述的系统,其特征在于,所述系统还包括对伤口流出物取样的进入口,所述进入口连接在所述导管上,并具有在被刺穿之后能够保持密封的能够重复密封式膜片。
4.根据权利要求1所述的系统,其特征在于,所述系统还包括用于将所述系统固定在支杆上的夹具。
5.根据权利要求1所述的系统,其特征在于,所述系统还包括用于容纳所述电泵的便携式壳体,所述系统具有用于将所述系统固定在支杆上的夹具。
6.根据权利要求1所述的系统,其特征在于,所述多孔垫由一种开孔聚合物组成。
7.根据权利要求1所述的系统,其特征在于,所述系统还包括向所述电泵供电的电源和用于管理该电源的电源管理装置,所述电源管理装置包括在预定的间隔之后停用显示器背光的机构。
8.根据权利要求1所述的系统,其特征在于,所述系统还包括马达控制器,该马达控制器能够确定用于达到目标压力的尝试性马达驱动功率,并在所述尝试性马达驱动功率不足以启动电动马达时防止向所述马达施加电功率。
9.根据权利要求1所述的系统,其特征在于,所述导管包括构成排放管和压力检测管的纵向支管。
10.根据权利要求9所述的系统,其特征在于,多个所述检测管围绕所述排放管设置。
11.根据权利要求9所述的系统,其特征在于,所述系统还包括对流出物取样的能够重复密封式进入口,所述进入口构成了所述排放管的附件。
12.根据权利要求1所述的系统,其特征在于,所述电泵是变频泵。
13.根据权利要求12所述的系统,其特征在于,所述系统还包括泵驱动系统,该泵驱动系统包括控制系统,该控制系统能够确定用于驱动所述变频泵以便使泵流量最大化的最佳驱动频率。
14.根据权利要求12所述的系统,其特征在于,所述系统还包括泵驱动系统,该泵驱动系统包括用于测量所述泵的压力的压力传感器。
15.根据权利要求13所述的系统,其特征在于,所述泵驱动系统还包括以所述最佳驱动频率驱动所述泵的变频驱动电路。
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