CN107072820A - 泡沫叠层敷料 - Google Patents
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Abstract
一种泡沫叠层敷料包括第一不同的疏水网状泡沫层,以及下置的第二不同的亲水层,其粘结于第一层并且具有与第一不同的疏水网状泡沫层大致相同的长度和宽度。
Description
技术领域
本发明涉及伤口敷料。更具体而言,本发明针对连同负压伤口治疗装置使用的伤口敷料。
背景技术
在伤口敷料的领域中,存在用于各种应用的许多不同类型的材料。在负压伤口敷料的情况下,典型地使用泡沫材料,伤口分泌液和/或清洁流体可穿过该泡沫材料。
亲水聚氨酯是亲水的,并且与受控输送装置,如伤口护理敷料中的水相容。亲水聚氨酯常规地由关于亲水聚氨酯预聚物的水相的乳化和固化来制成。水相可包含活性成分,在该情况下,成分分散在所得的泡沫的基体中。
泡沫的变型称为网状泡沫。这些泡沫构造成使得相对大的开口存在于构成泡沫结构的独立单元中,并且提供穿过其的空气或水的流。由于它们的典型的低密度和对应的每单位体积的低成本,故其通常用作过滤介质。这些泡沫是疏水的,即,它们不吸收水。
亲水聚氨酯可调配有活性成分,这不是关于常规网状聚氨酯的情况。亲水聚氨酯与水相容并且吸收水,而常规聚氨酯是疏水的并且与水不相容。亲水聚氨酯在其吸收性能力方面是有用的,其典型地具有较差的物理强度和相对高的密度,引起相对高的每单位体积成本。
本领域中的一种现有使用针对通过以聚氨酯预聚物乳液涂覆开室网状泡沫的内表面并且允许复合物固化来形成敷料。结果在于将开室聚氨酯泡沫用作亲水聚氨酯泡沫铸造在其上的支架或基底的泡沫复合物。现有技术提供了复合物,该复合物包括疏水支架泡沫,如开室或开室网状聚氨酯泡沫,其涂覆有开室亲水聚氨酯泡沫。这通过以聚氨酯预聚物乳液涂覆开室泡沫的内表面并且允许复合物固化来实现。结果在于将开室聚氨酯泡沫用作亲水聚氨酯泡沫铸造在其上的支架或基底的泡沫复合物。
尽管这些类型的敷料在某些应用中为有用的,但仍需要伤口敷料的领域中的改进。
发明内容
本发明的目的在于提供改进的泡沫叠层。
另一个目的在于通过向叠层提供不同的疏水泡沫层和不同的亲水泡沫层来改进伤口敷料。
本发明的另一个目的在于提供可用作与负压装置相关联的流体流穿过其的敷料的泡沫叠层。
因此,本发明针对一种泡沫叠层,其包括第一不同的疏水网状泡沫层和粘结于第一层的第二不同的亲水层。层可由热、粘合剂,或在形成过程期间粘结,其中两个层紧接地彼此设置,使得面对表面的部分在固化时机械地联锁。聚氨酯可用于形成疏水和亲水泡沫层两者。在优选实施例中,泡沫叠层螺旋切割有穿孔,以使得叠层能够容易撕开来适应特别伤口尺寸。
通过组合这两个类型的泡沫层,所得的叠层提供了优于现有技术的装置的优异优点,其提供伤口处理中的亲水层的优异吸收性特征,同时网状疏水层设置成邻近气密性密封层,该气密性密封层包绕敷料并且绕着伤口密封至皮肤。密封层典型地包括连接于负压装置的端口。网状疏水层实现真空在敷料之上的均匀分布,这促进优良的伤口愈合。
当连同以下描述、所附权利要求和附图阅读时,本发明的这些和其它的特征、方面和优点将对本领域技术人员而言为容易显而易见的。
附图说明
图1为本发明的泡沫叠层敷料的示意图。
图2为图1的泡沫叠层敷料的透视图。
图3绘出了作为负压伤口治疗系统的部分的图1中的泡沫叠层敷料的截面视图。
图4为本发明的一个实施例的示意图。
具体实施方式
在本发明的优选实施例的以下描述中,参照附图,该附图形成本发明的一部分,并且经由图示示出了其中可实践本发明的特定实施例。将理解的是,可使用其它实施例,并且结构变化可作出,而不脱离本发明的范围。
本发明的泡沫叠层敷料大体上由标记100表示,经由泵系统的使用促进伤口愈合。也称为真空引流或封闭吸力引流的负压伤口疗法(NPWT)可用作本发明的部分。
泡沫叠层100包括第一不同的疏水网状泡沫层102和粘结于第一层102的第二不同的亲水层104。层102和104可由热、粘合剂或在成型过程期间粘结,其中两层102和104紧接地彼此设置,使得面对表面106和108的部分在固化时分别机械地联锁。聚氨酯可用于形成疏水泡沫层102和亲水泡沫层104两者。在优选实施例中,泡沫叠层100可螺旋切割有穿孔110,以使得叠层能够容易撕开来适应特定的伤口尺寸。
通过组合这两个类型的泡沫层,所得的叠层100提供优于现有技术的装置的优异的优点,其提供伤口处理中的亲水层104的优异吸收性特征,同时网状疏水层设置成邻近气密性密封层52,其包绕泡沫叠层敷料100并且绕着伤口W密封至皮肤。密封层典型地包括连接于负压装置10的端口54。网状疏水层102实现真空在敷料100之上的均匀分布,这促进优良的伤口愈合。
在本发明的优选应用中,本发明的治疗装置大体上由标记10表示。治疗装置10可优选地包括壳体12,其可优选以防水方式形成来保护其中的构件。在该方面,壳体12可具有不透水的密封接近面板13,可经由不透水的密封接近面板13来接近构件。
装置10可包括处理器14,其可为微控制器,具有嵌入式微处理器、随机存取存储器(RAM)和闪速存储器(FM)。FM可优选地包含用于控制算法的编程指令。FM可优选地为非易失性的,并且在电力终止时保持其编程。RAM可由控制算法使用来用于储存变量,如,压力测量结果、报警数等,控制算法使用该变量,同时生成和保持真空。
膜键盘和发光二极管LED或液晶显示器(LCD)16可通过通信链路如线缆与处理器14电气地相关联。键盘开关提供功率控制,并且用于预设期望的压力/真空水平。发光二极管17,19可提供成指示与罐流体水平、敷料和罐中的压力泄漏,以及电源中剩余的电力相关联的报警状态。
微控制器14通过电连接与第一真空泵18和可选的第二真空泵20电气相关联并且控制它们的操作。第一真空泵18和可选的第二真空泵20可为许多类型中的一个,其包括例如在商标Parker Precision Fluidics®和Thomas®下出售的泵。真空泵18和20可使用例如往复式隔膜或活塞来产生真空,并且可典型地由直流(DC)马达供能,该直流(DC)马达还可可选地使用无刷换向器来用于提高可靠性和寿命。真空泵18和20可通过单内腔管24与一次性分泌液收集罐22气动地相关联。
在一个实施例中,罐22具有不超过1000ml的容积。这可在还未在伤口部位处实现止血的情况下防止患者的意外放血。罐22可具有定制设计,或者为现成的并且在商标DeRoyal®下出售。
参照图3,可为回流阀或过滤器的流体隔层26与罐22相关联,并且构造成防止收集在罐22中的流体逸出到管路24中和污染真空返回路径。隔层26可具有机械浮动设计,或者可具有一个或更多个疏水材料膜,如在商标GoreTex™下可得到的那些。隔层26还可由疏水多孔聚合物制成,如在商标MicroPore™下可得到的疏水多孔聚合物。使用疏水膜或阀的副隔层28与气动管路24连线插入,以在隔层26不能按预期操作的情况下防止流体进入到系统中。气动管路24可通过"T形"连接器连接于第一真空泵18和可选的第二真空泵20。
识别部件30如射频识别(RFID)标签可与罐22和与微处理器14可操作地相关联的RFID传感器32物理地相关联,使得微控制器14可将装置10的使用约束至预定罐22。因此,如果罐22不具有预定RFID芯片,则装置10将不操作。另一个实施例预想出了驻留在微控制器14上的软件,其将装置10的使用约束至预定时间段,如例如90天。以该方式,使用装置10的患者可使用装置10达规定时间段,并且接着装置10按照用于该患者的特别治疗计划自动地暂停。这还实现了下次敷料更换或医生预约的时间和日期的提醒。还设想出了微控制器14可操作地设有远程控制器15和通信链路,如收发器,其中装置10可在用于该患者的特定治疗计划结束时远程地关闭。同样地,远程控制器15可用于在治疗装置暂停之后提供附加时间。
真空压力传感器34与第一真空泵18和可选的真空泵20气动地相关联,并且与微控制器14电气地相关联。压力传感器34向微处理器提供真空压力信号,使得控制算法能够监测真空泵18和20的出口处的真空压力。
消声器可提供,并且与真空泵18和20的排放端口气动地相关联,并且构造成减小在操作期间由泵产生的排放噪音。在装置10的正常操作中,第一真空泵18可用于生成初始或"引发"真空,同时可选的第二真空泵20可用于保持系统内的期望真空,补偿任何泄漏或压力波动。真空泵20可比真空泵18更小且更安静,提供了用以保持期望压力而不干扰患者的手段。开关37可操作性地设置在壳体12上,与微控制器14可操作连接,以实现选择来自泵18/20的正压和负压。
一个或更多个电池38可优选地提供成容许装置10的便携操作。电池38可为锂离子(Lilon)、镍氢(NiMH)、镍镉(NiCd)或它们的等同物,并且可通过电连接与微控制器14电气相关联。电池38可为可再充类型,其优选地可除去地设置成与壳体12连接,并且可在需要时以副电池38替换。再充电器40提供成保持一个电池38一直充电。此外,设想出装置10可装备成由再充电器40或由与微控制器14相关的电路供能或充电(如果此类电源可用)。当外部电源不可用并且装置10将在便携模式中操作时,电池38将电力供应至装置10。电池38可为可再充电或可再处理的,并且可优选地以防水方式可除去地储存在壳体12内,壳体12还同样地容纳泵18,20和微控制器14。
第二压力传感器42通过传感器端口43与罐22气动地相关联。压力传感器42可与微控制器14电气地相关联,并且提供真空压力信号至微处理器,使得控制算法能够监测罐22和敷料11内的真空压力。"T形"连接器可连接于端口43、压力传感器42和真空卸压螺线管46,真空卸压螺线管46构造成在警报状态的情况下或如果关闭电源就减小罐22和敷料11中的压力。螺线管46可为例如在商标Parker Hannifin®或Pneutronics®下可得到的一种;螺线管46与微控制器14的微处理器电气地相关联并且由其控制。螺线管46可构造成在与其相关联的电线圈解除激励时将真空压力排至大气,如将是如果关闭电源的情况。孔口限制器48可可选地连线设有螺线管46和气动管44,以调节在螺线管46解除激励时真空减小至大气压力的速率。例如,孔口限制器48在商标AirLogic®下可得到。
伤口敷料11可优选地包括无菌泡沫叠层敷料100,半可透过透明粘合盖52,其可为聚氨酯材料的塑料片,如在商标DeRoyal®或Avery Denison ®下出售的。
半可透过粘合盖52可接着形成为包括入口端口56和吸入端口54。基底100构造成将真空压力均匀分布在整个伤面上,并且具有适合于促进颗粒组织的形成和接近伤口边缘的机械性质。
此外,当真空施加于敷料11时,基底100产生伤口的细胞水平下的微应力和宏应力,刺激各种生长因子和其它细胞活素的产生,并且促进细胞增殖。敷料11通过单内腔管44与罐22流体地相关联。由敷料11的基底100形成的腔中的真空压力与罐22内的真空压力减去管路44内的任何停滞流体的重量大体相同。
可为标准IV袋的流体器皿60容纳药用流体,如水性局部抗生素、止痛剂、生理漂白剂,或等渗盐水。流体器皿60通过端口56和单内腔管62可除去地连接于敷料11。
可选的流动控制装置64可与管路62连线放置,以容许流体流从器皿60到敷料11的准确调节。在正常操作中,在处理流体从器皿60移动穿过敷料11且到收集罐22中时,提供了连续伤口部位冲洗。该连续冲洗保持伤口清洁并且有助于控制感染。此外,伤口部位处产生且由基底52收集的流出物将在系统在真空下时除去至罐22。
装置10特别良好适合于提供治疗伤口冲洗和真空引流,并且提供了整装的塑料壳体,其构造成围绕腰穿上,或者携带在走动的患者的肩之上的口袋中,并且从未走动的患者的床的脚板或头板悬挂。膜键盘和显示器16提供成实现调整治疗参数和使单元开启和关闭。
按下膜开关16上的电力按钮将使装置10通电/断电。尽管设想出膜开关16装备有键来调整治疗压力升高和降低,但微控制器14可优选地装备成根据感测压力和状态控制压力,以将压力保持在-70mmHg到-150mmHg之间的可操作范围中,其中例如,工作范围在0到-500mmHg之间。尽管这些压力设置经由实例提供,但它们不旨在为限制性的,因为其它压力可用于伤口类型特定应用。膜16还可装备有指示泄漏报警的LED17和/或指示满罐报警的LED19。当检测到任一报警状态时,这些LED将连同也包括在装置10中的可听鸣响发光。
壳体12可并入隔间,该隔间以如下方式构造成以便接收和储存标准IV袋60,或者可在外部联接于其。IV袋60可容纳水性局部伤口处理流体,其由装置60使用来提供连续冲洗。带夹可提供用于附接于患者的带,并且可选的腰带或肩带提供给并未或不可穿上带的患者。
罐22提供用于分泌液收集,并且如本领域中目前已知的,可优选地构造有真空密封器件和相关联的流体隔层26、真空传感器端口43和相关联的保护性疏水过滤器、接触透亮的半透明本体、保证透亮的测量窗口、锁定器件和管路连接器件。收集罐22典型地具有小于1000ml的容积,以防止患者的意外放血(如果伤口中未实现止血)。流体隔层26可为例如在商标MicroPore®或GoreTex®下出售的那些,并且确保罐22的内容物不无意进入到壳体12的泵18,20中,并且随后引起其污染。
压力传感器42使得微控制器14能够测量罐22内的压力作为用于敷料11之下的治疗真空压力的代用物。
可选地,管路62可为多内腔管路,提供用于冲洗流体行进至敷料11的一个导管和用于真空引流的另一个导管。因此,IV袋60、管路62、敷料11和罐22提供封闭的流体通路。在该实施例中,罐22将为单次使用可弃置的,并且可填充有固化剂23,以使得内容物能够在弃置之前固化。固化剂为例如在商标DeRoyal®和Isolyzer®下可得到的。固化剂特别在患者移动时防止流体围绕罐内晃动,如如果患者以机动车辆行进则将是此情况。此外,固化剂为关于抗菌剂可用的,该抗菌剂可破坏病原体并且有助于防止细菌烟雾化。
在可选的多内腔管路62的末端处,可提供自粘合的敷料连接器57,用于将管路62附接于半可透过的透明粘合盖52来提供大致不透空气的密封。敷料连接器57可具有环形压敏粘合环,其具有在应用之前除去的释放衬里。端口56可形成为半可透过的透明粘合盖52中切割的孔,并且敷料连接器57将定位成与所述孔对准。这使得冲洗流体能够通过单个端口进入和离开敷料。在备选实施例中,管62可在终点处分叉,并且连接于两个敷料连接器57,这允许冲洗端口与真空引流端口物理地分离,因此强迫冲洗流体流动穿过敷料的整个长度(如果期望)。类似地,端口54和连接器55可提供成将可选的多内腔管路44连接于敷料11。在该布置中,第二内腔可用于直接地测量敷料11中的压力。
流体器皿60可具有如下类型,其包括位于器皿60的上面上的自密封针端口,以及位于器皿的下面上的调节的下滴端口。针端口容许引入皮下注射针用于输注水性局部伤口处理流体。这些水性局部流体可包括局部麻醉剂如利多卡因、抗生素如杆菌肽或硫酰胺-醋酸盐;生理漂白剂如Chlorpactin或Dakins溶液;以及防腐剂如Lavasept或Octenisept。调节的下滴端口容许器皿60内的流体缓慢且连续地流出到多孔基底100中,因此治疗益处可给予至伤口部位。单内腔引流管44提供足够的真空来将敷料11保持在低于大气压力下并且除去流体,该流体包括冲洗流和伤口分泌液。利用该改型,对外部流体器皿和相关联的管路和连接器的需要可消除,使敷料对于患者和临床医生,相似物而言更加用户友好。
在该备选实施例的典型临床使用中,敷料11由第一切割多孔基底100施加于伤口部位来配合伤口的边缘。接下来,半可透过的透明粘合盖52附接并且密封在敷料和伤口周边之上。近似3/8''直径的孔可在多孔基底100中心的半可透过的透明粘合盖52中产生。流体器皿60由粘合性环形环57附接,其中端口56与半可透过的透明粘合盖52中先前切割的孔对准。一旦流体器皿60气密性地密封于半可透过的透明粘合盖52,则适当制备的皮下注射针插入在自密封针端口中,并且流体器皿60随后填充有期望的水性局部伤口处理溶液。
对于大多数应用而言,示出了用于提供治疗伤口冲洗和真空引流的技术。单内腔引流管44提供用于施加真空和从伤口部位除去流体。流体器皿60可位于半可透过的基底100的外侧和上方。环形粘合环57设在端口56上,用于将单内腔冲洗管路62附接于半可透过的透明粘合盖52。类似地,针端口容许引入皮下注射针,用于输注如上文所述的水性局部伤口处理流体,例如,护理者可想要将局部抗生素添加至等渗盐水袋。可调整的可选流动控制装置64容许器皿60内的流体通过半可透过的透明粘合盖52中的孔56缓慢且连续地流出到多孔基底52中,因此治疗益处可给予至伤口部位。单内腔引流管44提供足够的真空来将敷料11保持在低于大气压力下并且除去流体,该流体包括冲洗流体和伤口分泌液。
由于用于敷料11的构造中的各种材料之间的潜在化学相互作用,故必须注意用于确保相容性的水性局部伤口流体的类型。
以上描述的实施例经由实例阐述并且不是限制性的。将容易显而易见的是,可对实施例作出明显的改型、偏离和变型。例如,描述为具有隔膜或活塞类型的真空泵还可为基于注射器的系统、波纹管或甚至振荡线性泵中的一种。因此,附于其的权利要求应当按包括任何此类改型、偏离和变型的它们的整个范围阅读。
Claims (5)
1.一种泡沫叠层敷料,其包括:
第一不同的疏水网状泡沫层;以及下置的第二不同的亲水层,其粘结于所述第一不同的疏水网状泡沫层,并且具有与所述第一不同的疏水网状泡沫层大致相同的长度和宽度。
2.根据权利要求1所述的泡沫叠层敷料,其特征在于,所述泡沫叠层敷料包括气密性密封层,其连接于并且覆盖所述第一不同的疏水网状泡沫层,并且具有大于所述第一不同的疏水网状泡沫层的尺寸,以包绕所述第一不同的疏水网状泡沫层和所述下置的第二不同的亲水层,所述泡沫容许绕着其密封至绕着伤口的皮肤。
3.根据权利要求1所述的泡沫叠层敷料,其特征在于,所述泡沫叠层敷料包括可操作地连接于所述气密性密封层上的端口的负压装置。
4.根据权利要求1所述的泡沫叠层敷料,其特征在于,所述层由热、粘合剂和机械联锁中的一种粘结。
5.根据权利要求1所述的泡沫叠层敷料,其特征在于,所述泡沫叠层敷料螺旋切割有穿孔,以使得所述泡沫叠层敷料能够容易撕开来适应特别伤口尺寸。
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PE20170995A1 (es) | 2017-07-14 |
MX2017000966A (es) | 2018-02-09 |
JP2017522968A (ja) | 2017-08-17 |
JP6959464B2 (ja) | 2021-11-02 |
WO2016014645A1 (en) | 2016-01-28 |
US20160022500A1 (en) | 2016-01-28 |
EP3171839B1 (en) | 2018-10-24 |
CA2955855A1 (en) | 2016-01-28 |
US11007082B2 (en) | 2021-05-18 |
CO2017001409A2 (es) | 2017-07-11 |
EP3171839A1 (en) | 2017-05-31 |
JP2021098059A (ja) | 2021-07-01 |
BR112017001200A2 (pt) | 2018-07-03 |
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