CN1511047A - 造口术装置 - Google Patents
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Abstract
一种环形部件,其具有一邻近侧,该邻近侧具有与造口术装置相结合使用的凸起表面,环形部件由轻质柔性材料制成,其中环形部件由下述材料制成a)实体的热塑性弹性体,例如以乙烯和辛烯的共聚物形式的聚烯烃弹性体,或者b)以模铸泡沫产品或整体泡沫产品形式的泡沫热塑性弹性体。环形部件本身由轻质、柔韧的弹性材料制成,同时其又具有足够的刚度以提供和保持造口术装置粘结薄片的凸起形状。
Description
技术领域
本发明涉及一种造口术装置,特别是涉及一种凸起元件以及包括该凸起元件的造口术装置。
背景技术
对于许多肠胃或尿道的疾病的外科治疗,在很多情况下结果是使结肠、回肠或输尿管通过外科手术而暴露,使病人留有腹部的人造口,或者在肾造口术或输尿管造口术中,使输尿管或导尿管暴露在背部区域、胸部区域或者腹部区域,由这些器官传送的身体排出物或废物将通过人造口或开口排出,并收集在收集袋中,该收集袋通常通过有着与人造口/输尿管/导尿管相适应的进口开口的粘胶片或板粘附在皮肤上。还有,对于瘘管,病人必须依靠一种装置来收集从该开口排出的身体物质。
造口术装置是众所周知的。这种装置可以是两件式或者是单件式,在这两种装置中,粘性隔板部件(或基板)安装在穿用者的腹部/背部/胸部。当为单件式装置时,接收部件或者接收袋安装在该基板上。当为两件式装置时,粘性隔板部件形成了身体侧部件的一部分,而接收部件或接收袋可释放地安装在身体侧造口术部件上,以接收该人造口流出的渗出物。
当使用单件式造口术装置时,包括将装置固定在皮肤上的粘性皮肤隔板在内的整个装置通常都被取下来用新的装置替换。当采用两件式装置时,身体侧的造口术部件将保留数天,只更换安装在身体侧部件上的接收部件或接收袋。用于安装造口术接收袋的安装装置可以是本身已知的系统,包括相配的连接环或者相配的凸缘以及粘性表面,该相配的连接环或者相配的凸缘以及粘性表面与身体侧部件的凸缘区域相配,并密封抵靠该凸缘区域。
生产带有邻近侧平的粘性皮肤隔板的造口术产品包括,生产适合用于人类皮肤的粘性的平盘,在平盘的两面上均提供塑料片材。在粘性平盘的远离(做过造口术手术的人的)身体侧的片材可以、例如通过胶合或者焊接将其固定在收集袋或者是连接部件上,所述连接部件与收集袋为可分离的连接。在粘性平盘的邻近侧的片材是保护性片材,其在使用之前可以去掉,然后基本上是利用粘性皮肤隔板平的邻近侧将造口术装置连接到使用者的皮肤上。
对于造口术病人,通常能看到与人造口周围皮肤的其他部分相比较,离人造口最近的皮肤,尤其是1-2cm的距离内,是凹陷的,并且位于凹坑或者是空洞中。对于这些病人来说,为了使造口术装置的粘结表面能够与凹坑或空洞内的全部皮肤相接触粘合,使用一种在接收人造口的开口附近的粘结表面有一部分是凸起的,并且朝向使用者突出的造口术产品是很方便的。特别是,为了保证防止粘性皮肤隔板的变质以及泄露,造口术装置与邻近人造口周围的皮肤很好地粘合非常重要。使用带有刚性凸起形状的粘结薄片也可以对于邻近人造口的区域施加一定的外部压力,特别是与凹陷的人造口相结合时,这种压力将保证人造口足够的凸起,以便帮助在不与人造口相邻的暴露的粘性皮肤隔板接触的情况下直接将废物排放到收集袋中,并且延长粘结薄片或薄板的使用寿命。粘性表面凸起部分的形状可以是,例如圆顶形或圆锥形,并且这种产品在指定的凸起产品中是众所周知的。在说明书的整个部分,不考虑具体的实施例,“凸起”一词是广义上的意思。
一般情况下,这种刚性的凸起形状可以通过插入相当坚硬的凸起接头来实现,例如,WO93/04646中公开的类型,其典型的是由例如EVA材料制成的,或者是WO93/18725中公开的类型,其典型的是由刚性或者半刚性的聚合物材料制成的,例如,聚丙烯、HD聚乙烯或者是聚苯乙烯。
EP317326中公开了一种包括三个基本部件的压力环组件,第一个是相当刚性的支撑环,优选的是由热塑性材料制成的,第二个是柔韧、有弹性、防水的可热成形的材料制成的中间环,该环固定在刚性支撑环的邻近侧表面的凸起上,第三个是柔韧、可变形的吸水皮肤隔板材料制成的隔板环,该材料同时具有干、湿粘性(TACK)。
US5607413和US5730735中公开了凸起造口术面板,为了减轻面板的重量,并且为了提供一种使用时比不具有凹槽的压力环更加柔韧舒适的压力环,其包括带有深环状凹槽的凸起压力环。另外,为了保持柔韧性,压力环的内部连接部分非常薄而且有弹性,并且内部连接部分薄的程度使得易于用剪刀剪切以扩大面板造口术接收孔。
尽管上述凸起压力环提供了一定程度的柔韧性,其也可能带来一些生产过程中的问题,例如在将其焊接到造口术面板的其他部件时将会产生破坏凸起压力环的风险。
因此,还需要提供一种与柔韧性相结合的低重量的造口术凸起压力环,同时,其又具有足够的刚度,以保持造口术装置的粘结薄片的凸起形状。
本发明提供一种同时针对上述问题的解决方案,并且在改进其中一个特征时并不影响其他的特征。
发明概述
本发明涉及一种环形部件,其具有一定的内周与外周之间的径向范围,并且其具有与造口术装置相结合使用的带有凸起表面的邻近侧。
本发明还涉及与造口术收集袋相结合使用的身体侧部件,并且包括一种环形部件,其具有一定的内周与外周之间的径向范围,并且其具有带有凸起表面的邻近侧。
另外,本发明还涉及一种收集袋形式的造口术装置,其中包括将所述装置固定在使用者皮肤上的粘性薄片,所述薄片带有接收人造口的孔。
本发明的详细描述
本发明涉及一种环形部件,其具有一邻近侧,该邻近侧具有与造口术装置相结合使用的凸起表面,环形部件由轻质柔韧材料制成,其中环形部件由下述材料制成:
a)实体的热塑性弹性体,例如以乙烯和辛烯的共聚物形式的聚烯烃弹性体,或者
b)以模铸泡沫产品或整体泡沫产品形式的泡沫热塑性弹性体。
一个惊奇的发现是,环形部件本身可以由轻质、柔韧的弹性材料制成,同时,其又具有足够的刚度以提供和保持造口术装置粘结薄片的凸起形状。
当试图改善根据本发明的环形部件的柔韧性时,可以通过选择材料的性能来实现,这以不同于与相应的已知产品有关的唯一可行的方式,在上述唯一可行的方式中,只有使用薄材可以提供足够的柔韧性,至于设计,由于薄材在加工过程中更具有破坏的风险,而且在使用过程中(由于过载)不可避免地更倾向于永久变形,因此必须特殊考虑。
当使用上述的传统材料时,在得到柔韧性与保证凸形环的形状稳定性方面必须折衷处理。
根据本发明,当使用轻质柔性材料时,可以得到相当高的柔韧性,所述韧软性改善了当使用者运动时的穿用舒适性。材料弹性性能的保持又将保证当运动时产生的应力消失时环形部件返回其原先的凸起形状。因此,根据本发明,环形部件的截面积比较大,从而可以提供较高强度保证大载荷下的承受能力,也能保持其柔韧性。
已经发现,实体热塑性材料,例如以乙烯和辛烯的共聚物形式的聚烯烃弹性体,或者以模铸泡沫产品或整体泡沫产品形式的泡沫热塑性弹性体都可以用于此目的。一种优选的此种弹性体是DuPont Dow生产的Engage8401聚烯烃弹性体。上述共聚物可用注射模铸法或挤压模铸法制成,其密度较低,因而减轻了产品的重量,也提供了一种本发明目的的合适的刚度。
合适的共聚物优选的根据ASTM D-1646标准的121℃下的Mooney Viscosity ML 1+4<5,根据ASTM D-638M,50mm/min条件下的极限拉伸强度为3-13(MPa)。
合适的泡沫材料可以是PE泡沫材料、EVA/PE泡沫材料或者由上述的热塑性弹性体材料而制成的泡沫材料。根据本发明的由热塑性弹性体材料制成的环形部件可以用于现有的产品线中,因为它们可以通过与生产普通的凸形环类似的方法生产,对于本领域的普通技术人员来说很容易,仅仅需要对焊接条件加以改变。
根据本发明的环形部件可以例如是WO93/04646或WO93/18725中所公开的类型。
第二方面,本发明涉及一种造口术身体侧部件,其包括将所述装置固定在使用者皮肤上的粘性薄片,所述薄片带有接收人造口的孔,以及连接装置,所述连接装置与接收从人造口排泄的分泌物的接收袋是可更换的连接,其特征在于:其具有环形部件,环形部件具有邻近侧,该邻近侧带有凸起表面,环形部件由轻质柔韧材料制成,其中所述环形部件由下述材料制成:
a)实体的热塑性弹性体,例如以乙烯和辛烯的共聚物形式的聚烯烃弹性体,或者
b)以模铸泡沫产品或整体泡沫产品形式的泡沫热塑性弹性体。
根据本发明的造口术身体侧部件可以用通常用于制造一次性造口术装置、伤口装置以及失禁装置的标准材料来生产。因此,粘性薄片可以由医疗级的隔膜材料来生产,例如US4367732、US5051259或US5714225中公开的配方。
所述连接装置可以是WO93/18725或WO94/18919中公开的相匹配的连接环的形式或者US5800415中公开的与粘性连接相匹配的连接凸缘的形式。
第三方面,本发明涉及一种收集袋形式的造口术装置,其中包括将所述装置固定在使用者皮肤上的粘性薄片,所述薄片带有接收人造口的孔,其特征在于:其具有一个环形部件,该环形部件具有一个邻近侧,该邻近侧带有凸起表面,环形部件由轻质柔韧材料制成,其中所述环形部件由下述材料制成:
a)实体的热塑性弹性体,例如以乙烯和辛烯的共聚物形式的聚烯烃弹性体,或者
b)以模铸泡沫产品或整体泡沫产品形式的泡沫热塑性弹性体。
根据本发明的收集袋可以用通常用于制造一次性造口术装置、伤口装置以及失禁装置的标准材料来生产。
Claims (4)
1.一种环形部件,其具有一邻近侧,该邻近侧具有与造口术装置相结合使用的凸起表面,环形部件由轻质柔性材料制成,其特征在于环形部件由下述材料制成:
a)实体的热塑性弹性体,例如以乙烯和辛烯的共聚物形式的聚烯烃弹性体,或者
b)以模铸泡沫产品或整体泡沫产品形式的泡沫热塑性弹性体。
2.如权利要求1所述的环形部件,其特征在于:所述环由下述材料制成,该材料具有根据ASTM D-1646的121℃下的门尼粘度ML1+4<5,根据ASTM D-638M,50mm/min条件下的3-13MPa的极限拉伸强度,70-100的硬度(Shore A,ASTM-2240)。
3.一种造口术身体侧部件,其包括将造口术装置固定在使用者皮肤上的粘性薄片,所述薄片带有接收人造口的孔,以及连接装置,所述连接装置与接收从人造口排泄的分泌物的接收袋是可更换的连接,其特征在于:其具有一环形部件,该环形部件具有一邻近侧,该邻近侧带有凸起表面,环形部件由轻质柔性材料制成,其中所述环形部件由下述材料制成:
a)实体的热塑性弹性体,例如以乙烯和辛烯的共聚物形式的聚烯烃弹性体,或者
b)以模铸泡沫产品或整体泡沫产品形式的泡沫热塑性弹性体。
4.一种收集袋形式的造口术装置,其中包括将所述装置固定在使用者皮肤上的粘性薄片,所述薄片带有接收人造口的孔,所述薄片还包括一个具有在内周和外周之间的径向范围的环形部件,其特征在于:其具有一环形部件,该环形部件具有一邻近侧,该邻近侧带有凸起表面,环形部件由轻质柔韧材料制成,其中所述环形部件由下述材料制成:
a)实体的热塑性弹性体,例如以乙烯和辛烯的共聚物形式的聚烯烃弹性体,或者
b)以模铸泡沫产品或整体泡沫产品形式的泡沫热塑性弹性体。
Applications Claiming Priority (2)
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DKPA200100821 | 2001-05-21 | ||
DK200100821A DK174925B1 (da) | 2001-05-21 | 2001-05-21 | Stomiindretning |
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CN1511047A true CN1511047A (zh) | 2004-07-07 |
CN1270784C CN1270784C (zh) | 2006-08-23 |
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CNB028103769A Expired - Lifetime CN1270784C (zh) | 2001-05-21 | 2002-05-21 | 造口术装置 |
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US (1) | US20040133175A1 (zh) |
EP (1) | EP1389136B1 (zh) |
JP (1) | JP4574948B2 (zh) |
CN (1) | CN1270784C (zh) |
AT (1) | ATE305805T1 (zh) |
AU (1) | AU2002316789B2 (zh) |
CA (1) | CA2447613C (zh) |
DE (1) | DE60206491T2 (zh) |
DK (2) | DK174925B1 (zh) |
ES (1) | ES2250668T3 (zh) |
HU (1) | HU225513B1 (zh) |
WO (1) | WO2002094333A2 (zh) |
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-
2001
- 2001-05-21 DK DK200100821A patent/DK174925B1/da not_active IP Right Cessation
-
2002
- 2002-05-21 CN CNB028103769A patent/CN1270784C/zh not_active Expired - Lifetime
- 2002-05-21 HU HU0400608A patent/HU225513B1/hu not_active IP Right Cessation
- 2002-05-21 ES ES02745161T patent/ES2250668T3/es not_active Expired - Lifetime
- 2002-05-21 US US10/476,874 patent/US20040133175A1/en not_active Abandoned
- 2002-05-21 DK DK02745161T patent/DK1389136T3/da active
- 2002-05-21 AU AU2002316789A patent/AU2002316789B2/en not_active Ceased
- 2002-05-21 AT AT02745161T patent/ATE305805T1/de not_active IP Right Cessation
- 2002-05-21 WO PCT/DK2002/000338 patent/WO2002094333A2/en active IP Right Grant
- 2002-05-21 EP EP02745161A patent/EP1389136B1/en not_active Expired - Lifetime
- 2002-05-21 DE DE60206491T patent/DE60206491T2/de not_active Expired - Lifetime
- 2002-05-21 JP JP2002591049A patent/JP4574948B2/ja not_active Expired - Fee Related
- 2002-05-21 CA CA2447613A patent/CA2447613C/en not_active Expired - Fee Related
Also Published As
Publication number | Publication date |
---|---|
CA2447613A1 (en) | 2002-11-28 |
AU2002316789B2 (en) | 2007-03-29 |
CA2447613C (en) | 2011-02-01 |
CN1270784C (zh) | 2006-08-23 |
JP4574948B2 (ja) | 2010-11-04 |
DE60206491D1 (de) | 2006-02-16 |
DK1389136T3 (da) | 2006-02-06 |
US20040133175A1 (en) | 2004-07-08 |
DK200100821A (da) | 2002-11-22 |
ATE305805T1 (de) | 2005-10-15 |
JP2005500093A (ja) | 2005-01-06 |
ES2250668T3 (es) | 2006-04-16 |
DK174925B1 (da) | 2004-02-23 |
HU225513B1 (en) | 2007-01-29 |
EP1389136A2 (en) | 2004-02-18 |
WO2002094333A2 (en) | 2002-11-28 |
HUP0400608A2 (en) | 2004-08-30 |
DE60206491T2 (de) | 2006-06-22 |
WO2002094333A3 (en) | 2003-02-06 |
EP1389136B1 (en) | 2005-10-05 |
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