CN104717939B - 原位人工膀胱内假体 - Google Patents
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- A61F2/02—Prostheses implantable into the body
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- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
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Abstract
一种原位人工膀胱内假体,该原位人工膀胱内假体包括能够与患者的尿道连接的第一部分(2)和与所述患者的输尿管连接的第二部分(3);所述第一部分(2)包括可塌缩的盖(4),该盖(4)由多层的硅酮膜制成并具有均涂覆有热解乱层碳的外表面(4a)和内表面(4b);所述第二部分(3)包括可再吸收的帽(7)与所述帽(7)联接的框架(9),所述帽(7)包括由PGA纤维制成的织物(8),框架(9)是使用PGA/PLA共聚物制成的;所述盖(4)和所述帽(7)沿着它们各自的边缘(4c、7a)连接在一起以限定封罩。
Description
技术领域
本发明涉及一种原位人工膀胱内假体。
背景技术
本发明的应用在于:在患者的膀胱遭受严重的、不可治愈的疾病以致危及膀胱的正确运行的情况下对患者的膀胱进行替换。
已知的膀胱内假体包括由层状硅酮膜制成的球囊外壳。
该球囊是充分刚性的以稳固地保持其形状并且是足够柔韧的以能够被手动压缩而确保将其排空。
外壳具有位于外壳下部中的连接元件以与患者的尿道进行连接。类似地,在顶部处定位有两个连接体以使得能够与输尿管进行连接。
这些连接是通过缝合或者通过简单互锁来实现的。
不利的是,已知的膀胱内假体具有一些缺点。
首先,借助于连接体的输尿管连接在某些情况下会引起输尿管狭窄的问题。
此外,这种类型的连接增加了感染的可能性。
实际上,在置换手术后,患者的尿道中被插入导管。有时存在以下情况:感染经由该导管进入假体,使得必需进行抗生素治疗。
然而,这种治疗在输尿管与内假体连接的区域内有效性降低,这是因为细菌负荷能够将其本身稳固地安置在构成内假体的人工材料上。
发明内容
在本文中,本发明的核心的技术任务是提出一种将现有技术的上述技术缺点克服的原位人工膀胱内假体。
特别地,本发明的目的是提供一种使得术后感染的可能性能够显著降低的原位人工膀胱内假体。
本发明的另一目的是提供一种使患者的输尿管狭窄的风险降低的原位人工膀胱内假体。
所提出的技术任务和所提出的目的基本上是通过下文中描述的原位人工膀胱内假体来实现的。
附图说明
根据以下对如附图中所示的原位人工膀胱内假体的优选但非穷举性的实施方式的非限制性描述,本发明的另外的特征和优势将更明显地显现,在附图中:
-图1为根据本发明的原位人工膀胱内假体的示意性侧视图;
-图2为图1示出的内假体的截面侧视图;
-图3为图2示出的内假体的细节的截面图;以及
-图4为图1示出的内假体的俯视图。
具体实施方式
参照附图,1作为整体表示原位人工膀胱内假体。
内假体1包括能够与患者的尿道连接的第一部分2和能够与患者的输尿管连接的第二部分3。
第一部分2和第二部分3是不同的并且是有区别的,但第一部分2和第二部分3被牢固地连接在一起以限定外壳,外壳内为用于容纳尿液的封罩。封罩具有大致介于100cm3与900cm3之间的体积、优选地为400cm3的体积。
特别地,第一部分2为永久型的部分,而第二部分3为可再吸收型的部分。
更特别地,第一部分2包括由多层的硅酮膜制成的盖4。
盖4的膜的厚度介于500μm与700μm之间、优选地为约600μm。
在优选的实施方式中,该膜大致包括20层,每层均大约30μm厚。
以此方式,盖4因此是充分刚性的以保持其形状,但同时盖4是充分柔韧的以能够从外侧推压以促进尿液的排出。
该膜是通过专利申请WO 2007/039159中示出的工艺来生产的,该专利申请附录于此以供参考。
通过示例的方式,所使用的硅酮可以包括用硅加强的二甲基硅氧烷和间位乙烯基硅氧烷(metavinyl-siloxane)的共聚物。
有利地,硅酮可以添加有诸如硫酸钡、二氧化钛之类的遮光剂,使得能够通过放射诊断技术来检测内假体1。
盖4具有外表面4a和内表面4b。
外表面4a和内表面4b上均应用有高度生物可相容的防护材料的相应的层。通过示例的方式,这种材料是厚度介于0.2μm与0.3μm之间的热解乱层碳。
碳层在盖4的外表面4a上的应用使得能够避免成形纤维囊附着于第一部分2的风险。碳层在盖4的内表面4b上的应用使得能够保护第一部分2免于受到尿液引起的腐蚀。
第一部分2还包括连接体5,该连接体5固定至盖4以使得患者的尿道能够连接至内假体1。
如图所示的,连接体5呈漏斗形状并且在膜中制出的开口6处胶合至盖4以允许尿液离开。
特别地,连接体5在连接体5的基部中的一个较大的基部处胶合至盖4。
根据优选的实施方式,连接体5具有15mm的高度和24mm的较大基部。
此外,较小的基部中的孔的直径为大约6mm并且厚度为大约1mm。连接体5由用插入在厚度中的网或网状物内部加强的硅酮制成。该网或网状物优选地由或制成。连接体5是使用诸如例如模制、浸渍或类似技术之类的已知技术制造的。
该网使得能够将患者的尿道以更简单和更稳固的方式缝合至连接体5。
第二部分3包括连接至盖4的可再吸收的帽7。特别地,帽7和盖4沿着它们各自的边缘7a、4c连接,使得各自的凹面面向彼此。
帽7包括大致平的、圆形的织物8和固定至织物8的框架9。框架9作为用于织物8的支承结构,使得织物8能够呈现为圆顶形,该圆顶形在纤维囊的重量增长的情况下也被这样地保持。
帽7的织物8是使用优选地源自均聚物PGA(聚乙醇酸交酯或聚乙醇酸)纤维的超轻线或单丝制成的。PGA是一种高度生物可相容的且可再吸收的聚合物并且对尿液有抵抗性。特别地,PGA的再吸收时间大约为一个月。
有利地,使用PGA纤维制作织物8允许肌肉纤维组织形成在内假体1的外侧上。在再吸收过程中,可看到在内侧形成了又被称作膀胱上皮的过渡上皮层。有利地,膀胱上皮层是不能渗透的,这是保证假体和形成的新膀胱的正确运行的必要事实。
织物8是能够通过以不同方式编织PGA线从而产生针织织物、机织织物或非织造织物而获得的。
优选地,织物8为针织织物、甚至更优选地为经编针织织物。
在这种情况下,织物8具有能够呈现具有充分小的结点的网构型的较粗糙表面。
更特别地,织物8的纬线是这样的:织物8的孔隙间隔小于200μm、优选地为大约160μm,从而与孔的大约0.02mm2的平均面积相应。这保证了尿液不能渗透,从而防止泄漏。
此外,织物8优选是有纹理的从而赋予其甚至更大的表面粗糙度和更大的刚度以及抗渗性。织物的更大的粗糙度限制了纤维囊的附着的风险。
仅通过示例的方式,织物8具有大致在8mm与10mm之间的直径。
再次仅通过示例的方式,织物8具有大致在0.3mm与0.6mm之间、更优选地介于0.4mm与0.53mm之间、甚至更优选地大致为0.45mm的厚度。
在帽7的织物8上设计有用于将患者的输尿管连接至内假体1的两个互锁区域13。当内假体1植入时,外科医生在帽7中的互锁区域13处做出孔以适应输尿管的直径。
应指出的是,示出的互锁区域13的位置仅是通过示例的方式给出的。
特别地,在植入内假体1的手术中,通过在互锁区域中借助于可再吸收线将输尿管缝合至帽7而将输尿管连接至第二部分3。
框架9包括以星形设置的多个臂10并且限定圆顶轮廓。更特别地,所述臂10都呈弯曲形状并且在位于帽7的顶部的接合部11处被固定在一起。
框架9对于结合盖4限定的封罩而言位于帽7的外侧。
特别地,框架9借助于可再吸收缝线固定至织物8。
通常,框架9——即,臂10和接合部11——的厚度介于0.1mm与10mm之间、优选地介于0.5mm与2mm之间。在优选实施方式中,厚度大致为1mm。
框架9是通过注塑表示为PGA/PLA(聚(乳-乙醇)酸)的乳酸与乙醇酸的共聚物来获得的,框架的圆顶形状是在借助于热成型而变热来赋予的。
由于乳酸为手性分子,因而存在不同类型的聚合物:PDLA、PLLA、PDLLA,其中,D和L代表两种立体异构体。PLLA具有37%的结晶度、介于50℃与80℃之间的玻璃转变温度以及介于173℃与178℃之间的解链温度,而由外消旋混合物的聚合反应得到的聚合物PDLLA是非结晶的聚合物。
术语“聚(乳)酸”在此处旨在表示所有不同的上述类型的PLA。
用于制成框架9的PGA/PLA共聚物是通过以数量计介于20%与30%之间的PGA以及以数量计相对应地介于70%与80%之间的PLA形成的。
特别优选的作为PGA/PLA(聚(乳-乙醇)酸)的是下述的聚(L-乳-乙醇)(PLLA/PGA)共聚物,在该共聚物中,L-乳酸以摩尔计占82-88%的摩尔百分比,而乙醇酸占18-12%的摩尔百分比。这种共聚物在商业上称作LG855S。
本申请惊人地发现:用上述PGA织物8——特别地在有纹理时——与PGA/PLA框架9结合制成的帽7展示出良好的机械一致性和充分的刚度,即使在有尿液存在时,也同样能够保证膀胱在排空和/或填充过程中正确地变形,同时展示出良好的抗尿液渗漏性。
此外,已经证明织物8和框架9在与生长的新组织接触时是中性的。这使装置被周围生长组织的细胞快速占据(population)。同时,已经证明了附着力由于包括织物8和框架9的聚合物与这些生物分子之间的减小的相互作用而被减小,由此保证了与患者的内部组织的融合。
盖4包括从所述盖4的边缘4c突出的带条12。
特别地,带条12沿着盖4的整个边缘4c延伸。
带条12由生物可相容的并且优选地不可再吸收的材料制成。
带条12在边缘7a处固定至帽7。特别地,带条12沿着帽7的整个边缘7a被固定。
优选地,带条12是借助于使用可再吸收线制成的缝合线而固定至帽7的。通过示例的方式,这种线可以由PGA形成。
在优选实施方式中,带条12是由和/或制成的织物形成的。根据(图3)示出的那样,带条12“嵌入”到构成盖4的膜中。换句话说,带条12被包括在硅酮膜的两个相邻层之间。特别地,带条12定位在位于盖4的外表面4a附近的两个层之间。
所描述的本发明由此达到了所提出的目的。实际上,由于输尿管连接至可再吸收部,因而输尿管逐渐与形成在帽上的新膀胱的生物组织相融合。
输尿管的生物材料与新膀胱的生物材料之间的连接使得术后感染的传播能够减少。实际上,在细菌负荷安置在生物组织而非人工组织上的情况下,抗生素药物的使用是有效的。因此,抗生素药物也能够有效地作用在内假体与输尿管之间的连接处,从而阻止感染增加。
此外,输尿管与可再吸收部之间的连接使得输尿管狭窄的风险能够减小。
Claims (12)
1.一种原位人工膀胱内假体,其特征在于,所述原位人工膀胱内假体包括能够与患者的尿道连接的第一部分(2)和能够与所述患者的输尿管连接的第二部分(3);
所述第一部分(2)包括可塌缩的盖(4),所述盖(4)由多层的硅酮膜制成并具有均涂覆有热解乱层碳的外表面(4a)和内表面(4b);
所述第二部分(3)包括可再吸收的帽(7)以及与所述帽(7)联接的框架(9),所述帽(7)包括由PGA纤维制成的织物(8),所述框架(9)是使用PGA/PLA共聚物制成的;所述盖(4)与所述帽(7)沿着它们各自的边缘(4c、7a)连接在一起以限定封罩。
2.根据权利要求1所述的原位人工膀胱内假体,其特征在于,所述盖(4)包括带条(12),所述带条(12)从所述盖(4)的所述边缘(4c)突出并且由生物可相容的且不可再吸收的材料制成;所述带条(12)固定至所述帽(7)的所述边缘(7a)。
3.根据权利要求2所述的原位人工膀胱内假体,其特征在于,所述带条(12)是由和/或制成的。
4.根据权利要求2所述的原位人工膀胱内假体,其特征在于,所述带条(12)被牢固地包括在所述硅酮膜的位于所述盖(4)的所述外表面(4a)处的两个相邻层之间。
5.根据权利要求2至4中的任一项所述的原位人工膀胱内假体,其特征在于,所述带条(12)沿着所述盖(4)的整个所述边缘(4c)延伸。
6.根据权利要求1至4中的任一项所述的原位人工膀胱内假体,其特征在于,所述框架(9)包括以星形设置的多个臂(10)并且限定圆顶轮廓,其中所述多个臂(10)都呈弯曲形状并且在位于所述帽的顶部的接合部处被固定在一起。
7.根据权利要求1至4中的任一项所述的原位人工膀胱内假体,其特征在于,所述帽(7)的所述织物(8)为经编针织的织物。
8.根据权利要求1至4中的任一项所述的原位人工膀胱内假体,其特征在于,所述PGA/PLA共聚物包括30%的PGA和70%的PLA。
9.根据权利要求1至4中的任一项所述的原位人工膀胱内假体,其特征在于,所述第一部分(2)包括连接体(5),所述连接体(5)连接至所述盖(4)以将所述盖(4)连接至所述尿道,所述连接体(5)呈大致漏斗形形状。
10.根据权利要求1至4中的任一项所述的原位人工膀胱内假体,其特征在于,所述盖(4)的所述硅酮膜的厚度介于500μm与700μm之间。
11.根据权利要求1至4中的任一项所述的原位人工膀胱内假体,其特征在于,所述帽(7)的所述织物(8)为有纹理的织物。
12.根据权利要求1至4中的任一项所述的原位人工膀胱内假体,其特征在于,所述盖(4)的所述硅酮膜的厚度为约600μm。
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IT001555A ITMI20121555A1 (it) | 2012-09-19 | 2012-09-19 | Endoprotesi ortotopica di vescica artificiale |
ITMI2012A001555 | 2012-09-19 | ||
PCT/IB2013/058599 WO2014045190A1 (en) | 2012-09-19 | 2013-09-17 | Orthotopic artificial bladder endoprosthesis |
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Publication number | Priority date | Publication date | Assignee | Title |
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ITMI20121743A1 (it) | 2012-10-16 | 2014-04-17 | Gianni Cancarini | Endoprotesi ortotopica di vescica artificiale |
WO2015140251A1 (en) * | 2014-03-21 | 2015-09-24 | Antonio Sambusseti | Drainage tube for urine in silicone with carbon coating for supporting an absorbable device for tissue reconstruction of urethral segment |
EA031708B1 (ru) * | 2014-04-14 | 2019-02-28 | Антонио Самбуссети | Ортотопический искусственный эндопротез мочевого пузыря |
US20180130592A1 (en) * | 2016-11-04 | 2018-05-10 | Ford Global Technologies, Llc | Inductor cooling systems and methods |
US11464532B2 (en) * | 2018-03-08 | 2022-10-11 | Cilag Gmbh International | Methods for estimating and controlling state of ultrasonic end effector |
CN117017567B (zh) * | 2023-08-12 | 2024-04-09 | 上海市第一人民医院 | 一种植入式膀胱收缩系统、工作方法及人造膀胱 |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2116838A5 (fr) * | 1970-12-09 | 1972-07-21 | Sowinski Kazimierz Maria | Prothese destinee a remplacer la vessie d'un patient |
CN101304706A (zh) * | 2005-10-03 | 2008-11-12 | 安东尼奥·桑布塞蒂 | 用于在部分膀胱切除术后替代一部分膀胱壁的补片 |
CN102271621A (zh) * | 2009-01-07 | 2011-12-07 | 安东尼奥·桑布塞蒂 | 原位人造膀胱假体 |
Family Cites Families (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6547826B2 (en) * | 1996-09-03 | 2003-04-15 | Maulana Azad Medical College | Method of organogenesis and tissue regeneration/repair using surgical techniques |
ITMI20051853A1 (it) | 2005-10-03 | 2007-04-04 | Sambusseti Antonio | Endoprotesi ortotopica di vescica artificiale e relativo metodo di produzione |
US7918897B2 (en) | 2006-02-10 | 2011-04-05 | Tengion, Inc. | Scaffolds for organ reconstruction and augmentation |
ITMI20072366A1 (it) * | 2007-12-18 | 2009-06-19 | Antonio Sambusseti | Endoprotesi ortotopica, a tasca, di vescica artificiale |
IT1395172B1 (it) * | 2009-08-14 | 2012-09-05 | Sambusseti | Placca concava (scaffold) riassorbibile per la sostituzione di una porzione di parete vescicale a seguito di vescitectomia parziale |
ITMI20092093A1 (it) * | 2009-11-27 | 2011-05-28 | Antonio Sambusseti | Patch riassorbibile in pga per la sostituzione di una porzione di parete vescicale a seguito di vescitectomia parziale |
EP2544726A1 (en) * | 2010-03-09 | 2013-01-16 | Tengion, Inc. | Cell-scaffold constructs |
US20110301706A1 (en) * | 2010-04-29 | 2011-12-08 | BioStruxs, LLC | Breast Reconstruction Device And Methods |
WO2011138371A1 (de) * | 2010-05-06 | 2011-11-10 | Otto-Von-Guericke-Universität Magdeburg Medizinische Fakultät | Harnblasenprothese für die subkutane implantation |
IT1401467B1 (it) | 2010-06-25 | 2013-07-26 | Sambusseti | Endoprotesi ortotopica di vescica artificiale |
ITMI20110387A1 (it) | 2011-03-11 | 2012-09-12 | Antonio Sambusseti | Emisfera per l'ampliamento vescicale in pazienti con bassa compliance |
ITMI20120380A1 (it) * | 2012-03-12 | 2013-09-13 | Antonio Sambusseti | Cuffia riassorbibile migliorata per l'ampliamento vescicale in pazienti con bassa compliance o per la sostituzione di una vasta porzione di vescica a seguito di bilarzia |
ITMI20120381A1 (it) * | 2012-03-12 | 2013-09-13 | Antonio Sambusseti | Patch riassorbibile in pga rinforzato per la sostituzione di una porzione di parete vescicale a seguito di vescitectomia parziale |
US20130317622A1 (en) | 2012-05-25 | 2013-11-28 | Antonio Sambusseti | Surgical method for grafting an artificial implant in a bladder and/or in a urethral or ureteral segment |
ITMI20121743A1 (it) | 2012-10-16 | 2014-04-17 | Gianni Cancarini | Endoprotesi ortotopica di vescica artificiale |
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Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2116838A5 (fr) * | 1970-12-09 | 1972-07-21 | Sowinski Kazimierz Maria | Prothese destinee a remplacer la vessie d'un patient |
CN101304706A (zh) * | 2005-10-03 | 2008-11-12 | 安东尼奥·桑布塞蒂 | 用于在部分膀胱切除术后替代一部分膀胱壁的补片 |
CN102271621A (zh) * | 2009-01-07 | 2011-12-07 | 安东尼奥·桑布塞蒂 | 原位人造膀胱假体 |
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ITMI20121555A1 (it) | 2014-03-20 |
PT2897554T (pt) | 2017-02-10 |
ES2611782T3 (es) | 2017-05-10 |
EP2897554A1 (en) | 2015-07-29 |
CY1118569T1 (el) | 2017-07-12 |
SMT201700059B (it) | 2017-03-08 |
EP2897554B1 (en) | 2016-11-02 |
RU2015114589A (ru) | 2016-11-10 |
WO2014045190A1 (en) | 2014-03-27 |
DK2897554T3 (en) | 2017-02-13 |
CN104717939A (zh) | 2015-06-17 |
HRP20170163T1 (hr) | 2017-03-24 |
SI2897554T1 (sl) | 2017-03-31 |
ME02657B (me) | 2017-06-20 |
RS55541B1 (sr) | 2017-05-31 |
US9393099B2 (en) | 2016-07-19 |
LT2897554T (lt) | 2017-02-10 |
US20160000552A1 (en) | 2016-01-07 |
PL2897554T3 (pl) | 2017-07-31 |
RU2640563C2 (ru) | 2018-01-09 |
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