TW201016254A - Reduced-pressure, wound-closure and treatment systems and methods - Google Patents
Reduced-pressure, wound-closure and treatment systems and methods Download PDFInfo
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- TW201016254A TW201016254A TW098116476A TW98116476A TW201016254A TW 201016254 A TW201016254 A TW 201016254A TW 098116476 A TW098116476 A TW 098116476A TW 98116476 A TW98116476 A TW 98116476A TW 201016254 A TW201016254 A TW 201016254A
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- Prior art keywords
- reduced pressure
- decompression
- wound
- seal
- attachment member
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Description
201016254 六、發明說明: 【發明所屬之技術領域】 本發明整體而言係關於醫療治療系統,且更特定而言係 關於減壓、傷口閉合及治療系統與方法。 本發明根據美國專利法35 U.S.C. § 119(e)規定主張2008 年 10 月 29 日申請之名稱為「116(111。6(1-?犷6381^6,\¥〇1111(1-Closure System and Method」之美國臨時專利申請案第 61/109,410號;2008年10月29日申請之名稱為「116(11^6(!-Pressure, Abdominal Treatment System and Method」之美 國臨時專利申請案第61/109,486號;名稱為「Open-Cavity, Reduced-Pressure Wound Dressing and System j 之美國臨 時專利申請案第61/1 09,390號;及2008年10月29曰申請之 名稱為「Reduced-Pressure, Deep-Tissue Closure System and Method」之美國臨時專利申請案第61/109,448號之權 益。所有該等臨時申請案皆出於所有目的以引用方式併入 本文中。 【先前技術】 不論一傷口或組織受損區域之病原為外傷、外科手術或 其他原因,適當的照護該傷口對最後結果係很重要的。當 該傷口牽涉到諸如腹膜腔且更一般而言係腹腔之需要再進 入之位置時,便存在特別的挑戰。很多時候,當外科手術 或外傷牽涉到腹腔時,建立一有助於再進入之傷口管理系 統係可使照護更完善且更容易,並且有助於改善諸如腹膜 炎、腹室併發症(ACS)以及可能會妨礙到傷口及内部器官 140503.doc 201016254 取終痊癒之感染等情況。在提供此照護時,最好可從該腔 移除不當的流體,有助於接近筋膜及其他組織,或者最後 有助於在傷口本身上面於表皮層處提供閉合力。除非另有 指明,否則在本文中所用之「或」字並不一定表示互斥 性。 目前,在表皮上之一腹部開口可利用縫合線、υ形釘、 夾具及其他機械裝置來使得皮膚可被固定及拉開。此等裝 ^ 置通常會造成刺破性傷口或造成其他傷口。若發生嚴重浮 腫,則在該閉合裝置上會形成巨大的壓力且該壓力可能會 造成傷害。例如’若該壓力由於浮腫而上升,則可能造成 缝合線斷裂。 針對可允許再進入至腹腔之整體系統,已有發展出許多 技術。一種手段係將毛巾置入至該腔中且然後利用諸如上 血鉗之夾具來將皮膚密合於該等毛巾上。雖然簡單且快 速,但其結果係被視為非完美的。另一手段係所謂的 • 「Bogota袋」。就此手段而言,一袋係被縫合至定位以覆 蓋敞開的腹部來提供一屏障。有時被稱之為「vac pack」 ' 之另一手段係將毛巾塞入傷口且然後將一引流管置入腹部 -中並以一敷巾覆蓋該腹部。最後,已有採用一減壓手段。 此一手段係揭示在Hunt等人讓渡給美國德州聖安東尼奥内 之KCI Licensing公司之美國專利第7 381 859號十。該美國 專利第7,3 81,859號出於所有目的以引用方式併入本文中。 【發明内容】 既有的傷口閉合裝置及減壓治療系統之問題可藉由在本 140503.doc 201016254 文中所述之說明性實施例之系統、裝置及方法來予以解 · 決。依照一說明性實施例,一種用於提供—閉合力至一串 者之一表面傷口的減壓、傷口閉合系統係包括:一 牙1 一 Ιτί 接構件,其用於可釋放地附接至該患者的表皮之—靠近該 表面傷口之一邊緣之第一部分;及一第二附接構件,其用 於可釋放地附接至該患者的表皮之一靠近該表面傷口之該 邊緣之一第二部分。該第一附接構件係與該第二附接構件 隔開。該減壓、傷口閉合系統進一步包括一密封收縮構 件,其被耦接至該第一附接構件及該第二附接構件且可操 _ 作以當處在減壓作用下時會收縮。該減壓、傷口閉合系統 係可操作以當減壓被供應至該密封收縮構件時,在該第一 附接構件與該第二附接構件之間會產生一閉合力。 依照另一說明性實施例,一種用於提供一閉合力至一串 者之一表面傷口的減壓、傷口閉合系統係包括:一第一附 接構件,其用於可釋放地附接至該患者的表皮之一靠近該 表面傷口之一邊緣之第一部分;及一第二附接構件,其用 於可釋放地附接至該患者的表皮之—靠近該表面傷口之肖 ❹ 邊緣之-第二部分。該第一附接構件係與該第二附接構件 隔開。該減壓、傷口閉合系統進一步包括一被耦接至該帛 一附接構件及該第二附接構件之圓周壁部。該減壓、傷口 · 閉合系統進-步包括一密封收縮構件,其被耗接至該圓周 土。卩之至乂部分且可操作以當處在減壓作用下時會收 縮。-減廢源係被流體式地輕接至該密封收縮構件且可操 作以輸送-減愿至該密封收縮構件。一閉合力係當該減塵 140503.doc -8 - 201016254 由該減壓源供應至該密封收縮構件時被產生。 依照另一說明性實施例,一種用於提供一閉合力至一患 者上之一表面傷口且用於輸送減壓至一組織部位之減壓、 傷口閉合及治療系統係包括一傷口閉合子系統及一減壓治 療子系統。 依照另一說明性實施例,一種製造一用於提供一閉合办 至一患者上之一表面傷口的減壓、傷口閉合系統之方法係 馨 括X下之步驟.形成—第一附接構件,其用於可釋放地 附接至該患者的表皮之一靠近該表面傷口之一邊緣的第一 部分;且形成_第二附接構件,其用於可釋放地附接至該 患者的表皮之一靠近該表面傷口之該邊緣的第二部分。製 造一減壓、傷口閉合系統之該方法係進一步包括形成一密 封收縮構件,其可操作以當處於減壓作用下時會收縮且耦 接該密封收縮構件至該第一附接構件與該第二附接構件。 依照另一說明性實施例,一種用於提供一閉合力至一患 參者上之一表面傷口的方法係包括以下之步驟:可釋放地附 接一第—附接構件至該患者的表皮之一靠近該纟面傷口之 . 一邊緣的第一部分;及可釋放地附接一第二附接構件至該 患者的表皮之一靠近該表面傷口之該邊緣之一第二部分。 該第一附接構件係與該第二附接構件隔開。該提供一閉合 办之方法進一步包括提供一密封收縮構件且流體式地耦接 該密封收縮構件至該第一附接構件及該第二附接構件。該 密封收縮構件係可可操作以當處在減壓作用下時會收縮。 該提供一閉合力之方法係進一步包括供應一減壓至該密封 140503.doc 201016254 收縮構件,藉此在該第一附接構件與該第二附接構件之間 產生一閉合力。 參照圖式及以下實施方式之說明’將可對該等說明性實 施例之其他目的、特徵及優點有更深入之瞭解。 【實施方式】 在說明性實施例之以下實施方式中,參照形成其一部分 之附圖。為使得熟習此項技術者能夠實踐本發明而足夠詳 細地描述此等實施例,且應理解,可利用其他實施例且可 作出邏輯結構性、機械性、電氣及化學改變,而不背離本 發明之精神或料。為避免為使得熟習此項技術者能夠實 踐本文中所述實施例所不需要之細節,本描述可省略熟習 此項技術者已知之某一資訊。因此,不應將以下實施方式 視為具有限制意義,且該等說明性實施例之範健由隨附 申請專利範圍界定。 請參考圖1-2,且首先參考圖!,其中顯示一減廢、傷口 閉合及治療系統100之一說明性實施例。該減壓、傷口閉 合及治療系統1〇〇可包括一減壓治療子系統1〇2及一傷口閉 合子系統104。該減壓治療子系統1〇2可用於以減壓來治療 一組織部位1〇6。該組織部位1〇6可以係任何人類動物或 八他生物之身體組織,包括骨骼組織、脂肪組織、肌肉組 織、真皮組織、血管組織、結締組織、軟骨、肌腱、韌帶 或任何其他組織。該組織部位】可位在—體腔中,諸如 腹腔110,且可包括各種不同組織層,包括在表皮108中 之一傷口。藉由減壓治療子系統1〇2之治療可包括移除流 140503.doc 201016254 體,諸如腹水或分泌物、輸送減壓或提供一保護性屏障。 在該說明性實施例中,該減壓、傷口閉合及治療系統 100係以該腹腔110及一具有傷口邊緣112之表面傷口 111的 内容來呈現。其他的皮下組織丨14亦可被打開,諸如脂肪 組織、肌肉、筋膜等等。該腹腔110如圖所示係具有腹部 内容物116,其形成一表面或支撐件。 該減壓、傷口閉合及治療系統1〇〇之減壓治療子系統1〇2 有助於將減壓輸送至該組織部位106及該腹腔110。該減壓 治療子系統102包括一被安置在該腹腔丨丨〇中之歧管u 8以 分佈該腹腔110内之減壓且接收流體。該歧管丨18可包括一 歧管構件120或與該歧管構件相聯結,或者在一非黏性封 套122中之第二歧管。該非黏性封套丨22具有位在一第一側 上之孔隙124及位在一第二、面向内(或面向組織)側上之孔 隙126。該等孔隙124及126有助於使流體如箭頭128所示般 流動。該等孔隙124及126可採用任何形狀,諸如長方形開 參 口、圓形開口、多邊形、狹缝(長形凹槽)等等。該非黏性 封套122可由可撓性薄膜所形成’諸如一聚胺基甲酸酯薄 , 膜、一敷巾材料或任何非黏性材料。 減壓可藉由該減壓治療子系統丨〇2而施加至該腹腔11 〇及 該組織部位106以有助於促進分泌物、腹水或其他液體、 細菌、纖維蛋白、壞死組織、毒素、殘留血液等等之移 除。減壓亦可在特定情況中來使用以刺激額外組織之生 長。在該組織部位1 〇6處具有一傷口的情況下,粒狀组織 之生長及分泌物與細菌之移除係有助於促進傷口之痊癒。 140503.doc 11 201016254 在一非傷口性或非缺陷性組織的情況中,減壓可用以促進 可被收成且移植至其他組織部位之組織的生長。在其他情 況中’流體移除可能係施加減壓之最主要理由。 在本文中所用之「減壓」泛指小於在該組織部位〗〇6處 之周圍壓力的壓力。在大部分情況中,該減壓係小於患者 所在位置處之大氣壓力。或者,該減壓可小於該組織部位 1〇6之流體靜力壓力。除非另有指明,否則在本文中所陳 述之壓力值係計示壓力。 該歧管118與歧管構件120被安置在腹腔11〇中且可被安 置於或靠近於該組織部位1 〇6。典型而言,容納該歧管構 件120之該非黏性封套122係被安置成抵靠該組織部位 1〇6,且詳言之,係靠近該腹部内容物116。該歧管118被 t置成相鄰於該非黏性封套丨22。該歧管1丨8及該歧管構件 120可採用許多形式β在本文中所用之術語「歧管」係指 一被提供用以輔助施加減壓至、輸送流體至一組織部位 (諸如該組織部位1〇6)或自該組織部位移除流體之物質或結 構。该歧管118及該歧管構件120—般包括複數個流動通道 或通路’其等係互連以增進被提供至靠近該歧管U8及歧 管構件120處之區域或欲自該區域移除之流體的分佈。該 歧管118及歧管構件12〇可由一生物相容性材料來形成,該 材料係可被放置成與組織相接觸且可分佈減壓。歧管之實 例可包括(但不限於)具有經配置以形成流動通道之結構性 疋件的裝置、諸如開放氣室發泡體之多孔性發泡體、多孔 性組織集合,以及包括或固化以包括流動通道之液體、凝 140503.doc •12- 201016254 膠及發泡體。 該歧管118及該歧管構件120可以係多孔性且可由發泡 體、薄紗、耗製墊或適於一特定生物應用之任何其他材 料。在一實施例中,該歧管118及歧管構件120係由一多孔 性發泡體所製成’其包括複數個用以作為流動通道之互連 氣室或細孔。該多孔性發泡體可以係一聚胺基曱酸醋、開 放氣室、網狀發泡體,諸如由美國德州聖安東尼奥市之 Kinetic Concepts公司所製造之GranuFoam®材料。其他實 施例可包括在特定位置處「封閉氣室」以有助於導引流 動。在某些情況中,該歧管118、歧管構件120及非黏性封 套122可用以分佈流體(諸如藥物、抗菌劑、生長激素及其 他溶液)至該組織部位106。其他層體可被包括作為該歧管 118或歧管構件120之部分,諸如吸收性材料、毛細作用材 料、疏水性材料及親水性材料。 一密封構件132可放置在表皮1〇8中之表面傷口 iu上, 且詳言之,其係經製造用以覆蓋該傷口邊緣112以提供一 氣動式密封。因此,該密封構件132在歧管118及非黏性封 套122上提供一密封。該密封構件132可以係一罩蓋,其用 以將歧管118與非黏性封套122牢固於該組織部位1〇6。雖 然該密封構和2可以“渗透性或半滲透性然而該密 封構件U2可在將密封構件132安襄在該歧管ιΐ8上之後於 該組織部位106處維持—減壓。該密封構件132可以係-可 撓性上覆式敷巾或薄m ’其係由聚石夕氧基化合物、丙烯 酸、水凝㈣水凝膠構成材料或者係包括不滲透性或針對 140503.doc -13- 201016254 特定組織部位所需要之滲透性特性之任何其他生物相容性 材料所製成。 該密封構件】32可進-步包括一用以將該密封構件132牢 固至該患者的表皮1〇8之附接裝置136。該附接裝置136可 採用任何形式;例如,可使用—密封帶或一黏膠134可沿 該密封構件132之一周邊或該密封構件132之任何部分而定 位以提供一氣動式密封。該黏膠134亦可預先施加且覆蓋 一在施加後可被移除之可釋放構件(未圖示)。 一第一減壓界面138(諸如一埠口 140或連接器)可用以將 減壓從一第一減壓輸送導管142輸送至該歧管118且至該減 壓輸送導管142。該第一減壓界面138亦可將任何分泌物、 腹水或其他流體從該歧管118輸送至該減壓輸送導管142。 在該歧管118中之減壓將該流體沿箭頭144所示之方向拉引 至該第一減壓輸送導管142。該第一減壓界面138允許流體 從該歧管11 8通往第一減壓輸送導管142。例如,利用該歧 管構件120所收集來自於該組織部位1〇6之流體係可經由該 第一減壓界面138而進入第一減壓輸送導管142。在另一實 施例中’該減壓治療子系統102可排除該第一減壓界面 138,且該第一減壓輸送導管142可直接插入至該密封構件 132及該歧管118中。該第一減壓輸送導管142可以係—醫 療導管、多内腔式構件、管件或用以輸送一減壓之任何其 他構件。 一減壓子系統148可用以供應被輸送至該第一減壓輸送 導管142之減壓。該減壓子系統148可包括一第一減壓單元 140503.doc •14· 201016254 或源150,其輸送減壓至一供應導管152,該供應導管則係 輸送減壓至一三通閥154。該減壓之一部分可經由一第二 減壓輸送導管156而離開該三通閥154。該減壓之另一部分 則可經由一減壓導管158而離開該三通閥154。許多裝置 .(諸如一減壓反饋單元16〇)被定位在該減壓導管158上,其 可例如給予該三通閥154有關於在該減壓導管158中之該減 壓之調節有關的反饋。該減壓導管158輸送該減壓至一罐 籲 子162,該罐子係可操作以容置從該組織部位106被輸送至 該罐子162之任何流體。離開該罐子162之減壓被輸送至該 第一減壓輸送導管142。該第一減壓輸送導管142可被指稱 為輸送一第二減壓或治療減壓。該第二減壓或治療減壓已 藉由該減麼子系統148而被處理成具有適當壓力及條件, 俾可使用於該組織部位1〇6之減壓治療。 許多不同裝置,例如代表性裝置166,可被增添至該第 一減壓輸送導管142之一中間部分164。被輸送至該第一減 • 壓輸送導管I42之該減壓係典型地經選擇而處在-50 mm Hg 至-500 mm Hg之範圍中’或更典型地係處在_1〇〇 mm Hg • 至-300 mm Hg之範圍中。該裝置166可以係一壓力反饋裝 置、一體積偵測系統、一血液偵測系統、一感染偵測系 統、一流動監視系統、一溫度監視系統等等。這些裝置之 某些可與其他部分一體成形;例如,該罐子162可包括一 或多個過濾器,例如一用以防止液體離開之疏水性過濾 器。 已有許多方法來形成可使用於該減壓、傷口閉合及洽療 140503.doc •15- 201016254 系統100之減壓。在如圖所示之說明性實施例中,該第一 減壓單元150係可兼用於傷口閉合及減壓治療之應用。在 一替代形式之實施例中,其適當地使用該第一減壓單元 150作為用於該第二減壓輸送導管156之源且具有一第二減 壓單元15 1(以虛線表示;)以輸送減壓至該減壓導管158。 作為該減壓、傷口閉合及治療系統丨〇〇之一態樣其最 好有助於提供一閉合力至該表面傷口 U1,且更具體而 言,係施加一閉合力於該等傷口邊緣112之間。如圖丨及2 所示’該傷口閉合子系統1〇4可用於此一目的。該傷口閉 合子系統104產生一由箭頭!70所表示之閉合力。該閉合力 係傳達至該患者的表皮1〇8且使該等傷口邊緣112朝向彼此 趨合。該傷口閉合子系統104可以係一用於閉合任何表面 傷口之獨立系統或可用以作為一較大系統(例如該減壓、 傷口閉合及治療系統100)之一部分。 該傷口閉合子系統104可包括複數個附接構件,例如一 第附接構件172及一第二附接構件184,其等係反向隔開 且靠近表面傷口 ill之傷口邊緣112。該第一附接構件172 具有一第一基部構件174及一第一壁部構件〗76。該第一基 部構件174具有一第一側178及一第二、面向(面向患者)側 180 〇該第一基部構件174及第一壁部構件176可由多種材 料製成’但以可提供某些可撓性之一材料為佳;例如,該 第一附接構件172可形成有第一基部構件174及該第一壁部 構件176係由聚丙烯或一硬質聚矽氧等材料所製成。一第 一黏膠182或另一附接裝置可被施加至第一基部構件174之 140503.doc -16- 201016254 第二、面向内(面向患者)側1 80,以使得該第一基部構件 174係可釋放地直接附接至該患者的表皮1〇8之一部分或者 若一聚胺基甲酸酯薄膜或另一密封構件丨3 2先被置放在該 表皮108上則便間接地附接。除了黏膠182以外,黏结材 料、U形釘或縫合線,或者其他侵入性或非侵入性手段可 用以將該第一基部構件174附接至完好的表皮組織。該第 一附接構件172可直接施加在表皮1〇8之頂部,使得無論任 籲 何力量被施加在該第一附接構件172上都可被直接或間接 地傳送至該表皮108。所謂施加該附接構件172至表皮1〇8 應視為包括施加在該密封構件i32之頂部上。 該第二附接構件丨84係幾乎從該第一附接構件172直接地 橫越該表面傷口 1U,例如表皮傷口。該第二附接構件184 係類似於第一附接構件172。雖然該傷口閉合子系統1〇4僅 顯不兩個附接構件172、184,然而其他的附接構件可以間 隔方式散佈於該表面傷口 1U周圍。此兩個附接構件172、 • I84配合一密封收縮構件188係可使由箭頭170所表示之閉 合力被產生,但額外的附接構件則允許力量被徑向橫越該 • 表面傷口 111之不同形狀來產生。 一或多個附接構件,例如附接構件i 72,係具有一用於 接收來自於該第二減壓輸送導管156之減壓的減壓界面。 例如,如圖2清楚所示,該第一附接構件172可包括一第二 減壓界面1 83。經由該第二減壓界面i 83所輸送之該減麗係 用以產生該閉合力。 該傷口閉合子系統104包括用以產生該閉合力之密封收 140503.doc -17- 201016254 縮構件188。該密封收縮構件ι88可由一收縮歧管材料或構 件所形成,其可以與該歧管n8為相同類型的材料。或 者,其可適當地使用一收縮歧管材料,其具有比用於歧管 118或一氣動式裝置之材料還要少的孔隙或細孔。此外, 亦可適當地具有一材料,且在垂直方向(圖】中所示之定向) 具有較少收縮性而在水平或橫向平面(圖!中所示之定向)上 具有較多收縮性。該密封收縮構件188具有一第一側19〇及 一第二、面向内(面向患者)側〗92。該密封收縮構件188亦 具有一周緣邊緣194。該密封收縮構件188可藉由具有施加 ❹ 至該第一側190之一第一密封構件丨96(圖2)及施加至該密封 收縮構件188之第二、面向内側192且密封周緣邊緣194之 一第二密封構件198而被密封。 該密封收縮構件188之周緣邊緣194可藉由一周緣密封構 件200予以密封。替代地或額外地,該第一壁部構件176亦 可用以作為該周緣密封構件以密封該周緣邊緣194或可採 用另一個密封性材料件。同樣地,該第二、面向内側192 亦可藉由置靠於密封構件132或患者的表皮1〇8上而被予密 © 封。該密封收縮構件i 88亦可藉由塗覆一不透氣材料而被 岔封。該密封收縮構件i 88可藉由第一及第二密封構件 . 、198予以密封,該等密封構件係由一聚胺基甲酸酯薄 , 膜或聚石夕氧所形成。該第一及第二密封構件196、198在其 兩端部可以超音波溶接、或RF熔接或其他方式耦接以覆蓋 〇玄周緣邊緣194。當減壓被施加至該密封收縮構件1 88時, °亥达、封收縮構件1 88會收縮以產生一閉合力,其係由箭頭 140503.doc -18- 201016254 170所表示。 該密封收縮構件1 8 8在該密封收縮構件18 8用以收納第一 減壓界面138之一延伸部分202的一部分上可形成有一開口 201。遠延伸部分202可延伸通過該密封收縮構件1 88且進 入至該歧管118。在一替代形式之實施例中,該第二減壓 界面183及該第二減壓輸送導管156可被省略且該第一減壓 ‘界面138的一部分係流體式地耦接至該密封收縮構件188。 因此,在此一替代性實施例中,可使用一單一減壓源及導 管來提供一閉合力且用於減壓治療。這真針對圖从及5B 之說明性實施例亦係如此。 在操作時,该減壓傷口閉合及治療系統1 〇〇可藉由首先 施加一歧管材料在該腹部内容物U6上而使用在一體腔 中,例如腹腔110。例如,具有非黏性封套122之歧管構件 120可放置在該腹部内容物116上且該歧管U8被安置成靠 近该非黏性封套122 〇該表面傷口丨丨i之傷口邊緣丨丨2係儘 參 可能的的程度攏合在一起,且然後該密封構件132被放置 在表皮108上以在表面傷口 in上提供一氣動式密封。該第 . 一附接構件172可利用第一黏膠182而施加至靠近傷口邊緣 112之患者的表皮108上(或如圖示在密封構件132上)。同樣 地’該第二附接構件1 84可施加於在相反側邊上靠近該傷 口邊緣112處。不論係在該第一及第二附接構件172及184 被施加至該表皮108之前或之後,該密封收縮構件188係被 麵接該第一及第二附接構件172及184。此耦接能以不同方 式來達成’諸如藉由利用黏膠189及191、黏結劑、黏著劑 140503.doc 19- 201016254 等等。可以作為該減壓埠口 140之第一減壓界面i38可被應 用而使得-延伸部分2G2伸人至該歧管U8t。該第一減麼 輸送導管142可流體式地純至該第—減壓界面138且流體 式地耦接至該第一減壓單元15〇(或一可選擇的第二減壓單 几151)。該第二減壓輸送導管156可流體式地耦接至該第 二減壓界面183。 該減壓、傷口閉合及治療系統1〇〇被啟動而使得第一減 壓單元150輸送減壓通過該三通閥154,該三通閥準備好經 由減壓導管158而被輸送至該第一減壓輸送導管142之第二 減壓(或治療減壓),以及被輸送至該第二減壓輸送導管156 之第一減壓(或閉合減壓)。經由該第一減壓輸送導管M2被 輸送之治療減壓係在歧管118處被實現,該歧管係拉引由 箭頭144及128所標示之流體且分佈減壓於該腹腔丨1〇中。 在此同時,該閉合減壓係經由第二減壓輸送導管156輸送 至密封收縮構件188,其造成密封收縮構件188收縮而產生 一由箭頭170所表示之閉合力,該閉合力將第一及第二附 接構件172及184及連帶將傷口邊緣112朝向彼此拉攏在一 起。 現請參考圖3A至圖3C ’其中顯示一用以在一表面傷口 上提供一閉合力之減壓閉合裝置300。該減壓閉合裝置3〇〇 可用以作為一減壓、傷口閉合及治療系統之部分,諸如圖 1之減壓、傷口閉合及治療系統1 〇〇,或者作為一獨立式裝 置。該減壓閉合裝置300具有複數個附接構件:一第—附 接構件302、一第二附接構件304、一第三附接構件3〇6及 140503.doc -20- 201016254 一第四附接構件308。每一附接構件3〇2、3〇4、3〇6 3〇8 具有一用以可釋放地附接該附接構件至患者的表皮(或至 密封構件)之附接裝置。例如,該第一附接構件3〇2包括 用以將第一附接構件3 02附接至患者的表皮之黏膠31 〇, 且同樣地,該第三附接構件3〇6具有一黏膠312。雖然未圖 不,该第二及第四附接構件亦具有—裝置,諸如一用以將 附接構件牢固至一患者的表皮之黏膠。雖然一般認為非侵 入式構件係較佳的,然而該等附接構件3〇2、3〇4、3〇6及 308亦可利用縫合線、u形釘或其他侵入式機械構件來予以 牢固。此外,亦可使用其他非侵入式附接裝置,諸如黏結 劑、黏著劑等等。 被耦接至複數個附接構件之一壁部314係形成一圓周壁 部,其具有一可放置一收縮構件3 16或收縮材料之内部空 間。該密封收縮構件316係在至少靠近每一附接構件3〇2、 304、306、308之位置點處被附接至壁部314。該壁部314 可由聚丙烯、硬質聚矽氧或當密封收縮構件316收縮時允 許該壁部314撓曲之其他半硬質材料所製成。該壁部314可 模製、模鑄或利用其他技術來形成。該密封收縮構件316 可由與圖1中之密封收縮構件丨88相同類型的材料所製成。 密封收縮構件3 16必須被密封且可藉由薄膜、層體或敷巾 予以後封。在密封收縮構件316上之薄膜或其他材料可被 施加至該第一側或一頂側318(針對圖示之定向)。該密封收 縮構件3 16亦可被至少部分由覆蓋該周緣邊緣之壁部3丨4、 在底部上提供一密封之一密封構件(例如圖丨中之密封構件 140503.doc •21· 201016254 132)、及一放置在頂側318上之一薄獏或敷巾來予以密 封。一密封劑亦可散佈在該頂側3 18上以形成—密封。嗜 密封收縮構件316可僅被封圍在一聚胺基甲酸酯薄膜中, 該已被熔接以形成一包圍該收縮構件3 16之封套。一開口 320可貫穿該密封收縮構件316而形成。該開口 32〇允許一 延伸至一歧管(例如圖丨中之歧管118)之一減壓界面的部分 放置在該減壓閉合裝置300的下方。該開口 32〇係類似於圖 1中之開口 20 1且可取決於所要用途來予以選擇。一減壓導 管322輸送減壓至密封收縮構件316中,這可藉由直接施加 該減壓導管322至密封收縮構件316之任何部分中來達成, 但亦可利用一形成在該壁部314之一部分上之減壓界面 324(例如一埠口)來達成。 在操作時,該等附接構件3〇2、304、306及308係放置在 表面傷口周圍且可釋放地附接至表皮(或密封構件)。相對 的附接構件(例如附接構件302及304)係位在表面傷口之相 對側邊上。因此,例如第一附接構件3〇2及第四附接構件 308係各自可釋放地被牢固至一傷口之位在不同間隔部分 處之一側邊上且附接構件3〇4及306係各自被放置在該傷口 之相對側邊上。當減壓閉合裝置3〇〇被安裝時,該減壓閉 合裝置300 —開始係位在非收縮位置中。一旦安裝後,減 壓被供應至該減壓導管322且該密封收縮構件3 16收縮而造 成外側壁部3 14之至少部分被朝向彼此拉攏且接著產生被 傳送於附接構件(例如302及304之間)的閉合力。因此,該 閉合力被產生且經由附接構件3〇2、3〇4、3〇6及3〇8而傳送 至表皮。圖3B顯示位在一非收縮位置之減壓閉合裝置 140503.doc -22- 201016254 300,且圖3C顯示位在收縮位置之減壓閉合裝置3〇〇。 現請參考圖4Α及4Β,其中顯示一減壓連接器4〇〇之—說 .明性實施例。該減壓連接器4〇〇係可操作以流體式連接兩 個不同的隔室或區域。在圖4Α及4Β之說明性實施例令, 該減壓連接器400具有一第一端部4〇2及—第二端部4〇4。 一進入部分406係形成在該第二端部4〇4上。該進入部分 406可經塑形為一倒置圓錐部分以有助於插入通過各種不 籲 同材料(諸如密封構件及歧管)。在該第一端部402上係定位 在複數個流槽408以有助於流體流動。一凸緣部分41〇可形 成在第一端部402與第二端部404之間。該凸緣部分41〇具 有一第一表面412及一第二表面414。在—替代形式之實施 例中,該第一端部402亦可經塑形且經構形以易於進入通 過一密封構件或其他材料。在圖5八及沾中顯示該減塵連 接器400之兩個不同的說明性應用。 請參考圖5Α,其中顯示—減壓、傷口閉合及治療系統 • 5〇〇之一部分。該減壓、傷口閉合及治療系統5〇〇大部分係 類似於圖1之減壓、傷口閉合及治療系統1〇〇,且大致上以 • 相同元件標號加上400來標示類似部件。一歧管518係故置 S -體腔(例如-腹腔510)以有助於在其中提供減壓治療。 圊示之該歧管518係靠近皮下組織514及一表面傷口 5ΐι。 一密封構件532係放置在該腹腔51〇及該表面傷口 5ιι上 之一患者的表皮508上。該表面傷σ5π具有傷口邊緣 512。該密封構件532具有一用以輔助與該患者的表皮5〇8 形成一氣動式密封之黏膠534 ^該密封構件532當施加時係 140503.doc -23- 201016254 在該腹腔510上方形成一氣動式密封。 圖中亦顯示一傷口閉合裝置或子系統之一部分571。該 部分571包括一密封收縮構件588之一部分。該密封收縮構 件5 88係至少部分藉由一第一密封構件596及一第二密封構 件598予以密封。該密封收縮構件588係至少在特定部分附 接至患者的表皮508 ^當減壓被供應至該密封收縮構件588 之一内部時,該密封收縮構件588收縮且藉此朝内拉攏且 產生一被傳送至表面傷口 511之閉合力。 在圖5A及5B之說明性實施例中,減壓係藉由一減壓源 供應至一減壓導管542。該減壓導管542係流體式地耦接至 一減壓界面538,該減壓界面係具有一延伸部分6〇2。在圖 5A之實施例中,該延伸部分6〇2延伸通過該密封構件^二且 進入至該歧管518中。因此,減壓被輸送至歧管518且將流 體拉向該延伸部分602,如箭頭544所示。在此一實施例 中,已增添該減壓連接器400。該減壓連接器4〇〇係經部署 而使該第一端部402位在密封收縮構件588之内部且使該第 二端部404位在歧管518中。該減壓連接器4〇〇藉此流體式 地搞接密封收縮構件588之内部與歧管518。減壓藉此從該 減壓界面538被輸送至該歧管518且被輸送至該密封收縮構 件588的内部。經由減壓連接器4〇〇被輸送的減壓係拉引位 在該密封收縮構件588中之流體,如箭頭545所標示。 該減壓連接器400之第一表面41 2抵靠密封構件532且該 第二表面414抵靠歧管518。該減壓連接器4〇〇能以多種方 式來部署。例如,參考圖3A及5A,該減壓連接器4〇〇可放 140503.doc •24- 201016254 置在密封收縮構件316之—氣室(例如氣室325)上方且被推 壓通過其上之密封構件。該進入部分406係經塑形以有助 . 於此進入其上之密封構件應在插入後自行密封,但密 封材料之-額外部分亦可增添於該插入點上方。在插入期 間’該減壓連接器4GG係被推人至該密封收縮構件316直到 該第表面414抵罪第二(針對圖示之定向的底部)密封構件 598且該進入部分4〇6從該密封收縮構件316延伸而出。現 φ 請主要參考圖5A,該進入部分406接著可被插入通過該密 封構件532且進人至歧管5財。如先前所述,可以採用許 多手段來部署該減壓連接器4〇〇且該減壓連#器4〇〇可以採 用許多不同的構形,但該經部署之減壓連接器4〇〇在功能 上係提供該密封收縮構件588與該歧管518之一流體式耦 接。 現請參考圖5B,其中顯示另一變化型式。在圖5B之實 施例中,該減壓界面538之延伸部分6〇2係終止於密封收縮 φ 構件588中且輸送密封收縮構件588中之減壓。該減壓連接 器400係以相同於先前所述之方式部署,但在此係輸送減 • 壓至歧管5 18。換言之,流體係經由該歧管5 18被抽吸通過 該減壓連接器400且通過該密封收縮構件588之一内部而到 達減壓界面538之延伸部分602且然後通過該減壓導管 542 ° 雖然已在某些說明性、非限制性實施例之背景中揭禾了 本發明及其優點,但應暸解,仍可實施各種改變、替代、 變換及變更,而不背離由隨附申請專利範圍界定之本發明 140503.doc -25· 201016254 之範疇。 【圖式簡單說明】 圖1係一減壓'傷口閉合及治療系統之一說明性實施例 的概要橫截面,其中一部分係以方塊示意圖顯示; 圖2係圖1之該減壓、傷口閉合及治療系统之—部分的概 要橫截面視圖; 圖3 A係一減壓、傷口閉合系統之一部分之一 說明性實施 例的概要、立體視圖; 圖3B及3C係圖3A之說明性實施例的概要平面視圖,其 中分別顯示處在一非收縮位置(圖3B)及一收縮位置(圖 3C); 圖4A係一減壓連接器之一概要立體視圖; 圖4B係圖4A之減壓連接器的正視圖; 圖5A係一減壓、傷口閉合及治療系統之另一說明性實施 例之一部分的概要橫截面視圖;及 圖5B係一減壓、傷口閉合及治療系統之另一說明性實施 例之一部分的概要橫截面視圖。 【主要元件符號說明】 100 減壓、傷口閉合及治療系統 102 減壓治療子系統 104 傷口閉合子系統 106 組織部位 108 表皮 110 腹腔 140503.doc -26 - 201016254 * Ill 表面傷口 112 傷口邊緣 114 皮下組織 116 腹部内容物 118 歧管 120 歧管構件 122 非黏性封套 ❹ 124 孔隙 126 孔隙 128 箭頭 132 密封構件 134 黏膠 136 附接裝置 138 第一減壓界面 140 蟀口 ❹ 142 第一減壓輸送導管 144 箭頭 148 減壓子系統 150 第一減壓單元 151 第二減壓單元 152 供應導管 154 三通閥 156 第二減壓輸送導管 158 減壓導管 140503.doc -27- 201016254 160 162 164 166 170 172 174 176 178 180 182 183 184 188 189 190 191 192 194 196 198 200 201 202 減壓反饋單元 罐子 中間部分 代表性裝置 箭頭 第一附接構件 第一基部構件 第一壁部構件 第一側 第二、面内(面向患者)側 第一黏膠 第二減壓界面 第二附接構件 密封收縮構件 黏膠 第一側 黏膠 第二、面向内側 周緣邊緣 第一密封構件 第二密封構件 周緣密封構件 開口 延伸部分 140503.doc -28- 201016254 300 減壓閉合裝置 302 第一附接構件 304 第二附接構件 306 第三附接構件 308 第四附接構件 310 黏膠 312 黏膠 314 壁部 316 收縮構件 318 頂側 320 開口 322 減壓導管 324 減壓界面 325 氣室 400 減壓連接器 402 第一端部 404 第二端部 406 進入部分 408 流槽 410 凸緣部分 412 第一表面 414 第二表面 500 減壓、傷口閉合及治療系統 508 患者的表皮 140503.doc ·29· 201016254 510 腹腔 511 表面傷口 512 傷口邊緣 514 皮下組織 518 歧管 532 密封構件 534 黏膠 538 減壓界面 542 減壓導管 544 箭頭 545 箭頭 571 部分 588 密封收縮構件 596 第一密封構件 598 第二密封構件 602 延伸部分 140503.doc -30
Claims (1)
- 201016254 七、申請專利範圍: 1_ 一種用於提供一閉合力至一患者上之一表面傷口的減 壓、傷口閉合系統,該減壓、傷口閉合系統包含: 一第一附接構件,其用於可釋放地附接至該患者的表 皮之一靠近該表面傷口之一邊緣的第一部分;一第二附接構件,其用於可釋放地附接至該患者的表 皮之一靠近該表面傷口之該邊緣的第二部分,其中該第 一附接構件係與該第二附接構件隔開; 弟一附接構件及該第 选封收縮構件,其被斜接 二附接構件且可操作以在減壓作用下收縮;且 其中當減壓被供應至該密封收縮構件時,在該第一附 接構件與該第二附接構件之間係產生一閉合力。 2. I:求項1之減壓、傷口閉合系統’其進-步包含-被 接至該第二附接構件之減壓界面。 3. 如請求項1之減壓、傷口閉合系統,其中: 附接構件包含一第一基部構件及—第一黏膠;且 4如=二附接構件包含-第二基部構件及-第二黏路。 I之減壓、傷口閉合系統,其進-步包含-被 構件壁部構件及—被料至該壁部 稱件之減壓界面。 其中該密封收縮榻 5·如請求項1之減壓、傷m统 件包含: 第二、面向患 —收縮歧管材料, 者側與一周緣邊緣; 其具有一第一側及 140503.doc 201016254 之 密封構件,其被安4成#近該㈣歧管材料 近該收縮歧管材料之 該第 第二密封構件,其被安置成靠 、面向患者側; 周緣雄封構件,其被安置成抵靠於該收縮歧管材料 之該周緣邊緣;且 該第一密封構件、第二密封構件及周緣密封構件 系可操作以氣動式地密封該收縮歧管材料。 項5之減壓、傷口閉合系統,其中該周緣密封構 件係包含一第三密封層。 7.如請求項5之減壓、傷口閉合系統,其中該周緣密封構 件包含一壁部。 附接構 8·如請求項1之減壓、傷口閉合系統,其中該第一 件包含: 一第一基部構件,其具有一第一側及一第二、面向 側; 一第一壁部’其被耦接至該第一基部構件;及 粵 一第一黏膠,其被耦接至該第一基部構件之該第二、 面向内側。 9. -種用於提供一閉合力至一患者上之一表面傷口的減 壓、傷口閉合系統,該減壓、傷口閉合系統包含: 複數個附接構件,其用於可釋放地附接至靠近該表面 傷口之一邊緣的該患者的表皮; 一圓周壁部,其被耦接至該複數個附接構件,該圓周 140503.doc -2- 201016254 壁部係用於設置在靠近該表面傷口; 一密封收縮構件,其被耦接至該圓周壁部之至少一部 分且可操作以在減壓作用下收縮; 減壓源,其被流體式地耦接至該密封收縮構件且可 操作以輸送一減壓至該密封收縮構件;且 其中當該減壓由該減壓源供應至該密封收縮構件時係 產生一閉合力。 ίο. 11. 12. 13. 如-月求項9之減壓、傷口閉合系统,其中該圓周壁部包 含聚丙埽。 如請求項9之減壓、傷口閉合系統,其中該圓周壁部包 含硬質聚石夕氧。 如請求項9之減壓、傷口閉合系統,其中該複數個附接 構件之每—附接構件係包含—第—基部構件及一第一黏 膠。 s求項9之減壓、傷口閉合系統,其中該密封收缩構 件包含: 收縮歧管材料’其具有一第一側及一第二、面向内 側與一周緣邊緣; 第ϋ構件’其被安置成靠近純縮歧管材料之 該第一側; …第’封構4牛,其被安置成靠近該收縮歧管材料之 a玄苐一、面向内側; ▲ °緣②封構件,其被安置成靠近該收縮歧管材料之 該周緣邊緣;且 140503.doc 201016254 其中該第一密封構件 係可操作以氣動式地密 14 15 16 17. .如請求項13之減漫、傷口閉合系統 件係包含一第三密封構件。 、第二密封構件及周緣密封構件 封該收縮歧管材料。 •如請求項13之減壓、傷口閉合系統 件包含一壁部。 如請求項13之減壓、 構件之每一者包含: 一第一基部構件, 側; 其中該周緣密封構 其中該周緣密封構 傷口閉合系統,其中該複數個附接 其具有一第一側及一第二、面向内 第-壁部’其被耦接至該第一基部構件;及 第黏膠纟被輕接至該第一基部構件之該第二、 面向内側。 -種用於提供一閉合力至一患者上之一表面傷口且用於 輸送減壓至-組織部位之減壓、傷口閉合及治療系統, 該減墨傷口閉合及治& # & & j : 一傷口閉合子系統,其包含: 第附接構件,其用於可釋放地附接至該患者的 表皮之—靠近該表面傷口之-邊緣的第-部分, 第一附接構件,其用於可釋放地附接至該患者的 表皮之—罪近該表面傷口之該邊緣的第二部分,其中該 第-附接構件係與該第二附接構件隔開, 一在封收縮構件,其被耦接至該第一附接構件及該 第附接構件且可操作以在減Μ作用下收縮, 140503.doc•4· 201016254 -閉合、減壓源,其可操作以輸送一第一減壓至該 密封收縮構件, ‘ #中#該第一減麼被供應至該密封收縮構件時,在 該第-附接構件與該第二附接構件之間係產生一閉合 力,及 一減壓治療子系統,其包含: . 。一歧管,其用於設置成靠近該組織部位,該歧管可 籲 操作以分佈減壓且用以接收流體, -密封構件,其詩放置在該患者的表皮上且可操 作以在該歧管上方形成一氣動式密封,及 一治療、減壓源,其可操作以輸送—第二減壓至該 歧管。 I8·如請求項17之減壓、傷°閉合及治療系統,其中該閉 合、減壓源包含該治療、減慶源。 19. 如請求項17之減壓、傷口閉合及治㈣統,其中㈣ φ 合、減壓源及該治療、減壓源包含: 一減壓單元; . 一減壓界面; 減壓輸送導管,其可操作以流體式地耦接該減璧單 元及該減壓界面; 其中該減壓界面係可操作以流體式軸接至該歧管;及 一減壓連接器,其可操作以流體式地耗接該密封收縮 構件及該歧管。 20. 如請求項17之減壓、傷口閉合及治療系統,其中該閉 140503.doc 201016254 合、減壓源及該治療、減壓源包含: 一減壓單元; 一減壓界面; 一減壓輸送導管,其可操作以流體式地耦接該減壓單 元及該減壓界面; 其中該減壓界面係可操作以流體式地耦接至該密封收 縮構件;及 一減Μ連接器’其可操作以流體式地耦接該密封收縮 構件及該歧管。 21. 如請求項17之減壓、傷口閉合及治療系統,其中該第二 減壓係介於-100 mm Hg及-350 mm Hg之間。 22. —種製造一用於提供一閉合力至一患者上之一表面傷口 的減壓、傷口閉合系統之方法,該方法包含以下之步 驟: 形成一第一附接構件,其用於可釋放地附接至該患者 的表皮之一靠近該表面傷口之一邊緣的第一部分; 形成一第二附接構件,其用於可釋放地附接至該患者 的表皮之一靠近該表面傷口之該邊緣的第二部分; 形成一密封收縮構件,其可操作以在減壓作用下收 縮;及 形成一減壓界面。 23. 如請求項22之製造方法,其進一步包含麵接該密封收縮 構件至該第一附接構件及該第二附接構件。 24. 如睛求項22之製造方法,其進—步包含流體式地耗接該 140503.doc -6 - 201016254 減壓界面至該密封收縮構件之步驟。 圓周壁部 二附捿構 25.如請求項22之製造方法,其進一步包含形成_ 且耦接該圓周壁部至該第一附接構件及該第 件。如請求項22之製造方法,其中耦接該密封收縮構件至該 第一附接構件及該第二附接構件之該步驟係包含耦接該 密封收縮構件至該圓周壁部之至少一部分的步驟。 一種提供一閉合力至一患者之一表面傷口的方法,該方 法包含以下之步驟: 可釋放地附接一第一附接構件至該患者的表皮之一靠 近該表面傷口之一邊緣的第一部分; 可釋放地附接一第二附接構件至該患者的表皮之—靠 近該表面傷口之該邊緣的第二部分,其中該第—附接構 件係與該第二附接構件隔開; 二提供一密封收縮構件,其被耦接至該第一附接構件及 第一附接構件且可操作以當處在減壓作用下會收縮丨及 么、應減壓至該密封收縮構件,藉此在該第一附接構件 及該第二附接構件之間產生一閉合力。 140503.doc
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TW098116493A TW201016201A (en) | 2008-10-29 | 2009-05-18 | Reduced-pressure, deep-tissue closure systems and methods |
TW098116472A TW201016252A (en) | 2008-10-29 | 2009-05-18 | Reduced-pressure, abdominal treatment systems and methods |
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TW098116475A TW201016253A (en) | 2008-10-29 | 2009-05-18 | Modular, reduced-pressure, wound-closure systems and methods |
TW098116467A TW201016251A (en) | 2008-10-29 | 2009-05-18 | Modular, reduced-pressure, wound-closure systems and methods |
TW098116477A TW201016256A (en) | 2008-10-29 | 2009-05-18 | Open-cavity, reduced-pressure treatment devices and systems |
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US (17) | US8142419B2 (zh) |
EP (14) | EP2896414B8 (zh) |
JP (12) | JP5329672B2 (zh) |
KR (7) | KR20110083693A (zh) |
CN (10) | CN102196829B (zh) |
AU (6) | AU2009310389B2 (zh) |
BR (5) | BRPI0914485A2 (zh) |
CA (6) | CA2741737C (zh) |
HK (1) | HK1159003A1 (zh) |
MX (6) | MX2011004524A (zh) |
RU (6) | RU2011114219A (zh) |
TW (6) | TW201016201A (zh) |
WO (6) | WO2010051073A1 (zh) |
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