TW201141448A - Dressings and methods for treating a tissue site on a patient - Google Patents
Dressings and methods for treating a tissue site on a patient Download PDFInfo
- Publication number
- TW201141448A TW201141448A TW100113257A TW100113257A TW201141448A TW 201141448 A TW201141448 A TW 201141448A TW 100113257 A TW100113257 A TW 100113257A TW 100113257 A TW100113257 A TW 100113257A TW 201141448 A TW201141448 A TW 201141448A
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- TW
- Taiwan
- Prior art keywords
- dressing
- cover
- tissue site
- liquid
- sealed space
- Prior art date
Links
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Classifications
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
- A61M1/98—Containers specifically adapted for negative pressure wound therapy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
- A61M1/98—Containers specifically adapted for negative pressure wound therapy
- A61M1/984—Containers specifically adapted for negative pressure wound therapy portable on the body
- A61M1/985—Containers specifically adapted for negative pressure wound therapy portable on the body the dressing itself forming the collection container
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00089—Wound bandages
- A61F2013/00119—Wound bandages elastic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00089—Wound bandages
- A61F2013/00246—Wound bandages in a special way pervious to air or vapours
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00361—Plasters
- A61F2013/00365—Plasters use
- A61F2013/00536—Plasters use for draining or irrigating wounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00361—Plasters
- A61F2013/00727—Plasters means for wound humidity control
- A61F2013/00731—Plasters means for wound humidity control with absorbing pads
- A61F2013/0074—Plasters means for wound humidity control with absorbing pads containing foams
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/71—Suction drainage systems
- A61M1/77—Suction-irrigation systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/80—Suction pumps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/75—General characteristics of the apparatus with filters
- A61M2205/7527—General characteristics of the apparatus with filters liquophilic, hydrophilic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/75—General characteristics of the apparatus with filters
- A61M2205/7536—General characteristics of the apparatus with filters allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Pulmonology (AREA)
- Surgery (AREA)
- Dermatology (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- External Artificial Organs (AREA)
- Surgical Instruments (AREA)
- Separation Using Semi-Permeable Membranes (AREA)
- Jet Pumps And Other Pumps (AREA)
Description
201141448 六、發明說明: 【發明所屬之技術領域】 本發月揭示内谷概言之係關於醫療系、統,且更具體而言 (仁不限於)係關於處理病患組織部位之敷料、方法及系 統。 ‘ 本發明主張以下文件在35 use第U9(e)部分下之權利: ^2010^-6^ 28 a f sf ^ r Evaporative Body Fluid
Containers and Meth〇ds」之美國臨時專利申請案第 61/359,2G5號’該專利出於所有目的以引用方式併入本文 中;於2010年4月16日申請之標題為「Reduced-Pressure Sources, Systems, and Methods Employing A Polymeric, Porous, Hydrophobic Material」之美國臨時專利申請案第 61/325,115號’該專利出於所有目的以引用方式併入本文 中,及於2010年6月28日申請之標題為「Dressings and Methods For Treating a Tissue Site On A patient」之美國臨 ◎ 時專利申凊案第61/359,1 81號,該專利出於所有目的以引 用方式併入本文中。 【先前技術】 ' 臨床研究及實踐已顯示將減壓提供至鄰近組織部位處可 ^ 增進並加速組織部位處新組織之生長。此現象之應用眾 多,但減壓之應用在處理傷口方面尤為成功。此處理(在 醤界通常稱為「負壓傷口療法」、「減壓療法」或「真空療 法」)提供可包括快速癒合及增加肉芽組織形成在内之多 種ϋ處。人們相信使用減壓處理低嚴重程度傷口亦將獲得 155464.doc 201141448 益處,但仍存在若干問題。 【發明内容】 括= 月性實施例,用於處理病患組織部位之敷料包 、η、組織部位處之傷口介面部件及覆件。 部分包含具有液體不可滲透、蒸氣可渗^膜之& “。该覆件可操作以在組織部位上方形成密封空間。該 液體不可滲透、蒸氣可滲透之膜容許密封空間中之所蒸發 ^例如’水洛氣或預充液)流出密封空間。所蒸發液體 之&出可在密封空間中產生減壓。 , 根據一說明性實施例,使用減壓處理組織部位之方法包 ; 71面部件置於鄰近組織部位處及用具有蒸發窗之 覆件覆蓋傷口介面部件。該蒸發窗包含液體不可滲透、蒸 孔可滲透之膜。該覆件在傷口介面部件上方形成密封空 間。邊方法進—步包括使來自組織部位之液體蒸發並經由 夜體不可滲透、瘵氣可滲透之膜流出密封空間。該蒸發可 使得在密封空間中產生減壓。 根據再說明性實施例,製造用於處理組織部位之敷料 之方法包括提供置於鄰近組織部位處之發泡體部件,提供 开y成有瘵發窗開口之覆件,及將液體不可滲透、蒸氣可滲 透之膜與6亥瘵發窗開口相連以形成蒸發窗。該液體不可滲 透γ蒸氣可滲透之膜可操作以容許所蒸發液體經由液體不 可滲透、蒸氣可滲透之膜來傳遞。 叮·^ "、、以下圖式及洋細說明來瞭解說明性實施例之其他 特徵及優點。 155464.doc 201141448 【實施方式】 在說明性實施例之以下詳細說明巾,參照 之附圖。該等實施例係經充分詳細地閣述以使熟習此項技 術者能實踐本發明’且應理解,可利用其他實施例且可作 出邏輯性結構、機械、電氣及化學改變,而不背離本發明 之精神或範4。為避免熟習此項技術者能夠實踐本文^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
已知之特定資訊。因此’不應認為以下詳細說明具有限制 性意義,且說明性實施例之範圍僅由隨附申請專利範圍加 以界定。 參照圖式且首先參照圖1,其展示用於處理病患1〇4組織 部位丨02之敷料10卜敷料100尤其包括容許所蒸發液體流 出敷料100之覆件108。組織部位102可為任何人類、動物 或其他生物體之身體組織,包括骨組織、脂肪组織、肌肉 組織、真皮組織、血管組織、結締組織、軟骨、腱、勒帶 或任一其他組織。 敷料100包括傷口介面部件(例如發泡體部件1〇6或紗 布)’其置於鄰近組織部位102處。敷料丨0〇亦包括覆件 108覆件1 〇 8之至少一部分形成有蒸發窗開口或孔口 128 ’該蒸發窗開口或孔口 128經液體不可滲透、蒸氣可滲 透之膜112覆蓋以形成蒸發窗丨10。覆件1〇8在組織部位1〇2 及發泡體部件1 〇6上方形成密封空間114。液體不可滲透、 ?备氣可滲透之膜112可操作以容許密封空間114中之已蒸發 液體(例如’水)如箭頭116所示流出密封空間114。舉例而 155464.doc 201141448 言,可將體液自組織部位102吸入發泡體部件ι〇6中且水可 自體液蒸發以形成水蒸氣而經由液體不可渗透、蒸氣可渗 透之膜112流出密封空間丨丨4。 可將發泡體部件106置於鄰近組織部位1〇2處並在減壓影 響下有助於自組織部位102去除液體(例如,體液)且可幫助 將減壓分佈至組織部位1()2。因此,發泡體部件⑽充當歧 管。本文所用術語「歧管」通常係指經提供以幫助向組織 部位102施加減壓、向其輸送流體或自其去除流體之物質 或結構。發泡體部件106或歧管通常包括複數個流動通道 或路徑,該等流動通道或路徑將提供至組織部位1〇2及自 其去除之流體分佈在發泡體部件1〇6周圍。在一說明性實 施例中,流動通道或路徑互連以改良所提供流體或自組織 部位102去除之流體之分佈。發泡體部件1〇6可為能經置放 而與組織部位1 02接觸並將減壓分佈至組織部位i 〇2之生物 相容性材料。傷口介面部件之實例可包括(例如但不限於) 具有以下之裝置:經佈置以形成流動通道之結構元件,例 如蜂窩狀發泡體、開孔發泡體、多孔組織收集件、包括或 固化後包括流動通道之液體、凝膠及發泡體。 —般來說,傷口介面部件118可係多孔且可係由發泡 體、紗布、蘇墊或任一其他適合特定生物應用之材料製 成。在一實施例中,傷口介面部件丨丨8包含發泡體部件】〇6 且係包括複數個互連泡孔或孔隙用作流動通道之多孔發泡 肢。多孔發泡體可係聚胺基曱酸醋、開孔、網狀發泡體, 例如由 Kinetic Concepts有限公司(San Ant〇ni〇, Texas)製造 155464.doc 201141448 之GranuFoam®材料。在一說明性實施例中,發泡體部件 106係疏水性或親水性聚胺基曱酸酯發泡體。發泡體部件 106可係另一開孔撓性聚合物發泡體,例如聚稀烴、乙稀 乙酸乙烯酯、聚矽氧、氟聚矽氧、氟彈性體、苯乙烯、丁 二烯或熱塑性彈性體。發泡體部件1〇6亦可係本文所提及 之任一其他材料。在某些情形下,發泡體部件1〇6亦可用 於將流體(例如藥物、抗菌藥、生長因子及各種溶液)分佈 〇 至組織部位1〇2。在發泡體部件1〇6中或其上可包括其他 層,例如吸收性材料、芯吸材料、疏水性材料及親水性材 料。 發泡體部件1 〇6可含有預充液或部分地或完全地經預充 液飽和預充液自發泡體部件1 0 6蒸發以幫助在密封空間 114内產生減壓。本文所用「產生減壓」或類似表達包括 (但不限於)以其他方式增大所產生或所供應之減壓。預充 液或預充溶劑可為蒸餾水、經處理以去除離子内含物之 〇 水、水、或有機溶劑(例如醇及其他極性溶劑)。在無預充 液之實施例中,液體(例如,水)自傷口單獨蒸發可產生減 壓。一般而言,來自組織部位102之液體或預充液蒸發可 ’ 使得在密封空間114内產生減塵。在本文件通篇中所用之 - 「或」不需要相互排他性。儘管施加至組織部位之減壓之 量及特性將通常視應用而有所變化,但減壓將通常介於 mm Hg (-667 Pa)與-300 mm Hg (-39.9 kPa)之間且更通常 "於 75 mm Hg (-9_9 kPa)與-300 mm Hg (-39.9 kPa)之間。 舉例而言,且並不限於,壓力可為_12、-12·5、、_i4、 155464.doc 201141448 -14.5、-15、-15.5、-16、-16.5、-17、-17.5、-18、-18.5、 -19、-19.5、-20、-20.5、-21、-21.5、-22、-22.5、-23、 -23.5、-24、-24.5、-25、-25.5、-26、-26.5 kPa或另一壓 力。 本文所用「減壓」通常係指小於正經受處理之組織部位 處之周圍壓力之壓力。在大多數情形中,此減壓將小於病 患所在位置之大氣壓。或者,減壓可小於組織部位處之流 體靜壓。除非另外指示,否則本文所述壓力定量值係表 左與本文所使一致,除非另外指示,否則減壓或真空壓 力之增加通常係指絕對塵力之相對降低。 傷口介面部件Π8(例如,發泡體部件1〇6)經覆件1〇8覆蓋 以產生密封空間114。覆件108具有第一側面12〇及面向病 患之第二側面122。覆件1〇8之面向病患之第二側面丨22可 置於鄰近發泡體部件1〇6處或其上方。覆 一 一第二一。第-部㈣可為任一提=體 雄封之材料。第一部分124可為(例如)不可滲透或半滲透彈 性材料。
「彈性」意指具有彈性體特性。彈性通常係指具有橡膠 狀特J·生之聚合物材料。更特定而言’大多數彈性體具有大 於100%之極限伸長率及較高回彈力。材料之回彈力係指 材料自彈性變形恢復之能力。彈性體之實例可包括(但不 ;)天Λ,、;橡膠、聚異戊二烯、丁苯橡膠、氯丁橡膠、聚 :二烯、了腈橡膠、丁基橡膠、乙丙橡膠、三元乙丙橡 、氯只化聚乙烯、聚琉橡膠、聚胺基甲酸酯(PU)、£VA 155464.doc 201141448 膜、共聚酯及聚矽氧。此外’第一部分124之特定實例包 括在面向病患之側面上具有黏著劑之敷巾、聚矽氧敷巾、 3M Tegaderm®敷巾、pu敷巾,例如購自 Avery Dennison公 司(Pasadena, California)者。 覆件108之第二部分126係液體不可滲透、蒸氣可滲透之 膜112。液體不可滲透、蒸氣可滲透之膜丨丨2容許蒸氣如箭 頭11 6所示離開或流出。同時,液體不可滲透、蒸氣可滲 0 透之膜112容許在容器104内維持減壓。液體不可滲透、蒸 氣可滲透之膜112防止液體傳遞。液體不可滲透、蒸氣可 滲透之膜112係能夠防止液體經由材料流入或流出且可操 作以容許蒸氣(例如,水蒸氣)經由該材料流出或傳遞之任 材料。液體不可滲透、蒸氣可滲透之膜丨丨2之非限制性 說明性實例包括高水蒸氣傳遞率(1^¥7^)膜或其他自親水 性聚合物形成之結構。說明性材料可包括聚乙烯醇、聚乙 酸乙稀醋、基於纖維素之材料(喊、醋、硝酸鹽等)、聚乙 〇 稀基比略°定_、聚胺基曱酸西旨、聚酸胺、聚S旨、聚丙烯酸 西曰及聚甲基丙稀酸醋、或聚丙烯醯胺。用於液體不可滲 & &氣可滲透之材料之蒸氣滲透率係指水蒸氣滲透率。 用於液體不可渗透、蒸氣可渗透之膜112之材料可彼此 乂聯6。、接枝或共聚。用於液體不可渗透、蒸氣可渗 透之膜112之材料可經表面處理以增強親水性。表面處理 可包括化學輕射、電漿輕射、光(UV)輻射、電暈輻射或其 他電離輻射。可囍由取士、/、#、 7成(W注)膜並使—些天然樹膠(例如 瓜爾膠、黃原膠及海萍 母术竣鹽)或明膠父聯來形成用於液體 155464,doc 201141448 不可渗透、蒸氣可滲透之膜112之材料。用於形成液體不 可渗透、蒸氣可滲透之膜丨丨2之材料通常亦充當細菌障 壁。儘管用於形成液體不可滲透、蒸氣可滲透之膜112之 材料完全不能透過氮及氧,但該材.料能透過水蒸氣。適宜 材料之一個特定非限制性實例係購自DuP〇nt e I De
Nernours 公司(Wilmington,Delaware)之 15 微米 Hytrel APA60015片材。 根據一說明性實施例,可在覆件1〇8中形成蒸發窗丨1〇。 瘵發窗1 ίο係容許蒸氣流出且不容許液體流出之覆件1〇8之 任一部分。在一實施例中,形成覆件108之材料容許蒸氣 傳遞,但可將材料或塗層施加至覆件丨〇8上或定位於與其 相鄰處(例如,面向病患之側面)以抑制蒸氣在覆件中至少 某些位置處之傳遞。舉例而言,可將黏著劑定位於覆件 108周邊以使覆件108與圍繞傷口或組織部位1〇2之組織聯 接且在蒸發窗110之期望位置處可省略。液體不可滲透、 蒸氣可滲透之膜112與覆件108可為同一材料,但不含黏著 劑或其他抑制蒸氣傳遞之物質。 參照圖2,蒸發窗110包括形成於覆件1〇8中之蒸發窗開 口或孔口 128(或多個孔口)。蒸發窗開口或孔口 128經液體 不可滲透、蒸氣可滲透之膜U2覆蓋。液體不可滲透、基 氣可滲透之膜U2係在孔口 128上方黏著至覆件1〇8之第二 部分124以形成蒸發窗11 〇。 根據一說明性實施例,用於處理病患1〇4組織部位1〇2之 方法包括將傷口介面部件118(例如,發泡體部件ι〇6)置於 155464.doc -10- 201141448 鄰近組織部位102處。可將覆件1〇8之第一部分以可釋 放方式固定至所處理組織部位1 〇2外側之病患皮膚13〇上。 使用覆件108在組織部位102上方形成密封空間丨14。利用 發泡體部件106之親水性性質並利用發泡體部件ι〇6内預充 液體蒸發所產生之減壓將來自組織部位1〇2之液體吸入發 泡體部件106中。當預充液體蒸發時,可在密封空間丨丨4中 產生減壓。在一說明性實施例中,預充液體或體液蒸發產 生減壓使得不利用外部減壓源而將適合於療法之減壓施 〇 至密封空間114。所蒸發液體或蒸氣經由液體不可滲透、 蒸氣可滲透之膜112自組織部位1 〇2或所蒸發預充液體離開 密封空間114。 由於液體自組織部位102蒸發,故敷料1 〇〇能夠隨時間流 逝收納並處理之液體多於敷料1〇〇能一次性保留之液體。 舉例而言’在一說明性實施例中,敷料1〇〇可容納3〇 cc液 體’即,敷料100可經30 cc液體完全飽和,但因存在蒸 Q 發,故可隨時間流逝收納40 cc液體。在此實例中,以飽和 容量來量測’敷料100處理133%的容量。在其他實施例 中’以飽和容量計,敷料1〇〇可處理n〇%、12〇0/〇、 130%、140%、150%、160%或更多之容量。 主要參照圖2 ’其展示用於處理組織部位1 〇2之敷料1 〇〇 之說明性實施例。圖2中敷料1 〇〇與圖1中敷料1 〇〇相同,只 是存在兩處主要改動。第一個差異在於吸收層132已安置 於覆件108之面向病患之第二側面ι22與發泡體部件1〇6之 第一側面107之間。吸收層132可為任一用於收納並儲存液 155464.doc -11 · 201141448 體之村料(例如,離子型)層, u之層其係基於父聯丙烯酸系、 土 ,酸系及~化丙歸酸系聚合物。吸收層⑴亦可為 非離子型,其係基於水溶性聚合物,例如海藻酸鹽、叛甲 基纖維素、聚乙烯基対㈣或其他㈣性材料"及收層 m收納並保留來自組織部位⑽之流體並提高敷料⑽容 :。亦可添加包括芯吸層(未顯示)在内之其他層。若添加 怒吸層’則其牵引液體並將其保留在期望位置。舉例而 言,芯吸層可牵引液體並保留抵靠液體不可滲透、蒸氣可 滲透之膜之液體。 第二主要差異係包括可去除釋放襯墊134或作用層。可 去除釋放襯墊1 34針對原本可能經由液體不可滲透、蒸氣 可滲透之膜112流出之蒸氣提供障壁。可去除釋放襯墊134 容許預充液在使用前存於發泡體部件丨〇6中而直到去除可 去除釋放襯墊134時才蒸發。 現主要參照圖3,其展示用於處理組織部位(例如圖1及2 中組織部位102)之敷料1〇〇之說明性實施例。圖3之敷料 1 00類似於圖1之敷料1 00,但具有兩個主要差異。第一個 差異在於包括單向閥門136。單向閥門136延伸穿過覆件 108並進入密封空間114。單向閥門ι36亦可延伸穿過液體 不可滲透、蒸氣可滲透之膜11 2。當向組織部位1 〇2(圖1)按 壓覆件1 0 8時’密封空間114中之空氣如箭頭1 3 8所示經由 單向閥門136排空。自密封空間114内去除空氣或其他氣體 有助於在密封空間114中產生減壓。經由單向閥門13 6排空 氣體或自密封空間蒸發並流出液體可在密封空間丨14中產 155464.doc 12 201141448 生減壓。因此,無需單獨減壓源即可在組織部位處實施減 壓處理。 在圖3之實施例中,覆件1 包括複數個孔口 14〇或蒸發 窗開口,其包含蒸發窗110。孔口 140經液體不可滲透、蒸 氣可渗透之膜112覆蓋以形成蒸發窗11〇。關於第二個差 ' 異,圖3之實施例亦包括吸收層132 » 現主要參照圖4,其展示用於處理組織部位(例如圖1及2 中組織部位102)之敷料100之說明性實施例。圖4之敷料 100類似於圖1中敷料100,但包括單向閥門136且亦包括壓 力調節閥門142。如圖3所示,單向閥門136延伸穿過覆件 108並進入密封空間114中,且壓力調節閥門142亦延伸穿 過覆件108並進入密封空間114中。 當在密封空間114内達到最大減壓值時,壓力調節閥門 142容許周圍壓力或周圍空氣進入密封空間114。引入周圍 空氣可降低減壓並將減壓保持低於最大值。壓力調節閥門 Q 142可呈多種形式,但顯示為具有球144與偏動部件146, 該偏動部件可使球144抵靠孔口 148偏動。當自密封空間 114連通至室150中之減壓高至足以使球144自孔口 ι48移開 時’將空氣引入室1 50中並將空氣連通至密封空間丨丨4中。 " 藉助此作用可將密封空間114内壓力調節至低於最大減壓 值。 現主要參照圖5。其展示敷料200之說明性實施例。敷料 200在許多方面類似於圖1之敷料100。然而,在此實施例 中敷料200包括包含第一發泡體252及第二發泡體254之 155464.doc -13- 201141448 發泡體部件206。第一發泡體252可為具有第一剛度之環形 部件。第二發泡體254可為圓形插人物,其插人第一發泡 體252之環形内部部分並具有第二剛度。第-剛度大於第 二剛度。因此,當在減塵下,第二發泡體254將比第一發 泡體252更㈣疊。剛性更大之第—發泡體⑸可藉由充當 迫使覆件208遠離病患之内部偏動部件而有助於在密封空 間214内產生真空。 發泡體部件206係由覆件208覆蓋,該覆件延伸超過所處 理組織部位邊界。覆件2〇8具有第一部分224及第二部分 226。覆件208之第一部分224通常在發泡體部件2〇6外側。 可使用附接裝置256(例如黏著劑或水狀膠體)將覆件2〇8固 定於病患皮膚。在部署前,附接裝置256可具有覆蓋面向 病患之側面257之釋放襯墊。覆件2〇8本身可係液體不可滲 透、蒸氣可滲透之材料,且至少第二部分226無黏著劑或 其他可能損害蒸氣傳遞之物質。 預充液體可安置於發泡體部件2〇6内。為防止在將敷料 200部署於組織部位上之前預充液體過早蒸發,可在第二 發泡體254上方將可去除釋放襯墊234以可釋放方式附接至 覆件208之第一側面220。可去除釋放襯墊234可與發泡體 部件206大小相同或比其大。在部署至病患上時去除可去 除釋放襯塾234。類似於圖4之敷料100,敷料200可包括單 向閥門236及壓力調節閥門242。 仍參照圖5,在根據一說明性實施例操作中,將發泡體 部件206置於鄰近擬處理之組織部位(例如圖1之組織部位 155464.doc -14- 201141448 102)處。若尚未實施,則將覆件2〇8置於發泡體部件206上 方並使用附接裝置256將覆件208固定至病患皮膚上。可將 可去除釋放襯墊234去除。敷料200可以物理方式預充,藉 由向組織部位按壓敷料200以使至少第二發泡體254部分地 指疊’從而迫使空氣通過單向閥門236以將初始減壓置於密 ’ 封空間214中d隨著來自組織部位之液體或預充液經由覆 件208之第二部分226蒸發並流出,密封空間214内之減壓 進一步增強。 〇 現主要參照圖6,其展示敷料300之說明性實施例。敷料 300在大多數方面類似於圖2之敷料1〇〇。敷料3〇〇包括置於 鄰近組織部位(例如圖1中組織部位丨〇2)處之發泡體部件 3 06、及用於自組織部位收納並保留液體之吸收層332。發 泡體部件306及吸收層332經覆件308覆蓋。覆件308在組織 部位及發泡體部件306上方形成密封空間314。覆件308具 有第一部分324及第二部分326。第二部分326包括蒸發窗 Q 310。液體不可滲透、蒸氣可滲透之膜312與蒸發窗310相 連且容許所蒸發液體自密封空間314内流出到達敷料3〇〇外 部。單向閥門33 6自敷料3 00外部延伸至密封空間3 14中並 容許密封空間314内氣體離開單向閥門336,但不容許氣體 進入。 敷料300進一步包括偏動部件,其在就位時使覆件3〇6遠 離病患偏動。舉例而言,偏動部件可包含具有第一端362 及第二端364之伸縮囊36〇β第一端362接合覆件3〇6之面向 組織之側面322且第二端364接合病患皮膚(未顯示)ι在根 155464.doc -】5· 201141448 據一說明性實施例操作中,在部署敷料3〇〇後,可抵靠病 患按壓敷料300,從而使密封空間314中之空氣離開單向閥 門336並同時使偏動部件(例如,伸縮囊36〇)至少部分地摺 疊或壓縮。當至少部分壓縮時,伸縮囊36〇企圖返回其自 由或自然位置且因此在覆件3〇6上產生力並牵引覆遠 離病患。此作用有助於(或更大減壓)在密封空間314内產生 真空。 現主要參照圖7,其展示敷料丨〇〇之說明性實施例。敷料 100在大多數方面類似於圖!之敷料100。然而,在此實施 例中,含有預充液168之容器166係安置於發泡體部件1〇6 之第一側面107上。容器166可包括弱化部分17〇,其適合 先於容器166之其他部分失效。在其他實施例中,可包括 任一類型閥門代替弱化部分i 7〇,其中閥門保留預充液直 至需要預充液時為止且然後使預充液可在減壓影響下流 出。 覆件108可覆蓋發泡體部件1〇6並形成密封空間ιΐ4。覆 件1〇8包括蒸發窗110,該蒸發窗係由孔口 128或蒸發窗開 口形成。在此說明性實施例中,蒸發窗11〇包括覆蓋孔口 128並延伸超過孔口 128之液體不可滲透、蒸氣可滲透之膜 112。因此,液體不可滲透、蒸氣可滲透之膜112之一部分 安置於覆件108之第一部分124與發泡體部件1〇6之間。可 去除釋放襯墊134可覆蓋蒸發窗11〇直至使用時為止。 仍主要參照圖7,在根據一說明性實施例操作中,將發 泡體部件106置於鄰近擬處理組織部位處並將覆件1〇8置於 155464.doc 16 201141448 發泡體部件1 〇ό上方並固定至該組織部位周圍之病患皮膚 上。然後可藉由按壓容器166使容器166破裂,或者可預先 抵靠堅硬表面或藉由其他方式使該容器破裂並將其立即置 於組織部位上。破裂後,容器166將預充液168釋放至發泡 體部件106上。在一些實施例中,可包括弱化部分17〇以控 制破裂點。將可去除釋放襯墊134自蒸發窗11〇去除。然後 可開始蒸發處理,從而有助於在密封空間i 14内產生減 壓。 Ο + 在另一說明性實施例中,在覆件108下方(對於圖j中所 示定向而言)包括微幫浦(例如,壓電幫浦)。微幫浦在密封 空間114内產生減壓。排放物可經由蒸發fu〇之液體不可 滲透、蒸氣可滲透之材料自微幫浦流出.或者或另外,排 放物可經由特定出口或單向閥門流出。 主要參照圖8,其展示用於處理病患404組織部位4〇2之 敷料400。敷料400除已添加強制通風裝置46〇以外在大多 〇 數方面類似於圖1之敷料100。敷料400尤其包括容許所蒸 發液體流出敷料400之覆件408。覆件408之至少一部分包 含液體不可滲透、蒸氣可滲透之膜412。舉例而言,可在 覆件408中形成蒸發窗開口或孔口 428,且孔口 428可經液 - 體不可滲透 '蒸氣可滲透之膜412覆蓋以形成蒸發窗41〇。 覆件408形成在組織部位1〇2及傷口介面部件418(例如,發 泡體部件406)上方密封空間414。液體不可滲透、蒸氣可 滲透之膜412可操作以容許密封空間414中已蒸發之液體 (例如’水)如箭頭41 6所示流出密封空間414。 355464.doc -17· 201141448 強制通風裝置4 6 0可為使空氣移動穿過液體不可滲透、 蒸氣可滲透之膜412以增加水蒸氣傳輪速率之任一裝置。 強制空氣可間歇或連續。強制通風裝置46〇可為風扇、靜 電裝置或壓電幫浦462。撓性播板464可在液體不可滲透、 蒸氣可渗透之膜412上方形成並以流體方式耦合至壓電幫 浦462以便自壓電幫浦462收納空氣或向其輸送空氣。可使 用敷巾f466或另一裝置來幫助將壓電幫浦462耦合至覆件 408。壓電幫浦462可位於緩衝部件468上。撓性擋板464可 為在液體不可滲透、蒸氣可滲透之膜412上方幫助自壓電 幫浦462引導通道中空氣或向壓電幫浦仏2引導通道中空氣 之任一裝置。舉例而言,撓性擋板464可為在液體不可滲 透、蒸氣可滲透之膜412上方形成之可充氣通路466且藉由 黏著劑(未顯示)保持抵靠在液體不可滲透、蒸氣可滲透之 膜412之至少一部分上。 應理解,本文所展示所有敷料皆可現場形成或可預先組 裝。可將預先組裝實施例封裝於密封袋内。 儘管已在某些說明性實施例之背景中揭示了本發明及其 優點,但應理解,可作出各種改變、取代、變換及變更而 不背離由隨附申請專利範圍界定之本發明範圍。作為非限 制性說明性實例,—實施例之組件可與所展示其他實施例 之組件一起使用。作為非限制性實例,可將圖4之單向閥 門136添加至圖7之敷料1〇〇中。作為另一非限制性實例: 可將圖8之強制通風裝置460添加至任一其他實施例中。作 為又一非限制性實例,可將釋放襯墊134施加至本文任一 155464.doc -18- 201141448 實施例。 應理解,上述益處及優點可與一個實施例相關或可與若 干個實施例相關。應進一步理解,提及‘一(an),物件時係 指彼等物件中之一或多者。 若適宜,本文所述方法之步驟可以任一適宜順序來實 施,或可同時實施。
若適宜,上述任一實例中之態樣可與所述任一其他實例 中之態樣組合,從而形成具有相當或不同特性且解決相同 或不同問題之其他實例。 應理解,上文對較佳實施例之說明僅係以實例方式來闡 述’且熟習此項技術者可作出各種修改。上文說明書、實 例及數據完整地闡述本發明實例性實施例之結構及應用。 儘官上文已以一定詳細程度或參照一或多個個別實施例闡 述了本發明之多個實施例’但熟習此項技術者可對所揭示 實施例作出多種變更而不背離本發明之範圍。 【圖式簡單說明】 圖1係用於處理組織部位之敷料之說明性實施例之示音 性透視圖,其中—部分係以截面顯示; ^ 圖2係用於處理組織部位之敷料之說明性實施例之 丨截面〃其中3亥敫料包括吸收層及可去除釋放襯墊; 圖3係詩處理組織部位之敷料之說明性實施例之 性截面’其中該敷料包括單向閥門; 意意 圖4係用於處理組織部位 性截面,《中該冑料包括壓 之敷料之說明性實施例 力調節閥門及單向閥門 之示意 155464.doc •19- 201141448 圖5係用於處理組織部位之敷料之說明性實施例之示意 性截面,其中該敷料包括第一發泡體及第二發泡體; 圖6係用於處理組織部位之敷料之說明性實施例之示意 性截面,其中該敷料包括伸縮囊; 圖7係用於處理組織部位之敷料之說明性實施例之示意 性截面,其中該敷料包括具有預充液之容器;且 圖8係用於處理組織部位之敷料之說明性實施例之示意 性截面。 【主要元件符號說明】 100 敷料 102 組織部位 104 病患 106 發泡體部件 107 第一側面 108 覆件 110 蒸發窗 112 液體不可滲透、蒸氣可滲透之膜 114 密封空間 116 箭頭 118 傷口介面部件 120 第一側面 122 面向病患之第二側面 124 第一部分 126 第二部分 128 蒸發窗開口或孔口 155464.doc -20- 201141448 130 病患皮膚 132 吸收層 134 可去除釋放襯墊 136 單向閥門 140 孔口 ' 142 壓力調節閥門 144 球 146 偏動部件 〇 14S 孔口 150 室 166 容器 168 預充液 170 弱化部分 200 敷料 206 發泡體部件 Ο 208 覆件 214 密封空間 220 第一側面 ' 224 第一部分 . 226 第二部分 234 可去除釋放襯塾 236 單向閥門 242 壓力調節閥門 252 第一發泡體 155464.doc -21 - 201141448 254 第二發泡體 256 附接裝置 257 面向病患之側 300 敷料 306 發泡體部件 308 覆件 310 蒸發窗 312 液體不可滲透 314 密封空間 322 面向組織之側 324 第一部分 326 第二部分 332 吸收層 336 單向閥門 360 伸縮囊 362 第一端 364 第二端 400 敷料 402 組織部位 404 病患 406 發泡體部件 408 覆件 410 蒸發窗 412 液體不可滲透 蒸氣可滲透之膜 蒸氣可滲透之膜 155464.doc -22· 201141448 418 傷口介面部件 428 孔口 460 強制通風裝置 462 壓電幫浦 464 撓性擋板 ' 466 敷巾帶/可充氣通路 468 缓衝部件 ο Ο 155464.doc -23-
Claims (1)
- 201141448 七、申請專利範圍: 1. 一種用於處理病患組織部位之敷料,該敷料包含: 傷口介面部件,其置於鄰近該組織部位處; 覆件’其中該覆件之至少一部分包含蒸發窗,該蒸發 窗具有液體不可滲透、蒸氣可滲透之膜; 其中該覆件可操作以在該組織部位上方形成密封空 間;且 其中該液體不可滲透、蒸氣可滲透之膜容許該密封空 間中已蒸發之液體流出該密封空間。 2·如請求項1之敷料,其中該敷料不與外部減壓源流體連 通0 3.如請求項1之敷料,其進一步包含單向閥門,其耦合至 該覆件以容許該密封空間中之流體在該覆件向該組織部 位移動時流出。 如求項1之敷料,其進一步包含壓力調節閥門,其耦 〇 w至肩覆件以容許周圍空氣進入該密封空間而防止該密 封空間中之壓力超出最大值。 5.如請求項1之敷料,其進一步包含: 壓力調節閥門’其耦合至該覆件以容許周圍空氣進入 ‘ ' 該密封空P弓·ir π 二間而防止該密封空間中之壓力超出最大值;及 早向閱門’其耦合至該覆件以容許該密封空間中之流 體在4覆件向H織部位移動時流出。 6 · 如請求項1 、 敷料’其進一步包含吸收層,該吸收層用 5 並儲存來自該組織部位之液體,該吸收層係安置 155464.doc 201141448 於該傷口介面部件與該覆件之間。 7.如凊求項1之敷料,其進一步包含可去除釋放層,該可 去除釋放層係以可釋放方式至少附接於該蒸發窗上,其 中該可去除釋放層包含流體障壁。 8_ :請求項i之敷料,其中該覆件包含第一部分及第二部 釦,且其中s亥第二部分包含該液體不可滲透、蒸氣可滲 透之膜。 9·如請求❾之敷料’其進—步包含儲存預充液之容器。 H).如請求項!之敷料’其進一步包含在該傷口介面部件中 之預充液。 11 _ 士明求項6之敷料,其進一步包含在該吸收層中之預充 液。 月求員1之敷料,其中該蒸發窗包含在該覆件中之複 數個孔口 ’該複數個孔口經該液體不可滲透、蒗氣可滲 透之膜覆蓋。 > 13. 如請求们之敷料,其中該傷口介面部件包含發泡體部 件。 14. 如請求項13之敷料,其中該發泡體部件包含: 第發泡體’其具有第一剛度且具有孔口; 第一發泡體,其具有第二剛度且安置於該第—發泡體 之δ亥孔口中; 其中該第一剛度大於該第二剛度。 15_如:項i之敷料,其中該傷口介面包含發泡體部件且 、 匕έ女置於該發泡體部件周圍之偏動部件。 155464.doc 201141448 其中該偏動部件包含位於該發泡體 其中1¾ &發窗係由該覆件中不含黏 16. 如請求項15之敷料 部件周圍之伸縮囊 17. 如請求項1之敷料 著劑之區域來界定 料…該覆件包含-部分上具有黏著 ㈣體不^透、蒸氣可渗透之膜包 3該敷巾材料中實質上不含黏著劑之區域。19·如請求項i之敷料,其進一步人 強制通風裝置,其與 °茨復件相連以迫使空翁穿過辞 ^便二乱穿H夜體不可渗透、蒸氣可滲 還之膜。 / 20. =^項19之敷料,其中該強制通風裂置包含壓電幫浦 進-步包含撓性擋板,該撓性擋板適於將空氣引導至 該廢電幫浦或自該壓電幫浦引導空氣穿過該液體不可滅 透、蒸氣可滲透之膜》 ^ 21·二種製造用於處理组織部位之敷料之方法,該方法包 提供置於鄰近該組織部位處之發泡體部件; 提供形成有蒸發窗開口之覆件; 、將液體不可滲透、蒸氣可滲透之膜與該蒸發窗開 連以形成蒸發窗;且 二其中該液體不可滲透、蒸氣可滲透之膜係可操作以容 4經瘵發液體傳送通過該液體不可滲透、蒸氣可滲 膜。 ' 4迷之 步包含在該液體不可渗透 22·如請求項21之方法,其進一 155464.doc 201141448 蒸氣可滲透之膜上方施加可去除釋放襯墊之步驟。 23. 如請求項21之方法’其進一步包含將預充液引入該發泡 體部件中。 24. 如請求項21之方法,其進一步包含將具有預充液之容器 置於該覆件之面向病患之側面。 25. 如請求項21之方法,其進一步包含將壓力調節閥門耦合 至該覆件。 26·如請求項2 1之方法,其進一步包含將單向閥門耦合至該 覆件。 27.如請求項2 1之方法’其進一步包含將單向閥門耦合至該 覆件並將壓力調節閥門搞合至該覆件。 155464.doc
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TW100113257A TW201141448A (en) | 2010-04-16 | 2011-04-15 | Dressings and methods for treating a tissue site on a patient |
TW100113262A TW201143822A (en) | 2010-04-16 | 2011-04-15 | Evaporative body-fluid containers and methods |
TW100113256A TW201141562A (en) | 2010-04-16 | 2011-04-15 | Reduced-pressure sources, systems, and methods employing a polymeric, porous, hydrophobic material |
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TW100113262A TW201143822A (en) | 2010-04-16 | 2011-04-15 | Evaporative body-fluid containers and methods |
TW100113256A TW201141562A (en) | 2010-04-16 | 2011-04-15 | Reduced-pressure sources, systems, and methods employing a polymeric, porous, hydrophobic material |
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US (9) | US8702665B2 (zh) |
EP (9) | EP3593776B8 (zh) |
JP (4) | JP5850535B2 (zh) |
CN (3) | CN102844055B (zh) |
AU (3) | AU2011239545B2 (zh) |
CA (3) | CA2800993C (zh) |
TW (3) | TW201141448A (zh) |
WO (3) | WO2011130570A1 (zh) |
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