TW200950832A - Reduced-pressure, compression systems and apparatuses for use on a curved body part - Google Patents
Reduced-pressure, compression systems and apparatuses for use on a curved body part Download PDFInfo
- Publication number
- TW200950832A TW200950832A TW98118109A TW98118109A TW200950832A TW 200950832 A TW200950832 A TW 200950832A TW 98118109 A TW98118109 A TW 98118109A TW 98118109 A TW98118109 A TW 98118109A TW 200950832 A TW200950832 A TW 200950832A
- Authority
- TW
- Taiwan
- Prior art keywords
- dressing
- pillow
- reduced pressure
- dressing assembly
- surface member
- Prior art date
Links
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- Rehabilitation Therapy (AREA)
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- Media Introduction/Drainage Providing Device (AREA)
- Surgical Instruments (AREA)
- External Artificial Organs (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
- Massaging Devices (AREA)
Description
200950832 六、發明說明: 【發明所屬之技術領域】 本發明一般而言係關於醫學治療系統,且更特定而言係 關於減壓傷口治療系統。 本發明根據35 U.S.C.§119(e)規定主張2008年5月30曰申 請之題為「Reduced-pressure Surgical Wound Treatment System」之美國臨時專利申請案第61/057,807號、2008年5 月 30 日申請之題為「Dressing Assembly For Subcutaneous Wound treatment Using Reduce Pressure」之美國臨時專利 申請案第61/057,798號、2008年5月30日申請之題為「See-Through, Reduced-Pressure Dressing」之美國臨時專利申 請案第61/057,808號、2008年5月30日申請之題為 「Reduced-Pressure Dressing Assembly For Use in Applying a Closing Force」之美國臨時專利申請案第 61/057,802號、2008年5月30日申請之題為「Reduced-Pressure,Linear-Wound Treatment System」之美國臨時專 利申請案第61/057,803號、2008年5月30曰申請之題為 「Reduced-Pressure, Compression System and Apparatus for use on a Curved Body Part」之美國臨時專利申請案第 61/057,800號、2008年5月30日申請之題為「Reduced-Pressure, Compression System and Apparatus for use on Breast Tissue」之美國臨時專利申請案第61/057,797號、 2008 年 5月 30 日申請之題為「8叩61*-入58〇1^6111:,116(111〇6(!-Pressure Wound Dressing and System」之美國臨時專利申 140735.doc 200950832 請案第61/057,805號、2008年5月30日申請之題為 「Reduced-Pressure,Compression System and Apparatus for use on a Joint」之美國臨時專利申請案第61/〇57,81〇 说、2008年12月10日申請之題為「Reduced-Pressure Wound treatment System Employing an Anisotropic Drape」之美國臨時專利申請案第61/121 362號及2〇〇9年j * 月 12 曰申請之題為「Reduced-Pressure,Compression ©System and Apparatus for use on a Joint」之美國臨時專利 申請案第61/144,067號之申請之權益。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】 醫師每年在全世界實施上百萬的外科方法。許多該等方 法實施為開放式外科手術且增加數目之手術正使用最低程 度侵入性外科手術實施’例如内窺鏡、關節鏡及腹腔鏡方 法。作為一個實例,美國社會審美整形外科報道:2007年 φ 在美國存在多於450,000例吸脂方法。 外科方法涉及皮膚及相關組織中之急性傷口(例如一切 口)。在許多情形下,在方法結束時使用一機械裝置(例如 " 釘或縫合線)使切口閉合,或使用黏合劑使其閉合。此 ,後,該傷口常常僅覆蓋有-乾燥無菌繃帶。當然,通常不 僅在表皮處存在更多破壞。 對於許多外科方法(尤其藉助最低程度侵入性技術實施 之彼等手術)’許多破壞或損壞在表皮下或處於皮下位 準。同樣’作為—個實例,在-種類型之吸脂方法中,在 140735.doc 200950832 引入一腫脹流體(生理鹽水、溫和止痛藥及腎上腺素)後, 外科醫生將使用一具有吸入功能之套管針及套管來移除脂 肪區。如此做,通常使皮下空隙及其他組織缺陷形成於離 該套管透過其放置之切口或設備透過其放置之其他切口遠 的組織部位處。受損組織將需要時間及護理來癒合且具有 許多潛在併發症及危險,包含例如水腫、血清腫、血踵、 進一步青肢及齋癌。 【發明内容】 根據一個說明性實施例 ❹ 體部位上之-所期望治療區提供一力之系統包含一用於放 置於該人之該所期望治療區上之敷料總成。該敷料總成且 有一帶有-第一端及一第二端之縱向部分。該敷料總成亦 03 ,、冑帛纟面及一第二面向内表面之内表面構件 〇 -有帛纟面及一第二面向内表面之敷料枕塾。該 敷料枕墊之該第二面向内表面係設置於該内表面構件之該 第表面上。該系統進一步包含:一可釋放圓周構件其 柄合至該敷料總成之該第—端及第二端;-密封子系統,、 其用於在該敷料總成上提供一流體密封;及一減壓子系 統,其用於向該敷料總成提供一減壓。 根據一個說明性實施例,一 體部位上之-所期望、、.疼;向-人之-曲線狀躺 °療^供-力之㈣包含-用於放 置於S亥人之該所期望 右Μ β 紅上之敷料總成。職料總成具 有一帶有一第一端— 含-且有一笛一主 帛-缟之縱向4分。該敷料總成包 /、 面及一第二面向内表面之第一材料及一 140735.doc -6 - 200950832 二:之=表第二面向内表面之第二材料。該第-以弟一面向内表面係設置於該第二材料之 面上。該系統進—步包含:一可釋放圓周構件 該敷料總成之該第—端及第二端;及—減遷子系统麵二至 於向該敷料總成提供一減壓。 ·其用 根據-個說明性實施例,—種用於向—人的 • f期望治療區提供-加磨力之系統包含…敷料绝成之: ❿、經成形及構形以放置於該人的躺幹之至少一部::成其 :釋:圓周連接器,其用於將該敷料總成固持 該敷料總成包含—圓周構件。該系統 進一步包3:—密封子系統,其用於在該敷 的表皮上提供-流體密封;及一減壓子系統,其 敷料總成提供減屋,藉此該系統可操作以在該聽敎= 一部分上產生一加壓力。 根據-個說明性實施例,一種用於向一人的躺幹上之一 β 所期望治療區提供一加麼力之系統包含-用於放置於节人 外表面構件之該第二面 之該所期望治療區上之敷料總成。該敷料總成包含一帶有 一第一端及一第二端之縱向部分及_具有一第一表面及一 严第二面向内表面之敷料枕塾。該敷料枕塾之該第二面向内 .纟面係設置於該内表面構件之該第—表面上。該敷料碑成 進一步包含一圍繞該敷料枕墊之包裹構件。該包裹構件包 含一具有一第一表面及一第二面向内表面之内表面構件及 -具有-第-表面及-第二面向内表面之外表面構件。該
之該第 140735.doc 200950832 表面°又置。該敷料枕墊係由具有大於25 kg/m3之一密度之 枕塾材料形成。該系統進一步包含:-可釋放圓周構 件,其耦合至該敷料總成之該第一端及第二端;及一密封 系’、先八用於在該敷料總成及該人的表皮上提供一流體 岔封該密封子系統包含:一包覆敷巾其延伸於該外表 面構件上’及封裝置,其用於在—人的表皮及該包覆 敷巾上提供一流體密封。 根據一個說明性實施例,一種製造一用於向一人之一曲 線狀軀體部位上之—所期望;台療區提供—加壓力之系統之 方法包含形成一經成形及構形以放置於該人之該所期望治 療區上之敷料總成之步驟。該方法進一步包含··提供一用 於將該敷料總成固持於該所期望治療區上之可釋放圓周連 接器;及提供一用於在該敷料總成及該人的表皮上提供一 流體密封之密封子系統。 根據一個說明性實施例,一種向一人之一曲線狀軀體部 位之至少一部分提供一力之方法包含如下步驟:將一敷料 攀成部署於該曲線狀軀體部位上。該敷料總成包含:一内 表面構件,其用於放置於該所期望治療區上且具有—第一 表面及一第二面向内表面;及一敷料枕墊,其具有一第一 表面及一第二面向内表面。該敷料枕墊之該第二面向内表 面係設置於該内表面構件之該第一表面上,藉此將該敷料 總成密封至該曲線狀軀體部位。該方法進一步包含向該敷 料總成提供減壓。該敷料枕墊在周圍壓力下具有一第一體 積(V!)且當在減壓下時具有一第二體積, 且VAV,。 140735.doc -8 - 200950832 根據一個說明性實施例,一種用於— L ^ 裡用於向—曲線狀軀體部位 提供-力之方法包含如下步驟:將—數料總成放置於一所 期望區上。該敷料總成具有一帶有一 ^ 第一端及一第二端之
縱向部分。該方法進一步包含:將該第—端以可釋放方式 麵合至該第二端以將該敷料總成之該縱向部分固持於該患 者上於該所期望治療區中;將一減壓源以流體方式搞合至 該敷料總成;及啟動該減壓源以向該敷料總成提供減壓。 將該敷料總成置於減壓下且使其收縮以形成一導引力。 參照圖式及以下實施方式’該等說明性實施例之其他目 標、特徵及優點將變得顯而易見。 【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 之隨附H且其中間解說明方式顯示其中可實踐本發 明之具體實施例。為使得熟習此項技術者能夠實踐本發明 而足狗詳細地描述該等實施例,且應理解,亦可利用其他 實施例’且可作出邏輯結構、機械、電氣及化學改變,而 不背離本發明之精神或!I圍。為避免並非為使得熟習此項 技術者&夠實踐本發明所需之細節,本描述可省略熟習此 術者所已知之某些資訊。因此,不應將以下實施方式 視為具有限制意義,且本發明之範圍僅由隨附申請專利範 圍加以界定。 參照圖1,JL顧子_田从 八』不用於向一人的軀幹4上之一所期望治 療區3提供―六夕 力之系統2。可在其中期望對一人的軀體之一 既定部分(例如’該軀幹、-手臂、腿或其他曲線狀躺體 140735.doc 200950832 部位)支撐之任一情 中對A 中應用系統2 ’但係在轉4之背景 7 丁在述。可在出於療法原因期望-力時應用系統 ,該療法原因係例如向一所期望、Λ 〜’、、 向内她切向力)及—舉二= 壓力或 ^ 升力或向上力,同時視情況移除 机體(例如流出物)。系統2可 組磁切… ㈣/α療皮下組織、治療表面 組織二##。如本文中所使用’皮下意指至少與皮下 北另樣深的組織’且亦可包含較深組織(包含器官)。除 非另外指示,否則如本文中 Τ所便用,或(or)J不需要相 可僅在出於化妝原因或根本不出於任何原因期望 支撐時應用系統2。 系統2允許將相對輕鬆地對一人的躺體之一部分給予支 撐’且系統2允許將由一單個系統或裝置容納各種大小之 軀體部位,藉此減小對大財產目錄之需要。在用於一傷口 時系統2可保持傷口乾燥、減小死空間形成、改良灌 注、減小血清速及血腫形成並減小對某些外科方法而言次 要之青腫及水腔。系統2亦向使用系統2之患者或人提供相 對舒適度。由“2形成之力可藉由變化遞送至系統2之減 廢來變化,且可使用—回饋迴路來允許減壓自動調節從而 即使在腫脹增加或減少時亦維持一治療部位處之一所期望 加Μ力。 現參照圖2,其呈現一根據一個說明性實施例之用於治 療一切開周圍區域中遭破壞皮下組織之說明性系統〗〇。在 一切口 12周圍之一切開周圍區域中顯示系統1〇,其通過表 皮14或皮膚及真皮16並到達下皮或皮下組織〗8中。皮下組 I40735.doc -10- 200950832 織18可包含眾多組織類型,例如脂肪組織或肌肉。顯示遭 破壞皮下組織部位20自切口 12延伸且在此情形下包含皮下 缺陷或空隙22。遭破壞皮下組織20常常係由外科方法(例 如吸脂)所導致。遭破壞皮下組織20可包含空隙(例如空隙 22)、開放空間及各種出於許多原因而可頗麻煩之缺陷。 舉例而言,空隙22可允許流體堆積且可導致水腫。如本文 中所使用’術5#「流體」一般係指氣體或液體;但亦可包 含任何其他可流動材料,包含(但不限於)凝膠、穋體或發 泡體。 可使用任一閉合器件(例如釘、縫合線或黏合劑)使切口 12閉合,但在此說明性實施例中顯示為藉助一縫合線13閉 合。系統10通常用於治療一區,且特定而言通常用於治療 一皮下組織部位20及皮下組織20周圍之組織,但系統1〇亦 可用於治療切口 12之一更有限區。 系統10包含一敷料總成30(其包含一成形敷料枕墊32(或 • 敷料枕塾))、一密封子系統60及一減壓子系統8〇。系統10 形成一由參考編號24表示之實現於皮下組織2〇處之淨加壓 力。如下文進一步描述,成形敷料枕墊32可經成形及構形 - 以允許加壓力24在患者表皮14上及表皮14下方相當均勻地 -分佈。否則,若與其他區相比較存在顯著增加之力之區, 則可導致皮膚刺激。系統1〇亦可操作以形成一向内力(或 閉合力)’亦即朝向敷料總成30之一内部部分。該向内力 係由參考編號26表示。向内力26可大致保持於表皮14之平 面内。換言之,向内力26主要在表皮14内操作。另外,系 140735.doc 200950832 統ίο可操作以將減壓遞送至切口 12。該減壓可實現於皮了 空隙22之位準處以幫助使彼區域中之組織靠近—在一起— 以及幫助移除任何空氣或任何其他流體(例如流出物)。 敷料總成30包含成形敷料枕墊32,該成形敷料枕墊具有 一第一侧34及一第二向内(面向組織)侧36。成形敷料枕墊 32可經定大小及成形以大致匹配遭破壞皮下組織2〇之所估 測區,雖然可使用一較大或較小大小❶成形敷料枕墊32具 有一周邊邊緣38。成形敷料枕墊32可係由許多不同枕墊材 料製成。在一個說明性實施例中’成形敷料枕墊32係由一 多孔且可滲透發泡體狀材料且更特定而言一當在一減壓下 時允許傷口流體之良好滲透性之網狀開放孔格聚胺基曱酸 酯或聚醚發泡體製成。一種已使用之此發泡體材料係自
Texas、San Antonio 之 Kinetic Concepts Inc. (KCI)購得之 VAC® Granufoam®材料。任一材料或材料組合可用於該枕 墊材料’只要該枕墊材料可操作以分佈減壓並提供所期望 力即可。 成形敷料枕墊32可係一經定大小及成形以均勻地分佈力 且分佈減壓之歧管。如本文中所使用,術語「歧管」一般 係指一如下物質或結構’其經提供以幫助將減壓施加至— 組織部位、將流體遞送至一組織部位或自一組織部位移除 流體。該歧管通常包含複數個互連流動通道或通路,以改 良向該歧管周圍之組織部位所提供或自該組織部位移除之 流體分佈。該歧管可係一生物相容材料,其能夠放置成與 組織部位接觸並將減壓分佈至該組織部位。歧管之實例可 140735.doc -12- 200950832 包含(例如,作X ΠΒ & 一从 、於)具有經配置以形成流動通道之結構 兀件之器件,語如九,, 如例如,蜂巢式發泡體、開放孔格發泡 體、多孔組織收隼哭放.^ ^ 、 益件、包含或凝固後包含流動通道之液 凝膠及發泡體。該歧管可係多孔且可係由發泡體、紗 I Μ席或任-其他適於-特定生物應用之材料製成。 . 纟他實施例可包含「閉合孔格」。在—些情形下,該歧管 !可用於將流體(例如,藥物、抗菌藥、生長因子及各種 ❹ ☆液)分佈至該組織部位。該歧管中或上可包含若干其他 層,例如吸收材料、芯吸材料、疏水材料及親水材料。 在.力400至600微米範圍中之如耐⑽爪®材料網狀孔有助 於實施歧管功能,但亦可使用其他材料。該醫學枕塾材料 (例如Granuf0am®材料)之密度通常在約13旧行3^ 6化他3 (20.8 kg/m3-25.6 kg/m3)之範圍中。在某些情形下,可期望 一具有比Granuf0am®材料密度高(較小孔大小)的材料。舉 例而言,可使用具有大於〗6 lb/ft3 (25 6 kg/m3)之—密度 Φ 之Granufoarn®材料或類似材料。作為另一實例,可使用具 有大於2.0 lb/ft3 (32 kg/m3)或 5.0 lb/ft3 (80·1 kg/m3)或甚至 更大之一密度之Granufoam®材料或類似材料。材料越密 • 集,針對一既定減壓可產生越高加壓力。若使用具有小於 .組織部位處組織之一密度之一發泡體作為醫學枕墊材料, 則可形成一舉升力。在一個說明性實施例中,該敷料總成 之一部分(例如邊緣)可施加一加壓力,而另一部分(例如一 中心部分)可提供一舉升力。 該枕墊材料可係一稍後黏製為該發泡體原始厚度之約 140735.doc -13· 200950832 (1/3)之厚度之網狀發泡體。在許多可能枕墊材料中,可使 用如下材料:Gramifoam®材料或_ F〇amex®技術發泡體 (卿W.f〇amex.com)。在某些情形下,期望在一微結合過程 中將離子銀添加至該發泡體或將其他物f (例如抗菌劑)添 加至4枕墊材料。端視在減壓施加期間所期望加壓力Μ之 準確定向,該枕墊材料可係各向同性或各向異纟。該枕墊 材料亦可係一生物可吸收材料。 密封子系統60包含一包覆敷巾62(敷巾)或密封構件。包 覆敷巾62可係-彈性材料或可係任一提供一流體密封之材 料:「流體密封」4「密封」意指在假^涉及該特定減壓 子糸統4情形下足以保持一所期望部位處之減壓之_密 封。「彈性」意指具有-彈性體之性質且一般而言係指— 具有橡膠狀性質之聚合材料。更具體而言,大多數彈:體 具有大於HH)%之伸長率及一明顯回彈量。一材料之回彈 係指材料自一彈性形變恢復之能力。彈性體之實例可包人 (但不限於):天然橡膠、聚異戊二烯、苯乙烯丁二:: 勝、氣丁二烯橡膠、聚丁二烯、腈橡膠、異丁缔橡膠、乙 丙橡膠、乙烯丙烯二烯單體、氣磺化聚乙烯、多坊 ^胺基甲酸醋、EVA膜、共聚醋及聚石夕氧。作㈣性 實例,包覆敷巾62可係、由如下材料形成,包含聚石夕氧、 3M Tegaderm®敷巾材料、丙烯酸敷巾材料(例如—。、 Avery購得之丙烯酸敷巾材料)或一切割敷巾材料。種可自 包覆敷巾62可耦合至枕墊32〇該耦合可以許多 生。包覆敷巾62及枕塾32可使用黏合劑叙合:方式發 1 J如—丙烯 140735.doc -14- 200950832 ι黏合劑、聚矽氧黏合劑、水凝膠、親水膠體等等。包 敷巾62及枕塾32可藉助熱結合超聲波結合及射頻結^等 等結合。該耦合可以多種離散樣式或更完全地發生。可向 該結合添加若干結構構件來使包覆敷巾62沿-所期望方向 各向異性地作用’亦即,形成-各向異性敷巾材料。一: 向異性敷巾材料幫助敷料總成30主要沿一既定方向移動, 亦即,僅在某一轴或某些軸周圍。 φ 在圖2之說明性實施例中,包覆敷巾62可經定大小以延 伸超過成形敷料枕塾32之一末端33上之周邊邊緣職而形 成一敷巾延伸部分64。敷巾延伸部分64具有一第一表面^ 及-第二面向内表面68。包覆敷巾62可使用一用於提供一 密封之密封裝置或器件69密封於患者之表皮14上。包覆敷 巾62及密封裝置69允許由減壓子系統8〇維持該組織部位處 之減壓。密封裝置69可採用眾多形式,例如一黏合劑7〇、 -密封膠帶、或敷巾膠帶或條帶、雙側敷巾膠帶、漿料、 〇 親水膠體、水凝膠或其他密封器件。若使用一膠帶,則其 可係由與包覆敷巾62相同的材料藉助一預施加壓敏黏合劑 形成。壓敏黏合劑70可施加於敷巾延伸部分料之第二表面 68上。黏合劑70在包覆敷巾62與患者之表皮14之間提供一 大致流體密封。黏合劑70可具有若干覆蓋黏合劑7〇之可移 除條帶,其在將敷巾延伸部分64施加至患者表皮14之前移 除。 減壓子系統80包含一減壓源82 ’該減壓源可採用許多不 同形式。減壓源82提供一減壓作為系統丨〇之一部分。減壓 140735.doc 15· 200950832 源8 2可係任一用於供應一減壓之器件,例如一真空果、辟 式吸入器件或其他源。雖然施加至一組織部位及成形敷料 枕墊32之減壓的量及性質將根據應用而變化,但該減壓通 常將在-5 mm Hg至-500 mm Hg之間且更通常在_1〇〇 mm Hg至-300 mm Hg之間。 如本文中所使用,「減壓」一般係指一小於正經受治療 之一組織部位處之周圍壓力之壓力。在大多數情形下,此 減壓將小於患者所在位置處之大氣壓力。另一選擇為,該 減壓可小於該組織部位處之一靜水壓力。除非另外指示, 否則本文中所述之壓力值係計示壓力。所遞送之減壓可係 恆定或變化(規範地或隨機地變化)減壓且可連續地或間斷 地遞送。雖然可使用術語之「真空」及「負壓力」來描述 施加至組織部位之壓力,但施加至該組織部位之實際壓力 可大於通常與完全真空相關聯之壓力。與本文中之使用一 致,減壓或真空壓力之一增加通常係指絕對壓力之一相對 減小。 為最大化患者移動性及輕鬆度,減壓源82可係一電池供 電、單用途減壓產生器。此一減壓源82促進在手術室中應 用且在復原階段期間為患者提供移動性及便利。減壓源82 具有一電池盒84及一罐區域86,該罐區域帶有提供對罐86 内抓體位準之一視覺指示之窗88。一插入隔膜過濾器(例 如疏水或疏油過濾器)可插入一減壓遞送導管或管道9〇與 減壓源82之間。 對於許多方法而言,據信,將導引患者穿戴系統10達3 140735.doc 200950832 至5天且可導引其穿戴系統1〇達15天或更久。仍然,與藉 助習用加壓衣物(現今,其在許多方法後穿戴多達六周 治療相比較,該治療時間係一受歡迎的時間週期。因此, 電池壽命及/或電力提供可需要容許多達15天的操作。亦 可利用其他減壓源,例如可自Texas、San Ant〇ni〇之kci購 得之V.A.C.⑧療法單元,或一壁式吸入單元。端視成形敷 料枕墊32與表皮14之間的流體密封之洩漏程度,減壓源μ 亦了由可攜式機械器件(例如一管中之一活塞)供應。 由減壓源82形成之減壓透過減壓遞送導管9〇遞送至一減 麼介面92,該減壓介面可係—肘形物。在—個說明性實 施例中,肘形珲94係一可自Texas、San Ant〇ni〇之κα購得 之TRAC®技術^減壓介㈣允許減㈣遞送至密封子系 統60且實現於密封子系統6〇之一内部部分内。在此說明性 實施例巾’槔94延伸通過包覆敷巾62且進人成形敷料枕塾 32中。
*在操作中’系統1〇可在一外科方法後於手術室中施加於 患者上或在另一時間應用。成形敷料枕墊32之第二表面36 放置於患者表皮14上’其中成形敷料枕墊32在遭破壞皮下 組織部位20上且其中一部分在切口 12上。敷料總成%可針 對由-康護提供者實施之方法中所涉及之典型應用來定大 敷料U成30可經定大小、成形及構形以對不同解剖應 用(例如腹部、胸腔、大腿、手臂等等)其作用。 '^匕覆敷巾62尚未耦合(見下文其他說明性實施例)至成 >敷料枕墊32 ’則包覆敷巾62接著放置於成形敷料枕墊32 140735.doc •17- 200950832 之第一表面34上,其中一額外部分延伸超過周邊邊緣38以 形成敷巾延伸部分64。可接著用膠帶將敷巾延伸部分料黏 至表皮14(見圖2中之172)或使用一黏合劑7〇(圖”來在包覆 敷巾62與患者表皮14之間形成一流體密封。該流體密封僅 而要足以允許系統1 0保持一治療部位處之一減壓。使用減 壓遞送導管90以流體方式耦合減壓介面92及減壓源82。可 接著啟動減壓源82並將減壓遞送至成形敷料枕墊32。 在成形敷料枕墊32處之壓力減小時,成形敷料枕墊32橫 向加壓及收縮並形成一半剛性基板,且因此出現許多有益 力及行為。減壓仍進一步透過成形敷料枕墊32傳輸以便在 切口 12處之患者表皮14處經歷減壓。至少在癒合過程的早 期階段’減壓透過切口 12實現並進入皮下組織2〇中,且該 壓力減小幫助閉合缺陷(例如皮下空隙22),且向該區大致 提供穩定性。遞送至成形敷料枕墊32之減壓亦形成同樣可 提供穩定性及療法之加壓力24。加壓力24不僅在表皮14 處。加壓力24向下延伸更深且可在皮下組織2〇位準處經歷 其。 在包覆敷巾62及成形敷料枕墊3 2在減壓的影響下橫向收 縮時,且在該向下力透過表皮14之泊松比作用時,形成一 向内力26’該内向力可幫助將一閉合力固持於切口 12上且 可向切口 12或治療部位大致提供額外穩定性》向内力26可 部分地依賴於成形敷料枕墊32與表皮14之間的摩擦以將該 力傳送至表皮14且可涉及藉助黏合劑70或在使用膠帶(圖2 中之172)之情形下透過摩擦自敷巾延伸部分64至表皮14之 140735.doc 18 200950832 力傳輸。同時,遞送至且穿過成形敷料枕墊32之減壓幫助 自切口 12移除任何流出物或其他流體。系統1〇亦在均勻施 加一力之情形下允許表皮14平滑一其修整該表皮之輪廓且 使其平滑。所有該等行為皆可改良切口 12及遭破壞皮下組 織20之癒合。 一個操作顧慮係避免在部署及使用系統1〇中之皮膚刺 激。因此,採用護理來避免皮膚刺激(例如患者表皮14起 泡),其可因次要剪切、次要應變或其他效應引起。為 此,成形敷料枕墊32之末端33可經成形以提供一均勻加壓 力分佈。末端33係枕墊32之外部成形部分且周邊邊緣大致 係成形敷料枕墊32之最外側部分或與患者表皮介接之最外 侧部分。末端33可係一斜切表面,但亦可使用其他形狀, 例如系統110中之一弓形形狀(圖2)。期望均勻地分佈合力 之形狀。與之對比,在使用一具有一正方形邊緣之敷料枕 塾時,在一包覆敷巾施加於該敷料枕墊上且施加至患者表 皮上時可形成一「帳篷區」。據信,該「帳篷區」貢獻於 具有皮膚刺激之組織。可藉由使成形枕墊32成形或藉由將 5亥包覆敷巾附裝至該敷料枕塾之一側區來避免該「帳蓬 區」。 成形敷料枕塾32之成形邊緣或末端允許將在無一大「邊 緣效應」之情形下形成一加壓力24 ;亦即,不導致剪切或 應力上升至一導致皮膚刺激(例如紅斑或起泡)之位準。該 成形部分逐漸分佈該力以避免刺激。小心地將該等力施加 至表皮14以避免刺激之方式一般稱為「均勻地分佈」加麼 140735.doc •19· 200950832 力24,但在字面意義上來說並不嚴格使用。可存在某此變 化’但不足以導致表皮14之刺激。作為對皮膚刺激之另一 預防’可在成形敷料枕墊32與患者表皮14之間添加—内層 (見圖11中之857)或將其放置於其他位置中,如下文進一步 結合其他說明性實施例所解釋。 期望將系統10應用於手術室中且允許系統1 〇保持在串者 上’直至已出現足夠癒合。在這點上,期望由視透型材料 形成包覆敷巾62、成形敷料枕墊32及任何其他層以允許康 護提供者獲得關於切口 12及遭破壞皮下組織2〇之癒合之視 覺暗示,而無須移除敷料總成3〇。 現參照圖3,其呈現一用於治療一患者中遭破壞皮下組 織之系統110之另一說明性實施例。系統丨1〇在大多數方面 類似於圖2之系統1〇,且在此實施例中類似部分一般係藉 由以100給該等編號加索引來指示。在此特定說明性實施 例中,系統110放置於未受損傷表皮115上,亦即,在此情 形下不存在切口或其他線性傷口。然而,存在包含一皮下 空隙122之遭破壞皮下組織12〇。無論是否存在一切口,系 統11 〇皆幫助治療遭破壞皮下組織丨2〇。 系統11〇包含一具有一成形敷料枕墊132之敷料總成 130。成形敷料枕墊132具有一第一側132及一第二面向内 側136。雖然顯示圖2之成形敷料枕墊32具有一梯形橫截 面,但圖3之成形敷料枕墊132具有一形成有一橢圓形形狀 (其帶有一具有輻射式邊緣之末端133)之橫截面,或具有一 弓形邊緣之橫截面。成形敷料枕墊132可成形有一有雙斜 140735.doc -20- 200950832 面的橫截面或其他形狀。如前所述,成形敷料枕墊132之 形狀促進均勻加壓力分佈到達一在減壓期間避免皮膚刺激 的程度。在圖3之說明性實施例中,一密封裝置169在包覆 敷巾162與患者之表皮114之間提供一流體密封。在此實例 中,密封裝置169係一密封膠帶172。 系統110包含一密封子系統160以在成形敷料枕墊132上 提供一流體密封。一減壓遞送導管190將減壓遞送至一與 密封子系統160之一内部部分處於流體連通之減壓介面 192(例如一琿 194)。 在此說明性實施例中,周圍壓力在包覆敷巾i 62之一第 一表面161上提供一力131且成形敷料枕墊132之收縮形成 一加壓力124從而提供一向下進入皮膚經歷且到達真皮U6 並可到達其他皮下位準118之淨力。同時,形成一大致平 面内向内導引力。該向内力可透過兩種不同機制形成。首 先,藉由一正被加壓之成形敷料枕墊132且在成形敷料枕 墊132加壓而成形敷料枕墊132被向内牵引時導致一係一向 内收縮力之向内力127。同時,由於施加減壓,因此包覆 敷巾162被牵引至接近末端133之區中,如由箭頭128所指 示。由於一敷巾延伸部分164緊固至表皮114,因此合力 128之水平分量將向内拉表皮114,如由向内力129所指 示0 現參照圖4,其在一曲線狀軀體部位200(例如一患者軀 幹)上顯示一用於治療一組織部位220(例如一遭破壞皮下組 織部位)之系統210。系統210包含一敷料總成230及一密封 140735.doc •21 · 200950832 子系統260。敷料總成230包含—成形敷料枕墊232。密封 子系統260包含一帶有一延伸部分264之包覆敷巾262。延 伸部分264可藉助一密封裝置(例如一黏合劑27〇)緊固至患 者表皮214。一減壓源(未顯示)向一減壓遞送導管29〇提供 減壓,該減壓遞送導管將減壓遞送至一減壓介面292。 減壓介面292將減壓遞送至成形敷料枕墊232。由於成形 敷料枕墊232在減壓的影響下加壓,因此形成一遞送至組 織部位220之淨加壓力224。在此實施例中,成形敷料枕塾 232之一末端233形成有一正交端。包覆敷巾262在一空隙 235周圍形成一「帳篷」區229。在減壓下包覆敷巾 被拉進空隙235中且藉此施加一形成一形成向内收縮力226 之力。 在系統210中,成形敷料枕墊232之曲率亦幫助形成一加 壓力。成形敷料枕墊232之一第一表面234具有一比成形敷 料枕墊232之一第二面向内表面236之一表面積大的表面 積。因此,在減壓了,此表面積差別亦促進形成—淨加壓 力 224。 現參照圖5 ’其呈現一用於治療一組織部位32〇(例如一 遭破壞皮下組織部位)之說明性系統31〇。系統31〇在大多 數方面大致類似於圖4之系統210,且類似部分係藉由以 100給圖4之參考編號加索引來指示。系統31〇應用至—曲 線狀軀體部位300,例如一患者軀幹。系統31〇呈現一接近 表皮3 14部署之完全圓周敷料總成33〇。 一敷料枕墊332係設置於表皮314上,且使用一敷巾或一 140735.doc •22· 200950832 包覆敷巾3 62來形成一含有敷料枕墊332之密封區。減壓透 過一減壓導管390遞送至一減壓介面392。減壓介面392將 減壓遞送至敷料枕墊332。在施加減壓期間形成之圓周力 在系統310中組合以形成向内加壓力324。該加慶力可高於 一扁平或局部軀幹應用,此乃因不卸載到達敷巾且到達皮 膚之力。 現參照圖6-8 ’其呈現一用於治療一患者之一治療區4】2 之系統410。在此圖解說明中所提供之治療係一到達治療 區412之力’該治療區在患者軀幹404上。治療亦可包含移 除切口處之流體。對此說明性實施例而言,所期望治療區 412顯示為患者腹部。若患者已進行了(例如)腫脹吸脂,則 期望使用系統41 0來施加一實現於切口處之加壓力、施加 一實現於真皮416處且實現於遭破壞皮下組織42〇處之加壓 力、達成靠近皮下組織418以及使該組織穩定以抵抗剪切 應力、及移除任何現有退出流體,例如腫脹流體或流出 物。系統410包含一在患者軀幹404周圍至少部分地沿圓周 延伸之敷料總成430。敷料總成430包含一敷料枕塾432, 該敷料枕墊具有一第一周邊邊緣439。 如圖8中清楚地所示,敷料枕墊432具有一第一表面434 及一第二面向内(或面向組織)表面436。敷料枕墊432分佈 減壓並向所期望治療區(例如治療區412)提供一力,該力可 係一加壓力或舉升力。一内表面構件440(其具有一第—表 面442及一第二面向内表面444)可設置於患者表皮414與敷 料枕墊432之間。敷料枕墊432之第二表面436可耦合(例如 140735.doc -23· 200950832 結合或併入)至内表面構件440之第一表面442。内表面構 件440可獨立於敷料枕墊432。内表面構件44〇可係流體可 滲透或不可滲透且可在敷料枕墊432與患者表皮之間提供 一障壁。在一個說明性實施例中,内表面構件44〇避免可 能因敷料枕墊432與患者皮虜介接而引起之皮膚刺激且促 進使用減壓移除表面處之汗及其他流體。 敷料枕墊432可係由此申請案中別處所述之枕墊材料中 之任一者製成。敷料枕墊432可包含並不完全均勻之枕墊 材料,此乃因可希望敷料枕墊432在某些地方更具有剛性 (且不提供同等程度的舉升)或可希望敷料枕墊43 2在某些地 方(例如像在以下胸罩實施例上之乳房處)較不具有剛性且 形成最大舉升。使用一具有變化性質之枕墊材料或使用兩 種或更多種經組合以形成枕墊材料之不同材料可使該枕墊 材料更具有剛性或較不具有剛性。在某些應用中,期望由 一蜂巢材料形成該枕墊材料’例如一由California、 Sunnyvale 之 Supracor Systems Inc 購得之熔化結 合型蜂巢材料。 敷料總成430可進一步包含一外表面構件446或外部構 件’ 4外表面構件具有一第一側448及一第二側450。内表 面構件440或内部構件及外表面構件446可藉助一預拉緊彈 性材料(例如一彈性纖維材料)製成;例如可使用一 Lycra® 牌材料。内表面構件440具有高收縮性以避免起皺紋,此 將在皮膚上導致接觸負載。此外,用作内表面構件44〇之 材料之低摩擦幫助減小對表皮造成剪切傷害之可能性。此 140735.doc -24- 200950832 外,内表面構件440或層之可決 減壓傳輸且為流出物移除提供’性導致到Κ織部位之 内部構件及外表面構件446可;^通人路。内表面構件物或 墊432之包層。 。以形成—圍繞敷料枕
外表面構件446之第二側CO 一矣而办 輕5至敷料杬墊432之第 表面叫。各種構件的輕合(例如,表 : 表面450至434)可以許多方式路斗. 表面料2及 參 Φ 發生,許多實例如下。可使 用黏CT劑(例如丙烯酸黏合劑、 朝戎赧胁堃β 聚矽氧黏合劑、水凝膠、 親水膠體等等)或可使用結合(例如熱結合 射頻結合等等)。該麵合可以多種樣切波:°戈 ^裡傈式發生或可涵蓋所有 形式。可將若干結構構件添加至該輕合以使該構件沿一所 期望方向各向異性地作用。另外,可在該枕墊内供應若干 支柱或其他機械元件以改變敷料枕墊432之加壓及特性。 敷料總成430在圖6至8中顯示為具有一大致矩形橫截 面’但亦可利用其他形狀來更提供一垂直舉升力(對圖认 7中所示之定向而言垂直)。雖然將敷料枕墊432顯示為一 整體構件,但敷料枕墊432亦可形成有若干不同枕墊材料 區段,該等不同枕墊材料區段各自具有不用減壓供應,且 甚至可具有一帶有負壓之區段。考量後一情形,可添加一 個或多個密封構件,可向該一個或多個密封構件提供一負 塵以幫助重新分佈負載或添加若干結構元件。 可以一包覆敷巾462覆蓋敷料枕墊432及任何額外層(例 如内表面構件440及外表面構件446),該包覆敷巾係一密 封子系統460之一部分。包覆敷巾462可延伸超過周邊邊緣 140735.doc -25- 200950832 438及439以形成敷巾延伸部分464,該敷巾延伸部分具有 一第一側460及一第二侧468。可藉由使用一密封裝置469 在敷巾延伸部分464與患者表皮414之間形成一流體密封, 該密封裝置例如一密封膠帶、敷巾膠帶471、一黏合劑(見 圖1中之黏合劑5)、漿料、親水膠體、水凝膠或其他密封 器件。敷巾膠帶471包含一黏合劑473。在某些應用中,可 · 在表皮414與敷料枕墊432或包覆敷巾462之間添加一墊片 材料。在另一實施例中,可僅將包覆敷巾462施加於敷料 枕墊432之第一側上,且接著在存在或不存在延伸部分464 · 之情形下使用一寬敷巾膠帶來密封敷料枕墊432之邊緣或 周邊部分。 在、封子系統460提供一流體密封,或以其他方式允許系 統410維持所期望治療部位412處之減壓。密封子系統46〇 較佳包含包覆敷巾462及密封裝置469。雖然描述為形成一 μ體後封’但實際上可存在某—茂漏且所得小空氣浪漏實 際上在整個敷料總成430上提供一低速空氣流動,其經分 佈且幫助移除濕氣。在—替代實施例中,替代使用包魏 〇 巾462,可使外表面構件446具有一氣密外部部分且可導引 敷巾膠帶覆蓋枕塾材料之邊緣以及其他未以其他方式密封 之部分。 - 部分地顯示一減麼子系統48〇且其類似於先前所呈現實 . 施例之減壓子系統,例如圖2之8〇。減壓子系統彻包含一 減壓介面492(例如肘形埠494),該減壓介面允許減麼源透 過-減壓導管479將減愿遞送至敷料總成㈣中且特… 140735.doc -26· 200950832 =至敷料枕墊432中。減壓子系統_可經控制以變化壓 攸而在患者之大小因水腫減少而發生改變時提供一怪定 加壓仇隼。該减壓源可供應一恨定減麼或—可變減壓。如 i述其他實施例,該減壓源可採用包含本文中別處所述 彼等形式之許多不同形式。 如圖7中清楚地所示,敷料總成43〇可在敷料枕塾432之 -部分上包含一轉變區452。轉變區452可成錐形或以其他
方式成形以減小厚度並增加撓性且最大化邊界處之剪切柔 量。此可幫助分佈任何集中剪切負載(例如由敷料總成43〇 之收縮所引起之彼等剪切負載)、患者移動性及由敷料/受 夾區與無支撐真皮之間的勁度不連續性所引起之負載集 中。轉變區452可轉變為一個或多個連接片454或接合元件 454 〇 接合元件454之一部分可包含若干扣件456,該等扣件可 係一鉤及環扣件、扣環或連接接合元件454之兩部分之其 φ 他器件。接合元件454及扣件456形成一圓周連接器且其中 敷料總成430在曲線狀軀體部位周圍完成一路徑或形成一 完全可釋放圓周構件458。因此,可釋放圓周構件458在患 者軀幹404周圍延伸以允許可釋放圓周構件458固持於軀幹 404上’且特定而言即使在減壓係由減壓子系統48〇遞送之 前亦將枕墊432固持於所期望治療區412上。可使用額外敷 巾膠帶來在接合元件454及扣件456上提供一流體密封。 轉變區452可包含敷料總成430之一第一端453及一第二 端455 ’且特定而言一顯示圍繞患者軀幹404之縱向部分 140735.doc -27- 200950832 457之端。因此使該兩個端在一起且由可釋放圓周構件458 以可釋放方式固持,該可釋放圓周構件包含若干接合元件 454及扣件456。 敷料枕墊432之第一表面434與第二表面436之表面積差 貢獻於產生一淨加壓(向内)力。該淨加壓力隨著敷料枕墊 432之第一表面434與敷料枕墊432之第二表面436之圓周比 率的增加而線性增加。因此’為形成一較大加壓,可使敷 料枕墊432較厚以增加該比率。敷料枕墊432之彎曲勁度亦 可影響所形成加壓力之遞送。若敷料43〇具有一低彎曲勁 度,則該淨加壓力相當均勻地分佈。簡要參照圖9,沿一 第二軸(其平行於542)及第一軸(其平行於54〇)之低彈性勁 度貢獻於減小敷料枕墊532之彎曲勁度。 現返回至圖6-8,在操作中,敷料總成43〇係放置在患者 之曲線狀軀體部位(例如,艇幹4〇4)周圍,其中敷料枕墊 432在所期望治療區412上。利用可釋放圓周連接器458(亦 即,啟動接合元件454及扣件456)形成完全可釋放圓周構 件。可啟動減壓子系統480以便減壓子系統48〇將減壓遞送 至在、封子系統460,從而致使將減壓遞送至敷料枕墊432。 敷料枕墊432可接著在減壓下加壓且塌縮以將支撐力遞送 至所期望治療區412。該支撐力可包含一加壓力,該加壓 力作用於患者軀幹中且向下進入表皮14、真皮416中且 向下到達遭破壞皮下組織420之皮下位準418。一個段之淨 加壓力在圖8中以參考編號424顯示《亦可形成一橫向力 426(亦即,朝向周邊邊緣439)或舉升或向上力426。 140735.doc •28- 200950832 現參照圖9,其顯示一敷料枕墊532之一部分,該敷料枕 墊係由一各向異性材料製成。一種可使用之各向異性材料 係可自Tytex Group (www.tytex.com)購得之AirX加壓材料 或織物。敷料枕墊532具有一第一表面534及一第二表面 536。其亦具有一對於圖6及7中所示之實施例而言將最接 近於人的頭部之頂部部分537,及一對於圖6及7中所示之 實施例而s將最接近於人的足部之底部部分539。出於描 述目的,敷料枕墊532具有三個分別平行於參考線54〇、 542及544之軸。敷料枕墊532之材料潛在地各向異性,此 意指其沿不同軸將具有不同機械性質。舉例而言,第一、 第二及第三軸中之至少兩者之間的加壓模數可不同。在一 個說明性實施例中,在期望提供一經 一 性材料可經選擇及定向讀佳^個或多㈣ 縮。在如現將考量之將一類似系統應用至乳房組織中尤直 期望此情形。 ❹ 參照圖10-14,其呈捃_田狄丄,< 丹至見用於向乳房組織提供一支撐力 之系統610。系統610包含—底、土的苗, ^ 5療法胸罩612以向一患者軀幹 604之一上部部分上之—乳 孔居£616中之乳房組織614提供 支撐。可在乳房組織614附近哎装卜 w ^ ^ , 町砹次其上之一所界定支撐區618 中提供支撐,其可已成為—外 外村方法(例如一局部戋全邱 乳房切除術或乳房增大方法) 一 ° )之對象。在乳房切除術之情 形下’支撐區618可支撐剩餘乳房組織。 系統610包含一敷料總成㈣,該敷料總成包含_且有一 第一表面034及一第二面向内 八有 内表面636之敷料枕墊632。敷 140735.doc •29- 200950832 料總成6;3 0可包含一具有一第一表面640及一第二面向内表 面642之内表面構件63 8。内表面構件63 8可在一第一表面 640上耦合至敷料枕墊632之第二表面636。敷料總成630亦 可包含一外表面構件644,該外表面構件具有一第一表面 646及一面向内表面648。外表面構件644可在一第二表面 上耦合至枕墊632之第一表面634。 一密封子系統660提供一流體密封,該流體密封足以當 在一來自一減壓子系統680之減壓下時在所期望支撐區618 中之患者表皮上維持一減壓。密封子系統66〇可採用許多 不同形式。本實施例包含一包覆敷巾662,該包裹敷巾覆 蓋敷料枕墊632且可延伸超過敷料枕墊632之周邊邊緣650 以形成若干延伸部分664, 一密封裝置667可應用至該等延 伸部分以與表皮形成流體密封。密封裝置667可採用眾多 形式’例如黏合劑、一密封膠帶668或條帶 '雙側密封膠 帶、漿料、親水膠體、水凝膠或其他密封器件。密封裝置 667亦可涉及如圖13中所示之若干額外元件。 現參照圖13 ’ 一閉合裝置667可如先前所述僅係一膠帶 668或一黏合劑或可進一步包含一可比敷料枕墊632處於更 大張力下之密封枕墊670。密封枕墊67〇使包覆敷巾662之 一部分在密封枕墊670上且可形成一隔間,減壓子系統68〇 將減壓遞送至該隔間或其可以流體方式連接至敷料枕墊 632以自減壓子系統680接收減壓。 現參照圖14,其呈現密封裝置667之一說明性替代實施 例。在此實施例中,外表面構件644及内表面構件638毗鄰 U0735.doc •30· 200950832 於彼此超過周邊邊緣650放置。外表面構件644之第二表面 648及内表面構件638之第一表面640可藉助任一已知方法 耦合至彼此。該等構件可以許多不同方式耦合,該等方式 包含以下方法中之一者:使用黏合劑’例如藉助丙稀酸黏 合劑、聚矽氧黏合劑、水凝膠、親水膠體等等;藉助熱結 ' 合、超聲波結合及射頻結合等等來結合;或其他方法。該 . 耦合可以多種樣式或更完全地發生。可向該結合添加結構 以使該材料沿一所期望方向各向異性地作用。圖14中之實 ® 施例顯示一施加於内表面構件638之第二表面642與患者表 皮611之間的黏合條帶674。在黏合條帶674施加於表皮611 上之前,黏合條帶674可覆蓋有一可移除襯背或條帶。 現主要參照圖10-12,現將根據療法胸罩612來解釋遞送 至支推區618之支撐力。胸罩612如先前所述結合敷料總成 630形成且包含一第一罩杯682及一第二罩杯684。在形成 罩杯682及684中,需要添加一個或多個接縫686。每一個 φ 罩杯682、6料形成一袋,例如圖n中所示之袋688。袋688 係用於接納乳房組織614,或在一乳房切除術之情形下, 可接納一臨時外科手術後假體(例如一以一超吸收材料覆 .蓋之矽膠插入物)以幫助收集流出物且幫助將壓力施加至 一下伏傷口。在一替代實施例中,可形成一單杯,其覆蓋 兩個乳房或更一般而言患者胸腔之一部分。 可將療法胸罩612分為兩部分以使單獨襯墊對每一個罩 杯682 684具有單獨密封子系統以便可向每一個罩杯 682、684供應不同壓力位準從而容許不同大小或情形。舉 140735.doc -31 - 200950832 例而言’若—個 乳房尚未成為_ 現主要參照圖12, 個乳房已成為—乳房切除術之對象且另一個 一乳房切除術之對象,則可期望不同減壓。 件654之轉變區652 個或多個扣件656, 合(未明確顯示,但 鉤及環構件、搭如
接合元件654可係一編織物材料及一
一減壓, 既wo(僅顯示其一部分)透過一減壓導管687遞送❹ 該減壓導管透過一減壓介面692(例如一肘形埠 694)與敷料枕塾632處於流體連通。 在操作中,藉由將療法胸罩612放置於軀幹6〇4上以便枕 墊632之至少一部分接近乳房組織614且較佳接近支撐區 618來利用系統61〇。敷料總成63〇連通接合元件654及扣件 656—起形成一可释放圓周連接器698,該可釋放圓周連接 器即使在施加來自減壓子系統68〇之減壓之前亦將療法胸 罩612固持於適當位置。一旦療法胸罩612處於適當位置,❹ 即啟動減壓子系統680並透過減壓介面692將減壓遞送至敷 料枕墊632。敷料枕墊632在減壓的影響下塌縮並收縮且藉 此導致在整個圓周連接器698上形成張力並向支撐區618或 . 向乳房組織614提供一加壓力及一支撑(向上)力之一元。 已顯示該等系統及裝置應用於各種軀體部位(例如腹部 及乳房)上’但亦可包含其他應用。舉例而言,在其中枕 墊總成可藉助一條類似於單車短褲之短褲固持於適當位置 140735.doc -32· 200950832 之情形下,該系統可用於—人之—大腿上。作為另一實 例,針對乳房組織描述之該等系統及裝置可經修改以形成 大的單刖杯’其可用於舉升及支撐一血管翳或其他懸垂 組織瓣片。仍作為-個更多實例,一按類似樣式製成針對 ㈣組織呈現之減_可在外科手術後詩雙丸狀支撑且 可併入至短褲中。 • 根據另-說明性實施例’-種向-人之一曲線狀軀體部 &之至少—部分提供—力之方法包含將-敷料總成部署於 該曲線狀軀體部位上之㈣。該敷料總成包含一之内表面 構件,該内表面構件用於放置於所期望治療區上且具有一 第一表面及一第二面向内表面。該敷料枕墊具有一第一表 面及一第二面向内表面。該敷料枕墊之該第二面向内表面 係設置於該内表面構件之該第一表面上。可將該敷料總成 密封至該曲線狀軀體部位。該方法進一步包含向該敷料總 成提供減壓。在施加減壓時,該敷料枕墊自在周圍壓力下 • 之一第一體積(v丨)變為在減壓下之一第二體積(v2)。換言 之,該第一體積大於該第二體積:Vi>V2。在體積改變 時,形成一導引力,其可包含一加壓部分、一舉升部分或 一向内閉合部分。 _ 雖然已在某些說明性、非限制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、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之 範圍。將瞭解,結合任一個實施例所述之任一特徵亦可適 用於任一其他實施例。 140735.doc •33· 200950832 【圖式簡單說明】 可藉由在結合隨附圖式時參昭以卜音你士 a _ 爹‘、、'以上貫施方式而獲得對本 發明之一更全面理解,其中: 圖!係一人的躺幹上所示之一減壓系統之一說明性實施 例之一部分之一示意性透視圖; 圖2係-切口上及遭破壞皮下組織上所示之—減壓系統 之-說明性實施例之-示意性透視圖(其—部分為橫截 面); 圖3係未受損傷皮膚上及一遭破壞皮下組織區上所示之❹ 一減壓系統之一說明性實施例之一部分之一橫截面; 圖4係顯示施加於一人之一軀幹上之一減壓系統之一說 明性實施例之一部分之示意性橫截面; 圖5係顯示施加於一人之一軀幹上之一減壓系統之一說 明性實施例之一部分之示意性橫截面; 圖6係一軀幹上所示之一減壓系統之一說明性實施例之 一部分之一前部示意性透視圖; 圖7係圖6中所示之說明性系統之一部分之一後部示意性❹ 透視圖; ~ 圖8係一減壓、加壓系統之一說明性實施例之—部分之 一示意性橫截面; , 圖9係一顯示一枕墊材料之示意性透視圖; - 圖10係一用於向乳房組織提供支撐之胸罩之一說明性實 施例之一前部示意性透視圖; 圖π係圖10之胸罩自一側截取之一橫截面; 140735.doc -34· 200950832 圖12係圖10-11之胸罩之一前部示意性透視圖,其中該 胸罩之一部分經釋放以顯示該胸罩之一背部部分; 圖13係圖10-12之胸罩之一部分之一示意性橫截面;及 圖14係圖10-12之胸罩之一部分之一示意性橫截面,其 顯示一說明性替代態樣。 【主要元件符號說明】 2 系統 3 所期望治療區
4 人的軀幹 5 黏合劑 10 系統 12 切口 13 縫合線 14 表皮 16 真皮 18 皮下組織 20 遭破壞皮下組織部位 22 空隙 24 加壓力 26 向内力 30 敷料總成 32 成形敷料枕墊 34 第一表面 36 第二表面 140735.doc -35- 200950832 38 周邊邊緣 60 密封子系統 62 包覆敷巾 64 敷巾延伸部分 66 第一表面 68 第二表面 69 密封裝置 70 黏合劑 80 減壓子系統 82 減壓源 84 電池盒 86 罐區域 88 窗 90 減壓遞送導管 92 減壓介面 94 肘形埠 110 系統 114 表皮 115 未受損傷表皮 116 真皮 118 皮下位準 120 遭破壞皮下組織 122 皮下空隙 124 加壓力 140735.doc -36- 200950832
127 向内力 128 合力 129 向内力 130 敷料總成 131 力 132 成形敷料枕墊 133 末端 136 第二面向内側 160 密封子系統 161 第一表面 162 包覆敷巾 164 敷巾延伸部分 169 密封裝置 172 密封膠帶 190 減壓遞送導管 192 減壓介面 194 埠 200 曲線狀軀體部位 210 系統 214 患者表皮 220 組織部位 224 淨加壓力 226 向内收縮力 229 「帳篷」區 140735.doc •37- 200950832 230 敷料總成 232 成形敷料枕墊 233 末端 234 第一表面 235 空隙 236 第二面向内表面 260 密封子系統 262 包覆敷巾 264 延伸部分 270 黏合劑 290 減壓遞送導管 292 減壓介面 300 曲線狀軀體部位 310 系統 314 表皮 320 組織部位 324 向内加壓力 330 完全圓周敷料總成 332 敷料枕墊 362 包覆敷巾 390 減壓導管 392 減壓介面 404 患者躯幹 410 系統 140735.doc -38- 200950832
412 所期望治療區 414 患者表皮 416 真皮 418 皮下位準 420 遭破壞皮下組織 424 淨加壓力 426 橫向力 430 敷料總成 432 敷料枕墊 434 第一表面 436 第二表面 438 周邊邊緣 439 第一周邊邊緣 440 内表面構件 442 第一表面 444 第二面向内表面 446 外表面構件 448 第一側 450 第二側 452 轉變區 453 第一端 454 接合元件 455 第二端 456 扣件 140735.doc •39- 200950832 457 458 460 462 464 466 468 469 471 473 479 480 492 494 532 534 536 537 539 604 610 611 612 612 614 縱向部分 可釋放圓周構件 密封子系統 包覆敷巾 敷巾延伸部分 第一側 第二側 密封裝置 敷巾膠帶 黏合劑 減壓導管 減壓子系統 減壓介面 財形埠 敷料枕墊 第一表面 第二表面 頂部部分 底部部分 軀幹 系統 患者表皮 療法胸罩 療法胸罩 乳房組織 140735.doc -40- 200950832
616 乳房區 618 所界定支撐'區 630 敷料總成 632 敷料枕墊 634 第一表面 636 第二面向内表面 638 内表面構件 640 第一表面 642 第二面向内表面 644 外表面構件 646 第一表面 648 面向内表面 650 周邊邊緣 652 . 轉變區 654 接合元件 656 扣件 660 密封子系統 662 包覆敷巾 664 延伸部分 667 密封裝置 668 密封膠帶 670 密封枕墊 674 黏合條帶 680 減壓子系統 140735.doc •41 - 200950832 682 第一罩杯 684 第二罩杯 686 接縫 687 減壓導管 688 袋 692 減壓介面 694 肘形埠 698 可釋放圓周連接器 140735.doc -42-
Claims (1)
- 200950832 七、申請專利範圍: 1. 一種用於向一人之一曲線狀軀體部位上之一所期望治療 區提供一力之系統,該系統包括: 一敷料總成,其用於放置於該人之該所期望治療區 上,該敷料總成具有一帶有一第一端及一第二端之縱向 部分; 其中該敷料總成包括: 一内表面構件,其具有一第一表面及一第二面向内 表面;及 -敷料枕墊’其具有一第一表面及一第二面向内表 面’其中該敷料枕墊之該第二面向内表面係設置於該 内表面構件之該第一表面上; ::釋放圓周構件’其輕合至該敷料總成之該第一端 及第一端; 封了:封子系統,其用於在該敷料總成上提供一流體密 =壓子“,其用於向該敷料總成提供 2·如凊求項1之彡、统,其中該 kg/m3之—密声夕^ 戮料枕墊係由具有大於25 在度之一枕墊材料形成。 3. 如請求項1之系& _ M 、、、,其中該敷料總成進一步包括一具有 第一表面及一第—而6 ± ^具有 外袅而_ 4 向内表面之外表面構件,其中嗲 外表面構件之該第- 丹叶具甲該 該第—表面上。 ° 面係設置於該敷料枕墊之 4. 如請求項1之系統, 、μ數料枕墊包括一具有一第 140735.doc 200950832 一、第二及第三輛夕欠人 -、第… 異性枕塾材料,且其中該第 步一及第三輪, 5.如請求们之李絲甘兩者之間的加塵模數不同。 斜。 糸、先’其中該内表面構件包括一彈性材 6. 如請求項1之& & 7如靖求^、,、中該内表面構件包括彈性纖維。 ^項1之系統,其中該敷料總成包括: 一外表面構件,其具 面,其中該外表面構件之” :第二面向内表 敷料枕塾之該第-表面::内表面係設置於該 其中該外表面構件包括—彈性材料。 8. 如請求項1之系統’其中該敷料總成包括: 一外表面構件,其具有一 品.^ 有第一表面及一第二面向内表 面’其中該外表面構件之該第_ ^ ^ ^ 适第一面向内表面係設置於該 敷料枕墊之該第一表面上;且 其中該外表面構件包括彈性纖維。 9. 如吻求項!之系統,其中該敷料總成進一步包括: 一外表面構件’其具有—第—表面及_第二面向内表 面’其中該外表面構件之該第二面向内表㈣合至該敷 料枕墊之該第一表面。 1〇.如請求項1之系統’其中該可釋放圓周連接器包括··-接合元件及一可釋放扣件。 11.如請求項〗之系統,g中該密封子系統包括: 一包覆敷巾,其延伸於該敷料總成上,·及 -密封裝置,其用於在該人的表皮與該包覆敷巾之間 140735.doc 200950832 k供該流體密封。 12·如凊求項1之系統’其中該減壓子系統包括: 減磨源,其用於提供減壓; 一減壓介面’其耦合至該密封子系統;及 減壓遞送導管,其用於將減壓自該減壓源提供至該 減壓介面。 13.如請求項1之系統, 其中該敷料總成包括: 響 外表面構件,其經定大小以延伸於該敷料枕墊上 且具有一第一表面及一第二面向内表面,其中該外表 面構件之該第二面向内表面係設置於該敷料枕墊之該 第一表面上; 其中該密封子系統包括: 一包覆敷巾,其延伸於該敷料枕墊上,及 一密封裝置,其用於在該人的表皮與該包覆敷巾之 _ 間提供該流體密封; 其中該減壓子系統包括: 一減壓源’其用於提供減壓, •一減壓介面,其耦合至該密封子系統,及 -減壓遞送導管,其詩將減壓自該減壓源提供至 該減壓介面。 14. -種用於向—人之—曲線狀躺體部位上之—所期望治療 區提供一力之系統,該系統包括: 一敷料總成,其用於放置於該人之兮 茨人(。亥所期望治療區 140735.doc 200950832 上’該敷料總成具有—帶 部分; # 其中該敷料總成包括: 一第—材料,其具有—第一 面;及 端及一 第二端之縱向 表面及一 第二面向内表 第一材料,其具有—第 面,其中該第一材料之該表面及-第二面向内表 第二g料之該第一表面上· 向内表面係設置於該 一可釋放圓周構件 及第二端;及 其耦合至該敷料總成之該第 一端 一減壓子系統,政 15 如請求項14之系統,、其中;5第:總成提供-減覆。 第二材料係-枕塾材料r第—材料係一彈性材料且該 16. 如請求項14之系統 產生一導引力。 其,該敷料總成可在減壓下操作以 17. 18. 如請求項14之系統,其中兮獻粗 丹1f鑌敷枓總成可在減壓下操以 產生一舉升力。 一種用於向一人的軀幹上之-所期望治療區提供一加壓 力之系統,該系統包括: 一敷料總成,其經成形及構形以玫置於該人的軀幹之 至少一部分上; 一可釋放圓周連接器’其用於將該敷料總成固持於該 躯幹上’其中該圓周連接器及該敷料總成包括一圓周構 件; 140735.doc -4 200950832 —了 ^ Ά '、統,其用於在該敷料總成及該人的表皮上 如供—流體密封;及 反上 一減壓子系& ^ m 4备达'、、、先,其用於向該敷料總成提供減壓,藉此 二、、”可操作以在該麵幹之至少一部分上產生一加壓 19::i項18之系統,其中該敷料總成包括-敷料枕墊, ㈣:庵势由一枕塾材料形成且經定大小以延伸於-所 二=::有:—表面及-― 系統’其中該敷料總成包括: 一内表面構件,其婉 再、-疋大小以延伸於該所期望治療區 上丑具有—第一志^&11 hrh 表面及—第二面向内表面;及 一敷料枕墊,其且有— 面,…、有第—表面及一第二面向内表 、中该敷料枕墊之該第_ 弟—面向内表面係設置於該内 表面構件之該第一表面上。 内表面構件,JL呈右一贫 . …、有第一表面及一第二面向内表 青长項18之系統’其中該敷料總成包括 ❹ —· Γ^Γ) -r- » >«. 面; 一敷料枕塾,其具右—梦 而,“ 第一表面及一第二面向内表 中該敷料枕塾之兮·笛_ & ± 本而槐M 第向内表面係設置於該内 表面構件之該第一表面上; 一外表面構件,其且有一 品“ 第—表面及—第二面向内表 ’八中該外表面構件之該第_ 第一面向内表面係設置於該 敷科枕墊之該第一表面上,·且 其1 t該内表面構件及琴· 稱忏及料表面構件_合以在該敷料 I40735.doc 200950832 枕塾上提供—流體密封。 22·如請求項18之系統,其中該敷料總成包括· 内表面構件,其經定大小以延伸於該所期望治療區 上且具有—第—表面及一第二面向内表面; -敷料枕塾’其具有一第—表面及一第二面向内表 面,其中該敷料枕墊之該第二面向内表面係設置於該内 表面構件之該第一表面上;且 〇 其中該敷料枕塾包括一具有—第一、第二及第三軸之 各向異性枕墊材料,且其中施加於該第-軸上之張力導 致該各向異性枕塾材料沿該第二轴之—大於ι:ι回應。 23. 如請求項18之系統’其中該敷料總成包括: -内表面構件,其經定大小以延伸於該所期 上且具有一第—表面及一第二面向内表面; 、〔 面:枕塾,其具有一第—表面及—第二面向内表 表面Li該敷料枕墊之該第二面向内表面係設置於該内 表面構件之該第一表面上;且 1 ❹ 其中該内表面構件包括一彈性材料。 24. 如請求項18之系統,其中該敷料總成包括: 上:m其經定大小以延伸於該所期望治療區 且具有一弟一表面及一第二面向内表面; 一敷料枕墊,其具有—笛—主工 而..^ 第表面及—第二面向内表 面,其中該敷料枕墊之該第二面向 円表 表面構件之該第-表面上;s表面係設置於該内 其中該内表面構件包括彈性纖維。 140735.doc ~ 6 - 200950832 25·如請求項丨8之系統,其中該敷料總成包括: 面向内表 一内表面構件,其具有一第—表面及一第 面; 一敷料枕塾,其具有一第一表面及一第二面向内表 面,其中該敷料枕墊之該第二面向内表面係設置於該内 表面構件之該第一表面上;及 -外表面構件,其具有一第—表面及一第二面向内表 面’其中該外表面構件之該第二面向内表面係設置於該 敷料枕墊之該第一表面上;且 其中該外表面構件包括一彈性材料。 26.如請求項18之系統,其中該敷料總成包括: 面; 面構件,其具有一第—表面及 第二面向内表 -敷料枕墊,其具有一第_表面及—第二面向内表 敷料枕墊之該第二面向内表面係設置於該内 表面構件之該第一表面上;及 面,件’其具有一第-表面及-第二面向内表 面構件之該第二面㈣表㈣#置於該 敷枓枕墊之該第一表面上;且 其中該外表面構件包括彈性纖維。 27·如請求項18之系統’其中該敷料總成包括: 第 面向内表 一内表面構件,其具有一第一表面及 面; 敷料枕塾,其呈右 货 其具有一第—表面及-第二面向内表 140735.doc 200950832 面’其中該敷料枕墊之該笫_ 之这第—面向内表面耦合至該内表 面構件之該第一表面;及 -外表面構件’纟具有-第一纟面及 面,其中該外表面構件之該° 料純*衣面稱件之該第-面向内表面耦合至該敷 枓枕墊之該第—表面。 28·如請求項18之系統,其中該敷料總成包括: 一=面構件,其具有—第_表面及_第二面向内表 且、.星疋大小以延伸於一所期望治療區上; 且且’其經定大小以延伸於—所期望治療區上 墊之,第类表面及一第二面向内表面’其中該敷料枕 第二表㈣設置於該内表面構件之該第-表面 上,及 一外表面構件,其呈右—筮 ± 而,… 帛一表面及一第二面向内表 其中该外表面構件之&主 第内表面係設置於該 敷科枕墊之該第一表面上。 29.如請求項18之系統,其中該密封子系統包括: -外部密封構件’其與該敷料枕墊相關聯·及 密封裝置,其詩在—人的表皮與該外部密封構件 之間提供一流體密封。 3〇·如請求項18之系統,其中該減壓子系統包括: 一減壓源,其用於提供—減壓; 一減Μ介面’其耦合至該密封子系統; 咸壓遞送導管’其用於將減壓自該減壓源提供至該 滅壓介面。 〜 140735.doc 200950832 31. —種用於向一人的軀幹上之一所期望治療區提供—加壓 力之系統,該系統包括: 敷料總成’其用於放置於該人之該所期望治療區 上’該敷科總成包括: 一縱向部分,其帶有一第一端及一第二端, 一敷料枕墊,其具有一第一表面及一第二面向内表 面,其中該敷料枕墊之該第二面向内表面係設置於該 内表面構件之該第一表面上, -包裹構件’其圍繞該敷料枕墊,纟中該包裹構件 包含-具有一第一表面及一第二面向内表面之内表面 構件,A—具有一第一表面及一第二面向内表面之外 表面構件,其中該外表面構件之該第二面向内表面接 近該敷料枕墊之該第一表面設置,且 其中該敷料枕墊係由具有大於25 kg/m3之一密度之 一枕墊材料形成; 可釋放圓周構件’其耦合至該敷料總成之該第一端 及第二端;及 社、封子系統’其用於在該敷料總成及該人的表皮上 提供-流體密封,該密封子系統包括: -包覆敷巾’其延伸於該外表面構件上,及 一密封裝置,其用^ ± 头用於在一人的表皮及該包覆敷巾上 提供一流體密封。 3 2 ·如请求項3 1之糸祕 '、統’其中該内表面構件包括一彈性材 料。 140735.doc 200950832 33. 如凊求項3〗之系統,其中該内表面構件包括彈性纖維。 34. 如請求項31之系統,其中該外表面構件包括一彈性物。 35. 如明求項31之系統,其中該外表面構件包括彈性纖維。 36. 如請求項31之系統,其中該敷料枕墊包括一具有一第一 轴、一第二軸及一第三轴之各向異性枕墊材料,且其中 沿該第一軸之一所施加張力導致該各向異性枕墊材料沿 該第二軸之一大於1:1回應。 37. —種製造一用於向一人之一曲線狀軀體部位上之一所期 望治療區提供-加壓力之系統之方法,該方法包括如下 步驟: 形成一經成形及構形以放置於該人之該所期望治療區 上之敷料總成; 提供一用於將該敷料總成固持於該所期望治療區上之 可釋放圓周連接器;及 提供一用於在該敷料總成及該人的表皮上提供一流體 密封之密封子系統。 38. 如睛求項37之方法,其進一步包括提供一用於向該敷料 總成提供減壓之減壓子系統之步驟,藉此該系統可操作 以在該所期望治療區之至少一部分上產生該加壓力。 39. 如請求項37之方法,其中該形成一敷料總成之步驟包括 如下步驟: 形成一經定大小以延伸於該所期望治療區上且具有一 第表面及一第二面向内表面之内表面構件; 形成一具有一第一表面及一第二面向内表面之敷料枕 140735.doc 200950832 墊;及 將該敷料枕墊之該第二表面設置於該内表面構件之該 第—表面上。 如吻求項37之方法,其中該形成一敷料總成之步驟包括 如下步驟: 形成一經定大小以延伸於該所期望治療區上且具有一 第表面及一第二面向内表面之内表面構件; 0 形成一經定大小以延伸於該内表面構件上且具有一第 一表面及—第二面向内表面之敷料枕墊; 將該敷料枕墊之該第二表面設置於該内表面構件之該 第一表面上; 形成具有一第一表面及一第二面向内表面之外表面 構件;及 將該外表面構件之該第二面向内表面設置於該敷料枕 墊之該第一表面上。 Φ 41· 一種向—人之一曲線狀軀體部位之至少一部分提供一力 之方法’該方法包括如下步驟: 將敷料總成部署於該曲線狀軀體部位上,其中該敷 料總成包括: 一内表面構件,其用於放置於該所期望治療區上且 具有—第一表面及一第二面向内表面;及 -敷料枕墊,其具有一第一表面及一第二面向内表 面,其中該敷料枕塾之該第二面向内表面係設置於該 内表面構件之該第一表面上 140735.doc 200950832 將該敷料總成密封至該曲線狀軀體部位; 向該數料總成提供減壓; 4、=斗枕墊在周圍壓力下具有一第-體積(〜且 田/壓下時具有一第二體積(v2),且V丨;>v2。 42. -種用於向—曲線狀軀體部位提供一力之 包括如下步驟: 4法 將敷料總成放置於一所期望區上; 其中該敷料總成具有一帶有一第一端及 向部分; 弟一鸲之縱 〇 將該第-端以可釋放方式麵合至該第二端以將該 成之該縱向部分固持於該患者上於該所期望治療區 將一減壓源以流體方式輕合至該敷料總成;及 啟動該減壓源以向該敷料總成提供減壓,藉此該敷料 總成被置於減壓下且收縮以形成一導引力。 如凊求項42之方法’其中該敷料總成包括一由具有大於2\kg/m3之一密度之一枕塾材料形成之敷料枕墊。 44·如吻求項42之方法,其中該敷料總成包括一由具有一密 度之-枕純料形成之敷料枕塾,該密度小於—表皮密 度,且其中該導引力係一舉升力。 140735.doc •12-
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TW98118068A TW201002376A (en) | 2008-05-30 | 2009-06-01 | Reduced-pressure, linear-wound treatment systems |
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TW98118080A TW201002276A (en) | 2008-05-30 | 2009-06-01 | Inflatable bladder dressings, systems, and methods |
TW98118065A TW200950830A (en) | 2008-05-30 | 2009-06-01 | Reduced pressure, compression systems and apparatuses for use on joints |
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TW98118064A TW200950829A (en) | 2008-05-30 | 2009-06-01 | See-through, reduced-pressure dressings and systems |
TW98118115A TW200950833A (en) | 2008-05-30 | 2009-06-01 | Reduced-pressure, compression systems and apparatuses for use on breast tissue |
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TW98118068A TW201002376A (en) | 2008-05-30 | 2009-06-01 | Reduced-pressure, linear-wound treatment systems |
TW98118067A TW201002375A (en) | 2008-05-30 | 2009-06-01 | Dressing assemblies for wound treatment using reduced pressure |
TW98118106A TW201002249A (en) | 2008-05-30 | 2009-06-01 | Reduced-pressure dressing assemblies for use in applying a closing force |
TW98118080A TW201002276A (en) | 2008-05-30 | 2009-06-01 | Inflatable bladder dressings, systems, and methods |
TW98118065A TW200950830A (en) | 2008-05-30 | 2009-06-01 | Reduced pressure, compression systems and apparatuses for use on joints |
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TW98118077A TW200950823A (en) | 2008-05-30 | 2009-06-01 | Super-absorbent, reduced-pressure wound dressings and systems |
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TW98118115A TW200950833A (en) | 2008-05-30 | 2009-06-01 | Reduced-pressure, compression systems and apparatuses for use on breast tissue |
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