TW200946151A - Foot manifolds, apparatuses, systems and methods for applying reduced pressure to a tissue site on a foot - Google Patents

Foot manifolds, apparatuses, systems and methods for applying reduced pressure to a tissue site on a foot Download PDF

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TW200946151A
TW200946151A TW098108347A TW98108347A TW200946151A TW 200946151 A TW200946151 A TW 200946151A TW 098108347 A TW098108347 A TW 098108347A TW 98108347 A TW98108347 A TW 98108347A TW 200946151 A TW200946151 A TW 200946151A
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Taiwan
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reduced pressure
void
tissue
foot
insole
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TW098108347A
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English (en)
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Ian James Hardman
Colin John Hall
Keith Patrick Heaton
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Kci Licensing Inc
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Publication of TW200946151A publication Critical patent/TW200946151A/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H9/00Pneumatic or hydraulic massage
    • A61H9/005Pneumatic massage
    • A61H9/0057Suction
    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43BCHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B3/00Footwear characterised by the shape or the use
    • A43B3/34Footwear characterised by the shape or the use with electrical or electronic arrangements
    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43BCHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B7/00Footwear with health or hygienic arrangements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/103Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/1036Measuring load distribution, e.g. podologic studies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/44Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
    • A61B5/441Skin evaluation, e.g. for skin disorder diagnosis
    • A61B5/447Skin evaluation, e.g. for skin disorder diagnosis specially adapted for aiding the prevention of ulcer or pressure sore development, i.e. before the ulcer or sore has developed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802Sensor mounted on worn items
    • A61B5/6804Garments; Clothes
    • A61B5/6807Footwear
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813Specially adapted to be attached to a specific body part
    • A61B5/6829Foot or ankle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0247Pressure sensors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16Physical interface with patient
    • A61H2201/1602Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
    • A61H2201/164Feet or leg, e.g. pedal
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T156/00Adhesive bonding and miscellaneous chemical manufacture
    • Y10T156/10Methods of surface bonding and/or assembly therefor
    • Y10T156/1052Methods of surface bonding and/or assembly therefor with cutting, punching, tearing or severing

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Biomedical Technology (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Epidemiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Computer Networks & Wireless Communication (AREA)
  • Dermatology (AREA)
  • Dentistry (AREA)
  • Microelectronics & Electronic Packaging (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rehabilitation Therapy (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Surgical Instruments (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)
  • Massaging Devices (AREA)
  • External Artificial Organs (AREA)
  • Footwear And Its Accessory, Manufacturing Method And Apparatuses (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Devices For Medical Bathing And Washing (AREA)

Description

200946151 六、發明說明: 【發明所屬之技術領域】 一般而言,該等說明性實施例係關於醫學治療系統,且 更特定而言係關於用於對-足部上之—組織部位施以減壓 之足部歧管、裝置、系統及方法。 【先前技術】 - 臨床研究及貫踐已顯示接近於一組織部位提供一減壓增 大且加速該組織部位處新組織之生長。此現象之應用眾 多,但減壓之應用已在治療傷口方面尤其成功。此治療 (在醫學團體中通常稱為「負壓力傷口療法」、「減璧療 法」或「真空療法」)提供若干益處,該等益處可包含肉 芽組織之較快癒合及增加之修復。 【發明内容】 根據一說明性實施例,一種用於對足部上之一組織部位 施以減壓之裝置包含.一内底;及一組織接觸表面,其覆 φ 蓋該内底之至少一部分。該組織接觸表面之至少一個部分 可移除以形成一空隙。該裝置亦可包含:一減壓介面,其 用於自一減壓源接收減壓;及至少一個流動通道,其以流 體方式輕合至該減壓介面及該空隙。 -在—個說明性實施例中,除上述裝置之外,一系統亦可 包3可操作以供應減壓之減壓源。該系統亦可包含一遞 送導官,該遞送導管可操作以將減壓自該減壓源遞送至該 裝置之減壓介面。 在—個說明性實施例中,一種用於對一足部上之一組織 139164.doc 200946151 部位施以減壓之方法包含:提供一足部歧管;及移除—組 織接觸表面之一覆蓋該足部歧管之一内底之部分以形成— 空隙。該方法亦包含:將該空隙與足部上之該組織部位對 準;及在該空隙與該組織部位之間形成一大致氣動密封。 該方法亦包含經由一流動通道將減壓自一減壓源施加至該 空隙以將減壓施加至該組織部位。 在一個說明性實施例中’一種製造一用於對一足部上之 一組織部位施以減壓之裝置之方法包含提供一内底及提供 一組織接觸表面。該方法亦包含用該組織接觸表面覆蓋該 内底之至少一部分以形成至少一個可操作以傳送減壓之流 動通道。 參照圖式及以下實施方式,該等說明性實施例之其他目 的、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 發明之精神或範疇。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-資訊。因,匕,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_僅由隨附 申請專利範圍界定。 參照圖丨,其呈現一用於向一患者之一足部1〇5上之一組 139164.doc 200946151 織部位102(例如一傷口 104)提供減壓治療之減壓治療系統 100之一說明性實施例。減壓治療系統100包含一自—減壓 源109接收減壓之足部歧管丨〇6,且其將減壓供應至足部 105上之一組織部位。足部歧管1〇6包含一内底1〇8,及— 覆蓋内底108之面向組織表面之組織接觸表面11〇。如本文 中所使用,「覆蓋」包含完全或部分覆蓋。減壓可透過一 遞送導官112遞送至足部歧管丨〇6,該遞送導管可插入至或 _ 另外以可移除方式耦合至一位於内底108之後部116處之減 壓介面114。組織接觸表面no之一部分可移除以形成一空 隙118 ’其可在足部歧管}〇6與足部1 〇5毗鄰時傷口 1 〇4對 準。内底108中之一個或多個流動通道12〇將減壓自減壓介 面114傳送至空隙118以將減壓治療遞送至傷口 1〇4。 如本文中所使用,「減壓」通常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 φ 減壓可小於該織部位處之一靜水壓力。在一個實施例中, 該減壓可最初在遞送導管112中並接近傷口 1〇4產生流體流 動°在傷口 104周圍之靜水壓力接近所期望減壓時,該流 動可減退且可維持該減壓。除非另外指示,否則本文_所 述之壓力值係計示壓力。所遞送之減壓可係靜態或動態 (經圖案化或隨機)且可被連續地或間歇地遞送。雖然可使 用術語「真空」及「負壓力」來描述施加至組織部位之壓 力,但施加至組織部位之實際壓力可大於通常與一完全真 空相關聯之壓力。與本文中之使用一致,減壓或真空壓力 139I64.doc 200946151 之-增加通常係指絕對壓力之一相對減小。除非另外指 示,否則如本文中所使用,「或」不需要相互排他。曰 傷口 104可係任一類型之傷口或受損傷組織區域,且可 包含來自外傷、手術或其他原因之傷口,例如-糖尿病性 潰瘍。包含傷口 104之組織部位1〇2可係任一人類、動物或 其他有機體之身體組織,包含骨組織、脂肪组織、肌肉= 織、真皮組織、脈管組織、結締組織、軟骨、腱、韌帶或 任一其他組織。組織部位1〇2之治療可包含移除流體(例 如’流出物)或遞送減壓。 在其中傷口 104係-足部潰癌之實例中,内底1〇8亦可用 於例如在患者正行走或站立時自傷口 1G4釋壓。組織接觸 表面110可與傷口 i 〇4周圍之組織維持接觸,藉此自傷口 104減輕壓力。施加於傷口 1〇4上之壓力因空隙ιΐ8毗鄰傷 104之存在而得以減小。特定而言,由於組織接觸表面 110之毗鄰傷口 1〇4之部分被移除,因此施加於傷口 上 之壓力得以減小。 足部歧管106可結合或替代治療鑄模系統(諸如全接觸鑄 杈及可移除石膏行走器)。舉例而言,足部歧管丨〇6可放置 於-由患者穿著之治療鑄模系統中。在另一實例中,足部 歧管106可插入至任一鞋類物品中,例如一鞋、靴、涼鞋 或輕軟鞋® 足部歧管106亦可以其他方式緊固至足部1〇5。舉例而 吕,一緊固構件122可至少部分地纏繞内底1〇8及足部 105。可使用黏合劑來防止緊固構件122展開。若需要,已 139164.doc 200946151 由緊固構件122纏繞之足部1 〇5及足部歧管i 〇6可放置於包 3 一治療鑄模系統之鞋類中。足部歧管1〇6亦可使用一個 或多個將足部歧管1〇6及足部105壓在彼此上之彈性帶緊固 至足部105。 在另一實例中’足部歧管1〇6可附著至足部105而不需要 緊固構件122或鞋類。在此實例中,足部歧管1〇6之組織接 觸表面no可係由一將足部105緊固至足部歧管1〇6之黏合 φ 劑材料製成或塗佈以該黏合材料。 一發泡體歧管124可插入至空隙11 8中。發泡體歧管124 幫助將減壓施加至傷口 1 〇4、將流體遞送至傷口 1 〇4或自傷 口 104移除流體。發泡體歧管124通常包含複數個經互連以 改良供至晚鄰發泡體歧管124之傷口 104及自其移除之流 體分佈之流動通道或路徑。發泡體歧管124可係一生物相 容材料,其能夠放置成與傷口 104接觸並將減壓分佈至傷 口 104。舉例而言,發泡體歧管124之實例可包含(但不限 φ 於):具有經配置以形成流動通道之結構元件之器件,諸 如(例如)包含蜂巢式發泡體、開放孔格發泡體、多孔組織 收集裝置、包含或凝固後包含流動通道之液體、凝膠及發 泡體。發泡體歧管124可係多孔且可係由發泡體、紗布、 黏製席或適合於一特定生物應用之任一其他材料製成。在 一個實施例中,發泡體歧管124係一多孔發泡體且包含複 數個充當流動通道之互連孔格或孔。該多孔發泡體可係一 聚胺基甲酸酯、開放孔格、網狀發泡體,例如,一由 Texas、San Antonio之 Kinetic Concepts有限公司製造之 139164.doc 200946151
GranuFoam®材料。在某些情形下’發泡體歧管124亦可用 於將流體(例如,藥物、抗菌藥、生長因子及各種溶液)分 佈至傷口 104。發泡體歧管124中或上可包含若干其他層, 例如吸收性材料、芯吸材料、疏水材料及親水材料。 減壓係透過流動通道120遞送至空隙118。雖然顯示足部 歧管106僅具有一單個流動通道12〇,但足部歧管1〇6亦可 具有諸如流動通道120之能夠藉助減壓介面I"以流體方式 連接内底108或組織接觸表面11〇之任一部分之任一數目之 流動通道。如下文圖中所描述,該等流動通道可互連形成 任一圖案或由内底108或組織接觸表面11〇上之一個或多個 凹槽界定。流動通道120亦可係一以流體方式將減壓介面 114耦合至空隙118之管或導管。 減壓係經由減壓介面1 14遞送至流動通道丨2〇。減壓介面 114可係任一能夠促進遞送導管112與足部歧管1〇6之間的 輕合(包含流體耦合)之插座、埠 '孔或其他附裝。如本文 中所使用’術語「耦合」包含經由一單獨物件耦合且包含 直接耦合。術語「柄合」亦囊括兩個或更多個组件,其藉 助於該等組件中之每一者係由相同片材料形成而彼此連 續。同樣’術s吾「搞合」可包含化學(例如經由一化學結 合)、機械、熱或電耦合。流體耦合意指流體在若干指定 部分或位置之間連通。 在一個非限制性實例中,減壓介面i 14可包含一遞送導 管112可插入至其中之孔’藉此形成一干涉配合。在遞送 導管1 12插入至減壓介面114中時,減壓可自減壓源1〇9遞 139164.doc 200946151 送至流動通道120及空隙us。亦可使用一機構來將遞送導 管112緊固至減壓介面114以防止遞送導管112被拉出減壓 介面114。在一個實施例中’遞送導管112與減壓介面U4 形成整體以便遞送導管112固定地耦合至減壓介面114。減 壓介面114亦可包含一轉環、鉸鏈或其他可移動附裝機構 以准許遞送導管112相對於内底1〇8移動或旋轉。
遞送導管112可包含一個或多個一流體可流過其之管 腔。在一個實施例中,遞送導管112包含兩個或更多個管 腔’其中之任一者可用於將減壓傳送至足部歧管1〇6、將 液體(例如流出物)傳送離足部歧管1〇6或將治療流體傳送至 足部歧管106。 減壓源109向足部歧管106提供減壓。減壓源1〇9可係供 應一減壓之任一構件,例如一真空泵。雖然施加至一部位 之減壓的量及性質通常將根據應用而變化,但該減壓通常 將介於-5 mm Hg與-500 mm Hg之間。 遞送導管112之-中間部分125可具有一個或多個器件, 諸如器们26。舉例而言,器件126可係另_流體儲藏器或 收集構件以保存流出物及所移除之其他流體。可包含於遞 ❹管112之中間部分125上或另外以流體方式福合至遞送 導管112之器件126之其他實例包含以下非限制性實例·一 麼力回饋器件、—容積偵測系統、-血液m统、-感 染_系統、一流動監控系,统、一溫度監控系統等等。某 些該等器件可與減壓源109形成整體。舉例而t,減壓源 109上之-減料128可包含—過渡器構件,該過濾器構件 I39164.doc 200946151 包含一個或多個過遽器(例如-氣味過攄器)。 在使用+患者或護理者可移除纽織接觸表面i 10之 -部分以形成空隙118。組織接觸表面11〇之被移除之部分 係以可拆卸方式配合至内底⑽,且可經選擇以使空隙m 在足部歧管1G6與nMG5彼此B轉時對準或以其他方式础 鄰傷口 104'組織接觸表面110上可包含若干柵格線或標記 以幫助選擇組織接觸表面11G之供移除之適#部分。發泡 體歧管124可插人至空隙118卜當在使用中時足部⑼ 及足部歧管爾此毗鄰安置以在空隙"8與傷口 ι〇4之間 形成:大致氣動密封。如下文所述,可以各種方式促進該 大致氣動密封,包含藉由使用一密封構件(未顯示)或接觸 組織層110自身。減壓可接著自減壓源1〇9施加至足部歧管 106。該減壓可透過遞送導管112傳送且經由減壓介面ιΐ4 及流動通道120進入空隙118中,藉此向傷口 1〇4提供減壓 治療。在傷口 1〇4處形成之大致氣動密封幫助將該減壓維 持在治療位準。 參照圖2、3 A-B及4A-B ’足部歧管206之一說明性實施 例包含内底208。足部歧管206亦包含支撐構件232,該等 支撐構件在功能上類似於圖1中之組織接觸表面丨丨〇。 在一個實施例中,内底208經成形且經定大小為接近足 部205之足底區230,但亦可僅覆蓋足底區230之一部分, 例如踵區。内底208亦可覆蓋足部205之腳背區、腳趾、侧 面或後部之所有部分或一部分。内底208包含一脊252,該 脊可幫助將足部205緊固至足部歧管206且防止内底208相 139164.doc -10- 200946151 對於足部205或傷口 204之移動。在另一實例中,内底2〇8 不具有脊252。 内底208可係由任一材料形成。舉例而言’内底2〇8可係 由一撓性或彈性材料組成,例如矽、聚胺基曱酸脂或一熱 塑彈〖生體。内底2〇8之撓性或彈性組成亦可促進内底2〇8插 入至一鞋類物品中。 支撐構件232形成一覆蓋内底2〇8之一面向組織表面234 ❹ 之層。支擇構件232接觸足部205之足底區230,且可提供 一可減小施加於傷口 204上之壓力之釋壓功能。雖然顯示 為六邊形,但支撐構件232亦可具有任一形狀,包含(但不 限於):一正方形、矩形、三角形、八邊形、多邊形、圓 形、卵形或不規則形狀。 流動通道220係安置於支撐構件232與内底2〇8之間,且 係由内底208之一面向組織表面254及支撐構件232之面向 内底側237上之凹槽236形成。凹槽236可係沿三個軸238、 φ 239、240形成。支撐構件232之每一側242可包含一凹槽 236。然而,某些支撐構件232(例如由支撐構件232形成之 .層之週邊244上之彼等支撐構件)可具有若干不包含一凹槽 236之側242。在支撐構件232覆蓋内底2〇8時,凹槽236形 成一互連流動通道220網路,該互連流動通道網路在支撐 構件232與内底208之間沿介面245分佈減壓。支撐構件232 與内底208接觸或可使用任一已知技術耦合至内底2〇8,包 含(但不限於):焊接(例如,超聲波或RF焊接)、結合、黏 合劑、水泥等。在一個實施例中,支撐構件232耦合至内 139I64.doc -II - 200946151 底208以密封流動通道220並阻止減壓洩漏出通至空隙218 之流動通道220。 在一個實施例中,凹槽236係拱形凹槽。然而,凹槽236 亦可具有任一形狀。舉例而言,凹槽236可具有一個或多 個直側壁,以便在支撐構件232耦合至内底208時形成一至 少部分多邊形流動通道。 支#構件232可包含一個或多個插入槽246。插入槽246 可適於接收一促進支撐構件232中之每一者之移除之器 ’ 件’例如一解剖刀。插入槽246可具有任一形狀,且該形 翁 狀可相依於欲用於支撐構件232之移除中之器件類型。 週邊244處之支撐構件232包含搭接248。在一個實例 中,搭接248僅包含於由支撐構件232形成之層之週邊244 上之彼等支撐構件232上。搭接248促進支撐構件232與内 底208之間的一密封連接。雖然顯示搭接248為多邊形凸起 物,但搭接248亦可係圓形凸起物或任一其他可促進支撐 構件232與内底208之間的一密封連接之凸起物。 支撐構件232亦可係由任一能夠支撐足部2〇5之材料製 〇 成。舉例而言,支撐構件232中之每一者可係由彈性、撓 性或軟材料製成。支撐構件232之彈性品質可減輕施加於 ‘ 組織部位上之壓力。可自其組成支撐構件232之材料之非 限制性實例包切(包含軟、可等形之外聚胺基甲酸脂 - 及一熱塑彈性體(TPE)。 支樓構件232中之任一者或多者可經移除以形成空隙 218。在圖2中’支標構件232a經移除以形成空隙。可 139J64.doc •12· 200946151 基於支樓構件232a在内底208上之位置來選擇其,以使傷 口 204在足部205毗鄰足部歧管206放置時毗鄰空隙218。支 撐構件23 2上可包含若干標記(例如字符)以幫助定位與傷口 204對準之支樓構件232a。在足部205施加至足部歧管206 時,一密封構件250可在空隙218周圍且在足部2〇5與支撐 構件232之間安置《足部2〇5可定位於密封圈25〇及支撐構 ' 件232上以便在空隙21 8處形成一密封。由密封構件250形 φ 成之密封幫助防止減壓自空隙218逸出,從而一治療減壓 可被維持在空隙218處且施加至傷口 2〇4。 後封構件250可具有任一形狀且可係由幫助在空隙Μ8處 形成一岔封之任一材料製成。舉例而言,密封構件25〇可 係一水凝膠圈。密封構件250亦可係由油灰、矽、封閉孔 格聚合物發泡體、TPE或一軟、撓性、彈性或黏合劑材料 形成。 在移除支撐構件232a時,空隙218可完全或部分地填充 Φ 以發泡體歧管224。在放置至空隙218中之前,發泡體歧管 224在容積上可小於、大於或約等於空隙218。發泡體歧管 224之形狀亦可係任一預定形狀或經定製以配合空隙218。 同樣,發泡體歧管224 —旦插入至空隙218中即可膨脹以填 充空隙218,且可壓在内底2〇8或毗鄰空隙218之支撐構件 232 上。 ,一個實施例中,泡體歧管224可自一發泡體片撕下或 切副。該發泡體片亦可經預切割以包含接近空隙之大 小或支撐構件232之大小的發泡體歧管224。在—替代實施 139164.doc •13· 200946151 例中’發泡體歧管224可在將足部205施加至足部歧管206 之前放置於傷口 204中或上。在另一實施例中,在藉助減 壓治療傷口 204時不需要使用發泡體歧管224。 空隙218中之發泡體歧管224可具有一接近支撐構件232 之高度的高度256 »發泡體歧管224亦可具有一大於支撐構 件232之高度的高度258,且該高度可觸及傷口 2〇4。在另 一實施例中,發泡體歧管224比支撐構件232之高度256 短。 在圖3B中,已移除圖3A中安置於支撐構件2321)與232(1 之間的支撐構件232c以形成空隙218。施加至足部歧管206 之減壓通過由内底208之凹槽236及面向組織表面254形成 之互連流動通道220以到達空隙2 1 8。如以上所解釋,可使 用密封構件2 5 0來在空隙21 8處形成一密封從而一治療減壓 被維持在空隙21 8處且施加至傷口 2〇4。在說明性實施例 中,減壓可僅施加至足部205之期望減壓治療之彼等部 分’同時使用支撐構件232支撐足部205之剩餘部分。 參照圖5及6,其根據一說明性實施例顯示一包含一密封 層510之足部歧管506。密封層51〇在功能上類似於圖i中之 接觸組織層110。密封層510係結合或以其他方式耦合至内 底508,且覆蓋内底508之所有部分或一部分。 内底508包含流動通道520,該等流動通道互連且由内底 508中之凹槽536及凸起物560形成。流動通道52〇形成一柵 格。然而,流動通道520可形成任一圖案,包含不規則圖 案或根本無圖案。在密封層510鄰接内底5〇8時,流動通道 139164.doc -14- 200946151 520由密封層510之一内底接觸側進一步界定。減壓可經由 遞送導管5 12提供至流動通道520。 密封層5 10可係由任一材料組成。舉例而言,密封層5丄〇 可係由一能夠在密封層51〇與内底5〇8之間提供一密封連接 之撓性材料組成。在一個非限制性實例中,密封層51 〇可 係一水凝膠層。密封層5 10之面向組織側562或面向内底側 . 可具有黏性。密封層510之面向組織側562與足部1〇5之間 參 的附著可幫助將足部1 〇5緊固至足部歧管5〇6。 可自密封層510識別、切割並移除一部分532以形成空隙 518。可使用任一能夠切割密封層51〇之器件移除部分 532,例如一解剖刀。一發泡體歧管可插入至空隙518令。 一足部可安置於密封層510之頂部上以便該足部上之一組 織部位(例如一傷口)鄰接空隙518。減壓可經由遞送導管 512傳送至流動通道52〇,且該減壓可透過流動通道傳 送至空隙5 18。 ® 密封層510之密封特性幫助防止傳送至空隙518之減壓逸 出,藉此維持一用於鄰接空隙518之組織部位之治療減 壓。因此,密封層510可消除對一密封構件之需要。使用 密封層510,空隙518可位於密封層51〇上之任一處,且密 •封層510之經移除以形成空隙518之部分532可具有任一形 狀。可基於一足部上一傷口 (例如一足部潰瘍)之位置及形 狀確定所移除部分532之位置及形狀。若干拇格標記(例如 柵格線)可列印或以其他方式包含於密封層川上以幫助識 別密封層510之應移除以將空隙518與一足部上之一傷口對 139164.doc -15- 200946151 之全面治療期間在 準之部分。該等柵格標記亦可在該傷口 替換密封層5〗0時確定該傷口之癒合進展 參照圖7,其根據-說明性實施例顯示—在功能上類似 於圖】中之遞送導管112之遞送導管712。遞送導管712具有 —細長形狀’該形狀具有-低外形1送導之該細 長形狀減輕施加至毗鄰遞送導管712之足部、踝或腿之若 干部分之壓力點。遞送導管712亦可具有其他形狀,諸如 圓形、橢圓形、多邊形或彎曲Γυ」形形狀。
遞送導管712亦可係由諸如一撓性、彈性或可壓縮材料 之任-材料製成。該撓性、彈性或可壓縮材料可減輕施加 =足部、踩或腿之晚鄰部分之壓力點。可自其形成遞送導 管712之材料之非限制性實例包含塑膠、耐綸、石夕、聚胺 基甲酸脂、TPE或PVC。
遞送導管712包含兩個管腔766、768。在一個實例中, 管腔766、768將減壓傳送至一足部歧管中之一個或多個流 動通道。遞送導管712可具有任一數目之管腔,包含三個 或更多個管腔。料’遞送導管712中之該等管腔中之一 者或多者可用於將流體(諸如液體或流出物)自一傷口輸運 至一流體收集裝置。在其他實施例中,管腔766、768可具 有任一形狀,諸如一圓形、橢圓形或多邊形形狀。 管腔766係由一第一壁77〇及一第二壁771約束。類似 地,官腔768係由一第—壁772及一第二壁773約束。第一 壁770、772分別包含若干凸起物774、775。凸起物774在 力石一由箭頭776指示之方向施加至遞送導管712時防止 139164.doc •16· 200946151 第一壁770觸及第二壁771。凸起物775在一力沿一由箭頭 776指示之方向施加至遞送導管712時防止第一壁772觸及 第二壁773。以此方式,凸起物774、775幫助防止管腔 766、768塌陷◦ 第二壁771、773分別包含若干凸起物777、778。凸起物 ' 774在一力沿一由箭頭776指示之方向施加至遞送導管712 - 時觸及凸起物777,以便第一壁770及第二壁771之不具有 凸起物774及777之部分彼此不觸及。類似地,凸起物775 在一力沿一由箭頭776指示之方向施加至遞送導管712時觸 及凸起物778,以便第一壁772及第二壁773之不具有凸起 物775及778之部分彼此不觸及。可以此方式防止管腔 766、768塌陷 ° 參照圖8,遞送導管812包含一成角度分隔物880,該分 隔物將管腔866、868彼此分開。成角度分隔物880可在一 足部、踝或腿沿一由箭頭876指示之方向壓在遞送導管8 12 φ 上時減輕該足部、踝或腿上之壓力點。在此實例中,成角 度分隔物880可在該足部、踝或腿沿一由箭頭876指示之方 向壓在遞送導管812上時變平。成角度分隔物880可與管腔 868之壁873或遞送導管812中之任一其他管腔壁形成一近 '似45度之角度。 參照圖9及10,其根據一說明性實施例顯示一内底908。 内底908可放置於足部905之一腳背區982上,且特定而言 足部905之腳趾區處。在一個實例中,内底908可係由一發 泡體(例如網狀發泡體)或一 GranuFoam®材料組成。内底 139164.doc -17- 200946151 908可經由緊固構件922耦合至足部9〇5之腳趾區。減壓可 使用自一減壓源遞送且經由遞送導管912遞送之減壓藉助 内底908減壓施加至該腳趾區。 内底908包含若干凸起物984,該等凸起物可插入足部 905之腳趾之間。内底9〇8亦可包含若干空隙918,減壓可 透過該等空隙施加至足部905之腳趾之間的一區。在另— 非限制性實例中,凸起物984中之每一者可放置於足部9〇5 之一個別腳趾上。凸起物984可具有任一促進減壓至足部 905之腳趾區之所期望部分之施加之形狀。 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 範脅。應瞭解,任-結合任—個實施例描述之特徵亦可適 用於任一其他實施例。 【圖式簡單說明】 圖1圖解說明一根據一說明性實施例之用於對一足部上 之一組織部位施以減壓之系統之一透視圖; 圖2圖解說明一根據一說明性實施例之用於對一足部上 之一組織部位施以減壓之裝置之一透視圖; 圖3A圖解說明圖2之裝置之一橫截面圖; 圖3B圖解說明圖2之裝置之一橫巷面圓 僙戳面圖,該裝置具有一 經移除以形成一空隙之支撐構件; 圖4A圖解說明圖2之裝置之—去撐椹批 支梡構件之—俯視透視 圖; 139364.doc -18· 200946151 圖4B圖解說明圖4A之支撐構件之一仰視透視圖; 圖5圖解說明一根據一說明性實施例之用於對一足部上 之一組織部位施以減壓之裝置之一分解透視圖; 圖6圖解說明圖5之裝置之一透視圖,其中一密封層之— 部分經移除以形成一空隙; 圖7圖解說明一根據一說明性實施例之遞送導管之一橫 截面圖;
圖8圖解說明一根據一說明性實施例之遞送導管之一橫 截面圖; 圖9圖解說明一根據一說明性實施例之用於對一足部上 之一組織部位施以減壓之裝置之一俯視圖;及 圖10圖解說明一根據一說明性實施例之施用至一足部上 之一組織部位之圖9之裝置之一透視圖。 【主要元件符號說明】 100 減壓治療系統 102 組織部位 104 傷口 105 足部 106 足部歧管 108 内底 109 減壓源 110 組織接觸表面 112 遞送導管 114 減壓介面 139164.doc •19- 200946151 116 後部 118 空隙 120 流動通道 122 緊固構件 124 發泡體歧管 125 中間部分 126 器件 128 減壓埠 204 傷口 205 足部 206 足部歧管 208 内底 218 空隙 220 流動通道 224 發泡體歧管 230 足底區 232 支撐構件 232a 支撐構件 232b 支撐構件 232c 支撐構件 232d 支撐構件 234 面向組織表面 236 凹槽 237 面向内底側 139164.doc -20- 200946151 ❹ 242 側 244 週邊 245 介面 246 插入槽 248 搭接 250 密封圈/密封才J 252 脊 254 面向組織表面 506 足部歧管 508 内底 510 密封層 512 遞送導管 518 空隙 520 流動通道 532 部分 536 凹槽 560 凸起物 562 面向組織側 712 遞送導管 766 管腔 768 管腔 770 第一壁 771 第二壁 772 第一壁 -21 - 139164.doc 200946151 773 第二壁 774 凸起物 775 凸起物 111 凸起物 778 凸起物 812 遞送導管 866 管腔 868 管腔 873 880 成角度分隔物 905 足部 908 内底 912 遞送導管 918 空隙 922 緊固構件 982 腳背區 984 凸起物 139164.doc . 22 -

Claims (1)

  1. 200946151 七、申請專利範圍: 1. 一種用於對一足部上之一組織部位施以減壓之系統,該 系統包括: 一減壓源’其可操作以供應該減壓; 足°卩歧管’其與該減壓源流體連通且可操作以將該 減壓供應至-足部上之__組織部位,該足部歧管包括: 一内底, 一組織接觸表面,其覆蓋該内底之至少一部分,該 且織接觸表面之至少一個部分可移除以形成一空隙, 一減壓介面,其用於自該減壓源接收減壓,及 至乂個流動通道,其以流體方式耦合至該減壓介 面及該空隙;及 一遞送導管’其可操作以將該減壓自該減壓源遞送至 該減壓介面。 2·如》月求項1之系統,其中該組織接觸表面包括複數個可 ❿ #除支撐構件,且其中該至少-個流動通道係由該複數 個可移除支撐構件中之每一者之一面向内底側上之至少 一個凹槽形成。 .3.如請求項1之系統,其中該組織接觸表面包括複數個可 • 移除支撐構件,且Φ q E , 其中忒至少一個流動通道包括複數個 由該複數個可移除支樓構件之 凹槽形成之互連流動通道。㈣側上之複數個 4· 項1之系統’其中該組織接觸表面包括複數個可 移除支撐構件,且其中該複數個可移除支撐構件中之每 139164.doc 200946151 一者之至少一個邊緣界定一插入槽之至少一部分,該插 入槽適於接收一促進移除該複數個可移除支撐構件中之 每一者之器件。 5.如請求項丨之系統,其中該至少一個流動通道係一將減 壓自該減壓壓力介面傳送至該空隙之管。 6_如請求項1之系統,其進一步包括: 一密封構件,其可操作以大致密封該空隙,該密封構 件適於安置於該複數個可移除支撐構件與該組織部位之 間。 7·如明求項1之系統,其中該組織接觸表面包括一密封 層,且其中該密封層之至少一部分可移除以形成該空 隙。 8. 如凊求項i之系統,其中該組織接觸表面包括一密封 層,且其中該至少一個流動通道係至少部分地由該内底 上之一凹槽形成。 9. 如明求項8之系統,其中該凹槽形成一柵格圖案。 10. 如請求項丨之系統,其進一步包括: 一發泡體歧管,其適於插入至該空隙中,且進一步適 於將減壓分佈至該組織部位。 11. 如請求項丨之系統,其進一步包括: 、遞送管’其輕合至該減壓介面且可操作以將減壓自 該減壓源傳送至該減壓介面。 12. 如明求項〗i之系統,其中該遞送導管具有一細長橫截面 形狀其中該遞送導管包括複數個可操作以將該減壓自 139164.doc 200946151 該減壓源傳送至該減壓介面之管腔’且其中該複數個管 腔中之每一者之至少一個壁具有一可操作以防止該管腔 知陷之凸起物。 13.如請求項1之系統,其進一步包括: 緊固構件’其可操作以此鄰該組織部位緊固該内 底0 • 14·如請求項i之系統,其中該空隙係毗鄰該組織部位,且 其中該減壓係經由該空隙施加至該組織部位。 I5· —種用於對一足部上之一組織部位施以減壓之裝置,該 裝置包括: ~ 底 、、且織接觸表面,其覆蓋該内底之至少一部分,該矣」 織接觸表面之至少—個部分可移除以形成_空隙; 減壓介面,其用於自一減壓源接收減壓;及 ❿ 至少一個流動通道,其以流體方式耦合至該減壓介否 及該空隙。 16. 如請求項】^ 胜 x ’,、中該組織接觸表面包括複數個3 示支揮構件,且其中該至少__個流動通道係由該複輿 個可移除支撐構件令之每一者之一面向内底側上之 一個凹槽形成。 17. 如請求項15之奘番 ^ , /、中5亥組織接觸表面包括複數個可 由今複件’且其中該至少—個流動通道包括複數個 由錢數個可移除切 凹槽形成之互連流動通道。⑽錢上之複敖個 18. 如請求項15之裝 具中該組織接觸表面包括複數個可 139164.doc 200946151 移除支樓構件,且其中該複數個 -者之至少-個邊緣p 支撐構件中之每 ^ ^ 瓊緣界定一插入槽之至,卜一部\ = :槽促進移除該複數個可移:支二件Γ: 19. 如請求項15之裝置,其中兮 再肀該至少一個流動通道係一 壓自該減壓介面傳送至該空隙之管。 ' ^ 20. 如請求項15之裝置,其進一步包括: :密封構件,其可操作以大致密封該空隙,該密封構 ❹ 件適於安置於該複數個可移除切構件與該組織部位之 間。 21. 如請求項15之裝置,装由兮 其中該組織接觸表面包括一密封 層,且其中該密封層之 口P刀可移除以形成該空 隙。 22. 如請求項15之裝置,其中該組織接觸表面包括一密封 層’且其中該至少—個流動通道係至少部分地由該内底 上之一凹槽形成。 〇 23. 如請求項22之裝置,其中該凹槽形成一拇格圖案。 24. 如請求項15之裝置,其進一步包括: -發泡體歧管,其適於插人至該空隙中,且進一少適 於將減壓分佈至該組織部位。 25. 如請求項15之裝置,其進一步包括: -遞送導管’其耦合至該減壓介面且可操作以將減塵 自該減壓源傳送至該減壓介面。 26. 如明求項25之裝置’其中該遞送導管具有—細長橫截面 139164.doc •4- 200946151 可操作以將該減壓自 ’且其中該複數個管 可操作以防止該管腔 形狀,其中該遞送導管包括複數個 該減壓源傳送至該減壓介面之管腔 腔中之每一者之至少一個壁具有一 塌陷之凸起物。 27·如請求項15之裝置,其進一步包括·· 組織部位緊固該内 一緊固構件,其可操作以毗鄰該 底0
    28. 如請求項1 5之裝置,盆中發*旭么 八 玉隙係眺鄰該組織部位,且 其中該減壓係經由該空隙施加至該組織部位。 29. 如請求項15之裝置,盆中螻细磁 ,、Τ碌組織接觸表面之該至少一個 部分係以可拆卸方式配合至該内底。 30. 一種用於對一足部上之一 方法包括: 組織部位施以減壓之方法,該 提供一足部歧管; 移除-組織接觸表面之一覆蓋該足部歧管之一内底之 部分以形成一空隙,· 將該空隙與該足部上之該組織部位對準; 在該空隙與該組織部位之間形成一大致氣動密封;及 ;經由-流動通道將減磨自一減廢源施加至該空隙以將 該減壓施加至該組織部位。 31.如明求項3〇之方法,其中該組織接觸表面包括複數個可 移除支撐構件’且其中移除—組織接觸表面之該部分包 含在該複數個可移除支撐構件中之—者處移除。 32.如請求項3〇之方法,其中該組織接觸表面包括一密封 139164.doc 200946151 層,且其中移除該密封層之該部分包含切掉一另該密封 層。 33. 如請求項30之方法,其中形成該大致氣動密封包含在該 組織接觸表面與該組織部位之間定位一密封構件。 34. 如請求項30之方法,其進一步包括: 將一發泡體歧管施加至該空隙中。 3、一種製造一用於對一足部上之—組織部位施以減壓之裝 置之方法’該方法包括: 提供一内底; 提供一組織接觸表面;及 用該組織接觸表面覆蓋該内底之至少一部分以形成至 少—個可操作以傳送減壓之流動通道。 36.如請求項35之方法,其進一步包括: 提供一減壓介面;及 將該減壓介面耦合至該内底。 139164.doc
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