TW200946150A - Offloading and reduced-pressure treatment systems and methods - Google Patents
Offloading and reduced-pressure treatment systems and methods Download PDFInfo
- Publication number
- TW200946150A TW200946150A TW098108290A TW98108290A TW200946150A TW 200946150 A TW200946150 A TW 200946150A TW 098108290 A TW098108290 A TW 098108290A TW 98108290 A TW98108290 A TW 98108290A TW 200946150 A TW200946150 A TW 200946150A
- Authority
- TW
- Taiwan
- Prior art keywords
- pressure
- layer
- pressure relief
- plantar
- decompression
- Prior art date
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61H—PHYSICAL 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
- A61H9/00—Pneumatic or hydraulic massage
- A61H9/005—Pneumatic massage
- A61H9/0057—Suction
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- A—HUMAN NECESSITIES
- A43—FOOTWEAR
- A43B—CHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
- A43B3/00—Footwear characterised by the shape or the use
- A43B3/34—Footwear characterised by the shape or the use with electrical or electronic arrangements
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- A—HUMAN NECESSITIES
- A43—FOOTWEAR
- A43B—CHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
- A43B7/00—Footwear with health or hygienic arrangements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
- A61B5/1036—Measuring load distribution, e.g. podologic studies
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/44—Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
- A61B5/441—Skin evaluation, e.g. for skin disorder diagnosis
- A61B5/447—Skin 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements 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
- A61B5/6802—Sensor mounted on worn items
- A61B5/6804—Garments; Clothes
- A61B5/6807—Footwear
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements 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
- A61B5/6813—Specially adapted to be attached to a specific body part
- A61B5/6829—Foot or ankle
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/02—Details of sensors specially adapted for in-vivo measurements
- A61B2562/0247—Pressure sensors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61H—PHYSICAL 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
- A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
- A61H2201/16—Physical interface with patient
- A61H2201/1602—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
- A61H2201/164—Feet or leg, e.g. pedal
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- Y—GENERAL 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
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T156/00—Adhesive bonding and miscellaneous chemical manufacture
- Y10T156/10—Methods of surface bonding and/or assembly therefor
- Y10T156/1052—Methods of surface bonding and/or assembly therefor with cutting, punching, tearing or severing
Landscapes
- 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)
- Pathology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
- Biomedical Technology (AREA)
- Biophysics (AREA)
- Physics & Mathematics (AREA)
- Epidemiology (AREA)
- Dentistry (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Dermatology (AREA)
- Computer Networks & Wireless Communication (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)
- Footwear And Its Accessory, Manufacturing Method And Apparatuses (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
- External Artificial Organs (AREA)
- Devices For Medical Bathing And Washing (AREA)
Description
200946150 六、發明說明: 【發明所屬之技術領域】 本發明根據35 USC § 119(e)之規定主張2008年3月13曰 申請之題為「System and Method for Applying Reduced Pressure to aTissue Site on a Foot」之美國臨時專利申請案 第61/036,433號之歸檔之權益,該案出於所有目的以引用 方式併入本文中。 【先前技術】 一般而言本發明係關於醫學治療系統,且更特定而古係 關於釋壓及減壓治療系統、器件及方法。 有時需要管理一患者足部或其他肢體上之醫學問題。許 多傷口或異常組織部位出現於一患者足部上。舉例而言, 糖尿病患者常常出現神經性足部狀況,諸如潰瘍。治療肢 體上且特定而言足部上之各種狀況可提出許多挑戰。治療 可能需要調節、減輕壓力及剪切力及震動吸收。若干器件 經常用於此等目❸。舉例而言,可使用—由全接觸禱模 (TCC)製成之全接觸石膏來藉由增加整個小腿上承載之重 量而提供減少之足底壓力。亦可使用眾多其他器件,例如 矯正動態系統夾板、神經性行走器'全接觸踝足矯正器 件、癒合涼鞋等等 該等器件f常涉及至冑口或組織部位 之受限通達。 【發明内容】 供用於肢體上之現有醫學治療器件及系統之問題係由本 文中所述之說明性實施例之系、统、器件及方法解^根據 139165.doc 200946150 —說明性實施例,一釋壓及減.廢治療系統包含一釋壓及減 壓治療斋件,該釋壓及減壓治療器件具有一由一釋壓歧管 材料形成之足底構件。該釋壓歧管材料包含一支撐層、一 壓力傳輸層及一第二障壁層。該釋壓及減壓治療系統進— . 步包含:一減壓介面,其以流體方式耦合至該足底構件之 壓力傳輸層;一減壓源;及一減壓遞送導管,其以流體方 式耦合至該減壓源且耦合至該釋壓及減壓治療器件。 _ 根據另一說明性實施例,一釋壓及減壓治療器件包含— 由一釋壓歧管材料形成之足底構件。該釋壓歧管材料包 含:-支撐層’其具有一第一表面及一第二表面;及—壓 力傳輸層,其具有-第-表面及一第二表s。該壓力傳輸 構件之第一表面係耦合至該支撐層之第二表面。該釋壓歧 管材料亦包含一第二障壁層,其具有一第一表面及一第二 表面。第一障壁層之第一表面係耦合至壓力傳輸層之第二 表面。該釋壓及減壓治療器件進—步包含一以流體方式耦 Ο δ至該足底構件之壓力傳輸層之減壓介面。該釋壓及減壓 治療器件可亦具有一腳背構件。 根據另一說明性實施例,一釋壓及減壓治療器件包含一 — 足底構件,其係由一釋壓歧管材料形成。該釋壓歧管材料 &含一支撐層、—壓力傳輸層及-第二障壁層。該釋壓及 減壓治療器件進一步包含一以流體方式耦合至該足底構件 之壓力傳輸層之減壓彳面κ樓層及該壓力傳輸層可係 一形成有一塗布以一不透氣材料之小孔式«40孔/公分)開 放孔格發泡體之單個層。 139165.doc 200946150 根據另一說明性實施例,製造一釋壓及減壓治療器件之 一方法包含提供釋壓歧管材料之一薄層並切割該薄層以形 成該釋壓及減壓治療器件之步驟。 根據另一說明性實施例,一種用於治療一患者足部上之 一足底傷口之方法包含提供一由一釋壓歧管材料形成且具 有一足底構件之釋壓及減壓治療器件之步驟。該治療一患 者足邛上之一足底傷口之方法進一步包含:移除該釋壓歧 管材料之一部分以接近患者之足底傷口形成一第一空隙; 將一第一治療歧管安置於該第一空隙中;及經由該壓力傳 輸層將減壓遞送至該第一空隙。 根據另一說明性實施例,一種用於治療一患者足部上之 一足底傷口及一腳背傷口之方法包含提供一由一釋壓歧管 材料形成之釋壓及減壓治療器件之步驟。該釋壓及減壓治 療器件具有底構件及—腳背構件。刻於治療一足底 傷口及-腳背傷口之方法進一步包含:移除該釋壓歧管材 料之-部分以接近患者之足底傷口形成一第一空隙;將一 第一治療歧管安置於㈣-线巾;移_釋壓歧管材料 之另一部分以接近患者之腳背傷口形成—第二空隙;將一 第=治療歧管安置於該第二空隙中;及經由該壓力傳輸層 將減壓遞送至該第一空隙及第二空隙。 參照圖式及以下實施方式 優點將變得顯而易見。 本發明之其他目標、特徵及 【實施方式】 參照形成其一部分 在說明性實施例之以下實施方式中 139165.doc -6 - 200946150 之隨附圖式。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的細節,本描述可省略熟 習此項技術者所已知的某一資訊。因此,不應將以下實施 方式視為具有一限制意義,且該等說明性實施例之範疇僅 由隨附申請專利範圍加以界定。 攀 本文中之系統、方法及器件促進一肢體(諸如,足部)上 之組織(例如,一傷口)之釋壓及減壓治療。關於治療方 案,臨床研究及實踐之近來形式已顯示接近於一組織部位 提供減壓增大並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」、 「減壓療法」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。除非另外指 示,否則如本文中使用,「或」不需要相互排他。 參照圖1-6,其呈現一釋壓及減壓治療系統1〇〇之一說明 - 性實施例。釋壓及減壓治療系統100包含一釋壓及減壓治 療器件102,其具有一足底構件1 04且可具有一腳背構件 106及一橋構件1〇8。橋構件ι〇8可具有一中心橋部分1〇7及 一介面部分109。足底構件ι〇4可操作以接收一患者足部 110之一足底區,該足底區可具有諸如一潰瘍之一足底傷 口 111(見圖5)。腳背構件1〇6可包含為釋壓及減壓治療器件 139165.doc 200946150 102之一部分且可操作以接收患者足部1丨〇之一腳背區 112,該腳背區可具有一腳背傷口 114。足底構件1〇4、腳 煮構件106及橋構件1〇8係由一釋壓歧管材料丨16形成。 參照圖2,其呈現釋壓歧管材料i丨6之一部分之一橫載面 圖。釋壓歧管材料116具有一第一面向組織表面118及一第 一表面120。從釋壓歧管材料116之第一面向組織表面118 開始,釋壓歧管材料116具有—支撐層128,該支撐層具有 一第一面向組織表面130及一第二表面132。釋壓歧管材料 116亦包含一壓力傳輸層134,該壓力傳輸層具有一第一面 向組織表面136及一第二表面138。壓力傳輸層134之第一 面向組織表面136係耦合至支擇層128之第二表面132。釋 壓歧官材料116亦包含一第一障壁層14〇,該第一障壁層具 有一第一面向組織表面142及一第二表面144。第一障壁層 14〇之第一面向組織表面142係耦合至壓力傳輸層n4之第 二表面138。壓力傳輸層134可經定大小以小於支撐層128 及第一障壁層140以便壓力傳輸層134可完全含在支撐層 128與第一障壁層140之間。 如本文中使用,術語「耦合」包含經由一單獨物件耦合 且包含直接麵合。術語「耦合」亦囊括兩個或更多個組 件’其藉助於由相同片材料形成之該等組件中之每一者而 彼此連續。同樣,術語「耦合」可包含化學(諸如經由一 化學結合)' 機械、熱或電耦合。流體耦合意指流體在若 干和疋部分或位置之間連通。三個層(支樓層128、壓力傳 輸層134及第一障壁層14〇)之總厚度較佳在4 „1111至15 mm 139165.doc 200946150 範圍内,且更佳在6 mm至10 mm之範圍内。 第障壁層140提供保護且幫助密封釋壓及減壓治療器 件102。第—障壁層14〇可係由各種材料形成,諸如一撓性 不透氣材料、流體不可滲透或抗流體材料。一適宜的不透 氣材料之一非限制性實例係一聚胺基f酸酯及織物材料, 且一更具體非限制性實例係一位於一經編織物(42%聚胺基 甲酸S曰及58%織物)上之聚胺基甲酸酯傳送塗層。第一障壁 層140亦可抗穿刺。 響 支樓層128提供一支撐結構且允許肉體壓力之釋壓。如 此,支撐層128自一正治療之傷口周圍移除壓力。支撐層 128可能能夠加襯墊、吸收震動、減輕壓力或可甚至控制 異常足部及腿部動作。作為一個說明性實例,支撐層128 可係由一封閉孔格發泡體形成。該閉合孔格發泡體可係由 一蜂巢式聚胺基甲酸酯發泡體形成。 壓力傳輸層13 4允許減壓經由該層傳輸且傳輸任何流體 φ (例如,流出物)。壓力傳輸層134之一個適宜的材料係一撓 性、開放孔格發泡體’例如,一可自Texas、San Antonio 之Kinetic Concepts有限公司購得之GranuFoam®材料。 - 在一替代實施例中,支撐層128及壓力傳輸層134可係一 . 單個層,其形成有一塗布以一不透氣材料之小孔式($4〇孔/ 公分或更小)開放孔格發泡體,該不透氣材料亦提供某一 釋壓強度。舉例而言,該小孔式發泡體可覆蓋以一乙稀基 材料。 再次參照圖1 -6,支撐層128之一部分可經切割及移除以 139165.doc -9- 200946150 形成與一足底傷口 111對準且大於足底傷口 U1之第一空隙 146或足底空隙。以此方式,足底構件ι〇4接近足底傷口 111提供一釋壓功能。以一類似方式,支撐層i28之另一部 分經切割及移除以在腳背構件1 〇6之一部分上形成一第二 空隙148或腳背空隙。同樣,第二空隙148幫助自患者足部 110上之一腳背傷口釋壓或保護並提供治療空間。一密封 構件115(例如,一諸如一親水膠體圈之黏合性材料圈)可用 於在釋壓及減壓治療器件1〇2與腳背傷口 114附近的患者皮 膚之間形成一氣動密封。類似於密封構件丨15之另一密封 構件162可放置在足底傷口 ln周圍。僅已顯示兩個傷口 (足底傷口 111及腳背傷口丨14),但可移除釋壓及減壓治療 器件102之若干額外部分以形成若干用於治療若干額外傷 口之空隙。 一減壓介面150可定位於釋壓及減壓治療器件1〇2上之任 一位置處且以流體方式耦合至釋壓歧管材料116之壓力傳 輸層134(亦即,與釋壓歧管材料116之壓力傳輸層134流體 連通)。若一實施例僅包含足底構件1〇4,則減壓介面15〇 係麵合至足底構件1()4之—部分。若該實施例中包含一腳 背構件106,則減壓介面15〇可_合至腳背構件ι〇6或足底 構件104。在m中所示之實施例中,減壓介面15()係麵合 至橋構件108之一部分。在耦合減壓介面15〇中透過第一 障壁層14G形成-孔隙且使減壓介面15()與壓力傳輸層 流體連通。橋構件108為減壓介面15〇提供一便利位置且係 以流體方式輕合至足底構件1〇4。若包含腳背構件1〇6,則 139165.doc •10· 200946150 橋構件108幫助耦合腳背構件ι〇6及足底構件1〇4且將減壓 介面1 50以流體方式耦合至腳背構件106之壓力傳輸層 134 ° 一減壓遞送導管152係以流體方式耦合至減壓介面150且 耦合至一減壓源154。減壓介面150可係一埠,諸如
Texas、San Antonio之 Kinetic Concepts有限公司之一 TRAC
Pad®介面或一 SensaT.R.A.C·™墊介面。減壓源154可係任 一用於供應減壓之器件或構件,諸如一真空栗、手動致動 〇 泵或一壁式吸入源。雖然施加至一組織部位(例如,傷口) 之減壓的量及性質將根據應用而變化,但該減壓將通常 在-5 mm Hg與-500 mm Hg之間且更通常在_150 mm Hg與_ 300 mm Hg之間。 如本文中所使用,術語「減壓」通常係指一小於一正經 受治療之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 ❹ 為,該減壓可小於與組織部位處之組織相關聯之一靜水壓 力。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減小可明 - 顯小於通常與一完全真空相關聯之壓力減小。減壓可最初 . 在組織部位之區域中產生流體流動。除非另外指示,否則 本文中所述之壓力值係計示壓力。類似地,提及減壓之增 加通常係指絕對壓力之一減少’而減壓之降低通常係指絕 對壓力之一增加。與本文中之使用—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。在一個說明性 139165.doc 200946150 實施例中,可使用San Antonio之Kinetic Concepts有限公司 之一 V.A.C.®療法單元作為減壓源154。 端視應用,可將複數個以流體方式耦合至減壓遞送導管 152。舉例而言,可包含一流體罐156或一代表性器件 158。代表性器件158可係另一流體儲藏器或罐以保存流出 物或所移除之其他流體。可包含於減壓遞送導管152上之 代表性器件158之其他實例包含以下非限制性實例:一壓 力回饋器件、一容積偵測系統、一血液偵測系統、一感染 偵測系統、一流動監控系統、一溫度監控系統、一過濾器 4專。6亥等器件中之某些可與一減壓源154形成整體。 現主要參照圖i及圖5,將描述釋壓及減壓治療器件 對足底傷口 111之應用。健康護理提供者在足部11〇放置在 足底構件104上時移除支撐層128在與足底傷口 ln對應或 對準之位置處之一第一部分。支撐層128可藉助一工具(諸 如,一解剖刀)切割及移除。在該第一部分被移除時,形 成第一空隙146。 一第一治療歧管160或足底治療歧管放置至該第一空隙 中。如本文中使用,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一組織部位、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 包含複數個流動通道或通路,該等流動通道或通路經互連 以改良在第一治療歧管160周圍提供至組織部位或傷口(例 如’足底傷口 111)及自其移除之流體分佈。第一治療歧管 160可係一生物相容材料,其能夠放置成與組織部位或傷 139165.doc •12- 200946150 口(例如,足底傷口 m)接觸,並將減壓分佈至組織部位或 傷口(例如,足底傷口 m)。舉例而言,治療歧管之實例可 包含(但不限於):具有經配置以形成流動通道之結構元件 之器件、諸如例如,蜂巢式發泡體、開放孔格發泡體、多 孔組織收集器件、包含或凝固後包含流動通道之液體、凝 膠及發泡體。第一治療歧管160可係多孔且可係由發泡 體、紗布、黏製席或任一其他適於一特定生物應用之材料 碜 製成。在一個實施例中,該治療歧管係一多孔發泡體且包 含複數値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,諸如,一由
Texas、San Antonio 之 Kinetic Concepts有限公司製造之
GranuFoam®材料。在某些情形下,治療歧管(例如,第一 治療歧管160)亦可用於將流體(諸如,藥物、抗菌藥、生長 因子及各種溶液)分佈至組織部位或傷口(例如,足底傷口 111)。該治療歧管中或上可包含若干其他層,諸如吸收材 Φ 料、芯吸材料、疏水材料及親水材料。 第一治療歧管160可稍微高於第一空隙146之高度(對於 圖5中所示之定向而言)以提供與足底傷口 ln之接觸。密 - 封構件162(其可係一黏合劑,諸如一親水膠體)接近足底傷 • 口 u 1施加至足部1 10之足底區,且足部1 10接著放置在足 底構件104上。足底傷口 111係與釋壓及減壓治療器件102 之第一空隙146對準且足部110放置在足底構件1〇4上。密 封構件162在第一空隙146上方在足底傷口 !丨丨周圍形成一 氣動密封,其含有第一治療歧管16〇。關於腳背構件1〇6, 139165.doc •13· 200946150 執行一類似程序以在腳背構件106中形成第二空隙148,且 一第二治療歧管或腳背治療歧管放置在第二空隙148中。 已放置在足部110上之釋壓及減壓治療器件102接著放置在 一石膏鞋、涼鞋或超碼鞋中。 減壓係供應至減壓介面150。減壓係在壓力傳輸層134中 傳輸至第一空隙146及第一治療歧管16〇與第二空隙148及 第二治療歧管。如圖5中之箭頭164所表明,減壓將來自足 底傷口 111之任何流體引至第一治療歧管16〇中且進入壓力 傳輸層134中,且如圖6中之箭頭166所表明,該等流體被 引至減壓介面150中。遞送至減壓介面15〇之該等流體可由 減壓遞送導管152遞送至流體罐156。 現參照圖7A及7B,其呈現一種用於製造釋壓及減壓治 療器件102之說明性製程。可提供釋壓歧管材料116之一薄 層168。舉例而言,可提供釋壓歧管材料116之一 30.5 cm x 30.5 cm薄層,其用於形成供用於一足部或其他肢體上之 釋壓及減壓治療器件102。一圖案17〇可對應於患者足部大 小而經標記及切割。在當前實施例中,足底構件1〇4係基 於一患者之一特定大小來定大小並接著製成圖案17〇。圖 案170經切割以如圖7B中所示形成一展開之釋壓及減壓治 療器件102。切割釋壓及減壓治療器件1〇2之邊緣172可覆 蓋以一撓性膠帶或喷塗以一快乾密封劑。接著,展開之釋 壓及減壓治療器件1〇2經摺疊以使該器件形成至如圖i、3 及4中所示之位置中。 現參照圖8 A、8B及9,其呈現一釋壓及減壓治療器件 139165.doc -14- 200946150 搬之另-說明性實施例。釋塵及減壓治療器件加類似於 圖μ之釋壓及減壓治療器件102,且若干類似或相同部分 係藉由以刚給該等參考標號加&丨來指示。釋壓及減屋 治療器件202具有-足底構件綱且可具有一腳背構件裏 及一橋構件208。橋構件208可具有一中心橋部分2〇7及一 介面部分209。足底構件204可操作以接收一患者足部之一
可具有-足底傷口之足底區。腳背構件寫可包含為釋壓 及減壓治療器件2 0 2之一部分且可操作以接收患者足部之 一可具有一腳背傷口之腳背區。足底構件2〇4、腳背構件 206及橋構件208係由一釋壓歧管材料216形成。 釋壓歧管材料216具有一支撐層228、壓力傳輸層234及 一第一障壁層240。支撐層228具有一第一面向組織表面及 一第二表面232。壓力傳輸層234具有一第一面向組織表面 及一第二表面238。第一障壁層240具有一第一面向組織表 面及一第二表面244。 一減壓介面250可應用於任何位置’但較佳地應用於橋 構件208之介面部分209上。減壓介面250係以流體方式輕 合至一減壓遞送導管252,該減壓遞送導管係以流體方式 耗合至一減壓源。 釋壓及減壓治療器件202包含一自橋構件208延伸之延伸 構件275。延伸構件275在使用期間幫助將釋壓及減壓治療 器件202緊固在適當位置。一緊固條276係附裝至延伸構件 275且以可釋放方式附裝至足底構件204之一部分。緊固條 276可係一片具有一黏合劑之敷巾材料或一鉤環構件等等。 139165.doc -15- 200946150 參照圖8A及圖8B ’可見釋壓及減壓治療器件202之一額 外特徵。在此實施例中’可見支撐層228之一調整部分 278。在使用中’調整部分278係放置在患者之趾骨或踱骨 下方。調整部分278可經切割以視需要容納不同大小的足 部或鞋。調整部分278允許釋壓及減壓治療器件2〇2將以一 設定大小加以製造並接著針對一特定使用者在一特定範圍 内定製。 參照圖8A及圖10 ’釋壓及減壓治療器件2〇2之一周長280 具有一密封件282。可以眾多方式形成密封件282,諸如膠 合、膠合並用一夾具之一唇緣擠壓以施加力(見圖1〇)、結 合、焊接、敷巾帶、水泥等等》密封件282向壓力傳輸層 234之邊緣提供一氣動密封且耦合支撐層228、壓力傳輸層 134及第一障壁層14〇。 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,而不背離如由隨附申_專利範圍界定之本發明之 範疇。 【圖式簡單說明】 為提供對該等說明性實施例及其某些特徵及優點之一更 全面理解’已參照結合隨附圖式取得之以上描述,其中: 圖1係-部分顯示為-方塊圖之_釋壓及減壓治療系統 之一說明性實施例之之—示意性透視圖; 圖係圖1之釋壓及減壓治療系統之—釋壓歧管之一部分 之一橫截面圖; 139165.doc 200946150 之釋壓及減壓 之釋壓及減壓 治療器件 治療器件 圖3係圖1之釋壓及減壓治療系統 之說明性實施例之一示意性透視圖 圖4係圖1之釋壓及減壓治療系統 之一示意性立面圖; 圖5係圖1之釋壓及減壓治療系統 之一足底構件之一縱向橫截面圖之 之釋壓及減壓治 一部分; 療器件 圖6係圖4之釋壓及減壓治療器 面圖; 件沿線6-6截取之一橫截
圖7A係釋壓歧管材料之一薄層 -立 < 一不意性透視圖 疊之前 圖7Β係-釋壓及減壓治療器件在切割之後且在指 之一示意性透視圖; 說明性實施例之一示 圖8Α係一釋壓及減壓治療器件之 意性平面圖; 圖8Β係圖8Α之一釋壓及減壓、Λ底„ ,口療态件之說明性實施例 沿線8Β-8Β截取之一放大橫截面圖; 圖9係圖8Α及8Β之釋壓及減壓治 〜ι〜原·态件之說明性實施例 之一示意性分解透視圖;且 圖1 〇係與圖8 Α之釋壓及減壓治疼 〜口摩盗件配合使用之釋壓歧 管之一部分之一橫截面圖。 【主要元件符號說明】 100 釋壓及減壓治療系統 102 釋壓及減壓治療器件 104 足底構件 106 腳背構件 139165.doc -17- 200946150 107 中心橋部分 108 橋構件 109 介面部分 110 足部 111 足底傷口 112 腳背區 114 腳背傷口 115 密封構件 116 釋壓歧管材料 118 第一面向組織表面 120 第二表面 128 支撐層 130 第一面向組織表面 132 第二表面 134 壓力傳輸層 136 第一面向組織表面 138 第二表面 140 第一障壁層 142 第一面向組織表面 144 第二表面 146 第一空隙 148 第二空隙 150 減壓介面 152 減壓遞送導管
139165.doc -18 · 200946150 154 減壓源 156 流體罐 158 代表性器件 160 第一治療歧管 162 密封構件 168 薄層 ' 170 圖案 172 邊緣 @ 202 釋壓及減壓治療器件 204 足底構件 206 腳背構件 207 中心橋部分 208 橋構件 209 介面部分 216 釋壓歧管材料 φ 228 支撐層 232 第二表面 234 壓力傳輸層 • 238 第二表面 240 第一障壁層 244 第二表面 250 減壓介面 252 減壓遞送導管 275 延伸構件 139165.doc -19- 200946150 276 緊固條 278 調整部分 280 周長 282 密封件
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Claims (1)
- 200946150 七、_請專利範圍: ι_ 一種釋壓及減壓治療系統,其包括: 治療器件 -釋壓及減壓治療器件’其令該釋壓及減壓 包括: 一足底構件,其由一釋壓歧管材料形成; 其中該釋壓歧管材料包括: 支律層,其具有一第—面向組織表面及-第 二表面, 一壓力傳輸層,其具有-第-面向組織表面及 一第二表面’該壓力傳輸構件之該第-面向組織 表面耦合至該支撐層之該第二表面,及 第障壁層,其具有—第—面向組織表面及 -第二表面’該第一障壁層之該第一面向組織表 面柄合至該壓力傳輸層之該第二表面; 一減壓介面,其以流體方式耦合至該足底構件之該 壓力傳輸層; 一減壓源;及 -減壓遞送導管,其以流體方式耦合至該減壓源並 輕合至该減壓介面。 2. 如請求項丨之釋壓及減壓洽療系統,其中該壓力傳輸層 係由該支撐層、該第一障壁層及一密封件囊封。 3. 如請求項1之釋壓及減壓治療系統,其中該釋壓及減壓 治療器件進一步包括一由該釋壓歧管材料形成之腳背構 件,其中該腳背構件之該壓力傳輸層係以流體方式耦合 139165.doc 200946150 至該足底構件之該壓力傳輸層。 、A ::項1之釋壓及減壓治療系統,其中該釋壓及減壓 :、件進步包括一由該釋壓歧管材料形成之橋構 ,且其中該橋構件之該壓力傳輸層係以流體方式耦合 至該足底構件之該壓力傳輸層,且其中該減 合至該橋構件。 印你稿 «求項1之釋壓及減壓治療系統,其中該釋壓及減壓 治療器件進一步包括: 3 一腳背構件,其由該釋壓歧管材料形成,且其中該腳 者構件之該壓力傳輸層係以流體方式柄合至該^底構件 之δ玄壓力傳輸層;及 -橋構件,其由該釋壓歧管材料形成,且其中該橋構 件之該壓力傳輸層係以流體方式耗合至該足底構件之該 壓力傳輪層’且其中該減壓介面係' 耦合至該橋構件。 6. 如請求項〗之釋壓及減壓治療系統,其中該釋壓歧管 料包括: 該壓力傳輸層包括一開放孔格發泡體材料,且 該支揮層包括一封閉孔格發泡體材料。 7. 如請求項丨之釋壓及減壓治療系統’其中該足底構件之 該支撐層之一部分可移除以形成一第一空隙,且該足底 構件之該壓力傳輸層可操作以將減壓傳送至該第—空 隙。 工 8·如請求項5之釋壓及減壓治療系統,其中該足底構件之 該支撐層之一部分可移除以形成一第一空隙,該足底構 139165.doc 200946150 件之該壓力傳輸層可操作以將減歷傳送至該第一空隱, 該腳背構件之該切層之-部分可移除以形成-第二空 陳’且該腳背構件之該塾力傳輸層可操作 至該第二空隙。 货泛 9. 一種釋壓及減壓治療器件,其包括: 一足底構件,該足底構件由—㈣歧管材料形成; 其中該釋廢歧管材料包括·· 一支擇層,其具有—第_表面及_第二表面; ^力傳輪層,其具有—第—表面及—第二表面, ㈣構件之該第_表面耗合至該支樓層之該第 -表面,及^ 兮if:障壁層,其具有一第一表面及-第二表面, ^第:障壁層之該第一表面麵合至該壓力傳輸層之該 弟一表面;及 力傳2介面’其以流體方式耦合至収底構件之該壓 10·如請求項9之釋壓及減壓 係由該支揮層、該第一障警廢0 /、令該壓力傳輸層 Λ 、 弟障壁層及一密封件囊封。 11.如π求項9之釋壓及減壓治療器件,其進 該釋壓歧管妯乂包括一由 該壓力傳==:構件,且其中該”構件之 傳輸層。體方式麵合至該足底構件之該塵力 如吻求項9之釋壓及減壓治療器件,其進 該釋壓歧管材料形成之橋構件,其中該橋構件:= 139165.doc 200946150 傳輸層係以流體方式為;人;5 # 万式耦D至该足底構件之該壓力傳輸 層,且其中該減壓介面係耦合至該橋構件。 13. 如請求項9之釋壓及減壓治療器件,其進一步包括: -腳背構件’其由該釋壓歧管材料形成,且其中該腳 背構件之該壓力傳輸層係以流體方式執合至該足底構件 之該壓力傳輸層;及 f橋構件’其由該釋壓歧管材料形成,其中該橋構件 之該壓力傳輸層係以流體方式耗合至収底構件之該壓 力傳輸層,且其中該減壓介面係耦合至該橋構件。 14. 如請求項13之釋壓及減壓治療器件,其中該足底構件之 該支撐層之-部分可移除以形成—第—空隙該足底構 件之該壓力傳輸層可操作以將減壓傳送至該第一空隙, 該腳背構件之該支揮層之—部分可移除以形成__第二空 隙且°亥腳奇構件之該壓力傳輸層可操作以將減壓傳送 至該第二空隙。 15. 如請求項9之釋壓及減壓治療器件,其中該釋壓歧管材 料包括: 該壓力傳輸層包括一開放孔格發泡體材料,且 該支撐層包括一封閉孔格發泡體材料。 16·如請求項9之釋麼及減壓治療器件,其中該足底構件之 該支撐層之一部分可移除以形成一第一空隙,且該足底 構件之該壓力傳輸層可操作以將減壓傳送至該第一空 隙。 二 17.如請求項9之釋壓及減壓治療器件,其申該釋壓歧管材 139J65.doc 200946150 :具:-周長,且其中該㈣歧管 長之密封構件密封。 接近該周 18_如請求項9之釋壓及 .^ 口療益件,其中該支撐層進— 步匕括一調整部分以促進 <对这釋壓及減壓治療器件 小的調整。 19. 一種釋壓及減壓治療器件,其包括: 足底構件,該足底構件由一釋壓歧管材料形成;其中該釋壓歧管材料包括:一支撲層、一壓力傳輪層 及一第一障壁層;及 一減壓介面,其以流體方式耦合至該足底構件之該壓 力傳輸層。 20. 如請求項19之釋壓及減壓治療器件,其中該支撐層及該 壓力傳輸層包括一形成有—小孔式d4〇個孔/公分)開放 孔格發泡體之單個層,該開放孔格發泡體形成該壓力傳 輸層且塗布以一不透氣材料以形成該支撐層。 21. 如请求項20之釋壓及減壓治療器件,其中該壓力傳輸層 係由該第一障壁層及該不透氣材料囊封。 22. —種製造一釋壓及減壓治療器件之方法,該方法包括: 提供釋壓歧管材料之一薄層,該釋壓歧管材料包括: 一支撐'層’其具有一第一表面及一第二表面, 一壓力傳輸層,其具有一第一表面及一第二表面, 該壓力傳輸構件之該第一表面耦合至該支撐層之該第 二表面,及 一第一障壁層,其具有一第一表面及一第二表面, 139165.doc 200946150 該第一障壁層之該第-表面輕合至該壓力傳輸層之該 第二表面;及 切割該薄層以形成該釋壓及減壓治療器件。 23. 24. 25. 26. 27. 如請求項22之製造方法,装推 .^ μ β , 再進—步包括摺疊該薄層以形 成該釋壓及減壓治療器件之步驟。 如請求項22之製造方法,其中: 該釋壓歧管材料之該壓力傳輪層包括一開放孔格發泡 體材料,且 © 該釋壓歧管材料之該支樓層包括一封閉孔格發泡體材 料。 如請求項22之製造方法,复由 ^ 其中切割該薄層以形成該釋壓 及減壓治療器件之該步驟& & 卞驟包括切割該薄層以形成一足底 構件、一橋構件及一腳背構件之步驟。 如請求項22之製造方法,甘+ ^ 其中該壓力傳輸層係由該支樓 層、該第一障壁層及一密封件囊封。 一種用於治療一患者足部 丨上之—足底傷口之方法,該方 ❹ 法包括如下步驟: 提供Φ #壓歧管材料形成之釋壓及減壓治 件’該釋壓及減壓治療琴杜目士 # @ 縻益件具有一足底構件,且其中兮 釋壓歧管材料包括: ^ 一支撐層,其具有一笛 ^ 第一表面及一第二表面, 一壓力傳輪層,直且 八具有一第一表面及一第二表面, 該壓力傳輸構件之# m 傅忏之該第一表面耦合至該支撐 二表面,及 弟 139165.doc •6 200946150 一第一障壁層’其具有一第一表面及一第二表面, 該第一障壁層之該第一表面耦合至該壓力傳輸層之該 第二表面; 移除該支撐層之一部分以接近該患者之該足底傷口形 成一第一空隙; 將一第一治療歧管安置於該第一空隙中;及 經由S亥壓力傳輸層將減壓遞送至該第一空隙。 28·如明求項27之用於治療一患者足部上之一足底傷口之方 法’其進一步包括在該第一空隙周圍安置一第一密封構 件之步驟’該第一密封構件可操作以在該支撐層與該患 者之皮膚之間形成一氣動密封。 29.如凊求項27之用於治療一患者足部上之一足底傷口之方 法,其中: 6亥釋壓歧官材料之該壓力傳輸層包括一開放孔格發泡 體材料,且 φ 該釋壓歧管材料之該支撐層包括一封閉孔格發泡體材 料。 30· -種用於治療一患者足部上之一足底傷口及一腳背傷口 ' 之方法,該方法包括如下步驟: • 提供一由一釋麼歧管材料形成之釋壓及減壓治療器 件’該釋壓及減壓治療器件具有一足底構件及一腳背構 件,且其中該釋壓歧管材料包括: 一支擇層,其具有—第-表面及一第二表面, 一壓力傳輸層,其具有—第一表面及一第二表面, 139165.doc 200946150 該壓力傳輸構件之該第一表面耦合至該支撐層之該第 二表面,及 一第一障壁層’其具有一第一表面及一第二表面, 該第一障壁層之該第一表面耦合至該壓力傳輸層之該 第二表面; 移除該支撐層之一部分以接近該患者之該足底傷口形 成一第一空隙; 將一第一治療歧管安置於該第一空隙中; 移除5亥支樓層之—部分以接近該患者之該腳背傷口形 成一第二空隙; 將一第二治療歧管安置於該第二空隙中;及 經由該壓力傳輸層將減壓遞送至該第一空隙及該第二 空隙。 3 1 ·如請求項30之用於治療一患者足部上之_足底傷口及一 腳者傷口之方法,其進一步包括:在該第一空隙周圍安 置一第一密封構件之步驟,該第一密封構件可操作以在 該足底構件之該支撐層與該患者之皮膚之間形成一氣動 密封;及在該第二空隙周圍安置一第二密封構件之步 驟’該第二密封構件可操作以在該腳背構件之該支撐層 與該患者皮膚之間形成一氣動密封。 32·如請求項31之用於治療一患者足部上之—足底傷口及一 腳背傷口之方法,其中: δ亥釋壓歧管材料之該壓力傳輸層包括一開放孔格發泡 體材料,且 139165.doc 200946150 該釋壓 料 歧管材料之該支撐層包括 閉孔格發泡體材 33.如請求項31之用於 _ 腳背傷口之方法,其中:部上之一足底傷口及 包括一開放孔格發泡 該釋壓歧管材料之該壓力傳輪層 體材料, 封閉孔格發泡體材 _ 該釋壓歧管材料之該支撐層包括一 料,且 該釋壓歧管材料之該第—隆增:思h Λ ^ , η 丨軍璧層包括一位於一經編織 物上之聚胺基曱酸酯傳送塗層。139165.doc 9-
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