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TWI417073B - 減壓、線性傷口閉合枕墊及系統、將一閉合力施加至一患者上之一線性傷口之方法及製造一減壓線性傷口閉合枕墊之方法 - Google Patents

減壓、線性傷口閉合枕墊及系統、將一閉合力施加至一患者上之一線性傷口之方法及製造一減壓線性傷口閉合枕墊之方法 Download PDF

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TWI417073B
TWI417073B TW098118112A TW98118112A TWI417073B TW I417073 B TWI417073 B TW I417073B TW 098118112 A TW098118112 A TW 098118112A TW 98118112 A TW98118112 A TW 98118112A TW I417073 B TWI417073 B TW I417073B
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Charles Alan Seegert
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    • 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
    • A61F13/05—Bandages or dressings; Absorbent pads specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
    • 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
    • A61M1/91—Suction aspects of the dressing
    • A61M1/915—Constructional details of the pressure distribution manifold
    • A—HUMAN NECESSITIES
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/01—Non-adhesive bandages or dressings
    • A61F13/01008—Non-adhesive bandages or dressings characterised by the material
    • A61F13/01017—Non-adhesive bandages or dressings characterised by the material synthetic, e.g. polymer based
    • 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
    • A61F13/01—Non-adhesive bandages or dressings
    • A61F13/01021—Non-adhesive bandages or dressings characterised by the structure of the dressing
    • 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
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00535—Surgical instruments, devices or methods pneumatically or hydraulically operated
    • A61B2017/00561—Surgical instruments, devices or methods pneumatically or hydraulically operated creating a vacuum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B2017/081—Tissue approximator
    • 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
    • A61M1/74—Suction control
    • A61M1/75—Intermittent or pulsating suction
    • 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
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
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Description

減壓、線性傷口閉合枕墊及系統、將一閉合力施加至一患者上之一線性傷口之方法及製造一減壓線性傷口閉合枕墊之方法
本發明一般而言係關於醫學治療系統，且更特定而言，係關於減壓線性傷口閉合枕墊及系統。
本發明根據35 U.S.C.§119(e)規定主張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號及2008年7月3日申請之題為「Reduced-Pressure,Linear Wound Closing Bolster and System」之美國臨時專利申請案第61/078,114號之申請之權益。所有此等臨時申請案出於所有目的以引用的方式併入本文中。
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一增加數目之手術正使用最低程度侵入性外科手術實施，例如關節鏡、腹腔鏡及內窺鏡方法。然而，實施的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)閉合切口，且該傷口僅覆蓋有一乾燥無菌繃帶。
使用釘或縫合線來閉合一急性傷口可具有不期望之副作用。舉例而言，釘及縫合線可緊密地接近其施加至的該等傷口邊緣，但此等機械閉合器件中間係不如此緊密閉合之間隙或區。此可在接近中間散佈有相對低應力區之閉合器件處導致高應力區。此又可影響結疤、癒合時間及傷口強度。
本文各種說明性實施例中顯示及描述之本發明解決線性傷口護理之某些態樣之缺點。「線性傷口」一般係指一無論是否呈一線之裂口或切口。根據一說明性實施例，一種用於處理一線性傷口之減壓線性傷口閉合枕墊包含一具有一第一閉合構件、一第二閉合構件及一內部空間之可樞轉框架。該可樞轉框架可操作以在一延伸位置與一收縮位置之間移動。該閉合枕墊進一步包含一設置於該內部空間內之歧管構件、一耦合至該第一閉合構件之第一夾持構件及一耦合至該第二閉合構件之第二夾持構件。該第一夾持構件用於將一閉合力自該第一閉合構件傳輸至該線性傷口之一第一邊緣。該第二夾持構件用於將一閉合力自該第二閉合構件傳輸至該線性傷口之一第二邊緣。
根據另一說明性實施例，一種減壓線性傷口閉合枕墊包含一用於放置於該線性傷口之一第一側上之第一閉合構件、一用於放置於該線性傷口之一第二側上之第二閉合構件及一第一連接構件。該枕墊亦包含一耦合該第一閉合構件與該連接構件之一部分之第一樞軸連接器、一耦合該第二構件與該連接構件之一部分之第二樞軸連接器及一耦合至該第一閉合構件之一內表面及該第二閉合構件之一內表面之歧管構件。該歧管構件在置於一減壓下時收縮。該枕墊亦包含一介面，該介面以流體方式耦合至用於將一減壓遞送至其的該歧管。
根據另一說明性實施例，一種減壓線性傷口治療系統包含一閉合枕墊，該閉合枕墊用於放置於一線性傷口上之患者之皮膚上且可操作以在一延伸位置與一壓縮位置之間移動。該閉合枕墊包括一具有一內部空間之可樞轉框架及一設置於該內部空間內且耦合至該可樞轉框架之歧管。該系統包含一用於在該閉合枕墊與該患者之間提供一流體密封之密封子系統及一用於將一減壓遞送至該密封子系統之減壓子系統。該密封子系統及減壓子系統可操作以將一減壓遞送至該閉合枕墊，且該閉合枕墊可在減壓下操作以到達該壓縮位置且藉此形成一向內力。
根據一個說明性實施例，一種減壓各向異性閉合枕墊包含一各向異性歧管構件，該各向異性歧管構件可在減壓下操作以沿一橫向方向比沿一縱向方向收縮得更多。該各向異性歧管構件包含一撓性歧管材料之複數個縱向歧管構件、複數個加強構件及一藉由耦合該複數個縱向歧管構件與該複數個加強構件而形成之各向異性枕墊本體。該各向異性枕墊本體可在減壓下操作以在垂直於該複數個加強構件之方向上比在平行於該複數個加強構件之方向上收縮得更多。
根據另一說明性實施例，一種將一閉合力施加至一患者上之一線性傷口之方法包含提供一減壓線性傷口閉合枕墊。其中該減壓線性傷口閉合枕墊包含一歧管構件及一可樞轉框架，該可樞轉框架具有一內部空間及一第一閉合構件與一第二閉合構件。該第一閉合構件具有一第一縱向邊緣及一第二縱向邊緣。該第二閉合構件具有第一縱向邊緣及一第二縱向邊緣。該方法包含接近該線性傷口之一第一邊緣放置該第一閉合構件之該第二縱向邊緣，及接近該線性傷口之一第二邊緣放置該第二閉合構件之該第二縱向邊緣。該方法亦包含在該可樞轉框架與該患者之皮膚之間形成一流體密封、將一減壓子系統耦合至一介面至該歧管構件及啟動減壓源。
根據另一說明性實施例，一種製造一減壓線性傷口閉合枕墊之方法包含形成一具有第一閉合構件、一第二閉合構件及一內部空間之可樞轉框架，該可樞轉框架可操作以在一延伸位置與一收縮位置之間移動。該方法包含在該內部空間內設置一歧管構件及提供一第一夾持構件，該第一夾持構件可操作以將一閉合力自該第一閉合構件傳輸至一線性傷口之一第一邊緣。該方法亦包含提供一第二夾持構件，可操作該第二夾持構件以將一閉合力自該第二閉合構件傳輸至該線性傷口之一第二邊緣。該方法可進一步包含將該歧管構件耦合至該可樞轉框架以使得當施加一減壓時，將該可樞轉框架自該延伸位置驅使至該收縮位置。
根據一個說明性實施例，一種用於處理一線性傷口之減壓線性傷口閉合枕墊包含一第一閉合構件、一第二閉合構件、一耦合該第一閉合構件與第二閉合構件之樞軸連接器及一至少部分地由該第一閉合構件及該第二閉合構件形成之內部空間。該樞軸連接器可操作以在一延伸位置與一壓縮位置之間移動。該閉合枕墊進一步包含一歧管構件，該歧管構件設置於該內部空間內且耦合至該第一閉合構件及第二閉合構件以使得當施加一減壓時，該可樞轉框架自該延伸位置被驅使至該壓縮位置。該閉合枕墊亦包含一用於將一閉合力自該第一閉合構件傳輸至一線性傷口之一第一邊緣之第一夾持構件及一用於將一閉合力自該第二閉合構件傳輸至該線性傷口之一第二邊緣之第二夾持構件。
該等說明性實施例可提供若干優點。以下係幾個實例。可想而知，該等說明性實施例之技術優點包含傷口在癒合過程期間能夠耐受更大力。另外，原本將不緊密且平滑地靠近之傷口邊緣在一使該等邊緣靠近之緊密位置中癒合。可縮短傷口獲得強度之時間。其亦可減小傷口處之傷疤形成。此等實例僅係一些可能實例。
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。
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圖式，且其中以圖解說明方式顯示其中可實踐本發明之具體較佳實施例。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、電氣及化學改變，而不背離本發明之精神或範圍。為避免並非為使得熟習此項技術者能夠實踐本發明所需之細節，本描述可省略熟習此項技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及2，其呈現一用於治療一線性傷口102(例如一裂口，或更通常地，一切口104)之減壓線性傷口閉合系統100之一說明性實施例。線性傷口102具有一第一邊緣106及一第二邊緣108。儘管線性傷口102可延伸至不同深度，但其顯示為一延伸通過表皮110、真皮112且進入皮下組織或下皮114之切口104。
一敷料總成118可放置於線性傷口102上且可與減壓一起使用以供應一向內或閉合力120，且亦可形成一壓縮力122。敷料總成118包含一可在一延伸位置(例如，圖1)與一壓縮位置之間移動之閉合枕墊126。一密封子系統178在敷料總成118與患者之表皮110之間提供一流體密封。一減壓子系統188向敷料總成118之一內部部分提供減壓且致使閉合枕墊126自該延伸位置被驅使至該壓縮位置且藉此向線性傷口102之兩個邊緣106、108提供向內閉合力120。
閉合力120主要保持於表皮110及真皮112內。閉合力120可提供線性傷口102之邊緣106及108之一平滑緊密靠近。另外，系統100可操作以將一減壓遞送至切口104，該減壓亦可實現於任一皮下空隙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。如本文所使用，術語「流體」一般係指氣體或流體，但亦可包含任一其他可流動材料。亦可形成一向下(針對圖1之定向)壓縮力122。
敷料總成118可包含閉合枕墊126及包覆敷巾180。閉合 枕墊126可以許多方式形成且在置於減壓下時具有形成一閉合力120之效應。系統100可進一步向線性傷口102提供一壓縮力122、且同時歧管減壓以用於減壓治療。
在圖1之說明性實施例中，閉合枕墊126形成有一可樞轉框架130。為形成圖1之可樞轉框架130，耦合一第一閉合構件132、第二閉合構件146及一連接構件160，如將描述。可樞轉框架130之構件可由任一材料(例如，一醫學級聚矽氧)製成。可樞轉框架130之構件可係擠壓、澆注模製、注射模製、吹塑模製而成或藉由其他製造技術形成。當可樞轉框架130部署於表皮110上及線性傷口102上時，該可樞轉框架在各端上(第一端及第二端或近端及遠端)係敞開的上，但由包覆敷巾180覆蓋以供使用。
第一閉合構件132具有一第一縱向邊緣134、第二縱向邊緣136、一第一橫向邊緣(類似於圖3B中之橫向邊緣238)、第二橫向邊緣(類似於圖3B中之橫向邊緣240)、一內表面142及一橫向軸144(圖2)。類似地，第二閉合構件146具有一第一縱向邊緣148、第二縱向邊緣150、一第一橫向邊緣(類似於圖3B中之橫向邊緣252)、第二橫向邊緣(類似於圖3B中之橫向邊緣254)、一內表面156及一類似於軸144(圖2)之橫向軸。連接構件160具有一第一縱向邊緣162、一第二縱向邊緣164、一第一橫向邊緣(類似於圖3B中之第一橫向邊緣266)及一第二橫向邊緣(類似於圖3B中之第二橫向邊緣268)。
一第一樞軸連接器170以可樞轉方式將第一閉合構件132 之第一縱向邊緣134耦合至連接構件160之第一縱向邊緣162。一第二樞軸連接器172以可樞轉方式將第二閉合構件146之第一縱向邊緣148耦合至連接構件160之第二縱向邊緣164。以可樞轉方式耦合之第一閉合構件132、第二閉合構件146及連接構件160共同形成可樞轉框架130且進一步界定一內部空間174。在一個變化中，可藉由使用一第一樞軸連接器將第一閉合構件132之第一縱向邊緣134耦合至第二閉合構件146之第一縱向邊緣148來形成可樞轉框架130。
第一樞軸連接器170可係將第一閉合構件132之第一縱向邊緣134固持至連接構件160之第一縱向邊緣162(或第二閉合構件146之第一縱向邊緣148)且允許相對移動之任一器件或系統。第一樞軸連接器170可係(舉例而言)一鋼琴式鉸鏈、一活動鉸鏈、蝶式鉸鏈、帶式鉸鏈、一絲帶連接、膠帶等等。樞軸連接器170亦可係一材料薄片中之一允許該薄片沿一邊緣摺疊及彎曲之凸紋。本文之其他連接器(例如連接器172)亦可係任一類型之連接器，例如此段落中提及之彼等連接器。
一第一夾持構件145可與第一閉合構件132之第二縱向邊緣136相關聯，且一第二夾持構件159可與第二閉合構件146之第二縱向邊緣150相關聯。夾持構件145、159可分別係一第一黏合條帶147及一第二黏合條帶161。另一選擇為，邊緣136、150可添加有高摩擦構件，例如軟聚矽氧，該等高摩擦構件能夠提供與皮膚之一摩擦介面以使得在邊 緣136、150移動時，該皮膚與邊緣136、150一起移動而其間沒有任何顯著滑動。夾持構件145及159可操作以將向內閉合力120自閉合構件132及146傳輸至患者之皮膚且藉此將線性傷口102之邊緣106與108驅使成緊密靠近。
一歧管構件175設置於可樞轉框架130之內部空間174內且可耦合至第一閉合構件132之內表面142及第二閉合構件146之內表面156。在一替代實施例中，歧管構件175可不耦合至內部空間174且減壓可使第一閉合構件132與第二閉合構件146主要朝向彼此移動。歧管構件175在置於減壓下時收縮且可操作以將一減壓分佈至線性傷口102。歧管構件175可由許多可能歧管材料製成。
如本文中作為一名詞使用之術語「歧管」一般係指一如下物質或結構，其經提供以輔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。在一個說明性實施例中，歧管構件175由一多孔及可滲透發泡體狀材料、且更特定而言一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甲酸酯或聚醚發泡體製成。已使用之一種此發泡體材料係可自Texas、San Antonio之Kinetic Concepts Inc.(KCI)購得之VAC® Granufoam® 敷料。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用歧管輸送減壓且在減壓下收縮即可。一歧管通常包含複數個互連之流動通道或通路，以改良向歧管周圍組織區提供或自該組織區移除之流體之分佈。歧管之實例可包括但不限於具有經配置以形成流動通道之結構元件之器件、蜂巢狀發泡體(例如開放孔格發泡體)、多孔組織收集器件及包含或凝固後包含流動通道之液體、凝膠及發泡體。該枕墊材料亦可係一材料組合或分層，舉例而言，一第一親水發泡體枕墊層可毗鄰一第二親水發泡體枕墊層設置以形成該枕墊材料。
在約400至600微米範圍中之Granufoam材料網狀孔有助於實施歧管功能，但亦可使用其他材料。可某些情形下，期望一具有比Granufoam材料密度更高(更小孔大小)的材料。歧管構件175可係一稍後黏製為歧管構件175之原始厚度之約1/3之厚度之網狀發泡體。在許多可能材料中，可使用如下材料：Granufoam材料或一Foamex技術發泡體(www.foamex.com )。在某些情形下，可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質(例如抗菌劑)添加至歧管構件175。端視在減壓期間所期望之力120、122之準確定向，歧管構件175可係各向同性或各向異性。歧管構件175亦可係一生物可吸收材料。
密封子系統178可包含一具有一第一側181及一第二側182之包覆敷巾180或敷巾。包覆敷巾180覆蓋敷料118且延伸通過枕墊126之一周邊邊緣176以形成一敷巾延伸部分183。敷巾延伸部分183具有一第一側184及一第二側185。可使用一密封裝置186將敷巾延伸部分183密封該患者。密封裝置186可採取眾多形式，例如一黏合密封膠帶187，或敷巾膠帶或條帶；雙側敷巾膠帶；黏合劑；漿料；親水膠體；水凝膠或其他密封器件。若使用一膠帶187，則膠帶187可由與包覆敷巾180相同之材料藉助延伸部分183之第二側185上之一預施加壓敏黏合劑形成。亦可使用一黏合劑在包覆敷巾180與患者之表皮110之間提供一大致流體密封。在將包覆敷巾180施加至該患者之前，該黏合劑可具有覆蓋已移除黏合劑之可移除條帶，或可施加敷巾180且可放置膠帶187以形成一密封。
包覆敷巾180可係一具有小於約20微米之孔大小之彈性材料。「彈性」意指具有一彈性體之性質且一般係指一具有橡膠狀性質之聚合物材料。更具體而言，大多數彈性體具有大於100%之伸長率及一顯著回彈量。一材料之回彈係指該材料自一彈性形變恢復之能力。彈性體之實例可包含(但不限於)：天然橡膠、聚異戊二烯、苯乙烯丁二烯橡膠、氯丁二烯橡膠、聚丁二烯、腈橡膠、異丁烯橡膠、乙丙橡膠、乙烯丙烯二烯單體、氯磺化聚乙烯、多硫橡膠、聚胺基甲酸酯、EVA膜、共聚酯、聚矽氧。包覆敷巾材料可包含一聚矽氧、3M Tegaderm敷巾材料、丙烯酸敷巾材料(例如，可自Avery購得之丙烯酸敷巾材料)或一切割敷巾材料。
包覆敷巾180可或可不耦合至枕墊126。若耦合，則該耦合可以許多方式發生。包覆敷巾180與枕墊126可使用黏合劑(例如一丙烯酸黏合劑、聚矽氧黏合劑、水凝膠、親水膠體等等)耦合。包覆敷巾180與枕墊126可藉由熱結合、超聲波結合及射頻結合等等結合。該耦合可以許多樣式或更完全地發生。可向該結合添加結構來使包覆敷巾180沿一所期望方向各向異性地作用，亦即，製成一各向異性敷巾材料。一各向異性敷巾材料幫助敷料總成118主要沿一既定方向移動，亦即，僅大圍繞某一軸或某些軸。此在一閉合應用中可尤其有用。
減壓子系統188包含一可採取許多不同形式之減壓源189。減壓源189將一減壓提供為系統100之一部分。知本文所使用，術語「減壓」一般係指一小於正接受治療之組織部位處之一周圍壓力之壓力。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組織之一靜水壓力。常常期望減壓源189形成一低於大氣壓力之連續減壓且亦能夠遞送一動態壓力亦即，使該減壓以一循環變化或以一連續或間歇模式操作。減壓之可操作範圍可視需要廣泛地變化，但通常將包含低於大氣之200 mm Hg。為最大化患者移動性及輕鬆度，減壓源189可係一電池供電、單用途減壓產生器。此一減壓源189促進在操作室中之應用且在復原階段期間為患者提供移動性及便利。
在圖1之說明性實施例中，顯示減壓源189具有一電池盒195及一罐區域190，該罐區域具有提供對罐190內流體位準之一視覺指示之窗191。一插入隔膜過濾器(例如疏水或疏油過濾器)可插入一導管或管道192與減壓源189之間。
由減壓源189形成之減壓透過遞送管或導管192遞送至一介面193，該介面可係一肘形埠194。在一個說明性實施例中，埠194係一可自Texas、San Antonio之KCI購得之TRAC技術埠。介面193允許減壓被遞送至密封子系統178且由歧管構件175接收。
在圖1及2之實施例中，應用來自減壓子系統188之減壓致使歧管構件175向內收縮，但因包覆敷巾180環繞樞軸框架130，故亦存在一置於樞軸框架130上之向下(針對所顯示之定向)力。在此特定實施例中，期望定向樞軸框架130之構件以使得該向下力將轉變成對閉合力120之一貢獻。如圖2中所示，此可藉由以一向內定向放置閉合構件132及146來達成。舉例而言，在橫截面中顯示第一閉合構件132具有一橫向軸144，該橫向軸與一正交於表皮110之參考線或軸143成一角度α。因此，向內角度α意指在將一力向下施加於連接構件160上時，該力將驅使第一構件132圍繞第一樞軸連接170樞轉且要向內塌縮。此幫助沿線性傷口102之方向驅使表皮110。
在操作中，可施加減壓線性傷口閉合系統100以進一步輔助已施加之機械閉合器件(例如縫合線或釘)，或可係用於線性傷口102之唯一及主要閉合源。在任一情形下，藉由將第一閉合構件132放置於第一傷口邊緣106上且將第二閉合構件146放置於第二傷口邊緣108上來施加系統100。第二縱向邊緣136上之夾持構件145用於嚙合傷口102之第一邊緣106。在所顯示之特定實施例中，第一夾持構件145係一黏合條帶147。因此，康護提供者將自黏合條帶147移除可視襯背且將接近第一邊緣106施加黏合條帶147。以一類似方式，此實施例中之第二夾持構件159係一黏合條帶161，且可移除一襯背且接近線性傷口102之第二邊緣108施加條帶161。以較早結合圖2所描述之以一向內角度放置閉合構件132及146之方式接近邊緣106及108施加黏合條帶147及161。應注意，在此特定實施例中，已將歧管構件175放置於由樞軸框架130形成之內部空間174內，但在其他應用中，可在將夾持構件145及159施加至表皮110之前插入歧管構件175。若還未將包覆敷巾180耦合至可樞轉框架130之一外表面，則接著將包覆敷巾180放置於框架130上且致使其延伸超過週邊邊緣170以形成敷巾延伸部分183。在此特定實施例中，接著施加黏合膠帶187以確保在敷巾180與患者之表皮110之間形成一流體密封。施加減壓介面193且將其耦合至遞送管192，該遞送管又耦合至減壓源189。
接著可啟動減壓源189以將減壓遞送至密封子系統178且更特定而言遞送至歧管構件175。歧管構件175由於經受減壓而收縮且連同樞軸框架130一起向下壓縮。力之組合朝向彼此且朝向傷口102地驅使第二橫向邊緣140及154、向下提供某一壓縮力且將減壓用歧管輸送至傷口102。
參照圖3A、3B及3C，其呈現一減壓線性傷口閉合系統200之另一實施例。許多部分類似於圖1及2之系統100之彼等部分且因此僅以100給該等編號加索引呈現可能關係。特別參照圖3A，注意兩個特定差異。首先，密封子系統278不涉及使用一包覆敷巾，但提供一可樞轉框架230，已將一第一端帽263(圖3B)及一第二端帽265(圖3B)添加至該可樞轉框架以形成一流體密封。介面293允許在不損害該流體密封之情形下將減壓供應至歧管構件275。其次，在應用中，可允許閉合構件232及246相對於正交於表皮之參考線(類似於圖2之參考線143)具有一向外角度。此乃因在此實施例中，通常將不存在一置於可樞轉框架230上之向下壓縮力。閉合構件232及246共同經驅使以主要藉由歧管構件275之收縮而提供向內力220。將減壓施加至歧管構件275致使閉合枕墊226自圖3A及3B中所示之一延伸位置移動至圖3C中所示之一壓縮位置。
參照圖3B，系統200包含樞軸框架130，顯示該樞軸框架定位有一平行於線性傷口202之傷口軸203延伸之縱長尺寸。線性傷口202具有第一邊緣206及第二邊緣208。第一閉合構件232具有第一橫向邊緣238及一第一縱向邊緣234。第二閉合構件246具有一第一橫向邊緣252及一第二橫向邊緣254。第二閉合構件246亦具有第一縱向邊緣248及第二縱向邊緣250。
端帽263及265可以若干不同方式形成以向樞軸框架130之端提供一流體密封。在此特定實施例中，該等端帽顯示為一已被施加以覆蓋該等端件之包覆敷巾材料之黏合部分。
在系統100及200中，可以一連續模式或一動態減壓模式供應由減壓子系統188及288遞送之減壓。在一動態模式中，該壓力以任一數目之不同曲線類型變化。舉例而言，參照圖4，其呈現減壓之施加之一個特定曲線。縱座標軸310給出減壓。應瞭解，此處減壓之一增長意指將顯示一較低計示壓力。橫坐標軸312給出經過之時間。因此，在此特定曲線中，該減壓斜升至一基線位準314且接著在此情形下以一較大減壓位準316與一較低減壓318之間的一正弦曲線變化。此減壓變化藉由使該等閉合力變化(例如，圖1及圖3之實施例之閉合力120及220之變化)而致使傷口微運動。
現在參照圖5，其呈現藉由使用該動態壓力(例如結合圖4給出之圖解說明)而促進之有利效應中之一者。顯示一透過表皮410、真皮412且甚至進入皮下組織414中之線性傷口402。線性傷口402由於力420而已經受動態微運動，該等力可已由一系統(例如，分別於圖1及圖3中之系統100或系統200)產生。該微移動致使膠原蛋白416以一平行於力420之定向沈積於傷口402中。
現在參照圖6，其呈現一用於向一線性傷口提供一閉合力之系統之另一實施例。在此系統中，一各向異性枕墊526形成有一各向異性本體528。各向異性本體528包括一各向異性歧管構件，該各向異性歧管構件可在減壓下操作以沿一橫向方向(亦即，平行於力520)比沿一縱向或縱長方向(亦即，垂直於力520)收縮得更多。
該各向異性本體可以許多方式形成。作為一個說明性實施例，可藉由利用複數個撓性或可壓縮歧管構件530及複數個加強縱向構件532來形成枕墊本體528。複數個撓性歧管構件530可類似於先前所描述之實施例中製成歧管構件175及275之材料。加強縱向構件532由一抑制沿一個或多個軸或方向之壓縮之材料或加強材料形成。該加強材料亦可抑制沿一個或多個軸之擴張。該加強材料可抑制沿一個或多個軸或方向之壓縮及擴張兩者。在一個說明性實施例中，加強縱向構件532係與歧管構件530組合以形成枕墊本體528之細絲。應瞭解，針對所顯示之定向，所產生之各向異性枕墊本體528將能夠沿一第一方向534收縮或壓縮，但不能以一大致方式沿一第二方向536收縮或壓縮。
在操作中，將各向異性閉合枕墊526向下放置於一線性傷口上，其中複數個加強構件532之縱長尺寸平行於該傷口延伸，亦即，其中該線性傷口大致平行於方向536。可將一類似於系統100之敷巾180之包覆敷巾施加於枕墊526上且可施加一類似於圖1之介面193之介面以遞送減壓。當將減壓遞送至各向異性閉合枕墊526時，其將沿第一方向534收縮且此致使在該傷口之兩個邊緣上導引向內力520，從而提供一閉合力。供應至各向異性枕墊526之減壓可如先前所論述動態變化或以一恆定模式提供。
依據前述內容應顯而易見，已提供一具有明顯優點之發明。雖然本發明僅以其幾個形式顯示，但其並不僅限於此，而是容許各種改變及修改，而不背離其精神。
100‧‧‧減壓線性傷口閉合系統
102‧‧‧線性傷口
104‧‧‧切口
106‧‧‧第一邊緣
108‧‧‧第二邊緣
110‧‧‧表皮
112‧‧‧真皮
114‧‧‧皮下組織或下皮
118‧‧‧敷料總成
120‧‧‧向內或閉合力
122‧‧‧壓縮力
126‧‧‧閉合枕墊
130‧‧‧可樞轉框架
132‧‧‧第一閉合構件
134‧‧‧第一縱向邊緣
136‧‧‧第二縱向邊緣
142‧‧‧內表面
145‧‧‧第一夾持構件
146‧‧‧第二閉合構件
147‧‧‧第一黏合條帶
148‧‧‧第一縱向邊緣
150‧‧‧第二縱向邊緣
156‧‧‧內表面
159‧‧‧第二夾持構件
160‧‧‧連接構件
161‧‧‧第二黏合條帶
162‧‧‧第一縱向邊緣
164‧‧‧第二縱向邊緣
170‧‧‧第一樞軸連接器
172‧‧‧第二樞軸連接器
174‧‧‧內部空間
175‧‧‧歧管構件
176．．．周邊邊緣
178．．．密封子系統
180．．．包覆敷巾
181．．．第一側
182．．．第二側
183．．．敷巾延伸部分
184．．．第一側
185．．．第二側
186．．．密封裝置
187．．．黏合密封膠帶
188．．．減壓子系統
189．．．減壓源
190．．．罐區域
191．．．窗
192．．．導管或管道
193．．．介面
194．．．肘形埠
195．．．電池盒
143．．．第一縱向邊緣
200．．．系統
202．．．線性傷口
220．．．閉合力
226．．．閉合枕墊
230．．．可樞轉框架
232．．．閉合構件
246．．．第二閉合構件
275．．．歧管構件
278．．．密封子系統
288．．．減壓子系統
293．．．介面
203．．．傷口軸
206．．．第一邊緣
208．．．第二邊緣
234．．．第一縱向邊緣
238．．．第一橫向邊緣
248．．．第一縱向邊緣
250．．．第二縱向邊緣
252．．．第一橫向邊緣
254．．．第二橫向邊緣
263．．．端帽
265．．．端帽
266．．．第一橫向邊緣
268．．．第二橫向邊緣
402．．．線性傷口
410．．．表皮
412．．．真皮
414．．．皮下組織
416．．．膠原蛋白
420．．．力
520．．．力
526．．．各向異性枕墊
528．．．各向異性本體
530．．．撓性或可壓縮歧管構件
532．．．加強縱向構件
可藉由在結合隨附圖式時參照以上實施方式而獲得對本發明之方法及裝置之一更全面理解，其中：圖1係一減壓線性傷口閉合系統之一說明性實施例之一示意性橫截面圖；圖2係圖1之說明性實施例之一第一閉合構件之一示意性細節；圖3A係顯示一減壓線性傷口閉合枕墊在一延伸位置中之一說明性實施例之一示意性橫截面圖；圖3B係亦顯示圖3A之閉合枕墊在延伸位置中之一示意性透視圖；圖3C係顯示圖3A及3B之閉合枕墊在一壓縮位置中之一示意性橫截面圖；圖4係一顯示遞送至一減壓線性傷口閉合系統之一動態減壓之一個可能曲線之示意性圖解；圖5係一顯示形成平行於所施加之閉合力之膠原蛋白之線性傷口之一示意性橫截面圖；且圖6係一閉合枕墊之另一說明性實施例之一示意性透視圖。
100．．．減壓線性傷口閉合系統
102．．．線性傷口
104．．．切口
106．．．第一邊緣
108．．．第二邊緣
110．．．表皮
112．．．真皮
114．．．皮下組織或下皮
118．．．敷料總成
120．．．向內或閉合力
122．．．壓縮力
126．．．閉合枕墊
130．．．可樞轉框架
132．．．第一閉合構件
134．．．第一縱向邊緣
136．．．第二縱向邊緣
142．．．內表面
145．．．第一夾持構件
146．．．第二閉合構件
147．．．第一黏合條帶
148．．．第一縱向邊緣
150．．．第二縱向邊緣
156．．．內表面
159．．．第二夾持構件
160．．．連接構件
161．．．黏合條帶
162．．．第一縱向邊緣
164．．．第二縱向邊緣
170．．．第一樞軸連接器
172．．．連接器
174．．．內部空間
175．．．歧管構件
176．．．周邊邊緣
178．．．密封子系統
180．．．包覆敷巾
181．．．第一側
182．．．第二側
183．．．敷巾延伸部分
184．．．第一側
185．．．第二側
186．．．密封裝置
187．．．黏合密封膠帶
188．．．減壓子系統
189．．．減壓源
190．．．罐區域
191．．．窗
192．．．導管或管道
193．．．介面
194．．．肘形埠
195．．．電池盒

Claims (17)

  1. 一種用於處理一線性傷口之減壓線性傷口閉合枕墊，該枕墊包括：一可樞轉框架，其具有一第一閉合構件、一第二閉合構件及一內部空間，該可樞轉框架可操作以在一延伸位置與一收縮位置之間移動；一歧管構件，其設置於該內部空間內；一第一夾持構件，其耦合至該第一閉合構件，該第一夾持構件用於將一閉合力自該第一閉合構件傳輸至該線性傷口之一第一邊緣；及一第二夾持構件，其耦合至該第二閉合構件，該第二夾持構件用於將一閉合力自該第二閉合構件傳輸至該線性傷口之一第二邊緣。
  2. 如請求項1之減壓線性傷口閉合枕墊，其中該可樞轉框架包括：該第一閉合構件；該第二閉合構件；一連接構件；一第一樞軸連接器，其耦合該第一閉合構件與該連接構件；及一第二樞軸連接器，其耦合該第二閉合構件與該連接構件。
  3. 如請求項1之減壓線性傷口閉合枕墊，其中該可樞轉框架包括： 該第一閉合構件；該第二閉合構件；及一樞軸連接器，其用於耦合該第一閉合構件與第二閉合構件。
  4. 如請求項1之減壓線性傷口閉合枕墊，其中該第一夾持構件包括一第一黏合條帶且該第二夾持構件包括一第二黏合條帶。
  5. 如請求項1之減壓線性傷口閉合枕墊，其中該第一夾持構件包括一耦合至該第一閉合構件之第一高摩擦構件，且該第二夾持構件包括一耦合至該第二閉合構件之第二高摩擦構件。
  6. 如請求項1之減壓線性傷口閉合枕墊，其中該可樞轉框架在一第一端及一第二端上係敞開的。
  7. 如請求項1之減壓線性傷口閉合枕墊，其中該歧管構件耦合至該可樞轉框架以使得當施加一減壓時，該可樞轉框架自該延伸位置被驅使至該收縮位置。
  8. 一種將一閉合力施加至一患者上之一線性傷口之方法，該方法包括以下步驟：提供一減壓線性傷口閉合枕墊，其中該減壓線性傷口閉合枕墊包括一歧管構件及一可樞轉框架，該可樞轉框架具有一內部空間及一具有一第一縱向邊緣及一第二縱向邊緣之第一閉合構件，且具有一具有一第一縱向邊緣及一第二縱向邊緣之第二閉合構件；接近該線性傷口之一第一邊緣放置該第一閉合構件之 該第二縱向邊緣；放置該第二閉合構件之該第二縱向邊緣接近該線性傷口之一第二邊緣；在可樞轉框架與該患者之皮膚之間形成一流體密封；及向該可樞轉框架之該內部空間提供一減壓。
  9. 如請求項8之方法，其中該向該內部空間提供該減壓之步驟包括提供一減壓循環型樣之步驟。
  10. 如請求項8之方法，其中該向該內部空間提供該減壓之步驟包括提供一可變減壓型樣之步驟。
  11. 如請求項8之方法，其中將該歧管構件耦合至該可樞轉框架。
  12. 一種製造一減壓線性傷口閉合枕墊之方法，該方法包括以下步驟：形成一具有一第一閉合構件、一第二閉合構件及一內部空間之可樞轉框架，該可樞轉框架可操作以在一延伸位置與一壓縮位置之間移動；在該內部空間內設置一歧管構件；提供一第一夾持構件，該第一夾持構件可操作以將一閉合力自該第一閉合構件傳輸至一線性傷口之一第一邊緣；及提供一第二夾持構件，該第二夾持構件可操作以將一閉合力自該第二閉合構件傳輸至該線性傷口之一第二邊緣。
  13. 如請求項12之方法，其進一步包括以下步驟：將該歧管構件耦合至該可樞轉框架以使得當施加一減壓時，將該可樞轉框架自該延伸位置驅使至該壓縮位置。
  14. 如請求項12之方法，其中該形成該可樞轉框架之步驟包括以下步驟：提供一第一閉合構件；提供一第二閉合構件；提供一連接構件；藉助一第一樞軸連接器耦合該第一閉合構件與該連接構件；及將一第二樞軸連接器耦合至該第二閉合構件及該連接構件。
  15. 如請求項12之方法，其中該形成該可樞轉框架之步驟包括：提供該第一閉合構件；提供該第二閉合構件；藉助一樞軸連接器耦合該第一閉合構件與第二閉合構件。
  16. 如請求項12之方法，其中該提供該第一夾持構件之步驟包括將一第一黏合條帶耦合至該第一閉合構件之步驟，且該提供該第二夾持構件之步驟包括將一第二黏合條帶耦合至該第二閉合構件。
  17. 如請求項12之方法，其中該提供該第一夾持構件之步驟包括提供一耦合至該第一閉合構件之第一高摩擦構件且 該提供該第二夾持構件之步驟包括提供一耦合至該第二閉合構件之第二高摩擦構件。
TW098118112A 2008-05-30 2009-06-01 減壓、線性傷口閉合枕墊及系統、將一閉合力施加至一患者上之一線性傷口之方法及製造一減壓線性傷口閉合枕墊之方法 TWI417073B (zh)

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