TW200821001A - Reduced pressure treatment system having blockage clearing and dual-zone pressure protection capabilities - Google Patents
Reduced pressure treatment system having blockage clearing and dual-zone pressure protection capabilities Download PDFInfo
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- TW200821001A TW200821001A TW096135021A TW96135021A TW200821001A TW 200821001 A TW200821001 A TW 200821001A TW 096135021 A TW096135021 A TW 096135021A TW 96135021 A TW96135021 A TW 96135021A TW 200821001 A TW200821001 A TW 200821001A
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- Health & Medical Sciences (AREA)
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- Agricultural Chemicals And Associated Chemicals (AREA)
Description
200821001 九、發明說明: 【發明所屬之技術領域】 本發明大體而言係關於組織治療裝置,且特定言之係關 於具有阻塞清理及雙區域壓力保護能力之減壓治療系統。 【先前技術】
臨床研究及實踐已顯示接近於組織位點提供減壓增加且 加速組織位點處新組織的生長。此現象之應用眾多,但減 壓之一特定應用已涉及治療創傷。此治療(在醫學界經常 稱作"負壓創傷療法"、"減壓療法”或"真空療法")提供許多 益處,包括上皮組織及皮下組織之遷移、改良之血流及創 傷位點處之組織的微變形。此等益處一同導致肉芽組織之 增強的發育及較快之復原時間。 雖然減壓可極大地有益於創傷護理及需要增強之組織生 長的其他情況,但必須控制施加至組織位點之減壓之量以 防止對組織的損害及大出血之可能性。因此存在對於能夠 平衡促使組織生長的減壓應用但防止可能引起對組織之損 害的咸m之過复μ用之藏m治療系统反方法之需要。 【發明内容】 藉由本發明之系統及方㈣解決存在於控制由組織治療 系統所施加之壓力中的問題。在-實施例中,提供減壓治 療系統,其包括流體連接至組織位點之減壓源。該系統進 一步包括一第一威庫駐罢 ^ . a應裝置,其與組織位點連通以量測組 位點處之第一壓力。挺报结一』一 徒供弟二感應裝置,其與減壓源連通 以量測減壓源處之第-默 一坠力。處理單元與第一感應裝置及 124287.doc 200821001 第二感應裝置連通且經組態以接收第一壓力及第二壓力且 判定減壓源與組織位點之間的壓差。處理單元進一步與減 壓源連通以調節由減壓源施加之壓力。調節壓力以使得壓 差(a)在阻塞存在於減壓源與組織位點之間之情況下不超過 弟隶大壓差’且(b)在無阻基存在於減壓源與組織位點之 . 間的情況下不超過第二最大壓差。 • 根據本發明之另一實施例,提供治療組織位點之方法。 該方法包括由減壓源將減壓施加至組織位點。在減壓源處 • 監視源壓力,且在組織位點處監視組織位點壓力。判定組 織位點與減壓源之間的壓差。若阻塞存在於減壓源與組織 位點之間,則將壓差限於第一最大壓差。若無阻塞存在於 減壓源與組織位點之間,則將壓差限於第二最大壓差。 在本發明之又一實施例中,減壓治療系統包括用於向組 織位點施加減壓之構件,用於監視用於施加減壓之構件處 的源壓力之構件及用於監視組織位點處之組織位點壓力之 才冓件。該系統進-步包括用於判定組織位點與用於施加減 壓之構件之間的壓差之構件。提供一構件以在阻塞存在於 組織位點與用於施加減壓之構件之間的情況下將壓差限於 • m壓差。㈣統進-步包括用於在無阻塞存在於組 • '織位點與用於施加減壓之構件之間的情況下將壓差限於高 於第一最大壓差之第二最大壓差之構件。 本發明之其他目標、特徵及優勢將參看隨後之圖式及詳 細描述而變得顯而易見。 【實施方式】 124287.doc 200821001 在以下較佳具體實施例的詳細說明中,參看形成其一部 分且以說明之方式展示本發明可實踐於之特定較佳實施例 的Ik附圖式。足夠詳細地描述此等實施例以使得熟習此項 技術者能夠實踐本發明,且應瞭解,可利用其他實施例且 可在不脫離本發明之精神或範疇的情況下進行邏輯結構、 機械、電力及化學改變。為了避免對於使熟習此項技術者 月b夠實踐本發明不必要之細節,描述可省略熟習此項技術 者已知的某些資訊。因此不以限制性意義來看待以下詳細 描述’且本發明之範疇僅由所附申請專利範圍界定。 術語’’減壓”在用於本文中時一般指代小於正經受治療之 組織位點處之環境壓力的壓力。在多數情況下,此減壓將 小於病人所在處之大氣壓力。雖然可使用術語,,真空"及 ’’負壓"來描述施加至組織位點之壓力,但施加至組織位點 之實際壓力可能顯著小於正常情況下與完全真空相關聯之 壓力。與此命名法相一致,減壓或真空壓力之增大指代絕 對壓力之相對減小,而減壓或真空壓力之減小指代絕對壓 力之相對增大。 術語”組織位點”在用於本文中時指代位於包括(但不限 於)肖路組織、脂肪組織、肌肉組織、真皮組織、血管組 織、結締組織、軟骨、腱或韌帶之任何組織上或組織内之 創傷或缺陷。術語"組織位點"可進—步指代未必受傷或存 在缺陷但替代地為需要添加額外組織或促進額外組織之生 長之區域的任何組織區域。舉例而言,可在某些組織區域 中使用減壓組織治療以使額外組織生長,可採集該額外組 124287.doc 200821001 織且將其移植至另一組織位置。 參看圖1,提供根據本發明之一實施例之減壓治療系統 100來將減壓傳遞至病人之組織位點102。減壓治療系統 100包括藉由管道108而流體連接至罐112之減壓源104。罐 112藉由管道116而流體連接至歧管配接器12〇,該歧管配 接器120與分配歧管124接觸且與其流體連通。分配歧管 124係置放為與組織位點ι〇2接觸。覆蓋物ι28定位於分配 歧官124上且較佳相對於圍繞組織位點1〇2之周界的組織密 封。歧管配接器120較佳凸起穿過覆蓋物128,且覆蓋物 128相對於歧管配接器12〇密封。覆蓋物U8可由不透性或 半透性材料製成以輔助維持組織位點102處之減壓。 为配歧管1 02主要負責將減壓分配至組織位點i 〇2,引導 滲出物及其他流體離開組織位點1〇2,誘發組織位點1〇2處 之微變形及支撐覆蓋物128以形成一空間,減壓在該空間 中得以維持。實務上,分配歧管124通常為諸如網狀聚胺 基甲酸酯或聚乙烯醇發泡體之開放氣室式發泡體。對開放 氣至式發泡體定大小以配合組織位點〖〇2,將其置放為與 組織102接觸且接著隨著組織開始生長且組織位點1〇2變得 較小而週期性地以較小塊發泡體來替換該開放氣室式發泡 體。開放氣室式發泡體之頻繁替換對於最小化組織向發泡 體之氣室中的向内生長為必要的。儘管普遍使用開放氣室 式發/包體,但可使用許多替代材料作為可替換分配歧管, 包括紗布及能夠提供分配特徵之任何其他材料。類似地, 不可替換之生物相容性材料可用作分配歧管,且既而允許 124287.doc 200821001 在組織位點1 02處保持於原位。在多數情況下,此等生物 相容性材料將充當用於新組織生長之支架,且在生物可吸 收之情況下將在治療期間或治療之後由病人的軀體所吸 收。 減壓治療系統100進一步包括與組織位點1 02連通以量測 組織位點102處之組織位點壓力的第一感應裝置132。第二 感應裝置136與減壓源104連通以量測減壓源104處之源壓 力。第一感應裝置132及第二感應裝置136可為壓力感應器 或能狗判定流體(亦即,液體或氣體)之壓力的任何其他類 型之感應器。第一感應裝置132及第二感應裝置136可包括 處理單元(未說明)以輔助收集、解譯、調節或傳輸資料。 感應裝置132、136與減壓治療系統1〇〇之流體組件之間的 實體連接可視所使用之感應裝置132、136的類型而變化。 類似地,每一感應裝置132、136連接至減壓治療系統1〇〇 之流體組件之實體位置可變化,只要可判定所要壓力或其 近似值即可。圖1中將第一感應裝置132說明為在接近歧管 配接器120處實體連接至管道116。但此為一可能組態,在 另一實施例中,第一感應裝置132為壓力感應器且經由管 道Π6之量測内腔而流體連接至覆蓋物128之下的空間。藉 由在管道116中提供多個内腔(至少一者用於傳遞減壓且至 少一者用於量測組織位點壓力),可距組織位點1 〇2遙遠地 定位第一感應裝置132。可將第一感應裝置132置放於多個 位置’只要由第一感應裝置132判定之組織位點壓力大體 上近似於組織位點102所暴露於之壓力即可。 124287.doc -10- 200821001 關於第二感應裝置136,第二感應裝置136可連接至管道 1〇8(說明於圖〗中)或連接至罐112以判定對應於減壓源 所輸出之減壓的源壓力。或者,可將第二感應裝置136置 放為最接近於減壓源104之輸出埠以直接量測由減壓源1〇4 產生之真空壓力之量。 仍參看圖1但亦參看圖2,減壓源1〇4及罐112可含於減壓 醫療單元140内或安裝於其上。醫療單元14〇亦可含有第一 感應裝置132及第二感應裝置136以及執行軟體214之處理 單元210。處理單元210可組態為具有相同或不同類型之一 或多個處理器。舉例而言,處理單元21〇可包括一或多個 處理器、邏輯、類比組件或使得包括諸如組織位點處之流 體壓力的資訊之信號能夠被接收到之任何其他電子設備。 處理單元210可進一步與以下組件連通:(i)用於儲存資 料及軟體碼之記憶體218,(ii)用於以無線方式、經由導線 或經由記憶體輸入裝置(未圖示)而與諸如閥或感應裝置的 其他裝置及系統連通之輸入/輸出(I/O)單元222,(iii)可儲 存諸如具有一或多個檔案之資料庫的一或多個資料儲存庫 228a-228n(統稱228)之儲存單元226,(iv)可能為或可能不 為觸碰敏感式之電子顯示器232及(v)能夠藉由使用音訊、 視覺或其他信號來以信號通知減壓醫療單元140之使用者 的警報器236。軟體214可組態為與其他裝置中之每一者 (例如’電子顯示器232)介接以允許對減壓治療之管理及觀 測。 處理單元210與第一感應裝置132及第二感應裝置136連 124287.doc 11 200821001 通以控制由減壓源104對減壓的施加。在操作中,指定目 標壓力(較佳由醫生或其他經批准之醫療人員)以供傳遞至 、、且織位點1 〇2。目標壓力為組織應暴露於之”理想"減壓。 目標壓力將自組織位點至組織位點而變化,但一般將基於 組成組織位點之組織的類型、損傷或創傷(若存在)之類 型、病人之醫學病況及主治醫師之優先選擇來選擇目標壓 力。在選擇目標壓力之後,操作減壓源1〇4以在創傷處達 成目標壓力。在多數情況下,歸因於減壓源1〇4與組織位 點102之間的壓力損失,將需要在比目標壓力之減壓高的 減壓(亦即,較低絕對壓力)下操作減壓源1〇4。此外,管道 内之參出物及其他流體之排出壓力(head pressure)可導致 組織位點102處之真空壓力的減小。在圖!中,減壓源1〇4 在組織位點102以上之高度η將判定由管道108、116中之流 體外加於組織位點1〇2上的排出壓力(head pressure)之量。 對於具有類似於水之密度之滲出物及流體,由一英呎流體 外加之排出壓力(head pressure)幾乎為25 mm Hg。自組織 點抽取之些k體可能比水重,且因此對組織位點1 Q2 處之壓力損失具有較顳著之影響。 作為由管道中之流體之重量所引起的潛在損失之實例, 對於特定組織位點之指定目標壓力可為_125 Hg。若將 減壓源104定位於組織位點以上四英呎處,且若減壓源ι〇4 與組織位點102之間的管道完全充滿流體,則由該流體外 加之排出壓力(head pressure)可幾乎為1〇〇 mm Hg。若將組 織位點定位於病人之諸如腳的下肢上,且將減壓源1〇4安 124287.doc -12- 200821001 裝於病人頭部附近或以上(例如,當病人處於輪椅中時將 其安裝於靜脈輸液架(IV pole)上),則此特定實例可非常普 遍。若管道中之流體之排出壓力(head pressure)為約1〇〇 mm Hg,則將需要施加約-225 mm Hg的源壓力以導致·j25 mm Hg之組織位點壓力。 可減小組織位點壓力(相對於源壓力)之另一因素為組織 位點102與減壓源104之間的管道阻塞。減壓源ι〇4與組織 位點102之間的壓差由於壓差至少部分由阻塞引起之可能 性而對於監視而言為重要的。若阻塞存在,則盡可能快地 清理阻基顯然非常重要。阻塞阻止指定目標壓力之施加, 此導致治療延時及較緩慢之復原。另一方面,藉由向管道 施加額外壓力來試圖清理阻塞在跨越阻塞之壓差變得過大 之情況下可為危險的。當在存在高減壓(相對於組織位點) 之情況下清理阻塞時,此高減壓幾乎立即傳達至組織位 點。額外減壓於組織位點處之快速衝擊可能引起對組織之 才貝害且起始大出血。 本文描述之減壓治療系統1〇〇提供保護以免由高壓差引 起對組織位點102之傷害。系統1〇〇使用”雙區域,,方法,其 中監視壓差且接著視阻塞是否存在而將其與兩個最大壓差 中之者進行比較。更特定言之,若尚未滿足組織位點 102之目標壓力,則減壓源1〇4處之源壓力將增大且由第二 感應裝置136監視。隨著源壓力繼續增大,由第一感應裝 置132監視組織位點壓力,且將判定組織位點與減壓源之 間的壓差。可由處理單元21〇在自第一感應裝置132及第二 124287.doc -13 - 200821001 感應裝置136接收資料之後計算壓差,或者可由與處理單 元210連通之單獨的感應裝置來量測壓差。 不允許減壓源繼續無限地增大源壓力。實情為,基於組 織位點102與減壓源104之間的壓差而限制源壓力。在最初 ”安全"或"綠色"區域操作中,將不允許壓差超過第一最大 壓差。臨床實踐已顯示約50 mm Hg為安全壓差量,且在一 實施例中,將第一最大壓差設定為約50 mm Hg。更特定言 之’已發現對於多數組織位點,突然清理阻塞(跨越其已 形成50 mm Hg之壓差)將不會引起對組織位點之傷害。在 許多”阻塞f’情況下,50 mm Hg或較小之壓差足以清理阻 基。然而’在阻塞未由此壓差量而清理之情況下,減壓治 療系統100將不允許僅進一步增大減壓來清理阻塞。實情 為,處理單元210向警報器236傳達指示阻塞之警報狀態, 且繼續在綠色區域參數内施加減壓(亦即,壓差不超過約 5 0 mm Hg)。 若壓差達到第一最大壓差(亦即,約5〇 mm Hg)且目標壓 力仍超過組織位點壓力,則執行阻塞測試。當減壓源1〇4 處之源壓力的改變未導致組織位點壓力之後續改變時,阻 塞存在於組織位點1〇2與減壓源1〇4之間。若改變以預定量 發生,則不存在阻塞。 若阻i測δ式判定不存在阻塞,且組織位點壓力仍不等於 目標壓力,則可增大源壓力。在此"紅色區域”操作中,將 二允許壓差超過第二最大壓差。纟—實施例巾,第二最大 壓差為約100 mm Hg。對於減壓治療系統1〇〇已證實阻塞不 124287.doc -14- 200821001 存在於減壓源104與組織位點102之間之情況提供紅色區域 操作參數。此操作模式在儘管反覆增大源壓力,但組織位 點處之過量流體排出壓力(head pressure)使得組織位點壓 力遠低於目標壓力之情況中尤為有用。 雖然較佳第一最大壓差為50 mm Hg且第二最大壓差為 100 mm Hg,但此等壓力值可視正接受治療之特定組織位 點及個別醫學考慮而變化。雖然上文所述之壓力保護系統 為’’雙區域”系統,但應明白,可使用具有兩個以上壓力參 數之多區域系統來提供額外保護。 參看圖3 ’根據本發明之一實施例之治療組織位點之方 法300包括:監視減壓源處之源壓力3〇4、監視組織位點處 之組織位點壓力308及判定組織位點與減壓源之間的壓差 312。若阻塞存在於減壓源與組織位點之間,則於316將壓 差限於第一最大壓差。若無阻塞存在於減壓源與組織位點 之間’則於320將壓差限於第二最大壓差。 應明白’自前述内容已提供具有顯著優勢之發明。雖然 本發明僅以其形式中之少數幾者而展示,但其不受限制, 而是容許在不脫離其精神的情況下進行各種改變及修改。 【圖式簡單說明】 圖1說明根據本發明之一實施例的具有減壓醫療單元之 減壓治療系統之示意圖; 圖2描緣圖1之減壓醫療單元之方塊圖;且 圖3說明根據本發明之一實施例的治療組織位點之例示 性方法之流程圖。 124287.doc •15· 200821001
【主要元件符號說明】 100 減壓治療系統 102 組織位點/組織 104 減壓源 108 管道 112 罐 116 管道 120 歧管配接器 124 分配歧管 128 覆蓋物 132 第一感應裝置 136 第二感應裝置 140 減壓醫療單元 210 處理單元 214 軟體 218 記憶體 222 輸入/輸出(I/O)單元 226 儲存早70 228a-228n 資料儲存庫 232 電子顯示器 236 警報器 Η 高度 124287.doc -16-
Claims (1)
- 200821001 十、申請專利範圍: 1 · 一種減壓治療系統,其包含: 一減壓源,其流體連接至一組織位點; 一第一感應裝置,其與該組織位點連通以量測該組織 位點處之一第一壓力; 一第二感應裝置,其與該減壓源連通以量測該減壓源 處之一第二壓力;及 一處理單元,其與該第一感應裝置及該第二感應裝置 連通’且經組態以接收該第一壓力及該第二壓力且判定 該減壓源與該組織位點之間的一壓差,該處理單元進一 步與該減壓源連通以調節由該減壓源施加之壓力,以使 得該壓差(a)在一阻塞存在於該減壓源與該組織位點之間 之情況下不超過一第一最大壓差,且(1))在無阻塞存在於 該減壓源與該組織位點之間的情況下不超過一第二最大 壓差。 2·如請求項!之系統,其進一步包含: 一罐’其流體連接於該組織位點與該減壓源之間;且 其中該第二感應裝置在該罐處量測該第二壓力來近似 於該減壓源之一壓力輸出。 3. 如睛求項1之系統,其中該第二最大壓差大於該第一最 大麼差。 4. 如請求項1之系統,其中該第一最大壓差為約5〇mmHg。 5·如請求項】之系統,其中該第二最大壓差為約1〇()ιηηΐΗ§。 6·如請求項1之系統,其中: 124287.doc 200821001 當存在一阻塞時,該處理單元進一步經組態以在該第 一最大壓差之限制内增大該第二壓力以清理該阻塞。 7·如請求項6之系統,其進一步包含: ^報裝置,其與該處理單元連通以在一阻塞於達到 該第一最大壓差之後無法清理時向一使用者告警。 8·如請求項1之系統,其進一步包含: •其中該處理單元進一步經組態以在該第一最大壓差與 該第二最大壓差中之一者的該等限制内改變該第二壓力 以使得該第一壓力達到一目標壓力。 9·如請求項1之系統,其進一步包含: 其中該處理單元進一步經組態以藉由改變該第二壓力 及監視該第一壓力之一改變檢查一阻塞之存在;且 〃中β處理單元經組態以在該第,壓力未發生改變時 指示一存在一阻塞之警報狀態。 10· —種治療一組織位點之方法,其包含: 由一減壓源將一減壓施加至一組織位點; 監視該減壓源處之一源壓力; 皿視u亥組織位點處之一組織位點壓力; 判疋該、、且織位點與該減壓源之間的一壓差; 右阻基存在於該減壓源與該組織位點之間,則將該 壓差限於一第一最大壓差;且 右…、阻基存在於該減壓源與該組織位點之間,則將該 壓差限於一第二最大壓差。 μ 11 ·如請求項10之方法,甘 ,、中該第二最大壓差大於該第一最 124287.doc -2- 200821001 大壓差。 12.如睛求項1〇之方法,其中該第一最大壓差為約5〇mmHg。 13·如睛求項1〇之方法,其中該第二最大壓差為約 mm Hg。 14·如明求項1 〇之方法,其中該判定該壓差之步驟進一步包 含監視該壓差。 15.如請求項1〇之方法,其進一步包含: 田存在一阻I時,在該第一最大壓差之限制内增大該 源壓力以清理該阻塞。 _ 16.如請求項10之方法,其進一步包含: 當存在一阻塞時,在該第一最大壓差之該等限制内增 大該源壓力以試圖清理該阻塞;及 若未清理該阻塞,則產生一警報以指示存在一阻塞。 17 ·如凊求項1 〇之方法,其進一步包含: 在該第一最大壓差與該第二最大壓差中之一者的該等 限制内改變該源壓力以使得該組織位點壓力達到一目標 壓力。 π 18·如請求項1〇之方法,其進一步包含: 藉由改變該源壓力及監視該組織位點壓力之一改變而 、判定是否存在一阻塞;及 在該組織位點壓力未發生改變時判定存在一阻爽。 19.如請求項18之方法,其中改變該源壓力進一步包含增大 該源壓力。 2〇· —種減壓治療系統,其包含: 一用於向一組織位點施加減壓之構件; 124287.doc 200821001 一用於監視該用於施加減壓之構件處之一源壓力的構 件; 一用於監視該組織位點處之一組織位點壓力之構件; 一用於判定該組織位點與該用於施加減壓之構件之間 的一壓差之構件; 一用於在一阻塞存在於該組織位點與該用於施加減壓 之構件之間的情況下將該壓差限於一第一最大壓差之構 件;及 用於在無阻塞存在於該組織位點與該用於施加減壓 之構件之間的情況下將該壓差限於一高於該第一最大壓 差之第二最大壓差之構件。 參 124287.doc
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TWI484945B (zh) * | 2010-06-22 | 2015-05-21 |
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