201141436 六、發明說明： 【發明所屬之技術領域】 本發明大體上係關於醫療系統，且更特定言之，係關於 組織清創系統及相關應用方法。 本發明根據35 USC § 119(e)主張2010年3月11日申請之 題為「Tissue Debridement Systems and Methods」之美國 臨時專利申請案第61/312,940號文構之權利，該文檔出於 所有目的以引用的方式併入本文中。 【先前技術】 壞死組織可延緩傷口癒合。因此，有時可能需要移除壞 死組織。用於傷口中壞死組織之治療性介入為清創術。現 有許多用於清創術之一般方法，例如機械方式 '酶方式或 化學方式、銳器方式（sharp)、生物手術及自解方式。清創 術之機械方法可能引起疼痛且需要高技術位準以防止損害 健康組織。此外，一些機械系統產生沿許多方向推進之大 規模殘碎組織。 【發明内容】 根據-說明性非限制性實施例，用於自患者組織位點移 除不良組織之线包括用於供應卫作氣體“作氣體供應 源及用於供應固態C〇2粒子之c〇2源。系統可進一步包括 用於供應減壓之減麼诉。金& + a 战/整源。系、统#包括流體,_接至 體供應源及C〇2源以用於桩 用於接收工作氣體及固態co2粒子之 供應管道。系統進—步台鉍，Λ /σ療頭，其流體性輕接 管道以用於接收工作氣體刀田能… Μ 下軋體及固態co2粒子且向所需位置處 154697.doc 201141436 的組織位點傳遞工作氣體及固態c〇2粒子》抽取管道流體 性耦接至治療頭且在減壓源存在情況下流體性耦接至減壓 源。系統經組態使得固態eh粒子撞擊至少一部分不良組 織以移除不良組織且抽取管道在減壓下將不良組織運走。 根據另一說明性非限制性實施例，自組織位點清除不良 組織之方法包括向不良組織傳遞固態eh粒子以切割不良 組織。使c〇2粒子經歷昇華以產生c〇2氣體。該方法進一 步包括移除c〇2氣體及已藉由固態c〇2粒子切割之不良組 織。 根據另一說明性非限制性實施例，製造用於自患者組織 位點移除不良組織之系統的方法包括以下步驟：提供用於 供應工作氣體之工作氣體供應源；提供用於供應固態C02 粒子之c〇2源；及提供用於供應減壓之減壓源。該方法進 一步包括形成治療頭及使工作氣體供應源及c〇2源流體性 耦接至治療頭。工作氣體及固態c〇2粒子傳遞至治療頭。 治療頭經組態以向所需位置處的組織位點傳遞工作氣體及 固態C〇2粒子。該方法進一步包括藉由抽取管道使治療頭 流體性耦接至減壓源。系統經組態以向不良組織傳遞固態 C〇2粒子以移除不良組織且在減壓下將不良組織自組織位 點運走。 根據另-說明性非限制性實施例，用於自患者組織位點 移除不良組織之系統包括用於供應卫作氣體之卫作氣體供 應源、用於供應固態CO2粒子之CO2源及流體性耦接至工 作軋體供應源及c〇2源以用於接收工作氣體及固態c〇2粒 154697.doc 201141436 子之供應管道。系統進一步包括治療頭，其耦接至供應管 道以用於接收工作氣體及固態c〇2粒子且向所需位置處的 組織位點傳遞工作氣體及固態c〇2粒子。系統經組態使得 固態c〇2粒子撞擊至少一部分不良組織以移除不 良組織。 參考以下圖式及詳細描述，說明性實施例之其他特徵及 優點將變得顯而易見。 【實施方式】 以下非限制性說明性實施例之詳細描述參考形成本發明 之一部分的伴隨圖式。足夠詳細地描述該等實施例使得熟 習此項技術者能夠實踐本發明，且應理解，可利用其他實 施例且可在不偏離本發明之精神或範疇的情況下產生邏輯 結構、機械、電及化學變化。為避免對使熟習此項技術者 能夠實踐本文中所描述之實施例不必要的細節，描述可能 省略熟習此項技術者已知的某些資訊。因此，以下詳細描 述不應視為限制含義且說明性實施例之範疇僅由隨附申請 專利範圍界定。 現參看圖1 -4，呈現用於自患者之組織位點丨〇4移除或清 除不良組織1〇2(例如壞死組織）之系統1〇〇之說明性實施 例。組織位點104展示為貫穿表皮1〇5之傷口 1〇3及一部分 皮下組織107，但組織位點1〇4可為包括健康照護提供者 112意欲移除之不良部分的任何組織位點。系統1〇〇使用固 態C〇2粒子（乾冰}111及工作氣體以定位及切割不良組織 102。系統1〇〇運送所切割之不良組織1〇2或其部分其可 稱為殘碎組織109。系統100在組織位點1〇4處幾乎不具有 154697.doc 201141436 殘碎組織1〇9之分佈β固態eh粒子lu可冷卻組織位點 1〇4(產生鎮痛作用）以使患者經歷之㈣減至最低。 系統100包括治療構件106，其包括治療頭1〇8且可包括 手柄110。治療構件106允許健康照護提供者112定位治療 頭108使其接近待移除之不良組織1〇2或其部分。治療頭 108具有由傳遞管道116、治療腔118及移除孔及管道12〇形 成之治療頭主體114。形成於治療頭主體114中之治療腔 118經定尺寸且經組態以在操作期間當治療頭1〇8置放於接 近不良組織102時接收不良組織i〇2或其部分。 傳遞管道116經傳遞孔119傳遞工作氣體至治療腔ιΐ8或 傳遞工作氣體及固態C〇2粒子11 i至治療腔〗丨8。移除管道 120經移除孔口 140(或孔）接收工作氣體、任何額外無 論C〇2為何種相）或殘碎組織且將内含物運走。如本文中使 用’除非另有說明，否貝IJ「或」無需相互排斥。傳遞孔 119及移除孔口 14〇可如圖υ中所示實質上經對準，或可 具有變化之未對準角度或程度（參看例如圖6)，但仍適用於 自組織位點移除殘碎組織或氣體。 當包括手柄110時，其耦接至治療頭108以形成治療構件 106。手柄110可具有流體性耦接至傳遞管道116之手柄傳 遞管道（未圖示卜手柄110亦可具有流體性耦接至移除管道 120之手柄移除管道（未圖示）。手柄傳遞管道及手柄移除管 道可分別流體性耦接至供應管道122及抽取管道124。或 者，傳遞管道116可直接流體性耦接至供應管道122且移除 管道120可直接流體性耦接至抽取管道124。在一些實施例 154697.doc 201141436 中’供應管道122及傳遞管道116可為一體式管道。供應管 道122及抽取管道124可為兩個獨立管道，其可含於外殼管 道126内。或者’供應管道ι22及抽取管道ι24可為多内腔 管道中的兩個内腔》 供應管道122流體性耦接至傳遞管道116，僅傳遞工作氣 體或傳遞工作氣體與固態C〇2粒子111(其可稱為清創混合 物）。工作氣體由工作氣體供應源丨28提供。工作氣體供應 源128通常為壓縮空氣源。然而，可使用其他氣體，諸如 二氧化碳、醫用氧或任何惰性、無危害氣體。工作氣體傳 遞至供應管道122中以用於由傳遞管道丨16最終引入治療腔 118中。工作氣體供應源128可為醫用級空氣泵或壓縮氣體 之容器《工作氣體供應源128可藉由閥或對泵之功率控制 來調節工作氣體之壓力。可藉由工作氣體控制開關130選 擇性控制閥或泵，該工作氣體控制開關13〇由第一控制鏈 路132耦接至工作氣體供應源128之閥或泵。因此，工作氣 體控制開關130可在第一位置與第二位置之間移動（遞增式 或連續式）以控制傳遞至治療腔1丨8之工作氣體之量。 可藉由C〇2源134將固態C〇2粒子111選擇性引入工作氣 體中。C〇2源134位於治療構件1〇6外部。c〇2源134可保持 粒子處於固相（通常約_8〇〇c )且控制傳遞至供應管道122中 之工作氣體中之固態C〇2粒子】u的速率。固態c〇2粒子i i ι 可為適用於移除不良組織丨〇2之任何大小。作為非限制性 實例，固態c〇2粒子U1可在10至1000微米（μΜ)範圍内或在 1〇至100微米（μΜ)範圍内。C〇2源134可包括一或多個閥或 I54697.doc 201141436 磨力源以用於將固態c〇2粒子lu以所選速率傳遞至供應管 道122中之工作氣體中。間或塵力源可由c〇2開關⑸控 制。c〇2開關m可由第二鏈路i勒接至c〇2源134處之間 或壓力源。在另一實施例中’可向供應管道122添加除固 . _以外的物質，例如結晶麻醉劑。如本文中使用，術 . 肖「耦接」包括經由獨立物件耦接且包括直接耦接。術語 「耦接」亦涵蓋兩個或兩個以上組件借助於由同一塊材料 形成之組件t之每一者彼此連接。又，術語「麵接」可包 括化學（諸如經化學鍵）、機械、熱或電㈣。流體麵接意 明流體可在指定部分或位置之間連通。 在工作氣體或清創混合物進入治療腔118後，物質可直 接穿過治療腔118或可撞擊治療腔118内的不良組織ι〇2且 藉此產生殘碎組織109。當固態c〇2粒子1U撞擊不良組織 1〇2時’固態C〇2粒子丨丨丨通常昇華（由固相昇華為氣相）。 存在於治療腔118中的工作氣體、固態c〇2粒子m、c〇2 氣體或殘碎組織109(「腔物質」）之任何組合均可經移除管 道120移除且最初可由移除孔口 14〇接收。移除孔口 14〇可 為移除管道120之末端處的放大部分以幫助將流體引導至 -移除管道120中。腔物質傳遞至抽取管道124中。 與治療腔118相比，抽取管道124可具有減壓。減壓可由 抽取管道124傳遞至移除管道12〇。減壓可由減壓源142傳 遞至抽取管道124。減壓源142可為任何用於供應減壓之器 件，諸如真空栗、壁面抽吸裝置（wall sucti〇n)或其他來 源。由減壓源14 2供應之減壓的量可由閥或提供至真空泵 154697.doc 201141436 之電源或其類似物調節且可由減壓開關144控制。減壓開 關144可藉由第二鏈路146或耦接作用與閥或減壓源142之 電源搞接。 收集構件148可流體性耦接至抽取管道丨24之一部分以收 集殘碎組織109及腔物質中的任何其他固體或液體。收集 構件148可尤其保留殘碎組織1〇9以進行測試或處置。 可提供包括工作氣體控制開關13〇、c〇2開關136及減壓 開關144或該等開關13〇、136、⑷之任何組合的主控制器 150。主控制器15〇可為使健康照護提供者“a便於接近開 關130、136及144的腳踏開關控制台。主控制器15〇亦可為 允許使用者輸入及幫助調節三個開關130、136及144以獲 得所需結果之電子控制器。因此，舉例而言，使用者可輸 入需要軟性㈣（諸如用於腐岐織）且可傳遞較低壓力之 工作氣體及較小固態C〇2粒子。作為另一實例使用者可 輸入需要硬性清創（諸如用於硬結病）且可傳遞較高壓力及 較大固態C02粒子。 在一說明性實施例中，徤康照護提供者1】2使用治療構 件1〇6定位治療頭108使其接近組織位點1〇4，且詳言之， 定位治療腔m使其接近不良組織1〇2。此日夺或在此之前， 健康照護提供者112起始自卫作氣體供應源128傳遞工作氣 體至~療腔118。隨著工作氣體（及其他物質）自傳遞管道 116經治療腔118傳遞至移除管道12〇，工作氣體與不良組 織102處或$良組織102中的流體相比之相對速度引起不良 組織102或其部分進人治療腔118中。儘管不受操作理論限 154697.doc 201141436 制’不良組織102由於文土里效應（venturi effect)或憑藉伯 努利原理（Bernoulli’s principle)進入治療腔118中。較快移 動之流體在治療腔11 8中產生低壓，其拉動或迫使不良組 織102進入治療腔118中。工作氣體之速度愈大，則迫使不 良組織102進入治療腔118中之力愈大。因此，可直接控制 移除之組織的量。 一旦如圖3所示不良組織1〇2處於治療腔118内，則健康 照s蔓k供者112啟動C〇2源134且引起固態c〇2粒子111進入 工作氣體中並形成如圖4所示撞擊不良組織1 〇2的清創混合 物。固態C〇2粒子111撞擊不良組織j 〇2且切割各部分以自 由產生所移除之殘碎組織109。與不良組織102撞擊時或撞 擊後不久，固態C〇2粒子ill昇華以產生c〇2氣體。殘碎組 織109、工作氣體及C〇2氣體以及任何固態c〇2粒子進入移 除孔口 140及移除管道12〇。殘碎組織109經抽取管道124傳 遞至收集構件148。殘碎組織109及其他流體可由來自減壓 源142之減壓拉入移除孔口 140中。 可使用多種變數控制所移除之不良組織1〇2之量：固態 C〇2粒子111之大小、固態C〇2粒子U1之數目或來自工作氣 體供應源128之工作氣體之壓力（及流動速率）。另一變數可 陳述為跨越治療腔118之壓力差，例如由工作氣體供應源 128供應之工作氣體之壓力與減壓源142之壓力之間的壓 差《較低壓差、較小粒子大小及較少粒子可用於輕度清 創，諸如用於軟性腐肉組織。較高壓差、較大粒子大小及 較多粒子可用於硬性結痂組織。可使用該等變數之任何組 154697.doc 201141436 合以幫助解決不同狀況。可控制工作氣體之流動速率、固 態C〇2粒子111之大小及粒子進料速率以提供組織位點丨〇4 之冷卻，咸信其提供鎮痛作用。可保持流動速率低到足以 避免冷灼傷或對組織位點104之滲透冷卻效應。治療頭1〇8 與表皮105之間的界面處可併入溫度探針（諸如熱敏電阻）且 可經軟體控制使用來自溫度探針之資訊以調節固態c〇2粒 子111之大小及工作氣體之流量。在一說明性、非限制性 實施例中，可在1-5巴之壓力下提供流動速率，其中固態 c〇2粒子ill在砂粒至大的針頭範圍内且在丨_2 m3/min下具 有500 g/min之流動速率。 圖1呈現使用複數個開關130、136以分別控制工作氣體 流動速率及固態C〇2粒子111流動速率之治療構件丨〇6。現 主要參看圖5，呈現治療構件206之另一說明性、非限制性 實施例’其可與系統（例如圖1之系統丨〇〇) 一起使用以用於 自患者之組織位點移除或清除不良組織（例如壞死組織）。 治療構件206在大部分態樣上與圖丨之治療構件1〇6類似。 治療構件206具有治療頭208及手柄210。治療頭2〇8具有形 成有治療腔218之治療頭主體214。 在該說明性實施例中，工作氣體控制開關23〇位於手柄 210上》傳遞至治療腔218之工作氣體之流動速率（壓力）由 工作氣體控制開關230控制，該工作氣體控制開關23〇可在 第一位置與第二位置之間移動，如箭頭26〇表示。工作氣 體控制開關230之移動可提供介於無流量條件與最大流量 條件之間的可變流量且可藉由連續控制或遞增控制實現。 154697.doc •12· 201141436 固態c〇2粒子之流動速率由c〇2開關236控制，該c〇2開關 236可為偏壓觸發器。當健康照護提供者準備切割拉入治 療腔218中之組織時，健康照護提供者拉動c〇2開關236以 傳遞固態C〇2粒子從而切割不良組織。 現主要參看圖6，呈現治療構件3〇6之另一說明性實施 例。治療構件3 06可用作系統（例如圖！之系統丨〇〇)之一部分 以自患者之組織位點3〇4移除或清除不良組織3〇2(例如壞 死組織）。治療構件306在許多方面與圖！之治療構件1〇6類 似。治療構件306具有治療頭308及手柄31〇。治療頭3〇8具 有由傳遞管道316、治療腔318及移除管道32〇形成之治療 頭主體314。然而，在該實施例中，傳遞管道316自移除管 道320移位且未與移除管道32〇實質上對準，而是處於不同 角度-在該實例中為幾乎18〇。不同。因此，經傳遞管道316 引入之清創混合物撞擊組織位點3〇4之不良組織3〇2且接著 由減壓吸入移除管道32〇中以運走以供收集或處置。傳遞 管道3ί6與移除管道32〇之間的角度可為實質上〇(參見圖^ 4)或180(參見圖6)，或其間任何角度，例如1〇。、2〇。、 30、40、50。、60。等。在另一實施例中，不良組織3〇2上 之撞擊角度可由健康照護提供者控制。對於大於45。之角 度，可能需要減壓系統以提供用於移除腔物質之抽吸力。 本文中之系統及方法可能存在許多替代例。再次參看圖 1-4，在替代性實施例中，可自程序開始時共同傳遞工作 氣體及©態叫粒+⑴⑽創混合物）。#創混合物迫使不 良組織10 2進入治療腔u 8中且㈣（包括移出）不良組織】〇 2 154697.doc -13- 201141436 以形成殘碎組織1 09。 在另替代性實施例中，替代工作氣體供應源128及減 壓源142均有助於跨越治療腔118之壓差，壓差可僅由工作 氣體供應源128傳遞之正壓引起或僅由減壓源142引起。在 壓差僅由減壓源142引起之實施例中，可添加密封部分或 也封材料以在治療頭丨〇8與組織位點丨〇4之間提供液封。 在另一替代性實施例中，c〇2源134亦可允許控制傳遞至 /〇療腔118之固態c〇2粒子ill之大小。此外，c〇2開關136 可允。午即時選擇粒子大小或可提供額外開關以用於此目 的。 在另一替代性實施例中，單一開關可提供對工作氣體及 固態c〇2粒子之控制。此外，調節開關可設定工作氣體與 固態c〇2粒子之比率，但傳遞速率可由單一開關控制，諸 如圖5中之開關230。 根據另一說明性實施例，自組織位點清除不良組織之方 法包括向不良組織傳遞固態C〇2粒子以切割不良組織。使 C〇2粒子經歷昇華以產生c〇2氣體β該方法進一步包括移 除C〇2氣體及已藉由固態c〇2粒子切割之不良組織。 根據另一說明性實施例，如系統1〇〇之一態樣產生固c〇2 粒子111。在該說明性非限制性實施例中，系統丨〇〇中包括 含有液態二氧化碳之加壓圓柱及經氣體或液體轉換產生 C〇2粒子之機制。在該實施例中’無需儲存或提供乾冰。 儘管已於某些說明性非限制性實施例之上下文中揭示本 發明及其優點，但應理解，可在不偏離由隨附申請專利範 154697.doc -14- 201141436 圍界定之本發明範疇的情況下作出各種改變、取代、置換 及變化。應瞭解，關於任一實施例描述之任何特徵亦可適 用於任何其他實施例。 應理解’上述效益及優點可關於一個實施例或可關於若 干實施例。應進一步理解，對『一』項目之參考係指該等 項目中之一或多者。 本文中所描述之方法之步驟可以任何適當次序執行或在 適當情況下同時執行。 在適當情況下’上述任何實例之態樣均可與所描述之任 何其他實例之態樣組合以形成具有可比較或不同性質及解 決相同或不同問題之其他實例。 應理解，以上較佳實施例之描述僅作為實例提供且熟習 此項技術者可作出各種修改。以上說明、實例及資料提供 本發明之例示性實施例之結構及用途之完整描述。儘管上 文已在$-細緻程度下或參考一或多紹固別實施例描述本 發明之各種實施例’但熟習此項技術者可在不偏離申請專 利範圍之範疇的情ί兄下對所揭示實施例作出冑多變化。 【圖式簡單說明】 圖1為用於自患者組織位點移除不良组織之說明性系統 之示意圖，其中-部分以橫截面形式展示且一部分以透視 圖形式展示； 圖2為圖i之說明性系統之一部分之示意性透視圖，其展 示一部分治療頭； 圖3為圖1及圖2中展示之說明性系統之治療頭之一 154697.doc -15· 201141436 的示意性橫截面； 圖4為圖3之治療頭之示意性橫截面，其展示切割不良组 織； ' 冶療構件之示意性側 圖5為用於移除不良組織之說明性 視圖；且 圖6為用於自組織位點移除不良 性治療頭之示意性橫截面。 ’、統之另一說明 【主要元件符號說明】 100 系統 102 不良組織 103 傷口 104 組織位點 105 表皮 106 治療構件 107 皮下組織 108 治療頭 109 殘碎組織 110 手柄 111 固態co2粒子 112 健康照護提供者 114 治療頭主體 116 傳遞管道 118 治療腔 119 傳遞孔 154697.doc • 16 - 201141436 120 移除管道 122 供應管道 124 抽取管道 126 外殼管道 128 工作氣體供應源 130 工作氣體控制開關 132 第一控制鏈路 134 C〇2源 136 C Ο 2開關 138 第二鏈路 140 移除孔口 142 減壓源 144 減壓開關 146 第三鏈路 148 收集構件 150 主控制器 206 治療構件 208 治療頭 210 手柄 214 治療頭主體 218 治療腔 230 工作氣體控制開關 236 <:〇2開關 260 箭頭 154697.doc •17- 201141436 302 不良組織 304 組織位點 306 治療構件 308 治療頭 310 手柄 314 治療頭主體 316 傳遞管道 318 治療腔 320 移除管道 154697.doc -18201141436 VI. Description of the Invention: TECHNICAL FIELD OF THE INVENTION The present invention relates generally to medical systems and, more particularly, to tissue debridement systems and related application methods. The present invention claims the benefit of U.S. Provisional Patent Application Serial No. 61/312,940, entitled "Tissue Debridement Systems and Methods", filed on March 11, 2010, which is hereby incorporated by reference. This is incorporated herein by reference. [Prior Art] Necrotic tissue can delay wound healing. Therefore, sometimes it may be necessary to remove bad tissue. The therapeutic intervention for necrotic tissue in the wound is debridement. There are many general methods for debridement, such as mechanical methods 'enzymatic or chemical, sharp, biological, and self-solving. The mechanical methods of debridement can cause pain and require high levels of technology to prevent damage to healthy tissue. In addition, some mechanical systems produce large-scale shredded tissue that advances in many directions. SUMMARY OF THE INVENTION According to an illustrative, non-limiting embodiment, a line for removing undesirable tissue from a patient tissue site includes a supply gas source for supplying gas as a source of gas and for supplying solid C〇2 particles. 〇2 source. The system may further include a reduction for the supply of decompression. Gold & + a war / whole source. Department, system # includes fluid, _ connected to the body supply source and C 〇 2 source for the pile It is used to receive the supply pipeline of working gas and solid co2 particles. The system is step-in step, Λ / σ treatment head, its fluid light pipe is used to receive the working gas knife field... Μ Lower rolling body and solid co2 particles And delivering the working gas and solid c〇2 particles to the tissue site of the desired location at 154697.doc 201141436. The extraction tubing is fluidly coupled to the treatment head and fluidly coupled to the reduced pressure source in the presence of a reduced pressure source. The system is configured such that solid eh particles impinge at least a portion of the undesirable tissue to remove undesirable tissue and the extraction conduit removes the undesirable tissue under reduced pressure. According to another illustrative, non-limiting embodiment, the self-organizing site removes undesirable tissue Method includes poor The tissue transfers solid eh particles to sever bad tissue. The c〇2 particles are subjected to sublimation to produce c〇2 gas. The method further includes removing the c〇2 gas and the bad tissue that has been cut by the solid c〇2 particles. In an illustrative, non-limiting embodiment, a method of making a system for removing undesirable tissue from a patient tissue site includes the steps of: providing a working gas supply source for supplying a working gas; providing a supply of solid CO 2 particles 〇2 source; and providing a reduced pressure source for supplying reduced pressure. The method further includes forming a treatment head and fluidly coupling the working gas supply source and the c〇2 source to the treatment head. Working gas and solid c〇2 particles Delivery to the treatment head. The treatment head is configured to deliver working gas and solid C〇2 particles to a tissue site at a desired location. The method further includes fluidly coupling the treatment head to the reduced pressure source by a withdrawal conduit. The system is configured to deliver solid C〇2 particles to the undesirable tissue to remove undesirable tissue and to transport the undesirable tissue from the tissue site under reduced pressure. According to another illustrative and non-limiting embodiment Systems for removing undesirable tissue from a patient tissue site include a source gas supply for supplying a gas, a CO2 source for supplying solid CO2 particles, and a fluid coupling to a working body supply and c〇 2 source for receiving a working gas and solid supply c〇2 154697.doc 201141436 sub-supply pipe. The system further includes a treatment head coupled to the supply conduit for receiving the working gas and the solid c〇2 particles and The tissue site at the desired location delivers working gas and solid c〇2 particles. The system is configured such that solid c〇2 particles impinge at least a portion of the bad tissue to remove undesirable tissue. Illustrative embodiments with reference to the following figures and detailed description Other features and advantages will become apparent. The following detailed description of the non-limiting illustrative embodiments refers to the accompanying drawings that form a part of the invention. The embodiments are described in sufficient detail to enable those skilled in the art to practice the invention. It is to be understood that other embodiments may be utilized and the structure, the Chemical changes. To avoid detail that would otherwise be apparent to those skilled in the art, the description may omit certain information known to those skilled in the art. Therefore, the following detailed description is not to be considered as limiting, and the scope of the illustrative embodiments is defined only by the scope of the accompanying claims. Referring now to Figures 1-4, an illustrative embodiment of a system for removing or removing undesirable tissue 1 (e.g., necrotic tissue) from a tissue site 丨〇4 of a patient is presented. The tissue site 104 is shown as a wound 1〇3 through the epidermis 1及5 and a portion of the subcutaneous tissue 107, but the tissue site 1〇4 can be any tissue site that includes the undesirable portion of the health care provider 112 that is intended to be removed. The system 1 uses solid C〇2 particles (dry ice} 111 and working gas to position and cut the poor tissue 102. The system 1 transports the cut bad tissue 1〇2 or a portion thereof which may be referred to as the broken tissue 109. The system 100 has almost no 154697 at the tissue site 1〇4.doc 201141436 Disperse tissue 1〇9 distribution β solid eh particles lu can cool the tissue site 1〇4 (generating analgesic effect) to make the patient experience the (four) reduction The system 100 includes a treatment member 106 that includes a treatment head 1 8 and can include a handle 110. The treatment member 106 allows the health care provider 112 to position the treatment head 108 adjacent to the undesirable tissue 1 2 to be removed or The treatment head 108 has a treatment head body 114 formed by a delivery conduit 116, a treatment lumen 118, and a removal aperture and conduit 12. The treatment lumen 118 formed in the treatment head body 114 is sized and configured for operation The defective tissue i〇2 or a portion thereof is received while the treatment head 1〇8 is placed close to the bad tissue 102. The delivery conduit 116 delivers working gas to the treatment chamber ι8 via the delivery orifice 119 or delivers working gas and solid C〇2 particles 11 Izhizhi Treatment Chamber 丨 8. Removal of the tubing 120 is performed by removing the orifice 140 (or the orifice to receive the working gas, any additional phase regardless of C〇2) or shredding the tissue and transporting the contents away. As used herein, unless otherwise stated, it is not necessary to mutually exclude each other. The transfer aperture 119 and the removal aperture 14 can be substantially aligned as shown in FIG. ,, or can have varying misalignment angles or degrees (see, eg, FIG. 6), but still apply to self-organizing site shifts. In addition to crushing tissue or gas. When the handle 110 is included, it is coupled to the treatment head 108 to form the treatment member 106. The handle 110 can have a handle transfer conduit fluidly coupled to the transfer conduit 116 (the handle handle 110 can also have a handle removal conduit (not shown) fluidly coupled to the removal conduit 120. The handle transfer conduit and The handle removal conduits may be fluidly coupled to the supply conduit 122 and the extraction conduit 124, respectively. Alternatively, the transfer conduit 116 may be directly fluidly coupled to the supply conduit 122 and the removal conduit 120 may be directly fluidly coupled to the extraction conduit 124. In some embodiments 154697.doc 201141436 the 'supply conduit 122 and the transfer conduit 116 may be a one-piece conduit. The supply conduit 122 and the extraction conduit 124 may be two separate conduits that may be contained within the outer casing conduit 126. or 'supply conduit The ι 22 and the extraction conduit ι 24 may be two lumens in the multi-lumen conduit. The supply conduit 122 is fluidly coupled to the delivery conduit 116, transferring only the working gas or delivering the working gas to the solid C〇2 particle 111 (which may be referred to as Debriding mixture. The working gas is supplied by a working gas supply 丨 28. The working gas supply source 128 is typically a source of compressed air. However, other gases may be used, such as two Carbon, medical oxygen, or any inert, non-hazardous gas. The working gas is delivered to the supply conduit 122 for final introduction into the treatment lumen 118 by the delivery conduit 16. The working gas supply 128 can be a medical grade air pump or The container for the compressed gas "the working gas supply source 128 can adjust the pressure of the working gas by means of a valve or power control of the pump. The valve or pump can be selectively controlled by the working gas control switch 130, the working gas control switch 13 The first control link 132 is coupled to a valve or pump of the working gas supply source 128. Thus, the working gas control switch 130 can be moved between the first position and the second position (incremental or continuous) to control delivery to the treatment The amount of working gas in chamber 1 丨 8. Solid C 〇 2 particles 111 can be selectively introduced into the working gas by C 〇 2 source 134. C 〇 2 source 134 is external to treatment member 1 〇 6. c 〇 2 source 134 The rate at which the particles are in a solid phase (typically about _8 〇〇c) and the solid C 〇 2 particles in the working gas supplied to the supply conduit 122 can be maintained. The solid c 〇 2 particles ii ι can be adapted for shifting Except bad organization丨〇2 Any size. As a non-limiting example, the solid c〇2 particle U1 may be in the range of 10 to 1000 microns (μΜ) or in the range of 1〇 to 100 microns (μΜ). The C〇2 source 134 may include one or more. Valve or I54697.doc 201141436 A source of friction for delivering solid c〇2 particles lu to the working gas in supply line 122 at a selected rate. The inter source or source of dust can be controlled by c〇2 switch (5). The switch m can be connected by a second link i to between the c〇2 source 134 or a pressure source. In another embodiment, a substance other than solids, such as a crystalline anesthetic, can be added to the supply conduit 122. As used herein, "couple" includes coupling via separate objects and including direct coupling. The term "coupled" also encompasses that two or more components are connected to each other by means of each of the components t formed from the same piece of material. Also, the term "face" may include chemistry (such as chemical bonding), mechanical, thermal or electrical (d). The fluid face connection means that the fluid can communicate between specified portions or locations. After the working gas or debridement mixture enters the treatment chamber 118, the substance can pass directly through the treatment chamber 118 or can impact the undesirable tissue ι2 in the treatment chamber 118 and thereby create a fragmented tissue 109. When the solid c〇2 particle 1U strikes the poor tissue 1〇2, the solid C〇2 particle is usually sublimed (sublimed from the solid phase to the gas phase). Any combination of working gas, solid c〇2 particles m, c〇2 gas or shredded tissue 109 ("cavity material") present in the treatment chamber 118 can be removed via the removal conduit 120 and initially removed by the removal orifice Port 14〇 received. Removal of the orifice 14 〇 may be to remove the enlarged portion at the end of the conduit 120 to help direct fluid into the - removal conduit 120. The cavity material is delivered to the extraction conduit 124. The extraction conduit 124 can have a reduced pressure as compared to the treatment lumen 118. The reduced pressure can be transferred to the removal conduit 12 by the extraction conduit 124. The reduced pressure can be transferred to the extraction conduit 124 by the reduced pressure source 142. The reduced pressure source 142 can be any device for supplying reduced pressure, such as a vacuum pump, wall sucti, or other source. The amount of reduced pressure supplied by the reduced pressure source 14 2 can be regulated by a valve or a power source or the like supplied to the vacuum pump 154697.doc 201141436 and can be controlled by the pressure reducing switch 144. The decompression switch 144 can be coupled to the power source of the valve or decompression source 142 by a second link 146 or coupling. The collection member 148 can be fluidly coupled to a portion of the extraction conduit 24 to collect the debris structure 109 and any other solids or liquids in the cavity material. The collection member 148 may in particular retain the broken tissue 1〇9 for testing or disposal. A main controller 150 including a working gas control switch 13A, a c〇2 switch 136, and a pressure reducing switch 144 or any combination of the switches 13A, 136, (4) may be provided. The main controller 15A may be a foot switch console for the health care provider "a to facilitate access to the switches 130, 136 and 144. The main controller 15A may also allow the user to input and assist in adjusting the three switches 130, 136. And 144 an electronic controller to obtain the desired result. Thus, for example, the user can input a working gas that requires softness (four) (such as for rot) and can deliver lower pressure and smaller solid C〇2 particles. As another example user may enter a need for hard debridement (such as for induration) and may deliver higher pressure and larger solid C02 particles. In an illustrative embodiment, the health care provider 1] 2 uses The treatment member 1〇6 positions the treatment head 108 to approach the tissue site 1〇4, and in particular, positions the treatment cavity m close to the undesirable tissue 1〇2. This day or before, the health care provider 112 The initial self-defense gas supply source 128 delivers a working gas to the treatment chamber 118. As the working gas (and other substances) is transferred from the delivery conduit 116 through the treatment lumen 118 to the removal conduit 12, the working gas is at the poor tissue 102 or $良组织102 The relative velocity of the fluid in the middle causes the poor tissue 102 or a portion thereof to enter the treatment cavity 118. Although not subject to the operational theory limit 154697.doc 201141436 The 'bad tissue 102' due to the venturi effect or by the Bernu The Bernoulli's principle enters the treatment chamber 118. The faster moving fluid creates a low pressure in the treatment chamber 118 that pulls or forces the poor tissue 102 into the treatment chamber 118. The greater the velocity of the working gas forces the undesirable tissue The greater the force of 102 into the treatment chamber 118. Thus, the amount of tissue removed can be directly controlled. Once the undesirable tissue 1〇2 is within the treatment chamber 118 as shown in Figure 3, the health photo s The C 〇 2 source 134 causes the solid c 〇 2 particle 111 to enter the working gas and form a debriding mixture of the poorly impinging tissue 1 〇 2 as shown in Fig. 4. The solid C 〇 2 particle 111 strikes the poor tissue j 〇 2 and cuts each Partially free to generate the removed debris tissue 109. The solid C〇2 particles ill sublimate to produce c〇2 gas when colliding with or after the bad tissue 102. Fragmented tissue 109, working gas and C〇2 The body and any solid c〇2 particles enter the removal orifice 140 and the removal conduit 12. The fragmented tissue 109 is transferred to the collection member 148 via the extraction conduit 124. The fragmented tissue 109 and other fluids may be subtracted from the reduced pressure source 142. Pressing into the removal orifice 140. A number of variables can be used to control the amount of undesirable tissue 1〇2 removed: the size of the solid C〇2 particles 111, the number of solid C〇2 particles U1, or from a working gas supply source. The pressure (and flow rate) of the working gas of 128. Another variable may be stated as the pressure differential across the treatment chamber 118, such as the pressure between the pressure of the working gas supplied by the working gas supply 128 and the pressure of the reduced pressure source 142. Poor "lower differential pressure, smaller particle size and fewer particles can be used for mild debridement, such as for soft carrion tissue. Higher pressure differentials, larger particle sizes, and more particles can be used for hard crust tissue. Any group of these variables can be used 154697.doc 201141436 to help resolve different situations. The flow rate of the working gas, the size of the solid C〇2 particles 111, and the particle feed rate can be controlled to provide cooling of the tissue site 丨〇4, which provides an analgesic effect. The flow rate can be kept low enough to avoid cold burns or osmotic cooling effects on the tissue site 104. A temperature probe (such as a thermistor) can be incorporated at the interface between the treatment head 1〇8 and the skin 105 and can be controlled by software using information from the temperature probe to adjust the size of the solid c〇2 particle 111 and the working gas. Traffic. In an illustrative, non-limiting embodiment, the flow rate can be provided at a pressure of from 1 to 5 bar, wherein the solid c〇2 particle ill has a grit to a large needle range and has a 丨_2 m3/min Flow rate of 500 g/min. Figure 1 presents a treatment member 使用6 that uses a plurality of switches 130, 136 to control the flow rate of the working gas and the flow rate of the solid C 〇 2 particles 111, respectively. Referring now primarily to Figure 5, another illustrative, non-limiting embodiment of a treatment member 206 is presented that can be used with a system (e.g., system 图 of Figure 1) for removal from a tissue site of a patient or Remove bad tissue (such as necrotic tissue). The treatment member 206 is similar in most aspects to the treatment member 1〇6 of the figure. The treatment member 206 has a treatment head 208 and a handle 210. The treatment head 2〇8 has a treatment head body 214 formed with a treatment lumen 218. In the illustrative embodiment, the working gas control switch 23 is located on the handle 210. The flow rate (pressure) of the working gas delivered to the treatment chamber 218 is controlled by the working gas control switch 230, which is The movement between the first position and the second position is indicated by arrow 26〇. The movement of the working gas control switch 230 provides variable flow between the no-flow condition and the maximum flow condition and can be achieved by continuous or incremental control. 154697.doc •12· 201141436 The flow rate of the solid c〇2 particles is controlled by a c〇2 switch 236, which can be a biasing trigger. When the health care provider is ready to cut the tissue pulled into the treatment cavity 218, the health care provider pulls the c〇2 switch 236 to deliver solid C〇2 particles to cut the bad tissue. Referring now primarily to Figure 6, another illustrative embodiment of a treatment member 3A is presented. The treatment member 306 can be used as part of a system (e.g., system 丨〇〇 of Figure!) to remove or remove undesirable tissue 3〇2 (e.g., dead tissue) from the patient's tissue site 3〇4. The treatment member 306 is in many aspects and figures! The treatment member 1〇6 is similar. The treatment member 306 has a treatment head 308 and a handle 31A. The treatment head 3 8 has a treatment head body 314 formed by a delivery conduit 316, a treatment lumen 318, and a removal conduit 32. However, in this embodiment, the transfer conduit 316 is displaced from the removal conduit 320 and is not substantially aligned with the removal conduit 32, but at a different angle - in this example, approximately 18 inches. different. Thus, the debridement mixture introduced via the delivery conduit 316 strikes the undesirable tissue 3〇2 of the tissue site 3〇4 and is then removed by decompression inhalation to remove the conduit 32 for transport away for disposal or disposal. The angle between the transfer conduit 3ί6 and the removal conduit 32〇 can be substantially 〇 (see Fig. 4) or 180 (see Fig. 6), or any angle therebetween, such as 1 〇. 2〇. , 30, 40, 50. 60. Wait. In another embodiment, the angle of impact on the undesirable tissue 3〇2 can be controlled by the health care provider. For greater than 45. At an angle, a decompression system may be required to provide a suction force for removing the cavity material. There may be many alternatives to the systems and methods herein. Referring again to Figures 1-4, in an alternative embodiment, the working gas and the state of the particle + (1) (10) can be collectively transferred from the beginning of the process. #创创混合物Forcing the bad tissue 10 2 into the treatment cavity u 8 and (4) (including removing) the bad tissue] 〇 2 154697.doc -13- 201141436 to form the broken tissue 1 09. In an alternative embodiment, both the alternate working gas supply source 128 and the reduced pressure source 142 contribute to a pressure differential across the treatment chamber 118, which may be caused only by the positive pressure delivered by the working gas supply source 128 or by only The pressure source 142 is caused. In embodiments where the pressure differential is only caused by the reduced pressure source 142, a sealing portion or a sealing material may be added to provide a liquid seal between the treatment head 8 and the tissue site 丨〇4. In another alternative embodiment, the c〇2 source 134 may also allow control of the size of the solid c〇2 particles ill that are delivered to the treatment chamber 118. In addition, the c〇2 switch 136 is acceptable. Instantly select the particle size at noon or provide additional switches for this purpose. In another alternative embodiment, a single switch provides control of the working gas and solid c〇2 particles. In addition, the adjustment switch sets the ratio of working gas to solid c〇2 particles, but the transfer rate can be controlled by a single switch, such as switch 230 in FIG. In accordance with another illustrative embodiment, a method of removing undesirable tissue from a tissue site includes delivering solid C〇2 particles to the undesirable tissue to sever bad tissue. The C〇2 particles are subjected to sublimation to produce c〇2 gas β. The method further comprises removing C〇2 gas and undesirable tissue that has been cleaved by solid c〇2 particles. According to another illustrative embodiment, solid c〇2 particles 111 are produced as in one aspect of system 1. In this illustrative, non-limiting embodiment, the system crucible includes a pressurized cylinder containing liquid carbon dioxide and a mechanism for gas or liquid conversion to produce C〇2 particles. In this embodiment, there is no need to store or provide dry ice. Although the present invention and its advantages are disclosed in the context of certain illustrative, non-limiting embodiments, it should be understood that the invention may be practiced without departing from the scope of the invention as defined by the accompanying claims 154 697. doc - 14 - 2011 414. Various changes, substitutions, substitutions and changes are made in the circumstances. It should be understood that any feature described in relation to any embodiment can be applied to any other embodiment. It should be understood that the above benefits and advantages may be related to one embodiment or may be related to the embodiments. It should be further understood that reference to the “one” item refers to one or more of these items. The steps of the methods described herein can be performed in any suitable order or concurrently where appropriate. Where appropriate, the aspects of any of the above examples may be combined with any of the other examples described to form other examples having comparable or different properties and solving the same or different problems. It is to be understood that the above description of the preferred embodiments are provided by way of example only, and various modifications may be made by those skilled in the art. The above description, examples and materials provide a complete description of the structure and use of the exemplary embodiments of the invention. Although the various embodiments of the present invention have been described above with a singularity or with reference to one or more embodiments, the skilled artisan can do so without departing from the scope of the claimed invention. The disclosed embodiments are subject to numerous variations. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic illustration of an illustrative system for removing undesirable tissue from a patient tissue site, wherein - a portion is shown in cross-section and a portion is shown in perspective; Figure 2 is a view of Figure i A schematic perspective view of a portion of an illustrative system showing a portion of a treatment head; FIG. 3 is a schematic cross section of one of the treatment heads of the illustrative system shown in FIGS. 1 and 2, 154697.doc -15· 201141436; 4 is a schematic cross section of the treatment head of FIG. 3, showing poorly cut tissue; 'Summary side view of the treatment member is an illustrative view for removing undesirable tissue; and FIG. 6 is for self-organization The site removes the schematic cross section of the defective treatment head. 'Description of the main components】 [Main component symbol description] 100 System 102 Bad tissue 103 Wounds 104 Tissue sites 105 Epidermis 106 Therapeutic components 107 Subcutaneous tissue 108 Treatment head 109 Fragmented tissue 110 Handle 111 Solid co2 particles 112 Health care provider 114 treatment head body 116 delivery conduit 118 treatment chamber 119 delivery orifice 154697.doc • 16 - 201141436 120 removal conduit 122 supply conduit 124 extraction conduit 126 housing conduit 128 working gas supply source 130 working gas control switch 132 first control link 134 C〇2 source 136 C Ο 2 switch 138 second link 140 removal aperture 142 decompression source 144 decompression switch 146 third link 148 collection member 150 main controller 206 treatment member 208 treatment head 210 handle 214 treatment head Body 218 treatment chamber 230 working gas control switch 236 <: 〇 2 switch 260 arrow 154697.doc • 17- 201141436 302 bad tissue 304 tissue site 306 treatment member 308 treatment head 310 handle 314 treatment head body 316 delivery conduit 318 treatment lumen 320 Remove Pipe 154697.doc -18