TWI325328B - System for percutaneously administering reduced pressure treatment using balloon dissection - Google Patents

System for percutaneously administering reduced pressure treatment using balloon dissection Download PDF

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TWI325328B
TWI325328B TW96111826A TW96111826A TWI325328B TW I325328 B TWI325328 B TW I325328B TW 96111826 A TW96111826 A TW 96111826A TW 96111826 A TW96111826 A TW 96111826A TW I325328 B TWI325328 B TW I325328B
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Taiwan
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reduced pressure
pressure delivery
tissue
manifold
delivery system
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TW96111826A
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Chinese (zh)
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TW200808393A (en
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Royce W Johnson
Larry D Swain
Douglas A Cornet
Michael Manwaring
Jonathan Kagan
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Kci Licensing Inc
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1325328 九、發明說明: 【發明所屬之技術領域】 本發明概言之係關於一種用於促進組織生長之系統及方 法’且更具體而言’係關於一種用於對—組織部位應用減 壓組織治療之系統。 【先前技術】 人們正在逐漸使用減壓治療來促進如若不使用減壓治療 會癒合很慢或者不癒合之軟組織傷口之傷口癒合。通常, 藉由一開放孔發泡體對傷口部位應用減低之壓力,該開放 孔發泡體用作一歧管來分佈減低之壓力。該開放孔發泡體 之尺寸適合於現有之傷口’與傷口相接觸,並隨後隨著傷 口開始癒合且變小而定期地更換成變小之發泡體。為使生 長入發泡體之孔中之組織量最小化,需要頻繁地更換開放 孔發泡體。在移除發泡體期間,正在生長之大量組織可使 患者感到疼痛。 減壓治療通常應用於不癒合性開放傷。在某些情形中, 所醫治之組織係皮下組織’且在其他情形中,該等組織位 於皮膚組織内或上面。在傳統上’減壓治療一直主要應用 於軟組織。減壓治療通常尚未用於治療封閉之深組織傷 口,乃因難以接近此等傷口。另外,減壓治療尚未與醫治 骨路缺損或促進骨路生長結合❹,此主要歸因於難以接 近月路之問題。藉由外科手術暴露出骨路來應用減壓治療 可能會造成比其所解決之問題更多之問題。最後,用於應 用減壓治療之器件及“之發展幾乎未超出開放孔發泡體 H9637.doc 1325328 件一用手使開放孔發泡體之形狀適合於傷口部位並隨後在 一減壓治療週期之後將其移除。 【發明内容】 本發明之系統及方法即解決現有傷口醫治系統及方法所 存在之問題。根據本發明之一實施例,提供一種減壓輸送 系統,以用於對一組織部位應用減低之壓力。該減壓輸送 系統包括一歧管輸送管,其具有至少兩個管腔及一具有複 數個流動通道之歧管。該歧管設置於該歧管輸送管之該等 管腔中之第一者中。提供一氣球,該氣球具有一内部空間 並能夠採取塌縮位置及膨脹位置。該氣球之内部空間流體 連接至該歧管輸送管之該等管腔中之第二者。 根據本發明之另一實施例,提供一減壓輸送系統,其包 括一具有一内部空間之不滲透性薄膜。.該不滲透性薄膜能 夠呈壓縮狀態與鬆弛狀態。將具有複數個流動通道之歧管 設置於不滲透性薄膜之内部空間内。該不滲透性薄膜之内 部空間内減低之壓力小於該不滲透性薄膜外部之壓力,以 減小該歧管在該不滲透性薄膜内所佔據之空間量。 根據本發明之再一實施例,提供一種減壓輪送系統,其 包括一具有至少一個通道及一遠端之歧管輸送管,該遠端 旎夠毗鄰該組織部位佈置。一具有複數個流動通道之歧管 經構造以經由該歧管輸送管之通道輸送至該組織部位。提 供一不滲透性薄膜,其可定位於該歧管輸送管之遠端處。 該不滲透性薄膜包括一内部空間並能夠採取—膨脹位置與 一塌縮位置中之至少一者。 119637.doc *: ^ 1325328 參照附圖及下文詳細說明,本發明之其他目的、特徵及 優點將變得一目了然。 【實施方式】 下文將參照附圖對較佳實施例進行詳細說明,該等附圖 構成本發明之一部分且其中以圖解方式顯示可實施本發明 之具體較佳貪施例。為使熟習此項技術者能夠實踐本發 明,足夠詳細地闡述該等實施例,且應瞭解,亦可利用其 他實施例,且可在邏輯結構、機械、電氣及化學方面作出 改動,此並不背離本發明之精神或範圍。為避免闡述並非 為使熟習此項技術者能夠實踐本發明所需之細節,本說明 可省略熟習此項技術者所習知之某些資訊。因此,不應將 下文5羊細說明視為具有限定意義,且本發明之範圍僅由隨 附申請專利範圍來界定。 本文中所用術語"彈性"意味著具有彈性體之特性。術語 "彈性體"大體係指具有像橡膠一樣之特性之聚合物材料。 更具體而言,大多數彈性體具有大於1〇〇%之伸長率及明 顯之回彈性程度。材料之回彈性係指材料能夠自彈性變形 恢復。彈性體之實例可包括但不限於:天然橡膠,聚異^ 一烯,苯乙烯丁二烯橡膠,氣丁二烯橡膠,聚丁二烯,腈 橡膠’異丁稀橡膠,乙稀丙烯橡膠,乙烯丙稀二烯單體^ 膠,氯磺化聚乙烯,聚硫橡膠,聚氨基曱酸酯,及聚矽 氧。 本文中所用術語"撓性,,係指物體或材料能夠彎曲或撓 曲。彈性材料通常呈撓性M旦在本文中所提及之撓性㈣ 119637.doc ::炙) 1325328 並非一定將所選材料僅限定為彈性體。將術語"繞性"與本 發明之材料或減壓輸送裝置結合使用大體係指該材料能夠 貼覆或緊密地匹配一組織部位之形狀。舉例而言,用於治 療骨骼缺損之減壓輸送裝置之撓性性質可使該裝置能夠= 繞或包繞具有缺損之骨骼部分。 本文中所用之術語"流體”總體上係指氣體或液體,但亦 可包含任何其他可流動之材料,包括但不限於凝膠、膠體 或泡珠。 本文中所用之術語"不滲透性"總體上係指薄膜、覆蓋物 或其他物質阻擋或減慢液體或氣體透過之能力。可使用不 滲透性來指代能阻擋液體透過、同時允許氣體透過薄膜之 覆蓋物、薄片或其他薄膜。儘管不滲透性薄膜可不透過液 體,然而該薄膜可只是降低所有或僅某些液體之透過率。 使用術語"不渗透性"並非旨在隱含著不滲透性薄膜高於或 低於任何特^業標準不渗透性量測值,例如水蒸氣傳遞 率(WVTR)之特定值。 本文中所用之術語"歧管"大體係指為有助於對一組織部 位應用減低之壓力、向該組織部位輸送流體或自該組織部 位移除流體而提供之物質或結構。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域提供或 自該組織區域移除之流體之分佈。歧管之實例可包括但不 限於具有經設置以形成流動通道之結構元件之裝置、蜂巢 狀發泡體(例如開放孔發泡體)' 多孔組織收集裝置、及包 含或凝固後包含流動通道之液體、凝膠及泡沫。 U9637.doc 1325328 本文中所用之術語"減低之壓力"大體係指在正接收治療 之組織部位處小於周圍壓力之壓力。在大多數情形中,此 種減低之壓力將小於患者所在位覃之環境壓力。另一選擇 為,該減低之壓力可小於組織部位處組織之靜水壓力。儘 管可使用術語”真空”及”負壓力"來描述施加至組織部位之 壓力,然而施加至組織部位之實際壓力可明顯低於通常與 純粹真空相關聯之壓力。減低之壓力可在開始時在管及組 織部位之區域中產生流體流動。隨著組織部位周圍之靜水 壓力接近所需之減低之壓力,該流動可能會減慢,且隨後 保持減低之壓力。除非另外指明外,本文十所述之壓力值 皆係表壓。 本文中所用之術語”支架"係指用於增強或促進細胞生長 及/或組織形成之物質或結構。支架通常係一三維多孔結 構,其為細胞生長提供一模板。支架可與灌注有、塗覆有 或由細胞、生長因子或其他用於促進細胞生長之營養劑構 成。可使用.支架作為根據本文所述實施例之歧管,以對組 織部位施行減壓組織治療。 本文中所用之術語"組織部位”係指位於任一組織上面或 以内之傷口或缺損,包括但不限於骨骼組織、脂肪組織、 肌肉組織、神經組織、皮膚組織、血管組織、結締組織、 軟骨、腱、或韌帶。術語"組織部位”可進一步係指任何組 織之區域,5玄4區域未必受傷或有缺損,而是想要增強或 促進該等區域中額外組織之生長。舉例而言,可在某些組 織區域中使用減壓組織治療來生長額外之組織,然後可收 119637.doc -10- 1325328 穫該額外冬組織並將其移植至另一組織部位上β 參見圖1-5,一種根據本發明廣理之減壓輸送裝置或翼 狀歧管211包括一具有凸脊部分215孓撓性障壁213以及一 對翼狀部分219。每一翼狀部分219皆沿凸脊部分2 15之對 置侧定位。凸脊部分21 5形成一拱形通道223,拱形通道 223既可延伸過也可不延伸過翼狀歧管21丨之整個長度。儘 管凸脊部分215可在翼狀歧管211上居中定位,以使各翼狀 部分219之寬度相等,然而凸脊部分215亦可如在圖丨_5中 所示偏置,從而使其中一個翼狀部分219寬於另一翼狀部 分219。如果將翼狀歧管211與骨骼再生或醫治結合使用且 較寬之翼狀歧管211將纏繞於附連至骨路上之固定硬體周 圍,則其中一個翼狀部分219之額外寬度可能特別有用。 撓性障壁2 1 3較佳由例如聚石夕氧聚合物等彈性材料製 成。適合之聚矽氧聚合物之一實例包括由位於carpinteria, California之Nusil Technologies公司製造之MED_6〇15。然 而應注意,撓性障壁21 3可由任何其他生物相容性、撓 性材料製成。撓性障壁2 1 3包封一撓性背襯227,以增強撓 性障壁213之強度及耐久性。包封撓性背襯227之撓性障壁 213在拱形通道223中之厚度可小於在翼狀部分219中之厚 度。若使用聚矽氧聚合物來形成撓性障壁213 ,則亦可使 用聚矽氧黏合劑來幫助黏合撓性背襯227。聚矽氧黏合劑 之實例可包括亦由Nusil Technol〇gies公司出售之med_ 1 。撓性背襯227較佳由聚酯針織織物製成,例如由位 於Tempe,Arizona之C.R· Bard公司所製造之⑼以製 119637.doc 1325328 成然而,撓性背襯227可由任何能增強撓性障壁2丨3之強 度及耐久性之生物相容性、撓性材料製成。在某些情況 下,右撓性障壁213由適當強度之材料製成,則可省卻撓 性背襯227。 較佳使撓性障壁2U或撓性背襯227不滲透液體、空氣及 其他氣體,或者另一選擇為,撓性背襯227與撓性障壁Η] 二者可不滲透液體、空氣及其他氣體。 挽I·生障壁213及撓性背襯227亦可由在使用減壓輸送裝置 2U之後不必自患者體内移出之生物可再吸收性材料製 成。適宜之生物可再吸收性材料可包括但不限於聚乳酸 (PLA)及聚乙醇酸(PGA)之聚合摻合物。該聚合摻合物亦可 包括但不限於聚碳酸酿、聚富馬酸醋、及。撓 性障壁213及撓性背襯227可進—步用作—新細胞生長支 架’或者可將-支架材料與撓性障壁213及撓性背襯227結 合使用來促進細胞生長。適宜之支架材料可包括但不限於 侧弓、膠原、PLA/PGA、珊灰石、碟酸鹽、或 經處理之同種異體移植材料。較佳地,該支架材料將具有 高的空隙比例(即高的空氣含量)。 在一實施财’可耗性背襯如㈣合方式岐至撓 性障壁213之表面上。若使用聚矽氧聚合物來形成撓性障 壁213 ’則亦可使用聚石夕氧黏合劑將撓性背—定至撓 性障壁213上。儘管當將撓性背襯227表面結合至撓性障壁 213上時黏合劑係較佳之 羊 宜之固定方法。之固疋方法,然而亦可使用任何適 119637.doc 1325328 撓性障壁213包含複數個在撓性障壁213之表面上自翼狀 部分219伸出之突起物231。突起物231可為圓柱形、球 形、半球形、立方體形、或任何其他形狀,只要每一突起 物231之至少某一部分所處之平面不同於與撓性背襯213上 固定有突起物23 1之侧相關聯之平面即可。就此而言,甚 至不要求一特定突起物231具有與其他突起物231相同之形 狀或尺寸;事實上,該等突起物231可包括不同形狀及尺 寸之隨機混合。因此,每一突起物231自撓性障壁213上伸 出之距離可各異,但亦可在該複數個突起物23丨中相一 致。 各突起物231在撓性障壁213上之佈置在該等突起物之間 形成複數個流動通道233。當該等突起物23丨具有—致之形 狀及尺寸且在撓性障壁213上均句相間時,形成於各突起 物231之間之流動通道233同樣地均勻。亦可利用突起物 23 1之尺寸、形狀及間距之變化來改變流動通道Μ〗之尺寸 及流動特性。 如在圖5中所示,一減壓輸送管24丨位於拱形通道223内 並固定至撓性障壁213上。減壓輸送管241可僅固定至撓性 障壁213或撓性背襯227上,或者管川可同時固定至^性 障壁213與撓性背襯227二者上。減壓輸送管μ在管冰之 遠端處包含-遠端孔口 243。管241可定位成使遠端孔口 =3沿拱形通道223位於任—點處,但管241較㈣位成使 遇端孔口 243沿拱形通道223之縱向長度位於大約中點處。 車交佳藉由沿-相料管241之縱向轴線以小於九十⑼^之 119637.doc 1325328 角度定向之平面切割管241,將遠端孔口 243製作成橢圓形 或卵圓形形狀。儘管孔口 243亦可為圓形,然而孔口 243之 橢圓形形狀會增強與形成於各突起物231間之流動通道233 之流體連通。 減壓輸送管241較佳由塗覆有paraiyne之聚矽氧或胺基甲 酸酯製成。然而,亦可使用任何醫療級管子材料來構造減 壓輸送管241»可塗覆該管之其他塗層包括肝素、抗凝血 劑、抗纖維蛋白原、抗附著劑、.抗凝血酶原、及親水性塗 層。 在一實施例中,作為對遠端孔口 243之替代或者除遠端 孔口 243之外,減壓輸送管241亦可包含沿減壓輸送管24 j 定位之排放開孔或排放孔口 25 1,以進一步增強減壓輸送 管241與流動通道233間之流體連通。減壓輸送管241可如 在圖1-5中所示僅沿拱形通道223之縱向長度之一部分定 位,或者另一選擇為’可沿拱形通道223之整個縱向長度 疋位。若定位成使減壓輸送管24 1佔據拱形通道223之整個 長度’則可對遠端孔口 243進行罩蓋,以使管24 1與流動通 道23 3間之所有流體連通皆經由排放開孔25 1進行。 減壓輸送管241進一步在管241之近端處包含一近端孔口 255。近端孔口 255經構造以與一減壓源相配合,在下文中 將參照圖9更詳細地說明該減壓源。圖丨_3、4a及5中所示 之減壓輸送管241僅包含單個管腔或通路259。然而,可使 減壓輸送官24 1包含多個管腔,例如在圖4B中所示之雙管 腔管261。雙管腔管261包含一第一管腔263及一第二管腔 119637.doc -14- 1325328 265。使用雙管腔管會在減壓輸送管241之近端與流動通道 233之間提供分離之流體連通路徑。舉例而言,可使用雙 管腔管261來達成減壓源與沿第一管腔263之流動通道233 之間的連通》第二管腔265可用於將流體引入至流動通道 233内。該流體可係經過濾之空氣或其他氣體、抗菌劑、 ,抗病毒劑、細胞生長促進劑、沖馮流體、化學活性流體或 任何其他流體。若期望經由分離之流體連通路徑將多種流 φ 體引入至流動通道233中,可使減壓輸送管具有不止兩個 管腔。 仍參見圖4Β’ 一水平間隔件271將減壓輸送管261之第一 及第二管腔263、265分離,從而使第一管腔263定位於第 一管腔265上方。第一管腔及第二管腔263、265之相對位 置可有所變化,此視如何在管腔263、265與流動通道233 之間提供流體連通而定。舉例而言,當第一管腔263如在 圖4Β中所示定位時,可提供類似於排放開孔251之排放開 # 孔來達成與流動通道233之連通。當第二管腔如在圖4Β中 所示定位時,第二管腔265可經由一類似於遠端孔口 243之 孔口與机動通道233連通。另一選擇為,可藉由一將 各官腔分離之垂直間隔件來使一減壓輸送管中之多個管腔 並排定位,或者可將該等管腔同心或同軸地定位。1325328 IX. INSTRUCTIONS OF THE INVENTION: TECHNICAL FIELD OF THE INVENTION The present invention relates generally to a system and method for promoting tissue growth and, more particularly, to a method for applying decompression tissue to a tissue site The system of treatment. [Prior Art] Decompression therapy is being gradually used to promote wound healing of soft tissue wounds that heal very slowly or not heal without using decompression therapy. Typically, the reduced pressure is applied to the wound site by an open-cell foam that acts as a manifold to distribute the reduced pressure. The open-cell foam is sized to be in contact with the wound in the prior art, and is then periodically replaced with a smaller foam as the wound begins to heal and become smaller. In order to minimize the amount of tissue growing into the pores of the foam, it is necessary to frequently replace the open pore foam. During the removal of the foam, the large amount of tissue that is growing can cause pain to the patient. Decompression therapy is usually applied to non-healing open wounds. In some cases, the tissue being treated is subcutaneous tissue' and in other instances, the tissue is located in or on the skin tissue. Traditionally, decompression therapy has been used primarily in soft tissue. Decompression therapy is not currently used to treat closed deep tissue wounds because it is difficult to access such wounds. In addition, decompression therapy has not been associated with the treatment of bone defects or the promotion of bone growth, which is mainly due to the difficulty of approaching the moon. Applying decompression therapy by surgically exposing the bone path may cause more problems than the problem it solves. Finally, the device used for the application of decompression therapy and "the development of almost no open hole foam H9637.doc 1325328 one hand to make the shape of the open-cell foam suitable for the wound site and then in a decompression treatment cycle Thereafter, the system and method of the present invention solves the problems of the prior wound healing system and method. According to an embodiment of the present invention, a reduced pressure delivery system is provided for use in an organization The reduced pressure is applied to the portion. The reduced pressure delivery system includes a manifold delivery tube having at least two lumens and a manifold having a plurality of flow channels. The manifolds are disposed on the manifolds of the manifold conduits In the first of the chambers, a balloon is provided, the balloon having an interior space and capable of adopting a collapsed position and an expanded position. The interior space of the balloon is fluidly coupled to the second of the lumens of the manifold delivery tube According to another embodiment of the present invention, a reduced pressure delivery system is provided that includes an impermeable membrane having an interior space. The impermeable membrane can be compressed a state and a relaxed state. A manifold having a plurality of flow channels is disposed in an inner space of the impermeable film. The pressure in the inner space of the impermeable film is reduced by less than the pressure outside the impermeable film to reduce According to still another embodiment of the present invention, there is provided a reduced pressure delivery system comprising a manifold delivery tube having at least one passage and a distal end, The distal end is disposed adjacent to the tissue site. A manifold having a plurality of flow channels is configured to be delivered to the tissue site via the channel of the manifold delivery tube. An impermeable membrane is provided that can be positioned at the dislocation The distal end of the tube delivery tube. The impermeable membrane includes an interior space and is capable of taking at least one of an expanded position and a collapsed position. 119637.doc *: ^ 1325328 Referring to the drawings and the following detailed description, Other objects, features and advantages of the invention will become apparent from the following description. Particular embodiments of the present invention are shown in the drawings and are intended to be illustrative of the preferred embodiments of the present invention. Other embodiments, and modifications may be made in the logical structure, mechanical, electrical, and chemical aspects without departing from the spirit or scope of the invention. To avoid the details required to enable the skilled artisan to practice the invention, This description may omit certain information that is familiar to those skilled in the art. Therefore, the following description should not be taken as limiting, and the scope of the invention is defined only by the scope of the accompanying claims. The term "elastic" means having the properties of an elastomer. The term "elastomer" large system refers to a polymer material having the same properties as rubber. More specifically, most elastomers have an elongation of greater than 1% and a significant degree of resilience. The resilience of a material means that the material recovers from elastic deformation. Examples of the elastomer may include, but are not limited to, natural rubber, polyisobutylene, styrene butadiene rubber, gas butadiene rubber, polybutadiene, nitrile rubber 'isobutyl rubber, ethylene propylene rubber, Ethylene propylene diene monomer, chlorosulfonated polyethylene, polysulfide rubber, polyamino phthalate, and polyfluorene oxide. The term "flexibility" as used herein refers to an object or material that is capable of bending or flexing. Elastomeric materials are generally flexible. Mdan is referred to herein as flexibility (iv) 119637.doc::炙) 1325328. The selected material is not necessarily limited to only elastomers. The use of the term "winding" in conjunction with the material of the invention or a reduced pressure delivery device means that the material can be applied or closely matched to the shape of a tissue site. For example, the flexible nature of a reduced pressure delivery device for treating a bone defect can enable the device to wrap or wrap around a bone portion having a defect. The term "fluid" as used herein generally refers to a gas or liquid, but may also include any other flowable material including, but not limited to, a gel, a gel or a bead. The term "impermeable" as used herein. " generally refers to the ability of a film, covering or other material to block or slow the penetration of liquids or gases. Impermeability can be used to refer to a covering, sheet or other film that blocks the passage of liquid while allowing gas to pass through the film. Although the impermeable film may be impermeable to liquids, the film may only reduce the transmission of all or only certain liquids. The term "imperviousness" is not intended to imply that the impervious film is above or below Any special standard impermeability measurement, such as a specific value of water vapor transmission rate (WVTR). The term "manifold" large system used herein refers to the pressure to help reduce the application of a tissue site. a substance or structure that delivers fluid to or removes fluid from the tissue site. The manifold typically includes a plurality of interconnected flow channels or pathways To improve the distribution of fluids provided to or removed from the tissue region surrounding the manifold. Examples of manifolds may include, but are not limited to, devices having structural elements configured to form flow channels, honeycomb-like foams (eg, Open-cell foams] 'Porous tissue collection devices, and liquids, gels, and foams containing or containing flow channels after solidification. U9637.doc 1325328 The term "reducing pressure" used in this article refers to receiving The tissue site of the treatment is less than the pressure of the surrounding pressure. In most cases, the pressure of this reduction will be less than the environmental pressure at which the patient is located. Alternatively, the pressure of the reduction may be less than the static water of the tissue at the tissue site. Pressure. Although the terms "vacuum" and "negative pressure" can be used to describe the pressure applied to a tissue site, the actual pressure applied to the tissue site can be significantly lower than the pressure typically associated with a pure vacuum. The reduced pressure creates fluid flow in the area of the tube and tissue at the beginning. As the hydrostatic pressure around the tissue site approaches the desired reduced pressure, the flow may slow down and then maintain the reduced pressure. Unless otherwise stated, the pressure values described in this document are gauge pressures. The term "scaffold" as used herein refers to a substance or structure used to enhance or promote cell growth and/or tissue formation. The scaffold is typically a three-dimensional porous structure that provides a template for cell growth. Coated with or consisting of cells, growth factors or other nutrients for promoting cell growth. A scaffold can be used as a manifold according to embodiments described herein to treat tissue sites with reduced pressure tissue treatment. The term "tissue site" refers to a wound or defect located above or within any tissue, including but not limited to bone tissue, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendon, or ligament. The term "tissue site" may further refer to the region of any tissue, which may not be injured or defective, but rather enhance or promote the growth of additional tissue in such regions. For example, in some organizations Decompression tissue treatment is used in the area to grow additional tissue, which can then be harvested 119637.doc -10- 1325328 to obtain the additional winter tissue and transplant it to another tissue site. See Figure 1-5, a broad The reduced pressure delivery device or wing manifold 211 includes a ridge portion 215 having a flexible barrier 213 and a pair of wing portions 219. Each wing portion 219 is positioned along the opposite side of the ridge portion 2 15 . The ridge portion 215 forms an arcuate passage 223 that may or may not extend over the entire length of the wing manifold 21. Although the ridge portion 215 may be centered on the wing manifold 211, To make the width of each wing portion 219 equal, however, the ridge portion 215 can also be offset as shown in Figure _5 such that one of the wing portions 219 is wider than the other wing portion 219. If the wing is to be Manifold 211 with bone regeneration or medical The combined use of a wider wing-shaped manifold 211 will wrap around a fixed hardware attached to the bone path, and the extra width of one of the wing portions 219 may be particularly useful. The flexible barrier 2 1 3 is preferably made of, for example, a poly An elastic material such as a sulphuric acid polymer. One example of a suitable polyoxyl polymer includes MED_6〇15 manufactured by Nusil Technologies of Carpinteria, California. However, it should be noted that the flexible barrier 21 3 may be any other organism. Made of a compatible, flexible material, the flexible barrier 2 1 3 encloses a flexible backing 227 to enhance the strength and durability of the flexible barrier 213. The flexible barrier 213 enclosing the flexible backing 227 is The thickness in the arcuate channel 223 can be less than the thickness in the wing portion 219. If a polysilicon polymer is used to form the flexible barrier 213, a polyoxygen oxide adhesive can also be used to help bond the flexible backing 227. Examples of polyoxynoxy binders may include med-1, also sold by the company Nusil Technol〇gies. The flexible backing 227 is preferably made of a polyester knit fabric, such as manufactured by CR Bard, Inc. of Tempe, Arizona. (9) by system 1 19637.doc 1325328 However, the flexible backing 227 can be made of any biocompatible, flexible material that enhances the strength and durability of the flexible barrier 2丨3. In some cases, the right flexible barrier 213 Made of a material of suitable strength, the flexible backing 227 can be dispensed with. Preferably, the flexible barrier 2U or flexible backing 227 is impermeable to liquids, air and other gases, or alternatively, the flexible backing 227 Both with flexible barriers] are impermeable to liquids, air and other gases. The barrier 213 and the flexible backing 227 can also be made of a bioresorbable material that does not have to be removed from the patient after use of the reduced pressure delivery device 2U. Suitable bioresorbable materials can include, but are not limited to, polymeric blends of polylactic acid (PLA) and polyglycolic acid (PGA). The polymeric blends can also include, but are not limited to, polycarbonate, polyfumarate, and. The flexible barrier 213 and flexible backing 227 can be used as a new cell growth support or the stent material can be used in conjunction with the flexible barrier 213 and flexible backing 227 to promote cell growth. Suitable scaffolding materials can include, but are not limited to, lateral arch, collagen, PLA/PGA, ashstone, discate, or treated allograft material. Preferably, the scaffold material will have a high void fraction (i.e., a high air content). In a implementation, the consumable backing is applied to the surface of the flexible barrier 213 as in the form of a (4) joint. If a polysiloxane polymer is used to form the flexible barrier 213', the flexible back can also be applied to the flexible barrier 213 using a polyoxo adhesive. Although the adhesive is a preferred method of attachment when the surface of the flexible backing 227 is bonded to the flexible barrier 213. The solid method, however, any suitable 119637.doc 1325328 flexible barrier 213 includes a plurality of protrusions 231 extending from the wing portion 219 on the surface of the flexible barrier 213. The protrusions 231 may be cylindrical, spherical, hemispherical, cubic, or any other shape as long as at least a portion of each of the protrusions 231 is located in a plane different from the protrusion 23 1 fixed to the flexible backing 213. The plane associated with the side can be. In this regard, it is not even required that a particular protrusion 231 have the same shape or size as the other protrusions 231; in fact, the protrusions 231 may comprise a random mixture of different shapes and sizes. Therefore, the distance from each of the protrusions 231 from the flexible barrier 213 may vary, but may also be uniform in the plurality of protrusions 23A. The projections 231 are disposed on the flexible barrier 213 to form a plurality of flow passages 233 between the projections. When the projections 23 have the same shape and size and are uniformly spaced on the flexible barrier 213, the flow passages 233 formed between the projections 231 are equally uniform. The size, shape and spacing of the protrusions 23 1 can also be used to vary the size and flow characteristics of the flow channel. As shown in Fig. 5, a reduced pressure delivery tube 24 is located in the arcuate passage 223 and is fixed to the flexible barrier 213. The reduced pressure delivery tube 241 may be fixed only to the flexible barrier 213 or the flexible backing 227, or the tube may be simultaneously fixed to both the barrier 213 and the flexible backing 227. The reduced pressure delivery tube μ contains a distal end opening 243 at the distal end of the tube ice. The tube 241 can be positioned such that the distal orifice = 3 is located at any point along the arcuate passage 223, but the tube 241 is positioned more than (four) such that the end orifice 243 is located at approximately the midpoint along the longitudinal length of the arcuate passage 223. The distal opening 243 is formed into an elliptical or oval shape by a planar cutting tube 241 oriented at an angle of less than ninety (9) 119637.doc 1325328 along the longitudinal axis of the phase tube 241. Although the aperture 243 may also be circular, the elliptical shape of the aperture 243 enhances fluid communication with the flow passage 233 formed between the projections 231. The reduced pressure delivery tube 241 is preferably made of polyoxyl or urethane coated with paraiyne. However, any medical grade tubing material can also be used to construct the reduced pressure delivery tube 241. Other coatings that can be applied to the tube include heparin, anticoagulant, antifibrinogen, anti-adherent, anti-prothrombin And a hydrophilic coating. In one embodiment, as an alternative to or in addition to the distal aperture 243, the reduced pressure delivery tube 241 can also include a discharge opening or discharge orifice 25 positioned along the reduced pressure delivery tube 24j. 1, to further enhance the fluid communication between the reduced pressure delivery pipe 241 and the flow passage 233. The reduced pressure delivery tube 241 can be positioned only partially along one of the longitudinal lengths of the arcuate passage 223 as shown in Figures 1-5, or alternatively selected to be "positioned along the entire longitudinal extent of the arcuate passage 223." If positioned such that the reduced pressure delivery tube 24 1 occupies the entire length of the arched passage 223, the distal opening 243 can be covered so that all fluid communication between the tube 24 1 and the flow passage 23 3 is discharged Hole 25 1 is performed. The reduced pressure delivery tube 241 further includes a proximal aperture 255 at the proximal end of the tube 241. The proximal orifice 255 is configured to cooperate with a source of reduced pressure, which will be described in greater detail below with respect to Figure 9. The reduced pressure delivery tube 241 shown in Figures _3, 4a and 5 contains only a single lumen or passage 259. However, the reduced pressure delivery reservoir 24 1 can include a plurality of lumens, such as the dual lumen lumen 261 shown in Figure 4B. The double lumen tube 261 includes a first lumen 263 and a second lumen 119637.doc -14-1325328 265. The use of a dual lumen tube provides a separate fluid communication path between the proximal end of the reduced pressure delivery tube 241 and the flow channel 233. For example, a dual lumen tube 261 can be used to achieve communication between the reduced pressure source and the flow channel 233 along the first lumen 263. The second lumen 265 can be used to introduce fluid into the flow channel 233. The fluid can be filtered air or other gas, antibacterial agent, antiviral agent, cell growth promoter, rushing fluid, chemically active fluid or any other fluid. If it is desired to introduce a plurality of flow bodies into the flow channels 233 via separate fluid communication paths, the reduced pressure delivery tubes can have more than two lumens. Still referring to Fig. 4'', a horizontal spacer 271 separates the first and second lumens 263, 265 of the reduced pressure delivery tube 261 such that the first lumen 263 is positioned above the first lumen 265. The relative positions of the first lumen and the second lumen 263, 265 may vary depending on how fluid communication is provided between the lumens 263, 265 and the flow channel 233. For example, when the first lumen 263 is positioned as shown in FIG. 4A, a discharge opening similar to the discharge opening 251 can be provided to achieve communication with the flow passage 233. When the second lumen is positioned as shown in Figure 4A, the second lumen 265 can be in communication with the motorized passage 233 via an orifice similar to the distal aperture 243. Alternatively, the plurality of lumens in a reduced pressure delivery tube can be positioned side by side by a vertical spacer separating the respective lumens, or the lumens can be positioned concentrically or coaxially.

至另一早·#腔管上、或者藉助若干帶單個或多個管腔之單 管腔管。另一選擇為,可 來貝現,包括如上文所述 可藉由將一單管腔管固定 119637.doc 15 1325328 獨、未固定之管來提供獨立之流體連通路徑。 若使用單獨之管來提供與流動通道233之單獨流體連通 路徑,凸脊部分215可包含多個拱形通道223,其中每一個 管—個拱形通道223。另一選擇為,可擴大拱形通道a]以 容納多個管。具有-與流體輸送管相分離之減壓輸送管減 壓輸送裝置之一實例將在下文中參照圖9進行更詳細To another morning, on the # lumen, or by means of a number of single lumen tubes with single or multiple lumens. Alternatively, the present invention can include a separate fluid communication path by attaching a single lumen tube to a single, unsecured tube as described above. If a separate tube is used to provide a separate fluid communication path with the flow passage 233, the ridge portion 215 can include a plurality of arcuate passages 223, each of which is an arcuate passage 223. Alternatively, the arched passage a] may be enlarged to accommodate a plurality of tubes. An example of a reduced pressure delivery tube pressure reducing delivery device having a separation from a fluid delivery tube will be described in more detail below with reference to FIG.

明。 、、田S 參見圖6-8,一根據本發明原理之減壓輸送裝置或翼狀 歧管311包括一具有凸脊部分315之撓性障壁313以及二對 翼狀部分3 19。每一翼狀部分319皆沿凸脊部分315之對置 側定位。凸脊部分315形成一拱形通道323,拱形通道η] 既可延伸過也可不延伸過翼狀歧管311之整個長度。儘管 凸脊部分315可在翼狀歧管311上居中定位,以使2翼狀部 分3 19之寬度相等,然而凸脊部分315亦可如在圖中所 示偏置,從而使其中一個翼狀部分319寬於另一翼狀部分 319。如果將翼狀歧管311與骨骼再生或醫治結合使用且= 寬之翼狀歧管311將纏繞於附連至骨骼上之固定硬體周 圍,則其中一個翼狀部分319之額外寬度可能特別有用。 一蜂巢狀材料327固定至撓性障壁313上,並可作為跨越 凸脊部分3 15及兩個翼狀部分319覆蓋撓性障壁313整個表 面之單片材料來提供。蜂巢狀材料327包括一毗鄰撓性障 壁313設置之固定表面(在圖6中不可見)、一與該固定表面 相對之分佈表面329、及複數個周邊表面33〇。 在貫施例中,撓性障壁3 13可類似於撓性障壁2丨3,並 119637.doc •16· 1325328 包含-撓性背襯。儘管黏合劑係—種用於將蜂巢狀材料 327固定至撓性障壁313之較佳方法1而亦可藉由任何宜 他適宜之固定方法來固定撓性障壁313與蜂巢狀材料切, 或者將其留給使用者在治療場所進行組裝。撓性障壁313 及/或撓性背襯用作一不滲透性障壁來阻擋例如液體、空 氣或其他氣體等流體透過。 . 在一實施例中,不可以分離方式提供轉性障壁及撓性背 φ 概來支持蜂巢狀材料327。❿是,蜂巢狀材料327可具有一 整體障壁層,該整體障壁層係蜂巢狀材料327之一不滲透 性部分。該障壁層可由封閉孔式材料形成,以防止流體透 過,從而替代撓性障壁313。若將一整體障壁層與蜂巢狀 材料327 —起使用,則該障壁層可包含如上文參照撓性障 壁313所述之凸脊部分及翼狀部分。 撓性障壁313較佳由例如聚矽氧聚合物等彈性材料製 成。適合之聚矽氧聚合物之一實例包括由位於carpinteria, • California 之 Nusil Techn〇1〇gies公司製造之med_6〇i5。然 而,應注意,撓性障壁3 13可由任何其他生物相容性、撓 性材料製成。若撓性障壁包封或以其他方式包含一撓性背 襯,則撓性背襯較佳由聚酯針織織物製成,例如由位於 Tempe,Arizona之C.R· Bard公司所製造之gard 6013製成。 然而,撓性背襯227可由任何能增強撓性障壁3丨3之強度及 耐久性之生物相容性、撓性材料製成。 在一實施例中,蜂巢狀材料327係一開放孔式、網狀聚 驗胺基甲酸醋發泡體,其孔隙尺寸介於約4〇〇_6〇〇微米範 H9637.doc 1325328 圍内。此種發泡體之一實例可包含由位於San Antonio,Bright. Referring to Figures 6-8, a reduced pressure delivery device or wing manifold 311 in accordance with the principles of the present invention includes a flexible barrier 313 having a ridge portion 315 and two pairs of wing portions 319. Each wing portion 319 is positioned along the opposite side of the ridge portion 315. The ridge portion 315 defines an arcuate passage 323 that may or may not extend over the entire length of the wing manifold 311. Although the ridge portions 315 can be centrally positioned on the wing manifold 311 such that the width of the two wing portions 3 19 are equal, the ridge portions 315 can also be offset as shown in the figures to provide one of the wings Portion 319 is wider than the other wing portion 319. The extra width of one of the wing portions 319 may be particularly useful if the winged manifold 311 is used in conjunction with bone regeneration or healing and the wide winged manifold 311 will wrap around a fixed hardware attached to the bone. . A honeycomb material 327 is secured to the flexible barrier 313 and is provided as a single piece of material that covers the entire surface of the flexible barrier 313 across the ridge portion 3 15 and the two wing portions 319. The honeycomb material 327 includes a fixed surface (not visible in Fig. 6) disposed adjacent to the flexible barrier 313, a distribution surface 329 opposite the fixed surface, and a plurality of peripheral surfaces 33A. In one embodiment, the flexible barrier 3 13 can be similar to the flexible barrier 2丨3, and 119637.doc •16·1325328 includes a flexible backing. Although the adhesive is a preferred method 1 for securing the honeycomb material 327 to the flexible barrier 313, the flexible barrier 313 may be fixed to the honeycomb material by any suitable fixing method, or It is left to the user for assembly at the treatment site. The flexible barrier 313 and/or flexible backing acts as an impermeable barrier to block the passage of fluids such as liquids, air or other gases. In an embodiment, the conductive barrier and the flexible back φ are not provided in a separable manner to substantially support the honeycomb material 327. Alternatively, the honeycomb material 327 can have an integral barrier layer that is an impermeable portion of the honeycomb material 327. The barrier layer may be formed of a closed cell material to prevent fluid from penetrating, thereby replacing the flexible barrier 313. If a monolithic barrier layer is used with the honeycomb material 327, the barrier layer may comprise raised portions and wing portions as described above with reference to the flexible barrier 313. The flexible barrier 313 is preferably made of an elastic material such as a polyoxynitride polymer. An example of a suitable polyoxyl polymer includes med_6〇i5 manufactured by Nusil Techn〇1〇gies, Inc. of Carpinteria, California. However, it should be noted that the flexible barrier 3 13 can be made of any other biocompatible, flexible material. If the flexible barrier encloses or otherwise comprises a flexible backing, the flexible backing is preferably made of a polyester knit fabric, such as gard 6013 manufactured by CR Bard, Inc. of Tempe, Arizona. . However, the flexible backing 227 can be made of any biocompatible, flexible material that enhances the strength and durability of the flexible barrier 3丨3. In one embodiment, the honeycomb material 327 is an open cell, reticulated urethane foam having a pore size between about 4 Å and 6 Å μm H9637.doc 1325328. An example of such a foam may be included by being located in San Antonio,

Texas之Kinetic Concepts公司製造之GranuFoam。蜂巢狀材 料3 2 7亦可係紗布、數墊、或任何其他能在三個維度上藉 由複數個通道提供流體連通之生物相容性材料。 蜂巢狀材料327主要係一種"開放孔式"材料,其包含流 體連接至毗鄰孔之複數個孔。藉由蜂巢狀材料327之”開放 孔在5亥荨開放孔"之間形成複數個流動通道。該等流動 通道能夠在蜂巢狀材料327中具有開放孔之該整個部分中 達成流體連通。該等孔及流動通道可具有一致之形狀及尺 寸,或者可包含圖案化或隨機之形狀及尺寸變化。蜂巢狀 材料327中孔之尺寸及形狀之變化會引起流動通道之變 化’且此等特性可用於改變流過蜂巢狀材料327之流體之 流動特性。蜂巢狀材料327可進一步包括含有"封閉孔"之 部分。蜂巢狀材料327中之封閉孔部分包含複數個孔,該 等孔中之大多數不流體連接至毗鄰孔。在上文中將一封閉 孔部分之一實例描述為一可代替撓性障壁3 13之障壁層。 類似地’可在蜂巢狀材料327中選擇性地設置封閉孔部 分’以防止流體透過蜂巢狀材料327之周邊表面330。 撓性障壁3 13及蜂巢狀材料3 2 7亦可由在使用減壓輸送裝 置3 11之後不必自患者體内移出之生物可再吸收性材料製 成。適宜之生物可再吸收性材料可包括但不限於聚乳酸 (PLA)及聚乙醇酸(PGA)之聚合摻合物。該聚合摻合物亦可 匕括彳一不限於聚奴酸醋、聚富馬酸酷、及capralactone。挽 性障壁3 13及蜂巢狀材料327可進一步用作一新細胞生長支 H9637.doc -18· 1325328 架,或者可將一支架材料與撓性障壁313、撓性背襯327及/ 或蜂巢狀材料327結合使用來促進細胞生長。適宜之支架 材料可包括但不限於磷酸鈣、膠原、pLA/pGA、珊瑚羥基 磷灰石、碳酸鹽、或經處理之同種異體移植材料。較佳 -地,該支架材料將具有高的空隙.比例(即高的空氣含量卜 一減壓輸送管341定位於拱形通道323内並固定至撓性障 壁313上。減壓輸送管341亦可固定至蜂巢狀材料327上, 或者在僅存在蜂巢狀材料327之情況下,減壓輸送管341可 僅固定至蜂巢狀材料327上。減壓輸送管341在管341之遠 端處包含一遠端孔口 343,其類似於圖5中之遠端孔口 243。減壓輸送管341可定位成使遠端孔口 343沿拱形通道 323位於任一點處,但較佳沿拱形通道323之縱向長度定位 於大約中點處。較佳藉由沿—相對於管341之縱向軸線以 小於九十(90)度之角度定向之平面切割管341,將遠端孔口 343製作成橢圓形或印圓形形狀。儘管該孔口亦可為圓 φ 形,然而孔口之橢圓形形狀會增強與蜂巢狀材料327中流 動通道之流體連通。 在一實施例中,減壓輸送管341亦可包含類似於圖5中之 排放開孔25 1之排放開孔或排放孔口(未顯示)。作為對遠端 孔口 343之替代或者除遠端孔口 343之外,還沿管341佈置 排放開孔,以進一步增強減壓輸送管341與流動通道間之 流體連通。如前面所述,減壓輸送管341可僅沿棋形通道 323之縱向長度之一部分定位,或者另一選擇為,可沿拱 形通道323之整個縱向長度定位。若定位成使減壓輸送管 119637.doc •19- “佔據整個拱形通道323,則可對遠端孔口 進行罩 蓋,以使管341與流動通道間之所有流體連通皆經由排放 開孔進行。 較佳地,蜂巢狀材料327覆蓋並直接接觸減壓輸送管 Ml。蜂巢狀材料327可連接至減壓輸送管341,或者蜂巢 =材料327可僅固定至撓性障壁3Π上1減壓輸送管341 疋位成使其僅延伸至棋形通道323之中點,則蜂巢狀材料 327亦可在拱形通道323中不包含減壓輸送管“I之區域中 連接至撓性障壁313之凸脊部分315。 減壓輸送管進-步在管341之近端處包含一近端孔口 355。近端孔口 355經構造以與一減壓源相配合,在下文中 將參照圖9更詳細地說明該減壓源。圖6-8中所示之減壓輸 送管341僅包含單個管腔或通路359。然而,可使減壓輸送 官341包含多個管腔,例如前面參照圖4β所述之多個管 腔。如前面所述,使用一多管腔管會在減壓輸送管341之 近端與流動通道之間提供分離之流體連通路徑。亦可藉由 具有與流動通道相連通之單個或多個管腔之單獨管來提供 该專单獨之流體連通路徑。 參見圖8A及8B,一根據本發明原理之減壓輸送裝置371 包括一減壓輸送管373,其在減壓輸送管373之遠端377處 具有一延伸部分375。延伸部分375較佳為拱形形狀,以與 減壓輸送管373之曲率相匹配。延伸部分375可藉由如下方 式形成:在遠端377處移除減壓輸送管373之一部分由此 形成一具有一凸肩383之切口 381。複數個突起物385設置GranuFoam, manufactured by Kinetic Concepts, Texas. The honeycomb material 3 2 7 can also be gauze, a number of pads, or any other biocompatible material that provides fluid communication in a plurality of dimensions in a plurality of channels. Honeycomb material 327 is primarily an "open-hole" material that includes a plurality of holes that are fluidly connected to adjacent holes. A plurality of flow channels are formed by the "open holes of the honeycomb material 327 between the 5 mm open holes". The flow channels are capable of achieving fluid communication in the entire portion of the honeycomb material 327 having open holes. The equal pores and flow channels can have a uniform shape and size, or can include patterned or random shapes and dimensional changes. Variations in the size and shape of the pores in the honeycomb material 327 can cause changes in the flow channels' and such characteristics are available. The flow characteristics of the fluid flowing through the honeycomb material 327 are varied. The honeycomb material 327 may further include a portion containing a "closed hole". The closed hole portion of the honeycomb material 327 includes a plurality of holes, among which Most are not fluidly connected to adjacent holes. One example of a closed hole portion is described above as a barrier layer that can replace the flexible barrier 3 13. Similarly, a closed hole can be selectively provided in the honeycomb material 327. Partially 'to prevent fluid from passing through the peripheral surface 330 of the honeycomb material 327. The flexible barrier 3 13 and the honeycomb material 3 2 7 may also be used by a reduced pressure delivery device The bioresorbable material that does not have to be removed from the patient after 3 11 can be made. Suitable bioresorbable materials can include, but are not limited to, polymeric blends of polylactic acid (PLA) and polyglycolic acid (PGA). The polymer blend may also be used as a new cell growth branch H9637.doc - not limited to poly vinegar, polyfumaric acid, and capralactone. The barrier barrier 3 13 and the honeycomb material 327 can be further used as a new cell growth branch H9637.doc - 18· 1325328, or a stent material may be used in conjunction with the flexible barrier 313, the flexible backing 327, and/or the honeycomb material 327 to promote cell growth. Suitable scaffold materials may include, but are not limited to, calcium phosphate, collagen, pLA/pGA, coral hydroxyapatite, carbonate, or treated allograft material. Preferably, the scaffold material will have a high void ratio (ie, a high air content). It is positioned in the arched passage 323 and fixed to the flexible barrier 313. The reduced pressure delivery tube 341 can also be fixed to the honeycomb material 327, or in the case where only the honeycomb material 327 is present, the reduced pressure delivery tube 341 can only Fixed to honeycomb material 327. The reduced pressure delivery tube 341 includes a distal opening 343 at the distal end of the tube 341, which is similar to the distal opening 243 of Figure 5. The reduced pressure delivery tube 341 can be positioned such that the distal opening 343 It is located at any point along the arcuate channel 323, but is preferably located at approximately the midpoint along the longitudinal length of the arcuate channel 323. Preferably, it is less than ninety (90) degrees along the longitudinal axis of the tube 341. The angle-oriented planar cutting tube 341 has an open-end aperture 343 formed in an elliptical or circular shape. Although the aperture may also have a circular φ shape, the elliptical shape of the aperture may be enhanced with the honeycomb material 327. The fluid communication of the flow channels. In one embodiment, the reduced pressure delivery tube 341 may also include a discharge opening or discharge orifice (not shown) similar to the discharge opening 25 in Figure 5. In addition to or in addition to the distal aperture 343, a discharge aperture is disposed along the tube 341 to further enhance fluid communication between the reduced pressure delivery tube 341 and the flow channel. As previously described, the reduced pressure delivery tube 341 can be positioned only partially along one of the longitudinal lengths of the chevable channel 323, or alternatively, can be positioned along the entire longitudinal length of the arcuate passage 323. If positioned such that the reduced pressure delivery tube 119637.doc • 19-“occupies the entire arched passage 323, the distal orifice can be capped such that all fluid communication between the tube 341 and the flow passage is via the discharge opening Preferably, the honeycomb material 327 covers and directly contacts the reduced pressure delivery tube M1. The honeycomb material 327 can be connected to the reduced pressure delivery tube 341, or the honeycomb = material 327 can be fixed only to the flexible barrier 3 The duct 341 is positioned such that it extends only to a point in the chevron channel 323, and the honeycomb material 327 can also be connected to the flexible barrier 313 in the region of the arched passage 323 that does not include the reduced pressure duct "I". The ridge portion 315. The reduced pressure delivery tube further includes a proximal orifice 355 at the proximal end of the tube 341. The proximal orifice 355 is configured to cooperate with a source of reduced pressure, which will be described in greater detail below with respect to Figure 9. The reduced pressure delivery tube 341 shown in Figures 6-8 contains only a single lumen or passage 359. However, the reduced-pressure delivery officer 341 can be provided with a plurality of lumens, such as the plurality of lumens previously described with reference to Figure 4β. As previously described, the use of a multi-lumen tube provides a separate fluid communication path between the proximal end of the reduced pressure delivery tube 341 and the flow channel. The separate fluid communication path can also be provided by a separate tube having a single or multiple lumens in communication with the flow channel. Referring to Figures 8A and 8B, a reduced pressure delivery device 371 in accordance with the principles of the present invention includes a reduced pressure delivery tube 373 having an extension 375 at a distal end 377 of the reduced pressure delivery tube 373. The extension portion 375 is preferably arched to match the curvature of the reduced pressure delivery tube 373. The extension portion 375 can be formed by removing a portion of the reduced pressure delivery tube 373 at the distal end 377 thereby forming a slit 381 having a shoulder 383. Multiple protrusions 385 set

Il9637.doc -20- 1325328 於減麼輸送管373之一内表面387上,以於該等突起物385 之間形成複數個流動通道391。突起物385之尺+ 八丁、形狀及 間距可類似於參照圖1-5所述之突起物。減壓輪送裝置371 特別適用於對能夠接納於切口 381内之結締組織應用減低 之壓力及在結缔組織上重新產生組織。韌帶、腱及軟骨即 係可由減壓輸送裝置371治療之組織之非限定性實例。 參見圖9,使用一類似於本文所述其他減壓輸送裝置之 減壓輸送裝置411對一組織部位413(例如患者之人體骨骼 41 5)應用減壓組織治療。當用於促進骨骼組織生長時,減 壓組織治療可提高與骨折、不癒合、空隙或其他骨骼缺損 相關聯之癒合率。進一步據認為,可使用減壓組織治療來 改善骨髓炎之恢復。該治療可進一步用於提高患骨髓炎之 患者之局部骨骼密度。最後,減壓組織治療可用於加速及 改善例如臀部植入體、膝蓋植入體、及固定器件等整形外 科植入體之 oseointegration 〇 仍參見圖9,減壓輸送裝置411包括一減壓輸送管419, 減壓輸送管419具有一流體連接至一減壓源427之近端 421。減壓源427係一幫浦或任何其他能夠經由減壓輸送管 419及與減壓輸送裝置411相關聯之複數個流動通道對組織 郤位4 13應用減低之壓力之器件。對組織部位4丨3應用減低 之壓力係藉由將減壓輸送裝置4丨丨之翼狀部分毗鄰組織部 位4 13佈置來達成,在該特定實例中,此涉及到圍繞骨骼 415中之空隙缺損429纏繞翼狀部分◊減壓輸送裝置4ιι可 藉由外科手術或經過皮膚插入。當經過皮膚插入時,減壓 119637.doc 1325328 輸送管419較佳穿過一穿透患者皮膚組織之無菌插入護套 插入0 應用減壓組織治療通常會在組織部位4 1 3周圍區域中產 生肉芽組織。肉芽組織係一種常常在人體中之組織修復之 月1J所形成之常見組織。在正常情況下,在存在異物時或在 傷口癒合期間可能會形成肉芽組織。肉芽組織通常用作健 康之取代組織之支架並進一步使得形成某種瘢痕組織。肉Il9637.doc -20- 1325328 is formed on one of the inner surfaces 387 of the delivery tube 373 to form a plurality of flow channels 391 between the protrusions 385. The protrusions 385 of the protrusions 385, the shape and the spacing may be similar to the protrusions described with reference to Figures 1-5. The reduced pressure delivery device 371 is particularly useful for applying reduced pressure to connective tissue that can be received within the incision 381 and regenerating tissue on connective tissue. The ligaments, tendons, and cartilage are non-limiting examples of tissue that can be treated by the reduced pressure delivery device 371. Referring to Figure 9, a reduced pressure tissue treatment is applied to a tissue site 413 (e.g., a human bone skeletal 41 5 of a patient) using a reduced pressure delivery device 411 similar to other reduced pressure delivery devices described herein. When used to promote bone tissue growth, decompression tissue treatment increases the rate of healing associated with fractures, non-union, voids, or other bone defects. It is further believed that reduced pressure tissue treatment can be used to improve the recovery of osteomyelitis. This treatment can be further used to increase the local bone density in patients with osteomyelitis. Finally, reduced pressure tissue treatment can be used to accelerate and improve the oseointegration of orthopedic implants such as buttock implants, knee implants, and fixation devices. Still referring to Figure 9, the reduced pressure delivery device 411 includes a reduced pressure delivery tube. 419, the reduced pressure delivery tube 419 has a proximal end 421 that is fluidly coupled to a reduced pressure source 427. The reduced pressure source 427 is a pump or any other device capable of applying a reduced pressure to the tissue but through a plurality of flow channels associated with the reduced pressure delivery tube 419 and the reduced pressure delivery device 411. Applying a reduced pressure to the tissue site 4丨3 is achieved by arranging the wing portion of the reduced pressure delivery device 4丨丨 adjacent the tissue site 4 13 , which in this particular example involves a void defect in the bone 415 The 429-wound wing portion ◊ decompression delivery device 4 ι can be inserted by surgery or through the skin. When inserted through the skin, the reduced pressure 119637.doc 1325328 delivery tube 419 preferably passes through a sterile insertion sheath that penetrates the patient's skin tissue. 0 Application of decompression tissue treatment typically produces granulation in the area surrounding the tissue site 4 1 3 organization. The granulation tissue is a common tissue formed by the month 1J, which is often repaired in the human body. Under normal conditions, granulation tissue may form during the presence of foreign bodies or during wound healing. Granulation tissue is commonly used as a scaffold for healthy replacement tissue and further to form certain scar tissue. meat

芽組織係高度血管化之組織,且在存在減低之壓力情況下 此種高度血管化組織之增強之生長率會促進組織部位413 處新組織之生長。The bud tissue is highly vascularized and the enhanced growth rate of such highly vascularized tissue promotes the growth of new tissue at tissue site 413 in the presence of reduced pressure.

仍參見圖9, 一流體輸送管431可在一遠端處流體連接至 減壓輸送裝置4 11之流動通道。流體輸送管43丨包括一流體 連接至一流體輸送源433之近端432。若正輸送至組織部位 之流體係空氣’則較佳藉由一能夠過濾小至〇 22 _之微 粒之過濾器434來過濾空氣,藉以對空氣進行淨化及殺 菌。尤其當組織部位413位於皮膚表面下面時,向組織部 位413引入卫氣會非常重要,此有利於良好地疏通組織部 ^ 藉以減輕或防止減壓輸送管419之阻塞。流體輸送 管431及流體輸送源433亦可用於向組織部位4Π引入其他 流體,包括但不限於抗菌劑、抗病毒劑、細胞生長促進 劑、沖洗流體、或其他化學活性m過皮膚插入時, 減壓輸送管43 1較佳穿過—空$ φ i ^ 牙0穿透患者皮膚組織之無菌插入 護套插入。 一壓力感測器435可藉 由可操作方式連接至流體輸送管Still referring to Fig. 9, a fluid delivery tube 431 can be fluidly coupled to the flow passage of the reduced pressure delivery device 4 11 at a distal end. Fluid delivery tube 43A includes a proximal end 432 that is fluidly coupled to a fluid delivery source 433. If the flow system air being delivered to the tissue site is filtered, the air is preferably filtered and sterilized by a filter 434 capable of filtering particles as small as 〇22 _. Particularly when the tissue site 413 is positioned beneath the surface of the skin, it may be important to introduce a deflation into the tissue site 413, which facilitates good drainage of the tissue portion to relieve or prevent occlusion of the reduced pressure delivery tube 419. The fluid delivery tube 431 and the fluid delivery source 433 can also be used to introduce other fluids to the tissue site 4, including but not limited to antimicrobial agents, antiviral agents, cell growth promoters, irrigation fluids, or other chemically active substances. The pressure delivery tube 43 1 is preferably inserted through a sterile insertion sheath that penetrates the patient's skin tissue through the space $ φ i ^ tooth 0. A pressure sensor 435 can be operatively coupled to the fluid delivery tube

Il9637.doc *22- 、3 431 ’以指示流體輪送 ^ ^ 1疋否被血液或其他體液堵塞。 壓力感測态435可藉由可摔作 J禪作方式連接至流體輸送源433以 提供回饋,藉以批也丨2丨 工 丨入至組織部位4 13之流體量。亦可 將止口閥(未顯示)以可捍作太 J J插作方式連接於流體輸送管431之 遠端附近,以防止血 又4共他體液進入流體輸送管43 1。 減麼輸送管419及产辦私、玄― 及机體輸送官431所提供之獨立流體連通 路徑可藉由諸多種不回 之方式來達成,包括如前面參照圖 4㈣述提供單個多管腔管。此項技術中之-般技術者將 用夕管腔管,與流體輸送管43 1相關聯之感測 ^他,、且件亦可類似地與減壓輸送管419中之一 敎管腔相關聯。較佳使與組織部位流體連通之任何管腔 或菅皆塗覆有抗凝血劑’以防止體液或血液在管腔或管内 堵塞彳塗覆該等管腔或管之其他塗層包括但不限於肝 素抗凝血劑、抗纖維蛋白原、抗附著劑、抗凝血酶原、 及親水性塗層。 參見圖10-19 ’試驗已證明當對骨骼組織應用減壓組織 治療時,會得到正面之效果。在—特定試驗中,對數只兔 員月應用減壓組織、治療,以確定其對於骨路生長及再 生^效果。該测試之具體目標係發現減壓組織治療對於在 _月上’又有缺知或損傷之兔子之效果、減壓組織治 在頭骨上具有臨界尺寸缺損之兔子之效果、及將—支架材 料與減a組織治療—起使用對於治療頭骨上之臨界尺;缺 才貝之政果。H則試方案及兔子數量列示於下表i中。 H9637.doc -; -23- 量 4 4 4 4 4 Μ^ΓΤ-γ-γ--方案 _ 之骨損藉由蜂巢狀發泡體(GrailUF〇am)在完好 應肖減壓組織治療(RPTT)達6天,隨後立即 損;在不應用減壓鮮織治療(RPTT)情況下 二置蜂、巢狀發泡體(G_F_)達6 ίΪ丁個在上面放置不銹鋼絲網之臨界尺寸缺損;一 ,士面放置磷酸鈣支架之臨界尺寸缺損;對該兩個 小時RPIT ;在手術2週後收穫組織 一個在上面放置不銹鋼絲網之臨界尺寸缺損;一 ^上面放置磷酸鈣支架之臨界尺寸缺損;對該兩個 小時RPTT ;在手術12遇德收蒋組继 i有一個在上面放置不銹鋼絲網之臨界尺寸缺損;一 f在上面放置磷酸鈣支架之臨界尺寸缺損;對該兩個 應用6天RPTT ;在手術2週後收穫組織 具有一個在上面放置不銹鋼絲網之臨界尺寸缺損;一 個在上面放置磷酸鈣支架之臨界尺寸缺損;對該兩個 Μ員應用6天RPTT ;在手術12週後收穫組織__ 具有一個在上面放置不銹鋼絲網之臨界尺寸缺損;一 個在上面放置磷酸鈣支架之臨界尺寸缺損;不應用 gjTT(控制);在手術2週後收穫組織 4 具有一個在上面放置不銹鋼絲網之臨界尺寸缺損;一 個在上面放置磷酸鈣支架之臨界尺寸缺損;不應用 RPTT(對照);在手術12週後收穫組織_ . i然對照(不進行外科手術;不施行RPTT) — 4 假手術(無缺損,不施行RPTT):在手術6天後收穫組織 表1 :試驗方案 臨界尺寸缺損係組織(例如頭骨)中之缺損,其尺寸足夠 大,從而將無法僅藉由自身恢復來癒合。對於兔子而言, 穿過頭骨鑽製一直徑約為15 mm之全厚度孔便會形成頭骨 之臨界尺寸缺損。 更具體地參見圖1 0,其圖解說明一具有原始、未經損壞 119637.doc -24- 1325328 之骨路之兔子頭骨之組織切片。頭骨之骨骼組織為品紅 色’周圍之軟組織為白色,且骨膜層由黃色星號來突出顯 示在圖11中圖解說明在應用減壓組織治療6天並隨後 立即收穫組織之後之兔子頭骨。可以看到骨骼及骨膜,且 已形成一層肉芽組織。在圖I2中,圖解說明在應用減壓組 織治療6天並隨後立即收穫組織之後之兔子頭骨。圖12中 之組織切片之特徵在於在肉芽組織下面形成新的骨骼組 織。該骨骼組織係由黃色星號來突出顯示。在圖13中,圖 解說明在應用減壓組織治療6天並隨後立即收穫組織之後 之兔子頭骨。可以看到新的骨骼及骨膜。藉由減壓組織治 療而开/成之月路組織之組織外觀非常類似於在正在經歷極 快速之新骨骼生長及沈積之非常幼小之動物中骨骼形成之 組織外觀。 更具體地參見圖14_19,其圖解說明數個照片及組織切 片,其顯示對具有臨界尺寸缺損之兔子頭骨施行減壓組織 治療之程序及結果。在圖14中’圖解說明一上面已形成兩 個臨界尺寸缺損之兔子頭骨。該等全厚度臨界尺寸缺損之 直徑約為15 在圖15中,已在其中一個臨界尺寸缺損 上面放置一不銹鋼絲網,並在第二臨界尺寸缺損内放置一 磷酸鈣支架。在圖16中,使用一類似於本文所述之減壓組 織治療裝置對該等臨界尺寸缺損應用減低之壓力。對每一 缺扣應用之壓力大小為_125 mm Hg之表壓。該減低之壓力 係根據表1中所列測試方案之一加以應用。在圖以中,圖 解况明在應用6天之減壓組織治療並在手術十二週後收穫 119637.doc -25- 、’且織之後之頭骨。所示切片包含磷酸鈣支架,其由紅色箭 頭表示應用減壓組織治療會達成新骨骼組織之顯著生 長,在圖17中,此由黃色星號突出顯示。骨路生長量明顯 大於在包含相同磷酸鈣支架、但不以減壓組織治療加以治 療之臨界尺寸缺損中之骨骼生長量。該觀察結果表明可 能存在一為誘發新骨骼形成反應所需之治療臨限值或持續 時間。減壓組織治療之效果在手術後12週所收集之樣本中 最為明顯,此表明減壓組織治療引起一連串生物事件,從 而增強新骨路組織之形成。 覆蓋有不銹鋼絲網(圖15)但在缺損中不放置支架材料之 臨界尺寸缺損用作動物内對照,其新骨骼生長微乎其微。 "亥等貝料突出表明恰當之支架材料之優點以及減壓組織治 療對支架融合和生物效能之正面效果。在圖18及19中,圖 解說明在六天之減壓組織治療之後經支架填充之臨界尺寸 缺損之射線照片。圖18圖解說明手術後兩週之缺損並顯示 在支架内沈積了一定之新骨骼。支架之主結構仍明顯可 見。圖19圖解說明手術十二周後之缺損,並顯示臨界尺寸 缺扣幾乎完全癒合且因組織融合(即在支架基質内形成新 骨路)而使主支架架構接近完全消失。 參見圆20 ’ 一根據本發明一實施例之減壓輸送系統7 11 對患者之組織部位7〖3施行減壓組織治療。減壓輸送系統 711包括—歧管輸送管721。歧管輸送管721可係一導液管 或套管’並可包括使歧管輸送管72 1能夠被導引至組織部 位7 13之器件’例如一導向單元及一導引金屬絲727。 li9637.doc -26- 1325328 可使用内窺鏡檢查、超音波、螢光屏檢查、聽診、觸診或 任何其他適宜之局部化技術來達成導引金屬絲727及歧管 輸送管721之放置及指引。提供歧管輸送管721來用於經過 皮膚將一減壓輸送裝置插入患者之组織部位713 ^當經過 • 皮膚插入時,歧管輸送管7;21較佳穿過一穿透患者皮膚組 ' 織之無菌插入護套插入。 . 在圖20中,組織部位713在毗鄰患者骨骼733上之骨折部 • 位73 1處包含骨骼組織。歧管輸送管72 1插穿過患者之皮膚 735及環繞骨骼733之任何軟組織739。如前面所述,組織 部位713亦可包含任意類型之組織,包括但不限於脂肪纽 織、肌肉組織、神經組織、皮膚組織、血管組織、結缔組 織、軟骨、腱、或韌帶。 參見圖21及22,其進一步圖解說明減壓輸送系統711。 歧管輪送管721可包括一錐形遠端743,以易於插穿過患者 之皮膚735及軟組織739。錐形遠端743可進一步經構造以 • 沿徑向向外撓曲至一開口位置,從而使遠端743之内徑將 基本相同於或大於管721之其他部分之内徑。遠端743之開 口位置在圖21中由虛線737示意性地顯示。 歧管輸送管721進一步包括一通路751,在通路751中包 含一減壓輸送裝置761或任何其他減壓輸送裝置。減壓輪 运裝置761包含一撓性障壁765及/或蜂巢狀材料π?,此類 似於參照圖6-8所述。撓性障壁765及/或蜂巢狀材料%?較 佳捲繞、折疊或以其他方式圍繞減壓輸送管769壓縮,= 減小減壓輸送裝置761在通路751内之截面積。 119637.docIl9637.doc *22-, 3 431 ' to indicate if the fluid is being delivered ^ ^ 1疋 is blocked by blood or other body fluids. The pressure sensing state 435 can be coupled to the fluid delivery source 433 by means of a fallback to provide feedback, whereby the amount of fluid that is forced into the tissue site 4 13 by the batch. A port valve (not shown) may also be attached to the vicinity of the distal end of the fluid delivery tube 431 in a manner that prevents blood from entering the fluid delivery tube 43 1 . The separate fluid communication paths provided by the delivery tube 419 and the delivery private, metaphysical, and body delivery 431 can be achieved by a variety of non-return methods, including providing a single multi-lumen tube as previously described with reference to Figure 4 (d). . A person skilled in the art will use a sinus tube, a sensor associated with the fluid delivery tube 43 1 , and the member may similarly be associated with one of the iliac lumens of the reduced pressure delivery tube 419. Union. Preferably, any lumen or fistula in fluid communication with the tissue site is coated with an anticoagulant ' to prevent body fluids or blood from clogging within the lumen or tube. Other coatings that coat the lumens or tubes include but not Limited to heparin anticoagulants, anti-fibrinogen, anti-adherent agents, anti-prothrombin, and hydrophilic coatings. See Figure 10-19. 'Experiments have shown that when decompressed tissue treatment is applied to bone tissue, a positive effect is obtained. In a specific trial, a logarithmic rabbit was treated with decompression tissue and treatment to determine its effect on bone growth and regeneration. The specific goal of the test was to find the effect of decompressive tissue treatment on rabbits with deficiencies or injuries on _month, the effect of decompression on rabbits with critical size defects on the skull, and the stent material. With the reduction of a tissue treatment - use for the treatment of the skull on the critical rule; lack of talent. The H test plan and the number of rabbits are listed in the following table i. H9637.doc -; -23- quantity 4 4 4 4 4 Μ^ΓΤ-γ-γ--the _ bone loss by the honeycomb foam (GrailUF〇am) in the intact decompression tissue treatment (RPTT ) for 6 days, followed by immediate damage; in the absence of decompression fresh weaving treatment (RPTT), two bees, nested foam (G_F_) up to 6 Ϊ 个 个 放置 放置 不锈钢 临界 临界 临界 临界 临界 临界 临界 临界 临界 临界 临界 临界 临界 临界 临界 临界 临界 临界 临界First, the critical dimension defect of the calcium phosphate stent placed on the surface; the RPIT for the two hours; the critical size defect of the stainless steel mesh placed on the tissue after 2 weeks of surgery; the critical size defect of the calcium phosphate stent placed above The two-hour RPTT; in the operation of the 12th encounter, the Jiang group has a critical dimension defect on which the stainless steel mesh is placed; a f placed the critical dimension defect of the calcium phosphate stent; Day RPTT; harvested tissue after 2 weeks of surgery had a critical size defect with a stainless steel mesh placed thereon; a critical size defect with a calcium phosphate scaffold placed thereon; 6 days RPTT applied to the two employees; 12 weeks after surgery After harvesting organization __ has one on top The critical dimension defect of the stainless steel wire mesh; a critical size defect in which the calcium phosphate stent is placed; no gjTT (control) is applied; the tissue 4 is harvested after 2 weeks of surgery has a critical dimension defect on which the stainless steel mesh is placed; Place the critical size defect of the calcium phosphate scaffold on it; do not apply RPTT (control); harvest tissue after 12 weeks of surgery _. I control (no surgery; no RPTT) - 4 sham surgery (no defect, no implementation) RPTT): Harvested tissue after 6 days of surgery Table 1: Defects in the critical dimension defect tissue (eg, skull) of the trial protocol are sufficiently large that they will not heal by their own recovery. For rabbits, drilling a full thickness hole of approximately 15 mm in diameter through the skull creates a critical dimension defect in the skull. Referring more specifically to Figure 10, a tissue section of a rabbit skull having an original, undamaged 119637.doc -24-1325328 bone path is illustrated. The skeletal tissue of the skull is magenta. The surrounding soft tissue is white, and the periosteal layer is highlighted by a yellow asterisk. The rabbit skull is illustrated in Figure 11 after application of reduced-pressure tissue treatment for 6 days and subsequent immediate harvesting of tissue. The bones and periosteum can be seen and a layer of granulation tissue has formed. In Figure I2, the rabbit skull is illustrated after application of decompression tissue treatment for 6 days followed by immediate harvesting of tissue. The tissue section of Figure 12 is characterized by the formation of a new skeletal tissue beneath the granulation tissue. This skeletal tissue is highlighted by a yellow asterisk. In Fig. 13, the rabbit skull after the application of the decompressed tissue treatment for 6 days and immediately after harvesting the tissue is illustrated. You can see new bones and periosteum. The tissue appearance of the Moon Road tissue, which is opened by decompression tissue treatment, is very similar to the tissue appearance of bone formation in very young animals that are experiencing extremely rapid new bone growth and deposition. Referring more specifically to Figures 14-19, several photographs and tissue cuts are illustrated which show procedures and results for decompressing tissue treatment of a rabbit skull having a critical size defect. In Fig. 14, 'a rabbit skull having two critical size defects formed thereon is illustrated. These full thickness critical dimension defects have a diameter of about 15. In Figure 15, a stainless steel wire mesh has been placed over one of the critical dimension defects and a calcium phosphate stent has been placed within the second critical dimension defect. In Figure 16, a reduced pressure is applied to the critical dimension defects using a reduced pressure tissue treatment device similar to that described herein. The pressure applied to each buckle is _125 mm Hg gauge. The reduced pressure is applied according to one of the test protocols listed in Table 1. In the figure, the figure shows that after 6 days of decompression tissue treatment and 12 weeks after surgery, the skull was harvested after 119637.doc -25-, and woven. The slice shown contains a calcium phosphate scaffold, which is indicated by a red arrow to the significant growth of new bone tissue using decompressive tissue treatment, which is highlighted by a yellow asterisk in Figure 17. The amount of bone growth was significantly greater than the amount of bone growth in critical size defects that were treated with the same calcium phosphate scaffold but not treated with decompressive tissue. This observation suggests that there may be a treatment threshold or duration required to induce a new bone formation response. The effect of decompression tissue treatment was most pronounced in the samples collected 12 weeks after surgery, suggesting that decompression tissue treatment caused a cascade of biological events that enhanced the formation of new bone pathways. The critical size defect covered with a stainless steel mesh (Fig. 15) but without the stent material in the defect was used as an intra-animal control with minimal bone growth. "Hai and other shell materials highlight the advantages of proper scaffold materials and the positive effects of decompressive tissue treatment on stent fusion and bioavailability. In Figures 18 and 19, a radiograph of a critical dimension defect filled with a stent after six days of decompression tissue treatment is illustrated. Figure 18 illustrates a defect two weeks after surgery and shows that a certain new bone has been deposited in the stent. The main structure of the bracket is still clearly visible. Figure 19 illustrates the defect after twelve weeks of surgery and shows that the critical dimension defect is almost completely healed and the main stent architecture is nearly completely lost due to tissue fusion (i.e., the formation of a new bone path within the stent matrix). Referring to the circle 20', a reduced-pressure delivery system 7 11 according to an embodiment of the present invention performs decompression tissue treatment on the tissue site 7 of the patient. The reduced pressure delivery system 711 includes a manifold delivery tube 721. Manifold delivery tube 721 can be a catheter or cannula' and can include a device that enables manifold delivery tube 72i to be guided to tissue portion 713, such as a guide unit and a guide wire 727. Li9637.doc -26- 1325328 Endoscopic examination, ultrasound, fluoroscopy, auscultation, palpation or any other suitable localization technique can be used to achieve placement of the guide wire 727 and manifold delivery tube 721 and Guidelines. A manifold delivery tube 721 is provided for inserting a reduced pressure delivery device through the skin into the tissue site of the patient. 713. When passing through the skin, the manifold delivery tube 7; 21 preferably passes through a patient's skin group. The woven sterile insert is inserted into the sheath. In Figure 20, the tissue site 713 contains skeletal tissue at the fracture portion of the patient's bone 733. Manifold delivery tube 72 1 is inserted through skin 735 of the patient and any soft tissue 739 surrounding bone 733. As previously mentioned, the tissue site 713 can also comprise any type of tissue including, but not limited to, fat, muscle, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendon, or ligament. Referring to Figures 21 and 22, a reduced pressure delivery system 711 is further illustrated. The manifold transfer tube 721 can include a tapered distal end 743 for easy insertion through the patient's skin 735 and soft tissue 739. The tapered distal end 743 can be further configured to flex radially outwardly to an open position such that the inner diameter of the distal end 743 will be substantially the same or larger than the inner diameter of other portions of the tube 721. The opening position of the distal end 743 is schematically shown by dashed line 737 in FIG. Manifold delivery tube 721 further includes a passageway 751 in which a reduced pressure delivery device 761 or any other reduced pressure delivery device is included. The reduced pressure wheeling device 761 includes a flexible barrier 765 and/or a honeycomb material π?, as described with reference to Figures 6-8. The flexible barrier 765 and/or the honeycomb material % is preferably wound, folded or otherwise compressed around the reduced pressure delivery tube 769, = reducing the cross-sectional area of the reduced pressure delivery device 761 within the passage 751. 119637.doc

、A •27· 1325328 減壓輸送裝置761可放置於通路751内並在將歧管輸送管 721之遠端743放置於組織部位713處之後導引至組織部位 713。另一選擇為,可在將歧管輸送管721插入患者體内之 月’J ’將減壓輸送裝置761預先定位於通路751内。若要將減 壓輸送裝置761穿過通路751推動,可使用一生物相容性潤 滑劑來減小減壓輸送裝置761與歧管輸送管721間之摩檫。 當已將遠端743定位於組織部位713處並將減壓輸送裝置 761輪送至遠端743之後,然後將減壓輸送裝置761朝遠端 743推動,從而使遠端743沿徑向向外膨脹至開口位置。將 減壓輸送裝置761推出歧管輸送管721,較佳推入毗鄰組織 部位713之空隙或空間内。該空隙或空間通常藉由切開軟 組織而形成,此可藉由經過皮膚之途徑來完成。在某些情 況下,組織部位7丨3可位於傷口部位處,且因傷口解剖而 自然地存在-空^在其他情況下,該空隙可藉由氣球分 離、銳器分離、純器分離、水力分離、氣動分離、超音波 刀離電烙術分離、雷射分離或任何其他適宜之分離技術 來开/成田減壓輸送裝置761進入毗鄰組織部位7丨3之空隙 時’減壓輸送裝置761之撓性障壁765及/或蜂巢狀材料767 解除捲繞、解除折疊或解除壓縮(參見圖22),從而使減壓 輸送裝置761可與組織部位713相接觸地放置。儘管並非必 需如此,然而可使撓性障壁765及/或蜂巢狀材料承受 經由減壓輸送管769提供之真空或減低之麈力,以壓縮撓 性障壁765及/或蜂巢狀材料W。可藉由如下方式來達成 援性障壁765及/或蜂巢狀材料767之解除折疊··釋放經由 119637.doc -28- 1325328 減麼輸送管769輸送之減低之麼力,或者經由㈣輸送管 769提供正塵力,以幫助完成解除捲繞之過程。可使用内 窺鏡檢查、超音波、#光屏檢查、聽診、觸診或任何其他 適宜之局部化技街來達成減壓輸送裝置76ι之最終放置及 操縱。在放置減壓輸送裝置761之後,較佳自患者體内取 出歧管輸送管721,但與減壓輸送裝置761相關聯之減愿輸 送管仍保留於原位,以便能夠經過皮膚對組織部位713施 加減低之壓力。 參見圖23-25,根據本發明一實施例之減壓輸送系統8】工 包括一具有一錐形遠端843之歧管輸送管82ι,錐形遠端 843經構造以沿徑向向外撓曲至一開口位置,從而使遠端 843之内徑將基本相同於或者大於在管82丨之其他部分處之 内徑。遠端843之開口位置在圖23-25中由虛線837示意性 地顯示。 歧管輸送管821進一步包括一通路,在該通路中包含— 類似於本文所述其他減壓輸送裝置之減壓輸送裝置861。 減壓輸送裝置861包含一撓性障壁865及/或蜂巢狀材料 867,撓性障壁865及/或蜂巢狀材料867較佳捲繞、折叠或 以其他方式圍繞減壓輸送管869壓縮,以減小減壓輸送裳 置8 6 1在通路内之截面積。 一具有一内表面873之不滲透性薄膜871圍繞減壓輸送裝 置86 1設置,以使減壓輸送裝置861含納於不滲透性薄膜 87 1之内表面873内。不滲透性薄膜87 1可係一氣球、講 套、或能夠防止流體透過之任何其他類型之薄膜,以使不 119637.doc •29· 1325328 滲透性薄膜871可採取壓縮位置(參見圖23)、鬆弛位置(參 見圖24)及膨脹位置(參見圖25及25八)中之至少一個位置。 不滲透性薄膜871可密封地連接至歧管輸送管821,從而使 • 不滲透性薄膜871之内部空間873與歧管輸送管821之通路 • 机體連通。另一選擇為,不滲透性薄膜871可固定至減壓 輸送:869上,從而使不滲透性薄膜丨之内部空間與 減左輸送管869之通路流體連通。不滲透性薄膜871轉而可 φ 固定至一與内部空間873流體連通之單獨控制管或控制管 腔上(例如參見圖25A) » 在一實施例中,可提供不滲透性薄膜8<71來進一步減小 減壓輸送裝置861在通路内之截面積,為此,對不滲透性 薄膜871之内β卩空間873施加一低於不滲透性薄膜π〗之周 圍環i兄壓力之壓力《由此排出内部空間873内相當大的一 邓刀工氣或其他流體,從而將不滲透性薄膜871置於圖Μ 中所不之壓縮位置。在該壓縮位置上,不滲透性薄膜871 φ 被向内吸引,從而對減壓輸送裝置861施加一壓力,以進 v減小減壓輸送裝置86丨之截面積。如前面參照圖2 i及 22所述,可在將歧管輸送管821之遠端843佈置於組織部位 處之後將減壓輸送裝置861輸送至組織部位。可使用内窺 鏡k查、超音波、螢光屏檢查、聽診、觸診或任何其他適 且之局。卩化技術來達成不滲透性薄膜87丨及減壓輸送裝置 861之放置及操縱。不滲透性薄膜1可包含不透射線之標 μ'881,此會改良不滲透性薄膜W1在其移除之前在螢光屏 檢查下之可視性。 119637.doc -30- · ,¾ 1325328 在將減壓輸送裝置861推動穿過遠端843之後,可釋放施 加至内部空間873之減低之壓力,以將不滲透性薄膜871置 於鬆弛位置上(參見圖24),藉以有利於更容易地自不滲透 性薄膜871中移出減壓輸送裝置861。可提供一移出器具 885(例如套管、口針或其他尖銳器具)來弄破不滲透性薄膜 871。較佳地,移除器具885穿過減壓輸送管869插入,並 月b夠推進至接觸不滲透性薄膜8 71。在弄破不渗透性薄膜 871之後,可經由歧管輸送管821抽出移出器具885及不滲 透性薄膜871 ’從而使減壓輸送裝置861之撓性障壁865及/ 或蜂巢狀材料867能夠解除捲繞、解除折疊或解除壓縮, 從而可使減壓輸送裝置861接觸組織部位放置。撓性障壁 865及/或蜂巢狀材料867之解除捲繞可在釋放内部空間873 中減低之壓力並移出不滲透性薄膜8 71之後自動地發生。 在某些情況下,可經由減壓輸送管869輸送正壓力來幫助 將撓性障壁865及/或蜂巢狀材料867解除捲繞或解除壓 知百。在最終放置減壓輸送裝置86丨之後,較佳自患者體内 移出歧管輸送管821 ’但與減壓輸送裝置861相關聯之減壓 輸送管869仍保留於原位’以便能夠經過皮膚對組織部位 施加減低之壓力。 不滲透性薄膜871亦可用於在將減壓輸送裝置86丨貼靠組 織部位放置之前分離毗鄰組織部位之組織。在穿過歧管輸 送管821之遠端843推動減壓輸送裝置861及完好之不滲透 性薄膜871之後,將空氣或另一種流體注入或泵送入不滲 透性薄膜871之内部空間873内。較佳使用液體來使不滲透 il9637.doc •31 ·, A • 27· 1325328 The reduced pressure delivery device 761 can be placed in the passage 751 and guided to the tissue site 713 after the distal end 743 of the manifold delivery tube 721 is placed at the tissue site 713. Alternatively, the reduced pressure delivery device 761 can be pre-positioned in the passage 751 at a month 'J' where the manifold delivery tube 721 is inserted into the patient. To push the pressure reducing delivery device 761 through the passage 751, a biocompatible lubricant can be used to reduce the friction between the reduced pressure delivery device 761 and the manifold delivery tube 721. After the distal end 743 has been positioned at the tissue site 713 and the reduced pressure delivery device 761 is rotated to the distal end 743, the reduced pressure delivery device 761 is then pushed toward the distal end 743 such that the distal end 743 is radially outward. Expand to the open position. The reduced pressure delivery device 761 is pushed out of the manifold delivery tube 721, preferably into a void or space adjacent the tissue site 713. This void or space is usually formed by incision of soft tissue, which can be accomplished by a route through the skin. In some cases, the tissue site 7丨3 can be located at the wound site and naturally exists due to the anatomy of the wound—in other cases, the void can be separated by a balloon, separated by a sharp device, separated by a pure device, and hydraulically Separation, pneumatic separation, ultrasonic knife separation from electrocautery, laser separation or any other suitable separation technique to open/field decompression delivery device 761 into the gap adjacent to the tissue site 7丨3 'reduced delivery device 761 The flexible barrier 765 and/or the honeycomb material 767 are unwound, unfolded, or decompressed (see FIG. 22) such that the reduced pressure delivery device 761 can be placed in contact with the tissue site 713. Although not necessarily required, the flexible barrier 765 and/or the honeycomb material may be subjected to a vacuum or reduced force provided via the reduced pressure delivery tube 769 to compress the flexible barrier 765 and/or the honeycomb material W. The relief of the aid barrier 765 and/or the honeycomb material 767 can be achieved by reducing the delivery of the delivery tube 769 via 119637.doc -28-13325328, or via the (four) delivery tube 769. Provides positive dust to help complete the unwinding process. End placement, manipulation, manipulation, auscultation, palpation, or any other suitable localization technique can be used to achieve final placement and manipulation of the reduced pressure delivery device 76i. After placement of the reduced pressure delivery device 761, the manifold delivery tube 721 is preferably removed from the patient, but the reduced delivery tube associated with the reduced pressure delivery device 761 remains in place to enable passage of the skin to tissue site 713 Apply a reduced pressure. Referring to Figures 23-25, a reduced pressure delivery system 8 in accordance with an embodiment of the present invention includes a manifold delivery tube 82i having a tapered distal end 843 that is configured to flex radially outwardly. The curve is bent to an open position such that the inner diameter of the distal end 843 will be substantially the same or larger than the inner diameter at the other portion of the tube 82. The position of the opening of the distal end 843 is shown schematically by dashed line 837 in Figures 23-25. Manifold delivery tube 821 further includes a passageway containing a reduced pressure delivery device 861 similar to other reduced pressure delivery devices described herein. The reduced pressure delivery device 861 includes a flexible barrier 865 and/or honeycomb material 867 that is preferably wound, folded, or otherwise compressed around the reduced pressure delivery tube 869 to reduce The small decompression transporter sets the cross-sectional area of the 8 6 1 in the passage. An impervious film 871 having an inner surface 873 is disposed around the reduced pressure delivery device 86 1 such that the reduced pressure delivery device 861 is contained within the inner surface 873 of the impermeable membrane 87 1 . The impervious film 87 1 can be a balloon, a sleeve, or any other type of film capable of preventing fluid permeation so that the permeable film 871 can take a compressed position (see Figure 23), At least one of a relaxed position (see Figure 24) and an expanded position (see Figures 25 and 25). The impervious film 871 is sealingly coupled to the manifold delivery tube 821 such that the interior space 873 of the impermeable membrane 871 communicates with the passageway of the manifold delivery tube 821. Alternatively, the impermeable membrane 871 can be secured to the reduced pressure delivery: 869 such that the interior space of the impermeable membrane crucible is in fluid communication with the passage of the reduced left delivery tube 869. The impermeable membrane 871 can in turn be φ fixed to a separate control tube or control lumen in fluid communication with the interior space 873 (see, for example, Figure 25A). In one embodiment, an impermeable membrane 8<71 can be provided. Further reducing the cross-sectional area of the reduced pressure conveying device 861 in the passage, for this purpose, applying a pressure lower than the pressure of the surrounding ring of the impervious film π to the β卩 space 873 within the impermeable film 871 This discharges a relatively large amount of Deng knife gas or other fluid within the interior space 873, thereby placing the impermeable membrane 871 in a compression position not shown in the figure. At the compressed position, the impermeable film 871 φ is attracted inwardly, thereby applying a pressure to the decompression conveying device 861 to reduce the cross-sectional area of the decompression conveying device 86. As previously described with reference to Figures 2i and 22, the reduced pressure delivery device 861 can be delivered to the tissue site after the distal end 843 of the manifold delivery tube 821 is disposed at the tissue site. Endoscopy k-checks, ultrasound, fluoroscopy, auscultation, palpation, or any other appropriate procedure can be used. Deuteration technology is used to achieve placement and manipulation of the impervious film 87 and the reduced pressure delivery device 861. The impermeable film 1 may contain the radiopaque label μ'881, which improves the visibility of the impermeable film W1 under the fluorescent screen inspection before it is removed. 119637.doc -30-, , 3⁄4 1325328 After pushing the reduced pressure delivery device 861 through the distal end 843, the reduced pressure applied to the interior space 873 can be released to place the impermeable membrane 871 in a relaxed position ( Referring to Figure 24), it is advantageous to more easily remove the reduced pressure delivery device 861 from the impermeable membrane 871. A removal device 885 (e.g., a cannula, a needle or other sharp instrument) can be provided to break the impermeable membrane 871. Preferably, the removal tool 885 is inserted through the reduced pressure delivery tube 869 and is advanced enough to contact the impermeable membrane 81. After the impervious film 871 is broken, the removal device 885 and the impermeable film 871' can be withdrawn via the manifold delivery tube 821 to enable the flexible barrier 865 and/or the honeycomb material 867 of the reduced pressure delivery device 861 to be unwound. Winding, unfolding or uncompressing allows the reduced pressure delivery device 861 to be placed in contact with the tissue site. The unwinding of the flexible barrier 865 and/or the honeycomb material 867 can occur automatically after releasing the reduced pressure in the interior space 873 and removing the impermeable membrane 81. In some cases, positive pressure may be delivered via the reduced pressure delivery tube 869 to help unwind or depress the flexible barrier 865 and/or the honeycomb material 867. After the final placement of the reduced pressure delivery device 86, the manifold delivery tube 821' is preferably removed from the patient but the reduced pressure delivery tube 869 associated with the reduced pressure delivery device 861 remains in place to enable passage through the skin pair The tissue site is subjected to reduced pressure. The impervious film 871 can also be used to separate tissue adjacent to the tissue site prior to placement of the reduced pressure delivery device 86(R) against the tissue site. After the reduced pressure delivery device 861 and the intact impermeable membrane 871 are pushed through the distal end 843 of the manifold delivery tube 821, air or another fluid is injected or pumped into the interior space 873 of the impermeable membrane 871. It is better to use liquid to make it impervious. il9637.doc •31 ·

釋來弄破不滲透性薄膜871, <二軋或其他流體,以使不 位置。然後,可如上文所解 並晚鄰組織部位插入減壓輸 送裝置861。 參見圖25A,若不滲透性薄臈871主要用於分離毗鄰組織 部位處之組織,則不滲透性薄膜871可密封地固定至歧管 輸迗管821上,從而使内部空間873與一關聯於或固定至歧 官輸送管821之辅助管腔或管891流體連通。輔助管腔891 可用於向内部空間873輸送液體、空氣或其他流體,以將 不滲透性薄膜871置於膨脹位置。在分離之後,可如前面 參照圖24所述使不滲透性薄膜871鬆弛並將其弄破。 參見圖26 ’根據本發明一實施例之減壓輸送系統911包 括一具有一錐形遠端943之歧管輸送管921,錐形遠端943 經構造以沿徑向向外-撓曲至一開口位置’從而使遠端943 之内控將基本相同於或者大於在管921之其他部分處之内 控。遠端943之開口位置在圖26中由虛線937示意性地顯 歧¥輸送管921進一步包括一通路,在該通路中包含一 119637.doc -32- 1325328 類似於本文所述其他減壓輸送裝置之減壓輸送裝置96ι。 減壓輸送裝置961包含一撓性障壁965及/或蜂巢狀材料 967,撓性障壁965及/或蜂巢狀材料967較佳捲繞、折疊或 以其他方式圍繞減壓輸送管969壓縮,以減小減壓輸送裝 置961在歧管輸送管92丨之通路内之截面積。 一具有一内表面973之不滲透性薄膜971圍繞減壓輸送裝 置961設置,以使減壓輸送裝置961含納於不滲透性薄膜 971之内表面973内。不滲透性薄膜97丨在不滲透性薄膜971 之一端上包含一膠封977,以提供一種自不滲透性薄膜971 上移出減壓輸送裝置961之替代方法。不滲透性薄膜971可 密封地連接至歧管輸送管921,從而使不滲透性薄膜971之 内部空間973與歧管輸送管921之通路流體連通。另一選擇 為,不滲透性薄臈971可固定至一與内部空間973流體連通 之單獨控制管(未顯示)。 類似於圖23中之不滲透性薄膜871,不滲透性薄膜971可 能夠防止流體透過,以使不滲透性薄臈971可採取壓縮位 置、鬆弛位置及膨脹位置中之至少一個位置。由於用於將 不滲透性薄膜971放置於壓縮位置及膨脹位置上之程序類 似於不滲透性薄膜871,因而僅對移出減壓輸送裝置961之 過程加以說明。 使用内窺鏡檢查、超音波、螢光屏檢查、聽診、觸診或 任何其他適宜之局部化技術將減壓輸送裝置961輸送至不 滲透性薄膜97i内之組織部位上並隨後將其正確地定位。 不滲透性薄膜971可包含不透射線之標誌981,此會改良不 H9637.doc -33· 1325328 渗透性薄膜971在其移除之前在螢光屏檢查下之可視性。 然後將減壓輸送裝置961穿過歧管輸送管921之遠端943加 以推動。可釋放施加至内部空間973之減低之壓力,以將 不滲透性薄膜971置於鬆弛位置上。然後,將減壓輸送裝 置961穿過膠封977推動,以推出不滲透性薄膜971。 參見圖26A,一根據本發明一實施例之減壓輸送系統985 可不包括類似於圖26所示歧管輸送管921之歧管輸送管。 而是’減壓輸送系統985可包括一導引金屬絲987、一減壓 輸送管9 89、及一減壓輸送裝置mi。減壓輸送裝置99 含複數個流體連接至減壓輸送管989之流動通道。並非使 用一獨立之歧管輸送管來輸送減壓輸送裝置991,而是將 減壓輸送裝置991及減壓輸送管989置於導引金屬絲987 上,經過皮膚將導引金屬絲987導引至一組織部位993上。 較佳地,導引金屬絲987及減壓輸送管989藉由一無菌護套 穿透患者之皮膚。藉由沿導引金屬絲987導引減壓輸送管 989及減壓輸送裝置991 ’可將減壓輸送裝置991置於組織 部位993處,以達成經過皮膚來應用減壓組織治療。 由於減壓輸送裝置991在輸送至組織部位993期間並不約 束於一歧管輸送管中,因而較佳在輸送期間使減壓輸送裝 置991保持處於壓縮位置。若使用一彈性發泡體作為減壓 輸送裝置991,可對該發泡體塗覆一種生物相容性可溶解 黏合劑並壓縮該發泡體。在到達該組織部位之後,體液或 經由減壓輸送管989輸送之其他流體會溶解該黏合劑,從 而使該發泡體膨脹而接觸組織部位。另一選擇為,可自一 119637.doc •34· 1325328 種壓縮之幹態水凝膠製成減壓輸送裝置991。該水凝膠在 輸送至組織部位993之後吸收水份,從而能夠使減壓輸送 裝置991膨脹。再一種減壓輸送裝置991可自熱活性材料 (例如聚乙二醇)製成’該熱活性材料在受到患者體溫之作 用時會膨脹。在再—實施例中,可在—可溶解薄膜中將經 壓縮之減壓輸送裝置991輸送至組織部位993。 參見圖27,一根據本發明一實施例之減壓輸送系統丨〇上工 包括一具有一遠端1〇43之歧管輸送管1〇21,遠端ι〇43插穿 過患者之一組織而接觸到組織部位1025。組織部位1 〇25可 包合一與傷口或其他缺損相關聯之空隙1029,或者另一選 擇為,可藉由分離(包括本文所述之分離技術)來形成一空 隙。 在將遠端1043毗鄰組織部位1〇25放置於空隙1〇29内之 後,經由歧管輸送管1〇21將一可注射、可傾倒或可流動之 減壓輸送裝置1035輸送至組織部位1025處。減壓輸送裝置 1035在輸送至組織部位期間較佳以一可流動狀態存在,且 然後在到達之後’形成複數個流動通道以便分佈減低之壓 力或流體。在某些情形中,該可流動材料在到達組織部位 處之後可藉由一乾燥過程、固化過程或其他化學或物理反 應而硬化成固體狀態。在其他情形中,該可流動材料在輸 送至組織部位之後可在原位形成發泡體。還有其他材料可 以凝膠狀狀態存在於組織部位1〇25處,但仍具有複數個用 於輸送減低之壓力之流動通道。輸送至組織部位1〇25處之 減壓輸送裝置1 035之量可足以部分地或完全填充空隙 119637.doc 1325328 1029。減壓輸送裝置1〇35可包含歧管與支架二者之態樣。 作為歧官,減壓輸送裝置丨035包含複數個孔或開放孔該 複數個孔或開放孔可在輸送至空隙1〇29之後形成於材料 中。3亥等孔或開放孔相互連通,由此形成複數個流動通 道。該等流動通道用於對組織部位1〇25應用及分佈減低之 壓力。作為支架,減壓輸送裝置丨〇3 5係生物可再吸收性的 並用作可在上面生長新組織之基材。 在一實施例中’減壓輸送裝置1035可包含分佈於整個液 體或黏性凝膠中之poragen,例如NaCl或其他鹽。在將該 液體或黏性凝膠輸送至組織部位1〇25之後,該材料貼覆至 空隙1029上並隨後固化成一實體。水溶性]^3(:1卩沉吨⑶在 存在體液之情況下溶解,從而留下一具有互連之孔或流動 通道之結構。對該等流動通道輸送減低之壓力及/或流 體。隨著新組織之形成,組織會長入減壓輪送裝置丨〇35之 孔内,並隨後最終隨著減壓輸送裝置1035之降解而取代減 壓輸送裝置1035。在該特定實例中,減壓輸送裝置1〇35不 僅用作歧管’而且還用作新組織生長支架。 在另一實施例中’減壓輸送裝置1035係—與4〇〇 μιη甘露 糖顆粒相混合之藻酸鹽。該等P〇ragen或顆粒可在組織部 位處被局部體液或被沖洗流體或輸送至減壓輸送裝置1〇35 之其他流體溶解》在溶解p〇ragen或顆粒之後,先前由該 等poragen或顆粒佔據之空間變成空隙,該等空隙彼此互 連’以在減壓輸送裝置1035内形成流動通道。 在材料中使用poragen來形成流動通道係有效的,但其 I19637.doc -36- 1325328 亦會形成尺寸僅限於大約所選poragen之粒徑之孔及流動 通道。可使用化學反應取代poragen藉由形成氣態副產物 而形成更大之孔。舉例而言,在一實施例中,可將一包含 碳酸氫鈉及擰檬酸微粒(可使用非化學計量)之可流動材料 輸送至組織部位1025。當該可流動材料在原位形成一發泡 體或固體時’體液將會引起碳酸氫鈉與檸檬酸間之酸鹼 反應。與依靠poragen溶解之技術相比,所形成之二氧化Interrupted to break the impervious film 871, <two rolling or other fluids, so as not to position. Then, the reduced pressure delivery device 861 can be inserted as described above and at the site of the adjacent tissue. Referring to Fig. 25A, if the impervious sheet 871 is primarily used to separate tissue adjacent to the tissue site, the impermeable membrane 871 can be sealingly secured to the manifold tube 821, thereby correlating the interior space 873 with Or the auxiliary lumen or tube 891 secured to the manifold delivery tube 821 is in fluid communication. The auxiliary lumen 891 can be used to deliver liquid, air or other fluid to the interior space 873 to place the impermeable membrane 871 in the expanded position. After the separation, the impermeable film 871 can be relaxed and broken as described above with reference to Fig. 24. Referring to Figure 26, a reduced pressure delivery system 911 in accordance with an embodiment of the present invention includes a manifold delivery tube 921 having a tapered distal end 943 that is configured to flex radially outwardly to a The open position 'so that the internal control of the distal end 943 will be substantially the same or greater than the internal control at other portions of the tube 921. The open position of the distal end 943 is schematically distorted by the dashed line 937 in Figure 26. The delivery tube 921 further includes a passageway containing a 119637.doc -32-1325328 similar to other reduced pressure delivery devices described herein. The pressure reducing conveying device 96ι. The reduced pressure delivery device 961 includes a flexible barrier 965 and/or honeycomb material 967 that is preferably wound, folded or otherwise compressed around the reduced pressure delivery tube 969 to reduce The cross-sectional area of the small reduced pressure delivery device 961 within the passage of the manifold delivery tube 92. An impervious film 971 having an inner surface 973 is disposed around the reduced pressure delivery device 961 such that the reduced pressure delivery device 961 is contained within the inner surface 973 of the impermeable membrane 971. The impermeable film 97A includes a seal 977 on one end of the impermeable film 971 to provide an alternative method of removing the reduced pressure delivery device 961 from the impermeable film 971. The impermeable membrane 971 is sealingly coupled to the manifold delivery tube 921 such that the interior space 973 of the impermeable membrane 971 is in fluid communication with the passage of the manifold delivery tube 921. Alternatively, the impervious sheet 971 can be secured to a separate control tube (not shown) in fluid communication with the interior space 973. Similar to the impermeable film 871 of Fig. 23, the impermeable film 971 can prevent fluid from permeating so that the impervious sheet 971 can take at least one of a compression position, a relaxed position, and an expanded position. Since the procedure for placing the impermeable film 971 on the compression position and the expansion position is similar to the impermeable film 871, only the process of removing the decompression conveying device 961 will be described. The reduced pressure delivery device 961 is delivered to the tissue site within the impermeable membrane 97i using endoscopy, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique and then correctly Positioning. The impermeable film 971 can include a radiopaque marker 981 which improves the visibility of the permeable film 971 under the screen inspection prior to its removal. The reduced pressure delivery device 961 is then pushed through the distal end 943 of the manifold delivery tube 921. The reduced pressure applied to the interior space 973 can be released to place the impermeable membrane 971 in a relaxed position. Then, the reduced pressure conveying device 961 is pushed through the glue seal 977 to push out the impervious film 971. Referring to Figure 26A, a reduced pressure delivery system 985 in accordance with an embodiment of the present invention may not include a manifold delivery tube similar to the manifold delivery tube 921 of Figure 26. Rather, the reduced pressure delivery system 985 can include a guide wire 987, a reduced pressure delivery tube 909, and a reduced pressure delivery device mi. The reduced pressure delivery device 99 includes a plurality of fluids connected to the flow passage of the reduced pressure delivery tube 989. Instead of using a separate manifold delivery tube to deliver the reduced pressure delivery device 991, the reduced pressure delivery device 991 and the reduced pressure delivery tube 989 are placed over the guide wire 987, which guides the guide wire 987 through the skin. To a tissue part 993. Preferably, the guide wire 987 and the reduced pressure delivery tube 989 penetrate the skin of the patient by a sterile sheath. The reduced pressure delivery device 991 can be placed at the tissue site 993 by guiding the reduced pressure delivery tube 989 and the reduced pressure delivery device 991' along the guide wire 987 to effect application of reduced pressure tissue treatment through the skin. Since the reduced pressure delivery device 991 is not constrained in a manifold delivery tube during delivery to the tissue site 993, it is preferred to maintain the reduced pressure delivery device 991 in the compressed position during delivery. If an elastic foam is used as the reduced pressure conveying means 991, the foam can be coated with a biocompatible soluble adhesive and the foam can be compressed. After reaching the tissue site, the body fluid or other fluid delivered via the reduced pressure delivery tube 989 dissolves the binder, thereby expanding the foam to contact the tissue site. Alternatively, a reduced pressure delivery device 991 can be fabricated from a compressed dry hydrogel of 119637.doc • 34·1325328. The hydrogel absorbs moisture after being transported to the tissue site 993, so that the reduced pressure delivery device 991 can be inflated. Still another reduced pressure delivery device 991 can be made from a thermally active material (e.g., polyethylene glycol)' that thermally expands upon exposure to the patient's body temperature. In a further embodiment, the compressed reduced pressure delivery device 991 can be delivered to the tissue site 993 in a dissolvable film. Referring to Fig. 27, a decompression delivery system according to an embodiment of the present invention includes a manifold delivery tube 1〇21 having a distal end 〇43, and a distal end 〇43 inserted through one of the patient tissues. The tissue portion 1025 is accessed. Tissue site 1 〇 25 may comprise a void 1029 associated with a wound or other defect, or alternatively, a void may be formed by separation, including the separation techniques described herein. After the distal end 1043 is placed adjacent to the tissue site 1〇25 in the void 1〇29, an injectable, pourable or flowable reduced pressure delivery device 1035 is delivered to the tissue site 1025 via the manifold delivery tube 1〇21. . The reduced pressure delivery device 1035 is preferably present in a flowable state during delivery to the tissue site, and then, upon arrival, forms a plurality of flow channels for distributing the reduced pressure or fluid. In some cases, the flowable material can be hardened to a solid state by a drying process, a curing process, or other chemical or physical reaction after reaching the tissue site. In other cases, the flowable material can form a foam in situ after delivery to the tissue site. Still other materials may exist in the gel state at the tissue site 1 〇 25, but still have a plurality of flow channels for delivering reduced pressure. The amount of reduced pressure delivery device 1 035 delivered to the tissue site 1 〇 25 may be sufficient to partially or completely fill the void 119637.doc 1325328 1029. The reduced pressure delivery device 1A can include both the manifold and the stent. As a discriminator, the reduced pressure delivery device 丨035 includes a plurality of holes or open holes which may be formed in the material after being transported to the gaps 1〇29. The three holes or the open holes communicate with each other, thereby forming a plurality of flow channels. These flow channels are used to apply and reduce the pressure on the tissue site 1〇25. As a stent, the reduced pressure delivery device is bioresorbable and serves as a substrate on which new tissue can be grown. In one embodiment, the reduced pressure delivery device 1035 can comprise a poragen, such as NaCl or other salt, distributed throughout the liquid or viscous gel. After the liquid or viscous gel is delivered to the tissue site 1 〇 25, the material is applied to the void 1029 and subsequently cured into a solid. Water-soluble]^3(:1 卩 吨 (3) dissolves in the presence of body fluids, leaving a structure with interconnected pores or flow channels that deliver reduced pressure and/or fluid to the flow channels. With the formation of a new tissue, the tissue leader enters the hole of the decompression transfer device 丨〇 35 and then eventually replaces the reduced pressure delivery device 1035 with the degradation of the reduced pressure delivery device 1035. In this particular example, the reduced pressure delivery The device 1〇35 is used not only as a manifold but also as a new tissue growth scaffold. In another embodiment, the 'reduced delivery device 1035 is an alginate mixed with 4〇〇μη mannose granules. P〇ragen or particles may be dissolved at the tissue site by local bodily fluids or by the flushing fluid or other fluids delivered to the reduced pressure delivery device 1〇35. After dissolving the p〇ragen or particles, previously occupied by the poragen or particles The space becomes a void that interconnects with each other to form a flow channel within the reduced pressure delivery device 1035. The use of poragen in the material to form the flow channel is effective, but its I19637.doc -36-1325328 will also form a ruler. It is limited to pores and flow channels of the particle size of the selected poragen. Chemical reactions can be used in place of poragen to form larger pores by forming gaseous by-products. For example, in one embodiment, one can contain hydrogen carbonate. The flowable material of sodium and citric acid microparticles (which can be used without a stoichiometry) is delivered to the tissue site 1025. When the flowable material forms a foam or solid in situ, the body fluid will cause sodium bicarbonate and citric acid. Acid-base reaction. Compared with the technology of relying on poragen dissolution, the formed dioxide

碳氣體微粒會在整個減壓輸送裝置1〇35中形成更大之孔及 流動通道。 減壓輸送裝置1035自液體或黏性凝膠向固體或發泡體之 轉變可藉由pH值、溫度、《、或與體液、化學品或輸送至 組織部位之其他物質之反應來觸發。亦可藉由混合多種反 應性組份來進行此種轉變。在一實施例中,藉由選擇由生 物:再吸收性聚合物製成之生物可再吸收性微球體來製備 減壓輸运裝置1035。該等微球體分散於—含有光起始劑及The carbon gas particles form larger pores and flow channels throughout the reduced pressure delivery device 1〇35. The conversion of the reduced pressure delivery device 1035 from a liquid or viscous gel to a solid or foam can be triggered by pH, temperature, ", or reaction with body fluids, chemicals, or other materials delivered to the tissue site. This transformation can also be carried out by mixing a plurality of reactive components. In one embodiment, the reduced pressure transport device 1035 is prepared by selecting bioresorbable microspheres made from a bio:resorbable polymer. The microspheres are dispersed in - containing a photoinitiator and

水凝膠形成材料(例如透明質酸、膠原或具有紅應基團 之聚乙二醇)之溶液中。使微球體-凝膠混合物暴露於光中 一暫之時間又,以使水凝膠局部地交聯並使水凝膠固定 於微球體上。姐山β μ 〇 一 排出多餘之溶液,並隨後對微球體進行乾 、’藉由庄#或傾倒,將該等微球體輸送至組織部位處, J迟之後邊混合物會吸收水份,且水凝膠塗層變成 水合塗μ。妙你 χ 曰後,再次將該混合物暴露於光中,由此使該 等微球體交聯,π二…。+ 而形成複數個流動通道。該等交聯之微 球體然後用作_ 认 用於向組織部位輸送減低之壓力之歧管及 119637.doc -37- .$:; 'i 一用於促進新組織生長之多孔支架。 除本文中之前述各實施例外,減壓輸送裝置1〇35可自各 種各樣之材料製成,包括但不限於磷酸鈣、膠原、藻酸 鹽、纖維素、或任何其他能夠以氣體、液體、凝膠、膏 糊油灰、漿液、懸浮液或其他可流動材料形式輪送至組 織部位並能夠形成與組識部位流體連通之多個流動路徑之 等效材料。該可流動材料可進一步包括固體微粒,例如顆 粒,若該等固體微粒之粒徑足夠小,貝,以能夠㉟由歧管輪 迗官1021流動。以可流動狀態輸送至組織部位之材料可在 原位聚合或形成凝膠。 如前面所述,可將減壓輸送裝置1〇35直接注射或傾倒至 毗鄰組織部位1025之空隙1029内。參見圖27A,歧管輪送 管1021可在歧管輸送管1〇21之遠端1〇43處包含不滲透性或 半滲透性薄膜1051 ^薄膜1〇51包含一内部空間1〇55,内部 空間1055與一固定至歧管輸送管1〇21之輔助管腔1〇57流體 連通。歧管輸送管1021係於一導引金屬絲1〇61上導引至組 織部位1025處。 減壓輸送裝置1035可經由辅助管腔1〇57來注射或傾倒, 以填充薄膜1051之内部空間1055。當流體或凝膠填充薄膜 1051時,薄膜1〇51膨脹以填充空隙1〇29,從而使薄膜接觸 組織部位1 025。當薄膜1 〇5 1膨脹時,薄膜1 〇5丨可用於分離 ®比鄰或靠近組織部位1025之額外組織《若薄膜丨〇5丨係不滲 透性薄膜,則可藉由物理方式弄破並移除之,從而使減壓 輸送裝置1035接觸組織部位1〇25。另一選擇為,薄膜1〇51 li9637.doc -38- 1325328 可自-種在存在體液或輸送至薄膜則之生物相容性溶劑 時會溶解之可溶解材料製成。若薄膜丨〇5丨係半滲透性,則 薄膜1051可保留於原位。半滲透性薄膜則能夠向組織部 位1025傳送減低之壓力及可能其他流體。 參見圖28,一種施行減壓組織治療之方法丨丨丨丨包括在 1115處藉由外科手術在毗鄰組織部位處插入一歧管,該歧 管具有自一撓性障壁伸出之複數個突起物,以在該等突起 物之間形成複數個流動通道。在1119處對該歧管進行定 位,使該等突起物中之至少一部分接觸該組織部位。在 II23處,經由該歧管對組織部位施加減低之壓力。 ,見0 2 9 種對一組織部位施行減壓組織治療之方法 1211包括在1215處經過皮膚毗鄰該組織部位插入一歧管。 該歧管可包含自一撓性障壁伸出之複數個突起物,以在該 等突起物之間形成複數個流動通道。另一選擇為,該歧管 可包含蜂巢狀材料,在該蜂巢狀材料内具有複數個流動通 道。另一選擇為,該歧管可由可注射或可傾倒之材料形 成,該可注射或可傾倒之材料輸送至該組織部位並在到達 該組織部位之後形成複數個流動通道。在1219處,對該歧 I進行定位’使該等流動通道之至少一部分與該組織部位 流體連通。在1223處,經由該歧管對組織部位施加減低之 壓力。 參見圖30,一種對組織部位施行減壓組織治療之方法 1311包括在1315處經過皮膚穿過患者之一組織插入一具有 通路之管,以使該管之遠端毗鄰該組織部位玫置。在1319 I19637.doc -39- 1325328 處,可使一與該管相關聯之氣球膨脹,以分離毗鄰該組織 部位之組織,藉以形成一空隙。在1323處,穿過該通道輸 送一歧管。該歧管可包含自一撓性障壁伸出之複數個突起 物,以在該等突起物之間形成複數個流動通道。另一選擇 為,該歧管可包含蜂巢狀材料,在該蜂巢狀材料内具有複 數個流動通道。另一選擇為,該歧管可如上文參照圖27所 述由輸送至该組織部位之可注射或可傾倒材料形成。在 1327處,對該歧管進行定位,使該等流動通道之至少一部 分與該組織部位流體連通。在1331處,經由一減壓輸送管 或任何其他輸送途徑藉由該歧管對該組織部位應用減低之 壓力。 參見圖3 1 ’ 一種對組織部位施行減壓組織治療之方法 1411包括在1415處經過皮膚穿過患者之一組織插入一具有 通路之管’以使該管之遠端毗鄰該組織部位放置。在1423 處,在一不滲透性護套内經由該通路將一歧管輸送至該組 織部位處,該不滲透性護套在1419處已經受一小於護套環 境壓力之第一減低之壓力。在1427處,將該護套弄破,以 使該歧管接觸該組織部位。在丨43丨處,經由該歧管對該組 織部位施加一第二減低之壓力。 參見圖32及33,一根據本發明一實施例之減壓輸送裝置 1511包括一用於替換患者腿節1517之現有股骨頭之整形外 科體假體1515。髖假體1515包括一柱部分1521及一頭部分 1525.柱部分1521細長,以便插入於一在腿節1517之骨幹 中鉸出之通路1529内。一多孔塗層1535設置於該柱部分周 119637.doc -40- 圍並較佳由燒結或玻璃化之陶瓷或金屬構造而成。另一選 擇為,可圍繞該枉部分設置一具有多孔特性之蜂巢狀材 料。複數個流動通道1541設置於髖假體i 5丨5之柱部分丨52 i 内,以使流動通道1541與多孔塗層丨535流體連通。一連接 埠1545流體連接至流動通道1541,該埠構造成可釋脫地連 接至一減壓輸送管1551及一減壓輸送源1 553 ^流動通道 1 541用於在植入髖假體15 1 5之後向環繞髖假體15 1 5之多孔 塗層1535及/或骨胳輸送減低之壓力。流動通道1541可包 含一與數個橫向分支管線1 547流體連通之主饋送管線 1543,該數個橫向分支管線1547與多孔塗層1535相連通。 橫向分支管線1545可如在圖32中所示垂直於主饋送管線 15 43定向,或者可與主饋送管線15 43成某些夾角定向。一 種用於分佈減低之壓力之替代方法包括:提供一中空之體 假體’並以一種能夠與多孔塗層15 3 5流體連通之蜂巢狀 (較佳係開放孔)材料來填充該假體之内部空間。 更具體地參見圖33 ’體假體1515可進一步在柱部分1521 内包括第二複數個流動通道15 6 1,以對環繞髖假體1 5丨5之 多孔塗層1 5 3 5及/或骨骼提供流體。該流體可包括經過濾 之空氣或其他氣體、抗菌劑、抗病毒劑、纟田胞生長促進 知丨沖洗流體、化學活性流體或任何其他流體。若期望將 多種流體引入至環繞髖假體1515之骨骼,可提供額外之流 體連通路徑。一連接埠1565流體連接至流動通道1561,該 埠1565構造成可釋脫地連接至一流體輸送管i 571及一流體 輸送源1 573。流動通道1 561可包含一與數個橫向分支管線 119637.doc -41 - 1325328 1 5 8 5流體連通之主饋送官線15 8 3,該數個橫向分支管線 1585與多孔塗層1535相連通。橫向分支管線1585可如在圖 33中所示垂直於主饋送管線15 83定向,或者可與主饋送管 線1583成某些夾角定向。 減低之壓力向第一複數個流動通道1 5 41之輸送及流體向 第二複數個流動通道1561之輸送可藉由單獨之管(例如減 壓輸送管1551及流體輸送管1571)來完成。另一選擇為, 可使用一如本文中前面所述具有多個管腔之管來分離用於 輸送減低之壓力與流體之連通路徑。應進一步注意,儘管 較佳在髖假體1515内提供分離之流體連通路徑,然而亦可 使用第一複數個流動通道1 5 4 1將減低之壓力與流體二者輸 送至環繞髖假體1 5 15之骨骼。 如前面所述,對骨骼組織應用減低之壓力會促進及加速 新骨骼組織之生長。藉由使用髖假體15 15作為歧管將減低 之壓力輸送至環繞髖假體之骨骼區域,會使腿節15 17之恢 復更快,且髖假體1 5 1 5會更成功地與骨骼結合於一起。提 供第二複數個流動通道1561來排放環繞髖假體1515之骨路 會改良環繞假體之新骨骼之成功再生。 在經由體假體15 15應用減低之壓力達一所選之時間量之 後’可將減壓輸送管1551及流體輸送管1571自連接琿 1545、1565斷開並自患者體中移出一較佳不使用外科手術 侵害性程序。連接埠1545、1565與管1551、1571間之連接 可係一可用手釋脫之連接’此可藉由在患者身體外侧對管 1S51、1571施加一軸向拉力來實施。另一選擇為,連接埠 U9637.doc -42· 1545、1565可在存在所選流體或化學品之條件下為生物可 再吸收性或可溶解的,以便可藉由使連接槔1545、1565暴 路於流體或化學品中而達成管1551.、1571之釋脫。管 1551、1571亦可由一種會在一段時間内溶解之生物可再吸 收性材料或一種在存在特定化學品或其他物質條件下會溶 解之活化材料製成。 減壓輸送源1553可在患者體外提供並連接至減壓輸送管 1551 ’以將減低之壓力輸送至髖假體1515。另一選擇為, 可將減壓輸送源1 5 5 3植入患者體内、髖假體丨5丨5上或附 近。將減壓輸送源1553放置於患者體内便無需使用經過皮 膚之流體連接。所植入之減壓輸送源15 5 3可係以可操作方 式連接至流動通道1 54 1之傳統幫浦。該幫浦可由植入於患 者體内之電池供電,或者可由經過皮膚電連接至該幫浦之 外部電池供電。該幫浦亦可由一經由流動通道丨54丨、丨56 i 輸送減低之壓力及使流體循環經過流動通道丨541、1 56 1之 化學反應來直接驅動。 儘管在圖32及33中僅圖解說明髖假體1515之柱部分1521 及頭部分1 525,然而應注意,本文所述之流動通道及用於 應用減壓組織治療之構件亦可應用於髖假體丨5 1 5中任何接 觸骨骼或其他組織之組件,包括例如臼杯。 參見圖34,一種用於修復患者關節之方法丨6丨丨包括在 1 6 1 5處b比鄰該關節在骨絡内植入一假體。該假體可係如上 文所述之髖假體或任何其他有助於恢復患者關節活動性之 假體。該假體包括複數個經構造以與骨骼流體連通之流動 119637.doc -43 - 1325328 通道。在1619處,經由該複數個流動通道對骨骼應用減低 之壓力’ m改良作又體之oseointegration 〇 參見圖35及36,一種根據本發明一實施例之減壓輸送裝 置1711包括一整形外科固定器件1715,以用於緊固患者的 包含骨折部位1719或其他缺損之骨骼1717。圖35及36中所 不之整形外科固定器件1715係一具有複數個通路1721之 板,該複數個通路1721用於使用螺釘1725、銷、螺栓或其 他緊固件將整形外科固定器件1715錨固至骨骼1717上。可 在整形外科固定器件1715之接觸骨骼1717之表面上設置一 多孔塗層1735。該多孔塗層較佳由燒結或玻璃化陶瓷或金 屬構造而成。另一選擇為,可在骨骼1717與整形外科固定 器件1715之間設置-具有多孔特性之蜂巢狀材料。複數個 流動通道1741設置於整形外科固定器件1715内,以使流動 。一連接埠1745流體連A solution of a hydrogel forming material such as hyaluronic acid, collagen or polyethylene glycol having a red group. The microsphere-gel mixture is exposed to light for a temporary period of time to partially crosslink the hydrogel and immobilize the hydrogel on the microspheres. Sister Shan μ μ μ 排出 排出 多余 多余 多余 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出 排出The gel coat becomes hydrated. After you χ ,, the mixture is again exposed to light, thereby crosslinking the microspheres, π 2... + Form a plurality of flow channels. The crosslinked microspheres are then used as a manifold for the delivery of reduced pressure to the tissue site and 119637.doc -37-.$:; 'i a porous scaffold for promoting new tissue growth. With the exception of the foregoing embodiments herein, the reduced pressure delivery device 1〇35 can be made from a variety of materials including, but not limited to, calcium phosphate, collagen, alginate, cellulose, or any other capable of being a gas or a liquid. , gel, paste putty, slurry, suspension, or other flowable material in the form of an equivalent material that is routed to the tissue site and capable of forming a plurality of flow paths in fluid communication with the identified portion. The flowable material may further comprise solid particles, such as particles, which if the particle size of the solid particles is sufficiently small to flow 35 by the manifold wheel 1021. The material delivered to the tissue site in a flowable state can be polymerized in situ or form a gel. As previously described, the reduced pressure delivery device 1〇35 can be directly injected or poured into the void 1029 adjacent the tissue site 1025. Referring to Fig. 27A, the manifold transfer tube 1021 may include an impermeable or semi-permeable membrane 1051 at the distal end 1〇43 of the manifold delivery tube 1〇21. The membrane 1〇51 includes an internal space 1〇55, internal The space 1055 is in fluid communication with an auxiliary lumen 1〇57 secured to the manifold delivery tube 1〇21. The manifold delivery tube 1021 is guided to a tissue portion 1025 on a guide wire 1〇61. The reduced pressure delivery device 1035 can be injected or poured through the auxiliary lumen 1〇57 to fill the interior space 1055 of the membrane 1051. When the fluid or gel fills the film 1051, the film 1〇51 expands to fill the voids 1〇29, thereby causing the film to contact the tissue site 1 025. When the film 1 〇5 1 is inflated, the film 1 〇5丨 can be used to separate the additional tissue adjacent to or close to the tissue site 1025. If the film 丨〇5丨 is an impermeable film, it can be physically broken and moved. In addition, the reduced pressure delivery device 1035 is brought into contact with the tissue site 1〇25. Alternatively, the film 1〇51 li9637.doc -38-1325328 can be made from a soluble material that will dissolve in the presence of a body fluid or a biocompatible solvent delivered to the film. If the film 丨〇5 is semi-permeable, the film 1051 can remain in place. The semi-permeable membrane is capable of delivering reduced pressure and possibly other fluids to the tissue site 1025. Referring to Figure 28, a method of performing reduced pressure tissue therapy includes surgically inserting a manifold at an adjacent tissue site at 1115, the manifold having a plurality of protrusions extending from a flexible barrier. To form a plurality of flow channels between the protrusions. The manifold is positioned at 1119 such that at least a portion of the projections contact the tissue site. At II23, a reduced pressure is applied to the tissue site via the manifold. See 0 0 9 Methods for performing decompressive tissue treatment on a tissue site 1211 includes inserting a manifold at 1215 through the skin adjacent to the tissue site. The manifold can include a plurality of protrusions extending from a flexible barrier to form a plurality of flow channels between the protrusions. Alternatively, the manifold can comprise a honeycomb material having a plurality of flow channels within the honeycomb material. Alternatively, the manifold can be formed from an injectable or pourable material that is delivered to the tissue site and that forms a plurality of flow channels upon reaching the tissue site. At 1219, the dislocation I is positioned 'to bring at least a portion of the flow channels in fluid communication with the tissue site. At 1223, a reduced pressure is applied to the tissue site via the manifold. Referring to Fig. 30, a method of applying reduced-pressure tissue treatment to a tissue site 1311 includes inserting a tube having a passage through the skin through a skin at 1315 such that the distal end of the tube is adjacent to the tissue site. At 1319 I19637.doc -39-13325328, a balloon associated with the tube can be inflated to separate tissue adjacent the tissue site to form a void. At 1323, a manifold is transported through the passage. The manifold can include a plurality of protrusions extending from a flexible barrier to form a plurality of flow channels between the protrusions. Alternatively, the manifold can comprise a honeycomb material having a plurality of flow channels therein. Alternatively, the manifold can be formed from an injectable or pourable material that is delivered to the tissue site as described above with reference to Figure 27. At 1327, the manifold is positioned such that at least a portion of the flow channels are in fluid communication with the tissue site. At 1331, the reduced pressure is applied to the tissue site via the manifold via a reduced pressure delivery tube or any other delivery route. Referring to Fig. 3 1 'A method of performing decompressive tissue treatment on a tissue site 1411 includes inserting a tube having a passage through the skin through a skin at 1415 such that the distal end of the tube is placed adjacent to the tissue site. At 1423, a manifold is conveyed through the passage to the tissue portion in an impervious jacket which has been subjected to a first reduced pressure at 1419 that is less than the sheath ambient pressure. At 1427, the sheath is broken to contact the manifold with the tissue site. At 丨43丨, a second reduced pressure is applied to the tissue portion via the manifold. Referring to Figures 32 and 33, a reduced pressure delivery device 1511 in accordance with an embodiment of the present invention includes an orthopaedic prosthesis 1515 for replacing an existing femoral head of a patient leg segment 1517. The hip prosthesis 1515 includes a post portion 1521 and a head portion 1525. The post portion 1521 is elongate for insertion into a passage 1529 that is hinged in the backbone of the leg portion 1517. A porous coating 1535 is disposed around the perimeter of the column portion 119637.doc -40- and is preferably constructed of sintered or vitrified ceramic or metal. Alternatively, a honeycomb material having a porous property can be disposed around the crucible portion. A plurality of flow channels 1541 are disposed within the column portion 丨 52 i of the hip prosthesis i 5丨5 such that the flow channel 1541 is in fluid communication with the porous coating port 535. A port 1545 is fluidly coupled to the flow channel 1541, the port is configured to be releasably coupled to a reduced pressure delivery tube 1551 and a reduced pressure delivery source 1 553. The flow channel 1 541 is used to implant the hip prosthesis 15 1 After 5, the reduced pressure is delivered to the porous coating 1535 and/or bone surrounding the hip prosthesis 15 15 . The flow channel 1541 can include a main feed line 1543 in fluid communication with a plurality of lateral branch lines 1 547 that are in communication with the porous coating 1535. The lateral branch line 1545 can be oriented perpendicular to the main feed line 15 43 as shown in Figure 32, or can be oriented at some angle to the main feed line 154. An alternative method for distributing the reduced pressure includes providing a hollow body prosthesis 'and filling the prosthesis with a honeycomb-like (preferably open-cell) material that is in fluid communication with the porous coating 153. Internal space. Referring more specifically to Figure 33, the body prosthesis 1515 can further include a second plurality of flow channels 15 6 1 within the column portion 1521 to the porous coating 1 5 3 5 surrounding the hip prosthesis 15 5 and/or The bone provides fluid. The fluid may include filtered air or other gas, an antibacterial agent, an antiviral agent, a cell growth promoting fluid, a chemically active fluid, or any other fluid. Additional fluid communication paths may be provided if it is desired to introduce multiple fluids into the bone surrounding the hip prosthesis 1515. A port 1565 is fluidly coupled to the flow channel 1561 which is configured to be releasably coupled to a fluid delivery tube i 571 and a fluid delivery source 1573. The flow channel 1 561 can include a main feed official line 15 8 3 in fluid communication with a plurality of lateral branch lines 119637.doc -41 - 1325328 1 5 8 5 that are in communication with the porous coating 1535. The lateral branch line 1585 can be oriented perpendicular to the main feed line 1583 as shown in Figure 33, or can be oriented at some angle to the main feed line 1583. The delivery of the reduced pressure to the first plurality of flow channels 1 5 41 and the transfer of fluid to the second plurality of flow channels 1561 can be accomplished by separate tubes (e.g., reduced pressure delivery tube 1551 and fluid delivery tube 1571). Alternatively, a tube having a plurality of lumens as previously described herein can be used to separate the communication path for delivery of reduced pressure and fluid. It should be further noted that although a separate fluid communication path is preferably provided within the hip prosthesis 1515, the first plurality of flow channels 1 5 4 1 can be used to deliver both the reduced pressure and fluid to the surrounding hip prosthesis 15 15 bones. As mentioned earlier, applying reduced stress to bone tissue promotes and accelerates the growth of new bone tissue. By using the hip prosthesis 15 15 as a manifold to deliver the reduced pressure to the bone area surrounding the hip prosthesis, the recovery of the leg section 15 17 is faster and the hip prosthesis 15 5 5 will be more successful with the bone Combine together. Providing a second plurality of flow channels 1561 to discharge the bone path around the hip prosthesis 1515 will improve the successful regeneration of the new bone surrounding the prosthesis. After the reduced pressure is applied via the body prosthesis 15 15 for a selected amount of time, the reduced pressure delivery tube 1551 and the fluid delivery tube 1571 can be disconnected from the ports 1545, 1565 and removed from the patient's body. Use surgical invasive procedures. The connection between the ports 1545, 1565 and the tubes 1551, 1571 can be a connection that can be released by hand. This can be performed by applying an axial pulling force to the tubes 1S51, 1571 outside the body of the patient. Alternatively, the port 963U9637.doc -42· 1545, 1565 can be bioresorbable or soluble in the presence of the selected fluid or chemical so that the sputum 1545, 1565 can be violently The release of tubes 1551., 1571 is achieved by the passage of fluids or chemicals. Tubes 1551, 1571 can also be made from a bioresorbable material that will dissolve over a period of time or an activating material that will dissolve in the presence of a particular chemical or other material. A reduced pressure delivery source 1553 can be provided outside the patient and attached to the reduced pressure delivery tube 1551' to deliver the reduced pressure to the hip prosthesis 1515. Alternatively, a reduced pressure delivery source 1 5 5 3 can be implanted into the patient, on or near the hip prosthesis 5丨5. Placing the reduced pressure delivery source 1553 into the patient does not require the use of a fluid connection through the skin. The implanted reduced pressure delivery source 15 53 can be operatively coupled to the conventional pump of the flow channel 1 54 1 . The pump can be powered by a battery implanted in the patient's body or by an external battery that is electrically connected to the pump via the skin. The pump can also be directly driven by a chemical reaction that delivers reduced pressure through the flow channels 丨54丨, 丨56 i and circulates fluid through the flow channels 丨 541, 156 1 . Although only the column portion 1521 and the head portion 1 525 of the hip prosthesis 1515 are illustrated in Figures 32 and 33, it should be noted that the flow channels described herein and components for applying reduced pressure tissue treatment may also be applied to hip falsehood. Any component of the body 5 5 that contacts bone or other tissue, including, for example, a cup. Referring to Figure 34, a method for repairing a patient's joint includes the implantation of a prosthesis within the ostium adjacent to the joint at 1<15> The prosthesis can be a hip prosthesis as described above or any other prosthesis that can help restore joint mobility in a patient. The prosthesis includes a plurality of channels 119637.doc -43 - 1325328 that are configured to be in fluid communication with the bone. At 1619, the reduced pressure is applied to the bone via the plurality of flow channels. The improved pressure delivery device 1711 includes an orthopaedic fixation device in accordance with an embodiment of the present invention. 1715, for fastening the patient's bone 1717 containing the fracture site 1719 or other defect. The orthopaedic fixation device 1715 of Figures 35 and 36 is a plate having a plurality of passages 1721 for anchoring the orthopaedic fixation device 1715 to the bone using screws 1725, pins, bolts or other fasteners. On 1717. A porous coating 1735 can be placed on the surface of the contact bone 1717 of the orthopedic fixation device 1715. The porous coating is preferably constructed of sintered or vitrified ceramic or metal. Alternatively, a honeycomb material having a porous property may be disposed between the bone 1717 and the orthopaedic fixation device 1715. A plurality of flow channels 1741 are disposed within the orthopaedic fixation device 1715 for flow. One connection 埠 1745 fluid connection

空之整形外科固定器件,並以— 通道1741與多孔塗層丨735流體連通。一 接至流動通道1741 ’該埠構造成連接至 之替代方法包括:提供一中 種能夠與多孔塗層丨735流 119637.doc • 44 - 1325328 體連通之蜂巢狀(較佳係開放孔)材料來填充該整形外科固 定器件之内部空間。 整形外科固定器件Π15可如在圖35中所示係一板,或者 另—選擇為,可係一固定器件,例如套管、矯形器、支 柱、或任何其他用於使骨骼之一部分穩定之器件。整形外 ’㈣定器件1715可it-步係用於固定假體或其他整料科 器件或所植入組織(例如骨骼組織或軟骨)之緊固件,其限 φ 制條件為該等緊固件包含用於向毗鄰或環繞該等緊固件之 組織輸送減低之壓力之流動通道。該等緊固件之實例可包 括銷、螺栓、螺釘或任何其他適宜之緊固件。 更具體地參見圖36,整形外科固定器件1715可進一步在 整形外科固定器件1715内包括第二複數個流動通道17=, 以對環繞整形外科固定器件1715之多孔塗層1735及/或骨 骼提供流體。該流體可包括經過濾之空氣或其他氣體、抗 菌劑、抗病毒劑、細胞生長促進劑、沖洗流體、化學活性 • “或任何其他流體。若期望將多種流體引入至環繞髖假體 1715之骨骼中,可提供額外之流體連通路徑。一連接埠 1765流體連接至流動通道1761,該埠1765構造成連接至— "il體輸送官1 77 1及一流體輸送源丨773。流動通道丨76丨可包 含一與數個橫向分支管線1785流體連通之主饋送管線 1783 ,該數個橫向分支管線1785與多孔塗層丨了^相連通。 杈向刀支皆線1785可如在圖33中所示垂直於主饋送管線 1783定向,或者可與主饋送管線1783成某些夾角定向。 減低之壓力向第一複數個流動通道174丨之輸送及流體向 119637.doc -45- 1325328 之管(例如減An orthopaedic fixation device is in fluid communication with the porous coating 丨735 in the channel 1741. An alternative method of connecting to the flow channel 1741 'the raft is configured to be connected to: providing a honeycomb-like (e.g. open pore) material capable of communicating with the porous coating 丨735 stream 119637.doc • 44 - 1325328 To fill the internal space of the orthopaedic fixation device. The orthopaedic fixation device 15 can be a plate as shown in Figure 35, or alternatively, can be a fixation device such as a cannula, orthosis, struts, or any other device for stabilizing a portion of the bone. . The externally shaped '(4) device 1715 can be used to fix the fasteners of the prosthesis or other whole material device or implanted tissue (such as bone tissue or cartilage), and the condition of the φ is that the fasteners contain A flow passage for delivering a reduced pressure to tissue adjacent or surrounding the fasteners. Examples of such fasteners may include pins, bolts, screws or any other suitable fastener. Referring more specifically to Figure 36, the orthopaedic fixation device 1715 can further include a second plurality of flow channels 17 = within the orthopaedic fixation device 1715 to provide fluid to the porous coating 1735 and/or bone surrounding the orthopaedic fixation device 1715. . The fluid may include filtered air or other gases, antibacterial agents, antiviral agents, cell growth promoters, irrigation fluids, chemically active "" or any other fluid. If it is desired to introduce multiple fluids into the bone surrounding the hip prosthesis 1715 An additional fluid communication path may be provided. A port 1765 is fluidly coupled to the flow channel 1761, the crucible 1765 being configured to be coupled to a <il body delivery officer 1 77 1 and a fluid delivery source 773. The flow channel 丨76 The crucible may include a main feed line 1783 in fluid communication with a plurality of lateral branch lines 1785, the plurality of lateral branch lines 1785 being in communication with the porous coating. The tangential branch line 1785 may be as shown in FIG. The orientation is oriented perpendicular to the main feed line 1783, or may be oriented at some angle to the main feed line 1783. The reduced pressure is directed to the first plurality of flow channels 174 and the fluid is directed to the tube of 119637.doc -45 - 1325328 (eg Less

第二複數個流動通道1761之輸送可藉由單獨 壓輸送管 可使用一 輸送減低之壓力與流體之連通路徑。應進一步注意,儘管 較佳在體假體1715内^供分離之流體連通路徑,然而亦可 使用第一複數個流動通道1741將減低之壓力與流體二者輸 送至毗鄰整形外科固定器件1715之骨絡。 使用整形外科固疋器件1715作為歧管來向0比鄰整形外科 固定器件1715之骨骼區域輸送減低之壓力會加快並改善骨 骼1717之缺損1 7 19之恢復。提供第二複數個流動通道丨^ 將流體傳送至環繞整形外科固定器件1715之骨骼會改良整 形外科固定器件附近之新骨骼之成功再生。 參見圖37,一種用於治癒骨骼之骨骼缺損之方法18u包 括在18 15處使用一整形外科固定器件來固定該骨骼。該整 形外科固定器件包含設置於該整形外科固定器件内之複數 個流動通道。在1 8 19處,經由該複數個流動通道對骨骼缺 損應用減低之壓力。 參見圖3 8,一種用於對—組織部位施行減壓組織治療之 方法1911包括:在1915處對一具有複數個流動通道之歧管 進行定位,以使該等流動通道之至少一部分與該組織部位 机體連通。在19 19處,經由該等流動通道對該組織部位應 用減低之壓力,並在1923處,經由該等流動通道向該組織 部位輸送一流體。 參見圖39,一種用於對—組織部位施行減壓組織治療之 H9637.doc -46- 1325328 方法2011包括:在2〇15處將一歧管輸送管之遠端毗鄰該組 織部位進行定位。在20 19處,經由該歧管輸送管向該組織 部位輸送一流體。該流體能夠填充毗鄰該組織部位之空隙 並變成一具有複數個與該組織部位流體連通之流動通道之 固‘4歧管。在2023處,經由該固態歧管之流動通道對該組 織部位應用減低之壓力。 參見圖40-48 ’ 一減壓輸送系統2111包括一主歧管 2115 ’主歧管2115具有一環繞一主流動通路2121之撓性壁 2117。撓性壁2117在一近端2123處連接至一減壓輸送管 2125。由於減壓輸送管2125之形狀通常將為圓形截面,且 由於主歧管2115之截面形狀可不同於圓形(即在圖40-45中 為矩形’而在圖46-48中為三角形),因而在減壓輸送管 2125與主歧管2115之間提供一過渡區2129。主歧管2115可 藉由膠黏方式連接至減壓輸送管2125、使用例如融合或嵌 件模壓等其他途徑進行連接、或者另一選擇為可藉由共擠 出而整體相連。減壓輸送管2125將減低之壓力輸送至主歧 官2 11 5,以供分佈於組織部位處或附近。 一防阻塞部件2135定位於該主歧管内,以防止在應用減 低之壓力期間主歧管2115塌縮並由此阻塞主流動通路 2121❶在一實施例中,防阻塞部件2135可係複數個突起物 2137(參見圖44),該複數個突起物2137設置於撓性壁up 之一内表面2141上並延伸入主流動通路2121内。在另一實 施例中,防阻塞部件2135可係設置於内表面2141上之單二 或多個脊2丨45(參見圖4〇及川。在又—實施例中防阻塞 119637.doc -47- 1325328 部件2135可包含設置於主流動通路内之蜂巢狀材料2149, 例如在圖47中所示者。防阻塞部件2135可係任何能夠嵌於 流動通路内或者能夠成一體地或以其他方式固定至撓性壁 2 11 7上之材料或結構。防阻塞部件2丨35能夠防止撓性壁 2117元全知縮,而仍使流體能夠經由主流動通路2 121流 . 動。 挽性壁2117進一步包括複數個穿透撓性壁2117之孔 鲁 2155,該等孔2155與主流動通路2121相連通。孔^乃使輸 送至主流動通路2121之減低之壓力能夠分佈至該組織部位 處。孔2155可選擇性地圍繞歧管2115之圓周定位,以優先 引導真空之輸送。舉例而言,在圖51中,可使孔面對骨 路、面對覆蓋組織或同時面對二者佈置。 減壓輸送管2125較佳包括一具有至少一個出口之第一導 管2161,該至少一個出口流體連接至主流動通路2ΐ2ι,以 向主流動通路2121輸送減低之壓力。亦可提供一第二導管 • 2163來以一種流體清洗主流動通路2121及第一導管2161 , 以防止或溶解因傷口分泌物及自組織部位吸出之其他流體 所造成之阻塞。第二導管較佳包括至少一個緊靠主流 動通路2121與第一導管2161之該至少一個出口中之至少一 者定位之出口。 更具體地參見圖40及41,在減壓輸送系統21u中第二 導管2163可包括用於沖洗主流動通路2ΐ2ι及第一導管湖 之多個導管。儘管撓性壁211 7中鱼囡令s #师& /、固疋至減壓輸送管2125 之端部相對之端部可如在圖4〇中所千支 τ所不為開口的,然而已發 119637.doc -48- 1325328 現,覆蓋撓性壁2117之端部可改良清洗功能之效能及可靠 性。較佳地,在撓性壁之被覆蓋端部與第二導管2163之端 部之間提供一頂隙2171。頂隙2171能夠在清洗製程期間達 成清洗流體之積聚,此有助於驅動沖洗流體經過主流動通 路2121流入第一導管2161内。 . 在圖41中亦圖解說明用作防阻塞部件2135之間隔件《居 . 中定位之間隔件使主流動通路2121分又進入兩個室内,此 *主歧管2115在其中-個室被阻塞JL藉由清洗無法溶解該 阻塞時仍能夠繼續運作。 參見圖49及50, —減壓輸送系統2211包括一與減壓輸送 管2217成一體之主歧管2215。減壓輸送管2217包括一中央 管腔2223及複數個輔助管腔2225 ^儘管辅助管腔2225可用 於量測組織部位處或附近之壓力,然而辅助管腔^以可進 一步用於清洗中央管腔2223,以防止或溶解阻塞物。複數 個孔2231與中央管腔助相連通,以分佈由中央管腔如 φ Z輸送之減低之壓力。如在圖5G中所示,較佳使孔則不 貝穿辅助官腔2225。在圖50中亦圖解說明減壓輸送管之埋 頭孔端,其在輔助管腔2225之端部以外形成一頂隙2241。 假若在應用減低之麼力期間使組織、支架或其他材料嗤合 減壓輸送管2217之端部,頂隙咖將會繼續允許向中央管 腔2 2 2 3輸送清洗流體。 在使用期間,圖4CM0所述之減壓輸送系統2iu、則 可直接‘用於組織部位上,以向組織部位分佈減低之壓 力主歧g之低矮形狀非常有利於經過皮膚裝設及移除本The second plurality of flow channels 1761 can be transported by a separate pressure transfer tube to provide a communication path for the reduced pressure and fluid. It should be further noted that although it is preferred to provide a separate fluid communication path within the body prosthesis 1715, the first plurality of flow channels 1741 can be used to deliver both the reduced pressure and fluid to the bone of the adjacent orthopaedic fixation device 1715. Network. The use of the orthopedic fixation device 1715 as a manifold to deliver reduced pressure to the bone region of the 0 adjacent orthopedic fixation device 1715 accelerates and improves the recovery of the defect 1717 of the bone 1717. Providing a second plurality of flow channels 将 transferring fluid to the bone surrounding the orthopaedic fixation device 1715 improves the successful regeneration of new bone adjacent the orthopaedic fixation device. Referring to Figure 37, a method 18u for healing a bone defect in a bone includes using an orthopedic fixation device at 18 15 to secure the bone. The orthopedic fixation device includes a plurality of flow channels disposed within the orthopaedic fixation device. At 1 8 19, the reduced pressure is applied to the bone defect via the plurality of flow channels. Referring to Figure 3, a method 1911 for performing a reduced-pressure tissue treatment on a tissue site includes: positioning a manifold having a plurality of flow channels at 1915 such that at least a portion of the flow channels are associated with the tissue The part body is connected. At 19 19, the reduced pressure is applied to the tissue site via the flow channels, and at 1923, a fluid is delivered to the tissue site via the flow channels. Referring to Fig. 39, a method for performing decompressive tissue treatment on a tissue site H9637.doc-46-1325328 Method 2011 includes positioning a distal end of a manifold tube adjacent to the tissue site at 2〇15. At 20 19, a fluid is delivered to the tissue site via the manifold delivery tube. The fluid is capable of filling a void adjacent the tissue site and becomes a solid '4 manifold having a plurality of flow channels in fluid communication with the tissue site. At 2023, a reduced pressure is applied to the tissue portion via the flow path of the solid manifold. Referring to Figures 40-48', a reduced pressure delivery system 2111 includes a primary manifold 2115. The primary manifold 2115 has a flexible wall 2117 that surrounds a main flow path 2121. The flexible wall 2117 is coupled to a reduced pressure delivery tube 2125 at a proximal end 2123. Since the shape of the reduced pressure delivery tube 2125 will generally be a circular cross section, and since the cross-sectional shape of the primary manifold 2115 can be different from the circular shape (i.e., rectangular in Figures 40-45 and triangular in Figures 46-48) Thus, a transition zone 2129 is provided between the reduced pressure delivery tube 2125 and the primary manifold 2115. The main manifold 2115 can be joined to the reduced pressure delivery tube 2125 by adhesive means, joined using other means such as fusion or insert molding, or alternatively selected to be integrally joined by coextrusion. The reduced pressure delivery tube 2125 delivers the reduced pressure to the primary ectopic 2 11 5 for distribution at or near the tissue site. An anti-blocking member 2135 is positioned within the main manifold to prevent the main manifold 2115 from collapsing and thereby blocking the main flow path 2121 during application of the reduced pressure. In one embodiment, the anti-blocking member 2135 can be provided with a plurality of protrusions 2137 (see Fig. 44), the plurality of protrusions 2137 are disposed on one of the inner surfaces 2141 of the flexible wall up and extend into the main flow path 2121. In another embodiment, the anti-blocking member 2135 can be disposed on the inner surface 2141 by a single two or more ridges 2丨45 (see Fig. 4 and the same. In another embodiment, the anti-blocking 119637.doc-47- 1325328 The component 2135 can include a honeycomb material 2149 disposed within the main flow path, such as shown in Figure 47. The anti-blocking component 2135 can be any that can be embedded within the flow path or can be integrally or otherwise secured to The material or structure on the flexible wall 2 11 7. The anti-blocking member 2丨35 prevents the flexible wall 2117 from being fully condensed while still allowing fluid to flow through the main flow path 2 121. The tractable wall 2117 further includes a plurality A hole 2155 penetrating the flexible wall 2117, the holes 2155 are in communication with the main flow path 2121. The hole allows the reduced pressure delivered to the main flow path 2121 to be distributed to the tissue site. The hole 2155 can be selected Positionally positioned around the circumference of the manifold 2115 to preferentially direct the delivery of the vacuum. For example, in Figure 51, the apertures may be placed facing the bone path, facing the covering tissue, or facing both at the same time. 2125 preferably includes one At least one outlet first conduit 2161, the at least one outlet being fluidly connected to the main flow passage 2ΐ2ι to deliver a reduced pressure to the main flow passage 2121. A second conduit 2163 may also be provided to clean the main flow passage 2121 with a fluid And the first conduit 2161 to prevent or dissolve the obstruction caused by the wound secretion and other fluids sucked from the tissue site. The second catheter preferably includes at least one of the at least one of the main flow path 2121 and the first conduit 2161. The outlet of at least one of the outlets is positioned. Referring more specifically to Figures 40 and 41, the second conduit 2163 in the reduced pressure delivery system 21u can include a plurality of conduits for flushing the main flow passages 2ΐ2 and the first conduit lake. In the flexible wall 211 7 , the end of the end portion opposite to the end of the decompression duct 2125 can be opened as shown in FIG. 119637.doc -48- 1325328 Now, covering the end of the flexible wall 2117 improves the effectiveness and reliability of the cleaning function. Preferably, at the covered end of the flexible wall and the end of the second conduit 2163 Between mention A headgap 2171. The headgap 2171 is capable of achieving accumulation of cleaning fluid during the cleaning process, which facilitates driving the flushing fluid through the main flow path 2121 into the first conduit 2161. Also illustrated in Figure 41 as an anti-blocking The spacer of the component 2135 "the centering spacer allows the main flow path 2121 to enter the two chambers again. This *the main manifold 2115 is blocked in one of the chambers. The JL can continue to operate when the cleaning cannot dissolve the blockage. Referring to Figures 49 and 50, the reduced pressure delivery system 2211 includes a primary manifold 2215 integral with the reduced pressure delivery tube 2217. The reduced pressure delivery tube 2217 includes a central lumen 2223 and a plurality of auxiliary lumens 2225. [Although the auxiliary lumen 2225 can be used to measure pressure at or near the tissue site, the auxiliary lumen can be further used to clean the central lumen. 2223 to prevent or dissolve obstructions. A plurality of apertures 2231 are in communication with the central lumen to distribute the reduced pressure delivered by the central lumen, such as φ Z . As shown in Figure 5G, it is preferred that the aperture does not pass through the auxiliary cavity 2225. The counterbore end of the reduced pressure delivery tube is also illustrated in Fig. 50, which forms a headspace 2241 outside the end of the auxiliary lumen 2225. If the tissue, stent or other material is kneaded to the end of the reduced pressure delivery tube 2217 during application of the reduced force, the headspace coffee will continue to allow delivery of cleaning fluid to the central lumen 2 2 2 3 . During use, the reduced-pressure delivery system 2iu described in Fig. 4CM0 can be directly used on the tissue site to reduce the distribution of the pressure to the tissue site. The low shape of the main gigaze is very advantageous for skin installation and removal. this

Il9637.doc -49- 1325328 文所述之技術。類似地’亦可藉由外科手術來嵌入主歧 管。 參見圖’主歧管2115、2215可與—輔助歧管則結合 使用。在圖51中,辅助歧管則包括—兩層式謎。輔助 歧管2321之第-層接觸—包含骨折部位之骨胳組織部位放 置。主歧管2115接_第_層放置,且辅助歧管則之第 -層置於主歧管2115及第-層之頂上。輔助歧管加丄能夠 達成主歧管2115與組織部位之間之流體連通,且仍防止組 織部位與主歧管2115之間直接接觸。 較佳地,辅助歧管2321係生物可吸收性的,幻吏輔助歧 管2321能夠在減壓治療完成之後保留於原位。一旦完成減 壓治療’便可在幾乎不會或根本不會擾動組織部位之情況 下自輔助歧管之該等層之間移出主歧管2115。在一實施例 中,主歧官可塗覆有潤滑材料或會形成水凝膠之材料,以 易於自該等層之間移出主歧管。 輔助歧管較佳用作新組織生長之支架。作為支架,辅助 歧管可由it自“下㈣組成之群組之至少—種材料構 成:聚乳酸、聚乙醇酸、聚己内冑、聚經基丁酸醋、聚經 戊酸、聚二氧六環醯胺、p〇ly〇nh〇esthers、聚磷腈、聚氨 基甲酸Sl、膠原 '透明質酸、聚胺基葡萄糖、經基鱗灰 石、磷酸鈣、硫酸鈣、碳酸鈣、生物玻璃、不銹鋼、鈦、 組、同種異體移植片及自體組織移植片。 上文所述之減壓輪送系統2m、2211之清洗功能可與本 文所述之任何歧管一起使用。對輸送減低之壓力之歧管或 119637.doc •50- 1325328 導管實施清洗之能力能防止形成會阻礙施行減低之壓力之 阻塞物。當組織部位附近之壓力達到平衡且組織部位周圍 流體之流出變慢時’通常會形成該等阻塞物。已發現,使 用空氣以一所選間隔將歧管及減壓導管清洗一所需時間量 會有助於防止或溶解阻塞物。Il9637.doc -49- 1325328 The technique described. Similarly, the main manifold can also be embedded by surgery. Referring to the figure, the main manifolds 2115, 2215 can be used in conjunction with the auxiliary manifold. In Figure 51, the auxiliary manifold includes a two-layer puzzle. The first layer of contact of the auxiliary manifold 2321 - the placement of the bone tissue portion of the fracture site. The main manifold 2115 is placed in the _th layer, and the first layer of the auxiliary manifold is placed on top of the main manifold 2115 and the first layer. Auxiliary manifold twisting can achieve fluid communication between the primary manifold 2115 and the tissue site and still prevent direct contact between the tissue site and the primary manifold 2115. Preferably, the auxiliary manifold 2321 is bioabsorbable and the phantom assist manifold 2321 can remain in place after the decompression therapy is completed. Once the decompression treatment is completed, the main manifold 2115 can be removed from between the layers of the auxiliary manifold with little or no disturbance to the tissue site. In one embodiment, the primary officer may be coated with a lubricating material or a material that will form a hydrogel to facilitate removal of the primary manifold from between the layers. The auxiliary manifold is preferably used as a support for new tissue growth. As a scaffold, the auxiliary manifold may be composed of at least one material of the group consisting of: "lower (four)": polylactic acid, polyglycolic acid, polycaprolactone, polybutyric acid vinegar, polyvaleric acid, polydioxane Hexacyclic guanamine, p〇ly〇nh〇esthers, polyphosphazene, polyuric acid Sl, collagen 'hyaluronic acid, polyaminoglucose, gram-based limestone, calcium phosphate, calcium sulfate, calcium carbonate, bioglass , stainless steel, titanium, group, allograft and autologous tissue grafts. The cleaning function of the decompression transfer system 2m, 2211 described above can be used with any of the manifolds described herein. Manifold of pressure or 119637.doc • 50-1325328 The ability of the catheter to perform cleaning prevents the formation of obstructions that impede the pressure to reduce the pressure. When the pressure near the tissue site reaches equilibrium and the flow of fluid around the tissue site slows down, it is usually These obstructions are formed. It has been found that using air to clean the manifold and decompression catheter at a selected interval for a desired amount of time can help prevent or dissolve the obstruction.

更具體而S,經由一第二導管輸送空氣,該第二導管與 輸送減低之壓力之第一導管分離。第二導管之一出口較佳 靠近歧管或靠近該第一導管之一出口。儘管可將空氣壓至 或推至第二導管之出口,然而較佳藉由組織部位處減低 之壓力經由第二導管吸入空氣。已發現,在許多情形中, 在應用減低之壓力期間以六十(60)秒鐘之間隔輸送空氣兩 (2)秒鐘便足以防止形成阻塞物。此種清洗計劃能提供足夠 之空氣來充分地移動歧管及第—導管内之流體,同時防止 引入過多之空氣。引人過多之空氣、或者以過高之間隔頻 率來引入空氣將會造成-不㉟夠在各次清洗循環之間返回 至減低之目標壓力之減壓系統。所選之輸送清洗流體之時 間量以及所選之輸送清洗流體之間隔通常將根據系統組件 (例如幫浦、管等)之設計及規格而異。然而,輸送空氣之 量及頻率應高至足以充分地清除阻塞物、同時仍能在各次 清洗循環之間恢復滿目標學力。 參見圖52 ’在-個例示性實施例中,一減壓輸送系統 24U包含一歧管2415,歧管2415流體連接至—第一導管 24i9及-第二導管2423。第—導管2419連接至一減壓二 2429,以向歧管2415提供減低之壓力^二導管勘包含 119637.doc -5]. 1325328 一出口 2435 ,出口 2435定位成與歧管2415流體連通並靠近 第一導管2419之出口。第二導管2423流體連接至一閥門 2439,當閥門2439置於開啟位置時,該閥門能夠達成第二 導管2423與環境空氣之間的連通。閥門2439以可操作方式 連接至一控制器2453,控制器2453能夠控制閥門2439之開 啟及關閉,以調節使用環境空氣對第二導管實施之清洗, 從而防止在歧管2415與第一導管2419内存在阻塞物。More specifically, S, air is delivered via a second conduit that is separated from the first conduit that delivers the reduced pressure. One of the outlets of the second conduit is preferably adjacent to or adjacent to one of the outlets of the first conduit. Although air may be pressurized or pushed to the outlet of the second conduit, it is preferred to draw air through the second conduit by the reduced pressure at the tissue site. It has been found that in many cases, delivering air for six (2) seconds at intervals of sixty (60) seconds during application of reduced pressure is sufficient to prevent the formation of obstructions. This cleaning program provides sufficient air to adequately move the fluid in the manifold and the first conduit while preventing excessive air introduction. Introducing too much air, or introducing air at too high a frequency interval, will result in a decompression system that is sufficient to return to a reduced target pressure between wash cycles. The amount of time selected to deliver the cleaning fluid and the interval between the selected cleaning fluids will generally vary depending on the design and specifications of the system components (eg, pumps, tubes, etc.). However, the amount and frequency of delivery air should be high enough to adequately remove obstructions while still recovering full target abilities between wash cycles. Referring to Fig. 52', in an exemplary embodiment, a reduced pressure delivery system 24U includes a manifold 2415 that is fluidly coupled to a first conduit 24i9 and a second conduit 2423. The first conduit 2419 is connected to a reduced pressure 2429 to provide a reduced pressure to the manifold 2415. The second conduit includes 119637.doc -5]. 1325328 an outlet 2435, the outlet 2435 is positioned in fluid communication with the manifold 2415 and adjacent The outlet of the first conduit 2419. The second conduit 2423 is fluidly coupled to a valve 2439 which is capable of achieving communication between the second conduit 2423 and ambient air when the valve 2439 is placed in the open position. Valve 2439 is operatively coupled to a controller 2453 that is capable of controlling the opening and closing of valve 2439 to regulate cleaning of the second conduit using ambient air to prevent memory in manifold 2415 and first conduit 2419 In the obstruction.

應注意,可使用任何流體(包括液體或氣體)來達成本文 所述之技術。儘管用於清洗流體之力較佳係減低之壓力在 組織部位處形成之吸力,然而類似於參照圖9所述,流體 輸送構件亦可藉由類似方式來輸送流體。 根據本文所述之系統及方法對組織部位施行減壓組織治 療可藉由如下方式來達成:對組織部位施加一足夠低之壓 力’並隨後在一所選時間段内保持該足夠低之壓力。另一It should be noted that any fluid (including liquids or gases) can be used to achieve the techniques described herein. Although the force for cleaning the fluid is preferably a suction formed by the reduced pressure at the tissue site, the fluid delivery member can also deliver the fluid in a similar manner, similar to that described with reference to Figure 9. Decompression tissue treatment of tissue sites in accordance with the systems and methods described herein can be accomplished by applying a sufficiently low pressure to the tissue site and then maintaining the sufficiently low pressure for a selected period of time. another

選擇為,施加至組織部位之減低之壓力可係循環性質。更 具體而言,所施加減低之壓力之大小可根據所選時間循環 而異。再一種施加減低之壓力之方法可隨機地改變減低之 壓力之大小。類似地,輸送至組織部位之流體之速率或量 可恆定不變、為週期性或者為隨機性。若為週期性,則流 體輸送可在施加減低之壓力期間進行,或者可在其中不在 施加減低之壓力之循環週期期間進行。儘管施加至組織部 位之減低之壓力之大小通常將根據組織部位之病理學及施 行減壓組織治療之環境而異,然而減低之壓力通常介於 約-5 mm Hg與-500 mm Hg之間 但更佳係介於 約' mm 119637.doc -52- C 'ι 1325328It is selected that the reduced pressure applied to the tissue site can be cyclic. More specifically, the magnitude of the applied reduced pressure may vary depending on the selected time cycle. Yet another method of applying the reduced pressure can randomly vary the magnitude of the reduced pressure. Similarly, the rate or amount of fluid delivered to the tissue site can be constant, periodic, or random. If it is periodic, the fluid delivery can be carried out during the application of the reduced pressure or during the cycle in which the reduced pressure is not applied. Although the magnitude of the reduced pressure applied to the tissue site will generally vary depending on the pathology of the tissue site and the environment in which the decompressed tissue treatment is performed, the reduced pressure is typically between about -5 mm Hg and -500 mm Hg but Better line between about 'mm 119637.doc -52- C 'ι 1325328

Hg與- 300 mm Hg之間。 儘管上文係參照組織生長及患者癒合來說明本發明之系 統及方法,然而應知道,該等用於施加減壓組織治療之系 統及方法可用於任何其中想要促進組織生長或癒合之活體 中。類似地,本發明之系統及方法可應用於任何組織,包 括但不限於骨骼組織、脂肪組織、肌肉組織、神經組織、 皮膚組織、血管組織、結缔組織、軟骨組織、腱或韌帶。 儘管組織之癒合可係如本文所述應用減壓組織治療之一著 重點,然而亦可使用減壓組織治療(尤其係對位於患者皮 膚下面之組織)之應用在不存在疾病、缺損或損傷之組織 中形成組織生長。舉例而言,可能期望使用經過皮膚之植 入技術來應用減壓組織治療,以在一組織部位處生長額外 之組織,並隨後收穫所述額外之組織。可將所收穫之組織 移植至另一組織部位,以取代有疾病或受損之組織,或者 另一選擇為’可將所收穫之組織移植給另一患者。 應注意,本文所述之減壓輸送裝置可與支架材料結合使 用來提高新組織之生長及生長速率,此亦頗為重要。支架 材料可放置於組織部位與減壓輸送裝置之間,或者減壓輸 送裝置本身可由用作新組織生長支架之生物可再吸收性材 料製成。 根據上文說明應顯而易見,本文提供一具有顯著優點之 發明。儘管本文僅以其幾種形式來顯示本發明,然而本發 明並不僅限於此,而是易於在不背離本發明精神之條件下 作出各種改動及修改。 119637.doc -53- 1^25328 【圖式簡單說明】 本專利Μ請㈣案包含至少—個帶顏色之圖式。可根 據要求並在支付必要費用之後由專利事務局提供帶彩圖之 本專利或專利申請公開案。 圖1繪示-根據本發明—實施例之減壓輸送裝置之透視 圖,該減壓輸送裝置具有複數個突起物自-撓性障壁伸出 以形成複數個流動通道; 圖2圖解說明圖丨所示減壓輸送裝置之正視圖; 圖3繪示圖丨所示減壓輸送裝置之俯視圖; 圖4Α圖解說明圖!所示減壓輸送裝置之側視圖,該減壓 輸送裝置具有一單管腔減壓輸送管; 圖辦示’所示減壓輸送裝置之—替代實施例之側視 圖’該減壓輸送裝置具有—雙管腔減壓輸送管; 圖5圖解說明圖i所示減壓輸送裳置之__放大透視圖; 圖6繪示一根據本發明一實施例之減壓輸送裝置之透視 圖,該減壓輸送裝置具有-附固至-撓性障壁上之蜂巢狀 材料,該撓性障壁具有__凸脊部分及―對翼狀部分,該蜂 巢狀材料具有複數個流動通道; 圖7圖解說明圖6所示減壓輸送裝置之-正視圖; 圖8繪示圖7所示減壓輸送裴置在XVII-XVII處剖切之剖 視側視圖; °Hg is between -300 mm Hg. Although the systems and methods of the present invention are described above with reference to tissue growth and patient healing, it should be understood that such systems and methods for applying reduced pressure tissue treatment can be used in any living body in which tissue growth or healing is desired to be promoted. . Similarly, the systems and methods of the present invention are applicable to any tissue including, but not limited to, bone tissue, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage tissue, tendon or ligament. Although tissue healing may be a focus of application of reduced-pressure tissue therapy as described herein, decompression tissue therapy (especially for tissues located beneath the patient's skin) may also be used in the absence of disease, defect or injury. Tissue growth is formed in the tissue. For example, it may be desirable to use a transdermal implant technique to apply reduced pressure tissue treatment to grow additional tissue at a tissue site and subsequently harvest the additional tissue. The harvested tissue can be transplanted to another tissue site to replace the diseased or damaged tissue, or alternatively the implanted tissue can be transplanted to another patient. It should be noted that the reduced pressure delivery device described herein can be combined with a stent material to increase the growth and growth rate of new tissue, which is also important. The stent material can be placed between the tissue site and the reduced pressure delivery device, or the reduced pressure delivery device itself can be made from a bioresorbable material that is used as a new tissue growth stent. It should be apparent from the above description that this document provides an invention with significant advantages. While the present invention has been shown in its several forms, the present invention is not limited thereto, but various modifications and changes can be made without departing from the spirit of the invention. 119637.doc -53- 1^25328 [Simple description of the drawing] This patent request (4) contains at least one color pattern. The patent or patent application publication with color drawings may be provided by the Patent Office upon request and after payment of the necessary fee. 1 is a perspective view of a reduced pressure delivery device having a plurality of protrusions extending from a flexible barrier to form a plurality of flow channels in accordance with the present invention; FIG. 2 is a diagram illustrating FIG. Figure 3 is a plan view of the reduced pressure conveying device shown in Figure 3; Figure 4 is a side view of the vacuum conveying device shown in Figure 4, the reduced pressure conveying device has a single tube Cavity decompression delivery tube; diagram showing the reduced pressure delivery device shown in the alternative - side view of an alternative embodiment 'the decompression delivery device has a double lumen decompression delivery tube; Figure 5 illustrates the decompression shown in Figure i Figure 6 illustrates a perspective view of a reduced pressure delivery device having a honeycomb material attached to a flexible barrier, in accordance with an embodiment of the present invention. The flexible barrier has a _ ridge portion and a pair of wing portions, the honeycomb material has a plurality of flow channels; FIG. 7 illustrates a front view of the pressure reducing conveying device shown in FIG. 6; The reduced pressure delivery device shown is cut at XVII-XVII Side view; [deg.]

圖8A圖解說明-種根據本發明—實施例之減壓輸送裳置 之剖視正視圖; V 圖崎示圖8A所示減壓輪送裝置之一側視圖; I19637.doc -54- :;^ 1325328 圖9圖解說明一種根據本發明一實施例之減壓輸送褒置 之一正視圖,其用於對患者之骨骼應用減壓組織治療; 圖10繪示一兔子頭骨之彩色組織切片,其顯示原始、未 經損壞之骨骼; 圖11圖解說明一兔子頭骨之彩色組織切片,其顯示在應 用減壓組織治療之後誘發之肉芽組織;Figure 8A is a cross-sectional front elevational view of a reduced-pressure delivery skirt in accordance with the present invention; Figure 5A is a side view of the reduced-pressure delivery device of Figure 8A; I19637.doc -54-:; ^ 1325328 FIG. 9 illustrates a front view of a reduced pressure delivery device for applying a reduced pressure tissue treatment to a patient's bone in accordance with an embodiment of the present invention; FIG. 10 depicts a colored tissue section of a rabbit skull, Showing raw, undamaged bones; Figure 11 illustrates a color tissue section of a rabbit skull showing granulation tissue induced after application of reduced pressure tissue treatment;

圖12繪示一兔子頭骨之彩色組織切片,其顯示在應用減 壓組織治療之後新骨骼之沈積; 其顯示在應 圖13圖解說明一兔子頭骨之彩色組織切片 用減壓組織治療之後新骨骼之沈積; 圖14繪示一兔子頭骨之彩色照片,在該頭骨中形成有兩 處臨界尺寸缺損; 圖15圖解說明圖14所示兔子頭#之彩色照片,其顯示嵌 入其中一處臨界尺寸缺損内之磷酸鈣支架及-覆蓋第二臨 界尺寸缺損之不銹鋼絲網;Figure 12 depicts a color tissue section of a rabbit skull showing deposition of new bone after application of reduced-pressure tissue treatment; it is shown in Figure 13 after a color tissue section of a rabbit skull is treated with decompressed tissue. Figure 14 depicts a color photograph of a rabbit skull in which two critical dimension defects are formed; Figure 15 illustrates a color photograph of the rabbit head # shown in Figure 14, which is shown embedded in one of the critical dimension defects Calcium phosphate scaffold and a stainless steel mesh covering the second critical dimension defect;

圖16圖解說明圖14所示务 听不兔子碩骨之彩色照片,其顯示對 臨界尺寸缺損應用減壓組織治療; 圖17圖解說明在實施減心織治療之後-兔子頭骨之彩 色組織切片’該組織切片顯示新骨路在磷酸鈣支架内之沈 積; 圖1 8繪示在實施減塵组鐵、么也丄 .c _ '與療,、天及實施手術兩週後圖 15所示經支架填充之臨 八J缺相之射線照片; 圖19繪示在實施減壓組織 闰, < 化 叫口麽,、天及實施手術十二週後 圖15所示經支架填充之臨 之L界尺寸缺損之射線照片; H9637.doc 1325328 圖2〇繪示一根據本發明一實施例之減壓輸送系統之正視 圖,該減壓輸送系統具有一歧管輸送管’其用於經過皮膚 將一減壓輸送裝置插入至一組織部位; 圖21圖解說明圖20所示歧管輸送管之放大正視圖,該歧 管輸送管包含一減壓輸送裝置,該減壓輸送裝置具有一挽 性障壁及/或一處於壓縮位置之蜂巢狀材料; 圖22繪不圖21所示歧管輸送管之放大正視圖,圖中顯示 在已自該歧管輸送管推入之後該減壓輸送裝置之撓性障壁 及/或蜂巢狀材料處於膨脹位置; 圖23圖解說明一種根據本發明一實施例之減壓輸送系統 之正視圖,該減壓輸送系統具有一用於經過皮膚將一減壓 輸送裝置插入至一組織部位之歧管輸送管,圖中顯示該減 壓輸送t置處於s亥歧管輸送管外側、但被一不渗透性薄膜 約束於一壓縮位置上; 圖24繪示圖23所示減壓輸送系統之一正視圖,圖中顯示 該減壓輸送裝置處於該歧管輸送管外側、但被一不滲透性 溥膜約束於一鬆他位置上; 圖25圖解說明圖23所示減壓輸送系統之一正視圖,圖中 顯示該減壓輸送裝置處於該歧管輸送管外側、但被一不滲 透性薄膜約束於一膨脹位置上; 圖25A圖解說明圖23所示減壓輸送系統之一正視圖,圖 中顯示該減壓輸送裝置處於該歧管輸送管外側、但於一膨 服位置上被一不滲透性薄膜環繞; 圖26繪示一種根據本發明一實施例之減壓輸送系統之正 119637.doc -56, 1325328 視圖,該減壓輸送系統具有一用於經過皮膚將—減壓輪送 裝置插入至一組織部位之歧管輸送管,圖中顯示該減壓= 送裝置處於該歧管輸送管外側、但受一具有膠封之 j 性薄膜約束; V透 圖26A繪示根據本發明一實施例之減壓輸送系統之 rsr»Figure 16 illustrates a color photograph of the skating bones of Figure 14 showing the application of reduced pressure tissue treatment to a critical size defect; Figure 17 illustrates the color tissue section of a rabbit skull after performing a heartbroken treatment. The tissue section shows the deposition of the new bone path in the calcium phosphate scaffold; Figure 18 shows the scaffold shown in Figure 15 after the implementation of the dust-removing group iron, 丄 丄.c _ ' and treatment, days and two weeks after the operation Filled with a radiograph of the missing phase J; Figure 19 shows the implementation of the decompression tissue 闰, &; 口 mouth, day and 12 weeks after the operation of the surgery shown in Figure 15 Radiograph of size defect; H9637.doc 1325328 FIG. 2A is a front elevational view of a reduced pressure delivery system having a manifold delivery tube that is used to pass through the skin, in accordance with an embodiment of the present invention. The reduced pressure delivery device is inserted into a tissue site; FIG. 21 illustrates an enlarged elevational view of the manifold delivery tube of FIG. 20, the manifold delivery tube including a reduced pressure delivery device having a resilient barrier and / or one in a compressed position Honeycomb material; Figure 22 depicts an enlarged front elevational view of the manifold delivery tube of Figure 21 showing the flexible barrier and/or honeycomb material of the reduced pressure delivery device after it has been pushed in from the manifold delivery tube Figure 23 illustrates a front view of a reduced pressure delivery system having a manifold for delivering a reduced pressure delivery device through a skin to a tissue site, in accordance with an embodiment of the present invention. The tube shows that the reduced pressure delivery t is placed outside the sig manifold tube but is constrained to a compression position by an impermeable membrane; FIG. 24 is a front view of the reduced pressure delivery system of FIG. The figure shows that the reduced pressure delivery device is outside the manifold tube but is constrained to a loose position by an impervious diaphragm; FIG. 25 illustrates a front view of the reduced pressure delivery system of FIG. The figure shows that the reduced pressure delivery device is outside the manifold tube but is constrained to an expanded position by an impermeable membrane; Figure 25A illustrates a front view of the reduced pressure delivery system of Figure 23, shown The reduction The pressure conveying device is located outside the manifold conveying pipe, but is surrounded by an impervious film at an expansion position; FIG. 26 illustrates a positive pressure 119637.doc-56 of the reduced pressure conveying system according to an embodiment of the present invention, 1325328 view, the reduced pressure delivery system has a manifold delivery tube for inserting a decompression-discharging device through the skin into a tissue site, the pressure reduction is shown in the figure = the delivery device is outside the manifold delivery tube, but Constrained by a j-film with a glue seal; V through Figure 26A illustrates rsr» of a reduced pressure delivery system in accordance with an embodiment of the present invention

圖2 7圖解說明一種根據本發明一實施例之減壓輪送系統 之正視圖,該減壓輸送系統具有一歧管輸送管,以用於經 過皮膚將一減麼輸送裝置注射至一組織部位; 圖27A圖解說明一種根據本發明一實施例之減壓輪送系 統之正視圖’該減壓輸送系統具有一歧管輸送管,以用於 經過皮膚將一減壓輸送裝置輸送至位於一組織部位處之^ 滲透性薄膜; 圖28繪示一種根據本發明一實施例對一組織部位施行減 壓組織治療之方法之流程圖;Figure 27 illustrates a front view of a reduced pressure delivery system having a manifold delivery tube for injecting a delivery device through a skin to a tissue site, in accordance with an embodiment of the present invention. Figure 27A illustrates a front view of a reduced pressure delivery system in accordance with an embodiment of the present invention. The reduced pressure delivery system has a manifold delivery tube for delivering a reduced pressure delivery device to an tissue through the skin. Permeable film at the site; FIG. 28 is a flow chart showing a method for performing decompression tissue treatment on a tissue site according to an embodiment of the present invention;

圖29圖解說明-種根據本發明一實施例對_@織部位施 行減壓組織治療之方法之流程圖; 圖30繪示一種根據本發明一實施例對一組織部位施行減 壓組織治療之方法之流程圖; 圖31圖解說明一種根據本發明一實施例對一組織部位施 行減壓組織治療之方法之流程圖; 圖32繪示一種根據本發明—實施例之減壓輪送裝置之剖 面正視圖,該減壓輸送裝置包括一髖假體,該髖假體具有 複數個流動通道’以用於對環繞該餘體之骨路區域施加 U9637.doc •57· 1325328 減低之壓力; 圖33圖解說明圖32所示髖假體之剖面正視圖,該駿假體 具有第二複數個流動通道,以用於將流體輸送至環繞該體 假體之骨骼區域; 圖34繪示一種根據本發明一實施例使用減壓組織治療來 修復患者關節之方法之流程圖; 圖3 5圖解說明一種根據本發明一實施例之減壓輸送裝置 之剖面正視圖,該減壓輸送裝置包含一矯形外科固定器 件,該矯形外科固定器件具有複數個流動通道,以用於對 毗鄰該矯形外科固定器件之骨骼區域應用減低之壓力; 圖36繪示圖35所示矯形外科固定器件之剖面正視圖,該 矮形外科固疋器件具有第二複數個流動通道,以用於將流 體輸送至此鄰該矯形外科固定器件之骨骼區域; 圖37圖解說明一種根據本發明一實施例用於使用減壓組 織治療來醫治骨骼之骨骼缺損之方法之流程圖; 圖3 8繪不一種根據本發明一實施例用於對一組織部位施 行減壓組織治療之方法之流程圖;以及 圖39圖解說明一種根據本發明一實施例用於對一組織部 位施行減壓組織治療之方法之流程圖。 圖40-48繪示根據本發明一實施例之減壓輸送系統之各 種視圖,該減壓輸送系統具有一主歧管,該主歧管包括— 環繞一主流動通道之撓性壁及位於該撓性壁中之複數個 孑L ; 圖49-50圖解說明一種根據本發明一實施例之減壓輪送 119637.doc •58- - 1325328 系統之透視圖及俯視剖面圖,該減壓輸送系統具有_ & 體地連接至一減壓輸送管之主歧管; 圖51繪示與一辅助歧管一起應用於一骨骼組織部位之圖 40-5 0所示主歧管之透視圖;以及 圖52圖解說明一種根據本發明一實施例具有一流體連接 至一第二導管之閥門之減壓輸送系統之示意圖。 【主要元件符號說明】29 is a flow chart showing a method for performing decompression tissue treatment on a _@ woven site according to an embodiment of the present invention; FIG. 30 is a view showing a method for performing decompression tissue treatment on a tissue site according to an embodiment of the present invention; FIG. 31 is a flow chart showing a method of performing decompression tissue treatment on a tissue site according to an embodiment of the present invention; FIG. 32 is a cross-sectional elevation view of a decompression roller device according to the present invention. In the figure, the reduced pressure delivery device comprises a hip prosthesis having a plurality of flow channels 'for applying a pressure of U9637.doc • 57· 1325328 to reduce the bone path surrounding the body; FIG. Illustrating a cross-sectional elevation view of the hip prosthesis of Figure 32, the prosthesis having a second plurality of flow channels for delivering fluid to a bone region surrounding the body prosthesis; Figure 34 depicts a Embodiments Flowchart of a method of repairing a joint of a patient using reduced pressure tissue treatment; FIG. 35 illustrates a cross-sectional elevation view of a reduced pressure delivery device in accordance with an embodiment of the present invention, the reduced pressure The delivery device comprises an orthopedic fixation device having a plurality of flow channels for applying a reduced pressure to a bone region adjacent to the orthopedic fixation device; FIG. 36 is a view of the orthopedic fixation device of FIG. A cross-sectional elevational view of the low profile surgical fixation device having a second plurality of flow channels for delivering fluid to the bone region adjacent the orthopedic fixation device; FIG. 37 illustrates an embodiment for use in accordance with an embodiment of the present invention A flow chart of a method for treating bone defects of bone using reduced pressure tissue treatment; FIG. 38 is a flow chart showing a method for performing decompression tissue treatment on a tissue site according to an embodiment of the present invention; and FIG. A flow chart of a method for performing decompression tissue treatment on a tissue site in accordance with an embodiment of the present invention is illustrated. 40-48 illustrate various views of a reduced pressure delivery system having a primary manifold including a flexible wall surrounding a primary flow channel and located therein, in accordance with an embodiment of the present invention A plurality of 孑L in the flexible wall; Figures 49-50 illustrate a perspective view and a top cross-sectional view of a reduced pressure wheeling 119637.doc • 58- - 1325328 system in accordance with an embodiment of the present invention, the reduced pressure delivery system a main manifold having _ & body connected to a reduced pressure delivery tube; FIG. 51 is a perspective view of the main manifold shown in FIG. 40-5 0 applied to a skeletal tissue portion together with an auxiliary manifold; Figure 52 illustrates a schematic diagram of a reduced pressure delivery system having a valve fluidly coupled to a second conduit, in accordance with one embodiment of the present invention. [Main component symbol description]

211 減壓輸送裝置或翼狀吱管 213 撓性障壁 215 凸脊部分 219 翼狀部分 223 拱形通道 227 撓性背襯 231 突起物 233 流動通道 241 減壓輸送管 243 遠端孔口 255 近端孔口 259 管腔或通路 261 雙管腔管 263 第—管腔 265 第二管腔 271 水平間隔件 311 減壓輪送裝置或翼狀歧營 119637.doc •59· 1325328 313 315 319 323 327 329 330 341211 decompression delivery device or wing tube 213 flexible barrier 215 ridge portion 219 wing portion 223 arched channel 227 flexible backing 231 protrusion 233 flow channel 241 decompression delivery tube 243 distal aperture 255 proximal end Orifice 259 lumen or passage 261 double lumen 263 first - lumen 265 second lumen 271 horizontal spacer 311 decompression or pterygium 119637.doc • 59· 1325328 313 315 319 323 327 329 330 341

355 359 371 373 375 377 381 383 385 387 391 411 413 415 419 撓性障壁 凸脊部分 翼狀部分 拱形通道 蜂巢狀材料 分佈表面 周邊表面 減壓輸送管 遠端孔口 近端孔口 管腔或通路 減壓輸送裝置 減壓輸送管 延伸部分 遠端 切口 凸肩 突起物 内表面 流動通道 減壓輸送裝置 組織部位 人體骨骼 減壓輸送管 119637.doc 1325328355 359 371 373 375 377 381 383 385 387 391 411 413 415 419 Flex barrier ridge part wing section arched channel honeycomb material distribution surface peripheral surface decompression duct distal orifice proximal orifice lumen or passage Decompression delivery device decompression delivery tube extension part distal incision shoulder protrusion inner surface flow channel decompression delivery device tissue part human bone decompression delivery tube 119637.doc 1325328

421 近端 427 減壓源 429 空隙缺損 431 流體輸送管 432 近端 433 流體輸送源 434 過遽器 435 壓力感測器 711 減壓輸送系統 713 組織部位 721 歧管輸送管 725 導向單元 727 導引金屬絲 731 骨折部位 733 患者骨骼 735 皮膚 739 軟組織 743 錐形遠端 751 通路 761 減壓輸送裝置 765 撓性障壁 767 蜂巢狀材料 769 減壓輸送管 811 減壓輸送系統 119637.doc -61 1325328421 proximal end 427 decompression source 429 void defect 431 fluid delivery tube 432 proximal end 433 fluid delivery source 434 filter 435 pressure sensor 711 decompression delivery system 713 tissue site 721 manifold delivery tube 725 guide unit 727 guide metal Silk 731 Fracture site 733 Patient bone 735 Skin 739 Soft tissue 743 Tapered distal end 751 Path 761 Reduced pressure delivery device 765 Flexible barrier 767 Honeycomb material 769 Reduced pressure delivery tube 811 Reduced pressure delivery system 119637.doc -61 1325328

821 歧管輸送管 837 虛線 843 遠端 861 減壓輸送裝置 865 撓性障壁 867 蜂巢狀材料 869 減壓輸送管 871 不滲透性薄膜 873 内表面 881 標諸 885 移出器具 891 輔助管腔或管 911 減壓輸送系統 921 歧管輸送管 937 虛線 943 遠端 961 減壓輸送裝置 965 撓性障壁 967 蜂巢狀材料 969 減壓輸送管 971 不滲透性薄膜 973 内表面 977 膠封 981 標諸 119637.doc -62 1325328821 manifold duct 837 dotted line 843 distal end 861 decompression conveyor 865 flexible barrier 867 honeycomb material 869 decompression duct 871 impervious membrane 873 inner surface 881 marking 885 removal device 891 auxiliary lumen or tube 911 minus Pressure delivery system 921 manifold delivery line 937 dashed line 943 distal end 961 decompression delivery device 965 flexible barrier 967 honeycomb material 969 decompression delivery tube 971 impervious film 973 inner surface 977 rubber seal 981 standard 119637.doc -62 1325328

985 減壓輸送系統 987 導引金屬絲 989 減壓輸送管 991 減壓輸送裝置 993 組織部位 1011 減壓輸送系統 1021 歧管輸送管 1025 組織部位 1029 空隙 1035 減壓輸送裝置 1043 遠端 1055 内部空間 1057 輔助管腔 1061 導引金屬絲 1511 減壓輸送裝置 1515 整形外科髖假體 1517 患者腿節 1521 柱部分 1525 頭部分 1529 通路 1535 多孔塗層 1541 流動通道 1543 主饋送管線 1545 橫向分支管線 119637.doc -63 - 1325328985 decompression conveying system 987 guiding wire 989 decompression conveying pipe 991 decompression conveying device 993 organization part 1011 decompression conveying system 1021 manifold conveying pipe 1025 organization part 1029 gap 1035 decompression conveying device 1043 remote end 1055 internal space 1057 Auxiliary lumen 1061 Guide wire 1511 Reduced pressure delivery device 1515 Orthopedic hip prosthesis 1517 Patient leg section 1521 Column section 1525 Head section 1529 Path 1535 Porous coating 1541 Flow channel 1543 Main feed line 1545 Lateral branch line 119637.doc - 63 - 1325328

1547 橫向分支管線 1551 減壓輸送管 1553 減壓輸送源 1565 連接埠 1571 流體輸送管 1573 流體輸送源 1583 主饋送管線 1585 橫向分支管線 1711 減壓輸送裝置 1715 整形外科固定器件 1717 骨骼 1719 骨折部位 1721 通路 1725 螺釘 1735 多孔塗層 1741 流動通道 1743 主饋送管線 1745 連接埠 1747 橫向分支管線 1751 減壓輸送管 1753 減壓輸送源 1761 流動通道 1765 連接埠 1771 流體輸送管 119637.doc -64- 13253281547 Transverse branch line 1551 Decompression line 1553 Reduced pressure supply 1565 Connection 埠1571 Fluid delivery tube 1573 Fluid delivery source 1583 Main feed line 1585 Transverse branch line 1711 Reduced pressure delivery device 1715 Orthopedic fixation device 1717 Bone 1719 Fracture 1721 Pathway 1725 Screw 1735 Perforated coating 1741 Flow channel 1743 Main feed line 1745 Connection 埠 1747 Lateral branch line 1751 Reduced pressure line 1753 Reduced pressure supply 1761 Flow channel 1765 Connection 埠 1771 Fluid transfer tube 119637.doc -64- 1325328

1773 流體輸送源 1783 主饋送管線 1785 橫向分支管線 2111 減壓輸送系統 2115 主歧管 2117 撓性壁 2121 主流動通路 2123 近端 2129 過渡區 2135 防阻塞部件 2137 突起物 2141 内表面 2145 脊 2149 蜂巢狀材料 2155 孔 2161 第一導管 2163 第二導管 2171 頂隙 2211 減壓輸送系統 2215 主歧管 2217 減壓輸送管 2223 中央管腔 2225 輔助管腔 2231 孔 119637.doc -65 1325328 2241 頂隙 2321 辅助歧管 2411 減壓輸送系統 2415 歧管 2419 第一導管 2423 第二導管 2429 減壓源 2435 出口 2439 閥門 2453 控制器1773 Fluid delivery source 1783 Main feed line 1785 Transverse branch line 2111 Reduced pressure delivery system 2115 Main manifold 2117 Flexible wall 2121 Main flow path 2123 Proximal 2129 Transition zone 2135 Anti-blocking part 2137 Protrusion 2141 Inner surface 2145 Ridge 2149 Honeycomb Material 2155 Hole 2161 First conduit 2163 Second conduit 2171 Headspace 2211 Reduced pressure delivery system 2215 Main manifold 2217 Pressure relief tube 2223 Central lumen 2225 Auxiliary lumen 2231 Hole 119637.doc -65 1325328 2241 Top gap 2321 Auxiliary Tube 2411 Pressure Delivery System 2415 Manifold 2419 First Catheter 2423 Second Catheter 2429 Decompression Source 2435 Outlet 2439 Valve 2453 Controller

119637.doc -66119637.doc -66

Claims (1)

十、申請專利範圍: h種用於街-組織部位應用減壓组織治療之減壓輸送系 統’其包括: 歧營輪送管,其具有至少兩個管腔; 歧^ ’ S具有複數個流動通道,該歧管言史置於該歧 管輸送管之該等管腔中一第—管腔内;及 氣球,其具有一内部空間並能夠採取塌縮及膨脹位 置’該内部空間流體連接至該歧管輸送管之該等管腔中 一第二管腔。 叫求項1之減壓輸送系統,其進一步包括一可操作地 Ά歧S輪送官相關聯之銳利尖端,以用於選擇性地刺 破該氣球。 3. 如請求項1之減壓輸送系統,其中該第-與第二管腔大 致上同車由。 4. 如明求項1之減壓輸送系統,其進一步包括一流體連接 至該複數個流動通道中至少一者之減壓輸送管。 5·如印求項4之減壓輸送系統,其中該減壓輸送管能夠自 該至少一個流動通道斷開。 6. 如請求項5之減壓輸送系统,其中該歧管係生物可再吸 收性的。 7. 如請求項4之減壓輸送系統,其進一步包括一流體連接 至該減壓輸送管之減壓源。 8. 如請求項4之減壓輸送系統,其中一減低之壓力藉由該 減壓輸送管施加至該至少一個流動通道。 U9637.doc 9. 如請求項8之減壓輸送系統,其中該減低之壓力係循環 地施加。 10. 11. 12. 13. 14. 15. 如請求項1之減壓輸送系統,其中該歧管輸送管係—導 液管。 如請求項1之減壓輸送系統,其中該歧管輸送管係一套 管。 如請求項1之減壓輸送系統,其進一步包括標誌,該等 標諸可操作地附著至該歧管輸送管與該歧管中至少一者 上’以使該歧管輸送管或該歧管相對於該組織部位之一 位置直觀化。 如請求項12之減壓輸送系統,其中該等標誌係不透射線 之標1¾。 如請求項1之減壓輸送系統,其中該歧管進一步包括: 一撓性壁,其環繞一主流動通路並適於緊靠該組織部 位放置’該撓性壁包含複數個穿過該撓性壁並與該主流 動通路連通之孔; 一防阻塞部件,其定位於該主流動通路内; 一第一導管,其具有至少一個流體連接至該主流動通 路之出口,以將減低之壓力輸送至該主流動通路; —第二導管,其具有至少一個出口,該至少一個出口 緊靠該主流動通路或該第一導管之該至少一個出口,以 在應用減低之壓力期間以一氣態流體來清洗該主流動通 路與該第一導管之該出口中之至少一者。 如凊求項14之減壓輸送系統,其中該防阻塞部件係設置 H9637.doc 1325328 於該撓性壁之-内表面上並延伸至該主流動通路内之複 數個突起物。 如請求項14之減壓輸送系統,其中該防阻塞部件係一定 位於該主流動通路内之蜂巢狀材料。 如請求項!之減壓輸送系統,其中該歧管進—步包括: 一撓性障壁; 一蜂巢狀材料,其毗鄰該撓性障壁設置,該蜂巢狀材 料包含該複數個流動通道;及 一減壓輸送管,其流體連接至該複數個流動通道中之 至少一者。 18·如請求項丨之減壓輸送系統,其中該氣球藉由一流體注 入該内部空間内而膨脹。 19.如明求項1之減壓輸送系統,其中該組織部位包括一硬 組織。 2 〇.如明求項1之減壓輸送系統,其中該組織部位包括一軟 組織。 2 1 ·種用於對一組織部位應用減壓組織治療之減壓輸送系 統,其包括: 一不滲透性薄膜,其具有—内部空間,該不滲透性薄 膜能夠採取壓縮及鬆弛狀態; 一歧管’其具有複數個流動通道,該歧管定位於該不 滲透性薄膜之該内部空間内;及 其中該不滲透性薄膜之該内部空間内一減低之壓力小 於該不滲透性薄膜外部之壓力,以減小該歧管在該不滲 119637.doc 1325328 透性薄膜内所佔據之一空間量。 22. 如請求項21之減壓輸送系統,其中該不渗透性薄膜經密 封以在該不滲透性薄膜内保持該減低之壓力。 23. 如請求項21之減壓輸送系統,其進一步包括一減壓源, 該減壓源流體連接至該不滲透性薄膜之該内部空間,以 在該内部空間内保持該減低之壓力。 24·如請求項21之減壓輸送系統,其中該不滲透性薄膜在接 觸體液或身體組織放置時可溶解。 25. 如請求項以之減壓輸送系統,其中該不滲透性薄膜能夠 採取一膨脹位置以分離她鄰該組織部位之組織。 26. 如請求項25之減壓輸送系統,其中該不滲透性薄膜藉由 一流體注入該内部空間内而膨服。 27. 如請求項21之減壓輸送系統,其進一步包括一具有—銳 利尖端之器具,以選擇性地弄破該不滲透性薄膜。 28. 如請求項2 1之減壓輸送系統,其進一步包括: —密封件’其設置於該不滲透性薄膜上;及 —用於透過該密封件推動該歧管之器具。 2 9.如請求項2 1之減壓輸送系統’其進一步包括標结,該等 標結、可操作地附著至該不滲透性薄膜與該歧管中至少— 者上,以使該不渗透性薄膜或該歧管相對於該組織部位 之一位置直觀化。 30.如請求項29之減壓輸送系統’其中該等標誌係不透射線 之標諸。 31·如請求項21之減壓輸送系統,其進一步包括一減壓輸送 119637.doc 1325328 管,該減壓輸送管具有一流體連接至該歧管之該等流動 通道中至少一者之遠端。 32. 如請求項3 1之減壓輸送系統’其進一步包括一減壓源, 該減壓源流體連接至該減壓輸送管之一近端,以將一第 二減低之壓力輸送至該至少一個流動通道。 33. 如請求項32之減壓輸送系統,其中該第二減低之壓力係 循環地施加。 34. 如請求項3 1之減壓輸送系統,其中該減壓輸送管能夠自 該至少一個流動通道斷開。 35. 如請求項34之減壓輸送系統,其中該歧管係生物可再吸 收性的。 36·如請求項2 1之減壓輸送系統,其中該歧管進一步包括: 一撓性壁,其環繞一主流動通路並適於緊靠該組織部 位放置,該撓性壁包含複數個穿過該撓性壁並與該主流 動通路連通之孔; 一防阻塞部件,其定位於該主流動通路内; 一第一導管,其具有至少一個流體連接至該主流動通 路之出口,以將減低之壓力輸送至該主流動通路; 一第二導管,其具有至少一個出口,該至少一個出口 緊靠該主流動通路或該第一導管之該至少一個出口以 在應用減低之壓力期間用一流體清洗該主流動通路與該 第一導管之該出口中之至少一者。 37.如%求項36之減壓輸送系統,其中該防阻塞部件係設置 於該撓性壁之一内表面上並延伸入該主流動通路内之複 )19637.(10, 1325328 數個突起物。 38·如晴求項36之減愿輪逆备姑 甘山―〜扣 ι侧迗系統,其中該防阻塞部件係一定 位於該主流動通路内之蜂巢狀材料。 39. 如請求項36之減壓輸送系、統,其中該流體係—氣體。 40. 如請求項36之減壓輪送系統,其中該流體係一液體。 41. 如請求項21之減壓輸送系統,其中該歧管進—步 一撓性障壁; 一蜂巢狀材料,其附著至該撓性障壁上,該蜂巢狀材 料包含该複數個流動通道;及 一減壓輸送管,其流體連接至該複數個流動通道中之 至少一者。 42. 如請求項21之減壓輸送系統,其中該組織部位包括一硬 組織。 4 3 ·如睛求項2 1之減壓輸送系統,其中該組織部位包括—軟 組織。 44. 一種用於對一組織部位應用減壓組織治療之減壓輸送系 統,其包括: 一歧管輸送管,其具有至少一個通路及一遠端,該遠 端能夠础鄰該組織部位放置; 一歧管,其具有複數個流動通道,該歧管經構造以穿 過該歧管輸送管之該通路被輸送至該組織部位;及 一不滲透性薄膜,其可定位於該歧管輸送管之該遠端 處,該不滲透性薄膜具有一内部空間並能夠採取一膨服 位置與一塌縮位置中之至少一者。 I19637.doc .. -a.X. Patent application scope: h kinds of decompression conveying system for decompressing tissue treatment in street-tissue site's includes: a squad wheel with at least two lumens; ^^' S has a plurality of a flow channel, the manifold is placed in a first lumen of the lumen of the manifold delivery tube; and a balloon having an interior space and capable of taking a collapsed and expanded position 'the internal space fluid connection a second lumen in the lumens of the manifold delivery tube. The reduced pressure delivery system of claim 1 further comprising a sharpened tip associated with the operative stalk for selectively puncturing the balloon. 3. The reduced pressure delivery system of claim 1, wherein the first and second lumens are substantially identical. 4. The reduced pressure delivery system of claim 1, further comprising a reduced pressure delivery tube fluidly coupled to at least one of the plurality of flow channels. 5. The reduced pressure delivery system of claim 4, wherein the reduced pressure delivery tube is disconnectable from the at least one flow channel. 6. The reduced pressure delivery system of claim 5, wherein the manifold is bioresorbable. 7. The reduced pressure delivery system of claim 4, further comprising a reduced pressure source fluidly coupled to the reduced pressure delivery tube. 8. The reduced pressure delivery system of claim 4, wherein a reduced pressure is applied to the at least one flow channel by the reduced pressure delivery tube. U9637.doc 9. The reduced pressure delivery system of claim 8, wherein the reduced pressure is applied cyclically. 10. 11. 12. 13. 14. 15. The reduced-pressure delivery system of claim 1, wherein the manifold is a conduit-pipe. The reduced pressure delivery system of claim 1, wherein the manifold delivery tube is a set of tubes. The reduced pressure delivery system of claim 1, further comprising a flag operatively attached to at least one of the manifold delivery tube and the manifold to cause the manifold delivery tube or the manifold The position is visualized relative to one of the tissue parts. The reduced pressure delivery system of claim 12, wherein the markers are radiopaque markers. The reduced pressure delivery system of claim 1, wherein the manifold further comprises: a flexible wall surrounding a main flow path and adapted to be placed against the tissue site 'the flexible wall comprising a plurality of flexures a wall and a hole communicating with the main flow path; an anti-blocking member positioned in the main flow path; a first conduit having at least one outlet fluidly connected to the main flow path for conveying the reduced pressure To the main flow passage; a second conduit having at least one outlet abutting the main flow passage or the at least one outlet of the first conduit to be in a gaseous fluid during application of the reduced pressure Cleaning at least one of the primary flow path and the outlet of the first conduit. The reduced pressure delivery system of claim 14, wherein the anti-blocking member is provided with H9637.doc 1325328 on the inner surface of the flexible wall and extending to a plurality of protrusions in the main flow path. The reduced pressure delivery system of claim 14, wherein the anti-blocking component is a honeycomb material that must be located within the main flow path. Such as the request item! The reduced pressure delivery system, wherein the manifold further comprises: a flexible barrier; a honeycomb material disposed adjacent to the flexible barrier, the honeycomb material comprising the plurality of flow channels; and a reduced pressure delivery tube And fluidly coupled to at least one of the plurality of flow channels. 18. The reduced pressure delivery system of claim 1, wherein the balloon is inflated by injecting a fluid into the interior space. 19. The reduced pressure delivery system of claim 1, wherein the tissue site comprises a hard tissue. 2. The reduced pressure delivery system of claim 1, wherein the tissue site comprises a soft tissue. 2 1 . A reduced-pressure delivery system for applying a reduced-pressure tissue treatment to a tissue site, comprising: an impermeable membrane having an internal space capable of taking a compressed and relaxed state; a tube having a plurality of flow passages positioned in the interior space of the impermeable membrane; and wherein the reduced pressure in the interior space of the impermeable membrane is less than the pressure external to the impermeable membrane To reduce the amount of space occupied by the manifold within the 119637.doc 1325328 permeable membrane. 22. The reduced pressure delivery system of claim 21, wherein the impermeable membrane is sealed to maintain the reduced pressure within the impermeable membrane. 23. The reduced pressure delivery system of claim 21, further comprising a reduced pressure source fluidly coupled to the interior space of the impermeable membrane to maintain the reduced pressure within the interior space. 24. The reduced pressure delivery system of claim 21, wherein the impermeable membrane is soluble upon contact with body fluids or body tissue. 25. A reduced pressure delivery system as claimed in claim 1, wherein the impermeable membrane is capable of adopting an expanded position to separate tissue adjacent to the tissue site. 26. The reduced pressure delivery system of claim 25, wherein the impermeable membrane is expanded by injecting a fluid into the interior space. 27. The reduced pressure delivery system of claim 21, further comprising an instrument having a sharp tip to selectively break the impermeable membrane. 28. The reduced pressure delivery system of claim 21, further comprising: - a seal ' disposed on the impermeable membrane; and - an means for propelling the manifold through the seal. 2 9. The reduced pressure delivery system of claim 2, further comprising a label operatively attached to at least the impervious membrane and the manifold to render the impervious The film or the manifold is visualized relative to the location of one of the tissue sites. 30. The reduced pressure delivery system of claim 29, wherein the markers are radiopaque. 31. The reduced pressure delivery system of claim 21, further comprising a reduced pressure delivery 119637.doc 1325328 tube having a distal end of at least one of the flow channels fluidly coupled to the manifold . 32. The reduced pressure delivery system of claim 3, further comprising a reduced pressure source fluidly coupled to a proximal end of the reduced pressure delivery tube to deliver a second reduced pressure to the at least A flow channel. 33. The reduced pressure delivery system of claim 32, wherein the second reduced pressure is applied cyclically. 34. The reduced pressure delivery system of claim 3, wherein the reduced pressure delivery tube is disconnectable from the at least one flow channel. 35. The reduced pressure delivery system of claim 34, wherein the manifold is bioresorbable. 36. The reduced pressure delivery system of claim 2, wherein the manifold further comprises: a flexible wall surrounding a main flow path and adapted to be placed against the tissue site, the flexible wall comprising a plurality of passes through a flexible wall and a hole communicating with the main flow path; an anti-blocking member positioned in the main flow path; a first conduit having at least one outlet fluidly connected to the main flow path to reduce a pressure is delivered to the main flow passage; a second conduit having at least one outlet abutting the main flow passage or the at least one outlet of the first conduit to use a fluid during application of the reduced pressure Cleaning at least one of the primary flow path and the outlet of the first conduit. 37. The reduced pressure delivery system of claim 36, wherein the anti-blocking member is disposed on an inner surface of the flexible wall and extends into the main flow path. 19637. (10, 1325328 number of protrusions 38. If the wish of the 36th reduction is reversed, the Guganshan-~ buckle side system, wherein the anti-blocking component is a honeycomb material that must be located in the main flow path. 39. A reduced pressure delivery system, wherein the flow system is a gas. 40. The reduced pressure delivery system of claim 36, wherein the flow system is a liquid. 41. The reduced pressure delivery system of claim 21, wherein the a stepped-flexible barrier; a honeycomb material attached to the flexible barrier, the honeycomb material comprising the plurality of flow channels; and a reduced pressure delivery tube fluidly coupled to the plurality of flow channels 42. The reduced pressure delivery system of claim 21, wherein the tissue site comprises a hard tissue. 4 3 . The reduced pressure delivery system of claim 2, wherein the tissue site comprises - soft tissue. 44. One for a tissue part A reduced pressure delivery system using reduced pressure tissue therapy, comprising: a manifold delivery tube having at least one passageway and a distal end, the distal end being positionable adjacent to the tissue site; a manifold having a plurality of flows a passageway configured to pass through the passage of the manifold delivery tube to the tissue site; and an impermeable membrane positioned at the distal end of the manifold delivery tube, the impermeable The film has an internal space and is capable of taking at least one of an expanded position and a collapsed position. I19637.doc .. -a.
TW96111826A 2007-03-13 2007-04-03 System for percutaneously administering reduced pressure treatment using balloon dissection TWI325328B (en)

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