TW200808393A - System for percutaneously administering reduced pressure treatment using balloon dissection - Google Patents
System for percutaneously administering reduced pressure treatment using balloon dissection Download PDFInfo
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- TW200808393A TW200808393A TW96111826A TW96111826A TW200808393A TW 200808393 A TW200808393 A TW 200808393A TW 96111826 A TW96111826 A TW 96111826A TW 96111826 A TW96111826 A TW 96111826A TW 200808393 A TW200808393 A TW 200808393A
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- reduced pressure
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Abstract
Description
200808393 九、發明說明: 【發明所屬之技術領域】 纟發明概言之係關於-種用於促進組織生長之系統及方 法,且更具體而言,係關於-種用於對一組織部位應用減 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療合。通常, # #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-歧管來分佈減低之麗力。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 〇開始癒合且變小而;t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, 戶斤醫治之組織係皮下組織,且在其他情形中,該等組織位 於皮膚組織内或卜&。A你从, ^上面在傳統上,減壓治療一直主要應用 於权、、且4 ;咸壓治療通常尚未用於治療封閉之深組織傷 # 75〒難以接近此等傷口。另外,減壓治療尚未與醫治 月:夬相或促進骨骼生長結合使用,此主要歸因於難以接 近骨絡之問題。藉由外科手術暴露出骨絡來應用減壓治療 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u ^ °牛及糸、、充之發展幾乎未超出開放孔發泡體 119637.doc 200808393 口部位並隨後在 件—用手使開放孔發泡體之形狀適合於傷 一減壓治療週期之後將其移除。 【發明内容】 本舍明之糸統及方法即解決 ^ |鮮决現有傷口醫治系統及方法所 存在之問題。根據本發明一给 " χ β您貝軛例,提供一種減壓輸送 糸統’以用於對一組織部/虛 / 立應用減低之壓力。該減壓輸送 系統包括一歧管輸送瞢,1目士 /、/、有至少兩個管腔及一具有複 數個流動通道之站營。d g200808393 IX. INSTRUCTIONS: [Technical field to which the invention pertains] The present invention relates to systems and methods for promoting tissue growth, and more particularly to the application of a tissue to a tissue site. Pressure tissue treatment system. ~ [Prior Art] People are gradually using decompression therapy to promote wound healing in soft tissue wounds that heal very slowly or not heal if they are not treated with decompression. Typically, ## is applied to the wound site by a reduced pressure of the open-cell foam, which acts as a manifold to distribute the reduced brilliance. The open-cell foam is sized to fit the existing wound, is in contact with the wound, and then begins to heal and become smaller as the wound begins; the t-stage is replaced with a smaller foam. 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 injuries. In some cases, the tissue to be treated is subcutaneous tissue, and in other cases, the tissue is located in the skin tissue or in & A you from, above, traditionally, decompression therapy has been mainly applied to the right, and 4; salty pressure therapy has not been used to treat closed deep tissue injuries # 75〒 difficult to access these wounds. In addition, decompression therapy has not been used in conjunction with the treatment of sputum or skeletal growth, which is mainly due to the difficulty of accessing the collaterals. Applying decompression therapy by surgically exposing the bone network may cause more problems than the problem it solves. Finally, the application of decompression therapy for u ^ ° cattle and sputum, and the development of the filling almost did not exceed the opening of the open-cell foam 119637.doc 200808393 and then in the shape of the open-hole foam It is removed after the injury-decompression treatment cycle. SUMMARY OF THE INVENTION The system and method of the present invention solves the problems existing in existing wound healing systems and methods. According to the present invention, a "pressure reducing conveyor system" is provided for reducing the pressure on a tissue portion/virtual/vertical application. The reduced pressure delivery system includes a manifold delivery port, 1 mesh/, /, at least two lumens, and a station with a plurality of flow channels. d g
卜 歧目該歧官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。該氣球之内衫間流體 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-具有-内部空間之不渗透性薄膜。該不參透性薄膜能 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 邛二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,提供一種減壓輸送系統,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 能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。 該不渗透性薄膜包括一内部空間並能夠採取一膨脹位置與 一塌縮位置中之至少一者。 119637.doc 200808393 參照附圖及下文謀纟% Ώ , 卜又咩細說明,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“、、附圖對較佳實施例進行詳細說明,該等附圖 構成本U之4分且其巾以圖解方式顯示可實施本發明 之具體較佳實施例m熟習此項技術者能夠實踐本發 月足夠洋、、、田地闡述該等實施例,且應瞭解,亦可利用其 他貝鈿例’且可在邏輯結構、機械、冑氣及化學方面作出 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 可省略热習此項技術者所習知之某些資訊。因&,不應將 下文洋細呪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,λ多數彈性體具有大於100%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^ 二烯,苯乙烯丁二烯橡膠,氯丁二烯橡膠,聚丁二烯,腈 橡膠,異Τ烯橡膠,乙烯丙烯橡膠,乙烯丙烯二晞單體^ 膠,氯磺化聚乙烯,聚硫橡膠,聚氨基甲酸酯,及浐 氧。 ΛΚ夕 本文中所用術語"撓性"係指物體或材料能夠彎曲或挣 曲。彈性材料通常呈撓性,但在本文中所提及之撓性材: 119637.doc 200808393 = 疋將所選材料僅限定為彈性體。將術語π撓性"與本 ^月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 、月骼缺知之減壓輸迗裝置之撓性性質可使該裝置能夠纏 繞或包繞具有缺損之骨絡部分。 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讀料,包括但不限於凝膠、膠體 或泡沫。 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,性來指代詠㈣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"不滲透性"並非旨在隱含著不滲透性薄膜高於或 低於任何特定4標準❹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。歧管之實例可包括作 限於具有經設置以形成流動通道之結構元件之筆置、蜂巢 狀發泡體(例如開放孔發泡體)、多孔組織收集裳置、及勺 含或凝固後包含流動通道之液體、凝膠及泡朱。 119637.doc 200808393 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置之環境壓力。另一選擇 為,该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 4 α卩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,本文中所述之壓力值 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’該等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。舉例而纟,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^收 119637.doc -10- 200808393 穫該額外之組織並將其移植至另一組織部位上。 參見圖1-5,一種根據本發明原理之減壓輪送裝置或翼 狀歧管2Π包括一具有凸脊部分215孓撓性障壁213以及」 對翼狀部分219。每一翼狀部分219皆沿凸脊部分之對 置侧定位。凸脊部分215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211之整個長度。= 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亦可如在圖卜$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: 衩寬之翼狀歧管211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2丨9之額外寬度可能特別有用。 撓性障壁213較佳由例如聚矽氧聚合物等彈性材料製 辱。適舍之聚矽氧聚合物之—實例包括由位於。…咖❿, Qalifomia之Nusil Technologies公司製造之med_6〇15。然 $ ’應注意,撓性障壁213可由任何其他生物相容性、撓 性材:料製成。撓性障壁213包封一撓性背襯227,以增強撓 $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 之一實例可包括亦由Nusil Techn〇l〇gies&3出售之med_ MU。撓性背襯227較佳由聚自旨針織織物製成,例如由位 今 Tempe,Arizona 之 C.R. Bard公司所製造之Bard 6〇13製 119637.doc 200808393 成。然而,撓性背襯227可由任何能增強撓性障壁213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,若撓性障壁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213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 二者可不滲透液體、空氣及其他氣體。 鲁 撓性障壁213及撓性背襯227亦可由在使用減壓輸送裝置 211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醋、聚富馬酸酿、及capralact〇ne。撓 性障壁2 13及撓性背襯227可進一步用作一新細胞生長支 架,或者可將一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 φ 磷酸鈣、膠原、PLA/PGA、珊瑚羥基磷灰石、碳酸鹽、或 餐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)。 在一實施例中,可將撓性背襯227以黏合方式固定至撓 怿障壁213之表面上。若使用聚矽氧聚合物來形成撓性障 >1 213 ’則亦可使用聚矽氧黏合劑將撓性背襯227固定至撓 性障壁213上。儘管當將撓性背襯227表面結合至撓性障壁 宜之固定方法。 119637.doc 200808393 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上 固定有突起物23 1之側相關聯之平面即可。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^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23丨在撓性障壁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231具有一致之形 狀及尺寸且在撓性障壁213上均勻相間時’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 231之尺寸、形狀及間距之變化來改變流動通道233之尺寸 及流動特性。 浚在05中所示,一減壓輸送管241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241可同時固定至撓性 障壁213與撓性背襯227二者上。減壓輸送管241在管241之 遠端處包含一遠端孔口 243。管241可定位成使遠端孔口 243沿拱形通道223位於任一點處,但管241較佳定位成使 遠端孔口 243沿拱形通道223之縱向長度位於大約中點處。 較佳藉由沿一相對於管241之縱向軸線以小於九十(9〇)度之 119637.doc -13- 200808393 角度定向之平面切割管241,將遠端孔口 243製作成橢圓形 或卵圓形开> 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23丨間之流動通道233 之流體連通。 減壓輸送管241較佳由塗覆有paraiyne之聚石夕氧或胺基甲 酸酯製成。然而,亦可使用任何醫療級管子材料來構造減 壓輸迗管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241 定位之排放開孔或排放孔口 251,以進一步增強減壓輸送 官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中所示僅沿棋形通道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 定位。若定位成使減壓輸送管241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241與流動通 道2 3 3間之所有流體連通皆經由排放開孔2 5 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1-3、4八及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 減壓輸送管241包含多個管腔,例如在圖4Β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- 200808393 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2 61來達成減壓源與沿第一管腔2 6 3之流動通道2 3 3 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、沖砟流體、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The ambiguity is disposed in the first of the lumens of the manifold delivery tube. A balloon is provided which has an internal space and is capable of taking a collapsed position and an expanded position. The inner garment of the balloon is fluidly coupled to a second one of the lumens of the manifold delivery tube. According to another embodiment of the present invention, a reduced pressure delivery system is provided which includes an impervious film having an internal space. The non-permeable film can be in a compressed state and a relaxed state. A manifold having a plurality of flow passages is disposed in the interior space of the impermeable membrane. The pressure within the impervious membrane is reduced by less than the pressure outside the impervious membrane to reduce the amount of space occupied by the manifold within the impervious membrane. In accordance with still another embodiment of the present invention, a reduced pressure delivery system is provided that includes a manifold delivery tube having at least one channel and a distal end, the distal end being positionable adjacent the tissue site. A manifold having a plurality of flow channels is configured to be delivered to the tissue site via a passageway of the manifold delivery tube. An impermeable membrane is provided which can be positioned at the distal end of the manifold 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 200808393 Other objects, features and advantages of the present invention will become apparent from the accompanying drawings. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT(S) The following is a detailed description of the preferred embodiments, which constitute a part of the present invention, and the drawings show the specific preferred embodiments of the present invention. The technicians can practice the implementation of this embodiment in sufficient oceans, fields, and fields, and it should be understood that other shellfish cases can be used and changes can be made in logical structures, machinery, helium, and chemistry. The teachings may omit certain information that is known to those skilled in the art in light of the spirit and scope of the invention. The following is not to be taken as limiting, and the scope of the invention is defined only by the scope of the accompanying claims. The term "elasticity" as used herein means having the properties of an elastomer. The term "elastomer" refers to a polymer material having the same properties as rubber: more specifically, λ most elastomers have an elongation of more than 100% and a significant degree of resilience. The resilience of the material refers to the material. It can recover from elastic deformation. Examples of elastomers may include, but are not limited to, natural, rubber, polyisobutylene, styrene butadiene rubber, chloroprene rubber, polybutadiene, nitrile rubber, isodecene. Rubber, ethylene propylene rubber, ethylene propylene dioxime monomer ^ gel, chlorosulfonated polyethylene, polysulfide rubber, polyurethane, and oxime. The term "flexible" used in this article refers to an object. Or the material can bend or bend. The elastic material is usually flexible, but the flexible material mentioned in this article: 119637.doc 200808393 = 疋 The selected material is limited to only the elastomer. The term π flexibility " The use of a large system in conjunction with the material of this month 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 use of a decompression device for the treatment of sacral dysfunction Sexual nature The device is capable of wrapping or wrapping a portion of the skeleton having a defect. The term "fluid" as used herein generally refers to a gas or liquid, but may also include any other flowable read material, including but not limited to gels, gels. Or foam. As used herein, the term "impervious" generally refers to the ability of a film, cover or other material to block or slow the penetration of a liquid or gas. Imperviousness can be used to refer to the covering of the crucible (four) body while allowing gas to pass through the cover, sheet or other film of the film. Although the impermeable film may be impermeable to liquids' however, the film may simply reduce the transmission of all or only certain liquids. The use of the term "impermeable" is not intended to imply that the impermeable film is above or below any particular 4 standard permeability measurement, such as a specific value for water vapor transmission rate (WVTR). As used herein, the term "manifold," large system refers to a substance or structure provided to facilitate the application of reduced pressure to a tissue site, the delivery or removal of fluid from the tissue site. The manifold typically includes a plurality of interconnected flow channels or passages to improve the distribution of fluids provided to or removed from the tissue region surrounding the manifold. Examples of the manifold may include a pen, a honeycomb foam (e.g., an open cell foam) having a structural member disposed to form a flow channel, a porous tissue collecting skirt, and a spoon containing or solidifying to contain a flow Channel liquid, gel and bubble. 119637.doc 200808393 The term "reduced stress" as used herein refers to a pressure at a tissue site that is receiving treatment that is less than the surrounding pressure. In most cases, the pressure of such reduction will be less than the environment in which the patient is located. Pressure. Alternatively, the reduced pressure may be less than the hydrostatic pressure of the tissue at the tissue site. Although the terms "vacuum" and "negative pressure" may be used to describe the pressure applied to the tissue site, the actual application to the tissue site The pressure can be significantly lower than the pressure normally associated with a pure vacuum. The reduced pressure can initially create fluid flow in the area of the tube and group 4 alpha clamp. As the hydrostatic pressure around the tissue site approaches the desired reduction The pressure, the flow may slow down, and then maintain the reduced pressure. Unless otherwise indicated, the pressure values described herein are gauge pressure. The term "scaffold" as used herein refers to the use of cells to enhance or promote cells. A substance or structure formed by growth and/or tissue. The scaffold is typically a three-dimensional porous structure that provides a template for cell growth. The rack may be infused with, coated with, or composed of cells, growth factors, or other nutrient agents for promoting cell growth. A scaffold may be used as a manifold according to embodiments described herein to decompress tissue at a tissue site Treatment. The term "tissue site" as used herein 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" can further refer to the region of any tissue that is not necessarily injured or defective, but rather wants to enhance or promote the growth of additional tissue in such regions. For example, decompression tissue treatment can be used in some tissue regions to grow additional tissue and then harvested. 119637.doc -10- 200808393 This additional tissue is obtained and transplanted to another tissue site. Referring to Figures 1-5, a reduced pressure wheeling device or wing manifold 2 in accordance with the principles of the present invention includes a rib portion 215, 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. The ridge portion 215 defines an arcuate passage 223 that may or may not extend over the entire length of the wing manifold 211. The tube ridge portion 215 can be centrally positioned on the wing manifold 211 such that the width of each wing portion 219 is equal, however the ridge portion 215 can also be offset as shown in Figure #, thereby One wing portion 219 is wider than the other wing portion 219. If the wing manifold 211 is used in conjunction with bone regeneration or healing: the wide width of the wing-shaped manifold 211 will be wrapped around the fixed hardware attached to the bone, and the extra width of one of the wing portions 2丨9 may be particularly it works. The flexible barrier 213 is preferably sterilized by an elastic material such as a polyoxyl polymer. Suitable polyoxyl polymers - examples include by. ...Curry, med_6〇15 manufactured by Nusil Technologies of Qalifomia. However, it should be noted that the flexible barrier 213 can be made of any other biocompatible, flexible material: material. The flexible barrier 213 encloses a flexible backing 227 to enhance the strength and durability of the barrier 213. The flexible barrier 213 enclosing the flexible backing 227 may have a thickness in the arcuate channel 223 that is less than the thickness in the wing portion 219. If a polyphthalocyanine polymer is used to form the flexible barrier 213, a poly-xylene adhesive can also be used to help bond the flexible backing 227. An example of a polyoxynoxy binder may include med_MU sold also by Nusil Techn〇l〇gies&3. The flexible backing 227 is preferably made of a poly-knitted fabric, for example, manufactured by Bard 6〇13, 119637.doc 200808393, manufactured by C. R. Bard, Inc., 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 213. In some cases, the flexible backing 227 can be dispensed with if the flexible barrier 213 is made of a material of suitable strength. Preferably, the flexible barrier 213 or flexible backing 227 is impermeable to liquids, air and other gases, or alternatively, both the flexible backing 227 and the flexible barrier are impermeable to liquids, air and other gases. The Lu flexible 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 211. 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, polyfumaric acid, and capralact〇ne. The flexible barrier 2 13 and the flexible backing 227 can be further used as a new cell growth support, or a stent material can be used in combination with the flexible barrier 213 and the flexible backing 227 to promote cell growth. Suitable scaffolding materials can include, but are not limited to, φ calcium phosphate, collagen, PLA/PGA, coral hydroxyapatite, carbonate, or meal-treated allograft materials. Preferably, the scaffold material will have a high void fraction (i.e., a high air content). In one embodiment, the flexible backing 227 can be secured to the surface of the flexure barrier 213 in an adhesive manner. If a polyether polymer is used to form the flexure barrier >1 213 ', the flexible backing 227 can also be secured to the flexible barrier 213 using a polyoxynitride adhesive. Although a method of securing the surface of the flexible backing 227 to the flexible barrier is preferred. 119637.doc 200808393 The 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 some portion of each protrusion 231 is located in a different plane than the protrusion 23 1 is attached to the flexible backing. The plane associated with the side can be. In this regard, it is not even required that a particular protrusion 231 have the shape or size of 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 arrangement of the projections 23 on the flexible barrier 213 forms a plurality of flow passages 233 between the projections. When the projections 231 have the same shape and size and are evenly spaced on the flexible barrier 213, the flow passages 233 formed between the projections 231 are equally uniform. The size and shape of the flow path 233 can also be varied by utilizing changes in the size, shape and spacing of the protrusions 231. As shown in Fig. 05, a reduced pressure delivery tube 241 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 241 may be simultaneously secured to both the flexible barrier 213 and the flexible backing 227. The reduced pressure delivery tube 241 includes a distal opening 243 at the distal end of the tube 241. The tube 241 can be positioned such that the distal aperture 243 is located at any point along the arcuate channel 223, but the tube 241 is preferably positioned such that the distal aperture 243 is located at approximately the midpoint along the longitudinal length of the arcuate channel 223. Preferably, the distal opening 243 is formed into an ellipse or egg by a planar cutting tube 241 oriented at an angle of 119637.doc -13 - 200808393 of less than ninety (9 ft) degrees relative to the longitudinal axis of the tube 241. Round open > shape. 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 each projection 23. The reduced pressure delivery tube 241 is preferably made of poly-stone or urethane coated with paraiyne. However, any medical grade tubing material can be used to construct the reduced pressure delivery manifold 241. Other coatings that can be applied to the tube include heparin, anticoagulants, anti-fibrinogen, anti-adherents, anti-prothrombin, and hydrophilic coatings. In an embodiment, as an alternative to or in addition to the distal aperture 243, the reduced pressure delivery tube 241 may also include a discharge aperture or discharge aperture 251 positioned along the reduced pressure delivery tube 241, To further enhance the fluid communication between the reduced pressure delivery 241 and the flow channel 233. The reduced pressure delivery tube 241 can be positioned only along one of the longitudinal extents of the chevable channel 223 as shown in Figure 15 or alternatively can be positioned along the entire longitudinal extent of the arcuate channel 223. If positioned such that the reduced pressure delivery tube 241 occupies the entire length of the arcuate channel 223, the distal aperture 243 can be capped such that all fluid communication between the tube 241 and the flow channel 233 is via the discharge opening 2 5 1 proceed. 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 1-3, 4 and 5 contains only a single lumen or passage 259. However, the reduced pressure delivery tube 241 can be provided with a plurality of lumens, such as the dual lumen tube 261 shown in Figure 4A. The double lumen tube 261 includes a first lumen 263 and a second lumen 119637.doc -14-200808393 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 2 61 can be used to achieve communication between the reduced pressure source and the flow channel 2 3 3 along the first lumen 2 63 . 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, flushing fluid, chemically active fluid or any other fluid. If it is desired to pass multiple streams via separate fluid communication paths
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4B,一水平間隔件271將減壓輸送管261之第一 及第一官腔263、265分離,從而使第一管腔263定位於第 一官腔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。舉例而纟,當第-管腔263如在 _ 4B中所不定位時,可提供類似於排放開孔⑸之排放開 孔來達成與流動通道233之連通。#第二f腔如在圖仙中 所示定位時,第二管腔265可經由一類似於遠端孔口 243之 =孔口與流動通道233連通。另—選擇為,可藉由一將 各官腔分離之垂直間隔件來使一 、 、 丁+從減座輸廷官中之多個管腔 亚疋位,或者可將該等管腔同心或同軸地定位。 之中:一般技術人員應易知’獨立流體連通路徑 ,、可猎由若干種不同之方式來實 提供-多管……包括如上文所述 至另—^ ” &擇為,可藉由將一單管腔管固定 另一早管腔管上、或者 ⑽ 猎助右干▼早個或多個管腔之單 119637.doc 15- 200808393 獨、未固定之管來提供獨立之流體連通路·捏。 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 管一個拱形通道223。另一選擇為,可擴大拱形通道η)以 容納多個管。具有一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進行更詳細說 明。 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以及一對 翼狀部分319。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Μ] 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,以使各翼 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 φ 319。如果將翼狀歧管311與骨骼再生或醫治結合使用且較 見之翼狀歧管3 11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315及兩個翼狀部分3 19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330。 在一實施例中,撓性障壁3丨3可類似於撓性障壁2丨3,並 119637.doc -16 - 200808393 包含一撓性背襯。儘管黏合劑係一種用於將蜂巢狀材料 327固定至撓性障壁313之較佳方法,然而亦可藉由任何其 他適宜之固定方法來固定撓性障壁313與蜂巢狀材料327, 或者將其邊給使用者在治療場所進行組裝。撓性障壁3 13 及/或撓性月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舞性障壁及撓性背 襯來支持蜂巢狀材料327。而是,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3 13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。適合之聚石夕氧聚合物之一實例包括由位於心咖^^, calif〇rnia之Nusil Technologies公司製造之med_6〇i5。然 而,應注意,撓性障壁313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 Bard 6〇13 製成。 然而,撓性背襯227可由任何能增強撓性障壁313之強度及 耐久性之生物相容性、撓性材料製成。 在-實施例中,蜂巢狀材料327係—開放孔式、網狀聚 胺基甲酸酿發泡m隙尺寸介於約修6〇〇微米範 119637.doc -17- 200808393 圍内。此種發泡體之一實例可包含由位於San Antonio,The introduction of the body into the flow channel 233 allows the reduced pressure delivery tube to have more than two lumens. Still referring to Fig. 4B, a horizontal spacer 271 separates the first and first official chambers 263, 265 of the reduced pressure delivery tube 261 such that the first lumen 263 is positioned above the first official chamber 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. By way of example, when the first lumen 263 is not positioned as in _4B, a discharge opening similar to the discharge opening (5) can be provided to achieve communication with the flow passage 233. When the second f-cavity is positioned as shown in the figure, the second lumen 265 can be in communication with the flow channel 233 via an orifice similar to the distal orifice 243. Alternatively, the plurality of lumens in the squadron may be subdivided by a vertical spacer separated from each official chamber, or the lumens may be concentric or coaxial Positioning. Among them: the general technical staff should be familiar with the 'independent fluid communication path, can be hunted in a number of different ways to provide - multi-tube ... including as described above to another ^ ^ Fix a single lumen tube to another early lumen tube, or (10) Hunting right dry ▼ early or multiple lumens 119637.doc 15- 200808393 Unique, unfixed tube to provide independent fluid communication path · If a separate tube is used to provide a separate fluid communication path with the flow channel 233, the ridge portion 215 can include a plurality of arcuate channels 223, each of which has an arcuate channel 223. Alternatively, the expandable arch can be expanded. Shaped channel η) to accommodate a plurality of tubes. An example of a reduced pressure delivery tube reduced pressure delivery device having a separation from the fluid delivery tube will be described in more detail below with reference to Figure 9. Referring to Figures 6-8, a principle in accordance with the present invention The reduced pressure delivery device or wing manifold 311 includes a flexible barrier 313 having a ridge portion 315 and a pair of wing portions 319. Each wing portion 319 is positioned along the opposite side of the ridge portion 315. Part 315 forms an arch The passage 323, the arched passage Μ] may or may not extend over the entire length of the wing-shaped manifold 311. Although the ridge portion 315 may be centrally positioned on the wing-shaped manifold 311 to divide the width of each wing by 3 19 Equal, however, the ridge portion 315 can also be offset as shown in the figures such that one of the wing portions 319 is wider than the other wing portion φ 319. If the wing manifold 311 is used in conjunction with bone regeneration or healing and An additional width of one of the wing portions 319 may be particularly useful, as the wing-shaped manifold 3 11 will be wrapped around a fixed hardware attached to the bone. A honeycomb material 327 is secured to the flexible barrier 313, It may be provided as a single piece of material that covers the entire surface of the flexible barrier 313 across the ridge portion 315 and the two wing portions 319. The honeycomb material 327 includes a fixed surface disposed adjacent the flexible barrier 313 (in Figure 6 Not visible), a distribution surface 329 opposite the fixed surface, and a plurality of peripheral surfaces 330. In an embodiment, the flexible barrier 3丨3 can be similar to the flexible barrier 2丨3, and 119637.doc -16 - 200808393 contains a flexible back Although the adhesive is a preferred method for securing the honeycomb material 327 to the flexible barrier 313, the flexible barrier 313 and the honeycomb material 327 may be fixed by any other suitable fixing method, or The user is assembled at the treatment site. The flexible barrier 3 13 and/or the flexible lining serves as an impervious barrier to block the passage of fluids such as liquids, air or other gases. In one embodiment, The separation provides a dance barrier and a flexible backing to support the honeycomb material 327. Instead, 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 a raised ridge portion and a wing portion 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 polyoxopolymer includes med_6〇i5 manufactured by Nusil Technologies, Inc. of Calif〇rnia. However, it should be noted that the flexible barrier 313 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 Bard 6〇13 manufactured by CR Bard, Inc. of Tempe, Arizona. production. However, the flexible backing 227 can be made of any biocompatible, flexible material that enhances the strength and durability of the flexible barrier 313. In the examples, the honeycomb material 327 is an open-cell, reticulated polyurethane-based foamed m-gap size ranging from about 6 μm to 119637.doc -17 to 200808393. 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327亦可係紗布、氈墊、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 體連接至晚鄰孔之複數個孔。藉由蜂巢狀材料3 2 7之,,開放 孔在该專π開放孔”之間形成複數個流動通道。該等流動 通道月b夠在蜂巢狀材料3 2 7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 動特性。蜂桌狀材料3 2 7可進一步包括含有’’封閉孔’’之 部为。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丨3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313及蜂巢狀材料327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 包括但不限於聚碳酸酯、聚富馬酸酯、及capralact〇ne。撓 性P早壁3 13及蜂巢狀材料327可進一步用作一新細胞生長支 119637.doc 200808393 木或者可將一支架材料與撓性障壁313、繞性背襯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、奴酸鹽、或經處理之同種異體移植材料。較佳 地’遠支架材料將具有高的空隙比例(即高的空氣含量)。 一減壓輸送管341定位於拱形通道323内並固定至撓性障 壁3 13上。減壓輪送管341亦可固定至蜂巢狀材料μ?上, 或者在僅存在蜂巢狀材料327之情況下,減壓輸送管“^可 僅固定至蜂巢狀材料327上。減壓輸送管341在管之遠 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。較佳藉由沿一相對於管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製作成橢圓形或卵圓形形狀。儘管該孔口亦可為圓 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251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可僅沿拱形通道 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- 200808393 341佔據整個拱形通道323,則可對遠端孔口 343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 341。蜂巢狀材料327可連接至減壓輸送管34ι ,或者蜂巢 狀材料327可僅固定至撓性障壁313上。若減壓輸送管341 定位成使其僅延伸至拱形通道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341之區域中 連接至撓性障壁313之凸脊部分315。 減壓輸送管341進一步在管341之近端處包含一近端孔口 3 55。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。圖心8中所示之減壓輸 送官341僅包含單個管腔或通路359。然而,可使減壓輸送 管341包含多個管腔,例如前面參照圖4B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 該等單獨之流體連通路徑。 參見圖8A及8B,一根據本發明原理之減壓輸送裝置 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 H9637.doc -20- 200808393GranuFoam, manufactured by Kinetic Concepts, Texas. Honeycomb material 327 can also be a gauze, felt pad, 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 comprising a plurality of pores fluidly connected to the adjacent pores. By the honeycomb material 327, the open pores are between the π open pores A plurality of flow channels are formed. The flow channels month b are sufficient to achieve fluid communication in the entire portion of the honeycomb material 3 27 having open pores. The apertures 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 apertures in the honeycomb material 327 can cause variations in the flow path' and such characteristics can be used to alter the dynamic properties of the fluid flowing through the honeycomb material 327. The bee-like material 3 2 7 may further include a portion containing a ''closed hole''. The closed cell portion of the honeycomb material 327 includes a plurality of holes, most of which are not fluidly connected to adjacent holes. An example of a closed hole portion is described above as a barrier layer that can replace the flexible barrier 3丨3. Similarly, a closed aperture portion can be selectively disposed in the honeycomb material 327 to prevent fluid from passing through the peripheral surface 330 of the honeycomb material 327. The flexible barrier 313 and the honeycomb material 327 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 31. 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, polycarbonates, polyfumarates, and capralact〇ne. The flexible P early wall 3 13 and the honeycomb material 327 can be further used as a new cell growth branch 119637.doc 200808393 wood or a stent material and a flexible barrier 313, a wound backing 327 and/or a honeycomb material 327 can be used. Used in combination to promote cell growth. Suitable scaffold materials can include, but are not limited to, calcium phosphate, collagen, pLA/pGA, coral hydroxyapatite, sulphate, or treated allograft materials. Preferably, the distal scaffold material will have a high void fraction (i.e., a high air content). A reduced pressure delivery tube 341 is positioned within the arcuate passage 323 and secured to the flexible barrier 313. The decompression transfer tube 341 may also be fixed to the honeycomb material μ?, or in the case where only the honeycomb material 327 is present, the decompression delivery tube “^ may be fixed only to the honeycomb material 327. The decompression delivery tube 341 A distal aperture 343 is included at the distal end of the tube, which is similar to the distal aperture 243 of Figure 5. The reduced pressure delivery tube 341 can be positioned such that the distal aperture 343 is located at any point along the arcuate channel 323 , but preferably positioned along the longitudinal length of the arcuate channel 323 at approximately the midpoint. Preferably, the tube 341 is cut along a plane oriented at an angle of less than ninety (90) degrees with respect to the longitudinal axis of the tube 341. The distal aperture 343 is formed in an elliptical or oval shape. Although the aperture may be circular, the elliptical shape of the aperture enhances fluid communication with the flow channel in the honeycomb material 327. The reduced pressure delivery tube 341 can also include a discharge opening or discharge orifice (not shown) similar to the discharge opening 251 of Figure 5. As an alternative to or in addition to the distal opening 343 In addition, a discharge opening is arranged along the tube 341 to further enhance the reduced pressure delivery. 341 is in fluid communication with the flow passage. As previously described, the reduced pressure delivery tube 341 can be positioned only along one of the longitudinal lengths of the arcuate passage 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 -19-200808393 341 occupies the entire arcuate channel 323, the distal aperture 343 can be covered so that all fluid communication between the tube 341 and the flow channel is via The discharge opening is preferably performed. Preferably, the honeycomb material 327 covers and directly contacts the reduced pressure delivery tube 341. The honeycomb material 327 may be attached to the reduced pressure delivery tube 34ι, or the honeycomb material 327 may be fixed only to the flexible barrier 313 If the reduced pressure delivery tube 341 is positioned such that it extends only to a point in the arcuate passage 323, the honeycomb material 327 can also be connected to the flexible barrier in the region of the arched passage 323 that does not include the reduced pressure delivery tube 341. The ridge portion 315 of the 313. The reduced pressure delivery tube 341 further includes a proximal aperture 355 at the proximal end of the tube 341. The proximal aperture 355 is configured to cooperate with a reduced pressure source, as will be described below 9 in more detail The reduced pressure source. The reduced pressure delivery 341 shown in the figure 8 contains only a single lumen or passage 359. However, the reduced pressure delivery tube 341 can be provided with a plurality of lumens, such as described above with reference to Figure 4B. a lumen. 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. Alternatively, it can have a single or A separate tube of a plurality of lumens provides the separate fluid communication paths. Referring to Figures 8A and 8B, a reduced pressure delivery device in accordance with the principles of the present invention includes a reduced pressure delivery tube 373 that is remote from the reduced pressure delivery tube 373 There is an extension 375 at end 377. 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 H9637.doc -20- 200808393
於減壓輸送管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之尺寸、形狀及 間距可類似於參照圖所述之突起物。減壓輸送裝置^^ 特別適用於對能夠接納於切口 381内之結締組織應用減低 之壓力及在結締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3 71治療之組織之非限定性實例。 參見圖9,使用-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4!3(例如 患者之人體骨骼 415)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-步據認為,可使用減壓組織治療^ 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。A plurality of flow passages 391 are formed between the projections 385 on an inner surface 387 of the reduced pressure delivery tube 373. The size, shape and spacing of the protrusions 385 can be similar to the protrusions described with reference to the figures. The reduced pressure delivery device is particularly suitable for applying reduced pressure to connective tissue that can be received in the incision 381 and regenerating tissue on the 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, decompression tissue treatment is applied to a tissue site 4!3 (e.g., human bone 415 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. Further, it is believed that decompression 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 oseointegration of orthopedic implants such as hip implants, knee implants, and fixation devices.
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 42i。減壓源427係一幫浦或任何其他能夠經由減壓輸送管 4 19及與減壓輸送裝置411相關聯之複數個流動通道對組織 部位413應用減低之壓力之器件。對組織部位413應用減低 之壓力係藉由將減壓輸送裝置411之翼狀部分毗鄰組織部 位4 13佈置來達成,在g亥特定實例中,此涉及到圍繞骨骼 415中之空隙缺損429纏繞翼狀部分。滅壓輸送裝置4ιι^ 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 -21 - 200808393 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。 應用減壓組織治療通常會在組織部位413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il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 芽組織係咼度血管化之組織,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。 仍芩見圖9, 一流體輸送管431可在一遠端處流體連接至 減壓輸运裝置411之流動通道。流體輸送管431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-能夠過濾、小至0.22 μιη之微 粒之過濾器434來過濾、空氣,#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引入空氣會非常重要,此有利於良好地疏通組織部 位413藉以減輕或防止減壓輸送管419之阻塞。流體輪送 管431及流體輸送源433亦可用於向組織部位413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、或其他化學活性劑。當經過皮膚插入時, 減S輸迗“31較佳穿過一穿透患者皮膚組織之無菌插入 護套插入。 一壓力感測器43 5可1、 了猎由可操作方式連接至流體輸送管 119637.doc '22- 200808393 «I,以指示流體輸送管431是否被血液或其他體液堵塞。 壓力感測H 435可藉由可操作方式連接至流體輸送源433以 提供回H,藉以控制引入至組織部位413之流體量。亦可 將止回閥(未顯不)以可操作方式連接於流體輸送管43 i之 退端附近,以防止血液或其他體液進入流體輸送管Μ」。 減壓輸送管419及流體輸送管431所提供之獨纟流體連通 路径可猎由諸多種不同之方式來達成,包括如前面參照圖Still referring to Fig. 9, the reduced pressure delivery device 411 includes a reduced pressure delivery tube 419 having a proximal end 42i 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 site 413 via a plurality of flow channels associated with the reduced pressure delivery tube 4 19 and the reduced pressure delivery device 411. Applying a reduced pressure to the tissue site 413 is accomplished by arranging the wing portions of the reduced pressure delivery device 411 adjacent the tissue site 4 13 , which in the specific example of the g Hai involves wrapping the wings around the void defect 429 in the bone 415 Shaped part. The pressure-reducing delivery device 4ιι^ is inserted by surgery or through the skin. When inserted through the skin, the reduced pressure 119637.doc -21 - 200808393 delivery tube 419 is preferably inserted through a sterile insertion sheath that penetrates the patient's skin tissue. The application of reduced pressure tissue treatment typically produces granulation tissue in the area surrounding the tissue site 413. Granulation tissue is a common tissue formed by the moon il, 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. The granulation tissue is a tissue that is vascularized, and the increased growth rate of such highly vascularized tissue promotes the growth of new tissue at the tissue site 413 in the presence of reduced pressure. Still referring to Fig. 9, a fluid delivery tube 431 can be fluidly coupled to the flow channel of the reduced pressure transport device 411 at a distal end. Fluid delivery tube 431 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 preferably filtered, the air is filtered and sterilized by a filter 434 capable of filtering and as small as 0.22 μηη. Especially when the tissue site 413 is positioned beneath the surface of the skin, it may be important to introduce air into the tissue site 413, which facilitates good drainage of the tissue site 413 to mitigate or prevent occlusion of the reduced pressure delivery tube 419. Fluid transfer tube 431 and fluid delivery source 433 can also be used to introduce other fluids to tissue site 413 including, but not limited to, antibacterial agents, antiviral agents, cell growth promoters, irrigation fluids, or other chemically active agents. When inserted through the skin, the sputum "31 is preferably inserted through a sterile insertion sheath that penetrates the patient's skin tissue. A pressure sensor 43 5 can be operatively coupled to the fluid delivery tube. 119637.doc '22- 200808393 «I, to indicate whether the fluid delivery tube 431 is blocked by blood or other bodily fluids. The pressure sensing H 435 can be operatively connected to the fluid delivery source 433 to provide back H, thereby controlling the introduction to The amount of fluid in the tissue site 413. A check valve (not shown) may also be operatively coupled adjacent the withdrawal end of the fluid delivery tube 43i to prevent blood or other bodily fluids from entering the fluid delivery tube. The unique fluid communication path provided by the reduced pressure delivery tube 419 and the fluid delivery tube 431 can be achieved in a number of different ways, including as previously described with reference to the drawings.
4B所賴供單個多管㈣。此項技術中之—般技術者將 知右使用一多管腔管,與流體輸送管431相關聯之感測 器閥門及其他組件亦可類似地與減壓輸送管4丨9中之一 特疋官腔相關聯。較佳使與組織部位流體連通之任何管腔 或官皆塗覆有抗凝血劑,以防止體液或血液在管腔或管内 堵塞可塗覆該等管腔或管之其他塗層包括但不限於肝 素抗减血劑、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。在一特定試驗中,對數只兔 子之頭骨應用減壓組織治療,以確^其對於骨絡生長及再 生之效果。該測試之具體目標係發現減壓組織治療對於在 頭骨上沒有缺損或損傷之兔子之效果、減壓組織治療對於 在碩骨上具有臨界尺寸缺損之兔子之效果、及將一支架材 料與減壓組織治療—起使用對於治療頭骨上之臨界尺寸缺 損之效果。具體測試方案及兔子數量列示於下表i中。、 H9637.doc -23 - 200808393 4 j 員月上無缺損,藉由蜂巢狀發泡體(GranuF〇amy^^^ ^骨膜頂上應用減壓組織治療(1〇>了1)達6天,隨後立 故穫組織 4 頃月上無缺損,在不應用減壓組織治療(RPTT)情況下 在完好之骨膜頂上放置蜂、巢狀發泡,體(GranuFoam)達6 後立即收穫組織 -------- - 4 具有一個在上面放置不銹鋼絲網之臨界尺寸缺損;一 個f上面放置磷酸鈣支架之臨界尺寸缺損;對該兩個 用24小時RPTT ;在手術2週後收穫组織 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;對該兩個 楚里塵用24小時RPTT ;在手術12週後收雜細繃 4 具有一個在上面放置不銹鋼絲網之臨界尺寸缺損;一 個在上面放置填酸药支架之臨界尺寸缺損;對該兩個 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 個在上面放置填酸支架之臨界尺寸缺損;對該兩個 .缺損應用6天RPTT ;在手術12週後收穫组^ 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(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 ' 4 天然對照(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1 5 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 〇,其圖解說明一具有原始、未經損壞 119637.doc -24- 200808393 之骨骼之兔子頭骨之也罐切κ _ ^ 又、、且織切片。頭骨之骨骼組織為品紅 色周圍之軟、、且織為白色,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务早通辱 π< 、 傻之鬼子頭月。可以看到骨骼及骨膜,且 已幵ν成I肉芽組織。在圖12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。圖以 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㈣,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 療而形成之骨絡組織之組織外觀非常類似於在正在經歷極 快速之新Μ生長及沈積之料料之㈣巾骨路形成之 組織外觀。 更具體地參見圖14 -19,並(S1 ^2 〇〇 具圖解祝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f。料全厚度臨界尺寸缺損之 直徑約為15 mm。在圖15中,已在其中—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 磷酸甸支架。在®16巾,使用—類似於本文料之減壓組 織治療裝置對該等臨界尺寸缺損應用減低之壓力。對每一 缺損應用之壓力大小為]25麵Hg之表壓。該減低之壓力 係根據表丨中所列測試方案之一加以應用。在圖口中,圖 解說明在應用6天之減壓組織治療並在手術十二週後收穫 119637.doc 200808393 組織之後之頭骨。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。骨骼生長量明顯 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絡生長量。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 而增強新骨絡組織之形成。 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。 該等資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®解說明手術十二周後之缺損,並顯示臨界尺寸 缺損幾乎完全癒合且因組織融合(即在支架基質内形成新 骨骼)而使主支架架構接近完全消失。 參見圖20,一根據本發明一實施例之減壓輸送系統711 對患者之組織部位713施行減壓組織治療。減壓輸送系統 711包括一歧管輸送管72ι。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721能夠被導引至組織部 位7Π之器件,例如一導向單元725及一導引金屬絲^巧。 119637 丨doc -26- 200808393 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組織部位713。當經過 皮膚插入時,歧管輸送管721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731處包含骨骼組織。歧管輸送管721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、或勤帶。 參見圖21及22,其進一步圖解說明減壓輸送系統7U。 歧官輸送管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 φ 〜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。減壓輸 送裝置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领述。撓性障壁765及/或蜂巢狀材料μ較 佳捲繞、折疊或以其他方式圍繞減壓輸送管769壓縮,以 減小減壓輸送裝置761在通路751内之截面積。 119637.doc -27 - 200808393 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 前,將減壓輸送裝置761預先定位於通路751内。若要將減 壓輸达裝置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間之摩擦。 當已將遠端743定位於組織部位713處並將減壓輸送裝置 761輸达至退端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 減壓輪送裝置761推出歧管輸送管721,較佳推人蛾鄰組織 部位713之空隙或空間内。肖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713可位於“部位處,|因傷口解剖: 自然地存在-空隙。在其他情況下,肖空隙可藉由氣球分 離、銳器分離、鈍器分離、水力分離、氣動分離、超音波 分離、電烙術分離、雷射分離或任何其他適宜之分離技術 來形成。當減壓輸送裝置761進入毗鄰組織部位713之也隙 時,減壓輸送裝置761之撓性障壁765及/或蜂巢狀材料工Μ 解除捲繞、解除折疊或解除壓縮(參見圖22),從而使 輸送震置761可與組織部位713相接觸地放置。儘管並非必 需如此,《而可使撓性障壁765及/或蜂巢狀材料Μ承爲 經由減壓輸送管769提供之真空或減低之壓力, 二 性障壁765及/或蜂襄狀材料加。可藉由如下方式來;J 撓性障壁⑹及/或蜂巢狀材料767之解除折疊放= 119637.doc -28- 200808393 減壓輸送管769輸送之減低之壓力,或者經由減壓輸送管 769提供正壓力,以幫助完成解除捲繞之過程。可使用内 窺鏡檢查' 超音波、螢光屏檢查、聽诊、觸診或任何其他 適宜之局部化技術來達成減壓輸送裝置761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相關聯之減壓輸 送管仍保留於原位,以便能夠經過皮膚對組織部位π]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η】 包括一具有一錐形遠端843之歧管輸送管821,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8 並 内徑。遠端⑷之開口位置一中由虛線:3:= 地顯示0 歧管輸送管821進一步包括一通路,在該通路中包含一 φ 類似於本文所述其他減壓輸送裝置之減壓輸送裝置861。 減壓輸运裝置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、折疊或 以其他方式圍繞減壓輸送管869壓縮,以減小減壓輸送裝 置861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 η又置以使減壓輸送裝置8 61含納於不滲透性薄膜 871之内表面873内。不滲透性薄膜871可係一氣球、護 套或肖b夠防止流體透過之任何其他類型之薄膜,以使不 119637.doc -29- 200808393 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25A)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,不渗透性薄膜π 1可固定至減壓 輸达管869上,從而使不滲透性薄膜871之内部空間^^與 減壓輸送管869之通路流體連通。不滲透性薄膜871轉而^ 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25 A)。 在一實施例中,可提供不滲透性薄膜871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之内部空間873施加一低於不滲透性薄膜87ι之周 圍%境壓力之壓力。由此排出内部空間873内相當大的一 部分空氣或其他流體,從而將不滲透性薄膜87i置於圖U 中所示之壓縮位置。在該壓縮位置上,不滲透性薄膜871 被向内吸引,從而對減壓輸送裝置861施加一壓力,以進 一步減小減壓輸送裝置861之截面積。如前面參照圖21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不滲透性薄膜丨及減壓輸送裝置 861之放置及操縱。不滲透性薄膜871可包含不透射線之標 誌8 8 1,此會改良不滲透性薄膜8 7丨在其移除之前在螢光屏 檢查下之可視性。 119637.doc -30- 200808393 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 8 85(例如套官、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 能夠推進至接觸不滲透性薄膜871。在弄破不滲透性薄膜 871之後,可經由歧管輸送管821抽出移出器具及不滲 透丨生薄膜8 71,仗而使減壓輸送裝置$ 61之撓性障壁8 $ $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 5及/或蜂巢狀材料8 6 7之解除捲繞可在釋放内部空間8 7 3 中減低之壓力並移出不滲透性薄膜871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 將撓卩早壁865及/或蜂巢狀材料867解除捲繞或解除壓 縮。在最終放置減壓輸送裝置861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%〗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 119637.doc -31- 200808393 性薄膜871膨脹,乃因液體之不可壓縮性使不滲透性薄膜 871此夠更均勻且更一致地私脹。不渗透性薄膜871可如在 圖25中所示沿徑向膨脹,或者沿定向膨脹,此視其製造方 法及在歧管輸送管821上之固定方式而定。當因空氣或流 體之壓力而使不滲透性薄膜871向外膨脹至膨脹位置(參見 圖2 5 )時,會®比鄰組織部位分離出一空隙。當該空隙足夠 大時,可釋放内部空間873中之空氣或其他流體,以使不 滲透性薄膜871能夠採取鬆弛位置。然後,可如上文所解 釋來弄破不滲透性薄膜871,並毗鄰組織部位插入減壓輸 送裝置861。 參見圖25A,若不滲透性薄膜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 輸送管82丨上,從而使内部空間873與一關聯於或固定至歧 管輸送管821之輔助管腔或管891流體連通。辅助管腔891 u用於向内邛空間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 苓照圖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9ιι包 八有錐形遠端943之歧管輸送管92 1,錐形遠端943 赵構造以沿徑向向外〜撓曲至一開口位置,從而使遠端943 之内後將基本相同於或者大於在管921之其他部分處之内 徑。遠端943之開口位置在圖26中由虛線937示意性地顯 示〇 支吕輸送官921進一步包括一通路,在該通路中包含一 U9637.ci0, -32 - 200808393 類似於本文所述其他_輸送裝置之減壓輸送裝置9Q。 減壓輸送^置961包含-繞性障壁奶及/或蜂巢狀材料 967,撓性_ 965及/或蜂巢狀材伽7較佳捲繞、折疊或 、、方式圍、、:^減壓輸送管969壓縮,以減小減壓輸送裝 置961在歧管輸送管⑵之通路内之截面積。4B depends on a single multi-tube (four). A person skilled in the art will know that a multi-lumen tube is used to the right, and the sensor valves and other components associated with the fluid delivery tube 431 can similarly be similar to one of the decompression tubes 4丨9. Associated with the official. Preferably, any lumen or body in fluid communication with the tissue site is coated with an anticoagulant to prevent body fluids or blood from clogging in the lumen or tube. Other coatings that can coat the lumen or tube include but not Limited to heparin anti-blood reducing agents, anti-fibrinogen, anti-adherent agents, anti-prothrombin, and hydrophilic coatings. Referring to Figures 10-19, trials have shown that when applied to decompressed tissue treatment of bone tissue, a positive effect is obtained. In a specific experiment, the skull of a rabbit was treated with decompressive tissue to confirm its effect on bone growth and regeneration. The specific objective of the test was to find the effect of decompression tissue treatment on rabbits that were not deficient or damaged on the skull, the effect of decompression tissue treatment on rabbits with critical size defects on the bone, and the decompression of a scaffold material. Tissue Therapy - The effect of using a critical size defect on the skull. The specific test protocol and number of rabbits are listed in table i below. H9637.doc -23 - 200808393 4 j There is no defect in the month of the month, and the honeycomb-shaped foam (GranuF〇amy^^^^ top of the periosteum is treated with decompression tissue (1〇>1) for 6 days. Afterwards, the organization was found to have no defects for 4 months, and the bee and nested foam were placed on the top of the intact periosteum without applying decompression tissue treatment (RPTT). The body was harvested immediately after the harvest (GranuFoam) reached 6 ----- - 4 has a critical size defect on which the stainless steel wire mesh is placed; a critical size defect in which the calcium phosphate stent is placed on one f; a 24-hour RPTT for the two; harvested tissue after 2 weeks of surgery Has a critical dimension defect on which the stainless steel mesh is placed; a critical dimension defect on which the calcium phosphate stent is placed; a 24-hour RPTT for the two Chuli dusts; a fine stretch 4 after 12 weeks of surgery has one The critical dimension defect of the stainless steel wire mesh placed thereon; a critical dimension defect on which the acid-filled drug stent is placed; the 6-day RPTT for the two; the harvested tissue after 2 weeks of surgery has a critical dimension of the stainless steel mesh placed thereon Defect The critical size defect was placed on the acid scaffold; the 6-day RPTT was applied to the two defects; the harvested group 4 after 12 weeks of surgery had a critical size defect on which the stainless steel mesh was placed; one placed on top of the calcium phosphate stent Critical size defect; _RPTT (control) is not applied; tissue is harvested after 2 weeks of surgery' 4 has a critical size defect with stainless steel mesh placed thereon; a critical size defect with calcium phosphate stent placed thereon; no RPTT applied (Control); harvested tissue after 12 weeks of surgery' 4 natural controls (no surgery; no RPTT) 4 sham surgery (no defect, no RPTT) · harvested tissue 6 days after surgery Table 1: Test protocol A critical dimension defect is a defect in a tissue (such as a skull) that is large enough to be healed by its own recovery. For rabbits, a full thickness hole of approximately 15 mm in diameter is drilled through the skull. The critical dimension defect of the skull is formed. See Figure 1 for more details, which illustrates a skeleton with original, undamaged 119637.doc -24- 200808393 The rabbit skull can also be cut κ _ ^ again, and weave the slice. The skeleton of the skull is soft around the magenta, and it is white, and the periosteum is highlighted by a yellow asterisk. In Figure 11, the illustration After applying the decompressed tissue treatment for 6 days and then immediately harvesting the tissue, it is early to humiliate π<, the stupid devil's head. The bone and periosteum can be seen and 幵 成 into I granulation tissue. In Figure 12, illustrated The rabbit skull after application of decompressed tissue treatment for 6 days followed by immediate harvesting of the tissue is illustrated. The tissue section of the figure is characterized by the formation of a new skeletal tissue beneath the granulation tissue. This skeletal tissue is highlighted by a yellow asterisk. In Figure (4), the rabbit skull is shown after application of reduced-pressure tissue treatment for 6 days followed by immediate harvesting of tissue. You can see new bones and periosteum. The tissue appearance of the osseous tissue formed by decompression tissue treatment is very similar to the appearance of the tissue formed by the (four) scalp road that is undergoing very rapid growth and deposition of new mites. More specifically, see Figures 14-19, and (S1^2 shows a number of photographs and tissue sections that show the procedure and results of decompressive tissue treatment of rabbit skulls with critical size defects. Figure 14 In the figure, a rabbit head f having two critical dimension defects formed thereon is illustrated. The full thickness critical dimension defect has a diameter of about 15 mm. In Fig. 15, a stainless steel wire mesh has been placed on one of the critical dimension defects. And placing a phosphate trap in the second critical dimension defect. In the ® 16 towel, use a pressure-reducing tissue treatment device similar to the one used here to apply the reduced pressure to the critical dimension defect. Pressure on each defect application The gauge is 25 gauge Hg. The reduced pressure is applied according to one of the test protocols listed in the table. In the figure, the illustration shows that after 6 days of decompression tissue treatment and after 12 weeks of surgery Harvest 119637.doc 200808393 Skull after tissue. The slice shown contains a calcium phosphate scaffold, which is indicated by a red arrow. Treatment with decompressed tissue will result in significant growth of new bone tissue, This is highlighted by the yellow asterisk in Figure 17. The amount of bone growth is significantly greater than the amount of skeletal growth in critical size defects that are treated with the same calcium phosphate scaffold but not treated with decompression tissue. There is a treatment threshold or duration required to induce a new bone formation reaction. The effect of decompression tissue treatment is most pronounced in the samples collected 12 weeks after surgery, indicating that decompression tissue treatment causes a cascade of biological events, thereby Enhances the formation of new bone structure. The critical size defect covered with stainless steel mesh (Fig. 15) but without the stent material in the defect is used as an intra-animal control, and the new bone growth is minimal. The data highlights the appropriate scaffold material. Advantages and positive effects of reduced-pressure tissue treatment on stent fusion and bioavailability. In Figures 18 and 19, radiographs of critical dimension defects filled with stents after six days of decompression tissue treatment are illustrated. Figure 18 illustrates Two weeks after the operation, the defect is revealed and • a certain new bone is deposited in the stent. The main structure of the stent It is still evident. Figure 19® illustrates the defect after 12 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 (ie, the formation of new bones within the stent matrix). 20. A reduced pressure delivery system 711 according to an embodiment of the present invention performs a reduced pressure tissue treatment on a tissue portion 713 of a patient. The reduced pressure delivery system 711 includes a manifold delivery tube 72. The manifold delivery tube 721 can be a fluid guide A tube or cannula and may include means for enabling the manifold delivery tube 721 to be guided to the tissue site 7, such as a guide unit 725 and a guide wire. 119637 丨doc -26- 200808393 Mirroring, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique to achieve placement and guidance of the guide wire 727 and manifold delivery tube 721. A manifold delivery tube 721 is provided for inserting a reduced pressure delivery device through the skin into the tissue site 713 of the patient. When inserted through the skin, the manifold delivery tube 721 is preferably inserted through a sterile insertion sheath that penetrates the patient's skin tissue. In Figure 20, the tissue site 713 contains bone tissue at a fracture site 731 adjacent the patient's bone 733. The manifold delivery tube 721 is inserted through the skin _ 735 of the patient and any soft tissue 739 surrounding the bone 733. As previously described, the tissue site 713 can also comprise any type of tissue including, but not limited to, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendon, or diligent band. Referring to Figures 21 and 22, the reduced pressure delivery system 7U is further illustrated. The esoteric delivery 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 outwardly from φ 〜 radially outward to an open position such that the inner diameter of the distal end 743 will be substantially the same or greater than the inner diameter of the remainder of the tube 721. The open position of the distal end 743, shown in Figure 21, is schematically shown by dashed line 737. 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 delivery device 761 includes a flexible barrier 765 and/or a honeycomb material π?, which is similar to that described with reference to FIG. The flexible barrier 765 and/or the honeycomb material μ are preferably wound, folded or otherwise compressed around the reduced pressure delivery tube 769 to reduce the cross-sectional area of the reduced pressure delivery device 761 within the passage 751. 119637.doc -27 - 200808393 The reduced pressure delivery device 761 can be placed within the passageway 751 and directed 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 within the passage 751 prior to insertion of the manifold delivery tube 721 into the patient. To push the reduced pressure delivery device 761 through passage 751, a biocompatible lubricant can be used to reduce friction between the reduced pressure delivery device 761 and the manifold delivery tube 721. When the distal end 743 has been positioned at the tissue site 713 and the reduced pressure delivery device 761 is delivered to the retraction end 743, then the reduced pressure delivery device 761 is urged toward the distal end 743 such that the distal end 743 is radially outwardly Expand to the open position. The decompression transfer device 761 is pushed out of the manifold delivery tube 721, preferably in the space or space of the moth adjacent tissue portion 713. The stenosis or space is usually formed by cutting the soft tissue, which can be done by the skin. In some cases the 'tissue site 713 can be located at the site, | due to wound dissection: naturally present - void. In other cases, the void can be separated by balloon, sharp separation, blunt separation, hydraulic separation, pneumatic Separation, ultrasonic separation, electrocautery separation, laser separation, or any other suitable separation technique is formed. When the reduced pressure delivery device 761 enters the gap adjacent the tissue site 713, the flexible barrier 765 of the reduced pressure delivery device 761 And/or honeycomb material work 解除 unwinding, unfolding or uncompressing (see Fig. 22) so that the delivery 718 can be placed in contact with the tissue site 713. Although not necessarily, "flexible The barrier 765 and/or the honeycomb material bearing the vacuum or reduced pressure provided by the reduced pressure delivery pipe 769, the amphoteric barrier 765 and/or the bee-like material may be added as follows; J flexible barrier (6) And/or the unfolding of the honeycomb material 767 = 119637.doc -28- 200808393 The reduced pressure delivered by the reduced pressure delivery pipe 769, or the positive pressure provided via the reduced pressure delivery pipe 769 to help complete the unwinding The process of wrapping. Ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique can be used to achieve final placement and manipulation of the reduced-pressure delivery device 761. After the device 761, the manifold delivery tube 721 is preferably removed from the patient, but the reduced pressure delivery tube associated with the reduced pressure delivery device 761 remains in place so as to be able to apply a reduced pressure to the tissue site π] through the skin. Referring to Figures 23-25, a reduced pressure delivery system η according to an embodiment of the present invention includes a manifold delivery tube 821 having a tapered distal end 843 that is configured to flex radially outwardly. Curved to an open position such that the inner diameter of the distal end 843 will be substantially the same or greater than the inner diameter of the tube 8. The opening position of the distal end (4) is indicated by a dashed line: 3: = ground. 0 manifold tube 821 further A passage is included in the passage including a reduced pressure delivery device 861 similar to the other reduced pressure delivery devices described herein. The reduced pressure transport device 861 includes a flexible barrier 865 and/or honeycomb material 867, flexible Barrier 865 and/or honeycomb The material 867 is preferably wound, folded or otherwise compressed around the reduced pressure delivery tube 869 to reduce the cross-sectional area of the reduced pressure delivery device 861 within the passageway. An impervious membrane 871 having an inner surface 873 is decompressed. The delivery device η is again disposed such that the reduced pressure delivery device 816 is contained within the inner surface 873 of the impermeable membrane 871. The impermeable membrane 871 can be a balloon, sheath or any other type that prevents fluid from penetrating. The film is such that the permeable film 871 of 119637.doc -29-200808393 can take at least one of a compressed position (see Figure 23), a relaxed position (see Figure 24), and an expanded position (see Figures 25 and 25A). The impervious film 871 is sealingly coupled to the manifold delivery tube 821 to communicate the interior space 873 of the impermeable membrane 871 with the passage body of the manifold delivery tube 821. Alternatively, the impermeable film π 1 may be fixed to the reduced pressure delivery tube 869 such that the internal space of the impermeable membrane 871 is in fluid communication with the passage of the reduced pressure delivery tube 869. The impermeable membrane 871 is in turn 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 871 can be provided to further reduce the cross-sectional area of the reduced pressure delivery device 861 within the passageway. To this end, a pressure lower than the ambient pressure of the impermeable film 87 is applied to the inner space 873 of the impermeable film 871. Thereby a substantial portion of the air or other fluid within the interior space 873 is expelled to place the impermeable membrane 87i in the compressed position shown in Figure U. In this compressed position, the impermeable film 871 is attracted inwardly, thereby applying a pressure to the reduced pressure conveying device 861 to further reduce the cross-sectional area of the reduced pressure conveying device 861. As previously described with reference to Figures 21 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. Endoscopic examination, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique can be used to achieve placement and manipulation of the impervious membrane and decompression delivery device 861. The impervious film 871 may contain a radiopaque marker 884, which improves the visibility of the impermeable film 8 7 在 under the fluorescent screen inspection prior to its removal. 119637.doc -30- 200808393 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 (see Figure 24). ), thereby facilitating easier removal of the reduced pressure delivery device 861 from the impermeable membrane 871. A removal device 8 85 (e.g., a sleeve, a needle or other sharp device) can be provided to break the impermeable film 871. Preferably, the removal tool 885 is inserted through the reduced pressure delivery tube 869 and is capable of being advanced to contact the impermeable membrane 871. After the impervious film 871 is broken, the removal device and the impermeable biofilm 8 71 can be withdrawn via the manifold delivery tube 821, thereby making the flexible barrier 8 $ and/or honeycomb of the reduced pressure delivery device $61 The material 867 can be unwound, unfolded, or decompressed, thereby allowing the reduced pressure delivery device 861 to be placed in contact with the tissue site. The unwinding of the flexible barrier 5 and/or the honeycomb material 836 can occur automatically after releasing the reduced pressure in the internal space 87 3 and removing the impermeable film 871. In some cases, positive pressure may be delivered via the reduced pressure delivery tube 869 to help unwind or uncompress the tread early wall 865 and/or the honeycomb material 867. After the final placement of the reduced pressure delivery device 861, 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 so as to be able to pass through the skin to the tissue Apply a reduced pressure to the area. The impermeable film 871 can also be used to separate tissue adjacent to the tissue site prior to placement of the reduced pressure delivery device % to 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. Preferably, the liquid is used to swell the impervious 119637.doc -31 - 200808393 film 871 because the incompressibility of the liquid renders the impermeable film 871 more uniform and more consistently bloated. The impermeable film 871 may expand radially as shown in Figure 25, or may expand in an orientation depending on the method of manufacture and the manner in which it is secured on the manifold tube 821. When the impervious film 871 is expanded outward to the expanded position due to the pressure of air or fluid (see Fig. 25), a gap is separated from the adjacent tissue portion. When the void is large enough, air or other fluid in the interior space 873 can be released to enable the impermeable membrane 871 to assume a relaxed position. Then, the impervious film 871 can be broken as explained above and inserted into the reduced pressure delivery device 861 adjacent to the tissue site. Referring to Figure 25A, if the impermeable membrane 871 is primarily used to separate tissue adjacent to the tissue site, the impermeable membrane 871 can be sealingly secured to the manifold delivery tube 82, thereby associating the interior space 873 with one or The auxiliary lumen or tube 891 secured to the manifold delivery tube 821 is in fluid communication. The auxiliary lumen 891 u is used to deliver liquid, air or other fluid to the medial space 873 to place the impermeable membrane 871 in the expanded position. After separation, the impermeable film 871 can be relaxed and broken as previously described with reference to Figure 24. Referring to Figure 26, a reduced pressure delivery system 9 ι 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八The position of the opening is such that the inside of the distal end 943 will be substantially the same or larger than the inner diameter at other portions of the tube 921. The opening position of the distal end 943 is schematically shown in FIG. 26 by the dashed line 937. The 〇 吕 输送 921 921 further includes a passageway containing a U9637.ci0, -32 - 200808393 similar to the other _ transport described herein. The device's reduced pressure delivery device 9Q. The reduced pressure delivery device 961 comprises a wrap-around barrier milk and/or a honeycomb material 967, and the flexible _965 and/or the honeycomb material gamma 7 preferably wrap, fold or, and surround, and: Tube 969 is compressed to reduce the cross-sectional area of the reduced pressure delivery device 961 within the passage of the manifold delivery tube (2).
具有一内表面973之不滲透性薄膜971圍繞減壓輸送裝 置961 w又置,以使減壓輸送裝置96ι含納於不滲透性薄膜 971之内表面973内。不滲透性薄膜971在不滲透性薄膜 鈿上匕έ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#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,不滲透性薄膜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 忐夠防止流體透過,以使不滲透性薄膜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971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- 200808393 滲透性薄膜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 賴性薄膜971置於鬆弛位置上。然後,將減壓輸送裝 置961牙過膠封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。 φ 而是,減壓輸送系統985可包括一導引金屬絲987、一減壓 輸送& 989、及一減壓輸送裝置991。減壓輸送裝置^包 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 鲁 989及減壓輸送裝置991,可將減壓輸送裝置的丨置於組織 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 束於歧管輸送管中,因而較隹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 而使该發泡體膨脹而接觸組織部位。另一選擇為,可自一 119637.doc -34- 200808393 種壓縮之幹態水凝膠製成減壓輸送裝置99卜該水凝膠在 組㈣位993之後吸收水份,從而能夠使減壓輸送 、二、脹再一種減壓輸送裝置"1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f曰膨羅。在再一實施例中,可在一可溶解薄膜中將經 壓縮之減壓輸送裝置991輸送至組織部位993。An impermeable film 971 having an inner surface 973 is disposed around the reduced pressure delivery device 961 w such that the reduced pressure delivery device 96 is contained within the inner surface 973 of the impermeable film 971. The impermeable film 971 is glued to the 977 on the impermeable film to provide a 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 impermeable membrane 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 penetrating so that the impermeable film 971 can take at least one of a compressed position, a relaxed position, and an expanded position. Since the procedure for placing the impermeable film 971 in the compression position and the expansion position is similar to that of 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 971 using endoscopy, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique and then correctly Positioning. The impermeable film 971 may comprise a radiopaque marker 981 which will improve the visibility of the permeable film 971 under the screen inspection prior to its removal, without the H9637.doc-33-200808393. 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 film 971 in a relaxed position. Then, the reduced pressure conveying device 961 is pushed by the rubber 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. Instead, the reduced pressure delivery system 985 can include a guide wire 987, a reduced pressure delivery & 989, and a reduced pressure delivery device 991. The reduced pressure delivery device comprises a plurality of fluidly connected flow channels to 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. By guiding the reduced pressure delivery tube 989 and the reduced pressure delivery device 991 along the guide wire 987, the fistula of the reduced pressure delivery device can be placed at the tissue site 993 to effect application of reduced pressure tissue through the skin. Since the reduced pressure delivery device 991 is not constrained in the manifold delivery tube during delivery to the tissue site 993, the reduced pressure delivery device 991 is maintained 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 hydrogel can be made from a compressed dry hydrogel of 119637.doc -34 - 200808393. The hydrogel absorbs water after the group (four) position 993, thereby enabling decompression The delivery, the second expansion, and a reduced pressure delivery device "1 can be made of a self-heating active material (for example, polyethylene glycol), which is inflated by the body temperature of the patient. In still another embodiment, the compressed reduced pressure delivery device 991 can be delivered to the tissue site 993 in a dissolvable film.
"圖27 根據本發明一實施例之減壓輸送系統1011 /、有遠舄1043之歧管輸送管1021,遠端1〇43插穿 過患者之—組織而接觸到組織部位1G25。組織部位1〇25可 包含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0 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,經由歧管輸送管將一可注射、可傾倒或可流動之 減壓輸运裝置1035輪送至組織部位1〇25處。減壓輸送裝置 1 035在輸运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 力或肌體。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。輸送至組織部位丨〇25處之 減壓輸送裝置1035之量可足以部分地或完全填充空隙 119637.doc -35- 200808393 1029。減壓輸送裝置1035可包含歧管與支架二者之態樣。 作為歧管’減壓輸送裝置1035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! 〇29之後形成於材料 中。該專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1035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p〇rageil,例如NaCl或其他鹽。在將該 液體或黏性凝膠輸送至組織部位丨025之後,該材料貼覆至 空隙1029上並隨後固化成一實體。水溶性NaC1 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,組織會長入減壓輸送裝置1〇35之 孔内’並隨後最終隨著減壓輸送裝置1〇35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係一與4⑽μηι甘露 糖顆粒相混合之藻酸鹽。該等p〇Tagen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丨〇35 之其他流體溶解。在溶解poragen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 119637.doc -36_ 200808393 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納與搏樣酸間之酸_驗 反應。與依靠poragen溶解之技術相比,所形成之二氧化 碳氣體微粒會在整個減壓輸送裝置1035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、.光、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 物可再吸收性聚合物製成之生物可再吸收性微球體來製備 減壓輸送裝置1035。該等微球體分散於一含有光起始劑及 _ 水凝膠形成材料(例如透明質酸、膠原或具有光反應基團 之聚乙二醇)之溶液中。使微球體-凝膠混合物暴露於光中 一短暫之時間段,以使水凝膠局部地交聯並使水凝膠固定 於微球體上。排出多餘之溶液,並隨後對微球體進行乾 • 丨呆。藉由注射或傾倒,將該等微球體輸送至組織部位處, 且在輸送之後,該混合物會吸收水份,且水凝膠塗層變成 水合塗層。然後,再次將該混合物暴露於光中,由此使該 等微球體交聯,從而形成複數個流動通道。該等交聯之微 球體然後用作一用於向組織部位輸送減低之壓力之歧管及 119637.doc -37- 200808393 用於促進新組織生長之多孔支架。 ’、 〒之前述各實施例外,減壓輪送裝置1035 種各樣之材杻制Α 谷 材枓I成,包括但不限於磷酸鈣、膠原、萍酸 鹽 '纖維音、, ^ 或任何其他能夠以氣體、液體、凝膠、膏 L '由灰、漿液、懸浮液或其他可流動材料形式輸送至組 4 4位亚能夠形成與組織部位流體連通之多個流動路徑之 等放材料。1¾可流動材料可進一步包括固體微粒,例如顆 ^外右4等固體微粒之粒徑足夠小,則其能夠經由歧管輸 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1035直接注射或傾倒至 毗鄰組織部位1025之空隙1029内。參見圖27A,歧管輸送 官1021可在歧管輸送管1021之遠端1043處包含不滲透性或 半滲透性薄膜1051。薄膜1051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之辅助管腔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1057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 1 05 1日守’薄膜1 〇5 1膨脹以填充空隙1 〇29,從而使薄膜接觸 組織部位1025。當薄膜1〇51膨脹時,薄膜1051可用於分離 毗鄰或靠近組織部位1025之額外組織。若薄膜1 〇5 1係不渗 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1025。另一選擇為,薄膜1〇51 119637.doc -38- 200808393 可自-種在存在體液或輸送至薄膜1G5l之生物相容性溶劑 時會溶解之可溶解材料製成。若薄膜贿係半渗透性,則 薄膜膽可保留於原位。半渗透性薄膜1()51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1111包括在 Π 15處藉由外科手術在毗鄰組織部位處插入一歧管,該歧 笞具有自撓性P早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 1123處’級由該歧管對組織部位施加減低之壓力。 參見圖29,一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 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131 5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1319 119637.doc -39- 200808393 處,可使-與該管相關聯之氣球膨脹,以分離眺鄰該组織 部位之組織,藉以形成-空隙。在⑽處,穿過該通道輸 送-歧管。該歧管可包含自—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-選擇為,該歧管可如上文參照圖㈣ 述由輸送至該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1431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輪送裝置 1511包括一用於替換患者腿節1517之現有股骨頭之整形外 科髖假體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- 200808393 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’可圍繞該柱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1515之柱部分1521 内,以使流動通道1541與多孔塗層1535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1553。流動通道 1541用於在植入髖假體1515之後向環繞髖假體1515之多孔 塗層1535及/或骨骼輸送減低之壓力。流動通道1541可包 含一與數個橫向分支管線i 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。 棱向分支管線1545可如在圖32中所示垂直於主饋送管線 1543定向’或者可與主饋送管線1543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··提供一中空之髖 假體’並以一種能夠與多孔塗層1535流體連通之蜂巢狀 (車父佳係開放孔)材料來填' 充該假體之内部空間。 更具體地參見圖33,髖假體1515可進一步在柱部分1521 内包括第一複數個流動通道丨5 6丨,以對環繞髖假體〗5丨5之 多孔塗層153 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、細胞生長促進 劑、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151 5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1571及一流體 輸送源1573。流動通道1561可包含一與數個橫向分支管線 119637.doc -41- 200808393 1585流體連通之主饋送管線1583,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1583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1541之輪送及流體向 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,偉管 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1541將減低之壓力與流體二者轉 送至環繞髖假體1515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1517之恢 復更快,且髖假體15 15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來排放環繞髖假體丨5 15之骨胳 會改良環繞假體之新骨骼之成功再生。 在經由髖假體1515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自連接淳 1545、1565斷開並自患者體中移出〜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 1551、1571施加一轴向拉力來實施。另一選擇為,連接蜂 119637.doc • 42- 200808393 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 露於流體或化學品中而達成管1551、1571之釋脫。管 15 5 1、15 71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1553植入患者體内、髖假體i 5〗5上或附 近。將減壓輸送源15 5 3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k動通道1 5 41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 i、丨56 j 輸送減低之壓力及使流體循環經過流動通道1541、1561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4刀15 2 5,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競假體丨5丨5中任何接 觸骨絡或其他組織之組件,包括例如臼杯。 參見圖34,一種用於修復患者關節之方法1611包括在 16 15處®比鄰該關節在骨路内植入一假體。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 - 200808393 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’以改良假體之〇Se〇integrati〇n。 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 示之整形外科固定器件1715係一具有複數個通路1721之<Fig. 27 According to an embodiment of the present invention, a reduced pressure delivery system 1011, a manifold delivery tube 1021 having a distal end 1043, and a distal end 1〇43 inserted through the tissue of the patient to contact the tissue site 1G25. The tissue site 1〇25 can comprise a void 1029 associated with a wound or other defect, or alternatively, can be formed by separation (including the separation technique described herein) to form a void 0 adjacent the tissue at the distal end 1043. After the site 1〇25 is placed in the gap 1〇29, an injectable, pourable or flowable reduced pressure transport device 1035 is rotated to the tissue site 1〇25 via the manifold delivery tube. The reduced pressure delivery device 1 035 preferably resides in a flowable state during transport to the tissue site, and then, upon arrival, forms a plurality of flow channels for distributing the reduced pressure or body. 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 1035 delivered to the tissue site 丨〇 25 may be sufficient to partially or completely fill the void 119637.doc -35 - 200808393 1029. The reduced pressure delivery device 1035 can include both a manifold and a stent. As a manifold, the reduced pressure delivery device 1035 includes a plurality of holes or open holes that can be delivered to the gap! 〇29 is formed in the material. The specific holes or 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 1035 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 p〇rageil, such as NaCl or other salts, distributed throughout the liquid or viscous gel. After the liquid or viscous gel is delivered to the tissue site 丨 025, the material is applied to the void 1029 and subsequently cured into a solid. The water-soluble NaC1 dissolves in the presence of body fluids, leaving a structure with interconnected pores or flow channels. The reduced flow and/or fluid is delivered to the flow channels. As the new organization is formed, the tissue will grow into the bore of the reduced pressure delivery device 1 〇 35 and then eventually replace the pressure reducing delivery device 1035 with the degradation of the reduced pressure delivery device 1 〇 35. In this particular example, the reduced pressure delivery device 1〇35 is used not only as a manifold' but also as a new tissue growth scaffold. In another embodiment, the reduced pressure delivery device 1035 is an alginate mixed with 4 (10) μηι mannose particles. The p〇Tagen or granules may be dissolved at the tissue site by local bodily fluids or by other fluids being flushed or delivered to the reduced pressure delivery device 丨〇35. After the poragen or granules are dissolved, the space previously occupied by the poragen or particles becomes a void which is interconnected with each other to form a flow passage in the reduced pressure conveying device 1035. The use of poragen in materials to form flow channels is effective, but 119637.doc -36_ 200808393 also forms pores and flow channels that are limited in size to the size of the selected poragen. A chemical reaction can be used in place of poragen to form larger pores by forming gaseous by-products. For example, in one embodiment, a flowable material comprising sodium bicarbonate and citric acid microparticles (which may be non-stoichiometric) may be delivered to tissue site 1025. When the flowable material forms a foam or solid in situ, the body fluid will cause an acid reaction between the sodium bicarbonate and the pump acid. The formed carbon dioxide gas particles form larger pores and ® flow channels throughout the reduced pressure delivery device 1035 as compared to the technique of relying on poragen dissolution. 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, light, 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 delivery device 1035 is prepared by selecting bioresorbable microspheres made from a bioresorbable polymer. The microspheres are dispersed in a solution containing a photoinitiator and a hydrogel forming material such as hyaluronic acid, collagen or polyethylene glycol having a photoreactive group. The microsphere-gel mixture is exposed to light for a brief period of time to partially crosslink the hydrogel and immobilize the hydrogel on the microspheres. Drain the excess solution and then dry the microspheres. The microspheres are delivered to the tissue site by injection or pouring, and after delivery, the mixture absorbs moisture and the hydrogel coating becomes a hydrated coating. Then, the mixture is again exposed to light, whereby the microspheres are crosslinked to form a plurality of flow channels. The crosslinked microspheres are then used as a manifold for delivering reduced pressure to the tissue site and a porous scaffold for promoting new tissue growth 119637.doc -37-200808393. ', 〒 前述 前述 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , 减压 减压 减压 减压 减压 减压 减压 减压 减压 减压 减压It can be delivered as a gas, liquid, gel, paste L' by ash, slurry, suspension or other flowable material to a group of four-dimensional sub-materials capable of forming a plurality of flow paths in fluid communication with the tissue site. The 13⁄4 flowable material may further comprise solid particles, for example, the solid particles of the outer right 4 are sufficiently small that they can flow through the manifold. 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 1035 can be directly injected or poured into the void 1029 adjacent the tissue site 1025. Referring to Figure 27A, the manifold delivery officer 1021 can include an impermeable or semi-permeable membrane 1051 at the distal end 1043 of the manifold delivery tube 1021. The membrane 1051 includes an internal space 1〇55 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 1057 to fill the interior space 1055 of the membrane 1051. When the fluid or gel fills the film, the film 1 〇5 1 expands to fill the void 1 〇 29, thereby causing the film to contact the tissue site 1025. When the film 1〇51 is inflated, the film 1051 can be used to separate additional tissue adjacent or adjacent to the tissue site 1025. If the film 1 〇 5 1 is an impermeable film, it can be physically broken and removed, thereby bringing the reduced pressure delivery device 1035 into contact with the tissue site 1025. Alternatively, the film 1〇51 119637.doc -38- 200808393 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 1G51. If the film is semi-permeable, the film can remain in place. The semi-permeable membrane 1() 51 is capable of delivering reduced pressure and possibly other fluids to the tissue site 1025. Referring to Fig. 28, a method 1111 for performing reduced pressure tissue treatment includes surgically inserting a manifold at an adjacent tissue site at a fistula 15 having a plurality of protrusions extending from the early wall of the flexible P. A plurality of flow channels are formed between the protrusions. The manifold is positioned at 1119 such that at least a portion of the projections contact the tissue site. At the 1123' level, a reduced pressure is applied to the tissue site by the manifold. Referring to Fig. 29, a method of applying reduced pressure tissue treatment to a tissue site 1211 includes inserting a manifold at 1215 through the skin adjacent 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. The injectable or pourable material is delivered to the tissue site and forms a plurality of flow channels upon reaching the tissue site. At 1219, the manifold is positioned such that at least a portion of the flow channels are 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 one of the skins at 131 5 such that the distal end of the tube is placed adjacent to the tissue site. At 1319 119637.doc -39-200808393, the balloon associated with the tube can be inflated to separate tissue adjacent to the tissue site, thereby forming a void. At (10), the manifold is transported through the passage. The manifold can include a plurality of protrusions extending from the 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 delivered to the tissue site as described above with reference to Figure (4). 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, a method of applying reduced pressure tissue treatment to 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 1431, 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 a plastic surgical hip 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 section 1517. A porous coating 1535 is disposed around the perimeter of the column 119637.doc -40 - 200808393 and is preferably constructed of sintered or vitrified ceramic or metal. Alternatively, a honeycomb material having a porous property may be disposed around the column portion. A plurality of flow channels 1541 are disposed within the post portion 1521 of the hip prosthesis 1515 to fluidly communicate the flow channel 1541 with the porous coating 1535. A connection port 1545 is fluidly coupled to the flow channel 1541 which is configured to be releasably coupled to a reduced pressure delivery tube 1551 and a reduced pressure delivery source 1553. The flow channel 1541 is used to deliver a reduced pressure to the porous coating 1535 and/or bone surrounding the hip prosthesis 1515 after implantation of the hip prosthesis 1515. The flow passage 1541 can include a main feed line 1543' that is in fluid communication with a plurality of transverse branch lines i 547. The plurality of transverse branch lines 1547 are in communication with the porous coating 1535. The rib branch line 1545 can be oriented perpendicular to the main feed line 1543 as shown in Figure 32 or can be oriented at some angle to the main feed line 1543. An alternative method for distributing reduced pressure includes providing a hollow hip prosthesis and filling the honeycomb with a honeycomb-like (opening hole) material that is in fluid communication with the porous coating 1535. The internal space of the body. Referring more specifically to Figure 33, the hip prosthesis 1515 can further include a first plurality of flow channels 丨5 6丨 within the post portion 1521 to the porous coating 153 5 and/or bone surrounding the hip prosthesis 丨5丨5 Provide fluid. The fluid may include filtered air or other gas, an antibacterial agent, an antiviral agent, a cell growth promoter, a flushing 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 151 5 . A port 1565 is fluidly coupled to the flow channel 1561 which is configured to be releasably coupled to a fluid delivery tube 1571 and a fluid delivery source 1573. The flow channel 1561 can include a main feed line 1583 in fluid communication with a plurality of lateral branch lines 119637.doc -41 - 200808393 1585 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 transfer of the reduced pressure to the first plurality of flow passages 1541 and the delivery of the fluid to the second plurality of flow passages 1561 can be accomplished by separate tubes (e.g., the reduced pressure delivery conduit 1551 and the fluid delivery conduit 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 the superior tube preferably provides a separate fluid communication path within the hip prosthesis 1515, however, the first plurality of flow channels 1541 can also be used to transfer both the reduced pressure and fluid to the bone surrounding the hip prosthesis 1515. 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 1517 is faster and the hip prosthesis 15 15 is more successfully integrated with the bone. . Providing a second plurality of flow channels 1561 to vent the bone surrounding the hip prosthesis 15 5 15 will improve the successful regeneration of the new bone surrounding the prosthesis. After applying the reduced pressure through the hip prosthesis 1515 for a selected amount of time, the reduced pressure delivery tube 1551 and the fluid delivery tube 1571 can be disconnected from the connection ports 1545, 1565 and removed from the patient's body - preferably not used Surgical invasive procedure. The connection between the ports 1545, 1565 and the tubes 1551, 1571 can be a connection that can be released by hand, which can be performed by applying an axial pulling force to the tubes 1551, 1571 outside the body of the patient. Alternatively, the connecting bee 119637.doc • 42- 200808393 1545, 1565 can be bioresorbable or soluble in the presence of the selected fluid or chemical so that the connection can be made 1545, 1565 Exposure to tubes 1551, 1571 is achieved by exposure to fluids or chemicals. The tubes 15 5 1 , 15 71 may also be made of 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, the reduced pressure delivery source 1553 can be implanted into the patient, on or near the hip prosthesis. Placing the reduced pressure delivery source 15 5 3 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 k-channel 1 51. 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 via flow channels 丨54i, 丨56j and circulates fluid through flow channels 1541, 1561. Although only the column portion 1521 and the head 4 knife 15 2 5 of the hip prosthesis 1515 are illustrated in FIGS. 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. Any component of the prosthetic body 丨5丨5 that contacts the ossicular or other tissue, including, for example, a cup. Referring to Fig. 34, a method 1611 for repairing a joint of a patient includes implanting a prosthesis in the bone path adjacent to the joint at 16 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 configured to be in fluid communication with the bone 119637.doc -43 - 200808393 channels. At 1619, the reduced pressure is applied to the bone via the plurality of flow channels to improve the 〇Se〇integrati〇n of the prosthesis. Referring to Figures 35 and 36, a reduced pressure delivery device 1711, in accordance with an embodiment of the present invention, includes an orthopaedic fixation device 1715 for fastening a bone 1717 of a patient that includes a fracture site 1719 or other defect. The orthopaedic fixation device 1715 shown in Figures 35 and 36 has a plurality of passages 1721
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i 7丨5錯固至骨絡丨7 i 7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173 5。该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之間設置一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 通道1741與多孔塗層1735流體連通。一連接埠1745流體連 接至流動通道1741,該埠構造成連接至一減壓輸送管 及一減壓輸送源1753。流動通道1741用於在將整形外科固 定為件1715固定至骨骼1717之後向多孔塗層^”及/或環 繞整形外科固定器件1715之骨絡輸送減低之壓力。流動通 道1741可包含-與數個橫向分支管線⑽流體連通之主饋 送管線m3 ’該數個橫向分支管線⑽與多孔塗層相 連通。橫向分支管線1747可如在圖35中所示垂直於主饋送 管線m3定向,或者可與主饋送管線1743成某些夾角定 向。-種用於分佈減低之壓力之替代方法包括:提供一中 空之整形外科岐器件,並以—種能夠與多孔塗層⑽流 119637.doc -44- 200808393 體連通之蜂巢狀(較佳係開放孔)材料來填 定器件之内部空間。 r针固 整形外科ϋ定料1715可如在圖35巾所示係—板, 另一選擇為,可# 一圊定51杜 > θ Τ係目疋為件,例如套管、矯形器 柱、或任何其他用於使骨路之一部分穩定之器件。整 件1715可進一步係用於固定假體或其他整形外科 :::所植入組織(例如骨路組織或軟骨)之緊固件,其限 2 “等緊ϋ件包含用於㈣鄰或環繞該等緊固件之 、、且織輸廷減低之壓力之流動通道 括雜 m 勒、遏邊專緊固件之實例可包 ㈣、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i7i5可進一 整形外科固定器件1715内包括第- ^在 以#f π μ & 弟—禝數個流動通道1761, 以對壞繞整形外科固定器件1715 絡提供流體。該流體可包括經過…氣戈:1:5及/或骨 _、抗病毒劑、細胞生長促進劑、沖洗流體、化學活: 劑或任何其他流體。若期望 17]S夕典财+ 禋机體引入至環繞髖假體 5之月时,可提供額外之流體連通路徑。— 1765流體連接至流動通道丨 ^ 巧垾1765構造成連接至一 流體輪送管㈤及-流體輸送源m 接 入 a ,瓜動通道1761可包 s 一與數個横向分支管線1785流體連通之主饋送管線 1 一783 ’该數個橫向分支管線1785與多孔塗層⑺ $ 橫向分支管線1785可如在圖33中所亍 1 1783^^, , ^ , 直於主饋送管線 —/ 管線1783成某些夾角定向。 減低之塵力向弟一複數個义 個抓動通遏1741之輸送及流體向 119637.doc •45- 200808393 第二複數個㈣通道1761之輸送可藉由單獨之管(❹減 壓輸送管1751及流體輸送管1771)來完成。另_為, 可使用-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—步注意,儘管 較佳在髖假體1715内提供分離之流體連通路徑,然而亦可 使用第-複數個流動通道1741將減低之壓力與流體二者輸 送至视鄰整形外科固定器件1715之骨骼。 使用整形外科固定器件1715作為歧管來向毗鄰整形外科 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1719之恢復。提供第二複數個流動通道i76i 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,——種用於治癒骨骼之骨骼缺損之方法1811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18 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38 ’ 一種用於對一組織部位施行減壓組織洽療之 方法1911包括:在1915處對一具有複數個流動通道之歧管 進行疋位’以使该等流動通道之至少一部分與該組織部位 流體連通。在1919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39,一種用於對一組織部位施行減壓組織治療之 U9637.doc -46- 200808393 方法2011包括··在2〇1 5處將一歧管輸送管之遠端毗鄰該組 織部位進行定位。在2019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 固態歧管。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4〇-45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、使用例如融合或後 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 管211 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 2121。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2117 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上之單個 或多個脊2145(參見圖40及41)。在又一實施例中,防阻塞 119637.doc -47- 200808393 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 2117上之材料或結構。防阻塞部件2135能夠防止撓性壁 2117完全塌縮’而仍使流體能夠經由主流動通路2丨2丨流 動。 撓性壁2117進一步包括複數個穿透撓性壁2117之孔 2155,該等孔2155與主流動通路2121相連通。孔2155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$真空之輸送。舉例而言,在圖5丨中,可使孔面對骨 路、面對覆盘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 & 2161,δ亥至少一個出口流體連接至主流動通路ha,以 白主/’il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k成之阻基。第二導管2163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。 ^具體地參見圖4〇及41,在減壓輸送系統2111中,第二 導&2163可包括用於沖洗主流動通路2121及第-導管2161 之多個導管。儘管撓性壁2117中與固定至減壓輸送管仙 之端部相對之端部可如在圖㈣所示為開口的,然而已發 U9637.doc * 48 - 200808393 現’覆蓋撓性壁2117之端部m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-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分又進人兩個室内,此The plate, the plurality of passages 1721 are used to align the orthopaedic fixation device i 7丨5 to the iliac crest 7 i 7 using screws 1725, pins, bolts or other fasteners. A porous coating 173 5 may be disposed 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 porous characteristics can 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 to fluidly communicate the flow channel 1741 with the porous coating 1735. A port 1745 is fluidly coupled to the flow channel 1741 which is configured to be coupled to a reduced pressure delivery tube and a reduced pressure delivery source 1753. The flow channel 1741 is used to deliver a reduced pressure to the bone coating of the porous coating and/or the orthopaedic fixation device 1715 after the orthopedic fixation member 1715 is secured to the bone 1717. The flow channel 1741 can include - and several The lateral branch line (10) is in fluid communication with the main feed line m3 'the plurality of lateral branch lines (10) are in communication with the porous coating. The lateral branch line 1747 can be oriented perpendicular to the main feed line m3 as shown in Figure 35, or can be associated with the main The feed line 1743 is oriented at some angle. An alternative method for distributing the reduced pressure includes providing a hollow orthopedic device and capable of flowing with the porous coating (10) 119637.doc -44 - 200808393 Connected honeycomb-shaped (preferably open-hole) material to fill the internal space of the device. r-needle plastic orthopedic material 1715 can be as shown in Figure 35, another choice is, can be #一圊The pedicle is a member, such as a cannula, an orthosis column, or any other device for stabilizing a portion of the bone. The entire piece 1715 can be further used to secure a prosthesis or other plastic surgery. ::: Fasteners for implanted tissue (eg, bone path tissue or cartilage), which are limited to 2 "equal tights containing pressure for (4) adjacent or surrounding the fasteners, and the pressure of the reduction Examples of passages that include miscellaneous and ribbed fasteners may include (4) bolts, screws, or any other suitable fastener. Referring more specifically to Fig. 36, the orthopaedic fixation device i7i5 can include a -f in the #f π μ & 禝-禝 number of flow channels 1761 to the orthopedic orthopedic fixation device 1715. The fluid is supplied. The fluid may include a gas: 1:5 and/or bone _, an antiviral agent, a cell growth promoter, a rinsing fluid, a chemical agent, or any other fluid. An additional fluid communication path is provided if the 17] S 典 财 + + 禋 body is introduced into the surrounding hip prosthesis 5 months. - 1765 fluidly connected to the flow channel 丨 ^ 垾 1765 is configured to be connected to a fluid transfer tube (5) and - fluid delivery source m is connected to a, the melon moving channel 1761 can be s-connected to a plurality of lateral branch lines 1785 The main feed line 1 - 783 'the plurality of transverse branch lines 1785 and the porous coating (7) $ transverse branch line 1785 can be as shown in Figure 33, 1 1783^^, ^, straight to the main feed line - / line 1783 Some angles are oriented. Reduce the dust force to the brothers, a number of righteous grips, the transmission and fluid flow to the 174637.doc •45- 200808393 The second plurality (four) of the channel 1761 can be transported by a separate tube (❹ decompression duct 1751 And the fluid delivery tube 1771) is completed. Alternatively, a tube having a plurality of lumens as previously described herein can be used to separate the communication path for delivering reduced pressure to fluid. It should be noted that although a separate fluid communication path is preferably provided within the hip prosthesis 1715, the first plurality of flow channels 1741 can be used to deliver both the reduced pressure and fluid to the adjacent orthopedic fixation device 1715. The bones. The use of the orthopedic fixation device 1715 as a manifold to deliver reduced pressure to the bone region of the adjacent orthopaedic fixation device 1715 accelerates and improves the recovery of the defect 1719 of the bone 1717. Providing a second plurality of flow channels i76i to deliver fluid to the bone surrounding the orthopaedic fixation device 1715 improves the successful regeneration of new bone adjacent the orthopaedic fixation device. Referring to Fig. 37, a method 1811 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 18 19, a reduced pressure is applied to the bone defect via the plurality of flow channels. Referring to Figure 38, a method 1911 for performing a decompression tissue therapy on a tissue site includes: at 1915, clamping a manifold having a plurality of flow channels to cause at least a portion of the flow channels to The tissue site is in fluid communication. At 1919, 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 U9637.doc-46-200808393 method for performing decompression tissue treatment on a tissue site includes: • positioning the distal end of a manifold tube adjacent to the tissue site at 2〇15 . At 2019, 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 becoming a solid 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 having a flexible wall 2117 surrounding a primary 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 4A-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 by other means such as fusion or back molding, or alternatively selected to be integrally joined by coextrusion. The reduced pressure delivery tube 2125 delivers the reduced pressure to the primary manifold 211 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) disposed on an inner surface 2141 of the flexible wall 2117 and extending into the main flow path 2121. In another embodiment, the anti-blocking member 2135 can be provided with a single or multiple ridges 2145 on the inner surface 2141 (see Figures 40 and 41). In yet another embodiment, the anti-blocking 119637.doc -47 - 200808393 component 2135 can include a honeycomb material 2149 disposed within the main flow path, such as shown in FIG. The anti-blocking member 2135 can be any material or structure that can be embedded within the flow passage or that can be integrally or otherwise secured to the flexible wall 2117. The anti-blocking member 2135 is capable of preventing the flexible wall 2117 from completely collapsing' while still allowing fluid to flow through the main flow path 2丨2丨. The flexible wall 2117 further includes a plurality of apertures 2155 that penetrate the flexible wall 2117, the apertures 2155 being in communication with the main flow path 2121. The aperture 2155 enables the reduced pressure delivered to the main flow path 2121 to be distributed to the tissue site. The aperture 2155 can be selectively positioned about the circumference of the manifold 2115 to preferentially direct the delivery of vacuum. For example, in Figure 5, the apertures can be placed facing the bone path, facing the tissue of the overlay, or both. The reduced pressure delivery tube 2125 preferably includes a first guide & 2161 having at least one outlet, at least one outlet fluidly connected to the main flow path ha, and the white main/'il moving path 2121 delivering a reduced pressure. A second conduit 2163 can also be provided to clean the main flow path 2121 and the first conduit 2161 with a fluid to prevent or dissolve the barriers formed by wound secretions and other fluids aspirated from the tissue site. The second conduit 2163 preferably includes at least one outlet positioned adjacent at least one of the main flow passage 2121. and the at least one outlet of the first conduit 2161. Referring specifically to Figures 4A and 41, in the reduced pressure delivery system 2111, the second guide & 2163 can include a plurality of conduits for flushing the main flow path 2121 and the first conduit 2161. Although the end of the flexible wall 2117 opposite to the end fixed to the decompression delivery tube can be open as shown in Figure (4), U9637.doc * 48 - 200808393 has been issued to cover the flexible wall 2117. The performance and reliability of the end m cleaning function. Preferably, a top gap 2171 is provided between the covered end of the flexible wall and the end of the second conduit 2163. The headspace 2171 is capable of achieving accumulation of cleaning fluid during the cleaning process, which helps drive the flushing fluid to flow into the first conduit 2161 through the primary flow path 2121. The spacer used as the anti-blocking member 2135 is also illustrated in FIG. The centrally located spacer causes the main flow path 2121 to enter the two chambers again.
使主歧管2115在其中一個室被阻塞且藉由清洗無法溶解該 阻塞時仍能夠繼續運作。 夢見圖49及50, 一減麗輸送系統22u包括一與減壓輸至 = 2217成-體之主歧管2215。㈣輸送管2217包括一中; 管腔2223及複數個辅助管腔咖。儘管辅助管腔加可月 於量測組織部位處或附近之壓力,鋏 J …、而補助管腔2225可ij 一步用於清洗中央管腔2223,以防止戎冰紹”办 丨万止次/合解阻塞物。複凄 個孔2231與中央管腔2223相連 Μ刀谛由中央管腔222 所輸送之減低之壓力。如在圖5〇中 孙如 Τ所不較佳使孔2231;? 貝牙辅·助管腔2225。在圖50中亦圖解 口鮮w兄明減壓輸送管之超 頭孔端,其在辅助管腔2225之 卜形成一頂隙2241 〇 叙右在應用減低之壓力期間使組織、 ☆ π μ、、,〃 < 文木或其他材料嚙告 減壓輸达管2217之端部,頂隙224 对曰~績允許向中央管 腔2223輸送清洗流體。 統2111 、 2211 分佈減低之壓 裝設及移除本 在使用期間,圖40-50所述之減壓輪送系 可直接應用於組織部位上,以向組織部位 力。主歧管之低矮形狀非常有利於經過皮膚 119637.doc -49 - 200808393 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51,主歧管2115、2215可與一辅助歧管2321結合 使用。在圖51中,辅助歧管2321包括一兩層式氈墊。辅助 歧管2321之第一層接觸一包含骨折部位之骨骼組織部位放 置。主歧管2115接觸該第一層放置,且辅助歧管2321之第 一層.置於主歧管2115及第一層之頂上。辅助歧管2321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,此使輔助歧 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,主歧管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 歧管可由選自由如下材料組成之群組之至少一種材料構 成:聚乳酸、聚乙醇酸、聚己内酯、聚羥基丁酸酯、聚羥 戊酸、聚二氧六環醯胺、p〇ly〇rthoesthers、聚礙腈、聚氨 基曱酸酯、膠原、透明質酸、聚胺基葡萄糖、羥基磷灰 石、構酸鈣、硫酸鈣、碳酸鈣、生物玻璃、不銹鋼、鈦、 鈕、同種異體移植片及自體組織移植片。 上文所述之減壓輸送系統2111、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- 200808393 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。 更具體而言,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 罪近歧管或罪近该弟一導管之一出口。儘管可將空氣壓至 或π推”至弟二導管之出口,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(6〇)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一導管内之流體,同時防止 引入過多之空氣。引入過多之空氣、或者以過高之間隔頻 率來引入空氣將會造成一不能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壓力。 參見圖52,在一個例示性實施例中,一減壓輸送系統 2411包含一歧管2415,歧管2415流體連接至一第一導管 2419及一第二導管mu。第一導管2419連接至一減壓源 2429,以向歧管2415提供減低之壓力。第二導管2423包含 119637.doc -51 - 200808393 =出口 2435,出口 2435定位成與歧管2415流體連通並靠近 第一導官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 導官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MM之= 啟及關閉’以調節使用環境空氣對第二導f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。 應注思,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。 mm 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 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mm Hg與-500 mm Hg之間,但更佳係介於約乃 119637.doc -52- 200808393The main manifold 2115 is allowed to continue to operate when one of the chambers is blocked and cannot be dissolved by the cleaning. Dreams of Figures 49 and 50, a reduced delivery system 22u includes a primary manifold 2215 that is decompressed to a pressure of 2217. (4) The delivery tube 2217 includes a middle; a lumen 2223 and a plurality of auxiliary lumens. Although the auxiliary lumen can be used to measure the pressure at or near the tissue site, the auxiliary lumen 2225 can be used to clean the central lumen 2223 in one step to prevent the ice from being smashed. The occlusion hole 2231 is connected to the central lumen 2223 and the reduced pressure is transmitted by the central lumen 222. As shown in Fig. 5, Sun Ruyi does not preferably make the hole 2231; The dental auxiliary and the auxiliary lumen 2225. In Fig. 50, the super-end hole end of the fresh-keeping vacuum tube is also illustrated, and a top gap 2241 is formed in the auxiliary lumen 2225. During the period, the tissue, ☆ π μ, , 〃 &; 文 文 文 文 文 文 文 或 或 或 或 或 或 或 或 或 或 或 或 224 224 224 224 224 224 224 224 224 224 224 224 224 224 224 224 224 224 224 224 224 224 224 224 224 224 224 224 2211 Reduced pressure mounting and removal During use, the decompression bearing system described in Figures 40-50 can be applied directly to the tissue site to force the tissue. The low profile of the main manifold is very beneficial. The technique described in the skin 119637.doc -49 - 200808393. Similarly, The main manifold is used in conjunction with an auxiliary manifold 2321. In Figure 51, the auxiliary manifold 2321 includes a two-layer felt pad. The auxiliary manifold 2321 The first layer contacts a bone tissue site containing the fracture site. The primary manifold 2115 is placed in contact with the first layer, and the first layer of the auxiliary manifold 2321 is placed on top of the primary manifold 2115 and the first layer. The tube 2321 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 secondary manifold 2321 is bioabsorbable, which aids The manifold 2321 can remain in place after the decompression treatment is completed. Once the decompression treatment is completed, the subject can be removed from the layers of the auxiliary manifold with little or no disturbance to the tissue site. Tube 2115. In one embodiment, the primary manifold 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 secondary manifold is preferably used for new tissue growth Bracket The tube may be composed of at least one material selected from the group consisting of polylactic acid, polyglycolic acid, polycaprolactone, polyhydroxybutyrate, polyvaleric acid, polydioxane, p〇ly 〇rthoesthers, polyurethane, polyaminophthalate, collagen, hyaluronic acid, polyaminoglucose, hydroxyapatite, calcium silicate, calcium sulfate, calcium carbonate, bioglass, stainless steel, titanium, button, allogeneic Transplant and autologous tissue grafts. The cleaning functions of the reduced pressure delivery systems 2111, 2211 described above can be used with any of the manifolds described herein. The ability to deliver a reduced pressure manifold or 119637.doc -50- 200808393 catheters prevents the formation of obstructions that impede the pressure to reduce. Such obstructions are typically formed when the pressure near the tissue site reaches equilibrium and the flow of fluid around the tissue site slows. It has been found that the use of air to purge the manifold and decompression catheter at a selected interval for a desired amount of time can help prevent or dissolve the obstruction. More specifically, 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 sinned near the manifold or sinned to one of the outlets of the younger one. Although the air may be pressurized or π pushed to the outlet of the second conduit, it is preferred to draw in air through the second conduit by the reduced pressure at the tissue site. It has been found that in many cases, during the application of reduced pressure Two (2) seconds of air delivery at intervals of sixty (6 inches) seconds is sufficient to prevent the formation of obstructions. This cleaning program provides sufficient air to adequately move the manifold and fluid in the first conduit while preventing Introducing too much air. Introducing too much air, or introducing air at too high a frequency, will result in a decompression system that cannot return to the reduced target pressure between wash cycles. The amount of time and the interval between 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, At the same time, the full target pressure can still be restored between wash cycles. Referring to Figure 52, in an exemplary embodiment, a reduced pressure delivery system 2411 includes a manifold 241 5. The manifold 2415 is fluidly coupled to a first conduit 2419 and a second conduit mu. The first conduit 2419 is coupled to a reduced pressure source 2429 to provide reduced pressure to the manifold 2415. The second conduit 2423 includes 119637.doc -51 - 200808393 = outlet 2435, the outlet 2435 is positioned in fluid communication with the manifold 2415 and proximate to the outlet of the first guide 2419. The second conduit 2423 is fluidly coupled to a valve 2439 that is when the valve 2439 is placed in the open position The communication between the second guide 2423 and the ambient air can be achieved. The valve 2439 is operatively coupled to a controller 2453, and the controller 2453 can control the valve MM = on and off to adjust the ambient air to the second guide. F-implemented cleaning to prevent obstructions from being present in manifold 2415 and first conduit 2419. It is contemplated that any fluid (including liquids or gases) can be used to achieve the techniques described herein, despite the force used to clean the fluid. Preferably, the reduced pressure creates a suction at the tissue site, however, similar to that described with reference to Figure 9, the fluid delivery member can also deliver fluid in a similar manner. mm according to the description herein The method of decompressing tissue tissue at a tissue site can be achieved by applying a sufficiently low pressure to the tissue site and then maintaining the sufficiently low pressure for a selected period of time. Another option is The reduced pressure applied to the tissue site can be cyclical. More specifically, the magnitude of the applied reduced pressure can vary depending on the selected time cycle. Yet another method of applying the reduced pressure can randomly change the reduced pressure. Similarly, the rate or amount of fluid delivered to the tissue site can be constant, periodic, or random. If periodic, fluid delivery can occur during the application of reduced pressure, or can be absent This is done during the cycle of applying the reduced pressure. 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 mm Hg and -500 mm Hg, but more Good is between about 119637.doc -52- 200808393
Hg與-300 mmHg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 括但不限於骨絡組織、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。 應注思,本文所述之減壓輸送裝置可與支架材料結合使 用來提南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 送装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- 200808393 【圖式簡單說明】 、、彳或申明案檔案包含至少一個帶顏色之圖式。可根 ,、、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繪示一根據本發明一實施例之減壓輸送裝置之透視 圖,该減壓輸送裝置具有複數個突起物自一撓性障壁伸出 以形成複數個流動通道; 圖2圖解既明圖1所示減壓輸送裝置之正視圖; 圖3綠示圖丨所示減壓輸送裝置之俯視圖; 圖A圖解δ兒明圖丨所示減壓輸送裝置之侧視圖,該減壓 輸运裝置具有一單管腔減壓輸送管; 圖4B綠示圖丨所示減壓輸送裝置之—#代實施例之侧視 圖該減壓輸送裝置具有一雙管腔減壓輸送管; 圖5圖解說明圖!所示減壓輸送裝置之一放大透視圖; 圖6、、、g不一根據本發明一實施例之減壓輸送裝置之透視 圖忒減壓輸运裝置具有一附固至一撓性障壁上之蜂巢狀 材料’錢㈣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一正視圖; 圖8、、會不圖7所不減壓輸送裝置在處剖切之剖 視側視圖; 〇 圖8A圖解說明_種根據本發明_實施例之減壓輸送農置 之剖視正視圖; 圖繪示圖8A所示減壓輪送裝置之一侧視圖; 119637.doc -54- 200808393 圖9圖解說明一種根據本發明一實施例之減壓輸送裝置 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,其顯示在鹿 用減壓組織治療之後誘發之肉芽組織; 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; 春 圖13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新骨胳之沈積; 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所示兔子頭骨之彩色照片,其顯示嵌 入其中一處臨界尺寸缺損内之磷酸鈣支架及一覆蓋第二臨 界尺寸缺損之不銹鋼絲網; • >圖16圖解說明圖14所示兔子頭骨之彩色照片,其顯示對 臨界尺寸缺損應用減壓組織治療; 圖17圖解說明在實施減壓組織治療之後一兔子頭骨之彩 色、且、哉切片,,亥組織切片顯示新骨骼在磷酸鈣支架内之 積; 圖18繪示在實施減壓組織治療六天及實施手術兩週後圖 斤丁、、、二支架填充之臨界尺寸缺損之射線照片; α圖19繪示在實施減壓組織治療六天及實施手術十二週後 回斤示,工支木填充之臨界尺寸缺損之射線照片; H9637.doc -55- 200808393 圖:〇繪不—根據本發明_實施例之減壓輪送系統之正視 :’該減壓輸送系統具有一歧管輸送管,|用於經過皮, 將一減壓輸送裝置插入至一組織部位; 月 該歧Between Hg and -300 mmHg. 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 harvested tissue can be transplanted to another patient. It should be noted that the reduced pressure delivery device described herein can be combined with the scaffold material to increase the growth and growth rate of the 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- 200808393 [Simple description of the schema] The 、, 彳 or declaration file contains at least one graphic with color. The patent or patent application publication with a color map is provided by the Patent Affairs Bureau after payment of the necessary fee. 1 is a perspective view of a reduced pressure conveying device having a plurality of protrusions extending from a flexible barrier to form a plurality of flow passages according to an embodiment of the present invention; 1 is a front view of the reduced pressure conveying device; FIG. 3 is a plan view showing the reduced pressure conveying device shown in Fig. 3; Fig. A is a side view showing the reduced pressure conveying device shown in Fig. Having a single lumen decompression delivery tube; Figure 4B is a green side view of the reduced pressure delivery device - a side view of the embodiment of the decompression delivery device having a dual lumen decompression delivery tube; Figure 5 illustrates Figure! An enlarged perspective view of one of the illustrated reduced pressure delivery devices; FIG. 6, and FIG. 3 are perspective views of a reduced pressure delivery device according to an embodiment of the present invention. The reduced pressure delivery device has an attachment to a flexible barrier. The honeycomb material 'money (four) wall 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 one of the pressure reducing conveying devices shown in FIG. 6; FIG. 8A illustrates a cross-sectional front view of a decompression conveying farm according to the present invention. FIG. 8A is a cross-sectional side view of the decompressing conveying device according to the present invention. Side view of one of the reduced pressure transfer devices shown in FIG. 8A; 119637.doc -54- 200808393 FIG. 9 illustrates a front view of a reduced pressure delivery device for use in a patient's bones in accordance with an embodiment of the present invention. Figure 1 depicts a colored tissue section of a rabbit skull showing the original, undamaged bone; Figure 11 illustrates a color tissue section of a rabbit skull that is shown to be induced after deer treatment with decompression tissue Granulation tissue; Figure 12 A color tissue section of a rabbit skull showing the deposition of new bone after application of decompressed tissue treatment; Figure 13 illustrates a color tissue section of a rabbit skull showing deposition of new bone after application of reduced pressure tissue treatment 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 skull shown in Figure 14 showing phosphoric acid embedded in one of the critical size defects Calcium stent and a stainless steel mesh covering the second critical dimension defect; • > Figure 16 illustrates a color photograph of the rabbit skull of Figure 14 showing the application of reduced pressure tissue treatment to a critical size defect; Figure 17 illustrates the implementation After the decompression tissue treatment, the color of a rabbit skull, and the sputum section, the Hei tissue section shows the product of the new bone in the calcium phosphate scaffold; Figure 18 shows the figure after performing the decompression tissue treatment for six days and two weeks after the operation. Radiographs of critical size defects filled with jin, ding, and two stents; α Figure 19 shows the implementation of decompression tissue treatment for six days and implementation of hands Twelve weeks later, the radiograph of the critical dimension defect filled with the work branch; H9637.doc -55- 200808393 Fig.: The drawing of the decompression system according to the present invention is the same: The reduced pressure delivery system has a manifold delivery tube, for transcutaneously, inserting a reduced pressure delivery device into a tissue site;
圖21圖解說明圖20所示歧管輸送管之放大正視圖, 官輸送管包含一減壓輸送裝置,該減壓輸送裝置具有 I*生障壁及/或一處於壓縮位置之蜂巢狀材料; 圖22繪示圖21所示歧管輸送管之放大正視圖,圖中顯示Figure 21 illustrates an enlarged elevational view of the manifold delivery tube of Figure 20, the official delivery tube including a reduced pressure delivery device having an I* bio-barrier and/or a honeycomb material in a compressed position; 22 is an enlarged front view showing the manifold conveying pipe shown in FIG. 21, which is shown in the figure.
在已自該歧管輸送管推入之後該減壓輸送裝置之撓性障: 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 < 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—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= 壓輸送裝置處於該歧管輸送管外側、⑮被—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Z 薄膜約束於一鬆弛位置上; / 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、但被一不參 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 观圖,圖 中顯示該減壓輸送裝置處於該歧管輸送管外側、 Ί一於一膨 脹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- 200808393 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 运裝置處於該歧管輸送f外側、但受—具有膠封之不渗透 性薄膜約束; 圖26A繪示根據本發明一實施例之減壓輪送系統之正視 圖; 圖27圖解說明-種根據本發明—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,以用於經 過皮膚將一減壓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輸送系 統之正視圖,該減壓輸送系統具有一歧管輪送管,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不 滲透性薄膜; 0 2 8、、、曰示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29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3 0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3 1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一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,以用於對環繞該髖假體之骨骼區域施加 119637.doc -57- 200808393 減低之壓力; 圖,解說明圖32所示競假體之剖面正視圖,該麗假體 具有第二複數個流動通道,以用於將流體輪送至環繞 假體之骨絡區域; 圖34繪示—種根據本發明_實施例使用減壓組織 修復患者關節之方法之流程圖; 、The flexible barrier of the reduced pressure delivery device after being pushed in from the manifold delivery tube: and/or the honeycomb material is in an expanded position; Figure 23 illustrates an embodiment of a reduced pressure delivery system in accordance with an embodiment of the present invention. The vacuum delivery system has a manifold delivery tube for inserting a decompression delivery device through the skin into a tissue site, the figure showing that the pressure delivery device is outside the manifold delivery tube, 15 is - The permeable membrane is constrained to a compression position; ', Figure 24 is a front elevational view of the reduced pressure delivery system of Figure 23, showing that the reduced pressure delivery device is outside the manifold delivery tube but is impervious Z film is constrained to a relaxed position; / Figure 25 illustrates a front view of the reduced pressure delivery system of Figure 23, showing the reduced pressure delivery device outside the manifold tube but with a non-permeable membrane Constrained to an expanded position; / Figure 25A illustrates a view of the reduced pressure delivery system of Figure 23, showing that the reduced pressure delivery device is outside the manifold delivery tube, and is in an expanded position </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> </ RTI> <RTIgt; a manifold duct of a tissue portion, the figure showing that the reduced pressure transport device is outside the manifold transport f, but is constrained by an impervious film having a glue seal; FIG. 26A illustrates an embodiment of the present invention Front view of a reduced pressure delivery system; Figure 27 illustrates a front view of a reduced pressure delivery system having a manifold delivery tube for a reduction through the skin, in accordance with an embodiment of the present invention. The pressure delivery device is injected into a tissue site; Figure 27A illustrates a front view of a reduced pressure delivery system having a manifold delivery tube for a reduction through the skin, in accordance with an embodiment of the present invention. The pressure delivery device is delivered to the impermeable film located at a tissue site; 0 2 8 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , Figure 29 illustrates a flow chart of a method for performing decompression tissue treatment on a tissue site in accordance with an embodiment of the present invention; Figure 30 illustrates a decompression tissue treatment of a tissue site in accordance with an embodiment of the present invention. FIG. 31 illustrates a flow chart of a method for performing decompression tissue treatment on a tissue site according to an embodiment of the present invention; FIG. 32 illustrates a decompression roller device according to an embodiment of the present invention. A cross-sectional elevational view of the reduced pressure delivery device including a hip prosthesis having a plurality of flow channels for applying a pressure reduction of 119637.doc -57 - 200808393 to a bone region surrounding the hip prosthesis; FIG. 32 is a cross-sectional elevational view of the prosthetic body shown in FIG. 32, the prosthesis having a second plurality of flow channels for transferring fluid to the bone region surrounding the prosthesis; FIG. A flow chart of a method for repairing a joint of a patient using reduced pressure tissue according to the present invention.
圖35圖解說明_種根據本發明—實施例之減壓輸送装置 之剖面正視圖,該減壓輸送裝置包含一矯形外科固^器 ,同形外科固疋器件具有複數個流動通道,以用於對 就鄰該矯形外科固定器件之骨㈣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 橋I外科固定器件具有第二複數個流動通道,以用於將流 體輸送至毗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38繪示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3 9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綠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,該主歧管包括一 環繞一主流動通道之撓性壁及位於該撓性壁中之複數個 孔; 圖49-50圖解說明一種根據本發明一實施例之減壓輸送 119637.doc -58 - 200808393 成一 系統之透視圖及俯視剖面圖,該減壓輸送系統農 體地連接至一減壓輸送管之主歧管; 、有 織部位之圖 圖5 1繪示與一辅助歧管一起應用於一骨骼組 40-50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】Figure 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 delivery device including an orthopedic fixation device having a plurality of flow channels for use in a pair The reduced pressure is applied to the bone (four) domain of the orthopedic fixation device; and FIG. 36 is a cross-sectional front view of the orthopedic fixation device of FIG. 35, the bridge I surgical fixation device has a second plurality of flow channels for use Flowing fluid to a bone region adjacent to the orthopedic fixation device; FIG. 37 illustrates a flow chart of a method for treating bone defects in bone using reduced pressure tissue therapy in accordance with an embodiment of the present invention; A flowchart of a method for performing decompression tissue treatment on a tissue site in accordance with an embodiment of the present invention; and FIG. 39 illustrates a method for performing decompression tissue treatment on a tissue site in accordance with an embodiment of the present invention flow chart. 40-48 are various views of a reduced pressure delivery system in accordance with an embodiment of the present invention, the reduced pressure delivery system having a main manifold including a flexible wall surrounding a main flow channel and located therein A plurality of apertures in a flexible wall; Figures 49-50 illustrate a perspective view and a top cross-sectional view of a reduced pressure delivery system 119637.doc-58 - 200808393 in accordance with an embodiment of the present invention, the reduced pressure delivery system Connected to a main manifold of a reduced pressure delivery tube; Figure 513 of the woven portion shows a perspective view of a primary manifold shown in conjunction with an auxiliary manifold for a bone group 40-50; and Figure 52 A schematic diagram of a reduced pressure delivery system having a valve fluidly coupled to a second conduit in accordance with an embodiment of the present invention is illustrated. [Main component symbol description]
211 減壓輸送裝置或翼狀歧管 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 第一管腔 265 第二管腔 271 水平間隔件 311 減壓輸送裝置或翼狀歧管 119637.doc -59- 200808393211 decompression delivery device or wing manifold 213 flex 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 tube 263 first lumen 265 second lumen 271 horizontal spacer 311 decompression delivery device or wing manifold 119637.doc -59- 200808393
313 撓性障壁 315 凸脊部分 319 翼狀部分 323 拱形通道 327 蜂巢狀材料 329 分佈表面 330 周邊表面 341 減壓輸送管 343 遠端孔口 355 近端孔口 359 管腔或通路 371 減壓輸送裝置 373 減壓輸送管 375 延伸部分 377 遠端 381 切口 383 凸肩 385 突起物 387 内表面 391 流動通道 411 減壓輸送裝置 413 組織部位 415 人體骨骼 419 減壓輸送管 119637.doc 60- 200808393313 Flex barrier 315 ridge portion 319 wing portion 323 arched channel 327 honeycomb material 329 distribution surface 330 peripheral surface 341 decompression delivery tube 343 distal orifice 355 proximal orifice 359 lumen or passage 371 reduced pressure delivery Device 373 decompression delivery tube 375 extension 377 distal end 381 incision 383 shoulder 385 protrusion 387 inner surface 391 flow channel 411 decompression delivery device 413 tissue site 415 human bone 419 decompression delivery tube 119637.doc 60- 200808393
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 過濾器 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 200808393421 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 wire 731 fracture site 733 patient bone 735 skin 739 soft tissue 743 conical distal end 751 pathway 761 decompression delivery device 765 flexible barrier 767 honeycomb material 769 decompression delivery tube 811 decompression delivery system 119637.doc 61 200808393
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 標誌 119637.doc 62 200808393821 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 tube 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 plastic seal 981 mark 119637.doc 62 200808393
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- 200808393985 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- 200808393
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- 2008083931547 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 porous coating 1741 flow channel 1743 main feed line 1745 connection 埠 1747 lateral branch line 1751 decompression delivery line 1753 decompression delivery source 1761 flow channel 1765 connection 埠 1771 fluid delivery tube 119637.doc -64- 200808393
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 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 辅助管腔 2231 119637.doc -65 200808393 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 2161 First conduit 2163 Second conduit 2171 Headspace 2211 Reduced pressure delivery system 2215 Main manifold 2217 Pressure relief tube 2223 Central lumen 2225 Secondary lumen 2231 119637.doc -65 200808393 2241 Top gap 2321 Auxiliary manifold 2411 Reduced pressure delivery system 2415 manifold 2419 first conduit 2423 second conduit 2429 decompression source 2435 outlet
2439 閥門 2453 控制器2439 valve 2453 controller
119637.doc 66-119637.doc 66-
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US11/717,892 US8029498B2 (en) | 2006-03-14 | 2007-03-13 | System for percutaneously administering reduced pressure treatment using balloon dissection |
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