TW200808396A - System and method for purging a reduced pressure apparatus during the administration of reduced pressure treatment - Google Patents

System and method for purging a reduced pressure apparatus during the administration of reduced pressure treatment Download PDF

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TW200808396A
TW200808396A TW96112901A TW96112901A TW200808396A TW 200808396 A TW200808396 A TW 200808396A TW 96112901 A TW96112901 A TW 96112901A TW 96112901 A TW96112901 A TW 96112901A TW 200808396 A TW200808396 A TW 200808396A
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Taiwan
Prior art keywords
tissue
reduced pressure
manifold
fluid
tissue site
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TW96112901A
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Chinese (zh)
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TWI346547B (en
Inventor
Royce W Johnson
Jonathan Paul Jaeb
Larry D Swain
Douglas A Cornet
Michael Manwaring
Jonathan Kagan
Keith Patrick Heaton
Christopher Brian Locke
Timothy Mark Robinson
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Kci Licensing Inc
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Priority claimed from US11/702,822 external-priority patent/US7651484B2/en
Priority claimed from US11/717,893 external-priority patent/US8235939B2/en
Application filed by Kci Licensing Inc filed Critical Kci Licensing Inc
Publication of TW200808396A publication Critical patent/TW200808396A/en
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Publication of TWI346547B publication Critical patent/TWI346547B/en

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Abstract

A reduced pressure delivery system for applying a reduced pressure to a tissue site is provided. The system includes a manifold having a plurality of flow channels. The manifold is configured to be placed adjacent the tissue site. A first conduit is in fluid communication with the flow channels of the manifold to deliver a reduced pressure to the flow channels. A second conduit is in fluid communication with the flow channels of the manifold and is operably connected to a valve. The valve selectively purges the second conduit with ambient air when the valve is positioned in an open position, and a controller is operably connected to the valve to place the valve in the open position for a selected amount of time at a selected interval during delivery of reduced pressure through the first conduit.

Description

200808396 九、發明說明: 【發明所屬之技術領域】 本發明概言之係關於一種用於促進組織生長之系統及方 法,且更具體而言,係關於一種用於對一 了 組織部位應用減 壓組織治療之系統。 【先前技術】200808396 IX. DESCRIPTION OF THE INVENTION: TECHNICAL FIELD OF THE INVENTION The present invention relates generally to a system and method for promoting tissue growth, and more particularly to a method for applying decompression to a tissue site Tissue treatment system. [Prior Art]

人們正在逐漸使用減壓治療來促進如若不使用減壓治療 會癒合很慢或者不癒合之軟組織傷口之傷口癒合。通常, 藉由一開放孔發泡體對傷口部位應用減低之壓力,該開放 孔發泡體用作一歧管來分佈減低之麼力。該開放孔發泡體 之尺寸適合於現有之傷口,與傷口相接觸,並隨後隨著傷 口開始癒合且變小而定期地更換成變 長入發泡體之孔中之組織量最小化,需要頻繁地更= 孔發泡體。在移除發泡體期間’正在生長之大量組織可使 患者感到疼痛。 減壓治療通常應用於不癒合性開放傷。在某些情形中, 所醫治之組織係皮下組織,且在其他情形中,組織位 於皮膚組織内或上面。在傳統上,減壓治療—直主要應用 於軟、、且、織減壓治療通常尚未用力治療封閉之深組織傷 口乃因難以接近此等傷口。另外,減壓治療尚未與醫治 月骼缺損或促進骨骼生長結合使用,此主要歸因於難以接 近月骼之問題。藉由外科手術暴露出骨骼來應用減壓治療 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/σ療之器件及系統之發展幾乎未超出開放孔發泡體 119763.doc 200808396 件用手使開放孔發泡體之形狀適合於傷口部位並隨後在 一減壓治療週期之後將其移除。 【發明内容】 本發明之系統及方法即解決現有傷口醫治系統及方法所 存在之問題。根據本發明之一實施例,提供一種減壓輸送 系統,以用於對一組織部位應用減低之壓力。該減壓輸送 糸、充匕括一具有複數個流動通道之歧管。該歧管經構造以 毗鄰該組織部位放置。一第一導管與該歧管之該等流動通 道流體連通,以將一減低之壓力輸送至該等流動通道。一 第二導管與該歧管之該等流動通道流體連通,並以可操作 方式連接至一閥門。當將該閥門定位於一開啟位置時,該 閥門選擇性地以周圍空間來清潔該第二導管,且一控制器 以可操作方式連接至該閥門,以在經由該第一導管輸送減 低之壓力期間,以一所選間隔將該閥門置於該開啟位置達 一所選之時間量。 根據本發明之另一實施例,提供一種對一組織部位施行 一減壓組織治療之方法。該方法包括··將一具有複數個流 動通道之歧管毗鄰該組織部位定位,以使該等流動通道之 至少一部分與該組織部位流體連通。經由一第一導管將一 減低之壓力應用至該組織部位,該第一導管具有與該等流 動通道流體連通之至少一個出口,並藉由經由一第二導管 將一流體輸送至一緊靠該第一導管之該至少一個出口之區 域’來清潔該第一導管中或附近之阻塞物。 根據本發明之又一實施例,提供一種對一組織部位施行 119763.doc 200808396 減壓組織冶療之方法。該方法包括:將一具有複數個流 動通道之歧管毗鄰該組織部位定位,以使該等流動通道之 至少 σ卩刀與5亥組織部位流體連通。經由一第一導管將一 減低之壓力應用至該組織部位,該第—導管具有與該等流 動通道流體連通之至少一個出口。開啟一與一第二導管以 可操作方式相關聯之閥門,以使該導管暴露於一流體,該 流體處於-大於該減低之壓力之壓力。以一所選間隔將該 閥門開啟一所選之時間量,以容許經由該第二導管來輸送 流體,從而幫助清除該第一導管内或附近之阻塞物。 參照附圖及下文詳細㈣,本發明之其他㈣、特徵及 優點將變得一目了然。 【實施方式】 下文將參照附圖對較佳實施例進行詳細說明,該等附圖 構成本發明之-部分且其中以圖解方式顯示可實施本發明 之具體較佳實施例。為使熟習此項技術者能夠實踐本發 明,足夠詳細地闡述該等實施例,且應瞭解,亦可利用其 他實施例,且可在邏輯結構、機械、電氣及化學方面作/出 改動’此並不背離本發明之精神或範圍。為避免闞述並非 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。因此,不應將 下文詳細說明視為具有限定意義,且本發明之範圍僅:隨 附申請專利範圍來界定。 4 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^ 119763.doc 200808396 更具體而言,大多數彈性體具有大於1〇〇%之伸長率及明 顯之回彈性程度。材料之回彈性係指材料能夠自彈性變妒 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,異丁婦橡膠’乙烯丙晞橡膠,乙稀丙婦二婦單體^ 膠’氯磺化聚乙烯,聚硫橡膠,聚氨基曱酸酯 氧。 本文中所用術語”撓性"係指物體或材料能夠彎曲或撓 曲。彈性材料通常呈撓性,但在本文中所提及之撓性材料 並非一定將所選材料僅限定為彈性體。將術語”撓性"與本 發明之材料或減壓輸送裝置結合使用大體係指該材料能夠 貼覆或緊密地匹配一組織部位之形狀。舉例而言,用於治 療骨絡缺損之減麼輸送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,作亦 • 彳包含任何其他可流動之材料,包括但不限於凝膠、膠體 或泡沫。 本文中所用之術語"不渗透性"總體上係指薄膜、覆蓋物 •《其他物質阻擋或減慢液體或氣體透過之能力。可使用不 料性來指代能阻擋液體透過、料允許氣體透過薄膜之 覆盍物、薄片或其他薄膜。儘管不渗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 低於任何特定工業標準不滲透性量測值,例如水蒸氣傳遞 119763.doc 200808396 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 it之流動通道或通路,以改良向歧管周圍組織區域提供或 自該組織區域移除之流體之分佈。歧管之實例可包括但不 限於具有經設置以形成流動通道之結構元件之裝置、蜂巢 狀發/包體(例如開放孔發泡體)、多孔組織收集裝置、及包 ® 含或凝固後包含流動通道之液體、凝膠及泡沫。 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,該減低之壓力可小於組織部位處組織之靜水壓力。儘 管可使用術語,,真空”及”負壓力”來描述施加至組織部位之 壓力,然而施加至組織部位之實際壓力可明顯低於通常與 _ 純粹真空相關聯之壓力。減低之壓力可在開始時在管及組 織部位之區域中產生流體流動。隨著組織部位周圍之靜水 壓力接近所需之減低之壓力,該流動可能會減慢,且隨後 , 保持減低之壓力。除非另外指明外,本文中所述之壓力值 _ 皆係表壓。 本文中所用之術語"支架”係指用於増強或促進細胞生長 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 H9763.doc -10- 200808396 成。可使用支架作為根據太寺έ 文所逑實施例之歧管,以對組 織部位施行減壓組織治療。 本文中所用之術語"板鑰邱你"Λ 辦4位係指位於任一組織上面或 以内之傷口或缺損,包括徊^: 1 t 匕枯仁不限於骨骼組織、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、或勃帶。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 促進該等區域巾額外組織之生長。舉例而言,可在某些組 織區域中使用減職織治絲生長額外之組織,然後可收 穫該額外之組織並將其移植至另一組織部位上。 參見圖1至圖5,一種根據本發明原理之減壓輸送裝置或 翼狀歧管211包括一具有凸脊部分215之撓性障壁213以及 一對翼狀部分219。每一翼狀部分219皆沿凸脊部分215之 對置側疋位。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。儘 管凸脊部分215可在翼狀歧管211上居中定位,以使各翼狀 部分219之寬度相等,然而凸脊部分215亦可如在圖1_5中 所示偏置,從而使其中一個翼狀部分219寬於另一翼狀部 分219。如果將翼狀歧管211與骨骼再生或醫治結合使用且 較寬之翼狀歧管211將纏繞於附連至骨骼上之固定硬體周 圍,則其中一個翼狀部分219之額外寬度可能特別有用。 撓性障壁213較佳由例如聚矽氧聚合物等彈性材料製 成。適合之聚矽氧聚合物之一實例包括由位於Carpinteria,Decompression therapy is increasingly being used to promote wound healing in soft tissue wounds that heal very slowly or not heal without the use of decompression therapy. Typically, the reduced pressure is applied to the wound site by an open-cell foam that acts as a manifold to distribute the reduced force. The open-cell foam is sized to be suitable for existing wounds, in contact with the wound, and then periodically replaced with the amount of tissue that is periodically elongated into the pores of the foam as the wound begins to heal and becomes smaller, requiring Frequently more = hole foam. The large amount of tissue that is growing during the removal of the foam can cause pain to the patient. Decompression therapy is usually applied to non-healing open wounds. In some cases, the tissue being treated is subcutaneous tissue, and in other instances, the tissue is located in or on the skin tissue. Traditionally, decompression therapy—mainly applied to soft, and lytic decompression treatments, has not been used to treat closed deep tissue wounds because it is difficult to access such wounds. In addition, decompression therapy has not been used in conjunction with the treatment of skeletal skeletal defects or the promotion of bone growth, which is mainly due to the difficulty of accessing the iliac. Applying decompression therapy by surgically exposing the bone may cause more problems than the problem it solves. Finally, the development of devices and systems for the application of decompression/sigma therapy has barely exceeded the open-cell foam 119763.doc 200808396. The shape of the open-cell foam is adapted to the wound site by hand and subsequently treated under reduced pressure. Remove it after the cycle. SUMMARY OF THE INVENTION The system and method of the present invention addresses the problems associated with prior wound healing systems and methods. In accordance with an embodiment of the present invention, a reduced pressure delivery system is provided for applying a reduced pressure to a tissue site. The reduced pressure delivery port comprises a manifold having a plurality of flow channels. The manifold is configured to be placed adjacent to the tissue site. A first conduit is in fluid communication with the flow passages of the manifold to deliver a reduced pressure to the flow passages. A second conduit is in fluid communication with the flow passages of the manifold and is operatively coupled to a valve. The valve selectively cleans the second conduit with a surrounding space when the valve is positioned in an open position, and a controller is operatively coupled to the valve to deliver reduced pressure via the first conduit The valve is placed in the open position for a selected amount of time at a selected interval. In accordance with another embodiment of the present invention, a method of administering a reduced pressure tissue treatment to a tissue site is provided. The method includes positioning a manifold having a plurality of flow channels adjacent the tissue site such that at least a portion of the flow channels are in fluid communication with the tissue site. Applying a reduced pressure to the tissue site via a first conduit having at least one outlet in fluid communication with the flow channels and delivering a fluid to the abutment via a second conduit An area of the at least one outlet of the first conduit to clean the obstruction in or near the first conduit. According to still another embodiment of the present invention, there is provided a method of performing 119763.doc 200808396 decompression tissue treatment on a tissue site. The method includes positioning a manifold having a plurality of flow channels adjacent the tissue site such that at least a σ file of the flow channels is in fluid communication with a 5 kel portion. A reduced pressure is applied to the tissue site via a first conduit having at least one outlet in fluid communication with the flow channels. An operatively associated valve is coupled to the second conduit to expose the conduit to a fluid at a pressure greater than the reduced pressure. The valve is opened for a selected amount of time at a selected interval to permit fluid to be delivered via the second conduit to assist in clearing obstructions in or near the first conduit. Other (four), features, and advantages of the present invention will become apparent from the accompanying drawings. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described in detail with reference to the accompanying drawings. The embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is understood that other embodiments may be utilized and may be modified in the logical, mechanical, electrical, and chemical aspects. The spirit or scope of the invention is not departed. In order to avoid obscuring the details required to enable the skilled artisan to practice the invention, this description may omit certain information that is known to those skilled in the art. Therefore, the following detailed description is not to be considered as limiting, and the scope of the invention 4 The term "elasticity" as used herein means having the properties of an elastomer. The term 'elastomer' large system refers to a polymer material having the same properties as rubber^119763.doc 200808396 More specifically, most elastomers It has an elongation of more than 1% and a significant degree of resilience. The resilience of a material means that the material recovers from elastic deformation. Examples of the elastomer may include, but are not limited to, natural rubber, polyisophthalene 'styrene butadiene rubber', chloroprene rubber, polybutadiene, nitrile rubber, isobutyl rubber, ethylene propylene rubber, Ethylene, propylene, women and women monomer ^ glue 'chlorosulfonated polyethylene, polysulfide rubber, polyamino phthalate oxygen. The term "flexible" as used herein refers to an object or material that is capable of bending or flexing. The elastic material is generally flexible, but the flexible materials referred to herein do not necessarily define the selected material only as an elastomer. The use of the term "flexible" in conjunction with a material of the invention or a reduced pressure delivery device means that the material is capable of conforming or closely matching the shape of a tissue site. For example, the flexible nature of the delivery device for treating a bone defect allows the device to wrap or wrap around a portion of the bone that has a defect. The term "fluid" as used herein generally refers to a gas or liquid, and also includes any other flowable material including, but not limited to, a gel, a gel or a foam. The term "impervious" as used herein generally refers to films, coverings, and the ability of other materials to block or slow the penetration of liquids or gases. Unexpected properties can be used to refer to coverings, sheets or other films that block the passage of liquids and allow gases to pass through 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 impervious film is above or below any particular industry standard impermeability measurement, such as the specific value of water vapor transmission 119763.doc 200808396 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 flow passages or passages for each other to improve the distribution of fluid supplied to or removed from the tissue region surrounding the manifold. Examples of manifolds can include, but are not limited to, devices having structural elements configured to form flow channels, honeycomb hair/packages (eg, open cell foams), porous tissue collection devices, and packages containing or solidified Liquid, gel and foam in the flow channel. As used herein, the term "reduced pressure" means a pressure that is less than the surrounding pressure at the tissue site being treated. In most cases, the reduced pressure will be less than the environmental pressure at the patient's location. Optionally, the reduced pressure can be less than the hydrostatic pressure of the tissue at the tissue site. Although the terms vacuum, and "negative pressure" can be used to describe the pressure applied to the tissue site, the actual pressure applied to the tissue site can be significant. Below the pressure normally associated with _ pure vacuum. The reduced pressure creates fluid flow in the area of the tube and tissue at the beginning. As the hydrostatic pressure around the tissue site approaches the desired reduced pressure, the flow may slow down and, subsequently, maintain the reduced pressure. Unless otherwise stated, the pressure values _ described herein are gauge pressures. The term "stent" as used herein refers to a substance or structure that is used to reinforce or promote cell growth and/or tissue formation. The scaffold is typically a three-dimensional porous structure that provides a template for cell growth. Coated with or consisting of cells, growth factors or other nutrient composition for promoting cell growth, H9763.doc -10- 200808396. The scaffold can be used as a manifold according to the embodiment of the Taisho , , Decompression tissue treatment is used. The term "plate key Qiu You" in this article refers to a wound or defect located above or within any tissue, including 徊^: 1 t 匕 仁 is not limited to skeletal tissue , adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendon, or belch. The term "organizational site" may further refer to the region of any organization that may not be injured or have Defects, but want to enhance or promote the growth of additional tissue in these regional tissues. For example, in some tissue areas, the use of reduced-texture silk growth additional groups can be used in some tissue areas. The additional tissue can then be harvested and transplanted to another tissue site. Referring to Figures 1 through 5, a reduced pressure delivery device or wing manifold 211 in accordance with the principles of the present invention includes a ridge portion 215 a flexible barrier 213 and a pair of wing portions 219. Each wing portion 219 is clamped along an opposite side of the ridge portion 215. The ridge portion 215 forms an arcuate passage 223 through which the arcuate passage 223 can extend The entire length of the wing manifold 211 may not extend. Although the ridge portions 215 may be centrally positioned on the wing manifold 211 such that the widths of the wing portions 219 are equal, the ridge portions 215 may also be as in Figure 1-5. The offset is shown such that one of the wing portions 219 is wider than the other wing portion 219. If the wing manifold 211 is used in conjunction with bone regeneration or healing and the wider wing manifold 211 will be wrapped around the attachment The extra width of one of the wing portions 219 may be particularly useful around the fixed hardware on the bone. The flexible barrier 213 is preferably made of an elastic material such as a polyoxyl polymer. An example includes a bit Carpinteria,

California之Nusil Technologies公司製造之MED-6015。然 119763.doc -11- 200808396 而,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,以增強挽 性背襯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中之厚 度。右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 Teehn〇1〇gies公司出售之med_ 1011。撓性背襯227較佳由聚酯針織織物製成,例如由位 於Tempe,ArizonaiC.R· Bard公司所製造之6〇13製 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213 二者可不滲透液體、空氣及其他氣體。 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酯、聚富馬酸酯、及capralact〇ne。撓 性P早壁213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 I19763.doc -12- 200808396 罐酸飼、膠原、、PLA/PGA、珊蝴經基鱗灰石、碳酸鹽、或 經處理之同種異體移植材料。較佳地,該支架材料將具有 高的空隙比例(即高的空氣含量)。 在一實施例中,可將撓性背襯227以黏合方式固定至撓 ^ 性P早壁213之表面上。若使用聚矽氧聚合物來形成撓性障 壁213,則亦可使用聚矽氧黏合劑將撓性背襯固定至撓 性P早壁213上。儘管當將撓性背襯227表面結合至撓性背襯 213上時黏合劑係較佳之固定方法,然而亦可使用任何適 響 宜之固定方法。 撓性障壁2 1 3包含複數個在撓性障壁2〗3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η)上 固定有突起物231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相同之形 φ 狀或尺寸;事實上,該等突起物231可包括不同形狀及尺 寸之隨機混合。因此,每一突起物231自撓性障壁213上伸 出之距離可各異,但亦可在該複數個突起物23丨中相一 * 致。 各突起物231在撓性障壁213上之佈置在該等突起物之間 形成複數個流動通道233。當該等突起物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 119763.doc -13- 200808396 及流動特性。 如在圖5中所示,一減壓輸送管241位於拱形通道223内 並口疋至撓性障壁213上。減壓輸送管241可僅固定至撓性 P早壁213或撓性背襯227上,或者管241可同時固定至撓性 尸早土 213與挽性背觀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,但管較佳芩位成使 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之縱向轴線以小於九十(9〇)度之 肖度定向之平面切割管241,將遠端孔口 243製作成橢圓形 或印圓形形狀。儘管孔口 243亦可為圓形,然而孔口 243之 橢圓形形狀會增強與形成於各突起物23!間之流動通道233 之流體連通。 減壓輸送管241較佳由塗覆有paralyne之聚石夕氧或胺基甲 酸醋製成。然而,亦可使用任何醫療級管子材料來構造減 壓輸送管241。可塗覆該管之其他塗層包括肝素、抗凝企 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 25 1,以進一步增強減壓輸送 管241與流動通道233間之流體連通。減壓輸送管241可如 在圖1至圖5中所示僅沿拱形通道223之縱向長度之一部分 定位’或者另一選擇為,可沿拱形通道223之整個縱向長 119763.doc • 14 - 200808396 度疋位。若定位成使減壓輸送管241佔據拱形通道之整 個長度,則可對遠端孔口 243進行罩蓋,以使管24ι與流動 通道233間之所有流體連通皆經由排放開孔251進行。 減壓輸送管241進一步在管241之近端處包含一近端孔口 255。近端孔口 255經構造以與一減壓源相配合,在下文中 將參照圖9更詳細地說明該減壓源。圖丨至圖3、圖4八及圖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4B中所 示之雙官腔管261。雙管腔管261包含一第一管腔263及一 第二管腔265。使用雙管腔管會在減壓輸送管241之近端與 流動通道233之間提供分離之流體連通路徑。舉例而言, 可使用雙管腔管261來達成減壓源與沿第一管腔263之流動 通道233之間的連通。第二管腔265可用於將流體引入至流 動通道233内。該流體可係經過濾之空氣或其他氣體、抗 菌劑、抗病秦劑、細胞生長促進劑、沖洗流體、化學活性 流體或任何其他流體。若期望經由分離之流體連通路徑將 多種流體引入至流動通道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 及第二管腔263、265分離,從而使第一管腔263定位於第 二官腔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。舉例而言,當第一管腔263如在 圖4B中所示定位時,可提供類似於排放開孔251之排放開 119763.doc -15- 200808396 孔來達成與流動通道233之連通。^ 所示定位外 田弟二管腔如在圖4Β中 ,端Γ! 腔263可經由―類似於遠端孔口⑷之 通知孔口與流動通道233連通。另— 交其跡\ k擇為’可藉由一將 各g脸为離之垂直間隔件來使一一 A 成昼輸迗管中之多個管腔 並排疋位’或者可將該等管腔同心或同軸地定位。MED-6015 manufactured by Nusil Technologies of California. While 119763.doc -11- 200808396, it should be noted that the flexible barrier 213 can be made of any other biocompatible, flexible material. The flexible barrier 213 encloses a flexible backing 227 to enhance the strength and durability of the traction backing 213. The flexible barrier 213 enveloping the flexible backing 227 may have a thickness in the arcuate channel 223 that is less than the thickness in the wing portion. By using a polyoxyl polymer to form the flexible barrier 213 to the right, a poly-xylene adhesive can also be used to help bond the flexible backing 227. An example of a polyoxynoxy binder may include med 1011, also sold by the company Nusil Teehn〇1〇gies. The flexible backing 227 is preferably made of a polyester knit fabric, for example, 6 〇 13 manufactured by Tempe, Arizonai C. R. Bard. 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 213 are impermeable to liquids, air and other gases. The flexible barrier 213 and 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, polycarbonates, polyfumarates, and capralact〇ne. The flexible P early wall 213 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, I19763.doc -12- 200808396 tank acid, collagen, PLA/PGA, sulphate, carbonate, or treated allograft material. 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 flexible P early wall 213 in an adhesive manner. If a polysiloxane polymer is used to form the flexible barrier 213, the flexible backing can also be secured to the flexible P early wall 213 using a polyoxyxylene adhesive. Although the adhesive is a preferred method of attachment when the surface of the flexible backing 227 is bonded to the flexible backing 213, any suitable attachment method can be used. The flexible barrier 2 1 3 includes a plurality of protrusions 231 extending from the wing portion 219 on the surface of the flexible barrier 2 3-1. 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 at a different plane than the flexible backing η) The plane associated with the side of 231 is sufficient. In this regard, it is not even required that a particular protrusion 231 has the same shape or size as the other protrusions 231; in fact, the protrusions 231 may comprise a random mixture of different shapes and sizes. Therefore, the distance from each of the protrusions 231 from the flexible barrier 213 can be varied, but it can also be phased out in the plurality of protrusions 23丨. The projections 231 are disposed on the flexible barrier 213 to form a plurality of flow passages 233 between the projections. When the projections 231 have the same shape and size and are evenly spaced across the flexible barrier 213, the flow passages 233 formed between the projections 231 are equally uniform. The size, shape and spacing of the protrusions 231 can also be used to vary the size of the flow channel 233 119763.doc -13- 200808396 and flow characteristics. As shown in Fig. 5, a reduced pressure delivery tube 241 is located in the arcuate passage 223 and ported to the flexible barrier 213. The reduced pressure delivery tube 241 can be attached only to the flexible P early wall 213 or the flexible backing 227, or the tube 241 can be simultaneously secured to both the flexible cadaver 213 and the tractable back 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 is preferably clamped such that the distal aperture 243 is located at approximately the midpoint along the longitudinal length of the arcuate channel 223. The distal aperture 243 is preferably formed in an elliptical or circular shape by cutting the tube 241 along a plane oriented less than ninety (9 ft) degrees with respect to the longitudinal axis of the tube 241. Although the aperture 243 may also be circular, the elliptical shape of the aperture 243 enhances fluid communication with the flow passage 233 formed between the projections 23!. The reduced pressure delivery tube 241 is preferably made of poly-stone or urethane coated with paralyne. However, any medical grade tube material can be used to construct the reduced pressure delivery tube 241. Other coatings that can be applied to the tube include heparin, anticoagulant agents, anti-fibrinogen, anti-adherent agents, anti-prothrombin, and hydrophilic coatings. In one embodiment, as an alternative to or in addition to the distal aperture 243, the reduced pressure delivery tube 241 may also include a discharge opening or discharge orifice 25 positioned along the reduced pressure delivery tube 241. To further enhance the fluid communication between the reduced pressure delivery tube 241 and the flow channel 233. The reduced pressure delivery tube 241 can be positioned only partially along one of the longitudinal lengths of the arcuate channel 223 as shown in Figures 1 through 5 or alternatively can be along the entire longitudinal length of the arched passage 223 119763.doc • 14 - 200808396 degrees. If positioned such that the reduced pressure delivery tube 241 occupies the entire length of the arcuate passageway, the distal orifice 243 can be capped such that all fluid communication between the tube 241 and the flow passage 233 is via the discharge opening 251. The reduced pressure delivery tube 241 further includes a proximal aperture 255 at the proximal end of the tube 241. The proximal orifice 255 is configured to cooperate with a source of reduced pressure, which will be described in greater detail below with respect to Figure 9. The reduced pressure delivery tube 241 shown in Figures 3, 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 4B. The double lumen tube 261 includes a first lumen 263 and a second lumen 265. The use of a dual lumen tube provides a separate fluid communication path between the proximal end of the reduced pressure delivery tube 241 and the flow channel 233. For example, a dual lumen tube 261 can be used to achieve communication between the reduced pressure source and the flow channel 233 along the first lumen 263. The second lumen 265 can be used to introduce fluid into the flow channel 233. The fluid may be filtered air or other gas, an antibacterial agent, an anti-disease agent, a cell growth promoter, a flushing fluid, a chemically active fluid, or any other fluid. If it is desired to introduce a plurality of fluids into the flow channel 233 via separate fluid communication paths, the reduced pressure delivery tube can have more than two lumens. Still referring to Fig. 4B, a horizontal spacer 271 separates the first and second lumens 263, 265 of the reduced pressure delivery tube 261 such that the first lumen 263 is positioned above the second lumen 265. The relative positions of the first lumen and the second lumen 263, 265 may vary depending on how fluid communication is provided between the lumens 263, 265 and the flow channel 233. For example, when the first lumen 263 is positioned as shown in Figure 4B, a discharge opening 119763.doc -15-200808396 similar to the discharge opening 251 can be provided to achieve communication with the flow passage 233. ^ Positioned outside the Tiandi two lumens as shown in Figure 4, the end of the cavity 263 can communicate with the flow channel 233 via a notification orifice similar to the distal orifice (4). In addition, the trace of \k is selected as 'by allowing each g face to be separated from the vertical spacer to make the one-to-one 昼 昼 多个 并 ' ' ' ' ' 或者 或者 或者 或者The cavity is positioned concentrically or coaxially.

之=技術中之一般技術人員應易知,獨立流體連通路徑 =供W之方式來實現,包括如上文所述 ,、夕官腔管。另-選擇為’可藉由將一單管腔管固定 至另-單管腔管上、或者藉助㈣帶單個或多個管腔之單 獨、未m定之管來提供獨立之流體連通路徑。 若使用單獨之管來提供與流動通道233之單獨流體連通 路徑,凸脊部分215可包含多個拱形通道223,盆中每一個 ^個拱形通道223。另一選擇為,可擴大梹形通道223以 容納多個管。具有一與流體輸送管相分離之減塵輸送管減 壓輸送裳置之一實例將在下文中參照圖9進行更詳細說 明。 芩見圖6至圖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3 15之對 置側疋位。凸脊部分3 15形成一拱形通道323,拱形通道 323既可延伸過也可不延伸過翼狀歧管3 i丨之整個長度。儘 笞凸脊部分315可在翼狀歧管3Π上居中定位,以使各翼狀部 为319之覓度相專,然而凸脊部分315亦可如在圖6至圖8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 119763.doc -16 - 200808396 319。如果將翼狀歧管311與骨骼再生或醫治結合使用且較 寬之翼狀歧管311將纏繞於附連至骨骼上之固定硬體周 圍,則其中一個翼狀部分319之額外寬度可能特別有用。 一蜂巢狀材料327固定至撓性障壁313上,並可作為跨越 凸脊部分3 15及兩個翼狀部分319覆蓋撓性障壁313整個表 面之單片材料來提供。蜂巢狀材料327包括一毗鄰撓性障 壁313設置之固定表面(在圖6中不可見)、一與該固定表面 相對之分佈表面329、及複數個周邊表面33〇。 在一實施例中,撓性障壁313可類似於撓性障壁213,並 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Μ?, 或者將其留給使用者在治療場所進行組裝。撓性障壁Μ〕 及/或撓性背襯用作一不滲透性障壁來阻擋例如液體、空 氣或其他氣體等流體透過。 襯來支持路留处从也丨。〇 7 «It will be readily apparent to one of ordinary skill in the art that independent fluid communication paths are implemented in a manner that is W, including as described above, in the case of a chamber. Alternatively - the option can be provided to provide a separate fluid communication path by securing a single lumen tube to another single lumen tube, or by (iv) a single, undefined tube with a single or multiple lumens. 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 the arcuate channels 223. Alternatively, the dome-shaped passage 223 can be enlarged to accommodate a plurality of tubes. An example of a reduced-pressure delivery tube with a dust-removing delivery tube separate from the fluid delivery tube will be described in more detail below with reference to FIG. Referring to Figures 6-8, a reduced pressure delivery device or wing manifold 311 in accordance with the principles of the present invention includes a flexible barrier 313 having a ridge portion 315 and a pair of wing portions 319. Each wing portion 319 is clamped along the opposite side of the ridge portion 3 15 . The ridge portion 3 15 defines an arcuate passage 323 that may or may not extend over the entire length of the wing manifold 3 i. The ridge portions 315 can be centrally positioned on the wing manifolds 3 such that the wings are 319 degrees apart, but the ridge portions 315 can also be offset as shown in FIGS. 6-8. Thus, one of the wing portions 319 is wider than the other wing portion 119763.doc -16 - 200808396 319. The extra width of one of the wing portions 319 may be particularly useful if the wing manifold 311 is used in conjunction with bone regeneration or healing and the wider wing manifold 311 will wrap around a fixed hardware attached to the bone. . A honeycomb material 327 is secured to the flexible barrier 313 and is provided as a single piece of material that covers the entire surface of the flexible barrier 313 across the ridge portion 3 15 and the two wing portions 319. The honeycomb material 327 includes a fixed surface (not visible in Fig. 6) disposed adjacent to the flexible barrier 313, a distribution surface 329 opposite the fixed surface, and a plurality of peripheral surfaces 33A. In an embodiment, the flexible barrier 313 can be similar to the flexible barrier 213 and includes a flexible backing. 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 can be secured by any other suitable fastening method, or It is left to the user for assembly at the treatment site. The flexible barrier 及 and/or the flexible backing acts as an impervious barrier to block the passage of fluids such as liquids, air or other gases. Lining to support the road to stay from the 丨. 〇 7 «

壁3 13所述之凸脊部分及翼狀部分。 在實施例中,彳不以分離方式提供捷性障壁及捷性背 整體障壁 性部分。 過,從而 材料327 - 撓性障壁313較佳由例如聚石夕氧聚合The ridge portion and the wing portion of the wall 3 13 . In an embodiment, the 彳 does not provide a sturdy barrier and a sinusal integral barrier. Then, the material 327 - the flexible barrier 313 is preferably polymerized by, for example, polysulfide

119763.doc 吵虱聚合物等彈性材料製 實例包括由位於Carpinteria, -17- 200808396119763.doc Arbitrarily made of elastic materials such as polymers, examples include by Carpinteria, -17- 200808396

California 之 Nusil Technologies公司製造之MED-6015。然 而,應注意,撓性栅攔3 13可由任何其他生物相容性、撓 性材料製成。若撓性障壁包封或以其他方式包含一撓性背 襯,則撓性背襯較佳由聚酯針織織物製成,例如由位於 Ternpe,Arizona之C.R. Bard公司所製造之Bard 6013製成。 然而,撓性背襯227可由任何能增強撓性柵欄313之強度及 耐久性之生物相容性、撓性材料製成。 在一實施例中,蜂巢狀材料327係一開放孔式、網狀聚 醚胺基曱酸酯發泡體,其孔隙尺寸介於約400-600微米範 圍内。此種發泡體之一實例可包含由位於San Antonio, Texas之Kinetic Concepts公司製造之GranuFoam。蜂巢狀材 料328亦可係紗布、氈墊、或任何其他能在三個維上藉由 複數個通道提供流體連通之生物相容性材料。 蜂巢狀材料327主要係一種”開放孔式”材料,其包含流 體連接至毗鄰孔之複數個孔。藉由蜂巢狀材料327之”開放 孔”在該等”開放孔”之間形成複數個流動通道。該等流動 通道能夠在蜂巢狀材料327中具有開放孔之該整個部分中 達成流體連通。該等胞及流動通道可具有一致之形狀及尺 寸,或者可包含圖案化或隨機之形狀及尺寸變化。蜂巢狀 材料327中孔之尺寸及形狀之變化會引起流動通道之變 化,且此等特性可用於改變流過蜂巢狀材料327之流體之 流動特性。蜂巢狀材料327可進一步包括含有”封閉孔”之 部分。蜂巢狀材料327中之封閉孔部分包含複數個孔,該 等孔中之大多數不流體連接至毗鄰孔。在上文中將一封閉 119763.doc -18 - 200808396 孔部分之一實例描述為一可代替撓性障壁313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33〇。 撓性障壁3 13及蜂巢狀材料327亦可由在使用減壓輸送裝 置311之後不必自患者體内移出之生物可再吸收性材料製 成適且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 架,或者可將一支架材料與撓性障壁313、撓性背襯327及/ 或蜂巢狀材料327結合使用來促進細胞生長。適宜之支架 材料可包括但不限於磷酸鈣、膠原、pLA/pGA、珊瑚羥基 磷灰石、碳酸鹽、或經處理之同種異體移植材料。^佳 地該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。減壓輸送管341亦可固定至蜂巢狀材料上, 或者在僅存在蜂巢狀材料327之情況下,減壓輸送管341可 僅固疋至蜂巢狀材料327上。減壓輸送管341在管Mi之遠 端處包含一遠端孔口 343,其類似於圖5中之遠端孔口 M3。減壓輸送管341可定位成使遠端孔口 343沿拱形通道 3位於任一點處,但較佳沿拱形通道323之縱向長度定位 :大約中點處。杈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製作成擴圓形或印圓形形狀。儘管該孔口亦可為圓 119763.doc -19- 200808396 形,然而孔口之橢圓形形狀會增強與蜂巢狀材料奶中流 動通道之流體連通。 在-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 (未暴員示)。作為對遠端 孔口 343之替代或者除遠端孔σ 343之外,還沿管⑷佈置 排放開孔H步增強減屢輸送管⑷與流動通道間之 流體連通。如前面所述,減壓輸送#341可僅沿拱形通道 323之縱向長度之—部分定位,或者另—選擇為,可沿供 形通道323之整個縱向長度定位。若定位成使減壓輸送管 佔據整個拱形通道323,則可對遠端孔口 343進行罩 盍,以使官341與流動通道間之所有流體連通皆經由排放 開孔進行。 車乂仏地,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,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 疋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 連接至挽性障壁3 13之凸脊部分3 15。 減壓輸送官341進一步在管341之近端處包含一近端孔口 355。近端孔口 355經構造以與一減壓源相配合,在下文中 將參照圖9更詳細地說明該減壓源。圖6至圖8中所示之減 壓輸送管341僅包含單個管腔或通路359。然而,可使減壓 輸迗官341包含多個管腔,例如前面參照圖4Β所述之多個 官腔。如前面所述,使用一多管腔管會在減壓輸送管341 119763.doc 200808396 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2 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3 83之切口 381。複數個突起物385設置 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1至圖5所述之突起物。減壓輸送裝置 371特別適用於對能夠接納於切口 381内之結締組織應用減 低之壓力及在結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371治療之組織之非限定性實例。 參見圖9,使用一類似於本文所述其他減壓輸送裝置之 減壓輸送裝置411對一組織部位413(例如患者之人體骨路 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。進一步據認為,可使用減壓組織治療來 改善骨髓炎之恢復。該治療可進一步用於提高患骨髓炎之 患者之局部骨骼密度。最後,減壓組織治療可用於加速及 改善例如臀部植入體、膝蓋植入體、及固定器件等整形外 科植入體之 〇seointegration。 119763.doc -21- 200808396 仍參見圖9 ’減壓輸送裝置411包括一減壓輸送管4丨9, 減壓輸送管419具有一流體連接至一減壓源427之近端 421。減壓源427係一幫浦或任何其他能夠經由減壓輸送管 419及與減壓輸送裝置411相關聯之複數個流動通道對組織 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413佈置來達成,在該特定實例中,此涉及到圍繞骨骼 415中之空隙缺損429纏繞翼狀部分。減壓輸送裝置411可 藉由外科手術或經過皮膚插入。當經過皮膚插入時,減壓 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 前所形成之常見組織。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。 仍參見圖9,一流體輸送管43 1可在一遠端處流體連接至 減壓輸送裝置411之流動通道。流體輸送管43丨包括一流體 連接至一流體輸送源433之近端432。若正輸送至組織部位 之流體係空氣,則較佳藉由一能夠過濾小至〇 22 μηι之微 粒之過濾器434來過濾空氣,藉以對空氣進行淨化及殺 119763.doc -22· 200808396 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。流體輸送 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, 減壓輸送管43 1較佳穿過一穿透患者皮膚組織之無菌插入 護套插入。 籲 一壓力感測器43 5可藉由可操作方式連接至流體輸送管 431 ’以指示流體輸送管431是否被血液或其他體液堵塞。 壓力感測器435可藉由可操作方式連接至流體輸送源433以 k供回饋,藉以控制引入至組織部位413之流體量。亦可 將一止回閥(未顯示)以可操作方式連接於流體輸送管431之 遠端附近’以防止血液或其他體液進入流體輸送管43 1。 減壓輸送管419及流體輸送管4 3丨所提供之獨立流體連通 # 路徑可藉由諸多種不同之方式來達成,包括如前面參照圖 4B所述提供單個多管腔管。此項技術中之一般技術者將 知,若使用一多管腔管,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419中之一 .特定官腔相關聯。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、抗凝血劑、抗纖維蛋白原、抗附著劑、抗凝血酶原、 及親水性塗層。 119763.doc -23- 200808396 ♦圖1 Gi圖19 ’試驗已證明當對骨n織應用減壓組 、哉療時’會得到正面之效果。在-特定試驗中,對數只 兔子之頭月應用減壓組織治療,以確定其對於骨絡生長及 放果該測试之具體目標係發現減壓組織治療對於 在頭月上沒有缺損或損傷之兔子之效果、減壓組織治療對 於在頭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一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。 土L數量 —_測試方案__ ^上上無缺損,藉由蜂巢狀發泡體(GranuFoam) 在元好之骨膜頂上應用減壓組織治療(RPTT)達6 天’隨後立即收穫組織____ 頭骨上無缺損;在不應用減壓組織治療(RPT 情況下在完好之骨膜頂上放置蜂巢狀發泡體 (GranuFoam)達6天,隨後立即收穫組織MED-6015 manufactured by Nusil Technologies of California. However, it should be noted that the flexible barrier 3 13 can be made of any other biocompatible, flexible material. If the flexible barrier encloses or otherwise comprises a flexible backing, the flexible backing is preferably made of a polyester knit fabric, such as Bard 6013 manufactured by C. R. Bard, Inc. of Ternpe, Arizona. However, the flexible backing 227 can be made of any biocompatible, flexible material that enhances the strength and durability of the flexible fence 313. In one embodiment, the honeycomb material 327 is an open cell, reticulated polyether amine phthalate foam having a pore size in the range of from about 400 to about 600 microns. An example of such a foam may include GranuFoam manufactured by Kinetic Concepts, Inc. of San Antonio, Texas. Honeycomb material 328 can also be gauze, felt, 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 cell" material that includes a plurality of holes that are fluidly connected to adjacent holes. A plurality of flow channels are formed between the "open holes" by the "open holes" of the honeycomb material 327. The flow channels are capable of achieving fluid communication in the entire portion of the honeycomb material 327 having open pores. The cells 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 passages and these characteristics can be used to alter the flow characteristics of the fluid flowing through the honeycomb material 327. The honeycomb material 327 can further include a portion containing a "closed pore." 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 portion of the 119763.doc -18 - 200808396 hole portion is described above as a barrier layer that can replace the flexible barrier 313. Similarly, a closed hole portion can be selectively provided in the honeycomb material 327 to prevent fluid from passing through the peripheral surface 33 of the honeycomb material 327. The flexible barrier 3 13 and the honeycomb material 327 may 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 311. Suitable bioresorbable materials may include, but are not limited to, poly A polymeric blend of lactic 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 scaffold, or a scaffold material can be used in combination with the flexible barrier 313, the flexible backing 327, and/or the honeycomb material 327 to promote Cell growth. Suitable scaffold materials can include, but are not limited to, calcium phosphate, collagen, pLA/pGA, coral hydroxyapatite, carbonate, or treated allograft materials. Preferably, the 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 reduced pressure delivery tube 341 can also be secured to the honeycomb material, or in the presence of only the honeycomb material 327, the reduced pressure delivery tube 341 can be fixed only to the honeycomb material 327. The reduced pressure delivery tube 341 includes a distal opening 343 at the distal end of the tube Mi, which is similar to the distal opening M3 of FIG. The reduced pressure delivery tube 341 can be positioned such that the distal aperture 343 is located at any point along the arcuate channel 3, but is preferably positioned along the longitudinal length of the arcuate channel 323: approximately at the midpoint. The distal aperture 343 is formed into an expanded circular or circular shape by cutting the tube 341 along a plane oriented at an angle of less than ninety (90) degrees with respect to the longitudinal axis of the tube 341. Although the orifice may also be in the shape of a circle 119763.doc -19-200808396, the elliptical shape of the orifice enhances fluid communication with the flow passage in the honeycomb material milk. In the embodiment, the reduced pressure delivery tube 341 may also include a discharge opening or discharge orifice (not shown) similar to the discharge opening 251 of FIG. As an alternative to or in addition to the distal aperture 343, a discharge opening H is placed along the tube (4) to enhance fluid communication between the delivery tube (4) and the flow channel. As previously described, the reduced pressure delivery #341 can be positioned only partially along the longitudinal length of the arched passage 323, or alternatively, can be positioned along the entire longitudinal extent of the shaped passage 323. If positioned such that the reduced pressure conduit occupies the entire arcuate passage 323, the distal orifice 343 can be shrouded such that all fluid communication between the official 341 and the flow passage is through the discharge opening. At the rut, the honeycomb material 327 covers and directly contacts the reduced pressure delivery pipe 341. The honeycomb material 327 can be attached to the reduced pressure delivery tube, or the honeycomb material 327 can be attached only to the flexible barrier 313. If the pressure-reducing duct 341 is clamped so as to extend only to a point in the arched passage 323, the honeycomb material 327 may also be connected to the barrier barrier in a region of the arched passage 323 that does not include the reduced-pressure duct 341. 3 13 ridge portion 3 15 . The reduced pressure delivery officer 341 further includes a proximal aperture 355 at the proximal end of the tube 341. The proximal orifice 355 is configured to cooperate with a source of reduced pressure, which will be described in greater detail below with respect to Figure 9. The reduced pressure delivery tube 341 shown in Figures 6 through 8 contains only a single lumen or passage 359. However, the reduced pressure sputum 341 can include a plurality of lumens, such as the plurality of lumens previously described with reference to Figure 4A. 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 119763.doc 200808396 and the flow channel. The separate fluid communication paths may also be provided by separate tubes having single or multiple lumens in communication with the flow channels. 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 having an extension 375 at a distal end 377 of the reduced pressure delivery tube 373. The extension portion 375 is preferably arched to match the curvature of the reduced pressure delivery tube 373. The extension portion 375 can be formed by removing a portion of the reduced pressure delivery tube 373 at the distal end 377, thereby forming a slit 381 having a shoulder 3 83. A plurality of protrusions 385 are disposed on an inner surface 387 of the reduced pressure delivery tube 373 to form a plurality of flow channels 391 between the protrusions 385. The size, shape and spacing of the protrusions 385 can be similar to the protrusions described with reference to Figures 1 to 5. The reduced pressure delivery device 371 is particularly useful for applying reduced pressure to connective tissue that can be received within the incision 381 and regenerating tissue on connective tissue. The ligaments, tendons, and cartilage are non-limiting examples of tissue that can be treated by the reduced pressure delivery device 371. Referring to Figure 9, a reduced pressure tissue treatment is applied to a tissue site 413 (e.g., the patient's human bone 415) using a reduced pressure delivery device 411 similar to other reduced pressure delivery devices described herein. When used to promote bone tissue growth, decompression tissue treatment increases the rate of healing associated with fractures, non-union, voids, or other bone defects. It is further believed that reduced pressure tissue treatment can be used to improve the recovery of osteomyelitis. This treatment can be further used to increase the local bone density in patients with osteomyelitis. Finally, decompression tissue treatment can be used to accelerate and improve 〇seointegration of orthopedic implants such as hip implants, knee implants, and fixation devices. 119763.doc -21- 200808396 Still referring to Fig. 9', the reduced pressure delivery device 411 includes a reduced pressure delivery tube 419 having a proximal end 421 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 419 and the reduced pressure delivery device 411. Applying a reduced pressure to the tissue site 413 is accomplished by arranging the wing portion of the reduced pressure delivery device 411 adjacent the tissue site 413, which in this particular example involves wrapping the wing portion around the void defect 429 in the bone 415. . The reduced pressure delivery device 411 can be inserted by surgery or through the skin. When inserted through the skin, the reduced pressure delivery tube 419 is preferably inserted through a sterile insertion sheath that penetrates the skin tissue of the patient. 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 that is often formed before tissue repair 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 43 1 can be fluidly coupled to the flow passage of the reduced pressure delivery device 411 at a distal end. Fluid delivery tube 43A includes a proximal end 432 that is fluidly coupled to a fluid delivery source 433. If the system air is being delivered to the tissue site, the air is preferably filtered by a filter 434 capable of filtering microparticles as small as 22 μηι, thereby purifying the air and killing the bacteria 119763.doc-22 200808396. 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 clearance of the tissue site 413, thereby relieving or preventing clogging of the reduced pressure delivery tube 419. Fluid delivery 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 reduced pressure delivery tube 43 1 is preferably inserted through a sterile insertion sheath that penetrates the skin tissue of the patient. A pressure sensor 43 5 can be operatively coupled to the fluid delivery tube 431 ' to indicate whether the fluid delivery tube 431 is blocked by blood or other bodily fluids. Pressure sensor 435 can be operatively coupled to fluid delivery source 433 for feedback to control the amount of fluid introduced to tissue site 413. A check valve (not shown) may also be operatively coupled to the vicinity of the distal end of the fluid delivery tube 431 to prevent blood or other bodily fluids from entering the fluid delivery tube 43 1 . The independent fluid communication # path provided by the reduced pressure delivery tube 419 and the fluid delivery tube 43 can be achieved in a number of different ways, including providing a single multi-lumen tube as previously described with reference to Figure 4B. One of ordinary skill in the art will recognize that if a multi-lumen tube is used, the sensing, valves, and other components associated with the fluid delivery tube 431 can similarly be associated with one of the reduced pressure delivery tubes 419. Specific bureaucratic associations. Preferably, any lumen or body in fluid communication with the tissue site is coated with an anticoagulant to prevent clogging of body fluids or blood within the lumen or tube. Other coatings that can coat such lumens or tubes include, but are not limited to, heparin, anticoagulants, anti-fibrinogen, anti-adherents, anti-prothrombin, and hydrophilic coatings. 119763.doc -23- 200808396 ♦ Figure 1 Gi Figure 19 'The test has proved that when the decompression group is applied to the bone n-ray, the treatment will have a positive effect. In a specific trial, decompression tissue treatment was applied to the first month of a rabbit to determine its specific target for bone growth and fruiting. The specific goal of this test was to find that there was no defect or injury in the first month of the decompression tissue treatment. The effect of rabbits, the effect of decompression tissue treatment on rabbits with critical size defects on the skull, and the effect of using a stent material with decompression tissue treatment on the treatment of critical size defects on the skull. The specific test protocol and number of rabbits are listed in table i below. Soil L quantity - _ test plan __ ^ no defect on the top, with the honeycomb foam (GranuFoam) on the top of the periosteum of Yuanhao applied decompression tissue treatment (RPTT) for 6 days 'then immediately harvested tissue ____ skull No defect; no decompression tissue treatment (GranuFoam) placed on top of intact periosteum for 6 days in RPT, followed by immediate harvesting of tissue

4 4 kr\2 # # t 寸寸ί 尺尺J 孓f在 臨臨τ; 之之ρτ 網架R 絲支時 鋼鈣小 銹酸24 不磷用 置置應 放放損 面面缺 上上個織 在在兩組 個個該穫 一 一對收 具損損週 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^ 損;對該兩個缺損應用24小時RPTT ;在手術1 ^ 週後收穫組織 具有一個在上面放置不銹鋼絲網之臨界尺寸缺 損;一個在上面放置磷酸鈣支架之臨界尺寸缺 損;對該兩個缺損應用6天RPTT ;在手術2週後! 收穫組織 具有一個在上面放置不銹鋼絲網之臨界尺寸缺 損;一個在上面放置構酸約支架之臨界尺寸缺 損;對該兩個缺損應用6天RPTT ;在手術12週 後收穫組織 119763.doc -24- 200808396 十有一個在上面放置不銹鋼絲網之臨界尺寸缺 ^ ; 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 缺缺組 寸寸穫 尺尺收 界界後 臨臨週 之之12 網架術 絲支手 鋼鈣在 銹酸; 不填照 置Ϊ#,放放T(f 面面T 上上RP 在在用 個個應 一不山·,·, 具損損織4 4 kr\2 # # t inch inch ruler J 孓f in the pro-Tu; ρτ grid R wire branch steel calcium small rust acid 24 non-phosphorus placement should be placed on the surface of the loss There is a critical dimension defect on which a stainless steel wire mesh is placed on each of the two sets of receiving damage weeks; a critical dimension of the calcium phosphate stent placed thereon; 24 hours for the two defects RPTT; harvested tissue 1 h week after surgery with a critical size defect with stainless steel mesh placed thereon; a critical size defect with a calcium phosphate scaffold placed thereon; 6 days RPTT applied to both defects; 2 weeks after surgery The harvested tissue has a critical size defect on which the stainless steel mesh is placed; a critical size defect on which the acid is placed on the stent; a 6-day RPTT is applied to the two defects; and the tissue is harvested 12 weeks after the surgery 119763.doc - 24- 200808396 Ten has a critical dimension of stainless steel mesh placed on it; a critical size defect in which a calcium phosphate stent is placed; no RPTT (control) is applied; tissue is harvested after 2 weeks of surgery The group is inch-inch and the ruler is bounded by the border of the 12th. The grid wire is hand-rolled with calcium in the rust acid; not filled with the Ϊ#, put the T (f face T on the upper RP in use) Should be a mountain, ··, with damage

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 s品界尺寸缺損係組織(例如頭骨)中之缺損,其尺寸足夠 大,從而將無法僅藉由自身恢復來癒合。對於兔子而言, 穿過頭骨鑽製一直徑約為15 mm之全厚度孔便會形成頭骨 之臨界尺寸缺損。 更具體地參見圖10,其圖解說明一具有原始、未經損壞 之骨骼之兔子頭骨之組織切片。頭骨之骨骼組織為品紅 色,周圍之軟組織為白色,且骨膜層由黃色星號來突出顯 示在圖11中,圖解說明在應用減壓組織治療6天並隨後 立即收穫組織之後之兔子頭骨。可以看到骨骼及骨膜,且 已形成一層肉芽組織。在圖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。圖以中 之組織切片之特徵在於在肉芽組織下面形成新的骨骼組 織。該骨縣組織係由黃色星號來突出顯示。在圖13中,圖 解說明在應用減壓組織治療6天並隨後立即收穫組織之後 之兔子頭骨。可以看到新的骨骼及骨膜。藉由減壓組織治 療而形成之骨骼組織之組織外觀非常類似於在正在經歷 119763.doc -25- 200808396 快速之新骨胳生長及沈積之非常幼小之動物中骨路形成之 組織外觀。 更具體地參見圖14至圖19,其圖解說明數個照片及組織 二片其顯不對具有臨界尺寸缺損之兔子頭骨施行減壓組 、、/口療之程序及結果。在圖14中,圖解說明一上面已形成 兩個臨界尺寸缺損之兔子頭骨。該等全厚度臨界尺寸缺損 ,直搜約為15匪。在圖15中,已在其中一個臨界尺寸缺 損上面放置-不錄鋼絲網,i在第^臨界尺寸缺損内放置 -磷酸鈣支架。在圖16中,使用一類似於本文所述之減壓 、、且織冶療袭置對該等臨界尺寸缺損應用減低之壓力。對每 缺知應用之壓力大小為_125 mm Hg之表壓。該減低之壓 力係根據表1中所列測試方案之一加以應用。在圖17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 隶為明顯’此表明減壓組織治療引起一連串生物事件义 而增強新骨骼組織之形成。 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。 119763.doc -26 - 200808396 钱寺育科哭出表明恰當之支架材料之優點以及減壓組織^ 療對支架融合和生物效能之正面效果。在圖18及19中; 解說明在六天之減壓組織治療之後經支架填充之臨界尺= 缺損之射線照片。圖18圖解說明手術後兩周之缺損並顯: 在支架内沈積了一定之新骨骼。支架之主結構仍明顯; 見。圖19®解說明手術十二週後之缺損,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 骨路)而使主支架架構接近完全消失。 苓見圖20,——根據本發明一實施例之減壓輸送系統m 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721。歧管輸送管721可係一導液管 或套管,並可包括使歧管輸送管721能夠被導引至組織部 位713之器件,例如一導向單元725及一導引金屬絲”?。 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 皮膚將一減壓输送裝置插入患者之組織部位7 i 3。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73 1處包含骨絡組織。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 119763.doc -27- 200808396 織、軟骨、腱、或韌帶。 參見圖21及22 ’其進一步圖解說明減壓輸送系統7n。 歧管輸送管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 沿徑向向外撓曲至一開口位置,從而使遠端743之内徑將 基本相同於或大於管721之其他部分之内徑。遠端743之開 口位置在圖21中由虛線7 3 7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767,此類 似於參照圖6-8所述。撓性障壁765及/或蜂巢狀材料767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。 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 壓輸送裝置761穿過通路751推動,可使用一生物相容性潤 滑劑來減小減壓輸送裝置761與歧管輸送管721間之摩擦。 當已將遠端743定位於組織部位713處並將減壓輸送裝置 761輸送至遠端743之後,然後將減壓輸送裝置761朝遠端 743推動’從而使遠端743沿徑向向外膨脹至開口位置。將 減壓輸送裝置761推出歧管輸送管721,較佳推入毗鄰組織 部位713之空隙或空間内。該空隙或空間通常藉由切開軟 119763.doc -28 - 200808396 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可位於傷口部位處,且因傷口解剖而 自然地存在-空隙。在其他情況下,該空隙可藉由充氣囊 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^減壓輸送裝置761進入贼鄰組織部位713之空 隙時,減壓輸送裝置761之撓性障壁765及/或蜂巢狀材料 767解除捲繞、解除折疊或解除壓縮(參見圖。"從而使減 壓輸送裝置761可與組織部位713相接觸地放置。儘管並非 必需如此,然而可使撓性障壁765及/或蜂巢狀材料767承 受經由減壓輸送管769提供之真空或減低之壓力,以壓縮 撓性障壁765及/或蜂巢狀材料767。可藉由如下方式來達 成撓性障壁765及/或蜂巢狀材料767之解除折疊:釋放經 由減壓輸送管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 内窥鏡檢查、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713 施加減低之壓力。 參見圖23至圖25,根據本發明一實施例之減壓輸送系統 811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 119763.doc -29 - 200808396 端843之内徑將基本相同於或者大於在管821之其他部分處 之内徑。遠端843之開口位置在圖23至圖25中由虛線837示 意性地顯示。 歧管輸送管821進一步包括一通路,在該通路中包含一 類似於本文所述其他減壓輸送裝置之減壓輸送裝置Mi。 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%?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。 具有一内表面873之不滲透性薄膜871圍繞減壓輸送裝 置861設置,以使減壓輸送裝置861含納於不滲透性薄膜 871之内表面873内。不滲透性薄膜871可係一充氣囊、護 套、或能夠防止流體透過之任何其他類型之薄膜,以使不 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)及膨服位置(參見圖25及25八)中之至少一個位置。 _ 不滲透性薄膜871可密封地連接至歧管輸送管821,從而使 不滲透性薄膜871之内部空間873與歧管輸送管821之通路 机體連通。另一選擇為,不滲透性薄膜87丨可固定至減壓 * 輸送官869上,從而使不滲透性薄膜871之内部空間873與 、 減壓輸送官869之通路流體連通。不滲透性薄膜871轉而可 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)。 在只施例中’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 119763.doc •30- 200808396 薄膜871之内部空間873施加一低於不滲透性薄膜"I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871置於圖23 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 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k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871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881,此會改良不滲透性薄膜871在其移除之前在螢光屏 檢查下之可視性。 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 性溥膜871中移出減壓輸送裝置861。可提供一移出器具 885(例如套管、口針或其他尖銳器具)來弄破不滲透性薄膜 871。較佳地,移除器具885穿過減壓輸送管869插入,並 成夠推進至接觸不滲透性薄膜87 1。在弄破不渗透性薄膜 871之後’可經由歧管輸送管821抽出移出器具885及不滲 透性薄膜871,從而使減壓輸送裝置861之撓性障壁865及/ 或蜂巢狀材料867能夠解除捲繞、解除折疊或解除壓縮, 從而可使減壓輸送裝置861接觸組織部位放置。撓性障壁 119763.doc -31- 200808396 865及/或蜂巢狀材料867之解除捲繞可在釋放内部空間873 中減低之壓力並移出不滲透性薄膜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 將撓性障壁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861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8 71之内部空間8 7 3内。較佳使用液體來使不滲透 性薄膜871膨脹,乃因液體之不可壓縮性使不滲透性薄膜 871能夠更均勻且更一致地膨脹。不滲透性薄膜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25)時,會毗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輪 送裝置861。 % 參見圖25Α,若不滲透性薄膜871主要用於分離毗鄰組織 119763.doc -32- 200808396 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821上,從而使内部空間873與一關聯於或固定至歧 管輸送管821之辅助管腔或管891流體連通。辅助管腔891 可用於向内部空間873輸送液體、空氣或其他流體,以將 不滲透性薄膜871置於膨脹位置。在分離之後,可如前面 參照圖24所述使不滲透性薄膜871鬆弛並將其弄破。 參見圖26,根據本發明一實施例之減壓輸送系統9丨工包 括一具有一錐形遠端943之歧管輸送管921,錐形遠端943 經構造以沿徑向向外撓曲至一開口位置,從而使遠端料3 之内徑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。 峡官輸送官921進一步包括一通路,在該通路中包含一 類似於本文所述其他減壓輸送裝置之減壓輸送裝置961。 減壓輸运裝置961包含一撓性障壁965及/或蜂巢狀材料 967,撓性障壁965及/或蜂巢狀材料967較佳捲繞、折疊或 以其他方式圍繞減壓輸送管969壓縮,以減小減壓輸送裝 置961在歧管輸送管921之通路内之截面積。 一具有一内表面973之不滲透性薄膜971圍繞減壓輸送裝 置961设置,以使減壓輸送裝置961含納於不滲透性薄膜 971之内表面973内。不滲透性薄膜971在不滲透性薄膜π] 之知上包έ 一膠封977,以提供一種自不滲透性薄膜971 上移出減壓輸送裝置961之替代方法。不渗透性薄膜9^1可 密封地連接至歧管輸送管921,從而使不滲透性薄膜971之 119763.doc -33- 200808396 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-與内冑空間973流體連通 之單獨控制管(未顯示)。 類似於圖23中之不滲透性薄膜871,不滲透性薄膜971可 能夠防止流體透過,以使不滲透性薄膜971可採取壓縮位 置、鬆弛位置及膨脹位置中之至少—個位置。由於用於將 不滲透性薄膜9 71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9 61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 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 不滲透性薄膜971置於鬆弛位置上。然後,將減壓輸送裝 置961穿過膠封977推動,以推出不滲透性薄膜971。 參見圖26A’ 一根據本發明一實施例之減壓輸送系統985 可不包括類似於圖26所示歧管輸送管921之歧管輸送管。 而是’減壓輸送系統985可包括一導引金屬絲987、一減壓 輸运官989、及一減壓輸送裝置991。減壓輸送裝置991包 各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 119763.doc -34- 200808396 減壓輸送裝置991及減壓輸送管989置於導引金屬絲987 上,經過皮膚將導引金屬絲987導引至一組織部位993上。 較佳地,導引金屬絲987及減壓輸送管989藉由一無菌護套 穿透患者之皮膚。藉由沿導引金屬絲987導引減壓輸送管 989及減壓輸送裝置991,可將減壓輸送裝置991置於組織 部位993處,以達成經過皮膚來應用減壓組織治療。 由於減壓輸送裝置991在輸送至組織部位993期間並不約 束於一歧管輸送管中,因而較佳在輸送期間使減壓輸送裝 置991保持處於壓縮位置。若使用一彈性發泡體作為減壓 輸送裝置991,可對該發泡體塗覆一種生物相容性可溶解 黏合劑並壓縮該發泡體。在到達該組織部位之後,體液或 經由減壓輸送管989輸送之其他流體會溶解該黏合劑,從 而使該發泡體膨脹而接觸組織部位。另一選擇為,可自一 種壓縮之幹態水凝膠製成減壓輸送裝置991。該水凝膠在 輸送至組織部位993之後吸收水份,從而能夠使減壓輸送 裝置991膨脹。再_種減壓輸送裝置991可自熱活性材料 (例如聚乙二醇)製成,該熱活性材料在受到患者體溫之作 用時會膨脹。在再-實施例中,可在—可溶解薄膜中將經 壓縮之減壓輸送裝置99丨輸送至組織部位。 參見圖27,一根據本發明一實施例之減壓輸送系統an °括/、有遠鸲1043之歧管輸送管1021,遠端1〇43插穿 過患者之一組織而接觸到組織部位1025。組織部位1025可 包3與傷口或其他缺損相關聯之空隙1029,或者另一選 擇為可藉由刀離(包括本文所述之分離技術)來形成一空 119763.doc -35- 200808396 隙。 在將遠端1043毗鄰組織部位1〇25放置於空隙ι〇29内之 後,經由歧管輸送管!021將一可注射、可傾倒或可流動之 減壓輸送裝置1035輸送至組織部位1〇25處。減壓輸送裝置 1035在輸送至組織部位期間較佳以一可流動狀態存在:且 然後在到達之後,形成複數個流動通道以便分佈減低之壓 力或流體。在某些情形中,該可流動材料在到達組織部位 處之後可藉由一乾燥過程、固化過程或其他化學或物理反 應而硬化成固體狀態。在其他情形中,該可流動材料在輸 送至組織部位之後可在原位形成發泡體。還有其他材料可 以凝膠狀狀態存在於組織部位1〇25處,但仍具有複數個用 於輸送減低之壓力之流動通道。輸送至組織部位〗5處之 減壓輸送裝置1035之量可足以部分地或完全填充空隙 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1〇35包含複數個孔或開放孔,該 複數個孔或開放孔可在輸送至空隙1〇29之後形成於材料 中。該等孔或開放孔相互連通,由此形成複數個流動通 道。該等流動通道用於對組織部位1〇25應用及分佈減低之 壓力。作為支架,減壓輸送裝置1 〇 3 5係生物可再吸收性的 並用作可在上面生長新組織之基材。 在一實施例中,減壓輸送裝置1035可包含分佈於整個液 體或黏性凝膠中之p〇ragen,例如NaCl或其他鹽。在將該 液體或黏性凝膠輸送至組織部位1025之後,該材料貼覆至 空隙1029上並隨後固化成一實體。水溶性NaCl poragen在 119763.doc -36- 200808396 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1〇35係一與4〇〇 μηι甘露 糖顆粒相混合之藻酸鹽。該等p〇ragen或顆粒可在組織部 位處被局部體液或被沖洗流體或輸送至減壓輸送裝置丨〇3 5 之其他流體溶解。在溶解P〇ragen或顆粒之後,先前由該 等poragen或顆粒佔據之空間變成空隙,該等空隙彼此互 連,以在減壓輸送裝置1〇35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 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 碳酸氫鈉及檸檬酸微粒(可使用非化學計量)之可流動材料 輸送至組織部位1025。當該可流動材料在原位形成一發泡 體或固體時,體液將會引起碳酸氫鈉與檸檬酸間之酸-鹼 反應。與依靠poragen溶解之技術相比,所形成之二氧化 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 119763.doc -37- 200808396 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燥。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一用於促進新組織 生長之多孔支架。 除本文中之前述各實施例外,減壓輸送裝置i 5可自各 種各樣之材料製成’包括但不限於磷酸鈣、膠原、藻酸 鹽、纖維素、或任何其他能夠以氣體、液體、凝膠、膏 糊、油灰、漿液、懸浮液或其他可流動材料形式輸送至組 、、哉U卩位並此夠形成與組織部位流體連通之多個流動路徑之 等效材料。該可流動材料可進一步包括固體微粒,例如顆 粒,若該等固體微粒之粒徑足夠小,則其能夠經由歧管輪 迗官1021流動。以可流動狀態輸送至組織部位之材料可在 原位聚合或形成凝膠。 如前面所述,可將減壓輸送裝置1〇35直接注射或傾倒至 119763.doc -38- 200808396 田比鄰組織部位1〇25之空隙1〇29内。參見圖27A,歧管輸送 管1021可在歧管輸送管1〇21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1055,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1061上導引至組 織部位1025處。 減壓輸送裝置1035可經由辅助管腔1〇57來注射或傾倒, 以填充薄膜1051之内部空間1055。當流體或凝膠填充薄膜 1051時,薄膜1051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1051膨脹時,薄膜1〇51可用於分離 毗鄰或靠近組織部位1〇25之額外組織。若薄膜1〇51係不滲 透性薄膜,則可藉由物理方式弄破並移除之,從而使減壓 輸送裝置1035接觸組織部位1〇25。另一選擇為,薄膜ι〇5ι 可自一種在存在體液或輸送至薄膜1〇51之生物相容性溶劑 時會溶解之可溶解材料製成。若薄膜1〇51係半滲透性,則 薄膜1051可保留於原位。半滲透性薄膜1〇51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&mi包括在 1115處藉由外科手術在毗鄰組織部位處插入一歧管,該歧 官具有自一撓性障壁伸出之複數個突起物,以在該等突起 物之間形成複數個流動通道。在1119處對該歧管進行定 位,使該等突起物中之至少一部分接觸該組織部位。在 1123處,、經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 119763.doc -39- 2008083964 sham operation (no defect, no RPTT): harvesting tissue after 6 days of surgery Table 1: Test plan s defect in the defect size tissue (such as the skull), the size is large enough that it cannot be used only by Self recovery to heal. For rabbits, drilling a full thickness hole of approximately 15 mm in diameter through the skull creates a critical dimension defect in the skull. Referring more specifically to Figure 10, a tissue section of a rabbit skull having primitive, undamaged bones is illustrated. The skeletal tissue of the skull is magenta, the surrounding soft tissue is white, and the periosteal layer is highlighted by a yellow asterisk in Figure 11, illustrating the rabbit skull after application of decompressed tissue treatment for 6 days followed by immediate harvesting of the tissue. The bones and periosteum can be seen and a layer of granulation tissue has formed. In Fig. 12, a rabbit skull after application of decompression tissue treatment for 6 days and subsequent harvesting of tissue immediately is illustrated. The tissue section in the figure is characterized by the formation of a new skeletal tissue beneath the granulation tissue. The bone county organization is highlighted by a yellow asterisk. In Fig. 13, the rabbit skull after the application of the decompressed tissue treatment for 6 days and immediately after harvesting the tissue is illustrated. You can see new bones and periosteum. The tissue appearance of bone tissue formed by decompressive tissue treatment is very similar to the tissue appearance of bone formation in very young animals that are undergoing rapid new bone growth and deposition in 119763.doc -25-200808396. Referring more specifically to Figures 14 through 19, several photographs and tissues are illustrated which show the procedure and results of decompression, //oral therapy for rabbit skulls having critical size defects. In Fig. 14, a rabbit skull having two critical size defects formed thereon is illustrated. These full thickness critical dimension defects are about 15 inches. In Figure 15, one of the critical dimension defects has been placed - no wire mesh is recorded, i is placed in the ^ critical dimension defect - calcium phosphate stent. In Fig. 16, a pressure similar to that described herein is used, and the weaving treatment is applied to reduce the critical dimension defect. The pressure applied to each of the missing applications is _125 mm Hg gauge. This reduced pressure is applied according to one of the test protocols listed in Table 1. In Fig. 17, a skull after application of a 6-day decompression tissue treatment and collecting tissue after 12 weeks of surgery is illustrated. The slice shown contains a calcium phosphate scaffold, which is indicated by a red arrow. The use of decompression tissue treatment results in significant growth of new bone tissue, which is highlighted by a yellow asterisk in Figure 17. The amount of bone growth is significantly greater than the amount of bone growth in critical size defects that are treated with the same calcium phosphate scaffold but not treated with decompressive tissue. This observation suggests that there may be a treatment threshold or duration required to induce a new bone formation response. The effect of decompression tissue treatment was evident in the samples collected 12 weeks after surgery. This indicates that decompression tissue treatment caused a cascade of biological events to enhance the formation of new bone tissue. The critical size defect covered with a stainless steel mesh (Fig. 15) but without the stent material in the defect was used as an intra-animal control with minimal bone growth. 119763.doc -26 - 200808396 Qian Si Yuke cried out the advantages of proper scaffolding materials and the positive effects of decompression tissue on stent fusion and bioavailability. In Figures 18 and 19; a radiograph of the critical ruler = defect of the stent after six days of decompression tissue treatment is illustrated. Figure 18 illustrates the defect two weeks after surgery and shows that a certain new bone has been deposited in the stent. The main structure of the stent is still obvious; see. 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 a new bone path within the stent matrix). Referring to Fig. 20, a reduced pressure delivery system m according to an embodiment of the present invention performs decompression tissue treatment on a tissue site 713 of a patient. The reduced pressure delivery system 711 includes a manifold delivery tube 721. The manifold delivery tube 721 can be a catheter or cannula and can include means for enabling the manifold delivery tube 721 to be guided to the tissue site 713, such as a guide unit 725 and a guide wire. The placement and guidance of the guide wire 727 and the manifold delivery tube 721 is accomplished using endoscopy, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique. Manifold delivery tube 721 is provided. For use to insert a reduced pressure delivery device through the skin into the tissue site 7 i 3 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. 20, the tissue site 713 includes bone tissue at a fracture site 73 1 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 119763.doc -27- 200808396 woven, cartilage, sputum, or Referring to Figures 21 and 22, it further illustrates a reduced pressure delivery system 7n. The manifold 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 It may be further configured to flex radially outwardly to an open position such that the inner diameter of the distal end 743 will be substantially the same or greater than the inner diameter of the other portions of the tube 721. The open position of the distal end 743 is in Figure 21 The manifold delivery tube 721 further includes a passageway 751 including a pressure relief delivery device 761 or any other reduced pressure delivery device. The reduced pressure delivery device 761 includes a flexible barrier. 765 and/or honeycomb material 767, similar to that described with reference to Figures 6-8. The flexible barrier 765 and/or honeycomb material 767 is preferably wound, folded or otherwise compressed around the reduced pressure delivery tube 769 to The cross-sectional area of the reduced-pressure delivery device 761 within the passage 751 is reduced. The reduced-pressure delivery device 761 can be placed within the passage 751 and guided to the tissue site after the distal end 743 of the manifold delivery tube 721 is placed at the tissue site 713 Another option for 713° is The reduced pressure delivery device 761 is pre-positioned in the passage 751 prior to insertion of the manifold delivery tube 721 into the patient. To push the reduced pressure delivery device 761 through the passage 751, a biocompatible lubricant can be used. The friction between the reduced pressure delivery device 761 and the manifold delivery tube 721 is reduced. After the distal end 743 has been positioned at the tissue site 713 and the reduced pressure delivery device 761 is delivered to the distal end 743, the reduced pressure delivery device 761 is then placed The distal end 743 is urged toward the distal end 743 to expand radially outward to the open position. The reduced pressure delivery device 761 is pushed out of the manifold delivery tube 721, preferably into the void or space adjacent the tissue site 713. This void or space is usually formed by cutting the soft tissue 119763.doc -28 - 200808396, which can be done by the skin route. In some cases, the tissue site 713 can be located at the wound site and naturally present - voids due to wound anatomy. In other cases, the void may be formed by aeration bladder separation, sharp separation, blunt separation, hydraulic separation, pneumatic separation, ultrasonic separation, electrocautery separation, laser separation, or any other suitable separation technique. When the pressure delivery device 761 enters the gap of the thief adjacent tissue portion 713, the flexible barrier 765 and/or the honeycomb material 767 of the reduced pressure delivery device 761 is unwound, unfolded, or decompressed (see Fig. " The delivery device 761 can be placed in contact with the tissue site 713. Although this need not be the case, the flexible barrier 765 and/or the honeycomb material 767 can be subjected to a vacuum or reduced pressure provided via the reduced pressure delivery tube 769 for compression flexing. The barrier 765 and/or the honeycomb material 767. The unfolding of the flexible barrier 765 and/or the honeycomb material 767 can be achieved by releasing the reduced pressure delivered via the reduced pressure delivery tube 769 or by depressurizing Delivery tube 769 provides positive pressure to assist in the process of unwinding. Endoscopy, ultrasound, fluoroscopy, auscultation, palpation, or any of its can be used. His suitable localization technique is used to achieve final placement and manipulation of the reduced pressure delivery device 761. After placement of the reduced pressure delivery device 761, the manifold delivery tube 721 is preferably removed from the patient, but associated with the reduced pressure delivery device 761 The reduced pressure delivery tube remains in place so as to be able to apply a reduced pressure to the tissue site 713 through the skin. Referring to Figures 23 through 25, the reduced pressure delivery system 811 according to an embodiment of the present invention includes a conical shape The manifold delivery tube 821 of the end 843, the tapered distal end 843 is configured to flex radially outwardly to an open position such that the inner diameter of the distal end 843763.doc -29 - 200808396 will be substantially the same or greater than The inner diameter at the other portion of the tube 821. The opening position of the distal end 843 is schematically shown by dashed lines 837 in Figures 23 through 25. The manifold delivery tube 821 further includes a passageway containing a similar The reduced pressure delivery device Mi of the other reduced pressure delivery device described herein. The reduced pressure delivery device 861 comprises a flexible barrier 865 and/or honeycomb material 867, flexible barrier 865 and/or honeycomb material %? Winding, folding It is compressed around the reduced pressure delivery tube 869 in other manners to reduce the cross-sectional area of the reduced pressure delivery device 861 in the passage. The impermeable membrane 871 having an inner surface 873 is disposed around the reduced pressure delivery device 861 to reduce The pressure delivery device 861 is contained within the inner surface 873 of the impermeable membrane 871. The impermeable membrane 871 can be an inflatable bladder, a sheath, or any other type of membrane capable of preventing fluid permeation, such that the impervious membrane The 871 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 25). 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 membrane 87 can be secured to the reduced pressure * delivery 869 such that the interior space 873 of the impermeable membrane 871 is in fluid communication with the passage of the reduced pressure delivery 869. The impermeable membrane 871 can in turn be secured to a separate control tube or control lumen in fluid communication with the interior space 873 (see, for example, Figure 25A). The impervious film 871 can be provided in the only embodiment to further reduce the cross-sectional area of the reduced pressure delivery device 861 within the passage. To this end, a pressure lower than the ambient pressure of the impervious film "I is applied to the internal space 873 of the impervious 119763.doc •30-200808396 film 871. A substantial portion of the air or other fluid within the interior space 873 is thereby expelled to place the impermeable membrane 871 in the compressed position shown in FIG. 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. The placement and manipulation of the impermeable membrane 871 and the reduced pressure delivery device 861 can be accomplished using endoscopic k-scanning, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique. The impermeable film 871 can include a radiopaque marker 881 which improves the visibility of the impermeable film 871 under the screen inspection prior to its removal. 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 The reduced pressure delivery device 861 is removed from the impervious diaphragm 871. A removal device 885 (e.g., a cannula, a needle or other sharp instrument) can be provided to break the impermeable membrane 871. Preferably, the removal tool 885 is inserted through the reduced pressure delivery tube 869 and advanced enough to contact the impermeable membrane 87 1 . After the impervious film 871 is broken, the removal device 885 and the impermeable film 871 can be withdrawn via the manifold transfer tube 821, so that the flexible barrier 865 and/or the honeycomb material 867 of the reduced pressure delivery device 861 can be unwound. Winding, unfolding or uncompressing allows the reduced pressure delivery device 861 to be placed in contact with the tissue site. The unwinding of the flexible barrier 119763.doc -31- 200808396 865 and/or the honeycomb material 867 can occur automatically after releasing the reduced pressure in the interior space 873 and removing the impermeable membrane 871. In some cases, positive pressure may be delivered via the reduced pressure delivery tube 869 to help unwind or uncompress the flexible barrier 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 861 against the tissue site. After pushing the reduced pressure delivery device 861 and the intact impermeable membrane 871 through the distal end 843 of the manifold delivery tube 821, air or another fluid is injected or pumped into the internal space of the impermeable membrane 81. 3 inside. It is preferred to use a liquid to swell the impermeable film 871 because the incompressibility of the liquid allows the impervious film 871 to expand more uniformly and more uniformly. 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 impermeable film 871 is expanded outward to the expanded position due to the pressure of air or fluid (see Fig. 25), a void is separated adjacent to the 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 the decompression transfer device 861 can be inserted adjacent to the tissue site. % Referring to Fig. 25A, if the impermeable film 871 is mainly used to separate the tissue at the site adjacent to the tissue 119763.doc -32 - 200808396, the impermeable film 871 can be hermetically fixed to the manifold delivery tube 821, thereby making the interior Space 873 is in fluid communication with an auxiliary lumen or tube 891 associated with or secured to manifold delivery tube 821. The auxiliary lumen 891 can be used to deliver liquid, air or other fluid to the interior space 873 to place the impermeable membrane 871 in the expanded position. After the separation, the impermeable film 871 can be relaxed and broken as described above with reference to Fig. 24. Referring to Figure 26, a reduced pressure delivery system 9 in accordance with an embodiment of the present invention includes a manifold delivery tube 921 having a tapered distal end 943 that is configured to flex radially outwardly to An open position such that the inner diameter of the distal feed 3 will be substantially the same or greater than the inner diameter at other portions of the tube 921. The position of the opening of the distal end 943 is schematically shown by dashed line 937 in FIG. The gaudal delivery officer 921 further includes a passageway in which a reduced pressure delivery device 961 similar to other reduced pressure delivery devices described herein is included. The reduced pressure transport device 961 includes a flexible barrier 965 and/or honeycomb material 967 that is preferably wound, folded or otherwise compressed around the reduced pressure delivery tube 969 to The cross-sectional area of the reduced pressure delivery device 961 within the passage of the manifold delivery tube 921 is reduced. An impervious film 971 having an inner surface 973 is disposed around the reduced pressure delivery device 961 such that the reduced pressure delivery device 961 is contained within the inner surface 973 of the impermeable membrane 971. The impermeable film 971 encloses a seal 977 on the impervious film π] to provide an alternative method of removing the reduced pressure delivery device 961 from the impermeable film 971. The impermeable membrane 9^1 is sealingly coupled to the manifold delivery tube 921 such that the 119763.doc -33-200808396 internal 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 medial space 973. Similar to the impermeable film 871 of Fig. 23, the impermeable film 971 can prevent fluid from permeating 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 791 at the compression position and the expansion position is similar to the impermeable film 871, only the process of removing the decompression conveying device 961 will be described. Delivery of the reduced-pressure delivery device 916 to the tissue site within the impermeable membrane 971 using endoscopy, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique and then correcting it Positioning. The impermeable film 971 can include a radiopaque marker 981 which improves the visibility of the impermeable film 971 under fluorescent screen inspection prior to its removal. The reduced pressure delivery device 961 is then pushed through the distal end 943 of the manifold delivery tube 921. The reduced pressure applied to the interior space 973 can be released to place the impermeable membrane 971 in a relaxed position. Then, the reduced pressure conveying device 961 is pushed through the glue seal 977 to push out the impervious film 971. Referring to Figure 26A', a reduced pressure delivery system 985 in accordance with an embodiment of the present invention may not include a manifold delivery tube similar to the manifold delivery tube 921 of Figure 26. Rather, the reduced pressure delivery system 985 can include a guide wire 987, a reduced pressure transport officer 989, and a reduced pressure delivery device 991. The reduced pressure delivery device 991 includes a plurality of fluids connected to the flow passage of the reduced pressure delivery tube 989. Instead of using a separate manifold delivery tube to deliver the reduced pressure delivery device 991, a 119763.doc -34 - 200808396 reduced pressure delivery device 991 and a reduced pressure delivery tube 989 are placed over the guide wire 987 through the skin. The guide wire 987 is guided to a tissue site 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 reduced pressure delivery device 991 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 a manifold delivery tube during delivery to the tissue site 993, it is preferred to maintain the reduced pressure delivery device 991 in the compressed position during delivery. If an elastic foam is used as the reduced pressure conveying means 991, the foam can be coated with a biocompatible soluble adhesive and the foam can be compressed. After reaching the tissue site, the body fluid or other fluid delivered via the reduced pressure delivery tube 989 dissolves the binder, thereby expanding the foam to contact the tissue site. Alternatively, a reduced pressure delivery device 991 can be formed from a compressed dry hydrogel. The hydrogel absorbs moisture after being transported to the tissue site 993, so that the reduced pressure delivery device 991 can be inflated. Further, the reduced pressure delivery device 991 can be made of a heat active material such as polyethylene glycol which expands when subjected to the patient's body temperature. In a further embodiment, the compressed reduced pressure delivery device 99 can be delivered to the tissue site in a dissolvable film. Referring to Fig. 27, a reduced pressure delivery system according to an embodiment of the present invention includes a manifold delivery tube 1021 having a distal end 1043 inserted distally through a tissue of a patient to contact a tissue site 1025. . The tissue site 1025 can include a void 1029 associated with the wound or other defect, or alternatively can be formed by knife separation (including the separation techniques described herein) to form an empty space 119763.doc -35 - 200808396. After the distal end 1043 is placed adjacent to the tissue site 1〇25 in the void ι 29, an injectable, pourable or flowable reduced pressure delivery device 1035 is delivered to the tissue site 1 through the manifold delivery tube!021. At the office. The reduced pressure delivery device 1035 is preferably present in a flowable state during delivery to the tissue site: and then, upon arrival, a plurality of flow channels are formed to distribute the reduced pressure or fluid. In some cases, the flowable material can be hardened to a solid state by a drying process, a curing process, or other chemical or physical reaction after reaching the tissue site. In other cases, the flowable material can form a foam in situ after delivery to the tissue site. Still other materials may exist in the gel state at the tissue site 1 〇 25, but still have a plurality of flow channels for delivering reduced pressure. The amount of reduced pressure delivery device 1035 delivered to the tissue site 5 may be sufficient to partially or completely fill the void 1029. The reduced pressure delivery device 1035 can include both a manifold and a stent. As the manifold, the pressure-reducing conveying device 1〇35 includes a plurality of holes or open holes which can be formed in the material after being conveyed to the gaps 1〇29. The 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 1 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ragen, 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 1025, the material is applied to the void 1029 and subsequently cured into a solid. The water-soluble NaCl poragen dissolves in the presence of body fluids at 119763.doc -36 - 200808396, 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 1〇35 is an alginate mixed with 4〇〇μηι mannose particles. The p〇ragen or granules may be dissolved at the tissue site by local body fluids or by the irrigated fluid or other fluid delivered to the reduced pressure delivery device 丨〇3 5 . After dissolving P〇ragen or particles, the space previously occupied by the poragen or particles becomes a void which is interconnected to form a flow passage in the reduced pressure conveying device 1〇35. The use of poragen in materials to form flow channels is effective, but it also forms pores and flow channels that are limited in size to the particle 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-base reaction between sodium bicarbonate and citric 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 by pH, temperature, light, or with body fluids, chemicals, or other delivery to the tissue site of 119763.doc -37-200808396 The reaction of matter triggers. 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. 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. Excess solution is drained and the microspheres are subsequently dried. 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. The mixture is then exposed to light again, thereby crosslinking the microspheres, thereby forming 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. With the exception of the foregoing embodiments herein, the reduced pressure delivery device i 5 can be made from a variety of materials including, but not limited to, calcium phosphate, collagen, alginate, cellulose, or any other gas, liquid, A gel, paste, putty, slurry, suspension, or other flowable material is delivered to the set, 哉U 并 position and is sufficient to form an equivalent of a plurality of flow paths in fluid communication with the tissue site. The flowable material may further comprise solid particles, such as particles, which are capable of flowing via the manifold wheel 1021 if the particle size of the solid particles is sufficiently small. The material delivered to the tissue site in a flowable state can be polymerized in situ or form a gel. As described above, the reduced-pressure delivery device 1〇35 can be directly injected or poured into the gap 1〇29 of the 119763.doc-38-200808396 field adjacent tissue site 1〇25. Referring to Fig. 27A, the manifold delivery tube 1021 can include an impermeable or semi-permeable membrane 1051 at the distal end 1043 of the manifold delivery tube 1〇21. The membrane 1051 includes an interior space 1055 that is in fluid communication with an auxiliary lumen 1〇57 that is 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 1061. The reduced pressure delivery device 1035 can be injected or poured through the auxiliary lumen 1〇57 to fill the interior space 1055 of the membrane 1051. When the fluid or gel fills the film 1051, the film 1051 expands to fill the voids 1〇29, thereby causing the film to contact the tissue site 1025. When the film 1051 is inflated, the film 1〇51 can be used to separate additional tissue adjacent to or near the tissue site 1〇25. If the film 1〇51 is an impermeable film, it can be physically broken and removed, so that the reduced pressure delivery device 1035 contacts the tissue site 1〇25. Alternatively, the film ι〇5ι 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 1〇51. If the film 1〇51 is semi-permeable, the film 1051 can remain in place. The semi-permeable membrane 1〇51 is capable of delivering reduced pressure and possibly other fluids to the tissue site 1025. Referring to Fig. 28, a method for performing decompressive tissue treatment & mi includes surgically inserting a manifold at an adjacent tissue site at 1115, the organ having a plurality of protrusions extending from a flexible barrier. 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 1123, a reduced pressure is applied to the tissue site via the manifold. Referring to Figure 29, a method for decompressing tissue treatment of a tissue site 119763.doc -39- 200808396

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-撓性障壁伸出之複數個突起物,以在該 等犬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 官進行定位’使該等流動通道之至少一部分與該組織部位 流體連通。1 1223處,經由該歧管對組織部位施加減低之 壓力。 參見圖30,一種對組織部位施行減壓組織治療之方法 1311包括在1315處經過皮膚穿過患者之一組織插入一具有 通路之管,以使該管之遠端毗鄰該組織部位放置。在i3i9 處’可使-與該管相關聯之充氣囊膨脹,以分離晚鄰該组 織部位之組織,藉以形成一空隙。在1323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,在該蜂巢狀材料内二 複數個流動通道。另一選擇為’該歧管可如上文參照圖27 所述由輸送至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,經由一減壓輪送管 或任何其他輸送途徑藉由該歧管對該組織部位應用減低: 壓力。 / ^ 119763.doc •40- 200808396 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。1211 includes inserting a manifold at 1215 through the skin adjacent the tissue site. The manifold can include a plurality of protrusions extending from the flexible barrier to form a plurality of flow channels between the canines. Alternatively, the manifold can comprise a honeycomb material having a plurality of flow channels within the honeycomb material. Alternatively, the manifold may be formed from an injectable or pourable material that is delivered to the tissue site and that forms a plurality of flow channels upon reaching the tissue site. At 1219, the ambiguity is positioned 'to bring at least a portion of the flow channels in fluid communication with the tissue site. At 1 1223, a reduced pressure is applied to the tissue site via the manifold. Referring to Fig. 30, a method of applying reduced pressure tissue treatment to a tissue site 1311 includes inserting a tube having a passage through the skin through a skin at 1315 such that the distal end of the tube is placed adjacent to the tissue site. At i3i9, the balloon associated with the tube can be inflated to separate tissue adjacent to the tissue site to form a void. At 1323, 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 may comprise a honeycomb material in which a plurality of flow channels are formed. Another option is that the manifold can be formed from an injectable or pourable material that is delivered to the tissue site as described above with reference to Figure 27. At 1327, the manifold is positioned such that at least a portion of the flow channels are in fluid communication with the tissue site. At 1331, the tissue site is subjected to a reduction by pressure via a manifold or any other delivery route: pressure. / ^ 119763.doc •40- 200808396 See Figure 3 1 'A method of performing decompressive tissue treatment on a tissue site 1411 includes inserting a tube with a passage through the skin through a tissue at 1415 to allow the tube to The distal end is placed adjacent to the tissue site. At 1423, a manifold is delivered to the tissue site via the passageway 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.

參見圖32及33 ’ 一根據本發明一實施例之減壓輸送裝置 1511包括一用於替換患者腿節1517之現有股骨頭之整形外 科髖假體15 1 5。髖假體15丨5包括一柱部分〗52〗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 中欽出之通路1529内。一多孔塗層1535設置於該柱部分周 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153 5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/或骨路輸送減低之壓力。流動通道η 41可包 含一與數個橫向分支管線〗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 119763.doc -41- 200808396 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 (較佳係開放孔)材料來填充該假體之内部空間。 更具體地參見圖33,髖假體1515可進一步在柱部分1521 内包括第二複數個流動通道1561,以對環繞髖假體15 15之 多孔塗層1535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15 15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 1585流體連通之主饋送管線1583,該數個橫向分支管線 15 85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15 41之輸送及流體向 第二複數個流動通道1561之輸送可藉由單獨之管(例如減 壓輸送管1551及流體輸送管i57丨)來完成。另一選擇為, 可使用一如本文中前面所述具有多個管腔之管來分離用於 輸送減低之壓力與流體之連通路徑。應進一步注意,儘管 較it在體假體15 15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輪 119763.doc -42- 200808396 送至環繞髖假體15 15之骨骼。 如前面所述,對骨骼組織應用減低之壓力會促進及加速 新骨赂組織之生長。藉由使用髖假體1515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1515會更成功地與骨骼結合於一起。提 供第二複數個流動通道1561來排放環繞髖假體1515之骨路 會改良環繞假體之新骨骼之成功再生。 在經由髖假體1 5 1 5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自連接璋 1545、1565斷開並自患者體中移出一較佳不使用外科手術 侵害性程序。連接埠1545、1565與管1551、1571間之連接 可係一可用手釋脫之連接,此可藉由在患者身體外側對管 1551、1571施加一軸向拉力來實施。另一選擇為,連接埠 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’以便可精由使連接璋15 4 $、1 $ 6 5暴 疼於流體或化學品中而達成管1551、1571之釋脫。管 1551、1571亦可由一種會在一段時間内溶解之生物可再吸 收性材料或一種在存在特定化學品或其他物質條件下會溶 解之活化材料製成。 減壓輸送源1553可在患者體外提供並連接至減壓輸送管 1551,以將減低之壓力輸送至髖假體1515。另一選擇為, 可將減壓輸送源1553植入患者體内、髖假體15 15上或附 近。將減壓輸送源1553放置於患者體内便無需使用經過皮 膚之流體連接。所植入之減壓輸送源1553可係以可操作方 119763.doc -43- 200808396 式連接至流動通道1541之傳統幫浦。該幫浦可由植入於患 者體内之電池供電,或者可由經過皮膚電連接至該幫浦之 外部電池供電。該幫浦亦可由一經由流動通道丨54丨、i56i 輸送減低之壓力及使流體循環經過流動通道丨54丨、丨56 i之 化學反應來直接驅動。 儘官在圖32及33中僅圖解說明髖假體1515之柱部分1521 及頭邛分1525 ’然而應注意,本文所述之流動通道及用於 應用減壓組織治療之構件亦可應用於髖假體i 5〗5中任何接 觸骨骼或其他組織之組件,包括例如臼杯。 參見圖34 ’ 一種用於修復患者關節之方法丨6丨丨包括在 1615處毗鄰該關節在骨骼内植入一假體。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 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ose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 板,該複數個通路1721用於使用螺釘1725、銷、螺栓或其 他緊固件將整形外科固定器件1715錨固至骨骼1717上。可 在整形外科固定器件1715之接觸骨骼1717之表面上設置一 夕孔塗層173 5。該多孔塗層較佳由燒結或玻璃化陶瓷或金 屬構造而成。另一選擇為,可在骨骼1717與整形外科固定 119763.doc -44- 200808396Referring 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 15 15 for replacing an existing femoral head of a patient leg segment 1517. The hip prosthesis 15丨5 includes a column portion 52 and a head portion 1525. The post portion 1521 is elongated to be inserted into a passage 1529 that is inserted into the backbone of the leg section 1517. A porous coating 1535 is disposed around the portion of the column 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 153 5 . 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 the bone path surrounding the hip prosthesis 1515 after implantation of the hip prosthesis 1515. The flow channel η 41 can include a main feed line 1543 in fluid communication with a plurality of lateral branch lines 547, the plurality of lateral branch lines 1547 being in communication with the porous coating 1535. The rib branch line 1545 can be oriented perpendicular to the main feed line 119763.doc -41 - 200808396 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 interior of the prosthesis with a honeycomb-like (preferably open-cell) material that is in fluid communication with the porous coating 1535. space. Referring more specifically to Figure 33, the hip prosthesis 1515 can further include a second plurality of flow channels 1561 within the post portion 1521 to provide fluid to the porous coating 1535 and/or bone surrounding the hip prosthesis 15 15 . 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 15 15 . 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 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 delivery of the reduced pressure to the first plurality of flow channels 154 and the delivery of fluid to the second plurality of flow channels 1561 can be accomplished by separate tubes (e.g., reduced pressure delivery tube 1551 and fluid delivery tube i57). Alternatively, a tube having a plurality of lumens as previously described herein can be used to separate the communication path for delivery of reduced pressure and fluid. It should be further noted that although a separate fluid communication path is provided within the body prosthesis 15 15 , the first plurality of flow channels 1541 can be used to deliver both the reduced pressure and the fluid wheel 119763.doc -42 - 200808396 The bone surrounding the hip prosthesis 15 15 . As mentioned earlier, the application of reduced stress to bone tissue promotes and accelerates the growth of new bone tissue. By using the hip prosthesis 1515 as a manifold to deliver the reduced pressure to the bone region surrounding the hip prosthesis, the leg segment 1517 will recover faster' and the hip prosthesis 1515 will more successfully engage the bone. Providing a second plurality of flow channels 1561 to discharge the bone path around the hip prosthesis 1515 will improve the successful regeneration of the new bone surrounding the prosthesis. After applying the reduced pressure through the hip prosthesis 1 5 1 5 for a selected amount of time, the decompression 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. Good does not use surgical invasive procedures. The connection between the ports 1545, 1565 and the tubes 1551, 1571 can be a connection that can be released by hand, which can be performed by applying an axial pulling force to the tubes 1551, 1571 outside the body of the patient. Alternatively, the ports 1545, 1565 can be bioresorbable or soluble in the presence of the selected fluid or chemical so that the essence can be compromised by the connection of the 璋15 4 $, 1 $ 6 5 Release of the tubes 1551, 1571 is achieved in a fluid or chemical. Tubes 1551, 1571 can also be made from a bioresorbable material that will dissolve over a period of time or an activating material that will dissolve in the presence of a particular chemical or other material. A reduced pressure delivery source 1553 can be provided outside the patient and connected to a 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 15 15 . Placing the reduced pressure delivery source 1553 into the patient does not require the use of a fluid connection through the skin. The implanted reduced pressure delivery source 1553 can be coupled to the conventional pump of the flow channel 1541 in an operable manner 119763.doc -43 - 200808396. The pump can be powered by a battery implanted in the patient's body or by an external battery that is electrically connected to the pump via the skin. The pump can also be directly driven by a chemical reaction that delivers reduced pressure through the flow channels 丨54丨, i56i and circulates fluid through the flow channels 丨54丨,丨56 i. In the figures 32 and 33, only the column portion 1521 of the hip prosthesis 1515 and the head segment 1525 are illustrated. However, it should be noted that the flow channels described herein and the components for applying the reduced pressure tissue treatment may also be applied to the hip. Any component of the prosthesis i 5 〗 5 that contacts bone or other tissue, including, for example, a cup. Referring to Figure 34', a method for repairing a patient's joint includes the implantation of a prosthesis within the bone adjacent to the joint at 1615. 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 flow channels configured to be in fluid communication with the bone. At 1619, the reduced pressure is applied to the bone via the plurality of flow channels to improve the ose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 is a plate having a plurality of passages 1721 for anchoring the orthopaedic fixation device 1715 to the bone using screws 1725, pins, bolts or other fasteners. On 1717. An evening coating 173 5 may be provided 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. Another option is to fix the bone 1717 with orthopedics 119763.doc -44- 200808396

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1751 及一減壓輸送源1753。流動通道1741用於在將整形外科固 定器件1715固定至骨骼1717之後向多孔塗層1735及/或環 繞整形外科固^器件1715之骨絡輸送減低之壓力。流動通 道1741可包含一與數個橫向分支管線1747流體連通之主饋 送管線1743 ’該數個橫向分支f線1747與多孔塗層⑽相 料。橫向分支管線1747可如在圖35中所示垂直於主饋送 管線1743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—中 空之整形外科固定器件,並以_種能夠與多孔塗層咖产 體連通之蜂巢狀(較佳係開放孔)材料來填充該整形外❹ 定器件之内部空間。 整形外科IU定n件1715可如在圖35巾所示H 另-:擇為,可係一固定器件’例如套管、矯形 柱、或任何其他詩使㈣之—部分敎之㈣。整 ==1715可進一步係用於固定假體或其他整料科 。件或所植入組織(例如骨骼組織或 制條件為該等緊固件包含用於向她鄰或環固= 組織輸送減低之壓力之流動通道。該等緊固件之=;牛: 括銷、螺栓、螺釘或任何其他適宜之緊固件。 °匕 更具體地參見圖36’整形外科固U件⑺5可進—步在 119763.doc -45- 200808396 正形外科固定器件1715内包括第二複數個流動通道1761, 以對%繞整形外科固定器件1715之多孔塗層1735及/或骨 縣提供流體。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 劑或任何其他流體。若期望將多種流體引入至環繞髖假體 1715之骨骼中,可提供額外之流體連通路徑。一連接埠 1765流體連接至流動通道1761,該埠1765構造成連接至〜 體輸送管1771及一流體輸送源丨773。流動通道丨76〗可包 含一與數個橫向分支管線1785流體連通之主饋送管線 1783,該數個橫向分支管線1785與多孔塗層1735相連通。 k向分支管線178 5可如在圖33中所示垂直於主饋送管線 1783定向,或者可與主饋送管線1783成某些夾角定向。 減低之壓力向第一複數個流動通道1741之輸送及流體向 第二複數個流動通道1761之輸送可藉由單獨之管(例如减 壓輸送管1751及流體輸送管ι771)來完成。另一選擇為, 可使用一如本文中前面所述具有多個管腔之管來分離用於 輸送減低之壓力與流體之連通路徑。應進一步注意,儘警 較佳在髖假體1715内提供分離之流體連通路徑,然而亦可 使用弟一複數個流動通道17 41將減低之壓力與流體二者於 送至毗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之骨絡區域輸送減低之壓力會加快並改盖典 骼1717之缺損1719之恢復。提供第二複數個流動通道1761 將流體傳送至環繞整形外科固定器件1715之骨骼會改良敫 119763.doc -46- 200808396 形外科固定器件附近之新骨骼之成功再生。 參見圖37 ’ -種用於治癒骨路之骨絡缺損之方法則包 在15處使用|形外科固定器件來固定該骨絡。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 個机動通道。在1819處’經由該複數個流動通道對骨路缺 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治療之 方法1911包括·在1915處對一具有複數個流動通道之歧管 =仃疋位,以使該等流動通道之至少一部分與該組織部位 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 方法2011包括·在2〇 15處將一歧管輸送管之遠端晚鄰該組 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至圖48,一減壓輸送系統21Π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4〇至圖 119763.doc -47- 200808396 45中為矩形,而在圖46至圖48中為三角形),因而在減壓 輸送管2125與主歧管2115之間提供一過渡區2129。主歧管 2115可藉由膠黏方式連接至減壓輸送管2125、使用例如融 合或嵌件模壓等其他途徑進行連接、或者另一選擇為可藉 由共擠出而整體相連。減壓輸送管2125將減低之壓力輸送 至主歧管2115,以供分佈於組織部位處或附近。 一防阻塞部件213 5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 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2121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 引導真空之輸送。舉例而言,在圖5 1中,可使孔面對骨 119763.doc -48- 200808396 路、面對覆蓋組織或同時面對二者佈置。 減壓輸送管2125較佳包括一具有至少一個出口之第一導 管2161,該至少一個出口流體連接至主流動通路2i2i,以 向主〉’1L動通路2121輸送減低之壓力。亦可提供^一第—導管 2163來以一種流體清洗主流動通路2121及第一導管2161, 以防止或溶解因傷口分泌物及自組織部位吸出之其他流體 所造成之阻塞。第二導管2163較佳包括至少一個緊靠主流 動通路2121與第一導管2丨61之該至少—個出口中之至少一 者定位之出口。 更具體地參見圖40及41,在減壓輸送系統2111中,第二 導管2163可包括用於沖洗主流動通路2121及第一導管2161 之多個導管。儘管撓性壁2117中與固定至減壓輸送管2125 之端部相對之端部可如在圖40中所示為開口的,然而已發 現,覆蓋撓性壁2117之端部可改良清洗功能之效能及可靠 性。較佳地,在撓性壁之被覆蓋端部與第二導管2163之端 部之間提供一頂隙2171。頂隙2171能夠在清洗製程期間達 成清洗流體之積聚,此有助於驅動沖洗流體經過主流動通 路2121流入第一導管2161内。 在圖41中亦圖解說明用作防阻塞部件2135之間隔件。居 中定位之間隔件使主流動通路2121分叉進入兩個室内,此 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。 參見圖49及50, 一減壓輸送系統2211包括一與減壓輸送 管2217成一體之主歧管2215。減壓輸送管2217包括一中央 119763.doc -49- 200808396 管腔2223及複數個辅助管腔22 k &辅助官腔2225可用 於量測組織部位處或附近之壓力 刀然而辅助管腔2225可進 一步用於清洗中央管腔2223,υ κ士 l上 ^ ^ U防止或溶解阻塞物。複數 個孔2231與中央管腔2223相連通 以分佈由中央管腔2223 所輸送之減低之壓力。如在B5G巾所示,較佳使孔2231不 貫穿辅助管腔2225。在圖5〇中亦圖解說明減壓輸送管之埋 頭孔端,其在辅助管腔2225之端部以外形成一頂隙2241。 假若在應用減低之壓力期間使組織、支架或其他材料喊合 減壓輸送管2217之端部’頂隙2241將會繼續允許向中央管 腔2223輸送清洗流體。 在使用期間,圖40至圖50所述之減壓輸送系統2111、 2211可直接應用於組織部位上,以向組織部位分佈減低之 壓力。主歧管之低矮形狀非常有利於經過皮膚裝設及移除 本文所述之技術。類似地,亦可藉由外科手術來嵌入主歧 管。 參見圖51,主歧管21丨5、ms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 二層置於主歧管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,輔助歧管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 119763.doc -50- 200808396 £ /口療I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g之該等層之間移出主歧管2ii5。在一實施例 中,主歧官可塗覆有潤滑材料或會形成水凝膠之材料,以 易於自該等層之間移出主歧管。 . 輔助歧管較佳用作新組織生長之支架。作為支架,辅助 . 歧管可由選自由如下材料組成之群組之至少一種材料構 - 《:聚乳酸、聚乙醇酸、聚己内酯、聚羥基丁酸酯、聚羥 戊酉夂^ 一乳/、環醯胺、polyorthoesthers、聚鱗腈、聚氨 ^ 基甲酸酉1、膠原、透明質酸、聚胺基葡萄糖、經基鱗灰 石、磷酸鈣、硫酸鈣、碳酸鈣、生物玻璃、不銹鋼、鈦、 钽、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 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 靠近歧管或靠近該第一導管之一出口。儘管可將空氣壓至 或”推”至第二導管之出口,然而較佳藉由組織部位處減低 之壓力經由第二導管吸入空氣。已發現,在許多情形中, 在應用減低之壓力期間以六十(60)秒鐘之間隔輸送空氣兩 119763.doc -51- 200808396 (2)秒鐘便足以防止形成阻塞物。此種清洗計劃能提供足狗 之空氣來充分地移動歧管及第一導管内之流體,同時防止 引入過多之线^人過多之空氣、或者以過高之間隔頻 率來引入空氣將會造成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24U。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24幻包含 一出口 2435,出口 2435定位成與歧管2415流體連通並靠近 第一導管2419之出口。第二導管2423流體連接至一閥門 2439,當閥門2439置於開啟位置時,該閥門能夠達成第二 導管2423與環境空氣之間的連通。閥門2439以可操作方式 連接至一控制器2453,控制器2453能夠控制閥門2439之開 啟及關閉,以調節使用環境空氣對第二導管實施之清洗, 從而防止在歧管2415與第一導管2419内存在阻塞物。 應注意,可使用任何流體(包括液體或氣體)來達成本文 所述之技術。儘官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。 119763.doc •52- 200808396 根據本文所述之糸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學 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 可怪定不變、為週期性或者為隨機性。若為週期性,則流 體輸送可在施加減低之壓力期間進行,或者可在其中不在 施加減低之壓力之循環週期期間進行。儘管施加至組織部 位之減低之壓力之大小通常將根據組織部位之病理學及施 行減壓組織治療之環境而異,然而減低之壓力通常介於 約-5 mm Hg與-500 mm Hg之間,但更佳係介於約_5瓜㈤ Hg與-300 mm Hg之間。 儘官上文係參照組織生長及患者癒合來說明本發明之系 、、先及方法然而應知道,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 括但不限於骨馳織、脂肪組織、肌肉組織、神經組織、 皮膚、、且、我血: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、、且織生長。舉例而言,可能期望使用經過皮膚之植 119763.doc -53- 200808396 入技術來應用減壓組織治療’以在_組織部位處生長額外 之組織,ϋ隨後收穫所述額外之i織。可將所㈣之組織 移植至另-組織部位,以取代有疾病或受損之組織,或者 另一選擇為,可將所收穫之組織移植給另一患者。 應注意,本文所述之減壓輸送裝置可與支架材料結合使 用來提高新組織之生長及生長速率,此亦頗為重要。支架 材料可放置於組織部位與減壓輸送裝置之間,或者減壓輸 送裝置本身可由用作新組織生長支架之生物可再吸收性材 料製成。 根據上文說明應顯而易見,本文提供一具有顯著優點之 發明。儘管本文僅以其幾種形式來顯示本發明,然而本發 明並不僅限於此,而是易於在不背離本發明精神之條件下 作出各種改動及修改。 【圖式簡單說明】 本專利或申請案檔案包含至少一個帶顏色之圖式。可根 據要求並在支付必要費用之後由專利事務局提供帶彩圖之 本專利或專利申請公開案。 圖1繪示一根據本發明一實施例之減壓輸送裝置之透視 圖,該減壓輸送裝置具有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圖解說明圖丨所示減壓輸送裝置之正視圖; 圖3繪示圖1所示減壓輸送裝置之俯視圖; 圖4Α圖解說明圖丨所示減壓輸送裝置之側視圖,該減壓 輸送裝置具有一單管腔減壓輸送管; 119763.doc -54- 200808396 圖4B繪示圖1所A honeycomb material having a porous property is disposed between the devices 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 1751 and a reduced pressure delivery source 1753. The flow channel 1741 is used to deliver a reduced pressure to the bone layer of the porous coating 1735 and/or the orthopaedic surgical device 1715 after the orthopedic fixation device 1715 is secured to the bone 1717. The flow channel 1741 can include a main feed line 1743' in fluid communication with a plurality of lateral branch lines 1747. The plurality of lateral branches f-line 1747 are associated with the porous coating (10). The lateral branch line 1747 can be oriented perpendicular to the main feed line 1743 as shown in Figure 35 or can be oriented at some angle to the main feed line 1743. An alternative method for distributing the reduced pressure includes providing a hollow orthopedic fixation device and filling the shaping with a honeycomb (preferably open pore) material capable of communicating with the porous coated coffee body Externally determine the internal space of the device. The orthopedic IU set 1715 can be as shown in Fig. 35, and can be attached to a fixed device such as a cannula, an orthopedic column, or any other poem (4). The whole ==1715 can be further used to fix the prosthesis or other whole materials. Piece or implanted tissue (eg, skeletal tissue or conditions such that the fasteners contain flow passages for lowering the pressure of her adjacent or ring-solid = tissue. These fasteners =; cattle: brackets, bolts , screw or any other suitable fastener. Referring more specifically to Figure 36, the orthopedic fixation member (7) 5 can be advanced to include a second plurality of flows within the orthopaedic fixation device 1715 at 119763.doc -45 - 200808396 The channel 1761 provides fluid to the porous coating 1735 and/or bone county of the %-wound orthopaedic fixation device 1715. The fluid may include filtered air or other gases, antibacterial agents, antiviral agents, cell growth promoters, rinses Fluid, chemically active agent, or any other fluid. If it is desired to introduce multiple fluids into the bone surrounding the hip prosthesis 1715, an additional fluid communication path may be provided. A port 1765 is fluidly coupled to the flow channel 1761, which is configured Connected to a body delivery tube 1771 and a fluid delivery source 773. The flow channel 76 can include a main feed line 1783 in fluid communication with a plurality of lateral branch lines 1785, the number The lateral branch line 1785 is in communication with the porous coating 1735. The k-direction branch line 178 5 can be oriented perpendicular to the main feed line 1783 as shown in Figure 33, or can be oriented at some angle to the main feed line 1783. The delivery of pressure to the first plurality of flow channels 1741 and the delivery of fluid to the second plurality of flow channels 1761 can be accomplished by separate tubes (eg, reduced pressure delivery tube 1751 and fluid delivery tube 1771). 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 a separate fluid communication path is provided within the hip prosthesis 1715 as soon as possible. However, it is also possible to use a plurality of flow channels 17 41 to deliver both the reduced pressure and fluid to the bone of the adjacent orthopaedic fixation device 1715. The orthopedic fixation device 1715 is used as a manifold to the adjacent orthopaedic fixation device 1715. The reduced pressure in the osseous region will accelerate and revert to the restoration of the defect 1719 of the skeleton 1717. A second plurality of flow channels 1761 are provided to deliver fluid to The bone around the orthopedic fixation device 1715 will improve the successful regeneration of the new bone near the 119763.doc -46- 200808396 shaped surgical fixation device. See Figure 37 - The method used to cure the bone defect of the bone path is included The orthopedic fixation device is used to secure the bone network at 15 locations. The orthopaedic fixation device includes a plurality of motorized channels disposed within the orthopaedic fixation device. At 1819, the application of the bone path defect is reduced via the plurality of flow channels Pressure 38. Referring to Figure 38, a method 1911 for treating a tissue site with reduced pressure tissue includes: at 1915, a manifold having a plurality of flow channels = 仃疋 position such that at least the flow channels are at least A portion of the body is in communication with the tissue site 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 method for performing decompression tissue treatment on a tissue site 2011 includes positioning a distal portion of a manifold delivery 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 through 48, a reduced pressure delivery system 21A 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 may be different from the circular shape (ie, rectangular in FIGS. 4A to 119763.doc -47 - 200808396 45, A triangle is shown in Figures 46-48, thus providing a transition zone 2129 between the reduced pressure delivery tube 2125 and the primary manifold 2115. The main manifold 2115 can be joined by adhesive means to the reduced pressure delivery tube 2125, using other means such as fusion or insert molding, or alternatively selected to be integrally joined by coextrusion. The reduced pressure delivery tube 2125 delivers the reduced pressure to the primary manifold 2115 for distribution at or near the tissue site. An anti-blocking member 213 5 is positioned within the main manifold to prevent the main manifold 2115 from collapsing and thereby blocking the main flow path 211 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 component 2135 can comprise 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 2121. The flexible wall 2117 further includes a plurality of apertures 2155' that penetrate the flexible wall 2117. The apertures 2155 are 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. Aperture 2155 is selectively positionable about the circumference of manifold 2115 to preferentially direct the delivery of vacuum. For example, in Figure 51, the holes can be placed facing the bones 119763.doc -48 - 200808396, facing the covering tissue or facing both. The reduced pressure delivery tube 2125 preferably includes a first conduit 2161 having at least one outlet fluidly coupled to the main flow passage 2i2i for delivering a reduced pressure to the primary > 1L moving passage 2121. A first 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 blockages caused by wound secretions and other fluids aspirated from the tissue site. The second conduit 2163 preferably includes at least one outlet positioned adjacent to at least one of the at least one of the main passage 2121 and the first conduit 2丨61. Referring more specifically to Figures 40 and 41, in the reduced pressure delivery system 2111, the second conduit 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 the end fixed to the reduced pressure delivery tube 2125 can be open as shown in Fig. 40, it has been found that covering the end of the flexible wall 2117 can improve the cleaning function. Performance and reliability. Preferably, a head 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 positioned spacer branches the main flow path 2121 into the two chambers, which causes the main manifold 2115 to continue to operate when one of the chambers is blocked and cannot be dissolved by the cleaning. Referring to Figures 49 and 50, a reduced pressure delivery system 2211 includes a primary manifold 2215 integral with the reduced pressure delivery conduit 2217. The reduced pressure delivery tube 2217 includes a central 119763.doc -49 - 200808396 lumen 2223 and a plurality of auxiliary lumens 22 k & the auxiliary lumen 2225 can be used to measure the pressure knife at or near the tissue site. However, the auxiliary lumen 2225 can be further For cleaning the central lumen 2223, υ κ 士 l ^ ^ U to prevent or dissolve the obstruction. A plurality of apertures 2231 communicate with the central lumen 2223 to distribute the reduced pressure delivered by the central lumen 2223. As shown in the B5G towel, it is preferred that the aperture 2231 does not extend through the auxiliary lumen 2225. The counterbore end of the reduced pressure delivery tube is also illustrated in Fig. 5A, which forms a headspace 2241 outside the end of the auxiliary lumen 2225. If the tissue, stent or other material is shouted during application of the reduced pressure, the end portion 2241 of the reduced pressure delivery tube 2217 will continue to allow delivery of cleaning fluid to the central lumen 2223. During use, the reduced pressure delivery systems 2111, 2211 of Figures 40 through 50 can be applied directly to the tissue site to distribute the reduced pressure to the tissue site. The low profile of the primary manifold is highly advantageous for rinsing and removing the techniques described herein. Similarly, the main manifold can also be embedded by surgery. Referring to Figure 51, the main manifolds 21, 5, ms can be used in conjunction with an auxiliary manifold 2321. In Figure 51, the auxiliary manifold 2321 includes a two layer felt pad. The first layer of the auxiliary manifold 2321 is placed in contact with a bone tissue site containing the fracture site. The primary manifold 2115 is placed in contact with the first layer, and the second layer of the secondary manifold 2321 is placed on top of the primary manifold 2115 and the first layer. The auxiliary manifold 2321 is capable of achieving fluid communication between the primary manifold 2115 and the tissue site and still prevents direct contact between the tissue site and the primary manifold 2115. Preferably, the auxiliary manifold 2321 is bioabsorbable, which enables the auxiliary manifold 2321 to remain in place after the decompression therapy is completed. Once the reduction is completed, the main manifold 2ii5 can be removed from the layers of the auxiliary g. with little or no disturbance to the tissue site. In one embodiment, the primary officer may be coated with a lubricating material or a material that will form a hydrogel to facilitate removal of the primary manifold from between the layers. The auxiliary manifold is preferably used as a support for new tissue growth. As a stent, the manifold may be composed of at least one material selected from the group consisting of polylactic acid, polyglycolic acid, polycaprolactone, polyhydroxybutyrate, polyhydroxyl /, cyclodecylamine, polyorthoesthers, polysquaric nitrile, polyaluminum hydrazide 1, collagen, hyaluronic acid, polyaminoglucose, gram-based limestone, calcium phosphate, calcium sulfate, calcium carbonate, bioglass, stainless steel , titanium, tantalum, allograft tablets 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 clean the manifold or conduit that delivers reduced pressure prevents the formation of obstructions that would impede the pressure to perform the reduction. Such obstructions are typically formed when the pressure near the tissue site reaches equilibrium and the outflow of fluid around the tissue site becomes slow. 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 adjacent to or adjacent to one of the outlets of the first conduit. Although the air can be pressurized or "pushed" to the outlet of the second conduit, it is preferred to draw air through the second conduit by the reduced pressure at the tissue site. It has been found that in many cases, air is delivered at intervals of sixty (60) seconds during the application of reduced pressure. 119763.doc -51 - 200808396 (2) seconds is sufficient to prevent the formation of obstructions. Such a cleaning program can provide the air of the foot to fully move the manifold and the fluid in the first conduit, while preventing the introduction of excessive lines of excess air, or introducing air at too high a frequency will result in a It is not possible to return to the decompression system of the reduced target pressure between wash cycles. The amount of time selected to deliver the cleaning fluid and the interval between the selected cleaning fluids will generally vary depending on the design and specifications of the system components (eg, pumps, tubes, etc.). However, the amount and frequency of delivery air should be high enough to adequately remove obstructions while still recovering the full target pressure between wash cycles. Referring to Fig. 52', in an exemplary embodiment, a reduced pressure delivery system 2411 includes a manifold 2415 that is fluidly coupled to a first conduit 2419 and a second conduit 24U. The first conduit 2419 is coupled to a reduced pressure source 2429 to provide reduced pressure to the manifold 2415. The second conduit 24 includes an outlet 2435 that is positioned in fluid communication with the manifold 2415 and adjacent the outlet of the first conduit 2419. The second conduit 2423 is fluidly coupled to a valve 2439 which is capable of achieving communication between the second conduit 2423 and ambient air when the valve 2439 is placed in the open position. Valve 2439 is operatively coupled to a controller 2453 that is capable of controlling the opening and closing of valve 2439 to regulate cleaning of the second conduit using ambient air to prevent memory in manifold 2415 and first conduit 2419 In the obstruction. It should be noted that any fluid (including liquids or gases) can be used to achieve the techniques described herein. It is preferred that the force used to clean the fluid is the suction created by the reduced pressure at the tissue site, although similar to that described with reference to Figure 9, the fluid delivery member can also deliver fluid in a similar manner. 119763.doc •52- 200808396 According to the system and method described herein, decompression tissue treatment of tissue sites can be achieved by: applying a low enough scholastic ability to the tissue site' and then at a selected time Maintain this low enough pressure within the segment. Alternatively, the reduced pressure applied to the tissue site can be cyclic. More specifically, the magnitude of the applied reduced pressure may vary depending on the selected time cycle. Yet another method of applying the reduced pressure can randomly vary the magnitude of the reduced pressure. Similarly, the rate or amount of fluid delivered to the tissue site can be ambiguous, periodic, or random. If it is periodic, the fluid delivery can be carried out during the application of the reduced pressure or during the cycle in which the reduced pressure is not applied. Although the magnitude of the reduced pressure applied to the tissue site will generally vary depending on the pathology of the tissue site and the environment in which the decompressive tissue treatment is performed, the reduced pressure is typically between about -5 mm Hg and -500 mm Hg. More preferably, the system is between about _5 melons (five) Hg and -300 mm Hg. The system, methods, and methods of the present invention are described above with reference to tissue growth and patient healing. However, it should be understood that such systems and methods for applying reduced pressure tissue therapy can be used in any of them where it is desired to promote tissue growth or healing. In the living body. Similarly, the systems and methods of the present invention are applicable to any tissue including, but not limited to, bone woven, adipose tissue, muscle tissue, nervous tissue, skin, and, my blood: tissue, connective tissue, cartilage tissue, sputum or ligament. Although tissue healing may be one of the focuses of applying reduced-pressure tissue treatment as described herein, however, decompression tissue treatment (especially for tissues located under the patient's skin) may also be used in the absence of disease, defect or injury. Formed in the tissue, and woven and grown. For example, it may be desirable to use a transdermal tissue 119763.doc-53-200808396 technique to apply reduced pressure tissue treatment' to grow additional tissue at the tissue site, which is subsequently harvested. The tissue of (4) 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 a stent material to increase the growth and growth rate of new tissue, which is also important. The stent material can be placed between the tissue site and the reduced pressure delivery device, or the reduced pressure delivery device itself can be made from a bioresorbable material that is used as a new tissue growth stent. It should be apparent from the above description that this document provides an invention with significant advantages. While the present invention has been shown in its several forms, the present invention is not limited thereto, but various modifications and changes can be made without departing from the spirit of the invention. [Simple description of the schema] This patent or application file contains at least one graphic with color. The patent or patent application publication with color drawings may be provided by the Patent Office upon request and after payment of the necessary fee. 1 is a perspective view of a reduced pressure 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; FIG. 2 is a diagram illustrating FIG. Figure 3 is a plan view of the reduced pressure conveying device shown in Figure 1; Figure 4A is a side view of the reduced pressure conveying device shown in Figure 4, the reduced pressure conveying device has a single tube Cavity decompression tube; 119763.doc -54- 200808396 Figure 4B shows Figure 1

材料,該撓性障壁具有一 一實施例之減壓輸送裝置之透視 一附固至一撓性障壁上之蜂巢狀 凸脊部分及一對翼狀部分,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繪不圖7所示減壓輸送裝置在χνπ-χνιι處剖切之 視側視圖; ° 圖8Α圖解說明一種根據本發明一實施例之減壓輸送裝置 之剖視正視圖; 圖8Β繪示圖8Α所示減壓輸送裝置之一側視圖; 圖9圖解說明一種根據本發明一實施例之減壓輸送袭置 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,其顯示在廉 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絡之沈積·, 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絡之沈積; 圖14繪示一兔子頭骨之彩色照片,在該頭骨中形成有兩 119763.doc -55- 200808396 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 色組織切片,該組織切片顯示新骨骼在磷酸鈣支架内之沈 積; 圖18繪示在實施減壓組織治療六天及實施手術兩周後圖 15所示經支架填充之臨界尺寸缺損之射線照片; 圖19繪示在實施減壓組織治療六天及實施手術十二周後 圖15所示經支架填充之臨界尺寸缺損之射線照片; 圖20繪示一根據本發明一實施例之減壓輸送系統之正視 圖,該減壓輸送系統具有一歧管輸送管,其用於經過皮膚 將一減壓輸送裝置插入至一組織部位; 圖21圖解說明圖20所示歧管輸送管之放大正視圖,該歧 管輸送管包含一減壓輸送裝置,該減壓輸送裝置具有一撓 性障壁及/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 在已自該歧管輸送管推入之後該減壓輸送裝置之撓性障壁 及/或蜂巢狀材料處於膨脹位置; 圖23圖解說明一種根據本發明一實施例之減壓輸送系統 之正視圖,該減壓輸送系統具有一用於經過皮膚將一減壓 119763.doc -56- 200808396 圖中顯示該減 不滲透性薄膜 輸送裝置插入至一組織部位之歧管輸送管, 壓輸送裝置處於該歧管輸送管外侧、但被— 約束於一壓縮位置上; 圖中顯示 不渗透性 圖24繪示圖23所示減壓輸送系統之一正視圖 該減壓輸送裝置處於該歧管輸送管外側、但被 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 一 〜止硯圖,圖中 顯示該減壓輸送裝置處於該歧管輸送管外侧、 1一破一不渗 曹 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_ 此说圖,圖 中顯示該減壓輸送裝置處於該歧管輸送管外側 。i叫、但於一膨 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輪送系統之正 視圖,該減壓輸送系統具有一用於經過皮膚將—減壓輸、关 裝置插入至一組織部位之歧管輸送管,圖中顯示該減壓= _ 送裝置處於該歧管輸送管外侧、但受一具有膠封之不參透 性薄膜約束; " 圖26 A繪示根據本發明一實施例之減壓輸送系統之正視 1¾¾ · 圖, 圖27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輸送管,以用於麵 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輸送管,以用於 119763.doc -57- 200808396 =過皮膚將-減壓輸送裝置輸送至位於—組織部位處之不 渗透性薄膜; 圖28繪示一種根據本發明一實施例對—組織部位施行減 麼組織治療之方法之流程圖; …圖29圖解說明—種根據本發明—實施例n織部位施 行減壓組織治療之方法之流程圖;a material, the flexible barrier having a see-through ridge portion and a pair of wing portions attached to a flexible barrier wall of the vacuum conveying device of the embodiment, the honeycomb material having a plurality of flow passages; Figure 7 illustrates a front view of one of the reduced-pressure conveying devices shown in Figure 6; Figure 8 illustrates a side view of the reduced-pressure conveying device shown in Figure 7 taken at χνπ-χνιι; ° Figure 8A illustrates a Figure 1 is a side elevational view of the reduced pressure delivery device of Figure 8A; Figure 9 illustrates a reduced pressure delivery device in accordance with an embodiment of the present invention. A front view for applying decompressive tissue treatment to the bone of the patient; Figure 10 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 , which shows the granulation tissue induced after the treatment of the inexpensive decompression tissue; FIG. 12 shows a color tissue section of a rabbit skull showing the deposition of the new bone network after the application of the decompressed tissue treatment, FIG. A color tissue section of a rabbit skull is shown, which shows the deposition of new bones after application of decompressed tissue treatment; Figure 14 depicts a color photograph of a rabbit skull in which two 119763.doc -55 - 200808396 are formed. Figure 15 illustrates a color photograph of the rabbit skull shown in Figure 14 showing a calcium phosphate scaffold embedded in one of the critical dimension defects and a stainless steel mesh covering the second critical dimension defect; Figure 16 illustrates Figure 14 is a color photograph of a rabbit skull showing the application of a reduced-pressure tissue treatment to a critical size defect; Figure 17 illustrates a color tissue section of a rabbit skull after performing a reduced-pressure tissue treatment showing the new bone in calcium phosphate Figure 18 shows a radiograph of the critical dimension defect filled with the stent shown in Figure 15 after performing the decompressed tissue treatment for six days and two weeks after the operation; Figure 19 shows the decompression tissue treatment for six days. And a radiograph of the critical dimension defect filled by the stent shown in FIG. 15 after performing the surgery for twelve weeks; FIG. 20 illustrates a photo according to the present invention. A front view of a reduced pressure delivery system of the embodiment having a manifold delivery tube for inserting a reduced pressure delivery device through a skin into a tissue site; FIG. 21 illustrates the manifold of FIG. An enlarged front view of the delivery tube, the manifold delivery tube comprising a reduced pressure delivery device having a flexible barrier and/or a honeycomb material in a compressed position; FIG. 22 depicts the difference shown in FIG. An enlarged front view of the tube delivery tube showing the flexible barrier and/or honeycomb material of the reduced pressure delivery device in an expanded position after being pushed in from the manifold delivery tube; Figure 23 illustrates a first embodiment in accordance with the present invention A front view of the reduced pressure delivery system of the embodiment, the reduced pressure delivery system having a reduced pressure 119763.doc-56-200808396 through the skin showing the reduced permeability film delivery device inserted into a tissue site Manifold delivery tube, the pressure delivery device is outside the manifold delivery tube, but is constrained to a compression position; the figure shows impermeability. Figure 24 shows one of the reduced pressure delivery systems shown in Figure 23. The pressure reducing conveying device is located outside the manifold conveying pipe but is restrained by a film at a relaxed position; FIG. 25 illustrates one of the pressure reducing conveying systems shown in FIG. 23, and the drawing is shown in the figure. The conveying device is located outside the manifold conveying pipe, and the first breaking and the non-permeable membrane are constrained to an expansion position; FIG. 25A illustrates the vacuum conveying system shown in FIG. 23, which is shown in the figure. The reduced pressure delivery device is outside the manifold delivery tube. i is called, but surrounded by an impermeable film at an expanded position; FIG. 26 is a front elevational view of a reduced pressure delivery system having a skin for use in accordance with an embodiment of the present invention; - the reduced pressure delivery and closing device is inserted into the manifold delivery tube of a tissue site, the figure shows that the decompression = _ delivery device is outside the manifold delivery tube, but is bound by a non-penetrating film with a glue seal; &quot 26A is a front elevational view of a reduced pressure delivery system in accordance with an embodiment of the present invention, and FIG. 27 illustrates a front view of a reduced pressure delivery system having a reduced pressure delivery system in accordance with an embodiment of the present invention. a manifold delivery tube for injecting a reduced pressure delivery device to a tissue site for overlying the skin; FIG. 27A illustrates a front view of a reduced pressure delivery system having a decompression delivery system in accordance with an embodiment of the present invention; Manifold delivery tube for use in 119763.doc -57 - 200808396 = over-skin-reduced delivery device to an impermeable film at the tissue site; FIG. 28 depicts an embodiment in accordance with the present invention - Save the purposes of the tissue site it flowchart of the method for treating tissue; ... illustrated in FIG. 29 - Species according to the invention - Example flowchart of a method of reduced pressure tissue treatment administered to the site of knitting row n;

圖崎示-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3〗圖解說明一種根據本發明—實_ _ 行減麼組織治療之方法之流程圖; 圖32緣示-種根據本發明—實施例之減壓輸送裝置之剖 面正視圖’該減壓輸送裝置包括一競假體,該競假體具有 複數個流動通道,以用於對環繞該競假體之骨路區域施加 減低之壓力;BRIEF DESCRIPTION OF THE DRAWINGS FIG. 3 is a flow chart showing a method for performing decompression tissue treatment on a tissue site according to an embodiment of the present invention; FIG. 3 illustrates a flow of a method for treating tissue according to the present invention. Figure 32 is a cross-sectional elevation view of a reduced pressure delivery device in accordance with the present invention. The reduced pressure delivery device includes a competitive body having a plurality of flow passages for surrounding Applying reduced pressure to the bone road area of the competitive body;

圖33圖解說明圖32所示髖 具有苐二複數個流動通道, 假體之骨骼區域; 饭體之剖面正視圖,該髖假體 以用於將流體輸送至環繞該髖 圖34繪示-種根據本發明—實施例使用減壓組織治療來 修復患者關節之方法之流程圖; 圖35圖解說明—種根據本發明—實施例之減壓輸送裝置 之剖面正視圖’該減壓輸送裝置包含—㈣外科固定器 件該續形外科固定器件具有複數個流動通道,以用於對 晚鄰該_外科固定器件之骨路區域制減低之壓力;、 圖36緣示圖35所示橋形外科固定器件之剖面正視圖,該 119763.doc -58- 200808396 績开/外科固疋☆件具有第二複數個流動通道,以用於將流 體輸送至晚鄰該矯形外科固μ件之骨路區域; 圖37圖解說明一種根據本發明一實施例用於使用減壓组 織治療來醫治骨路之骨路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Figure 33 illustrates the hip of Figure 32 having a plurality of flow channels, a skeletal region of the prosthesis; a cross-sectional elevation view of the ham prosthesis for delivering fluid to the surrounding hip. A flow chart of a method for repairing a joint of a patient using reduced pressure tissue treatment in accordance with the present invention - FIG. 35 illustrates a cross-sectional elevation view of a reduced pressure delivery device in accordance with the present invention - an embodiment of the reduced pressure delivery device includes - (4) Surgical fixation device The continuation surgical fixation device has a plurality of flow passages for reducing the pressure of the bone path region of the adjacent surgical fixation device; FIG. 36 is the edge of the bridge surgical fixation device shown in FIG. The front view of the section, the 119763.doc -58-200808396 performance/surgical fixation ☆ piece has a second plurality of flow channels for delivering fluid to the bone path area of the orthopaedic solid member; 37 illustrates a flow chart of a method for treating a bone path defect of a bone road using reduced pressure tissue therapy in accordance with an embodiment of the present invention; FIG. 38 illustrates a set for use in a group according to an embodiment of the present invention. The flowchart of a method of treating tissue site administered decompression; and

圖39圖解說明-種根據本發明—實施例用於對_組織部 位施行減壓組織治療之方法之流程圖。 圖40至圖48繪示根據本發明一實施例之減壓輸送系統之 各種視圖,該減壓輸送系統具有一主歧管,該主歧管包括 一核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至圖50圖解說明一種根據本發明一實施例之減壓輸 送系統之透視圖及俯視剖面圖,該減壓輸送系統具有一成 一體地連接至一減壓輸送管之主歧管; 圖51繪示與一輔助歧管一起應用於一骨骼組織部位之圖 40至圖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】 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 119763.doc •59- 200808396Figure 39 is a flow chart showing a method for performing decompression tissue treatment on a tissue portion in accordance with the present invention. 40 to 48 are various views of a reduced pressure delivery system having a main manifold including a core surrounding a flexible flow wall of a main flow passage, and a vacuum manifold according to an embodiment of the present invention. a plurality of holes in the flexible wall; FIGS. 49-50 illustrate a perspective view and a top cross-sectional view of a reduced pressure delivery system having an integral connection to the vacuum delivery system in accordance with an embodiment of the present invention a main manifold of a reduced pressure delivery tube; FIG. 51 is a perspective view of the main manifold shown in FIGS. 40 to 50 applied to a bone tissue portion together with an auxiliary manifold; and FIG. 52 illustrates a method according to the present invention. An embodiment has a schematic view of a reduced pressure delivery system fluidly coupled to a valve of a second conduit. [Main component symbol description] 211 Pressure reducing device or wing manifold 213 Flexural barrier 215 Ridge portion 219 Wing portion 119763.doc •59- 200808396

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 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 119763. doc -60- 200808396223 arched channel 227 flexible backing 231 protrusion 233 flow channel 241 decompression delivery tube 243 distal orifice 255 proximal orifice 259 lumen or passage 261 double lumen 263 first lumen 265 second lumen 271 Horizontal spacer 311 Vacuum delivery device or wing manifold 313 Flex barrier 315 Ridge portion 319 Wing portion 323 Arched channel 327 Honeycomb material 329 Distribution surface 330 Peripheral surface 341 Pressure relief tube 343 Distal orifice 355 proximal orifice 359 lumen or passage 119763. doc -60- 200808396

371 減壓輸送裝置 3 73 減壓輸送管 3 75 延伸部分 377 遠端 381 切口 3 83 凸肩 385 突起物 3 87 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 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 119763.doc -61 - 200808396371 Reduced pressure delivery device 3 73 Reduced pressure delivery tube 3 75 Extension 377 distal end 381 Incision 3 83 Shoulder 385 Protrusion 3 87 Inner surface 391 Flow channel 411 Reduced pressure delivery device 413 Tissue site 415 Human bone 419 Decompression tube 421 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 119763.doc -61 - 200808396

725 導向單元 727 導引金屬絲 731 骨折部位 733 患者骨絡 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 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 119763.doc -62- 200808396725 Guide unit 727 Guide wire 731 Fracture site 733 Patient bone 735 Skin 739 Soft tissue 743 Tapered distal end 751 Path 761 Reduced pressure delivery device 765 Flexible barrier 767 Honeycomb material 769 Decompression delivery tube 811 Decompression delivery system 821 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 label 885 removal device 119763.doc -62- 200808396

891 輔助管腔或管 911 減壓輸送系統 921 歧管輸送管 937 虛線 943 遠端 961 減壓輸送裝置 965 撓性障壁 967 蜂巢狀材料 969 減壓輸送管 971 不滲透性薄膜 973 内表面 977 膠封 981 標諸 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 119763.doc -63 - 200808396891 auxiliary lumen or tube 911 decompression 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 standard 985 decompression conveying system 987 guiding wire 989 decompression conveying pipe 991 decompression conveying device 993 tissue part 1011 decompression conveying system 1021 manifold conveying pipe 1025 tissue part 1029 gap 1035 decompression conveying device 1043 distal end 119763 .doc -63 - 200808396

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 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 119763.doc •64- 2008083961055 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 Transverse branch line 1547 Transverse branch line 1551 Decompression line 1553 Reduced pressure supply 1565 Connection 埠1571 Fluid delivery line 1573 Fluid delivery source 1583 Main feed line 1585 Transverse branch line 1711 Reduced pressure delivery device 1715 Orthopedic fixation device 1717 Bone 119763.doc •64 - 200808396

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 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 -65- 119763.doc 2008083961719 Fracture site 1721 Passage 1725 Screw 1735 Porous coating 1741 Flow channel 1743 Main feed line 1745 Connection 埠 1747 Lateral branch line 1751 Reduced pressure line 1753 Reduced pressure supply 1761 Flow channel 1765 Connection 埠 1771 Fluid delivery tube 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 Near end 2129 Transition zone 2135 Anti-blocking part 2137 Protrusion -65- 119763.doc 200808396

2141 内表面 2145 脊 2149 蜂巢狀材料 2155 孔 2161 第一導管 2163 第二導管 2171 頂隙 2211 減壓輸送系統 2215 主歧管 2217 減壓輸送管 2223 中央管腔 2225 輔助管腔 2231 孔 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π 2439 閥門 2453 控制器 119763.doc -66 -2141 Inner surface 2145 Ridge 2149 Honeycomb material 2155 Hole 2161 First conduit 2163 Second conduit 2171 Headspace 2211 Reduced pressure delivery system 2215 Main manifold 2217 Pressure relief tube 2223 Central lumen 2225 Secondary lumen 2231 Hole 2241 Clearance 2321 Auxiliary manifold 2411 decompression delivery system 2415 manifold 2419 first conduit 2423 second conduit 2429 decompression source 2435 out π 2439 valve 2453 controller 119763.doc -66 -

Claims (1)

200808396 十、申請專利範圍: 一種用於對一組織部位應用一減壓組織治療之減壓輸送 系統,其包括: 一具有複數個流動通道之歧管,該歧管經構造以毗鄰 該組織部位放置; 第一導官’其與該歧管之該等流動通道流體連通, 以將一減低之壓力輸送至該等流動通道; 第一導官’其與該歧管之該等流動通道流體連通; 一閥門’其以可操作方式連接至該第二導管,以在將 忒閥門定位於一開啟位置時選擇性地用周園空間清潔該 第二導管;及 :控制器,其以可操作方式連接至該閥門,以在經由 呑第一 s輸送減低之壓力期間在一所選間隔將該閥門 置於該開啟位置達一所選時間量。 2.200808396 X. Patent Application Range: A reduced-pressure delivery system for applying a reduced-pressure tissue treatment to a tissue site, comprising: a manifold having a plurality of flow channels, the manifold being configured to be placed adjacent to the tissue site The first pilot' is in fluid communication with the flow passages of the manifold to deliver a reduced pressure to the flow passages; the first pilot' is in fluid communication with the flow passages of the manifold; a valve operatively coupled to the second conduit to selectively clean the second conduit with the circumferential space when the helium valve is positioned in an open position; and: a controller operatively coupled To the valve, the valve is placed in the open position for a selected amount of time at a selected interval during the pressure reduction via the first s delivery. 2. 3. 4. 5. 6. 如請求項1之系統,其中·· "亥所選時間量約為兩秒鐘;及 “所選間隔約為六十秒鐘。 ϋ求項1之系統,其中該減低之壓力係循環地應用。 如明求項1之系統’其中在應用減低之壓力的一時間 /月/月間,經由該第二導管輸送該空氣。 4ζί3 jg / 如咬二、1之系統,其中該組織部位包括硬組織。 1 / 、之系、、先,其中該組織部位包括軟組織。 如請灰 之糸、、先其中該組織部位係由選自如下組 全 、、' 、、且織構成:脂肪組織,肌肉組織,神經組織, 119763.doc 200808396 膚組織,血管組織,結締組織,軟骨,腱,及韌帶。 3求項1之糸統’其中該歧管係一蜂巢狀發泡體。 9·如請求項1之系統,其中該第一導管及該第二導管係一 多管腔管内之管腔。 10·如研求項丨之系統,其中該第一導管與該第二導管係分 離之管。 Μ ιι· 一種對一組織部位施行一減壓組織治療之方法,其包 括: 〆、 _________將—具有複數個流動通道之歧管毗鄰該組織部位定 位以使該等流動通道之至少一部分與該組織部位流體 連通; 、經由一繁—m ^ u * ¥ &將一減低之壓力應用至該組織部位, 該第一導瞢呈古$ ,丨 守&至少一個與該等流動通道流體連通之出 口;及 —藉由經由一第二導管將一流體輸送至一緊靠該第一導 • &之該至少一個出口之區域來清潔該第一導管中或附近 之阻塞物。 12·如清求項11之方法 泰 其中該流體之壓力大於該減低之壓 力0 其中該流體係選自由經過濾空氣與 13 ·如睛求項11之方法 氮氣之群組。 14. 15. 如睛求項11之方法 ^ & ’其中循環地應用該減低之壓力。 如晴求項11之方法 4 ’其中在應用減低之壓力的一時間 期期間經由該第-道Μ A —導管輪送該流體。 119763.doc 200808396 16.如請求項15之Μ,其中該流體流動速率因該減低之壓 力而小於該流動速率。 胃求項15之方法,其中該流體流動速率因該減低之壓 力而小於該流動速率之1 / 1 〇。 18.如請求項15之方法,其中該流體流動速率因該減低之壓 力而小於5亥流動速率之1 / 1 〇 〇。 19·如請求項11之系統,其中該組織部位包括硬組織。 20·如印求項11之系統,其中該組織部位包括軟組織。 21·如請求項11之方法,其中該組織部位係由選自如下組織 群組之組織構成:脂肪組織,肌肉組織,神經組織,皮 膚、、且Λ 血管組織,結締組織,軟骨,腱,及韌帶。 22·如請求項11之方法,其中該歧管係一蜂巢狀發泡體。 如明求項11之方法,其中該第一導管與該第二導管係一 多管腔管内之管腔。 如π求項11之方法,其中該第一導管與該第二導管係分 離之管。 25. 如明求項u之方法,其中該流體在輸送之前係經過濾以 防止污染物進入。 26. 種對一組織部位施行一減壓組織治療之方法,其包 括: 將一具有複數個流動通道之歧管毗鄰該組織部位定 位 以使該等流動通道之至少一部分與該組織部位流體 連通; 、差由 第一導管將一減低之壓力應用至該組織部位, 119763.doc 200808396 一個與該等流動通道流體連通之出 開啟-與-第二導管以可操作方式 "&以一大於該減低壓力之壓力暴露於一流體,在 :所選間隔將該閥門開啟一所選時間量,以容許經由該 弟二導管來輸送該流體,從而幫助清除該第 : 附近之阻塞物。 円或 27·如請求項%之方法,其中··3. 4. 5. 6. In the system of claim 1, wherein the selected time is approximately two seconds; and “the selected interval is approximately sixty seconds. The system of claim 1 is Wherein the reduced pressure is applied cyclically. The system of claim 1 wherein the air is delivered via the second conduit during a time/month/month of application of the reduced pressure. 4ζί3 jg / such as bite 2, 1 a system, wherein the tissue site comprises a hard tissue. 1 / , a system, a first, wherein the tissue site comprises a soft tissue. If the gray matter is selected, the tissue site is selected from the group consisting of: , , And weaving composition: adipose tissue, muscle tissue, nerve tissue, 119763.doc 200808396 Skin tissue, vascular tissue, connective tissue, cartilage, tendon, and ligament. 3 The system of claim 1 'the manifold is a honeycomb 9. The system of claim 1, wherein the first catheter and the second catheter are lumens within a multi-lumen tube. 10. The system of the present invention, wherein the first catheter and the first Two conduits are separate tubes. Μ ιι· a pair The method of performing a reduced-pressure tissue treatment, comprising: 〆, _________ positioning a manifold having a plurality of flow channels adjacent to the tissue site such that at least a portion of the flow channels are in fluid communication with the tissue site; a complex-m ^ u * ¥ & apply a reduced pressure to the tissue site, the first guide is an ancient $, 丨 &&; at least one outlet in fluid communication with the flow channels; and - by A fluid is delivered to a region of the first conduit that is in close proximity to the at least one outlet of the first conduit via a second conduit to clean the obstruction in or near the first conduit. Wherein the pressure of the fluid is greater than the reduced pressure 0 wherein the flow system is selected from the group consisting of filtered air and a method of nitrogen. 14. 15. The method of claim 11 ^ & ' Wherein the reduced pressure is applied cyclically. Method 4 of the method of claim 11 wherein the fluid is transferred via the first ballast A during a period of application of the reduced pressure. 119763.doc The method of claim 15, wherein the fluid flow rate is less than the flow rate due to the reduced pressure. The method of claim 15, wherein the fluid flow rate is less than the flow rate due to the reduced pressure 18. The method of claim 15, wherein the fluid flow rate is less than 1 / 1 流动 of the flow rate of 5 kPa due to the reduced pressure. 19. The system of claim 11, wherein the tissue site comprises Hard organization. 20. The system of claim 11, wherein the tissue site comprises soft tissue. The method of claim 11, wherein the tissue site is composed of a tissue selected from the group consisting of adipose tissue, muscle tissue, nerve tissue, skin, and vasculature, connective tissue, cartilage, sputum, and ligament. The method of claim 11, wherein the manifold is a honeycomb foam. The method of claim 11, wherein the first catheter and the second catheter are a lumen within the plurality of lumens. A method of claim 11, wherein the first conduit is separate from the second conduit. 25. The method of claim u, wherein the fluid is filtered prior to delivery to prevent ingress of contaminants. 26. A method of performing a reduced pressure tissue treatment on a tissue site, comprising: positioning a manifold having a plurality of flow channels adjacent to the tissue site such that at least a portion of the flow channels are in fluid communication with the tissue site; Applying a reduced pressure to the tissue site by the first catheter, 119763.doc 200808396 An open-and-second catheter in fluid communication with the flow channels is <> The pressure reducing pressure is exposed to a fluid at a selected interval for opening the valve for a selected amount of time to permit delivery of the fluid via the second conduit to assist in clearing the obstruction in the vicinity:円 or 27·If the method of requesting %, where ·· 該所選時間量約為兩秒鐘;及 ~ ~ ~' — __ 該所選間隔約為六十秒鐘。 — - 28·如請求項26之方法’其中該流體係-氣態流體。 29.如請求項28之方法’其中該氣態流體係選自經過濾空 氣、氧氣、及氮氣之群組。 3〇·如凊求項26之方法,其中該流體係選自如下之群組:抗The selected amount of time is approximately two seconds; and ~ ~ ~' — __ The selected interval is approximately sixty seconds. — 28 — The method of claim 26 wherein the flow system is a gaseous fluid. 29. The method of claim 28 wherein the gaseous flow system is selected from the group consisting of filtered air, oxygen, and nitrogen. 3. The method of claim 26, wherein the flow system is selected from the group consisting of: 該第一導管具有至少 口;及 菌劑,抗病毒劑,細胞生長促進劑,清潔流體,化學活 性流體,及止痛劑。 31·如請求項26之方法,其中循環地應用該減低之壓力。 32·如請求項26之方法,其中在應用減低之壓力的一時間週 期期間經由該第二導管輸送該流體。 33·如請求項26之方法,其中該組織部位包括硬組織。 34·如請求項26之方法,其中該組織部位包括軟組織。 35·如請求項26之方法,其中該組織部位係由選自如下組織 群組之組織構成: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,及韌帶。 119763.doc 200808396 3 6.如請求項26之方法,其中該歧管係一蜂巢狀發泡體。 37·如請求項26之方法,其中該第一導管與該第二導管係一 多管腔管内之管腔。 38_如請求項26之方法,其中該第一導管與該第二導管係分 離之管。The first catheter has at least a mouth; and a microbial agent, an antiviral agent, a cell growth promoter, a cleaning fluid, a chemically active fluid, and an analgesic. 31. The method of claim 26, wherein the reduced pressure is applied cyclically. 32. The method of claim 26, wherein the fluid is delivered via the second conduit during a period of time during which the reduced pressure is applied. 33. The method of claim 26, wherein the tissue site comprises a hard tissue. 34. The method of claim 26, wherein the tissue site comprises soft tissue. The method of claim 26, wherein the tissue site is composed of a tissue selected from the group consisting of adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendon, and ligament. 6. The method of claim 26, wherein the manifold is a honeycomb foam. 37. The method of claim 26, wherein the first catheter and the second catheter are a lumen within a plurality of lumens. 38. The method of claim 26, wherein the first conduit is separate from the second conduit. 119763.doc119763.doc
TW096112901A 2007-02-06 2007-04-12 System and method for purging a reduced pressure apparatus during the administration of reduced pressure treatment TWI346547B (en)

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US11/702,822 US7651484B2 (en) 2006-02-06 2007-02-06 Systems and methods for improved connection to wound dressings in conjunction with reduced pressure wound treatment systems
US11/717,893 US8235939B2 (en) 2006-02-06 2007-03-13 System and method for purging a reduced pressure apparatus during the administration of reduced pressure treatment

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TW098136028A TWI359678B (en) 2007-02-06 2007-04-12 A system for applying reduced pressure to a tissue
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