TW200836785A - System for administering reduced pressure teratment having a manifold with a primary flow passage and a blockage prevention member - Google Patents

System for administering reduced pressure teratment having a manifold with a primary flow passage and a blockage prevention member Download PDF

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Publication number
TW200836785A
TW200836785A TW96112180A TW96112180A TW200836785A TW 200836785 A TW200836785 A TW 200836785A TW 96112180 A TW96112180 A TW 96112180A TW 96112180 A TW96112180 A TW 96112180A TW 200836785 A TW200836785 A TW 200836785A
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TW
Taiwan
Prior art keywords
reduced pressure
tissue
manifold
primary
tissue site
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TW96112180A
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Chinese (zh)
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TWI347205B (en
Inventor
Douglas A Cornet
Michael Manwaring
Larry D Swain
Jonathan Kagan
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Kci Licensing Inc
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Priority claimed from US11/724,072 external-priority patent/US20070219585A1/en
Application filed by Kci Licensing Inc filed Critical Kci Licensing Inc
Publication of TW200836785A publication Critical patent/TW200836785A/en
Application granted granted Critical
Publication of TWI347205B publication Critical patent/TWI347205B/en

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Abstract

A reduced pressure delivery system is provided and includes a primary manifold, a blockage prevention member, and first and second conduits in fluid communication with the primary manifold. The primary manifold includes a flexible wall surrounding a primary flow passage and is adapted to be placed in proximity to a tissue site. The blockage prevention member is positioned within the primary flow passage. A plurality of apertures is disposed in the flexible wall to communicate with the primary flow passage. The first conduit is fluidly connected to the primary flow passage to deliver reduced pressure through the primary flow passage and the plurality of apertures. The second conduit includes an outlet proximate the primary flow passage or an outlet of the first conduit to purge the primary flow passage or first conduit to prevent blockages.

Description

200836785 九、發明說明: 【發明所屬之技術領域】 本發明大體係關於一種促進組織生長之糸統或方法,且 更特定言之係關於一種向一組織部位施加減壓組織療法之 系統。 【先前技術】 現正愈來愈多地使用減壓療法促進在無減壓療法之情況 下緩慢癒合或無法癒合之軟組織創傷的創傷癒合。通常, fψ 1 經由用作分佈減壓之歧管的開孔發泡體(open_cell foam)將 減壓施加至創傷部位。改變開孔發泡體之尺寸以使其配合 現存創傷,將其置放於與創傷接觸之處且隨後當創傷開始 癒合且變小時定期以較小發泡體片加以替換。必需頻繁替 換開孔發泡體以使生長至發泡體孔中之組織量減至最少。 大量組織生長於發泡體孔中可能會在移除發泡體之過程中 使患者感到疼痛。 通常將減壓療法施加於無法癒合之開放式創傷。在一些 情況下,癒合組織為皮下組織,且在其他情況下,該等組 織係位於真皮組織内或真皮組織上 上。減壓療法主要慣用於200836785 IX. INSTRUCTIONS OF THE INVENTION: TECHNICAL FIELD OF THE INVENTION The present invention relates to a system or method for promoting tissue growth, and more particularly to a system for applying reduced pressure tissue therapy to a tissue site. [Prior Art] Decompression therapy is increasingly being used to promote wound healing of soft tissue wounds that heal slowly or fail to heal without decompression therapy. Typically, fψ 1 is applied to the wound site via an open-cell foam used as a manifold for distributing reduced pressure. The apertured foam is sized to fit the existing wound, placed in contact with the wound and then periodically replaced with a smaller foam sheet as the wound begins to heal and become smaller. It is necessary to frequently replace the open-cell foam to minimize the amount of tissue grown into the pores of the foam. The growth of a large amount of tissue in the pores of the foam may cause pain to the patient during removal of the foam. Decompression therapy is usually applied to open wounds that cannot heal. In some cases, the healing tissue is subcutaneous tissue, and in other cases, the tissue is located within or on the dermal tissue. Decompression therapy is mainly used

119640.doc 200836785 一段時間減壓療法後移除之開孔發泡體片更先進之進展。 【發明内容】 藉由本發明之系統及方法可解決現存創傷癒合系統及方 法所存在之問題。根據本發明之一實施例提供一種減壓傳 遞系統以向組織部位施加減壓。該減壓傳遞系統包括一主 要歧管,該主要歧管具有一;裒繞一主要流動通道且經調適 以置放於接近一組織部位處之可撓性壁。該可撓性壁包括 一内表面,該内表面具有複數個自該内表面之至少一部分 延伸且進入主要流動通道中之突起。該可撓性壁另外包括 複數個穿過可撓性壁與主要流動通道連通之小孔。第一管 道係與該主要流動通道流體連接以經由該主要流動通道及 該複數個小孔傳遞減壓。第二管道包括至少—個接近該主 要流動通道或該第一管道之至少一個出口之出 第一官道之至少一個出口處或其附近之阻滯。 口以淨化該 本發明之另一實施例提供一種減壓傳遞系統且其包括一 支g ΰ亥主要歧官具有環繞主要流動通道且經調適以 放於接近組織部位之處之可撓性壁。該可撓性壁包括複 少牙過可說性壁與主要流動通道連通之小孔。多泡材料 係疋位於主要流動通道内,且該多泡材料包括複數個流動 通路0第一总、苦〆 长 g、係與該主要流動通道流體連接以經由該主 勺動l道多泡材料及複數個小孔傳遞減壓。第二管道 , ^ 個接近該主要流動通道或該第一管道之至少/ 、 出口以淨化該第—管道之至少一個出口處或其附 119640.doc 200836785119640.doc 200836785 The advancement of open-cell foam tablets removed after a period of decompression therapy. SUMMARY OF THE INVENTION The problems of existing wound healing systems and methods can be solved by the system and method of the present invention. According to one embodiment of the invention, a reduced pressure delivery system is provided to apply reduced pressure to a tissue site. The reduced pressure delivery system includes a primary manifold having a plurality of flexible flow walls disposed about a primary flow channel and adapted for placement adjacent a tissue site. The flexible wall includes an inner surface having a plurality of protrusions extending from at least a portion of the inner surface and into the main flow passage. The flexible wall additionally includes a plurality of apertures that communicate with the primary flow passage through the flexible wall. A first conduit is fluidly coupled to the primary flow passage to deliver a reduced pressure via the primary flow passage and the plurality of orifices. The second conduit includes at least one retardation at or near at least one outlet of the first official passage adjacent the primary flow passage or the at least one outlet of the first conduit. Port to Purify This another embodiment of the present invention provides a reduced pressure delivery system and includes a flexible wall having a primary sulcus that surrounds the primary flow channel and is adapted to be placed proximate to the tissue site. The flexible wall includes an aperture through which the plurality of teeth communicate with the main flow passage. The multi-bubble material is located in the main flow channel, and the multi-bubble material comprises a plurality of flow channels 0, a first total, a bitter length g, and is fluidly connected to the main flow channel to move the multi-bubble material through the main spoon And a plurality of small holes pass the decompression. a second conduit, close to the main flow passage or at least / outlet of the first conduit to purify at least one outlet of the first conduit or its attachment 119640.doc 200836785

本發明之另一實施你丨與也 _ L 、例楗供一種減壓傳遞系統且其包括一 主要歧管,該主要歧瞢呈古班 衣、、兀主要流動通道且經調適以 置放於接近組織部位之處之可撓性壁。主要歧管包括定位 於t要流動通道内之阻滯防止元件。複數個小孔安置於該 ,、 支机動通道連通。次要歧管係定位於 鄰近该主要歧管處,日奴▲田、* *支以且經调適以與組織部位接觸,從而使 该次要歧管與該主要歧營漭_ &机體連通,但其亦經調適以防止 該主要歧管與組織部位接觸。第 _ 碼弟官道係與該主要流動通 道k體連接以經由該主要流動 動通道及该禝數個小孔傳遞減 壓。 在本發明之另一實施例中,用 Τ用於促進組織處組織生長之 方法包括以外科手術將主要歧管定位於接近組織部位處。 該主要歧管包括環繞主要流動通道之可撓性壁。該可撓性 壁包括複數個穿過可撓性壁與主要流動通道連通之小孔。 主要歧管另外包括定位於主要流 受机勳通道内之阻滯防止元 ί 件。該方法另外包括以外科手彳丨 行于術疋位次要歧管以使其與組 織部位接觸,從而使該次要歧管 夂&興逵主要歧管流體連通, 但防止該主要歧管與組織部位接 、 饮’減壓係經由主要流動 通道'複數個小孔及次要歧管傳遞至組織部位。 芩看下文之圖式及實施方式將對本發明之其他目的、特 徵及優勢顯而易見。 【實施方式】 j下文對於較佳實施例之詳細描述中,參考形成該等較 h施例之-部分的隨附圖<,且其中已藉助實行本發明 119640.doc 200836785 之例不性特定較佳實施例進行展示。已足夠詳細地對此等 貫施例進行描述以使熟習此項技術者能夠實行本發明,且 應瞭解可利用其他實施例且在不背離本發明之精神或範疇 之炀況下進行邏輯結構、機械、電子及化學之改變。為避 免非熟習此項技術者實行本發明所必需之細節,該描述可 旎省略某些熟習此項技術者已知之資訊。因此,不應將以 下實施方式理解為限制之義,且本發明之範疇僅由隨附申 請專利範圍界定。 如本文所使用之術語,,彈性”意謂具有彈性體之特性。術 語”彈性體"一般係指具有橡膠樣特性之聚合材料。更特定 言之,大部分彈性體均具有大於1〇〇%之伸長率及大量彈 性能。材料之彈性能係指材料由彈性變形回復之能力。彈 性體之實例可包括(但不限於)天然橡膠、聚異戊二烯、苯 乙烯丁二烯橡膠、氯丁二烯橡膠、聚丁二烯、腈橡膠、丁 基橡膠、乙烯丙烯橡膠、乙烯丙烯二烯單體、氯磺化聚乙 烯、聚硫鱗橡膠、聚胺基甲酸酯及聚矽氧。 如本文所使用之術語,,可撓性"係指能夠彎曲或撓曲之物 件或材料。彈性體材料通常具有可撓性,但本文提及可撓 性材料未必是將材料之選擇僅限於彈性體。結合本發明之 材料或減壓傳遞設備使用之術語”可撓性,,一般係指材料符 合或緊密匹配組織部位之形狀的能力。舉例而言,用於治 療骨骼缺損之減壓傳遞設備的可撓性質可使該設備包覆或 折疊於具有缺損之骨骼部分的周圍。 如本文所使用之術語"流體”一般係指氣體或液體,但亦 119640.doc 200836785Another embodiment of the present invention provides a reduced pressure delivery system and includes a primary manifold that is a conventional flow passage and is adapted to be placed in the main flow path. A flexible wall near the tissue site. The primary manifold includes a retardation preventing element positioned within the flow channel to be t. A plurality of small holes are disposed therein, and the motorized passages are connected. The secondary manifold is positioned adjacent to the main manifold, the Japanese slave, the field, and adapted to contact the tissue site, thereby making the secondary manifold and the primary manifold _ & The body is connected, but it is also adapted to prevent contact of the primary manifold with the tissue site. The first _ code is connected to the main flow channel k body to transmit the pressure reduction via the main flow passage and the plurality of small holes. In another embodiment of the invention, a method for promoting tissue growth at a tissue comprising surgically positioning a primary manifold proximate to a tissue site. The primary manifold includes a flexible wall that surrounds the primary flow channel. The flexible wall includes a plurality of apertures that communicate with the primary flow passage through the flexible wall. The primary manifold additionally includes a block prevention element located within the main flow channel. The method additionally includes surgically handing the secondary manifold to the surgical site to contact the tissue site, thereby fluidly connecting the secondary manifold and the primary manifold, but preventing the primary manifold The tissue is connected to the tissue site, and the decompression system is delivered to the tissue site through a plurality of small holes and a secondary manifold through the main flow channel. Other objects, features and advantages of the invention will be apparent from the description and appended claims. [Embodiment] Hereinafter, in the detailed description of the preferred embodiments, reference is made to the accompanying drawings of the portions forming the h-th embodiment, and wherein the specific example of the invention is 119640.doc 200836785 The preferred embodiment is shown. The present invention has been 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 the logical structure may be practiced without departing from the spirit or scope of the invention. Mechanical, electronic and chemical changes. To avoid the details necessary for the practice of the invention, the description may omit certain information known to those skilled in the art. Therefore, the following embodiments are not to be construed as limiting, and the scope of the invention is defined only by the scope of the accompanying claims. As used herein, the term "elastic" means having the properties of an elastomer. The term "elastomer" generally refers to a polymeric material having rubber-like properties. More specifically, most elastomers have an elongation of greater than 1% and a large amount of elastic properties. The elastic energy of a material refers to the ability of the material to recover from elastic deformation. Examples of the elastomer may include, but are not limited to, natural rubber, polyisoprene, styrene butadiene rubber, chloroprene rubber, polybutadiene, nitrile rubber, butyl rubber, ethylene propylene rubber, ethylene. Propylene diene monomer, chlorosulfonated polyethylene, polysulfide rubber, polyurethane, and polyoxyn oxide. As used herein, the term "flexible" refers to an article or material that is capable of bending or flexing. Elastomeric materials are generally flexible, but reference herein to flexible materials is not necessarily limited to the choice of materials to elastomers. The term "flexibility" as used in connection with the materials or reduced pressure delivery devices of the present invention generally refers to the ability of the material to conform to or closely match the shape of the tissue site. For example, a reduced pressure delivery device for treating bone defects may be used. The flexible material allows the device to be wrapped or folded around the portion of the bone having the defect. As used herein, the term "fluid" generally refers to a gas or liquid, but also 119640.doc 200836785

體及發泡體。Body and foam.

量測值,諸如水蒸氣轉移速率(WVTR)之特定值。The measured value, such as a specific value of the water vapor transfer rate (WVTR).

一般係指為協助將減壓施加 至組織部位、將流體傳遞至組織部位或將流體自組織部位 移除而提供的物質或結構。歧管通常包括複數個流動通路 或路徑,其經互連以改良提供至該歧管周圍之組織區域及 自該歧管周圍之組織區域移除之流體的分佈。歧管之實例 可包括(但不限於)具有經排列以形成流動通路之結構要件 的裝置、多泡發泡體(諸如開孔發泡體)、多孔組織集合及 包括或處理以包括流動通路之液體、凝膠及發泡體。 如本文所使用之術語,,減壓” 一般係指低於經歷治療之組 織部位處之周圍壓力的壓力。在大多數情況下,此減壓將 小於患者所處之大氣壓。或者,該減壓可小於組織部位處 之組織靜水壓力。儘管術語,,真空”及”負壓,,可用於描述施 加至組織部位之壓力,施加至組織部位之實際壓力可顯著 低於通$與元全真空相關之壓力。減壓可最初在管及組織 部位區域中產生流體流動。當組織部位周圍之靜水壓力接 119640.doc -10 - 200836785 近所需之減屢時,流動可減弱且隨後該減屢得以維持。除 非另作指示,否則本文所述之壓力值為表壓。 * 如本文所使用之術語”支架"係指用於增強或促進細胞生 長及/或組織形成之物質或結構。支架通常為提供細胞生 長之模板的三維多孔結構。可以細胞、生長因子或促進細 胞生長之其他養分灌輸、包覆或包含該支架。根據本文所 述之實施例’可將支架用作歧管以向組織部位施予減堡組 織療法。 如本文所使用之術語"組織部位"係指位於包括(但不限 於)骨骨各組織、脂肪組織、肌肉組織、神經組織、真皮組 織、血管組織、結締組織、軟骨、腱或韌帶之任何組織上 或其内之創傷或缺損。術語”組織部位"可另外指無需受傷 或缺損但作為需要添加額外組織或促進額外組織生長之代 曰區域的任何組織區域。舉例而言,在某些組織區域中可 使用減壓組織療法以生長可經採集且移植至另一組織位置 的額外組織。 參看圖1-5,根據本發明原理之減壓傳遞設備或翼狀歧 笞211匕括具有犬出部分2 1 $及一對側翼部分21 9之可撓性 P早壁213。各側翼部分219均係沿突出部分215之相對側定 位。突出部分215形成可延伸或不延伸翼狀歧管211之全長 的弓狀通路233。儘管突出部分215可位於翼狀歧管211之 中〜彳之而使邊側翼部分219之寬度相等,但如圖U所示亦 可偏私大出部分21 5 ,從而使一個側翼部分2丨9比另一側翼 P刀219覓。在將翼狀歧管211用於骨骼再生或癒合時,一 119640.doc 200836785 個側翼部分2 19之額外寬度可能特別有用',且將使較寬之 翼狀歧官211被包覆在附著至骨骼之固定器具周圍。 可撓性障壁213較佳係由彈性體材料(諸如矽氧聚合物) 形成。適當矽氧聚合物之實例包括Nusil Techn〇1〇gies 〇f Carpmteria,Calif0rnia製造之 MED-6〇15。然而,應注意可 撓性障壁213可由任何其他生物可相容之可撓性材料製 ^可抗丨生卩羊壁2 13其袠覆有增加該可撓性障壁213之強度 及耐久性之可撓性襯底227。弓狀通路223中,裹覆有可撓 襯底227之可撓性障壁2丨3之厚度可比在側翼部分219中 者低若使用矽氧聚合物形成可撓性障壁213,則亦可使 ,聚矽氧黏著劑幫助與可撓性襯底227之黏結。聚矽氧黏 著刎之貝例可包括亦由Nusil 銷售之一 1011。可撓性襯底227較佳係由聚酯針織物(諸如,由d Bard Tempe,Arlzona製造之 Bard 6〇13)製成。然而,可撓 性襯底227亦可由能夠增加可撓性障壁213之強度及财久性 之具生物相容性、可撓性之材料製成。在某些情況下,若 可抗[生障J 2 13係由適當強材料製成,則可省略可撓性襯 底 227。 友可挽性障壁213或可撓性襯底227若為不可滲透液體、空 ^ 一他氣體或另外可撓性襯底227與可撓性障壁213均不 可。透液體、空氣及其他氣體,係較佳的情況。 亦可由使用減壓傳遞設備211後無需自患者體内移除之 物可再吸收性材料建構可撓性障壁川及可挽性襯底 、田之生物可再吸收性材料可包括(但不限於)聚乳酸 119640.doc -12- 200836785 (PLA)與聚乙醇酸(PGA)之聚合摻合物。聚合摻合物亦可包 括(但不限於)聚碳酸酯、聚反丁烯二酸酯及己内酯。可挽 性障壁213及可撓性襯底227可另外用作新細胞生長之支 架,或可將支架材料與可撓性障壁213及可撓性襯底227組 合使用以促進細胞生長。適當之支架材料可包括(但不限 於)鱗酸妈、膠原蛋白、PLA/PGA、珊瑚經基磷灰石、碳 酸酯或經加工之同種異體移植物材料。該支架材料較佳將 具有高空隙分率(亦即,高空氣含量)。 在一實施例中,可撓性襯底227可黏附至可撓性障壁213 之表面。若使用聚矽氧聚合物形成可撓性障壁213,則亦 可使用聚矽氧黏著劑使可撓性襯底227附著至可撓性障壁 2 13。儘官當可撓性襯底227與可撓性障壁2丨3表面接合 時,黏著為較佳之附著方法,但亦可使用任何適當之附著 方法。 可撓性障壁213包括複數個自可撓性障壁2丨3表面上之側 翼部分219延伸之突起231。突起231可為圓柱形、球形、 半球形、立方體或任何其他形狀,只要各突起23丨之至少 某部分在與可撓性襯底213之附著突起23丨側相關之平面不 同的平面中即可。就此點看,特定突起23丨甚至不需要與 其他突起231具有相同形狀或尺寸;事實上,突起231可包 括不同形狀及尺寸之隨機混合。因此,各突起23丨自可撓 性卩早壁213延伸之距離可變化,但複數個突起231亦可保持 均一之距離。 可撓性障壁213上之突起23丨之位置於突起之間產生複數 119640.doc -13 - 200836785 個流動通路233。當突起231具有均一形狀及尺寸且於可撓 性卩早壁213上均一間隔時,突起23 1之間所產生之流動通路 233具有相似均一度。可使用突起23丨尺寸、形狀及間隔之 受化改變流動通路2 3 3之尺寸及流動特性。 如圖5所示’減壓傳遞管241係定位於弓狀通路223内且 附著至可撓性障壁213上。減壓傳遞管241可僅附著至可撓 f生P早壁2 13或可撓性襯底227,或該管241可附著至可撓性 障壁213與可撓性襯底227上。減壓傳遞管241包括在該管 241之返纟而處之逆端孔243。可定位該管24 1從而使遠端孔 243位於沿弓狀通路223之任何點處,但較佳定位該管241 從而使遠端孔243位於沿弓狀通路223之縱向長度之近中間 位置處。較佳藉由沿相對管241之縱向軸小於9〇度定向之 平面切割管241來將遠端孔243製成橢圓形或卵圓形。儘管 孔243亦可為圓形,但橢圓形之孔243增加與突起231之間 形成之流動通路233的流體連通。 減壓傳遞管241較佳係由經名為paraiyne2塗覆材料塗覆 之聚矽氧或胺基甲酸酯製成。然而,可使用任何醫藥級管 材構建減壓傳遞管241。可塗覆該管之其他塗料包括肝 素、抗凝劑、抗纖維蛋白原、抗附著、抗凝血酶原及親水 塗料。 在一實施例中,減壓傳遞管241亦可包括作為遠端孔243 之替代選擇之通風口或通風孔251或除遠端孔243外亦包括 通風口或通風孔25 1(其係沿減壓傳遞管241定位),從而進 一步增加減壓傳遞管241與流動通路233之間之流體連通。 119640.doc -14- 200836785 = 1·5所示’減壓傳遞管241可僅沿弓狀通路223之一部 ,向長度疋位,或另外可沿弓狀通路223之全部縱向長 度^位。若經^位從而使減Μ傳遞管241佔據弓狀通路⑵ 長則了後盍返知孔243從而出現穿過通風口 25 1之管 241與流動通路233之間的所有流體連通。 減壓傳遞管241另外在該管241之近端包括近端孔255。 近端孔255經組態以與減壓源緊密配合,該減壓源將於下 文中參考圖9得到更詳細之描述。圖卜3、从及$中所述之 傳遞e 241僅包括單管腔或通道259。’然而,減壓傳遞 e 241包括多個管腔(諸如圖仙中所述之雙管腔管加)係可 能的二雙管腔管261包括第一管腔263及第二管腔加。使 用雙官腔管提供單獨之減壓傳遞管241之近端與流動通路 233之間的流體連通路徑。舉例而言,使用雙管腔管Μ〗可 用於使減堡源與流動通路233之間沿第一管腔加連通。可 使用第二管腔265將流體引入流動通路233。該流體可為經 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。若需要 使多種流體經由單獨流體連通路徑引入流動通路233則 減壓傳遞管可具有兩個以上管腔。 、 仍芩看圖4B,水平間隔物271分隔減壓傳遞管261之第— b腔263與第二管腔265,從而使第一管腔定位於第二 管腔265之上。第一管腔263與第二管腔265之相對位置可 視如何使管腔263、265與流動通路233之間流體連通而變 化。舉例而言,當如圖4B所述定位第一管腔263時,可提 119640.doc -15- 200836785 傳遞管之多個管腔可關於分隔該等管腔之垂直間隔物彼此 定位’或該等管腔可同心或同軸排列。 供與通風口 251類似之通風口以使其與流動通路233連通。 1如圖4B所述定位第二管腔263時,第二管腔可經由與 遠端孔243類似之遠端孔與流動通路233連通。另外,減壓Generally refers to a substance or structure provided to assist in the application of reduced pressure to a tissue site, delivery of fluid to a tissue site, or removal of fluid from a tissue site. The manifold typically includes a plurality of flow passages or paths interconnected to improve the distribution of fluid provided to the tissue region surrounding the manifold and from the tissue region surrounding the manifold. Examples of manifolds can include, but are not limited to, devices having structural elements arranged to form flow channels, multi-foam foams (such as open cell foams), porous tissue collections, and including or treated to include flow paths. Liquid, gel and foam. As used herein, the term "decompression" generally refers to a pressure that is lower than the ambient pressure at the tissue site undergoing treatment. In most cases, this reduced pressure will be less than the atmospheric pressure at which the patient is located. Can be less than the tissue hydrostatic pressure 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 significantly lower than the full vacuum. Related pressures. Decompression can initially create fluid flow in the area of the tube and tissue. When the hydrostatic pressure around the tissue site is close to the required reduction, the flow can be attenuated and subsequently reduced. Repeatedly maintained. Unless otherwise indicated, the pressure values described herein are gauge pressure. * As used herein, the term "scaffold" refers to a substance or structure used to enhance or promote cell growth and/or tissue formation. The scaffold is typically a three-dimensional porous structure that provides a template for cell growth. The scaffold can be infused, coated or contained with cells, growth factors or other nutrients that promote cell growth. The stent can be used as a manifold to administer a reduced Fortune tissue therapy to a tissue site in accordance with the embodiments described herein. The term "tissue site" as used herein refers to, but is not limited to, bone tissue, adipose tissue, muscle tissue, nerve tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendon or ligament. Trauma or defect in or on any tissue. The term "tissue site" may additionally refer to any tissue region that does not require injury or defect but is a metastatic region where additional tissue or additional tissue growth is desired. For example, decompression tissue therapy may be used in certain tissue regions. Growing additional tissue that can be harvested and transplanted to another tissue location. Referring to Figures 1-5, a reduced pressure delivery device or winged jaw 211 in accordance with the principles of the present invention includes a canine portion 2 1 $ and a pair of flank portions 21 P. flexible P early wall 213. Each of the side wing portions 219 is positioned along the opposite side of the protruding portion 215. The protruding portion 215 forms an arcuate passage 233 that extends or does not extend the entire length of the winged manifold 211. The portion 215 can be located in the wing manifold 211 to make the width of the side wing portions 219 equal, but as shown in FIG. U, the portion 21 5 can also be biased, so that one wing portion 2丨9 is larger than the other. The flank P-knife 219. The extra width of a 119640.doc 200836785 flank portion 2 19 may be particularly useful when using the wing-shaped manifold 211 for bone regeneration or healing, and will result in a wider wing-shaped 219 Wrapped in The flexible barrier 213 is preferably formed of an elastomeric material such as a neon polymer. Examples of suitable oxygenated polymers include Nusil Techn〇1〇gies 〇f Carpmteria, manufactured by Calif0rnia MED-6〇15. However, it should be noted that the flexible barrier 213 may be made of any other biocompatible flexible material to prevent the growth of the sheep wall 2 13 and the addition of the flexible barrier 213 Flexible substrate 227 of strength and durability. In the arcuate passage 223, the thickness of the flexible barrier 2 丨 3 coated with the flexible substrate 227 may be lower than that in the flank portion 219. Forming the flexible barrier 213 may also allow the polyoxygen adhesive to aid adhesion to the flexible substrate 227. The example of the polyoxygenated adhesive may include one of 1011, also sold by Nusil. The bottom 227 is preferably made of a polyester knit fabric such as Bard 6〇13 manufactured by d Bard Tempe, Arlzona. However, the flexible substrate 227 can also be made to increase the strength and wealth of the flexible barrier 213. Made of biocompatible, flexible material. In this case, if it is resistant [the bioshield J 2 13 is made of a suitably strong material, the flexible substrate 227 can be omitted. The friendable barrier 213 or the flexible substrate 227 is impermeable to liquid, empty. ^ A gas or another flexible substrate 227 and the flexible barrier 213 are not permeable. Liquid, air and other gases are preferred. It may also be removed from the patient by using the reduced pressure delivery device 211. In addition to the resorbable material construction of the flexible barrier and the removable substrate, the bioresorbable material of the field may include, but is not limited to, polylactic acid 119640.doc -12- 200836785 (PLA) and poly A polymeric blend of glycolic acid (PGA). Polymeric blends can also include, but are not limited to, polycarbonates, polyfumarates, and caprolactone. The barrier barrier 213 and the flexible substrate 227 may additionally serve as a support for new cell growth, or the stent material may be used in combination with the flexible barrier 213 and the flexible substrate 227 to promote cell growth. Suitable scaffolding materials can include, but are not limited to, squamous acid, collagen, PLA/PGA, coral-based apatite, carbonate, or processed allograft materials. Preferably, the stent material will have a high void fraction (i.e., high air content). In an embodiment, the flexible substrate 227 can be adhered to the surface of the flexible barrier 213. If the flexible barrier 213 is formed using a polyoxyl polymer, the flexible substrate 227 can also be attached to the flexible barrier 2 13 using a polyoxygen adhesive. Adhesion is a preferred method of attachment when the flexible substrate 227 is bonded to the surface of the flexible barrier 2丨3, but any suitable attachment method can be used. The flexible barrier 213 includes a plurality of protrusions 231 extending from the side wing portions 219 on the surface of the flexible barrier 2丨3. The protrusions 231 may be cylindrical, spherical, hemispherical, cubic, or any other shape as long as at least some portion of each of the protrusions 23 is in a plane different from the plane associated with the side of the attachment protrusion 23 of the flexible substrate 213. . In this regard, the specific protrusions 23丨 do not even need to have the same shape or size as the other protrusions 231; in fact, the protrusions 231 may include random blends of different shapes and sizes. Therefore, the distance over which the projections 23 are extended from the flexible early wall 213 can be varied, but the plurality of projections 231 can also maintain a uniform distance. The position of the protrusion 23 on the flexible barrier 213 creates a plurality of 119640.doc -13 - 200836785 flow paths 233 between the protrusions. When the projections 231 have a uniform shape and size and are uniformly spaced apart on the flexible front wall 213, the flow passages 233 generated between the projections 23 1 have similar uniformity. The size, flow, and flow characteristics of the flow path 233 can be varied using the size, shape, and spacing of the protrusions 23丨. As shown in Fig. 5, the reduced pressure transmission tube 241 is positioned in the arcuate passage 223 and attached to the flexible barrier 213. The reduced pressure transfer tube 241 may be attached only to the flexible P early wall 2 13 or the flexible substrate 227, or the tube 241 may be attached to the flexible barrier 213 and the flexible substrate 227. The reduced pressure transfer tube 241 includes a reverse end hole 243 at the return of the tube 241. The tube 24 1 can be positioned such that the distal aperture 243 is located at any point along the arcuate passage 223, but the tube 241 is preferably positioned such that the distal aperture 243 is located approximately midway along the longitudinal length of the arcuate passage 223 . The distal aperture 243 is preferably elliptical or oval by means of a planar cutting tube 241 oriented less than 9 degrees from the longitudinal axis of the tube 241. Although the aperture 243 can also be circular, the elliptical aperture 243 increases fluid communication with the flow path 233 formed between the projections 231. The reduced pressure transfer tube 241 is preferably made of polyfluorene oxide or urethane coated with a coating material called paraiyne2. However, the reduced pressure delivery tube 241 can be constructed using any medical grade tubing. Other coatings that can be applied to the tube include heparin, anticoagulants, anti-fibrinogen, anti-adhesion, anti-prothrombin and hydrophilic coatings. In an embodiment, the reduced pressure transfer tube 241 may also include or be included in the vent or vent 251 as an alternative to the distal opening 243. The pressure transfer tube 241 is positioned to further increase fluid communication between the reduced pressure transfer tube 241 and the flow passage 233. 119640.doc -14- 200836785 = 1-5 The 'decompression transfer tube 241 can be clamped to the length only along one of the arcuate passages 223, or alternatively along the entire longitudinal extent of the arcuate passage 223. If the position is such that the damper transfer tube 241 occupies the arcuate passage (2), the squat return passage 243 causes all fluid communication between the tube 241 and the flow passage 233 through the vent 25 1 to occur. The reduced pressure delivery tube 241 additionally includes a proximal aperture 255 at the proximal end of the tube 241. The proximal aperture 255 is configured to closely mate with a reduced pressure source, which will be described in greater detail below with reference to FIG. The transfer e 241 described in Figure 3, and from $, includes only a single lumen or channel 259. However, the reduced pressure delivery e 241 includes a plurality of lumens (such as the double lumen tube plus described in Fig. 1). The possible dual lumen tubes 261 include a first lumen 263 and a second lumen plus. The dual official tube is used to provide a fluid communication path between the proximal end of the separate reduced pressure delivery tube 241 and the flow path 233. For example, the use of a dual lumen tube can be used to connect the depleted source to the flow path 233 along the first lumen. The second lumen 265 can be used to introduce fluid into the flow passage 233. The fluid can be filtered air or other gas, antibacterial agent, antiviral agent, cell growth promoter, irrigation fluid, chemically active fluid or any other fluid. If it is desired to introduce a plurality of fluids into the flow passage 233 via a separate fluid communication path, the reduced pressure transfer tube can have more than two lumens. 4B, the horizontal spacer 271 separates the -b cavity 263 and the second lumen 265 of the reduced pressure delivery tube 261 such that the first lumen is positioned above the second lumen 265. The relative position of the first lumen 263 to the second lumen 265 can vary depending on how fluid communication is made between the lumens 263, 265 and the flow passage 233. For example, when the first lumen 263 is positioned as described in FIG. 4B, the plurality of lumens of the 119640.doc -15-200836785 delivery tube can be positioned relative to each other with respect to the vertical spacers separating the lumens. The lumens can be arranged concentrically or coaxially. A vent similar to vent 251 is provided to communicate with flow passage 233. 1 When the second lumen 263 is positioned as illustrated in Figure 4B, the second lumen can be in communication with the flow passage 233 via a distal aperture similar to the distal aperture 243. In addition, decompression

熟習此項技術者應顯而易見,可以多種不同路徑(包括 提供如上文所述之多管腔管之路徑)實現獨立流體連通路 徑之供應。或者,可藉由使單管腔管附著至另一單管腔管 或藉由使用具有單管腔或多個管腔之單獨未附著之管來提 供獨立流體連通路徑。 若使用單獨管提供至流動通路233之單獨流體連通路 徑,則突出部分215可包括多個弓狀通路223,每管各一 個。另外,可擴大弓狀通路223以容納多個管。具有與流 體傳遞管分離之減壓傳遞管之減壓傳遞㈣的實例將於下 文參考圖9進行更詳細地討論。 參看圖6-8,根據本發明原理之減壓傳遞設備或翼狀歧 管311包括具有突出部分315及—對側翼部分319之可撓性 障壁313。各側翼部分3 19均係沿突出部分3 15之相對侧定 位。突出部分3 15形成可延伸或不延伸翼狀歧管311之全長 勺弓狀通路323。儘管突出部分315可位於翼狀歧管31丨之 中心從而使該侧翼部分319之尺寸相等,但如圖"所示亦 可偏私犬出部分3 1 5,從而使—側翼部分3丨9比另一側翼部 刀3 19見。在將翼狀歧管3丨丨用於骨骼再生或癒合時,一側 翼部分319之額外寬度可特別有用,且將使較寬之翼狀歧 119640.doc -16- 200836785 笞3 11包復在附著至骨骼之固定硬件周圍。 使夕泡材料327附著至可撓性障壁313,且可能以覆蓋整 i固可挽H P平壁3 13表面(延伸橫過突出部分315及兩個側翼 P刀9)之單材料工件提供。多泡材料327包括安置於 可撓性障壁313之鄰近位置處之附著表面(圖6中不可見)、 名附著表面相對之主要分佈表面329及複數個周邊表面 330 ° 在一實施例中,可撓性障壁313可與可撓性障壁213類似 且包括可撓性襯底。儘管可藉由任何其他適當之附著方法 或使使用者組合治療部位來附著可撓性障壁313及多泡材 料327,但黏著為使多泡材料327附著至可撓性障壁313之 較佳方法。可撓性障壁313及/或可撓性襯底用作傳輸流體 (褚如液體、空氣及其他氣體)之不透性障壁。 在-實施例中,可不單獨提供可撓性障壁及可撓性概底 來支持多泡材料327。相反,多泡材料327可具有作為多泡 材料3 2 7之不透性部分之一體式障壁層。該障壁層可由閉 孔材料形成以防止流體傳輸,從而取代可撓性障壁313。 若使用一體式障壁層及多泡材料3 2 7,則該障壁層可包括 如先前參考可撓性障壁313所述之突出部分及側翼部分。 可撓性障壁313較佳係由彈性體材料(諸如聚矽氧聚合物) 形成。適當聚梦氧聚合物之實例包括Nusil 〇fIt will be apparent to those skilled in the art that the supply of independent fluid communication paths can be achieved in a variety of different paths, including providing a multi-lumen tube path as described above. Alternatively, the independent fluid communication path can be provided by attaching a single lumen to another single lumen or by using a separate unattached tube having a single lumen or multiple lumens. If a separate tube is used to provide a separate fluid communication path to the flow path 233, the protruding portion 215 can include a plurality of arcuate passages 223, one for each tube. In addition, the arcuate passage 223 can be enlarged to accommodate a plurality of tubes. An example of reduced pressure transfer (4) having a reduced pressure transfer tube separate from the fluid transfer tube will be discussed in greater detail below with reference to FIG. Referring to Figures 6-8, a reduced pressure transfer device or wing manifold 311 in accordance with the principles of the present invention includes a flexible barrier 313 having a projection 315 and a pair of wing portions 319. Each of the side wing portions 3 19 is positioned along the opposite side of the protruding portion 3 15 . The projecting portion 3 15 forms a full length scooped arcuate passage 323 that may or may not extend over the wing manifold 311. Although the protruding portion 315 can be located at the center of the wing-shaped manifold 31丨 such that the flank portion 319 is equal in size, as shown in the ", the dog portion 3 1 5 can also be biased, thereby making the flank portion 3 丨 9 ratio See the other wing knife 3 19 . The extra width of the side wing portion 319 can be particularly useful when the wing manifold 3 is used for bone regeneration or healing, and will wrap the wider wing shape 119640.doc -16 - 200836785 笞3 11 Attached to the fixed hardware attached to the bone. The smear material 327 is attached to the flexible barrier 313 and may be provided as a single material workpiece covering the surface of the sturdy H P flat wall 313 (extending across the projection 315 and the two flank P knives 9). The multi-bubble material 327 includes an attachment surface (not visible in FIG. 6) disposed adjacent the flexible barrier 313, a major attachment surface 329 opposite the name attachment surface, and a plurality of peripheral surfaces 330°. In one embodiment, The flexible barrier 313 can be similar to the flexible barrier 213 and includes a flexible substrate. Although the flexible barrier 313 and the multi-foaming material 327 can be attached by any other suitable attachment method or by combining the treatment sites with the user, adhesion is a preferred method of attaching the multi-foam material 327 to the flexible barrier 313. The flexible barrier 313 and/or flexible substrate serves as an impervious barrier for transporting fluids such as liquids, air, and other gases. In an embodiment, the flexible barrier and the flexible base may not be provided separately to support the multi-foam material 327. In contrast, the multi-foam material 327 may have a bulk barrier layer as an impermeable portion of the multi-foam material 3 27 . The barrier layer may be formed of a closed cell material to prevent fluid transfer, thereby replacing the flexible barrier 313. If a one-piece barrier layer and a multi-bubble material 327 are used, the barrier layer can include projections and flank portions as previously described with reference to the flexible barrier 313. The flexible barrier 313 is preferably formed of an elastomeric material such as a polyoxyl polymer. Examples of suitable polyoxyl polymers include Nusil 〇f

CarPnueria,CaHf〇rnia製造之MED6〇i5。然而應注意可 撓性障壁3i3可由任何其他生物可相容之可撓性材:製 造。若可撓性障壁包裝或另外併入可撓性襯底,則該可撓 119640.doc •17- 200836785 f生概底較佳係由聚醋針織物(諸如,c r. Bard 〇f Tenipe,CarPnueria, MED6〇i5 manufactured by CaHf〇rnia. It should be noted, however, that the flexible barrier 3i3 can be made of any other biocompatible flexible material: If the flexible barrier is packaged or otherwise incorporated into a flexible substrate, the flexible 119640.doc • 17-200836785 is preferably made of a poly-knitted fabric (such as c r. Bard 〇f Tenipe,

Arizona製造之Bard 6〇13)製成。然而,可撓性襯底227可 由能夠增加可撓性障壁313之強度及耐久性之生物可相容 的可撓性材料製成。 在一實施例中,多泡材料327為孔徑在約400-600微米之 範圍内之開孔、網狀聚酯胺基曱酸酯發泡體。此發泡體之 實例可包括 Kinetic Concepts,lnc· 〇f San Antonio, Texas 製 造之GranuF〇am。多泡材料327亦可為薄紗、氈製墊或經由 複數個二維通路提供流體連通之任何其他生物可相容材 料。 夕/包材料327主要為包括複數個與相鄰孔室流體連接之 孔至的開孔材料。複數個流動通路係由多泡材料Μ?之,, 開孔形成且形成於多泡材料327之”開孔,,之間。流動通路 允許整個多泡材料327具有開孔之部分流體連通。孔室及 /政動通路之形狀及尺寸可均一,或可包括形狀及尺寸之圖 案化或無規變化。多泡材料327之孔室形狀及尺寸之變化 導致流動通路之變化,且此等特性可用於改變穿過多泡材 料327之流體的流動特性。多泡材料327可另外包括含有,, 閉孔”之部分。多泡材料327之此等閉孔部分含有複數個孔 室,大部分孔室均不與相鄰孔室流體連接。閉孔部分之實 例於上文中描述為可取代可撓性障壁3丨3之障壁層。類似 地,可將閉孔部分選擇性安置於多泡材料327中以防止穿 過夕泡材料327之周邊表面33〇的流體傳輸。 亦可由使用減壓傳遞設備311後無需自患者體内移除之 119640.doc -18- 200836785 可生物再吸收材料建構可撓性障壁313及多泡材料327。適 當之可生物再吸收材料可包括(但不限於)聚乳酸(pla)與 聚乙醇酸(PGA)之聚合摻合物。聚合摻合物亦可包括(但不 限於)聚碳酸酯、聚反丁烯二酸酯及己内酯。可撓性障壁 313及多泡材料327可另外用作新細胞生長之支架,或支架 材料可與可撓性障壁313、可撓性襯底327及/或多泡材料 327組合使用以促進細胞生長。適當之支架材料可包括(但 f 不限於)磷酸鈣、膠原蛋白、PLA/PGA、珊瑚羥基磷灰 ' 石、碳酸酯或經加工之同種異體移植物材料。支架材料較 佳將具有高空隙分率(亦即,高空氣含量)。 減壓傳遞管341係定位於弓狀通路323内且附著於可撓性 P早壁3 13上。減壓傳遞管34丨亦可附著至多泡材料327,或 僅在存在多泡材料327之情況下,減壓傳遞管341可僅附著 至多泡材料327。減壓傳遞管341包括在類似於圖5之遠端 孔243之管341的遠端處的遠端孔343。可定位減壓傳遞管 〔 341從而使遠端孔343位於沿弓狀通路323之任何點處,但 較佳位於沿弓狀通路323之縱向長度之近中間位置處。較 佳藉由沿相對管34 1之縱向轴小於90度定向之平面切割管 341來將遠端孔343製成橢圓形或卵圓形。儘管孔亦可為圓 形’但橢圓形之孔增加與多泡材料327中流動通路之流體 連通。 在一貫施例中,減壓傳遞管3 4 1亦可包括類似於圖5之通 風口 25 1之通風口或通風孔(未圖示)。通風口係作為遠端孔 343之替代選擇沿管341定位,或除遠端孔343外通風口亦 119640.doc -19- 200836785 沿管3 4 1定位,從而;隹 十 而進—步增加減壓傳遞管341與流動通路 之間之抓體連通。如前文所述,減壓傳遞管341可僅沿弓 狀通路323縱向長度之一部分定位,或另外可沿弓狀通路 323之全縱向長度^位。若㈣位從而使減壓傳遞管⑷佔 據整個弓狀通路323,則可封蓋遠端孔343從而經由通風口 發生管341與流動通路之間的所有流體連通。 夕泡材料327較佳覆蓋且直接接觸減壓傳遞管⑷。多 '、包 材料327可與減壓傳遞管⑷連接,或多泡材料327可簡單 地附著至可撓性障㈣3上。若定位減壓傳遞管341從而使 其僅延伸至弓狀通路323之中點,則多泡材料327亦可在弓 狀通路323不含有減壓傳遞管341之區域中與可撓性障壁 3 13之突出部分3 1 5連接。 減麼傳遞管341在該管341之近端處另外包括近端孔 355。近端孔355經組態以與減麼源緊密配合,該減壓源將 於下文中參考圖9得到更詳細之描述。圖6_8中所述之減壓 傳遞管341僅包括單管腔或通道359。然而,減壓傳遞管 341可能包括多個管腔(諸如先前參考圖4]5所述之彼等 者)。使用多管腔管於減壓傳遞管341之近端與先前所述之 流動通路之間提供單獨之流體連通路徑。亦可藉由分隔盘 流動通路連通具有單管腔或多管腔之管提供此等單獨之流 體連通路徑。 參看圖8A及8B,根據本發明原理之減壓傳遞設備371包 括在減壓傳遞管373之遠端377處具有擴張部分奶之減壓 傳遞管373。#廣張部分375較佳呈弓狀以匹配減壓傳遞管 119640.doc -20- 200836785 373之曲率。可藉由移除遠端π?處之一部分減壓傳遞管 Μ形成擴張部分375,從而形成具有管肩383之切斷381。 將=數個突起385安置於減壓傳遞管仍之内表面387上以 於突起385之間形成複數個流動通路391。突起385可與參 '所述之犬起具有相似尺寸、形狀及間距。減壓傳 遞叹備371尤其適於施加減壓且使切 丨 締組織上的組織再生。可由減壓傳遞設備371治 f 的非限制性實例為韌帶、腱及軟骨。 i. 、二看圖9,使用類似於本文所述之另一減壓傳遞設備之 減壓傳遞設備411將減壓組織療法施加至組織部位413(諸 如,人類患者之骨骼41 5)上。當用於促進骨骼組織生長 時,減壓組織療法可增加與骨折、骨骼不連、空隙或其他 骨赂缺損有關之癒合速帛。另夕卜,咸信可使用減壓組織療 法改良骨髓炎之恢復。可另外使用該療法增加罹患骨髓炎 之患者的局部骨骼密度。最終,可使用減壓組織療法加速 Q 且改良矯形植入物(諸如,髖植入物、膝蓋植入物及固定 裝置)之骨赂整合(〇860丨1^6 8^1:丨〇]1)。 仍參看圖9,減壓傳遞設備411包括具有與減壓源427流 體連接之近端421的減壓傳遞管419。減壓源427為泵或能 夠經由減壓傳遞管4 19及複數個與減壓傳遞設備41丨相連之 流動通路向組織部位4 13施加減壓的任何其他裝置。藉由 將減壓傳遞設備411之侧翼部分置放於鄰近組織部位* 13處 從而將減壓施加至組織部位413,在本實例中其涉及包覆 骨絡415中之空隙缺損429周圍之側翼部分。可以外科手術 119640.doc -21 - 200836785 方式或經皮插入減壓傳遞設備411。當經皮插入時,較佳 經由穿透患者皮膚組織之無菌插入套管插入減壓傳遞管 419 ° 施加減壓組織療法通常在環繞組織部位413之區域中產 生肉芽組織。肉芽組織為通常在體内組織修復之前形成之 ¥見組織。在正常情況下’肉芽組織可對外來體起反應而 幵y成或在創知癒合過程中形成。肉芽組織通常用作健康替 換、、且、、哉之支架且進一步引起某些疤痕組織之發育。肉芽組 織高度血管化,且在減壓下高度血管化之組織中生長及生 長速率之增加促進組織部位413處之新組織生長。 仍參看圖9,流體傳遞管431可在遠端與減壓傳遞設備 411之流動通路流體連接。流體傳遞管431包括與流體傳遞 源433流體連接之近端432。若傳遞至組織部位之流體為空 氣,則較佳藉由能夠過濾至少小至〇·22 μηι之微粒的過濾 器434來過濾空氣,以便清潔空氣且使其滅菌。將空氣引 入組織部位413、尤其當組織部位413位於皮膚表面以下 時,其對於促進組織部位413之良好排液從而減少或防止 減傳遞笞419之阻塞極為重要。亦可使用流體傳遞管工 及流體傳遞源433將其他流體引入組織部位413,該等其他 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。當經皮插入時,較佳經 由穿透患者皮膚組織之無菌插入套管插入流體傳遞管 431 〇 可使壓力感應器435可操作地連接至流體傳遞管431以指 119640.doc -22- 200836785 示流體傳遞管43 1是否吸留有血液或其他體液。可使壓力 感應器435可操作地連接至流體傳遞源433以提供反饋,從 而控制引入組織部位4 13中之流體量。亦可使止回閥(未圖 示)可操作地連接至接近流體傳遞管431之遠端以防止血液 或其他體液進入流體傳遞管431。 fMade in Arizona, Bard 6〇13). However, the flexible substrate 227 can be made of a biocompatible flexible material capable of increasing the strength and durability of the flexible barrier 313. In one embodiment, the multivesicular material 327 is an open cell, reticulated polyester amine phthalate foam having a pore size in the range of from about 400 to about 600 microns. Examples of such a foam may include GranuF〇am manufactured by Kinetic Concepts, lnc·〇f San Antonio, Texas. The multi-foam material 327 can also be a tissue, a felt pad or any other biocompatible material that provides fluid communication via a plurality of two-dimensional channels. The eve/package material 327 is primarily an open cell material comprising a plurality of holes fluidly connected to adjacent cells. The plurality of flow paths are formed by a multi-bubble material, the openings are formed and formed between the "openings" of the multi-bubble material 327. The flow path allows the entire multi-bubble material 327 to have partial fluid communication of the openings. The shape and size of the chamber and/or political pathways may be uniform or may include patterned or random variations in shape and size. Variations in the shape and size of the cells of the multi-bubble material 327 result in changes in the flow path, and such characteristics are available. The flow characteristics of the fluid passing through the multi-bubble material 327 are varied. The multi-foam material 327 may additionally include a portion containing, closed cells. These closed cells of the multi-bubble material 327 contain a plurality of cells, most of which are not in fluid connection with adjacent cells. An example of a closed cell portion is described above as a barrier layer that can replace the flexible barrier 3丨3. Similarly, the closed cell portion can be selectively disposed in the multi-foam material 327 to prevent fluid transport through the peripheral surface 33A of the luminescent material 327. The flexible barrier 313 and the multi-foam material 327 can also be constructed from the bioresorbable material 119640.doc -18- 200836785 after the use of the reduced pressure delivery device 311. Suitable bioresorbable materials can include, but are not limited to, polymeric blends of polylactic acid (pla) and polyglycolic acid (PGA). Polymeric blends can also include, but are not limited to, polycarbonates, polyfumarates, and caprolactones. The flexible barrier 313 and the multi-foam material 327 can additionally be used as a scaffold for new cell growth, or the scaffold material can be used in combination with the flexible barrier 313, the flexible substrate 327, and/or the multi-foam material 327 to promote cell growth. . Suitable scaffolding materials may include (but are not limited to) calcium phosphate, collagen, PLA/PGA, coral hydroxyapatite, stone, carbonate or processed allograft materials. Preferably, the scaffold material will have a high void fraction (i.e., high air content). The reduced pressure transmission tube 341 is positioned in the arcuate passage 323 and attached to the flexible P early wall 3 13 . The reduced pressure transfer tube 34A may also be attached to the multifoam material 327, or only in the presence of the multifoam material 327, the reduced pressure transfer tube 341 may be attached only to the multifoam material 327. The reduced pressure delivery tube 341 includes a distal end opening 343 at the distal end of the tube 341 that is similar to the distal aperture 243 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 passage 323, but preferably at a near intermediate position along the longitudinal length of the arcuate passage 323. Preferably, the distal aperture 343 is elliptical or oval by cutting the tube 341 in a plane oriented less than 90 degrees from the longitudinal axis of the tube 34 1 . Although the aperture may also be circular, the elliptical aperture increases fluid communication with the flow path in the multi-bubble material 327. In a consistent embodiment, the reduced pressure transfer tube 341 may also include a vent or vent (not shown) similar to the vent 25 of Figure 5. The venting port is positioned along the tube 341 as an alternative to the distal hole 343, or the venting port is located 119640.doc -19-200836785 along the tube 341 in addition to the distal hole 343, thereby The pressure transmitting tube 341 is in communication with the grasping body between the flow passages. As previously described, the reduced pressure transfer tube 341 can be positioned only along one of the longitudinal lengths of the arcuate passage 323, or alternatively along the full longitudinal length of the arcuate passage 323. If the (four) position is such that the reduced pressure transfer tube (4) occupies the entire arcuate passage 323, the distal end opening 343 can be closed to create all fluid communication between the tube 341 and the flow passage via the vent. The evening bubble material 327 preferably covers and directly contacts the reduced pressure transfer tube (4). Multiple ', the material 327 can be connected to the reduced pressure transfer tube (4), or the multi-bubble material 327 can be simply attached to the flexible barrier (4) 3. If the reduced pressure transfer tube 341 is positioned such that it extends only to a point in the arcuate passage 323, the multifoam material 327 may also be in the region where the arcuate passage 323 does not contain the reduced pressure transfer tube 341 and the flexible barrier 3 13 The protruding portion 3 1 5 is connected. The reduced delivery tube 341 additionally includes a proximal aperture 355 at the proximal end of the tube 341. The proximal bore 355 is configured to closely mate with a source of reduced pressure, which will be described in more detail below with reference to FIG. The reduced pressure delivery tube 341 illustrated in Figures 6-8 includes only a single lumen or channel 359. However, the reduced pressure delivery tube 341 may include a plurality of lumens (such as those previously described with reference to Figure 4). A multi-lumen tube is used to provide a separate fluid communication path between the proximal end of the reduced pressure delivery tube 341 and the previously described flow path. These separate fluid communication paths may also be provided by a separate flow path connecting the tubes having a single lumen or multiple lumens. Referring to Figures 8A and 8B, a reduced pressure delivery device 371 in accordance with the principles of the present invention includes a reduced pressure delivery tube 373 having an expanded portion of milk at a distal end 377 of the reduced pressure delivery tube 373. The wide section 375 is preferably bowed to match the curvature of the reduced pressure transfer tube 119640.doc -20- 200836785 373. The cut portion 381 having the shoulder 383 can be formed by removing a portion of the reduced pressure transfer tube at the distal end π to form the expanded portion 375. A plurality of protrusions 385 are placed on the inner surface 387 of the reduced-pressure transfer tube to form a plurality of flow paths 391 between the protrusions 385. The protrusions 385 can have similar dimensions, shapes, and spacings as the dogs described. The reduced pressure delivery sigh 371 is particularly suitable for applying reduced pressure and for regenerating tissue on the sputum tissue. Non-limiting examples of treatments f by the reduced pressure delivery device 371 are ligaments, tendons, and cartilage. i. 2, looking at Figure 9, decompression tissue therapy is applied to tissue site 413 (e.g., human patient's bone 41 5) using a reduced pressure delivery device 411 similar to another reduced pressure delivery device described herein. When used to promote bone tissue growth, decompression tissue therapy can increase the healing rate associated with fractures, nonunion, voids, or other bone defects. In addition, Xianxin can use the decompression tissue therapy to improve the recovery of osteomyelitis. This therapy can be additionally used to increase the local bone density of patients suffering from osteomyelitis. Finally, decompression tissue therapy can be used to accelerate Q and improve the integration of orthopedic implants (such as hip implants, knee implants, and fixation devices) (〇860丨1^6 8^1:丨〇] 1). Still referring to Fig. 9, the reduced pressure delivery device 411 includes a reduced pressure delivery tube 419 having a proximal end 421 that is fluidly coupled to a reduced pressure source 427. The reduced pressure source 427 is a pump or any other device capable of applying a reduced pressure to the tissue site 413 via a reduced pressure delivery tube 419 and a plurality of flow paths connected to the reduced pressure delivery device 41A. The reduced pressure is applied to the tissue site 413 by placing the flank portion of the reduced pressure delivery device 411 adjacent the tissue site * 13, which in this example involves the flank portion around the void defect 429 in the cladding 415 . The reduced pressure delivery device 411 can be inserted or surgically 119640.doc -21 - 200836785. When percutaneously inserted, it is preferred to insert a reduced pressure delivery tube via a sterile insertion cannula that penetrates the skin tissue of the patient. 419 ° The application of reduced pressure tissue therapy typically produces granulation tissue in the area surrounding the tissue site 413. The granulation tissue is formed by the tissue that is usually formed before tissue repair in the body. Under normal conditions, granulation tissue can react with foreign bodies or form during the healing process. Granulation tissue is commonly used as a replacement for health, and, and, in addition, it causes the development of certain scar tissue. The granulation tissue is highly vascularized, and growth and growth rate in tissues that are highly vascularized under reduced pressure promotes new tissue growth at the tissue site 413. Still referring to Fig. 9, fluid transfer tube 431 can be fluidly coupled to the flow path of reduced pressure delivery device 411 at the distal end. Fluid transfer tube 431 includes a proximal end 432 that is fluidly coupled to fluid transfer source 433. If the fluid delivered to the tissue site is air, it is preferred to filter the air by filtering the filter 434, which is capable of filtering at least particles as small as 22 Å, to clean the air and sterilize it. Introduction of air into the tissue site 413, particularly when the tissue site 413 is below the surface of the skin, is extremely important to promote good drainage of the tissue site 413 to reduce or prevent occlusion of the reduced delivery 419. Other fluids may also be introduced into tissue site 413 using fluid transfer plumbers and fluid transfer sources 433, including but not limited to antimicrobial agents, antiviral agents, cell growth promoters, irrigation fluids, or other chemical active agents. When percutaneously inserted, preferably inserted into the fluid transfer tube 431 via a sterile insertion cannula that penetrates the patient's skin tissue, the pressure sensor 435 can be operatively coupled to the fluid transfer tube 431 to indicate 119640.doc -22-200836785 Whether the fluid transfer tube 43 1 occludes blood or other body fluid. Pressure sensor 435 can be operatively coupled to fluid delivery source 433 to provide feedback to control the amount of fluid introduced into tissue site 413. A check valve (not shown) may also be operatively coupled to the distal end of the fluid transfer tube 431 to prevent blood or other bodily fluids from entering the fluid transfer tube 431. f

可以多種不同路徑實現由減壓傳遞管419及流體傳遞管 431所提供之獨立流體連通路徑,該等不同路徑包括提供 如先前參考圖4B所述之單管腔、多管腔管之路徑。普通熟 習此項技術者將認識到’若使用多管腔管,則感應器、閥 及與流體傳遞管431相連之其他組件亦可類似地與減壓傳 遞管419中之特定管腔相連。與組織部位流體連通之任何 管腔或管塗覆有抗凝劑以防止該管腔或管内體液或血液堆 積係較佳的。可塗覆瞢胪#其 孟復&胺或官之其他塗料包括(但不限於) 肝素、抗凝劑、抗纖維蛋白原、抗附著、抗凝血酶原及親 水塗料。 參看圖10 -19,測讀ρ显-也h 、 …已展不备鈿加至骨骼組織時減壓組 織療法之積極作用。在一牿 寻疋/貝J 4中,將減壓組織療法施 加至數隻兔之顱骨以確定其對骨骼生長及再生之作用。該 特定目標為發現_組織療法對顱骨無缺損或顧骨 ρ &的作用,減遷組織療法對顱骨具有臨界尺寸缺 上古:乍用’及使用支架材料及減壓組織療法治療顱骨 =有二界尺寸之缺損的作用。特㈣試方案及兔編號列 於下表1令。 U9640.doc -23 - 200836785 兔編號 _ -—-~ 4 顧月無缺損,經由多泡發泡體(Gr_F〇am)將減壓組繃 (RPTT)施加至完整骨膜頂部歷時6天,隨後立即採隼也織 4 顱月無缺知,在無RPTT之情況下將多泡發泡體(GranuF〇am 置放於完整骨膜頂部(對照)歷時6天,隨後立即搡隼細嬙 4 口1界尺寸缺扣及置放於缺損上之不銹鋼篩;一臨界尺寸缺 損及置放於缺損中之鱗酸約支架;施加至兩個 時RPTT ;術後2週採集組織 J 4 口臥界尺寸缺彳貝及置放於缺損上之不銹鋼篩;一臨界尺寸缺 損及置放於缺損中之磷酸鈣支架;施加至兩個缺、 B夺RPTT ;術後12週採集組織 、 , 4 t 。臣品界尺寸缺損及置放於缺損上之不銹鋼篩了二 損及置放於缺損中之磷酸鈣支架;施加至兩個缺損上之6天 RPTT 後2週採集組織______ 4 二臨界及置放於缺損上之不銹鋼篩尺寸缺 損及置放於缺損中之磷酸鈣支架;施加至兩個缺損上之6天 RPTTTjJ^12週採集組織 ' 4 Emi界尺寸缺損及置放於缺損上之不銹鋼篩;一臨界尺寸缺 損及置放於缺損中之磷酸鈣支架;未施加RPTT(對昭);術後 2週採 '、 4 ί i-- 及置放^缺損上€不銹鋼篩界尺寸缺 ’員及置放於缺損中之磷酸鈣支架;未施加RPTT(對昭);術後 12週毛隻^___ …、 。4 4 [ 術;無 RFnp - " ------- 損;無RPTT);術後6天採集組織 表1 :測試方案 、、且、、哉(例如,顧骨)中之缺損為臨界尺寸缺損,其尺寸足 夠大以致損傷僅經由生命修復無法癒合。對於兔而言,經 由顱骨鑽出直徑為約15 mm之全厚度洞(fuii_thickness hole)產生顱骨之臨界尺寸缺損。 更特疋地参看圖10,描述具有天然、未受損害之骨骼之 119640.doc -24- 200836785 兔顱骨的組織切片。將顱骨之骨骼組織塗上紫紅色,周圍 摩人組織為白色且以黃色星號突出骨膜層。在圖Η中,描述 施加減壓組織療法6天後立即採集組織後之兔顱骨。骨骼 及月膜可見且肉芽組織層已發育。在圖丨2中,施加減壓組 、哉療法6天後且立即採集組織後描述兔顱骨,。圖之組織 切片之特徵在於肉芽組織下面之新骨骼組織發育。以黃色 生唬犬出骨骼組織。在圖13中,施加減壓組織療法6天後 立即採集組織後描述兔顱骨。新骨骼及骨膜可見。對減壓 組織療法起反應之骨骼組織發育之組織學外觀與經歷新骨 骼之極快生長及沈積之極年輕動物體内骨骼發育之組織學 外觀極其類似。 更特疋參看圖1 9,描述若干相片及組織切片,展示 減£、、且、、我療去之私序及其對具有臨界尺寸缺損之兔顱骨治 療的μ果在圖14中,描述已產生兩個臨界尺寸缺損之兔 顱骨。全厚度臨界尺寸缺損之直徑為約15 mm。在圖15 中,已將不銹鋼篩置放於一臨界尺寸缺損上,且將磷酸鈣 支架置放於另一臨界尺寸缺損内。在圖16中,使用與本文 所述者類似之減壓組織治療設備將減壓施加至臨界尺寸缺 損處施加至各缺損之壓力量為-125 mm Hg標準壓力。根 據表1所列之方案中之一者施加減壓。在圖17中,描述六 天之減壓組織療法及術後十二週之採集後的顱骨組織切 片。所述切片包括魏約支架,其係由紅色箭頭指示。施 加減壓組織療法導致新骨骼組織之顯著生長,其在圖17中 以黃色星號突出。骨骼生長量顯著高於含有相同磷酸鈣支 119640.doc -25- 200836785 架但未經減壓έ处 翌、、且、、我療法治療之臨界尺寸缺損 此觀察結果表明,可”… #中的生長里。 臨限含量或治旅姓洁士 久應所而之 紐。在術後12週收集之試樣中減屢 、'且1療法之作用最顯著,表明減壓組織療法起始導 H 織形成增強之生物事件的級聯。 ί 缺損中經不銹鋼篩(圖15)但無支架材料覆蓋之臨界尺寸 :損用作具有最小新骨骼生長之動物内(intra-animal)對 ^。,等貧料顯示出適當支架材料之優勢及減壓組織療法 對支架整合及生物效能之積極作用。在圖18及19中,描述 減壓組織療法6天後經支架填充之臨界尺寸缺損的放射相 片。圖18描述術後兩週之缺損且指示支架内之部分新骨骼 沈積支木之基本結構亦顯而易見。圖19描述術後十二週 之缺損,且展示由組織整合(亦即,支架基質内新骨骼形 成)引起之臨界尺寸缺損之幾乎完全癒合及主要支架建構 之幾乎完全喪失。 參看圖20 ’本發明之一實施例之減壓傳遞系統7丨丨將減 壓組織療法傳遞至患者之組織部位713。減壓傳遞系統711 包括歧管傳遞管721。歧管傳遞管721可為導管或插管,且 可包括使歧管傳遞管721導引至組織部位713之特徵,諸如 操縱部件725及引線727。可藉由使用内視鏡檢法、超音、 螢光檢查、聽診、觸診或任何其他適當之定位技術實現引 線727及歧管傳遞管721之置放及定向。提供歧管傳遞管 721以將減壓傳遞設備經皮插入至患者之組織部位7丨3中。 當經皮插入時,較佳經由穿透患者皮膚組織之無菌插入套 119640.doc -26- 200836785 管插入歧管傳遞管721。 在圖20中,組織部位713包括鄰近患者骨骼733上之骨折 731處的骨骼組織。歧管傳遞管721係經由患者之皮膚735 及骨骼733周圍之任何軟組織739插入。如先前所討論,組 織部位71 3亦可包括任何其他類型之組織,包括(但不限於) 脂肪組織、肌肉組織、神經組織、真皮組織、血管組織、 結締組織、軟骨、腱或韌帶。 fThe independent fluid communication paths provided by the reduced pressure delivery tube 419 and the fluid transfer tube 431 can be implemented in a variety of different paths, including providing a single lumen, multi-lumen tube path as previously described with reference to Figure 4B. Those skilled in the art will recognize that if multiple lumen tubes are used, the sensors, valves, and other components associated with fluid delivery tube 431 can similarly be coupled to particular lumens in reduced pressure delivery tube 419. Any lumen or tube in fluid communication with the tissue site is coated with an anticoagulant to prevent bodily fluid or blood accumulation within the lumen or tube. Other coatings that can be coated with 其#其孟复&amine or official include, but are not limited to, heparin, anticoagulant, anti-fibrinogen, anti-adhesion, anti-prothrombin and hydrophilic coatings. Referring to Fig. 10-19, the positive effects of decompression tissue therapy when the ρ display-also h, ... has been added to the bone tissue. In a 疋 疋 / 贝 J 4, decompression tissue therapy was applied to the skulls of several rabbits to determine their effects on bone growth and regeneration. The specific goal is to discover the effect of tissue therapy on the skull without defect or Gu bone ρ & the tissue therapy for the skull has a critical size lack of antiquity: use 'and use scaffold material and decompression tissue therapy to treat the skull = two The role of the defect in the boundary size. The special (4) test plan and rabbit number are listed in Table 1 below. U9640.doc -23 - 200836785 Rabbit No. _ -—-~ 4 Gu Yue has no defect, and the decompression group (RPTT) is applied to the top of the intact periosteum via a multi-bubble foam (Gr_F〇am) for 6 days, then immediately The sputum was also woven. There was no sham of the skull. In the absence of RPTT, the multi-foam foam (GranuF〇am) was placed on the top of the intact periosteum (control) for 6 days, followed by a fine 嫱4 mouth 1 boundary size. Defective and stainless steel sieve placed on the defect; a critical size defect and squamous acid placed in the defect about the stent; applied to two RPTT; 2 weeks postoperatively, the tissue J 4 lateral size missing mussel And a stainless steel sieve placed on the defect; a critical size defect and a calcium phosphate stent placed in the defect; applied to two defects, B RPTT; tissue collected 12 weeks after surgery, 4 t. The defect and the stainless steel placed on the defect screened the second lesion and the calcium phosphate stent placed in the defect; the tissue was collected 2 weeks after the 6-day RPTT applied to the two defects. ______ 4 Two criticality and placed on the defect Stainless steel sieve size defect and calcium phosphate stent placed in the defect; applied to two 6 days of damage, RPTTTjJ^12 weeks of tissue collection of '4 Emi boundary size defect and stainless steel sieve placed on the defect; a critical size defect and calcium phosphate stent placed in the defect; no RPTT applied (pair); 2 weeks after surgery, ', 4 ί i-- and placement of the defect on the stainless steel screen boundary size of the 'spot and the calcium phosphate stent placed in the defect; no RPTT (pair); 12 weeks after surgery Only ^___ ..., .4 4 [ surgery; no RFnp - " ------- loss; no RPTT); 6 days after surgery to collect tissue Table 1: test protocol, and, 哉 (for example, Gu The defect in the bone is a critical size defect that is large enough that the injury cannot heal only through life restoration. For rabbits, a critical dimension defect of the skull is produced by drilling a fuii_thickness hole with a diameter of about 15 mm from the skull. Referring more specifically to Figure 10, a tissue section of a 119640.doc-24-200836785 rabbit skull having natural, unaffected bone is described. The bone tissue of the skull is painted in purple, the surrounding human tissue is white and the periosteum is highlighted by a yellow asterisk. In the figure, the rabbit skull after the tissue was collected immediately after applying the decompressed tissue therapy for 6 days was described. The bone and meniscus are visible and the granulation tissue layer is developed. In Fig. 2, the rabbit skull was described after applying a decompression group, sputum therapy for 6 days, and immediately collecting tissue. The tissue of the figure is characterized by the development of new bone tissue beneath the granulation tissue. Take the yellow oyster out of the bone tissue. In Fig. 13, the rabbit skull was described after the tissue was collected immediately after the application of the reduced-pressure tissue therapy for 6 days. New bones and periosteum are visible. The histological appearance of skeletal tissue development in response to decompression tissue therapy is very similar to the histological appearance of skeletal development in very young animals undergoing rapid growth and deposition of new bone. More specifically, referring to Figure 1 9, a number of photographs and tissue sections are shown, showing the reduction of the weight, and, and the private order of my treatment, and the effect of the treatment of rabbit skull with critical size defects. In Figure 14, the description has been Rabbit skulls with two critical size defects. The full thickness critical dimension defect has a diameter of about 15 mm. In Figure 15, the stainless steel screen has been placed on a critical dimension defect and the calcium phosphate stent is placed in another critical dimension defect. In Fig. 16, the pressure applied to each defect at a critical dimension defect using a reduced pressure tissue treatment device similar to that described herein is a standard pressure of -125 mm Hg. Decompression was applied according to one of the protocols listed in Table 1. In Fig. 17, a six-day decompression tissue therapy and a skull tissue slice after twelve weeks of postoperative treatment are described. The section includes a Weiyue stent, which is indicated by a red arrow. The application of decompression tissue therapy resulted in significant growth of new bone tissue, which is highlighted by a yellow asterisk in Figure 17. The amount of bone growth was significantly higher than the critical size defect containing the same calcium phosphate branch 119640.doc -25-200836785 but without decompression, and, and my treatment showed that it can be "...# In the growth. The threshold content or the treatment of the surname Jie Shi long should be the new one. In the samples collected 12 weeks after surgery, the effect of the reduction, 'and 1 therapy is the most significant, indicating the beginning of decompression tissue therapy H Weaving forms a cascade of enhanced biological events. ί Critical dimensions of stainless steel screens (Fig. 15) but not covered by scaffolds: damage is used as an intra-animal pair with minimal new bone growth, etc. The poor material showed the advantages of appropriate scaffold materials and the positive effects of decompression tissue therapy on stent integration and bioavailability. In Figures 18 and 19, radiographs of critical size defects filled with stents after 6 days of decompression tissue therapy are described. Figure 18 depicts the defect after two weeks of surgery and indicates the basic structure of some of the new bone deposition branches within the stent. Figure 19 depicts the defect after 12 weeks of surgery and is shown to be integrated by tissue (ie, new in the stent matrix). skeleton Almost complete healing of the critical size defect caused and complete loss of primary stent construction. Referring to Figure 20, a reduced pressure delivery system 7 of one embodiment of the present invention delivers reduced pressure tissue therapy to a tissue site 713 of a patient. The reduced pressure delivery system 711 includes a manifold transfer tube 721. The manifold transfer tube 721 can be a catheter or cannula and can include features that direct the manifold transfer tube 721 to the tissue site 713, such as the steering member 725 and lead 727 The placement and orientation of lead 727 and manifold transfer tube 721 can be accomplished by endoscopic examination, hypersonic, fluorescent examination, auscultation, palpation, or any other suitable positioning technique. Manifold delivery tube 721 is provided. The perfusion delivery device is percutaneously inserted into the tissue site 7丨3 of the patient. When percutaneously inserted, preferably through a sterile insertion sleeve 119640.doc -26-200836785 through the patient's skin tissue, the tube is inserted into the manifold delivery tube. 721. In Figure 20, tissue site 713 includes bone tissue adjacent to fracture 731 on patient bone 733. Manifold delivery tube 721 is via skin 735 of the patient and any soft tissue surrounding bone 733 7 39 insertion. As previously discussed, the tissue site 71 3 may also include any other type of tissue including, but not limited to, adipose tissue, muscle tissue, nerve tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendon or ligament f

參看圖2 1及22,進一步描述減壓傳遞系統7丨1。歧管傳 遞官721可包括楔形遠端743以減弱穿過患者皮膚735及軟 組織739之插入。楔形遠端743可另外經組態以向開口位置 外呈放射狀撓曲,從而使遠端743之内徑與管721其他部分 處之内徑實質相同或大於管72丨其他部分處之内徑。於圖 21中以虛線737示意性描述遠端743之開口位置。 歧管傳遞管721另外包括含有減壓傳遞設備761或任何其 他減壓傳遞設備之通道751。減壓傳遞設備761包括與參考 圖6-8所述者類似之可撓性障壁765及/或多泡性材料π?。 可抗性障壁765及/或多泡材料767較佳捲繞、折疊或另外 壓縮於減壓傳遞管769之周圍以減小通道751内減壓傳遞設 備761之截面積。 在將歧管傳遞管721之遠端743置放於組織部位713處 後,可將減壓傳遞設備761置放於通道751内,且將其導引 至組織部位7 1 3。另外,名蔣,AA- 一 乃卜在將歧官傳遞管721插入至患者體 内=前’可將減壓傳遞設備761預定位於通道751内。若將 減壓傳遞設備76 1推過通道75 1,目丨丨-Γ /士 、 I逋迢/51則可使用生物可相容潤滑 119640.doc -27- 200836785 劑減小減壓傳遞設備761與歧管傳遞管721之間之摩擦。當 已將遠端743定位於組織部位713處且已將減壓傳遞設備 761傳遞至遠端743時,隨後將減壓傳遞設備761推向遠端 743 ’導致遠端743向外放射狀擴張至開口位置中。將減壓 傳遞設備761推至歧管傳遞管721外,較佳至組織部位713 之空隙或空間中。通常藉由可由經皮方式實現之軟組織剝 離來形成空隙或空間。在某些情況下,組織部位713可位 於創傷部位處,且自然可因解剖創傷而存在空隙。在其他 情況中,可藉由氣球剝離、銳器剝離、鈍性剝離、水力剝 離(hydrodissection)、氣力剝離(pneumatic dissecti〇n)、超 音波剝離、電灼剝離、雷射剝離或任何其他適當之剝離技 術產生玉隙。§減壓傳遞設備7 6丨進入與組織部位73相鄰 之空隙時,減壓傳遞設備761之可撓性障壁765及/或多泡 材料767打開、伸展或解壓縮(參看圖22),從而能夠置放減 壓傳遞設備761而使其與組織部位713接觸。儘管非必需, 但可使可撓性障壁765及/或多泡性材料767經歷經由減壓 傳遞官769所供應之真空或減壓以壓縮可撓性障壁及/ 或多泡材料767。可藉由放鬆由減壓傳遞管769供應之減壓 或由減壓傳遞管769供應正壓以辅助打開過程來使可撓性 P早土 765及/或夕,包材料767伸展。可藉由使用内視鏡檢 法、超音、螢光檢查、聽診、觸診或任何其他適當之定位 技術實現減壓傳遞設備761之最終置放及操控。置放減壓 傳遞設備761後,較佳將歧管傳遞f72i自患者移除,但將 與減壓傳遞設備761相連之減壓傳遞管保留在原位以允許 119640.doc -28- 200836785 將減壓經皮施加至組織部位7 1 3。 參看圖23-25,本發明之一實施例之減壓傳遞系統811包 括具有楔形遠端843之歧管傳遞管821,該楔形遠端843經 組態以向開口位置外呈放射狀撓曲,從而使遠端843之内 徑與官821其他部分處之内徑實質相同或大於管821其他部 分處之内控。於圖23-25中以虛線837示意性描述遠端843 之開口位置。 歧官傳遞官821另外包括一含有與本文所述之其他減壓 傳遞敌備類似之減壓傳遞設備861的通道。減壓傳遞設備 861包括可撓性障壁865及/或多泡材料,其較佳捲繞、 折璺或另外壓縮於減壓傳遞管869周圍以減小通道内減壓 傳遞没備861之截面積。 將具有内部空間873之不透性膜871安置於減壓傳遞設備 861周圍,從而使不透性膜871之内部空間873内含有減壓 傳遞設備861。不透性膜871可為氣球、套管或能夠防止流 體傳輸之任何其他類型之膜,因此該不透性膜871可採取 壓縮位置(參看圖23)、鬆弛位置(參看圖24)及擴張位置(參 看圖25及25 A)之至少一者。可使不透性膜871與歧管傳遞 官821密閉連接,從而使不透性膜871之内部空間與歧 官傳遞管821之通道流體連通。可另外使不透性膜871附著 至減壓傳遞管869,從而使不透性膜871之内部空間873與 減壓傳遞管869之通道流體連通。另外,可使不透性膜 附著至與内部空間873流體連通之單獨控制管或控制管腔 (例如參看圖25A)。 119640.doc -29- 200836785 在一實施例中,可提供不透性膜871以進一步減小通道 内減壓傳遞設備861之截面積。為實現此目的,向不透性 膜871之内部空間873施加小於不透性膜871周圍之周圍壓 力的C力。藉此抽出内部空間873内之大部分空氣或其他 流體,使不透性膜871置於圖23所示之壓縮位置。在壓縮 位置處’向内拉伸不透性膜871,從而向減壓傳遞設備861 施加壓縮力以進一步減小減壓傳遞設備861之截面積。如 先如參考圖21及22所述’在將歧管傳遞管821之遠端843置 放於組織部位處後,可將減壓傳遞設備861傳遞至組織部 位。可藉由使用内視鏡檢法、超音、螢光檢查、聽診、觸 診或任何其他適當之定位技術實現不透性膜871及減壓傳 遞設備861之置放友操控。不透性膜871可包括不透射線標 記881 ’其在移除前改良螢光檢查下對不透性膜871之觀 測。 將減壓傳遞設備861推過遠端843後,可減弱施加至内部 空間873之減壓以使不透性膜87丨處於鬆弛位置(參看圖 24) ’由此使得能夠更容易地將減壓傳遞設備86丨自不透性 膜871移除。可提供移除儀器885(諸如套針、管心針或其 他尖銳儀器)使不透性膜871破裂。較佳經由減壓傳遞管 869插入移除儀器885,且其能夠前移至與不透性膜871接 觸處。不透性膜871破裂後,可經由歧管傳遞管821抽取移 除儀器8 85及不透性膜87},使減壓傳遞設備86丨之可撓性 障壁865及/或多泡材料867打開、伸展或解壓縮,從而可 將減壓傳遞設備861置於與組織部位接觸之處。減弱施加 119640.doc -30- 200836785 至内部空間873之減壓及移除不透性膜871後,可自動出現 可撓性障壁865及/或多泡材料867之打開。在一些情況 下,可經由減壓傳遞管869傳遞正壓以協助打開或解壓縮 可撓性障壁865及/或多泡材料867。最終置放減壓傳遞設 備861後,較佳將歧管傳遞管821自患者移除,但將與減壓 傳遞設備861相連之減壓傳遞管869保留在原位以允許將減 壓經皮施加至組織部位。 亦可使用不透性膜871來剝離與組織部位相鄰之組織, 隨後置放減壓傳遞設備861以與組織部位相抵。將減壓傳 遞設備861及完整不透性膜871推過歧管傳遞管821之遠端 843後,可將空氣或另一流體注射或抽吸至不透性膜871之 内部空間873中。由於液體之不可壓縮性使得不透性膜871 能夠更均勻且一致地擴張,因此較佳使用液體使不透性膜 871膨脹。如圖25所示,不透性膜871可呈放射狀或定向擴 張’此視其製造方法及對歧管傳遞管821之附著而定。由 於不透性膜87 1因空氣或流體之壓力而向外擴張至擴張位 置(參看圖25),故剝離與組織部位相鄰之空隙。當空隙足 夠大時,可將液體、空氣或其他流體自内部空間873釋放 以使不透性膜871採取鬆弛位置。隨後,可如先前所解釋 使不透性膜871破裂,且將減壓傳遞設備861插入至與組織 部位相鄰之位置處。 參看圖25A,若主要使用不透性膜871剝離與組織部位相 鄰之組織,則可使不透性膜871密閉地附著至歧管傳遞管 Ml,從而使内部空間873與同歧管傳遞管821相連或附著 H9640.doc -31 - 200836785 至该歧官傳遞管821之次級管腔或管891流體連通。可使用 -人級管腔891將液體、空氣或其他流體傳遞至内部空間873 以使不透性膜871置於擴張位置處。剝離後,可如先前參 考圖24所述鬆弛不透性膜871且使其破裂。 參看圖26 ’本發明之一實施例之減壓傳遞系統9丨丨包括 具有楔形遠端943之歧管傳遞管921,該楔形遠端943經組 悲以向開口位置外放射狀撓曲,從而使遠端943之内徑與 管921其他部分處之内徑實質相同或大於管921其他部分處 之内径。於圖26中以虛線937示意性描述遠端943之開口位 置。 歧管傳遞管921另外包括含有與本文所述之其他減壓傳 遞5又備類似之減壓傳遞設備9 61的通道。減壓傳遞設備9 6 1 包括可撓性障壁965及/或多泡材料967,其較佳捲繞、折 疊或另外壓縮於減壓傳遞管969周圍以減小歧管傳遞管921 之通道内減壓傳遞設備961之截面積。 將具有内部空間973之不透性膜971安置於減壓傳遞設備 961周圍’從而使不透性膜971之内部空間973内含有減壓 傳遞設備961。不透性膜971在不透性膜971之一端包括膠 封977 ’攸而提供一種將減壓傳遞設備96 1自不透性膜971 移除之替代性方法。可使不透性膜971之另一端與歧管傳 遞管9 2 1岔封連接’從而使不透性膜9 71之内部空間9 7 3與 歧管傳遞管921之通道流體連通。或者,可使不透性膜971 附著至與内部空間973流體連通之單獨控制管(未圖示)。 與圖2 3之不透性膜8 7 1類似,不透性膜9 7 1能夠防止流體 119640.doc -32, 200836785 傳輸,因此該不透性膜971可採取壓縮/位置、鬆弛位置及 擴張位置中之至少一者。由於將不透性膜置於壓縮位 置及擴張位置之程序與不透性膜871之彼等程序類似,故 僅描述移除減壓傳遞設備961之不同方法。—— 將減壓傳遞設備96 1傳遞至不透性膜97丨内之組織部位 處’且隨後使用内視鏡檢法、超音、螢光檢查、聽診、觸 診或任何其他適當之定位技術使其適當定位。不透性膜 971可包括不透射線標記98 i,其在移除前改良螢光檢查下 對不透性膜971之觀測。接著,將減壓傳遞設備96丨推過歧 管傳遞管921之遠端943。可減弱施加至内部空間973之減 壓以使不透性膜971處於鬆弛位置。接著,將減壓傳遞設 備961推過膠封977以使不透性膜971退出。 參看圖26A,本發明之一實施例之減壓傳遞系統985可不 包括與圖26之歧管傳遞管類似之歧管傳遞管92 1。換言 之’減壓傳遞系統985可包括引線987、減壓傳遞管989及 減壓傳遞設備99 1。減壓傳遞設備991包括複數個與減壓傳 遞管989流體連接之流動通路。將減壓傳遞設備991及減壓 傳遞管9 8 9置放於經皮導引至組織部位9 9 3處之引線9 8 7 上,以此來代替使用獨立歧管傳遞管傳遞減壓傳遞設備 9 91。引線9 8 7及減壓傳遞管9 8 9較佳經由無菌套管穿透患 者之皮膚。藉由沿導線987導引減壓傳遞管989及減壓傳遞 設備991,可將減壓傳遞設備991置放於組織部位993處以 允許經皮施加減壓組織療法。 由於在傳遞至組織部位993之過程中歧管傳遞管内未對 119640.doc -33 - 200836785 減壓傳遞設備9 9 1進行約束,故較佳在傳遞過程中將減壓 傳遞設備99 1固持於壓縮位置。若將彈性發泡體用作減壓 傳遞設備99 1,則可將生物可相容、可溶性黏著劑塗覆於 發泡體上且壓縮發泡體。到達組織部位後,經由減壓傳遞 管989傳遞之體液或其他流體使黏著劑溶解,使發泡體擴 張以與組織部位接觸。或者’可以經壓縮之無水水凝膠形 成減壓傳遞設備991。水凝膠於傳遞至組織部位993後吸收 水分,從而使減壓傳遞設備991擴張。可由在暴露至患者 之體熱時於組織部位993處擴張之熱活性材料(例如,聚乙 二醇)製造另一減壓傳遞設備99 1。在另一實施例中,可以 可为解膜將經壓縮之減壓傳遞設備9 91傳遞至組織部位9 9 3 處。 參看圖27,本發明之一實施例之減壓傳遞系統丨〇丨丨包括 具有遠端1043之歧管傳遞管1〇21,該遠端1〇43穿過患者之 組織插入以接近組織部位1025。組織部位丨〇25可包括與創 傷或其他缺損相關之空隙1029,或另外可藉由剝離(包括 如本文所述之剝離技術)產生空隙。 將遠端1043置放於與組織部位1〇25相鄰之空隙1〇29内 後,經由歧管傳遞管1〇21將可注射、可傾倒或可流動之減 壓傳遞設備1035傳遞至組織部位1025處。在傳遞至組織部 位之過私中’減壓傳遞設備1 〇3 5較佳以可流動狀態存在, 且隨後於到達後形成複數個用於分佈減壓或流體之流動通 路在些h況下,可流動材料可於到達組織部位後經由 乾燥製程、固化製程或其他化學反應或物理反應硬化成固 H9640.doc -34 - 200836785 悲。在其他情況下,可流動材料在傳遞至組織部位後可原 位形成發泡體。其他材料可以凝膠樣狀態存在於組織部位 1025處,但仍具有複數個用於傳遞減壓之流動通路。傳遞 至組織部位1 〇 2 5之減壓傳遞設備1 〇 3 5之量可足以部分戍完 全填充空隙1029。減壓傳遞設備1〇35可包括歧管與支架之 態樣。作為歧管,減壓傳遞設備1035包括複數個可於傳遞 至空隙1029後形成於材料中之孔或開孔。該等孔或開孔彼 此連通’從而產生複數個流動通路。流動.通路用於將減壓 施加且分佈於組織部位!025處。作為支架,減壓傳遞設備 1035可生物再吸收且用作新組織在其上及其内生長之基 質。 在一實施例中,減壓傳遞設備1035可包括分佈遍及液體 或黏性凝膠之P〇ragens,諸如NaCU^其他鹽。將液體或黏 膠傳遞至組織部位1025後,該材料與空隙1〇29相符且隨後 固化成固體塊狀物。在體液存在下水溶性NaC1卩沉叫⑼溶 解,存留具有互連孔或流動通路之結構。將減壓及/或流 體傳遞至流動通路。當新組織發育時,該組織生長於減壓 傳遞設備1035之孔中,且隨後隨著減壓傳遞設備1〇35之降 解,該組織最終替代該減壓傳遞設備1〇35。在此特定實例 中,減壓傳遞設備1035不僅用作歧管,且亦用作新組織生 長之支架。 在另一實施例中,減壓傳遞設備1035為混有4〇() μηι甘露 糖珠粒之褐藻酸鹽。可藉由局部體液或沖洗劑或傳遞至組 織部位處之減壓傳遞設備丨035之其他流體溶解p〇ragen或 119640.doc -35- 200836785 珠粒。溶解poragen4珠粒後,先前由p〇ragen或珠粒佔據 之空間變為與其他空隙互連而於減壓傳遞設備丨〇35内形成 流動通路之空隙。 使用poragen於材料内產生流動通路極為有效,但其亦 形成尺寸侷限於大致所選poragen之粒度之孔及流動通 路。可使用化學反應代替progen,從而因形成氣態副產物 而產生較大孔。舉例而言,在一實施例中,可將含有碳酸 氫鈉及擰檬酸微粒(可使用非化學計量之量)之可流動材料 傳遞至組織部位1025處。當可流動材料原位形成發泡體或 固體時’體液將起始碳酸氫鈉與檸檬酸之間的酸鹼反應。 所產生之所得二氧化碳氣體粒子於整個減壓傳遞設備1〇35 内產生比依靠poragen溶解技術所產生者大的孔及流動通 路。 可由pH值、溫度、光或與體液之反應、化學物質或傳遞 至組織部位處之其他物質觸發減壓傳遞設備1035由液體或 黏膠成為固體或發泡體之轉化。亦可藉由混合多種反應組 伤叙生σ亥轉化。在一實施例中,藉由選擇由任何可生物再 吸收+合物製得之可生物再吸收微球體來製備減壓傳遞設 備1035。將微球體分散於含有光引發劑及具有光反應性基 團之形成水凝膠之材料(諸如玻尿酸、膠原蛋白或聚乙二 酉予)的〉谷液中。使微球體-凝膠混合物短時間曝露至光,以 邛7刀父聯水凝膠且將水凝膠固定於微球體上。排出過量溶 液’且隨後乾燥微球體。藉由注射或傾倒將微球體傳遞至 、、、、、哉。卩位,且傳遞後混合物吸收水份,且水凝膠塗層發生 119640.doc -36- 200836785 水合。隨後’再次使混合物曝露至光,其使微球體交聯產 生複數個流動通路。接著,已交聯之微球體用作歧管以將 減壓傳遞至組織部位且作為多孔支架促進新組織生長。 如本文所述之前述實施例外,減壓傳遞設備丨〇3 5亦可由 各種材料製成,包括(但不限於)磷酸鈣、膠原蛋白、褐藻 酸鹽、纖維素或能夠以氣體、液體、凝膠、糊漿、漿料、 懸浮液或其他可流動材料之形式傳遞至組織部位且能夠形 〆 成多個與組織部位流體連通之流動路徑的任何其他相當之 材料。可流動材料可另外包括粒狀固體(諸如珠粒),若該 等粒狀固體之尺寸足夠小,則其能夠流過歧管傳遞管 1021。以可流動狀態傳遞至組織部位之材料可原位聚合或 凝膠化。 如先前所述,可直接將減壓傳遞設備1〇35注射或倒入與 組織部位1025相鄰之空隙1〇29。參看圖27A,歧管傳遞管 1021可在歧管傳遞管1〇21之遠端1〇43處包括不透性膜或半 〇 透性膜1051。膜1051包括與附著至歧管傳遞管1021之次級 官腔1057流體連通之内部空間1〇55。歧管傳遞管1〇21係經 引線1〇61導引至組織部位1025。 可經由次級官腔1〇57注射或倒入減壓傳遞設備1〇35以填 充膜1051之内部空間1〇55。當流體或凝膠填充膜1〇5丨時, 膜1〇51擴張以填充空隙1〇29,從而使該膜與組織部位〖ο。 接觸。當膜1051擴張時,可使用該膜1〇51剝離與組織部位 1025相鄰或接近之額外組織。若膜My為不透性膜,則可 使其貝體破裂且將其移除,存留與組織部位1〇25接觸之減 119640.doc -37- 200836785 壓傳遞設備1035。另外,膜1〇51可由在體液或可傳遞至膜 1051之生物可相容溶劑存在下溶解之可溶解材料製成。若 膜1051為半透性膜,則該膜1〇51可保留於原位。半透性臈 1051使減壓及可能之其他流體連通至組織部位ι〇25。、 參看圖28,向組織部位施予減壓組織療法之方法丨^包 括在1115處以外科手術將歧管插入與組織部位相鄰之位置 處,該歧管具有複數個自可撓性障壁延伸之突起以於該等 突起之間產生複數個流動通路。在1119處定位歧管從而使 至少一部分突起與組織部位接觸。在1123處,經由歧管將 減壓施加至組織部位。 苓看圖29,向組織部位施予減壓組織療法之方法丨21丨包 括在1215處將歧管經皮插入至與組織部位相鄰之位置處。 歧管可包括複數個自可撓性障壁延伸之突起以於該等突起 之間產生流動通路。另外,歧管可包括多泡材料,在該多 泡材料内具有複數個流動通路。或者,歧管可由傳遞至組 織部位且於到達組織部位處後形成複數個流動通路之可注 射或可傾倒材料形成。在1219處,定位歧管從而使至少一 部分流動通路與組織部位流體連通。在1223處,經由歧管 將減壓施加至組織部位。 參看圖3 0,向組織部位施予減壓組織療法之方法1 3 1 1包 括在13 15處將具有通道之管經皮插入穿過患者之組織,以 將管之遠端置放於與組織部位相鄰之位置處。在1319處, 可使與管相連之氣球膨脹以剝離與組織部位相鄰之組織, 籍此產生空隙。在Π23處,經由通道傳遞歧管。歧管可包 119640.doc -38- 200836785 括複數個自可撓性障壁延伸之突起以於該等突起之間產生 流動通路。另外,歧管可包括多泡材料,在該多泡材料内 具有複數個流動通路。或者,歧管可由如先前參考圖巧所 述傳遞至組織部位之可注射或可傾倒材料形成。在η” 處,將歧管定位於”中,&而使至少―部分流動通路與 組織部位流體連通。在1331處,經由減壓傳遞管或任何其 他傳遞構件經歧管將減壓施加至組織部位。 八 參看圖31,向組織部位施予減壓組織療法之方法14丨丨包 括在14 15處將具有通道之管經皮插入穿過患者之組織,以 將管之遠端置放於與組織部位相鄰之位置處。在1423處, 經由通道將歧管傳遞至不透性套管内之組織部位,在MB ^遍不透性套官已經歷比該套管之周圍壓力小之第一減 壓。在1427處,使套管破裂以使歧管與組織部位接觸。在 14 3 1處經由歧管將苐二減壓施加至組織部位。 茶看圖32及33,本發明之—實施例之減壓傳遞設備ΐ5ΐι &括用於曰代患者月又骨i 5 i 7之現存股骨頭的矯形髖假體 1515。髖假體1515包括桿部分1521及頭部分15乃。延長桿 部分1521以供插入股骨1517軸中經鉸孔之通道1529内。將 多孔塗層1535安置於桿部分周圍且其較佳係由燒結或玻化 陶竞或金屬建構。或者’可將具有多孔特性之多泡材料安 置於杯邛刀周目將複數個流動通路1541安置於髖假體 1 5 1 5 之桿部分 1 5 2 1 内,% 二 | 彳< 而使流動通路1541與多孔塗層 1 535流體連通。使連接通口 1545與流動通路mi流體連 接,該通口經組態以解除與減壓傳遞及減壓傳遞源 119640.doc -39- 200836785 1553之連接。植入後,使用流動通路1541將減壓傳遞至多 孔塗層1535及/或髖假體1515周圍之骨骼。流動通路i54i 可包括與若干橫向分支管線1 547流體連通之主要給料管線 1543,該等橫向分支管線1547與多孔塗層1535連通。如圖 32所述,该等橫向分支管線1545可與主要給料管線1543垂 直定向,或可與主要給料管線1543以一定角度定向。一種 用於分佈減壓之替代性方法包括:提供中空髖假體;及以 月匕夠與夕孔塗層1535流體連通之多泡(較佳為開孔)材料填 充假體之内部空間。 更特定參看圖33,髖假體15 15可於桿部分1521内另外包 括第二複數個流動通路丨56丨,以將流體提供至多孔塗層 1 5 3 5及/或體假體1 5 1 5周圍之骨胳。該流體可包括經過滤 之工氣或其他氣體、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。若需要將 多種流體引入髖假體151 5周圍之骨骼,則可提供額外流體 連通路控。使連接通口 1565與流動通路1561流體連接,該 通口 1565經組態以解除與流體傳遞管1571及流體傳遞源 1573之連接。流動通路1561可包括與若干橫向分支管線 1 5 85流體連通之主要給料管線1583,該等橫向分支管線 1585與多孔塗層1535連通。如圖33所述,該等横向分支管 線1585可與主要給料管線1583垂直定向,或可與主要給料 管線1 583以一定角度定向。 可藉由單獨管(諸如減壓傳遞管1551及流體傳遞管1571) 貫現減壓至第一複數個流動通路1541之傳遞及流體至第二 119640.doc -40- 200836785 複數個流動通路1561之傳遞。另外,可使用具有前述多個 管腔之管分隔傳遞減壓及流體之連通路徑。另外應注意, 儘官較佳於髖假體15 15内提供單獨之流體連通路徑,但亦 可使用第一複數個流動通路1541將減壓及流體傳遞至體假 體1515周圍之骨骼。 如先前所述,將減壓施加至骨骼組織促進且加速新骨骼 組織之生長。藉由使用作為歧管之髖假體1515將減壓傳遞 至髖假體周圍之骨骼區域,股骨1517恢復加快,且使髖假 體1515能夠更成功地與骨骼整合。提供第二複數個流動通 路1561以使髖假體151 5周圍之骨骼開孔從而改良假體周圍 新骨骼之成功產生。 經由體假體15 15施加減壓一段選定量之時間後,可使減 壓傳遞管1551及流體傳遞管1571與連接通口 1545、1565斷 開,且較佳在不利用外科手術侵入程序之情況下將其自患 者體内移除。連接通口 1545、1565與管1551、1571之間的 連接可為可手工解除之連接,該手工解除可藉由向患者體 外之官1551、1571施加軸向張力來實現。或者,連接通口 1545、1565可在所選擇之流體或化學物質存在下經生物再 吸收或溶解,從而可藉由將連接通口 1545、 體或化學物質來獲得管1551、1571之解除。管咖路= 亦可由經一段時間溶解之可生物再吸收之材料或在特定化 學物質或其他物質存在下溶解之活性材料製成。 可在患者體外提供減壓傳遞源1553,且使其與減壓傳遞 官1551連接以將減壓傳遞至髖假體1515。或者,可將減壓 119640.doc -41 - 200836785 傳遞源1553植入患者體内之髖假體151 5上或接近髖假體 1 5 1 5。將減壓傳遞源1 5 5 3置放於患者體内從而消除對經皮 流體連接之需求。所植入之減壓傳遞源丨553可為可操作地 連接至流動通路1541之慣用泵。可以植入患者體内之電池 為該泵提供動力,或可以與泵電連接且經皮連接之外部電 池為該泵提供動力。亦可藉由傳遞減壓且使流體經由流動 通路1541、1561循環之化學反應直接驅動泵。 儘管圖32及33中僅描述髖假體15 15之桿部分1521及頭部 分1 525 ’但應注意可將用於施加本文所述之減壓組織療法 之流動通路及構件應用於髖假體1515接觸骨骼或其他組織 (例如包括體臼)之任何其他組件。 參看圖34,一種用於修復患者關節之方法1611包括在 1 6 1 5處將假體植入與關節相鄰之骨骼内。該假體可為如上 文所述之髖假體或協助恢復患者關節活動性之任何其他假 體。假體包括複數個經組態以與骨骼流體連通之流動通Referring to Figures 21 and 22, the reduced pressure delivery system 7丨1 is further described. The manifold delivery officer 721 can include a tapered distal end 743 to attenuate insertion through the patient's skin 735 and soft tissue 739. The tapered distal end 743 can be additionally configured to flex radially outwardly of the open position such that the inner diameter of the distal end 743 is substantially the same as or greater than the inner diameter at the other portion of the tube 721. . The position of the opening of the distal end 743 is schematically depicted by a broken line 737 in FIG. Manifold transfer tube 721 additionally includes a passage 751 containing a reduced pressure delivery device 761 or any other reduced pressure delivery device. The reduced pressure delivery device 761 includes a flexible barrier 765 and/or a multi-foaming material π? similar to those described with reference to Figures 6-8. The resistant barrier 765 and/or the multi-bubble material 767 is preferably wound, folded or otherwise compressed around the reduced pressure transfer tube 769 to reduce the cross-sectional area of the reduced pressure transfer device 761 in the passage 751. After the distal end 743 of the manifold delivery tube 721 is placed at the tissue site 713, the reduced pressure delivery device 761 can be placed in the channel 751 and guided to the tissue site 713. In addition, named Jiang, AA-Yi Bu, in the insertion of the skeletal delivery tube 721 into the patient's body = front can be scheduled to be located in the channel 751. If the pressure reducing transmission device 76 1 is pushed through the passage 75 1, the target - Γ / 士, I 逋迢 / 51 can use the biocompatible lubrication 119640.doc -27- 200836785 agent to reduce the reduced pressure transmission device 761 Friction with the manifold transfer tube 721. When the distal end 743 has been positioned at the tissue site 713 and the reduced pressure delivery device 761 has been delivered to the distal end 743, then the reduced pressure delivery device 761 is pushed toward the distal end 743 ' resulting in the distal end 743 expanding radially outward to In the opening position. The reduced pressure delivery device 761 is pushed out of the manifold transfer tube 721, preferably into the void or space of the tissue site 713. Voids or spaces are typically formed by soft tissue stripping that can be achieved by transdermal means. In some cases, the tissue site 713 can be located at the wound site, and naturally there can be voids due to anatomical trauma. In other cases, it may be by balloon peeling, sharp stripping, blunt peeling, hydrodissection, pneumatic dissecting, ultrasonic peeling, electrocautery stripping, laser stripping or any other suitable The stripping technique produces a jade gap. § When the reduced pressure delivery device 76 enters the gap adjacent the tissue site 73, the flexible barrier 765 and/or the multifoam material 767 of the reduced pressure delivery device 761 opens, expands or decompresses (see Figure 22), thereby The reduced pressure delivery device 761 can be placed in contact with the tissue site 713. Although not required, the flexible barrier 765 and/or the multi-foaming material 767 can be subjected to vacuum or reduced pressure supplied via the reduced pressure delivery officer 769 to compress the flexible barrier and/or multi-bubble material 767. The flexible P early soil 765 and/or the evening bag material 767 can be stretched by relaxing the reduced pressure supplied by the reduced pressure transfer tube 769 or by supplying a positive pressure from the reduced pressure transfer tube 769 to assist the opening process. Final placement and manipulation of the reduced pressure delivery device 761 can be accomplished by endoscopic examination, hypersonic, fluorescent examination, auscultation, palpation, or any other suitable positioning technique. After the reduced pressure delivery device 761 is placed, the manifold delivery f72i is preferably removed from the patient, but the reduced pressure delivery tube associated with the reduced pressure delivery device 761 is retained in place to allow 119640.doc -28-200836785 to be reduced. The pressure is applied to the tissue site 7 1 3 percutaneously. Referring to Figures 23-25, a reduced pressure delivery system 811 of one embodiment of the present invention includes a manifold transfer tube 821 having a tapered distal end 843 that is configured to flex radially outwardly of the open position. Thus, the inner diameter of the distal end 843 is substantially the same as or greater than the inner diameter at the other portion of the tube 821. The position of the opening of the distal end 843 is schematically depicted by dashed lines 837 in Figures 23-25. The responsive officer 821 additionally includes a passageway containing a reduced pressure delivery device 861 similar to the other reduced pressure delivery devices described herein. The reduced pressure delivery device 861 includes a flexible barrier 865 and/or a multi-bubble material that is preferably wound, folded, or otherwise compressed around the reduced pressure transfer tube 869 to reduce the cross-sectional area of the reduced pressure transfer passage 861 within the passage. . The impervious membrane 871 having the internal space 873 is placed around the reduced-pressure delivery device 861 such that the internal space 873 of the impermeable membrane 871 contains the reduced-pressure delivery device 861. The impermeable membrane 871 can be a balloon, a cannula, or any other type of membrane capable of preventing fluid transport, such that the impermeable membrane 871 can assume a compressed position (see Figure 23), a relaxed position (see Figure 24), and an expanded position. (See Figures 25 and 25 A) at least one of them. The impermeable membrane 871 can be hermetically connected to the manifold transfer member 821 such that the interior space of the impermeable membrane 871 is in fluid communication with the passage of the eccentric transfer tube 821. The impermeable membrane 871 may be additionally attached to the reduced pressure transfer tube 869 such that the inner space 873 of the impermeable membrane 871 is in fluid communication with the passage of the reduced pressure transfer tube 869. Alternatively, the impermeable membrane can be attached to a separate control tube or control lumen in fluid communication with internal space 873 (see, for example, Figure 25A). 119640.doc -29- 200836785 In an embodiment, an impermeable membrane 871 may be provided to further reduce the cross-sectional area of the in-channel reduced pressure delivery device 861. To achieve this, a C force smaller than the surrounding pressure around the impermeable film 871 is applied to the inner space 873 of the impermeable film 871. Thereby, most of the air or other fluid in the interior space 873 is withdrawn, leaving the impermeable membrane 871 in the compressed position shown in FIG. The impermeable membrane 871 is stretched inward at the compression position, thereby applying a compressive force to the reduced pressure delivery device 861 to further reduce the cross-sectional area of the reduced pressure delivery device 861. As described earlier with reference to Figures 21 and 22, after the distal end 843 of the manifold delivery tube 821 is placed at the tissue site, the reduced pressure delivery device 861 can be delivered to the tissue site. The impervious membrane 871 and the decompression transfer device 861 can be manipulated by using endoscopic examination, supersonic, fluorescent examination, auscultation, palpation or any other suitable positioning technique. The impermeable membrane 871 can include a radiopaque marker 881' which observes the impermeable membrane 871 under a modified fluoroscopy prior to removal. After pushing the reduced pressure delivery device 861 through the distal end 843, the reduced pressure applied to the internal space 873 can be weakened to bring the impermeable membrane 87A into the relaxed position (see Fig. 24) 'thus enabling easier decompression The transfer device 86 is removed from the impermeable membrane 871. A removal instrument 885 (such as a trocar, stylet or other sharp instrument) can be provided to rupture the impermeable membrane 871. The removal instrument 885 is preferably inserted via the reduced pressure delivery tube 869 and is capable of being advanced to contact the impermeable membrane 871. After the impervious membrane 871 is broken, the removal instrument 8 85 and the impermeable membrane 87} can be extracted via the manifold transfer tube 821 to open the flexible barrier 865 and/or the multi-foam material 867 of the reduced pressure delivery device 86. , stretched or decompressed so that the reduced pressure delivery device 861 can be placed in contact with the tissue site. Attenuation of application 119640.doc -30- 200836785 After the decompression of internal space 873 and removal of impervious film 871, the opening of flexible barrier 865 and/or multi-foam material 867 may automatically occur. In some cases, a positive pressure may be delivered via the reduced pressure delivery tube 869 to assist in opening or decompressing the flexible barrier 865 and/or the multi-bubble material 867. After the decompression delivery device 861 is finally placed, the manifold delivery tube 821 is preferably removed from the patient, but the reduced pressure delivery tube 869 connected to the reduced pressure delivery device 861 is retained in place to allow for transdermal application of reduced pressure. To the tissue site. An impermeable membrane 871 can also be used to detach tissue adjacent to the tissue site, followed by placement of a reduced pressure delivery device 861 to offset the tissue site. After the reduced pressure delivery device 861 and the intact impervious membrane 871 are pushed past the distal end 843 of the manifold transfer tube 821, air or another fluid can be injected or aspirated into the interior space 873 of the impermeable membrane 871. Since the incompressibility of the liquid allows the impervious film 871 to expand more uniformly and uniformly, it is preferred to use a liquid to swell the impermeable film 871. As shown in Fig. 25, the impervious film 871 may be radially or directionally expanded, depending on the method of manufacture and the attachment of the manifold transfer tube 821. Since the impermeable membrane 87 1 expands outward to the expanded position due to the pressure of air or fluid (see Fig. 25), the void adjacent to the tissue site is peeled off. When the void is sufficiently large, liquid, air or other fluid may be released from the interior space 873 to cause the impermeable membrane 871 to assume a relaxed position. Subsequently, the impermeable membrane 871 can be ruptured as explained previously, and the reduced pressure delivery device 861 is inserted into a position adjacent to the tissue site. Referring to FIG. 25A, if the tissue adjacent to the tissue site is mainly peeled off using the impermeable membrane 871, the impermeable membrane 871 can be hermetically attached to the manifold transfer tube M1, thereby allowing the internal space 873 and the same manifold transfer tube. The 821 is connected or attached to H9640.doc-31 - 200836785 to the secondary lumen or tube 891 of the MIS discharge tube 821 for fluid communication. Liquid, air or other fluid may be delivered to the interior space 873 using a human lumen 891 to place the impermeable membrane 871 at the expanded position. After peeling, the impermeable membrane 871 can be relaxed and ruptured as previously described with reference to Figure 24. Referring to Figure 26, a reduced pressure delivery system 9A of one embodiment of the present invention includes a manifold transfer tube 921 having a tapered distal end 943 that is radially deflected outwardly toward the open position by the set of distal ends 943. The inner diameter of the distal end 943 is substantially the same as or greater than the inner diameter at other portions of the tube 921. The opening position of the distal end 943 is schematically depicted by a broken line 937 in FIG. Manifold transfer tube 921 additionally includes a passageway containing a reduced pressure delivery device 916 similar to the other reduced pressure delivery 5 described herein. The reduced pressure transfer device 916 includes a flexible barrier 965 and/or a multi-bubble material 967 that is preferably wound, folded or otherwise compressed around the reduced pressure transfer tube 969 to reduce the reduction in the passage of the manifold transfer tube 921. The cross-sectional area of the pressure transmitting device 961. The impervious film 971 having the internal space 973 is disposed around the reduced pressure transfer device 961' such that the internal space 973 of the impermeable film 971 contains the reduced pressure transfer device 961. The impermeable membrane 971 includes a seal 977' at one end of the impermeable membrane 971 to provide an alternative method of removing the reduced pressure delivery device 96 1 from the impermeable membrane 971. The other end of the impermeable membrane 971 can be sealed to the manifold delivery tube 9 1 1 such that the internal space 973 of the impermeable membrane 791 is in fluid communication with the passage of the manifold transfer tube 921. Alternatively, the impermeable membrane 971 can be attached to a separate control tube (not shown) in fluid communication with the interior space 973. Similar to the impervious membrane 87 1 1 of Figure 23, the impermeable membrane 197 prevents fluid 119640.doc -32, 200836785 from being transported, so the impervious membrane 971 can take compression/position, relaxed position and expansion At least one of the locations. Since the procedure for placing the impermeable membrane in the compressed position and the expanded position is similar to that of the impervious membrane 871, only the different methods of removing the reduced pressure delivery device 961 will be described. - delivery of the reduced pressure delivery device 96 1 to the tissue site within the impervious membrane 97" and subsequent use of endoscopy, ultrasound, fluoroscopy, auscultation, palpation or any other suitable positioning technique Make it properly positioned. The impermeable membrane 971 can include a radiopaque marker 98i that improves the observation of the impermeable membrane 971 under fluoroscopy prior to removal. Next, the reduced pressure delivery device 96 is pushed past the distal end 943 of the manifold transfer tube 921. The depressurization applied to the internal space 973 can be weakened to place the impermeable membrane 971 in a relaxed position. Next, the reduced pressure delivery device 961 is pushed through the glue seal 977 to withdraw the impermeable film 971. Referring to Figure 26A, a reduced pressure delivery system 985 of one embodiment of the present invention may not include a manifold transfer tube 92 1 similar to the manifold transfer tube of Figure 26 . In other words, the reduced pressure delivery system 985 can include a lead 987, a reduced pressure transfer tube 989, and a reduced pressure delivery device 99 1 . The reduced pressure delivery device 991 includes a plurality of flow paths that are fluidly coupled to the reduced pressure delivery tube 989. The pressure-reducing device 991 and the pressure-reducing transfer tube 9 8 9 are placed on the lead 9 8 7 that is percutaneously guided to the tissue portion 913, instead of using the independent manifold transfer tube to transmit the pressure-reducing device. 9 91. Lead 9 8 7 and reduced pressure delivery tube 9 8 9 preferably penetrate the skin of the patient via a sterile cannula. By guiding the reduced pressure delivery tube 989 and the reduced pressure delivery device 991 along the lead 987, the reduced pressure delivery device 991 can be placed at the tissue site 993 to allow percutaneous application of reduced pressure tissue therapy. Since the 119640.doc -33 - 200836785 pressure reducing device 911 is not constrained in the manifold transfer tube during delivery to the tissue site 993, it is preferred to hold the reduced pressure delivery device 99 1 in compression during delivery. position. If an elastic foam is used as the pressure reducing transfer device 99 1, a biocompatible, soluble adhesive can be applied to the foam and the foam can be compressed. Upon reaching the tissue site, the body fluid or other fluid delivered via the reduced pressure delivery tube 989 dissolves the adhesive and expands the foam to contact the tissue site. Alternatively, the reduced pressure transfer device 991 may be formed by a compressed anhydrous hydrogel. The hydrogel absorbs moisture after delivery to the tissue site 993, thereby expanding the reduced pressure delivery device 991. Another reduced pressure delivery device 99 1 can be made from a thermally active material (e.g., polyethylene glycol) that expands at the tissue site 993 upon exposure to body heat of the patient. In another embodiment, the compressed reduced pressure delivery device 917 can be delivered to the tissue site 913 for film unwinding. Referring to Figure 27, a reduced pressure delivery system 之一 of one embodiment of the present invention includes a manifold delivery tube 1 〇 21 having a distal end 1043 that is inserted through tissue of a patient to access tissue site 1025. . The tissue site 25 can include voids 1029 associated with wounds or other defects, or alternatively can be created by exfoliation, including stripping techniques as described herein. After the distal end 1043 is placed in the gap 1〇29 adjacent to the tissue site 1〇25, the injectable, pourable or flowable reduced-pressure delivery device 1035 is delivered to the tissue site via the manifold transfer tube 1〇21. 1025. In the case of delivery to the tissue site, the 'reduced pressure transfer device 1 〇 3 5 preferably exists in a flowable state, and then forms a plurality of flow paths for distributing the reduced pressure or fluid after arrival, in some cases, The flowable material can be hardened after reaching the tissue site through a drying process, a curing process or other chemical reaction or physical reaction to form a solid H9640.doc -34 - 200836785 sad. In other cases, the flowable material can form a foam in situ after delivery to the tissue site. Other materials may be present in the gel-like state at the tissue site 1025, but still have a plurality of flow paths for delivering reduced pressure. The amount of reduced pressure delivery device 1 〇 3 5 delivered to the tissue site 1 〇 2 5 may be sufficient to partially fill the gap 1029. The reduced pressure delivery device 1A can include the manifold and the stent. As a manifold, the reduced pressure transfer device 1035 includes a plurality of holes or openings that are formed in the material after being transferred to the voids 1029. The holes or openings are connected to each other' to create a plurality of flow paths. The flow path is used to apply and distribute the decompression to the tissue site! 025. As a stent, the reduced pressure delivery device 1035 is bioresorbable and serves as a substrate for new tissue to grow thereon and therein. In one embodiment, the reduced pressure delivery device 1035 can include P〇ragens, such as NaCU^ other salts, distributed throughout the liquid or viscous gel. After the liquid or adhesive is delivered to the tissue site 1025, the material conforms to the void 1〇29 and subsequently solidifies into a solid mass. The water-soluble NaC1 sputum (9) dissolves in the presence of body fluids, and retains a structure having interconnected pores or flow paths. The reduced pressure and/or fluid is transferred to the flow path. When a new tissue develops, the tissue grows in the pores of the reduced pressure delivery device 1035, and then the tissue eventually replaces the reduced pressure delivery device 1〇35 as the reduced pressure delivery device 1〇35 is degraded. In this particular example, the reduced pressure delivery device 1035 functions not only as a manifold but also as a stent for new tissue growth. In another embodiment, the reduced pressure delivery device 1035 is alginate mixed with 4 〇 () μ η mannose beads. The p〇ragen or 119640.doc-35-200836785 beads may be dissolved by a local body fluid or irrigant or other fluid delivered to the reduced pressure delivery device 丨035 at the tissue site. After the poragen4 beads are dissolved, the space previously occupied by p〇ragen or beads becomes a void which is interconnected with other spaces to form a flow path in the pressure-reducing transfer device 丨〇35. The use of poragen to create a flow path within the material is extremely effective, but it also forms pores and flow paths that are limited in size to the particle size of the selected poragen. Instead of progen, a chemical reaction can be used to create larger pores due to the formation of gaseous by-products. For example, in one embodiment, a flowable material comprising sodium bicarbonate and citric acid microparticles (which may be used in non-stoichiometric amounts) can be delivered to tissue site 1025. When the flowable material forms a foam or solid in situ, the body fluid will react with the acid and base between the initial sodium bicarbonate and the citric acid. The resulting carbon dioxide gas particles produced generate larger pores and flow paths throughout the reduced pressure transfer device 1 to 35 than those produced by the poragen dissolution technique. The conversion of the reduced pressure delivery device 1035 from a liquid or glue to a solid or foam can be triggered by pH, temperature, light or reaction with body fluids, chemicals or other materials delivered to the tissue site. It is also possible to describe the σ海 transformation by mixing multiple reaction groups. In one embodiment, the reduced pressure delivery device 1035 is prepared by selecting bioresorbable microspheres made from any bioresorbable compound. The microspheres are dispersed in a solution of a hydrogel-forming material (such as hyaluronic acid, collagen or polyethylene) containing a photoinitiator and a photoreactive group. The microsphere-gel mixture was exposed to light for a short period of time to bind the hydrogel to the 7-knife and fix the hydrogel to the microspheres. The excess solution was drained' and the microspheres were subsequently dried. The microspheres are delivered to , , , , , and by injection or pouring. The niobium is removed and the mixture absorbs moisture and the hydrogel coating hydrates 119640.doc -36-200836785. The mixture is then ' again exposed to light which crosslinks the microspheres to produce a plurality of flow paths. The crosslinked microspheres are then used as a manifold to deliver reduced pressure to the tissue site and promote new tissue growth as a porous scaffold. In addition to the foregoing embodiments described herein, the reduced pressure delivery device 丨〇35 can also be made from a variety of materials including, but not limited to, calcium phosphate, collagen, alginate, cellulose, or capable of being gas, liquid, condensed. Glue, paste, slurry, suspension, or other flowable material is delivered to the tissue site and can be shaped into any other equivalent material that is in fluid communication with the tissue site. The flowable material may additionally comprise particulate solids (such as beads) which are capable of flowing through the manifold transfer tube 1021 if the size of the particulate solids is sufficiently small. The material that is delivered to the tissue site in a flowable state can be polymerized or gelled in situ. As previously described, the reduced pressure delivery device 1〇35 can be directly injected or poured into the gap 1〇29 adjacent to the tissue site 1025. Referring to Fig. 27A, the manifold transfer tube 1021 may include an impermeable membrane or semi-permeable membrane 1051 at the distal end 1〇43 of the manifold transfer tube 1〇21. The membrane 1051 includes an interior space 1 〇 55 in fluid communication with a secondary chamber 1057 attached to the manifold transfer tube 1021. The manifold transfer tube 1〇21 is guided to the tissue site 1025 via the lead 1〇61. The pressure reducing transfer device 1〇35 can be injected or poured into the internal space 1〇55 of the membrane 1051 via the secondary chamber 1〇57. When the fluid or gel-filled film is 1〇5丨, the film 1〇51 is expanded to fill the voids 1〇29, thereby making the film and the tissue site. contact. When the membrane 1051 is expanded, the membrane 1〇51 can be used to strip additional tissue adjacent or adjacent to the tissue site 1025. If the membrane My is an impermeable membrane, the shell can be broken and removed, leaving a reduced pressure 119640.doc -37-200836785 pressure delivery device 1035 in contact with the tissue site 1〇25. Alternatively, membrane 1〇51 can be made of a dissolvable material that dissolves in the presence of body fluids or biocompatible solvents that can be delivered to membrane 1051. If the membrane 1051 is a semipermeable membrane, the membrane 1〇51 can remain in place. The semipermeable 臈 1051 connects the reduced pressure and possibly other fluids to the tissue site ι 25 . Referring to Figure 28, a method of administering reduced-pressure tissue therapy to a tissue site includes surgically inserting a manifold adjacent the tissue site at 1115, the manifold having a plurality of self-flexible barriers extending The protrusions create a plurality of flow paths between the protrusions. The manifold is positioned at 1119 such that at least a portion of the protrusions are in contact with the tissue site. At 1123, a reduced pressure is applied to the tissue site via the manifold. Referring to Figure 29, a method of administering reduced-pressure tissue therapy to a tissue site includes inserting a manifold percutaneously at 1215 adjacent to the tissue site. The manifold may include a plurality of protrusions extending from the flexible barrier to create a flow path between the protrusions. Additionally, the manifold can include a multi-vesicle material having a plurality of flow passages within the multi-vesicle material. Alternatively, the manifold may be formed of an injectable or pourable material that is delivered to the tissue site and that forms a plurality of flow paths upon reaching the tissue site. At 1219, the manifold is positioned such that at least a portion of the flow path is in fluid communication with the tissue site. At 1223, a reduced pressure is applied to the tissue site via the manifold. Referring to Figure 30, a method of administering reduced-pressure tissue therapy to a tissue site 1 3 1 1 includes percutaneously inserting a tube having a passage through the patient's tissue at 13 15 to place the distal end of the tube with the tissue The location is adjacent to the location. At 1319, the balloon associated with the tube can be inflated to strip tissue adjacent to the tissue site, thereby creating a void. At Π23, the manifold is passed through the passage. The manifold can be packaged 119640.doc -38- 200836785 to include a plurality of protrusions extending from the flexible barrier to create a flow path between the protrusions. Additionally, the manifold can include a multi-vesicle material having a plurality of flow passages within the multi-bubble material. Alternatively, the manifold can be formed from an injectable or pourable material that is delivered to the tissue site as previously described with reference to the drawings. At η", the manifold is positioned "in," and at least a portion of the flow path is in fluid communication with the tissue site. At 1331, reduced pressure is applied to the tissue site via a manifold via a reduced pressure delivery tube or any other delivery member. 8 Referring to Figure 31, a method of administering reduced-pressure tissue therapy to a tissue site 14 includes percutaneously inserting a tube having a passage through the patient's tissue at 14 15 to place the distal end of the tube with the tissue site. Adjacent to the location. At 1423, the manifold is transferred to the tissue site within the impermeable cannula via the channel, and the MB^pass impermeable sleeve has experienced a first depressurization that is less than the pressure around the cannula. At 1427, the cannula is ruptured to bring the manifold into contact with the tissue site. The decompression was applied to the tissue site via a manifold at 14 31. Tea looking at Figures 32 and 33, the reduced pressure delivery device of the present invention - ΐ5ΐι & includes an orthopaedic hip prosthesis 1515 for the surviving femoral head of the patient's month and bone i 5 i 7 . The hip prosthesis 1515 includes a stem portion 1521 and a head portion 15 . The extension rod portion 1521 is inserted into the reamed passage 1529 in the shaft of the femur 1517. The porous coating 1535 is placed around the stem portion and is preferably constructed of sintered or vitrified pottery or metal. Or 'a multi-foam material having a porous property can be placed on the cup file to place a plurality of flow passages 1541 in the rod portion 1 5 2 1 of the hip prosthesis 1 5 1 5, % 2 | 彳 < Flow passage 1541 is in fluid communication with porous coating 1 535. The connection port 1545 is fluidly coupled to the flow path mi, which is configured to release the connection to the reduced pressure transfer and reduced pressure transfer source 119640.doc -39 - 200836785 1553. After implantation, the reduced pressure is delivered to the bone around the porous coating 1535 and/or hip prosthesis 1515 using flow path 1541. The flow path i54i can include a primary feed line 1543 in fluid communication with a plurality of lateral branch lines 1 547 that are in communication with the porous coating 1535. As shown in Fig. 32, the transverse branch lines 1545 can be oriented perpendicular to the main feed line 1543 or can be oriented at an 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 multi-bubble (preferably open cell) material that is in fluid communication with the esophageal coating 1535. Referring more specifically to Figure 33, the hip prosthesis 15 15 can additionally include a second plurality of flow passages 丨 56 in the stem portion 1521 to provide fluid to the porous coating 1 5 3 5 and/or the body prosthesis 1 5 1 5 surrounding bones. The fluid may include filtered work gas or other gas, antibacterial agent, antiviral agent, cell growth promoter, irrigation fluid, chemically active fluid, or any other fluid. Additional fluid communication is provided if multiple fluids need to be introduced into the bone around the hip prosthesis 151 5 . The port 1565 is fluidly coupled to a flow passage 1561 that is configured to relieve connection to the fluid transfer tube 1571 and the fluid transfer source 1573. The flow passage 1561 can include a primary feed line 1583 in fluid communication with a plurality of transverse branch lines 158, the transverse branch lines 1585 being in communication with the porous coating 1535. As shown in Figure 33, the transverse branch lines 1585 can be oriented perpendicular to the main feed line 1583 or can be oriented at an angle to the main feed line 1 583. The pressure reduction to the first plurality of flow passages 1541 and the flow to the second 119640.doc -40 - 200836785 plurality of flow passages 1561 can be achieved by separate tubes (such as the reduced pressure transfer tube 1551 and the fluid transfer tube 1571) transfer. Further, a communication path for transferring the pressure reduction and the fluid may be separated by a tube having the plurality of lumens. Additionally, it should be noted that a separate fluid communication path is preferably provided within the hip prosthesis 15 15 , but the first plurality of flow passages 1541 can also be used to deliver reduced pressure and fluid to the bone surrounding the body prosthesis 1515 . As previously described, application of reduced pressure to bone tissue promotes and accelerates the growth of new bone tissue. By transferring the reduced pressure to the bone region around the hip prosthesis using the hip prosthesis 1515 as a manifold, the femur 1517 recovers faster and allows the hip prosthesis 1515 to more successfully integrate with the bone. A second plurality of flow paths 1561 are provided to open the bone around the hip prosthesis 151 5 to improve the successful creation of new bone around the prosthesis. After the decompression is applied through the body prosthesis 15 15 for a selected amount of time, the reduced pressure delivery tube 1551 and the fluid transfer tube 1571 can be disconnected from the connection ports 1545, 1565, and preferably without the use of a surgical invasive procedure. Remove it from the patient. The connection between the connecting ports 1545, 1565 and the tubes 1551, 1571 can be a manually removable connection which can be achieved by applying axial tension to the officials 1551, 1571 outside the patient. Alternatively, the connection ports 1545, 1565 can be bioresorbed or dissolved in the presence of a selected fluid or chemical, such that the removal of the tubes 1551, 1571 can be achieved by connecting the ports 1545, body or chemical. Tube Road = can also be made from bioresorbable materials that have been dissolved over a period of time or active materials that are dissolved in the presence of specific chemicals or other substances. A reduced pressure delivery source 1553 can be provided outside the patient and coupled to the reduced pressure delivery officer 1551 to deliver reduced pressure to the hip prosthesis 1515. Alternatively, the reduced pressure 119640.doc -41 - 200836785 delivery source 1553 can be implanted on or near the hip prosthesis 151 5 in the patient. The reduced pressure delivery source 1 5 5 3 is placed in the patient to eliminate the need for a percutaneous fluid connection. The implanted reduced pressure delivery source 553 can be a conventional pump that is operatively coupled to the flow path 1541. A battery that can be implanted in the patient powers the pump, or an external battery that can be electrically connected to the pump and connected percutaneously to power the pump. The pump can also be driven directly by a chemical reaction that delivers a reduced pressure and circulates fluid through the flow passages 1541, 1561. Although only the stem portion 1521 and the head portion 1 525 ' of the hip prosthesis 15 15 are depicted in FIGS. 32 and 33, it should be noted that flow passages and members for applying the reduced pressure tissue therapy described herein can be applied to the hip prosthesis 1515. Any other component that touches a bone or other tissue, such as a body. Referring to Figure 34, a method 1611 for repairing a patient's joint includes implanting the prosthesis into the bone adjacent the joint at 1651. The prosthesis can be a hip prosthesis as described above or any other prosthesis that assists in restoring the joint mobility of the patient. The prosthesis includes a plurality of flow passes configured to be in fluid communication with the bone

路。在1619處,經由複數個流動通路將減壓施加至骨骼以 改良假體之骨骼整合。 多看圖3 5及3 6,本發明之一貫施例之減壓傳遞設備17 “ 包括用於固定患者骨路1717(包括骨折1719或其他缺幻之 ^外科固定裝置1715。圖35及36中所述之矯形外科固定 Γ72置51715為具有複數個通道1721之面板,其係用於以螺桿 、大頭針、螺釘或其他扣件將矯形外科固定裝置 名田疋至骨路1717。可將多孔塗声1 夕札坌層1735女置於待與骨骼171 7 稷觸之矯形外科固定裝置 在置1715之表面上。多孔塗層較佳係 H9640.doc -42- 200836785 由燒結或玻化陶竞或金屬建構。或者,可將具有多孔特性 之多泡材料安置於骨骼1717與矯形外科固定裝置1715之 間。將複數個流動通路1741安置於矯形外科固定裝置i7i5 内’從而使流動通路1741與多孔塗層1735流體連通。使連 接通口⑽與流動通路1741流體連接,該通口經組態以與 減壓傳遞管1751及減壓傳遞源1753連接。將橋形外科固定 裝置1715固定至骨路1717後,使用流動通路1741將減壓傳 (road. At 1619, decompression is applied to the bone via a plurality of flow paths to improve skeletal integration of the prosthesis. Referring more to Figures 3 5 and 3, the reduced pressure delivery device 17 of the consistent embodiment of the present invention "includes a surgical fixation device 1717 for fixation of the patient's bone path 1717 (including fracture 1719 or other illusion. Figures 35 and 36) The orthopaedic fixation sputum 72 is configured as a panel having a plurality of channels 1721 for using a screw, a pin, a screw or other fastener to advance the orthopedic fixation device to the bone road 1717. 1 The sapporo layer 1735 female placed on the surface of the orthopedic fixation device to be contacted with the bone 171 7 . The porous coating is preferably H9640.doc -42- 200836785 from sintered or vitrified pottery or metal Alternatively, a multi-vesicular material having porous properties can be placed between the bone 1717 and the orthopedic fixation device 1715. A plurality of flow passages 1741 are placed within the orthopedic fixation device i7i5 to thereby make the flow passage 1741 and the porous coating 1735 is in fluid communication. The connection port (10) is fluidly coupled to the flow passage 1741, the port being configured to be coupled to the reduced pressure transfer tube 1751 and the reduced pressure delivery source 1753. The bridge surgical fixation device 1715 is secured to the bone path 1 After 717, the reduced pressure is transmitted using the flow path 1741 (

C 遞至多孔塗層1735及/或矯形外科固定裝置m3周圍之骨 路。流動通路1741可包括與若干橫向分支管線1747流體連 通之主要給料管線丨743, 層17 Λ 3㈣&向分支管線m7與多孔塗 ! H圖35所述,該等橫向分支管線1747可盘主 管線1743垂直定向’或可與主要給料管線⑽以一 =二向;種用於分佈減壓之替代性方法包括:提供 :工之矯形外科固定裝置;及以能夠與多 連通之多泡(較佳為開孔)材 日35机體 内部空間。 真充邊矯形外科固定裝置之 如圖35所示,矯形外科 外可為mu,m〜 可為―面板,或另 嫩之任" 撐臂、支桿或用於穩定-部 刀月骼之任何其他裝置。矯形外 用於附著假體或其他矯形 二15可另外為 織或軟骨)之扣件,…等广直入組織(例如,骨路組 與該等扣件相鄰或該等扣;;周件包括用於將減壓傳遞至 此等扣件之每#/ α圍之組織的流動通路即可。 當扣件^可包括大頭針、螺針、螺桿或任何其他適 119640.doc -43 - 200836785 更特定地參看圖36,矯形外科固定裝置1715可另外在镇 形外科固定裝置1715内包括第二複數個流動通路1761,以 將流體提供至多孔塗層17 3 5及/或矯形外科固定裝置1715 周圍之骨骼。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。若需要將多種流體引入矯形外科固定 裝置17 15周圍之骨骼,則可提供額外流體連通路徑。使連C is delivered to the porous coating 1735 and/or the bone path around the orthopedic fixation device m3. The flow passage 1741 can include a primary feed line 丨 743 in fluid communication with a plurality of transverse branch lines 1747, a layer 17 Λ 3 (four) & a branch line m7 and a porous coating! H. Figure 35, the lateral branch line 1747 can be in line with the line 1743 The vertical orientation 'may be one to two directions with the main feed line (10); an alternative method for distributing the reduced pressure includes: providing: an orthopedic fixation device; and a multi-bubble capable of being connected with (preferably Open hole) material 35 internal space of the body. The true orthopedic orthopedic fixation device is shown in Fig. 35, and the orthopedic surgery can be mu, m~ can be a "panel, or a different tender" arm, a struts or a stable - part of the skeletal skeletal Any other device. Orthopedic external attachments for attachment prostheses or other orthopedics 15 may additionally be woven or cartilage, etc., such as the skeletal group adjacent to the fasteners or the buckles; The reduced pressure is transmitted to the flow path of each of the #/α surrounding tissues of the fasteners. When the fasteners can include pins, screws, screws or any other suitable 119640.doc -43 - 200836785 More specifically 36, the orthopedic fixation device 1715 can additionally include a second plurality of flow passages 1761 within the orthopaedic fixation device 1715 to provide fluid to the bone surrounding the porous coating 173 and/or the orthopedic fixation device 1715. The fluid may include filtered air or other gas, antibacterial agent, antiviral agent, cell growth promoter, irrigation fluid, chemical active agent, or any other fluid. If desired, multiple fluids are introduced into the bone surrounding the orthopedic fixation device 17 15 , providing additional fluid communication paths.

接通口 1765與流動通路1761流體連接,該通口 1765經組態 以與流體傳遞管1771及流體傳遞源1773連接。流動通路 1761可包括與若干橫向分支管線1785流體連通之主要給料 官線1783,該等橫向分支管線1785與多孔塗層1735連通。 如圖33所述,該等橫向分支管線1785可與主要給料管線 1783垂直定向,或可與主要給料管線1783以一定角度定 向0 —可猎由單獨管(諸如減壓傳遞管1751及流體傳遞管1771) 貫現減壓至第一複數個流動通路HU之傳遞及流體至第二 5㈣動通路1761之傳遞。另外,可使用具有前述多個 官腔之管分隔傳遞減壓及流體之連通路徑。另外應注意, 儘:較=於矯形外科固定裝置1715内提供單獨之流料通 ^仁亦可使用第一複數個流動通路1741將減壓盥流體 傳遞至與矯形外科固定裝置i7i5相鄰之骨絡處。 形= 科固定裝置1715作為歧管將減壓傳遞至與矯 1717、 置1715相卻之骨絡區域從而加速且改良骨路 之缺知1719的恢復。提供第二複數個流動通路1761使 119640.doc -44- 200836785 /浪體與矯形外科固定裝置171 5周圍之骨絡連通將改良橋形 外科固定裝置附近新骨骼之成功產生。 參看圖37帛於癒合骨赂之骨絡缺損的方法1811包括在 1815處使用矯形外科固定裝置固定骨赂。矯形外科固定裝 置包括複數個安置於矯形外科固定裝置内之流動通路。在 1819處,經由該複數個流動通路將減壓施加至骨赂缺損 處。 多看圖3 8用於向組織部位施予減壓組織療法之方法 1911包括在1915處定位具有複數個流動通路之歧管從而使 至)一部为流動通路與組織部位流體連通。在丨9〖9處經由 流動通路將減壓施加至組織部位,且在1923處經由該等流 動通路將流體傳遞至組織部位。 參看圖39,向組織部位施予減壓組織療法之方法“丨丨包 括在20 15處將歧管傳遞管之遠端定位於與組織部位相鄰之 位置處。在2019處,經由歧管傳遞管將流體傳遞至組織部 位。该流體能夠填充與組織部位相鄰之空隙且成為具有複 數個與組織部位流體連通之流動通路的固體歧管。在2〇23 處經由固體歧管之流動通路將減壓施加至組織部位處。 參看圖40-48,減壓傳遞系統2111包括在主要流動通道 2121周圍具有可撓性壁2117之主要歧管2115。可撓性壁 2117係在近端2123處與減壓傳遞管2125連接。由於減壓傳 遞管2125之截面形狀通常將為圓形,且由於主要歧管 截面形狀可為除圓形外之其他形狀(亦即,圖4〇_45中之矩 形及圖46-48中之三角形),故於減壓傳遞管2125與主要歧 119640.doc -45 - 200836785 官2115之間提供轉接區2129。可使主要歧管2115與減壓傳 遞官2125黏接、使用諸如熔融或插入成型(insert m〇iding) 之其他方式連接或另外可藉由共射押出成型使其一體式連 接。減壓傳遞管2125將減壓傳遞至主要歧管2115以分佈於 組織部位處或組織部位附近。 阻W防止元件213 5係定位於主要歧管内以防止歧管2丨j 5 朋塌,且因此防止施加減壓之過程中主要流動通道2121的 Γ 阻滯。在一實施例中,阻滯防止元件2135可為複數個安置 % 於可撓性壁2117之内表面2141上且延伸至主要流動通道 2121中之突起2137(參看圖44)。在另一實施例中,阻滯防 止元件2135可為安置於内表面2141上之單個脊或多個脊 2145(參看圖40及41)。在另一實施例中,阻滯防止元件 2 1 35 了包括女置於主要流動通道内之多泡材料2149,諸如 圖47中所述者。阻滯防止元件2丨3 5可為能夠插入流動通道 内或能夠一體式或以其他方式附著至可撓性壁2丨丨7之任何 Q 材料或結構。阻滯防止元件2135能夠防止可撓性壁2117之 王。卩崩塌’同時亦使流體流過主要流動通道2丨2 i。 σ亥可撓性壁2117另外包括複數個穿過可撓性壁2丨丨7與主 要流動通道2121連通之小孔2155。小孔2155允許將減壓傳 遞至主要流動通道2121以分佈於組織部位。可將小孔21 55 迖擇性疋位於歧管211 5之圓周周圍以優先引導真空之傳 遞。舉例而言,在圖5丨中可置放小孔以使其面向骨骼、面 向上覆組織或二者。 減壓傳遞官2125較佳包括一具有與主要流動通道2121流 119640.doc -46- 200836785 體連接之至乂 —個出口之第一管道2i6i,以將降低之壓力 傳遞至主要流動通道2121。亦可提供第二管道2⑹以用流 體淨化主要㈣通道2121及第—管道,從而防止或消 除由創傷滲出物及自組織部位獲得之其他流體所引起之阻 滯:第二管道2163較佳包括至少一個定位於鄰近主要流動 通道2121之至少—者及第一管道2i6i之至少—個出口處之 出〇。 更特定地參看圖40及41,減壓傳遞系統2111第二管道 2163可包括多個用於淨化主要流動通道及第一管道 2161之&道。當可撓性壁2117之與附著至減壓傳遞管2125 之末端相反之末端如圖简述開啟時,已發現封蓋可換性 壁2117之該末端可改良淨化作用之效能及可靠性。較佳於 可撓性壁之經封蓋端與第二管道2163末端之間提供頂部空 間2 171頂邛空間21 71允許在淨化過程中積聚淨化流體, 其幫助驅動淨化流體穿過主要流動通道2121且進入第一管 道2161 。 圖41中亦描述用作阻滯防止元件2135之間隔物。位於中 央之間隔物將主要流動通道2121分為兩個腔室,當該等腔 至之一者被阻滯且無法進行淨化以消除該阻滯時此允許主 要歧官2115繼續操作。 蒼看圖49及5 0 ’減壓傳遞系統22丨丨包括與減壓傳遞管 2217—體式連接之主要歧管2215。減壓傳遞管2217包括中 央官腔2223及複數個附屬管腔2225。可使用附屬管腔以以 量測組織部位處或接近組織部位處之壓力,亦可進一步使 119640.doc -47- 200836785 用附屬管腔2225淨化中央管腔2223以防止或消除阻滯。複 數個小孔2231與中央管腔2223連通以分佈中央管腔^^傳 遞之減壓。如圖50所述,小孔2231較佳未穿透附屬管腔 2225。圖50中亦描述減壓傳遞管之埋頭端,其於附屬管腔 2225之末端外產生頂部空間2241。若在施加減壓之過程中 將組織、支架或其他材料與減壓傳遞管2217之末端嚙合, 則頂部空間2241將持續使淨化流體傳遞至中央管腔。 f 在操作中,可直接將圖40_50之減壓傳遞系統2111、 22 11轭加至組織部位以將減壓分佈於組織部位。本文所述 之經皮安裝及移除技術特別需要具有低輪廓形狀之主要歧 管。類似地,該等主要歧管亦可以外科手術插入。 參看圖51,可使主要歧管2115、2215與次要歧管“^組 合使用。在圖51中,次要歧管2321包括兩層氈製墊。次要 歧管2321之第一層係置放於與包括骨折之骨骼組織部位接 觸之位置處。主要歧管2115係置放於與第一層接觸處,且 ( 次要歧管2321之第二層係置放於主要歧管2115及第一層之 頂邛夂要歧官232 1允許主要歧管211 5與組織部位之間的 流體連通,亦防止組織部位與主要歧管2ii5之間的直接接 觸。 次要歧管232丨較佳為生物可吸收的,此使得次要歧管 咖能夠在完成減壓#法後保留於原#。完成減壓療法 後可將主要歧管2115自對組織部位具有極少干擾或無干 ^之人要歧官層之間移除。在-實施例中,可以潤滑材料 〆少成Jc續膠之材料塗覆主要歧管以使其容易地自層間移 H9640.doc -48- 200836785 除。 / 次要歧管較佳用作新組織生長之支架。作為支架,該次 要歧管可包含至少一種選自由以下物質組成之群之材料: 聚乳酸、聚乙醇酸、聚己内酯、聚經基丁酸酯、聚經基戊 酸酯、聚二氧環己酮、聚原酸酯、聚磷氮烯、聚胺基甲酸 醋、膠原蛋白、玻尿酸、聚葡萄胺糖、羥基磷灰石、鱗酸 妈、硫酸鈣、碳酸鈣、生物玻璃、不銹鋼、鈦、鈕、同種 異體移植物及自體移植物。 可將上文所述之減壓傳遞系統2111、2211之淨化功能用 於本文所述之歧管中之任一者。淨化傳遞減壓之歧管或管 道之能力將防止形成阻礙施予減壓之阻滯。當組織部位附 近之壓力達到平衡且組織部位周圍之流體流出減緩時,通 常出現此等阻滞。已發現,以所選之間隔用空氣淨化歧管 及減遂管道-段選定量之時間將協助防止或消除阻滞。 更具體言之,空氣係經由獨立於傳遞減屬之第一管道的 第二管道傳遞。第二管道之出口較佳接近歧管或第一管道 之出口。當加壓空氣且將其"推"至第二管道之出口時,較 佳藉由組織部位處減壓將空氣抽 ^ ^ 巧弟一官道。已發現在許 夕杬況下,在施加減壓之過程中 薛士 T以60秒之間隔傳遞空氣 瓜柃2秒將足以防止阻滯之形 〆 战此〉尹化時程提供足夠空 氣以充分移除歧管及第一管道 多空氣。引入過多空氣或以過=二同時防止引入過 «系統無法返回至淨化彳㈣^隔頻率引人空氣均將使 ^ 間的目標減壓。用於值# >尹化流體之所選時間量及傳遞 ' 1匕概體之所選間隔通常將 119640.doc - 49- 200836785 基於系統組件(例如,泵、管等)之設計及尺寸而變化。然 而,應以足夠高以充分清除阻滯同時使淨化循環之間恢復 完全目標壓力之量及頻率來傳遞空氣。 參看圖52,在一例示性實施例中,減壓傳遞系統2411包 括與第一管道2419及第二管道2423流體連接之歧管2415。 使第一管道2419與減壓源2429連接以將減壓提供至歧管 2415。第二管道2423包括經定位以與歧管2415流體連通且 接近第一管道2419之出口的出口 2435。第二管道2423係與 閥2439流體連接,當該閥處於開啟位置時其能夠使第二管 道2423與周圍空氣之間連通。該閥2439係可操作地連接至 控制器2453,該控制器2453能夠控制閥2439之開啟及關閉 從而調控周圍空氣對於第二管道之淨化,藉此防止歧管 2415及第一管道wig内阻滯。 應注意,可使用任何流體(包括液體或氣體)來實現本文 所述之淨化技術。儘管淨化流體之驅動力較佳為組織部位 處減壓之抽吸力,但亦可類似地藉由與參考圖9所論述者 類似之流體傳遞構件來傳遞流體。 可藉由向組織部位施加足夠之減壓且隨後維持該充足之 減壓歷時一段所選時間段來實現根據本文所述之系統及方 法進行之減壓組織療法至組織部位之施予。另外,實際上 施加至組織部位之減壓可具週期性。更具體言之,所施加 之減壓量可根據所選擇之時間週期而變化。施加減壓之另 一種方法可隨機變化減壓量。類似地,實際上傳遞至組織 口P位之流體速率或流體體積可恆定、具週期性或隨機變 119640.doc -50- 200836785 化。若為週期傳遞,則可在施加減壓之過程中發生流體傳 遞,或可在不施加減壓之週期段發生流體傳遞。儘管施加 至組織部位之減壓量通常將根據組織部位之病理學及施予 減壓組織療法之情況而變化,但該減壓通常將介於約_5 mm Hg與_500 mm Hg之間且更佳介於約-5 mm Hg與-300 mm Hg之間。 儘管已參考人類患者之組織生長及癒合來描述本發明之 系統及方法,但應認識到此等用於施加減壓組織療法之系 ζ 統及方法可用於需要促進組織生長或癒合之任何活的生物 體。類似地,可將本發明之系統及方法應用於任何組織, 包括(但不限於)骨縣組織、脂肪組織、肌肉組織、神經組 織、真皮組織、血管組織、結締組織、軟骨、腱或韌帶。 當癒合組織可為如本文所述施加減壓組織療法之一個關注 焦點時,亦可使用施加減壓組織療法、尤其施加至位於患 者皮膚下之組織之療法於未患病、缺損或損壞之組織中產 ij 纟組織生長。舉例而言’可能需要使用經皮植人技術施加 減壓組織療法以於隨後可經採集之組織部位處生長額外組 織。可將所採集之組織移植入另一組織部位以替換患病或 損壞之組織,或另外可將所採集之組織移植至另一患者。 亦應特別注意,本文所述之減壓傳遞設備可與支架材料 組合使用以增加新組織之生長及生長速率。可將支架材料 置放於組織部位與減壓傳遞設備之間,或減壓傳遞設備本 身可由用作新組織生長之支架之可生物再吸收材料製成。 自前述應顯而易見已提供具有顯著優勢之本發明。儘管 119640.doc -51 - 200836785 本發明僅以少量形式展示但並非僅限於此,而是在不偏離 本發明之精神之情況下可進行各種改變及修正。 【圖式簡單說明】 圖1描述本發明之一實施例之減壓傳遞設備之透視圖, δ亥減壓傳遞設備具有複數個自可挽性障壁延伸從而產生複 數個流動通路之突起; 圖2描述圖1之減壓傳遞設備之前視圖; 圖3描述圖1之減壓傳遞設備之頂視圖; 圖4 Α描述圖1之減壓傳遞設備之側視圖,該減壓傳遞設 備具有單管腔、減壓傳遞管; 圖4B描述圖1之減壓傳遞設備之一替代性實施例的侧視 圖,該減壓傳遞設備具有雙管腔、減壓傳遞管; 圖5描述圖1之減壓傳遞設備之放大的透視圖; 圖6描述本發明之一實施例之減壓傳遞設備之透視圖, 該減壓傳遞設備具有附著至具有突起部分及一對側翼部分 之可撓性障壁的多泡材料,該多泡材料具有複數個流動通 路; 圖7描述圖6之減壓傳遞設備之前視圖; 圖8描述於χνπ-χνπ處取得之圖7之減壓傳遞設備之截 面側視圖; 圖8 Α描述本發明之一實施例之減壓傳遞設備之截面前視 圖; 圖8B描述圖8 A之減壓傳遞設備之侧視圖; 圖9描述本發明一實施例之用於向患者之骨絡施加減壓 119640.doc -52- 200836785 組織療法的減壓傳遞設備之前視圖; 圖10描述兔顱骨之彩色組織切片,i展-工 ^ 八展不天然、未受損 之骨骼; 圖11描述施加減壓組織療法後兔顱骨之彩色組織切片, 其展示肉芽組織之誘導; 圖12描述施加減壓組織療法後兔顱骨之彩色組織切片, 其展示新骨骼之沈積; 圖13描述施加減壓組織療法後兔顱骨之彩色組織切片, 其展不新骨胳之沈積; 圖14描述顱骨中所形成之兩個具有臨界尺寸缺損之兔顱 骨的彩色相片; Λ 圖15描述圖14之兔顧骨之彩色相片,其展示插入該等臨 界尺寸缺損之一者内之磷酸鈣支架及覆蓋該等臨界尺寸缺 損之另一者之不銹鋼篩網; 圖16描述圖14之兔顱骨之彩色相片,其展示向臨界尺寸 缺損施加減壓組織療法; 圖17描述減壓組織療法後兔顱骨之彩色組織切片,該組 織切片展示磷酸鈣支架内新骨骼之沈積; 圖18描述減壓組織療法六天及術後兩週後圖15之經支架 填充之臨界尺寸缺損的射線照片; 圖19#田述減壓組織療法六天及術後十二週後圖1 $之經支 架填充之臨界尺寸缺損的射線照片; Θ 20¾述本發明之一實施例之減壓傳遞系統的前視圖, 該減壓傳遞系統具有用於將減壓傳遞設備經皮插入至組織 119640.doc -53 - 200836785 部位中之歧管傳遞管; 圖21描述圖20之歧管傳遞管之放大的前視圖,該歧管傳 遞管含有處於壓縮位置具有可撓性障壁及/或多泡材料之 減壓傳遞設備; 圖22描述圖21之歧管傳遞管之放大的前視圖,展示自歧 管傳遞管推出後處於擴張位置之減壓傳遞設備的可撓性障 壁及/或多泡材料; 圖23描述本發明之一實施例之減壓傳遞系統的前視圖, 5亥減壓傳遞糸統具有用於將減壓傳遞設備經皮插入組織部 位中之歧管傳遞管,該減壓傳遞設備係展示於歧管傳遞管 之外側但受處於壓縮位置之不透性膜約束; 圖24描述圖23之減壓傳遞系統的前視圖,該減壓傳遞設 備係展示於歧管傳遞管之外側但受處於鬆弛位置之不透性 膜約束; 圖25描述圖23之減壓傳遞系統的前視圖,該減壓傳遞設 備係展示於歧管傳遞管之外側但受處於擴張位置之不透性 膜約束; 圖25A描述圖23之減壓傳遞系統的前視圖,該減壓傳遞 設備係展示於歧管傳遞管之外側但經處於擴張位置之不透 性膜環繞; ^圖26描述本發明之—實施例之減壓傳遞系統的前視圖, 該減壓傳遞統具有用於將減壓傳遞設備經皮插入纪織部 位中之歧管傳遞管,該減壓傳遞設備係展示於歧遞: 之外側但受具有膠封之不透性膜約束; 、 119640.doc -54- 200836785 圖26A描述本發明之一實施例之減壓傳遞系統的前視 圖; 圖27描述本發明之一實施例之減壓傳遞系統的前視圖, 該減壓傳遞系統具有用於將減壓傳遞設備經皮注射至組織 部位中之歧管傳遞管; 圖27A描述本發明之一實施例之減壓傳遞系統的前視 圖,該減壓傳遞系統具有用於將減壓傳遞設備經皮傳遞至 疋位於組織部位中之不透性膜的歧管傳遞管; 圖28描述根據本發明之一實施例向組織部位施予減壓組 織療法之方法的流程圖; 圖29描述根據本發明之一實施例向組織部位施予減壓組 織療法之方法的流程圖; 圖3 0描述根據本發明之一實施例向組織部位施予減壓組 織療法之方法的流程圖; 圖3 1描述根據本發明之一實施例向組織部位施予減壓組 織療法之方法的流程圖; 圖3 2描述本發明之一實施例之減壓傳遞設備的截面前視 圖,該減壓傳遞設備包括髖假體,其具有複數個用於將減 壓施加至该體假體之骨絡區域周圍的流動通路; 圖33描述圖32之髖假體之截面前視圖,其具有另一複數 個用於將流體傳遞至髖假體之骨骼區域周圍的流動通路; 圖34描述根據本發明之一實施例使用減壓組織療法修復 患者之關節之方法的流程圖; 圖3 5描述根據本發明之一實施例之減壓傳遞設備的截面 119640.doc -55- 200836785 前視圖,該減壓傳遞設備包括羚报κ 、 埽形外科固定裝置,其具有 複數個用於將減壓施加至鄰近兮捧彡 州处适矯形外科固定裝置之骨骼 區域的流動通路; 圖36描述圖35之矯形外科固^裝置之截面前視圖,其具 有另-複數個用於將流體傳遞至鄰近該矯形外科固定裝置 之骨骼區域的流動通路; 圖37描述根據本發明之—實施例使用減壓組織療法癒合 骨骼之骨骼損傷之方法的流程圖; 圖38描述根據本發明之一實施例向組織部位施予減壓組 織療法之方法的流程圖;及 圖3 9描述根據本發明之一實施例向組織部位施予減壓組 織療法之方法的流程圖; 圖40-48描述根據本發明之一實施例之減壓傳遞系統的 各種視圖,該減壓傳遞系統具有主要歧管,其包括環繞主 要流動通道之可撓性壁及該可撓性壁中之複數個小孔; 圖49-5 0描述根據本發明之一實施例之減壓傳遞系統的 透視圖及截面頂視圖,該減壓傳遞系統具有與減壓傳遞管 一體式連接之主要歧管; 圖51描述圖40-50之與次要歧管一起施加至骨骼組織部 位之主要歧管的透視圖;及 圖52描述本發明一實施例之具有與第二管道流體連接之 閥的減壓傳遞系統的示意圖。 【主要元件符號說明】 211 翼狀歧管/減壓傳遞設備 119640.doc -56- 200836785The port 1765 is in fluid connection with a flow path 1761 that is configured to interface with the fluid transfer tube 1771 and the fluid transfer source 1773. The flow passage 1761 can include a primary feed line 1783 in fluid communication with a plurality of transverse branch lines 1785 that are in communication with the porous coating 1735. As depicted in Figure 33, the transverse branch lines 1785 can be oriented perpendicular to the main feed line 1783, or can be oriented at an angle to the main feed line 1783. - can be hunted by separate tubes (such as reduced pressure transfer tubes 1751 and fluid transfer tubes) 1771) The pressure is reduced to the transfer of the first plurality of flow paths HU and the transfer of the fluid to the second 5 (four) moving path 1761. Further, a communication path for transferring the pressure reduction and the fluid may be separated by a tube having the plurality of the above-mentioned official chambers. In addition, it should be noted that: a separate flow through the orthopedic fixation device 1715 can also be used to transfer the reduced pressure helium fluid to the bone adjacent to the orthopedic fixation device i7i5 using the first plurality of flow passages 1741 Network. Shape = Section Fixing Device 1715 acts as a manifold to transfer the reduced pressure to the collateral region of the 1717, 1715 phase to accelerate and improve the recovery of the defect 1719 of the bone path. Providing a second plurality of flow paths 1761 to connect the 119640.doc-44-200836785/wave body to the bone surrounding the orthopedic fixation device 171 5 will improve the successful creation of new bone near the bridge surgical fixation device. Referring to Figure 37, a method 1811 for healing a bone defect in a bone graft includes securing the bone at 1815 using an orthopedic fixation device. The orthopedic fixation device includes a plurality of flow paths disposed within the orthopedic fixation device. At 1819, a reduced pressure is applied to the bone defect via the plurality of flow paths. See Figure 38 for a method of administering reduced-pressure tissue therapy to a tissue site. 1911 includes positioning a manifold having a plurality of flow passages at 1915 such that one of the flow passages is in fluid communication with the tissue site. The reduced pressure is applied to the tissue site via the flow path at 丨9 〖9, and at 1923, the fluid is delivered to the tissue site via the flow paths. Referring to Figure 39, a method of administering reduced-pressure tissue therapy to a tissue site "includes positioning the distal end of the manifold delivery tube at a location adjacent to the tissue site at 2015. At 2019, via the manifold The tube delivers fluid to the tissue site. The fluid is capable of filling a void adjacent the tissue site and becomes a solid manifold having a plurality of flow paths in fluid communication with the tissue site. The flow path through the solid manifold at 2〇23 Decompression is applied to the tissue site. Referring to Figures 40-48, the reduced pressure delivery system 2111 includes a primary manifold 2115 having a flexible wall 2117 around the primary flow channel 2121. The flexible wall 2117 is attached at the proximal end 2123. The reduced pressure transfer tube 2125 is connected. Since the cross-sectional shape of the reduced pressure transfer tube 2125 will generally be circular, and since the main manifold cross-sectional shape may be other than a circular shape (i.e., the rectangle in Fig. 4〇_45) And the triangle in FIGS. 46-48), so that the transfer zone 2129 is provided between the reduced pressure transfer pipe 2125 and the main differential 119640.doc -45 - 200836785 2115. The main manifold 2115 can be adhered to the reduced pressure transfer officer 2125. Connect, use, etc. Other means of fusion or insert molding may be connected or otherwise integrally joined by co-injection molding. The reduced pressure delivery tube 2125 delivers reduced pressure to the primary manifold 2115 for distribution at the tissue site or The vicinity of the tissue site. The resistance preventing element 213 5 is positioned within the main manifold to prevent the manifold 2 from colliding, and thus preventing the enthalpy blockage of the main flow channel 2121 during application of decompression. In an embodiment The retardation preventing member 2135 may be a plurality of protrusions 2137 (see FIG. 44) that are disposed on the inner surface 2141 of the flexible wall 2117 and extend into the main flow channel 2121. In another embodiment, the block prevention is prevented. Element 2135 can be a single ridge or ridges 2145 disposed on inner surface 2141 (see Figures 40 and 41). In another embodiment, retardation preventing element 2 1 35 includes a female placed in the main flow channel. A multi-bubble material 2149, such as that described in Figure 47. The retardation preventing element 2丨3 5 can be any Q material that can be inserted into the flow channel or that can be integrally or otherwise attached to the flexible wall 2丨丨7 Or structure. Blocking preventing element 2135 It is sufficient to prevent the king of the flexible wall 2117. The collapse of the crucible also causes the fluid to flow through the main flow channel 2丨2 i. The σ海flexible wall 2117 additionally includes a plurality of flexible walls 2丨丨7 and the main The flow channel 2121 communicates with the small hole 2155. The small hole 2155 allows the reduced pressure to be transmitted to the main flow channel 2121 to be distributed at the tissue site. The small hole 21 55 can be selectively placed around the circumference of the manifold 211 5 to preferentially guide the vacuum. For example, a small hole can be placed in Figure 5A to face the bone, face up the tissue, or both. The reduced pressure transfer command 2125 preferably includes a first conduit 2i6i having an outlet connected to the main flow passage 2121, 119640.doc - 46 - 200836785, to deliver the reduced pressure to the primary flow passage 2121. A second conduit 2 (6) may also be provided to purify the primary (four) channel 2121 and the first conduit with fluid to prevent or eliminate blockage caused by the wound exudate and other fluids obtained from the tissue site: the second conduit 2163 preferably includes at least An exit pupil positioned at least adjacent to at least one of the main flow passages 2121 and the first conduit 2i6i. Referring more specifically to Figures 40 and 41, the reduced pressure delivery system 2111 second conduit 2163 can include a plurality of & passages for purifying the primary flow passage and the first conduit 2161. When the end of the flexible wall 2117 opposite the end attached to the reduced pressure transfer tube 2125 is opened as shown in the drawing, it has been found that the end of the cover replaceable wall 2117 can improve the efficiency and reliability of the purification. Preferably, a headspace is provided between the sealed end of the flexible wall and the end of the second conduit 2163. 2 171 The top space 21 71 allows for the accumulation of purge fluid during the purification process, which helps drive the purge fluid through the primary flow channel 2121. And enter the first pipe 2161. The spacer used as the retardation preventing member 2135 is also described in FIG. The centrally located spacer divides the primary flow channel 2121 into two chambers which allow the primary ambiguity 2115 to continue operation when one of the chambers is blocked and cannot be purged to eliminate the block. The view of Figures 49 and 50' decompression transfer system 22A includes a main manifold 2215 that is coupled to the reduced pressure transfer tube 2217. The reduced pressure delivery tube 2217 includes a central lumen 2223 and a plurality of accessory lumens 2225. The accessory lumen can be used to measure the pressure at or near the tissue site, and the central lumen 2223 can be further cleaned by the accessory lumen 2225 to prevent or eliminate blockage. A plurality of small holes 2231 communicate with the central lumen 2223 to distribute the reduced pressure of the central lumen. As shown in Fig. 50, the aperture 2231 preferably does not penetrate the accessory lumen 2225. Also shown in Fig. 50 is the countersunk end of the reduced pressure delivery tube which creates a headspace 2241 outside the end of the accessory lumen 2225. If tissue, stent or other material is engaged with the end of the reduced pressure delivery tube 2217 during application of reduced pressure, the headspace 2241 will continue to deliver the purified fluid to the central lumen. f In operation, the yoke of the reduced pressure delivery system 2111, 22 11 of Figures 40-50 can be directly applied to the tissue site to distribute the reduced pressure to the tissue site. The percutaneous mounting and removal techniques described herein specifically require a primary manifold having a low profile shape. Similarly, the primary manifolds can also be surgically inserted. Referring to Figure 51, the primary manifolds 2115, 2215 can be combined with the secondary manifolds. In Figure 51, the secondary manifolds 2321 include two layers of felt pads. The first layer of the secondary manifolds 2321 is coupled. Placed in contact with the skeletal tissue site including the fracture. The main manifold 2115 is placed in contact with the first layer, and (the second layer of the secondary manifold 2321 is placed in the main manifold 2115 and The top layer of the layer 232 1 allows fluid communication between the main manifold 211 5 and the tissue site, and also prevents direct contact between the tissue site and the primary manifold 2ii 5. The secondary manifold 232 is preferably Bioabsorbable, which allows the secondary manifold to remain in the original # after completion of the decompression method. After the decompression therapy is completed, the main manifold 2115 can be made with little or no interference from the tissue site. The interlayers are removed between the layers. In the embodiment, the material can be lubricated to reduce the Jc refill material to coat the main manifold to facilitate easy inter-layer migration. H9640.doc -48- 200836785. / Minor The manifold is preferably used as a support for new tissue growth. As a stent, the secondary manifold can contain at least a material selected from the group consisting of polylactic acid, polyglycolic acid, polycaprolactone, polybutyl butyrate, polyvalerate, polydioxanone, polyorthoester, poly Phosphazene, polyurethane urethane, collagen, hyaluronic acid, polyglucamine, hydroxyapatite, scaly mother, calcium sulfate, calcium carbonate, bioglass, stainless steel, titanium, button, allograft and self Body grafts. The purification function of the reduced pressure delivery systems 2111, 2211 described above can be used in any of the manifolds described herein. The ability to purify the manifold or conduit that delivers decompression will prevent the formation of obstructions. The decompression block is applied. These blocks usually occur when the pressure near the tissue site reaches equilibrium and the fluid flow around the tissue site slows down. It has been found that the air purification manifold and the reduced conduit are selected at selected intervals. - The selected amount of time will assist in preventing or eliminating the block. More specifically, the air is delivered via a second conduit that is independent of the first conduit to which the subtraction is passed. The outlet of the second conduit is preferably near the manifold or first The exit of the pipeline. Pressing the air and pushing it to the exit of the second pipe, it is better to use the decompression at the tissue site to pump the air out. It has been found that in the case of Xu Xi, the application is reduced. During the process of pressing, Xue Shi T will deliver air melon for 2 seconds at intervals of 60 seconds, which will be enough to prevent the blockage of the shape. The Yinhua time provides enough air to fully remove the manifold and the first pipe. Excessive air or over = two at the same time to prevent the introduction of the system * can not return to the purification 彳 (four) ^ the frequency of the introduction of air will reduce the target between the two. For the value # > Yinhua fluid selected time and The selected interval for passing the '1匕 profile' typically varies from 119640.doc - 49- 200836785 based on the design and size of the system components (eg, pumps, tubes, etc.). However, air should be delivered at a level and frequency high enough to adequately remove the blockage while restoring the full target pressure between the purge cycles. Referring to Fig. 52, in an exemplary embodiment, the reduced pressure delivery system 2411 includes a manifold 2415 that is fluidly coupled to the first conduit 2419 and the second conduit 2423. The first conduit 2419 is coupled to a reduced pressure source 2429 to provide reduced pressure to the manifold 2415. The second conduit 2423 includes an outlet 2435 that is positioned in fluid communication with the manifold 2415 and proximate the outlet of the first conduit 2419. The second conduit 2423 is in fluid connection with the valve 2439 which is capable of communicating the second conduit 2423 with ambient air when the valve is in the open position. The valve 2439 is operatively coupled to a controller 2453 that is capable of controlling the opening and closing of the valve 2439 to regulate the purification of the ambient air by the second conduit, thereby preventing the manifold 2415 and the first conduit from blocking within the wig . It should be noted that any fluid (including liquid or gas) can be used to achieve the purification techniques described herein. Although the driving force for purifying the fluid is preferably the suction force at the tissue site, the fluid can be similarly transferred by a fluid transfer member similar to that discussed with reference to FIG. Administration of reduced pressure tissue therapy to tissue sites according to the systems and methods described herein can be accomplished by applying sufficient decompression to the tissue site and then maintaining the sufficient decompression for a selected period of time. In addition, the decompression applied to the tissue site may be periodic. More specifically, the amount of reduced pressure applied can vary depending on the selected time period. Another method of applying decompression can vary the amount of decompression randomly. Similarly, the fluid rate or fluid volume actually delivered to the P-site of the tissue can be constant, periodic or random. In the case of periodic delivery, fluid transfer may occur during the application of reduced pressure, or fluid transfer may occur during the period in which no reduced pressure is applied. Although the amount of decompression applied to the tissue site will generally vary depending on the pathology of the tissue site and the administration of decompression tissue therapy, the decompression will typically be between about _5 mm Hg and _500 mm Hg and More preferably between about -5 mm Hg and -300 mm Hg. Although the systems and methods of the present invention have been described with reference to tissue growth and healing of human patients, it will be appreciated that such systems and methods for applying reduced pressure tissue therapy can be used for any activity that requires tissue growth or healing. organism. Similarly, the systems and methods of the present invention can be applied to any tissue including, but not limited to, bone county tissue, adipose tissue, muscle tissue, neural tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendon or ligament. When the healing tissue can be a focus of application of reduced pressure tissue therapy as described herein, it is also possible to use a therapy that applies reduced pressure tissue therapy, particularly to tissue located under the patient's skin, to an unaffected, defective or damaged tissue. Middle-aged ij 纟 tissue growth. For example, it may be desirable to apply decompression tissue therapy using percutaneous implantation techniques to grow additional tissue at subsequent tissue sites that may be harvested. The harvested tissue can be transplanted into another tissue site to replace diseased or damaged tissue, or the harvested tissue can be transplanted to another patient. It should also be noted that the reduced pressure delivery device described herein can be used in combination with a scaffolding material to increase the growth and growth rate of new tissue. 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 stent for new tissue growth. It will be apparent from the foregoing that the invention has been provided with significant advantages. Although the present invention has been shown in a limited number of forms, it is not limited thereto, and various changes and modifications may be made without departing from the spirit of the invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a reduced-pressure transmission apparatus according to an embodiment of the present invention. The δ-Hui pressure-reducing device has a plurality of protrusions extending from a self-releasable barrier to generate a plurality of flow paths; 3 is a front view of the reduced pressure transfer device of FIG. 1; FIG. 3 is a side view of the reduced pressure transfer device of FIG. 1; FIG. 4 is a side view of the reduced pressure transfer device of FIG. FIG. 4B depicts a side view of an alternative embodiment of the reduced pressure delivery device of FIG. 1 having a dual lumen, reduced pressure delivery tube; FIG. 5 depicts the reduced pressure delivery device of FIG. Figure 6 depicts a perspective view of a reduced pressure delivery device having an embodiment of the present invention, the reduced pressure delivery device having a multi-foam material attached to a flexible barrier having a raised portion and a pair of side portions, The multi-bubble material has a plurality of flow paths; FIG. 7 depicts a front view of the reduced pressure transfer device of FIG. 6; FIG. 8 depicts a cross-sectional side view of the reduced pressure transfer device of FIG. 7 taken at χνπ-χνπ; hair A cross-sectional front view of a reduced pressure delivery device of one embodiment; FIG. 8B depicts a side view of the reduced pressure delivery device of FIG. 8A; FIG. 9 depicts an embodiment of the present invention for applying a reduced pressure to a patient's bone network 119640. Doc -52- 200836785 Front view of the decompression delivery device for tissue therapy; Figure 10 depicts the color tissue section of the rabbit skull, showing the unnatural, undamaged bones; Figure 11 depicts the application of decompression tissue therapy Color tissue section of a rabbit skull showing the induction of granulation tissue; Figure 12 depicts a color tissue section of a rabbit skull after application of reduced-pressure tissue therapy showing the deposition of new bone; Figure 13 depicts the color of the rabbit skull after application of reduced-pressure tissue therapy Tissue section, which shows the deposition of new bones; Figure 14 depicts a color photograph of two rabbit skulls with critical size defects formed in the skull; Λ Figure 15 depicts the color photograph of the rabbit bone of Figure 14 showing its insertion a calcium phosphate scaffold in one of the critical dimension defects and a stainless steel mesh covering the other of the critical dimension defects; FIG. 16 depicts a color photograph of the rabbit skull of FIG. Decompression tissue therapy was applied to the critical dimension defect; Figure 17 depicts a color histological section of the rabbit skull after decompression tissue therapy showing the deposition of new bone in the calcium phosphate scaffold; Figure 18 depicts decompression tissue therapy for six days and surgery Radiographs of the critical dimension defects filled with stents in Figure 15 after the last two weeks; Figure 19# Tian Shu decompression tissue therapy for six days and twelve weeks after surgery Figure 1 Photograph of the critical size defect of stent-filled前 203⁄4 A front view of a reduced pressure delivery system of one embodiment of the present invention having a percutaneous insertion for transdermal insertion of a reduced pressure delivery device into a tissue 119640.doc-53 - 200836785 Figure 21 depicts an enlarged front elevational view of the manifold transfer tube of Figure 20, the manifold transfer tube containing a reduced pressure transfer device having a flexible barrier and/or a multi-bubble material in a compressed position; Figure 22 depicts Figure 21 An enlarged front view of the manifold transfer tube showing the flexible barrier and/or multi-foam material of the reduced pressure transfer device in an expanded position after the manifold transfer tube is pushed out; FIG. 23 depicts an implementation of the present invention A front view of a reduced pressure delivery system having a manifold transfer tube for percutaneous insertion of a reduced pressure delivery device into a tissue site, the reduced pressure delivery device being displayed on the outside of the manifold transfer tube However, it is constrained by an impermeable membrane in a compressed position; Figure 24 depicts a front view of the reduced pressure delivery system of Figure 23, shown in an outer membrane on the outside of the manifold transfer tube but in a relaxed position Figure 25 depicts a front view of the reduced pressure delivery system of Figure 23, shown on the outside of the manifold transfer tube but constrained by an impermeable membrane in the expanded position; Figure 25A depicts the reduced pressure of Figure 23 A front view of the delivery system, the reduced pressure delivery device being shown on the outside of the manifold transfer tube but surrounded by an impermeable membrane in an expanded position; FIG. 26 depicts a front view of the reduced pressure delivery system of the present invention. The reduced pressure delivery system has a manifold transfer tube for percutaneously inserting the reduced pressure delivery device into the woven portion, the reduced pressure delivery device being displayed on the outer side of the distraction: but being sealed by an impermeable membrane having a seal Constraint; 119640.doc -54- 200836785 Figure 26A depicts a front view of a reduced pressure delivery system in accordance with one embodiment of the present invention; Figure 27 depicts a front view of a reduced pressure delivery system in accordance with one embodiment of the present invention, the reduced pressure delivery system having A manifold transfer tube for percutaneously injecting a reduced pressure delivery device into a tissue site; FIG. 27A depicts a front view of a reduced pressure delivery system having an embodiment of the present invention, the reduced pressure delivery system having a reduced pressure delivery device A manifold delivery tube that is transdermally delivered to an impermeable membrane located in the tissue site; Figure 28 depicts a flow diagram of a method of administering decompression tissue therapy to a tissue site in accordance with an embodiment of the present invention; DETAILED DESCRIPTION OF THE INVENTION A flowchart of a method of administering reduced-pressure tissue therapy to a tissue site; FIG. 30 depicts a flow diagram of a method of administering reduced-pressure tissue therapy to a tissue site in accordance with an embodiment of the present invention; A flow chart of a method of administering reduced-pressure tissue therapy to a tissue site in accordance with an embodiment of the present invention; FIG. 3 is a cross-sectional front view of a reduced pressure delivery device in accordance with an embodiment of the present invention, the reduced pressure transmission The delivery device includes a hip prosthesis having a plurality of flow passages for applying a reduced pressure to the region of the bone region of the body prosthesis; Figure 33 depicts a cross-sectional front view of the hip prosthesis of Figure 32 having another plural Flow path for transferring fluid to the bone region of the hip prosthesis; FIG. 34 depicts a flow chart of a method for repairing a joint of a patient using reduced pressure tissue therapy in accordance with an embodiment of the present invention; FIG. A cross-section of a reduced-pressure delivery device of one embodiment 119640.doc-55-200836785 Front view, the reduced-pressure delivery device includes an antelope κ, a sacral surgical fixation device having a plurality of applications for applying reduced pressure to adjacent sputum Figure 36 depicts a cross-sectional front view of the orthopaedic fixation device of Figure 35 with a plurality of other embodiments for delivering fluid to adjacent the orthopedic fixation device Flow path of the skeletal region; Figure 37 depicts a flow chart of a method for healing bone damage of bone using reduced pressure tissue therapy in accordance with an embodiment of the present invention; DETAILED DESCRIPTION OF THE INVENTION A flowchart of a method of administering reduced-pressure tissue therapy to a tissue site; and Figure 39 depicts a flow diagram of a method of administering reduced-pressure tissue therapy to a tissue site in accordance with an embodiment of the present invention; 48 depicts various views of a reduced pressure delivery system having a primary manifold including a flexible wall surrounding a primary flow channel and a plurality of small ones in the flexible wall, in accordance with an embodiment of the present invention Figure 49-5 is a perspective view and a cross-sectional top view of a reduced pressure transfer system having a primary manifold integrally connected to a reduced pressure transfer tube, in accordance with an embodiment of the present invention; 40-50 are perspective views of a primary manifold applied to a bone tissue site with a secondary manifold; and FIG. 52 depicts a schematic view of a reduced pressure delivery system having a valve fluidly coupled to a second conduit in accordance with an embodiment of the present invention. . [Main component symbol description] 211 wing manifold/pressure reducing transmission equipment 119640.doc -56- 200836785

213 可撓性障壁 215 突出部分 219 侧翼部分 223 弓狀通路 227 可撓性襯底 231 突起 233 流動通路 241 減壓傳遞管 243 遠端孔 255 近端孔 259 單管腔/通道 261 雙管腔管 263 第一管腔 265 第二管腔 271 水平間隔物 311 翼狀歧管/減壓傳遞設備 313 可撓性障壁 315 突出部分 319 侧翼部分 323 弓狀通路 327 多泡材料 329 主要分佈表面 330 周邊表面 341 減壓傳遞管 119640.doc -57- 200836785 343 遠端孔 355 近端孔 359 單管腔/通道 371 減壓傳遞設備 373 減壓傳遞管 375 擴張部分 377 遠端 381 切斷 383 管肩 385 突起 387 内表面 391 流動通路 411 減壓傳遞設備 413 組織部位 415 人類骨骼 419 減壓傳遞管 421 近端 427 減壓源 429 空隙缺損 431 流體傳遞管 432 近端 433 流體傳遞源 434 過濾器 435 壓力感應器 119640.doc -58- 200836785 711 減壓傳遞系統 713 組織部位 721 歧管傳遞管 725 操縱部件 727 引線 731 骨折 733 骨骼 735 患者皮膚 737 虛線 739 軟組織 743 楔形遠端 751 通道 761 減壓傳遞設備 765 可撓性障壁 767 多泡材料 769 減壓傳遞管 811 減壓傳遞系統 821 歧管傳遞管 837 虛線 843 楔形遠端 861 減壓傳遞設備 8 65 可撓性障壁 867 多泡材料 869 減壓傳遞管 119640.doc -59 200836785 871 不透性膜 873 内部空間 881 不透射線標記 885 移除儀器 891 次級管腔/管 911 減壓傳遞系統 921 歧管傳遞管 937 虛線 943 楔形遠端 961 減壓傳遞設備 965 可撓性障壁 967 多泡材料 969 減壓傳遞管 971 不透性膜 973 内部空間 977 膠封 981 不透射線標記 985 減壓傳遞系統 987 引線 989 減壓傳遞管 991 減壓傳遞設備 993 組織部位 1011 減壓傳遞系統 1021 歧管傳遞管 119640.doc -60- 200836785 1025 1029 1035 1043 1051 1055 1057 1061 1111 1211 1311 1511 1515 1517 1521 1525 1529 1535 1541 1543 1545 1547 1551 1553 組織部位 空隙 減壓傳遞設備 遠端 不透性膜或半透性膜 内部空間 次級管腔 引線 方法 方法 方法 方法 矯形髖假體 股骨 桿部分 頭部分 通道 多孔塗層 流動通路 主要給料管線 連接通口 橫向分支管線 減壓傳遞管 減壓傳遞源 119640.doc -61 - 200836785 f213 Flexibility barrier 215 Projection 219 Flap section 223 Arched passage 227 Flexible substrate 231 Protrusion 233 Flow path 241 Pressure relief tube 243 Remote hole 255 Proximal hole 259 Single lumen/channel 261 Double lumen 263 First lumen 265 Second lumen 271 Horizontal spacer 311 Winged manifold/pressure relief device 313 Flexible barrier 315 Projection 319 Flank portion 323 Arched passage 327 Foam material 329 Main distribution surface 330 Peripheral surface 341 decompression transfer tube 119640.doc -57- 200836785 343 distal hole 355 proximal hole 359 single lumen / channel 371 decompression transfer device 373 decompression transfer tube 375 expanded portion 377 distal end 381 cut 383 shoulder 385 protrusion 387 Inner surface 391 Flow path 411 Reduced pressure transfer device 413 Tissue site 415 Human bone 419 Reduced pressure transfer tube 421 Proximal end 427 Decompression source 429 Void defect 431 Fluid transfer tube 432 Proximal end 433 Fluid transfer source 434 Filter 435 Pressure sensor 119640.doc -58- 200836785 711 Reduced pressure transfer system 713 Organization site 721 Manifold transfer tube 725 Component 727 Lead 731 Fracture 733 Bone 735 Patient skin 737 Dotted line 739 Soft tissue 743 Wedge distal 751 Channel 761 Pressure relief device 765 Flexible barrier 767 Multifoam material 769 Pressure relief tube 811 Pressure relief system 821 Manifold transfer tube 837 Dotted line 843 Wedge-shaped distal end 861 Decompression transfer device 8 65 Flexible barrier 867 Multi-foam material 869 Decompression transfer tube 119640.doc -59 200836785 871 Impervious film 873 Internal space 881 Radiopaque marker 885 Removal of instrument 891 times Stage tube/tube 911 Pressure relief system 921 Manifold transfer tube 937 Dotted line 943 Wedge-shaped distal end 961 Pressure relief transfer device 965 Flexible barrier 967 Multi-foam material 969 Decompression transfer tube 971 Impervious film 973 Interior space 977 Glue Seal 981 Radiopaque marker 985 Pressure relief system 987 Lead 989 Pressure relief tube 991 Pressure relief device 993 Tissue site 1011 Pressure relief system 1021 Manifold transfer tube 119640.doc -60- 200836785 1025 1029 1035 1043 1051 1055 1057 1061 1111 1211 1311 1511 1515 1517 1521 1525 1529 1535 1541 1543 1545 1547 1551 1553 Tissue site void pressure reduction device distal impermeable membrane or semipermeable membrane internal space secondary lumen lead method method orthopedic hip prosthesis femoral stem part head part channel porous coating flow path main feeding line connection Outlet lateral branch line decompression transfer tube decompression transfer source 119640.doc -61 - 200836785 f

1561 流動通路 1565 連接通口 1571 流體傳遞管 1573 流體傳遞源 1583 主要給料管線 1585 橫向分支管線 1611 方法 1711 減壓傳遞設備 1715 矯形外科固定裝置 1717 骨骼 1719 骨折 1721 通道 1725 螺桿 1735 多孔塗層 1741 流動通路 1743 主要給料管線 1745 連接通口 1747 橫向分支管線 1751 減壓傳遞管 1753 減壓傳遞源 1761 流動通路 1765 連接通口 1771 流體傳遞管 1773 流體傳遞源 119640.doc -62- 200836785 1783 主要給料管線 1785 橫向分支管線 1811 方法 1911 方法 2011 方法 2111 減壓傳遞系統 2115 主要歧管 2117 可撓性壁 2121 主要流動通道 2123 近端 2125 減壓傳遞管 2129 轉接區 2135 阻滯防止元件 2137 突起 2141 内表面 2145 脊 2149 多泡材料 2155 小孔 2161 第一管道 2163 第二管道 2171 頂部空間 2211 減壓傳遞系統 2215 主要歧管 2217 減壓傳遞管 -63 119640.doc 200836785 2223 中央管腔 2225 附屬管腔 2231 小孔 2241 頂部空間 2321 次級歧管 2411 減壓傳遞系統 2415 歧管 2419 第一管道 2423 第二管道 2429 減壓源 2435 出口 2439 閥 2453 控制器 119640.doc -64-1561 Flow path 1565 Connection port 1571 Fluid transfer tube 1573 Fluid transfer source 1583 Main feed line 1585 Transverse branch line 1611 Method 1711 Reduced pressure transfer device 1715 Orthopedic fixture 1717 Bone 1719 Fracture 1721 Channel 1725 Screw 1735 Porous coating 1741 Flow path 1743 Main feed line 1745 Connection port 1747 Lateral branch line 1751 Reduced pressure transfer line 1753 Reduced pressure transfer source 1761 Flow path 1765 Connection port 1771 Fluid transfer tube 1773 Fluid transfer source 119640.doc -62- 200836785 1783 Main feed line 1785 Landscape Branch line 1811 Method 1911 Method 2011 Method 2111 Reduced pressure transfer system 2115 Main manifold 2117 Flexible wall 2121 Main flow channel 2123 Proximal end 2125 Decompression transfer tube 2129 Adapter zone 2135 Blocking prevention element 2137 Protrusion 2141 Inner surface 2145 Ridge 2149 Multi-bubble material 2155 Small hole 2161 First pipe 2163 Second pipe 2171 Head space 2211 Pressure-reducing transfer system 2215 Main manifold 2217 Pressure-reducing transfer pipe -63 119640.doc 200836785 2223 Central lumen 2225 Auxiliary lumen 2231 Small hole 2241 Headspace 2321 Secondary manifold 2411 Pressure relief system 2415 Manifold 2419 First pipe 2423 Second pipe 2429 Pressure source 2435 Outlet 2439 Valve 2453 Controller 119640.doc -64-

Claims (1)

200836785 十、申請專利範圍: 1 · 一種用於向組織部位施加減壓組織療法之減壓傳遞系 統,其包含: 一主要歧管,其具有一環繞一主要流動通道且經調適 以置放於接近該組織部位處之可撓性壁,該可撓性壁包 括一内表面,該内表面具有複數個自其至少一部分延伸 且進入該主要流動通道中之突起,該可撓性壁另外包括 複數個穿過該可撓性壁且與該主要流動通道連通之小 孔; 一第一管道,其與該主要流動通道流體連接以經由該 主要流動通道及該複數個小孔傳遞減壓;及 -第二管道,其具有至少一個接近該主要流動通道或 該第一管道之至少一個出口之出口以淨化該第一管道之 至少一個出口處或其附近之阻滞。 2. 如請求们之系統,其中該第一管道及該第二管道為多 Ο 管腔管之部分。 其中該可撓性壁及該多管腔管經共 3. 如請求項2之系統 射押出成型。 4_如請求項1之系統,其中 該第-管道及該第二管道為一多管腔管之部分; 忒可撓性壁之一端係與該多管腔管連接;足 广主要流動通道在該可撓性壁與該多管腔 ά而相對之末端處經封蓋。 5·如明求項i之系統,其中該第二 吕逍主乂 4分定位於該 119640.doc 200836785 可撓性壁中。 6·如請求項1之系統,其中該可捭M辟总山殺# J稅性壁係由醫藥級矽氧聚 合物建構。 7.如請求们之系統,其中該可撓性壁於截面處大致上呈 矩形。 8·如明求項i之系統’其中該可撓性壁沿其軸向長度之至 少一部分大致上呈圓柱形。 9.如請求項8之系、统,其中該大致上呈圓柱形之可撓性壁 包夾成360度之弧。 10·如請求们之系統,其中該等突起藉由在經由該主要流 動通道施加減壓之過程中防止可撓性壁完全崩塌來防止 6玄主要流動通道阻塞。 η.如請求項1之系統,其中該組織部位包含選自由脂肪組 織、肌肉組織、神經組織、真皮組織、血管組織、結締 組織、軟骨、腱及韌帶組成之群之組織。 12.如凊求項丨之系統,其另外包含一經調適以定位於鄰近 該主要歧管處且使來自該主要歧管之減壓通向該組織部 位的次要歧管。 13 ·如明求項丨2之系統,其中該次要歧管為具生物可吸收 性。 14·如請求項12之系統,其中該次要歧管為—觀製塾。 15·如請求項12之系統,其中該次要歧管為一支架,且其包 各至夕一種選自由以下物負組成之群之材料:聚乳酸、 聚乙醇酸、聚己内酯、聚羥基丁酸酯、聚羥基戊酸酯、 119640.doc 200836785 聚二氧環己酮、聚原酸酯、聚磷氮烯、聚胺基甲酸酯、 膠原蛋白、玻尿酸、聚葡萄胺糖、羥基磷灰石、磷酸 鈣、硫酸鈣、碳酸鈣、生物玻璃、不銹銅、鈦、鈕、同 種異體移植物及自體移植物。 16. 一種用於向組織部位施加減壓組織療法之減壓傳遞系 統,其包含: 主要歧管,其具有一環繞一主要流動通道且經調適 ( 以置放於接近該組織部位處之可撓性壁,該可撓性壁包 括複數個穿過該可撓性壁且與該主要流動通道連通之小 子L ; 一多泡材料,其係定位於該主要流動通道内,該多泡 材料具有複數個流動通路; 一第一管道,其與該主要流動通道流體連接以經由該 主要流動通道、該多泡材料及該複數個小孔傳遞減壓; 及 C, 一第二管道,其具有至少一個接近該主要流動通道或 該第一管道之至少一個出口之出口以淨化該第一管道之 至少一個出口處或其附近之阻滯。 17·如凊求項16之系統,其中該第一管道及該第二管道為一 多管腔管之部分。 18·如睛求項17之系統,其中該可撓性壁及該多管腔管經丑 射押出成型。 ~ 19 如請求項16之系統,其中: 該第一管道及該第二管道為一多管腔管之部分; 119640.doc 200836785 該可撓性壁之一端係與該多管腔管連接;且 δ亥主要流動通道係在該 末端相斟夕古山老 撓性壁與該多管腔管連接之 不鈿相對之末端處經封蓋。 20·如請求項16之系統,苴 可撓性壁中。 …弟二管道至少部分定位於該 醫藥級矽氧聚 21 ·如請求項16之系統,直中兮 /、r巧可撓性壁係由 合物建構。 2 2 ·如清求項16之系统,直中兮 、八 w可铫性壁經增強以防止在減 壓下朋塌。 壁之截面大致上呈矩 23·如請求項16之系統,其中該可撓性 形0 2(如請求項16之系統,其中該可挽性壁沿其轴向長度之至 少一部分大致上呈圓柱形。 25. 如請求項24之系統’其中該大致上呈圓柱形之可撓性壁 包夾成360度之弧。 26. 如明求項16之系統,其中該多泡材料藉由在經由該主要 流動通道施加減壓之過程中防止可撓性壁完全崩塌來防 止該主要流動通道阻塞。 27. 如請求項m统’其中該組織部位包含選自由脂肪組 織、肌肉組織、神經組織、真皮組織、組織、結締 組織、敕骨、腱及韌帶組成之群之組織。 28. 如請求項16之系統,其中該多泡材料為_網狀聚胺基甲 酸酯發泡體。 29·如明求項16之系統,其另外包含一經調適以定位於鄰近 119640.doc 200836785 該主要歧管處且使來自該主要歧管之減壓通向該組織部 位之次要歧管。 30.如請求項29之系統,其中該次要歧管為具生物可吸收 性。 31·如請求項29之系統,其中該次要歧管為一氈製塾。 32·如請求項29之系統,其中該次要歧管為一支架,且其包 含至少一種選自由以下物質組成之群之材料:聚乳酸、 聚乙醇酸、$己内酯、聚羥基丁酸酯、聚羥基戊酸酯、 聚二氧環己酮、聚原酸酯、聚磷氮烯、聚胺基甲酸酯、 膠原蛋白、玻尿酸、聚葡萄胺糖、羥基磷灰石、磷酸 鈣、硫酸鈣、碳酸鈣、生物玻璃、不銹鋼、鈦、钽、同 種異體移植物及自體移植物。 33 · —種用於向組織部位施加減壓組織療法之減壓傳遞系 統,其包含: 主要歧管,其具有一環繞一主要流動通道且經調適 以置放於接近該組織部位處之可撓性壁,該主要歧管包 括一定位於該主要流動通道内之阻滯防止元件,該可撓 性壁包括複數個穿過該可撓性壁且與該主要流動通道連 通之小孔; 一次要歧官,其係定位於鄰近該主要歧管處,且經調 適以與該組織部位接觸從而與該主要歧管流體連通,但 其亦經調適以防止該主要歧管與該組織部位接觸;及 一第一管這’其與該主要流動通道流體連接以經由該 主要流動通道及該複數個小孔傳遞減壓。 119640.doc 200836785 元件為複數個安置 主要流動通道中之 34.如明求項33之系統,其中該阻滯防止 於該可撓性壁之内表面上且延伸至該 突起。 35.如請求項33之系統,其中該阻滞防止元件為一安置於該 主要流動通道内之多泡材料。 3 6 ·如請求項3 3之系统,苴中續々| 土势 亍、、九甲4 — 人要歧官為具生物可吸收 性0 37. 如請求項33之系統’其中該次要歧管為一氈製墊。 38. 如請求項33之系統,其中該次要歧管為一支架,且其包 含至少一種選自由以下物質組成之群之材料:聚 聚乙醇酸、聚己内醋、聚經基丁酸醋、聚經基戊酸醋、 聚二氧環己鲖、聚原酸酯、聚磷氮烯、聚胺基甲酸酯、 膠原蛋白、玻尿酸、聚葡萄胺糖、羥基磷灰石、磷酸 鈣、硫酸鈣、碳酸鈣、生物玻璃、不銹鋼、鈦、钽、同 種異體移植物及自體移植物。200836785 X. Patent Application Range: 1 · A reduced pressure delivery system for applying reduced pressure tissue therapy to a tissue site, comprising: a primary manifold having a surrounding primary flow channel and adapted for placement in proximity a flexible wall at the tissue site, the flexible wall including an inner surface having a plurality of protrusions extending from at least a portion thereof into the main flow channel, the flexible wall additionally comprising a plurality of a small hole that passes through the flexible wall and communicates with the main flow channel; a first pipe fluidly connected to the main flow channel to transmit a pressure reduction through the main flow channel and the plurality of small holes; and A second conduit having at least one outlet proximate to the primary flow passage or at least one outlet of the first conduit to purge a block at or near at least one outlet of the first conduit. 2. The system of claimants, wherein the first conduit and the second conduit are part of a multi-tube lumen. Wherein the flexible wall and the multi-lumen tube are collectively injection molded according to the system of claim 2. 4) The system of claim 1, wherein the first conduit and the second conduit are part of a multi-lumen tube; one end of the flexible wall is connected to the multi-lumen tube; the main flow channel of the foot is The flexible wall is capped at the end opposite the multi-lumen. 5. The system of claim i, wherein the second Lv逍 main 4 is located in the flexible wall of the 119640.doc 200836785. 6. The system of claim 1, wherein the taxable wall system is constructed from a pharmaceutical grade oxygen polymer. 7. The system of claimants, wherein the flexible wall is substantially rectangular in cross section. 8. The system of claim i wherein the flexible wall is substantially cylindrical along at least a portion of its axial length. 9. The system of claim 8, wherein the substantially cylindrical flexible wall is sandwiched into a 360 degree arc. 10. The system of claimants, wherein the protrusions prevent occlusion of the primary flow channel by preventing the flexible wall from completely collapsing during application of decompression via the primary flow channel. The system of claim 1, wherein the tissue site comprises a tissue selected from the group consisting of adipose tissue, muscle tissue, nerve tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendon, and ligament. 12. A system as claimed, further comprising a secondary manifold adapted to be positioned adjacent to the primary manifold and to provide reduced pressure from the primary manifold to the tissue portion. 13 • The system of claim 2, wherein the secondary manifold is bioabsorbable. 14. The system of claim 12, wherein the secondary manifold is a system. The system of claim 12, wherein the secondary manifold is a stent, and each of the packets is selected from the group consisting of polylactic acid, polyglycolic acid, polycaprolactone, and poly Hydroxybutyrate, polyhydroxyvalerate, 119640.doc 200836785 polydioxanone, polyorthoesters, polyphosphazenes, polyurethanes, collagen, hyaluronic acid, polyglucamine, hydroxyl Apatite, calcium phosphate, calcium sulfate, calcium carbonate, bioglass, stainless copper, titanium, knobs, allografts, and autografts. 16. A reduced pressure delivery system for applying reduced pressure tissue therapy to a tissue site, comprising: a primary manifold having a surrounding and a primary flow channel adapted (to be placed at a location proximate to the tissue site) a flexible wall comprising a plurality of small arms L passing through the flexible wall and in communication with the primary flow channel; a multi-bubble material positioned within the primary flow channel, the multi-vesicle material having a plurality a flow passage; a first conduit fluidly connected to the main flow passage to transmit a pressure reduction via the main flow passage, the multi-bubble material and the plurality of small holes; and C, a second conduit having at least one Approaching the outlet of the primary flow channel or at least one outlet of the first conduit to purge a block at or near at least one outlet of the first conduit. 17. The system of claim 16, wherein the first conduit and The second conduit is part of a multi-lumen tube. 18. The system of claim 17, wherein the flexible wall and the multi-lumen tube are formed by ugly extrusion. ~ 19 The system of claim 16 Wherein: the first conduit and the second conduit are part of a multi-lumen tube; 119640.doc 200836785 one end of the flexible wall is connected to the multi-lumen tube; and the main flow channel of the δH is at the end The old flexible wall of the 古古古山 is connected to the end of the multi-lumen tube at the opposite end. 20· The system of claim 16 is in the flexible wall. ... The second pipe is at least partially positioned The medical grade 矽oxypoly 21 · According to the system of claim 16, the straight middle 兮 /, r smart flexible wall system is constructed by the compound. 2 2 · As for the system of the clear item 16, the straight middle 兮, eight w can The spasm wall is reinforced to prevent collapse under reduced pressure. The cross section of the wall is substantially a moment 23. The system of claim 16, wherein the flexible shape is 0 2 (such as the system of claim 16 wherein the pullable The wall is substantially cylindrical along at least a portion of its axial length. 25. The system of claim 24 wherein the substantially cylindrical flexible wall is sandwiched into a 360 degree arc. The system of item 16, wherein the multi-bubble material is applied by subtraction through the primary flow channel Preventing the flexible wall from completely collapsing during the process to prevent clogging of the primary flow channel. 27. If the request portion contains a structure selected from the group consisting of adipose tissue, muscle tissue, nerve tissue, dermal tissue, tissue, connective tissue, The organization of the group consisting of the tibia, the tendon, and the ligament. 28. The system of claim 16, wherein the multifoam material is a reticular polyurethane foam. It additionally includes a secondary manifold that is adapted to be positioned adjacent to the primary manifold at 119640.doc 200836785 and to provide reduced pressure from the primary manifold to the tissue site. 30. The system of claim 29, wherein the secondary manifold is bioabsorbable. 31. The system of claim 29, wherein the secondary manifold is a felt. 32. The system of claim 29, wherein the secondary manifold is a stent and comprises at least one material selected from the group consisting of polylactic acid, polyglycolic acid, caprolactone, polyhydroxybutyric acid Esters, polyhydroxyvalerate, polydioxanone, polyorthoesters, polyphosphazenes, polyurethanes, collagen, hyaluronic acid, polyglucosamine, hydroxyapatite, calcium phosphate, Calcium sulfate, calcium carbonate, bioglass, stainless steel, titanium, tantalum, allografts and autografts. 33. A reduced pressure delivery system for applying reduced pressure tissue therapy to a tissue site, comprising: a primary manifold having a wrap around a primary flow channel and adapted for placement at a location proximate to the tissue site a main wall comprising a retardation preventing member located in the main flow passage, the flexible wall including a plurality of small holes passing through the flexible wall and communicating with the main flow passage; Officially positioned adjacent to the primary manifold and adapted to contact the tissue site for fluid communication with the primary manifold, but which is also adapted to prevent contact of the primary manifold with the tissue site; The first tube is ' fluidly coupled to the primary flow passage to deliver reduced pressure via the primary flow passage and the plurality of orifices. 119640.doc 200836785 The component is a plurality of the primary flow channels. The system of claim 33, wherein the block is prevented from extending onto the inner surface of the flexible wall and extending to the protrusion. 35. The system of claim 33, wherein the block prevention element is a multi-foam material disposed within the primary flow channel. 3 6 ·If the system of claim 3 3, 苴中々々|土势亍,,九甲4 —人要为官为生物可吸收性0 37. As requested in item 33 of the system The tube is a felt pad. 38. The system of claim 33, wherein the secondary manifold is a stent and comprises at least one material selected from the group consisting of polyglycolic acid, polycaprolactone, and polybutyrate vinegar , polyvaleric acid vinegar, polydioxanone, polyorthoesters, polyphosphazenes, polyurethanes, collagen, hyaluronic acid, polyglucamine, hydroxyapatite, calcium phosphate, Calcium sulfate, calcium carbonate, bioglass, stainless steel, titanium, tantalum, allografts and autografts. 39. —種促進組織部位處之組織生長之方法,其包含: 以外科手術將一主要歧管定位於接近該組織部位處, 該主要歧管具有一環繞一主要流動通道之可撓性壁,該 可撓性壁包括複數個穿過該可撓性壁且與該主要流動通 道連通之小孔,該主要歧管另外包括—定位於該主要流 動通道内之阻滯防止元件; 以外科手術定位一次要歧管以使其與該組織部位接 觸’從而使該次要歧管與該主要歧管流體連通,但防止 遠主要歧管與組織部位接觸;及 119640.doc 200836785 經由該主要流動通道、該複數個小孔及該次要歧管將 減壓傳遞至該組織部位。 4〇_如請求項39之方法,其中該阻滯防止元件為一安置於該 主要流動通道内之多泡材料,該多泡材料具有複數個流 動通路。 41.如1求項39之方法,其中該阻滯防止元件為複數個自該 了抗f生坌之内表面延伸且進入該主要流動通道中之突 起0 42·如明求項39之方法,其中該次要歧管為一氈製墊。 43. 如請求項39之方法,其中該次要歧管為一支架,且其包 各至 > 一種選自由以下物質組成之群之材料:聚乳酸、 ::乙醇酸、$己内_、聚羥基丁酸酯、$羥基戊酸酯、 二一氧裱己酮、聚原酸酯、聚磷氮烯、聚胺基甲酸酯、 膠原,白、玻尿酸、聚葡萄胺糖、經基石粦灰石、磷酸 鈣酸鈣、碳酸鈣、生物玻璃、不銹鋼、鈦、鈕、同 種異體移植物及自體移植物。 44. 如请求項39之方法,其另外包含: 45. 46. 在減壓組織療法完成後經皮移除該主要歧管。 如明求項39之方法,其另外包含·· 咸C、纟且織療法完成後經皮移除該主要歧管;且 /、中ΰ亥次要歧管為具生物可吸收性。 如明衣項3 9之方法,其另外包合以闲网/ : 、 八力匕3以周圍空氣淨化該主要 胤通道以防止該主要流動通道内阻滯。 119640.doc39. A method of promoting tissue growth at a tissue site, comprising: surgically positioning a primary manifold proximate to the tissue site, the primary manifold having a flexible wall surrounding a primary flow channel, The flexible wall includes a plurality of apertures through the flexible wall and in communication with the primary flow channel, the primary manifold additionally comprising a blocking element positioned within the primary flow channel; surgically positioned Once the manifold is to be in contact with the tissue site to thereby make the secondary manifold in fluid communication with the primary manifold, but preventing the distal primary manifold from contacting the tissue site; and 119640.doc 200836785 via the primary flow channel, The plurality of small holes and the secondary manifold deliver reduced pressure to the tissue site. The method of claim 39, wherein the retardation preventing member is a multi-bubble material disposed in the main flow channel, the multi-bubble material having a plurality of flow paths. The method of claim 39, wherein the retardation preventing member is a plurality of methods of extending from the inner surface of the anti-f sputum into the main flow channel, such as the method 39, The secondary manifold is a felt pad. 43. The method of claim 39, wherein the secondary manifold is a stent and the packages are each > a material selected from the group consisting of polylactic acid, :: glycolic acid, $hexine _, Polyhydroxybutyrate, hydroxyvalerate, dioxin, polyorthoester, polyphosphazene, polyurethane, collagen, white, hyaluronic acid, polyglucamine, sulphate Gray stone, calcium calcium phosphate, calcium carbonate, bioglass, stainless steel, titanium, button, allograft and autograft. 44. The method of claim 39, further comprising: 45. 46. removing the primary manifold after percutaneous tissue therapy is completed. The method of claim 39, further comprising: removing the primary manifold after the completion of the salty C, phlegm and woven therapy; and/, the secondary manifold of the Zhongyihai is bioabsorbable. For example, in the method of the garment item 39, it is additionally packaged with a free net/:, and an air force to purify the main channel by ambient air to prevent blockage in the main flow channel. 119640.doc
TW096112180A 2007-03-13 2007-04-04 System for administering reduced pressure teratment having a manifold with a primary flow passage and a blockage prevention member TWI347205B (en)

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