TWI362951B - System and method for percutaneously administering reduced pressure treatment using a flowable manifold - Google Patents
System and method for percutaneously administering reduced pressure treatment using a flowable manifold Download PDFInfo
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1362951 六、發明說明: 【發明所屬之技術領域】 本發明概言之係關於一種用於促進組織生長之系統及方 法,且更具體而言,係關於一種用於對—組織部位施以減 壓組織治療之系統。 【先如技術】 人們正在逐漸使用減壓治療來促進如若不使用減壓治療 會癒合很慢或者不癒合之軟組織傷口之傷口癒合。通常, 藉由一開放孔發泡體對傷口部位應用減低之壓力,該開放 孔發泡體用作-歧管來分佈減低之墨力。該開放孔發泡體 之尺寸適合於現有之傷口,與傷口相接觸,並隨後隨著傷 口開始癒合且變小而定期地更換成變小之發泡體。為使生 長入發泡體之孔t之組織量最小化,需要頻繁地更換開放 孔發泡體《在移除發泡體期間,正在生長之大量組織可使 患者感到疼痛。 減壓治療通常應用於不癒合性開放傷。在某些情形中, 所醫治之組織係皮下組織,且在其他情形,,該等組織位 於皮膚組織内或上面。在傳統上,減壓治療一直主要應用 於軟組織。減壓治療通常尚未用於治療封閉之深組織傷口 乃因難以接近此等傷口。另外’減壓治療尚未與醫治骨 :缺損或促進骨骼生長結合使用,此主要歸因於難以接近 月 ]題藉由外科手術暴露出骨絡來施以減廢治療可 能會造成比其所解決之問題更多之問題。最後,用於施以 減壓療之器件及系統之發展幾乎未超出開放孔發泡體件 154474.doc 1362951 —用手使開放孔發泡體之形狀適合於傷口部位並隨後在一 減壓治療週期之後將其移除。 【發明内容】 本發明之系統及方法即解決現有傷口醫治系統及方法所 存在之問題。根據本發明之—實施例,提供__種減壓治療 輪送系統,以用於對一組織部位施以減低之壓力。該減壓 輸送系統包括一具有一通路及一遠端之歧管輸送管,該遠 端經構造以經過皮膚***並毗鄰該組織部位放置。一可流 動材料可藉由該歧管輸送管經過皮膚輸送至該組織部位, 以使該可流動材料能夠填充毗鄰該組織部位之一空隙以 形成一具有複數個與該組織部位流體連通之流動通道之歧 管。提供一減壓輪送管,其能夠與該歧管之該等流動通道 流體連通。 根據本發明之另-實施例’提供一種對_組織部位施行 一減壓治療之方法’其包括:經過皮膚將—歧管輸送管之 一遠端毗鄰一組織部位定位。經由該歧管輪送管經過皮膚 向該組織部位輸送一可流動材料。該可流動材料能夠填充 毗鄰該組織部位之空隙並形成一具有複數個與該組織部位 流體連通之流動通道之歧管。經由該歧管之流動通道對該 組織部位施以減低之壓力。 參照附圖及下文詳細說明’本發明之其他目的特徵及 優點將變得一目了然。 【實施方式】 下文將參照附圖對較佳實施例進行詳細铕 呪月,該等附圖 154474.doc 1362951 構成本發明之-部分且其中以圖解方式顯示可實施本發明 之具體較佳實施例。為使熟習此項技術者能夠實踐本發明 ’足夠詳細地閣述該等實施例,且應瞭解,亦可利用兑他 實施例,且可在邏輯結構、機械、電氣及化學方面作出改 動’此並不背離本發明之精神或範圍。為避免閣述並非為 使熟習此項技術者能夠實踐本發明所需之細節,本說明可 省略熟習此項技術者所習知之某些資訊。因此,不應將下 文詳細說明視為具有限定意義,且本發明之範圍僅由隨附 申請專利範圍來界定。 本文令所用術語"彈性"意味著具有彈性體之特性。術語" 彈性體"大體係指具有像橡谬—樣之特性之聚合物材料。更 具體而言,大多數彈性體具有大於賺。之伸長率及明顯之 回彈性程度。材料之回彈性係指材料能夠自彈性變形恢復 =性體之實例可包括但不限於:天然橡膠,聚異戍二稀 ’苯乙烯丁二稀橡膠,氣丁二稀橡膠,聚丁二烯,猜橡膠 ,異丁稀橡膠’乙稀㈣橡膠,乙稀丙稀二料體橡朦, 氯磺化聚乙烯,聚硫橡膠’聚氨基甲酸醋,及聚矽氧。 本文中所用術語"撓性"係指物體或材料能夠弯曲或撓曲 。彈性材料通常呈挽性’但在本文中所提及之撓性材料並 非-定將所選材料僅限定為彈性體。將術語"挽性"與本發 明之材料或減壓輸送裝置結合使用大體係指該材料能夠貼 覆或緊密地匹配一組織部仇之形狀。舉例而言,用於治療 骨路缺損之減堡輸送裝置之撓性性質可使該裝置能夠缠繞 或包繞具有缺損之骨骼部分。 154474.doc 1362951 本文中所用之術語"流體"绝妒卜伤杜a _ 〜體上係指氣體或液體,但亦 可包含任何其他可流動之材料,包 付匕栝但不限於凝膠、膠體 或泡沐。 本文中所用之術語••不渗透性"總體上係指薄膜、覆蓋物 或其他物質阻擋或減慢液體或氣體透過之能力。可使用不 滲透性來指代能阻擋液體透過、同時允許氣體㈣薄膜之 覆蓋物、薄片或其他薄膜。儘管不滲透性薄膜可不透過液1362951 6. INSTRUCTIONS OF THE INVENTION: TECHNICAL FIELD OF THE INVENTION The present invention relates generally to a system and method for promoting tissue growth, and more particularly to a method for decompressing a tissue site Tissue treatment system. [First as technology] People are gradually using decompression therapy to promote wound healing in soft tissue wounds that heal very slowly or not heal without using decompression therapy. Typically, the reduced pressure is applied to the wound site by an open-cell foam that acts as a manifold to distribute the reduced ink force. The open-cell foam is sized to be suitable for existing wounds, in contact with the wound, and then periodically replaced with a smaller foam as the wound begins to heal and become smaller. In order to minimize the amount of tissue growing into the pores of the foam, it is necessary to frequently replace the open-cell foam. "The large amount of tissue that is growing during the removal of the foam can cause pain to the patient. Decompression therapy is usually applied to non-healing open wounds. In some cases, the tissue being treated is subcutaneous tissue, and in other instances, the tissue is located in or on the skin tissue. Traditionally, decompression therapy has been primarily used in soft tissue. Decompression therapy has not generally been used to treat closed deep tissue wounds due to the difficulty of accessing such wounds. In addition, 'decompression therapy has not been combined with healing bone: defect or promotion of bone growth, which is mainly due to difficulty in approaching the month.] The problem of surgical treatment of exposure to bone loss may result in less waste treatment than it is solved. More questions about the problem. Finally, the development of devices and systems for the application of decompression therapy has barely exceeded the open-cell foam member 154474.doc 1362951 - the shape of the open-cell foam is adapted to the wound site by hand and subsequently treated under reduced pressure Remove it after the cycle. SUMMARY OF THE INVENTION The system and method of the present invention addresses the problems associated with prior wound healing systems and methods. In accordance with an embodiment of the present invention, a decompression therapy delivery system is provided for applying a reduced pressure to a tissue site. The reduced pressure delivery system includes a manifold delivery tube having a passageway and a distal end configured to be inserted through the skin and placed adjacent to the tissue site. A flowable material can be transported through the skin to the tissue site by the manifold delivery tube to enable the flowable material to fill a void adjacent the tissue site to form a plurality of flow channels in fluid communication with the tissue site The manifold. A reduced pressure wheel is provided that is in fluid communication with the flow passages of the manifold. Another embodiment according to the present invention provides a method of performing a decompression treatment on a tissue site, which comprises positioning a distal end of a manifold delivery tube adjacent to a tissue site through the skin. A flowable material is delivered to the tissue site through the skin via the manifold. The flowable material is capable of filling a void adjacent the tissue site and forming a manifold having a plurality of flow channels in fluid communication with the tissue site. The tissue site is subjected to a reduced pressure via the flow passage of the manifold. Other objects and features of the present invention will become apparent from the following detailed description. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, preferred embodiments will be described in detail with reference to the accompanying drawings, which form a part of the present invention and in which . In order to enable those skilled in the art to practice the invention, the embodiments are described in sufficient detail, and it should be understood that embodiments may be utilized and modifications may be made in the logical, mechanical, electrical, and chemical aspects. The spirit or scope of the invention is not departed. To avoid obscuring the details required to practice the invention, those skilled in the art may omit certain information that is familiar to those skilled in the art. Therefore, the following detailed description is not to be considered as limiting, and the scope of the invention is defined by the scope of the appended claims. The term "elastic" used in this article means having the properties of an elastomer. The term "elastomer" large system refers to a polymer material having properties like rubber. More specifically, most elastomers have greater than earned. Elongation and apparent resilience. The resilience of the material means that the material can recover from elastic deformation. Examples of the physical body may include, but are not limited to, natural rubber, polyisophthalide dilute styrene butyl rubber, gas butyl rubber, polybutadiene, Guess rubber, isobutyl rubber 'ethylene (four) rubber, ethylene propylene dilute rubber, chlorosulfonated polyethylene, polysulfide rubber 'polyurethane vinegar, and polyfluorene. The term "flex" as used herein refers to an object or material that can bend or flex. Elastomeric materials are generally ductile' but the flexible materials referred to herein do not define the selected material only as an elastomer. The use of the term "tractability" in conjunction with the materials of the present invention or a reduced pressure delivery device means that the material can be applied or closely matched to the shape of a tissue. For example, the flexible nature of a reduced-bulk delivery device for treating a bone defect can enable the device to wrap or wrap around a bone portion having a defect. 154474.doc 1362951 The term "fluid" is used herein to refer to a gas or liquid, but may also include any other flowable material, including but not limited to a gel. , colloid or bubble. The term "• impermeability" as used herein generally refers to the ability of a film, covering or other material to block or slow the penetration of a liquid or gas. Impermeability can be used to refer to a covering, sheet or other film that blocks the passage of liquid while allowing gas (4) film. Although the impervious film can be impervious
體,然而該薄膜可只是降低所有或僅某些液體之透過率。 使用術語"不滲透性”並非旨在隱含著不滲透性薄膜高於或 低於任何特定X錢準不㈣性㈣值,例如水蒸氣傳遞 率(WVTR)之特定值。 本文中所用之術語"歧管"大體係指為有助於對一組織部 位施以減低之壓力、向該組織部位輸送流體或自該組織部 位移除流體而提供之物質或結構。歧管通常包含複數個互 連之流動通道或通路,以改良向歧管周圍組織區域提供或 自該組織區域移除之流體之分佈。歧管之實例可包括但不 限於具有經没置以形成流動通道之結構元件之裝置、蜂巢 狀發泡體(例如開放孔發泡體)、多孔組織收集裝置、及包 含或凝固後包含流動通道之液體、凝膠及泡沫。 本文中所用之術語”減低之壓力"大體係指在正接收治療 之組織部位處小於周圍壓力之壓力。在大多數情形中,此 種減低之壓力將小於患者所在位置之環境壓力。另一選擇 為’該減低之壓力可小於組織部位處組織之靜水壓力。儘 管可使用術s吾真空"及"負壓力"來描述施加至組織部位之 154474.doc 1362951 壓力,然而施加至組織部位之實際壓力可明顯低於通常與 純粹真空相關聯之虔力。減低之壓力可在開始時在管及組 織部位之區域中產生流體流動。隨著組織部位周圍之靜水 壓力接近所需之減低之壓力,該流動可能會減慢,且隨後 保持減低之壓力。除非另外指明外,本文中所述之壓力值 皆係表壓。 本文中所用之術語"支架”係指用於增強或促進細胞生長 及/或組織形成之物質或結構。支架通常係一三維多孔結 構,其為細胞生長提供一模板。支架可與灌注有、塗覆有 或由細胞、生長因子或其他用於促進細胞生長之營養劑構 成。可使用支架作為根據本文所述實施例之歧管,以對組 織部位施行減壓組織治療。 本文中所用之術語”組織部位”係指位於任一組織上面或 以内之傷口或缺損,包括但不限於骨骼組織、脂肪組織、 肌肉組織、神經組織、皮膚組織、血管組織、結締組織、 軟骨、腱、或韌帶。術語"組織部位"可進一步係指任何組 織之區域,該等區域未必受傷或有缺損,而是想要增強或 促進該等區域中額外組織之生長。舉例而言,可在某些組 織區域中使用減壓組織治療來生長額外之組織,然後可收 穫該額外之組織並將其移植至另一組織部位上。 參見圖1-5,一種根據本發明原理之減壓輸送裝置或翼 狀歧管211包括一具有凸脊部分215之撓性障壁213以及一 對翼狀部分219。每一翼狀部分219皆沿凸脊部分215之對 置側定位》凸脊部分215形成一拱形通道223,拱形通道 154474.doc 1362951 223既可延伸過也可不延伸過翼狀歧管211之整個長度。儘 管凸脊部分21 5可在翼狀歧管211上居中定位,以使各翼狀 部分219之寬度相等,然而凸脊部分215亦可如在圖15中 所不偏置,從而使其中一個翼狀部分219寬於另—翼狀部 分219。如果將翼狀歧管211與骨骼再生或醫治結合使用且 較寬之翼狀歧管211將纏繞於附連至骨骼上之固定硬體周 圍,則其中一個翼狀部分21 9之額外寬度可能特別有用。 撓性障壁213較佳由例如聚矽氧聚合物等彈性材料製成 。適合之聚矽氧聚合物之一實例包括由位於Carpinteda>Body, however, the film may simply reduce the transmission of all or only certain liquids. The use of the term "imperviousness" is not intended to imply that the impermeable film is above or below any particular X-value (IV) value, such as a specific value for water vapor transmission rate (WVTR). The term "management" large system refers to a substance or structure provided to help reduce pressure on a tissue site, deliver fluid to or remove fluid from the tissue site. The manifold typically contains plural Interconnected flow channels or passages to improve the distribution of fluids provided to or removed from the tissue area surrounding the manifold. Examples of manifolds may include, but are not limited to, structural elements that are not disposed to form flow channels Device, honeycomb foam (e.g., open cell foam), porous tissue collection device, and liquid, gel, and foam containing flow channels after solidification. The term "reduced pressure" is used herein. The system refers to the pressure at the tissue site that is receiving treatment that is less than the surrounding pressure. In most cases, this reduced pressure will be less than the environmental pressure at the patient's location. Another option is that the reduced pressure can be less than the hydrostatic pressure of the tissue at the tissue site. Although the vacuum can be used to describe the pressure applied to the tissue site 154474.doc 1362951, the actual pressure applied to the tissue site can be significantly lower than the force normally associated with pure vacuum. . The reduced pressure creates fluid flow in the area of the tube and tissue at the beginning. As the hydrostatic pressure around the tissue site approaches the desired reduced pressure, the flow may slow down and then maintain the reduced pressure. Unless otherwise stated, the pressure values described herein are gauge pressures. The term "stent" as used herein refers to a substance or structure used to enhance or promote cell growth and/or tissue formation. The scaffold is typically a three-dimensional porous structure that provides a template for cell growth. Coated with or consisting of cells, growth factors or other nutrients for promoting cell growth. A stent can be used as a manifold according to embodiments described herein to treat tissue sites with reduced pressure tissue treatment. By "tissue site" is meant a wound or defect located above or within any tissue, including but not limited to bone tissue, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendon, or ligament. The term "tissue site" may further refer to the region of any tissue that is not necessarily injured or defective, but which is intended to enhance or promote the growth of additional tissue in such regions. For example, in certain organizations Decompression tissue treatment is used in the area to grow additional tissue, which can then be harvested and transplanted to On a tissue site. Referring to Figures 1-5, a reduced pressure delivery device or wing manifold 211 in accordance with the principles of the present invention includes a flexible barrier 213 having a ridge portion 215 and a pair of wing portions 219. The portions 219 are all located along opposite sides of the ridge portion 215. The ridge portions 215 form an arcuate passage 223 that may or may not extend over the entire length of the wing manifold 211. Although the ridge portions 215 can be centrally positioned on the wing manifold 211 such that the widths of the wing portions 219 are equal, the ridge portions 215 can also be unbiased as in Figure 15, thereby making one of the wings The portion 219 is wider than the other wing portion 219. If the wing manifold 211 is used in conjunction with bone regeneration or healing and the wider wing manifold 211 will wrap around the fixed hardware attached to the bone, then The extra width of one of the wing portions 21 9 may be particularly useful. The flexible barrier 213 is preferably made of an elastomeric material such as a polyoxyl polymer. One example of a suitable polyoxyl polymer includes that it is located in Carpinteda>
California之Nusil Technologies公司製造之MED-6015。然 而’應注意’撓性障壁213可由任何其他生物相容性、撓 性材料製成。撓性障壁213包封一撓性背襯227,以增強撓 性障壁213之強度及耐久性。包封撓性背襯227之撓性障壁 213在拱形通道223中之厚度可小於在翼狀部分219中之厚 度。若使用聚矽氧聚合物來形成撓性障壁2丨3,則亦可使 用聚矽氧黏合劑來幫助黏合撓性背襯227。聚矽氧黏合劑 之實例了包括亦由Nusil Technologies公司出售之]viED_ 1011。撓性背襯227較佳由聚酯針織織物製成,例如由位 於Tempe,Arizona之C.R. Bard公司所製造之Bard 6〇13製成 然而,撓性背襯227可由任何能增強撓性障壁2丨3之強度 及耐久性之生物相容性、撓性材料製成。在某些情況下, 若撓性障壁2Π由適當強度之材料製成,則可省卻撓性背 襯 227。 較佳使撓性障壁213或撓性背襯227不滲透液體、空氣及 154474.doc 1362951 其他氣體,或者另一選擇為,撓性背襯227與撓性障壁2i3 二者可不滲透液體、空氣及其他氣體。 撓性障壁213及撓性背襯227亦可由在使用減壓輸送裝置 2 11之後不必自患者體内移出之生物可再吸收性材料製成 。適宜之生物可再吸收性材料可包括但不限於聚乳酸 (PLA)及聚乙醇酸(PGA)之聚合摻合物。該聚合摻合物亦可 包括但不限於聚碳酸酯、聚富馬酸酯、及capralact〇ne。撓 性障壁213及撓性背襯227可進一步用作一新細胞生長支架 ,或者可將一支架材料與撓性障壁213及撓性背襯227結合 使用來促進細胞生長。適宜之支架材料可包括但不限於磷 酸鈣、膠原、PLA/PGA、珊瑚羥基磷灰石、碳酸鹽、或經 處理之同種異體移植材料。較佳地,該支架材料將具有高 的空隙比例(即高的空氣含量)。 在一實施例中,可將撓性背襯227以黏合方式固定至撓 性障壁213之表面上。若使用聚矽氧聚合物來形成撓性障 壁213,則亦可使用聚矽氧黏合劑將撓性背襯227固定至撓 性障壁213上。儘管當將撓性背襯227表面結合至撓性背襯 213上時黏合劑係較佳之固定方法,然而亦可使用任何適 宜之固定方法。 撓性障壁213包含複數個在撓性障壁213之表面上自翼狀 部分219伸出之突起物23卜突起物231可為圓柱形、球形 、半球形、立方體形、或任何其他形狀,只要每一突起物 231之至少某一部分所處之平面不同於與撓性背襯η]上固 定有突起物231之側相關聯之平面即可。就此而言甚至 154474.doc •10· 1362951 不要求一特定突起物231具有與其他突起物23ι相同之形狀 或尺寸’事實上’該等突起物231可包括不同形狀及尺寸 之隨機混合。因此,每一突起物231自撓性障壁213上伸出 之距離可各異’但亦可在該複數個突起物23ι中相一致。 各突起物231在撓性障壁213上之佈置在該等突起物之間 形成複數個流動通道233。當該等突起物231具有一致之形 狀及尺寸且在撓性障壁213上均勻相間時,形成於各突起 物231之間之流動通道233同樣地均勻。亦可利用突起物 231之尺寸、形狀及間距之變化來改變流動通道233之尺寸 及流動特性。 如在圖5中所示,一減壓輸送管241位於拱形通道223内 並固定至撓性障壁213上。減壓輸送管241可僅固定至撓性 障壁2 13或撓性背襯227上,或者管24 1可同時固定至撓性 障壁213與撓性背襯227二者上。減壓輸送管以丨在管241之 遠端處包含一遠端孔口 243。管241可定位成使遠端孔口 M3沿拱形通道223位於任一點處,但管μ〗較佳定位成使 遠端孔口 243沿拱形通道223之縱向長度位於大約中點處。 較佳藉由沿一相對於管241之縱向軸線以小於九十(9〇)度之 角度定向之平面切割管241 ’將遠端孔口 243製作成橢圓形 或印圓形形狀。儘管孔口 243亦可為圓形,然而孔口 243之 擴圓形形狀會增強與形成於各突起物23丨間之流動通道233 之流體連通。 減壓輸送管241較佳由塗覆有paraiyne之聚矽氧或胺基曱酸 醋製成。然而’亦可使用任何醫療級管子材料來構造減壓輸 154474.doc 1362951 送官241。可塗覆該管之其他塗層包括肝素、抗凝血劑、抗 纖維蛋白原、抗附著劑 '抗凝血酶原、及親水性塗層。 在一實施例中’作為對遠端孔口 243之替代或者除遠端 孔口 243之外,減壓輸送管241亦可包含沿減壓輸送管24ι 疋位之排放開孔或排放孔口 25 1,以進一步增強減壓輸送 官241與流動通道233間之流體連通。減壓輸送管si〗可如 在圖1·5中所示僅沿拱形通道223之縱向長度之一部分定位 ,或者另一選擇為,可沿拱形通道223之整個縱向長度定 位。若定位成使減壓輸送管241佔據拱形通道223之整個長 度,則可對遠端孔口 243進行罩蓋,以使管241與流動通道 233間之所有流體連通皆經由排放開孔25 1進行。 減壓輸送管241進一步在管241之近端處包含一近端孔口 255。近端孔口 255經構造以與一減壓源相配合,在下文中 將參照圓9更詳細地說明該減壓源。圖〗_3、4Α及5中所示 之減壓輸送管241僅包含單個管腔或通路259。然而,可使 減壓輸送管241包含多個管腔,例如在圖4Β中所示之雙管 腔管26!。雙管腔管261包含一第一管腔263及一第二管腔 265使用雙管腔管會在減壓輸送管241之近端與流動通道 233之間&供为離之流體連通路捏。舉例而言可使用雙 s腔& 261來達成減壓源與沿第一管腔263之流動通道3 之間的連通。第二管腔265可用於將流體引入至流動通道 233内。該流體可係經過m氣或其他氣體、抗菌劑、 抗病毒劑、細胞生長促進劑、沖洗流豸、化學活性流體或 任何其他流體。若期望經由分離之流體連通㈣將多種流 154474.doc -12· 1362951 體引入至流動通道233中,可使減壓輸送管具有不止兩個 管腔。 仍參見圖4B ’ —水平間隔件271將減壓輸送管261之第一 及第一官腔263、265分離,從而使第一管腔263定位於第 一官腔265上方。第—管腔及第二管腔263、265之相對位 置可有所I化,此視如何在管腔263、2 65與流動通道233 之間提供流體連通而定。舉例而言,當第一管腔如在 圖4B中所不定位時,可提供類似於排放開孔251之排放開 孔來達成與流動通道233之連通.當第二管腔如在圖化中 所示定位時,第二管腔265可經由一類似於遠端孔口 Μ]之 遠端孔口與流動通道233連通。另—選擇為,可藉由一將 各管腔分離之垂直間隔件來使一減壓輸送管中之多個管腔 並排定位’或者可將該等管腔同心或同軸地定位。 此項技射之—般技術人員應易知,獨立流體連通路徑 之提供可藉由若干種不同之方式來實現’包括如上文所述 提供-多管腔管。另一選擇為,可藉由將一單管腔管固定 至另-單管腔管上、或者藉助若干帶單個或多個管腔之單 獨、未固定之管來提供獨立之流體連通路徑。 若使用單獨之管來提供與流動通道扣:單獨流體連通 路徑’凸脊部分215可包含多個换形通道223,其中每 管一個棋形通道⑵。另一選擇為,可擴大棋形通道223以 容納多個管。具有一與流體輸送管相分離之減 之一實例將在下文中參照圖9進行更詳細說明: 參見圖6·8,一根據本發明原理 義壓輸送裝置或翼狀 154474.doc 13. 1362951 歧管311包括一具有凸脊部分315之撓性障壁313以及—對 翼狀部分3 19。每一翼狀部分3 19皆沿凸脊部分3丨5之對置 側定位。凸脊部分315形成一拱形通道323,拱形通道323 既可延伸過也可不延伸過翼狀歧管311之整個長度。儘管 凸脊部分315可在翼狀歧管311上居中定位,以使各翼狀部 分3 19之寬度相等,然而凸脊部分315亦可如在圖68中所 示偏置,從而使其中一個翼狀部分319寬於另一翼狀部分 319。如果將翼狀歧管311與骨骼再生或醫治結合使用且較 寬之翼狀歧管311將纏繞於附連至骨骼上之固定硬體周圍 ,則其中一個翼狀部分3 19之額外寬度可能特別有用。 一蜂巢狀材料327固定至撓性障壁313上,並可作為跨越 凸脊部分315及兩個翼狀部分319覆蓋撓性障壁313整個表 面之單片材料來提供。蜂巢狀材料327包括一毗鄰撓性障 壁313設置之固定表面(在圖6中不可見)、一與該固定表面 相對之分佈表面329、及複數個周邊表面33〇。 在一實施例中,撓性障壁313可類似於撓性障壁213,並 包含-撓性背襯。儘管黏合劑係―種用於將蜂巢狀材料 327固疋至撓性障壁313之較佳方法然而亦可藉由任何立 他適宜之固定方法來固定挽性障壁313料巢狀#料3〜 或者將其留給使用者在治療場所進行組^撓性障壁⑴ 及/或撓性背襯用作-不滲透性障壁來阻擋例如液體、空 氣或其他氣體等流體透過。 實%例中,可不以分離方式提供撓性障壁及換性背 概來支持蜂巢狀材料327。而是,蜂巢狀材料327可具有- 154474.doc 1362951 整體障壁層,該整體障壁層係蜂巢狀材料327之一不滲透 陡。P刀。4障壁層可由封閉孔式材料形成以防止流體透 過,從而替代撓性障壁313。若將整體障壁層與蜂巢狀 材料327-起使用,則該障壁層可包含如上文參照撓性障 壁313所述之凸脊部分及翼狀部分。 撓性障壁313較佳由例如聚⑦氧聚合物等彈性材料製成 。適合之聚矽氧聚合物之一實例包括由位於。咖⑽, CaHfornia 之 Nusil Techn〇1〇gies 公司製造之 με〇 ⑷5。然 而,應注意,撓性柵欄313可由任何其他生物相容性、徺 性材料製成。若撓性障壁包封或以其他方式包含一撓性背 概,則撓性背襯較佳由聚醋針織織物製成,例如由位於 Tempe,Arizona 之 C.R. Bard 公司所製造之 Bard 6〇13 製成。 然而,撓性背襯227可由任何能增強撓性柵攔3丨3之強度及 耐久性之生物相容性、撓性材料製成。 在實知妁中,蜂巢狀材料327係一開放孔式、網狀聚 醚胺基甲酸酯發泡體,其孔隙尺寸介於約4〇〇_6〇〇微米範 圍内此種發泡體之一實例可包含由位於San Antonio,MED-6015 manufactured by Nusil Technologies of California. However, it should be noted that the flexible barrier 213 can be made of any other biocompatible, flexible material. The flexible barrier 213 encloses a flexible backing 227 to enhance the strength and durability of the flexible barrier 213. The flexible barrier 213 enclosing the flexible backing 227 may have a thickness in the arcuate channel 223 that is less than the thickness in the wing portion 219. If a polysiloxane polymer is used to form the flexible barrier 2丨3, a polyoxynitride adhesive can also be used to help bond the flexible backing 227. Examples of polyoxynoxy binders include viED_1011, also sold by Nusil Technologies. The flexible backing 227 is preferably made of a polyester knit fabric, such as Bard 6〇13 manufactured by CR Bard, Inc. of Tempe, Arizona. However, the flexible backing 227 can be reinforced by any flexible barrier 2 3 is made of biocompatibility and flexible material for strength and durability. In some cases, the flexible backing 227 can be dispensed with if the flexible barrier 2 is made of a material of suitable strength. Preferably, the flexible barrier 213 or the flexible backing 227 is impermeable to liquids, air, and other gases, or alternatively, both the flexible backing 227 and the flexible barrier 2i3 are impermeable to liquids, air, and Other gases. The flexible barrier 213 and flexible backing 227 can also be made of a bioresorbable material that does not have to be removed from the patient after use of the reduced pressure delivery device 21 . Suitable bioresorbable materials can include, but are not limited to, polymeric blends of polylactic acid (PLA) and polyglycolic acid (PGA). The polymeric blends can also include, but are not limited to, polycarbonates, polyfumarates, and capralact〇ne. The flexible barrier 213 and flexible backing 227 can be further utilized as a new cell growth scaffold or a scaffold material can be used in conjunction with the flexible barrier 213 and flexible backing 227 to promote cell growth. Suitable scaffolding materials can include, but are not limited to, calcium phosphate, collagen, PLA/PGA, coral hydroxyapatite, carbonate, or treated allograft materials. Preferably, the scaffold material will have a high void fraction (i.e., a high air content). In one embodiment, the flexible backing 227 can be secured to the surface of the flexible barrier 213 in an adhesive manner. If a polysiloxane polymer is used to form the flexible barrier 213, the flexible backing 227 can also be secured to the flexible barrier 213 using a polyoxynene adhesive. Although the adhesive is a preferred method of attachment when bonding the surface of the flexible backing 227 to the flexible backing 213, any suitable method of attachment can be used. The flexible barrier 213 includes a plurality of protrusions 23 extending from the wing portion 219 on the surface of the flexible barrier 213. The protrusions 231 may be cylindrical, spherical, hemispherical, cubic, or any other shape as long as each The plane in which at least a portion of a protrusion 231 is located is different from the plane associated with the side on which the protrusion 231 is fixed on the flexible backing η]. In this regard, even 154474.doc • 10· 1362951 does not require that a particular protrusion 231 have the same shape or size as the other protrusions 23 i. In fact, the protrusions 231 may comprise random blends of different shapes and sizes. Therefore, the distance each protrusion 231 protrudes from the flexible barrier 213 can be varied 'but can also coincide in the plurality of protrusions 23ι. The projections 231 are disposed on the flexible barrier 213 to form a plurality of flow passages 233 between the projections. When the projections 231 have the same shape and size and are evenly spaced across the flexible barrier 213, the flow passages 233 formed between the projections 231 are equally uniform. The size and shape of the flow path 233 can also be varied by utilizing changes in the size, shape and spacing of the protrusions 231. As shown in Fig. 5, a reduced pressure delivery tube 241 is located in the arcuate passage 223 and is fixed to the flexible barrier 213. The reduced pressure delivery tube 241 can be secured only to the flexible barrier 2 13 or the flexible backing 227, or the tube 24 1 can be simultaneously secured to both the flexible barrier 213 and the flexible backing 227. The reduced pressure delivery tube contains a distal opening 243 at the distal end of the tube 241. The tube 241 can be positioned such that the distal aperture M3 is located at any point along the arcuate channel 223, but the tube is preferably positioned such that the distal aperture 243 is located at approximately the midpoint along the longitudinal length of the arcuate channel 223. Preferably, the distal aperture 243 is formed into an elliptical or circular shape by a planar cutting tube 241' oriented at an angle of less than ninety (9 degrees) relative to the longitudinal axis of the tube 241. Although the aperture 243 may also be circular, the expanded circular shape of the aperture 243 enhances fluid communication with the flow passage 233 formed between each projection 23. The reduced pressure delivery tube 241 is preferably made of polypyrene or aminic vinegar coated with paraiyne. However, any medical grade pipe material can be used to construct a reduced pressure transmission 154474.doc 1362951. Other coatings that can be applied to the tube include heparin, anticoagulants, anti-fibrinogen, anti-adherent agents, anti-prothrombin, and hydrophilic coatings. In one embodiment, 'as an alternative to or in addition to the distal orifice 243, the reduced pressure delivery tube 241 may also include a discharge opening or discharge orifice 25 along the reduced pressure delivery conduit 24i. 1, to further enhance the fluid communication between the reduced pressure delivery official 241 and the flow channel 233. The reduced pressure delivery tube si can be positioned only along one of the longitudinal extents of the arcuate passage 223 as shown in Figure 1-5, or alternatively, can be positioned along the entire longitudinal extent of the arcuate passage 223. If positioned such that the reduced pressure delivery tube 241 occupies the entire length of the arcuate passage 223, the distal opening 243 can be capped such that all fluid communication between the tube 241 and the flow passage 233 is via the discharge opening 25 1 get on. The reduced pressure delivery tube 241 further includes a proximal aperture 255 at the proximal end of the tube 241. The proximal orifice 255 is configured to cooperate with a source of reduced pressure, which will be described in more detail below with reference to circle 9. The reduced pressure delivery tube 241 shown in Figures _3, 4A and 5 contains only a single lumen or passage 259. However, the reduced pressure delivery tube 241 can be provided with a plurality of lumens, such as the dual lumen tube 26! shown in Figure 4A. The double lumen tube 261 includes a first lumen 263 and a second lumen 265. The dual lumen tube is used between the proximal end of the reduced pressure delivery tube 241 and the flow channel 233. . For example, a dual s cavity & 261 can be used to achieve communication between the reduced pressure source and the flow channel 3 along the first lumen 263. The second lumen 265 can be used to introduce fluid into the flow channel 233. The fluid may be passed through a gas or other gas, an antibacterial agent, an antiviral agent, a cell growth promoter, a rinse drool, a chemically active fluid, or any other fluid. If it is desired to introduce a plurality of streams 154474.doc -12. 1362951 into the flow channel 233 via separate fluid communication (iv), the reduced pressure delivery tube can have more than two lumens. Still referring to Fig. 4B', the horizontal spacer 271 separates the first and first official chambers 263, 265 of the reduced pressure delivery tube 261 such that the first lumen 263 is positioned above the first official chamber 265. The relative positions of the first lumen and the second lumens 263, 265 may be differentiated depending on how fluid communication is provided between the lumens 263, 2 65 and the flow channel 233. For example, when the first lumen is not positioned as in FIG. 4B, a discharge opening similar to the discharge opening 251 can be provided to achieve communication with the flow channel 233. When the second lumen is in the image In the illustrated orientation, the second lumen 265 can be in communication with the flow channel 233 via a distal orifice similar to the distal orifice. Alternatively, the plurality of lumens in a reduced pressure delivery tube can be positioned side by side by a vertical spacer separating the lumens or the lumens can be positioned concentrically or coaxially. It will be readily apparent to those skilled in the art that the provision of independent fluid communication paths can be accomplished in a number of different ways including the provision of a multi-lumen tube as described above. Alternatively, a separate fluid communication path can be provided by securing a single lumen to another single lumen tube or by means of a plurality of separate, unsecured tubes with single or multiple lumens. If a separate tube is used to provide the flow channel buckle: the separate fluid communication path' ridge portion 215 can include a plurality of contoured channels 223, each of which has a chevable channel (2). Alternatively, the chevron channel 223 can be enlarged to accommodate a plurality of tubes. An example of a reduction with a fluid delivery tube will be described in more detail below with reference to Figure 9: See Figure 6.8, a pressure delivery device or wing 154474.doc 13. 1362951 manifold in accordance with the principles of the present invention The 311 includes a flexible barrier 313 having a ridge portion 315 and a pair of wing portions 319. Each wing portion 3 19 is positioned along the opposite side of the ridge portion 3丨5. The ridge portion 315 defines an arcuate passage 323 that may or may not extend over the entire length of the wing manifold 311. Although the ridge portions 315 can be centrally positioned on the wing manifold 311 such that the widths of the wing portions 319 are equal, the ridge portions 315 can also be offset as shown in Figure 68, thereby causing one of the wings The portion 319 is wider than the other wing portion 319. If the wing manifold 311 is used in conjunction with bone regeneration or healing and the wider wing manifold 311 will wrap around the fixed hardware attached to the bone, the extra width of one of the wing portions 3 19 may be exceptional it works. A honeycomb material 327 is secured to the flexible barrier 313 and is provided as a single piece of material that covers the entire surface of the flexible barrier 313 across the ridge portion 315 and the two wing portions 319. The honeycomb material 327 includes a fixed surface (not visible in Fig. 6) disposed adjacent to the flexible barrier 313, a distribution surface 329 opposite the fixed surface, and a plurality of peripheral surfaces 33A. In an embodiment, the flexible barrier 313 can be similar to the flexible barrier 213 and includes a flexible backing. Although the adhesive system is a preferred method for solidifying the honeycomb material 327 to the flexible barrier 313, it may be fixed by any suitable fixing method to fix the barrier 313 material. This is left to the user to perform a set of flexible barriers (1) and/or flexible backings at the treatment site to act as an impervious barrier to block the passage of fluids such as liquids, air or other gases. In the real case, the flexible barrier and the flexible backing may be provided in a separate manner to support the honeycomb material 327. Rather, the honeycomb material 327 can have a 154474.doc 1362951 integral barrier layer that is impervious to one of the honeycomb materials 327. P knife. The barrier layer may be formed of a closed-cell material to prevent fluid from penetrating, thereby replacing the flexible barrier 313. If the integral barrier layer is used with the honeycomb material 327, the barrier layer may comprise a raised ridge portion and a wing portion as described above with reference to the flexible barrier 313. The flexible barrier 313 is preferably made of an elastic material such as a polyoxy 7 polymer. An example of a suitable polyoxyl polymer includes the presence of it. Coffee (10), με〇 (4)5 manufactured by Nusil Techn〇1〇gies of CaHfornia. However, it should be noted that the flexible fence 313 can be made of any other biocompatible, inert material. If the flexible barrier encloses or otherwise includes a flexible backing, the flexible backing is preferably made of a woven knit fabric, such as Bard 6〇13 manufactured by CR Bard, Inc. of Tempe, Arizona. to make. However, the flexible backing 227 can be made of any biocompatible, flexible material that enhances the strength and durability of the flexible barrier 3丨3. In the known crucible, the honeycomb material 327 is an open-cell, network polyether urethane foam having a pore size of about 4 〇〇 6 6 μm. An example can be included by located in San Antonio,
Texas之Kinetic Concepts公司製造之GranuFoam。蜂巢狀材 料327亦可係紗布、氈墊、或任何其他能在三個維上藉由 複數個通道提供流體連通之生物相容性材料。 蜂巢狀材枓327主要係一種"開放孔式"材料,其包含流 體連接至晚鄰孔之複數個孔。藉由蜂巢狀材料327之”開放 孔”在該等”開放孔”之間形成複數個流動通道。該等流動 通道能夠在蜂巢狀材料327中具有開放孔之該整個部分中 154474.doc •15· 1362951 達成流體連通。該等胞及流動通道可具有一致之形狀及尺 寸’或者可包含圖案化或隨機之形狀及尺寸變化。蜂巢狀 材料327中孔之尺寸及形狀之變化會引起流動通道之變化 ’且此等特性可用於改變流過蜂巢狀材料327之流體之流 動特性。蜂巢狀材料327可進一步包括含有"封閉孔"之部 分。蜂巢狀材料327中之封閉孔部分包含複數個孔,該等 孔中之大多數不流體連接至她鄰孔。在上文中將一封閉孔 部分之一實例描述為一可代替撓性障壁313之障壁層。類 似地’可在蜂巢狀材料327中選擇性地設置封閉孔部分, 以防止流體透過蜂巢狀材料327之周邊表面330。 撓性障壁313及蜂巢狀材料327亦可由在使用減壓輸送裝 置3 11之後不必自患者體内移出之生物可再吸收性材料製 成。適宜之生物可再吸收性材料可包括但不限於聚乳酸 (PLA)及聚乙醇酸(pga)之聚合摻合物。該聚合摻合物亦可 包括但不限於聚碳酸酯、聚富馬酸酯、及capralact〇ne。撓 性障壁3 13及蜂巢狀材料327可進一步用作一新細胞生長支 架’或者可將一支架材料與撓性障壁313 '撓性背襯327 及/或蜂巢狀材料327結合使用來促進細胞生長。適宜之支 架材料可包括但不限於磷酸鈣、膠原、PLA/PGA、珊瑚羥 基碟灰石、碳酸鹽、或經處理之同種異體移植材料。較佳 地’ a亥支架材料將具有尚的空隙比例(即高的空氣含量)。 一減壓輸送管341定位於拱形通道323内並固定至撓性障 壁313上。減壓輸送管341亦可固定至蜂巢狀材料327上, 或者在僅存在蜂巢狀材料327之情況下,減壓輸送管341可 154474.doc -16 - 1362951 僅固定至蜂巢狀材料327.上。減壓輸送管341在管341之遠 端處包含一遠端孔口 343,其類似於圖5中之遠端孔口 243 。減壓輸送管341可定位成使遠端孔口 343沿拱形通道323 位於任一點處’但較佳沿拱形通道323之縱向長度定位於 大約中點處。較佳藉由沿一相對於管34〗之縱向軸線以小 於九十(90)度之角度定向之平面切割管341,將遠端孔口 343製作成橢圓形或卵圓形形狀。儘管該孔口亦可為圓形GranuFoam, manufactured by Kinetic Concepts, Texas. Honeycomb material 327 can also be a gauze, felt pad, or any other biocompatible material that provides fluid communication in a plurality of dimensions in a plurality of channels. Honeycomb 枓 327 is primarily a "open-hole" material that contains a plurality of holes that are fluidly connected to the adjacent hole. A plurality of flow channels are formed between the "open holes" by the "open holes" of the honeycomb material 327. The flow channels are capable of achieving fluid communication in the entire portion of the honeycomb material 327 having open pores 154474.doc • 15· 1362951. The cells and flow channels can have a uniform shape and size' or can include patterned or random shapes and dimensional changes. Variations in the size and shape of the apertures in the honeycomb material 327 can cause variations in the flow path' and such characteristics can be used to alter the flow characteristics of the fluid flowing through the honeycomb material 327. The honeycomb material 327 may further include a portion containing a "closed hole". The closed cell portion of the honeycomb material 327 includes a plurality of holes, most of which are not fluidly connected to her adjacent holes. An example of a closed hole portion is described above as a barrier layer that can replace the flexible barrier 313. A closed hole portion may be selectively disposed in the honeycomb material 327 to prevent fluid from penetrating the peripheral surface 330 of the honeycomb material 327. The flexible barrier 313 and the honeycomb material 327 can also be made of a bioresorbable material that does not have to be removed from the patient after use of the reduced pressure delivery device 31. Suitable bioresorbable materials can include, but are not limited to, polymeric blends of polylactic acid (PLA) and polyglycolic acid (pga). The polymeric blends can also include, but are not limited to, polycarbonates, polyfumarates, and capralact〇ne. The flexible barrier 3 13 and the honeycomb material 327 can be further used as a new cell growth scaffold' or a scaffold material can be used in combination with the flexible barrier 313 'flexible backing 327 and/or honeycomb material 327 to promote cell growth. . Suitable stent materials can include, but are not limited to, calcium phosphate, collagen, PLA/PGA, coral hydroxyapatite, carbonate, or treated allograft materials. Preferably, the material will have a void ratio (i.e., a high air content). A reduced pressure delivery tube 341 is positioned within the arcuate passage 323 and secured to the flexible barrier 313. The reduced pressure delivery tube 341 can also be secured to the honeycomb material 327, or in the presence of only the honeycomb material 327, the reduced pressure delivery tube 341 can be 154474.doc -16 - 1362951 only secured to the honeycomb material 327. The reduced pressure delivery tube 341 includes a distal opening 343 at the distal end of the tube 341 which is similar to the distal opening 243 of FIG. The reduced pressure delivery tube 341 can be positioned such that the distal aperture 343 is located at any point along the arcuate channel 323 but is preferably positioned at approximately the midpoint along the longitudinal extent of the arcuate channel 323. Preferably, the distal aperture 343 is formed into an elliptical or oval shape by cutting the tube 341 along a plane oriented at an angle of less than ninety (90) degrees with respect to the longitudinal axis of the tube 34. Although the aperture can also be circular
’然而孔口之橢圓形形狀會增強與蜂巢狀材料327中流動 通道之流體連通。 在實把例中,減壓輸送管341亦可包含類似於圖5中之 排放開孔25】之排放開孔或排放孔口(未顯示)。作為對遠端 孔口 343之替代或者除达端孔口 343之外,還沿管341佈置 排放開孔,以進一步增強減壓輸送管341與流動通道間之 流體連通。如前面所述,減壓輸送管341可僅沿拱形通道 323之縱向長度之一部分定位,或者另一選擇為,可沿拱 形通道323之整個縱向長度定位。若定位成使減壓輸送管 341佔據整個拱形通道323,則可對遠端孔口 進行罩蓋 ’以使管341與流動通道間之所有流體連通皆經由排放開 孔進行。 較佳地,蜂巢狀材料327覆蓋並直接接觸減壓輸送管W 。蜂巢狀材料327可連接至減壓輸送㈣卜或者蜂巢狀材 ㈣可僅固定至撓性障壁313上。若減壓輸送管34ι定位 成使其僅延伸至梹形通道323之中點,則蜂巢狀材料327亦 可在拱形通道323中不包含減壓輸送管⑷之區域中連接至 154474.doc 17 1362951 撓性障壁313之凸脊部分315。 減壓輸送管34!進一步在管341之近端處包含一近端孔口 355。近端孔口 355經構造以與一減壓源相配合,在下文中 將參照圖9更詳細地說明該減壓源。圖68中所示之減屋輸 ,管30僅包含單個管腔或通路⑽。然而,可使減壓輸送 管341包含多個管腔,例如前面參照圖扣所述之多個管腔 。如前面所述,使用一多管腔管會在減壓輸送管341之近 端與流動通道之間提供分離之流體連通路徑。亦可藉由具 有與流動通道相連通之單個或多個管腔之單獨管來提供該 等單獨之流體連通路徑。 參見圖8Α及8Β , —根據本發明原理之減壓輸送裝置37ι 包括一減壓輸送管373,其在減壓輸送管373之遠端377處 具有一延伸部分375。延伸部分375較佳為拱形形狀,以與 減壓輸送管373之曲率相匹配。延伸部分375可藉由如下方 式形成:在遠端377處移除減壓輸送管373之一部分,由此 形成一具有一凸肩383之切口 381。複數個突起物385設置 於減壓輸送管373之一内表面387上,以於該等突起物385 之間形成複數個流動通道391。突起物385之尺寸、形狀及 間距可類似於參照圖所述之突起物。減壓輸送裝置371 特別適用於對能夠接納於切口 381内之結締組織施以減低 之壓力及在結締組織上重新產生組織。勒帶、腱及軟骨即 係可由減壓輸送裝置3 71治療之組織之非限定性實例。 參見圖9,使用一類似於本文所述其他減壓輸送裝置之 減壓輸送裝置411對一組織部位413(例如患者之人體骨骼 154474.doc -18- 1362951 415)施以減壓組織治療。當用於促進骨骼組織生長時,減 壓組織治療可提高與骨折、不癒合、空隙或其他骨骼缺損 相關聯之癒合率。進一步據認為,可使用減壓組織治療來 改善骨髓炎之恢復。該治療可進一步用於提高患骨髓炎之 患者之局部f路密纟。最後,減壓組織治療可用於加速及 改善例如臀部植入體、膝蓋植入體、及固定器件等整形外 科植入體之 oseointegration。 仍參見圖9,減壓輸送裝置411包括一減壓輸送管々μ, 減壓輸送管41 9具有一流體連接至一減壓源427之近端42ι 。減壓源427係一幫浦或任何其他能夠經由減壓輸送管々Μ 及與減壓It送裝置411相關聯之複數個流動通道對組織部 位4丨3施以減低之壓力之器件。對組織部位413施以減低之 壓力係藉由將減壓輸送裝置4 i i之翼狀部分❹組織部位 413佈置來達成,在該特定實例中,此涉及到圍繞骨骼μ; 中之空隙缺損429纏繞翼狀部&。減壓輸送裝置4ιι可藉由 外科手術或經過皮膚***。當經過皮膚***時,減壓輸送 S 419較佳穿過—穿透患者皮膚組織之無菌***護套***。 施以減壓、纟且織治療通常會在組織部位413周圍區域中產 生肉芽,组織m織係一財常在人體中之組織修復之 則所形成之常見組織。在正常情況下,在存在異物時或在 傷口癒合期間可能會形成肉芽組織m且織通常用作健 康之取代組織之支架並進一步使得形成某種瘋痕組織。肉 芽組織係高度血管化之組織,且在存在減低之壓力情況下 此種高度血營化組織之增強之生長率會促進組織部位413 154474.doc 1362951 處新組織之生長》 仍參見圖9’ 一流體輸送管431可在一遠端處流體連接至 減壓輸送裝置411之流動通道。流體輸送管431包括一流體 連接至一流體輸送源433之近端432。若正輸送至組織部位 之流體係空氣’則較佳藉由一能夠過濾小至〇 22 μιη之微 粒之過濾器434來過濾空氣’藉以對空氣進行淨化及殺菌 尤其S組織部位41 3位於皮膚表面下面時,向組織部位 413引入空氣會非常重要,此有利於良好地疏通組織部位 413 ’藉以減輕或防止減壓輸送管419之阻塞β流體輸送管 43 1及流體輸送源433亦可用於向組織部位413引入其他流 體,包括但不限於抗菌劑 '抗病毒劑、細胞生長促進劑、 沖洗流體、或其他化學活性劑。當經過皮膚***時,減壓 輸送管43 1較佳穿過一穿透患者皮膚組織之無菌***護套 ***。 一壓力感測器43 5可藉由可操作方式連接至流體輸送管 43 1 ’以指示流體輸送管43 1是否被血液或其他體液堵塞。 壓力感測器435可藉由可操作方式連接至流體輸送源433以 提供回饋,藉以控制引入至組織部位4丨3之流體量。亦可 將一止回閥(未顯示)以可操作方式連接於流體輸送管43丨之 遠端附近’以防止血液或其他體液進入流體輸送管431。 減壓輸送管419及流體輸送管43 1所提供之獨立流體連通 路徑可藉由諸多種不同之方式來達成,包括如前面參照圖 4Β所述提供單個多管腔管。此項技術中之一般技術者將知 ’若使用一多管腔管,與流體輸送管43丨相關聯之感測器 154474.doc -20· 、閥門及其他批 、'且件亦可類似地與減壓輸送管419中之一特 定管腔相關聯。知 較佳使與組織部位流體連通之任何管腔或 管皆塗覆有抗越i β 舞血劑,以防止體液或血液在管腔或管内堵 塞。可塗霜兮·^ ^ 、官腔或管之其他塗層包括但不限於肝素、 抗凝血劑、括總 纖維蛋白原、抗附著劑、抗凝血酶原、及親 水性塗層。 參見圖10-19,4 λ & 武驗已證明¥對骨骼組織施以減壓組織 治療時,會#至|丨τ 子 正面之效果。在一特定試驗中,對數只兔 " 、減壓組織治療’以確定其對於骨路生長及再 生之效果。該%丨士 Ji 頭& /、试之具體目標係發現減壓組織治療對於在 又有缺損或損傷之兔子之效果、減壓組織治療對於 在頭骨上具有酢與However, the elliptical shape of the orifice enhances fluid communication with the flow channels in the honeycomb material 327. In the example, the reduced pressure delivery tube 341 may also include a discharge opening or discharge orifice (not shown) similar to the discharge opening 25 of Figure 5. In addition to or in addition to the distal orifice 343, a discharge opening is disposed along the tube 341 to further enhance fluid communication between the reduced pressure delivery tube 341 and the flow passage. As previously described, the reduced pressure delivery tube 341 can be positioned only partially along one of the longitudinal extents of the arcuate passage 323, or alternatively, can be positioned along the entire longitudinal extent of the arcuate passage 323. If positioned such that the reduced pressure delivery tube 341 occupies the entire arched passage 323, the distal opening can be covered' so that all fluid communication between the tube 341 and the flow passage is via the discharge opening. Preferably, the honeycomb material 327 covers and directly contacts the reduced pressure delivery tube W. The honeycomb material 327 can be attached to the reduced pressure transport (4) or the honeycomb material (4) can be fixed only to the flexible barrier 313. If the reduced pressure delivery tube 34i is positioned such that it extends only to a point in the meandering passage 323, the honeycomb material 327 can also be connected to the 154474.doc in the region of the arched passage 323 that does not include the reduced pressure delivery tube (4). 1362951 The ridge portion 315 of the flexible barrier 313. The reduced pressure delivery tube 34! further includes a proximal aperture 355 at the proximal end of the tube 341. The proximal orifice 355 is configured to cooperate with a source of reduced pressure, which will be described in greater detail below with respect to Figure 9. The reduced house, tube 30, shown in Figure 68, contains only a single lumen or passage (10). However, the reduced pressure delivery tube 341 can be provided with a plurality of lumens, such as the plurality of lumens previously described with reference to the drawings. As previously described, the use of a multi-lumen tube provides a separate fluid communication path between the proximal end of the reduced pressure delivery tube 341 and the flow channel. The separate fluid communication paths may also be provided by separate tubes having single or multiple lumens in communication with the flow channels. Referring to Figures 8A and 8B, a reduced pressure delivery device 37i in accordance with the principles of the present invention includes a reduced pressure delivery tube 373 having an extension 375 at a distal end 377 of the reduced pressure delivery tube 373. The extension portion 375 is preferably arched to match the curvature of the reduced pressure delivery tube 373. The extension portion 375 can be formed by removing a portion of the reduced pressure delivery tube 373 at the distal end 377, thereby forming a slit 381 having a shoulder 383. A plurality of protrusions 385 are disposed on an inner surface 387 of the reduced pressure delivery tube 373 to form a plurality of flow channels 391 between the protrusions 385. The size, shape and spacing of the protrusions 385 can be similar to the protrusions described with reference to the figures. The reduced pressure delivery device 371 is particularly suitable for applying reduced pressure to connective tissue that can be received in the incision 381 and regenerating tissue on the connective tissue. The band, the tendon and the cartilage are non-limiting examples of tissue that can be treated by the reduced pressure delivery device 371. Referring to Figure 9, a tissue site 413 (e.g., human bone 154474.doc -18-1362951 415 of the patient) is treated with reduced pressure tissue using a reduced pressure delivery device 411 similar to other reduced pressure delivery devices described herein. When used to promote bone tissue growth, decompression tissue treatment increases the rate of healing associated with fractures, non-union, voids, or other bone defects. It is further believed that reduced pressure tissue treatment can be used to improve the recovery of osteomyelitis. This treatment can be further used to improve local f road stimuli in patients with osteomyelitis. Finally, reduced pressure tissue treatment can be used to accelerate and improve oseointegration of orthopedic implants such as hip implants, knee implants, and fixation devices. Still referring to Fig. 9, the reduced pressure delivery device 411 includes a reduced pressure delivery tube 9μ having a proximal end 42i fluidly coupled to a reduced pressure source 427. The reduced pressure source 427 is a pump or any other device capable of applying a reduced pressure to the tissue portion 4丨3 via a plurality of flow passages associated with the reduced pressure delivery tube 々Μ and the reduced pressure It delivery device 411. Applying the reduced pressure to the tissue site 413 is accomplished by arranging the wing-shaped portion of the reduced-pressure delivery device 4 ii, in this particular example, which involves wrapping around the void defect 429 in the bone μ; Wings & The reduced pressure delivery device 4ι can be inserted by surgery or through the skin. When inserted through the skin, the reduced pressure delivery S 419 is preferably inserted through a sterile insertion sheath that penetrates the skin tissue of the patient. The application of decompression, sputum and weaving treatment usually produces granulation in the area around the tissue site 413, which is a common tissue formed by tissue repair in the human body. Under normal conditions, granulation tissue m may be formed in the presence of foreign bodies or during wound healing and is typically used as a scaffold for healthy replacement tissue and further to form a certain type of mad tissue. The granulation tissue is highly vascularized, and the increased growth rate of such highly vascularized tissue promotes the growth of new tissue at the tissue site 413 154474.doc 1362951 in the presence of reduced pressure. Still see Figure 9' The fluid delivery tube 431 can be fluidly coupled to the flow channel of the reduced pressure delivery device 411 at a distal end. Fluid delivery tube 431 includes a proximal end 432 that is fluidly coupled to a fluid delivery source 433. If the flow system air being delivered to the tissue site is preferably filtered by a filter 434 capable of filtering particles as small as 22 μm, the air is purified and sterilized, in particular, the S tissue portion 41 3 is located on the skin surface. In the following, it is very important to introduce air into the tissue site 413, which facilitates the good dredge of the tissue site 413 'to reduce or prevent the obstruction of the reduced pressure delivery tube 419. The beta fluid delivery tube 43 1 and the fluid delivery source 433 can also be used to the tissue. Site 413 introduces other fluids including, but not limited to, antibacterial agents, antiviral agents, cell growth promoters, irrigation fluids, or other chemically active agents. When inserted through the skin, the reduced pressure delivery tube 43 1 is preferably inserted through a sterile insertion sheath that penetrates the skin tissue of the patient. A pressure sensor 43 5 can be operatively coupled to the fluid delivery tube 43 1 ' to indicate whether the fluid delivery tube 43 1 is blocked by blood or other bodily fluids. Pressure sensor 435 can be operatively coupled to fluid delivery source 433 to provide feedback to control the amount of fluid introduced to tissue site 4丨3. A check valve (not shown) may also be operatively coupled to the vicinity of the distal end of the fluid delivery tube 43 to prevent blood or other bodily fluids from entering the fluid delivery tube 431. The separate fluid communication paths provided by the reduced pressure delivery tube 419 and the fluid delivery tube 43 1 can be accomplished in a number of different ways, including providing a single multi-lumen tube as previously described with reference to Figure 4A. Those of ordinary skill in the art will recognize that if a multi-lumen tube is used, the sensors associated with the fluid delivery tube 43 154474.doc -20·, valves and other batches, and Associated with one of the specific lumens of the reduced pressure delivery tube 419. It is preferred that any lumen or tube in fluid communication with the tissue site be coated with an anti-beta blood dance agent to prevent body fluid or blood from clogging within the lumen or tube. Other coatings that can be applied to the sputum, including the heparin, anticoagulant, total fibrinogen, anti-adherent, anti-prothrombin, and hydrophilic coatings. See Figure 10-19, 4 λ & The test has proved that the effect of ##||丨子子 is positive when applying decompression tissue treatment to bone tissue. In a particular trial, a logarithmic rabbit " decompressive tissue treatment' was used to determine its effect on bone path growth and regeneration. The specific goal of the % gentleman Ji head & /, test is to find the effect of decompression tissue treatment on rabbits with defects or injuries, decompression tissue treatment for the skull on the skull
I界尺寸缺損之兔子之效果、及將一支架材 料與減壓組織、;A σ療一起使用對於治療頭骨上之臨界尺寸缺 才貝之效果。旦·辦、、Bl Χ、— ^試方案及兔子數量列示於下表1中。 測試方案 4 4 4 4 膜音"’、缺損,藉由蜂巢狀發泡體(GranuFoam)在完好之骨 咸壓組織治療(RPTT)達6天,隨後立即收穫組織 頭二上無缺損;在不施以減壓組織治療(处丁乃情況下在完好 之月膜頂上放置蜂巢狀發泡體(GranuFoam)達6天,隨後立即 收穫組織 具有一個在上面放置不銹鋼絲網之臨界尺寸缺損;一個在上 面放置磷酸辦支架之臨界尺寸缺損;對該兩個缺損施以24小 時RPTT ;在手術2週後收穫組織_ 具有一個在上面放置不錄鋼絲網之臨界尺寸缺損;一個在上 面放置磷酸鈣支架之臨界尺寸缺損;對該兩個缺損施以24小 _Τ?ΐ>Τ1^;在手術12週後收穫組織____ •21 - J54474.doc 1362951 4 具有一個在上面放置不銹鋼絲網之臨界尺寸缺損;一個在上 面放置磷酸鈣支架之臨界尺寸缺損;對該兩個缺損施以6天 RPTT ;在手術2週後收穫組織 4 具有一個在上面放置不銹鋼絲網之臨界尺寸缺損;一個在上 面放置磷酸鈣支架之臨界尺寸缺損;對該兩個缺損施以6天 RPTT ;在手術12週後收穫組織 4 具有一個在上面放置不銹鋼絲網之臨界尺寸缺損;一個在上 面放置磷酸鈣支架之臨界尺寸缺損;不施以RPTT(控制);在 手術2週後收穫組織 4 具有一個在上面放置不銹鋼絲網之臨界尺寸缺損;一個在上 面放置磷酸鈣支架之臨界尺寸缺損;不施以RPTT(對照);在 手術12週後收穫組織 4 天然對照(不進行外科手術;不施行RPTT) 4 假手術(無缺損,不施行RPTT):在手術6天後收穫组織 表1 :測試方案 臨界尺寸缺損係组織(例如頭骨)中之缺損,其尺寸足夠 大’從而將無法僅藉由自身恢復來癒合。對於兔子而言, 穿過頭骨鑽製一直徑約為15 mm之全厚度孔便會形成頭骨 之臨界尺寸缺損。 更具體地參見圖10,其圖解說明一具有原始、未經損壞 之骨路之兔子頭骨之組織切片。頭骨之骨骼組織為品紅色 ’周圍之軟組織為白色’且骨膜層由黃色星號來突出顯示 。在圖11中,圖解說明在施以減壓組織治療6天並隨後立 即收穫組織之後之兔子頭骨。可以看到骨骼及骨膜,且已 形成一層肉芽組織。在圖12中,圖解說明在施以減壓組織 治療6天並隨後立即收穫組織之後之兔子頭骨。圖12中之 組織切片之特徵在於在肉芽組織下面形成新的骨骼組織。 '54474.doc -22· 1362951 該骨骼紐織係由黃色 afl Λ ιν ^ 琉术犬出顯不β在圖13中,圖解說 乂減壓組織治療6天並隨後立即收穫組織之後之兔 形成二Γ看到新的㈣及骨膜。藉由制組織治療而 形成之月骼組織之組織外觀 卜觀非吊類似於在正在經歷極快速 外觀。長及沉積之非常幼小之動物中骨骼形成之組織 更^體地參見圖14·19,其圖解說明數個照片及組織切 二恭^示對具有臨界尺寸缺損之兔子頭骨施行減壓組織 /σ 、之私序及結果。在圖丨4 ,^ ^ ^ ^ ^ ^ ^ 個臨界尺寸缺損之身…圓解說明上面已形成兩 寸缺相之兔子頭骨。該等全厚度臨界尺寸缺損之 直徑約為15麵。在圖15中,已在其中—個臨界尺寸缺損 上面放置-不義絲網,並在第二臨界尺寸缺損内放置一 ,支架。在圖16中,使用一類似於本文所述之減壓组 織轉裝置對該等臨界尺寸缺損施以減低之壓力。對每一 缺才貝施以之壓力大小為·125随Hg之表壓。該減低之壓力 係根據表丨中所列測試方案之—施加。在圖^,圖解說 明在施以6天之減壓組織治療並在手術十二週後收獲組織 之後之頭骨。所示切片包含磷酸鈣支架,其由紅色箭頭表 示。施以減壓組織治療會達成新骨骼組織之顯著生長,^ 圖17中,此由黃色星號突出顯示。骨骼生長量明顯大於在 包含相同磷酸鈣支架、但不以減壓組織治療加以治療之臨 界尺寸缺損中之骨骼生長量》該觀察結果表明, 、 』Sb存在 一為誘發新骨骼形成反應所需之治療臨限值或持續時門 減壓組織治療之效果在手術後12週所收集之樣太 ""不中最為明 154474.doc -23- 1362951 顯,此表明減壓組織治療引起一連串生物事件,從而增強 新骨骼組織之形成。 覆蓋有不錄鋼絲網(圖15)但在缺損申不放置支架材料之 臨界尺寸缺損用作動物内對照,其新骨骼生長微乎其微。 該等資料突出表明恰當之支架材料之優點以及減壓組織治 療對支架融合和生物效能之正面效果。在圖18及19中圖 解說明在六天之減壓組織治療之後經支架填充之臨界尺寸 缺損之射線照片。圖18圖解說明手術後兩週之缺損並顯示 在支架内沉積了一定之新骨骼。支架之主結構仍明顯可見 。圖19圖解說明手術十二週後之缺損,並顯示臨界尺寸缺 損幾乎完全癒合且因組織融合(即在支架基質内形成新骨 路)而使主支架架構接近完全消失。 參見圖20,一根據本發明一實施例之減壓輸送系統71】 對患者之組織部位713施行減壓組織治療。減壓輸送系統 711包括一歧管輸送管721。歧管輸送管721可係一導液管 或套管’並可包括使歧管輸送管72丨能夠被導引至組織部 位713之器件’例如一導向單元725及一導引金屬絲727。 可使用内窺鏡檢查、超音波、螢光屏檢查、聽診、觸診或 任何其他適宜之局部化技術來達成導引金屬絲727及歧管 輸送管721之放置及指引。提供歧管輸送管72丨來用於經過 皮膚將一減壓輸送裝置***患者之組織部位713 ^當經過 皮膚***時’歧管輸送管721較佳穿過一穿透患者皮膚組 織之無菌***護套插A。 在圖20中’組織部位713在毗鄰患者骨骼733上之骨折部 154474.doc -24- 1362951 位731處包含骨骼組織。歧管輸送管721插穿過患者之皮膚 735及環繞骨骼733之任何軟組織739。如前面所述,組織 部位713亦可包含任意類型之組織,包括但不限於脂肪組 織、肌肉組織、神經組織、皮膚組織、血管組織、結締組 織、軟骨、腱、或韌帶。 參見圖21及22,其進一步圖解說明減壓輸送系統711。 歧管輸送管721可包括一錐形遠端743,以易於插穿過患者 之皮膚735及軟組織739。錐形遠端743可進一步經構造以 徑向向外撓曲至一開口位置’從而使遠端743之内徑將 基本相同於或大於管721之其他部分之内徑。遠端743之開 口位置在圖21中由虛線737示意性地顯示。 歧官輸送管721進一步包括一通路751 ,在通路751中包 含一減壓輸送裝置761或任何其他減壓輸送裝置。減壓輸 运裝置761包含一撓性障壁765及/或蜂巢狀材料767,此類 似於參照圖6-8所述。撓性障壁765及/或蜂巢狀材料767較 佳捲繞、折疊或以其他方式圍繞減壓輸送管769壓縮以 減小減壓輸送裝置761在通路751内之截面積。 減壓輪送裝置761可放置於通路751内並在將歧管輪送管 721之遠端743放置於組織部位713處之後導引至組織部位 713。另一選擇為,可在將歧管輸送管721***患者體内之 月'J,將減壓輪送裝置761預先定位於通路751内。若要將減 壓輸送裝置761穿過通路75丨推動,可使用一生物相容性潤 滑劑來減小減壓輸送裝置761與歧管輸送管721間之摩擦。 當已將遠端743定位於組織部位713處並將減壓輸送裝置 154474.doc -25· 1362951 761輸送至遠端743之後,然後將減壓輸送裝置761朝遠端 743推動,從而使遠端743沿徑向向外膨脹至開口位置。將 減壓輸送裝置761推出歧管輸送管721,較佳推入毗鄰組織 部位713之空隙或空間内。該空隙或空間通常藉由切開軟 組織而形成,此可藉由經過皮膚之途徑來完成。在某些情 況下’組織部位7 13可位於傷口部位處,且因傷口解剖而 自然地存在一空隙。在其他情況下,該空隙可藉由充氣囊 分離、銳器分離、鈍器分離、水力分離、氣動分離、超音 波分綠、電路術分喊、雷射分離或任何其他適宜之分離技 術來形成。當減壓輸送裝置761進入毗鄰組織部位713之空 隙時’減壓輸送裝置761之撓性障壁765及/或蜂巢狀材料 767解除捲繞' 解除折疊或解除壓縮(參見圖22),從而使減 壓輸送裝置761可與組織部位713相接觸地放置。儘管並非 必需如此,然而可使撓性障壁765及/或蜂巢狀材料767承 受經由減壓輸送管769提供之真空或減低之壓力,以壓縮 撓性障壁765及/或蜂巢狀材料767 ^可藉由如下方式來達 成撓性障壁765及/或蜂巢狀材料767之解除折疊:釋放經 由減壓輸送管769輸送之減低之壓力,或者經由減壓輸送 管769提供正壓力,以幫助完成解除捲繞之過程。可使用 内窺鏡檢查、超音波、螢光屏檢查、聽診、觸診或任何其 他適宜之局部化技術來達成減壓輸送裝置761之最終放置 及操縱。在放置減壓輸送裝置761之後’較佳自患者體内 取出歧管輸送管72卜但與減壓輸送裝置761相關聯之減愿 輸送官仍保留於原位’以便能夠經過皮膚對組織部位 154474.doc •26· 1362951 施加減低之壓力。 參見圖23-25,根據本發明一實施例之減壓輸送系統811 包括一具有一錐形遠端843之歧管輸送管821,錐形遠端 843經構造以沿徑向向外撓曲至一開口位置,從而使遠端 843之内徑將基本相同於或者大於在管821之其他部分處之 内徑。遠端843之開口位置在圖23-25中由虛線837示意性 地顯示。 歧管輸送管821進一步包括一通路,在該通路中包含一 類似於本文所述其他減壓輸送裝置之減壓輸送裝置861。 減壓輸送裝置86 1包含一撓性障壁865及/或蜂巢狀材料867 ’撓性障壁865及/或蜂巢狀材料867較佳捲繞、折疊或以 其他方式圍繞減壓輸送管869壓縮,以減小減壓輸送裝置 861在通路内之截面積。 一具有一内表面873之不滲透性薄膜871圍繞減壓輸送裝 置861設置,以使減壓輸送裝置861含納於不滲透性薄膜 871之内表面873内》不滲透性薄膜871可係一充氣囊 '護 套、或能夠防止流體透過之任何其他類型之薄膜,以使不 滲透性薄膜871可採取壓縮位置(參見圖23)、鬆弛位置(參 見圖24)及膨脹位置(參見圖25及25 A)中之至少一個位置。 不滲透性薄膜87!可密封地連接至歧管輸送管821,從而使 不滲透性薄膜871之内部空間873與歧管輸送管821之通路 流體連通。另一選擇為,不滲透性薄膜871可固定至減壓 輸送管869上,從而使不滲透性薄膜871之内部空間873與 減壓輸送管869之通路流體連通。不渗透性薄膜871轉而;; 154474.doc -27- 1362951 固定至一與内部空間873流體連通之單獨控制管或控制管 腔上(例如參見圓25A)。 在一實施例中,可提供不滲透性薄膜871來進一步減小 減壓輸送裝置861在通路内之截面積,為此,對不滲透性 薄膜871之内部空間873施加一低於不滲透性薄膜87ι之周 圍裱境壓力之壓力。由此排出内部空間873内相當大的一The effect of the rabbit with size I defect and the effect of using a stent material with decompression tissue; A σ therapy for the treatment of critical dimensions on the skull. Dan, Office, Bl, and the number of rabbits are listed in Table 1 below. Test protocol 4 4 4 4 Membrane sound "', defect, in the intact bone-salt tissue treatment (RPTT) by honeycomb foam (GranuFoam) for 6 days, and immediately harvested the first two defects on the tissue; No decompression tissue treatment was applied (in the case of Ding Nai, the honeycomb foam (GranuFoam) was placed on the top of the membrane for 6 days, and immediately the harvested tissue had a critical size defect on which the stainless steel mesh was placed; The critical size defect of the phosphate stent was placed on it; the two defects were subjected to a 24-hour RPTT; the tissue was harvested 2 weeks after the surgery _ with a critical dimension defect on which the wire was placed; one placed on top of the calcium phosphate The critical size defect of the stent; 24 small _Τ?ΐ>Τ1^ for the two defects; harvested tissue after 12 weeks of surgery____ 21 - J54474.doc 1362951 4 has a criticality for placing stainless steel mesh on it Dimensional defect; a critical size defect in which the calcium phosphate scaffold was placed; 6 days of RPTT were applied to the two defects; harvested tissue 2 after 2 weeks of surgery had a criticality of placing stainless steel mesh on it Dimensional defect; a critical size defect in which the calcium phosphate scaffold was placed; 6 days of RPTT were applied to the two defects; harvested tissue 12 after 12 weeks of surgery had a critical dimension defect on which the stainless steel mesh was placed; one above Place the critical size defect of the calcium phosphate stent; do not apply RPTT (control); harvest tissue 4 after 2 weeks of surgery with a critical size defect on which the stainless steel mesh is placed; a critical size defect on which the calcium phosphate stent is placed; No RPTT (control); tissue harvested after 12 weeks of surgery 4 natural controls (no surgery; no RPTT) 4 sham surgery (no defect, no RPTT): harvested tissue 6 days after surgery : Test scenario Critical size defect A defect in a tissue (eg skull) that is large enough to be able to heal only by self-recovery. For rabbits, a diameter of approximately 15 mm is drilled through the skull. A full thickness hole will form a critical size defect of the skull. More specifically, see Figure 10, which illustrates a rabbit head with an original, undamaged bone path. The tissue section is sliced. The bone tissue of the skull is magenta 'The surrounding soft tissue is white' and the periosteal layer is highlighted by a yellow asterisk. In Figure 11, the illustration is given after treatment with decompressed tissue for 6 days and immediately after harvesting the tissue. Bunny skull. The bone and periosteum can be seen and a layer of granulation tissue has been formed. In Figure 12, the rabbit skull is treated after treatment with reduced-pressure tissue for 6 days and immediately after harvesting the tissue. It is characterized by the formation of new skeletal tissue under the granulation tissue. '54474.doc -22· 1362951 The skeletal woven fabric is shown by yellow afl Λ ιν ^ 琉 犬 在 在 在 在 在 在 在 在 在 在 在 在 在After treatment for 6 days and immediately after harvesting the tissue, the rabbits formed diterpene to see the new (four) and periosteum. The appearance of the tissue of the skeletal tissue formed by tissue treatment is similar to that of being experienced in a very fast appearance. The tissue formed by the bones in the very young and long-deposited animals is more closely seen in Figure 14.19, which illustrates several photographs and tissue cuts to demonstrate decompression tissue/σ on rabbit skulls with critical size defects. , private order and results. In Fig. 4, ^ ^ ^ ^ ^ ^ ^ ^ The body of the critical dimension defect... The circular solution shows that the rabbit skull with two inches of phase has been formed. These full thickness critical dimension defects have a diameter of approximately 15 faces. In Figure 15, a non-sense screen has been placed over one of the critical dimension defects and a stent is placed within the second critical dimension defect. In Figure 16, the reduced pressure is applied to the critical dimension defects using a reduced pressure tissue twisting device similar to that described herein. The pressure applied to each of the missing shells is 125 and the pressure of Hg. The reduced pressure is applied according to the test protocol listed in the Table. In Fig. 2, the skull is shown after 6 days of decompression tissue treatment and tissue harvesting after 12 weeks of surgery. The slice shown contains a calcium phosphate scaffold, which is indicated by a red arrow. Treatment with decompression tissue will result in significant growth of new bone tissue, ^ in Figure 17, highlighted by a yellow asterisk. The amount of bone growth is significantly greater than the amount of bone growth in critical size defects that are treated with the same calcium phosphate scaffold but not treated with decompressed tissue. This observation indicates that there is a need for Sb to induce a new bone formation reaction. The effect of treatment threshold or continuous time decompression tissue treatment is too high in the 12 weeks after surgery. The most obvious is 154474.doc -23- 1362951, which indicates that decompression tissue treatment causes a series of organisms. Events that enhance the formation of new bone tissue. The critical size defect covered with a non-recorded wire mesh (Fig. 15) but not placed in the defect was used as an intra-animal control, and the new bone growth was minimal. These data highlight the advantages of proper scaffold materials and the positive effects of decompressive tissue treatment on stent fusion and bioavailability. Radiographs of critical dimension defects filled with stents after six days of decompression tissue treatment are illustrated in Figures 18 and 19. Figure 18 illustrates a defect two weeks after surgery and shows that a certain new bone has been deposited in the stent. The main structure of the stent is still clearly visible. Figure 19 illustrates the defect after twelve weeks of surgery and shows that the critical dimension defect is almost completely healed and the main stent architecture is nearly completely lost due to tissue fusion (i.e., the formation of a new bone path within the stent matrix). Referring to Fig. 20, a reduced pressure delivery system 71 according to an embodiment of the present invention performs decompression tissue treatment on a tissue site 713 of a patient. The reduced pressure delivery system 711 includes a manifold delivery tube 721. The manifold delivery tube 721 can be a catheter or cannula' and can include a device that enables the manifold delivery tube 72 to be guided to the tissue portion 713, such as a guide unit 725 and a guide wire 727. The placement and guidance of the guide wire 727 and the manifold delivery tube 721 can be accomplished using endoscopy, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique. A manifold delivery tube 72 is provided for inserting a reduced pressure delivery device through the skin into the tissue site 713 of the patient. ^When inserted through the skin, the manifold delivery tube 721 preferably passes through a sterile insertion shield that penetrates the patient's skin tissue. Insert A. In Fig. 20, the tissue site 713 contains bone tissue at a fracture 154474.doc -24-1362951 position 731 adjacent to the patient's bone 733. The manifold delivery tube 721 is inserted through the skin 735 of the patient and any soft tissue 739 surrounding the bone 733. As mentioned previously, the tissue site 713 can also comprise any type of tissue including, but not limited to, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendon, or ligament. Referring to Figures 21 and 22, a reduced pressure delivery system 711 is further illustrated. The manifold delivery tube 721 can include a tapered distal end 743 for easy insertion through the patient's skin 735 and soft tissue 739. The tapered distal end 743 can be further configured to flex radially outwardly to an open position' such that the inner diameter of the distal end 743 will be substantially the same or greater than the inner diameter of other portions of the tube 721. The opening position of the distal end 743 is schematically shown by dashed line 737 in FIG. The manifold delivery tube 721 further includes a passageway 751 in which a reduced pressure delivery device 761 or any other reduced pressure delivery device is included. The reduced pressure transport device 761 includes a flexible barrier 765 and/or honeycomb material 767, as described with reference to Figures 6-8. The flexible barrier 765 and/or the honeycomb material 767 are preferably wound, folded or otherwise compressed around the reduced pressure delivery tube 769 to reduce the cross-sectional area of the reduced pressure delivery device 761 within the passageway 751. The reduced pressure delivery device 761 can be placed within the passageway 751 and directed to the tissue site 713 after the distal end 743 of the manifold wheel tube 721 is placed at the tissue site 713. Alternatively, the reduced pressure delivery device 761 can be pre-positioned in the passage 751 at a month 'J when the manifold delivery tube 721 is inserted into the patient. To push the pressure reducing delivery device 761 through the passage 75, a biocompatible lubricant can be used to reduce the friction between the reduced pressure delivery device 761 and the manifold delivery tube 721. When the distal end 743 has been positioned at the tissue site 713 and the reduced pressure delivery device 154474.doc -25·1362951 761 is delivered to the distal end 743, then the reduced pressure delivery device 761 is pushed toward the distal end 743, thereby enabling the distal end The 743 expands radially outward to the open position. The reduced pressure delivery device 761 is pushed out of the manifold delivery tube 721, preferably into a void or space adjacent the tissue site 713. This void or space is usually formed by incision of soft tissue, which can be accomplished by a route through the skin. In some cases the tissue site 713 can be located at the wound site and there is a natural void due to the anatomy of the wound. In other cases, the void may be formed by balloon separation, sharp separation, blunt separation, hydraulic separation, pneumatic separation, ultrasonic green separation, circuit shunting, laser separation, or any other suitable separation technique. When the reduced pressure delivery device 761 enters the gap adjacent the tissue site 713, the flexible barrier 765 of the reduced pressure delivery device 761 and/or the honeycomb material 767 is unwound to unfold or uncompress (see Figure 22), thereby reducing The pressure delivery device 761 can be placed in contact with the tissue site 713. Although not required, the flexible barrier 765 and/or the honeycomb material 767 can be subjected to a vacuum or reduced pressure provided via the reduced pressure delivery tube 769 to compress the flexible barrier 765 and/or the honeycomb material 767. The unfolding of the flexible barrier 765 and/or the honeycomb material 767 is achieved by releasing the reduced pressure delivered via the reduced pressure delivery tube 769 or providing a positive pressure via the reduced pressure delivery tube 769 to assist in the completion of the unwinding The process. The final placement and manipulation of the reduced pressure delivery device 761 can be accomplished using endoscopy, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique. After placing the reduced pressure delivery device 761, the manifold delivery tube 72 is preferably removed from the patient but the reduced delivery officer associated with the reduced pressure delivery device 761 remains in place to enable passage through the skin to tissue site 154474 .doc •26· 1362951 Apply pressure to reduce. Referring to Figures 23-25, a reduced pressure delivery system 811 in accordance with an embodiment of the present invention includes a manifold delivery tube 821 having a tapered distal end 843 that is configured to flex radially outwardly to An open position such that the inner diameter of the distal end 843 will be substantially the same or greater than the inner diameter at other portions of the tube 821. The position of the opening of the distal end 843 is shown schematically by dashed line 837 in Figures 23-25. Manifold delivery tube 821 further includes a passageway in which a reduced pressure delivery device 861 similar to other reduced pressure delivery devices described herein is included. The reduced pressure delivery device 86 1 includes a flexible barrier 865 and/or honeycomb material 867 'the flexible barrier 865 and/or the honeycomb material 867 is preferably wound, folded or otherwise compressed around the reduced pressure delivery tube 869 to The cross-sectional area of the reduced pressure delivery device 861 within the passage is reduced. An impervious film 871 having an inner surface 873 is disposed around the reduced pressure delivery device 861 such that the reduced pressure delivery device 861 is contained within the inner surface 873 of the impermeable membrane 871. The impervious membrane 871 can be inflated. The bladder 'sheath, or any other type of film that is capable of preventing fluid permeation, 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). At least one of the positions in A). The impermeable membrane 87! is sealingly coupled to the manifold delivery tube 821 such that the interior space 873 of the impermeable membrane 871 is in fluid communication with the passage of the manifold delivery tube 821. Alternatively, the impermeable membrane 871 can be secured to the reduced pressure delivery tube 869 such that the interior space 873 of the impermeable membrane 871 is in fluid communication with the passage of the reduced pressure delivery tube 869. The impermeable membrane 871 is rotated;; 154474.doc -27- 1362951 is attached to a separate control tube or control lumen in fluid communication with the interior space 873 (see, for example, circle 25A). In one embodiment, an impermeable membrane 871 can be provided to further reduce the cross-sectional area of the reduced pressure delivery device 861 within the passageway. For this purpose, a lower than impervious membrane is applied to the interior space 873 of the impermeable membrane 871. The pressure of the pressure around the environment. Thereby discharging a relatively large one in the internal space 873
。戸刀二氣或其他流體,從而將不滲透性薄膜871置於圖U 中所示之壓縮位置。在該壓縮位置上,不滲透性薄膜871. The squeegee or other fluid is placed to place the impermeable membrane 871 in the compressed position shown in Figure U. In this compressed position, the impermeable film 871
被向内吸引,從而對減壓輸送裝置861施加一壓力,以進 一步減小減壓輸送裝置861之截面積。如前面參照圖21及 22所述,可在將歧管輸送管821之遠端843佈置於組織部位 處之後將減壓輸送裝置861輸送至組織部位。可使用内窺 鏡檢查、超音波、螢光屏檢查、聽診、觸診或任何其他適 宜之局部化技術來達成不滲透性薄膜871及減壓輸送裝置 861之放置及操縱。不滲透性薄膜87ι可包含不透射線之標It is sucked inwardly to apply a pressure to the reduced pressure conveying device 861 to further reduce the sectional area of the reduced pressure conveying device 861. As previously described with reference to Figures 21 and 22, the reduced pressure delivery device 861 can be delivered to the tissue site after the distal end 843 of the manifold delivery tube 821 is disposed at the tissue site. Placement and manipulation of the impermeable membrane 871 and the reduced pressure delivery device 861 can be accomplished using endoscopic examination, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique. The impervious film 87ι may contain a radiopaque label
誌88卜此會改良不滲透性薄膜871在其移除之前在營光屏 檢查下之可視性。 在將減塵輸送裝置861推動穿過遠端843之後,可釋放施 加呈内部空間873之減低之壓力’以將不滲透性薄膜871置 於鬆弛位置上(參見圖24),藉以有利於更容易地自不渗透 性薄膜⑺中移出減|輸送裂㈣卜可提供—移出器具 885(例如套g、^針或其他尖銳^具)來弄破不滲透性薄膜 871。較佳地,移除器具⑻穿過減壓輸送管869***,並 能夠推進至接觸不滲隸薄膜871。在弄破^滲透性薄膜 154474.doc *28- 1362951 871之後,可經由歧管輸送管821抽出移出器具885及不滲 透性薄膜871 ’從而使減壓輸送裝置861之撓性障壁865及〆 或蜂巢狀材料867能夠解除捲繞、解除折疊或解除壓縮, 從而可使減壓輸送裝置861接觸組織部位放置。撓性障壁 . 865及/或蜂巢狀材料867之解除捲繞可在釋放内部空間873 . 中減低之壓力並移出不滲透性薄膜871之後自動地發生。 在某些情況下,可經由減壓輸送管869輸送正壓力來幫助 將撓性障壁865及/或蜂巢狀材料867解除捲繞或解除壓縮 。在最終放置減壓輸送裝置861之後,較佳自患者體内移 出歧管輸送管821 ’但與減壓輸送裝置861相關聯之減壓輸 送管869仍保留於原位,以便能夠經過皮膚對組織部位施 加減低之壓力。 . 不滲透性薄膜8 7 1亦可用於在將減壓輸送裝置8 6 1貼靠組 織郤位放置之剛分離她鄰組織部位之組織。在穿過歧管輸 送管821之遠端843推動減壓輸送裝置861及完好之不滲透 φ 性薄膜87 1之後,將空氣或另一種流體注入或泵送入不滲 透1生薄膜87丨之内部空間873内。較佳使用液體來使不滲透 性薄膜871膨脹,乃因液體之不可壓縮性使不渗透性薄膜 871此夠更均勻且更一致地膨脹。不滲透性薄膜87丨可如在 圖25中所示沿徑向膨脹’或者沿定向膨脹,此視其製造方 • 法及在歧管輸送管821上之固定彳式而定。當因空氣或流 .體之壓力而使不;f透性賴871向外膨脹至膨脹位置(參見 圖25)時,會毗鄰組織部位分離出一空隙。當該空隙足夠 大時,可釋放内部空間873中之空氣或其他流體,以使不 154474.doc •29- 1362951 滲透性薄膜871能夠採取鬆弛位置。然後,可如上文所解 釋來弄破不滲透性薄膜871,並毗鄰組織部位***減壓輪 送裝置861。 參見圖25Α,若不滲透性薄膜871主要用於分離毗鄰組織 部位處之組織,則不滲透性薄膜871可密封地固定至歧管 輪送管821上,從而使内部空間873與一關聯於或固定至歧 管輸送管821之辅助管腔或管891流體連通。辅助管腔891 可用於向内部空間873輸送液體、空氣或其他流體,以將 不滲透性薄膜871置於膨脹位置。在分離之後,可如前面 參照圖24所述使不滲透性薄膜871鬆弛並將其弄破。 參見圖26,根據本發明一實施例之減壓輸送系統91丨包 括一具有一錐形遠端943之歧管輸送管921,錐形遠端943 經構造以沿徑向向外撓曲至一開口位置,從而使遠端943之 内杈將基本相同於或者大於在管921之其他部分處之内徑。 遠鈿943之開口位置在圖26中由虛線937示意性地顯示。 歧管輸送管921進一步包括一通路,在該通路中包含一 類似於本文所述其他減壓輸送裝置之減壓輸送裝置961。 減壓輸送裝置961包含一撓性障壁965及/或蜂巢狀材料%? ,撓性障壁965及/或蜂巢狀材料967較佳捲繞、折疊或以 其他方式圍繞減壓輸送管969壓縮,以減小減壓輸送裝置 961在歧管輸送管921之通路内之戴面積。 一具有一内表面973之不滲透性薄膜971圍繞減壓輸送裝 置961設置,以使減壓輸送裝置96丨含納於不滲透性薄膜 之内表面973内》不滲透性薄膜971在不滲透性薄膜971 )54474.doc •30- 丄观951 -端上包含-膠封977,以提供—種自不參透性薄膜97i 上移出減壓輸送裝置961之#代方法。不_性薄"71可 密封地連接至歧管輸送管921,從而使不渗透性薄膜⑺之 内部空間973與歧管輸送管921之通路流體連通。另一選擇 為,不渗透性薄膜971可固定至一與内部空間973流體連通 之單獨控制管(未顯示)。 处類似於圖23中之不滲透性薄膜871,不滲透性薄膜971可This will improve the visibility of the impermeable film 871 under the camp screen inspection before it is removed. After pushing the dust-reducing conveyor 861 through the distal end 843, the reduced pressure applied to the interior space 873 can be released to place the impermeable membrane 871 in a relaxed position (see Figure 24), thereby facilitating easier Removal from the impermeable film (7) minus the delivery crack (4) may provide - removing the device 885 (eg, a set of g, ^ needles or other sharp tools) to break the impermeable film 871. Preferably, the removal device (8) is inserted through the reduced pressure delivery tube 869 and is capable of being advanced to contact the non-permeable membrane 871. After the permeable membrane 154474.doc *28-1362951 871 is broken, the removal device 885 and the impermeable film 871' can be withdrawn via the manifold delivery tube 821 to thereby make the flexible barrier 865 and/or the pressure-reducing device 861 The honeycomb material 867 can be unwound, unfolded, or decompressed, so that the reduced pressure delivery device 861 can be placed in contact with the tissue site. The unwinding of the flexible barrier 865 and/or the honeycomb material 867 can occur automatically after the reduced pressure is released and the impermeable film 871 is removed. In some cases, positive pressure may be delivered via the reduced pressure delivery tube 869 to help unwind or uncompress the flexible barrier 865 and/or the honeycomb material 867. After the final placement of the reduced pressure delivery device 861, the manifold delivery tube 821' is preferably removed from the patient's body but the reduced pressure delivery tube 869 associated with the reduced pressure delivery device 861 remains in place so as to be able to pass through the skin to the tissue Apply a reduced pressure to the area. The impervious film 871 can also be used for tissue that has just been placed in the tissue of the adjacent tissue where the reduced pressure delivery device 861 is placed against the tissue. After pushing the pressure reducing conveying device 861 and the intact impervious film 87 1 through the distal end 843 of the manifold conveying pipe 821, air or another fluid is injected or pumped into the interior of the impervious film 87 Within space 873. It is preferred to use a liquid to swell the impermeable film 871 because the incompressibility of the liquid causes the impervious film 871 to expand more uniformly and more uniformly. The impervious film 87 can be expanded radially or in an orientation as shown in Figure 25, depending on the method of manufacture and the fixed configuration on the manifold tube 821. When the pressure is due to the pressure of air or fluid, the permeable 871 expands outward to the expanded position (see Figure 25), and a gap is separated from the tissue site. When the void is large enough, the air or other fluid in the interior space 873 can be released so that the permeable membrane 871 can take a relaxed position. Then, the impervious film 871 can be broken as explained above, and the decompression transfer device 861 can be inserted adjacent to the tissue site. Referring to Figure 25A, if the impermeable membrane 871 is primarily used to separate tissue adjacent to the tissue site, the impermeable membrane 871 can be sealingly secured to the manifold transfer tube 821, thereby associating the interior space 873 with one or The auxiliary lumen or tube 891 secured to the manifold delivery tube 821 is in fluid communication. The auxiliary lumen 891 can be used to deliver liquid, air or other fluid to the interior space 873 to place the impermeable membrane 871 in the expanded position. After the separation, the impermeable film 871 can be relaxed and broken as described above with reference to Fig. 24. Referring to Figure 26, a reduced pressure delivery system 91A in accordance with an embodiment of the present invention includes a manifold delivery tube 921 having a tapered distal end 943 that is configured to flex radially outwardly to a The open position is such that the inner bore of the distal end 943 will be substantially the same or larger than the inner diameter at other portions of the tube 921. The opening position of the eye 943 is schematically shown by a broken line 937 in FIG. Manifold delivery tube 921 further includes a passageway in which a reduced pressure delivery device 961 similar to other reduced pressure delivery devices described herein is included. The reduced pressure delivery device 961 includes a flexible barrier 965 and/or a honeycomb material %?, and the flexible barrier 965 and/or the honeycomb material 967 is preferably wound, folded or otherwise compressed around the reduced pressure delivery tube 969 to The wearing area of the reduced pressure conveying device 961 in the passage of the manifold conveying pipe 921 is reduced. An impervious film 971 having an inner surface 973 is disposed around the reduced pressure delivery device 961 such that the reduced pressure delivery device 96 is contained within the inner surface 973 of the impermeable membrane. Impervious film 971 is impervious. Film 971) 54474.doc • 30- 丄 951 - The end contains a glue seal 977 to provide a # generation method for removing the reduced pressure delivery device 961 from the non-permeable film 97i. The non-sex thin "71 is sealingly coupled to the manifold delivery tube 921 such that the interior space 973 of the impermeable membrane (7) is in fluid communication with the passage of the manifold delivery tube 921. Alternatively, the impermeable membrane 971 can be secured to a separate control tube (not shown) in fluid communication with the interior space 973. Similar to the impervious film 871 in FIG. 23, the impervious film 971 can be
能夠防止流體料’以使轉透㈣膜971可採取壓縮位 置、鬆他位置及膨脹位置中之至少—個位置。由於用於將 不滲透性薄膜971放置於壓縮位置及膨脹位置上之程序類 似於不滲透性薄膜871,因而僅對移出減壓輸送裝置“丨之 過程加以說明。The fluid material can be prevented such that the transmissive (four) film 971 can take at least one of a compression position, a loose position and an expanded position. Since the procedure for placing the impermeable film 971 on the compressed position and the expanded position is similar to the impermeable film 871, only the process of removing the decompression conveying device "" will be described.
使用内窺鏡檢查、超音波、螢光屏檢查、聽診、觸診或 任何其他適宜之局部化技術將減壓輸送裝置961輸送至不 滲透性薄膜971内之組織部位上並隨後將其正確地定位。 不滲透性薄膜971可包含不透射線之標誌981,此會改良不 滲透性薄膜971在其移除之前在螢光屏檢查下之可視性。 然後將減壓輸送裝置961穿過歧管輸送管92 1之遠端943加 以推動。可釋放施加至内部空間973之減低之壓力,以將 不滲透性薄膜971置於鬆弛位置上。然後,將減壓輸送裝 置961穿過膠封977推動’以推出不滲透性薄膜971。 參見圖26A,一根據本發b月一實施例之減壓輸送系統985 可不包括類似於圖26所示歧管輸送管921之歧管輸送管。 而是’減壓輸送系統985可包括一導引金屬絲987、一減壓 154474.doc 31 - 1362951 輸送管989、及一減壓輸送裝置991。減壓輸送裝置991包 含複數個流體連接至減壓輸送管989之流動通道。並非使 用一獨立之歧管輸送管來輸送減壓輸送裝置991,而是將 減壓輸送裝置991及減壓輸送管989置於導引金屬絲987上 ,經過皮膚將導引金屬絲987導引至一組織部位993上。較 佳地’導引金屬絲987及減壓輸送管989藉由一無菌護套穿 透患者之皮膚。藉由沿導引金屬絲987導引減壓輸送管989 及減壓輸送裝置991,可將減壓輸送裝置991置於組織部位 993處,以達成經過皮膚來施以減壓組織治療。 由於減壓輸送裝置991在輸送至組織部位993期間並不約 束於一歧管輸送管中,因而較佳在輸送期間使減壓輸送裝 置991保持處於壓縮位置。若使用一彈性發泡體作為減壓 輸送裝置991 ’可對該發泡體塗覆一種生物相容性可溶解 黏合劑並壓縮該發泡體。在到達該組織部位之後,體液或 經由減壓輸送管989輸送之其他流體會溶解該黏合劑,從 而使该發泡體膨腸而接觸組織部位。另一選擇為,可自一 種壓縮之幹態水凝膠製成減壓輸送裝置991。該水凝膠在 輸送至組織部位993之後吸收水份,從而能夠使減壓輸送 裝置991膨脹。再一種減壓輸送裝置991可自熱活性材料( 例如聚乙二醇)製成,該熱活性材料在受到患者體溫之作 用時會膨服。在再-實施例中,可在__可溶解薄膜中將經 壓縮之減壓輸送裝置991輸送至組織部位993。 參見圖27,一根據本發明—實施例之減壓輸送系統1011 包括一具有一遠端1043之歧管輸送管1021,遠端1043插穿 154474.doc -32- 1362951 過患者之一組織而接觸到組織部位1〇25。組織部位1〇25可 包含一與傷口或其他缺損相關聯之空隙1〇29,或者另一選 擇為,可藉由分離(包括本文所述之分離技術)來形成一空 隙。 . 在將遠端丨043毗鄰組織部位1025放置於空隙1029内之後 . ,經由歧管輪送管1〇2丨將一可注射、可傾倒或可流動之減 壓輸送裝置1035輸送至組織部位1〇25處。減壓輸送裝置 1035在輸送至組織部位期間較佳以一可流動狀態存在,且 然後在到達之後,形成複數個流動通道以便分佈減低之壓 力或流體。在某些情形中,該可流動材料在到達組織部位 處之後可藉由一乾燥過程、固化過程或其他化學或物理反 應而硬化成固體狀態。在其他情形中,該可流動材料在輸 送至組織部位之後可在原位形成發泡體。還有其他材料可 以凝膠狀狀態存在於組織部位1〇25處,但仍具有複數個用 於輸送減低之壓力之流動通道。輸送至組織部位1〇25處之 φ 減壓輸送裝置1035之量可足以部分地或完全填充空隙1029 。減壓輸送裝置1035可包含歧管與支架二者之態樣。作為 歧管,減壓輸送裝置1〇35包含複數個孔或開放孔,該複數 個孔或開放礼可在輸送至空隙1〇29之後形成於材料中。該 等孔或開放礼相互連通,由此形成複數個流動通道。該等 流動通道用於對組織部位1025應用及分佈減低之壓力。作 為支架,減壓輸送裝置1〇35係生物可再吸收性的並用作可 在上面生長新組織之基材。 在一實施例中,減壓輸送裝置1035可包含分佈於整個液 154474.doc -33- 1362951 體或黏性凝夥中之poragen,例如NaCl或其他鹽。在將該 液體或黏性凝膠輸送至組織部位1025之後,該材料貼覆至 空隙1029上並隨後固化成一實體。水溶性NaCl P〇ragen在 存在體液之情況下溶解’從而留下一具有互連之孔或流動 通道之結構。對該等流動通道輸送減低之壓力及/或流體 。隨著新組織之形成,組織會長入減壓輸送裝置1〇35之孔 内,並隨後最終隨著減壓輸送裝置1035之降解而取代減壓 輸送裝置1035。在該特定實例中’減壓輸送裝置IQ〗〗不僅 用作歧管,而且還用作新組織生長支架。 在另一實施例中’減壓輸送裝置1035係一與400 μιη甘露 糖顆粒相混合之藻酸鹽。該等P〇ragen或顆粒可在組織部 位處被局部體液或被沖洗流體或輸送至減壓輸送裝置i 03 5 之其他流體溶解。在溶解poragen或顆粒之後,先前由該 等poragen或顆粒佔據之空間變成空隙,該等空隙彼此互 連,以在減壓輸送裝置1035内形成流動通道。 在材料中使用poragen來形成流動通道係有效的,但其 亦會形成尺寸僅限於大約所選poragen之粒經之孔及流動 通道。可使用化學反應取代poragen藉由形成氣態副產物 而形成更大之孔。舉例而言’在一實施例中,可將一包含 碳酸氫鈉及檸檬酸微粒(可使用非化學計量)之可流動材料 輸送至組織部位1025。當該可流動材料在原位形成一發泡 體或固體時’體液將會引起碳酸氫鈉與檸檬酸間之酸-鹼 反應。與依靠poragen溶解之技術相比,所形成之二氧化 被氣體微粒會在整個減壓輸送裝置1035中形成更大之孔及 154474.doc -34· 1362951 流動通道。 減壓輸送裝置1035自液體或黏性凝膠向固體或發泡體之 轉變可藉由ΡΗ值、溫度、光、或與體液、化學品或輸送至 組織部位之其他物質之反應來觸發。亦可藉由混合多種反 . 應性組份來進行此種轉變。在一實施例中,藉由選擇由生 • 物可再吸收性聚合物製成之生物可再吸收性微球體來製備 減壓輸送裝置1035。該等微球體分散於一含有光起始劑及 水凝膠形成材料(例如透明質酸、膠原或聚乙二醇)之溶液 ® 中。使微球體-凝膠混合物暴露於光中一短暫之時間段, 以使水凝膠局部地交聯並使水凝膠固定於微球體上。排出 多餘之溶液,並隨後對微球體進行乾燥。藉由注射或傾倒 ' ,將該等微球體輸送至組織部位處,且在輸送之後,該混 - 合物會吸收水份’且水凝膠塗層變成水合塗層。然後,再 次將該混合物暴露於光中,由此使該等微球體交聯,從而 形成複數個流動通道。該等交聯之微球體然後用作一用於 • 向組織部位輸送減低之壓力之歧管及一用於促進新組織生 長之多孔支架。 除本文中之前述各實施例外,減壓輸送裝置1〇35可自各 種各樣之材料製成,包括但不限於磷酸飼、耀原、藻酸鹽 纖,准素或任何其他能夠以氣體、液體、凝膝、膏糊、 • Α灰H懸浮液或其他可流動材料形式輸送至組織部 並能夠形成與組織部位流體連通之多個流動路徑之等效 材料。該可流動材料可進一步包括固體微粒,例如顆粒, 若該等固體微粒之粒徑足夠小,則其能夠經由歧管輸 Ϊ 54474.doc -35· 1362951 1021 〃IL動。以可流動狀態輸送至組織部位之材料可在原位 聚合或形成凝膠。 如前面所述,可將減壓輸送裝置1〇35直接注射或傾倒至 毗鄰組織部位1025之空隙1029内。參見圖27A,歧管輸送 S 1021可在歧官輸送管1021之遠端1043處包含不滲透性或 半滲透性薄膜1〇51,薄膜1〇51包含一内部空間1〇55,内部 工間1055與一固定至歧管輸送管1〇21之辅助管腔流體 連通。歧管輸送管1021係於一導引金屬絲1〇61上導引至組 織部位1025處。 減壓輸送裝置1〇35可經由輔助管腔1057來注射或傾倒, 以填充薄膜1051之内部空間1055。當流體或凝膠填充薄膜 1051時’薄膜1〇51膨脹以填充空隙1〇29 ’從而使薄膜接觸 組織部位1025。當薄膜1〇51膨脹時,薄膜1〇51可用於分離 她鄰或罪近組織部位丨〇25之額外組織。若薄膜丨〇5丨係不滲 透丨生薄膜,則可藉由物理方式弄破並移除之,從而使減壓 輸送裝置1035接觸組織部位1〇25。另一選擇為,薄膜1〇51 可自一種在存在體液或輸送至薄膜1051之生物相容性溶劑 時會溶解之可溶解材料製成。若薄膜丨05丨係半滲透性,則 薄膜1051可保留於原位。半滲透性薄膜丨〇5丨能夠向組織部 位1025傳送減低之壓力及可能其他流體。 參見圖28,一種施行減壓組織治療之方法丨丨丨丨包括在 1115處藉由外科手術在毗鄰組織部位處***一歧管,該歧 管具有自一撓性障壁伸出之複數個突起物,以在該等突起 物之間形成複數個流動通道。在1119處對該歧管進行定位 154474.doc •36- 叫951 ’使該等突起物中之至少一部分接觸該組織部位。在ιΐ23 處,經由該歧管對組織部位施加減低之壓力。 ,見圖29 ,—種對一組織部位施行減壓組織治療之方法 U11包括在1215處經過皮膚毗鄰該組織部位***一歧管。 可包含自一撓性障壁伸出之複數個突起物,以在該 ^突起物之間形成複數個流動通道。另一選擇為,該歧管 I包含蜂巢狀材料,在該蜂巢狀材料内具有複數個流動通 另L擇為,5亥歧管可由可注射或可傾倒之材料形成 :可/主射或可傾倒之材料輸送至該組織部位並在到達該 、·且織部位之後形成複數個流動通道。在1219處,對該歧管 進仃疋位,使該等流動通道之至少一部分與該組織部位流 體連通。在1223處,經由該歧管對組織部位施加減低之壓 力。 參見圖30,一種對組織部位施行減壓組織治療之方法 U11包括在1315處經過皮膚穿過患者之一組織***一具有 ' 之官以使5亥管之达端》Λ鄰該組織部位放置。在13 1 9 處,可使一與該管相關聯之充氣囊膨脹,以分離毗鄰該組 織部位之組織’藉以形成一空隙。在1323處,穿過該通道 輸送—歧管。該歧管可包含自一撓性障壁伸出之複數個突 起物,以在該等突起物之間形成複數個流動通道。另一選 擇為該歧管彳包含蜂巢狀材料,在該蜂巢狀材料内具有 複數個流動通道。另-選擇為,該歧f可如上文參照圖27 所述由輸送至該組織部位之可注射或可傾倒材料形成。在 1327處,對該歧官進行定位,使該等流動通道之至少一部 154474.doc -37· ^362951 分與該組織部位流體連通。在1331處,經由一減壓輸送管 或任何其他輸送途徑藉由該歧管對該組織部位應用減低之 壓力。 參見圖3 1,一種對组織部位施行減壓組織治療之方法 14丨1包括在1415處經過皮膚穿過患者之一組織***一具有 通路之管,以使該管之遠端毗鄰該組織部位放置。在1423 處’在一不滲透性護套内經由該通路將一歧管輸送至該組 織部位處,該不滲透性護套在丨41 9處已經受一小於護套環 境壓力之第一減低之壓力。在1427處,將該護套弄破,以 使該歧管接觸該組織部位。在丨43 1處,經由該歧管對該組 織部位施加一第二減低之壓力p 參見圖32及33,一根據本發明一實施例之減壓輸送裝置 1 5 11包括一用於替換患者腿節丨5丨7之現有股骨頭之整形外 科競假體1515。髖假體1515包括一柱部分1521及一頭部分 1525。柱部分1521細長,以便***於—在腿節1517之骨幹 中鉸出之通路1529内。一多孔塗層1 535設置於該柱部分周 圍並較佳由燒結或玻璃化之陶瓷或金屬構造而成。另一選 擇為’可圍繞該柱部分設置一具有多孔特性之蜂巢狀材料 。複數個流動通道1541設置於髖假體丨5 1 5之柱部分1 52 1内 ’以使流動通道1541與多孔塗層1535流體連通。一連接埠 1545流體連接至流動通道1541,該埠構造成可釋脫地連接 至一減壓輸送管1551及一減壓輸送源1553。流動通道1541 用於在植入髖假體1515之後向環繞髖假體1515之多孔塗層 1535及/或骨骼輸送減低之壓力。流動通道1541可包含一 154474.doc • 38· 與數個橫向分支管線1547流體連通之主饋送管線1543,該 數個橫向分支管線1547與多孔塗層1535相連通。橫向分支 管線1545可如在圖32中所示垂直於主饋送管線1543定向, 或者可與主饋送管線1543成某些夾角定向。一種用於分佈 減低之壓力之替代方法包括:提供_中空之競假體,並以 一種能夠與多孔塗層1535流體連通之蜂巢狀(較佳係開放 孔)材料來填充該假體之内部空間。 更具體地參見圖33,髖假體1515可進_步在柱部分1521 内包括第二複數個流動通道1561,以對環繞髖假體丨515之 夕孔塗層1535及/或骨骼提供流體。該流體可包括經過濾 之空氣或其他氣體、抗菌劑、抗病毒劑、細胞生長促進劑 、沖洗流體、化學活性流體或任何其他流體。若期望將多 種流體引入至環繞髖假體1515之骨骼,可提供額外之流體 連通路徑。一連接埠1565流體連接至流動通道丨56丨,該埠 1565構造成可釋脫地連接至一流體輸送管1571及一流體輪 送源1573。流動通道1561可包含一與數個橫向分支管線 1585流體連通之主饋送管線1583,該數個橫向分支管線 15 85與多孔塗層153 5相連通。橫向分支管線1585可如在圖 33中所示垂直於主饋送管線1583定向,或者可與主饋送管 線15 83成某些夾角定向。 減低之壓力向第一複數個流動通道15 41之輸送及流體向 第二複數個流動通道1561之輸送可藉由單獨之管(例如減 壓輸送管1551及流體輸送管1571)來完成。另一選擇為, 可使用一如本文中前面所述具有多個管腔之管來分離用於 ]54474.doc •39- 輸送減低之壓力與流體之連通路徑◦應進一步注意,儘管 較佳在髖假體1515内提供分離之流體連通路徑,然而亦可 使用第一複數個流動通道1541將減低之壓力與流體二者輸 送至環繞髖假體15 15之骨骼。 如前面所述,對骨骼組織應用減低之壓力會促進及加速 新骨骼組織之生長。藉由使用髖假體1 5 1 5作為歧管將減低 之壓力輸送至環繞體假體之骨路區域,會使腿節1517之恢 復更快’且髖假體1 5 15會更成功地與骨路結合於一起❶提 供第二複數個流動通道1561來排放環繞髖假體1515之骨骼 會改良環繞假體之新骨骼之成功再生。 在經由競假體1 5 1 5應用減低之壓力達一所選之時間量之 後,可將減壓輸送管1551及流體輸送管1571自連接埠1545 、1 565斷開並自患者體中移出—較佳不使用外科手術侵害 性程序。連接埠1545、1565與管1551、1571間之連接可係 可用手釋脫之連接’此可藉由在患者身體外側對管1551 、1571施加一轴向拉力來實施。另一選擇為,連接埠1545 、1565可在存在所選流體或化學品之條件下為生物可再吸 收性或可溶解的’以便可藉由使連接埠1545、1565暴露於 流體或化學品中而達成管1551、1571之釋脫。管1551、 1571亦可由一種會在一段時間内溶解之生物可再吸收性材 料或一種在存在特定化學品或其他物質條件下會溶解之活 化材料製成。 減壓輸送源1553可在患者體外提供並連接至減壓輸送管 155丨’以將減低之壓力輸送至髖假體1515。另一選擇為, 154474.doc •40· 1362951 可將減壓輸送源1553植入患者體内、髖假體15 15上或附近 。將減壓輸送源1553放置於患者體内便無需使用經過皮膚 之流體連接。所植入之減壓輸送源1553可係以可操作方式 連接至流動通道1541之傳統幫浦》該幫浦可由植入於患者 體内之電池供電’或者可由經過皮膚電連接至該幫浦之外 部電池供電。該幫浦亦可由一經由流動通道1 541、1561輸 送減低之壓力及使流體循環經過流動通道1541、1561之化 學反應來直接驅動。 儘管在圖32及33中僅圖解說明髖假體ι515之柱部分1521 及頭部分1 525,然而應注意,本文所述之流動通道及用於 應用減壓組織治療之構件亦可應用於髖假體1515中任何接 觸骨絡或其他組織之組件,包括例如臼杯。 參見圖34,一種用於修復患者關節之方法161丨包括在 1 615處毗鄰該關節在骨骼内植入一假體。該假體可係如上 文所述之髖假體或任何其他有助於恢復患者關節活動性之 假體。該假體包括複數個經構造以與骨骼流體連通之流動 通道。在1619處,經由該複數個流動通道對骨骼應用減低 之壓力,以改良假體之〇se〇integrati〇n。 參見圖35及36,一種根據本發明一實施例之減壓輸送裝 置1711包括一整形外科固定器件1715,以用於緊固患者的 包含骨折部位1719或其他缺損之骨骼1717。圖”及刊中所 示之整形外科固定器件1715係一具有複數個通路1721之板 ,該複數個通路1721用於使用螺釘1725、銷、螺栓或其他 緊固件將整形外科固定器件1715錨固至骨骼1717上。可在 154474.doc -41 · 1362951 整形外科固定器件1715之接觸骨骼ι71 7之表面上設置一多 孔塗層1735。該多孔塗層較佳由燒結或玻璃化陶瓷或金屬 構造而成。另一選擇為,可在骨骼1717與整形外科固定器 件1715之間設置一具有多孔特性之蜂巢狀材料。複數個流 動通道1741設置於整形外科固定器件1715内,以使流動通 道1741與多孔塗層Π35流體連通。一連接埠1745流體連接 至流動通道1741,該埠構造成連接至—減壓輸送管1751及 一減壓輸送源1753 ^流動通道1741用於在將整形外科固定 器件1715固定至骨骼1717之後向多孔塗層1735及/或環繞 整形外科S)定器件1715之骨路輸送減低之壓力。流動通道 1741可包含一與數個橫向分支管線1747流體連通之主饋送 管線m3’該數個橫向分支管線1747與多孔塗層1735相連 通。橫向分支管線m7可如在圖35中所示垂直於主饋送管 線1743定向’或者可與主饋送管線1743成某些夾角定向。 一種用於分佈減低之壓力之替代方法包括:提供一令办之 整形外科固;t器件,並以-種能夠與多孔塗層1735流二連 通之蜂巢狀(較佳係開放孔)材料來填充該整形外科固定器 件之内部空間。 ° 整形外科固定器件1715可如在圖35中所示係—板,或者 另一選擇為’可係一固定器件,例如套管、橋形器'支柱 、練何其他發使㈣之—部分敎U件。整形外科 固定器件m5可進-步係用於固定假體或其他整形外科器 件或所植人組織(例如骨路组織或軟骨)之緊固#,盆限制 條件為該等緊ϋ件包含用於“鄰或環繞該等緊固件之组 154474.doc •42· 織輪送減低之塵力之流動通道。該等緊固件之實例可包括 銷、螺栓、螺釘或任何其他適宜之緊固件。 更具體地參見圖36,整形外科固定器件1715可進一步在 -形外科固定器件1715内包括第二複數個流動通道ΐ76ι, ί衣’VO整形外科固定器件1715之多孔塗層及/或骨 路提供*體。该流體可包括經過滤之空氣或其他氣體、抗 菌幻抗病毒劑、細胞生長促進劑'沖洗流體、化學活性 m或任何其U。若期望將多種流體引人至環繞體假體 之月黙"令,可提供額外之流體連通路徑。一連接埠 1765机體連接至流動通道1761,該埠丨765構造成連接至一 流體輸送管177!及-流體輸送源1773。流動通道骑可包 含一與數個橫向分支管線1785流體連通之主饋送管線1783 。玄數個検向分支管線1785與多孔塗層丨735相連通。橫向 分支營線1785可如在圖33中所示垂直於主饋送管線1783定 向,或者可與主饋送管線1783成某些夾角定向。 減低之壓力向第一複數個流動通道丨74丨之輸送及流體向 第一複數個流動通道1761之輪送可藉由單獨之管(例如減 壓輸送管1751及流體輸送管1771)來完成。另一選擇為, 可使用一如本文中前面所述具有多個管腔之管來分離用於 輸送減低之壓力與流體之連通路徑。應進一步注意,儘管 較佳在髖假體171 5内提供分離之流體連通路徑,然而亦可 使用第一複數個流動通道1741將減低之壓力與流體二者輸 送至毗鄰整形外科固定器件1715之骨骼。 使用整形外科固定器件1715作為歧管來向毗鄰整形外科 154474.doc •43· 1362951 固定器件1715之骨骼區域輸送減低之壓力會加快並改善骨 骼1717之缺損1719之恢復。提供第二複數個流動通道1761 將流體傳送至環繞整形外科固定器件丨715之骨骼會改良整 形外科固定器件附近之新骨骼之成功再生。 參見圖37’ 一種用於治癒骨骼之骨骼缺損之方法1811包 括在1815處使用一整形外科固定器件來固定該骨路。該整 形外科固定器件包含設置於該整形外科固定器件内之複數 個流動通道。在1 819處’經由該複數個流動通道對骨骼缺 損應用減低之壓力。 參見圖3 8 ’ 一種用於對一組織部位施行減壓組織治療之 方法1911包括:在1915處對一具有複數個流動通道之歧管 進行定位’以使該等流動通道之至少一部分與該組織部位 流體連通。在1919處,經由該等流動通道對該組織部位應 用減低之壓力,並在1923處,經由該等流動通道向該組織 部位輸送一流體。 參見圖3 9,一種用於對一組織部位施行減壓組織治療之 方法2011包括:在2015處將一歧管輸送管之遠端毗鄰該組 織部位進行定位。在2019處,經由該歧管輸送管向該組織 部位輸送一流體。該流體能夠填充批鄰該組織部位之空隙 並變成一具有複數個與該組織部位流體連通之流動通道之 固態歧管。在2023處,經由該固態歧管之流動通道對該組 織部位應用減低之壓力。 參見圖40-48,一減壓輸送系統2111包括一主歧管2115 ’主歧管2115具有一環繞一主流動通路2121之挽性壁2117 154474.doc -44 - 1362951 。撓性壁2117在一近端2123處連接至一減壓輸送管2125。 由於減壓輸送管2125之形狀通常將為圓形截面,且由於主 歧管2115之戴面形狀可不同於圓形(即在圖4〇_45中為矩形 ,而在圖46-48中為三角形),因而在減壓輸送管2125與主 歧管2115之間提供一過渡區2129。主歧管2115可藉由膠黏 方式連接至減壓輸送管2125、使用例如融合或嵌件模壓等 其他途徑進行連接、或者另一選擇為可藉由共擠出而整體 相連。減壓輸送管2125將減低之壓力輸送至主歧管2115, 以供分佈於組織部位處或附近。 一防阻塞部件2135定位於該主歧管内,以防止在應用減 低之壓力期間主歧管2115塌縮並由此阻塞主流動通路2121 。在一實施例中,防阻塞部件2135可係複數個突起物 2137(參見圖44),該複數個突起物2137設置於撓性壁2117 之一内表面2141上並延伸入主流動通路2121内。在另一實 施例中’防阻塞部件2135可係設置於内表面2141上之單個 或多個脊2145(參見圖40及41)。在又一實施例中,防阻塞 部件2135可包含設置於主流動通路内之蜂巢狀材料2149, 例如在圖47令所示者。防阻塞部件2135可係任何能夠丧於 流動通路内或者能夠成一體地或以其他方式固定至撓性壁 2117上之材料或結構。防阻塞部件2135能夠防止撓性壁2117 完全塌縮,而仍使流體能夠經由主流動通路2121流動。 撓性壁2117進一步包括複數個穿透撓性壁2117之孔2155 ’該等孔2155與主流動通路2121相連通。孔2155使輸送至 主流動通路2121之減低之壓力能夠分佈至該組織部位處。 154474.doc • 45· 1362951 孔2155可選擇性地圍繞歧管2115之圓周定位,以優先引導 真空之輸送。舉例而言,在圖51中,可使孔面對骨骼、面 對覆蓋組織或同時面對二者佈置。 減壓輪送管2125較佳包括一具有至少一個出口之第一導 B 1該至少一個出口流體連接至主流動通路2121 ,以 向主流動通路2121輸送減低之壓力。亦可提供—第二導管 2163來以一種流體清洗主流動通路2121及第一導管2161, 以防止或溶解因傷口分泌物及自組織部位吸出之其他流體 所造成之阻塞。第二導管2163較佳包括至少一個緊靠主流 動通路2121與第一導管2161之該至少一個出口中之至少一 者定位之出口。 更具體地參見圖40及41,在減壓輸送系統2111中,第二 導管2163可包括用於沖洗主流動通路2121及第一導管2161 之多個導管。儘管撓性壁2117中與固定至減壓輸送管2125 之端部相對之端部可如在圖40中所示為開口的,然而已發 現覆蓋撓性壁211 7之端部可改良清洗功能之效能及可靠 性。較佳地,在撓性壁之被覆蓋端部與第二導管2163之端 部之間提供一頂隙2171。頂隙2171能夠在清洗製程期間達 成清洗流體之積聚,此有助於驅動沖洗流體經過主流動通 路2121流入第一導管2161内。 在圖41中亦圖解說明用作防阻塞部件2135之間隔件。居 中定位之間隔件使主流動通路2121分又進入兩個室内,此 使主歧管2115在其中一個室被阻塞且藉由清洗無法溶解該 阻塞時仍能夠繼續運作。 154474.doc •46· 1362951 爹圯圆49及50,一減壓輪这备姑〇 勒达系統22 11包括—與減壓輸送 = 2217成-體之主歧管2215。減壓輸送管2217包括一中央 官= 2223及複數個輔助管腔2225。儘管辅助管腔2225可用 於量測組織部位處或附近之壓力,然而輔助管腔Mb可進 一步用於清洗中央管腔2223,㈣止或溶解阻塞物。複數 個孔2231與$央管腔2223相連通,以分佈由中央管腔加 所輸送之減低之廢力。如在圖5〇中所示,較佳使孔2231不 貫穿輔助管腔2225。在圖50中亦圖解說明減壓輪送管之埋 頭孔端,其在輔助管腔2225之端部以外形成一頂隙^“。 假若在應用減低之壓力期間使組織、支架或其他材料嚙合 減壓輸送管2217之端部,頂隙2241將會繼續允許向中央管 腔2223輸送清洗流體β 在使用期間,圖40-50所述之減壓輸送系統2ηι、2211 可直接應用於組織部位上,以向組織部位分佈減低之壓力 。主歧管之低矮形狀非常有利於經過皮膚裝設及移除本文 所述之技術。類似地,亦可藉由外科手術來嵌入主歧管。 參見圖51 ’主歧管2115、22 15可與一輔助歧管2321結合 使用。在圖51中,輔助歧管2321包括一兩層式氈墊。輔助 歧管23 21之第一層接觸一包含骨折部位之骨路組織部位放 置。主歧管2115接觸該第一層放置’且輔助歧管2321之第 一層置於主歧管2115及第一層之頂上。輔助歧管2321能夠 達成主歧官2 11 5與組織部位之間之流體連通,且仍防止組 織部位與主歧管2115之間直接接觸。 較佳地’辅助歧管2321係生物可吸收性的,此使輔助歧 I54474.doc •47- 1362951 官2321能夠在減壓治療完成之後保留於原位。—旦完成減 壓治療,便可在幾乎不會或根本不會擾動組織部位之情況 下自辅助歧管之該等層之間移出主歧管2115。在— 貫施例 中,主歧管可塗覆有潤滑材料或會形成水凝膠之材料以 易於自該等層之間移出主歧管。 輔助歧管較佳用作新組織生長之支架。作為支架,輔助 歧管可由選自由如下材料組成之群組之至少一種材料構成 :聚乳酸、聚乙醇酸、聚己内酯、聚羥基丁酸酯、聚羥戊 酸、聚二氧六環醯胺、P〇ly〇rth〇esthers、聚碟腈聚氨某 甲酸酯、膠原、透明質酸、聚胺基葡萄糖、羥基磷灰石、 磷酸鈣、硫酸鈣、碳酸鈣、生物玻璃、不銹鋼、鈦、钽、 同種異體移植片及自體組織移植片。 上文所述之減壓輸送系統21 Π、2211之清洗功能可與本 文所述之任何歧管一起使用。對輸送減低之壓力之歧管戋 導管實施清洗之能力能防止形成會阻礙施行減低之壓力之 阻塞物。當組織部位附近之壓力達到平衡且組織部位周圍 流體之流出變慢時,通常會形成該等阻塞物。已發現,使 用空氣以一所選間隔將歧管及減壓導管清洗一所需時間量 會有助於防止或溶解阻塞物。 更具體而言,經由一第二導管輸送空氣,該第二導管與 輸送減低之壓力之第一導管分離。第二導管之一出口較佳 罪近歧官或靠近該第一導管之一出口。儘管可將空氣壓至 或推至第一導管之出口,然而較佳藉由組織部位處減低 之壓力經由第二導管吸入空氣。已發現,在許多情形中, 154474.doc •48· 1362951 在應用減低之壓力期間以六十(60)秒鐘之間隔輸送空氣兩 (2)秒鐘便足以防止形成阻塞物《此種清洗計劃能提供足夠 之空氣來充分地移動歧管及第一導管内之流體,同時防止 引入過多之空氣。引入過多之空氣、或者以過高之間隔頻 率來引入空氣將會造成一不能夠在各次清洗循環之間返回 至減低之目標壓力之減壓系統。所選之輸送清洗流體之時 間量以及所選之輸送清洗流體之間隔通常將根據系統組件 (例如幫浦、管等)之設計及規格而異。然而,輸送空氣之 量及頻率應高至足以充分地清除阻塞物、同時仍能在各次 清洗循環之間恢復滿目標壓力。 參見圖52,在一個例示性實施例中,一減壓輸送系統 2411包含一歧管2415’歧管24 15流體連接至一第一導管 2419及一第二導管2423。第一導管2419連接至一減壓源 2429,以向歧管24〖5提供減低之壓力。第二導管2423包含 一出口 2435 ’出口 2435定位成與歧管241 5流體連通並靠近 第一導管2419之出口。第二導管2423流體連接至一閥門 2439,當閥門2439置於開啟位置時,該閥門能夠達成第二 導官2423與環境空氣之間的連通。閥門2439以可操作方式 連接至一控制器2453,控制器2453能夠控制閥門2439之開 啟及關閉’以調節使用環境空氣對第二導管實施之清洗, 從而防止在歧管2415與第一導管2419内存在阻塞物。 應注意’可使用任何流體(包括液體或氣體)來達成本文 所述之技術。儘管用於清洗流體之力較佳係減低之壓力在 組織部位處形成之吸力,然而類似於參照圖9所述,流體 154474.doc •49· 1362951 輸送構件亦可藉由類似方式來輸送流體。 根據本文所述之系統及方法對組織部位施行減壓組織治 療可藉由如下方式來達成:對組織部位施加一足夠低之壓 力,並隨後在一所選時間段内保持該足夠低之壓力。另一 選擇為,施加至組織部位之減低之壓力可係循環性質。更 具體而言,所施加減低之壓力之大小可根據所選時間循環 而異。再一種施加減低之壓力之方法可隨機地改變減低之 壓力之大小。類似地’輸送至組織部位之流體之速率或量 可恒定不變、為週期性或者為隨機性。若為週期性,則流 體輸送可在施加減低之壓力期間進行,或者可在其中不在 施加減低之壓力之循環週期期間進行。儘管施加至組織部 位之減低之壓力之大小通常將根據組織部位之病理李及施 行減壓組織治療之環境而異,然而減低之壓力通常介於 約-5 mm Hg與-500 mm Hg之間,但更佳係介於約_5 mm Hg與-300 mm Hg之間。 儘管上文係參照組織生長及患者癒合來說明本發明之系 統及方法,然而應知道,該等用於施加減壓組織治療之系 統及方法可用於任何其中想要促進組織生長或癒合之活體 中。類似地,本發明之系統及方法可應用於任何組織,包 括但不限於骨骼組織、脂肪組織、肌肉組織、神經組織、 皮膚組織、血管組織、結締組織、軟骨組織、腱或韌帶。 儘管組織之癒合可係如本文所述應用減壓組織治療之一著 重點,然而亦可使用減壓組織治療(尤其係對位於患者皮 膚下面之組織)之應用在不存在疾病、缺損或損傷之組織 154474.doc -50· 1362951 中形成組織生長。舉例而言.’可能期望使用經過皮膚之植 入技術來應用減壓組織治療,以在一组織部位處生長額外 之組織,並隨後收穫所述額外之組織。可將所收穫之組織 移植至另一組織部位,以取代有疾病或受損之組織,或者 另一選擇為,可將所收穫之組織移植給另一患者。The reduced pressure delivery device 961 is delivered to the tissue site within the impermeable membrane 971 using endoscopy, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique and then correctly Positioning. The impermeable film 971 can include a radiopaque marker 981 which improves the visibility of the impermeable film 971 under fluorescent screen inspection prior to its removal. The reduced pressure delivery device 961 is then pushed through the distal end 943 of the manifold delivery tube 92 1 . The reduced pressure applied to the interior space 973 can be released to place the impermeable membrane 971 in a relaxed position. Then, the reduced pressure conveying device 961 is pushed through the rubber seal 977 to push out the impervious film 971. Referring to Figure 26A, a reduced pressure delivery system 985 in accordance with an embodiment of the present invention may not include a manifold delivery tube similar to the manifold delivery tube 921 of Figure 26. Rather, the reduced pressure delivery system 985 can include a guide wire 987 and a reduced pressure 154474. Doc 31 - 1362951 A delivery tube 989 and a reduced pressure delivery device 991. The reduced pressure delivery device 991 includes a plurality of fluid passages connected to the reduced pressure delivery tube 989. Instead of using a separate manifold tube to deliver the reduced pressure delivery device 991, the reduced pressure delivery device 991 and the reduced pressure delivery tube 989 are placed on the guide wire 987, which guides the guide wire 987 through the skin. To a tissue part 993. Preferably, the guide wire 987 and the reduced pressure delivery tube 989 penetrate the patient's skin with a sterile sheath. By guiding the reduced pressure delivery tube 989 and the reduced pressure delivery device 991 along the guide wire 987, the reduced pressure delivery device 991 can be placed at the tissue site 993 to effect decompression tissue treatment through the skin. Since the reduced pressure delivery device 991 is not constrained in a manifold delivery tube during delivery to the tissue site 993, it is preferred to maintain the reduced pressure delivery device 991 in the compressed position during delivery. If an elastic foam is used as the reduced pressure conveying means 991', the foam can be coated with a biocompatible soluble adhesive and the foam can be compressed. After reaching the tissue site, the body fluid or other fluid delivered via the reduced pressure delivery tube 989 dissolves the adhesive, thereby causing the foam to swell and contact the tissue site. Alternatively, a reduced pressure delivery device 991 can be formed from a compressed dry hydrogel. The hydrogel absorbs moisture after being transported to the tissue site 993, so that the reduced pressure delivery device 991 can be inflated. Still another reduced pressure delivery device 991 can be made from a thermally active material, such as polyethylene glycol, which will swell when subjected to the patient's body temperature. In a further embodiment, the compressed reduced pressure delivery device 991 can be delivered to the tissue site 993 in a __ dissolvable film. Referring to Figure 27, a reduced pressure delivery system 1011 according to the present invention includes a manifold delivery tube 1021 having a distal end 1043, and a distal end 1043 inserted through 154474. Doc -32- 1362951 A tissue of one of the patients is exposed to the tissue site 1〇25. The tissue site 1 〇 25 may comprise a void 1 〇 29 associated with a wound or other defect, or alternatively, a void may be formed by separation, including the separation techniques described herein. . After the distal jaw 043 is placed adjacent to the tissue site 1025 within the void 1029. An injectable, pourable or flowable pressure reducing delivery device 1035 is delivered to the tissue site 1〇25 via a manifold transfer tube 1〇2丨. The reduced pressure delivery device 1035 is preferably present in a flowable state during delivery to the tissue site, and then, upon arrival, a plurality of flow channels are formed to distribute the reduced pressure or fluid. In some cases, the flowable material can be hardened to a solid state by a drying process, a curing process, or other chemical or physical reaction after reaching the tissue site. In other cases, the flowable material can form a foam in situ after delivery to the tissue site. Still other materials may exist in the gel state at the tissue site 1 〇 25, but still have a plurality of flow channels for delivering reduced pressure. The amount of φ reduced pressure delivery device 1035 delivered to the tissue site 1 〇 25 may be sufficient to partially or completely fill the void 1029. The reduced pressure delivery device 1035 can include both a manifold and a stent. As a manifold, the reduced pressure delivery device 1A 35 includes a plurality of holes or open holes which are formed in the material after being conveyed to the gaps 1〇29. The holes or open rituals are interconnected to form a plurality of flow channels. These flow channels are used to apply and distribute reduced pressure to the tissue site 1025. As a stent, the reduced pressure delivery device 1 〇 35 is bioresorbable and serves as a substrate on which new tissue can be grown. In an embodiment, the reduced pressure delivery device 1035 can comprise a distribution throughout the liquid 154474. Doc -33- 1362951 Poragen in body or sticky condensate, such as NaCl or other salts. After the liquid or viscous gel is delivered to the tissue site 1025, the material is applied to the void 1029 and subsequently cured into a solid. The water-soluble NaCl P〇ragen dissolves in the presence of body fluids leaving a structure with interconnected pores or flow channels. The reduced flow and/or fluid is delivered to the flow channels. As the new tissue is formed, the tissue will grow into the bore of the reduced pressure delivery device 1 〇 35 and then eventually replace the reduced pressure delivery device 1035 with the degradation of the reduced pressure delivery device 1035. In this particular example, the 'reduced delivery device IQ' is used not only as a manifold but also as a new tissue growth scaffold. In another embodiment, the reduced pressure delivery device 1035 is an alginate mixed with 400 μη mannose particles. The P〇ragen or granules may be dissolved at the tissue site by a local bodily fluid or by a flushing fluid or other fluid delivered to the reduced pressure delivery device i035. After the poragen or particles are dissolved, the space previously occupied by the poragen or particles becomes a void which is interconnected to each other to form a flow passage in the reduced pressure conveying device 1035. The use of poragen in materials to form flow channels is effective, but it also forms pores and flow channels that are limited in size to only the pores of the selected poragen. A chemical reaction can be used in place of poragen to form larger pores by forming gaseous by-products. For example, in one embodiment, a flowable material comprising sodium bicarbonate and citric acid microparticles (which may be non-stoichiometric) may be delivered to tissue site 1025. When the flowable material forms a foam or solid in situ, the body fluid will cause an acid-base reaction between sodium bicarbonate and citric acid. Compared with the technique of relying on poragen dissolution, the formed oxidized gas particles will form larger pores in the entire pressure reducing conveying device 1035 and 154474. Doc -34· 1362951 Flow channel. The transition of the reduced pressure delivery device 1035 from a liquid or viscous gel to a solid or foam can be triggered by enthalpy, temperature, light, or reaction with body fluids, chemicals, or other materials delivered to the tissue site. It can also be mixed by a variety of counters. This change is made in response to the component. In one embodiment, the reduced pressure delivery device 1035 is prepared by selecting bioresorbable microspheres made from a bioresorbable polymer. The microspheres are dispersed in a solution containing a photoinitiator and a hydrogel forming material such as hyaluronic acid, collagen or polyethylene glycol. The microsphere-gel mixture is exposed to light for a brief period of time to partially crosslink the hydrogel and immobilize the hydrogel on the microspheres. Excess solution is drained and the microspheres are subsequently dried. The microspheres are delivered to the tissue site by injection or pouring, and after delivery, the mixture absorbs water' and the hydrogel coating becomes a hydrated coating. Then, the mixture is again exposed to light, whereby the microspheres are crosslinked to form a plurality of flow channels. The crosslinked microspheres are then used as a manifold for the delivery of reduced pressure to the tissue site and a porous scaffold for promoting the growth of new tissue. With the exception of the foregoing embodiments herein, the reduced pressure delivery device 1 can be made from a variety of materials including, but not limited to, phosphate feed, ray, alginate, quasi-prime or any other gas, Liquid, knee, paste, • ash H suspension or other flowable material is delivered to the tissue and is capable of forming an equivalent of a plurality of flow paths in fluid communication with the tissue site. The flowable material may further comprise solid particles, such as particles, which can be transported via a manifold if the particle size of the solid particles is sufficiently small. Doc -35· 1362951 1021 〃IL move. The material delivered to the tissue site in a flowable state can be polymerized in situ or form a gel. As previously described, the reduced pressure delivery device 1〇35 can be directly injected or poured into the void 1029 adjacent the tissue site 1025. Referring to FIG. 27A, the manifold delivery S 1021 may include an impermeable or semi-permeable membrane 1〇51 at the distal end 1043 of the manifold tube 1021, the membrane 1〇51 includes an internal space 1〇55, and the internal chamber 1055 It is in fluid communication with an auxiliary lumen fixed to the manifold delivery tube 1〇21. The manifold delivery tube 1021 is guided to a tissue portion 1025 on a guide wire 1〇61. The reduced pressure delivery device 1〇35 can be injected or poured through the auxiliary lumen 1057 to fill the internal space 1055 of the membrane 1051. When the fluid or gel fills the film 1051, the film 1〇51 expands to fill the voids 1〇29' so that the film contacts the tissue site 1025. When the film 1〇51 is inflated, the film 1〇51 can be used to separate the additional tissue of the adjacent or sinus proximal tissue site. If the film 丨〇5 不 does not penetrate the 丨 film, it can be physically broken and removed, so that the reduced pressure delivery device 1035 contacts the tissue site 1 〇 25. Alternatively, film 1〇51 can be made from a soluble material that will dissolve in the presence of body fluids or biocompatible solvents delivered to film 1051. If the film 丨05丨 is semi-permeable, the film 1051 can remain in place. The semi-permeable membrane 丨〇5丨 is capable of delivering reduced pressure and possibly other fluids to the tissue site 1025. Referring to Figure 28, a method of performing reduced pressure tissue therapy includes surgically inserting a manifold at an adjacent tissue site at 1115, the manifold having a plurality of protrusions extending from a flexible barrier. To form a plurality of flow channels between the protrusions. Positioning the manifold at 1119 154474. Doc • 36- is called 951 ' at least a portion of the projections are in contact with the tissue site. At ι 23, a reduced pressure is applied to the tissue site via the manifold. See Figure 29, a method of applying reduced-pressure tissue treatment to a tissue site. U11 includes inserting a manifold at 1215 through the skin adjacent to the tissue site. A plurality of protrusions extending from a flexible barrier may be included to form a plurality of flow channels between the protrusions. Alternatively, the manifold I comprises a honeycomb material having a plurality of fluids in the honeycomb material, and the 5H manifold may be formed of an injectable or pourable material: The poured material is delivered to the tissue site and forms a plurality of flow channels after reaching the woven site. At 1219, the manifold is clamped such that at least a portion of the flow channels are in fluid communication with the tissue site. At 1223, a reduced pressure is applied to the tissue site via the manifold. Referring to Fig. 30, a method of performing decompressive tissue treatment on a tissue site U11 includes inserting a tissue having one of the patients through the skin at 1315 to insert the end of the 5th tube to the tissue site. At 13 1 9 , an inflatable bladder associated with the tube can be inflated to separate tissue adjacent to the tissue portion to form a void. At 1323, a manifold is transported through the passage. The manifold can include a plurality of protrusions extending from a flexible barrier to form a plurality of flow channels between the protrusions. Alternatively, the manifold 彳 comprises a honeycomb material having a plurality of flow channels therein. Alternatively, the disparity f can be formed from an injectable or pourable material delivered to the tissue site as described above with reference to FIG. At 1327, the locator is positioned such that at least one of the flow channels is 154474. Doc -37· ^362951 is in fluid communication with the tissue site. At 1331, the reduced pressure is applied to the tissue site via the manifold via a reduced pressure delivery tube or any other delivery route. Referring to Fig. 3, a method for performing decompression tissue treatment on a tissue site 14丨1 includes inserting a tube having a passage through the skin through a skin at 1415 such that the distal end of the tube is adjacent to the tissue site. Place. At 1423, a manifold is delivered to the tissue site via the passageway in an impervious sheath that has been subjected to a first reduction in the ambient pressure of the sheath at the 丨41 9 pressure. At 1427, the sheath is broken to contact the manifold with the tissue site. At 丨43 1 , a second reduced pressure p is applied to the tissue site via the manifold. Referring to Figures 32 and 33, a reduced-pressure delivery device 151 according to an embodiment of the invention includes a replacement for a patient's leg. Fistula 5丨7 of the existing femoral head plastic surgery prosthesis 1515. The hip prosthesis 1515 includes a post portion 1521 and a head portion 1525. The post portion 1521 is elongate for insertion into a passage 1529 that is hinged in the backbone of the leg portion 1517. A porous coating 1 535 is disposed around the portion of the column and is preferably constructed of sintered or vitrified ceramic or metal. Alternatively, a honeycomb material having a porous property may be disposed around the column portion. A plurality of flow channels 1541 are disposed in the column portion 1 52 1 of the hip prosthesis 1 5 1 5 to fluidly communicate the flow channel 1541 with the porous coating 1535. A port 1545 is fluidly coupled to the flow passage 1541 which is configured to be releasably coupled to a reduced pressure delivery line 1551 and a reduced pressure delivery source 1553. The flow channel 1541 is used to deliver a reduced pressure to the porous coating 1535 and/or bone surrounding the hip prosthesis 1515 after implantation of the hip prosthesis 1515. The flow channel 1541 can comprise a 154474. Doc • 38. A main feed line 1543 in fluid communication with a plurality of transverse branch lines 1547, the plurality of lateral branch lines 1547 being in communication with the porous coating 1535. The lateral branch line 1545 can be oriented perpendicular to the main feed line 1543 as shown in Figure 32, or can be oriented at some angle to the main feed line 1543. An alternative method for distributing reduced pressure includes providing a hollowed out prosthesis and filling the interior of the prosthesis with a honeycomb-like (preferably open-cell) material that is in fluid communication with the porous coating 1535. . Referring more specifically to Figure 33, the hip prosthesis 1515 can include a second plurality of flow channels 1561 within the column portion 1521 to provide fluid to the smear coating 1535 and/or bone surrounding the hip prosthesis 515. The fluid can include filtered air or other gases, antibacterial agents, antiviral agents, cell growth promoters, irrigation fluids, chemically active fluids, or any other fluid. Additional fluid communication paths may be provided if multiple fluids are desired to be introduced into the bone surrounding the hip prosthesis 1515. A port 1565 is fluidly coupled to the flow channel 丨56, which is configured to be releasably coupled to a fluid delivery tube 1571 and a fluid carrier source 1573. The flow channel 1561 can include a main feed line 1583 in fluid communication with a plurality of lateral branch lines 1585 that are in communication with the porous coating 153 5 . The lateral branch line 1585 can be oriented perpendicular to the main feed line 1583 as shown in Figure 33, or can be oriented at some angle to the main feed line 158. The delivery of the reduced pressure to the first plurality of flow channels 154 and the delivery of fluid to the second plurality of flow channels 1561 can be accomplished by separate tubes (e.g., reduced pressure delivery tube 1551 and fluid delivery tube 1571). Alternatively, a tube having multiple lumens as previously described herein can be used for separation for 54474. Doc •39- Conveying reduced pressure and fluid communication path. It should be further noted that although a separate fluid communication path is preferred within the hip prosthesis 1515, the first plurality of flow channels 1541 can be used to reduce the pressure and Both fluids are delivered to the bone surrounding the hip prosthesis 15 15 . As mentioned earlier, applying reduced stress to bone tissue promotes and accelerates the growth of new bone tissue. By using the hip prosthesis 1 5 1 5 as a manifold to deliver the reduced pressure to the bone path area of the surrounding prosthesis, the recovery of the leg section 1517 will be faster and the hip prosthesis 15 5 will be more successful with The combination of the bone path and the second plurality of flow channels 1561 to discharge the bone surrounding the hip prosthesis 1515 improves the successful regeneration of the new bone surrounding the prosthesis. After applying the reduced pressure through the competitive body 1 5 1 5 for a selected amount of time, the reduced pressure delivery tube 1551 and the fluid delivery tube 1571 can be disconnected from the ports 1545, 1 565 and removed from the patient body - It is preferred not to use a surgical invasive procedure. The connection between the ports 1545, 1565 and the tubes 1551, 1571 can be by hand release. This can be accomplished by applying an axial pull to the tubes 1551, 1571 outside the body of the patient. Alternatively, the ports 1545, 1565 can be bioresorbable or soluble in the presence of a selected fluid or chemical so that the ports 1545, 1565 can be exposed to fluids or chemicals. And the release of the tubes 1551, 1571 is achieved. The tubes 1551, 1571 can also be made from a bioresorbable material that will dissolve over a period of time or a viable material that will dissolve in the presence of a particular chemical or other material. A reduced pressure delivery source 1553 can be provided outside the patient and attached to the reduced pressure delivery tube 155' to deliver the reduced pressure to the hip prosthesis 1515. Another option is, 154474. Doc •40· 1362951 A reduced-pressure delivery source 1553 can be implanted in a patient, on or near the hip prosthesis 15 15 . Placing the reduced pressure delivery source 1553 into the patient eliminates the need for fluid connections through the skin. The implanted reduced pressure delivery source 1553 can be a conventional pump operatively coupled to the flow channel 1541. The pump can be powered by a battery implanted in the patient's or can be electrically connected to the pump via the skin. External battery powered. The pump can also be directly driven by a chemical reaction that delivers reduced pressure via flow channels 1 541, 1561 and circulates fluid through flow channels 1541, 1561. Although only the column portion 1521 and the head portion 1 525 of the hip prosthesis ι515 are illustrated in Figures 32 and 33, it should be noted that the flow channels described herein and the components for applying reduced pressure tissue treatment may also be applied to hip falsehood. Any component of the body 1515 that contacts the osseous or other tissue, including, for example, a cup. Referring to Fig. 34, a method 161 for repairing a joint of a patient includes implanting a prosthesis in the bone adjacent to the joint at 1 615. The prosthesis can be a hip prosthesis as described above or any other prosthesis that can help restore joint mobility in a patient. The prosthesis includes a plurality of flow channels configured to be in fluid communication with the bone. At 1619, a reduced pressure is applied to the bone via the plurality of flow channels to improve the prosthesis se〇integrati〇n. Referring to Figures 35 and 36, a reduced pressure delivery device 1711, in accordance with an embodiment of the present invention, includes an orthopaedic fixation device 1715 for fastening a bone 1717 of a patient that includes a fracture site 1719 or other defect. The orthopaedic fixation device 1715, shown in the drawings, is a plate having a plurality of passages 1721 for anchoring the orthopaedic fixation device 1715 to the bone using screws 1725, pins, bolts or other fasteners. On 1717. Available at 154474. Doc -41 · 1362951 A multi-hole coating 1735 is placed on the surface of the contact ι 71 7 of the orthopedic fixation device 1715. The porous coating is preferably constructed of sintered or vitrified ceramic or metal. Alternatively, a honeycomb material having a porous nature can be disposed between the bone 1717 and the orthopaedic fixation device 1715. A plurality of flow channels 1741 are disposed within the orthopaedic fixation device 1715 to fluidly communicate the flow channel 1741 with the porous coating port 35. A port 1745 is fluidly coupled to the flow channel 1741, the crucible being configured to be coupled to the decompression delivery tube 1751 and a reduced pressure delivery source 1753. The flow channel 1741 is for use after securing the orthopaedic fixation device 1715 to the bone 1717. The coating 1735 and/or the orthopedic surgery S) is configured to reduce the pressure of the bone path delivery device 1715. The flow channel 1741 can include a main feed line m3' in fluid communication with a plurality of lateral branch lines 1747. The plurality of lateral branch lines 1747 are in communication with the porous coating 1735. The lateral branch line m7 can be oriented perpendicular to the main feed line 1743 as shown in Figure 35 or can be oriented at some angle to the main feed line 1743. An alternative method for distributing the reduced pressure includes providing an orthopaedic solid; t device and filling with a honeycomb (preferably open pore) material capable of communicating with the porous coating 1735 The internal space of the orthopaedic fixation device. ° The orthopaedic fixation device 1715 can be a tether as shown in Figure 35, or alternatively selected as a "fixable device, such as a cannula, a bridge", a struts, and other parts (4). U pieces. The orthopedic fixation device m5 can be used for fastening the prosthesis or other orthopedic device or the implanted tissue (such as bone tissue or cartilage). The basin limitation condition is that the tightness is included. In the group of adjacent or surrounding such fasteners 154474. Doc •42· Weaving the wheel to deliver a reduced flow of dust. Examples of such fasteners may include pins, bolts, screws or any other suitable fastener. Referring more specifically to Figure 36, the orthopaedic fixation device 1715 can further include a second plurality of flow channels 在 ι ι ι ι ι ι ι ι ι , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , *body. The fluid may include filtered air or other gas, anti-bacterial antiviral agent, cell growth promoter 'flushing fluid, chemically active m or any U. Additional fluid communication paths are provided if it is desired to introduce multiple fluids into the meniscus of the body prosthesis. A port 1765 body is coupled to the flow channel 1761 which is configured to be coupled to a fluid delivery tube 177! and a fluid delivery source 1773. The flow channel ride can include a main feed line 1783 in fluid communication with a plurality of lateral branch lines 1785. The mysterious branch line 1785 is in communication with the porous coating 丨735. The lateral branch line 1785 can be oriented perpendicular to the main feed line 1783 as shown in Figure 33, or can be oriented at some angle to the main feed line 1783. The delivery of the reduced pressure to the first plurality of flow channels 74 and the transfer of fluid to the first plurality of flow channels 1761 can be accomplished by separate tubes (e.g., reduced pressure delivery tube 1751 and fluid delivery tube 1771). Alternatively, a tube having a plurality of lumens as previously described herein can be used to separate the communication path for delivery of reduced pressure and fluid. It should be further noted that although a separate fluid communication path is preferably provided within the hip prosthesis 171 5, the first plurality of flow channels 1741 can be used to deliver both the reduced pressure and fluid to the bone of the adjacent orthopaedic fixation device 1715. . Use orthopedic fixation device 1715 as a manifold to access adjacent orthopedics 154474. Doc •43· 1362951 The reduced pressure of the bone area of the fixation device 1715 accelerates and improves the recovery of the defect 1719 of the bone 1717. Providing a second plurality of flow channels 1761 to deliver fluid to the bone surrounding the orthopaedic fixation device 715 improves the successful regeneration of new bone adjacent the orthopaedic fixation device. Referring to Fig. 37', a method 1811 for healing a bone defect in a bone includes using an orthopedic fixation device at 1815 to secure the bone path. The orthopedic fixation device includes a plurality of flow channels disposed within the orthopaedic fixation device. Applying a reduced pressure to the bone defect via the plurality of flow channels at 1 819'. Referring to Figure 3 8 'A method 1910 for performing a reduced-pressure tissue treatment on a tissue site includes: positioning a manifold having a plurality of flow channels at 1915 to cause at least a portion of the flow channels to be associated with the tissue The parts are in fluid communication. At 1919, the reduced pressure is applied to the tissue site via the flow channels, and at 1923, a fluid is delivered to the tissue site via the flow channels. Referring to Figure 3, a method for performing decompressive tissue treatment on a tissue site 2011 includes positioning a distal end of a manifold delivery tube adjacent the tissue site at 2015. At 2019, a fluid is delivered to the tissue site via the manifold delivery tube. The fluid is capable of filling a void adjacent the tissue site and becoming a solid manifold having a plurality of flow channels in fluid communication with the tissue site. At 2023, a reduced pressure is applied to the tissue portion via the flow path of the solid manifold. Referring to Figures 40-48, a reduced pressure delivery system 2111 includes a main manifold 2115. The main manifold 2115 has a ductal wall 2117 154474 surrounding a main flow path 2121. Doc -44 - 1362951. The flexible wall 2117 is coupled to a reduced pressure delivery tube 2125 at a proximal end 2123. Since the shape of the reduced pressure delivery tube 2125 will generally be a circular cross section, and because the shape of the wear surface of the primary manifold 2115 can be different from the circular shape (i.e., rectangular in Figures 4A-45, and in Figures 46-48) Triangle) thus provides a transition zone 2129 between the reduced pressure delivery tube 2125 and the primary manifold 2115. The main manifold 2115 can be adhesively joined to the reduced pressure delivery tube 2125, joined using other means such as fusion or insert molding, or alternatively selected to be integrally joined by coextrusion. The reduced pressure delivery tube 2125 delivers the reduced pressure to the primary manifold 2115 for distribution at or near the tissue site. An anti-blocking member 2135 is positioned within the main manifold to prevent the main manifold 2115 from collapsing and thereby blocking the main flow path 2121 during application of the reduced pressure. In one embodiment, the anti-blocking member 2135 can be provided with a plurality of protrusions 2137 (see FIG. 44) disposed on an inner surface 2141 of the flexible wall 2117 and extending into the main flow path 2121. In another embodiment, the anti-blocking member 2135 can be provided with a single or multiple ridges 2145 on the inner surface 2141 (see Figures 40 and 41). In yet another embodiment, the anti-blocking component 2135 can comprise a honeycomb material 2149 disposed within the main flow path, such as shown in Figure 47. The anti-blocking member 2135 can be any material or structure that can be lost in the flow path or can be integrally or otherwise secured to the flexible wall 2117. The anti-blocking member 2135 is capable of preventing the flexible wall 2117 from completely collapsing while still allowing fluid to flow through the main flow path 2121. The flexible wall 2117 further includes a plurality of apertures 2155' that penetrate the flexible wall 2117. The apertures 2155 are in communication with the main flow path 2121. The aperture 2155 enables the reduced pressure delivered to the main flow path 2121 to be distributed to the tissue site. 154474. Doc • 45· 1362951 The aperture 2155 can be selectively positioned around the circumference of the manifold 2115 to preferentially direct the delivery of vacuum. For example, in Figure 51, the apertures can be placed facing the bone, facing the tissue, or both. The reduced pressure transfer tube 2125 preferably includes a first guide B1 having at least one outlet fluidly coupled to the main flow passage 2121. to deliver a reduced pressure to the main flow passage 2121. A second conduit 2163 can also be provided to clean the main flow path 2121 and the first conduit 2161 with a fluid to prevent or dissolve blockages caused by wound secretions and other fluids aspirated from the tissue site. The second conduit 2163 preferably includes at least one outlet positioned adjacent at least one of the main flow passage 2121. and the at least one outlet of the first conduit 2161. Referring more specifically to Figures 40 and 41, in the reduced pressure delivery system 2111, the second conduit 2163 can include a plurality of conduits for flushing the main flow path 2121. and the first conduit 2161. Although the end of the flexible wall 2117 opposite the end fixed to the reduced pressure delivery tube 2125 can be open as shown in Fig. 40, it has been found that covering the end of the flexible wall 211 7 can improve the cleaning function. Performance and reliability. Preferably, a head gap 2171 is provided between the covered end of the flexible wall and the end of the second conduit 2163. The headspace 2171 is capable of achieving accumulation of cleaning fluid during the cleaning process, which helps drive the flushing fluid to flow into the first conduit 2161 through the primary flow path 2121. The spacer used as the anti-blocking member 2135 is also illustrated in FIG. The centrally located spacer causes the main flow path 2121. to again enter the two chambers, which causes the main manifold 2115 to continue to operate when one of the chambers is blocked and cannot be dissolved by cleaning. 154474. Doc • 46· 1362951 Round 49 and 50, a decompression wheel This abortion system, the Leda system 22 11 includes a main manifold 2215 with a reduced pressure delivery = 2217. The reduced pressure delivery tube 2217 includes a central officer = 2223 and a plurality of auxiliary lumens 2225. Although the auxiliary lumen 2225 can be used to measure the pressure at or near the tissue site, the auxiliary lumen Mb can be further used to clean the central lumen 2223, (4) to stop or dissolve the obstruction. A plurality of apertures 2231 are in communication with the central lumen 2223 to distribute the reduced waste force delivered by the central lumen. As shown in Fig. 5A, it is preferred that the aperture 2231 does not extend through the auxiliary lumen 2225. Also shown in Fig. 50 is the countersunk end of the reduced pressure wheel tube which forms a headspace outside the end of the auxiliary lumen 2225. If the tissue, stent or other material is engaged during the application of the reduced pressure At the end of the pressure delivery tube 2217, the headspace 2241 will continue to allow delivery of the cleaning fluid to the central lumen 2223. During use, the reduced pressure delivery systems 2ηι, 2211 illustrated in Figures 40-50 can be applied directly to the tissue site. The reduced pressure is distributed to the tissue site. The low profile of the primary manifold is highly advantageous for erecting and removing the techniques described herein. Similarly, the primary manifold can also be surgically inserted. See Figure 51. The primary manifolds 2115, 22 15 can be used in conjunction with an auxiliary manifold 2321. In Figure 51, the secondary manifold 2321 includes a two-layer felt pad. The first layer of the auxiliary manifold 23 21 contacts a fracture site. The bone path tissue site is placed. The primary manifold 2115 is in contact with the first layer and the first layer of the auxiliary manifold 2321 is placed on top of the primary manifold 2115 and the first layer. The secondary manifold 2321 can reach the primary profile 2 11 5 and the flow between the tissue parts Communication, and still preventing tissue site with a direct contact between the primary manifold 2115. Preferably 'secondary manifold 2321 is bioabsorbable lines, this auxiliary manifold I54474. Doc •47– 1362951 Officer 2321 can remain in place after decompression therapy is completed. Once the decompression therapy is completed, the primary manifold 2115 can be removed from between the layers of the auxiliary manifold with little or no disturbance to the tissue site. In one embodiment, the primary manifold may be coated with a lubricating material or a material that will form a hydrogel to facilitate removal of the primary manifold from between the layers. The auxiliary manifold is preferably used as a support for new tissue growth. As a stent, the auxiliary manifold may be composed of at least one material selected from the group consisting of polylactic acid, polyglycolic acid, polycaprolactone, polyhydroxybutyrate, polyvaleric acid, polydioxane Amine, P〇ly〇rth〇esthers, poly-disc nitrile polyformate, collagen, hyaluronic acid, polyaminoglucose, hydroxyapatite, calcium phosphate, calcium sulfate, calcium carbonate, bioglass, stainless steel, Titanium, tantalum, allograft tablets and autologous tissue grafts. The cleaning functions of the reduced pressure delivery systems 21 Π, 2211 described above can be used with any of the manifolds described herein. The ability to clean the manifold 输送 conduit for reduced pressure prevents the formation of obstructions that impede the pressure to perform the reduction. Such obstructions are typically formed when the pressure near the tissue site reaches equilibrium and the flow of fluid around the tissue site slows. It has been found that the use of air to purge the manifold and decompression catheter at a selected interval for a desired amount of time can help prevent or dissolve the obstruction. More specifically, air is delivered via a second conduit that is separated from the first conduit that delivers the reduced pressure. One of the outlets of the second conduit is preferably sinister or near one of the outlets of the first conduit. Although the air can be pressurized or pushed to the outlet of the first conduit, it is preferred to draw in air through the second conduit by the reduced pressure at the tissue site. It has been found that in many cases, 154474. Doc •48· 1362951 Two (2) seconds of air delivery at intervals of sixty (60) seconds during the application of reduced pressure is sufficient to prevent the formation of obstructions. “This cleaning program provides enough air to move sufficiently The tube and the fluid in the first conduit while preventing the introduction of excess air. Introducing too much air, or introducing air at too high a frequency interval, will result in a decompression system that cannot return to a reduced target pressure between wash cycles. The amount of time selected to deliver the cleaning fluid and the interval between the selected cleaning fluids will generally vary depending on the design and specifications of the system components (eg, pumps, tubes, etc.). However, the amount and frequency of delivery air should be high enough to adequately remove obstructions while still recovering the full target pressure between wash cycles. Referring to Fig. 52, in an exemplary embodiment, a reduced pressure delivery system 2411 includes a manifold 2415' manifold 24 15 fluidly coupled to a first conduit 2419 and a second conduit 2423. The first conduit 2419 is coupled to a reduced pressure source 2429 to provide a reduced pressure to the manifold 24. The second conduit 2423 includes an outlet 2435' outlet 2435 that is positioned in fluid communication with the manifold 241 5 and adjacent the outlet of the first conduit 2419. The second conduit 2423 is fluidly coupled to a valve 2439 which, when the valve 2439 is placed in the open position, is capable of achieving communication between the second guide 2423 and ambient air. Valve 2439 is operatively coupled to a controller 2453 that is capable of controlling opening and closing of valve 2439 to regulate cleaning of the second conduit using ambient air to prevent memory in manifold 2415 and first conduit 2419 In the obstruction. It should be noted that any fluid (including liquids or gases) may be used to achieve the techniques described herein. Although the force for cleaning the fluid is preferably a suction that is formed at the tissue site by the reduced pressure, similar to that described with reference to Figure 9, fluid 154474. Doc • 49· 1362951 The transport member can also deliver fluid in a similar manner. Decompression tissue treatment of a tissue site in accordance with the systems and methods described herein can be accomplished by applying a sufficiently low pressure to the tissue site and then maintaining the sufficiently low pressure for a selected period of time. Alternatively, the reduced pressure applied to the tissue site can be cyclic. More specifically, the magnitude of the applied reduced pressure may vary depending on the selected time cycle. Yet another method of applying the reduced pressure can randomly vary the magnitude of the reduced pressure. Similarly, the rate or amount of fluid delivered to the tissue site can be constant, periodic or random. If it is periodic, the fluid delivery can be carried out during the application of the reduced pressure or during the cycle in which the reduced pressure is not applied. Although the magnitude of the reduced pressure applied to the tissue site will generally vary depending on the pathology of the tissue site and the environment in which the decompressed tissue treatment is performed, the reduced pressure is typically between about -5 mm Hg and -500 mm Hg. However, the better is between about _5 mm Hg and -300 mm Hg. Although the systems and methods of the present invention are described above with reference to tissue growth and patient healing, it should be understood that such systems and methods for applying reduced pressure tissue treatment can be used in any living body in which tissue growth or healing is desired to be promoted. . Similarly, the systems and methods of the present invention are applicable to any tissue including, but not limited to, bone tissue, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage tissue, tendon or ligament. Although tissue healing may be a focus of application of reduced-pressure tissue therapy as described herein, decompression tissue therapy (especially for tissues located beneath the patient's skin) may also be used in the absence of disease, defect or injury. Organization 154474. Tissue growth was formed in doc -50· 1362951. For example. It may be desirable to apply a decompressed tissue treatment using a skin implant technique to grow additional tissue at a tissue site and subsequently harvest the additional tissue. The harvested tissue can be transplanted to another tissue site to replace the diseased or damaged tissue, or alternatively, the harvested tissue can be transplanted to another patient.
應注意,本文所述之減壓輸送裝置可與支架材料結合使 用來提高新組織之生長及生長速率,此亦頗為重要。支架 材料可放置於組織部位與減壓輸送裝置之間,或者減壓輸 送裝置本身可由用作新組織生長支架之生物可再吸收性材 料製成。 根據上文說明應顯而易見,本文提供一具有顯著優點之 發明。儘管本文僅以其幾種形式來顯示本發明,然而本發 明並不僅限於此,而是易於在不背離本發明精神之條件下 作出各種改動及修改。 【圖式簡單說明】It should be noted that the reduced pressure delivery device described herein can be combined with a stent material to increase the growth and growth rate of new tissue, which is also important. The stent material can be placed between the tissue site and the reduced pressure delivery device, or the reduced pressure delivery device itself can be made from a bioresorbable material that is used as a new tissue growth stent. It should be apparent from the above description that this document provides an invention with significant advantages. While the present invention has been shown in its several forms, the present invention is not limited thereto, but various modifications and changes can be made without departing from the spirit of the invention. [Simple description of the map]
本專利或申請案稽案包含至少—個帶顏色之圖式。可根 據要求並在支付必要費用之後由專利事務局提供帶彩圖之 本專利或專利申請公開案。 圖1繪示-根據本發明一實施例之減壓輸送裝置之透視 圖,該減壓輸送裝置具有複數個突起物自—撓性障壁伸出 以形成複數個流動通道; 圖2圖解說明圖1所示減壓輸送裝置之正視圖· 圖3繪示圖1所示減壓輸送裝置之俯視圖; 該減壓 圖4 A圖解說明圖1所示減壓輸送裝置之側視圖 154474.doc •51 · 1362951 輸送裝置具有一單管腔減壓輸送管; 阁圖⑽示圖1所示減1輸送裝置之一替代實施例之側視 該減壓輪送裝置具有—雙管腔減壓輸送管; 圖5圖解說明圖1所减壓輸送裝置之-放大透視圖; 圖6繪不-根據本發明—實施例之減壓輪送裝置之透視 圖’該減壓輸送裝置具有—附固至一橈性障壁上之蜂巢 =材;:撓性障壁具有一^脊部分及一對翼狀部分,該蜂 巢狀材料具有複數個流動通道; 圖7圖解說明圖6所示減壓輸送裝置之一正視圖; 圖8繪示圖7所示減壓輸送裝置在XVH-XVH處剖 視側視圖; 圖8A圖解說明_種㈣本發明_實施例之·輸送 之剖視正視圖; v置 圖8B繪示圖8A所示減壓輸送裝置之一側視圖; 圖9圖解說明一種根據本發明一實施例之減壓輸送 之-正視圖’其用於對患者之骨骼應用減壓組織治療广 圖10繪示-兔子頭骨之彩色組織切片,其顯示原始 經損壞之骨骼; ' ° '未 圖11圖解說明一兔子頭骨之彩色組織切片, 六頌不在廣 用減壓組織治療之後誘發之肉芽組織; 圖12繪示一兔子頭骨之彩色組織切片,其顯示在應用 壓組織治療之後新骨骼之沉積; "咸 圖13圖解說明一兔子頭骨之彩色組織切片,Α '、翔不在廯 用減壓組織治療之後新骨骼之沉積; 〜 154474.doc -52- 1362951 圖14繪示一兔子頭骨之彩色照片,在該頭骨中形成有兩 處臨界尺寸缺損; 圖丨5圖解說明圖14所示兔子頭骨之彩色照片,其顯示敢 入其中一處臨界尺寸缺損内之磷酸鈣支架及一覆蓋第二臨 界尺寸缺損之不銹鋼絲網; 圖16圖解說明圖14所示兔子頭骨之彩色照片,其顯示對 臨界尺寸缺損應用減壓組織治療; 圖17圖解說明在實施減壓組織治療之後一兔子頭骨之彩 色組織切片,該組織切片顯示新骨骼在磷酸鈣支架内之沉 積; 圖18繪示在實施減壓組織治療六天及實施手術兩週後圖 15所示經支架填充之臨界尺寸缺損之射線照片; 圖19繪示在實施減壓組織治療六天及實施手術十二週後 圖15所示經支架填充之臨界尺寸缺損之射線照片; 圖2 0繪示一根據本發明一實施例之減壓輸送系統之正視 圖,該減壓輸送系統具有一歧管輸送管,其用於經過皮膚 將一減壓輸送裝置***至一組織部位; 圖21圖解說明圖20所示歧管輸送管之放大正視圖,該歧 管輸送管包含一減壓輸送裝置,該減壓輸送裝置具有一撓 性障壁及/或一處於壓縮位置之蜂巢狀材料; 圖22繪示圖21所示歧管輸送管之放大正視圖,圖中顯示 在已自該歧管輸送管推入之後該減壓輸送裝置之撓性障壁 及/或蜂巢狀材料處於膨脹位置; 圖2 3圖解說明一種根據本發明一實施例之減壓輸送系統 154474.doc -53· 1362951 之正視圖’該減壓輸送系統具有一用於經過皮膚將一減壓 輸送裝置***至一組織部位之歧管輸送管,圖中顯示該減 壓輸送裝置處於該歧管輸送管外側、但被一不滲透性薄膜 約束於一壓縮位置上; 圖24繪示圖23所示減壓輸送系統之一正視圖,圖中顯示 該減壓輸送裝置處於該歧管輸送管外側、但被一不參透性 薄膜約束於一鬆弛位置上; 圖25圖解說明圖23所示減壓輸送系統之一正視圖,圖中 顯示該減壓輸送裝置處於該歧管輸送管外侧、但被—不珠 透性薄膜約束於一膨脹位置上; 圖25A圖解說明圖23所示減壓輸送系統之一正視圖,圖 中顯示該減壓輸送裝置處於該歧管輸送管外側、但在一膨 脹位置上被一不滲透性薄膜環繞; 圖26圖解說明一種根據本發明一實施例之減壓輸送系統 之正視圖,s亥減壓輸送系統具有一用於經過皮膚將—減壓 輸送裝置***至一組織部位之歧管輸送管,圖中顯示該減 壓輸送裝置處於該歧管輸送管外側、但受一具有膠封之不 滲透性薄膜約束; 圖26A繪示根據本發明一實施例之減壓輸送系統之正視 团 · 圍, 圖27圖解説明一種根據本發明一實施例之減壓輸送*** 之正視圖,該減壓輸送系統具有一歧管輸送管,以用於經 過皮膚將一減壓輸送裝置注射至一組織部位; 圖27A圖解說明一種根據本發明一實施例之減壓輪送系 154474.doc -54 - 1362951 統之正視圖,該減壓輸送系統具有一歧管輸送管,以用於 經過皮膚將一減壓輸送裝置輸送至位於一組織部位處之不 滲透性薄膜; 圖2 8繪示一種根據本發明一實施例對一組織部位施行減 壓組織治療之方法之流程圖; 圖2 9圖解說明一種根據本發明一實施例對—組織部位施 行減壓組織治療之方法之流程圖; 圖30繪示一種根據本發明一實施例對一組織部位施行減 壓組織治療之方法之流程圓; 圖31圖解說明一種根據本發明一實施例對一組織部位施 行減壓組織治療之方法之流程圖; 圖32繪示一種根據本發明一實施例之減壓輸送裝置之剖 面正視圖,該減壓輸送裝置包括一髖假體,該髖假體具有 複數個流動通道,以用於對環繞該髖假體之骨骼區域施加 減低之壓力; 圖33圖解說明圖32所示髖假體之剖面正視圖,該髖假體 具有第二複數個流動通道,以用於將流體輪送至環繞該髖 假體之骨骼區域; 圖3 4繪示一種根據本發明一實施例使用減壓組織治療來 修復患者關節之方法之流程圖; 圖35圖解說明一種根據本發明一實施例之減壓輸送裝置 之剖面正視圖,該減壓輸送裝置包含一矯形外科固定器件 ’該矯形外科m件具有複數個流動通道,以用於對她 鄰該矯形外科固定器件之骨骼區域應用減低之壓力; 154474.doc •55· 1362951 圖36繪示圖35所示矯形外科固定器件之剖面正視圖,該 矯形外科固定器件具有第二複數個流動通道,以用於將流 體輸送至毗鄰該矯形外科固定器件之骨骼區域; 圖37圖解說明一種根據本發明一實施例用於使用減壓組 織治療來醫治骨骼之骨骼缺損之方法之流程圖; 圖3 8繪示一種根據本發明一實施例用於對一組織部位施 行減壓組織治療之方法之流程圖;以及 圖39圖解說明一種根據本發明一實施例用於對一組織部 位施行減壓組織治療之方法之流程圖。 圖40-48繪示根據本發明一實施例之減壓輸送系統之各 種視圖’該減壓輸送系統具有一主歧管,該主歧管包括 一環繞一主流動通道之撓性壁及位於該撓性壁中之複數 個孔; 圖49-50圖解說明一種根據本發明一實施例之減壓輸送 系統之透視圖及俯視剖面圖,該減壓輸送系統具有—成— 體地連接至一減壓輸送管之主歧管; 圖51繪示與一辅助歧管一起應用於一骨骼組織部位之圖 40-50所示主歧管之透視圖;以及 圖52圖解說明一種根據本發明一實施例具有一流體連接 至一第二導管之閥門之減壓輸送系統之示意圖。 【主要元件符號說明】 211 減壓輸送裝置或翼狀歧管 213 撓性障壁 215 凸脊部分 154474.doc •56· 1362951This patent or application file contains at least one color pattern. The patent or patent application publication with color drawings may be provided by the Patent Office upon request and after payment of the necessary fee. 1 is a perspective view of a reduced pressure conveying device having a plurality of protrusions extending from a flexible barrier to form a plurality of flow passages according to an embodiment of the present invention; FIG. 2 illustrates FIG. 4 is a top view of the reduced pressure conveying device shown in FIG. 1; the pressure reducing FIG. 4A illustrates a side view of the reduced pressure conveying device shown in FIG. 1 154474.doc • 51 1362951 The conveying device has a single lumen decompression conveying pipe; the cabinet diagram (10) shows one of the minus 1 conveying devices shown in FIG. 1 , and the side of the decompression conveying device has a double lumen decompression conveying pipe; 5 illustrates an enlarged perspective view of the reduced pressure delivery device of FIG. 1; FIG. 6 depicts a perspective view of a reduced pressure delivery device according to the present invention - an embodiment of the reduced pressure delivery device having a - attaching property a honeycomb on the barrier: a flexible barrier having a ridge portion and a pair of wing portions, the honeycomb material having a plurality of flow passages; FIG. 7 is a front view showing one of the pressure reducing conveying devices shown in FIG. Figure 8 is a cross-sectional view of the vacuum conveying device shown in Figure 7 at XVH-XVH Figure 8A illustrates a cross-sectional front view of the present invention in accordance with the present invention. Figure 8B is a side elevational view of the reduced-pressure delivery device of Figure 8A; Figure 9 illustrates a A front view of a reduced pressure delivery of an embodiment of the invention is used to apply a reduced pressure tissue treatment to a patient's bones. Figure 10 depicts a colored tissue section of a rabbit skull showing the original damaged bone; '°' Figure 11 illustrates a color histological section of a rabbit skull, which is not a granulation tissue induced after extensive decompression tissue treatment; Figure 12 depicts a colored tissue section of a rabbit skull showing new bones after application of compression tissue therapy Deposition; < Salt Figure 13 illustrates a color tissue section of a rabbit skull, Α ', 廯 廯 廯 沉积 减压 减压 减压 减压 减压 减压 ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; a color photograph in which two critical size defects are formed; Figure 5 illustrates a color photograph of the rabbit skull shown in Figure 14 showing that it dares to enter one of the critical dimension defects Calcium acid scaffold and a stainless steel mesh covering the second critical dimension defect; Figure 16 illustrates a color photograph of the rabbit skull shown in Figure 14 showing the application of reduced pressure tissue treatment to a critical size defect; Figure 17 illustrates the implementation of decompression A tissue section of a rabbit skull after tissue treatment, the tissue section showing deposition of new bone in a calcium phosphate scaffold; Figure 18 depicts stent-filled as shown in Figure 15 after performing decompression tissue treatment for six days and two weeks of surgery Radiograph of critical dimension defect; FIG. 19 is a radiograph of the critical dimension defect filled by the stent shown in FIG. 15 after performing decompression tissue treatment for six days and performing twelve weeks of surgery; FIG. A front view of a reduced pressure delivery system of an embodiment of the present invention, the reduced pressure delivery system having a manifold delivery tube for inserting a reduced pressure delivery device through a skin into a tissue site; FIG. 21 illustrates FIG. An enlarged front view of the manifold delivery tube, the manifold delivery tube comprising a reduced pressure delivery device having a flexible barrier and/or a compression position Figure 12 is an enlarged front elevational view of the manifold delivery tube of Figure 21 showing the flexible barrier and/or honeycomb of the reduced pressure delivery device after being pushed from the manifold delivery tube The material is in an expanded position; FIG. 23 illustrates a front view of a reduced pressure delivery system 154474.doc-53·1362951 in accordance with an embodiment of the present invention. The reduced pressure delivery system has a reduced pressure delivery device for transcutaneous administration. a manifold delivery tube inserted into a tissue site, the figure showing that the reduced pressure delivery device is outside the manifold delivery tube but is constrained to a compressed position by an impermeable membrane; FIG. 24 depicts the reduction shown in FIG. A front view of a pressure delivery system showing the reduced pressure delivery device outside the manifold delivery tube but constrained to a relaxed position by a non-permeable membrane; Figure 25 illustrates the reduced pressure delivery system of Figure 23 a front view showing the reduced pressure delivery device outside the manifold delivery tube but constrained by a non-penetrating film in an expanded position; FIG. 25A illustrates one of the reduced pressure delivery systems illustrated in FIG. The view shows that the reduced pressure delivery device is outside the manifold tube but is surrounded by an impermeable membrane in an expanded position; FIG. 26 illustrates a front view of a reduced pressure delivery system in accordance with an embodiment of the present invention. The shai reduced pressure delivery system has a manifold delivery tube for inserting a decompression delivery device through the skin into a tissue site, the figure showing that the reduced pressure delivery device is outside the manifold delivery tube, but is subjected to a FIG. 26A illustrates a front view of a reduced pressure delivery system in accordance with an embodiment of the present invention, and FIG. 27 illustrates a front view of a reduced pressure delivery system in accordance with an embodiment of the present invention. The reduced pressure delivery system has a manifold delivery tube for injecting a reduced pressure delivery device through the skin to a tissue site; FIG. 27A illustrates a reduced pressure delivery system 154474.doc in accordance with an embodiment of the present invention. -54 - 1362951 In elevation, the reduced pressure delivery system has a manifold delivery tube for delivering a reduced pressure delivery device through the skin to a tissue site Permeable film; FIG. 28 is a flow chart showing a method for performing decompression tissue treatment on a tissue site according to an embodiment of the present invention; FIG. 29 is a view illustrating decompression of a tissue site according to an embodiment of the present invention. Figure 30 is a flow chart of a method of tissue decompression treatment according to an embodiment of the present invention; Figure 31 illustrates an embodiment of a tissue site according to an embodiment of the present invention. FIG. 32 is a cross-sectional elevation view of a reduced pressure delivery device including a hip prosthesis having a plurality of flows, in accordance with an embodiment of the present invention; a channel for applying a reduced pressure to a region of the bone surrounding the hip prosthesis; Figure 33 illustrates a cross-sectional elevation view of the hip prosthesis of Figure 32 having a second plurality of flow channels for Transferring fluid to a bone region surrounding the hip prosthesis; FIG. 34 illustrates a method of repairing a patient's joint using reduced pressure tissue treatment in accordance with an embodiment of the present invention Figure 35 illustrates a cross-sectional elevation view of a reduced pressure delivery device including an orthopedic fixation device having a plurality of flow channels for use with a plurality of flow channels, in accordance with an embodiment of the present invention. Applying a reduced pressure to the bone region of the orthopaedic fixation device; 154474.doc • 55· 1362951 FIG. 36 is a cross-sectional elevation view of the orthopedic fixation device of FIG. 35 having a second plurality of orthopedic fixation devices a flow channel for delivering fluid to a bone region adjacent to the orthopedic fixation device; FIG. 37 illustrates a flow chart of a method for treating bone defects in bone using reduced pressure tissue therapy in accordance with an embodiment of the present invention; Figure 38 is a flow chart showing a method for performing decompression tissue treatment on a tissue site in accordance with an embodiment of the present invention; and Figure 39 illustrates a method for decompressing a tissue site in accordance with an embodiment of the present invention. Flow chart of a method of organizing treatment. 40-48 illustrate various views of a reduced pressure delivery system in accordance with an embodiment of the present invention. The reduced pressure delivery system has a main manifold including a flexible wall surrounding a main flow channel and located therein. A plurality of apertures in a flexible wall; Figures 49-50 illustrate perspective and top cross-sectional views of a reduced pressure delivery system having a body-to-body connection to a subtraction, in accordance with an embodiment of the present invention. a primary manifold of the pressure delivery tube; FIG. 51 is a perspective view of the primary manifold shown in FIGS. 40-50 applied to a bone tissue site with an auxiliary manifold; and FIG. 52 illustrates an embodiment in accordance with the present invention. A schematic view of a reduced pressure delivery system having a valve fluidly coupled to a second conduit. [Main component symbol description] 211 Pressure reducing device or wing manifold 213 Flexural barrier 215 Ridge portion 154474.doc •56· 1362951
219 翼狀部分 223 拱形通道 227 撓性背襯 231 突起物 233 流動通道 241 減壓輸送管 243 遠端孔口 255 近端孔口 259 管腔或通路 261 雙管腔管 263 第一管腔 265 第二管腔 271 水平間隔件 311 減壓輸送裝置或翼狀歧管 313 撓性障壁 315 凸脊部分 319 翼狀部分 323 拱形通道 327 蜂巢狀材料 329 分佈表面 330 周邊表面 341 減壓輸送管 343 遠端孔口 355 近端孔口 154474.doc -57- 1362951 359 管腔或通路 371 減壓輸送裝置 373 減壓輸送管 375 延伸部分 377 遠端 381 切口 383 凸肩 385 突起物 387 内表面 391 流動通道 411 減壓輸送裝置 413 組織部位 415 人體骨骼 419 減壓輸送管 421 近端 427 減壓源 429 空隙缺損 431 流體輸送管 432 近端 433 流體輸送源 434 過遽器 435 壓力感測器 711 減壓輸送系統 713 組織部位 154474.doc -58- 1362951 ❿ 721 歧管輸送管 725 導向單元 727 導引金屬絲 731 骨折部位 733 患者骨骼 735 皮膚 739 軟組織 743 錐形遠端 751 通路 761 減壓輸送裝置 765 撓性障壁 767 蜂巢狀材料 769 減壓輸送管 811 減壓輸送系統 821 歧管輸送管 837 虛線 843 遠端 861 減壓輸送裝置 865 撓性障壁 867 蜂巢狀材料 869 減壓輸送管 871 不滲透性薄膜 873 内表面 881 標誌、 154474.doc -59- 1362951 885 移出器具 891 輔助管腔或管 911 減壓輸送系統 921 歧管輸送管 937 虛線 943 遠端 961 減壓輸送裝置 965 撓性障壁 967 蜂巢狀材料 969 減壓輸送管 971 不滲透性薄膜 973 内表面 977 膠封 981 標言志 985 減壓輸送系統 987 導引金屬絲 989 減壓輸送管 991 減壓輸送裝置 993 組織部位 1011 減壓輸送系統 1021 歧管輸送管 1025 組織部位 1029 空隙 1035 減壓輸送裝置 154474.doc -60- 1362951 1043 1055 1057 1061 1511 1515 1517 1521 籲 1525 1529 1535 1541 1543 1545 1547 1551219 wing portion 223 arched channel 227 flexible backing 231 protrusion 233 flow channel 241 decompression delivery tube 243 distal orifice 255 proximal orifice 259 lumen or passage 261 double lumen tube 263 first lumen 265 Second lumen 271 horizontal spacer 311 decompression delivery device or wing manifold 313 flexible barrier 315 ridge portion 319 wing portion 323 arcuate channel 327 honeycomb material 329 distribution surface 330 peripheral surface 341 decompression conduit 343 Distal orifice 355 proximal orifice 154474.doc -57- 1362951 359 lumen or passage 371 decompression delivery device 373 decompression delivery tube 375 extension 377 distal end 381 incision 383 shoulder 385 projection 387 inner surface 391 flow Channel 411 decompression delivery device 413 tissue site 415 human bone 419 decompression delivery tube 421 proximal end 427 decompression source 429 void defect 431 fluid delivery tube 432 proximal end 433 fluid delivery source 434 filter 435 pressure sensor 711 decompression Conveying system 713 Tissue site 154474.doc -58- 1362951 ❿ 721 Manifold duct 725 Guide unit 727 Guide wire 731 fracture site 733 patient bone 735 skin 739 soft tissue 743 tapered distal end 751 pathway 761 decompression delivery device 765 flexible barrier 767 honeycomb material 769 decompression delivery tube 811 decompression delivery system 821 manifold delivery tube 837 dotted line 843 distal 861 Pressure reducing device 865 Flexure barrier 867 Honeycomb material 869 Pressure reducing pipe 871 Impervious film 873 Inner surface 881 Mark, 154474.doc -59- 1362951 885 Removal device 891 Auxiliary lumen or tube 911 Reduced pressure delivery system 921 manifold pipe 937 dotted line 943 distal end 961 decompression conveying device 965 flexible barrier 967 honeycomb material 969 decompression pipe 971 impervious film 973 inner surface 977 rubber seal 981 mark 985 decompression conveying system 987 guide Wire 989 Pressure reducing pipe 991 Pressure reducing device 993 Tissue part 1011 Pressure reducing system 1021 Manhole pipe 1025 Organization part 1029 Void 1035 Pressure reducing device 154474.doc -60- 1362951 1043 1055 1057 1061 1511 1515 1517 1521 Call 1525 1529 1535 1541 1543 1545 1547 1551
1553 1565 1571 1573 1583 1585 1711 1715 遠端 内部空間 輔助管腔 導引金屬絲 減壓輸送裝置 整形外科髖假體 患者腿節 柱部分 頭部分 通路 多孔塗層 流動通道 主饋送管線 橫向分支管線 橫向分支管線 減壓輸送管 減壓輸送源 連接埠 流體輸送管 流體輸送源 主饋送管線 橫向分支管線 減壓輸送裝置 整形外科固定器件 154474.doc •61 · 1362951 1717 骨骼 1719 骨折部位 1721 通路 1725 螺釘 1735 多孔塗層 1741 流動通道 1743 主饋送管線 1745 連接埠 1747 橫向分支管線 1751 減壓輸送管 1753 減壓輸送源 1761 流動通道 1765 連接埠 1771 流體輸送管 1773 流體輸送源 1783 主饋送管線 1785 橫向分支管線 2111 減壓輸送系統 2115 主歧管 2117 撓性壁 2121 主流動通路 2123 近端 2129 過渡區 2135 防阻塞部件 -62- 154474.doc 13629511553 1565 1571 1573 1583 1585 1711 1715 distal internal space assisted lumen guiding wire decompression delivery device orthopedic hip prosthesis patient leg section part head section passage porous coating flow channel main feed line lateral branch line lateral branch line Decompression delivery tube decompression delivery source connection 埠 fluid delivery tube fluid delivery source main feed line lateral branch line decompression delivery device orthopedic fixation device 154474.doc •61 · 1362951 1717 bone 1719 fracture site 1721 pathway 1725 screw 1735 porous coating 1741 Flow channel 1743 Main feed line 1745 Connection 埠 1747 Lateral branch line 1751 Reduced pressure line 1753 Reduced pressure supply source 1761 Flow channel 1765 Connection 埠 1771 Fluid transfer line 1773 Fluid supply source 1783 Main feed line 1785 Lateral branch line 2111 Reduced pressure delivery System 2115 main manifold 2117 flexible wall 2121 main flow path 2123 proximal end 2129 transition zone 2135 anti-blocking component -62- 154474.doc 1362951
2137 突起物 2141 内表面 2145 脊 2149 蜂巢狀材料 2155 子L 2161 第一導管 2163 第二導管 2171 頂隙 2211 減壓輸送系統 2215 主歧管 2217 減壓輸送管 2223 中央管腔 2225 輔助管腔 2231 孔 2241 頂隙 2321 輔助歧管 2411 減壓輸送系統 2415 歧管 2419 第一導管 2423 第二導管 2429 減壓源 2435 出口 2439 閥門 2453 控制器 154474.doc •63-2137 protrusion 2141 inner surface 2145 ridge 2149 honeycomb material 2155 sub L 2161 first conduit 2163 second conduit 2171 headspace 2211 decompression delivery system 2215 main manifold 2217 decompression delivery tube 2223 central lumen 2225 auxiliary lumen 2231 hole 2241 Headspace 2321 Auxiliary Manifold 2411 Reduced Pressure Delivery System 2415 Manifold 2419 First Catheter 2423 Second Catheter 2429 Decompression Source 2435 Outlet 2439 Valve 2453 Controller 154474.doc •63-
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US11/724,073 US8267918B2 (en) | 2006-03-14 | 2007-03-13 | System and method for percutaneously administering reduced pressure treatment using a flowable manifold |
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TW201130531A TW201130531A (en) | 2011-09-16 |
TWI362951B true TWI362951B (en) | 2012-05-01 |
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TW100107836A TWI362951B (en) | 2007-03-13 | 2007-04-03 | System and method for percutaneously administering reduced pressure treatment using a flowable manifold |
TW96111827A TWI355948B (en) | 2007-03-13 | 2007-04-03 | System and method for percutaneously administering |
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TW96111827A TWI355948B (en) | 2007-03-13 | 2007-04-03 | System and method for percutaneously administering |
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TWI355948B (en) | 2012-01-11 |
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