TWI392472B - 用於活化骨骼及軟骨形成之組合物 - Google Patents
用於活化骨骼及軟骨形成之組合物 Download PDFInfo
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- TWI392472B TWI392472B TW097124462A TW97124462A TWI392472B TW I392472 B TWI392472 B TW I392472B TW 097124462 A TW097124462 A TW 097124462A TW 97124462 A TW97124462 A TW 97124462A TW I392472 B TWI392472 B TW I392472B
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- bone
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2002/3092—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
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- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2002/3093—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00089—Wound bandages
- A61F2013/00357—Wound bandages implanted wound fillings or covers
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/02—Bones
Description
本發明概括而言係關於組織治療系統,且特別地係關於透由減壓的運用藉以活化硬腦膜、骨膜或骨內膜,以促進新骨骼或軟骨組織生長之系統及方法。
本申請案主張經由引用併入之申請於2007年6月29日之美國臨時申請案第60/937,904號之權益。
臨床研究和實務業已證實,在組織部位附近提供減壓可以擴大及加速該組織部位新組織之生長。此現象有多方面的應用,而減壓應用在治療創傷尤其成功。此治療(在醫界常被稱為"負壓創傷療法"、"減壓療法"或"真空療法")提供諸多益處,包括較快速的癒合及肉芽組織快速的形成。典型地,減壓係經過透氣襯墊或其他各種裝置施用至組織。透氣襯墊包能將減壓分配至組織並輸送自組織所吸取之液體之細胞或氣孔。透氣襯墊常併入至具有促進治療之其他成分之繃帶中。
創傷癒合可以大致分成三個相互重疊之基礎階段:發炎、增生及成熟。發炎階段之特點在於止血和發炎。下一階段主要由血管生成、肉芽組織形成、膠原沉積及上皮形成組成。最後階段包括成熟及重塑。創傷癒合步驟之複雜性會因局部性因素(如局部缺血、水腫和感染)及系統性因素(如糖尿病、年齡、甲狀腺機能減退、營養不良和肥胖)增加。然而,創傷癒合之速限步驟常為血管生成。
在骨骼和軟骨癒合中,骨膜是發展為成骨細胞及成軟骨細胞之前驅細胞的主要來源。骨髓、骨內膜、小血管及纖維結締組織則為前驅細胞之次要來源。然而,骨骼及尤其軟骨癒合經常是緩慢的且常不足的。為此,醫界長期以來設法發展為骨骼及軟骨缺陷組織修復和替換之改進方法。
以具有顱面缺陷而言,成功修復或替代療法大大地因缺乏硬腦膜之內生性成骨性能力而受到阻礙。不幸地,人類硬腦膜在人約2歲以後開始迅速地失去其成骨性能力。當前針對顱面缺陷之再造技術係使用自生性、異源性及人工性物質來克服成熟硬腦膜之成骨性的不足。生長因子也常用於促進組織再生。這些技術可以達成恢復顱面缺陷之某些機能,但是該等皆先天受限於一些因素,如供應部位不健全、不可預見之移植物再吸收、不足的自生性資源、病毒性疾病傳播、免疫性不相容性、結構損壞、不符要求的美觀結果及成本。此外,已證明,經生長因子所誘導之造骨細胞最初源自於硬腦膜之未分化間質幹細胞,其後經覆蓋在結締組織上面之細胞(雖然有限)擴增,而非來自缺陷周圍顱骨中之細胞。細胞激素或其他因子係用以誘導源自於硬膜及覆蓋在結締組織上面之造骨細胞。
改良治癒骨骼及軟骨之方法因此是有必要的。本發明即滿足此需求。
針對骨骼及軟骨癒合既存方法所造成的問題可藉由本文所述之例示性實施例的系統及方法加以解決。在一個實施
例中,係提供一種包括在有其需要個體之某部位處活化成骨性或成軟骨活性之方法。該方法包括將減壓施用至個體某部位之硬腦膜、骨膜或骨內膜。
在另一個實施例中,係提供一種包括治療個體之骨骼或軟骨缺陷的方法。該方法包括將減壓施用至鄰近該缺陷之硬腦膜、骨膜或骨內膜。
在進一步實施例中,係提供利用減壓儀器以治療鄰近硬腦膜、骨膜或骨內膜之骨骼或軟骨缺陷。
在另一個實施例中,係提供一種治療骨骼或軟骨缺陷之組合物。該組合物包括減壓儀器和生物相容性支架。利用該組合物,該缺陷係鄰近硬腦膜、骨膜或骨內膜。
在更進一步之實施例中,係提供減壓儀器及生物相容性支架在製造供治療鄰近硬腦膜、骨膜或骨內膜之骨骼或軟骨缺陷之組合物之用途。
參考後附圖解及詳細說明,例示性實施例之其他目標、特徵及優點會是顯而易見的。
下列詳細說明之例示性實施例中,參考本說明部分附圖。這些實施例係經詳述,足以使熟識該技藝者實踐本發明,並咸欲理解可以使用其他實施例,且咸欲理解所進行的邏輯性結構學、機械學、電學及化學改變不會跳脫本發明之精神或範圍。為避免使熟識該技藝者實踐本文所述實施例非必要之細節,所述內容可能省略熟識該技藝者所熟知之某些資訊。因此,下列詳述內容不應視為具有限制
性,及該例示性實施例之範圍僅界定為附加申請專利範圍請求項。
在本說明書範圍內,術語"減壓"通常係指經受治療之組織部位之壓力低於外界壓力。大多數情況下,此減壓將低於病人所處之大氣壓力。雖然術語"真空"和"減壓"可用於描述施用於該組織部位之壓力,但施用至該組織部位之實際壓力明顯地高於正常下與絕對真空有關之壓力。與此命名法相符的是,減壓或真空壓力之增加係指絕對壓力之相對減少,而在減壓或真空壓力之減少則係指絕對壓力之相對增加。描述組織減壓治療之不同方法及組合物見於下列專利公開案:WO08042481A2、WO08036361A2、WO08036359A2、WO08036162A2、WO08013896A2、WO07143060A2、WO07133556A2、WO07133555A2、WO07106594A2、WO07106592A2、WO07106591A2、WO07106590A2、WO07106589A2、WO07092397A2、WO07067685A2、WO05033273A2、WO05009488A2、WO04105576A2、WO04060148A2、WO03092620A2、WO03018098A2、WO0061206A1、WO0038755A2、US20070123895、US7351250、US7346945、US7316672、US7279612、US7214202、US7186244、US7108683、US7077832、US7070584、US7004915、US6994702、US6951553、US6936037、US6856821、US6814079、US6767334、US6695823和US6135116。
此項應用係根據下列的發現:將減壓施用於鄰近硬腦
膜、骨膜或骨內膜之骨骼或軟骨上,透過硬腦膜(其中缺陷是顱面缺陷)、骨膜或骨內膜可誘導骨骼或軟骨形成。將泡沫繃帶應用至骨骼或軟骨也可以誘導新骨骼或軟骨形成,但無法達到減壓治療之程度。參見範例。
因此,在一些實施例中,該應用係關於在有其需要個體某部位活化成骨性或成軟骨活性之方法。該方法包括將減壓施用至個體某部位之硬腦膜、骨膜或骨內膜。較佳地,該個體係在鄰近硬腦膜、骨膜或骨內膜具有骨骼或軟骨缺陷。然而,該應用非局限於骨骼或軟骨缺陷之部位。例如,該個體可以此等方法處理無缺陷之未損傷硬腦膜、骨膜或骨內膜處,且所得新組織移植至身體其他有缺陷部位。
在一些實施例中,減壓係施用至硬腦膜。在其他實施例中,減壓係施用於骨膜。如範例4所示,藉由將骨膜短暫曝露在減壓下,未損傷骨骼中之骨內膜流體流動會增加。據信此骨內膜中所增加之流體流動可顯示出骨內膜中所增加之成骨性活性。因此,藉由將減壓施用至骨膜可誘導骨內膜之成骨性活性。
在其他實施例中,減壓用於骨內膜。此處理是有用的,例如,將減壓施用至骨骼裂口處,以便誘導骨生成至置於裂口處支架中。
該等方法非僅狹隘地局限於處理任一具體類型之缺陷。然而,咸欲承認,經以該等方法處理之個體中主要缺陷為(a)源自創傷,(b)由於癌症,(c)由於變性疾病(如骨關節
炎)或(d)先天性的。在一些實施例中,該缺陷係為骨骼缺陷。在其他實施例中,該缺陷為軟骨缺陷。
較佳地,生物相容性支架係放置在該部位,其中該部位包括缺陷,而生物相容性支架較佳係嵌入至該缺陷中。本方法不局限於使用任一具體生物相容性支架;許多有用之生物相容性支架在該項技藝中係為吾人所熟知的。在一些實施例中,該生物相容性支架為生物吸收性聚合物。在較佳實施例中,該生物吸收性聚合物為聚乳酸乙醇酸共聚物(PLAGA)聚合物或聚乙二醇-PLAGA共聚物。
該生物相容性支架亦可包括可促進創傷癒合之成分。此種成分包括細胞激素,例如,促進血管新生或細胞生長者(如脈管內皮細胞生長因子(vascular endothelial growth factor;VEGF))、鹼性成纖維細胞生長因子(basic fibroblast growth factor;bFGF)、血小板衍化生長因子(platelet derived growth factor;PDGF)、血管生成素(angiogenin)、血管生成素原-1(angiopoietin-1)、粒細胞集落-刺激因子(G-CSF)、肝細胞生長因子/散射因子(HGF/SF)、白介素-8(IL-8)、胎盤生長因子、血小板衍生內皮細胞生長因子(PD-ECGF)、血小板衍生生長因子-BB(PDGF-BB)、轉化生長因子-α(TGF-α)、轉化生長因子-β(TGF-β)、腫瘤壞死因子-α(TNF-α)、脈管內皮細胞生長因子(VEGF),或基質金屬蛋白酶(MMP)。其他有用地被歸入支架之其他成分包括抗生素,或能夠變成造骨細胞、成軟骨細胞或維管組織之細胞,例如胚胎幹細胞、成人造血幹細胞、骨髓基質細
胞或間質幹細胞。該等細胞可選擇性地以遺傳基因工程處理以表現出有用之蛋白質,諸如其中一種上述細胞激素。
在較佳實施例中,減壓可透過經連接至減壓源之歧管施用至缺陷,其中該歧管係多孔性的,並被置於缺陷上或缺陷內。另外較佳者,該歧管係來自可流動物質,該可流動物質透過歧管輸送導管可傳遞至組織部位,如此該可流動物質即可填補該缺陷。在一些實施例中,該歧管為生物吸收性聚合物並能充當生物相容性支架。此種生物吸收性聚合物之非限制性示例包括聚乳酸乙醇酸共聚物(PLAGA)聚合物或聚乙二醇-PLAGA共聚物。
圖1顯示應用到硬腦膜缺陷之方法之較佳範例。咸應注意,相同減壓系統可用於骨膜或骨內膜。
參考圖1所述本發明應用非限制性實施例係提供系統10,該系統包括流動性地連接到置於鄰近並與硬腦膜22接觸之歧管18之減壓源14。歧管18包括藉由減壓源14將減壓供應至硬腦膜22以分配減壓之任何生物相容性物質。歧管18係由多孔性材料形成或包括有助於分配減壓之流道。在一個實施例中,歧管18可包括支架,或該全體歧管可以是能夠支援新組織生長及結合之支架。該支架可併入新組織生長並在新組織修復或再生後仍留在原處。支架是從生物可吸收物質形成,該生物可吸收物質在組織修復或再生後可被身體吸收。
濾毒罐30係以非固定方式連接介於減壓源14和歧管18之間,以便在施用減壓期間捕集及保留從鄰近歧管18之區域
抽取組織流出物及其他液體。濾膜係以非固定方式連接介於歧管18和減壓源14之間,以便避免減壓源14被組織液及細菌的污染。較佳地,以液體連接減壓源14及歧管18(和任何其他液體成分)間則係藉由醫藥級導管34所提供。導管34可透過歧管接頭(未顯示)或透過直接置於導管34一端與歧管18接觸流暢地附著在歧管18,如此該導管34可直接與歧管18有關之氣孔或液體通道聯通。
在一個實施例中,歧管18為生物可吸收支架,且減壓源14透過導管34及該支架可將減壓供應至硬腦膜22。未囿於任何具體作用機制,據信在硬腦膜22上方所存在之減壓會給予硬腦膜張力,該張力可活化類似於在新生兒、發育未成熟硬腦膜所見顯型之表現作用。透過施加減壓及在硬腦膜上張力所引起的本身刺激作用足以將新骨骼及支援組織駐留在支架上。參見範例1。
減壓治療非狹隘性地局限於任一應用之特定時間。範例1確定1天(24小時)的時間足以誘導新骨形成、彌合缺陷裂口及有效的支架浸潤。在不同實施例中,該減壓可施用於各處0.1小時至144小時或更長的時間。在其他實施例中,該減壓可施用至少24小時。在其他範例中,該減壓可施用少於24小時(如12小時)。在其他實施例中,該減壓可施用為12小時至3天。
如範例2和3所建立者,係在骨膜或骨內膜上所要骨骼或軟骨生長部位(如在缺陷處))僅放置泡沫歧管(較佳地為GranuFoam)即可誘導骨骼或軟骨生長,儘管誘導效果沒
有減壓大。因此,咸預期將生物相容性泡沫置於鄰近硬腦膜、骨膜或骨內膜之缺陷而在無減壓下可有利地誘導骨骼或軟骨生長。
在另一個實施例中,本發明亦係關於一種治療個體骨骼或軟骨缺陷之方法。該方法包括將減壓施用至鄰近該缺陷之硬腦膜、骨膜或骨內膜。在一些實施例中,該減壓係施用於硬腦膜。在其他實施例中,該減壓係施用於骨膜。在其他實施例中,該減壓係施用於骨內膜。
如上所述之方法,在本方法中,生物相容性支架較佳地係嵌入至該缺陷中。該生物相容性支架較佳地為生物吸收性聚合物,最佳地為聚乳酸乙醇酸共聚物(PLAGA)聚合物或聚乙二醇-PLAGA共聚物。
在較佳實施例中,該減壓係透過經連接到減壓源之歧管施用於硬腦膜、骨膜或骨內膜。於此,該歧管是多孔性的,且被置於缺陷上或缺陷內。更佳地,該歧管來自可流動之物質,該物質透過歧管輸送導管傳遞至組織部位,如此該可流動物質即可填補該缺陷。尤其更佳地,該支架包括生物吸收性聚合物並能充當生物相容性支架。該生物吸收性聚合物最佳為聚乳酸乙醇酸共聚物(PLAGA)聚合物或聚乙二醇-PLAGA共聚物。
在這些方法中,該減壓可施用任一處0.1小時至144小時或更長的時間。在許多實施例中,該減壓施用至少24小時。
本申請案亦係關於提供利用減壓儀器以治療鄰近硬腦
膜、骨膜或骨內膜之骨骼或軟骨缺陷。如上所述之方法,該減壓儀器較佳包括經連接到減壓源之歧管,其中歧管為多孔性的,且被置於缺陷上或缺陷內。更佳地,歧管係來自可流動的物質,該物質透過歧管輸送導管傳遞至組織部位,如此可流動物質即可填補缺陷。
在其他的實施例中,本發明係關於用以治療骨骼或軟骨缺陷之組合物。本組合物包括減壓儀器和生物相容性支架,其中該缺陷鄰近硬腦膜、骨膜或骨內膜。該生物相容性支架較佳為生物吸收性聚合物,最佳為聚乳酸乙醇酸共聚物(PLAGA)聚合物或聚乙二醇-PLAGA共聚物。
在較佳組合物中,該減壓儀器包括經連接到減壓源之歧管。在這些實施例中,歧管為多孔性的。較佳地,該歧管包括生物相容性支架。更佳地,該歧管包括生物吸收性聚合物,最佳地為聚乳酸乙醇酸共聚物(PLAGA)聚合物或聚乙二醇-PLAGA共聚物。
在這些實施例中,該歧管較佳係來自可流動之物質,該物質可透過歧管輸送導管傳遞至組織部位,如此可流動物質即可填補該缺陷。
本申請案進一步係關於利用減壓儀器和生物相容性支架以製造供治療鄰近硬腦膜、骨膜或骨內膜之骨骼或軟骨缺陷之組合物之用途。該生物相容性支架較佳為生物吸收性聚合物,最佳為聚乳酸乙醇酸共聚物(PLAGA)聚合物或聚乙二醇-PLAGA共聚物。
基於該項用途,該減壓儀器較佳包括經連接到減壓源之
歧管,其中該歧管為多孔性的。更佳地,該歧管包括生物相容性支架。尤其更佳地,該歧管包括生物吸收性聚合物,最佳為聚乳酸乙醇酸共聚物(PLAGA)聚合物或聚乙二醇-PLAGA共聚物。
在較佳實施例中,該歧管係來自可流動之物質,該物質透過歧管輸送導管傳遞至組織部位,如此可流動物質即可填補該缺陷。
較佳實施例係敍述於下列範例中。考量此文所揭示之本發明專利說明書或實務,其他本文申請專利請求項範圍內之其他實施例對於熟識該技藝者是顯而易見的。咸意欲透過範例後之請求項所指之本發明範圍和精神,本專利說明書連同範例僅視為示範的。
參考圖2,透過支架執行頭蓋缺陷研究,以評估將減壓施用至未損傷硬腦膜之效果。在具有硬腦膜未損傷之兔子頭蓋骨內製造臨界尺寸缺陷。將類似圖1中所示之支架(即歧管及/或支架18)放置與硬腦膜接觸。進行若干測試,其不同在於施用減壓的時間上。進行控制組試驗,其中並未提供減壓至被放置與硬腦膜接觸之支架。針對每一特定缺陷進行12週之生命週期癒合(包括減壓施用時間),檢測頭蓋骨及支架之檢體。測定值包括觀察到的新骨骼區域大小、定量彌合評定百分比、總支架浸潤百分比,及新骨骼生長穿透至支架上半部。這些測量值列於下表1。
"新骨骼"係為形成於支架中之骨骼的總面積。"彌合評定"為彌合缺陷一邊至另一邊骨骼之百分比,其係通過缺陷中心測量。由於彌合評定可顯示出閉合該缺陷之有效性,故其為重要的臨床因素。"支架浸潤百分比"為被骨骼填補之支架中總可用空間之百分比。"上半部穿透"為骨骼在支架上半部之含量。
如表1所示,相對控制組檢體,減壓之施用會明顯地提高所有經測試之骨形成參數。研究期間,在組織支架嵌入前,必須小心保持未損傷的硬膜。在每個時間點,相較控制組,減壓在統計上會激勵更大量的新骨沉積,此顯示在施用1天後即可達到限值的情況。儘管較長時間之施用不會提高彌合評定,但較長的期間確實會影響骨沉積的分配,尤其在進一步從硬腦膜上去掉之上部組織支架。既然缺陷上方之軟組織不會受減壓影響,則觀察及量化之差異大概係與硬腦膜活化有關。
參考圖3至圖4C,拍攝如上所述之測試中獲得檢體之顯微照片。圖3所示係在兔子頭蓋骨中鄰近新形成骨骼45之
硬腦膜鞘之正常結構之顯微照片。另外呈現的是硬腦膜鞘40及新骨骼45之間之造骨細胞47。經受減壓後新骨形成及整合至支架之檢測結果證實未損傷硬腦膜對支架物質在成骨性反應之影響。圖4A是顯示在新骨形成區域55及無新骨形成區域60之間具有明顯分界之動物檢體之顯微照片。儘管兩個區域均包含支架物質62,但缺少未損傷的硬腦膜一致與未形成新骨有關。在圖4A中,新骨形成55位於未損傷硬膜64附近。圖4B所示係中樞神經系統組織70及組織支架75缺乏被未損傷硬腦膜分離之檢體。圖4B顯著地未出現新骨形成。相反地,圖4C顯示邊界明顯的硬腦膜80,且在與硬膜80密切接觸處有大量的新骨形成90。
評估泡沫歧管及減壓在誘導骨膜合成新骨骼之能力。曝露完整、未損傷的兔子顱骨骨膜。將GranuFoam(KCI Licensing,Inc.,San Antonio TX)泡沫繃帶施用於骨骼。在一些處理中,經泡沫覆蓋之骨骼還經受減壓處理。處理後,動物被處死,經處理骨骼經受石蠟包埋、切片及染色以評估該處理對新骨形成之效果。
圖5所示的是兔子中原始、未受損傷骨膜。箭頭表示骨膜薄層之位置。骨膜為薄的且不明顯的。相比之下,圖6顯示的是誘導覆蓋在骨膜上面之肉芽組織,其中該泡沫係保持與骨骼表面接觸6天而未經減壓處理。藉由將骨骼曝露於泡沫而未經減壓處理可誘導肉芽組織。此證明覆蓋在骨膜上面肉芽組織之泡沫誘導作用。圖7所示的是用泡沫
及減壓處理骨骼(-125 mm Hg)。僅泡沫處理即可提高新骨形成。圖8顯示經受泡沫及減壓之另一骨骼切片,其顯示新骨沈積在新形成肉芽組織下。新骨沉積覆蓋在原來骨膜-外皮分介面上。
總而言之,當僅施用泡沫時,此範例顯示可誘導新骨骼。透過泡沫施用減壓可更快及更廣泛發生骨形成。
將減壓療法施用於未損傷頭蓋薄膜之表面,可觀測到軟骨形成。這些觀測具有意義,其在於回應治療之軟骨形成是獨特的,而且在組織工程領域具有很大用處。這些形成係在缺乏支架物質且只施用減壓下觀測到的。控制組中並未觀測到軟骨形成。
因先天性異常或疾病及外傷之軟骨所造成的退化會產生巨大的臨床後果。因為缺乏血液供給及隨後創傷癒合反應,對軟骨之傷害一般無法藉由身體完全修復。全層關節軟骨傷害或骨軟骨病灶會引起正常發炎反應,但會導致較差的纖維軟骨形成。外科手術常為唯一選擇。針對修復軟骨傷害之治療常很少令人滿意,並且極少恢復全部功能或將組織還原至自然的標準狀態。此範例證明使用GranuFoam及減壓處理可從骨膜誘導新軟骨。
評估泡沫歧管及減壓針對誘導骨膜合成新軟骨之能力。曝露完整、未損傷的兔子頭蓋骨。GranuFoam(KCI Licensing,Inc.,San Antonio TX)泡沫繃帶係施用至骨骼。使用一些處理同時,經泡沫覆蓋之骨骼還經受減壓處理。
處理後,動物被處死,該經處理骨骼經受石蠟包埋、切片及著色以評估該處理對新骨形成之效果。
圖9所示是兔子頭蓋骨中原始、未損傷的骨膜。圓點表示介於皮層骨及骨膜薄層間之分界。相比之下,圖10A及B顯示,利用GranuFoam及減壓(-125 mm Hg),廣泛的軟骨組織係經誘導覆蓋在骨膜上面。
評估減壓處理對骨內膜之成骨性活性之誘導效果。使用對側的羊掌骨。將染劑普施安紅(procion red)(0.8%)引入至骨骼之經套管正中動脈中達10分鐘。一邊骨骼還經受減壓(-125 mm Hg)處理。對側骨骼則未受減壓處理。處理後,該骨骼以80%乙醇固定,接著透過綠色濾光鏡進行螢光顯微鏡檢查。圖11顯示結果。相較未經處理的骨骼(圖B),經減壓處理之骨骼(圖A)顯示尤其多的骨內膜表面之循環(係藉由測量普施安紅染色之強度),此顯示透過減壓可提高流體流動,即使治療係用於外部骨膜表面。
鑒於上述,可以看出本發明之若干優點已經實現,其他優點已經達到。
由於上述方法及組合物中可經變化而不會脫離本發明範圍,其意欲指前述內容及附圖中顯示之所含之所有主題應理解為說明性的而非具有限制性意義。
本說明書中援引之所有參考係以引用之方式併入。參考之討論於此僅旨在概括作者做出之主張,未承認任何參考組成在先工藝。申請人保留對援引參考之精確性及相關
性之權利。
10‧‧‧系統
14‧‧‧減壓源
18‧‧‧歧管及/或支架
22‧‧‧硬腦膜
30‧‧‧濾毒罐
34‧‧‧導管
40‧‧‧硬腦膜鞘
45‧‧‧新形成骨骼
47‧‧‧造骨細胞
55‧‧‧新骨形成區域
60‧‧‧無新骨形成區域
62‧‧‧支架物質
64‧‧‧未損傷硬膜
70‧‧‧中樞神經系統組織
75‧‧‧組織支架
80‧‧‧硬膜
90‧‧‧新骨形成
圖1為組織支架之示意圖,該組織支架係應用於頭蓋缺陷,如此該組織支架可與硬腦膜接觸。
圖2係為說明根據本發明實施例、施用於兔子頭蓋骨之骨骼誘導系統及方法,以透過未損傷硬腦膜之成骨性活化誘導新骨骼生長之圖片。
與經受根據本發明某些實施例之經減壓兔子頭蓋骨中之新形成帶骨相比,圖3是顯示動物檢體中硬腦膜鞘正常結構之顯微照片。
圖4為實驗結果之顯微照片。圖A係顯示在新骨形成區域及無新骨形成區域間具有明顯分界之動物檢體顯微照片。圖B為動物檢體之顯微照片,其中中樞神經系統組織及組織支架沒有被未損傷硬腦膜分離。圖C為動物檢體之顯微照片,其中新骨形成與未損傷硬腦膜密切接觸。
圖5為原始、未受損傷的兔子顱骨表面之顯微照片。
圖6為骨骼之顯微照片,該骨骼無減壓下與GranuFoam接觸6天。
圖7為骨骼之顯微照片,該骨骼係在減壓下與GranuFoam接觸6天。
圖8為骨骼之另一顯微照片,該骨骼係在減壓下與GranuFoam接觸6天。
圖9為未受損傷骨骼表面之顯微照片,具有淺薄的肌肉組織覆蓋在骨膜上面。圓點表示在皮層骨及骨膜薄層間之
分界。
圖10,圖A和B是顯示回應經與GranuFoam接觸及減壓下之軟骨組織之誘導之顯微照片。
圖11是顯示骨內膜表面與骨髓組織接合處之普施安紅染色之顯微照片(10X),(A)是在通過GranuFoam經減壓處理之骨骼或(B)是未經處理的對側控制組之骨骼。
10‧‧‧系統
14‧‧‧減壓源
18‧‧‧歧管及/或支架
22‧‧‧硬腦膜
30‧‧‧濾毒罐
34‧‧‧導管
Claims (15)
- 一種用以治療骨骼或軟骨缺陷之組合物,其包括減壓儀器及生物相容性支架,其中該減壓儀器係經設置以對鄰近該缺陷之硬腦膜施以減壓。
- 如請求項1之組合物,其中該生物相容性支架為生物可吸收性聚合物。
- 如請求項2之組合物,其中該生物可吸收性聚合物為聚乳酸乙醇酸共聚物(PLAGA)聚合物或聚乙二醇-PLAGA共聚物。
- 如請求項1至3中任一項之組合物,其中該減壓儀器包括經連接到減壓源之歧管,其中該歧管係多孔性的。
- 如請求項4之組合物,其中該歧管包括生物相容性支架。
- 如請求項4之組合物,其中該歧管包括生物可吸收性聚合物。
- 如請求項6之組合物,其中該生物可吸收性聚合物為聚乳酸乙醇酸共聚物(PLAGA)聚合物或聚乙二醇-PLAGA共聚物。
- 如請求項4之組合物,其中該歧管係來自可流動物質,該物質透過歧管輸送導管傳遞至組織部位,如此該可流動物質可填補該缺陷。
- 一種用於治療個體中鄰近硬腦膜之骨骼或軟骨缺陷之系統,其包含:一減壓源;以及 一歧管,其中該歧管係流動地連接至該源且置於鄰近硬腦膜處;其中該減壓係被施用於該硬腦膜。
- 如請求項9之系統,其進一步包含一歧管輸送導管,其中該歧管來自可流動物質,該物質透過歧管輸送導管傳遞至組織部位,如此該可流動物質可填補該缺陷。
- 如請求項9之系統,其中該歧管包括生物相容性支架。
- 如請求項11之系統,其中該生物相容性支架係生物可吸收性聚合物。
- 如請求項12之系統,其中該生物可吸收性聚合物為聚乳酸乙醇酸共聚物(PLAGA)聚合物或聚乙二醇-PLAGA共聚物。
- 如請求項9之系統,其中該歧管係置於鄰近該缺陷處,且對該硬腦膜、骨膜或骨內膜施以減壓。
- 如請求項9至13中任一項之系統,其中該歧管為多孔性的。
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MX (1) | MX2009013767A (zh) |
RU (1) | RU2447878C2 (zh) |
TW (1) | TWI392472B (zh) |
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JP2013078628A (ja) | 2013-05-02 |
RU2010101277A (ru) | 2011-08-10 |
JP2010532226A (ja) | 2010-10-07 |
MX2009013767A (es) | 2010-01-26 |
IL202671A0 (en) | 2010-06-30 |
HK1139850A1 (en) | 2010-09-30 |
JP5174158B2 (ja) | 2013-04-03 |
RU2447878C2 (ru) | 2012-04-20 |
CN101686894A (zh) | 2010-03-31 |
EP2160169A4 (en) | 2017-07-05 |
BRPI0811668A2 (pt) | 2015-02-10 |
CA2691681C (en) | 2015-12-01 |
US9271837B2 (en) | 2016-03-01 |
US20120165766A1 (en) | 2012-06-28 |
US20090005796A1 (en) | 2009-01-01 |
WO2009006226A1 (en) | 2009-01-08 |
TW200920303A (en) | 2009-05-16 |
US8894620B2 (en) | 2014-11-25 |
EP2160169A1 (en) | 2010-03-10 |
CA2691681A1 (en) | 2009-01-08 |
CN101686894B (zh) | 2012-07-25 |
KR20100076939A (ko) | 2010-07-06 |
ZA200908586B (en) | 2010-08-25 |
AU2008270564A1 (en) | 2009-01-08 |
JP5490869B2 (ja) | 2014-05-14 |
US8152783B2 (en) | 2012-04-10 |
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