CN102438672B - 分离血液成分的一体式装置 - Google Patents

分离血液成分的一体式装置 Download PDF

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CN102438672B
CN102438672B CN201080019707.7A CN201080019707A CN102438672B CN 102438672 B CN102438672 B CN 102438672B CN 201080019707 A CN201080019707 A CN 201080019707A CN 102438672 B CN102438672 B CN 102438672B
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buoyancy aid
disengagement chamber
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迈克尔·D·利奇
詹森·查瓦里亚
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Biomet Biologics LLC
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    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/25—Chemistry: analytical and immunological testing including sample preparation
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Abstract

一种分离装置，包括第一浮体(20)、第二浮体(22)、第一阀(65)和第二阀(67)。第一浮体被安装到浮体导柱(18)并被可滑动地安装在分离腔(12)内。第二浮体被可滑动地安装到导柱并能够在第一位置和第二位置之间移动。第二浮体(22)在第一位置时关闭第一阀(65)而打开第二阀(67)。第二浮体在第二位置时打开第一阀而关闭第二阀。第二浮体的密度使得在使装置旋转合适的时间后，混合物的第一成分被隔离在第一浮体和第二浮体之间而混合物的第二成分被隔离在第二浮体和分离腔的与通口相对的端部之间。

Description

分离血液成分的一体式装置
技术领域
本公开涉及无菌装置、系统，以及用于分离诸如血液的混合物的成分的方法。
背景技术
此部分的中的叙述仅提供与本公开相关的背景信息而不会构成现有技术。
全血包括各种不同的成分或者部分。例如，人类全血包括富血小板血浆(PRP)、贫血小板血浆(PPP)、红血球(RBCs)，以及白血球(WBCs)。这些不同的血液成分具有多种临床和实验用途。常规的血液分离装置必须用单独的注射器装载，该单独的注射器装有从诸如患者的血管的源头抽出的全血。然后，分离装置被离心，并且不同的注射器被用以从装置中抽出所分离的成分以输送到希望的区域。用单独的注射器来装载和卸载分离装置是麻烦、费时且不经济的。另外，每次转移血液就增大污染的可能性。
因而，需要一种一体式分离装置，以及使用方法，该一体式分离装置可以用于从诸如患者的源头直接抽出血液，并可以被离心以根据密度分离全血的不同成分，并且该一体式分离装置可以用于将选择的成分施放在希望的区域。
发明内容
本教导提供一种具有用于根据密度分离混合物的成分的分离腔的装置。该装置包括通口、浮体导柱、第一浮体、第二浮体、通路、第一阀以及第二阀。通口提供分离腔的内部和外部之间的流体连通。第一浮体被固定地安装到浮体导柱并且被可滑动地安装在分离腔内。第二浮体被可滑动地安装到浮体导柱并且能够沿着浮体导柱在第一位置和第二位置之间移动。通路被限定在浮体导柱内，并且与通口流体连通。浮体导柱内的第一阀与通路以及分离腔的介于第一浮体和第二浮体之间的区域流体连通。浮体导柱内的第二阀与通路以及分离腔的介于第二浮体和分离腔的与通口相对的端部之间的区域流体连通。第二浮体在第一位置时关闭第一阀而打开第二阀。第二浮体在第二位置时打开第一阀而关闭第二阀。第二浮体的密度使得在使装置被旋转合适的时间后，混合物的第一成分被隔离在第一浮体和第二浮体之间，而混合物的第二成分被隔离在第二浮体和分离腔的与通口相对的端部之间。
本教导还提供一种用于将全血分离成不同成分的方法。该方法包括以下步骤：通过分离腔的通口将全血直接从患者抽入分离腔，分离腔具有被固定地安装到浮体导柱的第一浮体和被可滑动地安装到浮体导柱的第二浮体，浮体导柱具有第一阀和第二阀，当第二浮体在第一位置时，第一阀关闭而第二阀打开，全血被通过第二阀抽入分离腔，进入介于第二浮体和被可滑动地安装在分离腔中的柱塞之间的区域；使腔在离心机中转动足够的时间，使得第二浮体移动到第二位置，其中第二浮体与第一浮体间隔开以关闭第二阀而打开第一阀，并且根据密度分离全血的成分，使得红血球在通口和第一浮体之间，富血小板血浆在第一浮体和第二浮体之间，而贫血小板血浆在第二浮体和柱塞之间；将柱塞压到分离腔内的第一距离，以使第一浮体从第二位置移动到第一位置以迫使富血小板血浆通过第一阀并通过通口到达分离腔之外，以关闭第一阀而打开第二阀；通过附连到通口的施放器将富血小板血浆直接施放到所关注区域；将柱塞进一步压到分离腔内的大于第一距离的第二距离，以迫使贫血小板血浆通过第二阀并通过通口到达分离腔之外；以及通过附连到通口的施放器将贫血小板血浆直接施放到所关注区域。
本教导还提供一种用于将骨髓抽取物分离成不同成分的方法。该方法包括：通过分离腔的通口将骨髓抽取物直接从患者抽入分离腔，分离腔具有固定地安装到浮体导柱的第一浮体和可滑动地安装到导柱的第二浮体，浮体导柱具有第一阀和第二阀，当第二浮体在第一位置时，第一阀关闭而第二阀打开，骨髓抽取物被通过第二阀抽入分离腔，进入介于第二浮体和可滑动地安装在分离腔中的柱塞之间的区域；使腔在离心机中转动足够的时间，使得第二浮体移动到第二位置，其中第二浮体与第一浮体间隔开，以关闭第二阀而打开第一阀，并且根据密度分离骨髓抽取物的成分，使得红血球在通口和第一浮体之间，多能细胞在第一浮体和第二浮体之间，而骨髓浆在第二浮体和柱塞之间；将柱塞压到分离腔内的第一距离以使第一浮体从第二位置移动到第一位置以迫使多能细胞通过第一阀并通过通口到达分离腔之外，以关闭第一阀而打开第二阀；通过附连到通口的施放器将多能细胞直接施放到所关注区域；将柱塞进一步压到分离腔内的大于第一距离的第二距离，以迫使骨髓浆通过第二阀并通过通口到达分离腔之外；以及通过附连到通口的施放器将骨髓浆直接施放到所关注区域。
本教导还提供一种具有用于根据密度分离混合物的成分的分离腔的装置，包括通口、第一浮体、以及第二浮体。通口提供分离腔的外部与内部之间的流体连通。第一浮体被可滑动地安装在分离腔内。第二浮体被可滑动地安装在分离腔内。第二浮体的密度使得在使装置旋转合适的时间后混合物的第一成分被隔离在第一浮体和第二浮体之间，而混合物的第二成分被隔离在第二浮体和分离腔的与通口相对的端部之间。
本教导还提供一种用于将全血分离为不同成分的方法。该方法包括：通过通口将全血直接从患者抽入分离腔，分离腔具有被可滑动地安装在分离腔中的第一浮体和被可滑动地安装在分离腔中的第二浮体，全血被抽入分离腔中，进入介于第二浮体和被可滑动地安装在分离腔中的柱塞之间的区域；使腔在离心机中转动足够的时间，使得第二浮体移动到第二位置，其中第二浮体与第一浮体间隔开，并且根据密度分离全血的成分，使得红血球在通口和第一浮体之间，富血小板血浆在第一浮体和第二浮体之间，而贫血小板血浆在第二浮体和柱塞之间；将柱塞压到分离腔内的第一距离，以使第一浮体从第二位置移动到第一位置，以迫使富血小板血浆通过通口到达分离腔之外；通过附连到通口的施放器将富血小板血浆直接施放到所关注区域；将柱塞进一步压到分离腔内的大于第一距离的第二距离，以迫使贫血小板血浆通过通口到达分离腔之外；以及通过附连到通口的施放器将贫血小板血浆直接施放到所关注区域。
根据本文所提供的描述，另外的适用范围将变得明显。应该理解，描述和具体示例仅意在起到说明作用而并非意在限制本公开的范围。
附图说明
本文中描述的图仅为了说明目的而并非意在以任何方式限制本公开的范围。
图1A是根据本教导的、用于分离多成分混合物的成分的装置的透视图；
图1B是图1A的装置的柱塞的分解图；
图2A是图1A的装置的沿图1A的线2A-2A截取的透视截面图；
图2B是图1A的装置的截面图；
图3A是图1A的装置的浮体导柱的截面图；
图3B是图3A的浮体导柱的分解透视图；
图3C是可以用于图1A的装置的另外的浮体导柱的分解透视图；
图4是图1A的装置的截面图，该装置已装有全血并被旋转合适的时间以根据密度分离全血的不同成分，贫血小板血浆在第二浮体和柱塞基部之间，富血小板血浆在第二浮体和第一浮体之间，而红血球在第一浮体和入口/出口之间；
图4A是如在图4中示出的装置的顶部透视图，其中柱塞基部通过锁定片(locking tab)紧固在装置的末端处；
图5是图1A的装置的截面图，其示出柱塞正在被致动以将富血小板血浆从装置中排出；以及
图6是图1A的装置的截面图，其示出柱塞正在被进一步致动以将贫血小板血浆从装置中排出。
具体实施方式
以下描述实质上仅为示例性的且并非意在限制本公开、应用或者使用。
首先参照图1A、1B、2A和2B，以附图标记10示出根据本教导的用于分离多成分混合物的成分的装置。装置10是一体式装置，该一体式装置可以用于从诸如患者的源头直接抽取多成分混合物，并且可以被离心以根据密度分离混合物的不同成分，并且该一体式装置可以用于将混合物的所选择的成分直接施放在希望的区域，诸如受伤部位。
装置10大体上包括：分离腔12；通口14，用于将多成分混合物抽入到分离腔12中以及用于从分离腔12分发所分离的成分；柱塞16；以及浮体导柱18，其上安装有第一浮体20和第二浮体22。
分离腔12可以为具有任意合适的尺寸或形状的任意合适的容器的形式。例如在所有图中所示出的，分离腔12可以为圆柱形并可以形成注射器的本体。分离腔12包括纵轴A。
柱塞16可滑动地安装在分离腔12内。具体地，柱塞16包括柱塞基部24和柱塞柄部26。柱塞基部24座置在分离腔12内，而柱塞柄部26从柱塞基部24以及从分离腔12延伸。
柱塞柄部26可以以任意合适的方式可拆卸地附连在基部24上。例如在图1B中示出的，柱塞基部24可以包括从基部24的上表面延伸的两个相对的锁定凸缘27。柱塞柄部26可以包括锁定片29，一旦将锁定片29放置在凸缘27之间并将柱塞柄部26转动90°以使得锁定片29位于凸缘27的下方并在凸缘27和基部24的其余部分之间时，则锁定片29与凸缘27配合。柱塞16便于通过在分离腔12中产生真空来将多成分混合物吸入分离腔12，以及便于将所分离的成分从分离器12分发出去，如在本文中进一步描述的。注射器手柄23从分离腔12的外表面延伸以便于操作和处理装置10。
待分离的多成分混合物通过通口14被抽入分离腔12中以及从分离腔12分发。通口14可以为允许待分离的多成分混合物通过的任何合适的贯通通口，其中待分离的多成分混合物诸如为全血。例如，通口14可以包括鲁尔锁(Luerlock)15。通口14可以与各种装置相配合，例如延伸管口21(图1)。
延伸管口21可以为任意合适的连接器，诸如所示出的鲁尔延伸部。管口21包括第一端处的第一鲁尔锁连接器31和第二端处的第二鲁尔锁连接器33。第一鲁尔锁31与通口14的鲁尔锁15相配合。第二鲁尔锁33与针头25(图1)或者喷头(未示出)相配合。第二鲁尔锁33可以为在针头25被取下时关闭的鲁尔驱动型阀。如此处进一步地描述的，管口21便于在保持装置10无菌的同时将通口14用作抽入口和排出口。
针头25用于将混合物抽入分离腔12中。针头25和喷头便于将混合物的各种成分施放在诸如受伤部位的输送部位。
另外参照图3A和3B，浮体导柱18包括第一端28和与第一端28相对的第二端30。浮体导柱18具有大体上为圆柱体的形状。导柱18限定中央通路或通道32。通道32从第一端28沿着导柱18的纵轴B延伸。如所示出的，通道32从第一端28延伸并在刚要到达第二端30之前终止。
另外参照图3C，以附图标记18′示出根据本教导的另外的浮体导柱。浮体导柱18′的也包括在导柱18中的特征用相同的附图标记标示，但包括撇(′)符号。本文中提出的关于导柱18的一般特征的描述也适用于导柱18′。导柱18和导柱18′之间的主要差异在于通道32′延伸至第二端30′以提供从第一端28′到第二端30′完全延伸通过浮体导柱18′的管道。
导柱18还包括至少一个第一孔34和至少一个第二孔36。第一孔34接近于第一端28而第二孔36接近于第二端30。如所示出的，导柱18包括两个第一孔34和两个第二孔36。两个第一孔34和两个第二孔36关于导柱18的外部圆周以180°间隔进行定位。第一孔34中的每一个的开口和第二孔36中的每一个的开口分别位于环形凹部37A和37B中。
第一孔34和第二孔36各自在通道32和分离腔12之间提供流体连通。如在图3C中示出的，导柱18′包括在第二端30′处的第三孔39。第三孔39便于通道32′和分离腔12′之间的流体连通。
在第二孔36的相对侧并且靠近第二孔36，为导柱18内的环形凹部38A和38B。环形凹部38A和38B各自分别容纳O形环40A和40B。如此处进一步描述的，O形环40A和40B便于第二浮体22沿着浮体导柱18的纵轴B在第一端28和第二端30之间移动并限制混合物流过O形环40A和40B。O形环40A和40B可以由诸如聚合材料的任意合适的材料制成。浮体导柱18位于分离腔12内使得导柱18的纵轴B沿着分离腔12的纵轴A延伸。
第一浮体20通常被成形为如直圆柱。另外参照图4，第一浮体20包括下表面或第一表面42和与下表面42相对的上表面或第二表面44。圆形侧壁46在下表面42的外部圆周和上表面44的外部圆周之间延伸。上表面44具有半球形状并相对于第一浮体20的其余部分凹入。下表面42具有半球形状并相对于第一浮体20的其余部分凸出。
通孔48延伸过第一浮体20的轴向中心。浮体导柱18位于通孔48中并以任意合适的方式，诸如以示出的通过压入配合或者用合适的粘合剂，固定地安装到通孔48。浮体导柱18被安装到第一浮体20，使得导柱18的第一端28座置在第一浮体20内靠近下表面42，其中第一孔34在上表面44处。具体地，导柱18被定位成使得第一孔34的大部分凹入第一浮体20的通孔48内，其中仅第一孔34的小部分在第一浮体20的中央处略高于上表面44。另外，由于第一孔34被定位在凹部37A内，因此第一孔34与第一浮体20间隔开。因此，在第一孔34和第二浮体22之间有微小的间隙，多成分混合物可以穿过该微小的间隙以提供第一孔和位于第一浮体20与第二浮体22之间的区域间的流体连通。由于上表面44是凹形的，第一孔34在完全跨越上表面44延伸且垂直于侧壁46的平面的下方凹入并且不穿过该平面。
第一浮体20位于分离腔12中，使得下表面42面向通口14且上表面44面向柱塞16。第一浮体20的圆形侧壁46面向分离腔12的内部侧壁50。当装置10没有转动或者旋转时，侧壁46接触分离腔12的内部侧壁50以限制正在被分离的多成分混合物在侧壁46和内部侧壁50之间通过。
第二浮体22大体上被成形为直圆锥。第二浮体22包括下表面或第一表面52以及与下表面52相对的上表面或第二表面54。圆柱形侧壁56在下表面52和上表面54之间延伸并且围绕第二浮体22的外围。上表面54朝着侧壁56向下倾斜。下表面52具有半球形状并相对于第二浮体22的其余部分凸出。侧壁56包括围绕侧壁56延伸的环形凹部58。环形凹部58容纳围绕第二浮体22的圆柱形侧壁56延伸的O形环60。当装置10没有转动或者旋转时，侧壁56接触分离腔12的内部侧壁50以限制正在被分离的多成分混合物在侧壁56和内部侧壁50之间通过。O形环60可以由任何合适的材料制成，该合适的材料便于第二浮体22在分离腔12内移动并限制混合物在侧壁56和内部侧壁50之间通过。例如，O形环60可以由合适的聚合材料制成。
通孔62延伸通过第二浮体22的中央。浮体导柱18位于通孔62内。第二浮体22可滑动地安装到导柱18以允许第二浮体22沿着分离腔12的纵轴A和通孔48的纵轴B可滑动地移动。第二浮体22座置在O形环40A和40B上，其便于第二浮体22移动并限制多成分混合物流过O形环40A和40B。由于O形环40A和40B的存在，第二浮体22与浮体导柱18的外表面41略微地间隔开。
第二浮体22可以在第二浮体22接触第一浮体20的第一位置(图2A和2B)和第二浮体22与第一浮体20间隔开的第二位置(图4)之间可滑动地移动。在第一位置中，第二浮体22的下表面52与第一浮体20的上表面44齐平，以限制多成分混合物通过第一孔34并进入分离腔12中。当第二浮体22在第一位置时，在第二孔36和分离腔12之间有通路，以提供导柱18的通道32与分离腔12的在第二浮体22和柱塞16之间的部分间的流体连通。由于第二孔36和O形环40B两者与第二浮体22之间的间隙，提供通路。
在第二位置，第二浮体22与第一浮体20间隔开并靠近导柱18的第二端30。导柱18包括第二端30处的环形突出部64(图3A)以防止第二浮体22从导柱18滑落。由于第二浮体22与第一浮体20间隔开，第一孔34与第一浮体20之间的间隙允许在导柱18的通道32与分离腔12的在第一浮体20和第二浮体22之间的部分间的流体连通。在第二位置中，第二浮体22与O形环配合，以阻塞第二孔36与分离腔12之间的通路并限制第二孔36与分离腔12的在第二浮体22之上的区域间的流体连通。
因而，第一孔34提供分离腔12与浮体导柱18的通道32之间的第一阀65，第二孔36提供分离腔12与浮体导柱18的通道32之间的第二阀67，浮体导柱18的通道32最终与通口14流体连通。由第二浮体22的位置控制混合物通过第一孔34和第二孔36的流通。当第二浮体22在第一位置时，第二浮体22不阻塞混合物流过第二孔36，因而打开通道32与分离腔12的在第二浮体22之上的区域之间的第二阀67。在第一位置中，第二浮体22限制混合物流过第一孔34并进入分离腔12，因而关闭在通道32与分离腔12的在第一浮体20和第二浮体22之间的区域间的第一阀65。
当第二浮体22在第二位置时，第二浮体阻塞混合物流过第二孔36，因而关闭在通道32与分离腔12的在第二浮体22之上的区域之间的第二阀67。在第二位置中，第二浮体22未限制混合物通过第一孔34，从而打开在通道32与分离腔12的在第一浮体20和第二浮体22之间的区域间的第一阀65。
第一浮体20和第二浮体22可以由任意合适的材料制成，该合适的材料允许第一浮体20和第二浮体22在装置10在离心机中转动或者旋转适当的时间时在分离腔12中移动，并稳定在待隔离的多成分混合物的不同成分之间。例如，当装置10用于分离全血的成分时，浮体20和22可以由任何合适的高密度聚乙烯材料(HDPE)制成。由HDPE制成的浮体20和22将具有允许全血分离的密度，使得：红血球(RBC)在通口14和第一浮体20之间；当第二浮体22在第二位置时，富血小板血浆、白膜层或富细胞成分(统称“PRP”)在第一浮体20和第二浮体22之间；并且贫血小板血浆(PPP)在第二浮体22和柱塞基部24之间。
第一浮体20被设置成具有大于第二浮体22的密度。具体地，第一浮体20可以具有在大约1.070g/ml和大约1.095g/ml之间的密度，诸如1.075g/ml。第二浮体22可以具有在大约0.93g/ml和大约0.95g/ml之间的密度，诸如0.945g/ml。包括第一浮体20、第二浮体22和浮体导柱18的组件可以具有在大约1.02g/ml和大约1.09g/ml之间的整体密度，诸如1.045g/ml。
第一连接器66被安装在第一浮体20的下表面42处。第一连接器66与通道32流体连通并延伸超过第一浮体20的下表面42。第二连接器68被安装在通口14上。第二连接器68从通口14延伸到分离腔12内。软管或导管70连接到第一连接器66和第二连接器68，以提供通口14和浮体导柱18之间的流体连通。
装置10可以用于根据密度将任意液体混合物的大部分分离成其组成成分。特别参照图2和图4至图6，以下描述操作装置10从全血中分离RBC、PPP和PRP的步骤。
在第一浮体20接近于通口14并且第二浮体22在第一位置的情况下，全血被装入装置10的分离腔12中，如在图2A和2B中示出的。在第一位置中，第二浮体22与第一浮体20接触以阻塞血液通过第一孔34进入分离腔12，从而关闭由第一孔34限定的第一阀65，并允许血液通过第二孔36进入分离腔12，从而打开由第二孔36限定的第二阀67。在装填之前，柱塞16被定位成使得柱塞基部24座置在分离腔12中的深处，并远离分离腔12的与通口14相对的端部72(图1)。
在延伸管口21的第一鲁尔锁31耦合到通口14的鲁尔锁15且针头25耦合到延伸管口21的第二鲁尔锁33的情况下，针头25插入全血的源头，诸如患者的血管。然后，柱塞16被向外拉以使柱塞基部24朝着腔12的端部72移动。如图2B所示，拉拔柱塞16在分离腔12中产生真空，真空抽吸全血通过通口14、管70、导柱18的通道32、第二孔36并进入到第二浮体22和柱塞基部24之间的分离腔12中。
可以抽取任意合适量的全血，诸如30ml或者60ml。分离腔的大小根据待分离的全血的量而变化。例如，如果要分离30ml的全血，则分离腔12的尺寸可以设定为以容纳大约51ml的流体。如果要分离60ml的全血，则分离腔12的尺寸可以设定为以容纳大约94ml的流体。第一浮体20和第二浮体22的直径可以改变，以配合不同直径的腔12。浮体20和22的密度可以保持相同，而与第一浮体和第二浮体的直径无关。
在血液被装入分离腔12后，通过使柱塞柄部26转动90°使得锁定片29不再啮合凸缘27，柱塞柄部26可以从柱塞基部24去除，并且可以从管口21的第二鲁尔锁连接器33上去除针头25。如果鲁尔锁连接器33为鲁尔阀，则其将在去除针头25时关闭。也可以用适当的无菌盖74(图4)关闭鲁尔锁连接器33。
为了防止在装置10旋转时柱塞基部24移动并施加压力于腔12中的全血，柱塞基部24的密度可以被设置成小于血液的密度。合适的锁定装置也可以用于紧固柱塞基部24。例如并如图4和图4A所示，在柱塞基部24大体上被定为成与注射器手柄23共面的情况下，锁定片76可以被插入锁定凸缘27的下方，使得锁定片76靠在注射器手柄23上并限制柱塞基部24的移动。
在全血座置在第二浮体22和柱塞基部24之间的情况下，装置10准备好进行旋转以根据密度分离全血的成分。使用诸如离心机的合适的旋转装置使装置10旋转。
装置10可以旋转任意合适的时间以分离血液的不同成分。例如，装置10可以以大约3200rpm旋转大约12至大约15分钟。当装置10旋转时，分离腔12的内部侧壁50从分离腔12的纵轴A向外弯曲或膨胀，以在第一浮体20的侧壁46和内部侧壁50之间以及在第二浮体22的侧壁56和内部侧壁50之间提供间隙，以允许第一浮体20和第二浮体22在分离腔12内移动并允许全血移动通过第一浮体20和第二浮体22。
当装置10转动时，不同的血液成分根据密度分离。另外，第一浮体20和第二浮体22沿着分离腔12的纵轴A可滑动地移动，直到各浮体到达浮体20和浮体22中的每一个的密度与周围血液成分的密度接近或者匹配的位置。具体地并如图4所示，第一浮体20离开通口14移动到在RBC和PRP之间的位置。第二浮体22移动到第二位置，使得第二浮体22与第一浮体20间隔开，使PRP在第一浮体20和第二浮体22之间。PPP稳定在第二浮体22和柱塞基部24之间。在第二位置中，第二浮体22打开分离腔12和通道32之间的由第一孔34限定的第一阀65而关闭由第二孔36限定的第二阀67。
为了从分离腔12提取不同的血液成分，装置10被从转动装置去除，柱塞柄部26重新附连到柱塞基部24，延伸管口21被去除，并且诸如喷头或者新的无菌针头25A的合适的施放器被直接耦接到通口14的鲁尔锁15。因而，通口14既是吸入口又是排出口。
为了保持通口14无菌，装置装配有附连到通口14的延伸管口21。通口14与环境隔离直到离心后将延伸管口21去除时。因而，通口14仅暴露于环境一次，这提高了通口14的无菌性。
如图5所示，柱塞16被推入分离腔12以对PPP和第二浮体22施加压力。第二浮体22被朝着第一浮体20推回并被推到第一位置。O形环60的存在避免了在由柱塞16施加压力于PPP时PPP围绕第二浮体22流通。O形环60还利于第二浮体22响应于柱塞16的制动而移动。
当在第二浮体22和第一浮体20之间的间隙关闭时，第一浮体20和第二浮体22之间的PRP被迫使通过由第一孔34限定的第一阀65。PRP通过第一孔34、通道32和软管70以移动至通口14。PRP从通口14处通过针头25A从装置10中排出至希望的区域。
被隔离的PRP可以用于一般的伤口愈合以及便于大多数的外科手术的完成。更具体地，PRP可以用于治疗骨折、骨不连接(non-union)、骨质缺损、肌腱炎和足底筋膜炎。PRP还可以结合全关节置换术、胃旁路术和骨移植手术使用。
在第二浮体22在第一位置的情况下，由导柱18中的第二孔36限定的第二阀67打开。如图6中所示，由柱塞16施加的持续的压力使第二浮体22和柱塞基部24之间的PPP穿过第二孔36。PPP通过第二孔36、通道32和软管70移动至通口14。PPP从装置10通过附连在通口14上的任何合适的施放器从通口14排出并施放到希望的区域。
PPP可以用于各种合适的目的，诸如促进伤口闭合。PPP也可以用作血纤蛋白粘合剂、血纤蛋白粘合胶以及用于面部重建。
通常不从分离装置10提取RBC。然而，本领域的技术人员将会理解，装置10可以设置有在通口14和第一浮体20之间的第三阀，可以通过该第三阀从装置10提取RBC。
因而，装置10提供一体式血液分离装置。装置10可以被放进无菌包中的无菌区。在装置10处于无菌区中并从无菌包中移除后，装置10可以如以上描述的被无菌人员用于从诸如患者血管的源头直接抽取血液，在离心期间分离RBC、PPP和PRP血液成分，并且将成分直接输送到受伤部位以促进愈合。装置10省去了用单独的注射器或者其它装置从患者身上抽取全血，将抽取的血液转移到适于离心的装置中，并将分离出的血液成分施放在受伤部位的必要。因此，装置10还消除了在不同注射器或者装置之间转移期间或者从无菌区到有菌区转移期间被污染的任何可能性。
装置10还可以用于分离骨髓抽取物的成分。例如，可以使用任何合适的骨髓抽取装置获取骨髓抽取物，骨髓抽取装置诸如是在2008年9月15日提交并授予Biomet Biologics，LLC的标题为骨髓抽取针的美国专利申请No.12/210,372中描述的装置，该申请通过引用并入到本文中。具体地，装置10可以通过鲁尔锁15和内部抽取针的鲁尔锁之间的配合直接附连到美国专利申请No.12/210,372中描述的内部抽取针上。
为了获取骨髓抽取物以进行分离，包括内部抽取针的骨髓抽取装置被推入到骨皮层中并最终到骨髓腔中，从骨髓腔中抽取骨髓抽取物。骨髓抽取物以与如以上描述的将全血抽入到装置10中的方式同样的方式被抽入到装置10中。可以使用任意合适的量的骨髓抽取物，诸如大约300cc、大约60cc、或者少于60cc。在将骨髓抽取物从骨髓腔中提取出之后，将适当量的合适的抗凝剂添加到骨髓抽取物中。
装置10以与如上关于全血的分离描述的方式同样的方式被离心。离心使骨髓抽取物分离，使得骨髓浆被隔离在第二浮体22和柱塞基部24之间。骨髓抽取物的重质成分，诸如RBC，被隔离在第一浮体20和通口14之间。多能细胞在当第二浮体22处于第二位置时形成在第一浮体20和第二浮体22之间的间隙中被隔离在第一浮体20和第二浮体22之间。可以以与上面关于PRP和PPP所述的方式同样的方式从装置10中去除多能细胞和骨髓浆。
当使用装置10从骨髓抽取物中隔离多能细胞时，第一浮体20被设置成具有大于第二浮体22的密度。当装置10用于分离骨髓抽取物的成分时第一浮体20的密度和第二浮体22的密度与装置10用于分离全血时浮体20和浮体22的密度大体上相同。
装置10可以用于根据密度将大部分液体混合物隔离成其组成成分。为了采用装置10分离不同成分，第一浮体20和第二浮体22的密度可以改变以接近待隔离的具体成分的密度。从而，待隔离的第一成分和第二成分将通过第二浮体22分离，使得第一成分被隔离在第一浮体20和第二浮体22之间而第二成分被隔离在第二浮体22和柱塞基部24之间。
本发明的描述实质上仅为示例性的，因此，没有脱离本发明的要点的变化意在处于本发明的范围内。这样的变化不被认为脱离本发明的精神和范围。

Claims (33)

1.一种具有用于根据密度分离混合物的成分的分离腔的装置，包括：
通口，其提供所述分离腔的内部和外部之间的流体连通；
浮体导柱；
第一浮体，其被固定地安装到所述浮体导柱并且被可滑动地安装在所述分离腔内；
第二浮体，其被可滑动地安装到所述浮体导柱并且能够沿着所述浮体导柱在第一位置和第二位置之间移动；
在所述浮体导柱内限定的通路，其与所述通口流体连通；
所述浮体导柱内的第一阀，其与所述通路以及所述分离腔的介于所述第一浮体和所述第二浮体之间的区域流体连通；
所述浮体导柱内的第二阀，其与所述通路以及所述分离腔的介于所述第二浮体和所述分离腔的与所述通口相对的端部之间的区域流体连通；
其中，所述第二浮体在处于所述第一位置时关闭所述第一阀而打开所述第二阀；并且
其中，所述第二浮体在处于所述第二位置时打开所述第一阀而关闭所述第二阀；并且
其中，所述第二浮体的密度使得在使所述装置被旋转合适的时间后，所述混合物的第一成分被隔离在所述第一浮体和所述第二浮体之间，而所述混合物的第二成分被隔离在所述第二浮体和所述分离腔的与所述通口相对的所述端部之间。
2.根据权利要求1所述的装置，其中，所述通口提供通向所述分离腔的通道，用于将所述混合物置入所述分离腔以及从所述分离腔提取所分离的成分。
3.根据权利要求1所述的装置，还包括能够在所述分离腔内可滑动地移动的柱塞，所述柱塞包括可拆卸地附连到柱塞柄部的柱塞基部。
4.根据权利要求3所述的装置，还包括柱塞止挡件，其限制所述柱塞的移动。
5.根据权利要求1所述的装置，其中，所述第一浮体的密度介于1.070g/ml和1.095g/ml之间。
6.根据权利要求1所述的装置，其中，所述第一浮体的密度大于所述第二浮体的密度。
7.根据权利要求1所述的装置，其中，所述第二浮体的密度介于0.93g/ml和0.955g/ml之间。
8.根据权利要求1所述的装置，其中，所述第一浮体具有面向所述第二浮体的顶部表面，所述顶部表面是凹的；并且
其中，所述第一浮体具有与所述顶部表面相对的底部表面，所述底部表面是凸的。
9.根据权利要求1所述的装置，其中，所述装置包括注射器。
10.根据权利要求9所述的装置，其中，所述注射器通过延伸管口连接到所述通口。
11.根据权利要求9所述的装置，其中，所述注射器直接连接到所述通口。
12.根据权利要求1所述的装置，其中，所述混合物包括以下之一：全血、血浆、单核细胞、骨髓抽取物、脊髓液和脂肪，并且所述第一浮体和所述第二浮体各自具有基于所述混合物而选择的密度。
13.根据权利要求1所述的装置，其中，所述第一浮体和所述第二浮体具有允许以下隔离的密度：富血小板血浆在所述第一浮体和所述第二浮体之间；红血球在所述第一浮体的与所述第二浮体相对的一侧；并且贫血小板血浆在所述第二浮体的与所述第一浮体相对的一侧。
14.根据权利要求1所述的装置，其中，所述第一浮体和所述第二浮体具有允许以下隔离的密度：多能细胞在所述第一浮体和所述第二浮体之间；红血球在所述第一浮体的与所述第二浮体相对的一侧；并且骨髓浆在所述第二浮体的与所述第一浮体相对的一侧。
15.根据权利要求1所述的装置，还包括软管，其将所述浮体导柱的所述通路连接到所述通口。
16.根据权利要求1所述的装置，还包括聚合物环，其围绕所述第二浮体的圆柱形侧壁延伸。
17.根据权利要求1所述的装置，还包括第一聚合物环和第二聚合物环，其各自围绕所述浮体导柱的外径延伸，所述第一聚合物环和所述第二聚合物环被定位在所述第二阀的相对侧。
18.一种用于将全血分离成不同成分的方法，包括：
通过分离腔的通口将所述全血从除了人体和动物体之外的源头抽入所述分离腔，所述分离腔具有被固定地安装到浮体导柱的第一浮体和被可滑动地安装到所述浮体导柱的第二浮体，所述浮体导柱具有第一阀和第二阀，当所述第二浮体在第一位置时，所述第一阀关闭而所述第二阀打开，所述全血通过所述第二阀被抽入所述分离腔，进入介于所述第二浮体和被可滑动地安装在所述分离腔中的柱塞之间的区域；
使所述腔在离心机中转动足够的时间，使得所述第二浮体移动到第二位置，其中所述第二浮体与所述第一浮体间隔开以关闭所述第二阀而打开所述第一阀，并且根据密度分离所述全血的所述成分，使得红血球在所述通口和所述第一浮体之间，富血小板血浆在所述第一浮体和所述第二浮体之间，而贫血小板血浆在所述第二浮体和所述柱塞之间；
将所述柱塞压到所述分离腔内的第一距离，以使所述第二浮体从所述第二位置移动到所述第一位置以迫使所述富血小板血浆通过所述第一阀并通过所述通口到达所述分离腔之外，以关闭所述第一阀而打开所述第二阀；以及
将所述柱塞进一步压到所述分离腔内的大于所述第一距离的第二距离，以迫使所述贫血小板血浆通过所述第二阀并通过所述通口到达所述分离腔之外，以施放到除了人体和动物体之外的区域。
19.根据权利要求18所述的方法，其中，使用通过延伸管口连接到所述通口的针头将所述全血通过所述通口抽入所述分离腔。
20.根据权利要求18所述的方法，其中，通过直接附连到所述通口的施放器来将所述贫血小板血浆迫出所述分离腔。
21.根据权利要求18所述的方法，还包括将所述全血抽入包括所述分离腔的注射器。
22.根据权利要求18所述的方法，还包括使所述分离腔转动，使得所述第一浮体和所述第二浮体沿着所述分离腔的纵轴移动。
23.根据权利要求18所述的方法，还包括在使所述分离腔在所述离心机中转动之前将柱塞柄部从所述柱塞的柱塞体移除，以及在所述腔在所述离心机中转动后将所述柱塞柄部重新附连到所述柱塞体。
24.根据权利要求18所述的方法，还包括通过附连到所述通口的喷头将所述富血小板血浆和所述贫血小板血浆从所述分离腔迫出。
25.根据权利要求18所述的方法，还包括在使所述腔转动之前限制所述柱塞的移动。
26.一种用于将骨髓抽取物分离成不同成分的方法，包括：
通过分离腔的通口将所述骨髓抽取物从除了人体和动物体之外的源头抽入所述分离腔，所述分离腔具有固定地安装到浮体导柱的第一浮体和可滑动地安装到所述导柱的第二浮体，所述浮体导柱具有第一阀和第二阀，当所述第二浮体在第一位置时，所述第一阀关闭而所述第二阀打开，所述骨髓抽取物通过所述第二阀被抽入所述分离腔，进入介于所述第二浮体和可滑动地安装在所述分离腔中的柱塞之间的区域；
使所述腔在离心机中转动足够的时间，使得所述第二浮体移动到第二位置，其中所述第二浮体与所述第一浮体间隔开，以关闭所述第二阀而打开所述第一阀，并且根据密度分离所述骨髓抽取物的所述成分，使得红血球在所述通口和所述第一浮体之间，多能细胞在所述第一浮体和所述第二浮体之间，而骨髓浆在所述第二浮体和所述柱塞之间；
将所述柱塞压到所述分离腔内的第一距离以使所述第二浮体从所述第二位置移动到所述第一位置以迫使所述多能细胞通过所述第一阀并通过所述通口到达所述分离腔之外，以关闭所述第一阀而打开所述第二阀；以及
将所述柱塞进一步压到所述分离腔内的大于所述第一距离的第二距离，以迫使所述骨髓浆通过所述第二阀并通过所述通口到达所述分离腔之外，以施放到除了人体和动物体之外的区域。
27.一种具有用于根据密度分离混合物的成分的分离腔的装置，包括：
通口，其提供所述混合物从所述腔的外部到所述腔的内部的流体连通；
第一浮体，其被可滑动地安装在所述分离腔内；
第二浮体，其被可滑动地安装在所述分离腔内；
浮体导柱；
在所述浮体导柱内限定的通路，其与所述通口流体连通；
所述浮体导柱内的第一阀，其与所述通路以及所述分离腔的介于所述第一浮体和所述第二浮体之间的区域流体连通；以及
所述浮体导柱内的第二阀，其与所述通路以及所述分离腔的介于所述第二浮体和所述分离腔的与所述通口相对的端部之间的区域流体连通；
其中，所述第二浮体的密度使得在使所述装置旋转合适的时间后，所述第二浮体打开所述第一阀而关闭所述第二阀，使得所述混合物的第一成分被隔离在所述第一浮体和所述第二浮体之间，而所述混合物的第二成分被隔离在所述第二浮体和所述分离腔的与所述通口相对的端部之间；并且
其中，所述通口提供所述第一成分和所述第二成分从所述腔的所述内部到所述腔的所述外部的流体连通。
28.根据权利要求27所述的装置，其中，所述第一浮体通过所述浮体导柱连接到所述第二浮体。
29.根据权利要求28所述的装置，其中，所述第一浮体被固定到所述浮体导柱而所述第二浮体被可滑动地安装到沿所述分离腔的纵轴延伸的所述浮体导柱。
30.根据权利要求27所述的装置，其中，所述第二浮体沿所述导柱从第一位置移动到第二位置，以打开所述第一阀而关闭所述第二阀。
31.一种用于将全血分离为不同成分的方法，包括：
通过通口将所述全血从除了人体和动物体之外的源头抽入分离腔，所述分离腔具有被可滑动地安装在所述分离腔中的第一浮体和被可滑动地安装在所述分离腔中的第二浮体，所述全血被抽入所述分离腔中，进入介于所述第二浮体和被可滑动地安装在所述分离腔中的柱塞之间的区域；
使所述腔在离心机中转动足够的时间，使得所述第二浮体移动到第二位置，其中所述第二浮体与所述第一浮体间隔开，并且根据密度分离所述全血的所述成分，使得红血球在所述通口和所述第一浮体之间，富血小板血浆在所述第一浮体和所述第二浮体之间，而贫血小板血浆在所述第二浮体和所述柱塞之间；
将所述柱塞压到所述分离腔内的第一距离，以使所述第二浮体从所述第二位置移动到第一位置，以迫使所述富血小板血浆通过所述通口到达所述分离腔之外；以及
将所述柱塞进一步压到所述分离腔内的大于所述第一距离的第二距离，以迫使所述贫血小板血浆通过所述通口到达所述分离腔之外，以施放到除了人体和动物体之外的区域。
32.根据权利要求31所述的方法，还包括通过使用延伸管口附连到所述通口的针头将所述全血抽入所述分离腔。
33.根据权利要求31所述的方法，其中，通过直接附连到所述通口的施放器将所述贫血小板血浆从所述分离腔迫出。
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