Density phase separation device
12 claims: 6 independent, 6 dependent
- 1内部を画成し、第1の端部、第2の端部、および前記第1の端部と前記第2の端部との間に延在する側壁部を有する、収集コンテナと、 フロートおよびバラストを備え、 前記収集コンテナ内で、 第1の位置からシーリング位置まで移動することが可能な、機械的セパレータとを備え た分離アセンブリであって、 分離アセンブリは、前記収集コンテナの前記第2の端部へ向かう力を発生させるために、前記収集コンテナに回転力を加えることにより、前記収集コンテナ内の液体試料を第1の相および第2の相に分離することを可能にし、 前記シーリング位置においては、シーリング外周部が、 前記側壁部の 内部 周囲部 の少なくとも一部分と前記 フロートの外方外周部 との間に確立され、前記シーリング外周部は、 収集コンテナの第2の端部から測定される場合に、 前記 側壁部の前記 内部 周囲部 の一部分 において 変動的な位置を有し、前記変動的な位置は、 前記収集コンテナの前記第2の端部を基準とした 平均シーリング高さを画定し、 前記機械的セパレータは、前記収集コンテナ内に おいて前記コンテナの前記第2の端部を基準とする 最大 のシーリング 高さおよび最小 のシーリング 高さを有し、前記平均シーリング高さ から、前記コンテナの第2の端部から前記機械的セパレータの底部までの高さを差し引いた値 は、前記最大 のシーリング 高さから前記最小 のシーリング 高さを差し引いた値を下回ることを特徴とする分離アセンブリ。
- 2内部を画成し、 第1の端部、第2の端部、および前記第1の端部と前記第2の端部との間に延在する側壁部を有する収集コンテナの前記第2の端部へ向かう力を発生させるために、前記収集コンテナに回転力を加えることにより、前記収集コンテナ内の液 体試料を 第1の相および第2の相に 分離する ことを可能にするための デバイスであって、 開口する貫通穴を有するセパレータを備え、前記貫通穴は前記セパレータの第1の端部における第1の開口表面と前記セパレータの第2の端部における第2の開口表面とを画成し、前記セパレータの第1の端部は前記セパレータの第2の端部と実質的に対向し、 前記貫通穴は、液体が通過するように構成され、前記セパレータは、 第1の密度を有するフロート、および 前記第1の密度よりも高い第2の密度を有するバラストを備え、 前記フロートの一部分が前記バラストの一部分に連結され、 前記フロートは、前記第1の開口表面の一部から、前記第2の開口表面の一部へと延在している前記セパレータの第1の外方表面を画定し、前記バラストは、第2の外方表面と、前記第1の外方表面と実質的に対向する第2の外方表面とを画成し、前記セパレータの少なくとも一部は、 前記収集コンテナに 回転力を 加える ことによって変形するように構成されていることを特徴とするデバイス。
- 3前記第1の開口表面および前記第2の開口表面は、前記フロート内に画成されていることを特徴とする請求項2に記載のデバイス。
- 4少なくとも前記デバイスの一部は、回転楕円面形状を有していることを特徴とする請求項2に記載のデバイス。
- 5第1の相および第2の相に 液体 試料を分離することを可能にするための分離アセンブリであって、 第1の端部、第2の端部、および前記第1の端部と前記第2の端部との間に延在する側壁部を有する、収集コンテナであり、前記第1の端部と前記第2の端部との間に長手方向軸を画定する、収集コンテナと、 中に画成された 開口した 貫通穴を有するセパレー タを 備えるデバイスであり、前記貫通穴は、前記セパレータの第1の端部において第1の開口表面を画成すると共に、前記セパレータの第2の端部において第2の開口表面を画定し、前記セパレータの前記第1の端部は、前記セパレータの前記第2の端部と実質的に対向し、前記貫通穴は、液体が通過するように構成され、前記セパレータは、第1の密度を有するフロートと、前記第1の密度よりも大きい第2の密度を有するバラストと、を有し、前記フロートの一部は、前記バラス ト の一部に連結され、 前記セパレータは 、流 体が前記セパレータと前記側壁との間を通過するのを防ぐ と共に、流体が前記開口した貫通穴を通過するのを防ぐために、 前記収集コンテナの側壁にシーリング係合す るシ ーリング外周部を含 み 、 前記収集コンテナの前記第2の端部へ向かう力を発生させるために、前記収集コンテナに回転力を加えることにより、前記収集コンテナ内の液体試料を第1の相および第2の相に分離することを可能にする ことを特徴とする分離アセンブリ。
- 6第1の相および第2の相に液体試料を分離することを可能にするためのアセンブリであって、 内部を画成する、第1の開口端部、第2の閉鎖端部、および前記第1の 開口 端部と前記第2の 閉鎖 端部との間に延在する側壁部を有し、前記開口端部と前記閉鎖端部との間で長手方向軸を画定する、収集コンテナと、 前記収集コンテナの前記開口端部とシーリング係合するように構成されたクロージャと、 前記収集コンテナ内に配置されると共に、前記収集コンテナへの流体試料の導入の間、初期の位置において前記開口端部に隣接する側壁の一部に係合するセパレータであって、 液 体が通過するのを許容するように画成された貫通穴を有するセパレータと、を備え、 前記セパレータは、 第1の密度を有するフロート、および 前記第1の密度よりも高い第2の密度を有するバラスト 、を 備え、 前記クロージャは、前記収集コンテナへと流体試料を導入するためカニューレによって穿刺可能であり、前記カニューレは、前記収集コンテナ へと被 検物 を 導入 する 間、前記セパレータから離間して おり、 前記収集コンテナの前記第2の端部へ向かう力を発生させるために、前記収集コンテナに回転力を加えることにより、前記収集コンテナ内の前記液体試料を第1の相および第2の相に分離することを可能にし、かつ 前記フロートの一部は、回転力を加える前に前記バラストの一部に連結されている ことを特徴とするアセンブリ。
- 7前記カニューレは、前記収集コンテナへの 被 検物の導入の間、前記セパレータに接触しないことを特徴とする請求項6に記載のアセンブリ。
- 8第1の端部、第2の端部、および前記第1の端部と前記第2の端部との間に延在する側壁部を有する収集コンテナの前記第2の端部へ向かう力を発生させるために、前記収集コンテナに回転力を加えることにより、前記収集コンテナ内の流体を第1の相および第2の相に 分離することを可能にするための分離アセンブリであって、 前記収集コンテナの前記第1の端部とシーリング係合するように構成されているクロージャと、 画成された貫通穴を有するセパレータを備えたデバイスと、を備え、 前記分離アセンブリ または 収集コンテ ナに前記 回転力を印加したとき、前記セパレータは、流体が通過するための収集コンテナの 前記第1の端部と前記第2の端部との間に画定される 長手方向軸 を 横断しない開口位置に前記貫通穴がある第1の位置から流体が受け取られるのを防ぐために、収集コンテナの長手軸と平行しない閉塞位置に前記貫通穴がある第2の位置へと移動し、 前記セパレータから前記収集コンテナへと被検物を導入する間 、カ ニューレが前記セパレータから離間し、 前記セパレータは少なくとも一つのシーリング外周を含み、 前記セパレータが前記第2の位置にあるとき、少なくとも一つのシーリング外周部が前記収集コンテナの側壁にシーリング係合して前記セパレータと前記側壁との間を 流 体が通過するのを防ぐと共に流体が前記貫通穴を通過するのを防止し、 前記セパレータの少なくとも一部は、回転力が印加されると変形するように構成されていることを特徴とする分離アセンブリ。
- 9前記カニューレは、前記収集コンテナへ と 前記被検物 を 導入 する 間、前記セパレータと接触しないことを特徴とする請求項8に記載の分離アセンブリ。
- 10前記貫通穴の少なくとも一部は、前記第1の位置において前記収集コンテナの長手方向軸に沿って配向され、かつ前記貫通穴の少なくとも一部は、前記第2の位置において前記収集コンテナの長手方向軸を横断する方向に配向されていることを特徴とする請求項8に記載の分離アセンブリ。
- 11第1の端部、第2の端部、および前記第1の端部と前記第2の端部との間に延在する側壁部を有する収集コンテナに、前記収集コンテナの第2の端部へ向かう力を発生させるために、回転力を加えることにより、前記収集コンテナ内の流体試料を 第1の相および第2の相に分離することを可能にするための分離アセンブリであって、 前記収集コンテナの前記第1の端部とシーリング係合するように構成されているクロージャと、 貫通穴を有する本体を備えるデバイスであって、 前記収集コンテナに回転力が加えられる前に 試料が収集コンテナへと貫通穴を通過するのを許容している間、前記収集コンテナの第1の部分とのシーリング係合を提供する第1のシーリング外周部と、 前記収集コンテナに加えられていた回転力を停止させた後、 前記第1の相と第2の相とを分離するためのバリアを維持する間、前記収集コンテナの第2の部分とのシーリング係合を提供する第2のシーリング外周部と、を備え、 前記貫通穴は貫通軸に沿って画定され、前記第1のシーリング外周と前記第2のシーリング外周とは、前記貫通軸に対して異なる角度で存 在す ることを特徴とする分離アセンブリ。
- 12前記クロージャは、収集コンテナへと被検物を導入するためカニューレによって穿刺可能であり、前記カニューレは前記収集コンテナへの前記 被検物 の導入の間、前記本体から離間していることを特徴とする請求項11に記載の分離アセンブリ。
Independent claims12
76 paragraphs, as filed
(Cross-reference of related applications) This application claims priority under US Patent Provisional Application No. 61 / 178,599, filed May 15, 2009. The entire disclosure of the application is incorporated herein by reference.
The present invention relates to a device for separating a relatively dense portion and a relatively low density portion of a fluid sample. More specifically, the present invention relates to devices for collecting and transporting fluid samples. The device and fluid sample are centrifuged to separate the relatively dense portion of the fluid sample from the relatively dense portion.
Diagnostic tests may require separating a patient's whole blood sample into multiple components such as serum or plasma (a component of a relatively low density phase) and red blood cells (a component of a relatively high density phase). Whole blood samples are typically collected by venipuncture via a syringe or a cannula or needle mounted in a vacuum blood collection test tube. After collection, the syringe or test tube is rotated in a centrifuge to separate blood into serum or plasma and red blood cells. In order to maintain this separated state, a barrier must be placed between the components of the relatively high density phase and the components of the relatively low density phase. This allows the separated components to be inspected later.
Various separation barriers have been used in collection devices to separate the areas between the relatively dense and relatively dense phases of a fluid sample. The most widely used devices include thixotropy gel materials such as polyester gel. However, current polyester gel serum separation test tubes require specialized manufacturing equipment to both prepare the gel and fill these test tubes. Moreover, the shelf life of gel-based separator products is limited. Over time, blood cells may be released from the gel mass and enter one or both of the separated phase components. In addition, commercially available gel barriers may chemically react with the sample. Therefore, if some chemicals are present in the blood sample when it is taken, an undesired chemical reaction with the gel interface can occur. In addition, if the instrument probe is inserted too deeply into the collection container, the instrument probe may become clogged when in contact with the gel.
In addition, several mechanical separators have been proposed that allow the use of a mechanical barrier between the relatively dense and relatively low density phases of the fluid sample. Conventional mechanical barriers are placed between relatively dense phase components and relatively low density phase components, taking advantage of the high gravity applied during centrifugation. To obtain proper orientation for plasma and serum subjects, conventional mechanical separators are typically placed above whole blood specimens collected prior to centrifugation. This generally requires a mechanical separator to be attached to the underside of the test tube closure so that blood filling occurs in or around the device when engaged with a blood collection set or phlebotomy needle. Become. This attachment is required to prevent premature movement of the separator during shipping, handling, and blood collection. Conventional mechanical separators are typically attached to the test tube closure by a mechanical interlock between the bellows component and the closure.
<p num="0006"> Conventional mechanical separators have some serious drawbacks. As illustrated in FIG. 1, conventional separators include a bellows 34 for forming a seal with a test tube or syringe wall 38. Typically, at least a portion of the bellows 34 is housed in or in contact with the closure 32. As illustrated in FIG. 1, the bellows 34 is recessed as the needle 30 enters through the closure 32. This creates an empty space 36 through which blood can be retained when the needle is inserted or removed. This results in the retention of the sample below the closure, resulting in a device pre-launch that the mechanical separator releases prematurely during blood collection, resulting in significant amounts of fluids such as serum and plasma. It can cause phase trapping, poor sample quality, and / or under certain circumstances can cause poor barriers. In addition, conventional mechanical separators are very costly and complex to manufacture due to complex multi-part manufacturing techniques.</p><p num="0007"> Therefore, there is a demand for separator devices that are compatible with standard sampling devices and reduce or eliminate the aforementioned problems with conventional separators. In addition, it is easy to use for separating blood samples, minimizing mutual contamination between the relatively dense and relatively low density phases of the sample during centrifugation, during storage and shipping. There is a demand for separator devices that are not affected by the temperature of the sample and are stable against radiation sterilization. In addition, there is a demand for integrally molded separator devices that require a relatively small number of relative moving parts and can further improve the ease of introduction of the test object into the collection container.</p>
<p num="0008"> The present invention is intended for assemblies for separating fluid samples into relatively dense and relatively low density phases. Desirably, the mechanical separators of the present invention can be used with a collection container such as a test tube and move in the test tube under the action of applied centrifugal force to separate those parts of the fluid sample. Is built like this. In some configurations, the test tube is a test tube for subject collection, comprising an open end, a closed end, and a side wall extending between the open end and the closed end. The side wall comprises an outer surface and an inner surface, and the test tube further comprises a closure arranged to fit within the open end of the test tube having a removable diaphragm. Alternatively, both ends of the test tube may be open, and both ends of the test tube may be sealed with an elastomer closure. At least one of the test tube closures may be provided with a removable diaphragm that can be needle punctured.</p><p num="0009"> The mechanical separator may be disposed in the test tube at a position between the top closure and the bottom of the test tube. The components of the separator ensure that the overall density of the separator is between the densities of the phases of the fluid sample, such as the relatively dense phase of the blood sample and the relatively low density phase. , Dimensioning and configuring.</p><p num="0010"> According to one embodiment of the present invention, the mechanical separator for separating the fluid sample into the first phase and the second phase in the collection container includes a separator body having a through hole defined therein. .. This through hole is configured to allow fluid to pass through. The separator body comprises a float having a first density and a ballast having a second density higher than the first density. A part of the float is connected to a part of the ballast.</p><p num="0011"> The mechanical separator may have a spheroidal shape. Optionally, the float may comprise an outer surface and a bonding surface, and the ballast may comprise a contact surface and an outer surface that are connected to the bonding surface of the float. The outer surface of the float and the outer surface of the ballast may be combined together to form a spheroid.</p><p num="0012"> In some configurations, the float defines a through hole configured to allow fluid to pass through. This through hole may have a circular cross section. In other configurations, the through hole may have an elliptical cross section. The through hole may be defined along the through axis and the float may be deformed in a direction perpendicular to the through axis when a rotational force is applied.</p><p num="0013"> In another configuration, the float further comprises a first extending tab adjacent to the first opening of the through hole and a second extending tab adjacent to the second opening of the through hole. At least a portion of the first extension tab and at least a portion of the second extension tab are provided above and around the through hole and extend radially outward from the float in a direction parallel to the through hole of the separator body. May be present. Optionally, the first extending tab, the upper surface of the float, and the second extending tab may form a convex upper float surface.</p><p num="0014"> In another configuration, the separator further comprises an extending tab band disposed around a portion of the outer surface of the float. Optionally, a first portion of the extending tab band is disposed adjacent to the first opening of the through hole and a second portion of the extending tab band is adjacent to the second opening of the through hole. Arranged. In a further configuration, at least one of the first and second portions of the extending tab band has a concave downward orientation. Optionally, at least one of the first and second portions of the extending tab band has an outward extending arc shape around at least one upper portion of the first opening and the second opening of the through hole. Oriented with. At least one of the first and second portions of the extending tab band may extend outward from the float in a direction parallel to the through axis. At least a portion of the first extending portion of the extending tab band and at least a portion of the second extending portion may have the same shape and curvature. In some configurations, the extending tab band is disposed between the first extending portion and the second extending portion, which is arranged on each connecting side of the separator body, and the first extending portion is provided. Further joints may be provided that connect the portions and the second extending portion. The first extending portion and the second extending portion of the extending tab band have a concave downward orientation, and the joint portion of the extending tab band has a concave upward orientation. In some configurations, the float may include an extended tab band. Optionally, the float and extending tab band may be formed from TPE and the ballast may be formed from PET.</p><p num="0015"> The mechanical separator may further include an initial engagement band disposed circumferentially around the separator body. The initial engagement band may be continuous or at least partially segmented. The initial engagement band and float may be made of the same material. The initial engagement band may bisect at least a portion of the ballast.</p><p num="0016"> In another configuration, the ballast may be provided with a joining structure for engaging with a base portion and a portion of the float. The joint structure may include a plurality of arms for engaging a portion of the float, and the joint structure may provide a flexure between the float and the ballast. Optionally, at least a portion of the float may have a circular outer circumference having a curved cross section perpendicular to the through hole. In some configurations, the float may include a joining structure for engaging a portion of the ballast. The joint structure may include a plurality of arms for engaging a portion of the ballast, and the joint structure may provide a flexure between the float and the ballast.</p><p num="0017"> According to another embodiment of the invention, the separation assembly for allowing the fluid sample to be separated into the first and second phases is the first end, the second end, and A collection container having a side wall extending between the first end and the second end is provided. This collection container defines a longitudinal axis between the first end and the second end. The separation assembly further comprises a mechanical separator having a separator body having a through hole defined therein. This separator body prevents the through hole from receiving fluid in it from a first initial position where the through hole is oriented to an open position to allow the passage of fluid when a rotational force is applied. It is configured to transition to a second sealing position oriented in the closed position of.</p><p num="0018"> In one configuration, the separation assembly further comprises a closure configured to seal engage with the first end of the collection container, and the mechanical separator is detachably engaged with a portion of the closure. The mechanical separator may be engaged to a portion of the closure in the first initial position and the mechanical separator may be engaged to a portion of the side wall of the collection container in the second sealing position. The closure provides an engaging boss that is placed in a portion of the through hole to form a fluid seal between a portion of the separator and the closure when the separator is in the first initial position. You may prepare. Optionally, at least a portion of the through holes in the mechanical separator is oriented along the longitudinal axis of the collection container in the first initial position and the through holes are longitudinal in the collection container in the second sealing position. Oriented perpendicular to the axis. The transition of the through hole from the open position to the closed position may occur with the rotation of the mechanical separator from the first initial position to the second sealing position. The mechanical separator may be hermetically engaged with a portion of the collection container at the second sealing position to prevent fluid from flowing into or around the mechanical separator.</p><p num="0019"> In some configurations, the separator body further comprises a first extending tab adjacent to the first opening of the through hole and a second extending tab adjacent to the second opening of the through hole. The first extension tab and the second extension tab may engage a portion of the side wall of the collection container at the second sealing position. In other configurations, the separator further comprises an extending tab band disposed around a portion of the outer surface of the float. The extending tab band may engage a portion of the side wall of the collection container at the second sealing position, and the extending tab band may provide a continuous seal with the side wall of the collecting container at the second sealing position. It may be formed.</p><p num="0020"> In other configurations, the ballast comprises a joining structure for engaging a portion of the float, at least a portion of the float having a circular outer circumference having a curved cross section perpendicular to the through hole. The outer outer peripheral portion of the float may form a continuous sealing portion with the side wall portion of the collection container at the second sealing position. Optionally, the float comprises a joining structure for engaging a portion of the ballast, at least a portion of the float having a circular outer circumference having a curved cross section perpendicular to the through hole, and of the float. The outer outer peripheral portion forms a continuous sealing portion with the side wall portion of the collection container at the second sealing position.</p><p num="0021"> According to another embodiment of the invention, the separation assembly for allowing the fluid sample to be separated into the first and second phases is the first end, the second end, and A collection container having a side wall extending between the first end and the second end is provided. The separation assembly further comprises a mechanical separator having a separator body having a through hole defined therein. The separator body has a first sealing outer periphery for sealing engagement with the first part of the collection container and allowing the sample to be sent through the through hole into the collection container, and a second part of the collection container. It is provided with a second sealing outer periphery for maintaining a barrier for separating between the first phase and the second phase while engaging the sealing with the portion of.</p><p num="0022"> The separation assembly may further include a closure configured to seal engage with the open end of the collection container, in which the mechanical separator is detachably engaged with a portion of the closure.</p><p num="0023"> According to another embodiment of the present invention, an open end, a closed end, in which a separation assembly for allowing the fluid sample to be separated into a first phase and a second phase defines the interior. , And a collection container having a side wall extending between the open and closed ends. The collection container further defines a longitudinal axis between the open and closed ends. The separation assembly further comprises a closure configured to seal engage with the open end of the collection container and a post configured to engage the closure and locate within the collection container. This post comprises post through holes aligned along the longitudinal axis of the collection container. The separation assembly further comprises a mechanical separator that is detachably engaged with the post. The mechanical separator comprises a separator body having through holes defined in it along a through axis, the through holes being configured to allow fluid to pass through. The separator body comprises a float having a first density and a ballast having a second density higher than the first density. A portion of the float is connected to a portion of the ballast and a portion of the post is received within the through hole of the separator to form a fluid path through the post and mechanical separator in the initial first position.</p><p num="0024"> The separator body may further include an initial engagement band disposed in the circumferential direction around a part of the separator body. The initial engagement band and float may be formed from the same material, and the initial engagement band may bisect at least a portion of the ballast. Optionally, the separator body is oriented from a first initial position where a portion of the post is disposed in a through hole and the separator body is oriented in an open position through which fluid can pass, when a rotational force is applied. The body is disengaged from the post and is configured to transition to a second sealing position, which is oriented in a closed position to prevent the through holes from receiving fluid in. The transition of the separator body from the open position to the closed position involves the axial movement of the separator body for disengaging from the post and the rotational movement of the separator body from the initial first position to the second sealing position. It may be included.</p><p num="0025"> According to yet another embodiment of the present invention, an open end, a closed end, in which a separation assembly for allowing the fluid sample to be separated into a first phase and a second phase defines the interior. It comprises a portion and a collection container having a side wall extending between an open end and a closed end. The collection container further defines a longitudinal axis between the open and closed ends. The separation assembly further comprises a closure configured to seal engage with the open end of the collection container. The closure comprises a receiving end for being located within the open end of the collection container, which defines an internal cavity and includes an undercut overhang extending within the internal cavity. The separation assembly further comprises a mechanical separator that is detachably engaged with the closure. The mechanical separator comprises a separator body having a through hole defined in it along a through axis, the through hole being configured to allow fluid to pass through. The separator body comprises a float having a first density and a ballast having a second density higher than the first density, and a part of the float is connected to a part of the ballast. The undercut protrusion of the closure may be disposed in the through hole of the separator, or at least a portion of the separator body may be disposed in the internal cavity of the closure in the initial first position.</p><p num="0026"> According to yet another embodiment of the invention, the collection container comprises a first region having an opening top and a first side wall defining a first interior and a first exterior. The collection container further comprises a second area having a closed bottom edge and a second side wall that define a second interior and a second exterior. The first and second regions may be aligned along the longitudinal axis so that the first and second interiors are in fluid communication. The diameter of the first interior may be larger than the diameter of the second interior, with at least one fluid flute extending between the first and second regions so that the fluid is first. It may be possible to pass through from the region of</p><p num="0027"> In some configurations, the first exterior has a 16 mm longitudinal section and the second exterior has a 13 mm longitudinal section. The first interior may be sized to accommodate the mechanical separator inside, and the second interior is at least a portion through which a portion of the mechanical separator passes in the absence of applied rotational force. The dimensions may be set so as to suppress the effect.</p><p num="0028"> According to yet another embodiment of the invention, a separation assembly for allowing the fluid sample to be separated into a first phase and a second phase defines the first interior and the first exterior. It has a first region with an upper end of the opening and a first side wall, and a second area with a closed bottom end and a second side wall defining a second interior and a second exterior. Equipped with a collection container. The first and second regions may be aligned along the longitudinal axis so that the first and second interiors are in fluid communication, with the diameter of the first interior. Larger than the second inner diameter. This separation assembly extends between the first and second regions and provides at least one fluid flute that allows the fluid to pass through from the first region to the second region. Further prepare. The separation assembly may further include a float with a first density and a mechanical separator with a ballast having a second density higher than the first density, with a portion of the float coupled to a portion of the ballast. To. At least a portion of the mechanical separator is prevented from entering the second region in the initial first position, and the mechanical separator is in the second region when a rotational force is applied to the second sealing position. Will be migrated to.</p><p num="0029"> The mechanical separator may include a separator body having through holes defined therein and configured to allow fluid to flow through it.</p><p num="0030"> According to a further embodiment of the present invention, a separation assembly for allowing the fluid sample to be separated into a first phase and a second phase defines the interior, a first end, a first. It comprises a collection container having two ends and a side wall extending between the first and second ends. This separation assembly further comprises a closure configured to seal engage with the open end of the collection container. The separation assembly further comprises a mechanical separator that is freely constrained by at least one of the closure and the side wall of the collection container in the initial first position. The mechanical separator comprises a separator body having a through hole defined in it along a through axis, the through hole being configured to allow fluid to pass through. The separator body comprises a float having a first density and a ballast having a second density higher than the first density, and a part of the float is connected to a part of the ballast. The separation assembly further comprises a carrier that is detachably engaged with a portion of the mechanical separator in the initial position, and when a rotational force is applied, the separator body is mechanical from the initial position where the fluid can pass through the through hole. The target separator shifts to a sealing position that prevents the passage of fluid in or around the separator body. Further, when a rotational force is applied, the carrier is disengaged from the mechanical separator.</p><p num="0031"> In yet another embodiment of the invention, the separation assembly defines the interior between the first end, the second end, and between the first and second ends. It comprises a separation assembly with a collection container having an extending side wall. This separation assembly includes floats and ballasts, and further includes a mechanical separator that can be moved from the first position to the sealing position. In the sealing position, the outer periphery of the ceiling is established between at least a part of the inside and the separator, and the outer circumference of the ceiling has a variable position around the part of the inside, and this variable position is average. Define the ceiling height. The mechanical separator further has a maximum height and a minimum height within the collection container, and the average sealing height is less than the maximum height minus the minimum height.</p><p num="0032"> The assembly of the present invention has advantages over existing separation products that use separation gels. In particular, the assemblies of the invention do not interfere with the analyte, but many gels interact with body fluids and / or specimens located within the collection container. Further, the assembly of the present invention is in that the separator does not require puncture of the separator to introduce the test object into the collection container, thus minimizing sample retention below the pre-launch and closure. , Advantages over existing mechanical separators. In addition, the structure of the mechanical separator minimizes the loss of captured fluid phases such as serum and plasma within the separator. Furthermore, the assembly of the present invention does not require complicated extrusion molding techniques during manufacturing, and two-shot molding techniques can be optimally utilized.</p><p num="0033"> Further details and advantages of the present invention will become apparent by reading the following detailed description in combination with the accompanying drawings.</p>
<figref num="1">It is a partial cross-sectional side view of the conventional mechanical separator.</figref><figref num="2">It is a perspective view of the mechanical separator assembly which has the float which defined the through hole according to one Embodiment of this invention.</figref><figref num="3">It is an alternative perspective view of the mechanical separator assembly of FIG.</figref><figref num="4">It is a top view of the mechanical separator of FIG.</figref><figref num="5">It is a side view of the mechanical separator of FIG.</figref><figref num="6">It is sectional drawing of the mechanical separator of FIG. 2 along the line AA of FIG.</figref><figref num="7">It is a front view of the mechanical separator of FIG.</figref><figref num="8">It is sectional drawing of the mechanical separator of FIG. 2 along the line BB of FIG.</figref><figref num="9">Alternative according to one embodiment of the invention, the first extending tab and the second extending tab have through-hole defined floats and ballasts that form a substantially convex upper float surface. It is a top view of the mechanical separator.</figref><figref num="10">It is a side view of the mechanical separator of FIG.</figref><figref num="11">It is sectional drawing of the mechanical separator of FIG. 9 along the line CC of FIG.</figref><figref num="12">It is a front view of the mechanical separator of FIG.</figref><figref num="13">It is sectional drawing of the mechanical separator of FIG. 9 along the line DD of FIG.</figref><figref num="14">FIG. 3 is a perspective view of an alternative mechanical separator having a float and a ballast defining an elliptical through hole according to an embodiment of the present invention.</figref><figref num="15">It is an alternative perspective view of the mechanical separator of FIG.</figref><figref num="16">It is a top view of the mechanical separator of FIG.</figref><figref num="17">It is a side view of the mechanical separator of FIG.</figref><figref num="18">It is sectional drawing of the mechanical separator of FIG. 15 along the line EE of FIG.</figref><figref num="19">It is a front view of the mechanical separator of FIG.</figref><figref num="20">FIG. 5 is a cross-sectional view of the mechanical separator of FIG. 15 along line FF of FIG.</figref><figref num="20A">FIG. 3 is a perspective view of a mechanical separator according to an embodiment of the present invention, which has a spheroidal shape and has a reduced separation distance between a first extending tab and a second extending tab.</figref><figref num="21">FIG. 8 is a cross-sectional view of an alternative mechanical separator having an elliptical interior along a cross-sectional line similar to that illustrated in FIG.</figref><figref num="22">FIG. 2 is a partial perspective view of a mechanical separator having an elliptical interior as shown in FIG.</figref><figref num="23">FIG. 8 is a cross-sectional view of an alternative mechanical separator having an elliptical through hole along a cross-sectional line similar to that illustrated in FIG.</figref><figref num="24">FIG. 3 is a partial perspective view of a mechanical separator having an elliptical through hole as shown in FIG.</figref><figref num="25">FIG. 8 is a cross-sectional view of an alternative mechanical separator having a substantially circular internal and side notch along a cross-sectional line similar to that illustrated in FIG.</figref><figref num="26">FIG. 5 is a partial perspective view of an alternative mechanical separator having substantially circular interior and side notches as illustrated in FIG.</figref><figref num="27">It is a partial cross-sectional side view of the mechanical separator of this invention attached to the closure by one Embodiment of this invention.</figref><figref num="28">FIG. 5 is a partial cross-sectional side view of a mechanical separator disposed within a collection container at an initial position to allow a fluid to pass through a through hole according to an embodiment of the present invention.</figref><figref num="29">As illustrated in FIG. 28, according to one embodiment of the invention, at a sealing position for providing a barrier between a relatively lightweight phase and a relatively dense phase in the collection container after application of rotational force. It is a partial cross-sectional side view of the mechanical separator arranged in the collection container.</figref><figref num="30">FIG. 5 is a perspective view of a mechanical separator according to an embodiment of the invention, having a seal line for engaging the collection container in the initial position.</figref><figref num="31">FIG. 30 is a perspective view of the mechanical separator of FIG. 30 having a sealing line for engaging the collection container at the sealing position.</figref><figref num="31A">FIG. 3 is a perspective view of a mechanical separator having a partially wavy surface according to an embodiment of the present invention.</figref><figref num="31B">It is a front view of the mechanical separator of FIG. 31A.</figref><figref num="31C">It is a perspective view of the mechanical separator according to one Embodiment of this invention.</figref><figref num="31D">It is the top view of the mechanical separator of FIG. 31C.</figref><figref num="31E">It is a side view of the mechanical separator of FIG. 31C.</figref><figref num="31F">It is sectional drawing of the mechanical separator of FIG. 31C along the line 31F-31F of FIG. 31E.</figref><figref num="31G">It is a side view of the mechanical separator of FIG. 31C.</figref><figref num="31H">It is sectional drawing of the mechanical separator of FIG. 31C along line 31H-31H of FIG. 31G.</figref><figref num="31I">It is the bottom view of the mechanical separator of FIG. 31C.</figref><figref num="32">FIG. 5 is a perspective view of a mechanical separator having an initial engagement band according to an embodiment of the present invention.</figref><figref num="33">FIG. 3 is an alternative perspective view of a mechanical separator having an initial engagement band as illustrated in FIG.</figref><figref num="34">FIG. 3 is a side view of a mechanical separator having an initial engagement band as illustrated in FIG.</figref><figref num="35">FIG. 3 is a partial cross-sectional side view of a mechanical separator having an initial engagement band of FIG. 33 engaged with a portion of a side wall of a collection container and a closure according to an embodiment of the present invention.</figref><figref num="35A">FIG. 5 is a perspective view of a mechanical separator having an extended tab band according to an embodiment of the present invention.</figref><figref num="35B">It is a left side view of the mechanical separator of FIG. 35A.</figref><figref num="35C">It is a front view of the mechanical separator of FIG. 35A.</figref><figref num="35C1">It is sectional drawing of the mechanical separator of FIG. 35A along line 35C1-35C1 of FIG. 35B.</figref><figref num="35D">It is sectional drawing of the mechanical separator of FIG. 35A along the line 35D-35D of FIG. 35C.</figref><figref num="35E">FIG. 3 is a perspective view of a mechanical separator having an alternative extending tab band according to an embodiment of the present invention.</figref><figref num="35F">FIG. 5 is a perspective view of a mechanical separator having a bonded structure according to an embodiment of the present invention.</figref><figref num="35G">It is a front view of the mechanical separator of FIG. 35F.</figref><figref num="35H">It is sectional drawing of the mechanical separator of FIG. 35G along the line 35H-35H of FIG. 35F.</figref><figref num="35I">It is the top view of the mechanical separator of FIG. 35F.</figref><figref num="35J">It is a schematic front view of the mechanical separator of FIG. 35F arranged in the collection container in various descending states in the collection container according to one embodiment of the present invention.</figref><figref num="35K">It is a schematic front view of the mechanical separator of FIG. 35J at the sealing position according to one embodiment of the present invention.</figref><figref num="35L">FIG. 5 is a perspective view of a mechanical separator having an alternative junction structure according to an embodiment of the present invention.</figref><figref num="35M">It is a perspective view of the mechanical separator of FIG. 35L.</figref><figref num="35N">FIG. 5 is a perspective view of a mechanical separator having an alternative junction structure according to an embodiment of the present invention.</figref><figref num="35O">It is a front view of the mechanical separator of FIG. 35N.</figref><figref num="36">FIG. 5 is a partial cross-sectional side view of a mechanical separator having a detour through hole at an initial position according to an embodiment of the present invention.</figref><figref num="37">FIG. 6 is a partial cross-sectional side view of the mechanical separator of FIG. 36 having a detour through hole at a sealing position according to an embodiment of the present invention.</figref><figref num="38">FIG. 3 is a concrete cross-sectional view of a mechanical separator having floats and ballasts separated by a thermoplastic elastomer section defining a through hole at the initial resting position, according to yet another embodiment of the present invention.</figref><figref num="39">FIG. 3 is a concrete cross-sectional view of the mechanical separator of FIG. 38 having floats and ballasts separated by a thermoplastic elastomer section defining a through hole at the operating position when a rotational force is applied.</figref><figref num="40">FIG. 5 is a cross-sectional side view of a separation assembly in which a mechanical separator is engaged with a portion of a collection container engaged with a closure according to an embodiment of the present invention.</figref><figref num="41">FIG. 5 is a cross-sectional side view of an alternative separation assembly in which a mechanical separator is engaged with a post engaged with an undercut of a closure according to an embodiment of the present invention.</figref><figref num="42">It is a partial cross-sectional perspective view of the closure of FIG. 41.</figref><figref num="43">It is a perspective front view of the post of FIG. 41.</figref><figref num="44">It is a perspective rear view of the post of FIG. 41.</figref><figref num="45">FIG. 5 is a side view of a collection container having a first region, a second region, and a plurality of fluid flutes according to an embodiment of the present invention.</figref><figref num="46">FIG. 5 is a cross-sectional partial side view of a separation assembly in which a mechanical separator is disposed in the collection container of FIG. 45 according to an embodiment of the present invention.</figref><figref num="46A">FIG. 5 is a cross-sectional side view of an alternative collection container for use with a mechanical separator according to an embodiment of the present invention.</figref><figref num="47">FIG. 5 is a cross-sectional side view of an alternative separation assembly in which a mechanical separator is engaged with a portion of a closure according to an embodiment of the invention.</figref><figref num="48">It is a partial cross-sectional perspective view of the closure of FIG. 47.</figref><figref num="49">FIG. 5 is a cross-sectional side view of a separated assembly in which a mechanical separator is engaged with a closure having an engaging boss according to an embodiment of the present invention.</figref><figref num="50">FIG. 5 is a cross-sectional side view of an alternative separation assembly in which a mechanical separator is engaged with a closure having an alternative engaging boss according to an embodiment of the present invention.</figref><figref num="51">FIG. 5 is a cross-sectional side view of the separated assembly of FIG. 50, wherein a sealant is disposed between a portion of the mechanical separator and a portion of the closure according to an embodiment of the present invention.</figref><figref num="52">FIG. 5 is a close sectional view of the sealant illustrated in FIG.</figref><figref num="53">FIG. 5 is a cross-sectional side view of an alternative separation assembly in which a mechanical separator is engaged with a closure having an alternative engaging boss according to an embodiment of the present invention.</figref><figref num="54">FIG. 5 is a cross-sectional side view of an alternative separation assembly in which a mechanical separator is engaged with a closure having an alternative engaging boss according to an embodiment of the present invention.</figref><figref num="55">FIG. 5 is a perspective view of the closure of FIG. 54 having engaging bosses with a plurality of hanging legs.</figref><figref num="56">FIG. 5 is a cross-sectional side view of an alternative separation assembly in which a mechanical separator is engaged with a molded insert according to an embodiment of the present invention.</figref><figref num="57">FIG. 5 is a perspective view of the molded insert of FIG. 56.</figref><figref num="58">FIG. 5 is a cross-sectional side view of an alternative separation assembly in which a mechanical separator is engaged with a molded insert according to an embodiment of the present invention.</figref><figref num="59">FIG. 5 is a cross-sectional side view of an alternative separation assembly in which a mechanical separator is engaged with a molded insert according to an embodiment of the present invention.</figref><figref num="60">FIG. 5 is a cross-sectional side view of an alternative separation assembly in which a mechanical separator is engaged with a carrier engaged with a portion of a closure according to an embodiment of the present invention.</figref><figref num="61">FIG. 5 is a cross-sectional side view of an alternative separation assembly in which a mechanical separator is engaged with an alternative carrier engaged with a portion of a closure according to an embodiment of the present invention.</figref><figref num="62">It is a perspective view of the carrier of FIG. 61.</figref><figref num="63">FIG. 5 is a cross-sectional side view of a separation assembly in which a carrier-engaged mechanical separator is in an initial position, according to an embodiment of the invention.</figref><figref num="64">FIG. 6 is a cross-sectional side view of the separated assembly of FIG. 63, wherein the mechanical separator disengaged from the carrier after application of a rotational force according to one embodiment of the present invention is in the sealing position.</figref><figref num="65">FIG. 5 is a cross-sectional side view of an alternative separation assembly in which a mechanical separator engaged with an alternative carrier is in the initial position according to an embodiment of the invention.</figref><figref num="66">FIG. 6 is a cross-sectional side view of the separated assembly of FIG. 65, wherein the mechanical separator disengaged from the carrier after application of rotational force is in the sealing position according to one embodiment of the present invention.</figref><figref num="67">FIG. 5 is a cross-sectional side view of an alternative separation assembly in which a mechanical separator engaged with a soluble carrier is in an initial position according to an embodiment of the invention.</figref><figref num="68">FIG. 6 is a cross-sectional side view of the separation assembly of FIG. 67, wherein the mechanical separator is in the sealing position, showing the carrier in a completely dissolved state after application of a rotational force according to one embodiment of the present invention.</figref>
In the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "upper", "lower", "lateral", "longitudinal" , And when similar spatial terms are used, these shall relate to the embodiments described as being oriented in the drawings. However, it should be understood that a number of alternative variants and examples can be envisioned, unless the opposite is explicitly stated. Further, it should be understood that the particular devices and embodiments shown in the accompanying drawings and described herein are merely exemplary embodiments of the invention.
The mechanical separators of the present invention are intended to be used with a collection container to separate the sample into relatively dense phase components and relatively low density phase components, as discussed herein. Will be done. For example, this mechanical separator uses buoyancy differences to constrict the sealing area when submerged in a subject subject to increased gravity due to applied rotational force or centrifugation, thereby causing serum from whole blood. Alternatively, it can be used to separate plasma. In one embodiment, the elevated gravity can be generated at a speed of at least 2,000 rpm, such as at least 3,400 rpm.
Referring to FIGS. 2-8, the mechanical separator 40 of the present invention comprises a separator body 41 comprising a float 42 and a ballast 44 connected to the float 42. In one embodiment, the float 42 has a first density, the ballast 44 has a second density, and the second density is higher than the first density. In another embodiment, the float 42 has a first buoyancy, the ballast 44 has a second buoyancy, and the first buoyancy is higher than the second buoyancy. In one embodiment, it is desirable that the float 42 of the mechanical separator 40 be made from a material that has a lower density than the liquid or subject intended to be separated into two phases. For example, if it is required to separate human blood into serum and plasma, it is desirable that the float 42 have a density of less than about 1.020 g / cc. In one configuration, the float 42 of the mechanical separator 40 may be extruded and / or molded from an elastically deformable and self-sealing material such as thermoplastic elastomer (TPE). In yet another embodiment, the float 42 is extruded and / or molded from an elastically deformable material that exhibits good sealing characteristics when contact with the collection container is established, as discussed herein. May be done. Maintaining float densities within these particular tolerances is relatively easy to obtain by using standard materials that do not require mixing, such as glass microspheres, to reduce the material density.
Further, the mechanical separator 40 includes a through hole 46 defined in the separator body 41, such as along the through axis T. As illustrated in FIGS. 3, 5, and 8, the through hole 46 extends through the entire separator body 41 and has a first opening 48 and a second opening aligned along a through axis T. May be provided with an opening of 50. In one configuration, the through hole 46 bisects or substantially bisects the volume center of the separator body 41. In one embodiment, the through hole 46 is completely disposed within the float 42. In a further embodiment, the float 42 has a first extending tab 52 adjacent to the first opening 48 of the through hole 46 and a second extending tab adjacent to the second opening 50 of the through hole 46. 54 may be further provided. The first extension tab 52 and / or the second extension tab 54 may be co-formed with the float 42 to form part of the float 42 itself. In another configuration, the first extension tab 52 and / or the second extension tab 54 may be formed individually and then joined to the float 42. The first extension tab 52 and the second extension tab 54 may be provided above the penetration axis T of the separator body 41, such as substantially above the penetration axis T of the separator body 41. Further, the first extension tab 52 and the second extension tab 54 penetrate substantially around a part of the through hole 46, such as in an outwardly extending arc shape around the upper portion 56 of the through hole 46. It may be provided around a part of the hole 46. In the first extension tab 52 and the second extension tab 54, the first extension tab 52 and the second extension tab 54 have the same shape and curvature, or substantially the same shape and curvature. May extend outward from the float 42 in a direction parallel or substantially parallel to the through axis T of the separator body 41 so as to have. In yet another embodiment, as illustrated in FIG. 8, the first extending tab 52 comprises a first outermost edge 68 at the upper outermost portion of the first side of the through hole 46. The extending tab 54 of 2 comprises a second outermost edge 70 at the corresponding upper outermost portion on the second side of the through hole 46. In one configuration Thus, the first outermost edge 68 extends outward by a longer distance than the lower outermost portion 72 on the first side of the through hole 46. Further, the second outermost edge 70 extends outward by a longer distance than the corresponding lower outermost portion 74 on the second side of the through hole 46. Therefore, the diameter D of the separator body 41 obtained centering on the first extending tab 52 and the second extending tab 54 around the upper portion of the through hole 46.<sub>1</sub>Is the diameter D of the separator body 41 obtained centering on the lower portion of the through hole 46 defined by the lower outermost portions 72 and 74.<sub>2</sub>Slightly larger than.
In one embodiment, the float 42 is adapted to engage a portion of the ballast 44 with an outer surface 58 having a generally arcuate shape, such as at least partially circular or substantially circular, FIG. And with the joint surface 60 illustrated in FIG. The ballast 44 was also adapted to join the outer surface 62, which also generally has an arcuate shape, such as at least partially circular or substantially circular, with the joining surface 60 of the float 42, also shown in FIG. 6 and It includes a contact surface 64 illustrated in FIG. In one embodiment, the outer surface 58 of the float 42 and the outer surface 62 of the ballast 44, together, form a generally circular outer portion, such as a spheroidal shape. It is described herein that the term "spheroidal shape" may include, in addition to a perfect sphere, other configurations that are aspects of the invention that may exhibit the slightly non-uniform diameter determined through the midpoint. Will be understood in the book. For example, the various planes obtained through the float 42 and ballast 44 that bisect the midpoint of the mechanical separator 40 are generally circular or ball-like, having a variable diameter but still having a spheroidal shape. A mechanical separator 40 can be provided. In one embodiment, the float 42 and the ballast 44 may be formed separately and later combined. In another embodiment, the float 42 and ballast 44 are co-extruded, such as by a two-shot or multi-shot process so that the components are integrally linked together to form the complete separator 41. It may be co-formed, such as being and / or integrally molded. In another configuration, this integral linkage between the float 42 and the ballast 44 is also by the material bond between the two components, by the mechanical interlock, or by the combination of the material bond and the mechanical interlock. You may be hung up. In addition, the float 42 and ballast 44 are made by independent post-molding operations such as glue, heat caulking, and / or ultrasonic welding. , May be linked together. As illustrated in FIGS. 6 and 8, the ballast 44 may include a mounting protrusion 66 that assists in engaging the ballast 44 and the float 42.
In one embodiment, it is desirable that the ballast 44 of the mechanical separator 40 be made from a material that has a higher density than the liquid intended to be separated into two phases. For example, if human blood is required to be separated into serum and plasma, ballast 44 should have a density of at least 1.029 g / cc. In one embodiment, the ballast 44 can be formed from mineral-filled polypropylene. As used herein, both the float 42 and the ballast 44 have a variety of biocompatibility, density stability, additive compatibility, and neutrality to the interaction, absorption, and leachability of the analyte. It is expected that it can also be formed from other materials.
Due to the density difference between the float 42 and the ballast 44, the mechanical separator 40 has a mass center R deviated from the volume center R1 of the separator body 41. Specifically, the volume of the separator body 41 occupied by the float 42 may be much larger than the volume of the separator body 41 occupied by the ballast 44. Therefore, in some embodiments, the center of mass R of the separator body 41 can deviate from the through hole 46.
According to another embodiment of the present invention, as illustrated in FIGS. 9-13, the mechanical separator 140 comprises, as described above, a separator body 141 having a float 142 and a ballast 144 and a through hole 146. Is defined in the float 142. In this configuration, specifically illustrated in FIGS. 10 and 13, the first extension tab 152 and the second extension tab 154 are substantially convex by being combined with the upper portion 155 of the float 142. Form an upper float surface 157 in the shape of a shape. As shown in FIG. 9, the vertical cross section of the separator body 141 is slightly deviated from the sphere, and the diagonally displaced end points 158 and 159 of the through hole 146 extending along the through axis T. Diameter D of the separator body extending to<sub>3</sub>Is a tangent to the separator body 141 and extends in the direction perpendicular to the through hole 146 between the outermost facing end points 160 and 161.<sub>4</sub>Slightly larger than. Thus, the endpoints (diagonally displaced endpoints 158, 159 and diagonally displaced endpoints 158A, 159A) may each comprise a thickened area of material such as TPE.
According to another embodiment, as illustrated in FIGS. 14-20, the mechanical separator 240 comprises a separator body 241 having a float 242 and a ballast 244, as described above, with a through hole 246 floating. It is defined in 242. In this configuration, the through hole 246 may have a substantially elliptical cross section, as specifically illustrated in FIGS. 18-19. In one embodiment, the main axis M of the elliptical portion illustrated in FIG.<sub>1</sub>Is oriented perpendicular to the through axis T illustrated in FIG. The main axis M of the elliptical part in the direction perpendicular to the through axis T<sub>1</sub>Due to the extension of the float 242, as discussed herein, the sub-axis M of the elliptical portion during the application of rotational force.<sub>2</sub>It may be configured to extend longer in the direction (shown in FIG. 18).
In this configuration, the curvature of the first extension tab 252 and the curvature of the second extension tab 254 make at least a portion of each of the elliptical first opening 248 and second opening 250 of the through axis T. It extends to substantially imitate. In another embodiment, the first extending tab 252 has at least a partially curved shape, such as having a convex shape, adjacent to the upper portion of the first opening 248 of the through hole 246. Provided. The second extending tab 254 may also have at least a partially curved shape, such as having a convex shape, and is provided adjacent to the upper portion of the second opening 250 of the through hole 246. May be good.
As illustrated in FIG. 20A, the mechanical separator 240A comprises a separator body 241A having a float 242A and a ballast 244A, as described above, with through holes 246A defined within the float 242A. In this configuration, the first extending tab 252A and the second extending tab 254A substantially coincide with the diameter 243A of the separator body 241A at the edge of the through hole 246A, and the first extending tab 252A And may have an elliptical longitudinal section slightly offset from diameter 243A at apex 247A of the second extending tab 254A. In this configuration, the first extension tab 252A and the second extension tab 254A abut a part of the test tube wall at the sealing position to form a barrier, as described herein. May be provided with an enlarged fillet 280A located at the edge of the first extending tab 252A and the second extending tab 254A adjacent to the through hole 246A. The enlarged fillet 280A can serve to facilitate the demarcation of cells around the mechanical separator when an applied rotational force is applied, as described herein. In addition, the magnifying fillet 280A has a large thickness and / or diameter, such as a wide taper adjacent to the end of the first extension tab 252A and the second extension tab 254A, along at least part of the through hole 246A. It may include an area of a first extension tab 252A and a second extension tab 254A that extend.
As illustrated in FIGS. 21-22, the mechanical separator 340 of the present invention may include a float 342 and a ballast 344, even with an elliptical interior 360 defining a substantially cylindrical through hole 346. Good. In this configuration, the elliptical interior 360 may include a filling material 362 dimensionally designed to fill the elliptical interior 360, leaving a substantially cylindrical through hole 346. In one embodiment, the filling material 362 may be a TPE material or other sufficiently flexible material. Alternatively, as illustrated in FIGS. 23-24, the mechanical separator 440 of the present invention with the float 442 and the ballast 444 may include an elliptical interior 460 defining an elliptical through hole 446. In yet another configuration, the mechanical separator 540 of the present invention with the float 542 and the ballast 544 may include through holes 546 with a circular cross section and an elliptical shape. Optionally, the float 542 may further include a slit 548 or a plurality of slits 548 adjacent to the interface 550 with the ballast 544 and the like. By providing the slit 548 defined in the float 542 or a plurality of slits 548, it may be possible to increase the elongation rate of the float 542 when a rotational force is applied, as discussed herein.
As illustrated in FIG. 27, the mechanical separator 40 of the present invention is a portion of a separation assembly 80 for separating a fluid sample into a first phase and a second phase in a collection container 82 having a closure 84. May be provided as. Specifically, the collection container 82 collects samples such as proteomics sample test tubes, molecular diagnostic sample test tubes, chemical sample test tubes, blood or other body fluid collection test tubes, coagulation sample test tubes, and hematology sample test tubes. It may be a test tube. Desirably, the collection container 82 is a vacuum blood collection test tube. In one embodiment, the collection container 82 may contain additional additives such as proteolytic enzyme inhibitors and blood clotting agents, as needed for a particular laboratory procedure. Such additives may be in the form of particles or liquids and may be sprayed onto the cylindrical side wall 86 of the collection container 82 or placed at the bottom of the collection container 82. The collection container 82 includes a closed bottom end 88, an opening top 90, and a cylindrical side wall 92 extending between them. The cylindrical side wall 92 has an inner surface having an inner diameter that extends substantially uniformly from the opening top 90 to a position substantially adjacent to the closed bottom end 88 along the longitudinal axis L of the collection container 82. Equipped with 94.
The collection container 82 may be made from one or more of the following materials: polypropylene, polyethylene, terephthalate (PET), glass, or a combination thereof. The collection container 82 can include a single wall structure or a plurality of wall structures. In addition, the collection container 82 may be constructed in any practical size to obtain a suitable biological sample. For example, the collection container 82 may be of similar size to a conventional large volume test tube, small volume test tube, or micro test tube, as is known in the art. In one particular embodiment, the collection container 82 may be a standard 13 ml vacuum blood collection test tube, also known in the art.
The upper end 90 of the opening is configured to at least partially receive the closure 84 therein to form a liquid permeable seal. Closure 84 comprises an upper end 96 and a lower end 98 configured to be at least partially received within the collection container 82. Multiple portions of the closure 84 adjacent to the top edge 90 define a maximum outer diameter that exceeds the inner diameter of the collection container 82. In one embodiment, the closure 84 comprises a punctureable removable diaphragm 100 that can be penetrated by a needle cannula (not shown). Multiple parts of the closure 84 extending downward from the bottom edge 98 are larger than the inner diameter of the collection container 82 at the top 96, from a smaller diameter that is approximately equal to or slightly smaller than the inner diameter of the collection container 82. It may be tapered up to the diameter. Therefore, the lower end 98 of the closure 84 can be pushed into a portion of the collection container 82 adjacent to the upper end 90 of the opening. The inherent elasticity of the closure 84 can ensure a sealing engagement with the inner surface 94 of the cylindrical side wall 86 of the collection container 82. In one embodiment, the closure 84 is formed from an integrally molded elastomeric material and can have any size and dimensions suitable to allow a sealing engagement with the collection container 82. Optionally, the closure 84 may be at least partially enclosed by a shield such as the Hemogard® Shield commercially available from Becton, Dickinson and Company.
As illustrated in FIG. 27, the mechanical separator 40 of the present invention is oriented within the collection container 82 at an initial position where the through hole 46 of the mechanical separator 40 is aligned with the opening top 90 of the collection container 82. obtain. In this initial position, the through hole 46 punctures the punctureable diaphragm 100 of the closure 84 and fluids into it from a needle cannula (not shown) or the like that is in fluid communication with the interior of the collection container 82. Is made to be able to pass. Further, the mechanical separator 40 is removed from a portion of the closure 84 so that the separator body 41 can move from the initial position as shown in FIGS. 27-28 to the sealing position as shown in FIG. 29. It may be freely engaged. In the initial position, the through hole 46 is oriented by the flow arrow F in an open position that allows the fluid to pass in the direction shown in FIG. Referring to FIG. 27, the initial open position of the through hole 46 is substantially aligned with the longitudinal axis L of the collection container 82. Referring to FIG. 29, when a rotational force is applied, such as during centrifugation, the mechanical separator 40 is disengaged from its engagement with the closure 84 and the through hole 46 is in a substantially closed position. It deforms enough to rotate to the sealing position in the direction indicated by the direction arrow D in FIG. In a substantially closed position, the float 42 with the first extension tab 52 and the second extension tab 54 forms a sealing engagement with the inner surface 94 of the collection container 82 and penetrates. Substantially prevents fluid from being received in the hole 46 or around the separator body 41.
In one configuration, the through hole 46 is substantially aligned with the opening top 90 of the collection container 82 along at least a portion of the longitudinal axis L in the open position, and the through hole 46 is this longitudinal in the closed position. It is substantially aligned perpendicular to the direction axis. It should be noted that the transition of the through hole 46 from the open position to the closed position occurs with the rotation of the mechanical separator 40 from the first initial position to the second closed position. In another configuration, the mechanical separator 40 is engaged with a portion of the closure 84 at the first sealing position and the mechanical separator 40 is a portion of the sidewall 86 of the collection container 82 at the second sealing position. Engage in. With reference to FIG. 27 again, the closure 84 may include an engagement boss 102 for engaging with the mechanical separator 40. In one configuration, the engaging boss 102 has a through hole 46 when the separator body 41 is in the first initial position to form a fluid seal between a portion of the separator body 41 and the closure 84. Located within a part.
In this initial position, the mechanical separator 40 can be attached to the closure 84 by a mechanical snap caused by an undercut in the through hole 46 that controls the release load of the mechanical separator 40. When the mechanical separator 40 is mounted on the closure 84, the mechanical separator 40 is placed between the side wall 86 of the collection container 82 along the first sealing outer circumference 104, as illustrated in FIG. Form a seal. When the test object is drawn into the collection container 82, the first sealing outer circumference 104 prevents blood from accumulating between the mechanical separator 40 and the closure 84. This reduces the formation of blood clots and / or fibrin chains that can disrupt the function of the mechanical separator 40. When a rotational force is applied and the mechanical separator 40 transitions as shown in FIG. 29, the mechanical separator 40 receives a rotational moment while still mounted on the closure 84 and is released from the closure 84. Is rotated by about 90 ° and is oriented so that the ballast 44 faces the bottom end 88 of the collection container 82.
When the mechanical separator 40 comes into contact with the fluid contained within the collection container 82, the air occupying the through hole 46 is gradually displaced by the fluid as the device sinks. When the mechanical separator 40 is submerged in the fluid, the float 42 has a greater buoyancy than the ballast 44, which creates a differential force in the mechanical separator. During centrifugation, this differential force causes the float 42 component to expand and contract away from the side wall 86 of the collection container 82, thereby reducing the effective diameter and resulting in relatively high density phase components and. A flow path is opened for fluids such as relatively low density phase components to flow across the separator 41. It should be noted that the float 42 may be configured to deform in a direction that is substantially perpendicular to the through hole 46. When the applied rotational force is removed, the float 42 returns to its original state, and the sealing area defined by the float 42 and the first extension tab 52 and the second extension tab 54 is illustrated in FIG. As such, it expands again to abut the inner surface 94 of the collection container along the second sealing outer periphery 106 to form a seal. Therefore, the mechanical separator 40 is designed to prevent fluid from passing between the separator 41 and the collection container 82 or around the separator 41 and the collection container 82, and further prevents the fluid from passing through the through hole 46. Prevent and thereby effectively establish a barrier. The second sealing periphery 106 establishes a barrier between the relatively high density phase and the relatively low density phase in the sample.
As illustrated in FIGS. 31A-31B, the mechanical separator 140A comprises a separator body 141A with a float 142A and a ballast 144A as discussed above, with through holes 146A defined within the float 142A. There is. In this configuration, the float 142A may include a partially wavy region 150A to form a surface to improve the surface demarcation of blood component debris during use. As discussed herein, when the separator 140A is submerged in a fluid sample such as blood, some blood constituents such as fibrin or cells either stick to the upper surface of the float 142A or of the float 142A. It may be trapped on the upper surface in other ways. According to this embodiment, the float 142A may include a wavy region 150A to improve the surface demarcation. According to another embodiment, the float 142A may include opposing wavy regions 150A, as illustrated in FIG. 31B and the like. The wavy region 150A may have any curved shape suitable for improving the surface demarcation of the float, such as elliptical, oval, and curved.
In this configuration, the separator 141A may also include a first extending tab 152A and a second extending tab 154A, which of the test tube wall at the sealing position, as described herein. An enlarged fillet 180A is placed at the edges of the first extending tab 152A and the second extending tab 154A adjacent to the through hole 146A to assist in forming a barrier in contact with a portion. The enlarged fillet 180A has a large thickness and / or diameter, such as a wide taper adjacent to the end of the first extending tab 152A and the second extending tab 154A, and extends along at least a portion of the through hole 146A. It may include one area of the existing first extension tab 152A and second extension tab 154A. In one configuration, the enlarged fillet 180A can facilitate cell demarcation around the mechanical separator 141A when applying an applied rotational force, as described herein.
According to a further embodiment of the present application, as illustrated in FIGS. 31C-31I, the mechanical separator 40D comprises a separator body 41D with a float 42D and a ballast 44D, as discussed above, and through holes. 46D is defined in the float 42D. In this configuration, the separator body 41D is substantially as illustrated in FIGS. 29 and 68 in order to improve the barrier seal between the mechanical separator 40D and the side wall of the collection container at the sealing position. It may have an egg-shaped outer outer periphery.
In this configuration, as shown in FIG. 31F, the through shaft T of the through hole 46D<sub>axis axis</sub>Diameter D of the separator body 41D, specifically the float 42D as illustrated in FIGS. 31D and 31G, obtained across the float 42D in the direction along.<sub>5</sub>Is the through shaft T of the through hole 46D as illustrated in FIG. 31F.<sub>axis axis</sub>The diameter D of the separator body 41D, specifically the float 42D as shown in FIG. 31D, which is obtained across the float 42D in the direction perpendicular to the vertical direction.<sub>6</sub>It may be less than. In this configuration, the through shaft T<sub>axis axis</sub>The diameter D of the separator body 41D, specifically the float 42D as shown in FIG. 31D, which is obtained across the float 42D at an angle of 45 ° to the float 42D.<sub>7</sub>May be larger than the through hole 46D, or the diameter D of the separator body 41D<sub>5</sub>And D<sub>6</sub>May be larger than. Further, in this configuration, as shown in FIG. 31F, the through shaft T of the through hole 46D<sub>axis axis</sub>Diameter D of ballast 44D obtained across ballast 44D along<sub>8</sub>Is the diameter D of the separator body 41D<sub>5</sub>, D<sub>6</sub>, And D<sub>7</sub>It may be less than any of.
By providing a float 42D with a diameter larger than the ballast 44D, the mechanical separator 40D is relatively such as a large volume TPE due to abutment and displacement of the sealing surface as described herein. It may be possible to have a low density material. Further, this embodiment comprises an extended tab band as discussed below in relation to FIGS. 35A-35E and / or an initial engagement band as discussed below in relation to FIGS. 33-35. May be good.
Referring to FIGS. 32 to 35, in a further configuration, the mechanical separator 40 may further include an initial engagement band 116 disposed circumferentially around the separator body 41. In a further configuration, the initial engagement band 116 may be disposed around the separator body 41 in a direction substantially perpendicular to the through hole 46. The initial engagement band 116 may be provided continuously around the separator body 41, or optionally, may be provided in a segment around the separator body 41. In yet another configuration, the float 42 and the initial engagement band 116 may be formed from the same material, such as TPE. The initial engagement band 116 may be provided such that the first portion 42A of the float 42 forms the initial engagement band 116 and the second portion 42B substantially bisects the ballast 44.
Specifically, as illustrated in FIG. 35, the initial engagement band 116 creates an interfacial engagement between the separator body 41 and the inner surface 94 of the collection container 82. In this configuration, the first sealing outer peripheral portion 104 around the separator body 41 is aligned with the initial engagement band 116. In the first sealing outer peripheral portion 104, fluid entering the collection container 82 from a cannula (not shown) disposed through the punctureable diaphragm 100 passes through the first opening 48 of the separator body 41. Assists in keeping the separator 41 in proper alignment with the opening top 90 of the collection container 82 so that it passes through the through hole 46 and exits the second opening 50.
According to yet another embodiment of the invention, as illustrated in FIGS. 35A-35E, the mechanical separator 40C comprises a separator body 41C having a float 42C and a ballast 44C. The separator body 41C includes a through hole 46C defined in the float 42C, such as being entirely defined in the float 42C. In this configuration, the float 42C may include an extended tab band 50C disposed around the outer surface 52C of the float 42C. In one embodiment, the extension tab band 50C has a first extension 54C adjacent to the first opening 56C of the through hole 46C and a second extension adjacent to the second opening 60C of the through hole 46C. May include a portion 58C. In this configuration, the first extension 54C and the second extension 58C may be provided substantially adjacent to at least a portion of each of the first opening 56C and the second opening 60C. .. The first extending portion 54C and the second extending portion 58C may each have a generally concave downward orientation.
Further, the first extending portion 54C and the second extending portion 58C are provided substantially around a part of the through hole 46C, such as in an outward extending arc shape around the upper portion of the through hole 46C. You may. A portion of the first extension 54C and a portion of the second extension 58C allow the first extension 54C and the second extension 58C to have substantially the same shape and curvature. In addition, the through shaft T of the separator body 41C<sub>A</sub>It may extend outward from the float 42C in a direction substantially parallel to.
Further, the extending tab band 50C is arranged between the first extending portion 54C and the second extending portion 58C on both sides of the separator body 41C, and the first extending portion 54C and the second extending portion 54C are arranged. A joint portion 62C connecting the existing portion 58C may be provided. Each of the joint portions 62C may have a generally concave upward orientation. In one embodiment, the junction 62C, the first extension 54C, and the second extension 58C are continuous between them and generally "rope" wrapped around a portion of the float 42C. Form a "like" appearance. In a further embodiment, the junction 62C, the first extension 54C, and the second extension 58C form a continuous sinusoidal shape around a portion of the outer surface 52C of the float 42C. .. In another embodiment, the extending tab band 50C may be co-formed with the float 42C to form a portion of the float 42C itself. In one alternative embodiment, the extending tab band 50C may be formed separately from the float 42C and later joined. In some configurations, the float 42C and the extending tab band 50C are both made from a relatively low density material such as TPE and the ballast 44C may be made from a relatively high density material such as PET.
In one embodiment specifically illustrated in FIGS. 35C and 35C1, the joint portions 62C, respectively, have approximately the same thickness T.<sub>J</sub>May have. In another embodiment, the first extending portion 54C and the second extending portion 58C also have approximately the same thickness T.<sub>J</sub>May have. The cross section of the extending tab band 50C may have any suitable sealing shape, such as circular, square, or ribbed. Further, in the present specification, it is expected that a plurality of extending tab bands 50C may be disposed around the outer surface 52C of the float 42C. With reference to FIGS. 35B and 35D, the first extension 54C and the second extension 58C together with the upper portion 64C of the float 42C generally define a spline or saddle shape, thickened shelf areas 54C1 and 58C1. May be provided respectively. The upper portion 64C of the float 42C and the extending tab band 50C may be configured to maximize the surface demarcation of blood component debris, in particular during use. As discussed herein, when the separator 40C is submerged in a fluid sample such as blood, some blood constituents such as fibrin or cells either stick to the upper surface of the float 42C or float 42C. It may be captured in other ways on the upper surface of the. The specific shape of the extended tab band 50C is intended to minimize the capture of blood component debris during use.
In yet another embodiment, as illustrated in FIG. 35E, the extending tab band 50C has a first extending on both sides of the first extending portion 54C, the second extending portion 58C, and the float 42C. A joint portion 62C may be provided which connects the portion 54C and the second extending portion 58C to form a continuous structure around the outer surface 52C of the float 42C. In this configuration, the thickened shelf area 54C1 of the first extending portion 54C and the thickening shelf area 58C1 of the second extending portion 58C improve the surface demarcation of the blood component waste in use and collect containers at the sealing position. Truncated longitudinal sections 54C2 and 58C2 are provided to provide additional structural support for the first extension 54C and the second extension 58C when forming the seal with (not shown). Each has.
When the mechanical separator 40C of the present embodiment is used, the extension tab band 50C is provided by the first extension tab and the second extension tab described above with reference to FIGS. 1-8. Similar to the defined seal, it forms a robust sealing surface that abuts a portion of the collection container wall (not shown). In some embodiments, the extended tab band 50C provides additional sealing and can minimize leakage between the mechanical separator 40C and the collection container. In addition, in configurations where the float 42C is formed from TPE, the extending tab band 50C is for strengthening the sealing by causing the TPE to not deform much under conventional applied rotational forces and to displace to another position. Provides a mechanism. By placing the arc-extending tab band 50C around the outer surface 52C of the float 42C, the TPE is uniformly abutted and displaced at the side wall of the collection container at the sealing position, as described herein. It becomes possible. The sealing surface of the mechanical separator 40C is the outer surface 52C of the float 42C corresponding to the position of the extending tab band 50C, because the extending tab band 50C can be provided with alternating concave upward orientation and concave downward orientation. Can be located at various heights around the.
In a further configuration, in the present specification, the mechanical separator 40C having the extending tab band 50C is provided with enhanced sealing between the extending tab band 50C and the collection container at the sealing position (as described above). It is intended that this can be suitable for use in a collection container with tilted orientation. Further, as used herein, it is intended that the mechanical separator 40C may include an initial engagement band 116, as similarly described above with reference to FIG. 35.
According to yet another embodiment of the present invention, as illustrated in FIGS. 35F-35G, the mechanical separator 40A comprises a separator body 41A having a float 42A and a ballast 44A. The separator body 41A includes a through hole 46A defined in the separator body 41A. In this configuration, the ballast 44A may include a base portion 52A and a joint structure 48A, such as a plurality of arms 50A, for engaging a portion of the float 42A. The ballast 44A, specifically the joint structure 48A, may be in a permanent engagement with a portion of the float 42A by integral molding, two-shot molding, welding, or other adhesive joining means. In one configuration, the float 42A may be formed from a relatively low density material such as TPE and the ballast 44A may be formed from a relatively high density material such as PET. In a further configuration, the mechanical separator 40A is such that the overall density of the separator 41A is the density of the relatively dense components of the blood sample, such as serum and red blood cells, and the density of the relatively low density components. The dimensions may be set so as to be between. In yet another embodiment, the overall density of separator 41A is 1.45 g / cm.<sup>3</sup>Is.
As illustrated in FIG. 35H, the ballast 44A may include a base portion 52A having a contact surface 54A and a joint surface 56A. In one configuration, the contact surface 54A may include a surface 58A that is at least partially curved to match the inward curvature of the collection container (not shown). The joint surface 56A may include an adhesive portion between the base portion 52A and the joint structure 48A. In one configuration, the joint surface 56A and the joint structure 48A are co-formed. In another configuration, the joint surface 56A and the joint structure 48A are formed separately and later brought into a permanent adhesive state via mechanical locking means or adhesive locking means.
The joint structure 48A may include a first end 60A for engaging the base portion 52A of the ballast 44A and a second end 62A for engaging a portion of the float 42A. The top view of the float 42A is a substantially circular outer circumference P, as illustrated in FIG. 35I.<sub>O</sub>The float 42A may have a substantially curved cross-sectional side surface, such as a substantially concave lower cross section as illustrated in FIG. 35H. In a further embodiment, the float 42A has a substantially concave lower cross section adjacent to the apex 64A of the float 42A and a float such as where the second end 62A of the junction structure 48A is mounted on the float 42A. Outer circumference P of 42A<sub>O</sub>It may have a slightly concave upward curve adjacent to the. In one configuration, the second end 62A of the joint structure 48A is first molded, then the float 42A is molded onto the second end 62A of the joint structure 48A, this second. A joint is formed with the end 62A. In another embodiment, the second end 62A of the bonded structure 48A is inserted into or adjacent to a portion of the float 42A and then relative to this portion. Combined or glued separately.
In one configuration, the junction structure 48A can provide flexures between the float 42A and the base portion 52A. The flexures form the bond between the first end 60A of the joint structure 48A and the base portion 52A, the bond between the second end 62A of the joint structure 48A and the float 42A, and It can be provided by at least one of the pivot points 68A of the junction structure 48A.
Referring to FIG. 35J, the mechanical separator 40A may be provided in the collection container 100A in the initial position, such as adjacent to the upper end 102A of the collection container 100A. The mechanical separator 40A engages with a portion of the stopper 104A such that a portion of the stopper 104A extends through the through hole 46A of the mechanical separator 40A, as described elsewhere herein. May be done. According to another embodiment of the present invention, in the mechanical separator 40A, the through hole 46A of the mechanical separator 40A is the longitudinal axis L of the collection container 100A.<sub>A</sub>A portion of the float 42A and a portion of the base portion 52A of the ballast 44A engage the inner surface of the collection container 100A and constrain the mechanical separator 40A within the upper end 102A of the collection container 100A so that it is aligned with. It may be provided so as to do so.
Referring again to FIG. 35J, the fluid subject 108A such as blood is introduced into the collection container 100A via the stopper 104A etc. and the mechanical separator 40A is oriented in the initial position as indicated by reference numeral A. Then, it is aligned with the through hole 46A of the mechanical separator 40A. When a rotational force is applied, the float 42A flexes, creating a flexure between the float 42A and the ballast 44A as described above. The resulting flexure deforms the through hole 46A, disengages the mechanical separator 40A from the stopper 104A, and begins to rotate in the direction indicated by the arrow R, as indicated by reference numeral B.
When the mechanical separator 40A is submerged in the fluid test 108A, the float 42A begins to be oriented upwards and the ballast 44A begins to be oriented downwards at the same time, as indicated by reference numeral C. .. While the rotational force is continuously applied, the ballast 44A is pulled downwards and the float 42A flexes away from the side wall 110A of the collection container, as indicated by reference numeral D. The float 42A is then deformed to form a relatively high density phase component and a relatively low density phase component between the float 42A and the side wall 110A of the collection container 100A, as indicated by reference numeral E. Allows to pass. This makes it possible to separate the components of the relatively high density phase and the components of the relatively low density phase in the fluid sample 108A, and further compare the components in the fluid sample 108A existing in the through hole 46A of the mechanical separator 40A. It is possible to separate the constituents of the high-density phase and the constituents of the relatively low-density phase.
Referring to FIG. 35K, when the application of rotational force is stopped, the mechanical separator 40A is placed between the separated relatively dense phase 112A and the separated relatively low density phase 114A at the sealing position. It will be in a state of being oriented to. At the same time, the flexure between the float 42A and the ballast 44A is completed and the float 42A is returned to its initial position as illustrated in FIG. 35I, thereby causing the outer periphery P.<sub>O</sub>A seal is formed between the container 100A and the inner peripheral portion of the side wall portion 110A of the collection container 100A. The float 42A has an outer perimeter P having an outer perimeter that is at least slightly larger than the inner perimeter of the side wall 110A of the collection container 100A.<sub>O</sub>A robust seal portion is formed between the inside and the peripheral portion of the side wall portion 110A of the collection container 100A.
Referring again to FIG. 35K, when the mechanical separator 40A is moved to the sealing position, the outer peripheral portion of the sealing is placed between at least a part of the inner peripheral portion of the side wall portion 110A and the mechanical separator 40A. P<sub>O</sub>Established along. Outer perimeter P, as illustrated in Figure 35K<sub>O</sub>The outer perimeter of the sealing along is has a variable position around the inner perimeter of the side wall 110A when measured from the closed bottom end 113A of the collection container 100A. In one configuration, the outer outer circumference P<sub>O</sub>The outer perimeter of the sealing along is a localized sealing position S that corresponds to the total height of the seal between the mechanical separator 40A, specifically the float 42A and the side wall 110A.<sub>1</sub>, S<sub>2</sub>, S<sub>3</sub>It has various sealing heights and so on. Therefore, the outer periphery of the ceiling is the each localized sealing position S.<sub>1</sub>, S<sub>2</sub>, S<sub>3</sub>Etc. have slightly different heights. In addition, the outer peripheral portion of the ceiling has each localized sealing position S.<sub>1</sub>, S<sub>2</sub>, S<sub>3</sub>Average ceiling height H corresponding to the average height of etc.<sub>Avg</sub>Demarcate, i.e. H<sub>Avg</sub>= Avg [S<sub>1</sub>, S<sub>2</sub>, S<sub>3</sub>And so on]. In addition, the mechanical separator 40A has a maximum height of H in the collection container.<sub>Max</sub>And minimum height H<sub>Min</sub>Have. Maximum height H<sub>Max</sub>Is the outer perimeter P<sub>O</sub>Corresponds to the distance between the highest sealing point along the line and the closed bottom end 113A of the collection container 100A. Minimum height H<sub>Min</sub>Is the outer perimeter P<sub>O</sub>And corresponds to the lowest sealing point along the closed bottom end 113A of the collection container 100A. According to one aspect of the invention, the average sealing height H<sub>Avg</sub>Is the maximum height H<sub>Max</sub>And minimum height H<sub>Min</sub>Less than the difference between, i.e. H<sub>Avg</sub><H<sub>Max</sub>-H<sub>Min</sub>Will be.
According to another embodiment of the invention, as illustrated in FIGS. 35L-35M, the mechanical separator 40B comprises a separator body 41B having a float 42B and a ballast 44B. The separator body 41B includes a through hole 46B defined in the separator body 41B. In this configuration, the float 42B may include a joint structure 48B, such as a plurality of arms 50B, for engaging a portion of the ballast 44B. Similar to the above, the joining structure 48B may be in a permanent engagement state with a portion of the ballast 44B by integral molding, two-shot molding, welding, or other adhesive joining means. In this configuration, the junction structure 48B exhibits high flexibility that can further facilitate the transition from the initial position to the sealing position, as described herein.
Referring again to FIGS. 35L to 35M, in one configuration, the float 42B includes a notch 60B within the float 42B. In one embodiment, the notch 60B may be located at the apex 62B of the float 42B and the outer perimeter P.<sub>O</sub>It does not extend inside. The notch 60B provides high flexure, which is a component of the relatively high density phase in use and relatively high density due to this high flexure, as illustrated in FIG. 35J with reference to reference numeral E. Allows the passage of low density phase components. In yet another configuration, the junction structure 48B may include an opening 64B configured such that a portion of the ballast 44B may pass through and be secured therein by a mechanical interlock or the like. In one embodiment, the joining structure 48B comprises a continuous arm 50B connected to a float 42B at a first end 68B and a second end 70B. The joint structure 48B may include an opening 64B in which the locking portion 72B of the ballast 44B extends. In one embodiment, the opening 64B may be disposed within the continuous arm 50B at a position opposite to the apex 62B of the float 42B. In another embodiment, the ballast 44B and the float 42B, such as the locking portion 72B, may be in a constant engagement state to minimize the distance between the float 42B and the ballast 44B.
With reference to FIGS. 35N-35O, in another embodiment of the invention, the mechanical separator 40B comprises a separator body 41B having a float 42B and a ballast 44B. The separator body 41B includes a through hole 46B defined in the separator body 41B. In this configuration, the float 42B may include a joint structure 48B, such as a plurality of arms 50B, for engaging a portion of the ballast 44B. Similar to the above, the joining structure 48B may include a continuous arm 50B connected to the float 42B at a first end 68B and a second end 70B. The joint structure 48B may include an opening 64B in which the locking portion 72B of the ballast 44B extends in, in a constitutive engagement state to minimize the distance between the float 42B and the ballast 44B. The ballast 44B may also include a support structure 74B adjacent to and connected to the joint structure 48B of the float 42B. In one embodiment, the support structure 74B of the ballast 44B may be co-formed with the joint structure 48B of the float 42B or permanently engaged with the joint structure 48B of the float 42B in another manner. Good. In a further embodiment, the junction structure 48B may define a recess configured to at least partially surround the support structure 74B. In yet another embodiment, the support structure 74B and the junction structure 48B allow the float 42B and ballast 44B to flex at least partially with respect to each other, as described herein. To do. In some configurations, the ballast notch 80B may be formed within the base portion 52B to reduce shrinkage of the ballast 44B during formation.
The through holes of the mechanical separators of the present invention are shown herein as linear bores with a spherical or elliptical cross section, but in the present specification, through holes 546 are illustrated in FIGS. 36-37. As such, it is also expected that a meandering or detour route for receiving the liquid in may be defined. In this configuration, the mechanical separator 540 includes a through hole 546 with a first opening 549 and a second opening 551 offset from each other. Specifically, the first opening 549 and the second opening 551 may be offset from each other by an angle of 60 ° or 90 ° or the like. As illustrated in FIG. 36, in the initial position, the first opening 549 is aligned with the upper opening end 590 of the collection container 582 shown in cross section herein. The fluid is fed through the through hole 546 in the direction indicated by the directional arrow R. In this configuration, at least one surface of the second opening 551 contacts the side wall of the collection container 582, while another surface of the second opening 551 is free inside the collection container 582. stay. Therefore, a gap is provided between the side wall of the collection container 582 and the second opening 551 of the through hole 546 so that fluid exits the through hole 546 and enters the interior of the collection container 582. Is possible.
When a rotational force is applied, the mechanical separator 540 is as illustrated in FIG. 36 along the direction arrow S due to the moments of the float and ballast components as described herein. It shifts from the initial position to the sealing position as shown in FIG. 37. In this configuration, both the first opening 549 and the second opening 551 of the through hole 546 are removed from the alignment with the upper opening end 590 of the collection container 582, and fluid is sent into the through hole 546. Be done not. A second sealing perimeter 595 is further established around the mechanical separator 540, allowing fluid to pass between the mechanical separator 540 and the collection container 582, or through the through hole 546 of the mechanical separator 540. It becomes impossible, so that the barrier is effectively established.
In yet another configuration, as illustrated in FIGS. 38-39, the extension of the mechanical separator 640 when a rotational force is applied is illustrated. In this configuration, the mechanical separator 640 may include a float 642 and a ballast 644, with a third section 643 joining the float 642 and the ballast 644. As used herein, it is expected that in this configuration both the float 642 and the ballast 644 can be made from substantially synthetic material, with the float 642 having a density lower than that of the ballast 644. .. A third section 643 formed from a flexible material such as TPE may be provided between these components to allow extension between these components. Upon centrifugation, the third section 643 elongates in a manner similar to that described in connection with the elongation of the float described above, as illustrated in FIG. As the third section 643 extends, the fluid passage surface 645, as illustrated in FIG. 39, as the direction in which the relatively dense and relatively low density phases of the fluid extend within the page. Can pass adjacent to.
Referring again to FIGS. 2, 40 and 41, the separator 41 may include the center of mass R of the separator 41 offset from the through axis T illustrated in FIG. In this configuration, the mechanical separator 40 engages the mechanical separator 40 with a portion of the closure 84 (shown in FIG. 41) or a portion of the side wall 86 of the collection container 82 (shown in FIG. 40). And the center of mass R is the first side S of the longitudinal axis L of the collection container 82<sub>1</sub>From the first position (as illustrated in FIGS. 40-41, etc.) oriented to, the mechanical separator 40 is disengaged from the closure or from the initial engagement position with the collection container, and the center of mass R Is oriented across the longitudinal axis L of the collection container 82 and is transferred to a second position as illustrated in FIG. 29 and the like. At some point, the float 42 of the mechanical separator 40 moves from the initial first position to the second sealing position as the center of mass R shifts between the longitudinal axes L of the collection container 82. Must be deformed in a direction substantially perpendicular to the through axis T of the separator body 41 to allow the transition. As the float 42 extends, the relatively dense and relatively low density phases of the subject are the mechanical separator 40, specifically the elongated float 42 and the side wall 86 of the collection container 82. Can pass between and. In the collection container 82, the mechanical separator is in the middle position. From this intermediate position, the mechanical separator can subsequently transition to the sealing position, where part of the float 42 is between the part inside the collection container at the end of the applied rotational force. Form a sealing engagement.
Therefore, the mechanical separator of the present invention has three operating stages, that is, the initial stage in which the test object is supplied through the through hole of the separator body, the separator is disengaged from the initial position, and the float 42 is extended. It is expected that there will be a transition between the intermediate stage, which allows the passage of relatively dense and relatively low density phases, and the sealing position where the float 42 forms a barrier on a portion of the collection container. May be done. During this series of steps, the mechanical separator may be considered as "open-open-closed". Here, the "open" stage is defined as the condition in which the mechanical separator does not form a sealing barrier with the collection container that prevents the passage of fluid in and around the collection container. In contrast, the "closed" stage is defined as the condition in which the mechanical separator forms a sealing barrier with the collection container that prevents the passage of fluid in and around the collection container.
In addition, the mechanical separators of the present invention are intended to be used with various closure constructs in the early stages. Referring to FIG. 40, the mechanical separator 40 may be held in its initial position by interference between the float 42 and the initial engagement band 116 and the side wall 86 of the collection container 82. In this configuration, the mechanical separator 40 is not constrained by any part of closure 84.
In another configuration, as illustrated in FIGS. 41-44, the separation assembly comprises a closure 84 and a post 180 that engages within a recess 181 of the closure 84. The post 180 may include a separator receiving end 182 and a closure engaging end 183. The closure engagement end 183 may be configured to be positioned within the recess 181 of the closure 84 and may optionally include at least one barb 184 for fixing the post 180 within the closure 84. .. The separator receiving end 182 may have any suitable longitudinal section so that it can be at least partially disposed within the through hole 46 of the separator body 41. In one embodiment, the separator receiving end 182 has a substantially circular cross section. In another embodiment, the separator receiving end 182 has a substantially elliptical cross section. The separator receiving end 182 is sized so that it can be disengaged from the mechanical separator 40 by fitting snugly into the through hole 46. In addition, the post 180 is configured to be located inside the collection container 82 and includes post through holes 186 aligned along the longitudinal axis of the collection container 82. When the mechanical separator 40 is engaged with the post 180, a fluid path is formed between the through hole 46 of the mechanical separator 40 and the post through hole 186 of the post 180. This effectively forms a "sealed" fluid path for feeding the fluid sample into the collection container 82. When a rotational force is applied, the mechanical separator undergoes a slight longitudinal movement prior to axial rotation as the mechanical separator is pulled downward from the post 180 as it is subjected to rotation. ..
Referring to FIGS. 45-46, an alternative comprising a collection container 782 having a first area 783 with an opening top 784 and a first side wall 785 defining a first inner 786 and a first outer 787. Separation assembly is illustrated. In addition, the collection container 782 comprises a second area having a closed bottom end 789 and a second side wall 790 defining a second inner 791 and a second outer 792. In this configuration, the first region 783 and the second region 788 have a longitudinal axis L such that the first interior 786 and the second interior 791 are in fluid communication.<sub>A</sub>Aligned along. The first interior 786 is the first diameter D<sub>F</sub>The second diameter 791 has a second diameter D<sub>S</sub>Has a first diameter D<sub>F</sub>Is the second diameter D<sub>S</sub>Greater than The collection container 782 is also at least one extending between the first region 783 and the second region 788, through which fluid can pass from the first region 783 to the second region 788. It is equipped with two fluid flutes 793. In this configuration, the first outer 787 of the first region 783 may have a longitudinal section that matches a 16 mm collection test tube, and the second outer 792 of the second region 788 may have a 13 mm collection test. It may have a longitudinal section that matches the tube.
The first interior 786 of the first region 783 may be sized to accommodate the mechanical separator 40 in any of the configurations described herein. The second interior 791 is sized to at least partially prevent a portion of the mechanical separator 40 from passing through it in its initial position and in the absence of applied rotational force. When a rotational force is applied, the float portion 42 of the mechanical separator 40 can be extended, thereby reducing the effective diameter of the mechanical separator 40 and mechanically into the second inner 791. The separator can be advanced. In this configuration, the orientation of the through hole 46 of the mechanical separator 40 is not a problem because the introduction of the fluid sample into the collection container 782 is done around the separator body 41 rather than through the through hole 46. It doesn't become. Specifically, the fluid is introduced into the collection container 782, into the first interior 786, and around the mechanical separator 40. The sample then travels into the second interior 791 by the fluid flute 793. Therefore, the initial orientation of the mechanical separator 40 is independent of the function of the separator in this embodiment.
According to a further embodiment of the invention, as illustrated in FIG. 46A, a mechanical separator extends between an open top end 784A and a closed bottom end 785A, as described herein. It can be used with a collection container 782A that has a slight taper along a portion of the existing side wall 783A. In this configuration, the collection container 782A comprises a first area indicator section A of FIG. 46A. The first region indicator section A is disposed along a portion of the side wall 783A at a distance of 786A from the upper end of the opening 784A. In addition, the collection container 782A may include a second region indicator section B of FIG. 46A. The second region indicator section B is disposed along a portion of the side wall 783 at a distance of 788A from the upper end of the opening 784A. In one configuration, the region defined between the first region indicator section A and the second region indicator section B may be substantially free of taper portions. In another configuration, the region defined between the first region indicator section A and the second region indicator section B may have a substantially minor inward taper. In a further embodiment, the region defined between the first region indicator section A and the second region indicator section B is relatively low with the separated relatively dense phase of the liquid to be separated. It can be about the expected separation transition with the density phase.
In yet another embodiment illustrated in FIGS. 47-48, the separation assembly comprises a closure 850 configured to seal engage with the collection container 852. Closure 850 comprises a receiving end 842 for placement within the open end 853 of the collection container 852. The receiving end 842 defines an internal cavity 854 and includes an undercut protrusion 855 extending within the internal cavity 854. The undercut protrusion 855 of the closure 850 is at least partially disposed within the through hole 46 of the mechanical separator 40 in the initial position. Further, in the initial position, at least a part of the separator body 41 is arranged in the internal cavity portion 854. By arranging the mechanical separator 40 in the internal cavity 854, the mechanical separator 40 is ensured to remain trapped in the closure 850 when assembling the closure 850 to the collection container 852. This configuration can be used with a collection container having a first region and a second region, as described above. When a rotational force is applied, the float 42 of the mechanical separator 40 extends and the mechanical separator 40 can be disengaged from the closure 850.
Then, with reference to FIGS. 49-59, various other engagements between the mechanical separator 40 and the closure 84 are further expected herein. As illustrated in FIG. 49, the mechanical separator 40 may include an angled engaging boss 900 disposed within the through hole 46 in the initial position. As illustrated in FIG. 50, the mechanical separator 40 may initially include a substantially cylindrical engaging boss 901 disposed within the through hole 46. The side portion 902 of the closure 903 is fitted into the first opening 905 to further secure the mechanical separator 40 to the closure 903 and to establish a "sealed" fluid path into the collection container 906 through the closure 903. It may be provided adjacent to the outer surface 904 of the adjacent mechanical separator 40.
With reference to FIGS. 51-52, a sealant 907 may be provided adjacent to the side portion 902 as described above to further secure the mechanical separator 40 and closure 903. The sealant 907 has sufficient adhesiveness to hold the mechanical separator 40 in place in the initial position, but sufficient to release the mechanical separator 40 from the closure 903 when a rotational force is applied. It may be a weakness.
Referring to FIG. 53, yet another alternative angled engaging boss 908 may be disposed in the through hole 46 in the initial position. With reference to FIGS. 54-55, the closure 910 may include at least one hanging arm 911, such as two, for engagement with the mechanical separator 40. In one configuration, each hanging arm 911 includes a contact protrusion 912 for engaging a portion of the mechanical separator 40 within the through hole 46 in the initial position. The interference between the contact protrusion 912 and the mechanical separator 40 constrains the mechanical separator 40 by the closure 910 in the initial position, but disengages the mechanical separator 40 from the closure 910 when a rotational force is applied. It may be sufficient to obtain.
With reference to FIGS. 56-57, the closure 915 may include a molding insert 916 having a wedge basket 917 for further fixing the molding insert 916 to the closure 915. As described above, the molded insert 916 may include a separator receiving end 918 for engaging the mechanical separator 40 through the through hole 46 and a closed engaging end 919, as described above. .. Referring to FIG. 58, another molding insert 920 may include at least one barb 921 for further fixing the molding insert 920 to the closure 922. With reference to FIG. 59, yet another molding insert 930 may include at least one protrusion 931 for further fixing the molding insert 930 to the closure 932.
With reference to FIGS. 60-68, the separation assembly disclosed herein may further include a carrier 650 that is detachably engaged with a portion of the mechanical separator 40 in its initial position. In each of these configurations, the carrier 650 is disengaged from the mechanical separator 40 when a rotational force is applied to prevent blood clots or fibrin chains from interfering with the operation of the mechanical separator 40. Enter the fluid phase located below 40.
As illustrated in FIG. 60, the carrier 650 is detachably engaged with a closure engaging portion 651 for detachably engaging a portion of the closure 652 and a portion of the mechanical separator 40, such as a through hole 46. It may be provided with a hanging portion 653 for fitting. As illustrated in FIG. 61, the carrier 650 may further include a closure engaging portion 651 having a plurality of flanges 654. Further, the carrier 650 may include a curved separator engaging portion 655 for engaging a portion of the mechanical separator 40, such as in the through hole 46. When a rotational force is applied, the mechanical separator 40 is disengaged from its initial position and rotates as described herein. As the mechanical separator 40 rotates, the curved separator engaging portion 655 contracts, allowing the mechanical separator 40 to separate from the carrier 650.
With reference to FIGS. 63-66, the carrier 650 may further be detachably connected to the mechanical separator 40 in the direction opposite to that of the closure 660. With reference to FIGS. 67-68, the carrier 650 may optionally be composed of a soluble material that diffuses into the sample when contacted, as illustrated in FIG. 68.
One of the important advantages of the mechanical separator of the present invention is that the mechanical separator does not require puncture by a needle cannula to allow the fluid sample to enter the collection container. In each of the above embodiments, when the assembly receives an applied rotational force such as centrifugation, each phase of the test object, such as blood, is displaced towards the bottom of the collection container with a relatively dense phase. , Begins to separate into a relatively low density phase that is displaced towards the top of the collection container. The applied rotational force urges the ballast of the mechanical separator in the direction of the closed bottom edge and the float in the direction of the top edge of the collection container. This movement of the ballast causes longitudinal deformation of the float. As a result, the float becomes longer and thinner and is concentrically separated inward from the inward surface of the cylindrical side wall of the collection container. Thus, the components of the relatively lightweight phase of blood can slide across the float and move upwards, as well as the components of the relatively heavy phase of blood can slide across the float. , It becomes possible to move downward.
As mentioned above, the mechanical separators of the present invention typically have a total density between the densities of the separated layers of blood. As a result, the mechanical separator has a relatively heavy phase component located between the mechanical separator and the closed bottom edge of the collection container, and a relatively lightweight phase component located at the top of the mechanical separator and the collection container. It will be stable at a certain position in the collection container while being located between the parts.
Upon reaching this single lowered state, the centrifuge is stopped and the float elastically returns to its unurgent state and to its sealing engagement with the inside of the cylindrical side wall of the collection container. The liquid phase formed can then be evaluated individually for analysis. In one embodiment, the assembled mechanical separator of the present invention may be scaled to fit within a 13 mm collection test tube.
In use, the mechanical separators of the present invention minimize device pre-launch and eliminate the need for cannula puncture, thereby virtually eliminating the need for sample retention below the closure. In addition, the reduced clearance of the mechanical separator minimizes the reduction of captured fluid phases such as serum and plasma.
Although the present invention will be described with reference to a number of different embodiments of mechanical separator assembly and usage, one of ordinary skill in the art can implement modifications and alternatives without departing from its scope and purpose. .. Therefore, the above detailed description is intended as exemplary rather than limiting.
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Numbers
- Publication
- 5986166
- Publication, DOCDB
- 5986166
- Publication, EPODOC
- JP5986166B
- Application
- 215392
- Application, DOCDB
- 2014215392
- Application, EPODOC
- JP20140215392
Titles2
- Japanese
- 密度相分離デバイス
- English
- Density phase separation device
Classification
- CPC, 17
- B01L3/50215
- B01D17/02
- B01L3/5021
- Y10T436/25375
- G01N33/491
- B01D17/12
- A61B5/15
- G01N33/49
- G01N1/18
- G01N33/48
- A61B5/157
- B01D21/2405
- B01D17/0217
- G01N1/34
- B01D21/262
- G01N1/4077
- G01N2001/4083
- IPC, 4
- G01N1 10
- G01N1 00
- G01N33 48
- B04B5 02
