JP2014516285A5 - - Google Patents
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- JP2014516285A5 JP2014516285A5 JP2014502746A JP2014502746A JP2014516285A5 JP 2014516285 A5 JP2014516285 A5 JP 2014516285A5 JP 2014502746 A JP2014502746 A JP 2014502746A JP 2014502746 A JP2014502746 A JP 2014502746A JP 2014516285 A5 JP2014516285 A5 JP 2014516285A5
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- portable system
- rbc
- carbon dioxide
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- 239000007789 gas Substances 0.000 claims description 51
- 229910052760 oxygen Inorganic materials 0.000 claims description 31
- 239000001301 oxygen Substances 0.000 claims description 31
- MYMOFIZGZYHOMD-UHFFFAOYSA-N oxygen Chemical compound O=O MYMOFIZGZYHOMD-UHFFFAOYSA-N 0.000 claims description 31
- 210000003743 Erythrocytes Anatomy 0.000 claims description 28
- 210000003324 RBC Anatomy 0.000 claims description 28
- 238000011010 flushing procedure Methods 0.000 claims description 26
- CURLTUGMZLYLDI-UHFFFAOYSA-N carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 claims description 15
- 229910002092 carbon dioxide Inorganic materials 0.000 claims description 15
- 239000001569 carbon dioxide Substances 0.000 claims description 15
- 210000004027 cells Anatomy 0.000 claims description 8
- 239000002594 sorbent Substances 0.000 claims description 8
- 239000012530 fluid Substances 0.000 claims description 5
- 239000000203 mixture Substances 0.000 claims description 5
- 239000011261 inert gas Substances 0.000 claims description 4
- 230000001105 regulatory Effects 0.000 claims description 4
- 230000000712 assembly Effects 0.000 claims 3
- 230000001954 sterilising Effects 0.000 claims 3
- 238000004659 sterilization and disinfection Methods 0.000 claims 2
- 210000004369 Blood Anatomy 0.000 description 8
- 239000008280 blood Substances 0.000 description 8
- 239000012510 hollow fiber Substances 0.000 description 5
- 210000000265 Leukocytes Anatomy 0.000 description 4
- 210000002381 Plasma Anatomy 0.000 description 2
- 230000001276 controlling effect Effects 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000006011 modification reaction Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Description
本発明は、特定の実施形態を詳細に説明するが、本開示の範囲に含まれ、当業者に知られる変更及び改変が存在することが理解される。従って、本開示は、この開示において述べたような開示の範囲内にあるこのような代替、改変及び変形の全てを包含することが意図されている。
また、好ましい構成態様として、本発明を次のように構成することもできる。
1. 赤血球(RBC)を処理するための携帯用システムであって、
血液バッグと、嫌気性保管バッグと、前記血液収集バッグと前記嫌気性保管バッグとの間に配置された酸素、及び/又は酸素及び二酸化炭素除去装置とを含む使い捨て血液収集セットと、
前記酸素/酸素及び二酸化炭素除去装置と流体連通するガス循環装置と、
を含み、前記ガス循環装置は、RBCが前記血液収集バッグから前記除去装置を通って前記嫌気性保管バッグの中に入るときに、前記除去装置を通してフラッシングガスを循環させることができる圧力源を含むことを特徴とする携帯用システム。
2. 前記除去装置は、カートリッジと、前記カートリッジ内で前記カートリッジの入口から出口まで延びる複数の中空繊維と、前記複数の中空繊維を取り囲む、前記フラッシングガスの通行のための連続空間とを含むことを特徴とする、上記1に記載の携帯用システム。
3. 前記複数の中空繊維は、ガス透過性材料又は多孔質材料を含み、且つ、赤血球を受け入れて運搬するように適合されることを特徴とする、上記2に記載の携帯用システム。
4. 前記ガス循環装置を収容するハウジングをさらに含み、前記ハウジングは、前記除去装置からフラッシングガスを受け入れるための入口マニホルドと、前記除去装置にフラッシングガスを供給するための出口マニホルドと、前記圧力源と前記出口マニホルドとの間に配置され、前記フラッシングガスから酸素、及び/又は酸素及び二酸化炭素を除去するための収着材とをさらに含むことを特徴とする、上記1に記載の携帯用システム。
5. 前記OCDD内の前記フラッシングガス中の酸素及び/又は二酸化炭素のレベルを検出するために、前記圧力源と前記収着材との間に配置されたセンサと、前記収着材と前記出口マニホルドとの間に配置された第2のセンサとをさらに含むことを特徴とする、上記4に記載の携帯用システム。
6. 前記除去装置は、白血球低減フィルタをさらに含むことを特徴とする、上記1に記載の携帯用システム。
7. 前記除去装置は、白血球低減フィルタ及び血漿分離器をさらに含むことを特徴とする、上記1に記載の携帯用システム。
8. 前記収集バッグに接続されたロードセルと、前記除去装置と前記嫌気性保管バッグとの間に配置された流量調整弁と、コントローラとをさらに含むことを特徴とする、上記1に記載の携帯用システム。
9. 前記ロードセルは、前記収集バッグ内のRBCの重量を測定し、前記コントローラは、前記RBCの前記重量を示す信号を受信し、前記流量調整弁に信号を伝達し、前記流量調整弁を調整してRBCの流れを制限又は促進し、それにより前記除去装置におけるフラッシングガスに対する前記RBCの曝露を制御することを特徴とする、上記8に記載の携帯用システム。
10. 前記除去装置と前記流量制御弁との間に配置された酸素飽和センサをさらに含み、前記コントローラは、前記RBC中の酸素飽和レベルを示す信号を受信し、前記流量調整弁に信号を送信し、前記流量制御弁を調整してRBCの流れを制限又は促進し、それにより前記除去装置におけるフラッシングガスに対する前記RBCの曝露を制御することを特徴とする、上記8に記載の携帯用システム。
11. 前記フラッシングガスは、Ar、He、N2、Ar/CO2、He/CO2若しくはN2/CO2、又は不活性ガス及び/若しくはCO2の任意の組み合わせを含むことを特徴とする、上記1に記載の携帯用システム。
12. 前記ハウジングに接続され、且つ前記ガス循環装置と流体連通する、複数の使い捨て血液収集セットをさらに含むことを特徴とする、上記1に記載の携帯用システム。
13. 前記圧力源は、ポンプ、真空又は加圧コンテナからなる群から選択されることを特徴とする、上記1に記載の携帯用システム。
14. 赤血球(RBC)を処理するための携帯用システムであって、
入口と出口とを有するカートリッジと、前記入口と前記出口との間に配置され、酸素又は酸素及び二酸化炭素除去(OCDD)装置を通してRBCを輸送するための複数の中空繊維とを含む、前記複数の中空繊維が連続空間によって取り囲まれた、OCDD装置と、
前記OCDD装置と流体連通するガス循環装置と
を含み、
前記ガス循環装置は、前記連続空間を通してフラッシングガスを循環させて、前記OCDD装置を通過するRBCから酸素及び/又は二酸化炭素を除去することができる、圧力源を含むことを特徴とする、携帯用システム。
15. 血液バッグ及び嫌気性保管バッグをさらに含み、前記血液バッグは前記入口に接続され、前記嫌気性保管バッグは前記出口に接続されることを特徴とする、上記14に記載の携帯用システム。
16. 外面を有するハウジングをさらに含み、前記ハウジングは、前記ガス循環装置を収容し、前記除去装置は、前記ハウジングの前記外面に直接結合されることを特徴とする、上記14に記載の携帯用システム。
17. 外面を有するハウジングをさらに含み、前記ハウジングは、前記ガス交換装置及び複数の除去装置を収容し、前記複数の除去装置は、前記ハウジングの前記外面に直接結合されることを特徴とする、上記14に記載の携帯用組立体。
18. ロードセル、流量調整弁、及びコントローラをさらに含み、前記ロードセルは、前記血液バッグ内のRBCの重量を測定し、前記コントローラは、前記RBCの前記重量を示す信号を受信し、前記流量調整弁に信号を伝達し、前記流量調整弁を調整してRBCの流れを制限又は促進し、それにより前記除去装置におけるフラッシングガスに対する前記RBCの曝露を減らし又は増やすことを特徴とする、上記14に記載の携帯用システム。
19. 前記除去装置と前記流量制御弁との間に配置された酸素飽和センサをさらに含み、前記コントローラは、前記RBC中の酸素飽和レベルを示す信号を受信し、前記流量調整弁に信号を送信し、前記流量制御弁を調整してRBCの流れを制限又は促進し、前記除去装置におけるフラッシングガスに対する前記RBCの曝露を減らし又は増やすことを特徴とする、上記18に記載の携帯用システム。
20. 前記ハウジングは、前記除去装置からフラッシングガスを受け入れるための入口マニホルドと、前記除去装置にフラッシングガスを供給するための出口マニホルドと、前記圧力源と前記出口マニホルドとの間に配置され、前記フラッシングガスから酸素又は酸素及び二酸化炭素を除去するための収着材とをさらに含むことを特徴とする、上記17に記載の携帯用システム。
21. 前記収着材中に受け入れられてろ過されたフラッシングガス中の酸素又は酸素及び二酸化炭素のレベルを検知するシステムセンサを前記収着材の両側にさらに含むことを特徴とする、上記20に記載の携帯用システム。
22. 前記除去装置は、白血球低減フィルタをさらに含むことを特徴とする、上記14に記載の携帯用システム。
23. 前記除去装置は、白血球低減フィルタ及び血漿分離器をさらに含むことを特徴とする、上記14に記載の携帯用システム。
24. 前記入口及び前記出口を通って流れるガスの気体パラメータのレベルを監視するために、前記除去装置と前記入口マニホルドとの間に配置されたフィルタ・センサ組立体と、前記除去装置と前記出口マニホルドとの間に配置されたフィルタ・センサ組立体とをさらに含むことを特徴とする、上記20に記載の携帯用システム。
25. 前記除去装置と前記入口マニホルドと前記除去装置との間に配置された前記フィルタ・センサ組立体、前記除去装置と前記出口マニホルドとの間に配置された前記フィルタ・センサ組立体、及び前記システムセンサは、前記システムを通って流れるガスの、酸素分圧、二酸化炭素分圧、温度、圧力、湿度、及びガス流量を測定することを特徴とする、上記24に記載の携帯用システム。
26. 前記フラッシングガスは、Ar、He、N2、Ar/CO2、He/CO2若しくはN2/CO2、又は不活性ガス及び/若しくはCO2の任意の組み合わせを含むことを特徴とする、上記14に記載の携帯用システム。
27. 前記圧力源は、ポンプ、真空又は加圧コンテナからなる群から選択されることを特徴とする、上記14に記載の携帯用システム。
While the invention will be described in detail with reference to specific embodiments, it will be understood that there are variations and modifications that fall within the scope of the disclosure and are known to those skilled in the art. Accordingly, the present disclosure is intended to embrace all such alternatives, modifications and variations that fall within the scope of the disclosure as set forth in this disclosure.
Moreover, as a preferable configuration aspect, the present invention can also be configured as follows.
1. A portable system for processing red blood cells (RBC),
A disposable blood collection set comprising a blood bag, an anaerobic storage bag, and an oxygen and / or oxygen and carbon dioxide removal device disposed between the blood collection bag and the anaerobic storage bag;
A gas circulation device in fluid communication with the oxygen / oxygen and carbon dioxide removal device;
The gas circulation device includes a pressure source that can circulate flushing gas through the removal device when an RBC enters the anaerobic storage bag from the blood collection bag through the removal device. A portable system characterized by that.
2. The removing device includes a cartridge, a plurality of hollow fibers extending from an inlet to an outlet of the cartridge in the cartridge, and a continuous space surrounding the plurality of hollow fibers for passage of the flushing gas. The portable system according to 1 above.
3. The portable system of claim 2, wherein the plurality of hollow fibers comprise a gas permeable material or a porous material and are adapted to receive and transport red blood cells.
4). A housing that houses the gas circulation device, the housing including an inlet manifold for receiving flushing gas from the removal device; an outlet manifold for supplying flushing gas to the removal device; the pressure source; The portable system according to claim 1, further comprising a sorbent disposed between an outlet manifold and for removing oxygen and / or oxygen and carbon dioxide from the flushing gas.
5. A sensor disposed between the pressure source and the sorbent to detect the level of oxygen and / or carbon dioxide in the flushing gas in the OCDD, the sorbent and the outlet manifold; The portable system according to claim 4, further comprising a second sensor disposed between the two.
6). 2. The portable system according to 1 above, wherein the removing device further includes a leukocyte reduction filter.
7). The portable system according to claim 1, wherein the removing device further includes a leukocyte reduction filter and a plasma separator.
8). The portable system according to claim 1, further comprising a load cell connected to the collection bag, a flow control valve disposed between the removal device and the anaerobic storage bag, and a controller. .
9. The load cell measures the weight of the RBC in the collection bag, and the controller receives a signal indicating the weight of the RBC, transmits a signal to the flow control valve, and adjusts the flow control valve. 9. The portable system of claim 8, wherein the portable system restricts or facilitates the flow of RBC, thereby controlling exposure of the RBC to flushing gas in the removal device.
10. An oxygen saturation sensor disposed between the removal device and the flow control valve, wherein the controller receives a signal indicating an oxygen saturation level in the RBC and sends a signal to the flow control valve; 9. The portable system of claim 8, wherein the flow control valve is adjusted to limit or facilitate RBC flow, thereby controlling exposure of the RBC to flushing gas in the removal device.
11. The flushing gas comprises Ar, He, N 2 , Ar / CO 2 , He / CO 2 or N 2 / CO 2 , or any combination of an inert gas and / or CO 2 , The portable system according to 1.
12 The portable system of claim 1, further comprising a plurality of disposable blood collection sets connected to the housing and in fluid communication with the gas circulation device.
13. The portable system according to claim 1, wherein the pressure source is selected from the group consisting of a pump, a vacuum or a pressurized container.
14 A portable system for processing red blood cells (RBC),
The plurality of cartridges including a cartridge having an inlet and an outlet, and a plurality of hollow fibers disposed between the inlet and the outlet and for transporting RBC through an oxygen or oxygen and carbon dioxide removal (OCDD) device. An OCDD device in which hollow fibers are surrounded by a continuous space;
A gas circulation device in fluid communication with the OCDD device;
The gas circulation device includes a pressure source that can circulate a flushing gas through the continuous space to remove oxygen and / or carbon dioxide from the RBC passing through the OCDD device. system.
15. 15. The portable system of claim 14, further comprising a blood bag and an anaerobic storage bag, wherein the blood bag is connected to the inlet and the anaerobic storage bag is connected to the outlet.
16. 15. The portable system of claim 14, further comprising a housing having an outer surface, wherein the housing houses the gas circulation device and the removal device is directly coupled to the outer surface of the housing.
17. 14. The housing according to claim 14, further comprising a housing having an outer surface, wherein the housing houses the gas exchange device and a plurality of removing devices, and the plurality of removing devices are directly coupled to the outer surface of the housing. A portable assembly according to claim 1.
18. The load cell further includes a load cell, a flow regulating valve, and a controller, wherein the load cell measures a weight of the RBC in the blood bag, the controller receives a signal indicating the weight of the RBC, and sends a signal to the flow regulating valve. 15. The portable device of claim 14, wherein said flow regulating valve is adjusted to restrict or facilitate RBC flow, thereby reducing or increasing exposure of said RBC to flushing gas in said removal device System.
19. An oxygen saturation sensor disposed between the removal device and the flow control valve, wherein the controller receives a signal indicating an oxygen saturation level in the RBC and sends a signal to the flow control valve; 19. The portable system of claim 18, wherein the flow control valve is adjusted to limit or facilitate RBC flow to reduce or increase exposure of the RBC to flushing gas in the removal device.
20. The housing is disposed between an inlet manifold for receiving flushing gas from the removal device, an outlet manifold for supplying flushing gas to the removal device, the pressure source and the outlet manifold, and the flushing gas 18. The portable system according to claim 17, further comprising a sorbent for removing oxygen or oxygen and carbon dioxide from the water.
21. 21. The system of claim 20, further comprising system sensors on both sides of the sorbent for detecting levels of oxygen or oxygen and carbon dioxide in the flushing gas received and filtered in the sorbent. Portable system.
22. 15. The portable system as described in 14 above, wherein the removing device further includes a leukocyte reduction filter.
23. 15. The portable system as set forth in claim 14, wherein the removal device further includes a leukocyte reduction filter and a plasma separator.
24. A filter and sensor assembly disposed between the removal device and the inlet manifold, and the removal device and the outlet manifold for monitoring the level of gas parameters of gas flowing through the inlet and the outlet; 21. The portable system of claim 20, further comprising a filter and sensor assembly disposed between the two.
25. The filter and sensor assembly disposed between the removal device, the inlet manifold and the removal device, the filter and sensor assembly disposed between the removal device and the outlet manifold, and the system sensor 25. The portable system as described in 24 above, wherein the system measures oxygen partial pressure, carbon dioxide partial pressure, temperature, pressure, humidity, and gas flow rate of gas flowing through the system.
26. The flushing gas comprises Ar, He, N 2 , Ar / CO 2 , He / CO 2 or N 2 / CO 2 , or any combination of an inert gas and / or CO 2 , 14. The portable system according to 14.
27. 15. The portable system of claim 14, wherein the pressure source is selected from the group consisting of a pump, a vacuum or a pressurized container.
Claims (8)
滅菌フラッシングガスを備え、1又は複数の酸素除去装置又は酸素及び二酸化炭素除去装置と流体連通するように配置することができるガス循環装置を含み、
前記ガス循環装置は、互いに流体連通した
フラッシングガスを備えたフラッシングガス源と、
ガス出口マニフォルドと、
第1ガス滅菌フィルタと、
第2ガス滅菌フィルタと、
1又は複数のセンサ組立体と、
ガス入口マニフォルドと、
コントローラと、を含み、
少なくとも1つ又は複数の前記センサ組立体は、酸素センサ、二酸化炭素センサ、及びそれらの組み合わせからなる群から選択されることを特徴とする携帯用システム。 A portable system for processing red blood cells (RBC),
A gas circulation device comprising a sterilizing flushing gas and arranged in fluid communication with one or more oxygen removal devices or oxygen and carbon dioxide removal devices;
The gas circulation devices are in fluid communication with each other
A flushing gas source with flushing gas;
A gas outlet manifold,
A first gas sterilization filter;
A second gas sterilization filter;
One or more sensor assemblies;
A gas inlet manifold,
A controller, and
The portable system , wherein the at least one or more sensor assemblies are selected from the group consisting of oxygen sensors, carbon dioxide sensors, and combinations thereof .
Applications Claiming Priority (3)
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US201161468377P | 2011-03-28 | 2011-03-28 | |
US61/468,377 | 2011-03-28 | ||
PCT/US2012/030930 WO2013022491A1 (en) | 2011-03-28 | 2012-03-28 | Method and system for removing oxygen and carbon dioxide during red cell blood processing using an inert carrier gas and manifold assembly |
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JP2016210712A Division JP2017074381A (en) | 2011-03-28 | 2016-10-27 | Method and system for depleting oxygen and carbon dioxide during red cell blood treatment using an inert carrier gas and manifold assembly |
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JP2014516285A5 true JP2014516285A5 (en) | 2015-05-14 |
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JP2014502746A Active JP6034362B2 (en) | 2011-03-28 | 2012-03-28 | Method and system for removing oxygen and carbon dioxide during erythrocyte blood processing using an inert carrier gas and manifold assembly |
JP2016210712A Pending JP2017074381A (en) | 2011-03-28 | 2016-10-27 | Method and system for depleting oxygen and carbon dioxide during red cell blood treatment using an inert carrier gas and manifold assembly |
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EP (1) | EP2691160A4 (en) |
JP (2) | JP6034362B2 (en) |
CN (2) | CN103492041B (en) |
AU (1) | AU2012294890B2 (en) |
CA (1) | CA2831465C (en) |
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