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1. 发明公开

EP3834858A1 SYSTEMS ENABLING ALTERNATIVE APPROACHES TO THERAPEUTIC RED BLOOD CELL EXCHANGE AND/OR THERAPEUTIC PLASMA EXCHANGE 审中-实审
公开(公告)号：EP3834858A1
公开(公告)日：2021-06-16
申请号：EP20212981.3
申请日：2020-12-10
申请人： Fenwal, Inc.
发明人： KUSTERS, Benjamin E. , MIN, Kyungyoon
IPC分类号： A61M1/26 , A61M1/36 , A61M1/38
摘要： Systems and methods are provided for therapeutic red blood cell exchange and/or therapeutic plasma exchange. A blood separation device includes a centrifugal separator, a spinning membrane separator drive unit, a pump system, and a controller. Blood is conveyed through a fluid flow circuit into either the centrifugal separator or the spinning membrane separator, which separates out the target blood component (red blood cells, in the case of therapeutic red blood cell exchange, or plasma, in the case of therapeutic plasma exchange). The target blood component is retained in the circuit as a waste product, while a replacement fluid is added to the remaining blood component(s), which is then conveyed to a recipient. In addition to allowing for execution of an exchange procedure using either a centrifugal separator or a spinning membrane separator drive unit, the blood separation device also allows for the use of differently sized spinning membrane separators.

2. 发明公开

EP3412334A1 APPARATUS AND METHOD FOR MECHANICALLY OPENING A CONNECTION SITE 有权
公开(公告)号：EP3412334A1
公开(公告)日：2018-12-12
申请号：EP18173887.3
申请日：2018-05-23
申请人： Fenwal, Inc.
发明人： KUSTERS, Benjamin E. , MIN, Kyungyoon
IPC分类号： A61M39/14 , B29C65/02 , A61M39/18 , B29C65/00
CPC分类号： B29C66/0324 , A61M39/14 , A61M39/143 , A61M39/146 , A61M39/18 , B29C57/10 , B29C65/02 , B29C65/7455 , B29C66/1142 , B29C66/5221 , B29C66/71 , B29C66/73921 , B29C66/857 , B29K2027/06 , B29L2023/007
摘要： Method and apparatus are disclosed for mechanically opening a heat-bonded connection site between two hollow, flexible, thermoplastic segments of a medical fluid flow path, the heat-bonded connection site having an axis. The connection site is compressed between two facing surfaces, and the facing surfaces are relatively moved to rotate the connection site about the connection site axis and to apply force to the connection site substantially perpendicular to the connection site axis.

3. 发明公开

EP3295973A1 SYSTEMS AND METHODS FOR DERIVING AND COLLECTING PLATELET PRODUCTS 有权
标题翻译：用于派生和收集血小板产品的系统和方法
公开(公告)号：EP3295973A1
公开(公告)日：2018-03-21
申请号：EP17191313.0
申请日：2017-09-15
申请人： Fenwal, Inc.
发明人： MIN, Kyungyoon , KUSTERS, Benjamin E. , BROWN, Richard I.
IPC分类号： A61M1/02 , A61M1/36 , A61M1/26
摘要： Systems and methods are provided for deriving a platelet product from a plurality of buffy coats. A plurality of buffy coats are separately collected, for example, using a conventional floor centrifuge. Plasma and/or a platelet additive solution may be added to the buffy coats. The buffy coats are pooled into a container and conveyed into a centrifuge or are sequentially conveyed into the centrifuge without being pooled, where they are continuously processed to separate platelets from the other cellular blood components. The separated platelets are conveyed out of the centrifuge as a platelet product, which may be passed through a leukocyte removal filter to reduce the white blood cell content of the platelet product. By continuously separating the buffy coats, fewer buffy coats are required to produce a single-dose platelet product, while also allowing for the derivation and collection of a plurality of single-dose platelet products.
摘要翻译：提供系统和方法用于从多个血沉棕黄层中导出血小板产品。例如，使用传统的地面离心机分别收集多个血沉棕黄层。血浆和/或血小板添加剂溶液可以加入血沉棕黄层。将血沉棕黄层收集在容器中并输送到离心机中，或者依次输送到离心机中而不被汇集，在那里它们被连续处理以将血小板与其他细胞血液成分分离。分离的血小板作为血小板产品输送出离心机，其可以通过白细胞去除过滤器以降低血小板产品的白血细胞含量。通过连续分离血沉棕黄层，需要更少的血沉棕黄层来生产单剂量血小板产品，同时还能够衍生和收集多个单剂量血小板产品。

4. 发明公开

EP3243561A1 METHOD FOR CONTROLLING FOULING DURING A SPINNING MEMBRANE FILTRATION PROCEDURE 有权
标题翻译：控制纺丝膜过滤过程中污垢的方法
公开(公告)号：EP3243561A1
公开(公告)日：2017-11-15
申请号：EP17169240.3
申请日：2017-05-03
申请人： Fenwal, Inc.
发明人： KUSTERS, Benjamin E. , MIN, Kyungyoon
IPC分类号： B01D63/16 , A61M1/34 , B01D61/22 , B01D61/32
CPC分类号： B01D65/08 , A61M1/265 , A61M1/3496 , A61M2205/3334 , A61M2205/3365 , B01D61/22 , B01D61/32 , B01D63/16 , B01D2311/14 , B01D2315/02 , B01D2321/2033 , C12N5/0641 , C12N5/0644
摘要： Methods for controlling a spinning membrane separator so as to limit fouling of the membrane by changing the rotation rate of the spinning membrane in response to the fouling rate, while maintaining a constant outlet cellular concentration. Increasing the spinner rotation rate will increase the strength of the Taylor vortices generated within the separator by the spinning of the membrane, which should reduce fouling of the membrane. The goal of the method is to rotate the spinning membrane at the slowest rate possible without unacceptable fouling. Two specific methods to control fouling are disclosed. In a first, unidirectional method, the spin rate of the membrane is only increased in response to undesirable fouling in order to prevent the fouling from continuing. In a second, bidirectional method, the spin rate of the membrane may be either increased or decreased in response to the measured fouling rate in order to maintain the fouling rate within a desired range.
摘要翻译：用于控制旋转膜分离器的方法以便通过响应于结垢速率改变旋转膜的旋转速率来限制膜的结垢，同时保持恒定的出口细胞浓度。增加旋转器旋转速率将增加分离器内通过旋转膜而产生的泰勒旋涡的强度，这将减少膜的结垢。该方法的目标是以尽可能最慢的速度旋转旋转膜而不会有不可接受的污染。公开了两种控制结垢的具体方法。在第一种单向方法中，膜的旋转速度仅响应于不希望的结垢而增加，以防止结垢继续。在第二种双向方法中，响应于测量的结垢速率，膜的旋转速率可以增加或减小，以便将结垢速率保持在期望的范围内。

5. 发明授权

EP2683471B1 MEMBRANE SEPARATION DEVICES, SYSTEMS AND METHODS EMPLOYING SAME 有权
标题翻译：膜分离装置，使用该装置的系统和方法
公开(公告)号：EP2683471B1
公开(公告)日：2017-08-02
申请号：EP12757433.3
申请日：2012-03-09
申请人： Fenwal, Inc.
发明人： KUSTERS, Benjamin E. , WEGENER, Christopher J. , BOGGS, Daniel R. , MIN, Kyungyoon
IPC分类号： B01D63/16 , B01D33/06
CPC分类号： A61M1/34 , A61M1/0272 , A61M1/0281 , A61M1/265 , A61M1/3403 , A61M1/3496 , A61M1/3633 , A61M1/3687 , A61M1/3692 , A61M1/38 , A61M2205/3331 , A61M2205/50 , A61M2205/60 , B01D61/18 , B01D63/06 , B01D63/16 , B01D2313/08 , B01D2313/20 , B01D2315/02 , G16H10/40
摘要： A membrane separation device for use in blood processing procedures is disclosed. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the spinning membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib or ridge associated with the spinning membrane that decreases the gap between the spinning membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into selected blood components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed.
摘要翻译：公开了一种用于血液处理程序的膜分离装置。在一个实施例中，提供了一种旋转膜分离器，其中在旋转膜和壳体之间的间隙中产生至少两个区域或区域，使得两个区域之间的流体的混合受到相关的径向肋或脊的抑制通过旋转膜减小旋转膜和壳体之间的间隙以限定两个流体区域，脊分离两个区域中的流体以最小化两者之间的混合。公开了自动系统和方法，用于将先前收集的全血单位分离成选定的血液成分，例如浓缩的红细胞和血浆，用于直接从供体收集红细胞和血浆，并用于细胞洗涤。还公开了数据管理系统和方法以及启动方法。

6. 发明公开

EP3137127A1 METHOD FOR CONTROLLING FOULING AND COMPLEMENT PROTEIN ACTIVATION DURING SPINNING MEMBRANE FILTRATION OF PLASMA FROM WHOLE BLOOD 有权
标题翻译：方法血浆从全血的自旋周期膜过滤过程中治理污染，KOMPLEMENTPROTEINAKTIVIERUNG
公开(公告)号：EP3137127A1
公开(公告)日：2017-03-08
申请号：EP14727140.7
申请日：2014-04-30
申请人： Fenwal, Inc.
发明人： KUSTERS, Benjamin E. , MIN, Kyungyoon , WEGENER, Christopher J. , BOGGS, Daniel R.
IPC分类号： A61M1/02 , A61M1/26 , A61M1/34 , B01D63/16 , A61M1/36
CPC分类号： A61M1/3496 , A61M1/0218 , A61M1/265 , A61M1/3633 , A61M2202/0429 , A61M2205/7563 , B01D63/16 , B01D65/08 , B01D71/34 , B01D71/50 , B01D2315/02 , B01D2321/2033
摘要： A system and method are provided for controlling fouling and complement protein activation during separation of plasma from whole blood using a spinning membrane separator. The separator includes a pair of relatively rotating surfaces spaced apart to define a gap therebetween, with at least one of the surfaces comprising a membrane that allows plasma to pass therethrough but substantially prevents the passage of red cells. In accordance with the method, the membrane material and membrane fabrication technique are selected so as that the resulting membrane both resists fouling and complement protein activation. In a specific embodiment, the membrane is has a smooth surface and substantially linear pores. The pores have a nominal diameter of less than 2 microns (so as to exclude platelets) and preferably a diameter of from 0.6 microns to 0.8 microns, as may be obtained by use of track-etching. In addition, the membrane material preferably is polycarbonate, as it has been determined that polycarbonate does not activate complement proteins.
摘要翻译：本发明提供一种系统和方法，用于控制结垢和从使用旋转膜分离全血的血浆的分离过程中补体蛋白的激活。分离器包括一对间隔开的相对旋转的表面的至它们之间限定间隙，与所述表面包含膜那样的至少一个允许血浆穿过那里，但基本上防止红细胞的通路。在该方法雅舞蹈，膜材料和膜制造技术的选择使得没有所得膜两者抵抗结垢和补体蛋白活化。在一个具体的实施方案中，膜是具有光滑的表面和基本上线性的孔。的孔具有小于2微米的标称直径（从而排除血小板）和优选的直径为0.6微米至0.8微米，如可以通过使用径迹蚀刻来获得。另外，膜材料优选为聚碳酸酯，因为它已经结束开采并聚碳酸酯不激活补体蛋白。

7. 发明公开

EP4447065A1 DEVICE SCREEN INTERACTION USING A SCANNER AND BIDIRECTIONAL DATA TRANSFER 审中-公开
公开(公告)号：EP4447065A1
公开(公告)日：2024-10-16
申请号：EP24169446.2
申请日：2024-04-10
申请人： Fenwal, Inc.
发明人： KUSTERS, Benjamin E. , MIN, Kyungyoon , MADSEN, James G.
IPC分类号： G16H20/17 , A61M1/00 , G16H20/40 , G16H40/63
CPC分类号： G16H40/63 , G16H20/17 , G16H20/40 , A61M1/3693 , A61M2205/607220130101 , A61M2205/605420130101 , A61M2205/359220130101 , A61M2205/358420130101 , A61M2205/50520130101 , A61M2205/1820130101
摘要： A biological fluid processing system and a method of executing a biological fluid processing procedure is disclosed. The biological fluid processing system includes a processing device, a scanner, and a data management system. The processing device includes a display screen and a controller which operates the processing device to implement a biological fluid processing procedure having a plurality of steps. The controller displays an image on the display screen. The scanner interacts with the device screen to retrieve data from the image and transmit the data to the data management system. The scanner and/or the data management system transmit a signal to the controller based on the data. The controller initiates at least one step of the biological fluid processing procedure upon receiving the signal.

8. 发明公开

EP4371590A3 MAXIMIZATION OF PLASMA COLLECTION AND COLLECTION OF BUFFY COAT OR WHITE BLOOD CELL LAYER USING COLLECTED PLASMA 审中-实审
公开(公告)号：EP4371590A3
公开(公告)日：2024-07-03
申请号：EP23209302.1
申请日：2023-11-13
申请人： Fenwal, Inc.
发明人： KUSTERS, Benjamin E. , BROWN, Richard I. , MIN, Kyungyoon
IPC分类号： A61M1/36
CPC分类号： A61M1/3696 , A61M1/36225 , A61M1/362266 , A61M2205/33120130101
摘要： A blood processing device includes a pump system, a valve system, a centrifuge, and a controller configured and/or programmed to control the operation of the pump system, the valve system, and the centrifuge to execute a blood separation procedure. The blood separation procedure executed by the controller includes pumping blood into the centrifuge, separating the blood in the centrifuge into red blood cells and plasma, and collecting portions of the separated red blood cells and plasma. Subsequently, a portion of the collected red blood cells is pumped back into the centrifuge to collect an additional amount of the separated plasma. A buffy coat or white blood cell layer may be formed between the separated red blood cells and plasma in the centrifuge. If so, a portion of the collected plasma may be pumped back into the centrifuge to harvest the buffy coat or white blood cell layer.

9. 发明公开

EP4310480A1 OPTICAL SYSTEMS AND METHODS FOR GRADING PLASMA DURING WHOLE BLOOD SEPARATION 审中-实审
公开(公告)号：EP4310480A1
公开(公告)日：2024-01-24
申请号：EP23186699.7
申请日：2023-07-20
申请人： Fenwal, Inc.
发明人： KUSTERS, Benjamin E.
IPC分类号： G01N21/31 , A61M1/36 , G01N33/49
摘要： An optical plasma grading system includes a broadband light source configured to emit light having wavelengths in a visible spectrum, an optical spectrometer configured to receive a reflected portion of the emitted light and analyze at least a portion of the received, reflected light to determine a main wavelength of the portion of the received reflected light, and a controller operably connected to the optical spectrometer, the controller configured to determine a plasma grade of the plasma based at least upon the main wavelength of the plasma.

10. 发明公开

EP4265337A1 INTERFACE DETECTION AND CONTROL USING A PHOTODETECTOR ARRAY 审中-实审
公开(公告)号：EP4265337A1
公开(公告)日：2023-10-25
申请号：EP23167895.4
申请日：2023-04-14
申请人： Fenwal, Inc.
发明人： KUSTERS, Benjamin E.
IPC分类号： B04B13/00 , A61M1/36
摘要： Systems and methods are provided for determining and controlling the location of an interface between separated fluid components within a channel of a centrifugal separation chamber being rotated about a rotational axis. Light from a light source is received by a collimator, which directs collimated light through the channel in a direction substantially parallel to the rotational axis. At least a portion of the collimated light exiting the channel is received by a light detector configured as a photodetector array. A signal emitted by the light detector is received by a controller, which determines the location of an interface between separated fluid components within the channel based at least in part on the signal. When the controller determines that the interface is not at a target location within the channel, the controller controls a centrifugal separator and/or a pump system to move the interface to the target location.

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