Parallel processing of fluid components
10130752 ยท 2018-11-20
Inventors
Cpc classification
A61M1/362261
HUMAN NECESSITIES
A61M1/3693
HUMAN NECESSITIES
A61M1/38
HUMAN NECESSITIES
A61M1/36225
HUMAN NECESSITIES
A61M1/362223
HUMAN NECESSITIES
A61M1/362227
HUMAN NECESSITIES
A61M1/3696
HUMAN NECESSITIES
International classification
A61M1/36
HUMAN NECESSITIES
A61M1/34
HUMAN NECESSITIES
A61M1/38
HUMAN NECESSITIES
Abstract
A kit for blood component processing comprising a fluid circuit into which blood is drawn, wherein the fluid circuit comprises a plurality of pathways; wherein the first pathway is configured to receive blood drawn from a blood source and leads to a separation device, wherein the separation device is configured to separate the blood into components; wherein the second pathway is configured to receive a first component from the separation device and transport at least a portion of the first component to a first processing device, wherein the first processing device may alter the first component to produce a first output; and wherein the third pathway is configured to receive a second component from the separation device and transport at least a portion of the second component to a second processing device, wherein the second processing device may alter the second component to produce a second output.
Claims
1. A blood processing method using a single fluid circuit and a single medical device comprising the steps of: receiving in a fluid circuit of a single medical device, blood drawn from a blood source, wherein the fluid circuit comprises a plurality of pathways; receiving in a first pathway of the single medical device, blood drawn from the blood source, the first pathway leading to a separation device of the single medical device; separating via the separation device the blood into plasma and red blood cells two or more components; receiving in a second pathway of the single medical device, the plasma a first component from the separation device; transporting via the second pathway at least a portion of the plasma first component to a first processing device; treating via the first processing device the plasma first component o produce a first output treated plasma into a third pathway; receiving in a fourth pathway of the single medical device, the red blood cells a second component from the separation device; transporting via the fourth pathway the red blood cells at least a portion of the second component to a container second processing device; receiving in a fifth pathway donated red blood cells; treating via the second processing device the second component in parallel with treatment of the first component by the first processing device, to produce a second output into a fifth pathway; converging the treated plasma first output from the third pathway and the donated red blood cells second output from the fifth pathway at a junction of the third and fifth pathways; and receiving in a sixth pathway of the single medical device, the converged plasma and donated red blood cells first and second outputs from the junction; wherein the second pathway and the fourth pathway transporting the plasma and the red blood cells, respectively, extend from a first cassette of the single medical device, wherein the fifth pathway extends from a second cassette of the single medical device and wherein the first pathway in and the sixth pathway extend from a third cassette of the single medical device.
2. The blood processing method of claim 1, wherein at least one of the first and second processing device devices is a column.
3. The blood processing method of claim 1, wherein at least one of the first processing device and second processing devices is configured to alter the plasma respective component by displacing at least a portion of the plasma respective component with albumin.
4. The blood processing method of claim 1, further comprising maintaining two or more pathways substantially isolated from each other via a layout of open and closed valves.
5. The blood processing method of claim 1, further comprising maintaining two or more pathways isolated from each other by way of open and closed valves.
6. The blood processing method of claim 1, further comprising altering via the first processing device the plasma first component in constitution to produce the treated plasma first output.
7. The blood processing method of claim 1 further comprising controlling flow through each of the first cassette, the second cassette and the third cassette with valves provided in the first cassette, the second cassette and the third cassette.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) Features, aspects, and advantages of the present embodiments will become apparent from the following description, appended claims, and the accompanying exemplary embodiments shown in the drawings, which are briefly described below.
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DETAILED DESCRIPTION
(15) There are several aspects of the present subject matter which may be embodied separately or together in the devices and systems described and claimed below. These aspects may be employed alone or in combination with other aspects of the subject matter described herein, and the description of these aspects together is not intended to preclude the use of these aspects separately or the claiming of such aspects separately or in different combinations as set forth in the claims appended hereto.
(16) Some embodiments may allow the simultaneous, parallel, or concurrent performance of differing component therapies for patients with diseases that affect more than one blood component or patients with multiple diseases that cumulatively affect more than one blood component.
(17) Some embodiments may obviate the practice of patients undergoing multiple component therapies (e.g., plasma and RBC therapies) in sequence and independently, with separate disposable fluid circuits and often separate machines.
(18) Some embodiments may shorten the time that it takes to complete an entire treatment and/or decrease the required number of disposable circuit kits.
(19) Some embodiments may decrease the number of patient needle insertions and/or extracorporeal circulations of patient blood.
(20) Simultaneous treatment of two different blood components may be implemented in some embodiments while maintaining the treatment phases of these blood components in separate and/or isolated pathways for the duration of treatment. Keeping these components in separate pathways while undergoing treatment within the same disposable fluid circuit kit may be achieved by some embodiments.
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(22) The fluid processing system 10 is used in combination with a single-use or disposable flow circuit 12, such as the one illustrated in
(23) The illustrated flow circuit 12 is a two needle system, which includes a pair of blood source access devices 14 and 14a (e.g., phlebotomy needles) for fluidly connecting a blood source (e.g., donor, patient, blood bag, etc.) with the flow circuit 12. The blood source access devices 14 and 14a are connected by tubing to a left cassette 16. A cassette may comprise a case made of plastic or other material configured to facilitate the flow of fluid therethrough. One of the blood source access devices 14 of the flow circuit 12 accesses blood from the blood source and is connected to the left cassette 16 by a y-connector 18. The other leg of the y-connector 18 is connected to tubing 20 which leads to a middle cassette 16a. The tubing 20 is connected, through the middle cassette 16a, to additional tubing 22, which includes a container access device 24 (e.g., a sharpened cannula or spike connector) for accessing the interior of an anticoagulant container (not illustrated). During a blood treatment operation, anticoagulant from the anticoagulant container may be added to the blood from the blood source at the y-connector 18 prior to entering the left cassette 16.
(24) The other blood source access device 14a may be used to deliver or return blood, a blood component, and/or some other replacement fluid to the blood source and is also connected to the left cassette 16 by a y-connector 26. The other leg of the y-connector 26 is connected to tubing 28 connected at its other end to a container access device 30. Although not illustrated, the container access device 30 may be associated with a container having an amount of fluid (e.g., saline) to be used to prime the flow circuit 12 and/or be delivered to the blood source via the blood source access device 14 or 14a.
(25) The left cassette 16 also includes tubing 32 which is connected to a blood separation chamber 34 of the flow circuit 12 (in a centrifugation system) or to a spinning membrane 35 (in a spinning membrane system) for flowing anticoagulated blood thereto. The blood separation chamber 34 or spinning membrane 35 separates the blood into its constituent parts and returns the blood components to other portions of the flow circuit 12. In one embodiment, cellular blood components, such as RBCs, are returned to a right cassette 16b of the flow circuit 12 from the blood separation chamber 34 or spinning membrane 35 via tubing 36 and y-connector 37, while substantially cell-free plasma is returned to the same right cassette 16b of the flow circuit 12 from the blood separation chamber 34 or spinning membrane 35 via tubing 38. The cellular blood components may be pumped through right cassette 16b to container 44, via tubing 46, where they are retained. The substantially cell-free plasma may be pumped through the right cassette 16b and into tubing 42, which may lead to a processing device 43 that selectively filters out designated pathogenic compounds from the plasma and/or may retain a portion of the plasma volume. The processing device 43 may be a plasma reduction container, or any device such as a column described in greater detail in International Publication No. WO 2012/141697 and U.S. Pat. No. 6,569,112, each of which is hereby incorporated by reference herein in its entirety, although any suitable processing device may be used. In the event that the treatment phase of plasma includes plasma reduction, substitution with a common replacement fluid such as saline or solution containing albumin or fresh frozen plasma drawn from container access devices 51 or 61 may be provided as part of the processing.
(26) As used throughout this disclosure, the term processing includes, for example, altering plasma volume, constitution, and/or composition. A volume alteration, for example, may comprise any change in the plasma volume before and after processing. Plasma reduction is one example of a volume alteration, in which the plasma volume before processing may be less than that after processing. Plasma reduction followed by substitution with a replacement fluid is an example of an alteration in constitution and/or composition, in which the plasma subsequent to processing may have a different constitution and/or composition from the plasma prior to processing.
(27) Although in the embodiment presented, both the cellular blood components and the substantially cell-free plasma are returned to the right cassette 16b of the flow circuit 12 via their respective tubings 36 and 38, their pathways within the cassette 16b may remain separate and independent. This may be achieved by a predetermined layout of open and closed valves configured to provide separate and/or independent pathways within cassette 16b. Referring to
(28) At a time point in close proximity to the retention of the cellular blood components in container 44, donated healthy red blood cells or an appropriate replacement fluid such as saline or albumin, may be drawn by container access device 51 or container access device 61. In an embodiment in which the healthy RBCs or appropriate replacement fluid are drawn by container access device 51, the donated RBCs or replacement fluid enters the middle cassette 16a via tubing 53 and are led by another predetermined layout of open and closed valves into tubing 40, this time a layout in which valves V7, V1, V2, V9, and V5 are closed, and valves V8, V10, and V4 are open. Meanwhile, treated plasma that has not been retained by the processing device 43 and/or treated plasma that has been filtered through processing device 43 may enter tubing 47. Both the healthy RBCs or replacement fluid from tubing 40 and the treated plasma from tubing 47 then may join pathways as treated whole blood at tubing 49 to jointly enter the left cassette 16. While in this particular embodiment, a specific valve arrangement and cassette 16a are disclosed, a different cassette or cassettes and/or a different valve arrangement may serve a similar purpose.
(29) Inside the left cassette 16, another predetermined layout of open and closed valves may ensure that the pathway of the treated whole blood back to the blood source remains separate and independent from the untreated whole blood that is entering the same left cassette 16 from tubing 15 and blood source access device 14. In one embodiment, valves V1, V2, V4, V5, and V9 remain closed while valves V3, V6, V7, V8, and V10 remain open to provide two separate and independent pathways for outgoing treated and in-coming untreated whole blood. The treated whole blood may leave the left cassette 16 via tubing 15a to blood source access device 14a, where it may re-enter the blood source as healthy whole blood.
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(31) Although in the embodiment presented, both the cellular blood components and the substantially cell-free plasma are returned to the right cassette 16b of the flow circuit 12, their pathways within the cassette 16b may remain separate and independent. This may be achieved by a predetermined layout of open and closed valves configured to provide separate and/or independent pathways within cassette 16b.
(32) At a time point in close proximity to the retention of the cellular blood components in container 44, donated healthy red blood cells or an appropriate replacement fluid such as saline or albumin, may be drawn by container access device 51. The donated RBCs or replacement fluid enters the middle cassette 16a. Meanwhile, treated plasma that has not been retained by the processing device 43 and/or treated plasma that has been filtered through processing device 43 may join pathways with the healthy RBCs or replacement fluid. Both the healthy RBCs or replacement fluid and the treated plasma may jointly enter the left cassette 16 as treated whole blood.
(33) Inside the left cassette 16, another predetermined layout of open and closed valves may ensure that the pathway of the treated whole blood back to the blood source remains separate and independent from the untreated whole blood that is entering the same left cassette 16 from tubing 15 and blood source access device 14. The treated whole blood may leave the left cassette 16 to blood source access device 14a, where it may re-enter the blood source as healthy whole blood.
(34) Referring to
(35) As an alternative to an embodiment in which healthy RBCs or replacement fluid and treated plasma join pathways as treated whole blood, treated RBCs and treated plasma may separately be collected in respective containers 40a and 47a, as depicted in
(36) Turning to the fluid processing system of
(37) When in a loading or unloading position, the spool 56 can be opened by movement at least partially out of the bowl 54, as
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(39) As
(40) As best shown in
(41) As
(42) Blood entering the blood separation chamber 34 is pumped thereinto by one or more pumps 92 of the fluid processing system 10 (
(43) Before beginning a given blood processing and collection procedure, the operator may load various components of the flow circuit 12 onto the sloped front panel 96 and centrifuge 52 of the centrifuge system 10. The blood separation chamber 34 and the umbilicus 48 of the flow circuit 12 are loaded into the centrifuge 52, with a portion of the umbilicus 48 extending outside of the interior of the fluid processing system 10, as shown in
(44) Each cassette 16-16b, one of which is shown in
(45) In one embodiment, the cassette 16, the interior wall 100, and the upper panel 108 may be made of a rigid medical grade plastic material, while the diaphragm 106 may be made of a flexible sheet of medical grade plastic. The upper panel 108 and the diaphragm 106 may be sealed about their peripheries to the peripheral edges of the top- and undersides 102, 104 of the cassette 16, respectively.
(46) As shown in
(47) The valve and sensing stations 110, 112 resemble shallow wells open on the cassette underside 104 (
(48) The sensing stations 112 are likewise closed by the interior wall 100 on the topside 102 of the cassette 16, except that each sensing station 112 includes three through holes or ports 120 in the interior wall 100 (
(49) In one embodiment, the flexible diaphragm 106 overlying the underside 104 of the cassette 16 is sealed by ultrasonic welding to the upstanding peripheral edges 116 of the valve and sensing stations 110, 112. This isolates the valve stations 110 and sensing stations 112 from each other and the rest of the system. In an alternative embodiment, the flexible diaphragm 106 can be seated against the upstanding edges 116 by an external positive force applied by the cassette holder 94 against the diaphragm 106. The positive force, like the ultrasonic weld, peripherally seals the valve and sensing stations 110, 112.
(50) The localized application of additional positive force (referred to herein as a closing force) upon the intermediate region of the diaphragm 106 overlying a valve station 110 serves to flex the diaphragm 106 into the valve station 110. Such closing force is provided by the cassette holder 94. The diaphragm 106 seats against one of the ports 118 to seal the port 118, which closes the valve station 110 to liquid flow. Upon removal of the closing force, fluid pressure within the valve station 110, the application of a vacuum to the outer surface of the diaphragm 106, and/or the plastic memory of the diaphragm 106 itself unseats the diaphragm 106 from the port 118, opening the valve station 110 to liquid flow.
(51) Upstanding channel sides or edges 122 rise from the interior wall 100 to peripherally surround and define the liquid paths 114, which are open on the topside 102 of the cassette 16. The liquid paths 114 are closed by the interior wall 100 on the underside 104 of the cassette 16, except for the ports 118, 120 of the valve and sensing stations 110, 112 (
(52) In the illustrated embodiment, ten pre-molded tube connectors 124 extend out along opposite side edges 126, 128 of each cassette 16. The tube connectors 124 are arranged five on one side edge 126 and five on the other side edge 128. The other side edges 130 of the cassette 16, as illustrated, are free of tube connectors. The tube connectors 124 are associated with external tubing (
(53) The tube connectors 124 communicate with various interior liquid paths 114, which constitute the liquid paths of the cassette 16 through which a fluid enters or exits the cassette 16. The remaining interior liquid paths 114 of the cassette 16 constitute branch paths that link the liquid paths 114 associated with the tube connectors 124 to each other through the valve stations 110 and sensing stations 112.
(54) Turning now to the cassette holders 94 (
(55) The flexible diaphragm 106 covering the underside 104 of the cassette 16 is urged into intimate contact with a valve and sensor array or assembly 132 by the cassette holder 94. The valve assembly 132 acts in concert with the valve stations 110 and sensing stations 112 of the cassette 16. The valve assembly 132 illustrated in
(56) In one embodiment, each valve actuator 134 includes an electrically actuated solenoid pin or piston 138. Each piston 138 is independently movable between an extended position and a retracted position. When in its extended position, the piston 138 presses against the region of the diaphragm 106 that overlies the associated valve station 110. In this position, the piston 138 flexes the diaphragm 106 into the associated valve station 110, thereby sealing the associated valve port 118. This closes the valve station 110 to liquid flow. When in its retracted position, the piston 138 does not apply force against the diaphragm 106. As before described, the plastic memory of the diaphragm 106 may be such that the removal of force is sufficient for the diaphragm to unseat from the valve port 118, thereby opening the valve station 110 to liquid flow. Alternatively, a vacuum may be applied to the diaphragm 106, for example by the vacuum port 140 illustrated in
(57) The pressure sensing transducers 136 sense liquid pressures in the sensing stations 112 of the cassette 16. The sensed pressures are transmitted to a controller of the centrifuge system 10 as part of its overall system monitoring function. If provided, the vacuum port 140 of the cassette holder 94 may provide suction to the diaphragm 106 of the cassette 16, drawing it into close contact with the transducers 136 for more accurate pressure readings.
(58) The embodiments disclosed herein are for the purpose of providing a description of the present subject matter, and it is understood that the subject matter may be embodied in various other forms and combinations not shown in detail. While described with reference to a blood component processing device, the subject matter presented herein may be applied to other fluid processing devices and medical devices. In some embodiments, the teachings herein could be used on any medical device that involves the parallel processing or treatment of fluid components. Therefore, specific embodiments and features disclosed herein are not to be interpreted as limiting the subject matter as defined in the accompanying claims.