JP4072173B2 - Extracorporeal blood treatment method and apparatus - Google Patents

Description

  The present invention relates generally to the field of extracorporeal blood processing, and more particularly to a method and apparatus that can be incorporated into a component removal system (eg, blood component collection, therapeutic).

  One type of extracorporeal blood treatment involves removing blood from a donor or patient for collection or treatment purposes, subjecting it to a blood component separation device (eg, a centrifuge), and various blood components (eg, red blood cells, white blood cells, platelets, plasma). ) Is a component removal method. One or more of these blood components are collected (eg, for therapeutic purposes) while the remainder is returned to the donor or patient.

  A number of factors affect the commercial viability of the component removal system. One factor relates to the system operator, and in particular to the time and / or expertise required of the individual preparing and operating the component removal system. For example, reducing the time required by an operator to install and remove disposable parts, and reducing the complexity of such operations, thereby increasing productivity and / or the potential for operator error. be able to. Further, reducing the operator's reliance on the system may lead to a reduction in operator error and / or a reduction in the qualifications desired / required of the operator of such a system.

  Donor-related factors can also negatively impact the commercial viability of component removal, including donor benefits and donor comfort. For example, donors generally have little time to visit a blood component collection facility for donation. As a result, in a collection facility, the amount of time that the donor spends primarily on collecting blood components is a factor to consider. Also, since at least one, and often two, access needles pierce the donor throughout the entire collection process, blood collection tends to be somewhat uncomfortable, so this is also the donor Related to comfort.

  Function-related factors continuously affect the commercial feasibility of component removal systems. Function is determined by the “collection efficiency” of the component removal system, which also reduces blood collection time and is expected to increase donor benefits. The “collection efficiency” of the system is of course measured in various ways, such as measuring the amount of a particular blood component collected in relation to the number of types of blood components that pass through the component removal system. The function may be evaluated based on the effects shown for various blood components. For example, it is desirable to minimize harmful effects (eg, reduce platelet activation) on blood component types as a result of component removal methods.

  The object of the present invention is generally to provide extracorporeal blood treatment. Since the various aspects of the present invention can be incorporated into a component removal system (eg, for blood component collection to remove “healthy” cells from blood or for therapeutic purposes to remove “unhealthy” cells from blood). The present invention has been described in terms of this particular application. However, at least some of the present invention is applicable to other extracorporeal blood treatments and are within the scope of the present invention.

  Component removal systems that can implement at least one or more aspects of the present invention generally include blood component removal devices (eg, membrane-based separation devices, blood into various blood components (red blood cells, white blood cells, platelets, and A rotating centrifuge element, such as a rotor, which supplies the force necessary to separate the plasma). In one embodiment, the separation device includes a channel that receives a blood treatment chamber. In general, a healthy human donor or a patient with some disease (donor / patient) is fluidly interconnected with a blood processing chamber by an extracorporeal tube circuit, preferably the blood processing chamber and the extracorporeal tube circuit are Collectively define a closed sterilization system. Once the fluid interconnection is established, blood is extracted from the donor / patient and applied to a blood component separation device so that at least one blood component is separated and removed from the blood for either collection or treatment. To.

  A first aspect of the invention relates to making it easier to attach a blood treatment chamber to a channel that couples to a centrifuge rotor. In one embodiment of this first aspect, the centrifuge rotor includes a blood treatment chamber mounting aperture on its sidewall. This sidewall extends only in some direction through the centrifuge rotor and further extends upward through the top of the centrifuge rotor. Thereby, the centrifuge rotor provides a facing surface for the mounting aperture portion characterized in that it extends to the side surface. The mounting aperture in the centrifuge rotor is further characterized by being substantially L-shaped. When the disposable blood processing chamber is inserted into this opening, it is deflected upward through the centrifugal rotor. Thus, the operator can grasp the blood processing chamber and attach it to the channel.

  Another embodiment of this first aspect relates to a drive assembly for a centrifuge rotor assembly. The rotor assembly includes a rotor housing, a channel mount having a channel coupled thereto, and a single gear that rotatably interconnects the rotor housing and the channel mount. By using this single gear and biasing this single gear radially against the mounting aperture described above in the centrifuge rotor, access to the mounting aperture is substantially affected by the drive assembly for the centrifuge rotor. Not receive. For example, any counterweight can be placed to establish rotational equilibrium of the centrifuge rotor by radially offsetting the single drive gear relative to the plane that bisects the mounting aperture Prevents harmful effects on access to the aperture.

  A second aspect of the invention relates to a cross-sectional configuration of at least a portion of a channel coupled to a channel housing that is interconnectable with a blood separation device. Generally, the channel itself is configured to hold a blood treatment chamber during a component removal procedure. This is particularly desirable when the blood component collection device is a centrifuge operating at a high rotational speed of 2,500 RPM or more and up to about 3,000 RPM. In one embodiment, the lip extends partially on top of the channel for the length of at least a portion of the channel.

  The lip in this second embodiment can be obtained by configuring at least one of the internal and external channel walls with a generally C-shaped cross-sectional configuration. In this case, the width of the upper and lower portions of the channel having the lip is reduced compared to the central portion of the channel. The upper and lower portions of these reduced width channels can receive portions of the blood processing chamber that are sealed together. This channel configuration also helps to reduce the stress imposed on these seals when pressurizing the blood treatment chamber during a component removal procedure.

  The third aspect of the present invention relates to a blood processing chamber, and more particularly to a blood processing chamber that is effectively mounted in a channel. In one embodiment of this third aspect, the blood treatment chamber overlaps the first and second ends and offsets in the radial direction, and provides a continuous flow path by utilizing the first and second connectors. To do. The first and second connectors are respectively positioned between the two ends of the blood processing chamber, communicate with the interior of the blood processing chamber, and when fitted, smoothly install the blood processing chamber in the correct position of the channel. One of the connectors may be a stub-like structure extending outward from the inner wall of the blood processing chamber, and the other connector may be a stub-like structure extending outward from the outer wall of the blood processing chamber. Good.

  Another example of this third aspect is a blood treatment chamber that is particularly effective for the channel described in the second aspect above. In this regard, the blood processing chamber is not only self-supporting, but is sufficiently rigid to be attached to the channel of the second aspect. However, the blood treatment chamber is also sufficiently flexible so that it can substantially conform to the shape of the channel during the component removal procedure. This is particularly desirable when shaping the channel to provide one or more desirable features for component removal procedures.

  When the blood processing chamber is attached to the channel, at least the blood processing chamber must be filled. In this regard, the fourth aspect of the invention preferably relates to filling with blood. The channel coupled to the channel housing that is rotatably interconnected with the centrifuge rotor includes a first cell separation stage. This first cell separation stage has a ratio of the volume of the channel with RBC to the volume of the channel without RBC less than or equal to the ratio of the hematocrit of red blood cells exiting the channel to the hematocrit of blood entering the channel. The dimensions should not exceed 1. This configuration allows the channel to be appropriately characterized as “blood-filled” because blood can be used to fill the blood processing chamber when placed in the channel.

  In one embodiment of this fourth aspect, the channel extends in a generally curvilinear manner around the axis of rotation of the channel housing in the first direction. This channel is aligned in a first direction and includes a first cell separation stage, a red blood cell dam, a platelet collection unit, a plasma collection unit, and a type of red blood cell and adjacent blood components (eg, buffy coat, lymphocytes, and platelets). An interface controller for controlling the radial position of at least one interface between Blood introduced into the channel is separated into red blood cells, white blood cells, platelets, and plasma layers in a first cell separation stage. It is preferred that only the separated platelets and plasma flow through the component removal procedure and including the filling of the blood processing chamber beyond the red blood cell dam that removes the platelets from the platelet collection channel. This is provided by an interface control mechanism that is located in the interface controller of the channel and maintains the position of the interface between the red blood cells and the buffy coat separated so that this state is maintained.

“Blood filling” is a term that encompasses various features, but in each case, blood is the first fluid that is introduced into the blood processing chamber. One feature of blood filling is the supply of separated plasma to the interface controller before the separated red blood cells cross the red blood cell dam and flow to the platelet collection section. Another feature is that the type of blood and / or blood component occupies the entire fluid-containing volume of the blood processing chamber before the separated red blood cells flow over the red blood cell dam to the platelet collection section.
One configuration of the channel that allows blood filling of the blood treatment chamber when mounted in the channel is that the volume of the channel portion that essentially contains plasma during the component removal procedure is essentially a channel that contains red blood cells during the component removal procedure The structure is smaller than the volume of the part. As a result, plasma is supplied to the interface control unit of the channel before the red blood cells flow over the red blood cell dam to the platelet collection stage, and the red blood cell buffy coat interface control function is obtained. The “small” degree of the channel volume described above that allows blood filling, especially in relation to a reference circle that has its origin at the axis of rotation of the centrifuge housing and crosses the channel at a predefined location in the red blood cell dam. It is prescribed. The volume of the channel containing plasma essentially separated in the component removal procedure is placed inside this reference circle (eg, V _PL ), and the volume of the channel containing red blood cells essentially separated in the component removal procedure is , Located outside the reference circle (eg, V _RBC ). In one embodiment, the V _PL / V _RBC ratio is less than about 0.3, preferably less than about 0.25. This desirable ratio can be achieved by making the channel width between the platelet collection portion and the plasma collection portion smaller than the channel width throughout the first cell separation stage. By utilizing this reduced width, the channel configuration between the platelet collection section and the plasma collection section can utilize the channel walls inside and outside the plane extending substantially vertically.

A fifth aspect of the present invention relates to filling a blood treatment chamber disposed in a channel of a channel housing. In addition to using blood for filling, the present invention is also applicable to removing air from the blood processing chamber during filling. A donor / patient blood transfer assembly fluidly interconnects the blood treatment chamber and the donor / patient and includes an air reservoir for receiving air exhausted from the blood treatment chamber upon blood filling. Various features associated with the channel of the fourth aspect of the invention described above can also be utilized in the fifth aspect.
A sixth aspect of the invention relates to filling a component removal system with blood and includes a system channel housing. The channel housing has a blood treatment channel coupled thereto, a blood treatment chamber disposed in the channel, and a blood inlet, a red blood cell outlet, and an interface control port. The interface control port is used to control the radial position of at least one interface between the separated red blood cells and the type of blood component located adjacent to the separated red blood cells.

  The method of this sixth aspect comprises rotating a channel housing with a blood treatment chamber positioned in the channel, introducing blood into the blood treatment chamber and filling the blood treatment chamber, at least red blood cells, platelets, And separating blood into plasma. Red blood cells are restricted from flowing beyond the red blood cells throughout the procedure, including filling the blood processing chamber. In this regard, plasma flow is supplied to the interface preparation port before any of the red blood cells can flow past the red blood cell dam. When this plasma reaches the interface control port, control of the radial position at the interface between the separated red blood cells and the adjacent red blood cell type is established so that the potential of the red blood cells flowing over the red blood cell dam decreases. The One or more of the various features described above with respect to the fourth and fifth aspects above may also be incorporated into this sixth aspect.

  A seventh aspect of the present invention is a method that can be used to fill a blood treatment chamber located in a channel of a channel housing with blood. In this method, a blood treatment chamber is placed in a channel on the channel housing and a donor / patient blood transfer assembly fluidly interconnects the donor / patient with the blood treatment chamber. The method generally includes rotating the channel housing at a first rotational speed simultaneously with the step of initiating blood flow from the donor / patient to the donor / patient blood transfer assembly. When the blood flow reaches the blood processing chamber, the rotational speed of the channel housing increases to the second rotational speed. When the entire blood processing chamber contains blood and / or one or more blood components, the rotational speed of the channel housing further increases to a third rotational speed. In one embodiment, the first rotational speed is about 180 RPM to about 220 RPM, preferably about 200 RPM, the second rotational speed is about 1,800 to about 2,200 RPM, and about 2,000 RPM. Preferably, the third rotational speed is from about 2,700 to about 3,300, preferably about 3,000. In the implementation of the method of this seventh aspect, a three-step method can be utilized, but the centrifuge speed need not be maintained at a fixed speed in each of the three “stages” (eg, the first stage is Filling the circuit from the donor / patient to the blood processing chamber, the second stage is filling the blood processing chamber, and the third stage is the remainder of the component removal procedure). One or more of the various features described above with respect to the fourth, fifth, and sixth aspects above can also be incorporated into this seventh aspect.

  The eighth aspect of the present invention relates to the step of filling the component removal system with blood. The component removal system includes a channel having a system coupled channel, a blood processing chamber disposed in the channel, a donor / patient blood transfer assembly fluidly interconnecting the donor / patient with the blood processing chamber and including a blood reservoir. Including housing. The method according to the eighth aspect includes first and second drawing steps. The first drawing step includes drawing blood from the donor / patient to the blood reservoir via the first portion of the donor / patient blood transfer assembly. After this first drawing step is completed, the blood drawing chamber is filled with donor / patient blood by performing a second drawing step. The second drawing step includes drawing blood from the donor / patient through the donor / patient blood transfer assembly, through the blood processing chamber, and back to the blood reservoir. One or more of the various features described above with respect to the fourth, fifth, sixth, and seventh aspects above may be incorporated into the eighth aspect.

  According to a ninth aspect of the present invention, blood treatment is performed such that blood is separated into at least two blood components, and at least one of these blood components is taken out from the blood treatment chamber via the blood component outlet. It relates to the introduction of blood into the room. The blood treatment chamber includes two interconnected sidewalls (eg, a substantially planar surface that defines the main body of the blood treatment chamber's fluid-containing volume) and the blood inlet extends through one of these sidewalls. Exists. Generally, blood exits the blood inlet within the blood processing chamber in a direction that is at least in the direction of the main flow of blood through the channel. The introduction of blood into the blood processing chamber has many features. For example, this introduction can be characterized as blood flowing from the blood inlet into the blood treatment chamber at an angle of less than 90 ° relative to a reference line extending perpendicular to the channel wall joining the blood inlet. This introduction can be further characterized by exiting the blood inlet in a direction that is substantially parallel to the direction of flow adjacent to the blood inlet. In one embodiment, the introduction to the blood processing chamber further reduces the possibility of interfering with this flow of red blood cells and / or reduces the impact on the flow characteristics of the portion of the blood processing chamber into which blood is introduced. As further characterized, red blood cells can actually flow through the blood inlet along the outer wall of the blood processing chamber. This introduction is further characterized by exiting the blood inlet in a direction that is substantially parallel to the side wall of the blood treatment chamber joining the blood inlet.

  A tenth aspect of the present invention relates to taking out platelets from a blood processing chamber. This tenth aspect is based on the adjacent channel wall of the blood processing chamber and the channels that collectively define a generally funnel-shaped blood component collection well for collecting at least one blood component (eg, platelets) flowing thereby. . In one embodiment, the blood processing chamber includes a blood inlet and a first blood component outlet. A support is disposed proximal to the blood component outlet and external to the fluid containing volume of the blood processing chamber. The support has a profile that directs the type of blood component desired toward the blood component outlet and is in an overlapping relationship with the outer surface of the blood treatment chamber. The support may be separable from the blood processing chamber so that it is positioned between the blood processing chamber and the associated channel wall after the blood processing chamber is attached to the channel. This support can also be fixedly interconnected with the blood processing chamber in some way. For example, this support part is interconnected with the outside of the blood processing chamber by a pivot or a hinge, and facilitates the mounting of the blood processing chamber and / or is supported at a predetermined position by the pressure of the blood processing chamber during component removal treatment. It is also possible to move parts and perform desired functions. Furthermore, the support can be formed integrally with the combined blood component outlet.

  In another embodiment related to this tenth aspect, the channel includes inner and outer channel walls and the generally funnel blood component collection well is formed of at least one of these channel walls. That is, the remaining material of the funnel-shaped blood component collection well is defined by the blood processing chamber as described above with respect to the first embodiment of the tenth aspect. In order for the blood treatment chamber described above to be effectively mounted on the blood treatment channel, in particular, one of its blood component outlets, the blood component outlet relief, extends radially beyond the blood component collection well defined by the channel wall. It extends (eg, if the well is on the outer wall of the channel, it will be more radially outward, but if the well is on the inner wall of the channel, it will be more radially inward). This escape is configured to move the support portion having the above-described contour joined to the outside of the blood processing chamber to a predetermined position by the pressure of the blood processing chamber, and to direct the desired blood component type to the blood component collection port. You can also

  In another embodiment of this tenth aspect, a method for processing blood with a component removal system includes attaching a blood processing chamber to a channel of a channel housing. A contoured support is disposed between the channel and the blood treatment channel. When blood is introduced into the blood processing chamber and the channel housing is rotated to separate the blood into various blood components, a part of the blood processing chamber is adapted to the channel, and another part of the blood processing chamber is joined to the blood processing chamber. By adapting to the shape of the supporting part, a substantially funnel-shaped platelet collecting well is defined. In order to further define the substantially funnel-shaped platelet collecting well, the support portion can be moved to a predetermined position by the pressure in the blood processing chamber. For example, this allows the support to direct platelets toward the platelet collection port of the blood processing chamber.

  The eleventh aspect of the present invention relates to a control that assists in automatically controlling the position of the interface between the red blood cell and the buffy coat to the red blood cell dam (ie, without operator action). The red blood cell dam restricts the flow of separated red blood cells to the platelet collection port. The control port extends through the blood treatment chamber and moves plasma and red blood cells to the platelet collection port as needed to reduce the possibility of red blood cells flowing “beyond” the red blood cell dam. At least a portion of the “selective” removal of red blood cells from the blood processing chamber via the control port function is based on its location within the channel. That is, the automatic control obtained at least in part by the control port is based on a control port that ensures a predetermined radial position within the channel. To facilitate achieving a predetermined radial position within this channel, the arrangement of the control ports is obtained independently of the thickness of the blood treatment chamber. In particular, the position of the control port does not depend on the thickness of the material forming the blood processing chamber.

  The desired objective for control of this eleventh aspect of the present invention is influenced by interconnecting the support or shield-like structure with the control port and placing the support on the outer surface of the blood treatment chamber. Sometimes. The support can then be positioned with respect to the inner surface of the channel, preferably in a recess specially designed to receive the support. This support may cause a significant change in the radial position of the control port when the blood treatment chamber is pressurized (eg, radial movement within the slot that receives the control port and extends the control port into the channel). ) May be more rigid than the blood processing chamber itself. These supports or shields are used for other blood inlets / outlets in the blood treatment chamber to keep the associated port in a predefined position the same and / or in the channel where the port joins. Along the discontinuity along the line can also be reduced.

  A twelfth aspect of the present invention relates to a clogging factor associated with the type of separated blood component in the separation stage of the blood processing chamber. The clogging factor is a number representing the degree to which the type of blood component is “clogged” at the separation stage and is at least dependent on the rotational speed of the channel housing and the flow rate to the blood treatment chamber. The clogging factor can be characterized by a dimensionless “density” of the classification of blood component types in the separation stage.

  One embodiment of this twelfth aspect comprises rotating a channel housing, supplying a flow to a blood treatment (eg, the flow also includes blood and generally an anticoagulant), Separating the blood component types and adjusting the rotational speed of the channel housing based on the change in flow rate. Since the clogging factor depends on the rotational speed of the channel housing and the flow rate to the blood treatment chamber, the method of this twelfth aspect can be used to maintain a substantially constant and predefined clogging factor. . In this regard, the clogging factor is preferably maintained at about 11 to about 15, with about 13 being preferred.

  Another embodiment of this twelfth aspect is a method for processing blood with a component removal system in which a blood processing chamber is disposed in a channel of a channel housing. The method includes rotating a channel housing, supplying a flow of blood (typically anticoagulation) to the blood treatment chamber at a rate of about 40 ml / min to about 70 ml / min, and a first stage of the channel. And separating the blood into a plurality of blood component types and extracting at least one blood component from the blood processing chamber. A clogging factor of at least about 10, more preferably at least about 10.2, is maintained in the first stage throughout the separating step. For a flow rate at about 50 ml / min, the clogging factor is further maintained at about 13 achieved by rotating the channel housing at a speed in excess of 2500 RPM, generally close to about 3,000 RPM. preferable.

  Another embodiment of this twelfth aspect of the invention relates to the construction of a channel coupled to a channel housing that is rotatably interconnected with a centrifuge rotor. The channel includes a first cell separation stage and a first blood component collection stage separated by a cell dam. At least one of the blood components is separated from the rest of the blood in the first cell separation stage and flows over the cell dam to the first blood component collection stage, and at least one other blood component is removed from the cell dam. It is preferable not to flow into the first blood component collection stage. The channel width or sedimentation distance at the end of the first separation stage in close contact with the cell dam is smaller than the channel width or sedimentation distance at the opposite end of the first cell separation stage. In one embodiment, the channel width / sedimentation distance in the first cell separation stage gradually decreases towards the cell dam. Using the above type of clogging factor, this channel configuration can be used to reduce the buffy coat volume (white blood cells, lymphocytes, and platelets) between red blood cells and platelets separated in the first stage. As a result, the number of platelets retained in the first cell separation stage is reduced.

  A thirteenth aspect of the present invention relates to a rinseback operation at the end of the component removal procedure, in which the remaining contents of the blood processing chamber are removed and returned to the donor / patient. In one embodiment, one or more mouths of the blood treatment chamber that join the sidewalls of the blood treatment chamber reduce the likelihood of the mouth closing during a rinseback procedure by interconnecting these ports with one or more pumps. Configured in a way The mouth is configured to have an orifice that is disposed most outwardly in the radial direction of the mouth. This may be accomplished by configuring the mouth end to position the orifice between the two protrusions so that the orifice is retracted inwardly of the protrusion. As a result, the opposing portion of the blood processing chamber is fitted with the protrusion during the rinse back, and the orifice is held away from the blood processing chamber, so that the flow to the orifice is not blocked.

  In another embodiment related to this thirteenth aspect, at least one narrow portion in the blood processing chamber is directed downwardly from the at least one blood component outlet joining the side wall of the blood processing chamber toward the lower portion of the blood processing chamber. Extend. For example, the operation of pulling out the blood component outlet from the blood processing chamber by the pumping operation at the time of rinsing back, and if the rotation of the channel housing is preferably terminated at the time of rinsing back, the contents of the blood processing chamber Starting at the bottom of the blood treatment chamber. The second narrow portion extends downward from the blood component outlet so that one passage extends away from the mouth in the opposite direction and the drawing operation is initiated at two arranged positions. May be.

  A fourteenth aspect of the invention relates to facilitating introduction / removal and removal of a blood treatment chamber to and from a channel associated with a channel housing upon completion of a component removal procedure, respectively. In general, the blood treatment chamber can be removed and attached to the channel by fitting a structure that blocks flow during component removal. This can be accomplished by interconnecting at least one, preferably a plurality of tabs or the like with the blood processing chamber. These tabs preferably extend beyond the fluid containing volume of the blood processing chamber and extend beyond the channel when the blood processing chamber is installed in the channel. The tab itself can be grasped by the operator of the component removal system and the blood treatment chamber can be attached to and removed from the channel. These tabs etc. are particularly useful when the lip is formed at the top of the channel described in connection with the second aspect and there is resistance that arises when inserting / removing the blood treatment chamber from the channel. It is believed that there is.

  A fifteenth aspect of the invention relates to providing a graphic operator interface for treatment. The graphic operator interface displays at least part of the component removal step, at least one of the required operator actions, to the operator as an image. These steps can be displayed with images in the order in which they should be performed. Further, in order to increase the operator's recognition of the order of the component removal steps displayed in the image, the image can be numbered. The image only shows the desired / necessary action for the operator, but can also be combined with the image using a short text description.

  The image can also be used to show the status of the component removal procedure to the operator, such as by color or shade distinction. For example, use a three-stage color or “shadow” distinction (for example, a color using three different colors and a shadow using a color that is the same color but has a different “darkness” level) An operator can be shown that one of three states is associated with a step associated with a particular image. One color or shade is used to indicate that the step associated with the image is not timely (eg, it is not yet ready to perform), while another color or shade is utilized and the step associated with the image is timely. (E.g., ready to run and / or being running), but using another color or shade, the steps associated with the image are being performed Can be shown. The status can also be conveyed by further indicating an indication that the steps associated with the displayed image have been completed. The image can further function as an operator input device. For example, a touch screen image can be utilized to touch one of the images on the display when the operator is ready to perform the steps associated with the image. This touch screen operation can produce an image in one or more that illustrates to the operator one or more steps or sub-steps that need to be performed at that particular time in component removal.

  The sixteenth aspect of the present invention also relates to the interface between the component removal system and the operator. One embodiment of the sixteenth aspect includes instructing the component removal system to address a first condition associated with component removal by executing a first protocol. In general, this “first state” is a component removal system that is resolved in various ways (eg, at least two), such as by implementing a first protocol or by executing a second protocol. There are several types of problems associated with. That is, the method “acts” a component removal system that addresses or “corrects” the first condition in one of a plurality of ways, how to address the first condition or No decision on whether to “correct” this is made by the operator.

  The method in this embodiment of the sixteenth aspect comprises the steps of introducing blood into a blood separation device, separating the blood into a plurality of blood component types, and extracting at least one blood component from the blood separation device. Including. The method also includes the step of the component removal system executing the first protocol after confirming the presence of the first condition associated with the component removal system. This “confirmation” of the first state can be performed based on an operator who observes the first state and inputs information regarding the presence of the first state to the component removal system. This method can be effectively incorporated into and / or utilized in the graphic interface described above with respect to the fifteenth aspect of the present invention.

  Another embodiment relating to this sixteenth aspect relates to a component removal system that utilizes an operator to address potential problems associated with component removal procedures. The method of the sixteenth aspect includes a step of introducing blood into a blood separation device, a step of separating blood into a plurality of types of blood components, and extracting at least one of these blood components from the blood separation device. And steps. The method further includes detecting a potential presence of a “first condition” associated with the component removal procedure. This “first state” is generally a number of potential problems and is detected by the system itself (eg, via an appropriate detector / sensor / monitor), the operator, and / or the donor / patient. be able to. When this first condition is detected, the operator is instructed by the component removal system (eg, via a computer interface) to perform an investigation of the system or a specific portion thereof. The operator is also presented with an instruction message to show the result of this investigation to the system. Based on the operator's response to the survey, the system may indicate an instruction message to the operator to take further action (eg, to address the first condition in a particular manner). Further, this method can be effectively incorporated into and / or utilized in the graphic interface described above with respect to the fifteenth aspect of the present invention.

  A seventeenth aspect of the present invention uses a single pressure sensing device to monitor positive and negative pressure changes in blood removal lines and blood return lines that can be interconnected with a donor / patient and for disposable blood treatments. It relates to an expression assembly. In one embodiment, a pressure sensitive diaphragm member contacts the blood at one wall in the module of the molded cassette member, the cassette member being an integral piece that fluidly interconnects the module with both the blood removal line and the blood return line. It also includes an internal passage defined in The use of a single pressure sensor reduces the cost and complexity of the components and provides significant accuracy benefits.

  The eighteenth aspect of the invention further includes a single needle for removal / return of whole blood / uncollected blood components and a reservoir fluidly interconnected to the single needle for accumulating blood components. Gas retention fluidly interconnected to a reservoir for receiving gas from the reservoir and returning the gas to the reservoir as the blood components that are not collected during the blood processing operation are periodically accumulated and processed And a disposable assembly for extracorporeal blood treatment. In one embodiment, the reservoir is intelligently defined within the molded cassette member. Installation of gas holding means avoids high internal pressure when the reservoir is filled with return blood components, thereby reducing gas suction at the liquid / gas interface, and the reservoir and interconnected configuration The need for element sealing is reduced.

  A nineteenth aspect of the present invention is a reservoir for accumulating uncollected blood components, and upper and lower ultrasonic sensors that can be positioned adjacent to the reservoir, inducing the start and stop of a blood return cycle Therefore, the present invention relates to an extracorporeal blood treatment apparatus including a cassette member having sensors each responsive to the presence or absence of an adjacent fluid in a reservoir. In a related aspect, the upper and lower ultrasonic sensors advantageously include a contact surface for dry docking directly with the reservoir, thereby avoiding the need to use a docking gel or other similar binding media. This nineteenth aspect is further defined as follows:

1. In a device for extracorporeal blood treatment,
Having a reservoir for supplying blood components not collected in the first mode and supplying the accumulated and uncollected blood components for return to the donor in a second mode separate from the first mode; Cassette,
A first ultrasonic sensor positionable adjacent to an upper portion of the reservoir, wherein the first ultrasonic sensor accumulates uncollected blood components at a first predetermined level of the reservoir; A first ultrasonic sensor that senses and generates a first signal accordingly, thereby ending the first mode and starting the second mode;
A second ultrasonic sensor positionable adjacent a lower portion of the reservoir, wherein the second ultrasonic sensor removes the uncollected blood component to a predetermined second level of the reservoir. A second ultrasonic sensor that generates a second signal until it is sensed that the second mode is detected, ends the second mode, and starts the first mode.

2. The reservoir is substantially rigid and
The first and second ultrasonic sensors each include a first signal transducer and an elastic contact surface for direct dry contact with the upper and lower portions of the reservoir. apparatus.

  3. The apparatus of claim 1 further comprising processor control means for receiving said first and second signals and controlling the start and end of said first and second modes accordingly. .

  4. The reservoir includes a front surface and a back surface, and an intermediate portion, the intermediate portion having a width from the front surface to the back surface that is smaller than a width of the upper and lower portions from the front surface to the back surface. The apparatus according to item 1.

5. A cassette member having a reservoir and having at least one blood component conduit means for moving a separated first blood component adjacent thereto;
A first flexible tubing line interconnected at a first end with the blood component conduit means, extending outwardly from the cassette member and interconnected with the reservoir at a second end;
A second flexible tubing line interconnected with the blood component conduit means at a first end and extending outwardly from the cassette member adjacent to the first flexible tubing line;
Collecting means interconnected with a second end of the first flexible tube line;
A valve assembly having a movable member positioned between the first flexible tube line and the second flexible tube line, and first and second contact surfaces, wherein the valve assembly has a first mode. The movable member and the first contact surface cooperate to close the first flexible tube line, and the separated first blood component passes through the second flexible tube. In the second mode separated from the first mode while flowing to the collecting means, the movable member and the second contact surface cooperate to close the second flexible tube line and to separate the second mode. A device for extracorporeal blood treatment comprising a valve assembly through which the first blood component is flowed to the reservoir via the first flexible tubing line.

  6. Detecting the presence of a second blood component different from the first blood component in the blood component conduit means and indicating the signal and the first mode accordingly and initiating the second mode 6. The apparatus of claim 5, further comprising detection means for

7. A cassette member for moving at least one of whole blood and blood components in use, the cassette member having a plurality of separation tube loops extending outwardly therefrom;
A plurality of separate flow control means for controlling the flow of fluid therethrough in contact with the loop corresponding to the tube loop;
At least one ultrasonic sensing means for sensing at least one predefined parameter relating to the movement of at least one of the whole blood and blood components via the cassette member for use;
Attachment means for selectively, safely and supportably receiving said cassette means in a substantially fixed position relative to said cassette means, said attachment means being connected to said plurality of flow control means and said sensing means. The plurality of tube loops are selectively movable relative to each other in the first position and the second position, and the plurality of tube loops correspond to the correspondence when moving the attachment means from the first position to the second position. The cassette member has a mounting means for generating a corresponding signal by the ultrasonic sensing means and thereby moving to an operating position for operating the sensing means. A device for extracorporeal blood treatment.

8. The attachment means is
A pivotable spring load member for engaging the cassette means, wherein the pivotable spring load member is pivotable in the first position and pivotable in the second position; The device for extracorporeal blood treatment according to claim 7, which is physically restricted.

  9. The cassette member further includes at least one U-shaped tube loop extending outwardly therefrom, wherein the at least one U-shaped tube loop is greater than a tube wall thickness of the second flexible tube line. 6. An apparatus according to claim 5, wherein the apparatus has a larger tube wall thickness.

  10. The wall of claim 9, wherein the wall thickness of the at least one tube loop is at least about 0.94 mm and the wall thickness of the second flexible tube line is less than about 0.58 mm. The device described.

  11. The apparatus of claim 5, wherein the second flexible tube line has a wall thickness of less than about 0.58 mm.

  12. The apparatus of claim 11, wherein the second contact surface comprises an elastic material.

13. The valve assembly is
Driving means for rotatably driving the movable member between a first position and a second position corresponding to the first and second modes of operation;
Indicating means interconnected with the drive means for synchronous rotational movement with the movable member;
6. The apparatus according to claim 5, further comprising: an optical sensor for optically sensing the position of the indicating member and supplying an output signal usable for controlling the driving means.

14. A cassette member for moving at least one of whole blood and blood components in use, the cassette member having a plurality of separation tube loops extending outwardly therefrom;
A plurality of separate flow control means for controlling the flow of fluid therethrough in contact with the loop corresponding to the tube loop;
At least one ultrasonic sensing means for sensing at least one predefined parameter relating to the movement of at least one of the whole blood and blood components via the cassette member in use;
Mounting means for selectively, safely and supportably receiving said cassette means in a substantially fixed position, said mounting means being in a first position relative to said plurality of flow control means and said sensing means. Between the first position and the second position, and when the attachment means is moved from the first position to the second position, the plurality of tube loops relative to the corresponding plurality of flow control means. An apparatus for extracorporeal blood treatment comprising moving to an operating position and mounting means for moving the cassette member to an operating position for operation of the sensing means at the same time as the ultrasonic sensing means exhibits a corresponding signal.

15. The attachment means is
15. The extracorporeal blood treatment according to claim 14, further comprising a pivotable spring member for engaging the cassette means, wherein the pivotable spring member is pivotable at the first position. apparatus.

  16. At least one of the separation flow control means is positioned in a predefined relationship with respect to the cassette member, and the pivotable spring member is physically limited from pivoting movement in the second position. The apparatus according to claim 15.

  17. The apparatus of claim 14, further comprising drive means for moving attachment means between the first position and the second position.

18. The drive means is
18. Apparatus according to claim 17 including force limiting means for limiting the maximum amount of driving force that can be supplied by said driving means to said mounting means to a pre-defined level.

19. Indicating means interconnected with the drive means that move in synchronism with the attachment means;
18. The apparatus of claim 17, further comprising optical sensor means for optically sensing the position of the indicating means and for providing an output signal usable to control the driving means.

  20. The apparatus of claim 14, wherein the cassette member further comprises a plurality of outwardly extending lips, and wherein the attachment means further comprises a plurality of channel projections for receiving the plurality of lips.

21. A molding cassette member,
An integrated internal fluid passage in direct fluid communication with blood removal conduit means for moving whole blood from the donor and blood return conduit means for transferring uncollected blood components to the donor;
A diaphragm member having an internal facing side in fluid communication with the internal integral passage and an external facing side accessible to the exterior, the diaphragm member being positioned in response to pressure changes in the blood removal conduit member and blood return conduit means A molded cassette member having a diaphragm member that is reactive;
For extracorporeal blood treatment comprising a pressure sensing member that is air coupled to the exterior facing side of the diaphragm member and that is positionable relative to the cassette member to provide an output signal responsive to the pressure change. Equipment.

  22. One of the cassette member and the pressure sensing means comprises an extending portion, another one of the cassette member and the pressure sensing means comprises a receiving portion, the extending portion and the receiving portion comprising the portion The device for extracorporeal blood treatment according to claim 21, wherein the devices are phase-engaged to establish an air coupling.

  23. The apparatus for extracorporeal blood treatment according to claim 22, wherein at least one joining portion of the extending portion and the receiving portion comprises an elastic surface.

  A twentieth aspect of the present invention comprises a cassette member having a reservoir, at least first and second flexible tube lines adjacently interconnected in a predefined distance relationship, and a flexible tube line. And a joint valve assembly having a movable member selectively positionable to bite one of the tube lines and separated in a first mode of operation. The invention relates to an extracorporeal blood treatment device in which components are collected by a collection means and the blood components separated in the second mode of operation are diverted to a reservoir. In one embodiment, multiple sets of first and second tube lines / collection means / and valve assemblies are provided, each set providing selective diversion of blood components to a separate collection means or normal reservoir. To do. Use of this configuration results in a compact disposable device that can be easily attached to the diverter valve assembly in a reliable manner.

  A twenty-first aspect of the invention relates to the mounting of a disposable cassette member having a plurality of tube loops extending to a plurality of flow control devices and at least one sensing device for extracorporeal blood treatment. An attachment means is used to selectively, safely and supportably receive the cassette member in a substantially fixed position thereto, the attachment means being selectively between the first position and the second position. When movable and the attachment means is moved from the first position to the second position, the tube loop moves to the operating position with the corresponding device of the flow control device and the cassette member moves to the appropriate position for operation of the sensing means. Moving. In one embodiment, the sensing means includes at least one pressure sensor for monitoring the fluid pressure in the blood removal passage of the cassette member and monitors the fluid level of blood components accumulated and not collected in the cassette reservoir. And further includes an ultrasonic sensor.

  The present invention will be described with reference to the accompanying drawings, which are useful in describing the relevant features. In general, all aspects of the invention relate to improvements in the blood component removal system of the method and structure. However, some of these improvements are applicable to other extracorporeal blood treatment applications and are within the scope of the present invention.

  The blood component removal system 2 is shown in FIG. 1, which allows a continuous blood component separation process. In general, whole blood is drawn from the donor / patient 4 and fed to a blood component separation device 6 where the blood is separated into various components, and at least one of these blood components is removed from the device 6. These components can then be supplied by another for subsequent use or undergo therapeutic treatment and returned to the donor / patient 4.

  In the blood component removal system 2, blood is drawn from the donor / patient 4 and sent through a disposable set that includes the extracorporeal tubing 10 and blood processing chamber 352 and defines a completely closed sterilization system. The disposable set 8 is attached to a blood component separator 6 that includes a pump / valve / sensor assembly 1000 for mating with the extracorporeal tubing 10 and a channel assembly 200 for mating with the disposable blood treatment chamber 352.

  Channel assembly 200 includes a channel housing 204 that is rotatably interconnected with a rotatable centrifuge rotor assembly 568 that supplies the centrifugal force necessary to separate blood into various blood components by centrifugation. Blood processing chamber 352 is connected to channel housing 204. Thus, blood flows from the donor / patient 4 through the extracorporeal tubing 10 and enters the rotating blood processing chamber 352. The blood in the blood processing chamber 352 is separated into various blood components, and at least one of these blood components (for example, platelets, plasma, red blood cells) is continuously removed from the blood processing chamber 352. Blood components that are not retained for collection or therapeutic treatment (eg, red blood cells, white blood cells, plasma) are also removed from the blood processing chamber 352 and returned to the donor / patient 4 via the extracorporeal tubing 10.

  The operation of the blood component separation device 6 is preferably controlled by one or more processors included therein, and interfaces with ever increasing PC user functions (eg, CDROM, modem, audio, networking and other capabilities). It would be advantageous to have multiple embedded personal computers that adapt the face. In this regard, the blood component separation device 6 includes a graphic interface 660 to assist the operator of the component removal system 2 according to various aspects of its operation.

Disposable Set: Extracorporeal Tube Circuit As shown in FIGS. 2A-2B, the blood filling extracorporeal circuit 10 comprises a cassette assembly 110 and a number of tube assemblies 20, 50, 60, 80, 90, 100 interconnected therewith. ing. In general, blood removal / return tube assembly 20 includes a single needle interface between donor / patient 4 and cassette assembly 110, and blood inlet / blood component tube subassembly 60 is between cassette assembly 110 and blood processing chamber 352. With an interface in between. Anticoagulation tube assembly 50, platelet collection tube assembly 80, plasma collection tube assembly 90, and vent bag tube subassembly 100 are also interconnected with cassette assembly 110. The extracorporeal tube circuit 10 and the blood treatment chamber 352 are preferably interconnected to form a closed disposable part after a single use.

Blood removal / return tube assembly 20 includes a needle subassembly 30 interconnected with blood removal tube 22, blood return tube 24 and anticoagulation tube 26 via a conventional manifold 28. Needle subassembly 30 includes a needle 32 having a protective needle sleeve 34 and a needle cap 36, and an interconnecting tube 38 between needle 32 and manifold 28. Needle subassembly 30 further includes a D sleeve 40 and a tube clamp 42 positioned about interconnect tube 38. Blood removal tube 22 may also include a Y connector 44 interconnected with blood sampling subassembly 46.
The cassette assembly 110 includes molded plastic plates 112 and 114 (see FIGS. 4A, 4B, and 5) before and after defining a rectangular cassette member 115 that is heat welded and has integral fluid passages. Cassette assembly 110 further includes a number of outwardly extending tube loops interconnecting each integral passage. The integral passageway is also interconnected to each tube assembly.

  In particular, cassette assembly 110 includes a first integral anticoagulant passage 120a interconnected with anticoagulant tube 26 of blood removal / return tube assembly 20. Cassette assembly 110 further includes a second integrated anticoagulant passage 120b and a pump-engaged anticoagulant loop 122 between the first and second integrated anticoagulant passages 120a, 120b. The second integrated anticoagulant passage 120 b is interconnected with the anticoagulant tube assembly 50. Anticoagulation tube assembly 50 includes a spike drip chamber 52 that can be connected to an anticoagulation source, an anticoagulation supply tube 54 and a sterilization filter 56. In use, the anticoagulant tube assembly 50 supplies anticoagulant to the blood removed from the donor / patient 4 to reduce or prevent coagulation in the extracorporeal tube circuit 10.

  Cassette assembly 110 also includes a first integral blood inlet passage 130a that is interconnected with blood removal tube 22 of blood removal / return tube assembly 20. The cassette assembly 110 includes a second integrated blood passage 130b and a pump-engaged blood inlet tube loop 132 between the first and second integrated blood inlet passages 130a, 130b. The first integrated blood inlet passage 130 a includes a first pressure sensing module 134 and an inlet filter 136, and the second integrated blood inlet passage 130 b includes a second pressure sensing module 138. Second integrated blood inlet passage 130 b is interconnected with blood inlet tube 62 of blood inlet / blood component tube assembly 60.

  A blood inlet tube 62 is also interconnected with the inlet 392 of the blood processing chamber 352 and supplies whole blood for processing as described below. To return the separated blood component back to the cassette assembly 110, the blood inlet / blood component tube assembly 60 is red blood cell (RBC) / plasma interconnected with corresponding outlets 492 and 520, 456, 420 of the blood processing chamber 352. An outlet tube 64, a platelet outlet tube 66, and a plasma outlet tube 68 are further included. The RBC / plasma outlet tube 64 includes a Y connector 70 with interconnect tube spars 64a and 64b. Blood inlet tube 62, RBC / plasma outlet tube 64, plasma outlet tube 68 and platelet outlet tube 66 all pass through first and second strain relief members 72 and 74 and braided bearing member 76 therebetween. This advantageously enables the sealless interconnection disclosed in US Pat. No. 4,425,112. As shown, the multi-hole connector 78 can be used in various tube lines.

  The platelet outlet tube 66 of the blood input / blood component tube assembly 60 includes a cuvette 65 for use in the detection of red blood cells (via the joined RBC efflux detector provided with the blood component separation device 6) of the cassette assembly 110. Interconnects with the first integral platelet passage 140a. Instead, the transparent member is preferably integrated into the cassette assembly 110 in fluid connection with the first integral platelet passage 140a and joined to the RBC outflow detector.

  The cassette assembly 110 further includes a pump-engaged platelet tube loop 142 interconnecting the first integral platelet passage 140a and the second integral platelet passage 140b. The second integral platelet passage 140b includes first and second spars 144a and 144b, respectively. The first spar 144 a is interconnected with the platelet collection tube assembly 80.

Platelet collection tube assembly 80 can receive separated platelets during operation and includes a platelet collection tube 82 and a platelet collection bag 84 interconnected via a Y connector 86. A slide clamp 88 is provided on the platelet collection tube 82.
The second spar 144b of the second integral platelet passage 140b is interconnected with the platelet return tube loop 146 of the cassette assembly 110 to remove separated platelets (eg, upon detection of RBC outflow during platelet collection) donor / patient. Return to 4. For this purpose, the platelet return tube loop 146 is interconnected with the upper part of the blood return reservoir formed integrally by the pre- and post-molding plates 112, 114 of the cassette member 115. As further described, one or more of the uncollected blood components, collectively referred to as return blood, are periodically accumulated and removed from the reservoir 150 during use. The rear plate 114 of the cassette member 115 also includes an integral frame corner 116 that defines a window 118 through the corner of the cassette member 115. Frame angle 116 includes a keyhole recess for receiving and directing platelet collection tube 82 and platelet return tube loop 146 in a pre-defined distance relationship within window 118.

The plasma outlet tube 68 of the blood inlet / blood component tube assembly 60 interconnects with the first integral plasma passage 160 a of the cassette assembly 110. The cassette assembly 110 further includes a pump-engaged plasma tube loop 162 interconnecting the first integral plasma passage 160a and the second integral plasma passage 160b. The second integral plasma passage 160b includes first and second spars 164a and 164b. The first spar 164 a is interconnected to the plasma collection tube assembly 90.
The plasma collection tube assembly 90 can be used to collect plasma in use and includes a plasma collection tube 92 and a plasma collection bag 94. A slide clamp 96 is provided on the plasma collection tube 92.

  The second spar 164b of the second integral plasma passage 160b is interconnected to the plasma return tube loop 166 and returns plasma to the donor / patient 4. For this purpose, the plasma return tube loop 166 is interconnected to the top of the blood return reservoir 150 of the cassette assembly 110. In addition, the keyhole recess 119 in the frame 116 of the cassette assembly 110 is utilized to maintain the plasma collection tube 92 and the plasma return tube loop 166 at a predefined distance relationship within the window 118.

  The RBC / outlet tube 64 of the blood inlet / blood component tube assembly 60 is interconnected with the integral RBC / plasma passage 170 of the cassette assembly 110. The integrated RBC / plasma passage 170 includes first and second spars 170a and 170b, respectively. The first spar 170 a is interconnected with the RBC / plasma return tube loop 172 and returns the separated RBC / plasma to the donor / patient 4. For this purpose, the RBC / plasma return tube loop 172 is interconnected to the top of the blood return reservoir 150 of the cassette assembly 110. The second spar 170b may be closed as shown or connected to an RBC / plasma collection tube assembly (not shown) for collecting RBC / plasma in use. The RBC / plasma return tube loop 172 (and the RBC / plasma collection tube, if provided) is maintained in the desired orientation within the window 118 by the keyhole recess 119 in the frame 116.

  The vent bag tube assembly 100 is also interconnected to the top of the blood return reservoir 150 of the cassette assembly 110. The vent bag tube assembly 100 includes a vent tube 102 and a vent bag 104. In use, sterilized air present in the cassette assembly 110 and in particular in the blood return reservoir 150 is periodically transferred to the vent tube 102 and vent bag 104 as described below. Get out of.

  The ventilation bag 94 may be provided with a sterilization gas pressure relief valve at the upper end (not shown). Further, it should be noted that for the vent bag tube assembly 100, additional integral passageways, integral chambers and tube loops can be included in the cassette assembly 110 to perform the same functions as the vent bag tube assembly 100.

  Platelet return tube loop 146, plasma return tube loop 166, and RBC / plasma return tube loop 172 are interconnected in a row at the top of blood return reservoir 150 directly adjacent to their forwardly projecting sidewall 152. Blood components flow under the inner wall of the blood return reservoir 150. Blood return reservoir 150 includes an enlarged, forwardly projecting central portion 154, a reduced upper portion 156, and a reduced lower portion 158 (see also FIG. 5). A filter 180 is disposed at the lower cylindrical outlet 182 of the blood return reservoir 150.

  The first integrated blood return passage 190a is interconnected to the outlet 182 of the blood return reservoir 150 and further interconnected to the second integrated blood return passage 190b via a pump-engaged blood return tube 192. The second integrated blood return passage 190 b is interconnected with the blood return tube 24 of the blood removal / return tube assembly 20 and returns blood to the donor / patient 4 via the needle assembly 30.

  As shown in FIGS. 2A-2B, pump-engaged tube loops 122, 132, 142, 162 and 192 extend from cassette member 115, creating an asymmetrical arrangement, so that the blood component separation device 6 can be inserted into the cassette for use. Facilitates proper attachment of the assembly 110. In this regard, to further facilitate mounting of the cassette assembly 110, the rear plate 114 of the cassette member 115 is shaped to show a shallow dished back with a rim extending around the entire perimeter of the window 118, and the end of the rim. The portion is substantially coplanar with the back of the upper, middle and lower portions 154, 156, 158 of the reservoir 150, and may define a recess through which the first and second pressure sensing modules 134 and 138 protrude. preferable.

The tube assemblies 20, 50, 60, 80, 90 and 100 and the cassette assembly 110 preferably comprise PVC tubes and plastic elements that allow the blood / blood components therein to be visually observed and monitored during use. . In addition, thin-walled PVC tubes (eg, less than about 0.023 inches) have been proven sterile docked for platelet collection tubes 82 and plasma collection tubes 92 and RBC / plasma tubes, if supplied (ie, 2 It is advantageous to use it for direct coupling of book tubes. Thick wall PVC tubing (e.g., 0.037 inches or greater) is preferably utilized for pump-engaged tubing loops 132, 142, 162, and 192.
Pump / Valve / Sensor Assembly As described above, the cassette assembly 110 is installed and operated in conjunction with the pump / valve / sensor assembly 1000 of the blood component separation device 6 in use. The pump / valve / sensor assembly 1000 is at an angle of approximately 45 ° upward (see FIG. 1) and includes a cassette mounting plate 1010 as shown in FIG. Including a number of peristaltic pump assemblies, flow diverter valve assemblies, pressure sensors and ultrasonic level sensors interconnected to the faceplate of blood collection device 6 for pumping, controlling and monitoring the flow of water.

  More particularly, anticoagulant pump assembly 1020 receives anticoagulant tube loop 122, blood inlet pump assembly 1030 receives blood inlet tube loop 132, platelet pump assembly 1040 receives platelet tube loop 142, and plasma pump assembly 1060. To receive a blood return tube loop 192 and a blood return pump assembly 1090 to receive a blood return tube loop 192. Each peristaltic pump assembly 1020, 1030, 1040, 1060 and 1090 includes rotors 1022, 1032, 1042, 1062 and 1092 and includes tracks 1024, 1034, 1044, 1064 and 1094 with corresponding tubes therebetween. A loop is positioned to control the passage and flow rate of the corresponding fluid.

  The platelet shunt valve assembly receives the platelet collection tube 82 and the platelet return tube loop 146, the plasma shunt valve assembly 1110 receives the plasma collection tube 92 and the plasma return tube loop 166, and the RBC / plasma shunt assembly 1120 receives the RBC / plasma return tube. 172 and, if supplied, are equipped to receive RBC / plasma collection tubes. As described above, each pair of tubes for collection and return of separated blood components is disposed in a pre-defined distance relationship within the window 118 of the cassette assembly 110 to thereby provide a corresponding diversion valve assembly. Promote installation. As described below, the platelet diverter valve assembly 1100, plasma diverter valve assembly 1110, and RBC / plasma diverter valve assembly 1120 are each closed to divert fluid flow through one of the corresponding pair of tubes. Rotating closure members 1400a, 1400b and 1400c are selectively positionable between walls 1104 and 1106, 1114 and 1116, and 1124 and 1126.

  Pressure sensors 1200 and 1260 (see also FIGS. 4A and 4B) are provided in the pump / valve / sensor assembly 1000 and the first and second of the cassette assembly 110 through the openings 1120 and 1140 of the cassette mounting plate 1100. Engage the pressure sensing modules 134 and 138 effectively. Similarly, ultrasonic level sensors 1300 and 1320 (see also FIG. 5) are provided to effectively engage the blood return reservoir 150 cassette assembly 110 through openings 1160 and 1180 in the cassette mounting plate 1100.

  As shown in FIGS. 4A and 4B, the first and second pressure sensing modules 134, 138 of the cassette assembly 110 are respectively positioned on a raised cylindrical sheet 134b, 138b formed on the rear plate of the cassette assembly 110. Along with the circular diaphragms 134a, 138a, annular plastic diaphragm retainers 134c, 138c are welded to the raised cylindrical sheets 134b, 138b to obtain a seal therebetween. With this arrangement, the diaphragms 134a, 138b react directly to the fluid pressure in the first and second integrated blood inlet passages 130a, 130b, respectively, and the pressure sensors 1200, 1260 cause the on-ring retainers 134c, 138c to move. The diaphragms 134a and 138a can be directly accessed. By monitoring the diaphragms 134a, 138a, the pressure sensors 1200, 1260 can monitor the fluid pressure in the first and second integrated blood inlet passages 130a, 130b. In this regard, the first integrated blood inlet passage 130a is in direct fluid communication with the blood removal tube 22, and the blood removal tube 22 and blood return tube 24 are fluidly interconnected via a common manifold 28, so that the first One pressure sensing module 134 is responsive to a common pressure in both the blood removal tube 22 and the blood return tube 24 during operation, and the first pressure sensor 1200 actually senses this common pressure. Should be noted.

  Further with respect to the first pressure sensing module 134 and the first pressure sensor 1200, FIG. 4A shows an air coupling arrangement that allows sensing of positive and negative pressure (ie, outward and inward of the diaphragm 134a). Cause deflection). To achieve an air seal between the first pressure sensor 1200 and the first pressure sensing module 134, the sensor 1202 includes an elastic (eg, rubber) conical fitting member 1202. Fitting member 1202 is attached to an air channel member 1204 having a nipple end that is received by a sloped cylindrical extension 134d of retainer 134c. The air channel member 1204 further includes an outer annular projection channel portion 1208 that includes an O-ring 1210 for shield sliding fit of the air channel member 1204 within the housing 1212. As shown in the figure, the housing 1212 includes an ear that joins a floating positioning member 1216 fixed to the face plate 6 a of the blood component separation device 6. As can be seen, this interface is provided with a slight clearance to allow slight lateral movement of the engagement member 1202 and the air channel member when the cassette assembly 110 is installed. The screw end of the housing 1212 extends through the face plate 6a of the blood component separator 6 and receives the nut 1220 while leaving a slight clearance between the nut 1220 and the face plate 6a. A spring 1222 is positioned within the housing 1212 and acts against the annular channel portion 1208 of the air channel member to provide a spring mounting interface between the first pressure sensor 1200 and the first pressure sensing module 134. A pressure sensing transducer 1224 engages the air channel member 1204 and senses positive and negative pressure changes within the sensing module and provides an output signal accordingly in use. As described below, the output signal of pressure transducer 1224 can be used to control the operation of blood input pump 1030 and blood return pump 1090 during operation.

  With respect to the second pressure sensing module 138 and the second pressure sensor 1260, FIG. 4B illustrates a direct contact coupling method that allows sensing positive pressure changes (ie, causing outward deflection of the diaphragm 138a). Such contact coupling facilitates mounting because the exact position of diaphragm 138a relative to second pressure sensor 1260 is not critical. As can be seen, the second pressure sensor 1260 includes a protruding end received by the ring retainer 138c of the sensing module 138 and directly contacts the diaphragm 138a. A pressure transducer 1264 is attached to the face plate 6a of the blood component separation device 6 via a ring 1266 that threadably engages a portion of the pressure transducer 1264 that extends through the face plate 6a. Pressure transducer 1264 provides an output signal that is responsive to positive pressure changes acting on diaphragm 138a.

  As shown in FIG. 5, when cassette assembly 110 is attached to pump / valve / sensor assembly 1000, ultrasonic level sensors 1300 and 1320 are positioned to monitor fluid levels in blood return reservoir 150. More specifically, the upper ultrasonic level sensor is positioned in contact with the reduced upper portion 156 of the blood return reservoir 150 and the lower ultrasonic level sensor 1320 is positioned in contact with the decreased lower portion 158 of the blood return reservoir 150.

  The ultrasonic sensors 1300, 1320 each have a pulse / contact with a contact surface (eg, urethane) 1304, 1324 that facilitates a shunt dry bond (ie, without a gel or other similar binding medium) to the blood return reservoir 150. Echo transducers 1302 and 1322 are provided. For example, the ultrasonic sensor may comprise a model Z-11405 transducer manufactured by Zevex (5175 Grepine Drive, Salt Lake City, Utah). Pulse / echo transducers 1302 and 1322 are disposed within the housing for interconnection with the faceplate of blood component separation device 6. The housings 1306, 1326 include flanges 1308, 1328 for engaging the front surface of the face plate 6a, and further include threaded ends 1308 extending through the face plate 6a to receive corresponding retaining nuts 1310, 1330. A slight clearance is provided between the flanges 1308 and 1328 and the face plate 6a. Springs 1312 and 1332 are positioned in housings 1306 and 1326 and act on corresponding pulse / echo transducers 1302 and 1332 via E-clips 1314 and 1334 disposed therebetween. Such spring mounting of the pulse / echo transducer provides a predetermined desired mounting pressure (eg, at least about 2.3 Kg) of the pulse / echo transducer 1302, 1332 to the reservoir 150 during operation. O-rings 1316, 1336 are provided intermediate the pulse / echo transducers 1302, 1322 and housings 1306, 1326 to provide a sliding seal therebetween. Cables 1318 and 1388 are interconnected to transducers 1302 and 1322 to provide a pulse signal and a return detection echo signal.

  By assessing the presence and timing of return ultrasound echo pulses, each of sensors 1300 and 1320 can be used to monitor the presence or absence of fluid in their corresponding echo section in blood return reservoir 150. Accordingly, it is possible to supply a pump control signal to the blood component separation device 6. More specifically, when the return blood accumulates up to the echo portion of the high level sensor 1300 during blood processing, the ultrasonic pulse emitted by the high level sensor 1300 easily passes through the return blood, and the outer side wall / An echo pulse reverberating from the air interface and having a predefined minimum intensity detected by the upper sensor 1300 within a predefined time after transmission is obtained. Upon receiving such an echo pulse, the upper sensor 1300 provides a signal for use by the blood component separation device 6 to remove accumulated return blood from the blood return reservoir 150 and move it to the donor / patient 4. Thus, the operation of the blood return pump 1090 is started.

  When the blood return pump 1090 removes the return blood from the reservoir 150 to the lower echo section, the ultrasonic pulse emitted by the low level sensor 1320 does not reverberate at the outer sidewall / air interface of the opposite reservoir, and is transmitted in advance after transmission. An echo pulse having a predefined minimum intensity detected by the low level sensor 1320 within a defined time is obtained. When this occurs, the low level sensor 1320 cannot supply a signal corresponding to the blood component separator 6, which automatically stops the blood return pump and returns blood from the blood return reservoir 150. Subsequent removal stops and the returned blood begins to accumulate in the reservoir 150 again. Therefore, in the blood processing mode, the blood component separation device 6 does not start the operation of the blood return pump 1090 unless it receives a signal from the upper ultrasonic sensor 1300 (until the signal is specified). Indicates the presence of return blood in the upper echo portion), and thereafter, if no signal is received from the ultrasonic sensor 1320, the operation of the blood return pump is automatically stopped. The absence of return blood in the department).

  In the first blood filling mode, reverse operation of blood return pump 1090 introduces whole blood from donor / patient 4 to reservoir 150 via blood return tube 24, integrated passages 190a, 190b, and tube loop 192. . When such whole blood accumulates even in the echo portion of the low level sensor 1320, the ultrasonic pulse emitted by the low level sensor 1320 passes through the blood, echoes from the outer sidewall / air interface of the opposing reservoir, and is transmitted. This produces an echo pulse having a predefined minimum intensity that is detected by the low level sensor 1320 within a later predefined time. When such an echo pulse is received in the blood filling mode, the low level sensor 1320 provides a signal used by the blood component separation device 6, stops the blood return pump 1090, and ends the blood filling mode. Next, the blood component separation device 6 starts the blood processing mode.

  Ultrasonic sensors 1300, 1320 can also be utilized to indicate and / or verify the desired mounting relationship of the cassette member 15 on the cassette mounting plate 1010 for blood processing operations. For this purpose, if the desired attachment has been achieved, the inner surface of the back side wall of the reservoir 150 (ie, the side wall with which the sensors 1300, 1320 contact) and the air contained in the reservoir 150 Sensors 1300, 1320 should be coupled to reservoir 150 and receive with a predefined minimum intensity within a predefined time after transmission so that the ultrasonic pulse will echo between the interfaces. If such echo pulses are received for both ultrasonic sensors 1300, 1320, the desired mounting relationship will be indicated and / or confirmed. Furthermore, the ultrasonic sensors 1300 and 1320 are used to detect echo pulses from the interface between the fluid contained in the reservoir 150 and the inner surface of the outer sidewall of the reservoir 150 in the upper and lower echo portions of the reservoir during operation. can do. If such an echo pulse can be detected within the corresponding predefined time window, the corresponding signal supplied by the ultrasonic sensors 1300, 1320 provides the input for the blood component separation device 6, The operation of blood return pump 1090 can be controlled.

  In the arrangement shown in the figure, the upper and lower ultrasonic sensors 1300 and 1320 are advantageously operated in combination with the reduced lower cross-sections 156 and 158 of the reservoir 150. The reduced upper and lower reservoir portions 154, 158 provide reliable detection of echo pulses when fluid is present in the upper and lower echo portions, and the expanded central portion 158 provides sufficient blood retention capability.

  FIG. 6 shows the respective components of the platelet diversion valve subassembly 1100, the plasma diversion valve subassembly 1100 and the RBC / plasma diversion valve subassembly 1120. Each subassembly includes a rotating closure member 1400 having a headed shaft member 1402 and a barrel sleeve 1404 that are respectively positioned and rotatable relative to each other. The subassembly further includes a main valve shaft 1406 positioned within a valve body 1408 that is secured to the face plate 6 a of the blood component separation device 6. An O-ring 1410 is provided in the recess of the main valve shaft 1406, and a sliding seal is obtained between the main valve shaft 1406 and the extended portion 1412 of the main valve body 1408. The main valve shaft 1406 is driven by a motor 1414 attached to a mount plate 1416 that is attached to and detached from the face plate 6a by an isolated leg 1418.

  Each diversion to position a rotating closure member 1400 for closure relative to one of the co-acting walls in the blood component separation device 6 (eg, 1104 or 1106 of the plasma diverter valve subassembly 1100) or for detachment of the cassette assembly 110 The valve subassembly includes three optical all-beam sensors 1420 (two shown) that are interconnected to the isolated legs 1418 via a support layer 1419, and an optical flap member 1422 that is interconnected to the main valve shaft 1406. It has. Each full beam sensor 1420 has a U-shaped configuration having a radiation source and a radiation receiver disposed on opposite legs. The optical overlap member 1422 has a reverse cap configuration with a rotatable side wall inserted between opposing legs of the sensor 1420. Optical overlap member 1422 includes a single window 1424 therethrough. As mentioned above, the position of the rotating closure member 1400 relative to the window 1424 of the optical overlap 1422 is well known, and the optical window 1424 passes between the opposing radiation source / receiver for a given optical sensor 1420. Then, the optical sensor 1420 supplies a signal according to the entire beam (indicating the position of the rotary closing member 1400), and uses this signal to control the operation of the motor 1414, thereby placing the rotary closing member 1400 at a desired position. To come. In order to generate and output such a signal, the support layer 1419 advantageously comprises a printed circuit board. The optical sensor 1420 is slightly “upstream” of a predetermined stop portion for closure or cassette mounting so that the motor 1414 can dynamically decelerate and position the rotary closure member 1400 within the desired portion. It is preferably positioned. However, to ensure the desired positioning of the closure, the main valve shaft 1406 includes a stopper 1426 and cooperates with a cross pin 1428 interconnected to the main valve shaft 1406 to stop the rotary closure member 1400 against the desired closure wall. Secure.

  Each of the closure walls 1104 and 1106, 1114 and 1116, and 1124 and 1126 are provided with arcuate reliefs (not shown) for receiving the rotatable barrels of the rotary closure members 1400a, 1400b and 1400c. . For example, such an arcuate relief has an arc distance of 20 ° and can provide tolerance for positioning the rotary closure members 1400a, 1400b, 1400c to achieve the desired tube closure. As shown in FIG. 3, the closure wall 1106 is provided with an elastic pad to optimize the use of a proven sterile docking tube for the platelet collection tube 82. Furthermore, as described above, the sterile docking tube can be advantageously used in the plasma collection tube 92 and, if supplied, the RBC / plasma collection tube (not shown), with a corresponding elastic pad (not shown). ) May be provided on the closing walls 1114 and 1124. In this regard, if the sterile docking tube is thin and has a relatively high spring rate, the use of an elastic pad coupled thereto increases the durability of the sterile docking tube.

  To establish an initial predefined set position of the cassette assembly 110 relative to the pump / valve / sensor assembly 1000, the cassette assembly 110 includes a downwardly extending angular positioning tab 15 and a lower channel protrusion 1102a in the cassette mounting plate 1010. And upper and lower end lips 17 that engage upper channel protrusions 1102b in pivotable spring mounted interlocking member 1104 that extends over the upper end of cassette mounting plate 1010. The interlocking member 1104 is spring mounted and is mounted via a spring positioned in the housing 1106 and at the same time positively engages the cassette assembly 110 and is a tab for revolving motion when the cassette is mounted against the spring mounting pressure. 1108 is provided. The interlocking member 1104 is positioned relative to the track 1094 of the return pump assembly 1090 and physically restricts the interlocking member 1104 from turning once the cassette assembly 110 is fully installed in the blood component separation device 6 for operation. This advantageously limits the removal and / or movement of the cassette assembly 110 during use.

  When the cassette assembly 110 is secured to the cassette mounting plate 1010, the mounting assembly 1500 retracts the cassette mounting plate 1010 toward the face plate 6a of the blood component separation device 6 and includes the fully mounted pump, valve and sensor described above. Establish a relationship. As shown in FIG. 7, mounting assembly 1500 includes two posts to which cassette mounting plate 1010 is supportably interconnected. The post 1502 extends through the face plate 6a of the blood collection device 6a and is interconnected to the cross-connecting member 1504. A drive nut 1506 is secured to the cross-connect member 1504 and engages the drive screw 1508. The drive screw 1508 is then rotatably interconnected to the drive motor via a coupling 1512, and the drive motor 1510 is attached to a platform 1514 that is supportably interconnected to the faceplate 6a via an isolated leg 1516. The drive motor 1510 rotates the drive screw 1508 so that the cross-connecting member 1504 and post 1502 selectively move the cassette mounting plate 1010 in a curved manner toward the face plate 6a during the mounting procedure and for removal of the cassette assembly 110. Are separated from the face plate 6a.

  To establish the desired position of the cassette mounting plate 1010, U-shaped optical all-beam assembly sensors 1520a and 1520b are attached to the post-bearing holder 1522 and the optical closure member 1524 having a window 1526 is interconnected to the cross-connect member 1504. To do. U-shaped optical sensors 1520a, 1520b each include a radiation source and a radiation receiver positioned on opposing extending legs, and optical closure member 1524 extends between the legs. The relative position between the cassette mounting plate 1010 and the optical sensors 1520a, 1520b is determined by detecting a path of radiation through the window 1526 using the optical sensor 1520 and providing a reactive signal thereto. As is well known, the position of the cassette mounting plate 1010 for loading and unloading can be automatically established. For example, when a full beam is received by the optical sensor 1520b, a signal is provided to stop the motor 1510 at a position where the cassette assembly 110 is fully attached to the pump / valve / sensor assembly for operation.

  In order to confirm such a mounting state, the first and second pressure sensors 1200 and 1260 and the upper and lower ultrasonic sensors 1300 and 1320 can be used. For example, a predefined minimum pressure value can be established and an actual value can be measured for each of the first and second pressure sensors 1200 and 1260 to confirm the desired mounting of the cassette assembly 110. Furthermore, it is particularly advantageous that the ultrasonic sensor 1300 is coupled to the reservoir 150 at the same time as described above, as described above, because echo pulses reverberate from the inner wall / air interface with a predetermined minimum strength within a predetermined time. And 1320 can advantageously be used to confirm the desired mounting.

The drive motor 1510 includes a number of reduction gears, and the final gear effectively couples with the slip clutch plate to provide the maximum amount of force applied by the cassette mounting plate 1010 (e.g., between the cassette mounting plate 1010 and the face plate 6a). It is preferable to limit (to the subject). In this regard, during the mounting cycle, the window 1526 of the optical closure member 1524 is moved from the position in the first optical path through the sensor 1520a to the second optical path through the sensor 1520b within a predetermined time. When the position is not moved, it is preferable that the drive motor 1510 includes a control function for automatically stopping or reversing the operation.
To summarize the mounting process, first the cassette mounting plate 1010 is placed in the extended position by the mounting assembly 1500. The cassette mounting plate 1010 in such an extended position is rotated away from the interlocking member 1104 cassette mounting plate 1010, the cassette assembly 110 is positioned on the cassette mounting plate 1010, and the lower end lip 17 of the cassette assembly 110 is moved to the cassette mounting plate 1010. The upper end lip 17 of the cassette assembly 110 is engaged by the upper channel protrusion 1102 b of the interlocking member 1104 simultaneously with the return rotation of the interlocking member 1104 received by the lower channel protrusion 1102 a. The mounting assembly 1500 is then actuated to retract the cassette mounting plate 1010 from its expanded position to its retracted position, and the tube loops 122, 132, 162, 142, 192 of the cassette assembly 110 are associated with the peristaltic pump assemblies 1020, 1030, 1060. Automatically positioned within 1040 and 1090. For this purpose, the respective rotor of the peristaltic pump assembly is also actuated to achieve a position where the corresponding tube loop is mounted. Further, for mounting purposes, the rotary closure members 1400a, 1400b and 1400c of the diverter valve assemblies 1100, 1110 and 1120 are each positioned in an intermediate position, and a corresponding series of tubes permit positioning on each side thereof.

  Simultaneously with retraction of the cassette mounting plate 1010, spring mounted ultrasonic sensors 1300 and 1320 are automatically coupled to the reservoir 150, and the first and second pressure sensors 1200 and 1260 are the first and second of the cassette assembly 110. Automatically couples to pressure sensing modules 134 and 138. In this fully loaded retracted position, the cassette assembly 110 is limited to pivoting movement of the interlocking member 1104 supplied by the trajectory 1094 of the return pump assembly 1090 from movement or removal due to the physical limitations described above.

  Further, when the cassette assembly 110 is mounted on the blood component separation device 6, the cuvette 65 provided on the face plate 6a is positioned in the RBC outflow detector 1600 (for example, the presence of red blood cells in the separated platelet fluid flow). And an optical sensor for supplying a corresponding signal). Similarly, a portion of the anticoagulant tube is positioned in an AC sensor 1700 (an ultrasonic sensor for confirming the presence of an anticoagulant and supplying a signal in the absence thereof) also provided on the face plate 6a. The

To remove cassette assembly 110 after use, each shunt valve assembly closing member 1400a, 1400b and 1400c is further positioned in an intermediate position between the corresponding closing walls, mounting assembly 1500 is actuated, and cassette mounting plate 1010 is moved to its position. Move from the retracted position to its extended position. At the same time, the rotors of the various peristaltic pump assemblies are activated so that the corresponding tube loops escape. In the extended position, the interlocking member 1104 pivots out of engagement with the cassette assembly 110 and removes and discards the cassette assembly 110.
Extracorporeal Tube Circuit and Pump / Valve / Sensor Assembly Operation During the initial blood filling mode of operation, the blood return pump 1090 is operated in reverse to remove the blood removal / return tube assembly 20, the integrated blood return passage 190, the blood return tube loop. The whole blood is moved 150 through 192. At the same time and / or prior to reverse operation of blood return pump 1090, anticoagulant peristaltic pump 1020 is operated and blood removal tube 22 and blood are removed from anticoagulation tube assembly 50 via manifold 28 via anticoagulation integral passageway 120. The return tube 24 is filled with an anticoagulant and supplied otherwise. When the low level ultrasonic sensor 1320 senses the presence of whole blood in the reservoir 150, a signal is provided and the blood component separation device 6 stops the blood return peristaltic pump 1090. As described below, during blood filling mode, blood inlet pump 1030 is also operated to move blood through blood inlet tube loop 132 to integrated blood inlet passage 130 and blood inlet / blood component tube assembly 60 for blood processing. Chamber 352 is filled.

  During the blood filling mode, the vent bag 100 receives air from the reservoir 150. In this regard, the closure members 1400 a, 1400 b, 1400 c of the diversion assemblies 1100, 1110, 1120 are each preferably positioned and divert flow to the reservoir 150. To facilitate blood filling, the cassette assembly 110 is angled approximately 45 ° upward in its loading position, and the integral chamber passageway of the cassette member 115 provides a plug flow with the whole blood and blood component inlet path from the bottom to the top. To do.

  In the blood processing mode, blood inlet peristaltic pump 1030, platelet peristaltic pump 1040 and plasma peristaltic pump 1060 are continuously operated, and closure members 1400a, 1400b, 1400c are used to collect or return the desired corresponding blood component. Positioned. During the blood removal submode, the blood return peristaltic pump 1090 is not operated, so that whole blood moves to the blood removal / return tube assembly 20 and the process chamber 352 via the cassette assembly 110 and the blood inlet / blood component tube assembly 60. Move to. In the blood removal submode, uncollected blood components move from the processing chamber 352 to the cassette assembly 110, and uncollected components are stored in a reservoir up to a predetermined level at which the upper level ultrasonic sensor provides a signal to be used by the blood component separation device 6. Move to 150 and accumulate. This signal terminates the blood removal submode and starts the blood return submode. More specifically, the blood return submode is initiated by forward operation of blood return peristaltic pump 1090. In this regard, in the blood return submode, the volume transfer rate of the returned blood through the blood return pipe loop using the blood return peristaltic pump 1090 is determined by the blood inlet pipe loop 132 using the blood inlet peristaltic pump 1030 according to a predetermined protocol. It is established by the blood component separation device 6 that it is larger than the volume transfer rate via Thus, the blood accumulated in the reservoir 150 moves to the blood return tube of the blood removal / return tube assembly 20 and returns to the donor / patient 4. In the blood processing mode, when the return blood accumulated in the reservoir 150 is removed below a predetermined level, no signal is supplied to the blood component separation device 6 by the low level ultrasonic sensor 1320 and at the same time, the blood component separation device 6 Automatically stops the blood return peristaltic pump 1090 and ends the blood return submode. Accordingly, since the blood inlet peristaltic pump 1030 is continuously operated, the blood removal sub-mode is automatically restarted.

  During the blood processing mode, the pressure sensor 1200 senses a change in negative / positive pressure in the blood removal tube 22 and the blood return tube 26 via the first integrated blood passage 130a. The pressure change monitored in this way is communicated to the blood component separation device 6, and then controls the blood inlet pump 1030 and return pump 1090 to maintain fluid pressure within a predetermined range during blood removal and blood return submodes. . Particularly in the blood removal sub-mode, when a negative pressure exceeding (that is, less than) a predetermined negative limit value is sensed, the blood component separation device 6 performs until the sensed negative pressure returns to within an allowable range. The operation of blood inlet pump 1030 is slowed down. When a positive pressure exceeding (ie, exceeding) a predetermined positive limit value is sensed during the blood return sub-mode, the blood component separation device 6 causes the blood return pump 1090 until the detected positive pressure returns to an allowable range. Reduce the speed of operation.

  The pressure sensor 1260 monitors the positive pressure in the second integrated blood inlet passage 130 b and the blood inlet tube 62. If the positive pressure thus sensed exceeds a predetermined maximum value, the blood component separation device 6 starts an appropriate reaction operation, including, for example, slowing down or stopping the centrifuge and the peristaltic pump. .

  During the blood processing mode, the blood component separation device 6 operates the anticoagulant pump 1020 that is responsive to a signal provided by a pre-defined protocol and supplied by an AC sensor 1700 (eg, indicating a degraded anticoagulation source). Control. The blood component separation device 6 also controls the operation of the shunt assemblies 1100, 1110, 1120 further according to the predetermined indication and the signal supplied by the RBC outflow detector 1600. Regarding the latter, when RBC outflow is detected in the separated platelet flow, the blood component separation device 6 diverts the separated platelet flow from the closing member 1400a to the return reservoir 150 until the RBC outflow is cleared. This prevents unwanted movement of red blood cells to the platelet collection tube assembly 80.

  In normal operation, whole blood passes through needle assembly 30, blood removal tube 22, cassette assembly 110 and blood inlet tube 62 to process chamber 352. As will be described in more detail, the whole blood is then separated in the processing chamber 352. Platelet flow travels from the processing chamber port 420, passes through the platelet tube 66, returns through the cassette assembly 110, and is collected at the collection assembly 80 or diverted to the reservoir 150. Similarly, the separated plasma exits processing chamber 352 via port 456 and returns from plasma tube 68 to cassette assembly 110 and is collected at platelet tube assembly 90 or diverted to reservoir 150. In addition, red blood cells and plasma (or white blood cells) pass through ports 492 and 520 of processing chamber 352 via RBC / plasma tube 64 and travel to reservoir 150 via cassette assembly 110. In this regard, the second spar 170b of the integral passage 170 can be connected to a separate RBC / plasma collector tube assembly (not shown), and the RBC / plasma diverter valve assembly 1120 can be operated for RBC / plasma collection. It can also be considered.

  As described above, when platelets, plasma, and RBC / plasma (or white blood cells) that have not been collected accumulate in the reservoir 150 up to the upper ultrasonic level sensor 1300, the operation of the return peristaltic pump 1090 is started and Are removed and returned to the donor / patient 4 via the return tube 24 and the needle assembly 20. When the fluid level at the reservoir 150 drops below the level of the lower ultrasonic level sensor 1320, the return peristaltic pump 1090 automatically stops and restarts the blood removal submode. The cycle of blood removal submode and blood return submode then continues until a pre-defined amount of platelets or other collected blood components is obtained.

  In one embodiment, the reservoir 150 and the upper and lower ultrasonic sensors 1300 and 1320 are configured so that approximately 50 ml of returned blood is removed from the reservoir 150 during each return submode and during each blood removal submode during the blood treatment mode. Provided to be accumulated. In this regard, in such an embodiment, the upper and lower levels attracted by the ultrasonic sensor 1300 reserve 1320 occur in the reservoir 150 at fluid volumes of about 15 ml and 65 ml, respectively. For such an embodiment, a volume transfer rate range of about 30 to 300 ml / min via a blood return tube loop 192 utilizing a return pump 1090 and a blood input tube loop 132 utilizing an input pump 1030. It may also be desirable to provide a volume transfer rate range of about 20 to 140 ml / min. Also, for such an embodiment, depending on the pressure sensed in the first pressure sensing module 134, a negative pressure limit of about -250 mmHg and a positive pressure limit of about 350 mmHg may result in an input pump 1030 and a return pump 1090. It is considered appropriate to control the speed of each. A positive pressure limit of about 1350 mmHg in the second sensing module 138 is considered adequate to induce slowdown or shutdown of the centrifuge and pump.

Channel Housing Channel assembly 200 is shown in FIGS. 8-23B and includes a channel housing 204 disposed in a rotary centrifuge rotor assembly 568 (FIGS. 1 and 24) to receive a disposable blood processing chamber. Referring to FIGS. 8-15 in more detail, the channel housing 204 has a diameter of preferably about 250 mm or less in order to obtain the desired size for the blood component separation device 6 (eg, to increase its portability). It has a cylindrical perimeter 206. Opening 328 extends longitudinally through channel housing 204 and includes a shaft 324 about which channel housing 204 rotates. The channel housing 204 can be formed of a material such as delrin, polycarbonate, or cast aluminum, and can be weighted and / or rotationally balanced with various cutouts or additives.
The primary function of the channel housing 204 is to provide an attachment for the blood treatment chamber 352 so that blood can be separated into various blood components in a desirable manner. In this regard, the channel housing 204 includes a generally concave channel 208 in which the blood treatment chamber 352 is positioned. The channel 208 is defined by an inner channel wall 212, an outer channel wall 216 that is radially spaced from the inner channel wall 212, and a channel base 220 positioned therebetween. The channel 208 also overlaps the first end 284 such that a continuous flow path is obtained around the rotational axis 324 from the first end 284 in a generally curvilinear manner around the rotational axis 324 of the channel housing 204. Extends to the end 288 of. That is, the angular arrangement between the first end 284 of the channel 208 and the second end 288 of the channel 208 is between 360 ° and up to about 390 °, and in the illustrated embodiment is about 380 °. Referring to FIG. 15, this angular arrangement includes a first reference trajectory 336 extending from the rotation axis 324 to the first end 284 and a second reference axis 336 extending from the rotation axis 324 to the second end 288 of the channel 208. Along the constant radius arc between the reference trajectory 340 and the angle β.

  Blood processing channel chamber 352 is disposed within channel 208. In general, blood is supplied to the blood processing chamber 352 when the channel housing 204 is rotated by the channel 208 and separated into various blood components by centrifugation, and various blood components are removed from the blood processing chamber 352 when the channel housing 204 is rotated. It is preferable. For example, channel 208 is configured to allow the use of a high packing factor (eg, a value that reflects how “tightly packed” red blood cells and other blood components are during centrifugation, More details). In addition, the channel 208 also desirably interacts with the blood processing chamber 352 during centrifugation (eg, by holding the blood processing chamber 352 in the channel 208 and maintaining the desired shape of the blood processing chamber 352). The channel 208 also allows blood filling of the blood treatment chamber 352 (ie, by using blood as the first fluid supplied to the blood treatment chamber 352 in the component removal procedure).

  The above characteristics of the channel 208 are obtained mainly by its configuration. In this regard, the channel housing 204 includes a blood inlet slot 224 that is generally concave and substantially perpendicular to the channel 208 at its inner channel wall 212 (eg, the blood inlet slot 224 joins the inner channel wall 212). . Blood inlet assembly 388 is positioned in this blood inlet slot 224 so that blood from donor / patient 4 is supplied to blood processing chamber 352 when in channel 208. By maintaining a substantially continuous surface along the inner channel wall 212 during the component removal procedure and reducing the possibility of the blood inlet assembly 388 deflecting radially inward within the blood inlet slot 224, blood processing For the chamber 352 to pressurize, a recess 228 is disposed in the inner wall 212, which includes a blood inlet slot 224 (eg, FIG. 14A). This recess 228 receives a shield 408 disposed around the blood inlet assembly 388 on the outer surface of the blood processing chamber 352, as will be described in more detail below.

  As shown in FIGS. 8-9, the RBC dam 232 of the channel 208 is positioned in a clockwise direction from the blood inlet slot 224, and its function is to cause other large cells such as RBC and WBC to rotate clockwise beyond the RBC dam 232. It is to prevent it from flowing in the direction. In general, the surface of the RBC dam 232 that interfaces with the fluid containing the volume of the blood processing chamber 352 can be defined as a substantially planar or end adjacent to the collection wall 236. At least in the portion of the channel 208 between the blood inlet 224 and the RBC dam 232, from the radially outermost layer to the radially innermost layer, red blood cells (RBC), white blood cells (WBC), platelets, and plasma The blood is separated into a plurality of layers of various blood components including Most of the separated RBCs are removed from the channel 208 via the RBC outlet assembly 516 located in the RBC outlet assembly coupled to the channel 208, but at least some of the RBCs are connected to the control port coupled to the channel 208. It can be removed from the channel 208 via a control port assembly 488 disposed in the slot 264.

  RBC outlet slot 272 is disposed in a counterclockwise direction from blood inlet slot 224 and includes a blood inlet slot 224 that is substantially concave and intersects channel 208 at its inner channel wall 212 in a substantially vertical configuration (eg, , RBC outlet slot 272 joins with inner channel wall 212). The RBC outlet assembly 516 to the inside of the blood treatment chamber 352 is such that the RBC separated from the component removal procedure is continuously removed from the blood treatment chamber 352 when in the channel 208 (eg, during rotation of the channel housing 204). In the RBC outlet slot 272. Blood processing by maintaining a substantially continuous surface along the inner channel wall 212 during the component removal procedure and reducing the possibility of the RBC outlet assembly 516 deflecting radially inward within the RBC outlet slot 272 In order for the chamber 352 to pressurize, a relief 276 is disposed in the inner wall 212, which includes the end of the RBC outlet slot 272 (eg, FIGS. 14A, 14B). The recess 276 receives a shield 538 disposed around the RBC outlet assembly 516 on the outer surface of the blood processing chamber 352 as described in more detail below.

  Control port slot 264 is disposed counterclockwise from RBC exit slot 272 and intersects channel 208 at its inner channel wall 212 in a substantially concave and substantially vertical fashion (eg, control port slot 264 is an inner channel). Join to wall 212). A control port assembly 488 into the blood processing chamber 352 is disposed in the control port slot 264 (eg, FIGS. 14A and 14C). By maintaining a substantially continuous surface along the inner channel wall 212 during the component removal procedure and reducing the possibility of the control port assembly 488 deflecting radially inward within the control port slot 264, blood processing For the chamber 352 to pressurize, a recess 268 is disposed in the inner wall 212 that includes the end of the control port slot 264. This recess 268 receives a shield 508 that is disposed around the control port assembly 488 on the outer surface of the blood processing chamber 352 as described in more detail below.

  The portion of the channel 208 that extends between the control port slot 264 and the RBC dam 232 can be characterized as the first stage of the channel 208. The first stage 312 is configured to primarily remove RBC from the channel 208 by taking advantage of the backflow to the platelet-rich plasma flow through the channel 208 that is clockwise. In this regard, the outer channel wall 216 extends along a curvilinear path from the RBC dam 232 to the blood inlet slot 224 that generally travels away from the axis of rotation 324 of the channel housing 204. That is, the radial arrangement of the outer channel wall 216 at the RBC dam 232 is smaller than the radial arrangement of the outer channel wall 216 at the blood inlet slot 224. The portion of the RBC outlet slot 272 that joins the channel 208 is also positioned radially outwardly further than the portion of the blood inlet slot 224 that joins the channel 208.

  In the first stage 312, blood flows in a plurality of layers of various blood components including red blood cells (RBC), white blood cells (WBC), platelets, and plasma from the radially outermost layer to the radially innermost layer. To be separated. Thus, the RBC settles against the outer channel wall 216 in the first stage 312. By centrifuging the RBC dam 232 to be a portion of the channel 210 that extends further inward toward the rotational axis 324 of the channel housing 204, the RBC dam is placed in the first stage 312 as described above. It becomes possible to hold separated RBCs and other large cells. That is, the RBC dam functions so that the RBC does not flow in the clockwise direction beyond the RBC dam 232.

  The separated RBCs and other large cells are external to induce flow in the clockwise direction (eg, generally opposite of the blood flow through the first stage 312) to the RBCs and other large cells. The channel wall 216 is removed from the first stage utilizing the above-described configuration. In particular, the isolated RBC and other large cells pass through the first stage 312 along the outer channel wall 216 through the blood inlet slot 224 and the corresponding blood inlet assembly 388 in the blood processing chamber 352; Flow into RBC outlet slot 272. To reduce the possibility of counter-clockwise flow other than a separate RBC supplied to the control port assembly 488 located in the control port slot 264 (eg, as described in more detail below, the RBC and control port A control port dam 280 is disposed between the blood inlet slot 224 and the RBC outlet slot 272 (so that there is a sharp boundary or interface between the plasma adjacent to the slot 264). That is, it is preferable to prevent any portion of the WBC or buffy coat that is radially adjacent to the separated RBC from passing over the control port dam 280 and into the control port slot 264. The “puffy coat” mainly includes the WBC, lymphocytes, and the radially outermost portion of the platelet layer. Thus, only substantially separated RBC and plasma are removed from the channel 208 via the RBC control slot 264, maintaining the interface control described above.

  The flow of RBC to the control port assembly 488 is generally relatively small. However, this flow capability is achieved by controlling the radial position of the interface between the RBC and plasma separated with respect to the control port assembly 488 and between the RBC and “buffy coat” separated with respect to the RBC dam 232. It is highly desirable in that the control port assembly 488 functions in conjunction with an RBC outlet assembly 516 that automatically controls the radial position of the interface. Control port assembly 488 and RBC outlet assembly 516 function automatically to provide a desired radial position in channel 208 that is generally adjacent to RBC dam 232 so that there is no outflow in RBC or buffy coat beyond RBC dam 232. Maintain the position of the interface between the RBC and the buffy coat separated by. This function is obtained by removing the RBC separated from the channel 208 at a rate that flows beyond the RBC dam 232 and contaminates the platelet collection with the aforementioned RBC and other large cell potential.

  Separated platelets that are located radially inward of the RBC layer, more specifically radially inward of the buffy coat, cause the RBC dam 232 to move with the plasma in a clockwise direction (eg, via platelet-rich plasma). It flows beyond. A substantially funnel-shaped platelet collection well 236 is positioned in a clockwise direction from the RBC dam 232 and is used to remove platelets from the channel 208 in platelet rich plasma. The configuration of the platelet collection well 236 is defined only by the portion of the outer channel well 216. The portion of the platelet well 236 defined by the configuration of the outer channel wall 216 includes a lower face 240, a left face 244, and a right face 248. Each of these faces 240, 244, 248 is substantially planar and tapers substantially outward with respect to the rotation axis 324 and inward toward the center of the platelet collection well 236.

  The remainder of the platelet collection well 236 is generally triangular 428 defined by the blood processing chamber 352 when installed in the channel 208, ie, disposed on the platelet outlet assembly 416 to the inside of the blood processing chamber 352, as described in more detail below. State. Platelet support recess 249 extends further radially outward from the portion of platelet collection well 236 defined by the configuration of outer channel wall 216 and primarily receives support 428 coupled to platelet collection port assembly 416. . Typically, the upper portion of the support 428 is positioned below and engages the upper lip 252 of the platelet support recess 249, while the portion of the fourth face 444 of the support 428 is positioned with respect to the two displaced shoulders 252. Is done. As a result, when the blood processing chamber 352 is pressurized and the platelets are directed to the platelet collection port assembly 416, the support portion 428 is positioned.

  Outer channel wall 216 is further configured to receive platelet collection tube 424. However, the upper platelet collection tube recess 254 and the lower platelet collection tube escape 255 are located further radially outward from the platelet support recess 249 to provide this function. Thus, the platelet collection tube 424 extends radially outward from the outer side wall of the blood processing chamber 352, and passes through the lower platelet collection tube escape 255 and the upper platelet collection tube escape 254 rearward or radially outward from the support portion 428. Extending upward and above the channel housing 204.

  Platelet-poor plasma can continue to flow in a clockwise direction through the channel 208 after the platelet collection well 236 and be removed from the channel 208. In this regard, the channel 208 includes a generally concave plasma outlet slot 256 disposed near the second end 288 of the channel 208 and intersects the channel 208 at its inner channel wall 212 in a substantially vertical fashion (eg, The plasma outlet slot 256 joins the inner channel wall 212). A plasma outlet assembly 452 into the interior of the blood processing chamber 352 is provided in the plasma outlet slot 256 so that the plasma is continuously removed from the blood processing chamber 352 during component removal (eg, during continuous rotation of the channel housing 204). Arranged. This plasma is collected and / or returned to the donor / patient 4. In order to increase the number of platelets that are separated and removed from the blood processing chamber 352 in a given component removal procedure, the configuration of the channel 208 between the platelet collection well 236 and the platelet outlet slot 256 is Platelets that separate from the plasma in the portion can actually flow backwards in a counterclockwise direction toward the platelet collection well 236 for removal from the channel 208. This provides for the outer channel wall 216 to be configured to extend from the platelet collection well 236 about a rotational axis 324 to a plasma outlet slot 256 that proceeds generally inward toward the rotational axis 324 of the channel housing 204 in a generally curvilinear manner. can do. As a result, the portion of the channel 208 that contains platelets 236 and extends from the platelet collection well 236 to the second end 288 is applied as the second stage 316 of the channel 208.

  Channel 208 is also configured to supply platelet-poor plasma to control port slot 264 and control port assembly 488 so that automatic control of the interface between the RBC and the buffy coat can be achieved with respect to RBC dam 232. In this regard, the first end 284 of the channel 208 is interconnected with the second end 288 of the channel 208 by a connector slot 260. Once the first connector 360 and the second connector 368 of the blood processing chamber 352 are connected, they can be collectively placed in this connector slot 260. Thus, a continuous flow path is provided in the blood treatment chamber 352, and for the purpose of automatic interface control functions, the RBC flows into the control port slot 264 in a counterclockwise direction and the plasma is controlled in a clockwise direction. The mouth slot 264 can flow. The portion of the channel 208 that extends from the first end 284 to the control port slot 264 can be applied as the third stage 320 of the channel 208.

As mentioned above, the configuration of the channel 208 is desirable and / or important in many ways. Accordingly, the dimensions of one embodiment of the channel 208 are shown herein, which is believed to contribute to the function of the channel 208 described below.
One desirable attribute of the channel 208 is to facilitate installation of the blood treatment chamber 352. This is obtained by constructing a channel 208 that includes faces 210 on either side of the channel 208 along the entire range. Typically, the surface 210 extends downward and inward toward the center of the channel 208, as shown, for example, in FIGS. In an embodiment, the angle of this plane is about 30 ° to 60 ° with respect to the horizontal, preferably about 45 °. Further, the configuration of the channel 208 maintains a blood processing chamber 352 within the channel 208 throughout the component removal procedure. This is particularly important in that the channel housing 254 preferably rotates at a relatively high rotational speed, such as about 3,000 RPM.

  Another desirable attribute of channel 208 is to provide a self-holding function for blood processing chamber 352. The configuration of the channel 208 in at least the first stage 312 and also preferably the portion of the platelet collection well 236 and the portion of the RBC dam 232 is such that the upper portion of the channel 208 includes a restriction (eg, the upper portion of the channel 208 in this portion). Configured so that the width decreases relative to its lower part). Although this configuration could be used in the portion of the second stage 316 located between the platelet well and the plasma outlet slot 256, in the illustrated embodiment, the channel 208 in this portion The width and settling distance are less than the width and settling distance of the channel 208 throughout the first stage 312. The use of this “reduced width” itself causes the second channel 316 so that the inner channel wall 212 and the outer channel wall 216 in this portion of the second stage 316 are surfaces that are normally planar and extend vertically. The blood processing chamber 352 can be sufficiently retained in the channel 208 of the “reduced width” portion of the stage 316.

  As best shown in the illustrated embodiment and in FIG. 12, the above “restriction” of the channel 208 is obtained by constructing an outer channel wall 216 having a generally C-shaped shape. In this portion of the channel 208, the channel 208 has an upper channel portion 292 having a first width, a central channel portion 300 having a second width greater than the first width, and a width smaller than the width of the central channel 300. And a lower channel portion 304 having a width generally equal to the width of the upper channel portion 292. This feature includes an upper lip 296 extending radially inwardly from the outer channel wall 216 to the inner channel wall 212, and a radially inward displacement from the outer channel wall 216 to the inner channel wall 212. However, the lower lip 308 is obtained. This lower lip 308 actually defines a portion of the channel base 220 but extends from the outer channel wall 216 to the inner channel wall 212 to define a notch 218.

  When the blood processing chamber 352 is attached to the channel 208, the fluid containing volume of the matching portion of the blood processing chamber 352 is disposed below the upper channel portion 292 and is essentially contained within the central channel portion 300. That is, the upper lip 296 “covers” the fluid-containing volume of the blood processing chamber 352 over at least a portion of its length. Thereby, the upper lip 296 functions to hold the blood treatment chamber 352 in the channel 208 when the channel housing 204 rotates. Further, the upper lip 296 reduces the possibility of creep by supporting the blood treatment chamber 352 proximal to the upper seal 380. The upper channel portion 292 and the lower channel portion 304 are, as will be described in detail below, an upper seal 380 and blood seal chamber 352 to the extent that stress induced in these portions of the blood treatment chamber 352 during the component removal procedure is reduced. It is multifunctional in that it is also effective for receiving and supporting the lower seal 384. A similarly configured upper lip and lower lip extend outwardly from the inner channel wall 212 to the outer channel wall 216 alone or in combination with the upper lip 296 and the lower lip 308 and this for the channel 208 It would be preferable to retain the same general shape as and provide the above functions.

  Another desirable attribute of the channel 208 is to allow the use of blood as a fluid that fills the blood processing chamber 352 with, for example, saline solution. The actual collection of blood components can be started immediately by filling with blood (i.e. separating the blood used for filling into at least one blood component type that is collected). Blood filling is the subject of a number of features with respect to the component removal system 2 and is based on the configuration of the channel 208. For example, the configuration of the channel 8 allows blood to become the first fluid that is introduced into the blood processing chamber 352 attached to the channel 208. Further, due to the configuration of the channel 208, any isolated RBC or other large cells described above may exceed the RBC dam 232 and flow into the second stage 316 in a clockwise direction (ie, efflux state) before the plasma flows. It is possible to flow in a clockwise direction through channel 208 and reach control port slot 264 (and control port assembly 488 of blood treatment chamber 352). That is, blood filling can be utilized because control of the interface between the separated RBC and buffy coat has been established before the RBC or WBC flows into the second stage 316. Blood filling may also be characterized as supplying RBC or a large number of the above-described large cells over the RBC dam 232 and supplying blood and / or blood components to the entire volume of the blood treatment chamber 352 before flowing to the second stage 316. Can do.

In order to achieve this desirable goal of filling blood processing chamber 352 with blood, the volume of channel 208 that normally does not have an RBC relative to the volume of channel 208 that has an RBC is channeled through channel 208 through blood inlet assembly 388. The ratio of hematocrit of RBC exiting channel 208 via RBC outlet assembly 516 to hematocrit of blood introduced into the cell must be less than one-half. This can be expressed mathematically as follows:
V ₂ / V ₁ <(H _RP / H _IN −1) / 2, where V ₂ = volume of channel 208 containing only plasma or plasma rich in platelets;
V ₁ = volume of channel 208 containing the RBCs of first stage 312 and third stage 320;
H _RP = hematocrit of packed RBC exiting channel 208 via RBC outlet assembly 516; and H _IN = hematocrit of blood entering channel 208 via blood inlet assembly 388;
It is.

This equation confirms the hematocrit in the RBC volume and confirms that it is calculated as (H _IN + H _RP ) / 2. If H _IN = 0.47 and H _RP = 0.75, this requires that the ratio V ₁ / V ₂ is less than 0.3 because blood filling is possible.
The above ratio is the ratio of the portion of channel 208 that is characterized as containing predominantly plasma (eg, V _PL ) to the volume of the portion of channel 208 that is characterized as predominantly containing RBC (eg, V _RBC ). Can be further characterized. Referring to FIG. 15, each of these volumes can be defined by a reference circle 332 that starts at the axis of rotation 324 and intersects the RBC dam 232 at the position shown in the figure that is considered the limit of the outflow condition. The portion of the channel 208 that is located outside this reference circle is primarily defined as the portion that contains the _RBC or defines the VRBC (eg, about 77.85 cc in the illustrated embodiment). portion of the channel 208 is disposed inside the circle 232 comprises predominantly plasma, or define a V _PL (e.g., about 19.6cc in the embodiment shown in the drawing) is defined as a portion. In the illustrated embodiment, the ratio V _PL / V _RBC is about 0.25, which is less than that described above for the theoretical calculation of blood filling (ie, 0.30 based on hematocrit comparison). To further achieve the above desired ratio, the width and height of the channel 208 across the second stage 316 (also in the third stage 320) positioned in a clockwise direction from the platelet well 236 are respectively Less than the width and height of the channel 208 across one stage.

  Another important feature regarding the configuration of the channel 208 is that the radially innermost portion of the inner channel wall 212 is joined to the plasma outlet slot 256. That is, the entire inner channel wall 212 is inclined toward the plasma outlet slot 256. This allows air present in the blood processing chamber 352 during filling to pass through the plasma outlet slot 256, and more particularly through the plasma outlet assembly 452, since air is the most dense fluid in the blood processing chamber 352 at this time. Air is removed from the chamber 352.

  Another desirable attribute of channel 208 is that it contributes to the availability of high clogging factors in the component removal procedure. Since the “clogging coefficient” is a dimensionless quantification of the degree of clogging of various blood components in the first stage 312, it reflects the interval between the various blood components. For this reason, the clogging factor can be seen in the same way as the theoretical density of a type (e.g. given the amount of space, this gives the maximum number of specific blood component types that can be included in this space. means).

The packing factor is further defined by the following formula:
PF = ω ² × R × (V _RBC / W) × V / Q _IN , where PF = clogging factor;
ω = rotational speed;
R = average radius of outer channel wall 216 at first cell separation stage 312;
Sedimentation rate of RBC at V _RBC = 1G;
V = functional volume of first cell separation stage 312;
W = average settling distance or width of channel 208; and Q _IN = total inlet flow to channel 208;
It is.

  As a result, the clogging factor used here depends not only on the configuration of the channel 208, particularly the configuration of the first stage 312, but also on the rotational speed used in the component removal procedure and the inlet flow to the blood processing chamber 352. . The following is a plugging factor associated with a blood treatment channel 208 having the dimensions described above:

N Q _in V G P @ R1st
(Rpm) ml / mi (ml) PF @R _AVG (Kg)
0 0 62.8 0.0 0.0 0.0
905 5 62.8 13.0 100.1 56
1279 10 62.8 13.0 200.2 112
1567 15 62.8 13.0 300.2 168
1809 20 62.8 13.0 400.3 224
2023 25 62.8 13.0 500.4 280
2216 30 62.8 13.0 600.5 336
FF8 2394 35 62.8 13.0 700.6 392
Gradient = .02 2559 40 62.8 13.0 800.6 448
2714 45 62.8 13.0 900.7 503
2861 50 62.8 13.0 1100.9 559
3001 55 62.8 13.0 1100.9 616
3001 60 62.8 11.9 1100.9 616
3001 65 62.8 11.0 1100.9 616
3001 70 62.8 10.2 1100.9 616
3001 75 62.8 9.5 1100.9 616
3001 80 62.8 8.9 1100.9 616
3001 85 62.8 8.4 1100.9 616
3001 90 62.8 7.9 1100.9 616
3001 95 62.8 7.5 1100.9 616
3001 100 62.8 7.1 1100.9 616
3001 105 62.8 6.8 1100.9 616
3001 110 62.8 6.5 1100.9 616
3001 115 62.8 6.2 1100.9 616
3001 120 62.8 6.0 1100.9 616
3001 125 62.8 5.7 1100.9 616
3001 130 62.8 5.5 1100.9 616
3001 135 62.8 5.3 1100.9 616
3001 140 62.8 5.1 1100.9 616

G force is shown for various rotational speeds in the middle of the first stage 312 and for the 10 inch outer diameter of the channel housing 204. The G force at about 2,560 RPM is about 800 G, while the G force at about 3,000 RPM is about 1,100 G.

  Increasing the clogging factor beyond a certain point results in a decrease in return for blood component type collection. That is, if the clogging factor is further increased, it is unlikely that the corresponding increase in collection efficiency will occur, and in fact, it will interfere with the collection of blood component types. A clogging factor in the range of about 11 to about 15, more preferably about 13, is optimal for collecting blood component types. Accordingly, the rotational speed of the channel housing 204 can be adjusted based on the inlet flow supplied to the blood treatment chamber 352 to maintain the clogging factor. For example, the desired operating speed of the centrifuge housing 204 during the normal course of component removal is about 3,000 RPM. However, this rotational speed can be reduced and “matched” to the inlet flow to the blood treatment chamber 352 to maintain the desired clogging factor. Similarly, the rotational speed of the channel housing 204 can be increased and “matched” to the increased inlet flow into the blood treatment chamber 352 to maintain the desired clogging factor.

  Due to the limitations associated with blood processing chamber 352, and more particularly, the various interconnected tubes (eg, providing a sealless loop), the desired clogging factor of about 13 described above is an inlet up to about 55 ml / min (instantaneous). Can be realized about the flow. Beyond 55 ml / min, the rotational speed will increase to over 3000 RPM and maintain a desirable packing factor of about 13. There are tubes that can withstand that rotational speed, but currently they are not approved for use in component removal. For currently approved tubes, the clogging factor can be maintained at a minimum of about 10, preferably at least about 10.2, with an inlet flow (instant) of about 40-70 ml / min.

  At the increased rotational speed described above, the channel 208 not only achieves an increased clogging factor, but also reduces the impact of this high clogging factor on the collection efficiency for platelet collection. In particular, the configuration of the channel 208 is selected to reduce the number of platelets retained in the first stage 312. The configuration of the channel 208 in the first stage 208 utilizes a progressive decrease in width or settling distance that travels from the blood inlet slot 224 to the RBC dam 232. That is, the width of the channel 208 proximal to the blood inlet slot 224 is smaller than the width of the channel 208 proximal to the RBC dam 232. This configuration of the channel 208 in the first stage reduces the volume of the “buffy coat” or more particularly the layer between the collected RBC and platelets. As described above, this buffy coat mainly includes WBC and lymphocytes, and the radially outermost portion of the platelet layer. The “soft film” is preferably held on the first stage 312 when the component is removed. This reduces the number of platelets retained in the first stage 312 due to the decreased width of the channel 208 proximal to the RBC dam 232, thereby reducing the number of platelets that flow to the platelet collection well 236. The number of

Disposable Set: Blood Processing Chamber The blood processing chamber 352 is placed in the channel 208 to directly join and receive the blood flow in the component removal procedure. The use of the blood treatment chamber 352 eliminates the need to sterilize the channel housing 204 after performing a component removal procedure, and the blood treatment chamber 352 can be abandoned and supplied with a disposable system. First, there are two important features related to the overall structure of the blood processing chamber 352. Blood processing chamber 352 is configured to be sufficiently rigid to be self-supporting in channel 208. Furthermore, the blood treatment chamber 352 is sufficiently rigid to be attached to the channel 208 having the above-described configuration (ie, the blood treatment chamber 352 has a reduced width before passage to the large width central channel portion 300. Must be directed through the upper channel portion 292). However, the blood treatment chamber 352 must also be sufficiently flexible to substantially conform to the shape of the channel 208 during the component removal procedure.

  In order to achieve the above-described features, the blood processing chamber 352 can be configured as follows. First, examples of the material for the blood processing chamber 352 include PVC, PETG, and polyolefin, and PVC is preferable. Furthermore, the thin wall of the blood treatment chamber is generally about 0.76 mm to 1.0 mm. Further, the durometer rating of the body of blood processing chamber 352 is typically about 50 Shore A to about 90 Shore A.

Referring primarily to FIGS. 16-23B, blood processing chamber 352 includes a first end 356 and a second end 364 that overlap and are radially spaced from first end 356. A first connector 360 is disposed proximal to the first end 356 and a second connector 368 is disposed proximal to the second end. When the first connector 360 and the second connector 368 are engaged (generally permanently), a continuous flow path is obtained through the blood treatment chamber 352. The structure in this blood processing chamber 352 facilitates the attachment of the channel 208 in place and also contributes to the automatic control of the interface between the isolated RBC and the buffy coat for the RBC dam 232 as described above.
Blood processing chamber 352 includes an inner wall 372 and an outer wall 376. In the illustrated embodiment, the blood treatment chamber 352 is formed by sealing two sets of materials (eg, RF welding). More specifically, the inner wall 372 and the outer wall 376 are joined along the entire length of the blood treatment chamber 352 and define an upper seal 380 and a lower seal 384. A seal is also provided at the end of blood processing chamber 352. The upper seal 380 is disposed in the upper channel portion 292 of the reduced width of the channel 208, while the lower seal 384 is disposed in the lower channel portion 304 of the reduced width of the channel 208 (eg, FIG. 19F). Also by this, the blood flow is supplied to the blood processing chamber 352, and when this is pressurized, the stress on the upper seal 380 and the lower seal 384 is reduced. That is, because the upper seal 380 and the lower seal 384 are effectively supported by the channel 208 during the component removal procedure, resistance is provided to the “pull out” of the upper seal 380 and the lower seal 384. A “flutter” shape can also be obtained by using two separate sheets to form the blood treatment chamber 352. This type of shape is advantageous at the time of rinsing back and also facilitates the attachment and removal of blood treatment chamber 352 from channel 208.

  Blood is introduced into blood processing chamber 352 via blood inlet assembly 388, and is shown in more detail in FIGS. 19A-19G. Initially, like all other ports, port 392 is welded to blood processing chamber 352 over a relatively small portion. This eliminates material movement due to the welding procedure which results in a smooth surface for mating with blood and / or blood component types.

  The blood inlet assembly 388 includes a blood inlet 392 and a blood inlet tube 412 that is fluidly interconnected thereto from outside the blood processing chamber 352. The blood inlet 392 extends through the inner wall 372 of the blood processing chamber 352 and beyond the inner wall 372 of the blood processing chamber 352. Typically, the blood inlet assembly 388 is configured to allow blood to be introduced into the blood processing chamber 352 during a component removal procedure without substantially detrimentally affecting the operation of the component removal system 2.

  Blood inlet 392 includes a substantially cylindrical sidewall 396. A slot 404 extending substantially vertically is disposed proximal to the end of the side wall 396 of the blood inlet 392, and the slot 404 is substantially parallel to the inner wall 372 and the outer wall 376 of the blood treatment chamber 352. Because the slot 404 protrudes in a clockwise direction, the blood flow in the channel 208 is typically directed to the RBC dam 232. A vane 400 is positioned at the end of the cylindrical side wall 396 and is positioned to be substantially parallel to the inner side wall 372 and directs blood flow out through the slot 404. As shown in FIG. 19D, the vane 400 includes a generally V-shaped notch inside the blood inlet 392, the exact extent of which defines the “height” of the slot 404.

  The desired flow of blood into the blood treatment chamber 352 during a component removal procedure is the subject of a number of features, each provided by the blood inlet assembly 388 described above. First, the flow of blood into the blood treatment chamber is characterized by an angle of less than 90 ° with respect to a reference line that is perpendicular to the inner wall 372 of the blood treatment chamber 352. That is, blood is injected through the blood treatment chamber 352 in a direction that is at least a partial direction of the desired flow of blood. Further, the desired flow of blood into the blood treatment chamber 352 can be characterized as reducing the effect on other flow characteristics within the blood treatment chamber 352 at the blood inlet 392.

  The separated RBC also flows along the outer wall 376 of the blood treatment chamber 352 adjacent to the outer channel wall 216 and past the blood inlet 392 to the RBC outlet assembly 516 as shown in FIGS. 19E and 19G. The desired flow of blood to the blood processing chamber 352 is further characterized by being substantially parallel to at least one other flow at the portion of the blood inlet 392 (eg, substantially parallel to the flow of RBC556). Inject blood). This manner of introducing blood into the blood treatment chamber 352 is further characterized by not significantly affecting at least one other flow in the portion of the blood inlet 392.

  As described above, the blood inlet assembly 388 is surface bonded to the inner wall 372 of the blood treatment quality 352 so as to minimize discontinuities along the inner channel wall 212 within the region of the blood inlet slot 224 including the blood inlet 392. The Specifically, a shield 408 is integrally provided around the blood inlet 392. The shield 408 is disposed on the outer surface of the blood treatment quality 352 and joined to the inner wall 372. The shield 408 is in at least partially overlapping relationship with the inner wall 372. Further, when the shield 408 is formed integrally with the inlet 392, it is not necessary to attach it to the inner wall 372. The inlet 392 is mounted symmetrically with the shield 408 to improve manufacturing efficiency. As shown below, the entire shield and its blood-related mouth have such characteristics.

  Usually, the shield 408 is more rigid than the inner wall 372 of the blood treatment chamber 352. This increased stiffness can be obtained by utilizing a more rigid material for the shield 408 than used for the inner wall 372. For example, the durometer rated range of the material forming the shield 408 is about 90 Shore A to about 130 Shore A, but the material durometer rated range forming the inner wall 372 of the blood treatment chamber 352 is also about 50 in one embodiment. Shore A to about 90 Shore A. This durometer rating (when the shield 408 and the port 392 are integrally formed) also strengthens the seal between the port 392 and the tube installed therein.

  In installing the blood treatment chamber 352 in the channel 208, placing the blood inlet 392 in the blood inlet slot 224 positions the shield 408 within a recess 228 formed in the inner channel wall 212. The blood inlet slot 224 also joins the inner channel wall 212, more specifically, the recess 228. That is, the recess 228 includes one end of the blood inlet slot 224 and is disposed about it. Preferably, the thickness of the shield 408 is substantially equal to the depth in the recess 228 so that the amount of discontinuity along the inner channel wall 212 in the portion of the blood inlet slot 224 is reduced or minimized. Due to the increased stiffness of the shield 408 relative to the material forming the blood processing chamber 352, when the blood processing chamber 352 is pressurized during a component removal procedure, the shield 408 may have the blood processing chamber 352 and / or blood inlet to the blood inlet 224. Restrict movement of 392. That is, shield 408 limits and preferably minimizes the deflection of blood processing chamber 352 to blood inlet slot 224 during treatment. Further, since the shield 408 is integrally formed with the blood inlet 392, the radial position of the vertical slot 404 at the blood inlet 392 does not depend on the thickness of the material forming the blood processing chamber 352.

  In the first stage 312, the blood supplied to the blood processing chamber 352 by the blood inlet assembly 388 is separated into RBC, WBC, platelets, and plasma. The RBC and WBC are preferably retained in the first stage 312 and are not allowed to flow past the RBC dam 232 and into the platelet collection well 236 in a clockwise direction. Instead, the RBC and WBC are caused to flow along the outer channel wall 216 in a counterclockwise direction past the blood inlet 392 toward the RBC outlet assembly 516 of the blood treatment chamber 352. That is, RBC outlet assembly 516 is disposed in a counterclockwise direction from blood inlet assembly 388. However, as described above, the control port dam 280 prevents the flow buffy coat control assembly 488 and provides a sharp interface between the separated RBC and the plasma in the vicinity of the control port assembly 488. This boundary surface can be used to control the radial position of the interface between the RBC and the buffy coat in the RBC dam 232 portion.

  The RBC outlet assembly 516 is shown in more detail in FIGS. 20A-20D and typically includes an RBC inlet 520 and an RBC outlet tube 540 that are fluidly interconnected with the exterior of the blood processing chamber 352. The RBC outlet 520 extends through the inner wall 372 of the blood processing chamber 352 and beyond this into the blood processing chamber 352. In addition to removing the RBC from the blood treatment chamber 352 during the component removal procedure, the RBC outlet assembly is combined with the control port assembly 488 in a manner described in more detail below, such as the RBC dam 232 (eg, RBC flows over the RBC dam 232). To automatically control the radial position of the interface between the isolated RBC and buffy coat.

  RBC outlet 520 is capable of obstructing flow during rinseback (ie, when evacuating blood processing chamber 352 at the same time as blood component separation is completed to return most of its contents to donor / patient 4). It is also configured to reduce sex. At the time of rinsing back, the rotation of the channel housing 204 is completed and a relatively important drawing operation (for example, pumping out) is used to remove the entire contents from the blood processing chamber 352. The end of the RBC outlet 520 is provided with a central recess 532 between the protrusions 524 and 528 including a first protrusion 524 and a second protrusion 528 spaced apart and including the orifice 536 for the blood outlet 520 described above. It is done. The first protrusion 524 and the second protrusion 528 each further extend beyond the inner wall 372 of the blood processing chamber 352 at a distance greater than the central recess 532. Thus, when the outer wall 376 contacts the inner wall 372 during rinsing back, the first protrusion 524 and the second protrusion 528 displace the central recess 532 and the orifice 536 away from the outer wall 376. Accordingly, the orifice 536 in an open state is held so that the flow through the rinse back is not hindered.

  As described above, the RBC outlet assembly 516 joins with the inner wall 372 of the blood treatment chamber 352 in a manner that minimizes discontinuities along the inner channel wall 212 in the region of the RBC outlet 272 that includes the RBC outlet assembly 520. To do. In particular, a shield 538 is integrally formed with the RBC outlet 520 and disposed around it. The shield 538 is disposed on the outer surface of the blood processing chamber 352 and is joined to the inner wall 372 thereof. The shield 538 is at least partially overlapping the inner wall 372. Further, when the shield 538 is formed integrally with the port 520, it is not necessary to adhere to the inner wall 372. Usually, the shield 538 is more rigid than the inner wall 372. This increase in stiffness is obtained by utilizing a material for the shield 538 that is more rigid than that used for the inner wall 372. For example, the durometer rating range of the material forming the shield 538 is about 90 Shore A to about 130 Shore A, but the material durometer rating range forming the inner wall 372 of the blood treatment chamber 352 is also about 50 in one embodiment. Shore A to about 90 Shore A.

  When mounting the blood treatment chamber 352 in the channel 208, placing the blood outlet 520 in the blood outlet slot 272 positions the shield 538 within the relief 228 formed in the inner channel wall 212. Also, the RBC outlet slot 272 intersects the inner channel wall 212, more specifically the recess 276. That is, the recess 276 includes one end of the RBC exit slot 272 and is disposed about it. Preferably, the thickness of the shield 538 is substantially equal to the depth or thickness in the recess 276 such that the amount of discontinuity along the inner channel wall 212 in the portion of the RBC outlet slot 272 is reduced or minimized. To. Due to the increased stiffness of the shield 538 relative to the material forming the blood processing chamber 352, when the blood processing chamber 352 is pressurized during a component removal procedure, the shield 538 may have a blood processing chamber 352 and / or RBC into the RBC outlet slot 272. Restrict movement of exit slot 520. That is, the shield 538 limits and preferably minimizes the deflection of the blood treatment chamber 352 to the RBC outlet slot 272 during the procedure. Further, since the shield 538 is formed integrally with the RBC outlet 520, the radial position of the orifice 536 is not affected by the thickness of the material forming the blood processing chamber 352.

  The separated platelets flow past the RBC dam 232 into the second stage 316 of the channel 208 in platelet rich plasma. The blood processing chamber 352 includes a platelet collection port assembly 416 that continuously removes these platelets from the processing chamber 352 throughout the component removal procedure. Details are shown in FIGS. 8, 16, and 21A to 21B. Typically, the platelet collection port assembly 416 is positioned in a clockwise direction from the blood inlet assembly 388 and the RBC dam 232 when the blood processing chamber 352 is attached to the channel 208. Further, the platelet collection port assembly 416 joins with the outer wall 376 of the blood processing chamber 352.

  Platelet collection port assembly 416 is disposed in platelet support relief 249 and platelet outlet tube 254 disposed radially outward from the portion of platelet collection well 236 defined by outer channel wall 216 of channel 208. Platelet collection port assembly 416 typically includes a platelet collection port 420 and a platelet collection tube 424 that is fluidly interconnected with the outside of blood processing chamber 352. The orifice 422 of the platelet collection port 420 is substantially flush with the inner surface of the outer wall 376 of the blood processing chamber 352. Further, the radial position of the orifice 422 is established by engagement of the boundary of the recesses 249 and / or 254 with a portion of the platelet collection port 420.

  Platelet collection port 420 is welded to blood processing chamber 352. The thickness of the overlapping portion between the platelet collection port 420 and the blood processing chamber 352 is substantially equal. As the weld is heated, mixing of the two materials is observed. Accordingly, when the blood collection port 420 pressurizes the blood processing chamber 352, the outer channel wall 216 can be substantially bent.

  The blood processing chamber 352 and outer channel wall 216 of channel 210 collectively define a platelet collection well 236. The contribution of the blood processing chamber 352 to the platelets 236 is substantially disposed on the platelet collection port 420 vertically and hinged to the outer wall 376 and / or the mounting plate 426 of the platelet collection port 420 at locations 430. In particular, it is obtained by the rigid support portion 428. The contoured support 428 joins the outer surface of the outer wall 376 of the blood processing chamber 352 (ie, the support overlaps the side wall 376 of the blood processing chamber 352 and does not need to adhere across the entire interface with it). And a first face 432 and a second face 436 disposed at different angular positions. The upper portion of the first face 432 extends to the top of the blood processing chamber 352, while the lower portion of the first face 432 generally coincides with the upper seal 380 in the blood processing chamber 352. The second face 436 is the primary surface that joins the outer wall 376 in the fluid containing volume portion of the blood processing chamber 352 and directs platelets to the platelet collection port 420.

  When the blood processing chamber 352 is pressurized, the support portion 428 moves to a predetermined position defined by the platelet collection escape 252 portion. In particular, the third face 440 is held below the upper lip 254 at the upper periphery of the platelet support recess 249, and the two sides of the fourth face 444 are against the shoulder 252 disposed on the angular side of the platelet support relief 249. Is positioned. A platelet tube notch 448 is formed in the support portion 428 at a substantially intersection between the third face 440 and the fourth face 444. Thus, the platelet collection tube 426 extends from the platelet collection port 420 to the platelet collection tube escape 254 and passes through the central opening 328 to the platelet tube notch 448 and, if necessary, beyond the channel housing 204. To do.

  To increase the purity of the collected platelets, the platelet purification system described in US patent application Ser. Nos. 08 / 423,578 and 08 / 423,583 can be placed in the platelet collection tube 424. Please refer to these documents for details.

  Platelet-poor plasma flows beyond the platelet collection well 236 and reaches the plasma outlet assembly 452. Here, some of the platelets can be collected by removing the poor plasma from the blood treatment chamber 352, but in some cases, this “separated” plasma can also be returned to the donor / patient 4. The plasma port 456 is also used for filling the blood processing chamber 352 in that air is removed from the blood processing chamber 352 via the plasma port 456. Referring to FIG. 22, the plasma outlet assembly 452 includes a plasma outlet 456 and a plasma outlet tube 476 that is fluidly interconnected with the exterior of the blood processing chamber 352. The plasma outlet 456 extends through the inner wall 372 of the blood processing chamber 352 and beyond this into the blood processing chamber 352. Plasma outlet 456 is disposed between second end 364 of blood processing chamber 352 and second connector 368.

  Plasma outlet 456 is capable of obstructing flow during rinseback (ie, when evacuating blood processing chamber 352 simultaneously with the end of blood component separation to return most of its contents to donor / patient 4). Also configured to reduce sex. At the time of rinsing back, the rotation of the channel housing 204 is completed and a relatively important drawing operation (for example, pumping out) is used to remove the entire contents from the blood processing chamber 352. The end of the plasma outlet 456 includes a central recess 468 disposed therebetween that includes a first protrusion 460 and a second protrusion 464 spaced apart and includes the orifice 472 described above for the plasma outlet 456. The first protrusion 460 and the second protrusion 464 each further extend beyond the inner wall 372 of the blood processing chamber 352 at a distance greater than the central recess. Thus, when the outer wall 376 contacts the inner wall 372 during the rinse back, the first protrusion 460 and the second protrusion 464 displace the central recess 468 and the orifice 472 away from the outer wall 376. Accordingly, the orifice 472 in an open state is held so that the flow through the rinse back is not hindered.

  To further assist the removal from the blood treatment chamber 352 after the component removal procedure is complete and during the rinse back, the first passage 480 and the second passage to the blood treatment chamber 352 (eg, via a heat seal, RF seal). Passages 484 are formed and typically extend downward from the plasma outlet 456 toward the bottom of the blood treatment chamber 352. The first passage 480 and the second passage 484 are disposed on opposite sides of the plasma outlet 456. With this configuration, the drawing operation via the plasma outlet 456 starts at the lower part of the blood processing chamber 352 at the position displaced by two.

  A portion of the separated plasma is also used to automatically control the position of the interface between the separated RBC and buffy coat in the first stage 312, particularly the radial position of this interface relative to the RBC dam 232. Used. Plasma that provides this interface control function is removed from the blood treatment chamber 352 by the control port assembly 488 shown in FIGS. 23A-23B. Control port assembly 488 is disposed in a clockwise direction from plasma outlet assembly 452 and proximal to RBC outlet assembly, ie, between first end 284 of channel 208 and RBC outlet assembly 516. Thus, this plasma flows from the second stage 316 to the third stage 320 to provide this function.

  Control port assembly 488 typically includes a control port 492 and a control port tube 512 that is fluidly interconnected with the exterior of blood processing chamber 352. The control port 492 extends through the inner wall 372 of the blood processing chamber 352 and beyond this to the inside of the blood processing chamber 352. Positioning of the orifice 504 in the control port 492 in the radial direction does not depend on the thickness of the material forming the blood processing chamber 352. Instead, the control port 492 includes a shoulder 496 for engaging or installing the structure in the control port slot 264 and accurately positioning the orifice 504 at a predetermined radial location in the channel 208. Furthermore, this predetermined radial position is substantially maintained even after the blood treatment chamber is pressurized. In this regard, control port assembly 488 joins with inner wall 372 of blood processing chamber 352 in a manner that minimizes discontinuities along inner channel wall 212 in the portion of the control port slot in which control port 492 is located. . In particular, a shield 508 is formed around the control port 492. The shield 508 is at least partially in overlapping relationship with the inner wall 372. Further, when the shield 508 is integrally formed with the control port 492, it is not necessary to adhere to the inner wall 372. Typically, the shield 508 is more rigid than the inner wall 372 so that the orifice 504 of the control port 492 can be maintained at a desired radial location within the channel 208. This increased stiffness can be obtained by utilizing a more rigid material for the shield 508 than used for the inner wall 372. For example, the durometer rated range of the material forming the shield 508 is about 90 Shore A to about 130 Shore A, but the material durometer rated range forming the inner wall 372 of the blood treatment chamber 352 is also about 50 in one embodiment. Shore A to about 90 Shore A.

  The control port assembly 488 and the RBC outlet assembly 516 function in combination to control the radial position of the interface between the RBC and the buffy membrane separated relative to the RBC dam 232. Two structural differences between the RBC outlet assembly 516 and the control port assembly 488 contribute to achieve this automatic control. Initially, the orifice 536 to the RBC outlet 520 is further arranged inside the blood processing chamber 352 than the control port 492. In one embodiment, the orifice 538 of the RBC outlet 520 is located further radially outward than the orifice 504 of the control port 492. Further, the diameter of the RBC outlet pipe 540 is larger than the diameter of the control port pipe 512. In one embodiment, the inner diameter of the RBC outlet tube 540 is about 2.4 mm, while the inner diameter of the control tube 512 is about 0.89 mm. The control port pipe 512 and the RBC outlet pipe 540 are also coupled to a normal return pipe 546 via a three-way pipe jack 544 that assists in obtaining an automatic interface control function.

  Automatic interface position control is obtained utilizing RBC outlet assembly 516 and control port assembly 488 as follows. Initially, channel 208 has two interfaces that are important for this automatic interface position control function. One of these interfaces is the RBC / puffy interface associated with the RBC dam 232. However, the portion of the control port assembly 488 further obtained using the control port dam 280 also has an RBC / plasma interface. Control port dam 280 allows substantially only RBC to flow to the control port assembly in a counterclockwise direction.

  When the interface between the RBC and the plasma moves radially inward to the rotation axis 324, the RBC starts to flow from the control port pipe 512 as well as the RBC outlet pipe 540. This generally reduces the flow through the small diameter control port 512 due to the higher viscosity and density of the RBC compared to plasma flowing through the control port 512. As a result, the flow through the large diameter RBC outlet tube 540 needs to increase because the flow through the return tube 546 needs to be the same. As a result, a large amount of RBC is removed from the first stage 312, and the interface between the RBC and the buffy coat and the interface between the RBC and plasma related to the RBC dam 232 both move radially outward. That is, this changes the radial position of each of these interfaces. Thus, the likelihood of RBC flowing past the RBC dam 232 and into the platelet collection well 236 is reduced.

  When the position of the interface between the RBC and plasma progresses radially outward, the amount of RBC exiting the blood treatment chamber 352 via the control port 512 decreases, so the flow through the control port tube increases. This reduces the RBC flow through the RBC outlet tube 540 because the flow through the return tube 546 needs to be the same. This reduces the number of RBCs removed from the channel 208 and causes both the RBC and buffy coat interface and the RBC and plasma interface associated with the RBC dam 232 to move radially inward. That is, this changes the radial position of each of these interfaces.

  The above-mentioned tubes joined to the blood processing chamber 352, that is, the blood inlet tube 412, the platelet collecting tube 424, the platelet outlet tube 476, and the return tube 546 pass through the central opening of the housing 204 downward. A tube jacket 548 is placed around the various tubes and protects the tubes as the channel 204 rotates. These tubes are also fluidly connected to an extracorporeal tube circuit 10 that further supplies for fluid communication between the donor / patient 4 and the blood processing chamber 352.

  The blood treatment chamber 352 also includes a function for installing and removing it from the channel 208. Referring back to FIG. 16, blood processing chamber 352 also includes at least one, preferably a plurality of tabs 552. The tab 552 can be formed integrally with the blood treatment chamber 352 (eg, formed by a seal that also forms an upper seal 380). However, the tabs 552 can be attached separately. Nevertheless, the tab 552 preferably extends vertically over the fluid containing volume of the blood treatment chamber 352 and extends a distance such that the tab 552 actually protrudes over the channel housing 204. Thereby, the tab 552 provides a non-fluid containing structure that is advantageous for an operator to grasp the blood treatment chamber 352 and attach / remove to / from the channel 208 (ie, non-blood through it during a component removal procedure). Provide a structure that allows the operator to grasp what has no associated flow). Tab 552 is particularly effective because of the resistance that is provided to the attachment and removal of blood treatment chamber 352 to / from channel 208.

Centrifuge rotor assembly Channel assembly 200 is attached to a centrifuge rotor assembly 568 that rotates channel assembly 200 and separates blood into various blood components by centrifugation. The centrifuge rotor assembly 568 is primarily shown in FIGS. 24-25 and typically includes a lower rotor housing 584 having a lower gear 588. An input or drive shaft 576 is disposed within the lower rotor housing 584 and is rotatably driven by a suitable motor 572. The input / drive shaft 576 includes a platform 580 attached to the upper portion thereof, the rotor body 592 is detachably interconnected with the 580, and rotates together with the input / drive shaft 576 as it is rotated by the motor 572.

  The centrifuge rotor assembly 568 further includes an upper rotor housing 632 that includes a mounting ring 644 in which the channel housing 204 is positioned. Upper rotor housing 632 and lower rotor housing 584 are rotatably interconnected by pinion assembly 612 to rotate channel housing 204 at twice the speed of rotor body 592. Pinion assembly 612 is attached to rotor body 592 and includes a pinion mounting assembly 616 and a rotating pinion 620. The pinion 620 is joined to the lower gear 588 and the drive gear 636 attached to the attachment ring 644. The gear ratio is set so that the upper rotor housing 633 rotates twice each time the rotor body 562 rotates once. The rotary seal for the tube joined to the blood processing chamber 352 is not necessary at this gear ratio. In one embodiment, a lower gear 588, a pinion 620, and a driven gear 636 are provided.

The centrifuge rotor 568 has a structure to facilitate mounting the blood treatment chamber 352 in the channel 208. In this regard, the rotor body 592 has an L-shaped blood processing chamber mounting aperture 597. The aperture 597 includes a lower aperture 600 that extends substantially horizontally through the sidewall 596 of the rotor body 592 and only partially into the rotor body 592. The periphery of the lower aperture 600 is defined by a left concave wall 601, a rear concave wall 603, and an upper rotor housing 632.
The mounting aperture 597 also has an upper aperture 598 that intersects the lower aperture 600 at 599 and penetrates the upper portion of the rotor body 592 upward. The upper aperture 598 is aligned with a central opening 640 that extends substantially vertically within the upper rotor 632. As described above, the channel housing 204 includes a central opening 328. The blood processing chamber 352 can be deflected upwardly from the location of the back concave wall 603 if desired, and can be folded through the upper aperture 598, the central opening 640, and the central opening 328 of the channel housing 204. Next, the operator grasps the blood processing chamber 352 and attaches it to the channel 208.

  The centrifuge rotor assembly 568 includes a number of additional features to facilitate attachment of the blood processing chamber 352 in the channel 208. First, the rotor body 592 is offset in the radial direction with respect to the lower aperture 600. In one embodiment, the reference axis bisects the lower aperture 600 outward, which can be referred to as the “zero axis”. The axis about which the pinion 620 rotates is displaced from this “zero axis” at an angle α of about 40 ° in the illustrated embodiment. It is believed that an angle α of −40 ° can also be used. Positioning pinion 620 at an angle greater than ± 40 ° will initiate interference with access to mounting aperture 597. The angle α may be less than 40 ° or 0 °, but the pinion at 0 ° results in a counterweight 608 that potentially interferes with access to the mounting aperture 597. Thus, based on the foregoing, the pinion assembly 612 in FIG. 25 has been rotated around the axis about which the centrifuge rotor assembly 568 rotates to facilitate illustration.

  An upper counterweight 604 and a lower counterweight 608 are arranged to rotate the upper rotor housing 632 relative to the rotor body 592 using only a single drive gear, or the rotor body 592 proximal to the upper and lower ends of the lower aperture 600. Removably connect to. Due to the offset positioning of the pinion 620 relative to the lower aperture, the upper and lower counterweights 604, 608 are also offset radially relative to the lower aperture 600. That is, since the upper and lower counterweights 604 and 608 are “shifted toward the side surface” with respect to the lower aperture 600, access to the upper and lower counterweights 604 and 608 is substantially unaffected by the counterweights 604 and 608. A tube mounting arm 624 also substantially adheres to the rotor body 592 and engages the tube jacket 548. The tube mounting arm 624 further provides a rotational balance of the rotor body 592.

  Another feature of the centrifuge rotor assembly 568 that contributes to mounting the blood processing chamber 352 upward via the rotor body 592 is the size of the lower aperture 600. As shown in FIG. 25B, the “width” of the lower aperture can be defined by an angle θ that ranges from about 70 ° to about 90 °, and is about 74 ° in the illustrated embodiment. The back wall 603, the left wall 601, and the right wall 602 are also defined by a radius in the range of about 44.5 mm to about 57.15 mm, which in the illustrated embodiment is about 51.00 mm to about 51.61 mm. is there.

Component Removal Protocol One protocol is summarized below to perform a component removal procedure on donor / patient 4 utilizing system 2 described above. First, an operator attaches the cassette assembly 110 to the pump / valve / sensor assembly 1000 of the blood separation device 6 and attaches various bags (eg, bags 114, 94, 84) to the blood component separation device 6. Next, the operator installs the blood processing chamber 352 in the channel 208 disposed in the channel housing 204. The channel housing 8 is also attached to the centrifuge rotor assembly 568, particularly the mounting ring 644. More specifically, the operator can fold the blood processing chamber 352 and insert it into the blood processing chamber mounting aperture 597 of the rotor body 592. Due to the arcuate concave configuration of the mounting aperture 597, specifically the lower aperture 600, the blood treatment chamber 352 is deflected upward through the upper aperture 598, the central opening 640 of the upper rotor housing, and the central opening 328 of the channel housing 294. To do. Next, the operator grasps the blood processing chamber 352 and pulls it upward away from the channel housing 204.

  When blood processing chamber 352 is installed via centrifuge rotor assembly 568, the operator attaches blood processing chamber 352 to channel 208 of channel housing 204. Typically, the operator adjusts the position of the blood processing chamber 352 relative to the channel 208 (eg, the blood inlet 392 is aligned vertically with the blood inlet slot 224, and the platelet collection port 420 is the platelet support escape 249 and the platelet collection tube escape 254. The plasma outlet 456 is aligned vertically with the plasma outlet slot 256, the control port 492 is aligned vertically with the control port slot 264, and the RBC outlet 520 is aligned vertically with the RBC outlet slot 272). Furthermore, the presence of the chamfered portion 210 is promoted in addition to the mounting of the blood processing chamber 352 by the interconnection of the connector 360 and the second connector 368, which are preferably fixed.

  With the blood processing chamber 352 properly positioned, the operator directs the blood processing chamber 352 through the upper channel portion 292 of the reduced width of the channel 208 until the blood processing chamber 352 hits the channel base 220. In this case, the longitudinal range of the blood treatment chamber 352 disposed in the portion of the channel 208 including the first stage 312, the RBC dam 232, and the platelet collection stage 316 is disposed as follows: 1) Upper seal 380 is disposed in the upper channel portion 292; 2) the fluid containing volume of the blood processing chamber 352 is disposed in the central channel portion 300; and 3) the lower seal 384 is disposed in the lower channel portion 304. The mouth (port) described above is also placed in each slot in the channel housing 204 by the operator at the same time. Further, a shield 408 associated with the blood inlet assembly 388 is disposed in a recess 228 coupled to the blood inlet slot 224. Similarly, a shield 538 coupled with the RBC outlet assembly 516 is disposed in a recess 276 associated with the RBC slot 272. Further, the shield 508 associated with the control port assembly 488 is disposed in the recess 268 associated with the control port slot 264.

A pressure test is performed on the circuit 10 and the processing chamber 352 with the extracorporeal tube circuit 10 and the blood processing chamber 352 mounted in the manner described above to confirm that there is no leakage. The donor / patient 4 is then fluidly interconnected with the extracorporeal tube circuit 10 (by inserting an access needle 37 into the donor / patient 4). Further, the anticoagulant tube 54 is filled between the anticoagulant supply (joined with the spike drip member) and the manifold 48. In addition, blood return peristaltic pump 1090 is operated in reverse to draw blood from donor / patient 4 via blood return tube 28 and fill blood return tube 28 and store until blood is detected by low level sensor 1320. Fill site 150 with blood from donor / patient 4.
Blood processing chamber 352 must also be filled for component removal procedures. In one embodiment, blood filling can be utilized in that blood becomes the first liquid introduced into blood processing chamber 352. Blood flow from the donor / patient 4 to the extracorporeal tube circuit 10 is a centrifuge rotor that rotates the channel housing 204 at a rotational speed of about 150 RPM to about 250 RPM, typically about 200 RPM for a rotor diameter of about 10 ″. Starting at assembly 568. This low rotational speed not only reduces the possibility of air locks occurring in blood processing chamber 352, but also minimizes preheating of blood processing chamber 352. This "first stage". The rotation speed in "" can be changed without having to be fixed.

  When the blood flow reaches the blood processing chamber 352, the rotational speed of the channel housing 204 increases from about 1,500 RPM to about 2,500 RPM, preferably about 2,000 RPM, for a rotor diameter of about 250 mm. The blood supplied to 352 is separated into various blood components even during the filling treatment. Furthermore, in this “second stage”, the rotational speed can be changed without having to be fixed. For effective blood filling, flow must be supplied to the control port assembly 488 before the RBC flows past the RBC control port assembly 488 in a clockwise direction. This is also obtained by the configuration of the channel 208.

  What is important is that in this “second stage” of blood filling treatment, the air present in the blood processing chamber 352 is removed from the blood processing chamber 352, and the above-mentioned rotational speed in this “second stage” causes the air lock to move. The possibility is also reduced. More specifically, the air present in the blood processing chamber 352 has a density lower than that of whole blood and all kinds of blood components. As described above, the radially innermost portion of the inner channel wall 212 is at the intersection between the plasma outlet slot 256 and the inner channel wall 212. As a result, air present in the blood processing chamber 352 gathers near the plasma outlet 456, is removed from the blood processing chamber 352 via the plasma outlet tube 476, and is supplied to the ventilation bag 114.

  When blood treatment chamber 352 contains blood and / or blood components throughout it, the rotational speed of channel housing 204 is from about 2,750 RPM to about 3,250 RPM, preferably about 3,000 RPM, for a rotor diameter of about 250 mm. Its normal operating speed increases. This completes the blood filling procedure.

  During the blood filling procedure described above and throughout the remainder of the component removal procedure, the blood component types are separated from each other and removed from the blood processing chamber 352 based on the blood component types. Throughout the component removal procedure, the whole blood flow is supplied to the blood processing chamber 352 via the blood inlet assembly 416 and directed to the first stage 312. Control mouth dam 280 also reduces the likelihood of blood flowing in the counterclockwise direction in channel 208.

  In the first stage 312, the blood is separated from the radially outermost layer to the radially innermost layer into a plurality of blood component layers lined with RBC, WBC, platelets, and plasma. Thus, the RBC settles against the outer channel wall 216 at the first cell separation stage 312. By configuring the RBC dam 232 to be a portion of the channel 210 that extends further inward toward the rotational axis 321 of the channel 204, the RBC dam 232 can hold the separated red blood cells in the first stage 312.

  The separated RBC utilizes the above-described configuration of the outer channel wall 216 that induces the flow of the RBC in a counterclockwise direction (eg, generally opposite to the blood flow through the first cell separation stage 312). It is removed from the first stage 312. That is, the portion of the channel 208 proximal to the RBC outlet assembly 516 is located further from the rotational axis 324 of the channel housing 204 than the portion of the channel 210 proximal to the RBC dam 232. Thus, the separated RBC flows through the first stage 312 in a counterclockwise direction along the outer channel wall 216 and past the blood inlet assembly 388 on the blood processing chamber 352 to the RBC outlet assembly 516. . The vertical slot 404 of the blood inlet 392 is substantially parallel to the inner channel wall 212 of the blood processing chamber 352, the outer channel wall 216, the inner wall 372, and the outer wall 376 of the blood processing chamber 352, so The introduction of blood into the blood treatment chamber 352 substantially affects the flow of the RBC along the outer channel wall 216 because it is oriented in the direction of rotation, ie, in the direction of the RBC dam 232 and is located proximal to the inner channel wall 212. Will not affect. As a result, the RBC is effectively undisturbed and past the blood inlet 392 to the RBC outlet assembly 516 and removed from the blood processing chamber 352. These RBCs can be collected and / or returned to the donor / patient 4.

  Platelets are less dense than RBCs, cross over RBC dams 232 and flow to platelet collection wells 236 in platelet rich plasma where they are removed from blood processing chamber 352 by platelet collection assembly 416. In addition, the blood processing chamber 352 through the support 428 and the outer channel wall 216 collectively defines a platelet collection well 236 when the blood processing chamber 352 is pressurized. That is, a portion of the platelet collection well 236 is defined by a lower face 240 and side faces 244, 248 formed in the outer channel wall 216, and the rest is a platelet support recess 249 simultaneously with the pressurization of the blood processing chamber 352. The second face 436 of the support portion 428 defines the position of the support portion 428 when moved to a predetermined position.

  Platelet-poor plasma is less dense than platelets and continuously flows in a clockwise direction through the second stage 316 to the plasma outlet assembly 452, where at least a portion of the plasma is removed from the blood processing chamber 352. Is done. This plasma can be collected and / or returned to the donor / patient 4. However, some plasma continues to flow in the clockwise direction to the third stage 320, through which it reaches the control port assembly 488, which automates the position of the interface between the RBC and platelets in the manner described above. Provide dynamic control.

Graphic Computer Interface The component removal system 2 further includes a graphic computer interface 660 shown in FIG. 1 to assist the operator in performing the various steps of the protocol used in the component removal procedure by the component removal system 2. The following description describes an interface for use by English-speaking operators. For other operations and / or languages, of course, the textual part of the interface is applied accordingly. The graphic computer interface 660 includes a computer display having “touch screen” functionality. Other suitable input devices (eg, keyboards) may be utilized alone or in combination with a touch screen. For example, a known thin film type pump pause and centrifuge stop button can be provided. The graphic interface 660 allows the operator to provide the necessary input to the component removal system 2 so that parameters associated with the operation of the component removal system are determined (eg, various control parameters associated with the operation of the component removal system 2). The interface 660 also assists the operator by providing images of at least some steps of the component removal procedure. Further, interface 660 communicates the status of the component removal procedure to the operator. In addition, interface 660 can be used to activate standardized set operations (ie, the operator only needs to confirm the problem and indicate it to interface 660, which component removal system 2 corrects). ).

  Referring to FIG. 26, at the beginning of the component removal procedure, a master screen 696 is displayed on the display 664 to the operator. Each of the master screen 696 and the screen displayed to the operator by the interface 600 includes a status bar 676. Status bar 676 includes a pre-system icon set 700. The system pre-processing icon set 700 includes a wear icon 704 (representing the shape of the blood component separation device 6) and collectively images the operator that the disposable set 8 should be worn on the blood component separation device 6. It has an arrow that extends downward. The word “LOAD” is also positioned below the mounting icon 704 and provides instructions to the operator in short text for the required action.

  The system pre-processing icon set 700 is an information icon 708 (open filing holder) that informs the operator that some information about the donor / patient 4, treatment protocol and / or blood component separation device 6 should be obtained and entered. Express). This information is utilized by the component removal system to calculate one or more parameters associated with the component removal procedure (eg, inlet flow to the blood treatment chamber 352) and / or the predicted yield of one or more blood components (eg, The amount of certain blood component types that are expected to be collected based on certain parameters, such as delivery time. The word “INFO” is also positioned under the information icon 708 and indicates to the operator in short text about the required action. An information icon 708 is also positioned to the right of the wearing icon 704 to indicate to the operator that it is not absolute, but preferred to perform the steps associated with the information icon 708 after the steps associated with the wearing icon 704 are completed. .

  The status bar 676 also includes a collection icon set 712. The collection icon set 712 is a donor / patient pretreatment icon 716 (donor / patient 4 shape) that images the operator that the donor / patient 4 is currently fluidly interconnected with the blood component separator 6. Is also included. The word “PREPARE” is also positioned under the donor / patient pretreatment icon 716 to indicate to the operator in short text about the required action. The donor / patient pretreatment icon 716 is also positioned to the right of the information icon 708 and the steps associated with the donor / patient pretreatment icon 716 are performed only after the steps associated with the wear icon 704 and the information icon 798 are completed. Is shown to the operator.

  The collection icon set 712 also includes a side-provided icon 720 that collectively conveys to the operator an image that the step of starting this action should now be performed as the actual collection procedure begins. Including. The word “DONATE” is also positioned under the donation icon, indicating a short text to the operator about the required action. The pre-delivery icon 720 is also positioned to the right of the donor / patient pre-treatment icon 716, and the steps associated with the donation / patient icon 720 should be performed only after the steps associated with the donor / patient pre-treatment icon 716 are complete. Show to member.

  The status bar 676 is generally above the removal icon 724 (representing the shape of the blood component separator 6) and a collective image to the operator that the disposable set should now be removed from the blood component separator 6 Includes an extending arrow. The word “UNLOAD” is also positioned under the removal icon 724 and gives a short text indication to the operator about the required action. A removal icon 724 is also positioned to the right of the offer icon 720 to indicate to the operator that the steps associated with the removal icon 724 should be performed after the steps associated with the offer icon 720 are complete.

  System ready icon set 700, collection icon set 712, and removal icon 724 in status bar 676 illustrate certain basic steps of the component removal procedure. That is, the left and right positioning of the various icons tells the operator the desired order in which the steps associated with those icons should be performed. In addition, the individual icons 704, 708, 716, 720, and 724 are used to convey the status of the component removal procedure to the operator through three-stage color discrimination (ie, one color one state) and / or three-stage shade discrimination. . “Shade” includes variations of a given color and includes using variations based on “light” and / or “dark” (eg, light gray, medium gray, and dark gray). That is, the “achromatic scale” method is utilized and is included through the use of color and / or shade discrimination.

  The first state conveyed to the operator by the icon in the status bar 676 is that the step associated with each icon is not ready to be executed. That is, the execution of this step is timely and quick. This first state is conveyed to the operator by displaying a related icon of the first color such as white. The corresponding text description is also shown in this first color. As described above, the first “shade” is also used to convey this first state.

  The second state communicated to the operator by an icon in the status bar 676 is that the steps associated with each icon are ready for execution or are actually executing. That is, the operator is shown that the execution of this component removal step is now timely. This second state is communicated to the operator by displaying a related icon of the second color such as yellow. The corresponding text description is also shown in this second color. As described above, the second “shade” is also used to convey this second state.

A third state conveyed to the operator by icons in the status bar 676 is that the steps associated with each icon have already been performed. That is, the operator is informed that this component removal step has been completed. This third state is conveyed to the operator by displaying a third color related icon such as gray. The corresponding text description is also shown in this third color. As described above, the third “shade” is also used to convey this third state.
Based on the above, it is believed that simply looking at the status bar 676 will convey important information to the operator. For example, the operator is presented with an image showing the basic steps of the component removal procedure. In addition, the operator is shown text that indicates the basic steps of the component removal procedure. In addition, the operator is shown the desired order in which these steps should be performed. Finally, the operator is shown the status of the component removal treatment by the above three-stage color / shade distinction.

  The master screen 696 and all other screens displayed to the operator by the interface 660 during the component removal procedure also include a work area 688. Work area 688 provides multiple functions. First, the work area 688 displays additional information regarding the performance of the component removal procedure to the operator (possibly with images and text) (eg, component removal procedure indicating some “states” encountered during the component removal procedure). Additional sub-steps). In addition, work area 688 also displays additional information regarding the status of the component removal procedure to the operator. Further, the work area 688 allows the operator to interact with the computer interface 660, such as by permitting / requesting the operator to enter certain information.

  With continued reference to FIG. 26, the work area 688 of the master screen 696 displays a wear system button 728 and a donor / patient info button 780. The operator touches one of these buttons 728, 780 (ie, the display 696 has “touch screen” capabilities) to generate another screen and / or computer interface 660 to provide information to the operator. Input of information can be promoted. The operator can initially touch either the wear system button 728 or the donor / patient info button 780 at the beginning of the component removal procedure. That is, the order in which the steps associated with the wear system button 728 are performed in relation to the component removal steps associated with the donor / patient info button 780 is not important (ie, the steps associated with the wear system button are the donor / patient). Can be performed before or after the step associated with the info button 780). The component removal procedure will first be described with respect to an operator who chooses to activate the wear system button 728 via a touch screen function.

  Actuation of the wear system button 728 generates a wear procedure screen 732 on the computer display 664 shown in FIG. The installation procedure screen 732 displays a number of images to the operator in a work area 688 regarding the steps that must be performed to prepare the blood component separation device 6 for component removal procedures. First, a hang image 736 is displayed, which requires various bags (eg, an AC bag (not shown), a plasma collection bag 94, a platelet collection bag 84) to be attached to the blood component separation device 6, usually this step. Tells the operator how it is affected by the image. The word “HANG” is also positioned on the hang image 736 and indicates to the operator in short text about the required action. As a result, there are two types of image displays shown to the operator in connection with the special operator actions necessary to prepare the blood component separation device 6 for component removal treatment. Further, the hang image 736 is placed on the left side of the attachment treatment screen indicating that this is the first step or sub-step associated with the attachment icon 704. The number “1” is also placed adjacent to the word “hang” to provide the operator with other information in the desired order.

  A distinct color (eg yellow) or shade can be used to direct the operator's attention to a specific part of the device or screen. The attachment treatment screen 732 also displays an insertion image 740 to the operator in the work area 688. The inset image 740 requires the cassette assembly 110 to be attached to the pump / valve / sensor assembly 1000 of the blood component separation device 6, and this step is usually an image of how the operator performs this operation. Tell. The word “INSERT” is also positioned on the inset image 740 and gives instructions to the operator in short text for the required action. The insert image 740 is also positioned to the right of the hang image 736 to indicate to the operator that it is not necessary, but preferred, to perform the steps associated with the insert image after the steps associated with the hang image 736 are completed. The number “2” is also placed adjacent to the word “insert” to provide the operator with other information in the desired order.

The mounting treatment screen 732 also displays a mounting image 744 to the operator in the work area 688. The wearing image 744 requires the blood treatment chamber 352 to be attached to the channel 208 of the channel housing 204 of the centrifuge rotor assembly 568, and usually communicates to the operator how this step is affected by the operator. . The word “LOAD” is also positioned on the wearing image 744 and a short text is given to the operator for the required action. The wearing image 744 is also positioned to the right of the insertion image 740 to indicate to the operator that it is not necessary but preferable to perform the steps associated with the wearing image 744 after the steps associated with the insertion image 740 have been completed. . The number “3” is also placed adjacent to the word “mounted” to provide the operator with other information in the desired order.
Finally, the wear procedure screen 732 displays a closed image 748. The closed image 748 needs to close the door of the blood component separator that houses the centrifuge rotor assembly 568, and usually tells the operator how this step is performed. The word “CLOSE” is also positioned on the closed image 748 to indicate to the operator a short text for the required action. The closure image 748 is also positioned to the right of the wearing image 744 to indicate to the operator that the steps associated with the closing image 748 are performed after the steps associated with the wearing image 744 are complete. The number “4” is also placed adjacent to the word “closed” to provide the operator with other information in the desired order.

  In summary, the work area 688 of the mounting treatment screen 732 provides the operator with what type of steps must be performed for this aspect of the component removal procedure, and how these steps are typically performed. In addition to communicating, the work area 688 of the mounting procedure screen 732 also specifies the order in which these steps should be performed by two “methods”. First, image graphics 736, 740, 744 and 748 are displayed sequentially from side to side, specifying the desired order of execution. In addition, the four steps are identified by numbers next to the one-word text description associated with them.

  If additional guidance regarding any of the steps displayed on the mounting procedure screen 732 is required, the operator can touch a help button 692 provided on the mounting procedure screen 732. This displays a menu of screens on which the operator can continuously view and / or show the help screen number associated with the mounting procedure screen 732. FIG. 28 shows a help screen 764 relating to mounting a blood treatment chamber 352 in channel 208 of channel 204. In the case of the help screen 764, it is not noted that the work area 688 of the mounting procedure screen 732 is retained (ie, a text description of the four basic steps one word and an order identifier by associated number). In addition, the help screen 764 provides the operator with further details regarding the nature of the additional image regarding one or more specific steps or sub-step aspects, or in this case, mounting the blood treatment chamber 352 in the channel 208. . When the operator exits the help screen 764 by touching the continue button 752 on the help screen 764, the operator returns to the mounting procedure screen 732 of FIG. Various other screens in the graphic interface 660 include a help button 692 to provide this type of functionality.

  When the operator completes each of the four steps or sub-steps shown on the attachment treatment screen 732, the operator touches the continue button 752 below the attachment treatment screen 732. If the operator wants to return to the start operation screen 696 while performing the steps or sub-steps associated with the mounting procedure screen 732, he can touch the display screen 664 in the portion of the return button 756. A return button 756 can be provided on the various screens to return the operator to the previous screen if acceptable. Further, if the operator wishes to end the mounting procedure while performing the steps or sub-steps associated with the mounting procedure screen 732, the operator touches the display screen 664 in the portion of the exit mounting or cancel button 760. Can do. A mounting interrupt or cancel button is provided on various other screens to provide options to the operator and exit the mounting procedure as needed.

  When the operator touches the continue button 752 on the wearing procedure screen 732, a disposable pressure test screen 768 is created on the display 664, one example of which is shown in FIG. Typically, the disposable pressure test screen 768 must perform certain steps to allow pressure testing of the disposable set 8 and also image the operator how this is affected. In this regard, the donor / patient access line clamp image 769 images the blood removal / return tube assembly 20 to the donor / patient 4 and in particular the interconnect tube 38 must be sealed. Donor / patient sample line clamp image 770 images the operator that the sample line of sample subassembly 46 must also be sealed. When the operator completes these steps, the operator touches the continue button 752 and a test in progress screen 772 is displayed to the operator, telling the operator in image and text that the test procedure is being performed, and this Is shown in FIG.

  After the pressure test of the disposable set 8 is completed, an AC interconnect screen 776 appears on the display 664, one example of which is shown in FIG. The AC interconnect screen 776 requires that the anticoagulant tube assembly 50, specifically the spike drip member 52 of the extracorporeal tube circuit 10, fluidly interconnects with an AC bag (not shown), and usually also this is the operator. Tells the operator how to do this with an image. When this step is completed by the operator, the operator touches the continue button 752 on the display 664.

  The AC interconnect is the last step associated with the wearing icon 704 and the operator returns to the master screen 696. The master screen 696 then represents the current status of the component removal procedure and is shown in FIG. That is, the color or shade of the wearing icon 704 changes from the second color / shade to the third color / shade, indicating that all steps associated with the wearing icon 704 have been completed by the operator. In addition, a status check 730 also appears on the mounting system button 728 in the work area 688. The wear system button 728 turns gray for the duration of the treatment, indicating that the system setup cannot be repeated. As a result, two different types of instructions are presented to the operator for the current state regarding the mounting procedure. Changes in the status of the donor / patient data entry portion of the component removal procedure are also information in the status bar 676 in the second color / shade that indicates to the operator that it is currently appropriate to initiate this aspect of the component removal procedure. It is updated by indicating

  The operator touches the info button 780 on the display 664 of the master screen 696 to input an information item part for component removal treatment. This results in a donor / patient data screen 778 on display 664, one example of which is shown in FIG. Donor / patient data screen 788 includes a gender type button 792, a height button 796, and a weight button 808. The operator can indicate the donor / patient 4 by touching the relevant portion of the separate split type button 792, and the selected gender is displayed to the operator (eg, by color discrimination). Further, the operator can input the height and weight of the donor / patient 4 by touching the height button 796 and the weight button 808, respectively. When the height button 796 and the weight button 808 are combined by the operator, as shown in FIG. 34, the keypad 804 is overlaid on the button for inputting the information. The keypad 804 can be used to input the height and weight of the donor / patient 4 and this information is also displayed to the operator.

  The information entered by the operator on the donor / patient data screen 788 is used to calculate, for example, the total blood volume of the donor / patient 4, the result of the calculation being the total blood volume display on the donor / patient data screen 788. The total blood volume of donor / patient 4 shown at 790 can be used to measure various parameters associated with the component removal procedure and / or determine the number of blood components that are considered to be collected in the procedure. When the operator completes these data entry procedures, he touches the continue button 752 displayed at the bottom of the donor / patient data screen 788 after all necessary information has been entered.

  After the steps associated with the donor / patient data screen 788 are completed, a lab data entry screen 810 is generated on the computer display 664 and one example is shown in FIG. 35 as shown by the operator. The lab input screen 810 prompts the operator to enter the time of the collection procedure by touching the provide time button 840 that will cause the keypad 804 to overlap the provide time button 832 (not shown). The provided time entered by the operator is displayed on the time display 860, which indicates the duration of the treatment. Further, the provision time input by the operator can be displayed on the provision time button 840. The donation time is used, for example, to predict the number of blood components (eg, platelets, plasma) that are considered to be collected during the procedure.

  The lab data screen 810 also instructs the operator to enter the donor / patient 4 hematocrit by touching the hematocrit button 842. This places the keypad 804 over the hematocrit button 842, and the operator can then enter the hematocrit of the donor / patient 4 (eg, measured by laboratory analysis of a blood sample from the donor / patient 4), This can be displayed on the hematocrit button 842. The donor / patient 4 hematocrit is utilized by one or more aspects of the component removal procedure.

  The lab data screen 810 also instructs the operator to enter the donor / patient 4 platelet precount by touching the platelet precount button 843. This places the keypad 804 over the platelet precount button 843, and the operator can then enter the donor / patient 4 platelet precount (eg, by laboratory analysis of a blood sample from the donor / patient 4). This can be displayed on the platelet precount button 843. The donor / patient 4 platelet precount is utilized by one or more aspects of the component removal procedure.

  When the operator has entered all the necessary information, the operator touches the continue button 752, which returns the operator to the master screen 696, which represents the current status of the component removal procedure, as shown in FIG. . Now that all the steps associated with the information icon 708 have been completed, the color / shade of the information icon 708 has changed from the second color / shade to the third color / shade, and all the related steps have been completed. Tell the operator that In addition, a status check 784 also appears on the donor / patient info button 780 in the work area 688. As a result, two different types of instructions are provided to the operator for the current state of this aspect of the component removal procedure. In addition, a change in the status of the component removal treatment collection sicon set 712 changes the color / shade of the donor / patient pretreatment icon 716 in the status bar 676 from the first color / shade to the second color / shade. Update. The master screen 696 now also shows an execute button 802, the steps associated with the collection icon set 712 are currently executed, and the display by the image is shown to the operator.

  The initial screen for the steps associated with the collection icon set 712 is the donor / patient pretreatment screen 812A shown in FIG. The donor / patient pretreatment screen 812A communicates to the operator with an image the steps that must be performed in relation to the donor / patient 4 fluidly interconnected with the blood component separation device. Initially, a donor / patient connection image 816 is displayed, which tells the operator with an image how the access needle needs to be attached to the donor / patient 4 and this step is usually performed by the operator. The term “CONNECT” is also positioned on the donor / patient connection image 816, and the operator is instructed by short text for the required action. The donor / patient connection image 816 is located on the left side of the donor / patient pretreatment screen 812A indicating that this is the first step or sub-step associated with the donor / patient pretreatment icon 716. The number “1” is also placed adjacent to the word “connection” to provide the operator with other information in the desired order.

  The donor / patient pretreatment screen 812A also displays an open image 820 on the display 664. The open image 820 informs the operator with an image that the clamp 42 of the interconnect tube 38 and the tube clamp of the sample assembly 46 need to be removed, and how this step is usually performed by the operator. . The word “OPEN” is also positioned on the open flow image 820 to indicate to the operator in short text about the required action. Open image 820 is placed to the right of donor / patient connection image 816 indicating that the steps associated with open image 820 should only be performed after the steps associated with donor / patient connection image 816 are complete. The number “2” is also placed adjacent to the word “open” to provide the operator with other information in the desired order.

  The donor / patient pretreatment screen 812A also displays a flow image 824 on the display 664. The flow image 824 informs the operator with an image that there is currently a blood flow from the donor / patient 4 to the blood removal / return tube assembly 20, specifically the blood removal tube 22, and the sample subassembly 46. The word “FLOW” is also positioned on the flow image 824, giving the operator a short text explanation of what happens at this point. The flow image 824 is placed to the right of the open image 820 indicating that the state associated with the flow image 824 occurs only after the steps associated with the open image 820 are complete. The number “3” is also placed adjacent to the word “flow” to provide the operator with other information in the desired order.

  In summary, the work area 688 on the donor / patient pretreatment screen 812A indicates what type of steps must be performed for this aspect of the component removal procedure, and how these steps are typically performed. As well as specifying the order in which these steps should be performed in two ways. First, image graphics 816, 820, and 824 are continuously displayed on the left and right. In addition, three steps are identified by numbers next to the one-word text description associated with them.

  When the operator completes all of the steps associated with the donor / patient pretreatment screen 812A, the operator touches the continue button 752, thereby displaying the second donor / patient pretreatment screen 812B as shown in FIG. It becomes. The donor / patient pretreatment screen 812B clamps the sample line to terminate blood flow from the donor / patient 4 to the sample subassembly 46 and how this step is typically performed by the operator. Including a closed image 828 that conveys the image to the operator. The word “CLOSE” is also positioned on the closed image 828 and indicates to the operator in short text about the required action. Closed image 828 is placed on the left side of donor / patient pretreatment screen 812B indicating that this is the first step or sub-step associated with donor / patient pretreatment 812B. However, the number “4” is also placed adjacent to the word “closed” to indicate that this is actually the fourth step associated with donor / patient pretreatment.

  The donor / patient pretreatment screen 812B also displays a seal flow image 832 on the display 664. The seal flow image 832 tells the operator in an image how the sample line of the sample subassembly 46 is currently to be sealed and how this step is usually performed by the operator. The word “SEAL” is also positioned on the seal flow image 832 to indicate to the operator in short text about the required action. Seal flow image 832 is positioned to the right of closure image 828 indicating that the condition associated with seal flow image 832 occurs only after the steps associated with closure image 828 are complete. The number “5” is also placed adjacent to the word “seal” to provide the operator with other information in the desired order, which is actually the fifth step associated with donor / patient pretreatment. It shows that.

  In summary, the work area 688 on the donor / patient pretreatment screen 812B indicates what type of steps must be performed for this aspect of the component removal procedure, and how these steps are typically performed. As well as the work area 688 on the donor / patient pretreatment screen 812B also specifies the order in which these steps should be performed in two ways. First, image graphics 828, 832, and 836 are displayed sequentially from side to side. In addition, the four steps are identified by numbers next to the one-word text description associated with them.

  When the operator completes all of the donor / patient pretreatment, the operator can touch the start fill button 846 on the donor / patient pretreatment screen 812B, which causes the extracorporeal tubing 10 and blood treatment chamber 352 described above. As blood filling starts, the execution screen 844 shown in FIG. 39 is displayed. The execution screen 844 mainly displays information related to the component removal treatment to the operator. For example, the run screen 844 may display a blood pressure display 848 (ie, to communicate the donor / patient extracorporeal blood pressure to the operator), a platelet display 852 (ie, to provide the operator with an estimate of the number of platelets being collected). A plasma collection display 856 (ie, to inform the operator of the amount of plasma currently collected), and a time display 860 (eg, the time that has elapsed since the start of the collection procedure (the left bar is illustrated and described above) Time) as well as the amount of time remaining in the collection procedure (right bar shown and above). A control button (not shown) can be provided to toggle between the time remaining display and the start and stop time display.

  Execution screen 844 provides blood from donor / patient 4 (eg, utilizing a single needle and fluidly interconnecting blood component separator 6 and donor / patient 4) (eg, It also indicates whether it has been removed (by displaying “withdrawing in progress”) or has been returned to the donor / patient 4 (eg, by displaying “in progress of return”). This information indicates that blood is being returned to the donor / patient 4 if the donor / patient 4 maintains a constant blood pressure by squeezing objects to assist in the removal of blood from the donor / patient 4. In the meantime, it is considered effective for the donor / patient in that the donor / patient 4 is instructed to stop these movements.

  During the component removal procedure, the component removal system 2 can detect several states obtained by investigation by the operator. If one of these conditions is detected, an appropriate warning screen is displayed to the operator. One embodiment of warning screen 864 is shown in FIG. First, alert screen 864 communicates potential problems with system 2 in text via problem graphic 868. This text is useful for ensuring that the operator understands the problem. The warning screen 864 includes an action image 872 that graphically tells the operator what action to take in connection with the problem. Some operations may be difficult or impossible for the system 2 itself to perform. Finally, the warning screen includes a check result array 876 that allows the operator to indicate the result of the check. In the illustrated embodiment, the array 876 includes a blood leak button 906, a moisture button 908, and a no leak button 910.

  Depending on the selections made by the operator in the inspection results array 876, additional questions can be presented to the operator in another screen that requires further investigation and / or specifies the desired therapeutic action. For example, the refill warning screen 878 of FIG. 41 can be generated by an operator touching the moisture button 908 on the warning screen 864. The replenishment warning screen 878 includes a therapeutic action image 912 and therapeutic action text 914 to inform the operator how to correct the identified problem.

  The computer interface 660 allows the operator to initiate several types of corrective actions based on processing decisions made by and / or communicated to the operator. For example, various screens of interface 660 include troubleshooting buttons 898 that generate one or more troubleshooting. These troubleshooting screens include menus or the like that can indicate to the operator what kind of potential problems exist.

  One embodiment of a troubleshooting screen 880 is shown in FIG. Troubleshooting screen 880 includes a donor / patient sting button 922. This button 922 can be used by the operator to treat the effect of AC on the donor / patient 4 in response to the donor / patient exhibiting a “stinging sensation” or alternatively an “AC response”. When the operator hits the “down arrow” of the donor / patient sting button 922, the system 2 attempts to correct its condition in a predetermined manner (ie, a predetermined protocol is preferentially performed and this protocol is Does not require any action or decision). When the stinging sensation is no longer present, the operator uses the “up arrow” button to return the donor / patient stinging button 922 bar to its initial position.

The troubleshooting screen 880 also includes a clamping button 924. This button 924 is used by the operator if undesirable clamping of the collected product (eg, platelets) is observed. When the operator hits the “down arrow” of the clamping button 924, the system 2 attempts to correct its state in a pre-defined manner (ie, a given protocol is preferentially performed and this protocol is No action or decision is required). When clamping is no longer observed by the operator, the operator can use the “up arrow” button to move the bar of the clamping button 924 back to its initial position.
Troubleshooting screen 880 includes an outflow button 916 and a “plasma line aeration” button 918. The outflow button 916 is used by the operator if red blood cells are observed flowing in the platelet outlet tube 66, the platelet collection bag 84, and / or beyond the RBC dam 232. Activation of the outflow button 916 via touch screen capability is performed in the system 2 using a predetermined protocol, but preferably an automatic protocol is executed by the system 2 to correct this condition. Similarly, if the operator confirms air in the plasma line 918 and uses the button 918, the system 2 more preferably automatically corrects this condition using a predetermined protocol.

  An “other problem button” 920 can be utilized to generate another troubleshooting screen to indicate other problems that may occur in the component removal procedure. Also, preferably, when an operator touches an associated button indicating a particular problem, a predetermined protocol is preferably used automatically to correct this problem.

  When the collection portion of the component removal procedure is complete, a rinse back screen 884 appears on the display 664, indicating that a rinse back procedure is currently being performed, as shown in FIG. When the rinseback is complete, the color / shade of the provided icon 720 changes from the second color to the third color / shade, indicating that all the steps associated with this aspect of the component removal procedure have been completed. In addition, the color / shade of the removal icon 724 also changes from the first color / shade to the second color / shade, indicating to the operator that the steps associated with them can now be performed.

When the rinseback is complete, an end-of-execution screen appears on the display 664 and the last collection data (eg, the related yield of platelets and plasma collected at the time of treatment) and treatment has been completed as shown in FIG. By displaying “execution complete”). The operator can then touch the continue button 752.
When the rinseback procedure is complete, a removal screen 892 is shown on the display 664, which is shown in FIG. The removal screen 892 can continuously display the number of images to the operator, telling the steps to complete and finish the procedure. For example, a seal / removal image 900 is initially displayed on the removal screen 892, with the images sealing the tubes leading to the platelet and plasma collection bags 84, 94, respectively, so that the platelet and plasma collection bags 84, 94 can be removed, respectively. Tell the operator. When the operator touches the continue button 752, the cut image 902 is shown on the removal screen and the image can be communicated to the operator that the access needle 32 should be removed from the donor / patient 4. When the operator touches the continue button 752, a removal image 904 is shown on the removal screen 892, and the image shows the operator that the disposable set 8 should be removed from the blood component separation device 6 and properly positioned. Tell.

  The computer interface 660 provides many advantages. For example, the computer interface 660 utilizes three-stage color discrimination to advantageously communicate the status of the component removal procedure to the operator. If the step associated with the icon is not ready for execution, the icon is shown in one color / shade, but if the step associated with the icon is ready for execution or has been executed, another The icon is shown in one color / shade and the icon is shown in yet another one color / shade if the step associated with the icon has been completed. In addition, the computer interface 660 shows the operator with images for at least some of the steps of the component removal procedure. In addition, the desired sequence of at least basic steps of the component removal procedure is communicated to the operator. Finally, certain conditions can be corrected by the interface 660, and after appropriate operator input, these are corrected by the system 2 according to a predefined protocol.

  The foregoing description of the present invention has been presented for purposes of illustration and description. Furthermore, the description is not intended to limit the invention to the form disclosed herein. As a result, changes and modifications consistent with the skill and knowledge of the above-mentioned techniques and related techniques are within the scope of the present invention. The above-described embodiments further illustrate the best mode known for practicing the invention, and other persons skilled in the art will be required by the same or different embodiments and specific applications or uses of the present invention. It is a further object to enable the present invention to be utilized in various modifications. The appended claims are intended to be construed to include alternative embodiments to the extent permitted by the prior art.

It is a perspective view of one Example in a component removal system. FIG. 2 shows an extracorporeal tube circuit and its cassette assembly for the system of FIG. FIG. 2 shows an extracorporeal tube circuit and its cassette assembly for the system of FIG. FIG. 2 is a front view of a pump / valve / sensor assembly for the system of FIG. 2B is a cross-sectional side view of first and second pressure sensor modules of the outer tube circuit of FIG. 2A coupled with corresponding pressure sensors of the pump / valve / sensor assembly of FIG. 2B is a cross-sectional side view of first and second pressure sensor modules of the outer tube circuit of FIG. 2A coupled with corresponding pressure sensors of the pump / valve / sensor assembly of FIG. 2B is a cross-sectional side view of the upper and lower ultrasonic sensors in the pump / valve / sensor assembly of FIG. 3 coupled to the reservoir of the extracorporeal tube circuit cassette assembly of FIG. 2A. FIG. 4 is a cross-sectional side view of a platelet bypass valve subassembly in the pump / valve / sensor assembly of FIG. 3. FIG. 4 illustrates a cassette mounting plate mounting assembly in the pump / valve / sensor assembly of FIG. 3. FIG. 2 is a perspective view of a channel assembly from the system of FIG. FIG. 9 is a top view of the channel housing from the channel assembly of FIG. 8 showing the dimensions. FIG. 9 is a top view of the channel housing from the channel assembly of FIG. 8 showing the dimensions. FIG. 10 is a cross-sectional view taken along line 10-10 of FIG. FIG. 9 is a cross-sectional perspective view of a platelet collecting well portion of the channel housing of FIG. 8. It is the sectional side view which looked at the platelet collection well part of the channel housing of FIG. 8 upwards. FIG. 10 is a cross-sectional view of the channel housing taken along line 12-12 of FIG. FIG. 14 is a cross-sectional view of the channel housing taken along line 13-13 of FIG. FIG. 9 is a top view of the blood inlet slot, RBC outlet slot, and control port slot of the channel housing of FIG. FIG. 9 is a cross-sectional perspective view of the whole blood inlet slot portion of the channel housing of FIG. 8. FIG. 9 is a cross-sectional perspective view of a control port slot portion of the channel housing of FIG. 8. FIG. 9 is a top view of the channel of FIG. 8 showing the ratio of red blood cell volume to plasma volume. FIG. 9 is a perspective view of the blood treatment chamber of the channel assembly of FIG. 8 in an exploded state. It is sectional drawing of the blood processing chamber at the time of interconnection. FIG. 19 is a cross-sectional view of the blood treatment chamber taken along line 18-18 of FIG. FIG. 9 is a cross-sectional perspective view of a blood inlet assembly for the blood processing chamber of FIG. FIG. 9 is a longitudinal cross-sectional view of a blood inlet assembly for the blood processing chamber of FIG. FIG. 9 is a cross-sectional view of a blood inlet assembly joined to the blood treatment chamber of FIG. FIG. 19B is a perspective view inside the blood inlet blade of FIG. 19C. FIG. 9 is a cross-sectional perspective view of blood introduced into the blood processing chamber of FIG. 8 during component removal treatment. It is sectional drawing of the blood introduce | transduced in the blood processing chamber and channel of FIG. 8 at the time of a component removal treatment. It is sectional drawing which looked at the blood introduce | transduced into the blood processing chamber and channel of FIG. 8 at the time of a component removal treatment. FIG. 9 is a cross-sectional perspective view of the red blood cell outlet assembly joined to the blood treatment chamber of FIG. FIG. 20B is a longitudinal cross-sectional view of the red blood cell outlet assembly of FIG. 20A. FIG. 9 is a cross-sectional perspective view of the red blood cell inlet assembly joined to the blood treatment chamber of FIG. 8 in the rinse back at the end of the component removal procedure. FIG. 9 is a cross-sectional view of the erythrocyte inlet assembly joined to the blood processing chamber of FIG. 8 in the rinse back at the end of the component removal treatment as seen downward. FIG. 9 is a cross-sectional view of a platelet outlet assembly for the blood treatment chamber of FIG. FIG. 21B is a plan view of the platelet outlet assembly of FIG. 21A from inside the channel. FIG. 9 is a cross-sectional perspective view of a plasma port assembly for the blood treatment chamber of FIG. FIG. 9 is a cross-sectional perspective view of the control port assembly of the blood treatment chamber of FIG. FIG. 9 is a cross-sectional view of the control assembly joined to the blood treatment chamber of FIG. FIG. 2 is a perspective view of a centrifuge rotor assembly for the system of FIG. FIG. 25 is a longitudinal sectional view of the centrifuge rotor assembly of FIG. 24. FIG. 25 is a top view of a rotor body of the rotor assembly of FIG. 24. FIG. 25 is a top view of the rotor body of the rotor assembly in FIG. 24 with the upper counterweight removed to show the lower counterweight. It is a front view of the rotor main body of FIG. FIG. 25 is a perspective view of the left side of the blood processing chamber aperture in the rotor body of FIG. 24. It is sectional drawing of the rotor main body of FIG. FIG. 2 is a diagram illustrating a “master screen” for the computer graphic interface of the component removal system of FIG. 1. FIG. 2 is a diagram illustrating a “mounting procedure screen” for the computer graphic interface of the component removal system of FIG. 1. It is a figure which shows one Example of the "help screen" for the installation procedure of FIG. FIG. 2 shows a “disposable pressure test screen” for the computer graphic interface of the component removal system of FIG. 1. FIG. 2 is a diagram illustrating an “in-progress pressure test screen” for the component removal computer graphic interface of FIG. 1. FIG. 2 shows an “AC Interconnect Screen” for the component removal computer graphic interface of FIG. 1. It is a figure which shows the "master screen" of FIG. 26 updated in order to show completion of mounting | wearing of a disposable part. FIG. 2 shows a “donor / patient data screen” for the computer graphic interface of the component removal system of FIG. 1. FIG. 2 illustrates a “weight input screen” for the computer graphic interface of the component removal system of FIG. 1. FIG. 2 shows a “lab data screen” for the computer graphic interface of the component removal system of FIG. 1. FIG. 27 shows the “master screen” of FIG. 26 being updated to show completion of donor / patient preparation. FIG. 2 shows a first “donor / patient preparation screen” for the computer graphic interface of the component removal system of FIG. 1. FIG. 4 shows a second “donor / patient preparation screen” for the computer graphic interface of the component removal system of FIG. 1. FIG. 2 is a diagram illustrating an “execution screen” for the computer graphic interface of the component removal system of FIG. 1. FIG. 2 is a diagram illustrating one embodiment of an “alarm screen” for the computer graphic interface of the component removal system of FIG. 1. FIG. 41 is a diagram illustrating an “auxiliary alarm screen” for the alarm screen of FIG. 40. FIG. 2 is a diagram illustrating one embodiment of a “troubleshooting screen” for the computer graphic interface of the component removal system of FIG. 1. FIG. 2 is a diagram illustrating a “final execution data display screen” for the computer graphic interface of the component removal system of FIG. 1. FIG. 2 is a diagram showing a “rinse back screen” for the computer graphic interface of the component removal system of FIG. 1. FIG. 2 shows a “detach screen” for the computer graphic interface of the component removal system of FIG. 1.

Claims (21)

A blood component removal system (2),
A centrifuge rotor (568);
A channel housing (204) coupled to the centrifuge rotor (568) and including a blood treatment channel (208);
The blood processing channel (208)
A first cell separation stage (312) having a blood inlet (224, 388) and an RBC outlet (272, 516), which is adapted to contain red blood cells during blood processing and has a first volume V1. One cell separation stage;
At least one other cell separation stage (316), which contains only plasma or platelet rich plasma and has a second volume V2 , and
The blood component removal system is configured to use whole blood as fluid filling, and satisfies the formula (1).
V2 / V1 <(HRP / HIN-1) / 2 (1)
Where V2 = volume of channel (208) containing only plasma or plasma rich in platelets; V1 = volume of channel (208) containing RBC; HRP = channel (208 via the RBC outlet assembly (516) ) And the hematocrit of the packed RBC that exits); and HIN = the hematocrit of blood entering the channel (208) via the blood inlet assembly (388). The system of claim 1, wherein the at least one other stage (316) includes a portion of the channel that essentially contains plasma ( _VPL ) during a blood component removal process, and the portion that includes the plasma. Is smaller than the first cell separation stage (312), and the first cell separation stage (312) essentially includes RBC (V _RBC ) during the blood component removal process.   3. The system according to claim 2, wherein the relative size of the plasma-containing portion and the RBC-containing portion is in a reference circle (332) having its origin on the axis of rotation of the centrifugal rotor (568). The reference circle (332) intersects the RBC dam (232), and the volume of the portion containing plasma is located radially inward from the reference circle (332), A system in which the volume of the portion including the RBC is arranged radially outward of the reference circle (332).   3. The system of claim 2, wherein the ratio of the volume of the plasma containing portion to the volume of the RBC containing portion is less than 0.3.   5. The system of claim 4, wherein the ratio is less than 0.25.   The system according to any one of claims 2 to 4, wherein the width of the channel (208) between the portion containing plasma and the platelet collection region (236) is determined by the first cell separation. A system that is smaller than the width of the channel (208) across the stage (312).   The system of claim 6, wherein the channel (208) between the plasma-containing portion and the platelet collection region (236) has a flat inner wall (212) and an outer wall (216) extending substantially vertically. System.   The system of claim 1, further comprising a blood processing chamber (352) disposed in the blood processing channel (208) and means (256, 452) for exhausting air from the blood processing chamber (352). System.   A system according to claim 8, wherein said means for venting air (256, 452) comprises a radially innermost portion of said channel (208).   The system of claim 9, further comprising a disposable blood treatment chamber (352), the chamber (352) comprising a container (104) for receiving air exhausted from the chamber (352) by priming water.   The system according to claim 1, wherein the blood treatment channel (208) extends in a curve in a first direction about an axis of rotation of the channel housing (204), the channel (208) 1 including the first cell separation stage (312), the RBC dam (232), the platelet collection region (236), the plasma collection region (452), and the interface control region, and the RBC and adjacent blood component types A system including an interface control port (488) that controls the radial position of at least one interface between the two.   12. The system according to any one of the preceding claims, further comprising a control device for the centrifugal rotor (568), the control device comprising the rotor (568) at least in a first time portion. Rotate the channel housing (204) at a first angular velocity during a period of time and rotate the channel housing (204) at a second angular velocity greater than the first angular velocity for at least a second time period. And rotating the channel housing (204) at a third angular velocity greater than the second angular velocity for at least a third time portion.   13. The system of claim 12, wherein the first rotational speed is in the range of about 180 RPM to about 220 RPM, the second rotational speed is in the range of about 1,800 RPM to about 2,200 RPM, and the third rotational speed is about 2, A system that ranges from 700 RPM to about 3,000 RPM.   12. The system of claim 11, further comprising a first channel having a first and second end, the channel (208) having inner and outer channel walls (212, 216) and a channel bottom located therebetween. Cell separation stage (312), wherein the second end is located away from the first end in the first direction, and from the first cell separation stage (312) The first cell separation stage (312) includes a cell dam (232) positioned away in one direction, and a width of a second end of the first cell separation stage (312) is larger than a width of a first end of the first cell separation stage (312). And a system including a first blood component collection stage.   15. The system according to any one of claims 1 to 14, further comprising a disposable set, the disposable set being positionable in the channel (208) and being first and second relative to each other. A blood processing chamber (352) including a connecting side wall (372, 376), a blood inlet port (392), and a platelet outlet port (420) continuous with one of the first and second side walls (372, 376); And the first and second on the outer surface of the blood processing chamber (352) in a relationship disposed near the platelet outlet port (420) and overlapping the outer surface of the blood processing chamber (352). A system comprising a support (428) attached to one of the side walls (372, 376).   15. The system according to any one of claims 1 to 14, further comprising a disposable set, said disposable set comprising a blood removal tube means (22) for transporting whole blood from a donor; Blood return tube means (24) for returning blood components not collected by the donor, the first part of the blood removal tube means (22) and the first part of the blood return tube means (24) being directly liquid And is connected in direct fluid communication with one of the first portion of the blood removal tube means (22) and the first portion of the blood return tube means (24). Pressure sensing means (134, 138), which pressure sensing means (134, 138) are responsive to pressure fluctuations in the first portion of the blood removal tube means (22) and the blood return tube means (24). System.   15. The system according to any one of claims 1 to 14, further comprising a disposable set, wherein the disposable set removes whole blood from the donor in a first mode, the first mode. A single needle (30) that returns blood components that are not collected in the donor in a second mode separate from the single needle (30) for delivering whole blood from the donor in the first mode. And a blood return tube means (24) fluidly connected to the single needle (30) for transporting blood components not collected in the second mode. A first liquid reservoir (150) connected to one end of the blood return tube means (24) for accumulating blood components not collected in the first mode; From the reservoir (150) Gas retaining means (100) coupled to the reservoir (150) for receiving gas and coupled to the reservoir (150) for returning gas to the reservoir (150) in the second mode. ) And a system including.   15. The system according to claim 1, further comprising a blood removal tube means (22) for conveying whole blood from the donor and a blood return tube means (24) for conveying uncollected blood to the donor. ), A first blood component tube means (80, 90) for conveying the separated first blood component, and a molded cassette member (110), the cassette member (110) being blood that is not collected A first integral reservoir (150) for accumulating components and connected to the blood return tube means (24) and a first integral part of the first blood component tube means (80, 90). Internal passageway (130a) and a first flexible member connected to the first integral internal passageway (130a) at a first end and to the integral internal reservoir (150) at a second end. Tube loop (132), and Both a second flexible tube loop (162) connected at an end to the first integral internal passageway (130a) and the first and second flexible tube loops (132, 162). Positioning means defined by an integral edge portion of the molded cassette member (110), wherein the first ends are supportably engaged to maintain the positions of the first ends at a predetermined distance. (17).   15. The system according to any one of claims 1 to 14, further comprising a disposable set, the disposable set being a blood treatment chamber (352) positionable in the blood treatment channel (208). The blood treatment chamber (352) having first and second sidewalls (372, 376) spaced radially when the blood treatment chamber (352) is positioned within the blood channel (208); 352), a blood inlet port (392) connected to one of the first and second side walls (372, 376), and a vane (400) for guiding blood through the blood inlet port (392). In the blood processing chamber (352) at an angle to a reference line extending perpendicular to a portion of the blood processing chamber (352) adjacent to the blood inlet port (392), System including a serial blades (400), and a first blood component outlet port (420).   15. The system according to any one of claims 1 to 14, further comprising a disposable set, the disposable set comprising a blood treatment chamber (352) positionable within the channel (208), The blood treatment chamber (352) includes a whole blood inlet port (392), a first blood component outlet port (420), and a first tab (552), the tab (552) comprising the blood treatment chamber. Extends at a sufficient distance vertically beyond the adjacent portion of (352) and is at least one gripping member when the blood treatment chamber (352) is disposed within the channel (208). system.   15. The system according to any one of claims 1 to 14, further comprising a disposable set, the disposable set being positionable in the channel (208) and first and second. A blood processing chamber (352) having an end (356, 364), and a first communicating with the interior of the blood processing chamber (352), located between the first and second ends (356, 364). Between the first connector (360) and the first and second ends (354, 364), and communicates with the inside of the blood processing chamber (352), and is connected to the first connector (360). An engaging second connector (456); a blood inlet port (396) communicating with the interior of the blood processing chamber (352) and positioned between the first and second connectors (360, 456); The blood treatment chamber (352) First system including a blood component outlet port (420) located between and first and second connectors communicates with the parts (360,456).

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