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[0001] This application claims the benefit of priority under 35 U.S.C. § 119(e) of the following U.S. provisional patent applications: No. 60/373,083, filed Apr. 16, 2002, and No. 60/405,667, filed Aug. 23, 2002.
[0002] 1. Field of the Invention
[0003] The present invention relates to a system, apparatus, and method for processing components of blood. In particular, some aspects of the invention relate to processing blood components through the use of centrifugal separation, filtration, and/or any other form of processing.
[0004] 2. Description of the Related Art
[0005] Whole blood consists of various liquid components and particle components. The liquid portion of blood is largely made up of plasma, and the particle components include red blood cells (erythrocytes), white blood cells (leukocytes), and platelets (thrombocytes). While these constituents have similar densities, their average density relationship, in order of decreasing density, is as follows: red blood cells, white blood cells, platelets, and plasma. In terms of size, the particle constituents are related, in order of decreasing size, as follows: white blood cells, red blood cells, and platelets. Most current separation devices rely on density and size differences or surface chemistry characteristics to separate blood components.
[0006] Separation of certain blood components is often required for certain therapeutic treatments involving infusion of particular blood components into a patient. For example, in a number of treatments involving infusion of platelets, there is sometimes a desire to separate out at least some leukocytes and/or red blood cells before infusing a platelet-rich blood component collection into a patient.
[0007] For these and other reasons, there is a need to adopt approaches to processing components of blood.
[0008] In the following description, certain aspects and embodiments of the present invention will become evident. It should be understood that the invention, in its broadest sense, could be practiced without having one or more features of these aspects and embodiments. It should also be understood that these aspects and embodiments are merely exemplary.
[0009] One aspect of the invention relates to a system for processing blood components. The system may comprise a separation chamber including a chamber interior in which blood components are centrifugally separated and an outlet port for passing at least some centrifugally separated blood components from the chamber interior. A flow path may be in flow communication with the outlet port of the separation chamber. The apparatus may further comprise a filter including a filter inlet in flow communication with the flow path, a porous filtration medium configured to filter at least some of at least one blood component (e.g., leukocytes, platelets, and/or red blood cells) from centrifugally separated blood components passed to the filter via the flow path, and a filter outlet for filtered blood components. The system may further comprise a rotor configured to be rotated about an axis of rotation. The rotor may comprise a first portion configured to receive the separation chamber and a second portion configured to receive the filter, wherein the first and second portions may be positioned with respect to one another so that when the separation chamber is received in the first portion and the filter is received in the second portion, the filter is closer than the interior of the separation chamber to the axis of rotation. The system may be configured so that the rotor rotates during filtering of at least one blood component via the filter.
[0010] In another aspect, the system may be configured so that when the filter is received in the second portion, the filter is eccentric with respect to the axis of rotation. For example, the system may be configured so that the filter is at least close to the axis of rotation (i.e., close to the axis of rotation or intersecting the axis of rotation at least partially) and so that the axis of rotation does not intersect an interior flow path defined by the filter. In some examples, when the filter is received in the second portion, the filter may be offset from the axis of rotation so that the axis of rotation does not intersect the filter. In some examples, the filter is eccentrically positioned so that blood components exit a housing of the filter (and/or enter the filter itself) at a location that is at least close to the rotor's axis of rotation, as compared to the location where the blood components enter the filter housing (and/or where the blood components exit the filter itself).
[0011] In a further aspect, the system may be configured so that when the filter is received in the second portion, a filter housing outflow port is located closer than a filter housing inflow port and/or the porous filtration medium to the axis of rotation. In another aspect, the filter housing outflow port may be above the filter housing inflow port.
[0012] In an additional aspect, the filter may comprise a filter housing defining an interior space containing the porous filtration medium, wherein the filter inlet and filter outlet may be in flow communication with the interior space, and wherein the system may be configured so that when the filter is received in the second portion, the filter is positioned so that blood components flow in the interior space in a direction facing generally toward the axis of rotation. In some examples, the filter housing defines a filter housing inflow port for passing blood components to the interior space and a filter housing outflow port for passing blood components from the interior space. The system may be configured so that when the filter is received in the second portion, the filter housing outflow port is closer than the filter housing inflow port (and/or the porous filtration medium) to the axis of rotation. In an exemplary arrangement, the filter housing outflow port is above the filter housing inflow port.
[0013] In a further aspect, the second portion may comprise at least one of a ledge and a slot configured to receive the filter, the at least one of a ledge and a slot being positioned under a top surface of the rotor. Alternatively (or additionally), the rotor may comprise a holder configured to hold the filter with respect to the rotor.
[0014] There are many possible arrangements for the flow path. In some examples, the flow path may include tubing. For example, the flow path may include a first tubing portion having one end coupled to the outlet port of the separation chamber and another end coupled to the filter inlet. In addition, the apparatus may also include a second tubing portion having an end coupled to the filter outlet, wherein the second tubing portion extends in a direction facing generally away from the axis of rotation. Further, the system may include a third tubing portion downstream from the second tubing portion, wherein the third tubing portion extends in a direction facing generally toward the axis of rotation.
[0015] In one more aspect, the rotor may comprise a groove configured to receive at least some of the tubing (e.g., at least some of the second and third tubing portions).
[0016] One other aspect relates to an apparatus for use with a centrifuge for processing blood components. The apparatus could be configured in a number of different ways. According to one aspect, the apparatus may comprise the separation chamber, the flow path, and the filter. In some embodiments, the apparatus is configured to be disposed after being used for processing of blood components.
[0017] In some embodiments, the rotor's axis of rotation may extend through the second portion of the rotor.
[0018] In another aspect, the system may comprise at least one valving member on the centrifuge rotor, the valving member being configured to control flow of at least some of the blood components during rotation of the rotor. In some examples, the valving member may comprise a tubing clamp.
[0019] In a further aspect, the system may comprise at least one sealing member on the centrifuge rotor, the sealing member being configured to create a seal during rotation of the rotor. For example, the sealing member may comprise a tubing welder.
[0020] In one further aspect, the rotor may comprise at least one support member configured to support the chamber, wherein the at least one support member may comprise a guide groove configured to receive a portion of the tubing line and a controllable clamp and/or welder associated with the groove. For example, the clamp may be configured to controllably occlude flow of blood components through the tubing line. In some examples, the chamber may comprise at least one guide hole configured to receive the at least one support member.
[0021] In some embodiments, the rotor may comprise a plurality of support members located in an asymmetric fashion with respect to the axis of rotation, and the chamber may comprise a plurality of guide holes, each of the guide holes being configured to receive a respective one of the support members.
[0022] According to another aspect, the system may further comprise a pump configured to pump at least some blood components from the chamber. The system may also comprise a pressure sensor configured to sense pressure of the pumped blood components, wherein the system may be configured to control the pump based on at least the pressure sensed by the pressure sensor.
[0023] A further aspect relates to a system comprising a chamber (e.g., a blood separation chamber) that may comprise an interior configured to contain separated blood components, and an outlet port for passing at least some of the separated blood components from the interior. A flow path may be in flow communication with the outlet port of the chamber. The system may further comprise a filter comprising a filter inlet in flow communication with the flow path, a porous filtration medium configured to filter at least some of at least one blood component from separated blood components passed to the filter via the flow path, and a filter outlet for filtered blood components. In addition, the system may also comprise a pump configured to pump at least some of the separated blood components from the chamber to the filter via the flow path, and a pressure sensor configured to sense pressure of blood components pumped to the filter. The system may be configured to control the pump based on at least the pressure sensed by the pressure sensor.
[0024] In some embodiments, the pump may comprise a portion of a centrifuge and/or at least a portion of a blood component expressor.
[0025] According to another aspect, the system may be configured such that the system calculates a difference between pressures sensed by the pressure sensor in at least one time interval, determines when the calculated difference is at least a predetermined amount, and controls the pump in response to at least the determination that the calculated difference is at least the predetermined amount.
[0026] In yet another aspect, there is a system that may comprises a separation chamber comprising a chamber interior in which blood components are centrifugally separated, and an outlet port for passing at least some of the centrifugally separated blood components from the chamber interior. A flow path may be in flow communication with the outlet port of the separation chamber. The system also may comprise a pump configured to pump at least some of the centrifugally separated blood components from the chamber and through the flow path, and a pressure sensor configured to sense pressure of blood components pumped by the pump. In addition, the system may comprise a centrifuge rotor configured to be rotated about an axis of rotation, the rotor comprising a portion configured to receive the separation chamber. The system may be configured such that the system calculates a difference between pressures sensed by the pressure sensor in at least one time interval, determines when the calculated difference is at least a predetermined amount, and controls the pump in response to at least the determination that the calculated difference is at least the predetermined amount.
[0027] Many different types of chambers are possible. In some embodiments, the chamber may have a ring shape.
[0028] According to another aspect, the chamber may comprise a bag (e.g., a blood component separation bag). For example, at least a portion of the bag may be formed of at least one of flexible and semi-rigid material so that the chamber interior has a variable volume. In some embodiments, the bag may have a generally annular ring shape defining a central opening.
[0029] In another aspect, the chamber interior may include a tapered portion leading to the outlet port.
[0030] In a further aspect, the chamber may be configured so that the chamber has a variable volume, and the pump may be configured to reduce the volume of the chamber interior. In one example, the pump may be configured to apply pressure to the chamber via hydraulic fluid. Such an example may also include a sensor configured to sense pressure of pumped blood products, wherein the sensor may be configured to sense pressure of the hydraulic fluid. Certain aspects of the invention could be practiced with or without a pump and/or pressure sensor, and when such structure is present, there are many possible forms of pumping and sensing configurations that could be used.
[0031] In an even further aspect, the system may further comprise an optical sensor, and the system may be configured to control the pump based on at least one of information sensed by the optical sensor and pressure sensed by the pressure sensor. In one example, an optical sensor may be positioned to sense blood components in the chamber, and/or an optical sensor may be positioned to sense blood components at another location, such as a location associated with the flow path (e.g., at a tubing line in flow communication with the filter).
[0032] In another aspect, the system may be configured so that the pump pumps blood components from the chamber during rotation of the centrifuge rotor.
[0033] In a further aspect, the apparatus may further comprise a collection container comprising an inlet in flow communication with the filter outlet and/or the flow path, and/or a portion of the rotor may further comprise a cavity configured to receive the collection container and possibly also the filter. In some examples, there may be more than one collection container and/or at least one collection container may be located outside of a centrifugal field during blood component processing.
[0034] One more aspect of the invention relates to a method of processing blood components.
[0035] Some exemplary methods may include providing a system disclosed herein. The term “providing” is used in a broad sense, and refers to, but is not limited to, making available for use, manufacturing, enabling usage, giving, supplying, obtaining, getting a hold of, acquiring, purchasing, selling, distributing, possessing, making ready for use, forming and/or obtaining intermediate product(s), and/or placing in a position ready for use.
[0036] In one more aspect, a method may comprise placing a separation chamber in a first portion of a centrifuge rotor and a filter in a second portion of the rotor, wherein the filter is located closer than an interior of the separation chamber to the axis of rotation of the rotor, and wherein the filter comprises a porous filtration medium. The method may further comprise rotating the centrifuge rotor, the separation chamber, and the filter about the axis of rotation of the centrifuge rotor, wherein the blood components are centrifugally separated in the chamber interior. In addition, the method may comprise removing at least some of the centrifugally separated blood components from the separation chamber, and filtering the removed blood components with the filter so as to filter at least some of at least one blood component (e.g., leukocytes, platelets, and/or red blood cells) from the removed blood-components, wherein at least a portion of the filtering occurs during said rotating.
[0037] In another aspect, the method may further comprise pumping at least some of the centrifugally separated blood components from the chamber to the filter. A further aspect may include sensing pressure of pumped blood components, and controlling the pumping based on at least the sensed pressure.
[0038] In yet another aspect, there is a method comprising pumping at least some separated blood components from a chamber (e.g., a blood separation chamber or any other type of chamber structure), filtering the pumped blood components with a filter so as to filter at least some of at least one blood component from the pumped blood components, sensing pressure of blood components pumped to the filter, and controlling the pumping based on at least the pressure sensed by the pressure sensor. In some examples, the chamber may be rotated (e.g., via a centrifuge) and separated blood components may be pumped from the chamber while the chamber is received on a centrifuge rotor and/or after the chamber is removed from a centrifuge rotor.
[0039] A further aspect relates to a method of determining a location of at least one interface during processing of blood components, wherein the method comprises pumping at least some centrifugally separated blood components from a chamber, sensing pressure of the pumped blood components, and determining a location of at least one interface based on the sensed pressure, wherein the interface is associated with the pumped blood components. For example, the interface may be an interface between blood components and air, and/or an interface between differing blood components.
[0040] In another aspect, the method may comprise calculating a difference between pressures sensed in at least one time interval, determining when the calculated difference is at least a predetermined amount, and controlling the pumping in response to at least the determination that the calculated difference is at least the predetermined amount.
[0041] According to another aspect, there is a method of processing blood components, comprising rotating a chamber about an axis of rotation, wherein blood components are centrifugally separated in the chamber, pumping at least some separated blood components from the chamber, sensing pressure of pumped blood components, calculating a difference between pressures sensed in at least one time interval, determining when the calculated difference is at least a predetermined amount, and controlling the pumping in response to at least the determination that the calculated difference is at least the predetermined amount.
[0042] In another aspect, the method may further comprise passing blood components (e.g., filtered blood components) into at least one collection bag.
[0043] In a further aspect, the blood components in the chamber may be blood components of a buffy coat. Buffy coat blood components are generally blood components that result from a procedure where platelets and leukocytes along with some amount of red blood cells and plasma have been separated from whole blood. Alternatively, any other substance containing one or more blood components could be processed.
[0044] In some examples, whole blood may be processed in the method. For example, whole blood may be introduced into the chamber (e.g., from one/or more donors, and/or from one or more containers containing blood donated by one or more donors). In the processing of whole blood, any number of blood components may be centrifugally separated, filtered, and/or processed in any other way. For example, components of whole blood may be separated and pumped into separate, respective containers (optionally while being filtered via one or more filters).
[0045] In one more aspect, when blood components are pumped, the pumping may comprise reducing the volume of an interior of the chamber. For example, the method may comprise applying pressure to the chamber via hydraulic fluid.
[0046] In another aspect, the pumping may occur during rotation of a centrifuge rotor.
[0047] In yet another aspect, the method may comprise optically sensing pumped blood products, and controlling the pumping based on at least one of optically sensed information and sensed pressure. For example, the optically sensing may comprise optically sensing blood components in the chamber and/or optically sensing blood components in a tubing line (e.g., a tubing line in flow communication with a filter).
[0048] In another aspect, the method may further comprise causing at least one valving member on the centrifuge rotor to control flow of at least some of the blood components during rotation of the rotor. As mentioned above, the valving member may comprise a tubing clamp.
[0049] In a further aspect, the method may further comprise causing at least one sealing member on the centrifuge rotor to create a seal during rotation of the rotor. As mentioned above, the sealing member may comprise a tubing welder.
[0050] Aside from the structural and procedural arrangements set forth above, the invention could include a number of other arrangements such as those explained hereinafter. It is to be understood that both the foregoing description and the following description are exemplary only.
[0051] The accompanying drawings are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments and, together with the description, serve to explain some principles of the invention. In the drawings,
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[0069] Reference will now be made in detail to a few exemplary embodiments of the invention. Wherever possible, the same reference numbers are used in the drawings and the description to refer to the same or like parts.
[0070]
[0071] The chamber
[0072] As described in more detail below, hydraulic fluid in a space
[0073] The centrifuge rotor
[0074] Each of the support members
[0075] One or more of the supports
[0076] As shown schematically in
[0077] As shown in
[0078]
[0079]
[0080] In some examples, such as that of
[0081]
[0082]
[0083] One feature in common with the filter examples of
[0084] As partially shown in
[0085] Although the embodiments of
[0086] In the embodiments of
[0087] The filtration medium
[0088] The filter
[0089] As shown in
[0090] In some embodiments, there may be lids (not shown) other than the lid
[0091] As shown in
[0092] At least a portion of the chamber
[0093] The chamber
[0094] An alternative embodiment of a chamber
[0095] Referring again to
[0096] When the chamber
[0097] Although the embodiments shown in the drawings include a separation chamber in the form of a ring-shaped bag, it should be understood that there are many alternative forms of separation chamber configurations that could be used. For example, the separation chamber could be in the form of a bag other than a ring-shaped bag. Alternatively, the separation chamber could be in other non-bag forms, such as, for example, in the form of one of the separation vessels disclosed in U.S. Pat. No. 6,334,842.
[0098] In one alternative embodiment (not shown), a filter similar to (or identical to) filter
[0099]