Systems and methods for volume reduction of blood products prior to transfusion

Abstract

To provide methods and systems for transfusing reduced-volume blood components.SOLUTION: Previously collected blood components are introduced into a fluid circuit 60 associated with an apparatus 12 that separates a component into a reduced volume blood component and supernatant. The reduced-volume blood component 48 is transfused to a patient 11 in need of the component without a risk of circulatory overload.SELECTED DRAWING: Figure 1

Description

Technical Field

[0005]

[0001] This disclosure relates to the processing, collection, and transfusion of blood components. More specifically, this disclosure relates to the infusion / transfusion of volume-reduced blood components to avoid circulatory overload in patients receiving transfusion of blood components.

Background Art

[0002] Administration / transfusion of blood and / or blood components is common in the treatment of patients suffering from diseases or blood loss. However, it is more typical and economical to administer individual components to patients who need them rather than infusing whole blood.

[0003] Whole blood is composed of various cellular components such as red blood cells, white blood cells, and platelets suspended in its liquid component, plasma. Whole blood can be separated into its constituent components (cells or liquid), and the desired separated components can be administered to patients who need that specific component.

[0004] For example, platelet administration (transfusion) is often prescribed for cancer patients whose ability to produce platelets has been reduced by chemotherapy. Red blood cells are usually administered to patients suffering from blood loss, anemia, or other disorders. Plasma infusion may also be prescribed for therapeutic reasons, and recently, the collection and administration of stem cells have attracted wide interest in the medical community.

[0005] Transfusion of an excessive amount of blood components can lead to transfusion-associated circulatory overload (TACO). TACO is a serious transfusion complication caused by rapid transfusion of blood products. TACO is defined as acute pulmonary edema due to circulatory overload within 6 to 12 hours after transfusion. Currently, TACO is prevented by avoiding unnecessary transfusions and transfusing small amounts of blood at a slow rate. If TACO is suspected, the transfusion is stopped and the patient receives oxygen, diuretics, and other treatments for heart failure. <​It is desirable to completely avoid TACO without requiring the above-mentioned remedial procedures. Furthermore, it is desirable to reduce the total volume of transfused blood by removing the supernatant, i.e., plasma, or additive solutions such as platelet preservation solutions (PAS) or red blood cell additive solutions commonly used for preserving collected blood components, before transfusion. In this way, the patient can receive the necessary blood components (red blood cells, platelets, etc.) without excess supernatant. [Overview of the project]

[0007] There are several embodiments of the subject matter that can be embodied separately or together in the methods and systems described and claimed below. These embodiments can be used alone or in combination with other embodiments of the subject matter described herein, and describing these embodiments together is not intended to preclude the use of these embodiments separately or claiming such embodiments separately or as sets in different combinations within the claims attached herein.

[0008] In one embodiment, the present disclosure relates to a method for transfusing blood components to a patient. The method involves accessing the patient's vascular system with a disposable fluid circuit and a fluid-communicating needle. The circuit is mounted on a device including a first pump, a second pump and a separation drive unit. The fluid circuit includes a priming solution container, a waste container and a final volume-reduced blood component container, and a separation chamber configured to be mounted on the separation drive unit of the device. The method further includes mounting a pre-collected blood component container to the disposable fluid circuit and first introducing the priming solution from the priming solution container into at least a portion of the fluid circuit, including the separation chamber.

[0009] Once the fluid circuit is primed, the method includes the steps of pumping the collected blood components from a container holding the previously collected blood components into at least a portion of the fluid circuit, which includes a separation chamber, and separating the collected blood components in the separation chamber into a reduced-volume blood component and a supernatant component.

[0010] According to this method, the separated supernatant is collected in a waste container, and the reduced-volume collected blood components are collected in a final reduced-volume blood component container. This method further includes opening a channel between the final blood component container and the patient's vascular system to deliver the reduced-volume collected blood components to the patient.

[0011] In another aspect of the present disclosure, a system for transfusing volume-reduced blood components to a patient includes a reusable separation and transfusion device comprising a first pump, a second pump, and a separator drive unit. A disposable fluid circuit is associated with the reusable separation and transfusion device, and the fluid circuit includes tubing that defines the flow paths between a vascular access device, a separation chamber, a final product container, a supernatant container, and containers for priming solution and collected blood components. [Brief explanation of the drawing]

[0012] [Figure 1] This is a schematic diagram of the system described herein, used for processing and injecting platelets.

[0013] [Figure 2] This is a schematic diagram of the system in Figure 1 during the priming of the fluid circuit.

[0014] [Figure 3] Figure 1 is a schematic diagram of the system during the processing of pre-collected platelets.

[0015] [Figure 4] Figure 1 is a schematic diagram of the system during the infusion of volume-reduced platelets into a patient.

[0016] [Figure 5] Figure 1 is a schematic diagram of the system after the injection of volume-reduced platelets is complete.

[0017] [Figure 6] This is a schematic diagram of the system described herein, used for injecting red blood cells.

[0018] [Figure 7] It is a schematic diagram of the system of FIG. 6 during priming of the fluid circuit.

[0019] [Figure 8] It is a schematic diagram of the system of FIG. 6 during processing of pre-collected red blood cells.

[0020] [Figure 9] It is a schematic diagram of the system of FIG. 6 during injection of volume-reduced red blood cells into a patient.

[0021] [Figure 10] It is a schematic diagram of the system after injection of volume-reduced red blood cells into a patient.

Mode for Carrying Out the Invention

[0022] The embodiments disclosed in this specification are intended to provide an explanation of the subject matter, and it is understood that the subject matter can be embodied in various other forms and combinations that are not shown in detail. Therefore, the specific designs and features disclosed in this specification should not be construed as limiting the subject matter defined in the appended claims.

[0023] Figure 1 shows a system 10 for processing previously collected blood components and infusing a reduced volume of those components into patient 11. As shown in Figure 1, the system 10 includes a reusable device 12 which includes a first pump 14, a second pump 16, and a separator drive unit that receives the separation chamber of a disposable fluid circuit, described later. The device 12 may be of a compact design suitable for placement next to or near the chair or bedside of patient 11 receiving the infusion. Pumps 14 and 16 may be peristaltic pumps configured to receive the tube segments of the fluid circuit, but other types of pumps may be used instead. The device 12 may also include a clamp which is similarly configured to receive the tube segments and can be opened and closed to automatically control the flow of fluid through the tube segments. Alternatively, the clamp may be a manually operated clamp such as a roller clamp or Roberts clamp associated with the disposable fluid circuit.

[0024] The operation of pumps 14 and 16, the separation drive unit, and the automatic (i.e., non-manual) clamp (if present) is controlled by a control unit. According to embodiments, the control unit may include a programmable microprocessor that can be programmed to operate the blood processing apparatus according to a process. The control unit can be coupled to one or more of the structures of the blood processing apparatus, such as the aforementioned pumps, automatic clamp, and separator drive unit. The control unit can receive information (e.g., in the form of signals) from these structures or provide commands (e.g., in the form of signals) to these structures to control their operation. The control unit can also be coupled to scales and sensors to provide commands to these devices to control their operation. The control unit may be directly electrically connected to these structures, or it may be directly connected to other intermediate devices that are directly connected to and coupled to these structures.

[0025] The device 12 may also include a user interface (not shown), such as a touchscreen or keypad, which allows the operator to selectively control the operating device 12, including starting and stopping pump rotation, opening and closing clamps, and activating the isolation drive unit.

[0026] As described above, system 10 also includes a disposable fluid circuit 20 which may be at least partially attached to or otherwise associated with device 12. The disposable fluid circuit 20 includes interconnected tubes, pre-attached containers, and / or attachment points for attaching the containers, as well as patient access devices such as a venous needle 22 for accessing the vascular system of patient 11. The needle 22 is connected to an inlet tube 24 which defines a flow path for blood components to be injected into patient 11 and is in flow communication with the patient. The inlet tube 24 may include a (manually operated) clamp 25 upstream of the needle 22 to control the flow to patient 11 through the inlet tube 24. A filter 26 may also be included in the fluid circuit 20 to filter out leukocytes or other undesirable cells or particles from the blood components to be injected.

[0027] As shown in Figure 1, the disposable fluid circuit 20 includes a separator or separation chamber 30 for mounting to the separation drive unit of the apparatus 12. In one embodiment, the separator or separation chamber may be a rotating membrane separator of the type described in U.S. Patent No. 5,194,145, which is incorporated herein by reference. The rotating membrane separator 30 includes an inlet 32 ​​into which pre-collected blood components are introduced, and two outlets 34 and 36 from which the separated supernatant and blood components with a desired volume reduction exit the separator 30, respectively. In this regard, the membrane of the separator 30 includes pores of a size such that the desired component does not pass through the membrane (exits from port 36) and the supernatant can freely pass through the membrane (exits from port 34).

[0028] If the device 12 does not include automatically operated clamps, the fluid circuit may include manually operated clamps 40 and 42 that are positioned on the pipe segments and compress the pipes to close the flow paths within the pipes.

[0029] The disposable fluid circuit 20 may be equipped with pre-installed empty plastic containers for receiving blood components separated from the separator 30. In one embodiment, a container 46 may be pre-installed in the fluid circuit 20. The container 46 is in flow communication with the outlet 34 of the separator 30 and may be associated with the peristaltic pump 16. An empty container 48 may be pre-installed and in flow communication with the outlet 36 of the separator 30.

[0030] Other containers can be attached to the fluid circuit 20 during use. In one embodiment, a container 50 containing a solution useful for priming the fluid circuit 20 can be aseptically attached to the fluid circuit 20. In another embodiment, the fluid circuit 20 may be provided as a kit with the pre-filled container 50 pre-attached. A container 52 containing previously collected blood components can similarly be attached to the fluid circuit 20 during injection. Like the priming solution container 50, it can be attached aseptically, as is known to those skilled in the art.

[0031] As shown in Figure 1, containers 50 and 52 can be attached to tube segments 54 and 56, which are joined at a branching section (member) 58 located upstream of where tube segment 60 is loaded into the intake pump 14. Thus, the pump 14 draws the priming solution and previously collected blood components into the fluid circuit 20 and separator 30, in sequence, as will be described in detail below.

[0032] The system shown in Figure 1 is particularly well suited for processing previously collected platelets and injecting the volume-reduced platelet product into the patient. Similarly configured systems can be used to process and inject other blood components, such as red blood cells, as described in relation to Figures 6-10. Further other types of blood components can be processed and injected using the systems and methods described herein. For illustrative purposes only, and not limiting, the processing and injection of previously collected platelets and red blood cells are described here.

[0033] Figure 2 shows the system of Figure 1 during the priming sequence in the processing and infusion of previously collected platelets. As shown in Figure 2, a container 50 containing the priming solution is attached to the fluid circuit 20. The priming solution may be any solution commonly used for processing blood components, such as platelet preservation solutions (PAS), such as physiological saline (0.9% NaCl) or the solution described in U.S. Patent No. 9,402,866, the contents of which are incorporated herein by reference. As described above, the container 50 is aseptically attached to the fluid circuit 20.

[0034] The fluid circuit 20 is also fitted with a container 52 of previously collected platelets. Platelets are typically collected from donors using apheresis equipment such as the AMICUS separator, available from Fenwall, Incorporated in Lake Zurich, Illinois, an affiliate of Fresenius Kaby AG in Bad Homburg, Germany. The platelet container 52 can hold one or more doses of platelets. Once the tubes of the circuit 20 are loaded onto pumps 14 and 16, the separator 30 is attached to the separator drive unit, and the needle 22 is inserted into the vein of the patient 11, the circuit 20 is ready for priming. With clamps 25 and 42 in the closed position and clamp 40 in the open position, the pump 14 is operated (rotated) to draw the priming solution from the container 50 into the fluid circuit and into the separator 30 via the inlet 32. The separator 30 can be operated so that its rotating membrane rotates slowly during the priming sequence. Similarly, the pump 16 can be activated to remove the priming solution from the separator 30 and direct it towards the waste container 46. Most of the priming solution is collected in container 46, but a small amount of priming solution may exit the separator 30 through the outlet port 36 and flow into container 48. Once the priming sequence is complete, processing of the previously collected platelets begins.

[0035] As shown in Figure 3, in the platelet processing sequence, clamp 40 is in the closed position, and clamps 42 and 25 are in the open position. At this point, pump 14 is activated again to draw the previously collected platelets from container 50 into the now-primed fluid circuit 20. The platelets are introduced into separator 30 through inlet 32 ​​and separated into platelets and a supernatant that may contain plasma and pre-added PAS (for storage). The pores of the membrane are sized so that the separated platelets cannot pass through the membrane. Instead, the platelets accumulate in the gap between the outer surface of the membrane and the inner surface of the separator housing and eventually exit the separator through outlet 36 and flow into the “final” product container 48. The supernatant passes through the membrane and is pumped by pump 16 through outlet 34 to waste container 46. During processing, clamp 25 is open, and the reduced volume of platelets collected in container 48 begins to be discharged from container 48, passes through filter 26, and is delivered to patient 11.

[0036] Once the entire volume of previously collected platelets has been processed and container 52 is empty (which can be visually confirmed or determined by the change in the weight of container 52 suspended from the weighing scale of the device 12), the processing of platelets from the original volume in container 52 to the reduced volume in container 48 is complete. As shown in Figure 4, at this finishing stage, pumps 14 and 16 are turned off. With clamp 25 in the open position, the slow gravity infusion / infusion of the volume-reduced platelets to patient 11, which was started during the previous processing stage, continues. As shown in Figure 5, when container 48 is empty, the infusion / infusion is complete. In one embodiment, the volume of platelets can be reduced, for example, from an initial volume of 300 mL to a transfusionable reduced volume of 100 mL, or more preferably to 50 mL or 30 mL.

[0037] The reusable devices and associated fluid circuits of the type described above can also be used for processing and injecting / transfusing previously collected red blood cells. As seen in Figure 6, the fluid circuit 20 is associated with the reusable device 12 as described above. A container 52 holding the previously collected red blood cells is aseptically attached to the fluid circuit 20.

[0038] Once the tubing of circuit 20 is loaded onto pumps 14 and 16, the separator 30 is attached to the separator drive unit, and the needle 22 is inserted into the patient's vein 11, circuit 20 is ready for priming. As shown in Figure 7, with clamps 25 and 42 in the closed position and clamp 40 in the open position, pump 14 is operated (rotates) to draw the priming solution (e.g., saline) from container 50 into the fluid circuit and into separator 30 through inlet 32. Separator 30 can be operated so that its rotating membrane rotates slowly during the priming sequence. Similarly, pump 16 can be operated to remove the priming solution from separator 30 and direct it towards waste container 46. Most of the priming solution is collected in container 46, but some of the priming solution may exit separator 30 through outlet port 36 and flow into the container. Once the priming sequence is complete, processing of the previously collected red blood cells begins.

[0039] As shown in Figure 8, in the red blood cell processing sequence, clamp 40 is in the closed position and clamps 42 and 25 are in the open position. At this point, pump 14 is activated again, and the previously collected red blood cells are drawn into the primed fluid circuit 20. The red blood cells are introduced into separator 30 through inlet 32, where they are separated into red blood cells and a supernatant that may contain plasma and red blood cell additive / preservation solution. The pores of the membrane are sized so that the separated red blood cells cannot pass through the membrane. Instead, the red blood cells accumulate in the gap between the outer surface of the membrane and the inner surface of the separator housing, and eventually exit the separator through outlet 36 and flow into the “final” container 48. The supernatant passes through the membrane and is pumped by pump 16 through outlet 34 to the waste container 46. During processing, clamp 25 is open, and the reduced volume of red blood cells collected in container 48 begins to be discharged from container 48, passes through filter 26, and is delivered to patient 11.

[0040] Once the entire volume of red blood cells collected earlier has been processed and container 52 is empty (which can be visually confirmed or determined by the change in the weight of container 52 suspended from the weighing scale of the device 12), the processing of red blood cells from the original volume in container 52 to the reduced volume in container 48 is complete. As shown in Figure 9, at this finishing stage, pumps 14 and 16 are turned off. With clamp 25 in the open position, the slow gravity infusion / infusion of the volume-reduced red blood cells into patient 11, which was started during the previous processing stage, continues. As shown in Figure 10, when container 48 is empty, the infusion / transfusion of red blood cells is complete. In one embodiment, the volume of red blood cells can be reduced, for example, from an initial volume of 250 mL to a transfusion-ready reduced volume of 200 mL. Reducing the amount of supernatant remaining with the red blood cells "washes" the red blood cells and removes undesirable elements present in the original supernatant, such as free hemoglobin.

[0041] As described above, improved methods and systems for processing pre-collected blood components are disclosed to reduce or avoid the occurrence of TACO. The above description is for illustrative purposes only and is not intended to limit the scope of the invention to any specific methods, systems, apparatus, or devices described herein.

[0042] manner Appearance 1. A method for transfusing blood components to a patient, comprising accessing the patient's vascular system using a needle in fluid communication with a disposable fluid circuit attached to a device including a first pump, a second pump, and a separation drive unit. The fluid circuit comprises a container for priming solution, a waste container for waste, a final volume-reduced blood component container for the final volume-reduced blood component, and a separation chamber. The method includes attaching a container for collecting blood components to a disposable fluid circuit; introducing a priming solution from a container for priming solution into at least a portion of the fluid circuit, including a separation chamber; pumping the collected blood components from the container for collecting blood components into at least a portion of the fluid circuit, including a separation chamber; separating the collected blood components in the separation chamber into a volume-reduced blood component and a supernatant component; collecting the supernatant in a waste container and collecting the volume-reduced collected blood components in a final volume-reduced blood component container; opening a flow path between the final volume-reduced blood component container and the patient's vascular system; and delivering the volume-reduced collected blood components to the patient.

[0043] Appearance 2. The method according to embodiment 1, comprising introducing a priming solution by operating a first pump.

[0044] Appearance 3. The method according to embodiment 2, comprising collecting the supernatant liquid into a waste container by operating a second pump to remove the supernatant liquid through the outlet port of the separator.

[0045] Appearance 4. The method according to any one of embodiments 1 to 3, wherein the separation chamber comprises a rotating membrane.

[0046] Appearance 5. The method according to any one of embodiments 1 to 4, wherein the collected blood components include red blood cells.

[0047] Appearance 6. The method according to any one of embodiments 1 to 4, wherein the collected blood components include platelets.

[0048] Appearance 7. The method according to any one of embodiments 1 to 6, comprising pumping the blood components collected by operating a first pump.

[0049] Appearance 8. The method according to any one of embodiments 1 to 7, comprising attaching a container for containing collected blood components to a fluid circuit.

[0050] Appearance 9. The method according to any one of embodiments 1 to 8, comprising selectively controlling the flow of a priming solution and collected blood components.

[0051] Appearance 10. The method according to embodiment 1, comprising filtering the volume-reduced components between the steps of opening a channel between a final volume-reduced blood component container and the patient's vascular system and delivering the volume-reduced collected blood components to the patient.

[0052] Appearance 11. A system for transfusing volume-reduced blood components to a patient, comprising a reusable separation and transfusion device including a first pump, a second pump, and a separator drive unit, and a disposable fluid circuit associated with the reusable separation and transfusion device, the fluid circuit comprising a vascular access device, a separation chamber, a container for containing the final product, a container for containing waste, and a tube defining a flow path between the container, a container for containing a priming solution, and a container for containing the collected blood components.

[0053] Appearance 12. The system according to embodiment 11, wherein the first pump is associated with a tube that defines a flow path to a container containing a priming solution and a flow path that defines a flow path to a container containing pre-collected blood components.

[0054] Appearance 13. The system according to embodiment 11 or embodiment 12, wherein the first pump is associated with a pipe that defines a flow path communicating with a separation chamber.

[0055] Appearance 14. The system according to embodiment 12 or embodiment 13, wherein a tube defining a flow path to a container for priming solution and a tube defining a flow path to a container for pre-collected blood components are connected by a branching member.

[0056] Appearance 15. The system according to embodiment 14, further comprising a first flow control unit associated with a tube that defines a flow path to a container for containing a priming solution, and a second flow control unit associated with a tube that defines a flow path to a container for containing pre-collected blood components, wherein the first flow control unit and the second flow control unit are located upstream of the branching member.

[0057] Appearance 16. The system according to any one of embodiments 11 to 15, wherein the disposable fluid circuit further comprises a filter located between a container for containing the final product and a vascular access device.

[0058] Appearance 17. The system according to embodiment 16 further comprises a flow control unit located between the filter and the vascular access device, which is a disposable fluid circuit.

[0059] Appearance 18. The system according to embodiment 17, wherein the flow control unit is a manually operated clamp.

Claims

1. 1. A system for transfusing a volume-reduced blood component into a patient, comprising: a. a reusable blood separation and transfusion device including a first pump, a second pump, and a separator drive unit; b) a disposable fluid circuit associated with the reusable separation and transfusion device, the fluid circuit comprising a vascular access device, a separation chamber, a container containing a final product, a container containing waste, and tubing defining flow paths between the container, a container containing a priming solution, and a container containing collected blood components.

2. 10. The system of claim 1, wherein the first pump is associated with a tube defining a flow path to a container containing a priming solution and a flow path defining a flow path to a container containing a pre-collected blood component.

3. The system of claim 1 or claim 2, wherein the first pump is associated with a tube that defines a flow path that communicates with a separation chamber.

4. 4. The system of claim 3, wherein the tube defining the flow path to the container containing the priming solution and the tube defining the flow path to the container containing the pre-collected blood components are connected by a branching member.

5. 5. The system of claim 4, further comprising a first flow control section associated with a tube defining a flow path to a container containing the priming solution, and a second flow control section associated with a tube defining a flow path to a container containing the pre-collected blood component, the first flow control section and the second flow control section being located upstream of the branching member.

6. 10. The system of claim 1, wherein the disposable fluid circuit further comprises a filter positioned between a container containing the final product and the vascular access device.

7. The system of claim 6 , wherein the disposable fluid circuit further comprises a flow control located between the filter and the vascular access device.

8. 8. The system of claim 7, wherein the flow control is a manually operated clamp.

9. 1. A method of transfusing a blood component into a patient, comprising: (a) accessing a patient's vascular system with a needle in fluid communication with a disposable fluid circuit attached to a device including a first pump, a second pump, and a separation drive, the fluid circuit including a container containing a priming solution, a waste container containing waste, a final reduced-volume blood component container containing a volume-reduced final blood component, and a separation chamber; (b) attaching a container containing collected blood components to the disposable fluid circuit; (c) introducing a priming solution from a container containing the priming solution into at least a portion of the fluid circuit that includes the separation chamber; (d) pumping the collected blood components from a container containing the collected blood components into at least a portion of the fluid circuit that includes the separation chamber; (e) separating the collected blood components into a volume-reduced blood component and a supernatant component in the separation chamber; (f) collecting the supernatant in the waste container and collecting the reduced volume collected blood components in the final volume reduced blood component container; (g) opening a fluid path between the final volume-reduced blood component container and the vascular system of the patient; (h) a method of transfusing a blood component into a patient, comprising delivering said volume-reduced collected blood component to said patient.

10. 10. The method of claim 9, comprising introducing the priming solution by actuating the first pump.

11. 11. The method of claim 10, comprising collecting the supernatant in the waste container by operating the second pump to remove the supernatant through an outlet port of the separator.

12. 12. The method of any one of claims 9 to 11, wherein the separation chamber comprises a spinning membrane.

13. The method of claim 9 , wherein the collected blood components include red blood cells.

14. 10. The method of claim 9, wherein the collected blood component comprises platelets.

15. 10. The method of claim 9, further comprising pumping the collected blood component by actuating the first pump.

16. 10. The method of claim 9, further comprising attaching a container containing the collected blood components to the fluid circuit.

17. 10. The method of claim 9, comprising selectively controlling the flow of the priming solution and the collected blood components.

18. 10. The method of claim 9, comprising filtering the reduced volume component between (g) and (h).

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