Dynamic adjustment of components of a detection assembly
By dynamically adjusting the detection components, the performance degradation caused by improper installation of the detection components was resolved, thereby improving the accuracy and efficiency of the fluid processing process.
Patent Information
- Application Number
- CN202110307511.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2020-03-25
- Filing Date
- 2021-03-23
- Publication Date
- 2025-10-21
- Estimated Expiration
- 2041-03-23
AI Technical Summary
In existing blood processing systems, improper installation of detection components can lead to performance degradation, affecting the accuracy and efficiency of fluid monitoring.
The controller dynamically adjusts the components of the detection assembly to ensure their correct position and orientation relative to the fluid handling device, including the adjustment of the light source and detector of the optical sensor assembly, thereby enabling accurate monitoring of the fluid component interface.
It improves the performance of the detection components, ensures the accuracy and efficiency of the fluid handling process, and reduces errors in fluid composition and operation.
Smart Images

Figure CN113440672B_ABST
Abstract
Description
[0001] Cross-application of related applications
[0002] This application claims the benefit of and priority to U.S. Provisional Patent Application Serial No. 62 / 994,492, filed on March 25, 2020, the contents of which are incorporated herein by reference. Technical Field
[0003] The present disclosure relates to detection assemblies and, more particularly, to dynamic adjustment of components of detection assemblies. Background Art
[0004] Now, a variety of blood processing systems make it possible to collect specific blood components rather than whole blood from a blood source. Generally speaking, in such systems, whole blood is extracted from a source, specific blood components or ingredients are removed and collected, and remaining blood components are returned to the source.
[0005] In general, whole blood is separated into its component by centrifugation. This requires that whole blood be extracted from blood after it and before it is returned to the source by centrifuge. In order to avoid the pollution and possible infection in the source, blood is preferably contained in a sealed, aseptic fluid flow circuit during the whole centrifugation. Therefore, typical blood treatment systems include permanent, reusable centrifuge components and disposable, sealed and aseptic fluid treatment components, which include the hardware (drive system, pump, valve actuator, programmable controller etc.) that rotates blood and pumps blood, and the fluid treatment components are mounted on the hardware. During the collection process, the centrifuge component engages with the disposable centrifuge chamber of the fluid treatment component and rotates the disposable centrifuge chamber of the fluid treatment component. However, blood is only actually contacted with the fluid treatment component, and this component is only used once and then discarded.
[0006] When whole blood is spun by means of a centrifuge, heavier (higher specific gravity) components, such as red blood cells, move radially outward away from the center of rotation toward the outer, or "high-G" walls, of the separation chamber. Lighter (lower specific gravity) components, such as plasma, move toward the inner, or "low-G" walls of the separation chamber. Some of these components can be selectively removed from the whole blood by forming appropriately positioned channel seals and outlet ports in the separation chamber.
[0007] It is known to use optical sensor assemblies to monitor the flow of blood and / or blood components through a flow circuit in a centrifuge and to determine various characteristics of the flow. For example, PCT Patent Application Publication No. WO 2018 / 053217 A1 (which is incorporated herein by reference) relates to an optical sensor assembly for observing a centrifugal chamber to detect and control the position of an interface between separated blood components. In this assembly, as in any other detection assembly, appropriate alignment of the various components of the detection assembly relative to the object being monitored is necessary to ensure that the fluid is correctly monitored during operation. It may be the case that the fluid flow circuit is mounted to the hardware in a manner that affects the performance of the detection assembly, so that it is advantageous to be able to dynamically adjust one or more components of the detection assembly in response to the orientation of the disposable circuit mounted on the hardware (or in response to some other factors), thereby improving performance. Summary of the Invention
[0008] The present subject matter has several aspects that can be implemented individually or together in the devices and systems described and claimed below. These aspects can be employed individually or in combination with other aspects of the subject matter described herein, and describing these aspects together is not intended to preclude the use of these aspects alone or from being claimed alone or in different combinations as set forth in the claims appended hereto.
[0009] In one aspect, a fluid handling device includes a detection assembly having a source and a detector. The source is associated with a component of the fluid handling device, is arranged in an initial position and initial orientation relative to the component of the fluid handling device, and is configured to transmit a signal. The detector is associated with a structure of the fluid handling device, is arranged in an initial position and initial orientation relative to the structure of the fluid handling device, and is configured to receive at least a portion of the signal. The detection assembly also includes an adjustment system associated with the source and / or an adjustment system associated with the detector. The controller of the fluid handling device is configured to control the adjustment system associated with the source to adjust the position and / or orientation of the source relative to the component of the fluid handling device and / or adjust the position and / or orientation of a component of the source relative to another component of the source. The controller is configured to control the adjustment system associated with the detector to adjust the position and / or orientation of the detector relative to the structure of the fluid handling device and / or adjust the position and / or orientation of a component of the detector relative to another component of the detector.
[0010] In another aspect, a method for monitoring a fluid and / or fluid component in a fluid handling device is provided, wherein the source is associated with a component of the fluid handling device and is disposed in an initial position and orientation relative to the component of the fluid handling device, and the detector is associated with a structure of the fluid handling device and is disposed in an initial position and orientation relative to the structure of the fluid handling device. The method comprises transmitting a signal from the source to the fluid and / or fluid component in the fluid handling device, wherein at least a portion of the signal is received by the detector. Adjusting the position and / or orientation of the source relative to the component of the fluid handling device, the position and / or orientation of the detector relative to the structure of the fluid handling device, the position and / or orientation of a component of the source relative to another component of the source, and / or the position and / or orientation of a component of the detector relative to another component of the detector is performed. BRIEF DESCRIPTION OF THE DRAWINGS
[0011] Figure 1 is a perspective view of an exemplary fluid treatment apparatus incorporating components of a fluid treatment system according to an aspect of the present disclosure;
[0012] Figure 2 is a schematic diagram of an exemplary disposable fluid flow circuit that can be installed to Figure 1 a fluid processing device to complete a fluid processing system according to one aspect of the present disclosure;
[0013] Figure 3 yes Figure 1 A perspective view of an exemplary centrifugal separator of a fluid processing apparatus of claim 1, wherein a centrifugal separation chamber of a fluid flow circuit is installed in the centrifugal separator;
[0014] Figure 4 is a top view of an exemplary cartridge for a fluid flow circuit that can be actuated to perform operations with Figure 1 Various different fluid processing processes associated with the fluid processing device shown in ;
[0015] Figure 5 yes Figure 3 A perspective view of a centrifugal separator, wherein selected portions of the centrifugal separator are cut away to illustrate a light source of an interface monitoring assembly;
[0016] Figure 6 yes Figure 3 A perspective view of a centrifugal separator, wherein the light source operates to transmit a light beam to a light detector of the interface monitoring assembly;
[0017] Figure 7 yes Figure 3 A perspective view of a centrifugal separator, wherein selected portions of the centrifugal separator are cut away to illustrate a light source and a light detector of an interface monitoring assembly;
[0018] Figure 8 is a perspective view of an exemplary centrifuge chamber of a fluid flow circuit;
[0019] Figure 9 yes Figure 8 A front view of a centrifugal separation chamber;
[0020] Figure 10 It passes through Figure 8 A bottom perspective view of a fluid flow path of a centrifugal separation chamber;
[0021] Figure 11 yes Figures 8 to 10 an enlarged perspective view of a portion of a channel of a centrifuge chamber, wherein an interface between separated fluid components is located at a (generally) desired location on an inclined surface defined within the channel;
[0022] Figure 12 yes Figure 11 An enlarged perspective view of a channel and an inclined surface, wherein the interface is located at a (usually) undesirable high position on the inclined surface;
[0023] Figure 13 yes Figure 11 An enlarged perspective view of a channel and an inclined surface, wherein the interface is located at a (typically) undesirable low position on the inclined surface;
[0024] Figure 14 is with Figures 8 to 10 A perspective view of a prismatic reflector used in combination with a centrifugal separation chamber;
[0025] Figure 15 yes Figure 14 a perspective view of a prismatic reflector showing light being transmitted through the prismatic reflector;
[0026] Figure 16 is a schematic diagram of an exemplary mechanism for adjusting the position and / or orientation of components of a detection assembly; and
[0027] Figure 17 is a schematic diagram of another exemplary mechanism for adjusting the position and / or orientation of a component of a detection assembly. DETAILED DESCRIPTION
[0028] The various embodiments disclosed herein are for the purpose of providing a description of the present subject matter, and it should be understood that the present subject matter can be implemented in a variety of other forms and combinations that are not shown in detail. Therefore, the various specific designs and features disclosed herein should not be interpreted as limiting the subject matter defined in the appended claims.
[0029] Figures 1 to 17Components of a blood or fluid processing system that implements various aspects of the present subject matter are shown. Although the system may be described herein in terms of its use in separating blood into two or more components, it should be understood that the system according to the present disclosure can be used to process a variety of biological or body fluids (including fluids containing body fluids and non-body fluids, such as anticoagulated blood), as well as non-body fluids. In addition, although an optical monitoring or detection assembly is described herein, it should be understood that the principles described herein (i.e., the possibility of dynamically adjusting one or more components of the detection assembly) can be applied to other types of monitoring or detection assemblies, such as an ultrasonic detection assembly for detecting air in a fluid line.
[0030] The fluid treatment system according to the present disclosure generally includes two main components, a durable and reusable fluid treatment device 10 ( Figure 1 ) and disposable fluid flow circuit 12 ( Figure 2 While the disposable fluid flow circuit 12 may be advantageous for processing bodily fluids, it should be understood that the principles described herein are applicable to non-bodily fluids, in which case the disposable fluid flow circuit may be omitted.
[0031] The illustrated fluid processing apparatus 10 includes a rotary membrane separator drive unit 14 ( Figure 1 ), centrifuge or centrifugal separator 16 ( Figure 3 ), additional components for controlling the flow of fluid through the disposable flow circuit 12, and the controller 18 ( Figure 1 ), the controller 18 controls the operation of the other components of the fluid handling device 10 (including the detection assembly) to perform the process selected by the operator. The principles described herein with respect to the dynamic adjustment of the components of the detection assembly are not limited to any particular fluid handling system or process, and therefore the complete fluid handling device or process will not be described in detail herein. However, for Figure 1 A detailed description of the fluid processing apparatus 10 and various exemplary processes that can be performed using such a system can be found in PCT Patent Application Publication No. WO 2018 / 053217 A1.
[0032] I. Durable fluid handling device
[0033] Fluid processing device 10( Figure 1 ) is configured as a durable item capable of long-term use. It should be understood that Figure 1 The fluid processing device 10 is merely an example of one possible configuration, and the fluid processing device according to the present disclosure may be configured in various ways. For example, it is within the scope of the present disclosure to omit either or both of the rotary membrane separator drive unit 14 and the centrifugal separator 16 from the fluid processing device, and to instead process the fluid without separating the fluid.
[0034] In the illustrated embodiment, the fluid treatment apparatus 10 is implemented in a single housing or casing 20. The illustrated casing 20 includes a generally horizontal portion 22 (which may include inclined or angled faces or upper surfaces for enhanced visibility and ergonomics) and a generally vertical portion 24. The rotary membrane separator drive unit 14 and the centrifugal separator 16 are shown as being incorporated into the generally horizontal portion 22 of the casing 20, while the controller 18 is shown as being incorporated into the generally vertical portion 24.
[0035] A. Rotary membrane separator drive unit
[0036] The illustrated fluid processing apparatus 10 includes a rotor support or a rotary membrane separator drive unit 14 ( Figure 1 ), the rotor support or rotary membrane separator drive unit 14 is used to accommodate the fluid flow circuit 12 ( Figure 2 ) is a generally cylindrical rotating membrane separator 26. U.S. Patent No. 5,194,145 (which is incorporated herein by reference) describes an exemplary rotating membrane separator drive unit that is suitable for being incorporated into the fluid processing device 10, however, it should be understood that the rotating membrane separator drive unit 14 can be configured in different ways without departing from the scope of the present disclosure. The principles described herein related to the adjustment of the components of the detection assembly can be practiced in conjunction with any configuration of the rotating membrane separator or in the absence of a rotating membrane separator, and therefore, the rotating membrane separator drive unit 14 will not be described in detail herein.
[0037] B. Centrifugal Separator
[0038] The present invention describes the adjustment of the components of the detection assembly in the context of the detection assembly of the centrifugal separator 16. Therefore, for the purpose of illustration, the present invention will describe a specific configuration of the centrifugal separator 16 and the associated centrifugal separation chamber 32 and the detection assembly. However, it should be understood that such principles can be practiced in conjunction with any configuration of the centrifugal separator 16 or in the absence of a centrifugal separator.
[0039] The illustrated centrifuge 16 includes a centrifuge chamber 34 that can accommodate the other components of the centrifuge 16 ( Figure 3 The centrifuge chamber 34 may include a lid 36 that is opened to insert and remove the centrifuge chamber 32 of the fluid flow circuit 12. During the separation process, the lid 36 may be closed so that the centrifuge chamber 32 is positioned within the centrifuge chamber 34 as the centrifuge chamber 32 rotates or turns about the axis 38 under the power of the electric drive motor or rotor 40 of the centrifuge 16.
[0040] The specific configuration and operation of the centrifuge 16 depends on the specific configuration of the centrifuge chamber 32 of the fluid flow circuit 12. In one embodiment, the structure and operation of the centrifuge 16 are similar to the structure and operation of the ALYX system manufactured by Fenwal, Inc. of Lake Zurich, Illinois, a subsidiary of Fresenius Kabi AG of Bad Homburg, Germany, as described in more detail in U.S. Patent No. 8,075,468, which is incorporated herein by reference. More specifically, the centrifuge 16 can include a bracket or support 42 that holds the centrifuge chamber 32 and a yoke member 44. The yoke member 44 engages an umbilicus 46 of the fluid flow circuit 12 that extends between the centrifuge chamber 32 and a cassette 48 of the fluid flow circuit 12 ( Figure 4 Yoke member 44 causes umbilicus 46 to orbit around centrifuge chamber 32 at a rotational speed of 1ω. As it orbits centrifuge chamber 36, umbilicus 46 also twists about its own axis. According to known designs, as umbilicus 46 rotates at 1ω, the twisting of umbilicus 46 about its axis, combined with yoke member 44, imparts a rotation of 2ω to centrifuge chamber 36. The relative rotation of yoke member 44 at a rotational speed of 1ω and centrifuge chamber 36 at a rotational speed of 2ω keeps umbilicus 46 from twisting, thereby avoiding the need to rotate the seal.
[0041] Fluid is introduced into the centrifuge chamber 32 through the umbilical tube 46, wherein the fluid is separated within the centrifuge chamber 32 (e.g., into less dense components, such as platelet-rich plasma, if the fluid is blood, and into more dense components, such as packed red blood cells, if the fluid is blood) due to the centrifugal force generated by the rotation of the centrifuge chamber 32. Components of the interface monitoring assembly may be positioned within the centrifuge chamber 16 to monitor the separation of the fluid within the centrifuge chamber 32. Figures 5 to 7 As shown, the interface monitoring assembly can include a light source 50 and a light detector 52, the light detector 52 being positioned and oriented to receive at least a portion of the light emitted by the light source 50. The illustrated light source 50 and light detector 52 are associated with a fixed surface of the centrifuge chamber 34, but either or both of the illustrated light source 50 and light detector 52 can alternatively be associated with a movable structure or component of the fluid processing device 10, as described in U.S. Patent No. 5,316,667, which is incorporated herein by reference. Furthermore, as will be described in greater detail herein, according to another aspect of the present disclosure, the position and / or orientation of the light source 50 and / or light detector 52 can be adjusted relative to the structure or component of the fluid processing device 10 with which it is associated.
[0042] The initial or default orientation and position of the various components of the interface monitoring assembly depends, at least in part, on the specific configuration of the centrifuge chamber 32. Generally speaking, however, a light source 50 emits a light beam "L" (e.g., a laser beam) through the separated fluid components within the centrifuge chamber 32 (which may be formed from a material that substantially transmits light L, or at least light L of a specific wavelength, without absorbing light). A portion of the light L reaches a light detector 52, which transmits a signal to the controller 18 indicating the position of the interface between the separated fluid components. If the controller 18 determines that the interface is in an incorrect position (which may affect the separation efficiency of the centrifuge 16 and / or the quality of the separated blood components), the controller 18 may issue commands to the appropriate components of the blood separation device 10 to modify the operation of those components to move the interface to the appropriate position.
[0043] C. Other components of the fluid handling device
[0044] In addition to the rotary membrane separator drive unit 14 and the centrifugal separator 16, the fluid processing device 10 may also include other components arranged in a compact manner to assist in fluid processing. Exemplary components (including a pump system, a cassette station 54 for accommodating cassettes 48 of the fluid flow circuit 12) are described in more detail in PCT Patent Application Publication No. WO 2018 / 053217A1.
[0045] Among the various components of the fluid processing device 10 are a plurality of detection assemblies D1 to D3. Although the adjustment principles described herein are presented with reference to the interface detection assembly of the centrifugal separator 16, it should be understood that similar principles can be applied to the other detection assemblies D1 to D3, as well as to detection assemblies configured differently from the detection assemblies described herein.
[0046] One of the detection components includes a centrifuge outlet sensor D1 for determining one or more characteristics of the fluid flowing out of the centrifuge 16. If the fluid flowing out of the centrifuge 16 includes red blood cells, the centrifuge outlet sensor D1 can be configured to determine the hematocrit of the fluid. If the fluid flowing out of the centrifuge 16 is platelet-rich plasma, the centrifuge outlet sensor D1 can be configured to determine the platelet concentration of the platelet-rich plasma. The centrifuge outlet sensor D1 can detect one or more characteristics of the fluid by optically monitoring the fluid as it flows through the tubes of the fluid flow circuit 12 or by any other suitable method. The controller 18 can receive a signal from the centrifuge outlet sensor D1 indicating one or more characteristics of the fluid flowing out of the centrifuge 16 and use the signal to optimize a process based on the characteristic or characteristics.
[0047] Another of the detection assemblies includes a spinner outlet sensor D2 that receives a tube of the fluid flow circuit 12 that allows separated fluid components to flow out of the rotating membrane separator 26 of the fluid flow circuit 12 .
[0048] The third detection component in the detection assembly includes an air detector D3 (e.g., an ultrasonic bubble detector) that houses the tubing of the fluid flow circuit 12 that allows fluid to flow to the receiver. It may be desirable to prevent air from reaching the receiver so that the air detector D3 can send a signal to the controller 18 indicating the presence or absence of air in the tubing. If the signal indicates the presence of air in the tubing, the controller 18 can initiate an alarm or error condition to alert the operator of the condition and / or take corrective action to prevent air from reaching the receiver (e.g., by reversing the flow of fluid through the tubing or diverting the fluid to a vent location).
[0049] D.Controller
[0050] As described above, the fluid treatment apparatus 10 includes a controller 18 that is suitably configured and / or programmed to control the operation of the fluid treatment apparatus 10. In one embodiment, the controller 18 includes a main processing unit (MPU), which may include, for example, a Pentium 2000 manufactured by Intel Corporation. TM , although other types of conventional microprocessors may be used. In one embodiment, controller 18 may be mounted within generally vertical portion 24 of housing 20, adjacent to or incorporated into an operator interface station (e.g., a touch screen). In other embodiments, controller 18 and the operator interface station may be associated with generally horizontal portion 22 or may be incorporated into a separate device that is connected (physically, via a cable, etc., or wirelessly) to fluid handling device 10.
[0051] The controller 18 is configured and / or programmed to perform at least one fluid processing application, but more advantageously, the controller 18 is configured and / or programmed to perform a plurality of different fluid processing applications. For example, the controller 18 can be configured and / or programmed to perform one or more of the following processes: a two-unit red blood cell collection process, a plasma collection process, a plasma / red blood cell collection process, a red blood cell / platelet / plasma collection process, a platelet collection process, a platelet / plasma collection process, and a mononuclear cell collection process. Additional or alternative process applications (e.g., plasma exchange, red blood cell exchange, and photopheresis) may be included without departing from the scope of the present disclosure.
[0052] More particularly, when performing any of these fluid processing applications, the controller 18 is configured and / or programmed to control one or more of the following tasks: drawing fluid into a fluid flow circuit 12 installed in the fluid processing device 10, conveying the fluid through the fluid flow circuit 12 to a location for separation (i.e., to the rotary membrane separator 26 or the centrifugal separation chamber 32 of the fluid flow circuit 12), separating the fluid into two or more components as desired, and conveying the separated components to a storage container to a second location for further separation (e.g., to either the rotary membrane separator 26 and the centrifugal separation chamber 32 not used in the initial separation stage) or to a receiver (which may be the donor from which the fluid was initially drawn).
[0053] This may include instructing the rotary membrane separator drive unit 14 and / or the centrifugal separator 16 to operate at a particular rotational speed, and instructing a pump to deliver fluid at a particular flow rate through a portion of the fluid flow circuit 12. Thus, although a particular component of the fluid processing apparatus 10 (e.g., the rotary membrane separator drive unit 14 or the centrifugal separator 16) may be described herein as performing a particular function, it should be understood that the component is controlled by the controller 18 to perform that function.
[0054] Before, during, and after the process, the controller 18 can receive signals from various components of the fluid processing device 10 to monitor various aspects of the operation of the fluid processing device 10 and the characteristics of the fluid and separated fluid components as they flow through the fluid flow circuit 12. If the operation and / or one or more characteristics of the fluid or any of the separated fluid components are outside of an acceptable range, the controller 18 can initiate an alarm or error condition to alert the operator and / or take action to attempt to correct the condition. Appropriate corrective action will depend on the specific error condition and may include actions that can be performed with or without operator involvement.
[0055] For example, the controller 18 can include an interface control module that receives signals from the light detector 52 of the interface monitoring assembly and the centrifuge outlet sensor D1. The signal received by the controller 18 from the light detector 52 indicates the position of the interface between the separated fluid components within the centrifuge chamber 32, while the signal from the centrifuge outlet sensor D1 indicates whether the target interface position should be adjusted. If the controller 18 determines that the interface is in the wrong position, it can issue commands to the appropriate components of the fluid processing device 10 to modify their operation to move the interface to the correct position. For example, the controller 18 can instruct the pump to cause blood to flow into the centrifuge chamber 32 at different rates and / or cause the separated fluid components to be removed from the centrifuge chamber 32 at different rates and / or cause the centrifuge chamber 32 to rotate at different speeds via the centrifuge 16.
[0056] As will be described in greater detail, if controller 18 determines that the performance of the detection assembly would be improved by adjusting one or more components of the detection assembly, controller 18 may issue commands to adjust such components appropriately.
[0057] II. Disposable Fluid Flow Circuit
[0058] A. Overview
[0059] As for the fluid flow circuit or flow device 12 ( Figures 2 to 11 ), which is intended to be a sterile, single-use, disposable item. Prior to commencing a given procedure, an operator loads the various components of the fluid flow circuit 12 in the housing 20 associated with the fluid separation device 10. Proper operation of the various detection assemblies of the fluid processing device 10 may depend on the fluid flow circuit 12 being properly oriented relative to the detection assembly, such that care should be taken when installing the fluid flow circuit 12 to the fluid processing device 10. However, in the event that one or more of the components of the fluid flow circuit 12 fail to be properly oriented relative to the associated detection assembly of the fluid processing device 10, one or more of the components of the detection assembly may be adjusted to improve the performance of the detection assembly. Although improper installation or misalignment of the fluid flow circuit 12 may be a common reason for adjusting components of the detection assembly, it should be understood that other reasons exist such that the principles described herein are not limited to use in fluid processing systems that employ disposable fluid flow circuits.
[0060] Once the fluid flow circuit 12 is installed on the fluid treatment device 10, the controller 18 implements a process based on a preset protocol, taking into account other inputs from the operator. After completing the process, the operator removes the fluid flow circuit 12 from its association with the fluid treatment device 10. The portion of the fluid flow circuit 12 that holds the collected fluid component or components (e.g., a collection container or bag) is removed from the housing 20 and retained for storage, immediate use, or further processing. The remaining portion of the fluid flow circuit 12 is removed from the housing 20 and discarded.
[0061] A variety of different disposable fluid flow circuits can be used in conjunction with the fluid processing device 10, wherein the appropriate fluid flow circuit depends on the procedure to be performed using the system. However, in general, the fluid flow circuit 12 includes a cartridge 48 ( Figure 4 ), the other components of the fluid flow circuit 12 are connected to the cassette 48 by flexible tubing. In one embodiment, the cassette 48 is configured in a similar manner to the cassette of U.S. Patent No. 5,868,696 (which patent is incorporated herein by reference), but is adapted to include additional components (e.g., more tubing circuits T1 to T6) and functionality.
[0062] Other components may include a plurality of fluid containers F1 to F8 (for holding, for example, fluid to be processed, separated fluid components, intravenous fluid, or additive solutions), one or more fluid source access devices (e.g., connectors for allowing fluid to enter the fluid containers), and a rotating membrane separator 26 and / or a centrifugal separation chamber 32 ( Figure 2 ).
[0063] B. Centrifugal separation chamber
[0064] Figure 8 and Figure 9 An exemplary centrifuge chamber 32 is shown, and Figure 10 The fluid flow path defined by the centrifuge chamber 32 is illustrated. In the illustrated embodiment, the body of the centrifuge chamber 32 is preformed into a desired shape and configuration (e.g., by injection molding) from a rigid, biocompatible plastic material, such as non-plasticized medical-grade acrylonitrile-butadiene-styrene (ABS). All contours, ports, channels, and walls that affect the fluid separation process are performed in a single injection molding operation. Alternatively, the centrifuge chamber 32 can be formed from separate molded parts, or from nested cup-shaped subassemblies, or from two symmetrical halves.
[0065] The underside of the centrifuge chamber 32 includes a shaped receiving portion 56 adapted to receive the end of the umbilicus 46 of the fluid flow circuit 12 ( Figure 3A suitable receptacle 56 and the manner in which the umbilicus 46 may cooperate with the receptacle 56 to deliver fluid to and remove fluid from the centrifuge chamber 32 are described in greater detail in U.S. Patent No. 8,075,468.
[0066] The illustrated centrifuge chamber 32 has radially spaced inner (low-g) and outer (high-g) sidewall portions 58 and 60, a bottom or first end wall portion 62, and a cover or second end wall portion 64. The cover 64 comprises a simple flat portion that can be easily welded or otherwise fastened to the body of the centrifuge chamber 32. The wall portions 58 and 60, the bottom 62, and the cover 64 together define a closed, generally annular passage 66 ( Figure 10 ).
[0067] An inlet 68 in communication with the passage 66 is defined between opposing inner radial walls 70 and 72. One of the inner walls 70 joins the outer (high-g) wall portion 60 and separates the upstream and downstream ends of the passage 66. The inner walls 70 and 72 define the inlet passage 68 of the centrifuge chamber 32, which, in one flow configuration, allows fluid to flow from the umbilicus 46 to the upstream end of the passage 66.
[0068] The illustrated centrifuge chamber 32 also includes a corresponding first outlet 74 and a second outlet 76, which can be defined by opposing surfaces of the inner radial wall. Both the first outlet 74 and the second outlet 76 extend radially inward from the passage 66. The first outlet 74 extends radially inward from an opening located at the inner sidewall portion 58 in the illustrated embodiment, while the second outlet 76 extends radially inward from an opening associated with the outer sidewall portion 60. The illustrated first outlet 74 is positioned adjacent to the inlet 68 (near the upstream end of the passage 66), while the second outlet 76 can be positioned at the opposite, downstream end of the passage 66.
[0069] It should be understood that Figure 8 The centrifuge chamber 32 shown is exemplary only, and the centrifuge chamber 32 may be configured in various ways without departing from the scope of the present disclosure. For example, PCT Patent Application Publication No. WO2018 / 053217 A1 describes other exemplary centrifuge chamber configurations. Additionally, as described above, although the principles related to adjusting the components of the detection assembly are described herein in the context of a detection assembly that monitors fluid separation within the centrifuge chamber 32, it should be understood that these principles are applicable to detection assemblies configured to monitor other objects.
[0070] 1. Principles of centrifugal separation and interface detection
[0071] As the centrifugal separation chamber 32 rotates about the rotation axis 38, the fluid flowing into the channel 66 separates into a light dense layer "R" and a light less dense layer "P" ( Figure 11-13 ). The optically dense layer R is formed when larger and / or heavier fluid particles are moved toward the outer (high-g) wall portion 60 under the action of centrifugal force. If the fluid being separated is blood, the optically dense layer R will generally include red blood cells, but other cellular components (e.g., larger white blood cells) may also be present in the optically dense layer R depending on the speed at which the centrifuge chamber 32 is rotated.
[0072] If the fluid being separated is blood, the light-poor dense layer P typically includes plasma components, such as platelet-rich plasma or platelet-poor plasma. Other components (e.g., smaller white blood cells and anticoagulants) may also be present in the light-poor dense layer P, depending on the speed at which the centrifuge chamber 32 rotates and the length of time the blood resides in the centrifuge chamber 32.
[0073] In one embodiment, when the light dense layer R is separated from the light less dense layer P, the fluid introduced into the channel 66 via the inlet 68 will flow in a generally clockwise direction (in Figure 8 The light dense layer R continues to move in a clockwise direction as it travels along the outer sidewall portion 60 along the length of the channel 66 from the upstream end to the downstream end, where it exits the channel 66 through the second outlet 76. The less light dense layer P, separated from the light dense layer R, reverses direction and moves counterclockwise along the inner sidewall portion 58 to the first outlet 74 adjacent to the inlet 68.
[0074] The transition between the optically dense layer R and the optically less dense layer P can be referred to as interface "N". If the fluid being separated is blood, the interface N includes mononuclear cells and peripheral blood stem cells. The position of the interface N within the channel 66 of the centrifuge chamber 32 can be changed dynamically during fluid processing, such as Figures 11 to 13 If the position of the interface N is too high (ie, if the interface N is too close to the inner wall portion 58 and the first outlet 74, as shown in FIG. Figure 12 ), the red blood cells may flow into the first outlet 74, thereby potentially adversely affecting the quality of the low-density component (platelet-rich plasma or platelet-poor plasma). On the other hand, if the position of the interface N is too low (i.e., the interface N is too far from the inner wall portion 58, as shown in FIG. Figure 13 The ideal or target interface position can be determined experimentally and can vary depending on any of a number of factors (e.g., the configuration of the centrifuge chamber 32, the rate at which the centrifuge chamber 32 rotates about the axis of rotation 38, etc.).
[0075] As described above, the fluid processing device 10 may include an interface monitoring assembly (including a light source 50 and a light detector 52), a centrifuge outlet sensor D1, and a controller 18 having an interface control module to monitor and, if necessary, control or correct the position of the interface N. In the illustrated embodiment, the centrifuge chamber 32 is formed with an inclined surface 78 that extends from the high g wall portion 60 through at least a portion of the channel 66 at an angle α. Figure 8 as well as Figures 11 to 13 In one embodiment, the angle α measured relative to the axis of rotation 38 is approximately 25°. Figures 11 to 13 The orientation of ramp 78 is shown when viewed from the low-g sidewall portion 58 of centrifuge chamber 32. Although a flexible separation chamber is described, the overall structure and function of ramp 78 may be better understood with reference to U.S. Patent No. 5,632,893, which is incorporated herein by reference.
[0076] Bevel 78 makes the interface N between the light-dense layer R and the light-less dense layer P easier to identify for inspection, displaying the light-dense layer R, the light-less dense layer P, and the interface N for observation through the light-transmissive portion of the centrifuge chamber 32. To this end, bevel 78 and at least a portion of the centrifuge chamber 32 angularly aligned with bevel 78 can be formed of a light-transmissive material, although it may be advantageous for the entire centrifuge chamber 32 to be formed of the same light-transmissive material.
[0077] In the illustrated embodiment, the light source 50 of the interface monitoring system is associated with a fixture or wall of the centrifuge chamber 34 and is oriented to emit light L directed toward the axis of rotation 38 of the centrifugal separator 16, as shown. Figures 5 to 7 If the light detector 52 is positioned at an angle relative to the light source 50 (as in the illustrated embodiment), the light L emitted by the light source 50 must be redirected from its original path before the light L will reach the light detector 52. In the illustrated embodiment, the light L is redirected by a reflector associated with the light-transmissive portion of the inner sidewall portion 58, as shown. Figure 5 and Figure 6 The reflector may be a separate piece secured to the inner sidewall portion 58 (eg, by being bonded thereto) or may be integrally formed with the body of the centrifuge chamber 66 .
[0078] In one embodiment, the reflector may be a reflective surface, such as a mirror, oriented (e.g., at a 45° angle) to direct the light L emitted by the light source 50 to the light detector 52. In another embodiment, the reflector is configured as a prismatic reflector 80 ( Figure 7 、 Figure 14 and Figure 15), the prismatic reflector 80 is formed of a light-transmitting material (eg, a transparent plastic material) and has an inner wall 82 and an outer wall 84 and a first end wall 86 and a second end wall 88 ( Figure 14 ). The inner wall 82 is positioned against the inner sidewall portion 58 of the centrifuge chamber 32 and is oriented approximately perpendicular to the initial path of the light L from the light source 50. This allows the light L from the light source 50 to enter the prismatic reflector 80 via the inner wall 82 while continuing along its initial path. The light L continues to pass through the prismatic reflector 80 along its initial path until it encounters the first end wall 86. The first end wall 86 is oriented at a certain angle (e.g., approximately a 45° angle) relative to the inner wall 82 and the second end wall 88 so that the light L is redirected within the prismatic reflector 80 rather than exiting the prismatic reflector 80 via the first end wall 86.
[0079] The first end wall 86 directs the light L toward the second end wall 88 at an angle to its initial path (the angle may be approximately 90°, directing the light L from a path toward the rotation axis 38 to a path generally parallel to the rotation axis 38). Figure 15 ). The first end wall 86 and the inner and outer walls 82, 84 of the prismatic reflector 80 can be configured to transmit the redirected light L from the first end wall 86 to the second end wall 88 by total internal reflection. The second end wall 88 is oriented substantially perpendicular to the redirected path of the light L through the prismatic reflector 80, so that the light L will exit the prismatic reflector 80 through the second end wall 88, continuing along its redirected path. In one embodiment, the second end wall 88 is roughened or textured or otherwise treated or conditioned to diffuse the light L as it exits the prismatic reflector 80, which can better ensure that the light L reaches the light detector 52 ( Figure 7 ).
[0080] The prismatic reflector 80 can be aligned at an angle with respect to the bevel 78 so that light L from the light source 50 will only enter the prismatic reflector 80 when the bevel 78 has been rotated into the path of the light L. At all other times (when the bevel 78 is not in the path of the light L), the light L will not reach the prismatic reflector 80 and, therefore, will not reach the light detector 52.
[0081] When the ramp 78 is first rotated into the initial path of light L from the light source 50, the light L will begin to reach the prismatic reflector 80, which directs the light L to the light detector 52. This causes the voltage output of the light detector 52 (i.e., the signal transmitted from the light detector 52 to the controller 18) to increase to a non-zero value or state. The ramp 78 and the prismatic reflector 80 are eventually rotated out of alignment with the light source 50, at which point no light L will reach the prismatic reflector 80, and the voltage output of the light detector 52 will return to a low or zero state.
[0082] During the time that the ramp 78 and the prismatic reflector 80 rotate through the path of the light L from the light source 50, the light L continues to pass through the channel 66 and the fluid in the channel 66. At least a portion of the light L (i.e., the portion that is not absorbed or reflected by the fluid) exits the channel 66 by striking and entering the light-transmissive portion of the inner sidewall portion 58. The light L passes through the inner sidewall portion 58 and enters the prismatic reflector 80, which redirects the light L from its initial path to the light detector 52, as described above.
[0083] The light detector 52 generates a signal that is transmitted to the interface control module of the controller 18, which can determine the position of the interface N on the inclined surface 78. In one embodiment, the position of the interface N is associated with a change in the amount of light L transmitted through the light-poor dense layer P and the light-dense layer R. For example, the light source 50 can be configured to emit light L that is more easily transmitted through platelet-rich plasma or platelet-poor plasma than through red blood cells, such as red visible light (from a laser or a light source L configured in a different manner), which is substantially absorbed by red blood cells. The light-poor dense layer P and the light-dense layer R each occupy a specific portion of the inclined surface 78, so that the light detector 52 receives different amounts of light L depending on whether the light L travels through the light-poor dense layer P on the inclined surface 78 or the light-dense layer R on the inclined surface 78. The percentage of the inclined surface 78 occupied by each layer is related to the position of the interface N in the channel 66. Thus, by measuring the amount of time that the voltage output or signal from the light detector 52 is relatively high (corresponding to the P time during which the light L passes through only the less light-dense layer on the inclined surface 78), the controller 18 can determine the position of the interface N and, if necessary, take steps to correct the position of the interface INT. An exemplary method for adjusting the position of the interface N is described in more detail in PCT Patent Application Publication No. WO 2018 / 053217 A1.
[0084] 2. Adjustment of components of the detection assembly
[0085] It should be understood that light L from the light source 50 must reach the light detector 52 to determine (and adjust) the position of the interface N. The initial or default orientation and position of the light source 50 and the light detector 52 assume a specific orientation and position of the prismatic reflector 80, which depends on the correct installation and orientation of the centrifuge chamber 32 into the centrifuge chamber 34. Therefore, if the centrifuge chamber 32 is not properly installed and oriented, the prismatic reflector 80 may not properly direct the light L from the light source 50 to the light detector 52. Even if the centrifuge chamber 32 is properly installed and oriented, the prismatic reflector 80 may not be ideally positioned and / or oriented to direct the light L from the light source 50 to the light detector 52 (e.g., due to imperfections in the configuration of the centrifuge chamber 32).
[0086] According to one aspect of the present disclosure, the interface monitoring assembly includes a regulating system 90 ( Figure 16 ), the adjustment system 90 is associated with the light source 50 and is configured to adjust the position and / or orientation of the light source 50 relative to the portion of the centrifuge chamber 34 associated with the light source 50. The adjustment system 90 can be configured in various ways without departing from the scope of the present disclosure, but in the illustrated embodiment, the adjustment system 90 includes three elongated legs 92 secured to a wall or surface of the centrifuge chamber 34. The three legs 92 are arranged in an equilateral triangle and are generally parallel to each other and extend orthogonally from the wall of the centrifuge chamber 34. A hole or opening 94 is defined in the wall of the centrifuge chamber 34 in the space between the legs 92, which allows light L from the light source 50 to pass through the wall of the centrifuge chamber 34 and reach the centrifuge chamber 34 mounted therein.
[0087] Each leg 92 includes an associated support 96 that is movable along at least a portion of the length of the leg 92 toward and away from the wall of the centrifuge chamber 34. The supports 96 can be moved by any suitable drive mechanism, such as a motor, wherein the supports 96 can be moved independently of each other.
[0088] Each support 96 includes an arm 98 extending between the support 96 and the light source 50. The end of each arm 98 is pivotally connected to the light source 50 and the associated support 96 to allow adjustment of the position of the light source 50 relative to the support 96. This arrangement allows the light source 50 to be moved to a wide range of positions within the three-dimensional space defined between the legs 92, so that each support 96 can be moved along the corresponding leg 92 to a desired position to accommodate the desired position of the light source 50. In addition to allowing adjustment of the position of the light source 50 relative to the associated wall of the centrifuge chamber 34, the illustrated arrangement also allows adjustment of the orientation of the light source 50 relative to the wall of the centrifuge chamber 34, so that the light source 50 can be arranged to emit light L at various angles through the hole or opening 94.
[0089] In addition to (or in lieu of) any adjustment system associated with the light source 50, an adjustment system may be associated with the light detector 52 and configured to adjust the position and / or orientation of the light detector 52 relative to the portion of the centrifuge chamber 34 associated with the light detector 52. The adjustment system associated with the light detector 52 may be configured in various ways without departing from the scope of the present disclosure, but is preferably configured in a manner similar to that described herein. Figure 17 In the illustrated embodiment of the present invention, the conditioning system 100 includes a frame 102 that is connected to a wall or surface of the centrifuge chamber 34. The frame 102 includes two generally parallel legs 104 extending orthogonally from the wall of the centrifuge chamber 34, and a crossbar 106 extending between the legs 104. Apertures or openings 108 are defined in the wall of the centrifuge chamber 34 within the space between the legs 104, which allow light L to pass through the wall of the centrifuge chamber 34 to reach the light detector 52.
[0090] The upper end of each leg 104 (at Figure 17 The frame 102 is associated with a track (in an orientation) to allow the frame 102 to move in a direction transverse to the length of the crossbar 106. The frame 102 can be moved along the track by any suitable drive mechanism, such as a motor. This direction of movement can be understood as movement in the "x" direction of a Cartesian coordinate system.
[0091] The light detector 52 is associated with the crossbar 106 by a support 110 that is movable along at least a portion of the length of the crossbar 106 at each end of the crossbar 106 toward and away from the legs 104. The support 110 can be moved by any suitable drive mechanism, such as a motor. The direction of movement can be understood as movement in the "y" direction of a Cartesian coordinate system.
[0092] In one embodiment, the crossbar 106 is configured to move toward and away from the wall of the centrifuge chamber 34 along at least a portion of the length of the leg 104. In another embodiment, the crossbar 106 can be fixedly secured to the leg 104, while the support member 110 (or a portion thereof) can be movable relative to the crossbar 106 in a direction parallel to the length of the leg 104 toward and away from the wall of the centrifuge chamber 34. In either case, such movement can be achieved by any suitable drive mechanism, such as a motor. The direction of movement can be understood as movement in the "z" direction of a Cartesian coordinate system.
[0093] Thus, the illustrated arrangement allows the light detector 52 to be moved within a wide range of positions within the three-dimensional space above the aperture or opening 108 defined in the wall of the centrifuge chamber 34. In addition to allowing the position of the light detector 52 relative to the associated wall of the centrifuge chamber 34 to be adjusted, the illustrated arrangement can also allow the orientation of the light detector 52 relative to the wall of the centrifuge chamber 34 to be adjusted. For example, this can be achieved by allowing the support 110 or a portion of the support 110 to pivot relative to the crossbar 106, thereby allowing the light detector 52 to be arranged to receive light L through the aperture or opening 108 at various angles.
[0094] It should be understood that Figure 16 and Figure 17 The adjustment systems 90 and 100 are merely exemplary, and the adjustment systems for adjusting the position and / or orientation of the source and detector of the detection assembly may be configured in different ways without departing from the scope of the present disclosure. For example, Figure 17 A regulating system of the type shown may be used in conjunction with a source, while Figure 16An adjustment system of the type shown can be used in conjunction with a detector. In other embodiments, the adjustment system can be configured to adjust only the position of the source or detector (without adjusting the orientation of the source or detector) or only the orientation of the source or detector (without adjusting the position of the source or detector). In addition, adjusting the orientation of the source or detector is not limited to adjusting the angle or tilt of the source or detector, but also includes rotating the source or detector around its central axis. It should also be understood that adjustment of the source or detector of the detection assembly is not limited to detection assemblies using light, but can be used in conjunction with detection assemblies that transmit other signals from the source to the detector (e.g., ultrasonic detection assemblies).
[0095] The adjustment system associated with the detection assembly can be controlled by the controller 18 of the fluid treatment device 10. The source and detector of the detection assembly can be set in an initial position and orientation. When the controller 18 determines that it is desired to reposition and / or reorient the source and / or detector, the controller 18 can issue a command to the appropriate drive mechanism of the associated adjustment system to move the source and / or detector to the new position and / or to the new orientation. The controller 18 can determine that repositioning and / or reorienting of the components of the detection assembly is desired according to any suitable method. In one embodiment, the controller 18 receives a signal from the detector, which is compared to an expected signal. In the case of an interface monitoring assembly, saline can be delivered through the fluid flow circuit 12 mounted on the fluid treatment device 10 to prime the fluid flow circuit 12. The light L transmitted to the light detector 52 will have certain characteristics, which cause a specific signal to be sent from the light detector 52 to the controller 18. If the properties of the light L received by the light detector 52 differ from the properties of the light L that the light detector 52 expects to receive after the light has passed through the saline, then there will be a difference between one or more corresponding characteristics of the signal actually transmitted from the light detector 52 to the controller 18 and the expected signal (e.g., the voltage of the signal). If one or more characteristics of the signal differ from the corresponding characteristics of the expected signal, the controller 18 can determine that the performance of the detection assembly can be improved by adjusting the position and / or orientation of the source and / or detector.
[0096] Alternatively, rather than comparing the signal from the detector with an expected signal, the controller 18 can be configured to issue commands to appropriate drive mechanisms of the associated adjustment system to move the source and / or detector to various new positions and / or orientations. During repositioning and / or reorientation, the source continues to send signals that are at least partially received by the detector, wherein the detector sends a signal to the controller 18 that indicates the nature of the signal received by the detector. The controller 18 monitors the signal transmitted from the detector to the controller 18 to determine when the signal has optimal characteristics (e.g., when the signal has a maximum voltage) and then commands the adjustment system to move the source and / or detector to the position and / or orientation that produces the optimal signal. It may be advantageous to perform such an adjustment process before fluid processing begins to avoid introducing any factors that would tend to change the nature of the signals received and transmitted by the detector (other than adjusting components of the detection assembly). However, it is within the scope of the present disclosure that such an adjustment process occurs during fluid processing, particularly when a steady state is reached.
[0097] Often, due to the alignment of components of the fluid flow circuit 12 mounted on the fluid treatment device 10, it is necessary to adjust the position and / or orientation of components of the detection assembly. Therefore, in another embodiment, the detection assembly can be configured to transmit an orientation signal to the controller 18, which can indicate the position and / or orientation of the components of the fluid flow circuit 12. If the orientation signal indicates to the controller 18 that the performance of the detection assembly would be improved by adjusting the position and / or orientation of any of the components of the detection assembly, the controller 18 can command an appropriate adjustment system to correctly position and / or orient such component. In one embodiment, the components of the fluid flow circuit can be provided with one or more markings that indicate the orientation of the component when mounted to the fluid treatment device. The detection assembly determines the position of the markings and transmits this information as an orientation signal to the controller of the fluid treatment device. If the controller determines that one or more of the markings is not correctly positioned (e.g., by comparing the orientation signal with an expected signal), the controller commands an appropriate adjustment system to correctly position and / or orient the components of the detection assembly. For example, if the markings are oriented in a square around a target location of a component for receiving a signal from a source, the controller can reposition and / or reorient the source so that the source is aligned with the target location at the center of the square defined by the markings. Other indicators besides markings (e.g., areas of a component in a fluid flow circuit having a particular thickness that uniquely affects the amount of light received by the detector) and other methods can be used to determine the position and orientation of components of a fluid flow circuit.
[0098] Even if the monitoring components of the fluid flow circuit 12 have been correctly installed, it may be appropriate to adjust the position and / or orientation of one or more components of the detection assembly. For example, if the fluid processing device is configured to perform a variety of processes, the fluid flow circuits unique to each process may be configured differently, requiring adjustment of the position and / or orientation of at least one component of the detection assembly. In the illustrated embodiment, this may include differently configured centrifuge chambers having differently configured prismatic reflectors, wherein at least two of the centrifuge chambers are optimally monitored by the same detection assembly having differently positioned and / or oriented components.
[0099] Since the alignment and configuration of the components of the fluid flow circuit 12 will not change during the process, it is sufficient that adjustments to the detection components are performed once, such as during the calibration phase of the process. For example, one or more detection components may be adjusted once the fluid flow circuit 12 has been mounted to the fluid handling device 10, before the fluid flow circuit 12 is primed. In another embodiment, adjustments are made at some other early stage of the process, such as while the fluid flow circuit 12 is being primed. Once the necessary adjustments are made, the position and orientation of the detection components may be fixed relative to associated structures or components of the fluid handling device for the remainder of the process. However, while it is generally sufficient to make only one adjustment, it is within the scope of the present disclosure to make adjustments to the components of the detection components more than once during the process, as may be necessary in the event that the position and / or orientation of components of the fluid flow circuit unexpectedly change during the process.
[0100] Instead of (or in addition to) adjusting the position and / or orientation of the entire source or detector, the adjustment system can be configured to adjust the position and / or orientation of the components of the source or detector relative to the components of the same device. For example, in the case where the source is configured to emit light, the lens of the source can be repositioned and / or reoriented relative to other components of the light source to change its focus. The controller 18 can also control other dynamic adjustments to the various components of the source or detector, wherein the specific configuration of the associated adjustment system depends on the nature of the adjustment to be performed on the components. It should be understood that the above-described method of the controller 18 determines that the source or detector needs to be adjusted and then implements such adjustment, which is also applicable to the adjustment of the various components of the source or detector. Therefore, the position and / or orientation of the entire source or detector can be adjusted during the process (for example, during the calibration phase and / or during the fluid separation phase), and the adjustment of the various components of the source or detector can also be carried out simultaneously.
[0101] Although the detection assembly of the illustrated fluid handling device 10 is associated with a fixed component or structure of the fluid handling device 10, the adjustment principles described herein can be used in conjunction with a detection assembly having a component associated with a movable component of the fluid handling device. Therefore, it should be understood that adjustment of the position and / or orientation of a component of the detection assembly by the action of an adjustment system according to the present disclosure is different from the change in position and orientation that occurs when such a component is incorporated into a movable component or structure of the fluid handling device, but instead occurs when the position and / or orientation of such a component of the detection assembly is adjusted relative to the component or structure of the fluid handling device with which the component of the detection assembly is associated. For example, if the light source 50 of the interface monitoring assembly is incorporated into the yoke member 44, then movement of the entire yoke member 44 during the fluid separation process will not be considered as adjustment of the position and / or orientation of the light source 50 achieved by the adjustment system according to the present disclosure. Instead, the adjustment system will be configured to reposition and / or reorient the light source 50 relative to the yoke member 44 itself.
[0102] According to another aspect of the present disclosure, the properties of the signal emitted by source 50 can be adjusted. For example, when source 50 is configured as a light source configured to emit light having a single wavelength (or light having multiple wavelengths within a specific range), the adjustment system can be configured to adjust light source 50 to emit light having a different wavelength (or light having multiple wavelengths within different ranges). This can be achieved, for example, by providing multiple light sources (e.g., multiple lasers configured to emit light of different colors), with only one light source enabled at a time. When it is determined that a different type of light would be advantageous (e.g., based on assessed different fluid properties or feedback from controller 18 indicating that different light may improve detection component performance), controller 18 can instruct the adjustment system to deactivate one light source and activate another. This can include swapping the positions of the two light sources or moving the first light source out of position and the second light source into the position previously occupied by the first light source. In such a configuration, any number of light sources can be provided. It should be understood that this is only one possible method for adjusting the properties of the signal emitted by source 50, and other methods may be employed without departing from the scope of the present disclosure. It should also be understood that, depending on the particular mechanism used to adjust the properties of the signal, such adjustment may be considered an adjustment of the position and / or orientation of the source 50 .
[0103] Similarly, just as the properties of the signal emitted by source 50 can be adjusted, the properties of detector 52 can be adjusted by an adjustment system according to the present disclosure. For example, when detector 50 is configured as a light detector configured to analyze light having a single wavelength (or light having multiple wavelengths within a specific range), the adjustment system can be configured to adjust light detector 50 to analyze light having a different wavelength (or light having multiple wavelengths within different ranges). This can be achieved, for example, by providing multiple filters, each configured to filter out light of a different wavelength. When it is determined that analyzing light of a different wavelength or wavelength range would be advantageous (e.g., based on different fluid properties assessed or feedback from controller 18 that analyzing different wavelengths or wavelength ranges can improve the performance of the detection assembly), controller 18 can instruct the adjustment system to replace one filter with another (or to adopt a filter if one is not currently in use). This can include swapping the positions of two filters or moving the first filter out of position and moving the second filter into the position previously occupied by the first filter. Any number of filters may be employed, such that the adjustment may also include the controller 18 instructing the adjustment system to simultaneously activate two or more filters or instructing the adjustment system to deactivate all of the filters. It should be understood that this is merely one possible method of adjusting the properties of the detector 52, and that other methods may be employed without departing from the scope of the present disclosure. It should also be understood that, depending on the particular mechanism used to adjust the properties of the detector 52, such adjustment may be considered an adjustment of the position and / or orientation of the detector 52.
[0104] All aspects
[0105] Aspect 1. A fluid processing device, which includes a detection component and a controller, the detection component including a source and a detector, the source being associated with a component of the fluid processing device, being set in an initial position and initial orientation relative to the component of the fluid processing device and being configured to emit a signal, the detector being associated with a structure of the fluid processing device, being set in an initial position and initial orientation relative to the structure of the fluid processing device and being configured to receive at least a portion of the signal, wherein the detection component also includes: an adjustment system associated with the source, wherein the controller is configured to control the adjustment system to adjust the position and / or orientation of the source relative to the component of the fluid processing device and / or the position and / or orientation of the component of the source relative to another component of the source; and / or an adjustment system associated with the detector, wherein the controller is configured to control the adjustment system to adjust the position and / or orientation of the detector relative to the structure of the fluid processing device and / or the position and / or orientation of the component of the detector relative to another component of the detector.
[0106] Aspect 2. The fluid treatment device according to aspect 1, wherein the source is associated with a fixed component of the fluid treatment device.
[0107] Aspect 3. The fluid treatment device according to aspect 1, wherein the source is associated with a movable component of the fluid treatment device.
[0108] Aspect 4. The fluid handling device according to any of the preceding aspects, wherein the detector is associated with a fixed structure of the fluid handling device.
[0109] Aspect 5. The fluid handling device according to any one of aspects 1 to 3, wherein the detector is associated with a movable structure of the fluid handling device.
[0110] Aspect 6. A fluid processing device according to any of the preceding aspects, wherein the controller is configured to receive a signal from the detector, compare the signal from the detector with an expected signal from the detector, and when a characteristic of the signal from the detector is less than a corresponding characteristic of the expected signal, control the adjustment system associated with the source to adjust the position and / or orientation of the source relative to the component of the fluid processing device and / or the position and / or orientation of the component of the source relative to the other component of the source, and / or control the adjustment system associated with the detector to adjust the position and / or orientation of the detector relative to the structure of the fluid processing device and / or the position and / or orientation of the component of the detector relative to the other component of the detector, thereby enhancing the characteristic of the signal from the detector.
[0111] Aspect 7. A fluid processing device according to any of the preceding aspects, wherein the fluid processing device is configured to accommodate a fluid flow circuit for guiding fluid flow through the fluid processing device, and the controller is configured to receive an orientation signal indicating the position and / or orientation of a component of the fluid flow circuit associated with the fluid processing device, determine whether the position and / or orientation of the component of the fluid flow circuit is different from an expected position and / or expected orientation, and when the position and / or orientation of the component of the fluid flow circuit is different from the expected position and / or expected orientation, control the adjustment system associated with the source to adjust the position and / or orientation of the source relative to the component of the fluid processing device and / or the position and / or orientation of the component of the source relative to the other component of the source, and / or control the adjustment system associated with the detector to adjust the position and / or orientation of the detector relative to the structure of the fluid processing device and / or the position and / or orientation of the component of the detector relative to the other component of the detector, thereby indicating the position and / or orientation of the component of the fluid flow circuit.
[0112] Aspect 8. The fluid processing apparatus according to any of the preceding aspects, wherein the adjustment system associated with the source is configured to adjust the position of the source and / or the position of components of the source in three dimensions.
[0113] Aspect 9. A fluid processing device according to any of the preceding aspects, wherein the adjustment system associated with the detector is configured to adjust the position of the detector and / or the position of a component of the detector in three dimensions.
[0114] Aspect 10. The fluid processing device according to any of the preceding aspects, wherein the source comprises a light source and the detector comprises a light detector.
[0115] Aspect 11. The fluid processing device according to Aspect 10, wherein the component of the source includes a lens.
[0116] Aspect 12. A method for monitoring fluid and / or fluid components in a fluid processing equipment comprising a source and a detector, wherein the source is associated with a component of the fluid processing device and is arranged in an initial position and initial orientation relative to the component of the fluid processing device, and the detector is associated with a structure of the fluid processing device and is arranged in an initial position and initial orientation relative to the structure of the fluid processing device, the method comprising: transmitting a signal from the source to the fluid and / or fluid components in the fluid processing device; receiving at least a portion of the signal through the detector; and adjusting the position and / or orientation of the source relative to the component of the fluid processing device, the position and / or orientation of the detector relative to the structure of the fluid processing device, the position and / or orientation of a component of the source relative to another component of the source, and / or the position and / or orientation of a component of the detector relative to another component of the detector.
[0117] Aspect 13. The method according to aspect 12, wherein the source is stationary while transmitting the signal.
[0118] Aspect 14. The method of aspect 12, wherein the source is moving while transmitting the signal.
[0119] Aspect 15. The method according to any one of aspects 12 to 14, wherein the detector is stationary while receiving at least a portion of the signal.
[0120] Aspect 16. The method according to any one of aspects 12 to 14, wherein the detector is moving while receiving at least a portion of the signal.
[0121] Aspect 17. The method according to any one of Aspects 12 to 16 further includes: comparing the signal from the detector with the expected signal from the detector, and when the characteristics of the signal from the detector are smaller than the corresponding characteristics of the expected signal, adjusting the position and / or orientation of the source relative to the component of the fluid processing device and / or the position and / or orientation of the component of the source relative to the other component of the source, and / or adjusting the position and / or orientation of the detector relative to the structure of the fluid processing device and / or the position and / or orientation of the component of the detector relative to the other component of the detector, thereby enhancing the characteristics of the signal from the detector.
[0122] Aspect 18. A method according to any one of Aspects 12 to 17, wherein the fluid handling device is configured to accommodate a fluid flow circuit, which is used to guide fluid flow through the fluid handling device, and the method further includes: determining whether the position and / or orientation of a component of the fluid flow circuit accommodated by the fluid handling device is different from the expected position and / or expected orientation, and when the position and / or orientation of the component of the fluid flow circuit is different from the expected position and / or the expected orientation, adjusting the position and / or orientation of the source relative to the component of the fluid handling device and / or the position and / or orientation of the component of the source relative to the other component of the source, and / or adjusting the position and / or orientation of the detector relative to the structure of the fluid handling device and / or the position and / or orientation of the component of the detector relative to the other component of the detector, thereby indicating the position and / or orientation of the component of the fluid flow circuit.
[0123] Aspect 19. The method of any one of aspects 12 to 18, wherein the source comprises a light source and the detector comprises a light detector.
[0124] Aspect 20. The method of aspect 19, wherein the component of the source comprises a lens.
[0125] It will be understood that the embodiments and examples described above illustrate some of the applications of the principles of the present invention. Without departing from the spirit and scope of the claimed subject matter, those skilled in the art may make many modifications, including combinations of features that are individually disclosed or claimed herein. For these reasons, the scope of the present invention is not limited to the above description but is set forth in the appended claims, and it should be understood that the claims may be directed to features of the present invention, including combinations of features that are individually disclosed or claimed herein.
Claims
1. A fluid processing device, comprising: A detection component, the detection component comprising: a source associated with a component of the fluid handling device, disposed in an initial position and orientation relative to the component of the fluid handling device, and configured to transmit a signal, and a detector associated with a structure of the fluid handling device, disposed in an initial position and orientation relative to the structure of the fluid handling device, and configured to receive at least a portion of the signal; and controller, where The detection component also includes: a regulation system associated with the source, wherein the controller is configured to control the regulation system to adjust the position and / or orientation of the source relative to the component of the fluid treatment device and / or the position and / or orientation of a component of the source relative to another component of the source, and / or an adjustment system associated with the detector, wherein the controller is configured to control the adjustment system to adjust the position and / or orientation of the detector relative to the structure of the fluid handling device and / or the position and / or orientation of a component of the detector relative to another component of the detector, and The controller is configured to: controlling a regulating system associated with the source to move the source to a plurality of different positions and / or orientations relative to the component of the fluid handling device and / or to move the component of the source to a plurality of different positions and / or orientations relative to the further component of the source, and / or controlling a regulating system associated with the detector to move the detector to a plurality of different positions and / or orientations relative to the structure of the fluid handling device and / or to move the component of the detector to a plurality of different positions and / or orientations relative to the further component of the detector, receiving a signal from the detector when the source, the component of the source, the detector and / or the component of the detector is in the plurality of different positions and / or orientations, comparing the signals from the detectors to each other when the signals from the detectors have a maximum voltage to determine the position and / or orientation of the source, the component of the source, the detector, and / or the component of the detector, and controlling a regulating system associated with the source to move the source and / or the component of the source to a position and / or orientation in which the signal from the detector has a maximum voltage and / or controlling a regulating system associated with the detector to move the detector and / or the component of the detector to a position and / or orientation in which the signal from the detector has a maximum voltage.
2. The fluid processing device according to claim 1, wherein: The source is associated with a stationary component of the fluid handling device.
3. The fluid processing device according to claim 1, wherein: The source is associated with a movable component of the fluid handling device.
4. The fluid processing device according to claim 1, wherein: The detector is associated with a fixed structure of the fluid handling device.
5. The fluid processing device according to claim 1, wherein: The detector is associated with a movable structure of the fluid handling device.
6. A fluid processing device, comprising: A detection component, the detection component comprising: a source associated with a component of the fluid handling device, disposed in an initial position and orientation relative to the component of the fluid handling device, and configured to transmit a signal, and a detector associated with a structure of the fluid handling device, disposed in an initial position and orientation relative to the structure of the fluid handling device, and configured to receive at least a portion of the signal; and controller, where The detection component also includes: a regulation system associated with the source, wherein the controller is configured to control the regulation system to adjust the position and / or orientation of the source relative to the component of the fluid treatment device and / or the position and / or orientation of a component of the source relative to another component of the source, and / or an adjustment system associated with the detector, wherein the controller is configured to control the adjustment system to adjust the position and / or orientation of the detector relative to the structure of the fluid handling device and / or the position and / or orientation of a component of the detector relative to another component of the detector, and The controller is configured to: receiving a signal from the detector, comparing the signal from the detector to a reference signal from the detector, and When the voltage of the signal from the detector is less than the corresponding voltage of the reference signal, the adjustment system associated with the source is controlled to adjust the position and / or orientation of the source relative to the component of the fluid processing device and / or the position and / or orientation of the component of the source relative to the other component of the source, and / or the adjustment system associated with the detector is controlled to adjust the position and / or orientation of the detector relative to the structure of the fluid processing device and / or the position and / or orientation of the component of the detector relative to the other component of the detector, thereby enhancing the voltage of the signal from the detector.
7. A fluid processing device, comprising: A detection component, the detection component comprising: a source associated with a component of the fluid handling device, disposed in an initial position and orientation relative to the component of the fluid handling device, and configured to transmit a signal, and a detector associated with a structure of the fluid handling device, disposed in an initial position and orientation relative to the structure of the fluid handling device, and configured to receive at least a portion of the signal; and controller, where The detection component also includes: a regulation system associated with the source, wherein the controller is configured to control the regulation system to adjust the position and / or orientation of the source relative to the component of the fluid treatment device and / or the position and / or orientation of a component of the source relative to another component of the source, and / or an adjustment system associated with the detector, wherein the controller is configured to control the adjustment system to adjust the position and / or orientation of the detector relative to the structure of the fluid handling device and / or the position and / or orientation of a component of the detector relative to another component of the detector, and The fluid handling device is configured to house a fluid flow circuit for directing fluid flow through the fluid handling device, and The controller is configured to: receiving an orientation signal indicative of a position and / or orientation of a component of a fluid flow circuit associated with the fluid handling device, determining whether the position and / or orientation of the component of the fluid flow circuit is different from an expected position and / or expected orientation, and When the position and / or orientation of the component of the fluid flow circuit is different from the expected position and / or the expected orientation, the adjustment system associated with the source is controlled to adjust the position and / or orientation of the source relative to the component of the fluid processing device and / or the position and / or orientation of the component of the source relative to the other component of the source, and / or the adjustment system associated with the detector is controlled to adjust the position and / or orientation of the detector relative to the structure of the fluid processing device and / or the position and / or orientation of the component of the detector relative to the other component of the detector, thereby accounting for the position and / or orientation of the component of the fluid flow circuit.
8. The fluid processing device according to any one of claims 1, 6 and 7, wherein: An adjustment system associated with the source is configured to adjust the position of the source and / or the position of components of the source in three dimensions.
9. The fluid processing device according to any one of claims 1, 6 and 7, wherein: An adjustment system associated with the detector is configured to adjust the position of the detector and / or the position of components of the detector in three dimensions.
10. The fluid processing device according to any one of claims 1, 6 and 7, wherein: The source comprises a light source and the detector comprises a light detector.
11. The fluid processing device according to claim 10, wherein: The component of the source includes a lens.
12. A method of monitoring fluid and / or fluid components in a fluid handling device comprising a source and a detector, the source being associated with a component of the fluid handling device and disposed in an initial position and orientation relative to the component of the fluid handling device, and the detector being associated with a structure of the fluid handling device and disposed in an initial position and orientation relative to the structure of the fluid handling device, the method comprising: transmitting a signal from the source to the fluid and / or fluid components in the fluid processing device; receiving at least a portion of the signal via the detector; moving the source to a plurality of different positions and / or orientations relative to the component of the fluid handling device and / or moving a component of the source to a plurality of different positions and / or orientations relative to another component of the source, and / or moving the detector to a plurality of different positions and / or orientations relative to the structure of the fluid handling device and / or moving a component of the detector to a plurality of different positions and / or orientations relative to another component of the detector; receiving a signal from the detector when the source, the component of the source, the detector, and / or the component of the detector is in the plurality of different positions and / or orientations; comparing the signals from the detectors to one another when the signals from the detectors have a maximum voltage to determine the position and / or orientation of the source, the component of the source, the detector, and / or the component of the detector; as well as The source and / or the detector and / or the component of the source and / or the component of the detector are moved to a position and / or orientation in which the signal from the detector has a maximum voltage.
13. The method according to claim 12, wherein: The source is stationary while transmitting the signal.
14. The method according to claim 12, wherein: The source is moving while transmitting the signal.
15. The method according to claim 12, wherein: The detector is stationary while receiving the at least a portion of the signal.
16. The method according to claim 12, wherein: The detector is moving while receiving the at least a portion of the signal.
17. A method of monitoring fluid and / or fluid components in a fluid handling device comprising a source and a detector, the source being associated with a component of the fluid handling device and disposed in an initial position and orientation relative to the component of the fluid handling device, and the detector being associated with a structure of the fluid handling device and disposed in an initial position and orientation relative to the structure of the fluid handling device, the method comprising: transmitting a signal from the source to the fluid and / or fluid components in the fluid processing device; receiving at least a portion of the signal via the detector; transmitting a signal from the detector; comparing the signal from the detector to a reference signal from the detector; and When the voltage of the signal from the detector is less than the corresponding voltage of the reference signal, the position and / or orientation of the source relative to the component of the fluid processing device and / or the position and / or orientation of the component of the source relative to another component of the source are adjusted, and / or the position and / or orientation of the detector relative to the structure of the fluid processing device and / or the position and / or orientation of the component of the detector relative to another component of the detector are adjusted, thereby enhancing the voltage of the signal from the detector.
18. A method of monitoring a fluid and / or fluid components in a fluid handling device, the fluid handling device being configured to house a fluid flow circuit for directing fluid flow through the fluid handling device, the fluid handling device comprising a source and a detector, the source being associated with a component of the fluid handling device and disposed in an initial position and orientation relative to the component, and the detector being associated with a structure of the fluid handling device and disposed in an initial position and orientation relative to the structure, the method comprising: transmitting a signal from the source to the fluid and / or fluid components in the fluid processing device; receiving at least a portion of the signal via the detector; determining whether a position and / or orientation of a component of a fluid flow circuit housed by the fluid handling device differs from an expected position and / or expected orientation; and When the position and / or orientation of the component of the fluid flow circuit is different from the expected position and / or the expected orientation, the position and / or orientation of the source relative to the component of the fluid processing device and / or the position and / or orientation of the component of the source relative to another component of the source are adjusted, and / or the position and / or orientation of the detector relative to the structure of the fluid processing device and / or the position and / or orientation of the component of the detector relative to another component of the detector are adjusted to account for the position and / or orientation of the component of the fluid flow circuit.
19. The method according to any one of claims 12, 17 and 18, wherein: The source comprises a light source and the detector comprises a light detector.
20. The method according to claim 19, wherein The component of the source includes a lens.
Citation Information
Patent Citations
Method and apparatus for separation of matter from suspension
US5194145A
Time based interface detection systems for blood processing apparatus
US5316667A
Enhanced yield blood processing systems with angled interface control surface
US5632893A
Peristaltic pump tube holder with pump tube shield and cover
US5868696A
Systems and methods for mid-processing calculation of blood composition
US8075468B2