SYSTEM FOR ULTRAFILTRATION OF BLOOD
20230025881 · 2023-01-26
Inventors
Cpc classification
A61M60/113
HUMAN NECESSITIES
A61M60/837
HUMAN NECESSITIES
A61M60/109
HUMAN NECESSITIES
A61M60/438
HUMAN NECESSITIES
A61M1/34
HUMAN NECESSITIES
A61M1/3606
HUMAN NECESSITIES
International classification
A61M1/34
HUMAN NECESSITIES
A61M1/36
HUMAN NECESSITIES
A61M60/113
HUMAN NECESSITIES
Abstract
A blood ultrafiltration system comprises a blood filter with first and second compartments separated by a semipermeable membrane. Blood input and blood output lines are connected in fluid communication with the first compartment. An effluent line is connected in fluid communication with the second compartment. A peristaltic pump is arranged for repeated engagement with first and second line segments. In a first arrangement, the first line segment is part of the blood input line or the blood output line and the second line segment is part of the effluent line. In a second arrangement, the first line segment is part of the blood input line and the second line segment is part of the blood output line. The system is operable, by the peristaltic pump, to pump blood through the blood filter and control the extraction of ultrafiltrate in the blood filter.
Claims
1: A system for ultrafiltration of blood, the system comprising: a blood filter defining an internal chamber and comprising a semipermeable membrane arranged to separate the internal chamber into first and second compartments, a blood input line and a blood output line respectively connected to the blood filter in fluid communication with the first compartment, an effluent line connected to the blood filter in fluid communication with the second compartment, and a peristaltic pump that is arranged for repeated engagement with a first and a second line segment and configured in accordance with a first or second segment arrangement, wherein the first segment arrangement comprises the first line segment being part of the blood input line or the blood output line and the second line segment being part of the effluent line, and wherein the second segment arrangement comprises the first line segment being part of the blood input line and the second line segment being part of the blood output line, wherein the peristaltic pump, when operated to repeatedly engage the first and second line segments, produces a flow rate in the effluent line that is equal to a difference between a flow rate in the blood input line and a flow rate in the blood output line, and wherein the flow rate in the effluent line is a flow rate of ultrafiltrate driven through the semipermeable membrane by a pressure gradient between the first and second compartments created by the operation of the peristaltic pump.
2: The system of claim 1, wherein the first and second line segments are configured to, when the peristaltic pump is operated to repeatedly engage the first and second line segments, produce a first fluid flow in the first line segment and a second fluid flow in the second line segment, wherein the first and second line segments are configured to produce the second fluid flow as a predefined fraction of the first fluid flow.
3: The system of claim 2, wherein the peristaltic pump is configured in accordance with the first segment arrangement, and the predefined fraction is approximately 0.01-0.25 when the first line segment is part of the blood input line, or approximately 0.01-0.33 when the first line segment is part of the blood output line.
4: The system of claim 2, wherein the peristaltic pump is configured in accordance with the second segment arrangement, and the predefined fraction is approximately 0.75-0.99.
5: The system of claim 2, wherein the first and second line segments are configured to, when the peristaltic pump is configured in accordance with the first segment arrangement and operated to repeatedly engage the first and second line segments, produce the first fluid flow in the blood input line towards the blood filter or in the blood output line away from the blood filter and produce the second fluid flow in the effluent line away from the blood filter.
6: The system of claim 2, wherein the first and second line segments are configured to, when the peristaltic pump is configured in accordance with the second segment arrangement and operated to repeatedly engage the first and second line segments, produce the first fluid flow in the blood input line towards the blood filter and produce the second fluid flow in the blood output line away from the blood filter.
7: The system of claim 1, wherein the first and second line segments define a respective internal fluid channel, wherein the internal fluid channel of the first line segment is dimensioned to provide a larger stroke volume than the internal fluid channel of the second line segment when engaged by the peristaltic pump.
8: The system of claim 7, wherein the internal fluid channel of the first line segment has a larger cross-sectional area than the internal channel of the second line segment.
9: The system of claim 1, wherein the peristaltic pump comprises a pump head that is configured to receive the first and second line segments, wherein the pump head comprises a moveable actuator that is arranged to concurrently engage and compress the first and second line segments.
10: The system of claim 1, further comprising a valve, which is arranged in or on the effluent line and operable to selectively restrict the effluent line.
11: The system of claim 10, wherein the peristaltic pump is configured in accordance with the first segment arrangement, and wherein the valve is arranged in or on the effluent line between the blood filter and the peristaltic pump.
12: The system of claim 10, further comprising a control device, which is connected to operate the peristaltic pump and to selectively operate the valve during operation of the peristaltic pump to cause a pre-set amount of fluid to be pumped through the effluent line during a predefined time period.
13: A method of configuring a system for ultrafiltration of blood, the method comprising: providing a peristaltic pump that is configured for repeated engagement with a first and a second line segment; providing a blood filtering arrangement comprising a blood filter, which defines an internal chamber and comprises a semipermeable membrane arranged to separate the internal chamber into first and second compartments, a blood input line and a blood output line for connection to the blood filter in fluid communication with the first compartment, and an effluent line for connection to the blood filter in fluid communication with the second compartment; and arranging the first and second line segments in the peristaltic pump in accordance with a first or second segment arrangement, wherein the first segment arrangement comprises the first line segment being part of the blood input line or the blood output line and the second line segment being part of the effluent line, and wherein the second segment arrangement comprises the first line segment being part of the blood input line and the second line segment being part of the blood output line.
14: The method of claim 13, further comprising operating the peristaltic pump to repeatedly engage the first and second line segments to produce a flow rate in the effluent line that is equal to a difference between a flow rate in the blood input line and a flow rate in the blood output line.
15: The method of claim 14, wherein the flow rate in the effluent line is a flow rate of ultrafiltrate driven through the semipermeable membrane by a pressure gradient between the first and second compartments created by the operation of the peristaltic pump.
16: The method of claim 14, wherein the first and second line segments, when the peristaltic pump is operated to repeatedly engage the first and second line segments, produce a first fluid flow in the first line segment and a second fluid flow in the second line segment, wherein the first and second line segments produce the second fluid flow as a predefined fraction of the first fluid flow.
17: The method of claim 14, wherein the first and second line segments, when the peristaltic pump is configured in accordance with the first segment arrangement and operated to repeatedly engage the first and second line segments, produce the first fluid flow in the blood input line towards the blood filter or in the blood output line away from the blood filter and produce the second fluid flow in the effluent line away from the blood filter.
18: The method of claim 14, wherein the first and second line segments, when the peristaltic pump is configured in accordance with the second segment arrangement and operated to repeatedly engage the first and second line segments, produce the first fluid flow in the blood input line towards the blood filter and produce the second fluid flow in the blood output line away from the blood filter.
19: The method of claim 14, wherein when the peristaltic pump is configured in accordance with the first segment arrangement, the predefined fraction is approximately 0.01-0.25 when the first line segment is part of the blood input line, or approximately 0.01-0.33 when the first line segment is part of the blood output line.
20: The method of claim 14, wherein the peristaltic pump is configured in accordance with the second segment arrangement, and the predefined fraction is approximately 0.75-0.99.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0035] Embodiments will now be described herein by way of example only, with reference to the accompanying schematic drawings.
[0036]
[0037]
[0038]
[0039]
[0040]
[0041]
[0042]
[0043]
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0044] Embodiments will now be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all, embodiments are shown. Indeed, the subject of the present disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure may satisfy applicable legal requirements. Like reference signs refer to like elements throughout.
[0045] Also, it will be understood that, where possible, any of the advantages, features, functions, devices, and/or operational aspects of any of the embodiments described and/or contemplated herein may be included in any of the other embodiments described and/or contemplated herein, and/or vice versa. In addition, where possible, any terms expressed in the singular form herein are meant to also include the plural form and/or vice versa, unless explicitly stated otherwise. As used herein, “at least one” shall mean “one or more” and these phrases are intended to be interchangeable. Accordingly, the terms “a” and/or “an” shall mean “at least one” or “one or more”, even though the phrase “one or more” or “at least one” is also used herein. As used herein, except where the context requires otherwise owing to express language or necessary implication, the word “comprise” or variations such as “comprises” or “comprising” is used in an inclusive sense, that is, to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments.
[0046] It will furthermore be understood that, although the terms first, second, etc. may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. For example, a first element could be termed a second element, and, similarly, a second element could be termed a first element, without departing the scope of the present disclosure. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items.
[0047] As used herein, a “peristaltic pump” has its ordinary meaning and designates a pumping device that operates to pump a fluid through a flexible tube, which is supported on a fixed frame or backstop, by repeatedly engaging an actuator with the flexible tube. Ideally, the engagement fully compresses (“occludes”) the flexible tube against the backstop. A positive displacement pumping action is produced by moving the location of the engagement location along the flexible tube. Peristaltic pumps may be subdivided into two major types, rotary or roller types, and linear or in-line types. In rotary types, the actuator comprises rollers that engage the flexible tube and move in an arc along the flexible tube on the backstop. In linear types, the actuator engages the flexible tube at right angles to the direction of flow through the flexible tube. The actuator may comprise a plurality of compressive elements, typically active, that engage the flexible tube in a defined sequence to produce the pumping action.
[0048] As used herein, a “pump head” has its ordinary meaning and designates the portion of a peristaltic pump that comprises the backstop and the actuator and may also comprise one or more motors for driving the actuator. The pump head may be configured to permit installation of the flexible tube in proper alignment with the backstop and the actuator. Alternatively, the flexible tube may be (semi-)permanently installed in the pump head and present inlet and outlet connectors for connection to external tubing.
[0049] As used herein, “ultrafiltration” (UF) has its ordinary meaning and designates a process of removing a fluid, mainly containing water, from blood plasma without substantially changing the concentration of small solutes (molecules of up to 20,000-30,000 daltons), which thus is substantially the same in the ultrafiltrate as in the plasma. As used in the present disclosure, the ultrafiltration is performed in isolation and not concurrent with dialysis treatment. This type of ultrafiltration is sometimes referred to as “isolated ultrafiltration”.
[0050] Other well-known functions or constructions may not be described in detail for brevity and/or clarity. Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
[0051] The embodiments described herein relate to a system for removing excess fluid in human or animal subjects. The excess fluid is generally known in the art as “filtrate” or “ultrafiltrate”, and such a system will be denoted “ultrafiltration system” hereinafter. Embodiments are based on the insight that it is possible to reduce the number of pumps in an ultrafiltration system by use of a peristaltic pump configured as a “double channel pump”. Such peristaltic pumps are commercially available and are also known as “dual lumen pumps” or “double lumen pumps”. This type of peristaltic pump comprises an actuator configured to concurrently engage one or more tubular elements defining two internal channels. By clever installation of such a peristaltic pump, in accordance with embodiments, it is possible to provide an ultrafiltration system with few components, and thus at a potentially reduced cost, weight and/or complexity. Embodiments are exemplified in the following for peristaltic pumps of rotary type but are equally applicable to other peristaltic pumps.
[0052]
[0053] The system 1 further comprises an effluent line 10c, which may also comprise flexible tubing that defines an internal fluid channel and which is connected at one end to a connector 13c on the filter 12 in fluid communication with the ultrafiltrate compartment 12b. At its other end, the effluent line 10c is connected to a container or vessel 16 (as shown) or a drain. As shown, a valve 17 may be arranged in or on the effluent line 10c. The valve 17 may be configured as an on/off valve which is operable to open and close the effluent line 10c, or a restriction valve which is operable to change the flow resistance through the effluent line 10c. In one example, the valve 17 is a pinch valve or a clamp arranged to engage the outside of the effluent line 10c.
[0054] The system 1 further comprises a double-channel peristaltic pump 14, which is arranged to engage a line segment in the first blood line 10a and a line segment in the effluent line 10c.
[0055] It is to be understood that
[0056] The system 1 further comprises an electronic control device (“controller”) 20 which is configured to generate one or more control signals Ci for operative components of the system. For example, a first control signal may be generated for operating the pump 14 and a second control signal may be generated for operating the valve 17. The controller 20 may also receive and process sensor signal(s) Si from one or more sensors in the system 1, for example to implement safety functions for detecting system malfunction and/or for use when generating the control signals Ci.
[0057] In operation, when the system 1 is connected to the subject 100 and the pump 14 is active as indicated by a circular arrow in
[0058]
[0059]
[0060] Turning to
[0061] To facilitate installation of the line segments 10a′, 10c′ inside the pump head 140, the line segments 10a′, 10c′ may be formed into a unit, for example by being joined by a web portion 10d′ as shown in
[0062] The line segments 10a′, 10c′ may differ significantly in outer diameter to accommodate the area ratio. The difference in outer diameter will result in a difference in height between the line segments 10a′, 10c′ on one or both sides of the line segments 10a′, 10c′ when installed in the pump head. In
[0063] The blood lines 10a, 10b and the effluent line 10c may be provided as a set of disposables which are connected to the subject 100 and installed in an ultrafiltration machine that comprises the pump 14 and the controller 20, and optionally the container 16. Such a set of disposables in commonly denoted “line set” in the art. The set of disposables may also include the filter 12. The lines 10a, 10b, 10c and the filter 12 may be provided as separate components that are interconnected before installation, or they may be delivered as a preassembled unit. The line segments 10a′, 10c′ may also be part of such a set of disposables. It is conceivable that a range of sets are provided for selection by the operator of the ultrafiltration machine, where the respective set is configured to produce a specific fraction F. If the line segments 10a′, 10c′ are separate components for connection to the lines 10a, 10c, the line segments 10a′, 10c′ may be provided as a separate set of disposables.
[0064]
[0065] In operation, when the system 1 is connected to the subject 100 and the pump 14 is active as indicated by a circular arrow in
[0066]
[0067] In operation, when the system 1 is connected to the subject 100 and the pump 14 is active as indicated by a circular arrow in
[0068]
[0069] It may be noted that the foregoing examples of area ratio between line segments presume that the line segments have a substantially uniform cross-sectional area along their extent. Embodiments are not so limited.
[0070] In the examples shown in
[0071]
[0072] The ultrafiltration system 1 as described herein may be suitable for ambulatory use, by way of its potential for low weight, low cost and low complexity. In ambulatory use, the system 1 is worn or otherwise carried by the subject 100. However, the system 1 is equally suitable for stationary use, for example in a home, a dialysis clinic or a hospital. Further, the system 1 may be continuously or intermittently operated for ultrafiltration of the subject's blood in accordance with any known ultrafiltration therapy, including but not limited to acute intermittent ultrafiltration and Slow Continuous Ultrafiltration (SCUF).
[0073] The invention has mainly been described above with reference to a few embodiments. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope and spirit of the invention, which is defined and limited only by the appended patent claims.