瑞典专利SE1050729A1 Bubble reducers to eliminate gas bubbles from a flow

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Summary The present invention relates to a microbubble reducer for removing gas bubbles from a waste comprising non-Newtonian liquid, the microbubble reducer comprising an inlet (10) at a low point, a curved channel (4) comprising a gas outlet (5). at a high point, an outlet (6) at a low point, and a lumen (21) running through said inlet (10), through said curved channel (4), through said gas outlet (5), and through said outlet (6) . Furthermore, the present invention relates to a method for removing gas bubbles from a stream comprising non-Newtonian liquid by means of the microbubble reducer, as well as various different uses of the microbubble reducer.
公开号:SE1050729A1
申请号:SE1050729
申请日:2010-07-02
公开日:2011-01-04
发明作者:Per Jonsson；Bernd Stegmayr；Ulf Forsberg；Christopher Stegmayr
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专利说明:

15 20 25 30 2 is required for access to the bloodstream. But even the dialysis procedure itself entails inherent risks that require monitoring manually and by automatic landing systems.
Hernodialysis is performed using two separate fluid loops. Through one loop (blood loop) blood is led from the patient to the dialyzer and back to the patient. The second fluid loop passes dialysis fluid through the dialyzer to allow slag products and water to be removed from the blood by diffusion and convection into the dialysis fluid.
The physical principle of dialysis is diffusion across a semipermeable membrane in the so-called dialyzer. The dialyzer is an alter housing where the blood loop and the fluid loop are in contact with each other across the semipermeable membrane. Blood from the patient is discharged (from either an arterio-venous access or from a dialysis catheter) to an artery tube and by means of a blood pump through the dialyzer where the residual products are to be removed. The purified blood is returned to the patient via a venous tube.
Although the blood loop is apparently a closed system, air leaks into the bloodstream during the dialysis process. Either due to air remaining in the hose system after the filling procedure, but it can also leak air through joints in connection points.
To avoid potentially harmful effects of air exposure to blood ﬂ fate and further to the body, the blood loop is monitored using infrared and / or ultrasound safety systems (air guard).
The risk associated with the inflow of large air bubbles into the blood has long been a concern for those working in the dialysis industry. As a result, air emboli can become life-threatening for patients undergoing hernodialysis. This has led to extensive development efforts being put on detectors and the country sister for monitoring as well as the development of various methods for air separation from the system. An important underlying assessment that guided the development of these systems for air separation and air detection is the consensus that prevails among researchers regarding increasing risk with increasing bubble size and leakage of air per unit time. However, microbubbles are not attributed any significance. Generally, bubbles for 100 hours are considered to collapse in the blood and other small bubbles are absorbed. In addition, the lungs act as a barrier for bubbles larger than 20 μm (Polaschegg, Amf Organs, (2007), 31, 911-912). This paradigm, together with the practical impossibility of preventing microbubbles, has dictated today's industry standard.
The venous tube for blood in the dialysis system normally contains a venous chamber that makes it possible to remove larger air bubbles from the system, but they are only effective in removing relatively large bubbles. As a result of the industry's position on microbubbles, these systems have been judged to be adequate for clinical use. However, there is considerable scientific evidence that air emboli pass through the venous chamber without sounding an alarm (Jonsson, P., et al., "Air bubbles pass the security system of the dialysis device without alarm", Artif Organs, (2007), 31 (2): 132-9).
The venous chamber is only intended to separate larger air bubbles.
Extensive data collected by the inventors during the work of this invention show that microbubbles pass into the patient's vessels (Forsberg, U., er al., “Microboli, developed during hemodialysis, pass the lung barrier and may cause ischemic lesions in organs such as the brain ”, Nephrol Dial Transplant, (2010), Epub ahead of print). Studies show that hemodialysis causes the entrails of emboli (clots) to increase significantly in arteries such as the carotid artery, the carotid artery (one of the most important blood vessels that supply the brain).
In addition to an increased risk of lung damage, arterial microembolism can thus contribute to an increased incidence of brain damage and premature aging, including reduced nerve pathway functions. This risk is increased if you are exposed to this often and for a long time (eg hemodialysis patients). These data indicate that there is a newly discovered need to reduce and remove microbubbles in addition to larger air bubbles. 10 15 20 25 30 The existing window frames usually have a vertical so-called. drip chamber. The blood enters at a high point and flows out at a low point. This should make it possible for large bubbles, bubbles with a buoyancy force exceeding the pulling force of fate, to be able to rise vertically towards the top of the venous chamber. The force of liquid verkar works in the opposite direction. Different variants of existing venous chambers are designed for e.g. circular flows in the venous chamber, but there are also chambers with the appearance of straight blocks. WO 2006/030263, for example, discloses an air guard having a supply hose, a blood chamber. The chamber has a relatively large segment to reduce blood flow and make it easier for gases to move away from the blood while forming a gas zone over it. The flow out ends with an ascending hose. As a result of the prevailing paradigm, the venous chambers existing on the market are designed to remove only relatively large air bubbles but not microbubbles (bubbles with a diameter below 50-400 μm). In general, many systems are coarse instruments for removing gas and most even promote the creation and / or containment of microbubbles through their construction. The systems are also not particularly adapted for non-Newtonian and relatively viscous liquids such as blood, where the removal of small vortices in the blood is critical. Current designs overlook the properties of the blood, which often results in the formation of blood clots in areas with low blood flow, including altars where low flow is present or air has accumulated, or in corners of used equipment. This has a negative effect on the ability to remove air bubbles but also on dialysis as such. In addition, existing systems usually have a very complex design with many parts that entail manufacturing difficulties with an increased risk of air leakage.
Summary of the invention The object of the invention is to overcome said disadvantages in the treatment and to satisfy the needs in the technical field by providing a simple, easy-to-manufacture and optimized device for effectively separating gas bubbles, both relatively large bubbles but specifically microbubbles. from a flow comprising non-Newtonian fluid, for example in extracorporeal circulation or infusion therapy with venous blood entry. In addition, the invention describes both the use and the method for separating gas bubbles from a flow comprising non-Newtonian liquid and equipment comprising said device.
More specifically, the present invention describes an apparatus, i.e. a microbubble reducer, for eliminating gas bubbles from a stream comprising non-Newtonian liquid. The device is capable of eliminating bubbles of various sizes, but the fact that it has the capacity to remove so-called microbubbles from a flow of non-Newtonian fluid results in substantially improved properties from a clinical perspective. The microbubble reducer may be arranged so that said flow passes a maximum of one or two other devices before introduction into a patient and to remove gas bubbles as much as possible. The microbubble reducer comprises an inlet (10) at a low point, a curved channel (4) comprising a gas outlet (5) at a high point, an outlet (6) at a low point, and a lumen (21) which runs through said inlet (10), through said curved channel (4), through said gas outlet (5), and through said outlet (6). The lumen (21) of the microbubble reducer has an increasing cross-sectional area as it passes through the inlet (10) in the direction of the curved channel (4), and in addition the lumen (2l) of the inlet (10) is arranged at an angle between -20 ° and 75 ° relative to a horizontal plane.
The invention also exhibits a total lack of sharp angles, edges and so-called "dead space" (spaces with substantially no ﬂ velocity). The fact that the device only has soft transitions between different parts, and lacks edges / corners, sharp angles and "dead space", is critical for maintaining a laminar flow and minimizing eddy currents, this to further improve gravity. bubble separation and eliminate stagnant parts of the liquid in the device and thereby reduce blood clotting (coagulation) In accordance with one embodiment, the passage of the lumen (21) through said inlet (10), through said curved channel (4), can be reduced. through said gas outlet (5), and through said outlet (6) is described by at least one continuous function without singularities, i.e. that the lumen (21) has no sharp edges, corners or any dead space where the flow becomes substantially stagnant.
By utilizing exceptional gas separation, the invention can thus solve an acidified problem, the elimination of microbubbles, and significantly reduce the clinical consequences of this overlooked but nonetheless important phenomenon.
Brief description of the figures Figure 1. Example of a schematic illustration of an embodiment of the present invention, which shows an inlet (10) with continuously increasing cross-sectional area.
Figure 2. Example of a schematic illustration of an embodiment of the present invention showing an inlet (10) and three segments (1, 2, 3) with a constant but different cross-sectional area.
Figure 3. Example of a schematic illustration of an embodiment of the present invention, showing an inlet (10) with two initial segments (1,2) arranged horizontally and a third segment (3) placed in an inclined manner.
Figure 4. Example of a schematic illustration of an embodiment of the present invention, showing an inlet (10) with three sloping segments with different cross-sectional areas and with varying sloping slopes (1, 2, 3). In addition, the figure shows the supply channel (30) with a lumen (41) which can optionally be added to device-CH. Figure 5. Example of a schematic illustration of an embodiment of the present invention, where the device is arranged with components commonly used in dialysis.
Figure 6. Comparative diagram of microbubbles / minute relatively different flow rates for existing device A and a prototype of the invention on the market.
Figure 7. Comparative diagram of microbubbles / minute relatively different fatalities for device B existing on the market and a prototype of the invention.
Figure S. The figure shows how the length of the supply channel (30) affects the removal of microbubbles. A longer supply channel (30) improves bubble separation.
Figure 9. The figure shows how the angle of the inlet (10) affects the removal of microbubbles. An angle of the lumen (21) of the inlet (10) about approximately 45 ° results in optimal bubble separation.
Figure 10. Definition of the angular range used to define the present invention. The arrows indicate the direction of fate.
Figure ll. The figure shows how the number of bubbles decreases with increasing length of the lumen (21) of the inlet (10). The length indicated on the x-axis refers to the length from the beginning of the lumen (21) until the v turns downwards relative to a horizontal plane, measured along the lower edge of the lumen (21).
Detailed description of the invention The present invention comprises a device, e.g. a venous chamber, to eliminate, remove and / or significantly reduce the amount of gas bubbles, of size down to 2.5 μm, from a flow comprising non-Newtonian liquid, a method for removing gas bubbles from a desiccant comprising non-Nevtonian fluid, a dialysis apparatus provided with the invention and the use of said device in removing gas bubbles from streams comprising non-Newtonian fluids, especially in connection with hemodialysis applications.
The terms and terms used in the present application shall be construed primarily in accordance with their accepted meaning in the respective technical field.
However, certain concepts and terms will be further defined below to facilitate and clarify certain aspects of the present invention.
The term "lumen" is to be understood as including a cavity of a certain extent and / or a channel. The term “continuous function” is to be understood in accordance with accepted definitions, ie as a coherent function that is coherent / continuous in all points in an arbitrary interval. The term “singularity” or “singular point” shall be understood as a point where an otherwise analytical function is not defined and / or a point where a function is not derivable. The terms "singularity" or "singular point" are to be understood in this context as descriptive corners, sharp edges, and / or dead volumes, i.e. a lumen that can be described by a continuous function without singularities has essentially only smooth and / or smooth surfaces and shows a substantially total lack of corners, sharp edges, and / or dead volumes. "Non-Newtonian liquid" is to be understood to relate to a liquid whose viscosity changes with changes in the velocity gradient in the liquid (shear rate) which depends on e.g. ﬂ the rate of fate, such as blood, blood plasma and blood replacement fluids. The term “between -2 (} ° and 75 ° relative to a horizontal plane” should be understood to relate to the whole range between ~ 20 ° and 75 °, including 0 ° (Figure 10).
When said term "between -20 ° and 75 ° relative to a horizontal plane" is used in connection with the angle of the inlet (10) or of the supply channel (30) of said device, it is to be understood that these parts of the device may be arranged with a slope 5 0 °, an inclination of 20 ° and completely horizontal, ie with an angle of substantially = 0 °. Of course, those skilled in the art will immediately recognize that an angular range of 10 ° and 75 ° also includes an angle of 0 °, i.e. that horizontal arrangement of the inlet (10) and / or supply channel (30) is also included. of the definition. The term "flow passes a maximum of one or two other devices before insertion into a patient" is clear to those skilled in the art and should be understood to include that a maximum of one or two other types of medical devices (eg a safety device or a filter) are placed between the device in accordance with the present invention and a patient to receive the flow of non-Newtonian fluid from which gas bubbles have been removed by the microbubble reducer.
As can be further understood from the description and examples, the term "curved channel" relates to a tubular object or hose having a curved shape, preferably the shape of an inverted U with the curved point at the top; The terms "Air", "gas", "gas bubbles" and "bubbles" describe unwanted gaseous components that occur in a liquid and / or blood ﬂ destiny, the tin "horizontal plane" refers to any plane that is considered parallel to the earth's surface. The term "low point" refers to the lower part of the device, below the high point and substantially lower than the upper part of the curved channel, while the term "high point" refers to the highest part of the channel in the device, including above or next to the curved the channel. The flow direction can be used to indicate whether a slope is rising or falling.
A first aspect of the present invention relates to a device, i.e. a microbubble reducer, for eliminating gas bubbles from a waste comprising non-Newtonian liquid. The device is capable of eliminating bubbles of various sizes, but the fact that it has the capacity to remove so-called microbubbles from a flow of non-Newtonian fluid results in substantially improved properties from a clinical perspective. The microbubble reducer may be arranged so that said flow passes a maximum of one or two other devices before introduction into a patient, in order to remove gas bubbles as far as possible. The microbubble reducer comprises an inlet (10) at a low point, a curved channel (4) comprising a gas outlet (5) at a high point, an outlet (6) at a low point, and a 10 15 20 25 30 10 lumens (21) running through said inlet (10), through said curved channel (4), through said gas outlet (5), and through said outlet (6). The lumen (21) of the microbubble reducer has an increasing cross-sectional area as it passes through the inlet (10) in the direction of the curved channel (4), and in addition the lumen (21) of the inlet (10) is arranged at an angle between -20 ° and 75 ° relative to a horizontal plane, which of course includes that the inlet can also be arranged horizontally.
The increasing cross-sectional area along the inlet (10) towards the curved channel (4) results in a reduced flow rate of the liquid, which facilitates ascent and thus separation / removal of gas bubbles from the liquid. The gas that is separated can be vented out at the highest point of the curved channel (4) through a gas outlet (5), before the non-Newtonian fluid travels through the outlet (6) further in the venous direction.
The ieke-Newtonian liquid is led into the system through an inlet (10). The inlet (10) is oriented at an angle between -20 ° and 70 ° relative to the horizontal plane, i.e. including 0 ° degrees (the inlet can thus be arranged horizontally), in order to cause the gas bubbles to be distributed along the upper part of the flow. For bubbles with a small diameter, this is easiest to achieve through high shear stress as the viscosity of the blood decreases. The inlet (10) of the present invention has an increasing cross-sectional area in the venous direction, i.e. along the direction of fate, which results in reduced flow rate, decorative pressure of the liquid and, in the case of supersaturation, further separation of the gases in the liquid. The length of the inlet (10) can be modified to affect the separation of gas bubbles, i.e. longer inlets make it easier for bubbles to rise to the upper part of the flow (at higher flows). After passing the inlet, the blood reaches the curved channel, whereby the gas bubbles are removed via the gas outlet, located at the high point of the curved channel. The upper part of the device, i.e. the curved channel, allows bubbles to collect and join to larger bubbles, which can be removed via the gas outlet. The said gas outlet can be manufactured in a number of different ways by the person skilled in the art. Thereafter, the blood is returned, substantially without harmful gas bubbles, to the patient via the outlet of the device.
Overall, as a result of its physical design, the device separates both relatively large bubbles and microbubbles, which reduces the risk of adverse events occurring during replacement therapy for renal failure, plasmapheresis / apheresis, haemoperfusion, plasma ﬁltration or similar treatments (ie extra - corporal blood or fluid management) and infusion therapy included.
The rising slope and the increasing cross-sectional area of the inlet (10) result in increased lifting force for the bubbles and the absence of edges and sharp angles results in a laminar flow without disturbances. The result of the force, between the blood flow and the lifting force of the bubbles, is constantly directed upwards, except after the curved channel, which results in distinct advantages over other devices used in this field / discipline.
Lots of parameters affect a flow involving non-Nevvtonian fluid, for example a blood ﬂ fate, which makes, for example, dialysis processes very complex and difficult to control. A small cross-sectional area results in a higher soldering rate and thus a higher shear rate, which, for blood, means lower viscosity. In addition, water is often removed from the blood during dialysis, at varying rates. As a result, the blood that returns to the patient through the venous part of the tube has varying but generally abnormally high blood cell concentration, which in turn leads to abnormally high viscosity. In addition, the ﬂ rate of fate of blood ﬂ fate varies greatly, depending on a number of factors such as prescribed treatment and the availability of good blood vessels, which further increases the complexity of the dialysis process. Accordingly, it is of utmost importance to optimize the arrangement and characteristics of the dialysis tubing in order to streamline the removal of air and minimize clot formation in liquids of varying viscosity.
The invention also shows a total lack of sharp angles, edges and so-called “dead space” (spaces with essentially no speed of fate). The fact that the device only has soft transitions between different parts, and lacks edges / corners, sharp angles and "dead space", is critical for maintaining an iaminate ﬂ fate and minimizing eddy currents, this for to further improve gravity-influenced bubble separation and eliminate stagnant parts of the liquid in the device and thereby reduce blood clotting (coagulation). According to an embodiment, the passage of the lumen (21) through said inlet (10), through said curved channel (4), through said gas outlet (5), and through said outlet (6) can be described by at least one continuous function without singularities. , that is to say that the lumen (21) has no sharp edges, corners or any dead space where the fate becomes substantially stationary, and that the lumen (21) can always be described by a coherent feature.
The fact that the device is completely free of sharp angles and / or edges brings a significant advantage in terms of reduced disorder and reduced number of eddy formations as well as the absence of dead space and reduction of slow flowing blood, which both increases the separation of bubbles of all sizes, including microbubbles, and counteracts the risk of coagulation, which is a problem that can be identified in a number of other gas separation devices. Furthermore, the combination of the above-mentioned functions results in a laminar blood ﬂ fate, optimized for the elimination of gas bubbles.
In order to minimize the amount of blood outside the body at any time during treatment, said device should have as small a filling volume as possible. Effective removal of harmful air from the system is crucial. Therefore, the optimized physical properties in accordance with the present invention are of paramount importance.
In one embodiment of the invention, the curved channel is in the form of an inverted U. The U-chamber is oriented with a smooth transition to further promote a linear flow without disorder in the ﬂ. The hose component, i.e. the lumen (21), in the present invention may preferably have a circular cross-section, but other geometric shapes without sharp angles and edges, e.g. oval, are also within the scope of the present invention. For example, an oval version of the tube (i.e. a tube / lumen with two different radii) in the present invention would give rise to a higher shear rate which is an advantageous property at certain concentrations of blood. In this case, the vertical radius is larger than the horizontal radius. This leads to an increased shear rate, which can be a desirable effect at certain blood concentrations. In addition, in accordance with the present invention, the tube / lumen may have different cross-sections below the inlet (10), for example the initial shape may be oval because the terminating part of the tube is circular or vice versa. Furthermore, within the scope of the invention, the different segments may have different cross-sectional shapes and forms together with continuous and smooth transitions.
According to a further embodiment, the lumen (21) of the inlet (10) of the present invention may have a length of at least 2 cm, of at least 3 centimeters, of at least 4 cm, of at least 5 cm, of at least 10 cm, of at least 15 cm of at least 20 if, of at least 25 cm, of at least 30 cm, of at least 35 cm, of at least 40 cm, of at least 45 cm, of at least 50 cm, of at least 55 cm, of at least 60 cm, or of at least 1 m Figure 11 shows how bubble removal improves with the length of the lumen (21) of the inlet (10), i.e. the longer the lumen (21), the more effective the bubble removal.
According to a further embodiment, the microbubble reducer may further comprise a supply channel (30) comprising a lumen (41), said supply channel (30) being arranged so that said lumen (41) merges with the lumen (21) of the inlet (10) (Figure 4). .
Said supply channel (30) may have a length of at least 1 cm, of at least 2 cm, of at least 3 centimeters, of at least 4 cm, of at least 5 cm, of at least 10 cm, of at least 15 cm, of at least 20 cm, of at least 25 cm, of at least 30 cm, of at least 35 cm, of at least 40 cm, of at least 45 cm, of at least 50 cm, of at least 55 cm, of at least 60 cm, or of at least 1 m.
Figure 8 clearly illustrates how the length of the supply channel (30) contributes to optimizing the removal of bubbles of different sizes. Furthermore, in a further embodiment in accordance with the present invention, the supply channel (30) may be arranged at an angle between -20 ° and 70 ° relative to the horizontal plane, i.e. including 0 ° degrees (the supply channel ( 30) can thus be arranged horizontally), in order to cause the gas bubbles to be distributed along the upper part of the ﬂ.
In a further embodiment, the distance from the beginning of the inlet (10) to the lumen (21) of the highest point of the curved channel (4) may be at least 3 cm, at least 4 cm, at least 5 cm, at least 10 cm, at least 15 cm, at least 20 cm , at least 25 cm, at least 30 cm, at least 35 cm, at least 40 cm, at least 45 cm, at least 50 cm, at least 55 cm, at least 60 cm, or at least 1 m. The distance from the beginning of the inlet (10) to the curved channel ( 4) the highest point shall be understood as the distance from a central point in a cross section of the lumen (21) at the beginning of the inlet (10) to the highest point of the lumen (21) in the curved channel (4).
According to a further embodiment of the invention, the lumen (21) of the angle of the inlet (10) relative to the horizontal plane may vary from 0 ° to 75 °, i.e. from a horizontal arrangement to 75 °, preferably between 35 ° and 55 °, and preferably 45 ° relative to the horizontal plane, in order to avoid bubbles getting stuck and instead help the upward movement of the bubbles inside the device (ie promote the separation of bubbles from the liquid and avoid mixing bubbles separated into liquid) again). Figure 9 shows the separation of bubbles of different sizes at different angles of the inlet (10) and the said figure clearly indicates that an inlet (10) arranged at approximately 45 ° optimizes the bubble removal.
The inlet (10) can have an increasing cross-sectional area towards the curved channel, either arranged in such a way that the increase takes place in segments or through a continuous increase.
The above-mentioned increase in cross-sectional area results in reduced flow rate, but also reduces the pressure in the liquid, which also allows smaller bubbles to expand and thus have greater lifting force, which enhances the separation effect. According to another embodiment of the invention, the lumen (21) of the inlet (10) is divided into at least two segments, each of which has a slope of -20 ° and '70 ° relative to the horizontal plane. , including 0 ° degrees (ie the lumen (21) of the inlet (10) can also be arranged horizontally), to optimize the bubble separation.
Figure 1 represents an embodiment of the present invention with continuously increasing cross-sectional area on the lumen (21) of the inlet (10), where non-Nevtonian fluid, for example blood, enters the device through segment (1) and continues further through segment (1). 2) and (3). The increase in area and the inclination of the inlet relative to the horizontal plane facilitates the separation of bubbles of all sizes. The blood is then passed on to the curved channel (4), where gas bubbles are removed through a gas outlet (S), before the blood is returned to the patient through the outlet (6). The parts in Figure 1 are of course primarily for illustrative purposes and are not to be construed as limiting the device in any way. Furthermore, as a variant of the invention, the shape of the inlet (10) can be described, instead of linearly rising, as an exponential or logarithmic function or some other form with appropriate changes. An inlet (10) which has an increasing cross-sectional area but within an angular sector has natural advantages in terms of manufacture and adaptation to different dialysis systems.
Figure 2 represents another embodiment of the invention, where the inlet (10) is divided into three segments with different but intrasegmental constant cross-sectional area, i.e. that the cross-sectional area of segment (1) is smaller than the cross-sectional area of segment (2) which in turn is smaller than the cross-sectional area of segment 3. In this way, the blood ﬂ fate which enters the device through segment (1) can continue through segment (2) and finally through segment (3), obtain a concomitant reduction of the fate rate for optimized separation of bubbles before it flows into the curved channel (4), where gas is removed through the gas outlet (S), and the blood is finally returned to the patient through the outlet (6) - 10 15 20 25 30 16 In the discharge form represented by Figure 3, segments (1) and segments (2) of the inlet (10) are oriented horizontally, i.e. with an angle of 0 ° relative to the horizontal plane, which have in principle a constant intrasegrinal cross-sectional area, where segment (2) has a larger cross-sectional area than segment (1), in order to achieve effective bubble separation.
After leaving segment (2), the flow rises approximately 45 ° through segment (3) and then reaches the curved channel (4). In the present embodiment of the invention, the curved channel (4) has a shape which closely mimics the shape of an inverted U, with gas outlet (5) located at the highest point of the said U-shape. Finally, the blood leaves the device through the outlet (6), which is in principle placed perpendicular to the horizontal plane, and continues in the venous direction.
According to another embodiment of the present invention, represented by Figure 4, segments (1) of the inlet (10) have a smaller inclination relative to the horizontal plane compared to the other segments in the inlet. Segment (1) also has a smaller cross-sectional area than the other segments, in order to optimize the separation of gas. In addition, segment (1) has a constant cross-sectional area, segment (2) has a steeper slope than segment (1) but also a continuously increasing cross-sectional area. The blood then flows further through segment 3 and then through the curved canal (4). Gas is removed at the gas outlet (5) before the blood leaves the device at the outlet (6).
In one embodiment, referred to as Figure 5, the embodiment in Figure 3 is arranged together with components commonly used in dialysis contexts. The device is arranged together with the holder (8) for the dialysis machine, a venous core (9) and a priming detector and / or bubble detector (6). Furthermore, the device is equipped with additional holders (11) and (12) to increase the safety of device CH.
All of the above exemplary embodiments in accordance with the present invention allow easy adjustment of the device, to enable use in conjunction with various types of dialysis machines and apparatus, without the need for the machines and apparatus to be adapted or modified.
The segmented inlets of certain embodiments of the device can optionally be manufactured individually, in order to enable individual modification and replacement of a specific segment. However, in accordance with another embodiment, a segmented inlet of the device can be manufactured in one piece, to simplify the manufacture.
In a further embodiment, the lumen (21) of the microbubble reducer may have a cross-sectional area of between 1 mm 2 and 800 mm 2.
Furthermore, according to the invention, the first segment of the lumen (21) of the inlet (10) may have a cross-sectional area of between 1 mm 2 and 30 mm 2, preferably about 16 mm 2. The second segment can have a cross-sectional area of between lrnrng and 210mm2, preferably about l50mrn2. The third segment may have a cross-sectional area of between linmz and 2751nm 2, preferably about 2001111112. The purpose of the various segments is to optimize bubble separation with respect to shear stress, intended blood fate, and blood concentrations. This is critical for the separation of microbubbles.
According to another embodiment of the present invention, the lumen (21) of the outlet (6) is located perpendicular to the horizontal plane, preferably with a deviation of less than 80 ° in any direction but even more advantageously with an angle of less than 45 ° and preferably with a deviation of less than 20 ° in any direction. The preferred location of the outlet must be adapted to facilitate both the use of the device but also to fit connections to various dialysis machines.
In accordance with a further embodiment of the present invention, the device, i.e. the lumen (21) and optionally the lumen (41) of the microbubble reducer, is in principle completely filled with non-Newtonian liquid during use, in order to optimize the removal of air from the flow. In contrast to the use procedures of other devices in the field, the device in question does not need an air zone to function, which results in simplified handling and increased efficiency in gas removal. The user of the equipment is expected to fill the device all the way to the top, where the fluid level is controlled either manually or with a detector, to optimize the editing of bubbles and minimize blood contact with air to prevent coagulation.
According to yet another embodiment of the present invention, the microbubble reducer is constructed with at least one filter. The filter can be placed anywhere in the device, but preferably at or near the outlet, to remove any blood clots. Furthermore, according to the invention, the microbubble reducer is arranged together with at least one level detector, selected from the group comprising inter alia an optical detector, ultrasonic detector and a conductance detector, or a bubble detector on the outlet hose from the device.
A further embodiment of the present invention shows that the curved channel or gas outlet of the device is arranged to enable manual reading of the level of fate or by means of a control device. This is to facilitate optimized flow detection, which further improves the handling and safety of the invention. In accordance with a further embodiment, the curved channel (4) or the gas outlet (5) can be arranged so that reading of the liquid level can be done either manually or by means of a control device.
In a further embodiment, the non-Newtonian fluid may be selected from a group consisting of blood, blood plasma, blood replacement fluids, plasma proteins, plasma substitutes, blood substitutes, albumin and / or other plasma protein solutions, gelatin preparations and hemoglobin cros höglvicarous, liquids such as dextran solutions and hydroxyethyl starch. In accordance with another embodiment, an additional wall is located in the lumen (21, 41) of the device, to further increase the shear stress at certain flows and conditions when desired. In addition, the inclusion of a wall can further reduce the viscosity of the blood, which is a desired effect in e.g. low ﬂ fate rates.
One aspect of the present invention relates to a method of removing gas bubbles from a flow of non-Newtonian liquid. The method comprises connecting the microbubble reducer to a liquid source, transporting the liquid through the lumen (21), and alternatively also the lumen (41) of the microbubble reducer, separating gas from the flow, removing separated gas through the gas outlet (5) and finally transporting the non-Newtonian liquid. through the outlet (6), to a patient. In addition, in one embodiment, the gas outlet (5) can be used to maintain a high liquid level in the upper part of the curved channel.
Another aspect of the present invention is an apparatus comprising the microbubble reducer connected to a dialysis machine, for the purpose of removing gas bubbles which may cause clinically relevant problems for the patient undergoing the dialysis treatment.
Further aspects of the invention relate to the use of the device for dialysis or similar treatments considered suitable by a person skilled in the art, and more specifically, in accordance with an embodiment of the present invention, for hemodialysis, for plasma exchange, for infusion of blood and other non- Nevvtonian fluids, as well as in a heart-lung machine.
Examples Material and method A prototype developed based on the present invention was compared with other leading products on the market, competing devices A and B. A Standardized Bubble Generator was used to create bubbles of varying size, including microbubbles, in a solution that is often used as a blood substitute in dialysis procedures. The solution used contains dextran and albumin and has the same viscosity as normal blood.
The solution was recycled from a solution-filled container, where bubbles were created by the bubble generator, to the inlet hose of the dialysis system for either the competing devices A and B or the prototype of the present invention. The bubbles present downstream of the vena cava were detected by an ultrasonic sensor made by Hatteland Instrument (Royken, Norway). The measurements were made alternately between the systems for the different blood fates in order to reduce the risk of uneven bubble distribution between the measurements.
At least ten measurements were made for each system and at each ﬂ velocity (200, 300, 400, 500 and 600 ml / rnin) were cerebral statistically performed with a non-parametric paired Wilcoxon test.
Results The following data were collected based on the use of a dialysis system approximately designed in accordance with Figure 3. The divergence between two comparative tests stems from variations in the exposure of microbubbles per minute between the different ﬂ feasibility measurements.
Table 1. Comparison between the prototype based on the present invention and device A.
Flow rate Prototype Device A% increase P = (ml / min) (bubbles / min) (bubbles / min) 200 20.3 1 18 581 0.005 300 30.8 223 724 0.005 400 8.80 31.6 359 0.011 450 2, 90 10 21 500 6.70 121 1810 0.005 600 28.4 71.0 386 Table 2. Comparison between the prototype based on the current invention and device B.
Flow rate Prototype Device B% increase P = (ml / min) (bubbles / min) (bubbles / min) 200 0.167 0.583 350 0.059 300 1.73 18.5 1070 0.005 400 7.10 37.3 525 0.005 500 50, 8 350 688 0.005 600 402 1170 290 0.005 As can be seen from Table 1 and Table 2 as well as Figure 6 and Figure 7, the prototype of the current design significantly reduced the amount of microbubbles compared to leading products on the market today. The above results demonstrate the significant advantage in terms of bubble elimination and thus indicate reduced clinical consequences in the use of the present invention.

权利要求:
Claims (1)
[1]
A microbubble reducer for removing gas bubbles from a stream comprising non-Newtonian liquid, the microbubble reducer comprising an inlet (10) at a low point, a curved channel (4) comprising a gas outlet (4). 5) at a high point, an outlet (6) at a low point, and a lumen (21) running through said inlet (10), through said curved channel (4), through said gas outlet (5), and through said outlet (6), said microbubble reducer being characterized in that said lumen (21) has an increasing cross-sectional area as it passes through the inlet (10) in the direction of the curved channel (4), and that the lumen (21) of the inlet (10) is arranged at an angle between -20 ° and 75 ° relative to a horizontal plane. Microbubble reducer according to claim 1, wherein the passage of the lumen (21) through said inlet (10), through said curved channel (4), through said gas outlet (5), and through said outlet (6) can be described by at least one continuous function without singularities. . Microbubble reducer according to one of Claims 1 or 2, in which the curved channel (4) has the shape of a substantially upturned and nerve-shaped U. Microbubble reducer according to any one of claims 1-3, wherein said lumen (21) of said inlet (10) has a length of at least 2 cm. . A microbubble reducer according to any one of claims 1-4, further comprising a supply channel (30) comprising a lumen (41), said supply channel (30) being arranged so that said lumen (41) merges with the lumen (21) of the inlet (10), wherein said supply channel (30) has a length of at least 1 centimeter. . Microbubble reducer according to claim 5, wherein said supply channel (30) is arranged at an angle between -20 ° and 75 ° relative to a horizontal plane. . Microbubble reducer according to one of Claims 1 to 6, in which the distance from the beginning of the inlet (10) to the lumen (21) of the highest point of the curved channel (4) is at least 3 cm. A microbubble reducer according to any one of claims 1 to 7, wherein the lumen (21) of the inlet (10) is arranged horizontally and / or is arranged at an angle between 0 'and 75 ° relative to a horizontal plane. , preferably arranged at an angle between 35 ° and 55 ° relative to a horizontal plane and most preferably arranged at an angle of 45 ° relative to a horizontal plane. A microbubble reducer according to any one of claims 1-8, wherein the lumen (21) of the inlet (10) is divided into at least two segments, each of the segments being arranged at an angle between -20 ° and 75 ° relative to a horizontal plane. . A microbubble reducer according to any one of claims 1 to 9, wherein said lumen (21) of said inlet (10), said curved channel (4), said gas outlet (5) and / or said outlet (6) has a cross-sectional area of between about 1 mm 2 and about 8001111112. A microbubble reducer according to any one of claims 9-10, wherein the lumen (Z1) of a first segment (1) of said inlet (10) has a cross-sectional area of melian approximately 1 mm 2 and about 30 mm 2, preferably about 1 mm 2. A microbubble reducer according to any one of claims 9-11, wherein the lumen (21) of a second segment (2) of said inlet (10) has a cross-sectional area of between about 1 mm 2 and about 21 mm 2, preferably about 150 mm 2. A microbubble reducer according to any one of claims 9 to 12, wherein the lumen (21) of a third segment (3) of the inlet (10) has a cross-sectional area of melian approximately 1 mlnz and approximately 275 mm 2, preferably a cross-sectional area of approximately zoommz. Microbubble reducer according to one of Claims 1 to 13, in which the lumen (21) of the outlet (6) is arranged perpendicular to the horizontal plane. A microbubble reducer according to any one of claims 1 to 14, wherein said microbubble reducer is substantially filled with non-Newtonian liquid during operation. A microbubble reducer according to any one of claims 1-15, wherein the microbubble reducer is provided with at least one filter. A microbubble reducer according to any one of claims 1 to 16, wherein the microbubble reducer is arranged with at least one level detector selected from a group consisting of an optical detector, an ultrasonic detector and a conductance detector, alternatively a bubble detector placed on the outlet ( 6). A liquid microbubble reducer according to any one of claims 1-17, wherein the curved channel (4) or the gas outlet (S) are arranged so that reading of the liquid level can be done either manually or by means of a control device. A microbubble reducer according to any one of claims 1 to 18, wherein the non-Newtonian fluid is selected from the group consisting of blood, blood plasma and blood replacement fluids. A method of removing gas bubbles from a stream comprising non-Newtonian liquid, comprising the steps of: (i) connecting the microbubble reducer to a source comprising non-Newtonian liquid; (ii) transporting the liquid through the microbubble reducer; (iii) separating gas bubbles from the non-Newtonian liquid; (iv) removing the separated gas bubbles through the gas outlet (5); and (v) transporting the non-Newtonian liquid through the outlet (6). A method according to claim 20, wherein the gas outlet (5) is used to maintain a level of blood flow which is as high as possible in the upper part of the curved channel (4). Apparatus comprising the microbubble reducer according to claims 1-19, wherein the microbubble reducer is connected to a dialysis machine. Use of the microbubble reducer according to any one of claims 1-19, for dialysis or similar treatment. Use of the microbubble reducer according to any one of claims 1-19 for hemodialysis, for plasma exchange, for infusion of blood and other non-Newtonian fluids, and in a heart-lung machine.

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法律状态:

优先权:

申请号 | 申请日 | 专利标题

SE0950521|2009-07-03|

US23315209P| true| 2009-08-12|2009-08-12|

SE1050729A|SE536054C2|2009-07-03|2010-07-02|Microbubble reducers to eliminate gas bubbles from a flow containing non-Newtonian fluid|SE1050729A| SE536054C2|2009-07-03|2010-07-02|Microbubble reducers to eliminate gas bubbles from a flow containing non-Newtonian fluid|

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