WO2009104038A1 - An extracorporeal fluid circuit - Google Patents

An extracorporeal fluid circuit Download PDF

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Publication number
WO2009104038A1
WO2009104038A1 PCT/IB2008/000369 IB2008000369W WO2009104038A1 WO 2009104038 A1 WO2009104038 A1 WO 2009104038A1 IB 2008000369 W IB2008000369 W IB 2008000369W WO 2009104038 A1 WO2009104038 A1 WO 2009104038A1
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WO
WIPO (PCT)
Prior art keywords
fluid passage
fluid
circuit
course
blood
Prior art date
Application number
PCT/IB2008/000369
Other languages
French (fr)
Inventor
Luca Caleffi
Ranko Sakota
Giuseppe Franzoni
Original Assignee
Gambro Lundia Ab
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Gambro Lundia Ab filed Critical Gambro Lundia Ab
Priority to PCT/IB2008/000369 priority Critical patent/WO2009104038A1/en
Publication of WO2009104038A1 publication Critical patent/WO2009104038A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34Filtering material out of the blood by passing it through a membrane, i.e. haemofiltration, diafiltration
    • A61M1/342Adding solutions to the blood, e.g. substitution solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34Filtering material out of the blood by passing it through a membrane, i.e. haemofiltration, diafiltration
    • A61M1/342Adding solutions to the blood, e.g. substitution solutions
    • A61M1/3424Substitution fluid path
    • A61M1/3431Substitution fluid path upstream the filter
    • A61M1/3434Substitution fluid path upstream the filter with pre-dilution and post-dilution
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34Filtering material out of the blood by passing it through a membrane, i.e. haemofiltration, diafiltration
    • A61M1/342Adding solutions to the blood, e.g. substitution solutions
    • A61M1/3424Substitution fluid path
    • A61M1/3437Substitution fluid path downstream the filter, e.g. post-dilution with filtrate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3627Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D19/00Degasification of liquids
    • B01D19/0036Flash degasification
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/12General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/123General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with incorporated reservoirs

Abstract

An extracorporeal blood circuit defines a blood course comprising a first conduit (27) having an upturned U shape. The extracorporeal blood circuit comprises an expansion chamber (24) for an infusion fluid connected to a second conduit (28) by a pump tube coupled to a tube- deforming pump. The second conduit is horizontal and opens tangentially into the first conduit. The first conduit, the second conduit and the expansion chamber are integrated in a single rigid body (20). The circuit prevents kinking and other occlusions thereof.

Description

"An Extracorporeal Fluid Circuit"

DESCRIPTION BACKGROUND OF THE INVENTION

[0001] The invention relates to an extracorporeal fluid circuit and to an extracorporeal blood treatment apparatus using the extracorporeal fluid circuit.

[0002] Specifically, though not exclusively, the invention can be usefully applied for infusion of a fluid into an extracorporeal blood flow, such as for example in infusion of a replacement fluid during the course of a hem(dia)filtration treatment, or infusion of a medication during an extracorporeal blood treatment, or infusion of a buffer solution in an AFB (Acetate Free Biofiltration) treatment, and so on.

[0003] The prior art comprises WO 02/061318, which describes an apparatus for fluid transport used in the medical field, in which a support element has a U-shaped channel having a semicircular transversal section for housing a tract of flexible transport pipe. WO 02/061318 illustrates another apparatus for fluid transport, in which a support element has a first and a second portions, connected by means of a hinge; both the first and the second portions have a curved channel with a semicircular transversal section; when the support element is closed by rotating the two portions about the hinge, the two portions are symmetrically facing, one on the other, and the two channels meet one another so as to form a single curved closed channel having a circular transversal section, which stably houses a flexible fluid transport pipe. [0004] WO 2007/050211 describes an integrated extracorporeal circuit having a rigid body with a flat surface provided with one or more recesses, covered by a flexible wall. One of the recesses defines, in collaboration with the flexible wall, a gas-liquid separation chamber provided with a microporous hydrophobic membrane vent. [0005] WO 95/17218 describes a medical fluid circuit in which a circuit tray receives and holds in ordered and compact positions all the various parts of the circuit, such as the processor chamber, the fluid containers, the cassettes, fluid transport pipes and so on.

[0006] US 5311908 illustrates an integrated apparatus for fluid transport. The apparatus comprises a plurality of flexible tubes intercommunicating with one another, all being incorporated in a rigid cassette frame. [0007] EP 568275 describes various embodiments of an extracorporeal blood circuit having an expansion chamber for the separation of air bubbles from the blood flow and an infusion fluid conduit opening onto a blood conduit which carries the blood to the expansion chamber. In one of these examples the blood conduit forms a U-shaped curve and the infusion fluid conduit opens on the external side of the curve.

SUMMARY OF THE INVENTION

[0008] An aim of the present invention is to provide an extracorporeal fluid circuit which can ensure a regular and controlled flow both of the extracorporeal blood and of an infusion fluid which is introduced into the blood itself.

[0009] A further aim of the invention is to provide an extracorporeal fluid circuit in which the risk of formation of kinking and other occlusions in the circuit is considerably reduced.

[0010] An advantage of the invention is to provide a constructively simple and economical circuit.

[0011] A further advantage is to make available a circuit in which the formation of kinking and other occlusions and irregularities are prevented, in particular in a zone of the circuit in which the extracorporeal blood flow receives an infusion fluid flow.

[0012] A still further advantage is that it gives rise to a small-size circuit which is easy and immediate to use.

[0013] These aims and advantages and more besides are all attained by the invention as it is characterised in one or more of the accompanying claims.

[0014] In a specific embodiment of the invention, the fluid circuit comprises an expansion chamber and a tract of tube which are both rigid and which are also rigidly connected to one another. The expansion chamber is configured for gas-liquid separation in a flow of infusion liquid, while the tract of tube is configured for the transport of blood. The fluid circuit comprises a fluid connection which is configured for sending the infusion fluid from the expansion chamber to the tract of tube. [0015] In a specific embodiment, the tract of rigid tube forms a bend and receives the infusion fluid on an external side of the bend. In the contact zone between the infusion fluid and the blood, the direction of the infusion fluid flow can be tangential and equal to the blood flow direction.

[0016] In a specific embodiment, the fluid circuit comprises a pump tube configured for coupling with a fluid transport pump. The above- cited pump tube is configured for transporting the infusion fluid from the expansion chamber to the tube tract.

[0017] In a specific embodiment, the pump tube is fluidly arranged between the expansion chamber and the tube tract. The pump tube may be supported by the expansion chamber. [0018] In a specific embodiment, the fluid circuit comprises a transport conduit for the infusion fluid which is fluidly arranged between the expansion chamber and the tube tract. The above-cited transport conduit for the infusion fluid is rigid and is further rigidly connected both to the above-mentioned expansion chamber and to the tube tract. [0019] Further characteristics and advantages of the present invention will better emerge from the detailed description that follows, of at least an embodiment of the invention, illustrated by way of non-limiting example in the accompanying figures of the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS [0020] The description will be made herein below with reference to the accompanying figures of the drawings, which are provided by way of non-limiting example.

[0021] Figure 1 is an extracorporeal blood apparatus comprising a fluid circuit of the invention. [0022] Figure 2 shows a detail of the fluid circuit of figure 1 in greater detail.

[0023] Figure 3 shows a second embodiment of the fluid circuit.

[0024] Figure 4 is a lateral view from the right of figure 3.

[0025] Figure 5 is a lateral view from the right of figure 4. [0026] Figure 6 is a view from the bottom of figure 5.

[0027] Figure 7 is a view from the top of figure 5.

[0028] Figure 8 is a section made according to the plane VIII-VIII of figure 3.

[0029] Figure 9 is a section made according to the plane IX-IX of figure 5. [0030] Figure 10 is a section made according to the plane X-X of figure 5.

DETAILED DESCRIPTION

[0031] With reference to figures 1, 1 denotes in its entirety an extracorporeal blood treatment apparatus. The extracorporeal blood treatment apparatus 1 comprises a membrane exchanger 2 for an extracorporeal blood treatment. The membrane exchanger 2 can be, for example, a dialyser, a hemofilter, a hemodiafilter, a plasma exchanger, an ultrafllter for congestive hear failure, or another membrane device of known type for performing an extracorporeal treatment. The membrane exchanger 2 has a blood chamber 3 and a fluid chamber 4 which are separated from one another by a semipermeable membrane 5. The extracorporeal blood treatment apparatus 1 comprises a fluid circuit having a discharge line 6 which connects the fluid chamber 4 with a drainage 7. The fluid circuit can optionally have a supply line 8 which connects a treatment fluid source 9 to the fluid chamber 4. The fluid circuit is provided with various elements, not illustrated, such as for example the actuators and sensors with which the fluid circuit of any of the prior-art hemodialysis or hemo(dia)fϊltration apparatus is provided. [0032] The extracorporeal blood treatment apparatus 1 comprises an extracorporeal fluid circuit connected to the blood chamber 4. The extracorporeal fluid circuit includes a blood path which can have, as in the specific case described herein, an arterial line 10 and a venous line 11. The arterial line 10 is configured for removing the blood from a patient 12 and for sending it on to the blood chamber 3. The venous line 11 is configured for returning the blood treated in the blood chamber 3 to the patient 12. The connection between the patient 12 and the extracorporeal blood path can be realised by any of the vascular access devices of known type. [0033] The extracorporeal blood treatment apparatus 1 optionally comprises a blood pump 13 for moving the blood along the extracorporeal circuit. The blood pump 13 can be operatively associated to the arterial line 10, as in the illustrated example. The extracorporeal circuit can comprise one or more of the various elements (such as for example one or more access sites for sample removal or injection of substances, one or more expansion chambers, one or more air bubble separators, one or more devices for connection to pressure sensors, one or more service lines for performing various services such as supply of priming fluid, introduction of a medical fluid, level regulation in an expansion chamber, etc., portions configured for coupling with hematocrit sensors and/or air bubble sensors and/or blood presence/absence sensors, manual and/or automatic clamps, etc.) with which blood circuits of known type are equipped, such as for example extracorporeal blood circuits used in dialysis apparatus.

[0034] In the specific embodiment, and purely by way of example, the following have been indicated: the presence of an expansion chamber 14 arranged on the venous line 11 for air-blood separation, as well as the presence of a block valve 15 (automatically controlled by the control unit of the apparatus 1) arranged on the venous line 11 between the expansion chamber 14 and the patient 12. However, the blood circuit can be provided with other elements (of known type and not illustrated for the sake of simplicity) apart from those indicated.

[0035] The extracorporeal fluid circuit is further provided with an infusion system denoted in its entirely by 16. The infusion system 16 is configured for introducing an infusion fluid into the extracorporeal blood path. The infusion fluid can comprise any one of the fluids which, according to the prior art, can be introduced into the extracorporeal blood during an extracorporeal blood treatment. Optionally the infusion fluid can comprise a substitution fluid in a hemo(dia)filtration treatment, or a buffer solution (for example bicarbonate) in an extracorporeal blood treatment (for example a kidney failure treatment).

[0036] In the specific embodiment the infusion system 16 is configured for introducing the infusion fluid into the venous line 11. It is however possible for the infusion system 16 to be predisposed for introducing the infusion fluid into the arterial line 10 as well, in addition (simultaneously or alternatedly) or alternatively of the introduction thereof into the venous line 11.

[0037] The infusion system 16 optionally comprises an infusion fluid source which, in the example, comprises a batch container 17 of an infusion fluid. The infusion fluid source can be any known-type infusion fluid source, such as for example a source comprising an on-line preparation device of a medical fluid, for instance starting from water and concentrates (such as for example any on-line preparator of substitution fluid used in a hemo(dia)filtration apparatus).

[0038] The infusion system 16 optionally comprises an infusion fluid path which connects the infusion fluid source 17 to an infusion zone arranged on a blood path defined by the extracorporeal circuit. The infusion system 16 optionally comprises an infusion fluid pump 18 for moving the infusion fluid from the source 17 to the extracorporeal blood path. The infusion fluid pump 18 can, for example, comprise a tube- deforming pump (peristaltic pump). In the specific case the infusion fluid pump 18 comprises a tube deformation pump of a rotary type. The infusion fluid pump 18 is optionally configured for coupling with a pump tube 19. The pump tube 19 comprises, in the specific case, a tract of curved tube, for example a U-shaped tube, of known type. The pump tube 19 defines a tract of infusion fluid circuit.

[0039] The infusion system 16 comprises a rigid body 20 which is illustrated in greater detail in figure 2. The rigid body 20 defines a first fluid passage port 21, a second fluid passage port 22, and a third fluid passage port 23. The first fluid passage port 21 optionally comprises a tubular connector for tubes. This tubular connector for tubes may comprise one of the known tubular connectors configured for removable connections of medical tubes, for example luer coupling, hansen coupling, quick-connective coupling, etc., or for permanent connections of medical tubes, for example by welding or gluing. The second fluid passage port 22 optionally comprises a tubular connector for tubes. This tubular connector for tubes may comprise one of the known tubular connectors configured for removable connections of medical tubes, for example luer coupling, hansen coupling, quick-connective coupling, etc., or for permanent connections of medical tubes, for example by welding or gluing. The third fluid passage port 23 optionally comprises a tubular connector for tubes. This tubular connector for tubes may comprise one of the known tubular connectors configured for removable connections of medical tubes, for example luer coupling, hansen coupling, quick- connective coupling, etc., or for permanent connections of medical tubes, for example by welding or gluing.

[0040] The rigid body 20 further defines an expansion chamber 24 having an inlet 25 and an outlet 26. The inlet 25 is optionally arranged above the outlet 26, with reference to a use configuration of the chamber

24. The expansion chamber 24 is provided with a bottom and a top, with reference to the use configuration of the expansion chamber 24. The outlet 26 is optionally arranged on the bottom of the expansion chamber 24. The inlet 25 is optionally arranged at an intermediate level comprises between the bottom and the top. The inlet 25 communicates with the first fluid passage port 21. The first fluid passage port 21 is optionally arranged on a top of the rigid body 20. The first fluid passage port 21 has a longitudinal axis which is optionally directed vertically. The first fluid passage port 21 is optionally upwards-facing. [0041] The expansion chamber 24 is configured for degassing a liquid which flows from the inlet 25 to the outlet 26. In the specific case the liquid to be degassed is the infusion fluid coming from the infusion fluid source 17, as will be more fully described herein below. The expansion chamber 24 is optionally configured for operating in a way such as to define, during a the flow of the liquid to be degassed from the inlet 25 to the outlet 26, a gas-liquid separation level. The upper portion of the expansion chamber, i.e. the portion situated above the liquid level, functions as a gas-accumulation zone, while the lower portion, situated below the liquid level, is full of liquid. The liquid level is predetermined, in a known way, such that the inlet 25 and the outlet 26 are arranged below the level.

[0042] It is however possible to have the expansion chamber realised as any of the expansion chambers used in known-type extracorporeal blood circuits or infusion circuits, such as for example an expansion chamber for gas-liquid separation of the complete-filling type with a gas vent provided with a hydrophobic membrane, or an expansion chamber for gas-liquid separation of the hydrophilic type for non-dissolved gas filtration and with a gas vent provided with a hydrophobic membrane, etc.

[0043] The rigid body 20 further defines a first fluid passage conduit

27 which extends between the second and the third fluid passage port 22 and 23. The rigid body 20 further defines a second fluid passage conduit

28 having a first end 28a and a second end 28b. The first end 28a is connected, either directly or (as in the illustrated example) indirectly, to the outlet 26 of the expansion chamber 24. The second end 28b may be attached to the first fluid passage conduit 27. The second fluid passage conduit 28 may open into the first fluid passage conduit 27 at an end zone. The end zone gives rise to a mixing zone between the infusion fluid, borne by the second conduit 28, and the extracorporeal blood, borne by the first conduit 27. Optionally, both the first conduit 27 and the second conduit 28 are rigid, as in the illustrated example. It is possible to have one only of the two above-mentioned conduits 27 and 28 rigid, the conduit 27 or the conduit 28. [0044] The blood path comprises a first flexible tube and a second flexible tube, each of which is configured for blood transport. The first flexible tube has an end connected (removably or permanently) to the second fluid passage port 22. The second flexible tube has an end connected (removably or permanently) to the third fluid passage port 23. In the specific case the first and the second flexible tubes are two tracts of the above-cited extracorporeal blood path. Optionally, as in the specific case, the first flexible tube is comprised in an initial tract of the venous line 11 which goes from the blood chamber 3 to the second port 22, while the second flexible tube is comprised in a final tract of the venous line 11 which goes from third port 23 to the patient 12. In this specific case the first conduit 27 substantially forms an intermediate tract of the venous line 11 comprised between the above-mentioned initial and final tracts. [0045] In a further embodiment (see figures 2 to 10, in which the same elements as those in figures 1 and 2 have been denoted using the same numbers) the extracorporeal fluid circuit (which can be associated to the apparatus 1 of figure 1) further comprises a pressure sensor 34 for emitting a signal indicating the pressure in the expansion chamber 24. The pressure sensor 34 can comprise any known pressure sensor used in a fluid circuit for medical use. In particular the pressure sensor 34 may be an elastically-deformable membrane sensor having an internal side which faces towards the inside of the expansion chamber 24 and an external side which communicates with a pressure transducer (of known type and not illustrated) connected to the control unit of the treatment apparatus 1. The pressure transducer may be predisposed such as to be able to measure the pressure in the inside of the expansion chamber 24.

[0046] The elastically-deformable membrane sensor 34 may be solidly associated to the body of the expansion chamber 24. In particular, the membrane can have the edge thereof tightly engaged between two half-shells which are part of the body of the expansion chamber 24. It is possible to use other types of known pressure sensors, such as for example the pressure sensors already used in the medical field for measuring the pressure in extracorporeal blood circuits. In particular it is possible to use a pressure sensor comprising a service line connecting the expansion chamber 24 with a pressure transducer - in turn connected to the control unit of the treatment apparatus - via the interpositioning of a transducer-protector device having a hydrophobic membrane (also known as a blood catcher). [0047] The extracorporeal fluid circuit comprises a blood course tract with is realised by a flexible conduit to which a rigid conduit follows, which in turn is followed by a flexible conduit. The inlet zone of the infusion fluid into the blood course is situated at a blood course tract defined by at least a rigid wall. In substance the blood course has a tract which is defined by at least a rigid wall and which is preceded and followed, respectively, by two tracts defined by at least a flexible wall.

[0048] The infusion fluid course terminates (optionally with a terminal tract which is at least partly rigid) at a tract of blood course which is at least partly rigid. The at least partly-rigid tract of blood course can, in the specific case, form a curve. The at least partly-rigid tract of blood course can, as in the specific case, be integrated with an expansion chamber configured for gas-liquid separation in the flow of infusion fluid before the flow itself opens into the blood course at the above-mentioned at least partly-rigid tract of blood circuit; the at least partly-rigid tract of blood course and the expansion chamber for the infusion fluid are integrated in a rigid body; the rigid body can optionally support a pump tube 19 for moving the infusion fluid.

[0049] The infusion system 16 comprises a third flexible tube 29, configured for the infusion fluid transport. The third flexible tube 29 has a first end connected to the first fluid passage port 21 and a second end connected to the infusion fluid source 17. The third flexible tube 29 is configured to fluidly connect the infusion fluid source with the expansion chamber 24 defined by the rigid body 20. The third flexible tube 29 and the batch container 27 of the infusion fluid are disposable elements, optionally made of plastic.

[0050] The connection between the infusion fluid source and the rigid body 20 (in particular with the expansion chamber 24) can be made in another way, for example by means of a non-disposable conduit, or by means of a rigid conduit (disposable or not), or by means of the direct connection of the first port 21 with an on-line supply system of infusion fluid, etc.

[0051] The pump tube 19 can define, as in the specific embodiment described herein, a fluid circuit comprised between the outlet 26 of the expansion chamber 24 and the first end 28a of the second conduit 28. The pump tube 19 optionally has two opposite ends supported by the rigid body 20. In the specific embodiment the rigid body 20 defines a fourth fluid passage port 30 and a fifth fluid passage port 31. The fourth and fifth fluid passage ports 30 and 31 each comprise a tubular connector for coupling (both mechanical, for example by welding or gluing or a fluid connection) with an end of a tube. In the specific case the two opposite ends of the pump tube 19 are supported by the fourth and fifth fluid passage port 30 and 31. In particular the two opposite ends of the pump tube 19 are in fluid connection with the fourth and fifth fluid pasage port 30 and 31. The fourth fluid passage port 30 is, in the specific embodiment, in fluid connection (direct or, as in the described embodiment, indirect), with the outlet 26 of the expansion chamber 24. The fifth fluid passage port 31 is, in the present embodiment, in fluid connection (indirect or, as in the present embodiment, direct) with the first end 28a of the second fluid passage 28.

[0052] The rigid body 20 defines a third fluid passage conduit 32 extended between the first fluid passage port 21 and the inlet 25 of the expansion chamber 24. The third fluid passage conduit 32 extends on a first side of the expansion chamber 24 in a prevalently vertical direction, with reference to a use configuration of the expansion chamber (the configuration in which the plane of figure 2 is a vertical elevation plane). The first side of the expansion chamber 24 extends between the bottom and the top of the expansion chamber 24 itself. In the use configuration of the expansion chamber 24 the rotation axis of the infusion fluid pump 18 is arranged horizontally, and the pump tube 19 extends on a vertical lie plane.

[0053] The rigid body 20 defines a fourth fluid passage conduit 33 which defines a fluid circuit (for the infusion fluid in this case) comprised between the outlet 26 and the expansion chamber 24 and the first end 28a of the second fluid passage conduit 28. The pump tube 19 is fluidically interposed between the fourth fluid passage conduit 33 and the second fluid passage conduit 28. In the specific case the fourth fluid passage conduit 33 defines a fluid course comprised between the outlet 26 of the expansion chamber 24 and the pump tube 19.

[0054] The fourth fluid passage conduit 33 extends on a second side of the expansion chamber 24 in a prevalently vertical direction, with reference to the use configuration of the expansion chamber. The second side of the expansion chamber 24 extends between the bottom and the top of the chamber. The second side of the expansion chamber 24 is opposite the above-mentioned first side of the expansion chamber 24.

[0055] The third and the fourth fluid passage conduit, respectively 32 and 33, are arranged on two opposite sides of the expansion chamber 24; optionally these opposite sides each extend between the bottom and the top of the expansion chamber 24. The third and fourth fluid passages, respectively 32 and 33, are both extended in a prevalently vertical direction, with reference to the use configuration of the expansion chamber. In the specific case the pump tube 19 defines a fluid course comprised between the fourth fluid passage conduit 33 and the first end 28a of the second fluid passage conduit 28.

[0056] The rigid body 20 integrates the expansion chamber 24 (which serves in particular for the gas-liquid separation of the infusion fluid), the first conduit 27 (which serves in particular for connecting up two portions of the blood course realised at least in part with flexible tubes) and the second conduit 28 (which serves in particular for transporting the infusion fluid from the expansion chamber 24 of the first conduit 27), such that the three elements are solidly connected to one another. In particular the reciprocal connection between these three elements is configured such that the reciprocal positioning thereof is predefined and stable. This can enable, for example, easy manoeuvring of the elements, such as in particular to improve the ease of the mounting operations onto the treatment apparatus of an extracorporeal circuit provided with an infusion system. [0057] The fact that the mixing zone between the infusion fluid and the extracorporeal blood is realised by a rigid structure incorporated in an expansion chamber of the infusion fluid, reduces the risk of irregularity in the flows of the various liquids involved (blood, infusion fluid and mixture thereof) and/or occluding the transport conduits and/or deforming the conduits themselves (deformations such as, for example, kinking of flexible tubes).

[0058] The optional fact that the rigid body is the support of the infusion fluid pump tube enables a reduction to be made in the overall size of infusion system and facilitates the mounting thereof in an operative position.

[0059] The rigid body 20 can optionally be made of plastic. The rigid body 20 can be realised in various ways, such as for example by assembly (gluing, welding, etc.) of two half-shells; the half-shells can be realised, for example, by moulding of plastic material. [0060] The first fluid passage conduit 27 optionally has a longitudinal axis which forms a curve with a concave internal side facing downwards, with reference to the use configuration of the expansion chamber 24. The second fluid passage conduit 28 optionally has a substantially straight longitudinal axis with a horizontal direction, with reference to the use configuration of the expansion chamber. The first and second fluid passage conduits 27 and 28 optionally have two longitudinal axes which may be substantially tangential to one another. The first and second fluid passage conduits 27 and 28 are optionally arranged below the expansion chamber 24, with reference to the use configuration of the expansion chamber.

[0061] The fluid circuit described herein with reference to figures 1 and 2 comprises an extracorporeal blood course and an infusion fluid course. The blood course can comprise, as in the specific case, an extracorporeal blood circuit configured for connecting a patient 12 with a blood chamber 3 of a membrane device 2 for extracorporeal blood treatment. The infusion fluid course opens into the blood course.

[0062] The blood course comprises a rigid tube which forms a curve. The above-cited rigid tube can comprise, for example, the above- described first conduit 27. The curve formed by the rigid tube has a convex external side which is at least part upward-facing, with reference to a use configuration of the rigid tube (the configuration in which the plane of figure 2 is a vertical elevation plane).

[0063] The infusion fluid course can comprise, for example, the above-described second conduit 28. The infusion fluid course can comprise any part or the whole course formed by the above-described infusion fluid system 16. The infusion fluid course opens into the blood course at the above-described external convex side. The curve formed by the rigid tube has an upturned-U shape, with reference to the use configuration of the rigid tube.

[0064] The infusion fluid course ends in the blood course in an end zone. The infusion fluid course and the blood course are conformed and reciprocally arranged such that in the end zone the movement direction of the infusion fluid includes at least a component going in the same direction as the blood movement. In particular, in the end zone the movement direction of the infusion fluid is tangential to the movement direction of the blood.

[0065] The infusion fluid course has a terminal tract that ends in the blood course with a substantially horizontal direction, with reference to the use configuration of the rigid tube. The terminal tract of the infusion fluid course can be realised, for example, by the second conduit 28. The terminal tract of the infusion fluid course, i.e. the tract which ends in the blood course, can be rigid.

[0066] The terminal tract of the infusion fluid course and the curved rigid tube of the blood course are integrated in a single rigid body, which in the example comprises the rigid body 20 described above.

[0067] In the specific case the curved rigid tube (i.e. the first conduit 27) has a straight transversal section with an average diameter comprised between 3 and 15 millimetres. In particular the curved rigid tube can have a straight transversal section having an average diameter comprised between 3 and 8 millimetres, for example about 5 millimetres (as in the specific embodiment of figure 2). In the end zone, the curved rigid tube optionally has a radius of curvature comprised between 10 and 40 millimetres. In particular the rigid curved tube can have, in the end zone, a radius of curvature comprised between 10 and 25 millimetres, for example about 15 millimetres (as in the specific example of figure 2).

[0068] The rigid curved tube has a straight transversal section having a determined average diameter D, and further has, in the end zone, a determined radius of curvature R. The R/D ratio between the radius of curvature R and the average diameter D can be comprised between 1.5 and 7.5. In particular the R/D ration between the radius of curvature R and the average diameter D can be comprised between 2 and 5, for example about 3 (as in the specific example of figure 2).

[0069] The curved rigid tube can have a straight transversal section having a substantially constant diameter. The curved rigid tube can be extended along an arc, for example an arc of circumference, which subtends an angle greater than 60 degrees. In the specific case of figure 2, the curved rigid tube extends along an arc of circumference which has an angle of about 180 degrees. The curved rigid tube may extend along an arc (of circumference) which subtends an angle greater than 90 degrees. The curved rigid tube may extend along an arc (of circumference) which subtends an angle comprised between 90 and 270 degrees. The curved rigid tube may extend along an arc (of circumference) which, downstream of the end zone of the infusion fluid course, subtends an angle greater than 30 or 45 or 60 degrees. In the specific case of figure 2, the curved rigid tube extends along an arc of circumference which, downstream of the end zone of the infusion fluid course, subtends an angle of about 90 degrees.

[0070] The curve rigid tube and the expansion chamber are separated from one another by an impermeable and rigid wall which defines the bottom of the expansion chamber.

[0071] The particular structure and configuration of the curved rigid tube included in the blood course (which in the special embodiment described herein comprises the first conduit 27) and the terminal tract of the infusion fluid course (which in the specific case comprises the second conduit 28) enables an optimal mixture between the two flows in a relatively-small mixing space. [0072] It is also reduced the risk of forming turbulence, or bubbles, or foam, or whirls, or other irregularities in the flow, especially after the mixing zone. A further advantage is a low risk of damages to the blood.

Claims

1. An extracorporeal fluid circuit, comprising a rigid body defining: at least a first fluid passage port, a second fluid passage port, and a third fluid passage port; an expansion chamber having an inlet and an outlet, said expansion chamber being configured for degassing a liquid flowing from said inlet to said outlet, said inlet communicating with said first fluid passage port; a first fluid passage conduit which extends between said second fluid passage port and said third fluid passage port; and a second fluid passage conduit having a first end and a second end, said first end being connected to said outlet of said expansion chamber, said second end being connected on said first fluid passage conduit.
2. The circuit of claim 1, comprising a first flexible tube configured for blood transport, having an end which is connected to said second fluid passage port.
3. The circuit of claim 1 or 2, comprising a second flexible tube configured for blood transport, having an end which is connected to said third fluid passage port.
4. The circuit of any one of the preceding claims, comprising a third flexible tube configured for transport of an infusion fluid, said third flexible tube having a first end and a second end, said first end of said third flexible tube being connected to said first fluid passage port, said second end of said third flexible tube being configured for connection with a source of the infusion fluid.
5. The circuit of any one of the preceding claims, comprising a batch container of an infusion fluid, said batch container being connected to said first fluid passage port.
6. The circuit of any one of the preceding claims, comprising a p puummpp tube configured for coupling with a tube-deforming pump, said pump tube defining a fluid course comprised between said outlet of said expansion chamber and said first end of said second fluid passage.
7. The circuit of any one of the preceding claims, comprising a pump tube configured for coupling with a tube-deforming pump, said pump tube having two ends supported by said rigid body.
8. The circuit of claim 6, wherein said rigid body defines a fourth fluid passage port and a fifth fluid passage port, said two ends of said pump tube being supported by and being in fluid connection with said fourth fluid passage port and said fifth fluid passage port.
9. The circuit of claim 8, wherein said fourth fluid passage port is in fluid connection with said outlet of said expansion chamber, and wherein said fifth fluid passage port is in fluid connection with said first end of said second fluid passage conduit.
10. The circuit of any one of the preceding claims, wherein said rigid body defines a third fluid passage conduit which defines a fluid course comprised between said first fluid passage port and said inlet of said expansion chamber.
11. The circuit of claim 10, wherein said third fluid passage conduit extends on a first side of said expansion chamber in a prevalently vertical direction, with reference to a use configuration of said expansion chamber.
12. The circuit of any one of the preceding claims, wherein said rigid body defines a fourth fluid passage conduit which defines a fluid course comprised between said outlet of said expansion chamber and said first end of said second fluid passage conduit.
13. The circuit of claim 12, wherein said fourth fluid passage conduit extends on a second side of said expansion chamber in a prevalentry vertical direction, with reference to a use configuration of said expansion chamber.
14. The circuit of claim 13, wherein said second side is opposite a first side of said expansion chamber, and wherein said rigid body defines a third fluid passage conduit extended on said first side of said expansion chamber; said third fluid passage conduit being extended between said first fluid passage port and said inlet of said expansion chamber; said third fluid passage conduit being extended in a prevalently vertical direction, with reference to said use configuration.
15. The circuit of any one of the claims 12 to 14, comprising a pump tube configured for coupling with a tube-deforming pump, said pump tube defining a fluid course comprised between said fourth fluid passage conduit and said first end of said second fluid passage conduit.
16. The circuit of any one of the preceding claims, wherein said first fluid passage conduit has a longitudinal axis which forms a curve with a concave internal side facing downwards with reference to a use configuration of said expansion chamber.
17. The circuit of any one of the preceding claims, wherein said second fluid passage conduit has a horizontally-directed and substantially straight longitudinal axis with reference to a use configuration of said expansion chamber.
18. The circuit of any one of the preceding claims, wherein said first fluid passage conduit and said second fluid passage conduit have two longitudinal axes which are substantially tangential to one another.
19. The circuit of any one of the preceding claims, wherein said first fluid passage conduit and said second fluid passage conduit are arranged below said expansion chamber, with reference to a use configuration of said expansion chamber.
20. The circuit of any one of the preceding claims, comprising an extracorporeal blood course and an infusion fluid course which ends in said extracorporeal blood course; said extracorporeal blood course comprising at least a rigid tube; said first fluid passage conduit defining at least a part of said rigid tube.
21. The circuit of claim 20, wherein said rigid tube forms a curve having a convex external side at least partly facing upwards, with reference to a use configuration of said rigid tube; said infusion fluid course ending in said blood course at said convex external side.
22. The circuit of claim 21, wherein said curve formed by said rigid tube has an upturned U-shape.
23. The circuit of any one of the claims 20 to 22, wherein said infusion fluid course ends in said blood course in an end zone; said infusion fluid course and said blood course being configured such that in said end zone the movement direction of the infusion fluid has at least a movement component going in the movement direction of the blood.
24. The circuit of claim 23, wherein said infusion fluid course and said blood course are configured such that in said end zone the movement direction of the infusion fluid is substantially tangential to the movement direction of the blood.
25. The circuit of any one of the claims 20 to 24, wherein said infusion blood course has a terminal tract which ends in said blood course and which has a substantially horizontal direction, with reference to a use configuration of said rigid tube.
26. The circuit of any one of the claims 20 to 25, wherein said infusion fluid course has a terminal tract which ends in said blood course, said terminal tract being rigid; said second fluid passage conduit defining at least a part of said terminal tract.
27. The circuit of claim 26, wherein said rigid terminal tract of said infusion fluid course and said curved rigid tube of said blood course are integrated in said rigid body.
28. The circuit of any one of the claims 20 to 27, wherein said curved rigid tube has a straight transversal section having an average diameter comprised between 3 and 15 millimetres.
29. The circuit of any one of the claims 20 to 28, wherein said curved rigid tube has, in an end zone in which said infusion fluid course ends in said blood course, a radius of curvature comprised between 10 and 40 millimetres.
30. The circuit of any one of the claims 20 to 29, wherein said curved rigid tube has a straight transversal section with a determined average diameter, and further has, in an end zone in which said infusion fluid ends in said blood course, a determined radius of curvature, the ratio between said determined radius of curvature and said determined average diameter being comprised between 1.5 and 7.5.
31. The circuit of any one of the claims 20 to 30, wherein said curved rigid tube has a straight transversal section with a substantially constant diameter.
32. The circuit of any one of the claims 20 to 31, wherein said curved rigid tube extends along an arc which subtends an angle greater than 60 degrees.
33. The circuit of any one of the claims 20 to 32, wherein said curved rigid tube extends along an arc which, downstream of an end zone in which said infusion fluid course ends in said blood course, subtends an angle greater than 30 degrees.
34. An extracorporeal blood treatment apparatus, comprising: a membrane exchanger for extracorporeal blood treatment, the membrane exchanger having a blood chamber and a fluid chamber which are separated from one another by a semipermeable membrane; an extracorporeal fluid circuit made according to any one of the preceding claims, wherein said second fluid passage port and/or said third fluid passage port are/is connected to said blood chamber.
PCT/IB2008/000369 2008-02-19 2008-02-19 An extracorporeal fluid circuit WO2009104038A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IB2008/000369 WO2009104038A1 (en) 2008-02-19 2008-02-19 An extracorporeal fluid circuit

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DE212008000102U DE212008000102U1 (en) 2008-02-19 2008-02-19 Extracorporeal fluid circuit
PCT/IB2008/000369 WO2009104038A1 (en) 2008-02-19 2008-02-19 An extracorporeal fluid circuit

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US5273517A (en) 1991-07-09 1993-12-28 Haemonetics Corporation Blood processing method and apparatus with disposable cassette
CA2155735A1 (en) 1993-12-22 1995-06-29 Richard C. Giesler Self-priming drip chamber with enhanced visibility
US7571744B2 (en) 2001-01-31 2009-08-11 Hemerus Medical, Llc Multi-purpose tubing apparatus
US7871391B2 (en) 2005-10-21 2011-01-18 Fresenius Medical Care Holdings, Inc. Extracorporeal fluid circuit

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US4681606A (en) * 1986-02-26 1987-07-21 Cobe Laboratories, Inc. Drip chamber
EP0568275A2 (en) * 1992-04-30 1993-11-03 David S. Utterberg Blood air trap chamber

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