WO2009155248A1 - Appareil de traitement du sang ayant une distribution à flux ramifié - Google Patents

Appareil de traitement du sang ayant une distribution à flux ramifié Download PDF

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Publication number
WO2009155248A1
WO2009155248A1 PCT/US2009/047402 US2009047402W WO2009155248A1 WO 2009155248 A1 WO2009155248 A1 WO 2009155248A1 US 2009047402 W US2009047402 W US 2009047402W WO 2009155248 A1 WO2009155248 A1 WO 2009155248A1
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WO
WIPO (PCT)
Prior art keywords
blood
stage
hollow fiber
flow
flow channels
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Application number
PCT/US2009/047402
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English (en)
Inventor
Thomas H. Cauley
Peter G. Linde
Gregory G. Raleigh
Original Assignee
Triaxis Medical Devices, Inc.
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 Triaxis Medical Devices, Inc. filed Critical Triaxis Medical Devices, Inc.
Publication of WO2009155248A1 publication Critical patent/WO2009155248A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1698—Blood oxygenators with or without heat-exchangers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/02—Reverse osmosis; Hyperfiltration ; Nanofiltration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2313/00—Details relating to membrane modules or apparatus
    • B01D2313/10—Specific supply elements
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2313/00—Details relating to membrane modules or apparatus
    • B01D2313/12—Specific discharge elements

Definitions

  • the present invention relates generally to medical systems and methods. More particularly, the present invention relates to methods and systems for blood treatment where an inlet flow is divided and distributed to one or more blood treatment modules, such as, hollow fiber bundles.
  • the toxin clearance efficiency of a hemodialyzer is important both to the patient and the treatment facility.
  • a targeted level of blood cleaning typically referred to as the urea reduction ratio or URR
  • the first is the blood removal rate from the patient.
  • the second is the treatment time.
  • the third is the toxin removal efficiency of the hemodialyzer. It is always advantageous to reduce the treatment time. Not only is it preferable for the patient, shorter treatment times per patient allow the treatment facility to serve the needs of more patients.
  • Blood dialyzer efficiency depends on a number of factors. Of particular interest to the present invention, toxin removal efficiency of the dialyzer depends on the ability to evenly distribute blood flow among all of the individual micro fibers in the micro fiber bundle.
  • Hemodialysis micro fiber bundles typically contain from 1 ,000 to 500,000 individual micro fibers, each of which is subject to blockage and fouling, particularly from coagulation and clotting of blood within the fiber lumen.
  • Such coagulation and clotting can come from slow or stagnant flow within the fiber lumen and/or may originate upstream of the fibers themselves in the flow distribution manifolds and headers of the hemodialyzer. Regardless of the origin of the clotting or coagulation, lost or reduced flow through individual fibers decreases the membrane area available for hemodialysis and causes higher flow rates through the membranes which remain patent. Both these circumstances result in reduced toxin removal efficiencies for the hemodialyzer as a whole.
  • HIT heparin induced thrombocytopenia
  • Extra corporeal membrane oxygenation is a form of mechanical cardiopulmonary support which is commonly applied intraoperatively to facilitate cardiac surgery which employs the cardiopulmonary bypass technique. Although far less common, prolonged cardiopulmonary support delivered in an intensive care unit is also possible.
  • ECMO venoarterial
  • VV venovenous
  • VA venoarterial
  • VV venovenous
  • VA venoarterial
  • VV venovenous
  • Both provide respiratory support, but only VA ECMO provides hemodynamic support.
  • ECMO may be operated in a pump driven circuit or in a pumpless circuit.
  • ECMO devices are typically constructed of a bundle of gas permeable hollow fibers in a housing where gas passes through the hollow fibers and blood flows around the outside of the fibers.
  • the distribution of blood from is generally accomplished using a single distribution chamber on one side of the hollow fiber bundle and a collection chamber on the exit side.
  • This technology can be applied to ECMO devices where the blood passes either through the hollow fibers or outside the hollow fibers as well as in multiple bundle geometries (round, annular, rectangular).
  • Pumpless Extracorporeal Lung Assist is a gas exchange device proposed for use in patients with severe gas-exchange disorders such as acute respiratory distress syndrome (ARDS), severe pneumonia and other conditions associated with hypercapnia and hypoxia.
  • PECLA devices are typically constructed of a bundle of gas permeable hollow fibers in a housing where gas passes through the hollow fibers and blood flows around the outside.
  • the distribution of the blood in these devices is accomplished using a single distribution chamber.
  • the high pressure drop across the device limits the flow rate of blood through the device and, thus, the rate of oxygen mass transfer is limited.
  • the requirement of substantial anticoagulation is necessary to prevent fouling of the device.
  • Apheresis is the process of removing a specific component from blood and returning the remaining components to a blood donor or patient, in order to collect more of one particular part of the blood than could be separated from a unit of whole blood.
  • plasmapheresis is a process usually carried out using a hemofiltration device wherein plasma is separated from blood, and sent to waste. In its place, components such as saline or fresh frozen plasma (FFP) are added; this process has the end result of reducing components in plasma which are harmful to the patient. Examples of diseases commonly treated in this fashion are Goodpasture's syndrome, acute and chronic inflammatory demyelinating polyradiculoneuropathy, Myasthenia gravis and Thrombotic Thrombocytopenia Purpura (TTP).
  • Hemoconcentrators are devices that perform selective removal of plasma water and some dissolved solutes by way of an ultrafiltration membrane.
  • Hemoconcentrators are routinely used during pediatric cardiopulmonary bypass (CPB) to remove free plasma water and various inflammatory mediators. They employ blood distribution manifolds similar to that of standard dialyzers, and hence require anticoagulation for use, and suffer many of the same complications seen in other blood treatment devices.
  • CPB pediatric cardiopulmonary bypass
  • the sharp edges of the thin disks and rapid changes in blood flow direction they cause can impart significant shear forces on the blood, which can cause hemolysis, which can cause sheer activation of platelets and result in coagulation in the micro fibers of the dialyzer.
  • the use of the distribution disks does nothing to relieve the dead flow zones which are found at the interface between the blood inlet manifold or header and the inlet end of the hollow fiber bundle.
  • the individual microfibers are typically spaced apart by a distance several or more times their diameters so that the lumen coverage of the inlet end of the fiber bundle is typically from 15% to 40%, causing regions of both turbulence and dead flow as the blood flow transitions from the inlet manifold into the individual fibers.
  • Such flow risks both have shear forces which can damage the blood as well as blood coagulation and clotting which can occlude the individual fibers.
  • the present invention provides blood treatment apparatus designs having a reduced risk of coagulation and clotting in microfibers and other components of the blood flow path.
  • Coagulation and clotting risk is reduced by controlling and maintaining the flow and shear rates through the individual fibers as well as other components of the flow path above a minimum threshold level to avoid stagnation and dead zones which allow coagulation and clotting.
  • the flow rates are limited below a maximum threshold in order to avoid shearing and turbulence which can cause hemolysis, platelet activation (coagulation) and potential degradation of the blood.
  • the hemodialyzers and other blood treatment apparatus are designed to have a very uniform flow velocity distribution over an inlet surface of a blood treatment module, such as among the individual hollow micro fibers as well as through other components of the flow path.
  • ECMO Pump driven and pumpless Extracorporeal Membrane Oxygenation
  • PECLA Pumpless Extracorporeal Lung Assist
  • Apheresis plasmapheresis
  • Hemoconcentration is a few examples of extracorporeal treatment devices that would benefit from the enhanced flow distribution, reduced anticoagulation requirement and reduced pressure drops achieved with the use of this technology.
  • Such flow control and uniformity may be achieved by distributing an inlet flow of the blood evenly and uniformly across the inlet surface(s) of one or more hollow fiber bundles being employed in the blood dialyzer.
  • the present invention provides for dividing or "branching" the inlet blood flow into a plurality of independent, separate flow streams which in turn are distributed evenly and uniformly over the inlet surface(s) of the hollow fiber bundle(s). More particularly, the present invention will provide for at least two stages of such flow division, usually at least three stages of flow division, and often four or more stages of flow division. Usually, the cross-sectional or "flow" areas of each flow channel or path of each successive stage will be reduced to maintain a generally constant flow velocity to further reduce turbulence and flow disruption.
  • the total flow in each successive stage will remain substantially constant, with the cross- sectional area of the individual flow path or channel in the successive stage being a fraction of the cross-sectional area of the flow path in the prior stage. That is, if a flow channel at one stage has a total cross-sectional area A, and the flow is divided into "n" flow paths in the next flow stage, the area of each flow path in the successive stage will usually be A/n (assuming that the successive flow paths are intended to carry substantially equal flow volumes).
  • the use of such flow division or branching allows the inlet blood flow to be divided into a relatively large number of end stage flow channels (i.e. the final flow channels in the flow distribution network which deliver blood to the hollow fiber bundle).
  • the inlet flow will be divided into at least about 10 end stage flow channels, more usually at least about 25 end stage flow channels, and often about 50 end stage flow channels, and frequently 100 end stage flow channels or more.
  • the flow uniformity from each of the end stage flow channels may be enhanced by providing flow diverter structures which further minimize flow disruption as the blood enters the lumens of the individual micro fibers in the fiber bundle.
  • flow diverter structures which further minimize flow disruption as the blood enters the lumens of the individual micro fibers in the fiber bundle.
  • flow diverter structures are described in copending application 61/172,664 (Attorney Docket No. 027543-000200US), filed on April 24, 2009, the full disclosure of which is incorporated herein by reference.
  • Such flow diverter structures will typically be provided at the outlet of each individual end stage flow channel between said flow channel and a sector of the hemodialysis micro fiber bundle.
  • the flow distribution networks of the present invention may be employed to deliver uniform blood flow to hollow fiber bundles having a single inlet surface where the plurality of end stage flow channels are uniformly distributed over the single inlet surface.
  • the flow distribution networks may be utilized to deliver flow to the inlet surfaces of a plurality of individual hollow fiber bundles, where one or more such end stage flow channels can provide flow to each of the individual hollow fiber bundles.
  • a hemodialysis apparatus comprises an enclosure having a blood inlet, a blood outlet, a dialysate inlet, and a dialysate outlet. At least one hollow fiber bundle is disposed within the enclosure and includes an inlet end and an outlet end. The hollow fiber bundle is arranged within the enclosure so that the inlet end receives blood from the blood inlet, and the outlet end delivers blood to the blood outlet.
  • a blood flow distribution network is disposed between the blood inlet of the enclosure and the inlet end of the hollow fiber bundle(s). The blood flow distribution network has at least one passage which receives blood from the blood inlet.
  • Said at least one passage branches into a first plurality of first stage flow channels to achieve a first stage of blood flow distribution. At least some of the first stage flow channels branch into second pluralities of second stage flow channels to achieve a second stage of blood flow distribution.
  • the blood flow will be divided into at least two downstream components, usually at least three downstream components, and often four or more downstream components.
  • each flow channel in each stage will branch into flow channels in the next stage until a sufficient number of branching stages have been achieved, usually at least three stages of branching, often at least four stages of branching, and sometimes more.
  • each stage of branched flow channels will comprise channels having smaller cross-sectional areas than those of the prior stage. That is, the first passage of the blood flow distribution network which receives blood from the blood inlet will have an area adequate to receive the entire volume and flow rate of blood to be treated, typically in the range from 1 mm 2 to 100 mm 2 .
  • the first passage will then divide into a plurality of first stage flow channels where each of the first stage flow channels has an area which is a fraction of the area of the first passage. That is, if the first passage branches or divides into four first stage flow channels, each of the first stage flow channels will have an area less than that of the first passage, typically being about one-quarter of the cross-sectional area of the first flow passage so that the flow will generally divide equally with minimum change in flow velocity and reduced turbulence.
  • the second stage flow channels will have a cross-sectional area which is a fraction of the cross-sectional areas of the first stage flow channels, usually being "1/n," where n equals the number of branches in the second stage of the flow channels.
  • each successive flow channel stage can be readily determined, and the end stage flow channels will typically have very small cross-sectional areas, usually being in the range from about 0.4 mm to 4 mm , often in the range from about 0.4 mm to 2 mm .
  • the end stage flow channels will usually be distributed in a generally uniform pattern over a single, continuous inlet end of the hollow fiber bundle.
  • generally uniform it is meant that the density of the end stage flow channels over any given unit area will vary by no more than ⁇ 25% from the average density, preferably varying by 15% or less.
  • each such hollow fiber bundle will typically be fed by a plurality of the end stage flow channels.
  • each of the multiplicity of hollow fiber bundles will have the same size and number of hollow fibers, and each inlet end will receive its proportionate share of the total number of end stage flow channels.
  • the end stage flow channels for each of the individual hollow fiber bundles will be uniformly distributed, as defined above, over the inlet ends of the hollow fiber bundle and flow diverters may optionally be used for achieving even greater flow uniformity into the individual hollow fiber bundles.
  • the blood flow distribution networks of the present invention may take a variety of specific forms.
  • the branched flow channels in each stage may be arranged in a plane which is generally parallel to the inlet flow axis.
  • the branching flow channel network may be arranged in one or more planes which is/are generally perpendicular to the inlet blood flow. In other cases, combinations of parallel, perpendicular, and other flow channel orientations may be employed.
  • the first and second stage flow channels are arranged in a plane which is generally perpendicular to the axis of blood flow inlet. If a single such planar array is utilized, the end stage flow channels will typically be arranged in a linear array. Optionally, by employing two or more planar distribution arrays in series, a two-dimensional array of end stage flow channels may be provided.
  • all stages of the branching flow channels may be arranged in a planar structure or array which may be arranged in parallel with the inlet end(s) of the hollow fiber bundle(s).
  • a diffuser plate may be disposed between the perpendicular blood diffuser array and the inlet end of the hollow fiber bundle.
  • the diffuser plate will include a plurality of flow diverters which are arranged to receive blood flow from individual end stage flow channels and to deliver the blood to a sector of the individual hollow fibers in the bundle.
  • methods for dialyzing a blood flow comprise dividing the blood flow into a first plurality of first stage flows. At least some of the first stage flows are divided into a second plurality of second stage flows, and optionally at least some of the second stage flows may be divided into a third plurality of third stage flows and at least some of the third stage flows may be divided into fourth stage flows. While four such flow divisions will usually be sufficient, it will be appreciated that fifth, sixth, and even more stages of flow division may be provided within the scope of the present invention.
  • the final divided flow stage will be referred to as the "end stage flow,” and each of the end stage flows are delivered to an inlet end of a hollow fiber bundle, and the blood flow through the hollow fiber bundle is dialyzed using a dialysate flow in an otherwise conventional manner.
  • the end stage flows may be delivered to an inlet end of the single hollow fiber bundle, generally as described above with respect to the apparatus of the present invention, or the end stage flows may be separately delivered to a plurality of inlet ends of a plurality of hollow fiber bundles. In all cases, the end stage flows will preferably be substantially uniformly distributed over the inlet end(s) of the hollow fiber bundle(s), where uniformity has been previously defined.
  • the initial blood flow to be dialyzed is usually oriented in an axial direction, and the blood flow may be divided into successive stage flows in one or more planar arrays of flow channels.
  • the blood flow may be divided in a single planar array having two, three, four, or more stages of flow division, where the end stage flow channels will typically be arranged in a linear array.
  • the inlet blood flow may pass through successive planar arrays of branching flow channels where a first array may provide a linear array of flow channels and a plurality of secondary planar arrays may receive blood from each of the flow channels of the first planar array to further divide those flows into multiple end stage or intermediate stage flows.
  • Using successive plane arrays can provide for two-dimensional end stage flow channel arrays.
  • the inlet blood flow may be initially diverted to flow in a planar array which is perpendicular to the blood flow and parallel to the inlet end(s) of the hollow fiber bundle(s).
  • the perpendicular flow channel arrays may provide for a highly uniform two-dimensional array of end stage flow channels for uniformly delivering blood to the inlet end(s) of the hollow fiber bundle(s).
  • flow diverter structures may be provided between the two-dimensional end stage arrays and the inlet end(s) of the hollow fiber bundle(s).
  • FIG. 1 is a schematic illustration of a flow distribution network constructed in accordance with the principles of the present invention delivering blood to an inlet end of a single hollow fiber bundle.
  • Fig. 2 is a schematic view similar to Fig. 1 , where the flow distribution network is delivering blood to a plurality of inlet ends of a plurality of hollow fiber bundle(s).
  • FIG. 3 A and 3 B illustrate flow division according to the present invention in three dimensions.
  • Fig. 4 illustrates the use of planar flow distribution arrays for delivering divided flow to a plurality of individual hollow fiber bundles.
  • Fig. 5 illustrates an alternative flow distribution network where the divided flows recombine to deliver a plurality of end stage blood flows to the inlet end of a single hollow fiber bundle.
  • Fig. 6 is similar to Fig. 5, except that the flow distribution network is delivering flow to a plurality of individual hollow fiber bundles.
  • Fig. 7 is a perspective view of a dialyzer cap constructed in accordance with the principles of the present invention with portions broken away.
  • Fig. 8 is the top view of the dialyzer cap of Fig. 7, with portions broken away illustrating four stages of flow diversion in a single plane.
  • Fig. 9 is a bottom view of the dialyzer cap of Fig. 7 illustrating a plurality of diffuser cells which receive blood from the end stage flow channels shown in Fig. 8.
  • Fig. 10 is a schematic illustration of how the flow in the dialyzer cap of Fig. 7 progresses from the end stage flow channels to the diffuser cells and then to the inlet surface of the hollow fiber bundle of the dialyzer.
  • a first exemplary hemodialyzer 10 constructed in accordance with the present invention comprises an inlet flow distribution network 12, an enclosure 14, a hollow fiber bundle 16 within the enclosure, and an outlet flow distribution network 18.
  • a flow of blood to be treated enters in through a main passage 20 which divides into a pair of first stage flow channels 22, each of which in turn are divided into a pair of second stage flow channels 24.
  • the eight third stage (end stage) flow channels 26 deliver the blood into an open plenum 28 which lies between the outlets of the flow channels 26 and the inlet surface 30 of the hollow fiber bundle 16.
  • the division of the inlet flow through passage 20 into eight generally equal outlet flows through the end stage flow channels 26 will be sufficient to enhance the flow uniformity and dialyzer efficiency.
  • Various flow diverter structures could be provided within the plenum 28, as described in commonly owned, copending application 61/172,664 (Attorney Docket No. 027543-000200US), the full disclosure of which has been previously incorporated herein by reference.
  • Blood passing through the hollow fiber bundle 16 will be dialyzed by a dialysate flow which can be introduced through dialysate inlet 32 and collected at dialysate outlet 34.
  • the outlet flow collection network 18 is a mirror image of the inlet flow distribution network 12, where eight separate inlet flow channels collect the blood and converge through stages into a single outlet passage 34. While use of such a converging flow collection network is generally preferred, it will be appreciated that flow uniformity is less critical after the blood has passed through the flow dialyzer and a variety of other flow collection manifolds and networks could be implemented in place of the illustrated flow collection network 18.
  • a second exemplary hemodialyzer 40 is illustrated in Fig. 2.
  • Hemodialyzer 40 is similar in most respects to the first exemplary hemodialyzer 10, including an identical inlet flow distribution network 12 and outlet flow collection network 18.
  • the hemodialyzer 40 differs from dialyzer 10, however in that a plurality of individual hollow fiber bundles 42 are provided, with each bundle being aligned with one end stage flow channel 26 and with the corresponding inlet flow channel in the outlet collection network 18.
  • Dialysis efficiency might be further improved by employing hollow fiber bundles 42 having closely packed inlet ends, as described in commonly owned, copending application 61/172,664 (Attorney Docket No. 027543- 00011 OUS), the full disclosure of which has been previously incorporated herein by reference.
  • the flow distribution networks 12 and collection networks 18 are shown to have generally "planar" configurations where the end stage flow channels 26 are arranged in a linear array. While such structures are useful and achieve many of the objectives of the present invention, it will often be desirable to use cylindrical, square, or other hemodialyzer configurations having a two-dimensional inlet end. It will be appreciated, as shown in Figs.
  • the branching flow distribution networks can be implemented in three dimensions.
  • the inlet passage 20 could branch into four radically diverging first stage flow channels 22A, with each of the four first stage flow channels in turn branching into four second stage flow channels 24a, and in turn branching into four third stage flow channels 26a.
  • the single initial flow through passage 20 will be divided into 64 end stage flows through flow channels 26a.
  • Such branching is also illustrated in Fig. 3B where the image is flattened out to show each stage of branching and the general relative size of the flow channels in each stage.
  • the provision of two-dimensional end stage arrays can be achieved in other ways.
  • a plurality of planar arrays can be joined in a series-parallel arrangement to feed a rectangular array of individual hollow fiber bundles 52.
  • the hemodialyzer 50 includes a first planar array 54 which includes an inlet passage 56 which opens into a network of passages which divide the flow through first and second stages into four second stage outlets 56.
  • Each of the second stage flow channels 56 is connected to one additional planar array 58 which further divides the flow into eight flow channels 60 to feed the eight hollow fiber bundles 52 which are in that planar structure.
  • the planar arrays 58 could be constructed similarly to the array 40 shown in Fig. 2.
  • the four planar arrays 58 are vertically stacked to, in effect, provide a two- dimensional array including a total of 32 hollow fiber bundles 54 arranged in a generally square or rectangular configuration. Outlet ends 62 of the four planar arrays 58 are delivered to an outlet collection array 64 which may be constructed similarly to the inlet array 54.
  • a fourth exemplary hemodialyzer 70 is illustrated in Fig. 5 and includes an inlet flow distribution network 72 where the inlet passage 74 branches at a number of nodal points 76, eventually providing six end stage flow channels 78.
  • the six flow channels 78 feed blood into plenum 80 which in turn flows the blood into a single hollow fiber bundle 82. Blood from the hollow fiber bundle 82 flows into an outlet distribution network 84 which may be constructed similarly to the inlet distribution network 72.
  • a fifth exemplary hemodialyzer 80 may include inlet and outlet flow distribution networks 72a and 84a which are identical to those shown in Fig. 5.
  • the hemodialyzer employs a plurality of individual hollow fiber bundles 86, where each bundle receives blood from a single one of the end stage flow channels 78.
  • the individual hollow fiber bundles 86 may employ tightly packed inlet ends 88 of the type described in commonly owned, copending application 61/172,664 (Attorney Docket No. 027543 -000200US), the full disclosure of which has previously been incorporated herein by reference.
  • the hemodialyzer 70 may further include a plurality of flow diverters 90 to further enhance the blood flow into the constricted inlet ends of the hollow fiber bundles 88.
  • a dialyzer end cap 100 is illustrated in Figs. 7-9 and is of a type which can be mounted at either of the inlet or outlet end of a conventional hollow fiber dialysis bundle.
  • the dialysis end cap 100 includes an inlet port connector 102 which can be connected to a conventional blood inlet flow line and a sidewall 104 which can be threaded on to the end of the hollow fiber dialysis bundle housing (not shown). Between the blood flow port inlet 102 and a bottom surface 106 of the end cap 100, a plurality of dividing or branching flow channels 110 are formed in a disk portion 112 of the end cap. As best seen in Fig.
  • an axial inlet passage 114 divides into a plurality of first stage flow channels 110a which in turn branch into a plurality of second stage flow channels 110b.
  • the second stage flow channels 1 10b divide into a plurality of third stage flow channels 1 10c which, in turn, divide into a plurality of fourth stage flow channels HOd, which are the end stage flow channels.
  • the axial inlet flow channel 110 divides into a total of eight first stage flow channels, which each divide into a total of three second stage flow channels 110b, which each in turn divide into a total of three third stage flow channels 110c, which each divide into five fourth or end stage flow channels 1 1 Od.
  • each end stage flow channel 110 will ultimately divide into a total of 360 end stage flow channels.
  • Each end stage flow channel will terminate in a via 120, i.e. a vertical passage through the thickness of the disk portion 112 of the end cap, as best seen in Fig. 7.
  • the vias 120 each terminate in a diffuser cell 122 formed in the bottom surface 106 of the end cap, as best seen in the enlarged portion of Fig. 9.
  • the diffuser cells 122 (of which the full 360 are illustrated in Fig. 9 to evenly distribute or spread the blood over the inlet end 130 of a hollow fiber bundle 132, as shown schematically in Fig. 10.
  • each of the diffuser cells 122 could include a diverter structure (not shown but previously described) in order to further enhance the flow distribution.

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Abstract

L'invention porte sur un appareil de traitement du sang qui comprend une enceinte renfermant un ou plusieurs modules de traitement du sang, typiquement, des faisceaux de fibres creuses. Un réseau de distribution d'entrée de flux de sang divise un flux de sang d'entrée en une série d'étages de flux de sang individuels successifs afin d'augmenter l'uniformité de la distribution du flux de sang dans les faisceaux de fibres creuses. Le flux de sang d'entrée peut être divisé en deux, trois, quatre étages ou plus, fournissant un grand nombre de canaux de flux d'étage final pour introduire du sang dans le faisceau de fibres creuses.
PCT/US2009/047402 2008-06-16 2009-06-15 Appareil de traitement du sang ayant une distribution à flux ramifié WO2009155248A1 (fr)

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US6167908P 2008-06-16 2008-06-16
US61/061,679 2008-06-16
US17266409P 2009-04-24 2009-04-24
US61/172,664 2009-04-24

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3090768A1 (fr) * 2015-05-07 2016-11-09 Novalung GmbH Dispositif doté de section d'admission destiné au traitement d'un liquide biologique
US10286137B2 (en) 2013-05-17 2019-05-14 Novalung Gmbh Oxygenator module, oxygenator and production method
WO2020026198A3 (fr) * 2018-08-03 2020-04-09 Palti Yoram Prof Systèmes d'écoulements de fluides répartis à débit égalisé

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4173537A (en) * 1977-05-23 1979-11-06 Newhart Earle E Integral artificial kidney unit
US5942112A (en) * 1997-10-17 1999-08-24 Ishak; Noshi A. Hollow fiber ultradialyzer apparatus
US20020190000A1 (en) * 1999-12-23 2002-12-19 Ulrich Baurmeister Haemofiltration system
US20030050622A1 (en) * 2001-09-11 2003-03-13 The University Of Michigan Device and method to maintain vascularization near implant
US20030075498A1 (en) * 2001-06-01 2003-04-24 Watkins Randolph H. Hemodialyzer headers

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4173537A (en) * 1977-05-23 1979-11-06 Newhart Earle E Integral artificial kidney unit
US5942112A (en) * 1997-10-17 1999-08-24 Ishak; Noshi A. Hollow fiber ultradialyzer apparatus
US20020190000A1 (en) * 1999-12-23 2002-12-19 Ulrich Baurmeister Haemofiltration system
US20030075498A1 (en) * 2001-06-01 2003-04-24 Watkins Randolph H. Hemodialyzer headers
US20030050622A1 (en) * 2001-09-11 2003-03-13 The University Of Michigan Device and method to maintain vascularization near implant

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10286137B2 (en) 2013-05-17 2019-05-14 Novalung Gmbh Oxygenator module, oxygenator and production method
EP3090768A1 (fr) * 2015-05-07 2016-11-09 Novalung GmbH Dispositif doté de section d'admission destiné au traitement d'un liquide biologique
WO2016177476A1 (fr) * 2015-05-07 2016-11-10 Novalung Gmbh Dispositif présentant une partie d'amenée pour le traitement d'un liquide biologique
US10610629B2 (en) 2015-05-07 2020-04-07 Novalung Gmbh Device with inlet portion for treating a biological liquid
WO2020026198A3 (fr) * 2018-08-03 2020-04-09 Palti Yoram Prof Systèmes d'écoulements de fluides répartis à débit égalisé
CN112512666A (zh) * 2018-08-03 2021-03-16 尤伦·帕提 流速率均衡的分布式液流系统
EP3858400A1 (fr) * 2018-08-03 2021-08-04 Yoram Palti Systèmes d'écoulements de fluides répartis à débit égalisé
US11255841B2 (en) 2018-08-03 2022-02-22 Nano2Cure Ltd. Distributed fluid-flow systems with equalized flow rate

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