EP2704763A1

EP2704763A1 - Exchanger device

Info

Publication number: EP2704763A1
Application number: EP12719665.7A
Authority: EP
Inventors: Thomas Schmitz-Rode; Ulrich Steinseifer; Jutta Arens; Peter SCHLANSTEIN; Ralf BORCHARDT
Original assignee: Dritte Patentportfolio Beteiligungs GmbH and Co KG
Current assignee: Dritte Patentportfolio Beteiligungs GmbH and Co KG
Priority date: 2011-05-04
Filing date: 2012-05-02
Publication date: 2014-03-12
Also published as: AU2012251678A1; KR20140015437A; CN103501833A; EA201301119A1; CA2830449A1; AU2012251678B2; JP2014518696A; US20140061116A1; WO2012150233A1; DE102011100439A1

Abstract

The invention relates to an exchanger device for transferring mass and/or energy between a first and second medium. The device comprises a chamber which has a first inlet and outlet of the first medium and through which the first medium can flow, and the chamber is equipped with at least one mass- and/or energy-permeable exchanger hollow fiber, preferably a plurality of mass- and/or energy-permeable exchanger hollow fibers, which is/are connected at one end to a second inlet and at the other end to a second outlet of the second medium, wherein the second medium can flow through the fiber(s) and the first medium can flow around the fiber(s). The chamber is equipped with at least one pump element by means of which the first medium can be displaced out of the chamber and sucked into the chamber in a pulsing manner. The pump element has an elastically deformable element and is connected to a third inlet of a third medium that is used as a driving medium, said pump element being expandable by the third medium.

Description

-Exchange device

description

The invention relates to an exchanger device for effecting a material and / or energy exchange between a first and second medium, having a first inlet and outlet of the first medium and having the first medium through which chamber in which at least one fabric and / or energy-permeable exchanger hollow fiber, preferably a plurality of mass and / or energy-permeable exchanger hollow fibers, which is connected at one end to a second inlet and at the other end to a second outlet of the second medium and from the second Medium can be flowed through and flowed around by the first medium is / are, wherein in the chamber at least one pumping element is arranged, by means of which the first medium can be pulsed out of the chamber displaceable and sucked into the chamber and having an elastically deformable element.

Such generic devices find their field of use, for example, in medical technology and in particular in the applications of blood purification, such. Dialysis, blood separation or artificial lungs

(Oxygenators).

In the field of application of the oxygenators, it is provided to allow the blood to flow as a first medium through a chamber in which at least one material and / or energy-permeable hollow fiber, in a preferred embodiment, a plurality of material and / or energy-permeable Hollow fibers is arranged, which is flowed through by the second medium, in particular oxygen, and is flowed around by the first medium. Hollow fiber modules for this purpose are described in WO 2011/023605 Al.

When C0 _2- enriched blood originating from the body of a living organism is pumped through the chamber, the result is a difference

Partial pressures of oxygen and C0 ₂ on the two sides of the material and / or energy-permeable hollow fiber, a mass transfer in the sense that C0 ₂ from the Blood is removed and this is enriched with oxygen from the hollow fibers. Thus, such a device can work as an artificial lung and, for example, partially or completely take over the lung function of a patient.

As far as in this description of the invention an oxygenator, d. H. an artificial lung, is described in more detail, this is not to be construed as a limitation, but only as an exemplary application. The device described here can in principle be used for the material or energy exchange between any media and not only in medical technology, but also in other industrial applications.

To achieve adequate and defined flow rates of a first medium through said chamber, in particular of the blood through the chamber

usually used external pumps. In the scope of the

Oxygenators this means that in addition to the generic device, a pump must be provided, is pumped with the blood from the body of a patient through the device and then back into the body of the patient.

The said principle requires that in the generic devices and the pump used externally results in a significant volume, which must be filled by the first medium, such as in this application, the blood.

In WO 2008/104353 AI an exchange device of the above. Art suggested that has an integrated pumping function and therefore requires no external pump volumes.

The invention has for its object to provide a further improved device of this kind, which provides particular advantages in terms of work and patient safety. This object is achieved by an exchanger device having the features of claim 1. Advantageous further developments of the invention

Thought are the subject of the dependent claims.

According to the invention, it is departed from using one of the two media involved in the material or energy exchange at the same time as the medium for reducing the pumping function, and this function is realized with an additional (third) medium. Therefore, the invention also includes the idea of at least one separate inlet for that as a drive medium for the

Provide pumping serving medium.

In one embodiment of the invention, a plurality of elastically deformable pump hollow fibers are arranged as pumping elements in the chamber, and these are connected to the third inlet.

In the particularly important in medical use execution of

Device as an oxygenator is the second medium is oxygen, and accordingly, an oxygen storage or an oxygen source is connected to the second inlet of the device. As the third medium can be used in a particularly simple and cost-effective manner air, in which case then set up for the corresponding (third) inlet for pulsation operation

Air pump is connected. The essential for the pumping pulsating expansion and contraction of the pumping element or especially the plurality of elastically expandable hollow fibers can be achieved here advantageously with a pump element closed on one side or hollow fibers sealed on one side; So in this version, there is no flow for the third medium.

In one embodiment, it is provided that the chamber on the one hand to the third inlet and on the other hand, the entrance of the pump hollow fiber or the

Entrances of the pump hollow fibers adjacent first part-chamber, a second inlet adjacent to the second part-chamber and a first inlet and outlet adjacent and the exchanger hollow fiber or exchanger hollow fibers receiving third part chamber. This subdivision of the device interior is in the sense of a clear function assignment and delineation, especially in the meaningful distribution of media over the available internal volume of the

Device for ensuring an optimized pumping and exchange function.

In another embodiment, a liquid, in particular physiological saline solution, serves as the third medium, and it is a corresponding one

Liquid reservoir provided. In one embodiment of this embodiment is associated with the mass transfer function of an energy exchange function, for example, to be enriched with oxygen blood of a patient at the same time to maintain body temperature. In this embodiment, the pumping element or the pumping hollow fibers are open on both sides and integrated into a fluid circuit of the third medium, to which a heat source for heating the third medium is assigned.

In this case, a sensible functional subdivision of the exchanger device provides that the chamber has a first sub-chamber adjacent to the third inlet on the one hand and the inlet of the pumped hollow fiber or the inlets of the pumped hollow fibers, a second sub-chamber adjacent to the second inlet. Chamber, one of the first inlet and outlet adjacent and the exchange hollow fiber or exchanger hollow fibers receiving third part chamber and on the one hand the output of the pump hollow fiber or the outputs of the pump hollow fibers and on the other hand, the third sequence adjacent fourth part chamber having.

A further embodiment of the invention provides that the first inlet and outlet for the first medium, each with a controllable valve for timed interruption of the inflow or outflow of the second medium are provided. Here, in a particularly advantageous manner, which avoids the provision of a closing body in the inlet and outlet, the controllable valves are preferred as

Hose clamp valves formed. In particular, the apparatus comprises a pump and valve control unit adapted to synchronously control the pump for the third medium and the valves at the first inlet and outlet for effecting delivery of the first medium through the chamber from the inlet to the outlet. Another embodiment is characterized by a flow sensor at the first inlet and / or outlet, which is in particular connected to a sensor signal input of the pump and valve control and / or the heat source in the circuit of the third medium. A further embodiment, which can advantageously be combined with the aforementioned, comprises a bubble detector at the first outlet, which is in particular connected to a sensor signal input of the pump and valve control unit. With such a sensor, the precision of the control and the patient safety of the proposed device can be further improved.

In a further embodiment of the invention, the exchanger device has a cylindrical or prismatic housing, wherein in particular the first and second inlet in a peripheral wall and the third inlet are arranged in an end face and the or each exchanger hollow fiber substantially perpendicular to the cylinder axis or longitudinal extent the prism and the or each pumping element substantially parallel to the cylinder axis or

Longitudinal extension of the prism are aligned. In one embodiment of this housing construction, the first outlet in the circumferential wall of the housing, in particular with respect to the first inlet, and the second outlet in the opposite or opposite the connection for the third medium end face, offset from the first inlet and the first outlet, in the

Circumferential wall arranged.

In an important embodiment, the exchanger device according to the invention is a blood oxygenator. Another important design or use is as a dialysis machine. In principle, the device may be at least partially implantable in both applications.

Incidentally, advantages and expediencies of the invention will become apparent from the following description of exemplary embodiments and aspects with reference to the figures. From these show: Fig. 1 is a schematic diagram of an arrangement in which an inventive

Exchanger device is used in an important medical application,

Fig. FIG. 2 shows a schematic cross-sectional representation of an embodiment of the device according to the invention and FIG

Fig. 3 shows a schematic cross-sectional representation of a further embodiment, with identification of different functional areas.

The oxygenator arrangement 1 shown in FIG. 1 for realizing an "artificial lung" on a patient P comprises as its core an exchange device (oxygenator) 3 which supplies oxygen-poor blood Bi from the patient P via hose lines (not separately designated) the oxygen-rich blood B _{2 is} withdrawn and returned to the patient for supplying the blood Bi, the exchanger device 3 has a first inlet 5a, and the

Derivation of the oxygen-enriched blood B ₂ , it has a first sequence 5b. At the first inlet 5a, a first controllable valve 7a is arranged, and at the first outlet 5b, a second controllable valve 7b is arranged.

Via a second inlet 9a, the exchanger device 3 is supplied with oxygen O ₂ , and via a second outlet 9b it is introduced

Oxygen / carbon dioxide mixture derived 0 ₂ / C0 ₂ . In the embodiment shown, the exchanger device 3 is operated with physiological saline solution S as a drive medium, which is supplied to it via a third inlet I Ia and is discharged from the device via a third outlet I Ib. The saline solution S is pulsed by a suitable liquid pump 13 in a liquid circulation through the exchanger device 3, including a third valve I Ia and third drain Ib each have a controllable valve 15a and 15b is provided. By a heater 17, the saline solution can be suitably tempered to an additional heat exchanger function of

Exchanger device 3 heat losses of blood B ₂ during the

Compensate for oxygenation. To control the operation of the feed pump 13, the heater 17 and the controllable valves 7a, 7b, 15a and 15b, a pump and valve control unit 19 is provided with integrated heating control function, which has conventional (not shown) input and programming means. Incidentally, the pump and valve control unit 19 is connected on the input side to a blood flow sensor 21 on the first inlet 5a and a bubble detector 23 on the first outlet 5b and for processing sensor signals of these sensors 21, 23 for suitable control of the pump 13 and the controllable valves for setting a adequate delivery and to avoid bubbles formed in the oxygen-enriched blood B ₂ . In a modified embodiment (not shown), sampling and / or sensory detection of the blood oxygen saturation can also be provided on the blood and blood flow, and the signals of corresponding sensors or analysis results can also be stored in the pump and valve control unit suitable control regime of the arrangement 1 are evaluated.

Fig. 2 shows a schematic cross-sectional view of the exchanger device 3 in its internal structure. Parts already shown in FIG. 1 and already described above are designated by the same numbers as in FIG. 1 and will not be explained again here. The embodiment differs from that shown in FIG. 1 insofar as no controllable valves are present or shown at the third inlet and outlet I Ia, I Ib.

The functional core of the exchanger device 3 is a bundle of gas-permeable hollow fibers 31, which are arranged in a cylindrical housing 33 of the exchanger device substantially in the direction of the cylinder axis and whose one ends adjacent to the second inlet (for oxygen supply) 9a and the other Ends adjacent to the second drain (for oxygen / carbon dioxide discharge) 9b lie. Oxygen is introduced into these hollow fibers 31 and flows through them to their opposite end. In the central region of the interior (the "chamber") 35 of the exchanger device 3 are the

Hollow fibers 31 flow around the blood supplied via the first inlet 5a, and there is an oxygen enrichment and at the same time carbon dioxide depletion in the blood; the hollow fibers 31 thus act as exchange hollow fibers. In order to convey the media to be exchanged for gas, that is to say the blood Bi / B ₂ (also referred to above as the first medium) and the oxygen 0 ₂ (also referred to above as the second medium), a pulsatile pumping movement is realized in the exchanger device 3 , by pulsating supply of saline S in a group of substantially along the cylinder axis arranged pump hollow fibers (silicone tubes) 37, which elastic

are expandable. The pump hollow fibers 37 are designed in particular coiled, for example, fibers with a diameter of 2 mm and a

Wall thickness of 0.15 mm and can be wound using (temporarily introduced) AI cores. Their jerky expansion as a result of the pulsating supply of saline S as a drive medium, in conjunction with a correspondingly controlled actuation of the valves 7a, 7b on the Blututz- and -ablauf 5a, 5b, the desired conveying operations. The

Groups of hollow fibers 31 and 37 are connected via suitable connectors 31a and 37a to the respective inlets and outflows 9a, 9b and IIa, IIb, respectively.

If, in deviation from the illustrated embodiment, compressed air is used as the drive medium of the exchanger device, circulation can be dispensed with and the third sequence (IIb in FIG. 2) can be omitted, in which case modified, remote from the inlet of the third medium Ends sealed pump hollow fibers are used. In such an embodiment, the second outlet (for the used exchange gases) can then also be placed on the lower end face of the housing of the exchanger device.

Such a modified exchanger device 3 'is - again in

schematic cross-sectional view - shown in Fig. 3. Again, this is the

Denomination based on Fig. 1 and 2, and already above

Parts or areas described are not explained again. The mentioned sealing of the ends of the pump hollow fibers 37 'facing away from the third inlet IIa for the air A serving as drive medium here is realized here by end plugs 37b. The sealing of the fiber ends, for example, by means of a commercially available two-component silicone using a centrifuge respectively. It can be seen that the third sequence is dispensed with and the second outlet 9b 'is placed in its place.

The essential functional areas in the interior of the exchanger device 3 'can be a first, adjacent to the third inlet I Ia sub-chamber 35th, a second, the second inlet 9a adjacent part-chamber 35.2' and finally a third, the first and outlet 5a, 5b adjacent partial chamber 35.3 '

differ. In the first part-chamber, the drive medium (here the air A) is supplied and "cached", in the second sub-chamber 35.2 'takes place the oxygen supply and distribution, and in the third sub-chamber 35.3' finally carried the passage of the blood through the exchanger device, connected to the functionally essential gas exchange and if necessary (as described above in connection with FIG. 2) one

Heat exchange. In the third part-chamber are also the elastic

expandable pump hollow fibers or at least substantial portions of the same.

The device described operates with continuous oxygen supply via the second inlet 9a and the third inlet I Ia supplied air pressure pulses, which can be supplied in an expedient embodiment between 20 and 140 pulses / min and a pressure difference of up to 600 mm Hg, wherein the

Ratio between systolic and diastolic phase can be varied between 0.2 and 0.8; All of these are merely convenient example values. The

Air pressure pulses cause a periodic expansion and contraction of the pump hollow fibers and in combination with a timely controlled opening and closing of the blood circulation and drainage 5a, 5b via the there arranged valves 7a, 7b, a conveying blood through the third part-chamber 35.3 ', associated with the desired oxygenation over the in the

Exchanger hollow fibers 31, which are lapped by the blood, present oxygen.

The embodiment of the invention is not limited to the examples and highlighted aspects described herein, but also in a variety of ways

Modifications possible, which are within the scope of professional action.

Claims

claims

1. exchanger device for effecting a substance and / or

Energy exchange between a first and second medium, with a first inlet and outlet of the first medium having and can be flowed through by the first medium chamber in which at least one mass and / or energy-permeable exchanger hollow fiber, preferably a variety of fabric and / or energy-permeable exchanger hollow fibers, is arranged, which is connected at one end to a second inlet and at the other end to a second outlet of the second medium and can be flowed through by the second medium and can flow around the first medium / are, in the Chamber is arranged at least one pumping element, by means of which the first medium is pulsed out of the chamber displaceable and sucked into the chamber and having an elastically deformable element and connected to a third inlet serving as a drive medium third medium and expandable from the third medium ,

2. exchanger device according to claim 1, wherein in the chamber a plurality of elastically deformable pump hollow fibers are arranged as pumping elements and connected to the third inlet.

3. exchanger device according to claim 1 or 2, with an oxygen storage connected to the second inlet as a source of the second medium and connected to the third inlet, arranged for pulsation operation air pump as a source of the third medium.

4. exchanger device according to one of the preceding claims, wherein the chamber on the one hand, the third inlet and on the other hand, the entrance of the pump hollow fiber or the inputs of the pump hollow fibers adjacent first part chamber, a second inlet adjacent the second part chamber and having a first inlet and outlet adjacent and the exchanger hollow fiber or exchanger hollow fibers receiving third part chamber.

5. exchanger device according to claim 3 or 4, wherein the remote from the third inlet ends of the pump hollow fibers are closed.

6. exchanger device according to claim 1 or 2, with an oxygen storage connected to the second inlet as a source of the second medium and connected to the third inlet, set up for pulsation operation and connected to a liquid reservoir

Liquid pump as a source of the third medium.

7. exchanger apparatus according to claim 6, wherein the chamber has a third sequence, the pump hollow fibers open on both sides and in a

Liquid circuit of the third medium are integrated, the one

Heat source for heating the third medium is assigned.

8. exchanger device according to claim 6 or 7, wherein in

Liquid reservoir and optional fluid circuit saline solution is included.

9. exchanger device according to one of claims 6 to 8, wherein the chamber on the one hand, the third inlet and on the other hand the entrance of the pump hollow fiber or the inputs of the pump hollow fibers adjacent first part-chamber, a second inlet adjacent second part Chamber, a the first inlet and outlet adjacent and the exchanger hollow fiber or exchanger hollow fibers receiving third part chamber and on the one hand the output of the pump hollow fiber or the outputs of the pump hollow fibers and on the other hand, the third sequence adjacent fourth part chamber having.

10. exchanger device according to one of the preceding claims, wherein the first inlet and outlet for the first medium are each provided with a controllable valve for the timed interruption of the inflow or outflow of the second medium.

11. exchanger device according to claim 10, wherein the controllable valves are designed as hose clamp valves.

12. exchanger apparatus according to claim 10 or 11, with a pump and valve control unit for synchronized control of the pump for the third medium and the valves at the first inlet and outlet for effecting a conveying of the first medium through the chamber from the inlet to the outlet is formed.

13. exchanger device according to one of the preceding claims, with a flow sensor at the first inlet and / or outlet, which is in particular connected to a sensor signal input of the pump and valve control and / or the heat source in the circulation of the third medium.

14. exchanger device according to one of the preceding claims, with a bubble detector at the first outlet, in particular with a

Sensor signal input of the pump and valve control unit is connected.

15. exchanger device according to one of the preceding claims, with a cylindrical or prismatic housing, wherein the first and second inlet in a peripheral wall and the third inlet are arranged in an end face and the or each exchanger hollow fiber substantially perpendicular to the cylinder axis or longitudinal extent of the prism and this or that

Pumping element substantially parallel to the cylinder axis or

Longitudinal extension of the prism are aligned.

16. exchanger apparatus according to claim 15, wherein the first sequence in the

Peripheral wall of the housing, in particular with respect to the first inlet, and the second outlet in the connection for the third medium

opposite end face or near this, offset from the first inlet and the first outlet, is arranged in the peripheral wall.

17. exchanger device according to one of the preceding claims,

designed as, in particular at least partially implantable, blood oxygenator.

18. exchanger device according to one of claims 1 to 15, designed as, in particular at least partially implantable, dialysis machine.