INFUSION SYSTEM AND CATHETER FOR SUCH AN INFUSION SYSTEM

20230355868 · 2023-11-09

    Inventors

    Cpc classification

    International classification

    Abstract

    An infusion system and method for providing different medical fluids to a patient. The infusion system, which can be used in complex infusion therapies, includes a catheter with a catheter tube and at least one lumen extending longitudinally through the catheter tube between a proximal tube end and a distal tube end. A plurality of pump devices are each connected to the at least one lumen so as to convey fluid. A control device is connected to the pump devices and adapted to control the pump devices so that the different medical fluids can be delivered through the at least one lumen by the pump devices in time division multiplex. The catheter can include the pump devices. Each pump device can be configured as a micropump mounted at the proximal tube end.

    Claims

    1. An infusion system for providing different medical fluids to a patient, the infusion system comprising: a catheter comprising a catheter tube and at least one lumen that extends longitudinally through the catheter tube between a proximal tube end and a distal tube end; a plurality of pump devices, each of the plurality of pump devices being connected to the at least one lumen to convey fluid; and a control device connected to the plurality of pump devices, the control device being adapted to control the plurality of pump devices so that the different medical fluids are deliverable through the at least one lumen by the plurality of pump devices in time division multiplex, the catheter comprising the plurality of pump devices, and the plurality of pump devices comprising a plurality of micropumps, each micropump being mounted at the proximal tube end.

    2. The infusion system according to claim 1, wherein the plurality of micropumps are each adapted to deliver with a delivery rate of from 0.05 ml/min to 500 ml/min, and wherein the control device is adapted to control the delivery rate.

    3. The infusion system according to claim 2, wherein the control device is adapted to control the delivery rate as a function of a predetermined overall delivery rate

    4. The infusion system according to claim 1, wherein the plurality of micropumps are each adapted for intermittent delivery with a cycle time of between 1 s and 100 s, and wherein the control device is adapted to control the cycle time.

    5. The infusion system according to claim 4, wherein the control device is adapted to control the cycle time as a function of a predetermined overall delivery rate.

    6. The infusion system according to claim 1, wherein the different medical fluids comprise a first medical fluid, a second medical fluid and a third medical fluid, and wherein the plurality of micropumps comprise a first micropump for delivering the first medical fluid, a second micropump for delivering the second medical fluid and a third micropump for delivering the third medical fluid, the control device being adapted to control the first micropump, the second micropump and the third micropump so that first doses of the first medical fluid and second doses of the second medical fluid are deliverable through the at least one lumen in time division multiplex while being physically separated by the third medical fluid.

    7. The infusion system according to claim 6, wherein at least the first micropump is adapted to reverse a delivery direction, and the control device is adapted to control the first micropump so that a first dose of the first medical fluid, provided into the at least one lumen, is partially aspirated from the at least one lumen by a reversal of the delivery direction.

    8. The infusion system according to claim 1, wherein the at least one lumen comprises a first lumen having hydrophobic surface properties and a second lumen having lipophobic surface properties.

    9. The infusion system according to claim 1, wherein the catheter has a syringe adapter.

    10. The infusion system according to claim 1, wherein the catheter is adapted as a disposable product for single use, and the control device is adapted for multiple uses.

    11. A catheter for an infusion system, the catheter comprising the catheter according to claim 1.

    Description

    BRIEF DESCRIPTION OF THE DRAWING FIGURES

    [0015] Further advantages and features of the present disclosure may be found in the following description of preferred exemplary embodiments that are represented with the aid of the drawings.

    [0016] FIG. 1 shows a schematically simplified representation of an embodiment of an infusion system according to the present disclosure with an embodiment of a catheter according to the present disclosure and a control device.

    [0017] FIG. 2 shows a schematically simplified sectional representation of a single-lumen catheter tube of the catheter according to FIG. 1 during delivery of a plurality of medical fluids along a delivery direction.

    [0018] FIG. 3 shows a schematically simplified sectional representation of a dual-lumen catheter tube as a variant of the catheter tube according to FIG. 2.

    [0019] FIGS. 4A to 4D each show a schematically simplified sectional representation to illustrate successive steps of the functionality of the infusion system according to FIG. 1.

    DETAILED DESCRIPTION

    [0020] An infusion system 1 according to FIG. 1 is adapted to provide different medical fluids F1 to F5 to a patient. The infusion system 1 is represented in a schematically simplified way and has a catheter 2 and a control device 7. In the embodiment according to FIG. 1, the catheter 2 is configured as a single-lumen catheter and has a catheter tube 3 with a (single) lumen 4. The lumen 4 extends longitudinally through the catheter tube 3 between a proximal tube end 5 and a distal tube end 6.

    [0021] In alternative embodiments, the catheter is configured as a dual-lumen catheter, as may be seen in FIG. 3. As another alternative, the catheter may have more than two lumina. In the case of multi-lumen catheters, various incompatible infusions may also be provided simultaneously to the patient.

    [0022] The catheter 2 furthermore has a plurality of pump devices, which are each connected to the lumen 4 so as to convey fluid, as may be seen in FIG. 1. In the exemplary embodiment shown, the catheter 2 has five pump devices.

    [0023] The specific number of the pump devices is not essential for the underlying present disclosure. In one embodiment which is not represented in the drawings, the catheter 2 has two, three, four or more than five, more than 10 or even more than 20 pump devices.

    [0024] In the present case, the pump devices are each configured as a micropump P1 to P5 and are mounted at the proximal tube end 5. In the embodiments shown, the micropumps P1 to P5 are each mounted at the proximal tube end 5 in such a way that an outlet A1 to A5 of each micropump P1 to P5 debouches directly into the lumen 4, as may be seen in FIG. 1. In the present case, the micropumps P1, P2, P4 and P5 are arranged in a radial direction with respect to a tube wall 11 of the catheter tube 3, whereas the micropump P3 is arranged in an axial direction with respect to the tube wall 11 of the catheter tube 3 at the proximal tube end 5. In another embodiment, alternatively all the micropumps are arranged in a radial direction with respect to the tube wall of the catheter tube.

    [0025] In the exemplary embodiment shown according to FIG. 1, the catheter tube 3 has a distal catheter tip 10 at the distal tube end 6. In the present case, the distal catheter tip 10 is an integral part of the catheter tube 3, and to this extent is formed by the distal tube end 6 of the latter. In one embodiment which is not represented in the drawings, the distal catheter tip is configured in the form of a separate component and is assembled firmly with the distal tube end of the catheter tube. The one lumen 4 in the embodiment shown has a distal exit opening 12 in the region of the catheter tip 10, as may be seen in FIG. 1.

    [0026] The catheter tube 3 is in the present case manufactured in a manner known to a person skilled in the art from a flexible plastic material suitable for medical applications.

    [0027] The micropumps P1 to P5 are represented in a schematically very simplified manner in the figures. The micropumps P1 to P5 may for example be configured according to the design of a membrane pump or a roller pump, and may be mechanically and/or electrically driven and synchronized according to requirements and the specific application.

    [0028] The micropumps P1 to P5 have according to FIG. 1 supply lines Z1 to Z5 on the inlet side, which are connected in a manner known per se to infusion bags or the like (not represented in the figures) so as to convey fluid.

    [0029] The control device 7 is connected to the plurality of micropumps P1 to P5. In the embodiments shown, the control device 7 is connected wirelessly to the plurality of micropumps P1 to P5. In one embodiment which is not represented in the drawings, the control device 7 is connected to the plurality of micropumps P1 to P5 by wires. The control device 7 is adapted to control the plurality of micropumps P1 to P5 in such a way that the different medical fluids F1 to F5 can be delivered by means of the plurality of micropumps P1 to P5 in time division multiplex through the lumen 4 in a delivery direction FR, as may be seen in FIG. 2. In this case, the micropumps P1 to P5 are driven in such a way that predetermined doses, in particular microdoses, of the different medical fluids F1 to F5 are pumped into the catheter 2 at predetermined cycle times. In the embodiments shown, the control device 7 is adapted in such a way that the plurality of micropumps P1 to P5 can also be active simultaneously. In this way, it is possible that a plurality of medical fluids which are mutually compatible, and which may therefore be mixed, can be provided simultaneously even with a single-lumen catheter, as is represented by way of example in FIG. 2 with the medical fluids F4 and F5. In an embodiment with a dual-lumen catheter, different mutually incompatible infusions may thereby also be provided simultaneously to the patient in a respective lumen. In detail, FIG. 2 shows a schematically very simplified sectional representation of the single-lumen catheter tube 3 according to FIG. 1. Individual doses, in particular microdoses, of the plurality of medical fluids F1 to F5 are represented in the catheter tube 3 with a delivery direction FR. In the exemplary embodiment shown, the individual doses of the medical fluids F1 to F3 are delivered successively along the delivery direction FR, whereas the individual doses of the medical fluids F4 and F5 are delivered simultaneously, in particular mixed with one another.

    [0030] In the embodiments shown, the micropumps P1 to P5 are each adapted for delivery with a delivery rate of from 0.05 ml/min to 500 ml/min, preferably from 0.1 ml/min to 300 ml/min. In the present case, the control device 7 is adapted to control the delivery rates of each individual micropump P1 to P5. With this configuration of the present disclosure, the delivery rate of each micropump P1 to P5 can preferably be set by the control device 7, particularly according to the medicament.

    [0031] In the embodiments shown, the micropumps P1 to P5 are each adapted for intermittent delivery with a cycle time of between 1 s and 100 s, preferably between 5 s and s. In the present case, the control device 7 is adapted to control the cycle times. With this configuration of the present disclosure, the cycle time of each micropump P1 to P5 can preferably be set by the control device 7, particularly according to the medicament. In other embodiments, the delivery rate of the micropumps P1 to P5 is designed to be controllable, that is to say the delivery quantity of the micropumps P1 to P5 is dependent not only on the cycle length but also on the demand.

    [0032] In the embodiments shown, the control device 7 is adapted to control the delivery rates and/or the cycle times as a function of a predetermined overall delivery rate. In the present case, the overall delivery rate is made up of the delivery rates of the individual micropumps P1 to P5. The control device 7 preferably controls the delivery rate and/or the cycle time of each individual micropump P1 to P5 as a function of the predetermined overall delivery rate.

    [0033] In the embodiments shown, the micropumps P1 to P5 comprise a first micropump P1 for delivering a first medical fluid F1, a second micropump P2 for delivering a second medical fluid F2 and a third micropump P3 for delivering a third medical fluid F3. In the present case, the control device 7 is adapted to control the first, second and third micropumps P1, P2, P3 in such a way that first doses of the first medical fluid F1 and second doses of the second medical fluid F2 can successively be delivered through the at least one lumen 4 in time division multiplex while being physically separated by means of the third medical fluid F3, as may be seen particularly in FIG. 2. The third medical fluid F3 is preferably a separator fluid, for example a saline solution. In the exemplary embodiment shown according to FIG. 2, the separator fluid in the form of the third medical fluid F3 is pumped in between the first medical fluid F1 and the second medical fluid F2 and thereby physically separates them from one another. The third medical fluid F3 is in the present case compatible with the first medical fluid F1 and the second medical fluid F2.

    [0034] In the embodiments shown, at least the first micropump P1 is adapted to reverse its delivery direction FR1. In the present case, the control device 7 is adapted to control the first micropump P1 in such a way that a first dose of the first medical fluid F1, delivered into the at least one lumen 4, can be partially aspirated, i.e. sucked, from the at least one lumen 4 by means of a reversal of the delivery direction FR1, as is represented in FIG. 4A to 4D.

    [0035] FIG. 4A to 4D each show a schematically simplified sectional representation to illustrate successive steps of the functionality of the embodiment of the infusion system 1 according to FIG. 1. In the present case, the functionality is described by way of example with the aid of the micropumps P1 and P3. The micropumps P2, P4 and P5 are not represented separately in FIG. 4A to 4D. As already mentioned, the first micropump P1 is adapted to deliver the first medical fluid F1 and the third micropump P3 is adapted to deliver the third medical fluid F3, the third medical fluid F3 being a separator fluid in the present case. In the exemplary embodiment shown, the third micropump P3 is driven in such a way that continuous delivery of the third medical fluid F3 takes place into the lumen 4 in a delivery direction FR3. The first micropump P1 is in the present case time-controlled. In FIG. 4A, the first micropump P1 is deactivated so that it has a delivery rate of 0 ml/min. If the first micropump P1 is briefly activated, it delivers a dose of the first medical fluid F1 along its delivery direction FR1 into the lumen 4, as may be seen in FIG. 4B. In FIG. 4C, the first micropump P1 is again deactivated. The third medical fluid F3 functions as a carrier fluid and entrains at least a part of the delivered dose of the first medical fluid F1 along the delivery direction FR, as may be seen in FIG. 4D. In FIG. 4D, the first micropump P1 is driven in such a way that its delivery direction FR1 is reversed into an opposite delivery direction FR1′. A residual part of the dose of the first medical fluid F1, not yet delivered into the lumen 4, and preferably a small dose of the third medical fluid F3, that is to say in the present case the separator fluid, is thereby aspirated in the opposite delivery direction FR1′, a direction away from the lumen 4. In this way, further entrainment, in particular unintentional entrainment, of the first medical fluid F1 by the third medical fluid F3 or by a further medical fluid, delivered by means of one of the micropumps P2, P4, P5 not separately shown, can be avoided. Mixing of incompatible medical fluids is consequently counteracted particularly effectively.

    [0036] In the variant according to FIG. 3, the catheter tube 3′ has at least one further lumen 8, the lumen 4 having hydrophobic surface properties and the further lumen 8 having lipophobic surface properties, or vice versa. The surface properties of the lumen 4 are defined by the surface properties of an inner side 13, delimiting this lumen 4, of the tube wall 11 of the catheter tube 3′. Owing to the hydrophobic surface properties of the lumen 4, it has a low wettability for water-based fluids in the manner of the lotus effect, so that the flow behaviour and/or the delivery rate is promoted for water-based medical fluids because of a minimized drag on the inner side 13 of the tube wall 11. The surface properties of the further lumen 8 are defined by the surface properties of an inner side 14, delimiting this further lumen 8, of the tube wall 11 of the catheter tube 3′. Owing to the lipophobic surface properties of the further lumen 8, it has a low wettability for fat-based fluids in the manner of the lotus effect, so that the flow behaviour and/or the delivery rate is promoted for fat-based medical fluids because of a minimized drag on the inner side 14 of the tube wall 11. In the present case, residue-free delivery of medical fluids F1 to F5 is promoted in corresponding use by the different surface properties of the lumina 4, 8, so that unintentional mixing of the medical fluids F1 to F5 can in turn be prevented.

    [0037] In the embodiments shown, the catheter 2 has a syringe adapter 9, which is represented in a schematically simplified manner in FIG. 1 as a block. The syringe adapter 9 functions as a kind of fluid connector and is connected to the at least one lumen 4 so as to convey fluid. In different embodiments, the syringe adapter 9 may be configured differently, and may for example be a Luer connector, an NRFit connector, a non-Luer connector or the like. In this way, for example in emergencies, it is possible to supply a particular medical fluid rapidly and straightforwardly through the syringe adapter 9 to the catheter 2, and therefore to the patient. In the present case, the syringe adapter 9 is arranged at the proximal tube end 5. In other embodiments, the syringe adapter 9 may be arranged further in the direction of the distal tube end 6.

    [0038] In the embodiments shown, the catheter 2 is adapted as a disposable product for single use. The control device 7 is preferably adapted for multiple use.

    [0039] In the present case, the micropumps P1 to P5 are each mounted inseparably at the proximal tube end 5 of the catheter tube 3.