WO2003017831A1 - Procede et dispositif pour determiner a long terme la concentration d'au moins une substance d'un liquide corporel - Google Patents

Procede et dispositif pour determiner a long terme la concentration d'au moins une substance d'un liquide corporel Download PDF

Info

Publication number
WO2003017831A1
WO2003017831A1 PCT/EP2002/008116 EP0208116W WO03017831A1 WO 2003017831 A1 WO2003017831 A1 WO 2003017831A1 EP 0208116 W EP0208116 W EP 0208116W WO 03017831 A1 WO03017831 A1 WO 03017831A1
Authority
WO
WIPO (PCT)
Prior art keywords
hollow fiber
buffer solution
liquid mixture
body fluid
pump
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/EP2002/008116
Other languages
German (de)
English (en)
Inventor
Horst Frankenberger
Wolfgang Kerner
Heike Hufnagel
Martin Krahwinkel
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of WO2003017831A1 publication Critical patent/WO2003017831A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848—Needles
    • A61B5/6849—Needles in combination with a needle set
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14525—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using microdialysis
    • A61B5/14528—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using microdialysis invasively
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement

Definitions

  • the invention relates to a method according to the preamble of claim 1 or claim 4 and a device according to the preamble of claim 8 or claim 12.
  • the body fluid comes into diffusion contact with the buffer solution to form a liquid mixture (dialysate) within the outer lumen, the dialysate either after an incubation period (pulsatile operation) or continuously (continuously Licher operation) is transported by means of a displacement to a measuring device (sensor) arranged outside the body, which enables the concentration of at least one substance in the body fluid to be determined.
  • a measuring device sensor arranged outside the body, which enables the concentration of at least one substance in the body fluid to be determined.
  • a long-term determination of the content of different substances in the body can be useful in many different ways, such as the quasi-continuous measurement of glucose concentrations when setting up diabetes for insulin therapy or the examination of the half-life of medication in a patient's body.
  • the methods and devices known from the prior art do not always provide satisfactorily meaningful measurement results.
  • the known devices are structurally relatively complicated, the resulting comfort of the known devices is not satisfactory for the patient.
  • a method is proposed with the features of claim 1, which is characterized in that the body fluid and additionally contact the buffer solution in the region of an open end of the hollow fiber facing the body.
  • the open end of the hollow fiber provides an additional diffusion area in the tissue of the body, in which the buffer solution supplied is more rapidly enriched with a substance of the body fluid, with the formation of a liquid mixture.
  • the diffusion of the substance into the buffer solution which is faster in relation to a semipermeable material of a membrane, is due to the fact that the body fluid in the region of the open end of the hollow fiber comes into direct contact with the buffer solution located therein, i.e.
  • Molecules are recorded as the diameter of the membrane pores. This enables an analysis of additional substances that would not be possible in a closed system.
  • the body fluid and the buffer solution advantageously come into direct operative contact with one another within the open end or outside the same or at the open end.
  • An active contact outside the open end can take place, for example, on an outer buffer solution drop which is formed and adheres to the hollow fiber at the end. This ensures a rapid formation of a liquid mixture that can be evaluated reliably, regardless of the respective degree of filling of the region of the open end of the hollow fiber with buffer solution.
  • the hollow fiber is preferably filled with an amount of buffer solution which is at least as large as the volume of the interior enclosed by the hollow fiber wall.
  • a method is proposed with the features of claim 4, which is characterized in that the buffer solution and the liquid mixture are at least partially passed through at least one common section of the line system.
  • the line system can be made shorter, with a correspondingly smaller liquid volume, in particular between the preferably single-lumen hollow fiber and the measuring device, has to be moved.
  • the determination method can thus be carried out using a smaller total volume of buffer solution.
  • a lower operating pressure is thereby also sufficient for filling the hollow fiber with buffer solution or for removing the liquid mixture therefrom.
  • the preferably single-lumen hollow fiber itself can additionally or exclusively be understood as a common section of the line system.
  • the system according to the invention is particularly advantageous if, for example, a calibration or a rinsing of a measuring sensor is to be carried out, since the calibration or rinsing solution receives no contact with a dialysate section and thus no patient contact.
  • the buffer solution and the liquid mixture are passed through the common section at separate times. In this way, a precise and trouble-free determination of the concentration of a substance in a body fluid is possible, since the buffer solution is only conveyed into an interior of the hollow fiber that is free of liquid mixtures.
  • the measuring device is advantageously rinsed with a buffer solution which has not been brought into contact with the patient.
  • This enables a so-called “single-point calibration" of the measuring device (sensor) to be carried out before or during a respective measurement (“in-vivo calibration”).
  • This enables a measurement of a respective liquid mixture sample under defined measurement conditions by means of the extracorporeal measuring device (sensor).
  • An undesired “offset drift” is reliably prevented, so that even in the case of long-term measurements, no correction calculations with respect to the measured values obtained have to be carried out.
  • the buffer solution As part of an "in vivo calibration", it is possible to enrich the buffer solution with a defined concentration of measurement solution and to move it within the line system in such a way that it comes into direct active contact with the measuring device (sensor), the buffer solution advantageously has not previously come into diffusion contact with the patient's body fluid. Furthermore, the measuring system can be started before
  • in vivo measurement can be calibrated using an “in vitro measurement program” ("pre-in vitro calibration”).
  • pre-in vitro calibration A success check is carried out in such a way that after the "in vitro calibration” has been completed, a clear decision can be made as to whether the sensor is working correctly. If this is the case, the actual "in vivo measurement” with implantation of the dialysis fiber takes place. From this point in time, the arrangement enables recalibration of the measuring system.
  • the concentration of the substance is preferably determined by the measuring device at measuring intervals and will be located in the hollow fiber. Ending liquid mixture between the measuring intervals and at different times to fill the hollow fiber with buffer solution transported from the hollow fiber to the measuring device. This is a discontinuous determination of the concentration of the substance, and the measurement intervals may also be of different sizes.
  • Such a variably predeterminable measurement sequence can be controlled, for example, by means of a suitable control device in such a way that the method can be carried out automatically.
  • a device with the features of claim 8 is also proposed, which is characterized in that one end of the hollow fiber facing the buffer is designed as an open end, so that additional mixing of the buffer solution and the body fluid in the region of the open end is formed the hollow fiber can be done.
  • the hollow fiber has a mechanical stabilizing element at its open end, in particular made of non-elastic material. Such stiffening of the open end of the hollow fiber serves to prevent undesired premature collapse of the hollow fiber.
  • An end region of the hollow fiber facing the body is advantageously located in a puncture needle.
  • the puncture needle on its side preferably have openings.
  • the injection needle also serves to stabilize the open end of the hollow fiber, and at the same time, due to the suitably large openings on the side surfaces of the injection needle and its preferably open end, rapid diffusion of at least one substance of a body fluid into the buffer solution in the hollow phase, in particular is guaranteed in the area of the open end of the hollow fiber.
  • the hollow fiber is preferably spaced from the wall of the injection needle in the region of the open end.
  • the puncture needle can serve in the other areas of the hollow fiber to mechanically stabilize the same and also provide protection for the same during the pumping and suction phases.
  • a device with the features of claim 12 is proposed to achieve the object, which is characterized in that the line system has at least partially a common section.
  • the advantages mentioned in relation to the corresponding method can be achieved.
  • such a device allows lower operating pressures to be set when using the device with respect to double-lumen dialysis catheter designs of the prior art.
  • This enables the use of very small pumps, such as piezo pumps, so that the device can be miniaturized.
  • the comfort of the device for the patient can advantageously be improved considerably.
  • the hollow fiber is preferably connected at its end facing away from the body to part of the common section of the line system.
  • the hollow fiber itself can also be regarded as a common section, so that it makes sense to arrange this further part of the common section of the line system directly after the hollow fiber. Alternatively, however, it is also conceivable to consider the hollow fiber as the sole common section.
  • the common section comprises the entire line system and the pump device contains a single pump.
  • a single pump has, in particular, a buffer solution storage container and a liquid mixture storage container.
  • the measuring device is located outside the body between the hollow fiber and the pump device.
  • the measuring device is in particular a sterilizable, extracorporeal sensor.
  • a single-point calibration of the measuring device (sensor) can also be carried out in this embodiment.
  • a bacterial filter can optionally be additionally arranged between the measuring device and the hollow fiber. This reliably prevents non-sterile substances from entering the patient through the line system.
  • the part of the common section of the conduit system which is connected to the end of the hollow fiber remote from the body is connected to a connecting unit which has an essentially T-shaped penetration channel and in part separates the supply line from the discharge line.
  • a non-sterilizable measuring device sensor lying outside the patient is used.
  • the measuring device is arranged in the separate part of the lead line, so that only a liquid mixture with the same can come into active contact to carry out a measurement, but not fresh buffer solution that has not yet come into contact with the patient's body fluid. In contrast, fresh buffer solution can come into contact with the measuring device during a rinsing process.
  • the through-flow channel preferably contains a rectilinear through-flow section for conveying the liquid mixture to the measuring device and an angular through-flow section for conveying the buffer solution to the hollow phase, the through-flow sections containing a common partial section.
  • the common section of the flow channel is part of the common section of the line system.
  • the pump device advantageously has a buffer solution feed pump and a liquid mixture drain pump. This enables the supply line and the discharge line, with the exception of the common section of the line system, to be separated from one another and to be operatively connected to a separately assigned pump.
  • the pumps can be controlled by means of a suitable control device in such a way that automated operation of the device is possible.
  • the hollow fiber is preferably designed as a single-lumen dialysis fiber catheter.
  • Figure 1 is a schematic representation of an inventive device according to a first embodiment
  • Figure 2 is a schematic representation of a device according to the invention according to a second embodiment
  • Figure 3 is a schematic sectional view of a connecting unit of Figure 2 on an enlarged scale
  • FIG. 4 shows a schematic illustration of an end region of a hollow fiber of the device according to the invention in accordance with a possible embodiment in a side view and on an enlarged scale;
  • FIG. 5 shows a schematic top view of the end region of the hollow fiber of FIG. 4;
  • Figure 6 is a schematic side view of a puncture needle with a hollow fiber according to the invention on an enlarged scale
  • Figure 13 is a schematic representation of a detail of a device according to the invention on an enlarged scale according to another embodiment.
  • FIG. 1 shows a schematic representation of a device, generally designated 10, for long-term determination of the concentration of at least one substance in a body fluid of an organism (not shown).
  • the device 10 contains a hollow fiber 11 which can be inserted into a body and thereby comes into contact with at least one body fluid and into which a buffer solution is transportable.
  • the at least partially designed as a membrane hollow fiber wall 12 of the hollow fiber 11 allows mixing of the buffer solution and the body fluid in the hollow fiber 11 to form a liquid mixture.
  • a measuring device 13 of the device 10 arranged outside the body serves to determine the concentration of the substance in the liquid mixture formed in the hollow fiber 11 and thus in the body liquid.
  • the device 10 has a line system 18 containing the hollow fiber 11 with a feed line 23 for transporting the buffer solution from a pump unit 19 to the hollow fiber 11 and a discharge line 24 for transporting the liquid mixture formed in the hollow fiber 11 to the measuring device 13 and from there to the pump device 19.
  • the lead strand 23 is identical to the lead strand 24 and forms a common section 17, which also includes the hollow fiber 11.
  • the pump device 19, consisting of a single pump 25, is responsible both for the buffer solution supply line and for the liquid mixture discharge line (double arrow 36).
  • the pump 25 is preferably designed as a piston pump and can be actuated in a corresponding manner in accordance with the double arrow 35 by means of a control device 34.
  • the pump 25 has both a buffer solution storage container and a liquid mixture storage container (not shown).
  • the measuring device 13, through which the line system 18 leads, is operatively connected to a registration unit 41, which is also arranged outside the patient. Between the measuring device 13 and the hollow fiber 11, a bacterial filter 26 is arranged through which a part of the line system 18 leads.
  • the hollow fiber wall 12 designed as a membrane allows the buffer solution and the body fluid to be mixed in the hollow fiber 11 to form the liquid mixture.
  • the hollow fiber wall 12 thus serves as a diffusion path.
  • the end of the hollow fiber 11 facing the body of the patient (not shown) is advantageously designed as an open end 15, so that additional mixing of the buffer solution and the body fluid can take place in the region 14 of the open end 15 of the hollow fiber 11.
  • FIG. 2 shows an alternative embodiment of a device, also designated 10, for long-term determination of the concentration of at least one substance in a body fluid of an organism (not shown).
  • Corresponding functional units were provided with the same reference numerals with the embodiment according to FIG. 1.
  • the common section 17 of the supply line 23 and the discharge line 24 does not extend over the entire line system 18, but merely forms the line line from the hollow fiber 11 and up to a connection unit 28.
  • the connection unit 28 serves this purpose ,
  • the pump device 19 consists of a buffer solution feed pump 32, which is operatively connected to the feed line 23, and a liquid mixture drain pump 33, which is operatively connected to the drain line 24. Both pumps 32, 33 are operatively connected to a suitable control device 34 and in particular are designed as piston pumps.
  • the discharge pump 33 When the discharge pump 33 is actuated according to arrow 39 by means of the control device 34, the liquid mixture formed in the interior 16 of the hollow fiber 11 by means of diffusion is sucked out and thus the same is conveyed through the hollow fiber 11 into the common section 17 by the connecting unit 28 and through the separate part of the drain line 24 to the drain pump 33.
  • the feed pump 32 contains a buffer solution reservoir (not shown), while the drain pump 33 is provided with a liquid mixture reservoir (not shown).
  • FIG. 3 shows a schematic sectional illustration of the connecting unit 28 of FIG. 2 on an enlarged scale.
  • the connection unit 28 has an essentially T-shaped throughflow channel 27, which has a rectilinear throughflow section 29 for conveying the liquid mixture to the measuring device 13 (see also FIG. 2) and an angular flow section 30 for conveying the buffer solution to the hollow fiber 11.
  • the flow sections 29,. 30 a common subsection 31.
  • the connection unit 28 installed in the device 10 is also located outside the patient and ensures a connection between the common section 17 and the separate supply line 23 or the separate lead line 24 and a direct connection between the separate part of the supply line 23 and the lead line 24
  • the connecting unit 28 is preferably made of plexiglass, since this material is transparent and can be processed relatively easily in terms of production technology.
  • the separate part of the supply line 23 and the discharge line 24 and the common section 17 of the line system 18 can be fastened to the connecting unit 28 by means of an optionally non-destructive adhesive connection. Since the measuring device 13 (sensor) is positioned in the immediate vicinity of the liquid mixture outlet of the connection unit 28, a relatively small liquid volume in the line system 18 is advantageously shifted in order to carry out a new measuring cycle.
  • the device 10 can thus be operated with a very small amount of buffer solution. Furthermore, with a relatively close arrangement of the measuring device 13 to the hollow fiber 11, an increase in the meaningfulness of the individual measured values is achieved, since during the transport phase (displacement phase) Mixing processes with pure buffer solution hardly occur.
  • connection unit 28 as a direct connection between the separate part of the supply line 23 and the discharge line 24, allows the extracorporeal measuring device 13 to be rinsed with fresh buffer solution at any time, which has not yet been in contact with the patient, but directly from the buffer solution line pump 32 through the Separate part of the feed line 23 to the connection unit 28 and from this through the separate part of the discharge line 24 to the measuring device 13 and from there to the liquid mixture discharge pump 33 is transported.
  • Such rinsing of the measuring device 13 can be used, for example, to calibrate the same one point and prevents a so-called “offset drift” of the measured values.
  • a non-sterilizable measuring device 13 can be used, which, thanks to the connection unit 28, can be rinsed with fresh buffer solution.
  • the embodiment according to FIG. 2 enables “online calibration” of the device 10, so that on the one hand a so-called “in vitro calibration” of the hollow fiber 11 and on the other hand a so-called “in vivo calibration” of the same is carried out during a measurement can be.
  • Such an “online calibration” can be carried out, for example, with solutions of a preselectable concentration, for example 5 mmol / l of a glucose solution.
  • this embodiment allows to at any time during a measurement "Add buffer additives, such as heparin or surface-active biocompatible substances.
  • the functioning of the device 10 according to FIGS. 1 or 2 is as follows:
  • the interior 16 of the hollow fiber 11 is filled with a buffer solution by means of the pump device 19 (pump 25 or feed pump 32).
  • the pump device 19 remains out of operation and diffusion processes take place between the buffer solution located in the hollow fiber 11 and the body fluid surrounding the hollow fiber wall 12 and the open end 15 of the hollow fiber 11.
  • the diffusion processes thus take place through the pores of the hollow fiber wall 12 in the form of a membrane and also in the area 14 of the open end 15 of the hollow fiber 11 (direct contact between the buffer solution and body fluid or extracellular fluid).
  • the buffer solution located in the interior 16 of the hollow fiber 11 is enriched with at least one substance of the body fluid to form a liquid mixture.
  • the pump device 19 (pump 25 or drainage pump 33) is then activated by means of the control device 34 such that the liquid mixture located in the interior 16 of the hollow fiber 11 through the drainage line 24 and in particular through the measuring device 13 (arranged extracorporeally) up to a liquid mixture storage container is transported.
  • the hollow fiber 11 can have a mechanical stabilizing element 20 at its open end 15, in particular made of non-elastic material. This prevents an undesired premature collapse of the hollow fiber 11 in the region 14 of the open end 15.
  • an end region facing the body of a patient not shown
  • the injection needle 22 which is also open at the end, has a plurality of openings 42 on its side surfaces spaced apart from the hollow fiber 11, so that a diffusion process described above between a buffer solution and a body fluid can also take place with an injection needle 22 with a hollow fiber 11.
  • the hollow fiber 11 is in particular a single-lumen dialysis fiber catheter.
  • FIG. 7 shows an alternative exemplary embodiment of the schematically illustrated device 10 in relation to FIG. 1.
  • a control valve 45 is provided in the line system 18, which is interposed with respect to the pump device 19 and the measuring device 13.
  • a collecting container 46 is operatively connected to the control valve 45 by means of a portion of the discharge line 24.
  • the pump device 19 and the control valve 45 are controlled by means of the control device 34.
  • the position of the pump device 19 is shown by arrow 43, while arrow 44 indicates the suction operating position of the pump device 19.
  • the measurement sequence by means of the device 10 of FIG. 7 can be carried out as follows:
  • the hollow fiber 11 dialysis fiber
  • the hollow fiber 11 is completely filled with a liquid by means of the pump device 19 in the pump operating position (filling phase).
  • a subsequent suction phase is initiated by means of the control device 34, that is to say the liquid is displaced from the hollow fiber 11 into the measuring device 13.
  • the pump device 19 is again in the rest position.
  • a new suction phase is then initiated, during which the liquid is sucked through the control valve 45 by means of the pump device 19 into the feed line 23 without mixing with the liquid stored in the pump device 19.
  • the control valve 45 is now switched by means of the control device 34, so that the liquid located in the supply line 23 can be pumped in excess into the collecting container 46 (waste container) by means of the pump device 19 during a shift phase.
  • FIG. 8 shows a further, alternative embodiment of the device, generally designated 10.
  • a further control valve 47 is additionally provided in the line system 18.
  • the control valve 47 is interposed with respect to the pump device 19 and the control valve 45 and at the same time is operatively connected to a reservoir 48.
  • the control valve 47 is adjustable or switchable by means of the control device 34.
  • the reservoir 48 contains the amount of liquid required for an entire "in vivo measurement insert”.
  • the collecting container 46 is designed in such a way that it is suitable for holding the entire amount of liquid required.
  • the pump device 19 contains
  • the collecting container 46 and the storage container 48 can advantageously be of variable design, for example in the form of a compressible bag, so that miniaturization of the device is possible.
  • the following measurement sequence can be carried out by means of the device 10 in FIG. 8: First, the control valve 47 is switched by means of the control device 34 in such a way that liquid from the pre- Storage container 48 can be sucked into the pump device 19 (partial quantity supply) (suction phase). The control valve 47 is then switched to a further operating position in which the hollow fiber 11 (dialysis fiber) can be completely filled with liquid by means of the pump device 19 (filling phase). After an incubation period, the liquid in the hollow fiber 11 is sucked in by means of the pump device 19 until the dialysate is displaced into the measuring device 13 (suction phase).
  • FIG. 9 shows a further, alternative embodiment of the device 10 with reference to the exemplary embodiment in FIG. 2.
  • the device 10 in FIG. 9 contains two pump devices 19 which can be actuated according to the double arrows 50, 51 by means of the control device 34, the upper one in FIG Pump device 19 serves simultaneously as a partial collection container and the lower pump device 19 simultaneously serves as a partial quantity storage container.
  • the functioning of the device 10 is such that the control valve 47 is switched by means of the control device 34 in such a way that liquid is sucked out of the storage container 49 into the lower pump device 19 (partial quantity storage container). The control valve 47 is then switched over in such a way that the lower pump device 19 is separated from the reservoir 49 and a free flow to the connection unit 28 is ensured.
  • control valve 45 is switched in such a way that the upper pump unit 19 (partial collection container) can be emptied by pumping the liquid from the same pump device 19 into the collecting container 46. Thereafter, the control valve 45 is switched into an operating position separating the collecting container 46 from the upper pump device 19 and connecting the latter to the measuring device 13. The switching of the control valves 45 and 47 and the actuation of the upper and lower pumping devices 19 can optionally also take place simultaneously. During the subsequent filling phase, the lower pump device 19 (partial quantity storage container) releases so much liquid that the hollow fiber 11 (dialysis fiber) is completely filled.
  • the liquid is sucked out of the hollow fiber 11 by means of the upper pump device 19, so that the dialysate is displaced into the measuring device 13.
  • the measuring device 13 liquid is sucked in by means of the upper pumping device 19 (partial collection container), the lower pumping device 19 (partial quantity storage container) allowing part of the line system 18 to be flushed with liquid.
  • the volumes of the partial quantity containers (pump devices 19) are preferably assumed to be of equal size, which ensure either a one-off measurement or a plurality of measuring cycles before a new supply quantity is sucked in and the partial quantity accumulated is released to the collecting container 46.
  • several measurements can be carried out in succession with a single filling of the partial quantity storage container (lower pump device 19). After a first individual measurement has been completed, the upper pump device 19 can be emptied
  • FIG. 10 shows a further, alternative embodiment of the device 10, a roller pump 54 with two separate liquid circuits being used.
  • two control valves 52, 53 as well as a collecting container 46 and a storage container 48 are provided.
  • the operation of the device 10 is such that the control valve 53 is opened and the control valve 52 is closed by means of the control device 34, so that after the roller pump 54 has been actuated, the control valve 53 direction 34, the hollow fiber 11 (dialysis fiber) can be completely filled with liquid.
  • the roller pump 54 is in the rest position (motor switched off).
  • the control valves 52, 53 are switched in the direction of an equalization line section 55 in order to achieve pressure equalization.
  • the control valve 52 is opened while the control valve 53 is closed.
  • the suction phase is initiated by switching on the motor and thus the roller pump 54.
  • a measuring phase follows during which the roller pump 54 is switched off and the control valves 52, 53 are activated again in the direction of the compensation line section 55 for pressure compensation. Subsequently, both control valves 52, 53 are opened and the roller pump 54 is activated, initiating a liquid collection phase. Finally, for the subsequent pressure compensation, the roller pump 54 is switched off, the control valves 52, 53 being activated again in the direction of the compensation line section 55.
  • FIG. 11 shows a further, alternative exemplary embodiment of the device 10, three pump devices 56, 58, 60 and three control valves 57, 59, 61 being used here.
  • the measuring sequence by means of the device 10 takes place in such a way that the control valve 61 is opened to fill the hollow fiber 11 with liquid and the pump device 60 is actuated by means of the control device 34 according to arrow 64.
  • all control valves 57, 59 and 61 are closed.
  • control valve 57 is opened and the pump device 56 is actuated according to the arrow 62 by means of the control device 34, so that the dialysate is sucked out of the hollow fiber 11 into an intermediate manifold section 75 of the line system 18.
  • All control valves 57, 59, 61 are opened to initiate a pumping, suction and measuring phase.
  • the pump device 60 is actuated according to arrow 64 (flushing supply).
  • the pump device 58 is activated in accordance with arrow 63 (pump reagent supply, mixing with dialysate) and the pump device 56 in accordance with arrow 62 (suction pump collecting container).
  • the liquid delivery rate is equal to the sum of the amount of rinsing liquid and reagent liquid.
  • FIG. 12 shows a further, alternative embodiment of the device 10 with two pump devices 65, 67 and a reagent reservoir 66. Furthermore, two control valves 68, 69 are provided.
  • the measuring sequence by means of the device 10 is such that the control valve 69 (directional valve) is switched to the “fill” position (arrow 73), so that a free supply of liquid from the pump device 67 into the hollow fiber 11 (dialysis fiber) is possible.
  • pump device 67 is actuated according to arrow 71 by means of control device 34.
  • all pump devices 65, 67 are out of operation.
  • the control valve 69 (directional valve) is then switched to the “suction” position (arrow 74) and the pump device 65 is activated according to arrow 70.
  • the control valve 68 is opened so that access to the reagent reservoir 66 is created, and the control valve 69 (directional valve) is switched to the “flushing” position (arrow 72) so that the pumping device 67 (flushing supply) are in direct connection with the pump device 65 (collecting container).
  • the pump devices 65 and 67 are then activated in accordance with arrows 70 and 71, respectively.
  • FIG. 13 shows a schematic illustration of a possible detail of the device 10 on an enlarged scale.
  • the hollow fiber 11 received in the puncture needle 22 is shown using stabilizing elements 20, the lead 24 of the line system 18 connecting the hollow fiber 11 to the measuring device 13.
  • the measuring device 13 has a sensor housing 76 which contains a flat underside which adheres to an adhesive plaster 78.
  • the adhesive plaster 78 is used to fasten the sensor housing 76 to the patient's skin surface.
  • the sensor housing 76 is designed such that it forms a mechanical holding possibility as a puncture aid for the implantation of the integrated hollow fiber 11 (dialysis fiber) and injection needle 22.
  • a holding device 77 which can be removed if necessary after implantation of the hollow fiber 11 and the injection needle 22.
  • connection unit 28 (not shown in FIG. 13) in such a way that the same the recording of a measurement sensor system or a corresponding fluid system also takes over.
  • the discharge line 24 can be reduced in such a way that it takes on the task of an exchange surface for the sensor elements (flow cell, location of contact between the measuring liquid and sensor system).

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Medical Informatics (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Optics & Photonics (AREA)
  • Emergency Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne un dispositif (10) qui comprend une fibre creuse (11) en contact actif avec au moins un liquide corporel dans un corps, cette fibre pouvant être remplie d'une solution tampon et permettant le mélange de la solution tampon avec le liquide corporel pour former un mélange liquide. Un dispositif de mesure (13) placé notamment à l'extérieur du corps sert à déterminer la concentration d'une substance du mélange liquide formé dans la fibre creuse (11). Un système de conduits (18) associé à la fibre creuse (11) comporte une ligne d'alimentation (23) pour transporter la solution tampon vers la fibre creuse (11) et une ligne d'évacuation (24) pour transporter le mélange liquide formé dans la fibre creuse (11) au moins jusqu'au dispositif de mesure (13). Ledit dispositif (10) comporte au moins un dispositif de pompage (19) pour transporter la solution tampon du mélange liquide à travers le système de conduits (18). Selon l'invention, la ligne d'alimentation (23) et la ligne d'évacuation (24) ont au moins en partie un tronçon (17) commun du système de conduits (18). En outre ou en alternative, une extrémité de la fibre creuse (11) tournée vers le corps peut être ouverte (15).
PCT/EP2002/008116 2001-08-25 2002-07-20 Procede et dispositif pour determiner a long terme la concentration d'au moins une substance d'un liquide corporel Ceased WO2003017831A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE2001141732 DE10141732A1 (de) 2001-08-25 2001-08-25 Verfahren und Vorrichtung zur Langzeitbestimmung der Konzentration mindestens einer Substanz in einer Körperflüssigkeit
DE10141732.2 2001-08-25

Publications (1)

Publication Number Publication Date
WO2003017831A1 true WO2003017831A1 (fr) 2003-03-06

Family

ID=7696623

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2002/008116 Ceased WO2003017831A1 (fr) 2001-08-25 2002-07-20 Procede et dispositif pour determiner a long terme la concentration d'au moins une substance d'un liquide corporel

Country Status (2)

Country Link
DE (1) DE10141732A1 (fr)
WO (1) WO2003017831A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114391097A (zh) * 2019-08-02 2022-04-22 恩德莱斯和豪斯集团服务股份公司 用于校准、验证和/或调整传感器的移动系统和用于校准、验证和/或调整传感器的方法

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006027586A1 (fr) * 2004-09-08 2006-03-16 Alertis Medical As Capteur

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0367752A1 (fr) * 1988-10-31 1990-05-09 AVL Medical Instruments AG Dispositif pour déterminer la concentration d'une ou plusieurs substances présentes dans le tissu vivant
DE4426694A1 (de) 1994-07-28 1996-02-08 Eppendorf Geraetebau Netheler Verfahren und Vorrichtung zur Langzeitbestimmung des Gehaltes von mindestens einer Substanz in Körperflüssigkeiten
WO2000022977A1 (fr) * 1998-10-19 2000-04-27 Meinhard Knoll Systeme de capteur a invasion minimale

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0367752A1 (fr) * 1988-10-31 1990-05-09 AVL Medical Instruments AG Dispositif pour déterminer la concentration d'une ou plusieurs substances présentes dans le tissu vivant
DE4426694A1 (de) 1994-07-28 1996-02-08 Eppendorf Geraetebau Netheler Verfahren und Vorrichtung zur Langzeitbestimmung des Gehaltes von mindestens einer Substanz in Körperflüssigkeiten
WO2000022977A1 (fr) * 1998-10-19 2000-04-27 Meinhard Knoll Systeme de capteur a invasion minimale

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
TRAJANOSKI Z ET AL: "Continuous ex vivo monitoring of glucose in blood and subcutaneous tissue fluid", ENGINEERING IN MEDICINE AND BIOLOGY SOCIETY, 1994. ENGINEERING ADVANCES: NEW OPPORTUNITIES FOR BIOMEDICAL ENGINEERS., PROCEEDINGS OF THE 16TH ANNUAL INTERNATIONAL CONFERENCE OF THE IEEE BALTIMORE, MD, USA 3-6 NOV. 1994, NEW YORK, NY, USA,IEEE, US, 3 November 1994 (1994-11-03), pages 814 - 815, XP010145654, ISBN: 0-7803-2050-6 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114391097A (zh) * 2019-08-02 2022-04-22 恩德莱斯和豪斯集团服务股份公司 用于校准、验证和/或调整传感器的移动系统和用于校准、验证和/或调整传感器的方法
CN114391097B (zh) * 2019-08-02 2024-06-11 恩德莱斯和豪斯集团服务股份公司 用于校准、验证和/或调整传感器的移动系统和用于校准、验证和/或调整传感器的方法
US12566152B2 (en) 2019-08-02 2026-03-03 Endress+Hauser Group Services Ag Mobile system for calibrating, verifying and/or adjusting a sensor and method for calibrating, verifying and/or adjusting a sensor

Also Published As

Publication number Publication date
DE10141732A1 (de) 2003-03-06

Similar Documents

Publication Publication Date Title
DE4422100C1 (de) Flexible medizinische Verpackungseinheit für die Hämodialyse zur Herstellung eines Dialysierflüssigkeit-Konzentrats sowie Vorrichtung hierfür
EP0300008B1 (fr) Dispositif pour determiner des parametres interessants dans des organismus vivants
EP0154002B1 (fr) Dispositif pour prise d'échantillons sanguins pour le diagnostic des fonctions du corps
DE3524824C2 (fr)
DE4001760C2 (fr)
DE3855267T2 (de) Gerät zum Ansaugen von Blut
DE60028818T2 (de) Gerät zum Verabreichen einer therapeutischen Substanz mit kontrollierter Dosierung bei endoluminalen Behandlungen
DE69921569T2 (de) Nadelhalterung für Arterienpunktion
DE2103187C3 (de) Medizinische Wegwerfvorrichtung zum Absaugen von Flüssigkeiten
DE2605004C3 (de) Vorrichtung zum Ansaugen von Blut eines Patienten und zur Behandlung des Blutes mit einem Antikoagulans
EP0367752B1 (fr) Dispositif pour déterminer la concentration d'une ou plusieurs substances présentes dans le tissu vivant
EP2240082B1 (fr) Dispositif de prélèvement de matière biologique
DE2105453C3 (de) Medizinische Mengendosiervorrichtung
DE2734247A1 (de) Vorrichtung zur fortlaufenden chemischen analyse im lebenden koerper
DE2605005A1 (de) Verfahren und vorrichtung zum dosierten zufuehren von antikoagulans
WO2009043555A1 (fr) Système de perfusion et de prélèvement d'un fluide corporel et son procédé de fonctionnement
DE4426387A1 (de) Pumpensystem zur echtzeitregelbaren Injektion von R¦ntgenkontrastmittel und Dilatation von Blutgefäßstenosen
DE19601214A1 (de) Vorrichtung zur Abnahme von Blut
EP0586740B1 (fr) Dispositif pour éviter le passage des bulles d'air
WO2001064104A1 (fr) Dispositif permettant d'extraire au moins une substance d'un liquide du corps
EP0973573B1 (fr) Catheter pour mesurer des parametres chimiques, a introduire notamment dans des tissus biologiques, liquides ou similaires
WO2003017831A1 (fr) Procede et dispositif pour determiner a long terme la concentration d'au moins une substance d'un liquide corporel
DE3405706A1 (de) Verfahren zur gewinnung von blutplasma und filtervorrichtung zur ausuebung dieses verfahrens
DE102004054496B4 (de) Drainagekammer zur Aufnahme von Körperfluiden, insbesondere von Liquor
DE3601730A1 (de) Verfahren und vorrichtung zur erkennung und regulierung von koerperfluessigkeitswerten

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): JP

Kind code of ref document: A1

Designated state(s): JP US

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR IE IT LU MC NL PT SE SK TR

Kind code of ref document: A1

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FR GB GR IE IT LU MC NL PT SE SK TR

121 Ep: the epo has been informed by wipo that ep was designated in this application
122 Ep: pct application non-entry in european phase
NENP Non-entry into the national phase

Ref country code: JP

WWW Wipo information: withdrawn in national office

Country of ref document: JP