EP1211976A1 - Device for conducting in vivo measurements of quantities in living organisms - Google Patents

Device for conducting in vivo measurements of quantities in living organisms

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Publication number
EP1211976A1
EP1211976A1 EP20000960215 EP00960215A EP1211976A1 EP 1211976 A1 EP1211976 A1 EP 1211976A1 EP 20000960215 EP20000960215 EP 20000960215 EP 00960215 A EP00960215 A EP 00960215A EP 1211976 A1 EP1211976 A1 EP 1211976A1
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EP
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Prior art keywords
φ
sensor
tube
cn
rt
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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.)
Withdrawn
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EP20000960215
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German (de)
French (fr)
Inventor
Thomas Pieber
Lukas Schaupp
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Pieber Thomas
Schaupp Lukas
Original Assignee
Thomas Pieber
Lukas Schaupp
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement

Abstract

The invention relates to a device (10) for conducting in vivo measurements of quantities in living organisms. Said device comprises a catheter-like tube (11) which accommodates, in a removable manner, a needle (14) that is provided for inserting the tube into the organism. The device also comprises at least one opening (12) in the wall of the tube (11) and is equipped with a sensor (18) for detecting the quantity to be measured inside the tube. The sensor (18) is mounted on a separate elongated support (17) whose cross-section is smaller than that of the inside of the tube. The support can be inserted into the tube (11) after pulling the needle (14) out of the tube (11).

Description

Means for in vivo measurement of quantities in living organisms

The invention relates to a device for in vivo measurement of quantities in living organisms, with a catheter-like tube, which receives an intended for insertion of the tube into the organism insertion needle can be pulled out, having at least one opening in the wall of the pipe, and with a sensor for detection of the quantity to be measured within the pipe.

In many areas of medicine and in comparable fields, it is often necessary to repeatedly or continuously measure, especially to derailments homeostasis determine concentrations or compositions of body fluids and, if necessary to treat. For example, diabetes mellitus is a derailment of metabolism which is manifested by various symptoms, a therapy with insulin, which regulates blood glucose concentration is possible. Although this therapy significantly promotes the well-being of patients with insulin, late complications such as premature blindness, heart and kidney failure and neuropathy can usually not be avoided, but only delayed. One of the main reasons for the long-term consequences of this disease is not optimal adjustment of the insulin injections for blood glucose. In order to adjust the insulin injections to the needs of the body corresponding to the glucose concentration must therefore be repeated (or continuously), and be accurately measured.

To measure the glucose in the body a variety of methods have been proposed: blood glucose meters; not-in-invasive measurements; indirect determination of glucose over other body parameters; or measurement of glucose in blood from different body fluids such as in saliva, sweat or urine. Because of the difficulty in measuring these liquids attention was paid to the quantification of glucose in the tissue fluid in recent years strengthened, which has a close relationship with the plasma glucose. Problems that occur in the blood, such as blood clotting, infection risk or protein load are hereby greatly reduced, if they are not at all avoided.

Also for the continuous measurement of glucose in the tissue fluid different options have been proposed: 1. Minimally invasive sampling methods, such as the open micro kroperfusionstechnik, microdialysis or ultrafiltration technology;

2. Sensors, which are introduced directly into the tissue; or

3. techniques with which the tissue fluid is collected through the skin (so-called. Suction technique, inverse ion tophorese).

In addition to the open flow microperfusion and microdialysis have sensors which are inserted directly into the tissue to be particularly suitable for a continuous measurement system.

In the open flow microperfusion and microdialysis a perfusing a mounted tissue catheter is carried out with a rinsing liquid, which liquid is mixed with the open flow microperfusion over open perforations to the tissue, whereas exchange takes place across a membrane in the microdialysis. This membrane allows the one hand, that the exchange of molecules between the tissue and rinsing fluid can be selectively controlled, on the other hand this property by deposition of endogenous substances (mostly proteins, but also cells) is changed. This deposition is accompanied by a change in the transport properties of the molecules across the membrane, which is reflected in a reduced concentration of the molecules in the rinsing liquid. By macroscopic perforations in the open microperfusion this disadvantage can be avoided.

The equilibration between tissue fluid and rinsing fluid is a function of the exchange surface and the flow velocity of the washing liquid. At infinity, low-flow full equilibration between the two fluids takes place. Due to the slow flow rate, two major drawbacks incurred by the measurement of substances in the rinsing liquid: 1. the amount of liquid recovered per unit time is very low; and 2. the delay due to the length of hose (system delay) is correspondingly large.

For this reason, a higher Fließgeschwindig- is often chosen ness, more liquid to have faster. The disadvantage of this mode is to incomplete mixing of the two fluids, which - if possible - must be balanced by measurements of other parameters, providing additional requirements arising on measurement technology, which proves to be difficult, especially for online measurements.

In addition to the sampling techniques that enable ex vivo measurement (sensor outside the body), there are already proposed for in vivo measurements, wherein the sensor is introduced directly into the tissue. In addition to the increased requirements of the sensor with respect to biocompatibility, mechanical stability and size of the problem of calibration of the sensor must be considered. Although the sensors have very good in vitro characteristics, are observed in vivo change of parameters of the sensors. To accommodate these changes, there are different approaches: a commonly used approach is to calibrate the sensor value against one or more blood tests: going to imply that - in the case of glucose monitoring, for example - the glucose concentration in the tissue fluid is equal to the blood , In order to make this statement, the glucose concentration between blood and Gewebsflüs- must reside ing into an equilibrium state, since there is a time shift between these two compartments. In addition to the painful burden of the person concerned, the Wegkalibrieren of changes (such as inflammation in the tissue encapsulation of the sensor) is a significant disadvantage of this measurement.

To avoid the disadvantages of the sampling techniques (time lag, incomplete equilibration, intervening membrane) and the implanted sensor (not Calibration possibility, mechanical stability), a sensor (eg, a glucose, lactate or glutamate sensor) in a specially shaped catheter or generally be mounted tube or hose and introduced with the aid of the tissue, see FIG. for example, US 5,299,571 A or US 5,568,806 A. The catheter has a macroscopic opening, so that there can be an exchange between tissue fluid and the sensor. After the introduction of the catheter by using an existing in a lumen insertion needle into the corresponding tissue, these insertion needle is removed from the catheter. The insertion needle or the associated lumen occupies a large part of the cross section of the catheter, and in a second lumen adjacent said insertion needle receiving lumen, the sensor is fixedly arranged, the said opening in the catheter tube is adjacent. From this sensor corresponding lines to the outside lead to allow a connection to a measurement electronics. The catheter tube is relatively expensive because of the two special lumen in the production, wherein, moreover, is a relatively large cross-section, namely the insertion needle receiving lumen, not usable for carrying out the measurement and to be regarded as lost volume.

There have been proposed other types of catheter systems, see. US 5,779,665 A, US 5,586,553 A or US 5,390,671 A, wherein there is present the insertion needle outside of the catheter tube, approximately parallel thereto (US 5,779,665 A) or with inclusion of the catheter tube. This brings disadvantages when setting of the catheter itself, such as an unreliable entrainment of the catheter tube over a filament (US 5779665 A), and pain during penetration of the relatively thick of unit insertion needle together with the catheter tube. In these known arrangements is the sensor for the remaining catheter tube, having been also proposed, see FIG. US 5,390,671 A, slidably mounting the sensor on a stiff, strip-fenförmigen, cranked carrier in the catheter tube.

In the latter embodiments, a set cutlery is provided or required to place the catheter with the sensor, which entails an additional burden.

The object of the invention is now to provide a measuring device to provide as stated in the introduction, which makes it possible to work when setting the catheter-like protective tube with the smallest cross-sections, so that the setting of the catheter or catheter-like tube can be performed easily and substantially without pain, wherein, moreover, no Put cutlery necessary and trained personnel are not required, but rather a self-application is possible.

The inventive device of the initially defined kind is characterized in that the sensor on a separate elongated support, as known per se, is mounted, the cross-sectional dimensions are smaller than those of the tube interior, and after withdrawal of the insertion needle from the tube in this tube can be inserted.

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Of particular advantage, it is also when the separate sensor carrier is of tubular design. Namely, when the support of the sensor constructed in the form of a tube (and the sensor on the outside of the tube positioned), it can be additionally incorporated in an advantageous manner, a substance, in particular a drug, for example insulin, through the inner lumen of the carrier tube, if this substance should not come directly into contact with the sensor.

For increased inflow of this substance (s), it is also advantageous if the tubular sensor carrier adjacent its open distal end having at least one opening in its wall.

In order to reliably prevent a back flow of the substance in the space between the sensor carrier and the catheter tube, and thus a direct contact of the substance with the sensor, it is furthermore suitable if at a location between the open distal end or, if the opening in the wall of the tubular sensor carrier on the one hand and the sensor a sealing against the inner wall of the catheter-like tube ring seal is located on the other hand on the tubular support. Thus, when a gasket is mounted between the carrier top and the sensor, the substance can only escape into the tissue.

Due to the inventive embodiment as a whole can thus be measured directly on site, the sensor can be calibrated and "maintained," it can be introduced for measuring active substances, and may also include substances in response to the measurement result in only single penetration of the fabric to the the latter are supplied.

Through the direct introduction of the sensor into the tissue, the ambient temperature is determined by the body temperature, which is relatively constant, under normal circumstances. For this reason, a temperature measurement, just as it is needed for ex vivo measurements omitted. By eliminating pump devices, as required for sampling techniques, the design of the device is considerably simplified, reducing the cost can be reduced. When sampling techniques generally peristaltic pumps are used, as can thus synchronize different flow directions, the most energy for the deformation of the pump tubing is required in this type of pumps and therefore a very poor efficiency, the result (which especially in critical portable devices). As can be used in the invention means for the supply of calibration or rinsing liquid or of active and therapeutic substances syringe pumps, the system also requires less energy to operate it.

The elimination of suction pumps no dilution of the tissue fluid by a rinsing or CALIBRATORS results tion solution, whereby there is a completely equilibrated solution at the sensor provided in the normal measuring operation of the inventive device; thereby the Wiederfin- must dung rate no longer be determined. Since the body is not permanently removed from tissue fluid, the tissue fluid around the catheter can not impoverish. The only consumption of tissue fluid takes place directly at the sensor; But this consumption is negligible.

For intensive, sure contact of the sensor with the tissue fluid in this case it is also advantageous if the wall of the catheter-like tube in the region of the sensor body having a plurality of openings in the axial direction one behind the other. This allows tissue fluid through a plurality of openings, that is, macroscopic perforations arrive in the wall of the catheter tube to the sensor, whereby, moreover, the respective position of the sensor is relatively uncritical, so that upon insertion of the carrier with the sensor in the catheter-like tube after retraction of the insertion needle, a precise sensor position must not be achieved.

In order to reliably prevent during insertion of the carrier with the sensor in the catheter-like tube a possible damage to the sensor by rubbing on the inner wall of the catheter tube, it is desirable that the sensor in the radial direction as possible has or small dimensions as little as possible from the carrier protrudes. Accordingly, an advantage if the sensor in thin-film technology or silicon technology, as known per se, is carried out. Furthermore, it is therefor also advantageous if the sensor is at least partially embedded in the carrier. The sensor can in carrier longitudinal direction have a greater extent than usual, and this, if a plurality of openings in the catheter tube are present, is particularly advantageous.

The measuring principle of the sensors is known per se, and it may consist of physical or chemical processes as well as from

Diameter of the support for the sensor can be adapted to the inner tube, so that the sensor on the surface of the carrier can be inserted into the catheter without problems. In the smallest embodiment of the arrangement (outer diameter catheter 0.6 mm, diameter of the support 0.3 mm), which corresponds to the size of a needle insulin pump, may be the radial extent of the sensor than 0.15 mm. These dimensions can use the aforementioned sensor technologies, especially with the thin-film and silicon technology can be realized easily.

Finally, it is for safety reasons to also safely eliminate damage to the connection lines to and from the sensor, further advantageous if the sensor embedded electrical lines is connected to the carrier.

The invention will be further explained below with reference to the drawings illustrated preferred embodiments, however, it shall not be restricted. In detail:

Fig. 1 shows schematically a measuring device according to the invention in operation;

Fig. 2A, 2B and 2C show successive phases in attaching the catheter-like tube of the present measuring device with the aid of an insertion needle (s. Fig. 2A), wherein the insertion needle is then withdrawn (s. Fig. 2B), and finally a carrier with a sensor is inserted into the catheter-like tube (see Fig. 2C.);

. Fig. 3 is an axial section through the catheter-like tube with the therein located on the carrier sensor in Figure 1 compared to a larger scale;

4 and 5 are cross-sections according to lines IV-IV and VV in Fig. 3.

Fig. 6, 7 and 8 in Figs. 3 to 5 corresponding representations of a modified device in longitudinal section (Fig. 6) or in transverse sections (Fig. 7, 8), wherein the sensor is arranged in a recess of the carrier here and the connecting leads are embedded to the sensor in the carrier; and

Fig. 9 a diagram showing the operation during calibration and measurement using the present measuring device.

In Fig. 1 is a schematically shown device for in vivo measurement of quantities in living organisms, said

The distal end 30 of the carrier 17, hereafter simply called internal pipe, which is open, opens into the lumen 31, which is formed through the catheter 11, see FIG. ., Except Fig 2C also Figures 1 and 3. The proximal portion of the original lumen of the catheter 11 through the seal 28 from the distal part - separated, thus forming a new lumen, namely the annular channel 35 - which is referred to herein as lumens 31 ,

In order to increase the outlet area of ​​the lumen 32, which is formed from the inner tube 17, additional perforations 33 are arranged close to the distal end of the inner tube 17th The enlargement of the exit face to make it difficult for clogging of the inner tube 17, because of the possibility that tissue particles 11 have penetrated into the catheter lumen 31 through the distal end face 34 of the catheter 11 or through front perforations 12 'to the catheter. With proper application of the device may be through the inner tube 17 has a substance, in particular a drug, for example insulin, this further introduced into the formed by the catheter 11 lumen 31, and then by through the distal end face 34 and possibly by the foremost perforations 12 'in the tissue become. This drug may (but need not) be supplied in response to the measurement by the sensor 18th

The sensor 18 is mounted according to Fig. 1 to 4 on the surface (outer side) of the inner tube 17. The connecting cables 19 of the sensor 18 can easily res Innenroh- present on the surface of 17 or be embedded in this (see. Fig. 5 and 6). These connection lines 19 are led through the base 16 for the inner tube 17 through to the evaluation and control unit 20th The base 16 may be either in the catheter 11, that is, its extension 15, screwed or inserted (for example, Luer adapter clamped).

The sensor 18 is through the perforations 12 with the tissue fluid in connection. Preferably, the sensor 18 is located immediately below one of the openings 12 in order to keep the migration path of the lymph as short as possible. Through the base 16 for the inner tube 17 a further tube is performed for rinsing and calibration liquids as line 25th These liquids pass via the annular channel 35, which is formed from the inner wall of the catheter 11 and the outside of the inner tube 17, to the sensor 18 and can pass directly into the tissue through the openings 12th

In order to avoid a direct contact of the respective liquid, which is introduced via the lumen 32 of the inner tube 17 by means of the pump 22, with the sensor 18, the seal 28 is mounted between the two fluid spaces. This seal 28 also serves during insertion of the inner tube 17 to the sensor (s. Fig. 2C) as distance and Führungselernent to wegzuhalten the attached behind sensor 18 from the inner wall of the catheter 11 and so damage to the sensor 18 during the insertion of the inner tube 17 sure to be avoided.

To achieve an even greater security in this respect can, apart from the embedded connection lines 19 are also provided for the sensor 18, as already mentioned, to mount the sensor 18 in a recess of the inner tube 17, as shown in Fig. 6 and 7 it can be seen , Incidentally, the embodiment is shown in FIG. 6 to 8 that according to Fig. 1 to 5, so that a repetition of the description can be unnecessary.

Subsequently, still for completeness sake to the procedure for calibrating the measuring device on the basis of Fig. 8 will be explained in more detail.

The calibration of the sensor 18 is effected by means of a librationsflüssigkeit Ka, which through the channel 35 between the catheter 11 and the support (inner tube) 17 is brought to the sensor 18th The calibration liquid contains a certain, known concentration of the substance to be measured (for example, glucose measurement, a concentration of 5 mmol / 1 glucose). The develops thereby electric current of an amperometric glucose sensor 18 may be associated with this glucose concentration. E is the sensitivity of the sensor 18 (change in current per change in concentration in nA / mmol / 1) known, the concentration of the substance of interest to be back-calculated based on the measured current. Is the sensitivity of the sensor 18 is not known, the sensor 18 with two calibration liquids of different concentrations must be calibrated. The sensitivity E and the zero current I 0 of the system can be calculated from the known concentration difference and the difference of the two currents of the sensor 18 resulting at these concentrations.

In Fig. 9, an example for the calibration of a glucose sensor 18 and a subsequent measurement of glucose is comparable anschaulicht. In Fig. 9 while the arrows indicate the direction of information flow; the numbers 1 to 8 correspond to the sequence during calibration and measurement.

In general, the relationship between a glucose concentration G x and the corresponding measured current l x are given in the linear range with:

I, X = X + EC I 0,

with the sensitivity E and the zero current I 0th By calibration with two different calibration solutions with the - known - τ concentrations G and G 2 and the currents correspondingly determined I 1 and I 2, the sensitivity E and the zero current I 0 of the sensor 18 can therefore be determined as follows:

E = (I 2 -I 1) / (G 2 -G 1)

1 ^ 1 -EC,

With knowledge of the sensitivity E and of the zero current I 0, in turn, the glucose concentration G acting on the sensor 18 can be calculated by measuring the current x I x:

G X = (I x -I 0) / E

The result for the calibration of the system the following procedure:

1. applied to the sensor 18 with a Kalibrationsmedium

Second Measurement of the associated stream 1

3. applied to the sensor 18 to the other Kalibrationsmedium G 2

4. Measurement of the associated current I 2

5. Calculation of system parameters E, I 0

6. Check the system parameters on the size and change

7. Measurement of the current I X

8. Calculation of the corresponding glucose concentration G X

If the calibration at regular intervals, can be determined by a change in the sensitivity of the E and Nullstro- mes I 0, the operating behavior of the sensor 18th Changes in sensitivity E and the neutral current I 0 may have different causes and consequences have: Decreased enzyme action, deposits or encapsulation with endogenous substances (protection against foreign bodies). By the determination of two quantities (E, I 0) may be deduced as to the cause, and it can be caused to the corresponding steps of: In a deposition or encapsulation is the possibility this flush with the calibration liquid and to restore the original sensitivity again. If the unsuccessful, can be estimated the lifetime of the sensor 18 and thus the time for a timely change of the sensor 18 determined by the decrease in sensitivity or increase E of the zero current I 0th

Another advantage is in the described device, the in vivo calibration: where the concentrations determined to the device are compared with blood values. The determination example of the glucose from the blood is a standard procedure and is performed by the patient several times a day even. the relation is changed between the two determined values ​​(determined glucose in the blood to glucose in the tissue fluid), can be deduced to a change in the body. The change can be physiologically (time delay between the two signals), but also pathophysiologically (inflammation around the catheter 11 around rejection response, ...). Also, due to these changes, appropriate steps can be performed (for example, replace sensor 18, new puncture catheter 11, check system).

Claims

claims
1. A device (10) for in vivo measurement of quantities in living organisms, with a catheter-like tube (11) which receives an intended for insertion of the tube into the organism insertion needle (14) can be pulled out, having at least one opening (12) in the wall of the tube (11), and with a sensor (18) for detecting the quantity to be measured inside the tube (11), characterized in that the sensor (18) on a separate elongated support (17) is mounted, whose cross-sectional dimensions are smaller than those of the tube interior, and after pulling out the insertion needle (14) from the tube (11) in said tube (11) is insertable.
2. Device according to claim 1, characterized in that between the sensor carrier (17) in which the tube (11) inserted state and the inner wall of the tube (11) a cross-sectionally generally annular channel (35) for a rinsing or the like or calibration liquid. is formed.
3. Device according to claim 1 or 2, characterized in that the separate sensor carrier (17) is tubular.
4. A device according to claim 3, characterized in that the tubular sensor support (17) adjacent its open distal end (30) has at least one opening (33) in its wall.
5. Device according to claim 3 or 4, characterized in that at a location between the open distal end (30) and optionally the aperture (33) in the wall of the tubular sensor carrier (17) on the one hand and the sensor (18) on the other hand on the tubular support (17) against the inner wall of the catheter-like tube (11) sealing annular gasket (28) is arranged.
6. Device according to one of claims 1 to 5, characterized in that the wall of the catheter-like tube (11) in the region of the sensor body having a plurality of openings (12) in the axial direction one behind the other.
7. Device according to one of claims 1 to 6, characterized in that the sensor (18) is constructed in thin-film technology.
8. Device according to one of claims 1 to 6, characterized in that the sensor (18) is made in silicon technology.
9. Device according to one of claims 1 to 8, characterized in that the sensor (18) at least partially into the carrier (17) is embedded.
10. Device according to one of claims 1 to 9, characterized in that the sensor (18) in the carrier (17) is connected embedded electrical lines (19).
EP20000960215 1999-09-17 2000-09-18 Device for conducting in vivo measurements of quantities in living organisms Withdrawn EP1211976A1 (en)

Priority Applications (3)

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AT159499 1999-09-17
AT159499 1999-09-17
PCT/AT2000/000247 WO2001021064A1 (en) 1999-09-17 2000-09-18 Device for conducting in vivo measurements of quantities in living organisms

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