GB2309644A

GB2309644A - Device for diagnosis/therapy of a metabolic disturbance

Info

Publication number: GB2309644A
Application number: GB9525091A
Authority: GB
Inventors: Wolfgang Wagner
Original assignee: Individual
Current assignee: Individual
Priority date: 1995-05-22
Filing date: 1995-12-07
Publication date: 1997-08-06
Anticipated expiration: 2015-12-07
Also published as: GB9525091D0; GB2309644B

Abstract

The device, which is particularly for insulin measurement/injection, comprises a housing having means such as a suction cup or springs 8/sliding sheets 9 for producing and maintaining a skin fold, a cannula and sensor/probe for metabolic measurement, means for moving the cannula etc. towards and away from the skin fold, a measuring device consisting of a light source, light receiver and control unit, and an injection/metering device. A solenoid or motor may serve to move the cannula etc. and the sensor may include a light conducting fibre leading to a colour changing reaction layer. The cannula may be so arranged as to engage the skin fold on a slant.

Description

-----Se C i f i c a t i o n The invention relates to the medical technique, dealing specifically with metabolism measurements mainly -by diabetics and with the insulin injection.

The invention is an improvement, especially of the PCTW086/01728 (published on 03/27/86) and the Euro Patent Application 0301165 (published on 02/01/89).

Getting the sensor in reliable contact with blood or tissue liquid in each case on the occasion of device contact (with the body) by means of a single puncture of the skin remained problematic concerning the pro pcsed task. During the raising of the skin by means of traction and especially by means of negative (air) pressure in a suction cup, a cavity results void of vessels and liquid under the raised skin into which the cannula point projects. Finally, it is very difficult with suction application alone, maintain tentlike raising of skin for the relatively long intervals required for measurements.The more expensive, relating to time and technique displacing of blood or tissue liquid was chosen to avoid damage of the bcdy by reagents; a requirement which. is escaped with the introduction of permanent catheters for direct measurement. Mainly, the short intervall of brood empteness in the skin after suction, should be used to reduce pain and for better light permeability.

The intervall for gaining of substratum for measurement should be shortened, the measuring cannula reduced in price, the metering process still drawn nearer to the cannula iust for the smallest amounts. Of cour- se the prick wcund should be kept as small as possible, the area of injury should P tested with regard to aptitude, that is, exemption of diseases. Finally, the implantation of a "permanent sensor" -as described under "sugar watch" on Ulmer Universitatsmagazin; uni ulm intern 179/Febr.1993 from the team Prof.Dr.Pfeiffer- should be arranged with less pain.

After meantime even "permanent" sensors -that means sch for multiple measurements- are made smaller, such a kind for the single measurement can be transported or placed under the skin through finest cannulas as usual tcday for the insulin apply. In so far as an optical measuring sensor a capillary was intended, the terminal portion of it may consist of a cellulose acetate membrane with properties to fix the glucose and protect the bcdy for the leaving of the poisonous cclour change material. But such a coating can ccnsist of a polycarbonate membrane behind the reagent layers as well as hydrophilic matter as siligagel or basic aluminium oxyd.

Prior art The invention is based on injection into skin, which is lifted up inside of a suction cup, as described by M.Demarchi (US Patent 1.934,046 from 11/07/33) and G.N.Hein (U.S. Patent 2.743,723), and on a multitude of inventor's patents and patent applications which beginn with DE; P 25 51 991.0 to P 25 51 993.1. By H.Malm (US Patent 2,66C,169 on 11/24/53) leaf springs squeeze the skin to a fold. The building of a skin fold by tension from an adhesiv plaster was described in Dt P 37 30 469 by the inventor, a mtlti-functional solenoid and a skin sqeezing inside of a suction cup is shown in Euro Pat.Appl.No 88103775.8 (open as 0 301 165,03 on 02/01/89).

B r i e f s u m m a r y o f t h e i n v e n t i o n Borrowing from my experience of developing pressure jet injectors, the puncture of a skin knob from the side offers many advantages: the cannula prick-in takes place on a slant, a particularly advantageous horizontal or nearly hcrizontal position to the supporting surface or body surface, also nearly perpendicular to the rising direction of the skin in a suction cup and preferably in marginal ginal area of that.

Because the skin firmly clings to the latter irrespective of the highest level of the skin knob, a special stop or detend on or around the cannula for a stage of the intracutaneous placement of the cannula point is nct necessary for this purpose. A measurement is nct needed in this to prevent, first, a further lowering. (In an example of the invention such a device is described as a component, whereby a ring, which surrounds the cannula, consists of three supporting braces, which can be retracted into the base of the housing. The cannula can pierce then deeper under the skin for injecting the drug).

The firm spatial relation of the skin to the suction cup rim allows an exact pushing forward of the cannula with a predeterminable depth of puncture. The parallel position of the cannula, and suitably alos the step syringes, which deliver the drug, promotes like-wise the flat design of the device. The latter is more easily transportable and prevents a tilting away of the suction cup from the drawn-up skin; it securs on this manner the stability of position during use.

The squeezing mechanism consisting of a pair of sheets or plates which approach the skin knob from exterior, was supplemented by the example of several hooks or claws inwardly resilient turned around the rounded suction cup rim. The former works with a rough marginal surface upon the lifted up skin by suction at its knobe base.

If the injection cannula is prick-in, laterally from the suction cup rim, the cannula, for its part, obstructs the premature retraction of the skin out of the suction cup and thereby also out of the cannula.

The roof is designed with appropriate folds which are strapped along a rail to prevent the roof from beeing pulled downwards by negative air pressure. This is done in a preferred solution example of an elastic suction cup which is compressed lateral from a circle shape to an ellipse. In a such case the vacuum can be conserved even when the skin is squeezed.

The negative pressure is produced by the extension of an elastic bag, the large surface of which is connected to the surface of a covering plate for the housing and the inner side of a lid which is shiftable against the device. This connection is preferrably produced by a corresponding groove and tongue (as dovetail or meander). The bag is connected with the suction cup by a hose.

It is manually compressed against pressure springs between the base of the housing and the lid. A flexible joint of the tube socket or flanged nozzlestpartly surround *which the pressure springs, with their support, permits a lid closure in stages. Finally, (electrical) contacts shall report the engagement of all flanged nozzles and arresting elements on spring or release stops, before the device can be brought in further function.

But the lid closure itself is locked, so that other functions can proceed as such of spring tightening for the clamping or squeezing mechanism and, mainly, the lifting (or sinking) of an unused cannula into the funnel toward the suction cup by means of a sliding wedge.

In the elected example, the squeezing mechanism ccnsists of tension and pressure springs arranged two by two sideways on the housing. The tightening of these is effected by smoothing away of wedge slants from ledges influenced by a roller (in pairs) fitted each on a dcwnward projecting strap which is lowered with the lid. The ends of the springs on the two sliding carriages which are fastened opposite each other to rims of the suction cup, respectively at its laterally extending straps, are fixed by other sliding ledges on a release stop, again fitted in pairs. Counter-ends of the springs are shiftable on a lever one against other around of the lever axle.

A lever locking is released by a rope or tow toward the sliding carriage for cannula thrust, when the cannula is withdrawn out from the skin. Pressure as well as tension springs of the skin squeezing mechanism can be released again and they are additionally led back in their locking position over a resilient tow-line in connection with the forementioned carriage.

The cannula are stored in sleeves which are united one with other by rubber threads to a closed chain ring.

The transport of the latter for the exchange of a used cannula is achieved either by a pin which is guided on a carriage, the former passing in the zig-zag guided link of a bearing drum for the cannula chain, or by carrying of a separating or spacing wedge, which engages between two cannula sleeves being lifted over a stationary trapezoid guide by a bar and sunk again after the retreat of the spacing wedge from the cannula sleeve. A carriage as a slideaway for the cannula transport of the single cannula in the direction of the suction cup works to a tube, first, which insert the sleeve with the cannula in a funnel in the housing carriage of the skin squeezing mechanism.The cannula, intended for use, is pressed down into the plane of the suction cup rim over a slant guidance on the housing carriage and/or its counter carriage for the opposite suction cup rim during the tightening of the skin squeezing mechanism. After this, an inner sleeve is shoved past the folded bellows -with the sensor thread inside- onto the cannula piece. Due the friction between the cannula piece and the sleeve, which it surrounds, the latter is first shoved up to the stop in the funnel. The friction between cannula piece and sleeve is now overcome, so that the cannula shaft is pressed into the skin.

After the tension of spring has been surmounted between the inner sleeve or tube and the guide pin, which is stored inside of the latter, the top of guide pin pene trates a cup-like recess on the end of the folded bel lows of the cannula and compresses the latter. The sen sor thread leaves with its end, finaly, the cannula shaft, and lies in the subcutaneous tissue, where it can be saturated with tissue liquid.

The retreat of the sensor thread to behind the cannula shaft, which extends and respectively overstretches the folded bellows, happens during the thrust motion of the slideaway or carriage for the cannula transport.

In this moment, a segment projecting from the outer sleeve works to a lever, fastened at the inner sleeve, the counter-end working thereby toward the guide pin and reverses its direction of motion. The outer sleeve rotates, on its place, with the segment around a cylinder, which is fastened onto the inner sleeve rep.the inner tube, with nap inserting in a coiled slot into the position which releases the thrust motion of the segment.

The latter leaves the support ring on the inner sleeve through a recess of that supporting ring and operates the lever. After the lever has been arrested, the cannula is sunk deeper into the subcutaneous tissue (after performance of the metabolism measurement, for example, or for an eventual injection use).

If the thrust of the sensor thread'is performed out of a cannula point, which has left the skin and is shoved further, ready for injection, into the subcutaneous tis sue, the lever or eccentric mechanism can be omitted.

The retreat of the sensor thread is then simply trans ferred to the return phase of the carriage for the can nula thrust. This return phase is interrupted thereby by an eventual injection phase (while the block is switched oner to the control gear).

As control gear for switching between particular func tional blocks, a centrifugally operated switch has been chosen. In the variation of a worm gear, the radial and spring resilient operation pin has to reach the inser tion position after more than one rotation either on the inner axle or on the outer cylinder for the drive or transport. The rotation speed is therefore essential, which can be restricted by an electric motor resistance or over shortly chopped driving currents. When such a two-start switching is used, the one block switch posi tion is occupied for the carriage movement in bcth di rections. For the metering of two drugs, ratched wheels are installed to cause an effect to the step piston thrust, for example, to function only for one drug sort with motor turning to the left, and for the other sort exceptionally with motor turning to the right.

A hand switch must be provided to reverse the effective motor direction for the turning back the metering screws in the exit position before the exchange of the drug cartridges.

A three-start gear is presented as an alternative.

Thereby spindle or wedge produced terminal thrust movements of each of the functional blocks are transferred to the pinion or driving gear over a bar. The driving gear or pinion is screwed along the square motor axis -postponed to the reduction gear- and shoved into the mesh with the three operations wheels for the functional blocks, one after other. This shifting motion is rend (setting forth next page) ered possible over a bridging muffle or sleeve of the pinion axle as a prolongating member of the motor axis.

It is limited at this time, by a cross (cam) pin inside of a switching sleeve, which is fixed along the sliding direction, guided in a slanting inner groove of the latter. The groove has recesses which prevent the pin or cam movement, corresponding to the inserting position or mesh between the pinion and the operating wheel.

The cam moves into a counter-excess which hinders the return to the exit position with a slight rotation by a slant of that counter-recess by the influence of a pressure spring. When a further sliding movement of the bar is effected by the carriage of the last switched functional block in the final working stage of the latter, the cam is shifted to the next higher arresting recess. After two such shiftings, the cam falls back into the exit position over a steep flank of the groove with an adjacent longitudinal groove. The shifting movement of the bar to successfully effect the carriage motion of the next functional block is maintained by an additional toothed wheel, which is shoved onto the bar and pinion- separated from the latter by a pressure spring. That toothed wheel turning free around the axle has naps toward the pinion which mesh with naps of the latter when touching each other. The additional toothed wheel is then taken with by the pinion. When the pressure from the bar is released, the additional toothed wheel leaves the ratched wheel, which transitory enlarges the pinion. The mesh of the naps are influenced by the leaf spring between the additional wheel and the pinion until the new shifting of the bar over the carriage of the next functional block in its final stage.

When a pinion is rotated on a screw by means of a toothed wheel on a parallel driving axle, the former is taken with over connection plates to the pinion (while the screw is braked in a certain extend). In this condition, said plates or screw shiftings can be used for certain operation thrusts which are layed down with regard to stretches. When the pinion, which has naps on both marginal sides, meshs with such naps of one of both toothed wheels, which are firmly connected to both end of said screw, any chosen rotations can be tapped over the related toothed wheel, which is taken with another axle parallel to the screw. The rotation -for each case in counter direction- can be used for an alternating metering of drug.

But a solenoid can be applied for different functions one after another. In example of Fig.25-30, the switching into another function is effected by the sectoral rotation of a u-formed hammer, which is joined with the solenoid, over a torsion-push-sleeve. The operations completed with the hammer are rendered possible by a square bush fixes the square hammer axis to the rotation of a tensioned coil spring- between the torsion push sleeve and the hammer- up to a small circular cross section in the 0-position of the hammer. The rotation in the bush happens then after each stroke up to the stop of the hammer arm at a half groove which is resilient mainly parallelly to the hammer axis. That half groove is left by the hammer arm after each operation stroke.The return of the hammer can also be used by spring tension on further operations slides; the attenuation of the movement of the solenoid is also desirable. Different sliding courses can be obtained with levers of different arm length. A second lever, which is connected to the end of a first lever, can reverse the operation direction once more.

The arrangement of the injection cannula transverse or nearly transverse to the suction cup axis and the puncture near the suction cup rim -and therefore near the skinknob base is significantly advantageous because the sensor thread can be placed directly over the muscle skins (fascia) into the body liquid. If the sensor thread or sensor carrier has a bent pretension, which is directed toward the body, the security of such a liquid contact of the sensor can still be increased. The accuracy of the gauge length increases, if only the terminal segment is measuring active.

This can be accomplished by building of an electric gauge length inside of the cannula piece, while the thread segment bearing the enzymatic layer, by means of a inner coating of the narrow thread channel inside of the cannula piece, can receive a conductive internal jacket of a known extension. Additionally, the jackel is suitable to transfer signals by division toward separated electrods. If the cannula (point) orifice is bent adverse to the body the cannula of course must be secured against rotation, perhaps by an ovale design.

The metabolism measurement first in the cannula piece outside of the body excludes interferences by self-contained potentials of muscles, particularly heart muscle cells. The measuring potentials, wich can be tapped up, may be placed at 10 up to 14 Volts and inside of the milli-ampre area. Newly developed passive sensors seem to be more advantageous using the isolating properties of glucose opposite an electrical current for a quantitative measuring application -as described in PCT/ DE85/00313 based on sepharose-convalanin A.

Proposuals for optical measuring cannulas are also contained, for example, the insertion of a small foil or "confetti" punched out of a usual measuring strip with optical active surface pigment while the surface below (rearward) remains hydroscopic or liquid adhesive. When two of such small foils are connected -perhaps sticked with "PRITT"- by their surfaces which are not measuring active and patched to a carrier thread, the measurements can be simultaneously performed. (This is done properly in two different ranges of sensivity as customary glucose (pocket-) photometers). If light conducting as carrier thread, the adjacent colour-active reaction zone herewith can be lit from a light source inserted in the cup-like recess of the folded bellows at the cannula piece or from a light carrier or fibre. The reflected light can be measured with regard to attenuation or reduction.A single light fibre can be used as well for the light introduction as to the light derivation or re flection when the method of optical coupling is applied.

The opposite active layer is scanned by light rays projected along the carrier thread (out of this) through the folded bellows into an oblique positioned mirror ring, on the base of the cannula piece, and projected to the end of the thread with the colour layer. The optical light path reflects from there, over the mirror ring to the area of the cup-like recess of the folded bellows, where light conducting fibres of the guide pin are adjacent to an annular light window.

In another example, the carrier thread of the doublefaced colour measuring cylinder consists of paper or another material of optically indifferent quality. While the liquid saturate colour measuring cylinder is retracted into the cannula piece, the former is solved from the thread by a narrowness which engages with an insertion of the carrier thread. Each of the two bent hollow needles or tube segments centrally fitted with light conducting fibres are then approached from both sides through bores or recesses in the cannula piece -from above and belowto the colour measuring zones. Each one of the light fibres provide the light admission and to the light derivation to the photometer. To shorten the cannula completely, the folded bellows can be replaced by a piston, in the cap or bowl-like recess of which the button formed head or end of the guide pin enters to depress the cannula piece for with the shaft with annular groove for the drug supply at first together with the sensor thread. While the piston is retired, a swelling on the end of the measuring or sensor tread effects the piston to be retired in the sleeve together with the cannula.

A further depression of the guide pin pushes back the sensor thread into the piston and the sleeve. When the piston is now fixed by a cross bar, the guide pin can be released again from it ta desired position.

But the cannula shaft itself could come in question as a reference electrode by suitable choice of material.

One can suppose that the procedure, described above by Churchousi can be recommended for a shortening of the measuring interval. For a passive electrical sensor we have only suggested sepharose convalanin A at our disposal as doping (c.p.Fig.105; PCT/DE85/00313 W086/01728).

To depress such a cannula capillary or bristle, according the newer type, into the skin or under the skin we propose its mounting at a kind of folded bellows, which is patched to the cannula piece and sealed to it. The use of rubber elastic material as bunane or silicone is thereby most suitable. When the drug entrance to the cannula piece is left laterally over an annular groove -even to apply any insulin sorts together- then it is necessary to seal upward the insulin channel above the cannula shaft. That is done, most simply, by a kind of terminal "dish" at the end of the sensor, but which could be put cross inside of the shaft; and this even because the "dish" one sided abuts against the cannula point when the sensor retreats. The dish can be pressed then as a valve against a narrow space between the folded bellows and the cannula piece.

A more large-scale solution ear marks on this interface the insertion of a plate with a knock valve, behind which the sensor can retreat after measurement by an overstretching using a fork on the upper pot for the small folded bellows(Fig.l4). Supports used as projections from the underside of the cannula piece form an arrest up to which the cannula shall be first depressed against the skin.

In the maintime, various authors were working especially with the creation of test electrodes, but also with glucose measurement. Autor Churchousi, Stephen John, Bambury Oxfordshire (published on 09/22/88) applies a potential on his enzymatic electrodes to equalize the current alteration through the sample and to reduce the measuring interval from the current 10 minutes to 20 seconds to 3 minutes. The reaction is the usual: Glucose + 02converts to glucose-acid and H202 by influence of glucose oxidase. Churchousi applies as an "inner" layer, cellulose acetate which prevents the passing through of low-molecular material.

Then a close-adherent layer of the enzyme itself is applied. A porous carrier layer shall retain colloide and cellular elements. Ch. pleads for the laminated membrane of Newman US PS 3 979 274 and sends an operating potential in advance to the increased potential. Dobsn, John Vincent, from Hartlepool, Durham (UK) DE 2513613 (published on 10/02/75) uses copper instead of platinum for his electrodes with ion-sensitive material and as synthetic resin, araldite resin AY 103, Koester HT 972.

But the sensor-technique is also an essential scope of my invention.

Sitting forth with next page) A silver layer can be steamed up as reference electrode from the free end of the sensor to the cannula piece, which once again, from outside can be isolated by polycarbonate or synthetic resin or glass powder. But the cannula shaft itself comes into question as reference electrode with a suitable choice of material. The process was probably recommended by Churchousi for a shortening the measuring interval. For a passive electrical sensor we are exclusively skilled according the proposal for sepharose concavalin A as coating (see Fig.105 PCT/DE85/00313/W0 86 /01728).

To sink such a sensor capillary or sensor bristle of more recent construction into or under the skin, we propose fixing it on a kind of folded bellows mounted on a cannula piece and tightened toward the latter. Thereby the use of rubber-elastic material as bunane or silicone is the cheapest solution. If exiting the drug inlet or orifice into the cannula piece laterally over an annular groove -of course to apply several drugs simultaneouslyit is necessary to seal up of insulin channel through the cannula shaft upwards. This task is performed simply by a kind of closing "disk" at the end of the sensor which can be placed obliquely inside of the cannula shaft; because an one-sided knocking of the "disk" against the cannula point while the sensor retreads.The disk can be pressed against an narrow space between the folded bellows and the cannula piece, forming a valve with the elasticity of the folded bellows.

A more expensiv solution provides the mounting of a plate with knock valve or flap on this boundary, behind which the sensor can be retracted after the measurement by a overstretching movement by means of the fork in the upper pot for the small folded bellows(Fig.14). Props as projections from the bottom surface of the (cannula) piece build a stop down to which the cannula should be first sunk to the skin.

The cannula point lies then in the skin.

In Fig.9 we have such a situation -without the projections drawn in. It appeared for the blood sampling that the pricks slanting to the skin are far richer, because the net of the larger skin capillaries are rather cut into by the cannula point. A slanting prick is reached in Fig.9 by arranging the cannula eccentrically inside the suction cup. With a cannula according Fig.14, blood can be sucked into the measuring chamber after the upper smaller folded bellows have been already depressed during the reextension of the latter. Through said small folded bellows -but also through the one in Fig.9, the cannula of which, is fitted only for diagnostic use- ph-neutral fluid can be injected into the skin and from ther sucked back again into the measuring chamber after a certain period of concentration with metabolism products (also glucose).A cannula as in Fig.14 is further depressed before the injection, whereby the projections snap off laterally while stronger power is applied from above.

The more elegant solution example GE Fig.13 presupposes a contact of the depressed measuring probe (of the sensor) with the subcutaneous tissue. Such contact is effected by a device according Fig.l - 8, while the drawn up skin is sidewards mechanically compressed into a fold by a kind of slide and the sensor is squeezed in between (inside of the fold). Both tension cocking levers for the sliding sheets - which can also be replaced by bows- can e connected on their part by a bow or cross bar which is suitable for a simultaneous operation. Instead of releasing the spring stop by means of two haSd buttons, this is effected automatically over the gear expanded or developped for that function, which is what happens, of course in a device according to DE 38 065 74.

But also the squeezing sheets -resp.forms of squeezing sheets can be, of course, further varied. While the example of Fig.l - 6 shows a compressing of the skin mainly around the sensor with convexity in the middle by approaching, the Fig.8 shows a concave sheet insertion. If -as is also in DE 38 065 74- two vaccum pumps are provided for use, the sensor can be activated after the squeezing operation and is able to answer, resp.to reinforce, the suction on the skin. The squeezing sheet, namely, can be constructed very flat, perhaps of teflon, additionally "self-lubricating", and they can come in such a way to guarantee the sealing off of the suction cup (what the round bow would not be able to do). But the detention of the clamping spring after the measurement resp.injection, of course, is automatically effected in a device according to the (DE 38 065 74) mechanism described here.A schematical representation was preferred.

In Fig.14 two examples were given for a metering of insulin. To the left the mounting-in of the step syringe (OPTI PEN etc.), now customary in the trade, whereby in the automatical type of DE 3806574, the expensive push-button repetition mechanism of the metering screw is replaced by the throttled gear propulsion of the metering screw -perhaps through a Bowden cable. The example on the right approaches directly the "metering pots" to the annular groovve of the cannula piece. The small metering sleeve is pressed upon and emptied by the groove guide of the right hand imaged wheel, with the small metering sleeve being closed from behind by the valve cone of the inner rod.In another wheel position, the thicker tube is released and the fluid stream from inside of the folded bellows to the larbgermetering uni.t is expelled through the annular groove into the cannula. The degree of the sectoral motion of the wheel determines wether the small dose or the larger administered.

The possibility to administer any dos is level in the shortest period results from the addition of the single cycles of the metering sleeves. The wheel or roller movement with the wedged groove guide is effected by a kind of freewheeling drive. The sector movement is thereby permitted in one direction over a Bowden wire effecting a countermovement of the wheel into the starting position by a rotation spring while the drive rests. But the metering cycles may be effected of course by different stroke levers of a solenoid, if different wedge segments move by the former either the inner rod or the thicker tube with its sleeves for their forcing out in the direction of the annular groove of the cannula piece.

For the preparation of the spring tension of the clamping slide mechanism according to Fig.l-3, a tow-line may be yet mentioned which rising at the axle of scissors for the spreading of the sheets, expands over a rail guided roll then inside of a drawing sleeve parallel to the (tension) spring cocking lever. Its cross bar or bow -because the tow-line equipment is fitted also symmetrically and in double on both sides of the suction cup has a similar bow connecting the drawing sleeves, covering each other, so that the springs ere brought to a base or final tension (the plates or sheets being approached) until the resting of the tension cock levers in a single handling and, at the same time, the sliding sheets are spread asunder because the drawing sleeves are a partition of the clamping or sliding sheets. (But tension bows and tow-lines can be fastened separately).In the case of an automatized device type, the angular stop in the Fig.3 would be properly transferred to the fixing axle of each tension cock lever of both sides on a clamping plate or sliding sheet and activated by tension from the inside of the device.

In the case that the diaphanic glucose measurement using the rotation of the plane of polarization or the molecular dispersion by laser application (perhaps in accordance with Dr.Arno Mueller Ulm) the use of the blood empty please should probably be useful in drawing up the skin by suction, also, on the other hand with the cloupling with the needle less pressure jet injection in the suction cup. (This combination, the application of a diagnostic sensor cannula in one suction cup and an jet injector in a second suction cup could be advantageous in cases of special diagnostic needles without possibility of injection).

Separated or coupled suction cups could be suitable, as well as the transmission of measured values compared with the programme, for metering command from the measuring instrument by cable or wireless to such an overpressure injector inside of a suction cup(Fig.l0).

When a so called "sugar watch" is used on the hand joint it would be expedient to make the hormone amounts, provided for the injection, visible and to be able to program arbitrary dosage alterations but eventually to program from the "sugar watch". Always it recommends the optical ccntrol of the injection (or puncture) area with regard to the aptitude and the supplementary and subsequent recording o all programme and measuring and dcsage values for a simultaneous survey of the metabolism and treatment situation.

Brief description of the drawings Figur 1 shows in the vertical section along the section line A - B of the plan view of Fig.2 the suction cup of a man.ually operated device in a scale 1 : 1.

Figure 2 shows in the plan view from below the device according to Figur 1 before the skin squeezing.

Figur 3 shows in a longitudinal section along the section line C - D of Fig.2 tension levers and tensions springs for the sqeezing slides in natural size.

To the left the longitudinal section through a release or trip-out stop.

Figure 4 shows in a longitudinal section in a scale 1 : 1 the detail of a spring tension lever; to the right, a cross section along section line A - B through the release stop is given.

Figure 5 shows a vertical section along the section line E - F of Fig.2 in a natural size the suction cup as in Fig.l but in the condition of skin sqeezing.

Figure 6 is a plan view from below to the device during the skin squeezing in a scale 1 : 1.

Figure 7 shows the device according to Fig.7 in a cross section near the squeezing slides.

Figure 9 shows in a natural size a longitudinal section through the suction cup with an eccentric cannula insertion into the suction cup.

Figure 10 shows in a longitudinal section in a natural size a rouble suction cup by separation between diagnosis end injection, which occurs here in the suction jet procedure, but can be replaced by the injection cannula.

Figure 11 shows a longitudinal section through a portion of an optical sensor cannula in a scale 20 : 1.

Figure 3.2 shows a longitudinal section through a portion of an electric active sensor cannula in scale 20 : 1.

Figure 13 shows a longitudinal section through a sensor cannula with a valve mechanism for the injection channel in a scale 1 : 1.

Figure 14 shows a longitudinal section in a scale 4 : 1 through the detail of a sensor cannula onto the roof of a su ction cup with special support against the skin for the intracutaneous diagnosis and with an special metering device.

Figure 15 shows a sensor cannula in connection with te lower part of an injection syringelas customary in the trades( in a longitudinal section and a scale 2 : 1 .To the left the detail of a pretensioned sensor.

Figure 16 gives a principle set up of the combination and the cooperation of the parts of the device.

Figure 17 shows a device for a more pain-less introduction of a permament sensor or probe under the skin in a longitudinal section and about natural size while the skin is arisen before the lowering of the probe.

Figure 18 shows a device as Fig.17 in a condition after the introduction of the probe at after the skin have been lowered.

Figur 19 shows an automatical device similar as that of Fig.l-7 in a longitudinal section in a scale 1 : 1.

Figure 20 gives a detail of the Fig.l with a section line which is higher at the chain of of the cannula with the thrust device for the cannula in naturale size before the cannula is shoved in to the funnel of the suction cup. To the right a cross section through the drum with spiral groove of said thrust device. Below of this cross section a cannula is shown, wich is shoved into the funnel. Quite below a cross section through a cannula adjacent to the funnel with trust device is shown.

Figure 21 shows in a natural size above the detail of the section cup of Fig.l and 2 in connection with two drug cartridges an a cannula befor the funnel in a longitudinal section. Under that a cross section is shown through both slides for a lowering a cannula against the funnel of the suction cup.

Below a frontal section is given along the section line A - B of the longitudinal section above, drawn through the cannula chain an the drug cartridges.

Below to the left in a frontal section in a scale 2 : 1 the schematic rolling up of a cannula change mechanism; to the rigtht a cross section through a another change mechanism in a scale 1 : 1.

Figure 22 shows in a natural size a cross section through the device of Fig.l-8 laterally near to a wall with mechanism for the spring tightening for the skin squeezing. In the middle a detail of a slide stop for the springs in a longitudinal section.

To the right of the middle the detail of the counter stop for the springs above in a frontal, below in a longitudinal section.

Below the functional stage with the straingthened springs is shown in a cross section as above but in detail.

Figure 23 is a cross section through a device according to Fig.l-8 in natural size showing the lid mechanism for the vaccum production. To the rigt a frontal section through a release carriage.

Figure 24 shows a longitudinal section through the detail o. an centrifugally operated switch for the cannula thrust and the metering.

Figure 25 shows a longitudinal section in a natural size of as gear switch as alternative to that of Fig.24. To the right a rolling up of the guiding groove for the cross pin of the motor axis in a scale 2 : 1.

Figure 25 shows in a frontal plan view the tranmitting gear wheels from the motor to the operation wheels as a possibility in a device as thus of Fig.l-7 in a natural size. Below a horizontal section of a detail to clearifize a wheel position und function. To the right a wheel an. axle detail in a longitudinal section.

Figure 27 shows in a longitudinal section an example of the triggering of three release functions by three solenoids with details of the release stops.

The scale is about 1 : 1.

Figure 28 shows a longitudinal section through the detail of an relaise mechanism for suction production by a bag extension with a lid raising and a release of the skin squeezing mechanism in a second step by a slide movement in one direction, The scale is 2 : 1.

Figure 29 shows in a natural size a longitudinal section through a detail of a motor driven gear transmission for thrust and rotation operations.

To the right below, the side view to a ratched wheel, broken off for showing the pawl.

The scale is about 3 : 1.

Figure 30 shows in a scale of about 3 : 1 the electric current contact on an operating wheel or a pinion to contrcl the functional stage by special isolating of wheel portions an by contact springs. The scale is about 3 : 1. To the left a side view, to the right a longitudinal section is given.

Figure 31 shows in above in a natural size a

section through a suction cup with controlled raventilation nozzle and a control window at the suction cup rim. Below in a scale of about 4 : 1 the optical skin controll with light conducting over the windcw and the adjacent skin in horizontal section.

Fiqure 32 shows 1 : 1, shortened in the breadth, a

vcLw Yto a control panel; to the right a mathematical procedure, Figure 33 shows in a longitudinal section in a scale : l an device with suction cup, special skin sqeezing mechanism by rotable claws, optical skin control device, props for a intracutaneously cannula fixation by an optical sensor cannula, and a portion of an injector in a stage before the skin raising and squeezing.

Figure 34 shows above in a longitudinal section the device of Fig.33 in the stage after skin raising and with skin squeezing.

In the middle the plan view from below of the suction cup roof with the mechanism for the tilting of the props before the cannula can sink under the skin before the injection.

Below a perspective slant plan view on the bottom ring with steep flanks for the operation of the skin squeezing mechanism.

Figure 35 shows a longitudinal section through an optical sensor cannula with measuring arrangement for the embracing of a both colour active sides of a sen sor cylinder in a scale of 2 : l , the latter below to the right with the end of the carrier thread in a scale : 1.

Figure 36 shows in a scale of about 2 : l the four functional stages A - D for the operation of a sensor cannula in relation to its cover sleeve by thrust operating pin.

Figure 37 shows in a scale : 1 a longitudinal section through a sensor cannula with worm-shaped pretensioned sensor thread.

Figure 38 shows in naturale size a motor driven switching 3ear for rotation and thrust functions as an alternative to Fig.29. Below a vertical section along the section line A - B of the longitudinal section is shown.

Figure 39 shows in a longitudinal section in a scale 3 : 1 a sensor cannula for a device perhaps to Fig .40 with three different functional stages. To the right a vertical section through two sensor cannulas in a thread connection.

Figure 40 gives three vertical sections along the section line A - F of the device with a multifunctional solenoid as means of mobility for the cannula thrust. In the middle the elastic suction cup is shown. The left half of the device is omitted.

Above to the right a longitudinal section through a wall of housing with an arrangement of sliding bolts.

Figure 41 shows in a horizontal section in a scale of 2 : 1 according that one of Fig.40 below.

In the middle and below a wall edge of the housing with the mechanism for switching over by a sectoral hammer turning, above with stop function of the stop sleeve, below after the relay se immediately before the hammer turning.

Figure 42 shows a frontal section through the device with the cannula chain, similar to that of Fig.21.

Below to the left a partial cannula chain with a connecting spring clamp.

Figure 43 shows in a horizontal section and a scale of 2 : 1 a metering device with two solenoids. Above the additional transmission gear(997) for the coarse metering for one of both solenoids.

Below to the left a frontal section through the switching mechanism for the running directions, to the right a wheel with waved insertion of an engaging leaf spring for stabilization for the rotations steps.

Figure'44 is a horizontal section through the device near the bottom plate showing the arresting or stop mechanism for both skin squeezing sheets and the the seat valve operation for the suction reduction in the suction cup, stored in a container with negative pressure (see Fig.40). The left half of the device is shortened.

Above to the left, an arresting block is Shown in a scale 2 : l; in the middle left the trifting effect of the impact of the switching stick to the arresting rod for the arresting blocks are demonstrated.

Above to the right of the middle the seat valve is shown for the suction transfer in a scale 2 : 1.

Above to the right detals of the overcoming release arrangement for the skin sucking and squeezing are given in frontal and vertical sections in a natural size.

Figure 45 shows in a natural size in a horizontal section along the sliding bolt(l.i7',Fig.40 above) the power transfer to the cannula advance by the solenoid.

A detail is given in stage C Figure 46 shows in a natural size a horizontal section through the right half of the device in stage C with demonstration of the mechanism of hammer retreat by a strong tension spring of both spools for the cannula chain, the motor with coupling wheels, and the vacuum pump.

Above to the left, a detail of the coupling wheels, above horizontally, below frontal sectioned in a scale 1 : 1.

Figure 47 shows a detail in a horizontal section similar as in Fig.45 but along the slant of the sliding bolt(115) on the functional stage D for the closing of the drug outlet openings for the drug cartridges(see Fig.21).

Figure 48 shows a horizontal section in a natural size similar to Fig.56; the left half of the device is omitted again. The Fig.shows the position of both drug cartridges and the mechanism fot the cannula exchange according to the functional stage A.

To the right, above, a detail of a groove in the spool for the cannula exchange in a scale 2 : 1 with a schematical rolling up of the groove.

Under that a guiding bridge for a cross beam for a preventing of a hanging down of the latter in a cross section.

Below from the left to the right, a vertical section throuah a detail of a torsion-push-sleeve with sectorally turning of hammer controlled by a light beam.

To the right a detail of the hammer and the light beam in a frontal plan view.

Figure 49 shows above the detail of a coupling mechanism between the hammer and the solenoid with torsionpush-device in a horizontal section for a switching ovento an permanent operating function as the cannula chain exchange.

Below a frontal section is shown through the sliding key along the section line A - B of the upper detail.

The scale is 2 : 1.

Figure 50 is a horizontal section through a drug cartridge with metering piston in contact with the metering screw and th cap with bent cannula to the funnel of the suction cup in natural size.

Figure 51 is a horizontal section in a scale 1 : 2 through a device according to that of Fig.39 - 49 with supplementary demonstration of the position of the battery and the electronic control unit.

Figure 52 shows in a scale 2 : 1, above in a vertical section, below in a horizontal section a key of the programme panel with arresting ledges, in the middle the springy mechanism for the release of a row of keys in a horizontal section and a side view to the key for the the release of the programme keys or pots.

Figure 53 is a principle set up of the control unit with the electrical switching and circuit system.

Figure 54 gives the details of a carriage of an overcoming mechanism for the power coupling with the hammer of a double-active solenoid in natural size, above in a vertical section in stage A with coupling on of the front slide (black) during the motion to the left, and below the transport of the slide behind (black) during the hammer motion to the right, bcth effective straight lines shortened by slotes.

Below the vertical sections a similar construction is shown in a horizontal section with demonstration of the hammer engagement in the slide with a final enlargment or bar of the former. Under the bar (dashed drawn in another sectoral position) the (cross) bar is shown iri a vertical section, all these in natural size.

Figure 55 shows a mechanism for the moving of the bent tube segments with light conducting fibres of Fig.35 driven by the hammer of the solenoid. This is drawn in natural size in a horinzontal section.

Figure 56 shows a segment of a recording tape with minimal indices in a plan view at a scale of about 2 : 1.

Fig.57 shows a tabular calculation of the insulin dosages in consequence of the input for loads with meals and achievements by the patient. The table refers to predates given by the patient and their efexspected effect to the sugar level.

Fig.58 is a further part of the tabular calculation in Fig.57. It refers to the calculation of the insulin dosage in relation to the intermediately calculation results.

Fig.59 gives a statistic variance function for the ascertainment of the injection time.

Fig.60 is a principle set up of an device for an optical skin control.

Fig.61 shows a more developped example of the device in Fig.17,18 in naturale size, above in a longitudinal section, below in a cross section along the section line A - B of the longitudinal section.

With Fig.81 begins the demcnstration of an supplementing device for providing of a jet injector with metabolism measured values, especially with tissue sugar values.

This is done on a somewhat reduced scale in a rolling up on a horizontal or longitudinal sectional view. Above, tc the left the top of a sensor bristle bearing sleeve at a raturale size. Below, to the left, an enlarged vertical or cross section for a locking device against the retreat of the bristle, laterally with a partial side view.

Fig. 63 is a schematic vertical or cross section through the device of Fig. Below, a horizontal or longitudinal section is shown through the detail of the pressure dcna- tcr support.

Fig.zQ shows in an enlarged detail two functional stage of a special pLsh-rotation mechanism for device according te Fig.63 on a horizontal or longitudinal section.

Below, to the left, the four switching positions(A-D) are schematically detail led projected in a side view.

Fjg. trschematically illustrates a much enlarged sensor capillary an its operation in a hcrizontal or longitudinal section bv hand activated syringe.

Fig.Gb gives much erlarged a special sleeve for a sensor bristle ard a additional device for the injecting of it in a horizontal or longitudinal section. Above, to the left, a shortened detail of the sleeve in the stage of being broken off. Quite to the left, a vertical or cross section is shown through this sleeve.

Fig. 67 shows on similar conditions as Fig.50 the variation of a jet injection of the bristle by pressurized gas Above in a cross section stacking sheets for the elec tical contact with the bristle in two stages. *are shown Fig. shows -he variation for the introduction of the bristle (enlarged details above to the right) as a drill.

Fig.69 to the left a bristle device a a carrier for a small measuring cylinder, to the right, enlarged the reflex opti cal evaluatiol.

D e t a i 1 1 e d d e s c r iq t i o n of the drawings Figure 1 shows a longitudinal section along the section line A - B of Fig.2 with the suction cup(l), the cover pot (2) shoved on from above in the former with the syringe attachment cone(3), from which a drug channel leads to the annular groove of the cannula(4) with folded bellows, the sensor or measuring thread being attached to the upper limitation of the former projecting inside the cannula shaft lumen. The detachable brachet plate(5) can guide the pin(6) (able to be depressed) for the lowering of the sensor uptill distinctly outsinde of the cannula point.The hose (7) leads from the cover pot(2) to a suction source (not shown) perhaps the usual 20 ml-plastic syringe with a selflocking piston The tension springs(8) for the sliding sheets are mounted inside a guiding groove of the suction cup(l) -represented in dashes because it is situated behind the section plane. The axle of scissors(10) for the scissor beams toward the sliding sheets(9) -Fig.3- serves the tow-line (11) which is led over the groove of the roll(12).

Figure 2 gives a top view from below to a device for the squeezing of the skin and shows besides the suction cup(l), the sliding sheets(9) with bearing (face) of its central convexity and the bow(14) for the spring slide or tension spring lever(l3) and the drawing sleeve(l5) for the activation of the tow-line.

Figure 3 shows in a longitudinal section along the section line C - D of Fig.2 the square of the axle of scissors(lO) for the type for manual control of all locking devices.

Both crossing over scissor beams are connected with the axle(l6) on the (top pieces or) straps of the sliding sheets(9). The left of the latter has the cross pin(l7) for the end of the tension spring(8), the right end of which on this side is connected with the bow(14). While the scissor beams are scattered by thumb pressure from above on the axle of scissors, the tension spring(8) is yet relativily tensioned after the lock pin(l8) is released by activation of the respective push-button.

Also the stop ball(19) -for the attachment on the bow (14)on the end of the tow-line was (passively) dislocated behind the -sc'iematically shown- narrowness of the fork (20) to the right. As well the tension spring lever, as the drawing sleeve is fixed on the right hand sliding sheet and both are carried along relatively with the latter to the housing of the device.

To the left of the axle of scissors the latter is shown in a cross section turned about 90 degree.

After a rivet-like axle widening, the square meshes to the sqare bore of the spreaded beams of scissors and prevents them from rotation around the axle; the beams of scissors can rotate around the subsequent round axle segment to the right, after the square has been displaced to the left, out of the insertion with the said beam, by the movement of the push-button from right to left against the pressure spring.

This is done on both sides of the device with simultaneous button-inward operation.

Figure 4 shows in a top view to Fig.3 the detail of a spring tension lever(l3) while extended to the right, whereby the tension spring(8) ist tensioned and the lock all8) has arrested the lever motion.

This happens -as shown to the right cross section A - B of the described longitudinal section- by influence of a pressure spring between push-button and counter-bearing, whereby the pin of the lock(l8) overcomes the spring tension lever clout halfways, and crosses to them in an annular groove with the shoulder of its insertion.

Figure 5 shows in a longitudinal section, along the section line E - F of Fig.2, the suction cup(l) with the cover trough or pot(2), with the pin(6) depressed inside of the guide of the bracket plate against the cannula(4).

Through this, the sensor filament is sunk between the skin fold which is built by the approximation of the sliding sheets(9) alter the suction influence through hose(7).

The sensor filament now has skin and herewith body liquid contact and can deliver after the measured values uptake of this, which can be transferred over the signal conduc- tion (not shown) through the small folded bellows of the cannula piece(4) and to the measuring instrument, not shown.

Figure 4 shows in a top view to Fig.3 the detail of a spring tension lever(l3) while extended to the right, whereby the tension spring(8) ist tensioned and the lock (18) has arrested the lever motion.

This happens -as shown to the right cross section A - B of the described longitudinal section- by influence of a pressure spring between push-button and counter-bearing, whereby the pin of the lock(l8) overcomes the spring tension lever bout halfways, and crosses to them in an annular groove with the shoulder of its insertion.

Figure 5 shows in a longitudinal section, along the section line E - F of Fig.2, the suction cup(l) with the ccver trough or pct(2), with the pin(6) depressed inside of the guide of the bracket plate against the cannula(4).

Through this, the sensor filament is sunk between the skin fold which is built by the approximation of the sliding sheets(9) after the suction influence through hose(7).

Figure 6 shows a top view of the device, from below, as described in Fig.2, but in a stage after the release of the tensions springs by the pressure operation of both locks. Only the suction cup(l) and the sliding sheets(9) are demonstrated. The skin is indicated by dash-and-dot lines in every case. In the centre, the sensor thread or measuring filament(21) is shown.

To prepare a device according to Fig.l-6 for use, the bracket plate(5) with pin(6) must be removed and a new cannula must be inserted into the sealing in the centre of cover trough or pot(2). After this the bracket plate is attached again with the pin being drawn up. The syringe filled with insulin is tightely shoved on the syringe attachment piece the piston of the vacuum syringe is sunk into the stop. While the left hand embraces the housing, perhaps the suction cup of the device, the right hand draws the bow laying under this with the drawing sleeve -Fig.2.

Thereby the tension spring(8) is at first pretensioned by the withdrawl of the spring slide or tension spring lever (13) until that is arrested in the iock(l8) -Fig.3,4. The drawing sleeves(l5) glide first past the tow-line(ll) -Fig.

3-to find resistance with their narrowing of the fork(20) or claw then on the stop ball. With further tension on both bows,the right sliding sheet(l4) and the spring slide or tension spring lever(l3) mcve together against the tension spring; both sliding sheets are driven asunder by the four beams of scissors, because the tow-line(ll) -Fig.l,3- works now over the roll(12) and sinks the axle of the scissors(lO) until their square form hinders the upward movement.

For the applicetion, the suction is put on the pre-cleaned skin and the syringe piston of the big vacuum syringe is retracted, whereby the skin is lifted into the suction cup.

The sensor thread or filament is sunk now under the skin exceeding the cannula by pressure on the pin(6). Then, the narrowing of the sliding sheets to the suction cup is effected by pressure against the axle of the scissores(lO) by means of the thumb and the index (sidewardly). The glu ccse content is measured on the measuring instrument after a respective influence period of the tissue liquid under the skin fold to the sensor. The eventual dosage correcting calculated, the respective insulin amount is injected under the skin through the annular groove of the cannula. ~ Both locks are pressed again now with the thumb and index so that the tension of the tension springs toward the skin decreases. But the syringe prop of the vacuum syringe can now be lowered and the suction cup reventilated thus.With the described manner of operation the insulin is injected past the depressed sensor inside of the cannula shaft. Because the folded bellows is compressed over the cannula piece, an appreciable amount of insulin cannot escape, thus a valve mechanism is not necessary.

As mentioned before, most of the above demonstrated manual functional actions shall be automatized in a prior described manner or one leaning toward that.

Figure 7 shows in a schematically longitudinal section, the detail of a suction cup corresponding to that in Fig.5 To the left, the stage of the sucking on of the skin is described and to the right, that of the skin squeezing.

Below the longitudinal sections the respective cross sections are drawn at the level of the lower suction cup rim, closed by the sliding sheets(9)', to the right more than tc the left side(Fig.8).

If the sliding sheets border closely (rectilinearly) or are brought finally to overlapping, these can serve togetr- er as a lid covering for the suction cup.

In Figure 7 the effective principle of both functional steps are demonstrated immediately before the sucking on of the skin to the left and during the skin squeezing (to the rigtht). Inside of the suction cup(l) with a rigid wall a further elastic suction cup(22) is fitted, fastened at the roof of the rigid suction cup. The inner elastic suction cup has an ovalbase shape (as in Fig.8 to the seen the right). The suction derivation is performed with separate channels out of the inner elastic suction cup as well out of the interstice between the elastic and rigid suction cup through the two-way cock valve(23). On the four fixing points(24) the lower rim of the elastic suction cup is ccnnected with the sliding sheets(9). The latter are drawn apart on the stage shown to the left.The two-way cock valve(23) is adjusted so that the joined suction source -perhaps a plastic syringe or a jet pump-(symbolized by an arrow) profed effective through both channels and the skin was already drawn up in the elastic suction cup (demonstrated with dash-and-dot line). To the right handed demonstrated functional stage, the rotation of the (two-)way cock valve is preceeded about 180 angle degrees, so that only the inner space of the suction cup around the cannula(4) remains under suction influence. The release of the sliding sheets(9) -as described to Fig.l-6- effects the invasion of air into the interstice between rigid an elastic suction cup. The skin is laced in now in the plane of the suction cup rims and by pressure on the folded bellows through the cannula piece (perhaps by an index), before the releasing of the sliding sheets, actually approached to the sensor thread or filament, so that the latter is able to take up liquid with the measuring substrate. After the suction effect is stopped and the tension springs are released -Fig.3,4 (preceeds, suitably1 by the release of the finger pressure against the cannula), the skin is retracted downwardly from the cannula.

After the two-way valve is changed-over, the left functional stage of the left is restored. The shunt wire(25) for the measuring signals of the diagnostic cannula is drawn.

Figure 9 gives a longitudinal section through a suction cup, into which the skin (bounded with dash-dot-lines) is drawn-up after a suction source (arrow) is joined.

The point of the cannula shaft is positioned inside of the skin while the cannula is fitted eccentrically thanks to the (not shown) introduction stop for the shaft after it has pierced and injured the veine net of the former.

The folded bellows connecting to the cannula piece(4) is filled up with a tissue peacable rinsing fluid, which is emptied out of the cannula point into the skin by the manual compression of the folded bellows and sucked back by the release of the folded bellows after the rinsing fluid is saturated with the substratum, which should be measured. On the reaction layer -symbolized by small crosses- the signal values can be produced an admitted to the measuring instrument through the shunt wire(25). A special kind of such a cannula which is suitable for injection use is described in Fig.l4.

Figure 10 shows in a longitudinal section two suction cups being joint by a hinged joint(28) and connected with a suction source(arrow). For space requirement the hinged joint is drawn-in immediately at the place of contact of both suction cups; in praxis something distance is provided here so that enough skin is placed at its disposal for the snatching up into both suction cups. Into the centre of the suction cup to the left, a usual over pressure syringe (29) is shoved which delivers the hormone after the information of the skin contact over a contact switch not shown), resp. the signal, is delivered acoustically and optically (and eventually by vibration) for the manual release of the overpressure syringe.

The light source(30) projects -connected with the measuring instrument resp.with the control unit- over the shunt wire(25) light on the skin, while the latter is lifted by suction influence. The light which is reflected out of the ray beam from above, slantingly or horizontally reflected, is controlled according to the intensity and compared according the sequence of tense and eventually with stored earlier measured values. The injection is stopped, when different reflexion values are measured shortly before the skin knob is covered by the nozzle bearing portion of the overpressure syringe. (Injections in diseased skin areas shall be avoided in such manner).

Light source or emitters and light receivers lay opposite one another in the suction cup to the left, to determine metabolic parameters in a known manner during the phase of blood emptiness (especially) diaphanic but without injury (in connection with a measuring and control unit). But both suction cups can be activated one after other separated or on different skin areas depending on the functional technical need.

Figure 11 shows a longitudinal section through a sensor in the mode of a measuring capillary perhaps to a scale of 20 : 1 in its unfixed terminal segment, as it is determined to project ir.to the skin.

Light ccnductinc fibres(31) inside of the plastic capillary(32) ccnnect with a light source (not shown) and project their light at least partially to the preferable reflecting and convex closing or protective seal(34), from which the light is projected from'inside to the terminal segment(33) of the measuring capillary and from there influences the light intensity of the light transferred from the light ccnducting fibres to the photometer (not shown).

But the terminal segment of the capillary before the closing or protective seal(34) can be filled up with bodies of glass or plastic with light reflecting or deflecting properties or with a respective fibre network, to meliorate The prerequisites for influencing of the light intensity by influencing reagent mixture on the inner wall of the terminal segment(33) of the measuring capillary. Such substances are today customary in the trade for test strips are loaded with blood by hand. Not least of which because of their toxicity to the body, the terminal segment(33) of the capillary must be coated imperviously (symbolized with dashed lines) for the measuring substance. The alteration of light intensity deliveres the standard for the influence of the measuring substrate (of the glucose) and of its amount of enrichment in the blood or tissue liquid.

Figure 12 shows a longitudinal section through a sensor -similar to that of Fig.ll- in the mode of a sensor bristle or of a measuring thread or filament to the scale of about 20 : 1 in its unfixed terminal segment, as destined to project into the skin. The soul or the core thread per example constitutes a metal filament (perhaps platinum), around which lay enzyme layers, in a thickness sufficient for a measuring purposes, as immobilize-d GOD eventually posterior to a cellulose acetate membrane and subsequent a protection and filter with membrane, for example, of polycarbonate.But .he immobilized GCD can be coated as mixture with Kieselgtlhr or silicagel or basic aluminium hydroxit or but cellulose derivates, to promote the streaming in of (body) liquid and glucose. But other membranes and enzymatic layers are known for an active electron setting free measuring equipment. Sepharose convalanin A can be used as enzymatic lea tier for a passive sensor, which weakens a current stream transmitted from the central electrode (platinum soul) to an outer ccnducting layer, respective the voltage of tat layer.

The enzymatic layer(36) is svmbolized by little crosses, the outer membrane(37) as dashed lines. The current con ducting membrane -per example of vaporized-up silver(38) is drawn with dash-and-dot lines. Over this, an electrical isolating layer should be coated up until the ccntact tap ping. Enzymatic coat and outer membrane are necessary on ly functionally on the terminal segment of the sensor thread. In the drawn-in example, the transition between a synthetic resin coat(39) of the platinum soul(35) to the terminal segment with enzymatic coating occurs by overlapping.

Figure 13 shows to a scale of about 2 : 1 -while the shaft broath is yet more enlarged- a sensor cannula with annular groove or notch(40) for the admission of the drug to the cannula shaft(41). The sensor which is put into the latter, and fastened above at the cover membrane of the foldes bel lows(26), projects below out from the cannula point an ter minates into a cone(42). The folded bellows over the cannu la piece(4) is pressed together by means of the lever(43).

The platinum resp.metallic soul of the sensor contacts with the lever and its line to the measuring instrument.

The current conducting membrane of the sensor contacts on the surface of the folded bellows rover a sivered stripe to the line(44) which leads off from the cannula uptake bush on the suction cup roof. If the lever is left, the folded bellows is stretch and the sensor is retired in the can nula shaft. The cone meets a movement stop on the channel narrowness at the upper end of the (cannula) piece and is weakly retracted to the channel from below. When fluid is injected through the annular groove, the fluid pres sure reinforces the valve effect of the cone preventing a drug discharge upwardly into the folded bellows.

Figure 14 shows, in the longitudinal section a detail of a special type of a device according to Fig.l-6. It describes the cannula passage with a cannula for diagnostic and injection use as it would be suitable, particularly, for an application according to the example in Fig.9. To the left, a customary step syringe is integrated above the suction cup roof, to the right a metering device for a drug metering in mtering cycles of two different dosages.

The size is about 4 : 1 The cannula shaft(41) is made of steel, the remaining cannula portions of rubber-elastic material. Three supports (45) distributed over the undersurface of the cannula piece (4) prevents, of first, too deep a penetration of the cannula point under the skin. If stronger pressure from above occurs by depressing the fork(46) of the device, the supports are bent laterally away, so that the shaft can sink deeper under the skin before the injection.

Before the shaft picks into the skin, the small folded bellows(47) have been previously compressed by depression of the pin(6) which serves at the same time as light conductor in the direction of the photometer or -as is hereon an electrical sensor -Fig.12- as a carrier of an electrical condition toward the measuring instrument so that the air contained in it can escape through the shaft. After the puncture into the skin, the pin(6) can be sunk together with the fork(46) further, and the folded bellows(26) thereby is compressed and the capillary(44) which projects in the O-position through the valve flap into the cannula piece, is depressed up to under the cannula point.When the pin(6) is lifted up and the folded bellows(47) is unfolded again, the injury collected blood is sucked back into the reaction chamber and supported by capillary suction. From the former, the measuring signals are transmitted through a wire along the small folded bellows toward the annular groove of the upper bowl or trough(50), from there the signals are mediated further over the fork(46) to the measuring instrument. Correspondingly the pin(6) has con tact to the reference electrode projecting downward ail the way to the reaction layer. The pin(6) is lifted slightly over the 0- or basis position before the injection and therewith the capillary(49) is retracted behind the valve flap(48) while the folded bellows(26) is also developed again by the lifting of the fork(46).A further short elevation motion of the fork(46) after the injection effects the sealing off of the drug inlet openings(51) by the piston of the cannula piece(4). If a step syringe customary in the trade is used, the seal(52) of the drug inlet openings from the syringe is necessary resp.the cut off cannula which is screwed to the step syringe and the replacement of the former by the feed line(72).

The metering device, drawn to the left, has a small(53) and large(54) metering sleeve, whereby the margin of the latter is sealed mounted on the housing chamber(55).

The inner rod, terminating with a small disk inside of the small metering sleeve, has the valve cone(56) behind the latter and it is tightened inside of the tube(57).

The large metering sleeve has -well as the smaller one- a trough-like recess on the face which is turned off from the drug outlet, into which the cone(58) of the tube can engage. The folded bellows(59) extends from the large recess of the valve seat to the right hand end of the housing chamber(55) ito which the drug feed line flows. (The supply line from the drug store container is not shown).

The tube(57) and the inner rod are dislocated over the large(62) or the small(63) wedge conical or groove guidance on the wheel(61) to the left in direction of the annular groove of the cannula piece and return to the right to their wedge conical or groove guidance cc.rreponding to the clearsnce of the latter by the elasticity of the metering sleeves and the folded bellows as well as the fluid pressure. For that, the wheel(61) is turned again and again in the basis or start position by the coiled spring(64). The transport wheel(65), driven for that in counter direction by a Bowden wire, drives the wheel(61) meshing with the pawed tooth.The coiled spring works into the counter direction when the drive comes to the standstill. (The mechanism is suitably replaced by a "freewheel mechanism" as customary in cars). To the extent of the sector motion of the wheel(61) the small or the large metering sleeve is emptied corresponding to the annular groove guidance. The formation of the metering to the rounding or radius of the cannula piece(4) is not shown.

Mainly lateral projecting ledges on the small metering sleeve must close the annular groove of the the cannula piece for the drug output; but either one of the drug inlet opening bores must terminate in the annular groove or the latter must be secured against turning as shown in Fig.l to the right in a cross section.

Figure 15 reproduces an example for solution whereby the metabolism measurement is achieved over one or several sensors after the prick-on of the cannula shaft(41) by means of the conical sleeve(67) which is sunk up to the posterior portion of the cannula piece of an injection syringe (after protective cap -not shown- is removed).

The sensor -only built, for example, as an optical typecontinues its light conduction fibre in a cable te the connective plug for the photometer. The protective sleeve for the shaft is already withdrawl off; the cap-like membrane(69) protects against pollution of the receiving funnel(70) for the conical sleeve(67). The supporting braces (7l)prevent a drawing of the sensor out of the cannula and are torn off during the depression of the syringe at the fastening of the top of the syringe cone at the lower small receiving cone(72).

Besides the total representation to the scale 2 : 1, the terminal segment of an optical sensor is drawn to a scale of about 40 : l . The reaction layer(27) is applied in this case to the end of the light conducting fiber -drawn with little cross lines, see Fig.9,ll- and coated with a substrate permeable outer membrane(37).

To the right a solution variation is shown in the cross section, whereby the cannula piece -here by oval design - is secured against turning.

Below, a longitudinal section through the cannula shaft at the cannula piece shows in what manner a curved sensor, railing inside of the shaft, curves to the left with its convex deflection against the shaft point in the shoved out portion. Thereby the contact of its end with the humid undersurface of the skin is facilitated, because the axle of curvature of the sensor is chosen vertically to the skin fold direction. The drawing is to a scale of 4 : l . 1 Several light conducting fibres can be connected to one another or deliver single measured values each, which are compared with one another and joined in a usual manner.

Figure 16 delivers a schematicall-; general view of the combination and the cooperation of the parts of the device in a diagnostic-therapeutic complete conception of which the demonstrated invention is a part. The measuring signal receiver(73, perhaps a suction cup with sensor) stands in a firm or functional connection (by cable or waves) to the measuring instrument(74); the latter again connects with the programming unit(75) for the drug metering, to which it mediates the measured values. The programming unit again transmits its commands to the injection device(76).

The measuring instrument makes the measured values visible on a display; in this case wireless on a "sugar watch" (see prior arts:Prof.Pfeiffer Ulm). From the "sugar watch" dcsage changes can be effected by wireless commands to the programming nit(75). In the counter-direction, desired, a undesired dosage amount are registered (76) to the "sugar watch;'(77). The programming can also be influenced over the key-board of the programme application(78), which may be connected offen with the injection device but permits as a rule the imput of metabolism measuring results.

A tempory connection -usually a plug connection- with the programming unit toward the recording device(80) makes all functional data visible as a rule in connection with a battery charging on public mains. But the recording device can be integrated in the programming unit(75) with or without measuring instrument(74). The unit of the measured value receiver and injection device has already been described. Especially for Fig.l-6, the measuring instrument and cable connection to the sensor are omitted for simplification; they may be supplemented and understood from later figures.

Figures 17 and 18 show in the longitudinal section, in a natural size, a device for a less pain-poor introduction of a permanent measuring probe(81) under the skin. The sealing piston(82) is drawn up from its position on Fig.18 inside of the suction piston at the cross plate(83), there lifting the skin. The permanent measuring probe was introduced a bit before in the seal(84) in the central rod -with the cannula shaft below. The cannula can be pricked through the raised skin and through the former the permanent measuring probe can be shoved under the skin. Finally, the sealing piston(82) can be lowered again by the lowering of the cross plate(83). The cannula can be retracted out of the skin while the central rod being held firmly. The skin falls again downward because the vacuum space is suspended.The permanent measuring probe(81) is now fixed between the skin and the cannula and the suction piston will be removed upwardly along the measuring probe.

It can be fastened near or on the measuring instrument beared on the body.

Figure 19 shows a nearly natural sized device in a longitudinal section at about the level of the drug cartridges, matching the design of the invention altogether.

The small folded bellows(314) around the measuring layer bearing or sensor thread appears too short against the overall length of the cannula shaft(41). The sensor cannula is stored in the sleeve(691), the soft and elastic protective membrane of which are not shown in front and behind. The guiding pin(6) for the cannula lies inside of the inner tube(693). At the inner tube, the plunger (694) is fastened which is moved by the lever(695) with tow-line(696) after the release functions of said lever (695) or before them. The drawn bars(315), with dashedand-dot lines, are carried along to other device mechanisms in different deflections. Thus a bar leads toward the sliding carriage(697), which has a thread block shifted by the rotation of the belonging spindle or screw.

The bifurcated bars(698) thus prevent a turning together of the thread block. The spindle our screw is driven over a gear transmission and the chain(88), then over the inner axle(715) of the centrifugally operated switch. The annular roller(699) of the latter stands over the translation gear wheels, gearing down(54) in a permanent connection with the motor axis(51). The gear wheel is driven over the outer cylinder(700) of the centrifugally operated switch with the corresponding axis. The axis of the gear wheel(701) works through the sprocket wheel for the drive of the sliding carriage(697) to the ratched wheels(702,703). The bevel gear which turns free around the end of the axis meshs with naps of the mobile, to one direction, portion of the ratched wheel(302).

The rotation is transferred over the bevel gear(705) with firm seat on its cross axle to the metering screw(716).

To turn back the metering screw after emptying or changing of the drug cartridge, the sliding switch(713;see Fig.2Candl) must be moved by hand to the left, to set the ratched wheel(703) in function, operating in opposite direction. The ratched wheel(706) is driven from the gear wheel(701) and its axis onto which its rotation transfers over the tube segment(709) to the connecting sleeve(710) over a peg guidance in a -not shown- longitudinal slot of the former and through the sliding of the carriage(711) on the connecting sleeve to the metering screw -if the motor direction is changed. The metering screw moves out place and thereby into the stationary thread block(712).

Against this, the spool(714) for the transport of the chain ring of the cannulas can turn freely around the metering screw while it is already stored in the stationary drum(718). The metering screw(713) can be rotated to the sliding carriage(711). The latter pushes the connecting sleeve over the tube segment(709). The metering piston (720), classed with said mechanism, was advanced maximally into the drug cartridge over the schematically dash-anddot lined linkage(719), in the shown stage. The functions run analoguely over the metering screw(716). Fold-down swivel hinges(7211722) still are there provided, the stabilized springing or resilience of which are omitted. The spools for the chain ring of the cannulas approach one another by lifting the swinging arms against the spring tension, which renders possible a changing the cannula chain.

The front slide(723) is connected over the supporting pillars(724,725;see Fig.2) with the rim of the elastic suction cup(l). Two sliding ledges(726,727;see Fig.3) make the connection to the remaining housing. But the connection strap(728) and the tension spring(729) are installed in pairs. The same is also true for the connection strap (730) between tne injecting sliding carriage(731;see Fig.l) and the pressure spring(732). Both springs work opposite one another for skin squeezing. (The suction cup roof is demonstrated in folds over the suction cup in dashed lines.

as it corresponds to the stage during the skin squeezing, in which the four supporting pillars are approached one pair to another each in connection with a sliding sheet (9), namely with the front slide(723) and the injection sliding carriage(731). The flanged nozzle(258) for the uptake of the pressure spring(287) -spaced four time to the edge of the housing- is visible as with lowered lid (see Fig.5).

The motor driven toothed wheels(708,748) serve to the switch of the motion for the metering screw(716). The drive runs over the bevel wheels(704,705), the cross axle, and the corresponding bevel wheels. The battery(255), the measuring device, and the electric control unit(300) lay in interstice.

Figure 20gives a portion cut of the longitudinal section of Fig.lj. The supporting pillars(725,724) on the rim of the elastic suction cup(l) from the (not shown) front slide(723;Fig.b) and the supporting pillars(735,736) are marked with the extended suction cup; the sliding sheet (9) belonging to the injection sliding carriage is drawn in twice, to clarify its dislocation motion. For the support of the suction cup roof the folds of the latter are supported by the ledge(737) in pairs.

The latters are mounted at the front slide and able to slide along the rail(738, see Fig.zX under the covering plate(283). The roof fastening is completed over the straps(739) sliding along the rail.

A chain ring with sensor cannulas containing sleeves(691), held together by elastic rubber threads, is guided over the spool(714) in pairs. The transport mechanism of the spool is explaind in Fig.B. The mechanism for the cannula thrust against the suction cup is illustrated in a cross section along section line A - B of the longitudinal section below at a scale of 2 : 1. The plunger(694), secured against rotation, is led through the bifurcated, fixed support(740).

in which the drum(714) with the coiled slot turns because the axle pin(766) of the plunger is guided there. The rotation of the drum is transferred over the nap(747) in the longitudinal slot of the outern sleeve(745). Because the end of the axle pin engages in an annular fold(769) of the outer sleeve, the latter is showed over the drum away. The thrust movement is transmitted to the inner tube (693) over the tongue(742) at the outer sleeve. Finally, the tongue comes into a gape of the collar ring(743) on the inner tube. The lever(744) is stored in the gallow (741) fastened on the inner tube. The lever works the central pin(767) and is activated itself by the tongue(742) of the sensor thread leading back into the cannula. (The detail shows the condition after the compression of the folded bellows).The further shifting of the guide pin(6) works over the spring(746) against the central pin. The measuring signals reach from the guide pin (6) out of the slot into the inner tube over the wires(25) into the measuring instrument. Profil projections are drawn to the funnel(749) which mark the deep steps of piercing the sleeve and the cannula piece, and are of elastic material. The position of both drug inlet openings (750)corresponds to the final position for the movement of the cannula piece(4) caused by a border ledge of the funnel. Drug inlet openings and annular groove of the cannula piece or body cover for the injection. The pin(768) projects out of the outer sleeve(745) into a slot of the inner tube. Thus it can be brought back in the exit position with an inversion of motion.The exampled outlined solution approaches the type of sensor cannula particularly described in Fig.15-18.

Figure 2'iåbove gives, in a longitudinal section, a detail about the suction cup(l) and the injection sliding carriage(731). A part of the sliding sheet(9) of the front sleeve or stick(723) is not yet shown. The latter is seen below in the detail as a frontal section (in approx.

natural size), to demonstrate the mechanism for the lowering of the cannula out of the chain ring into the position infront of a deep laying funnel for the suction cup. A ledge projecting from the front sleeve(723) ends in a kind of roof slant(751) turned backwards. A ledge terminates in a roof slant opposite to the latter and connected with the injection carriage. The demonstrated functional stage displays both ledges in the position before the tensioning pressure springs(8,732) for the skin squeezing mechanism has tightened. (The latter more closely described with Fig.4). If the springs are tightended and the suction cup is returned to its circular shape, both roof slants approach each other pressing the cannula within its sleeve -which lies below (under said roof slants)- downwards out of the chain ring which is drawn along under said roof slants.The mechanism for cannula transport along the chain ring is clearly demonstrated by the frontal section along the section line A - B of the upper longitudinal section. The canula sleeve(691), pressed downward out of the chain row by the corresponding concave excavation of the roof slant(751), lies in the centre. With the chain row, it is further connected by stretched rubber threads. The spring lies to both sides of the fastening clamp(ll9) for the insulin cartridge(ll4).

The injection carriage is carried on rolls(752). The sliding ledges(726,727) extend in a rail guide at the bottom of the housing, the wall thickness of which is not drawn in. The spool(714) for transporting of the chain ring is excavated correspondingly radially (as a sprocket wheel).

The lateral reciprocally paired slide is listed below to the right in a cross section over the length of the device, that is perpendicularly to the transversal section. Two sleeves(691) in rubber tape connection are reproduced between which a transport wedge(753) engages, separating from behind. The transport wedge is moved by the connecting rod(752), turned from the cannulas. Thus Thus a displacement of the chain row takes places for one cannula breadth. The transport wedge retracted from the sleeves during the drop of the cross pin on to the steep flank of the trapezoid guidance, (dashed drawing) under the influence of an omitted spring. The connecting rod thereby slides parallel to the sleeves on a disk guiding to the slot of the slide(757).The power from the functional linkage over the lever(695;Fig.l) activates the slide(757) which is shoved along the rail(758).

Shifting the chain ring for one member to another can be effected over the zig-zag guidance of a wheel which is coupled with the spool(714). The detail below to the left gives in a size about 6 : 1 partial rolling up its course and at the same time the engaging the cam(759). This effects the transport of the sleeves by the driven rod to and fro. But here again the construction of the mechanism is provided in pairs affecting both spools.

Figure 11 shows a cross section along the largest extension of the device at a scale of about of 1 : 1 near the sidewall of the housing which again is provided in pairs for both sides. The mechanism for the skin squeezing shall be demonstrated. The detail in the centre shows in a longitudinal section the release stop(760) for the tension springs. To the right, the small detail of the spring arresting stop is shown in a frontal view (from the right hand), above in a cross section. Finally, a detail below reproduces the both springs analogous to the cross section of upper drawing.The lever strap(762) (with slot guidance for the axis connection with the ledge(763) for the fixing of the tension spring, while the connection with the ledge for the pressure spring is articulated, is moved by rope or tow(761) -perhaps over the shifting lever(695;Fig. which moves to the effect that the release stop(765) hinders the levrAabove).

The front slide(723) and the injection carriage(731) are bolted by the release stop(760) while the suction cup develops. The ledge with the roll(770) laterally descending (all again in pairs) from the lid(260) is lowered with the sinking of the lid against the pressure spring (287). Thereby (in the demonstrated stage) the wedge slants were pressed asunder. As well the tension spring (8), the pressure spring(732) is thereby tightened.

The release stop is activated by towing force from the drive for the cannula transport (functional block A).

The suction rims then approach with resilient suspension because they are connected by tension and pressure springs (8,732). The flanged nozzle(258) which was arrested after the lowering of the lid, was released (c.p.Fig.S) immediately after the suction cup was put on the skin and the latter was optically controlled(c.P.Fig.13,15).

The bag(257), whose walls are fastened onto the lid(260) and covering plate(283), expands ar.d works over the suction hose(129) lifting against the skin inside of the suction cup(l).

The detail below reproduces, in the cross section, the stage after the uptake of the measuring substrate, resp.

the injection. For this, the release stop(765) is triggered over tow-pulling from the functional Block A.

Tension and pressure spring(8,732) could be released by treading asunder the ends of the ledges(763,764). Pulling asunder of the ledges is promoted by the pulling the tow-line(774) which is fastened On the spur(773) of the ledge(763). The same is valid for the tow-line(775) over the return rolls(771,772). The latter leads around the release stop(/65). Both tow-lines are spring resilient and lead over a commun line to the control gear resp. functional block A (c.p.Fig-lt), The revolving roll(776) for the release rope of the release stop has its axle in its prop(777).

Figure l3 shows in a cross section along the section line C - D of the longitudinal section of Fig.l the arresting mechanism of the device lid in natural size.

The attachment of the bag(257) above on the lid(260) and below on the covering plate(283) is achieved over a longitudinal ripe profile of the bag in a parallel arrangement, which is shoved in corresponding grooves of the attachment surfaces. The profile is drawn at a distance, to the left, in the form of a dovetail, to the right, meander like. On the base or socket standing on the bottom of the device, the carriage(288) is slidable along the rail(289).

The tension spring(290) prevents that the flanged nozzle (258) can be depressed and with it the lid(260), connected with the nozzle. The cord(291) must be pulled first by the control gear (functional block A) over the roll (292; flanged nozzle to the left). When the flanged nozzle is depressed against the pressure spring(287; to the right), the border ring(778) of the flanges nozzle hooks onto the carriage(288). The latter is represented with its rail guidance below in detail in a frontal section.

A rubber elastic mounting of the plates of the flanged nozzle on the lid represents a lid of kesser-mount(780); in this way a power safety lid closure is rendered possible by unequally (in time) pressing down the flanged nozzles.

Figure tes reproduces, in a longitudinal section at a scale of about 2 : 1, the detail of a centrifugally operated switch as described already in Fig.19. The ratched gear wheels in pairs(703,702) and (707,706) were shifted to the left on the sliding switch(717;c.p.Fig.l4); thus the metering screws crn be spooled back this way. The direction of the motor chooses one of the two. Over a toothed wheel to the roll(699) the drive runs from the gear transmission wheels(54) after the motor over a toothed wheel to the roll(699). The slide(606) which is formed as pin determines the choice of the functional block, as the case may be either in the worm guidance (shaft) of the inner axle(715) -as drawn or in the worm groove of the outern cylinder(699).The slide(606) contains a portion which is permanently magnetic and is held in the roll in a more centripedal position by permanent magnets. With centrifugal power it is pushed with the motor rotating speedily outward into the worm groove guidance of the outer cylinder, in order to rotate the outer cylinder when the end of groove is reached. (During the continuation of the rotation direction, the speed of rotation no longer makes a difference for switching function). The switching situation shown would transfer, with rotations against the worm groove, the power over the inner axle(715) and the toothed wheels and the free-turning axle sleeve(781) over the switching chain(52) to the functional block A for the cannula retreat.

If the direction of the motor is changed, it would solely alter the direction speed for switching chain slightly.

(The motor retardation can be reached through electrical resistance or through an interrupted staccato current supply). With a more speedy run, a power transmission is achieved through the outer cylinder and the wider gear wheel to the gear wheel(701). The gear wheel rotates its axis and, through the axle sleeve(781), the ratched wheel (703). The bevel gear wheel(704) is driven over the gear wheel(782) and another gear wheel rotating on the same axle. Thus the bevel gear(709) is driven on the cross axis toward the corresponding metering screw (functional stage B). This happens through a border toothing of the bevel gear(704). The ratched wheel(702) goes out of function because its cam(783) has left its counterpart on the turning; bevel gear on its axle. The motor turning in opposite direction is transferred by the ratched wheel(707) in mesh with the toothed wheel(708) over the tube segment to the other metering screw. (The thread direction of the metering screws are suitably coordinated against each other in such a way no switching over is necessary on the centrifugally operated switch for changes of metering).

With the manual operation of the sliding switch(717), the ratched wheel(706) is pushed to the left over an annular groove into the axle and has thereby lost its axle mesh.

Figure)5 shows in natural size, the longitudinal section of another solution for the switching between functional blockes. Because in this case a switching happens in three different operation wheels, a sliding switch is not necessary for the spooling back of the metering screws. The metering screws are positioned for forward and back motion for functional block B or C, respectively. The free turning toothed wheel with the leaf spring (785) may approach to the pinion(351) through the switching bar(789) -on the final stage of the sliding function of the block A(c.p.Fig.ll)- by tightening the pressure spring(495). The forementioned toothed wheel lies in front of the pinion(351) on the motor axle of course, in close connexion with the gear transmission or reduction gear.This gear drives with sliding seal on the axis the operating gear wheel(293) for the block A.

Because the cam(783) moves into related recess, the preceeding toothed wheel is rotated by the pinion. This drives the operation gear(293) when the pinion is shoved to the right toward the operation gear(790) for the switching or functional block B. The cross pin(788) of the motor axis is moved and mounted in the (also rotating) flanged socket(786), inside of the coiled groove (787) with three recesses corresponding to the switch position. Each recess offers support, first, against shifting to the right of the motor axis and in the opposite direction after the shifting motion is released.

The last backward movement to the left is achieved by the tension spring(784) between the cross stay(791) and the housing wlll. As shown in the detail to the left at a scale of about 3 : 1, the cross pin is restored to a position corresponding to the functional block A after the functional stage B.

The pressure spring(495) is relaxed by releasing the pressure on the switching bar(789). The leaf spring(785) in the recess of the toothed wheel creates a division of the forementioned toothed wheels, so that the nap(783) leaves the pinion. Holding plates(124) can secure connection to further toothed wheels for the transfer of operational functions. The sliding sleeve inside of the motor axis is not drawn.

For variation, the flanged socket(789) can be secured against rotation. The motor power is then transferred to the pinion from a parallel axis through a gear wheel which is lead with the pinion in a holding plate connection. Thus the pinion(351) like the operating wheel turns freely around the axis.

Figure2below reproduces, to the left, in a frontal section, and to the right in a longitudinal section, and below in a cross section in natural size, a detail of the power transfer from the motor axis(51) over the operation gear wheels(790,23,792), tor example, to the ratched wheels(702,703;707,706) and other driving elements. When a switching gear (corresponding to Fig.7) is used, the power transfer is suitably achieved possibly according to the arrangement in Fig.ll. The insertion of the gear wheel(793) creates the interior shape because the mechanism for shifting the metering screw is placed in parallel position.

Figure 27shows three solenoids in longitudinal section and in a schematical composition for functional release.

Their functional organes come in approximate natural size as an alternative solution. The prolongation of the anchor or rod(l9) of the pushing solenoid(556) demonstrates its operational direction with dashed lines.

The lid mechanism for the suction production was released by the pulling back of the carriage(288) by means of the cord(291) over the roll(292). Thereby the pressure spring (287) was effective after the movement of the flange nozzle(258) was released. The tension spring(290) has already brought back the carriage again in its locking position.

When a border ring(778) is used as in Fig.5, an inadverte lid sinking iD not prevented with reventilation of the suction cup.

The solenoid(555) has not yet released the release stop (760) between the front slive and a ledge of the injection carriage(731) and therewith the skin squeezing is not yet achieved. Opposite the solenoid(556) the detail about the fixation of the tension and pressure spring(8,732) is repeated from Fig.4. The classed with lock(765) is actually activated after the release stop(760, above) and it should be in an engaged position for the leaning on the tensioned spring. (The latter are here in a released condition before the activation of the solenoid(556).

Figure S 8 gives an example for the transfer of a lever thrust movement -it may be caused by a motor gear or a solenoid on two functions, for example, the lid mechanism ane the skin squeezing. As scale of the mechanism, one was chosen to about 3 : 1 . The wheel segment(794) Is rotates arcund the axle(795). The cord(291) from the slide or sliding carriage(288) and the tow-line(799) from the release stop(760) are chosen according the length and mounting Flace on the periphery of the wheel sector so as to activate one another.

The symmetric between the periphery of the wheel and the device wall expanded tension spring(796) can produce a kind of release point, that is, a delay between the release functions which can be used for the optical skin control.

The leaf spring(797) on a cam of the driving bolt(798) in a bore of the slide presses the release bolt against the tooting of the wheel segment. The latter shows there a locking effect for the influence of the bolt in one direction; the backward movement is brought about then over power moments of another mechanism (not reffered to here) which is eventually classed with another functional block.

Figure 29 shc;ws in about natural size, in a longitufinal section, the detail of a power transfer to a func tion-1 block from a motor (not drawn) and an operation wheel. The operation wheel(792) chosen is specially large and lies under the pinion(800) which is driven from the former. In te demonstrated functional stage, the lateral naps(783) of the pinion approache likewise naps of the toothed wheel(802) firmly connected to the screw(801) about which the pinion can rotate. This is done to rotate .'iaid toothed wheel(802) and therewith the screw.

Holding plates(124) prevent the toothed wheel(80 ) -which without transfer function can also be a disk- from shifting latErally. The toothed wheel(803), is like a toothed whee(BO4), connected with the screw(801) but able to rotate abcut that. The screwed sleeve(804), in which the screw(80) projects, is firmly connected with the toothed wheel(803), The plunger for the thrust of the piston in the drug cartridge can be moved directly over the bar(806) whicn is connected with the screw(805).

Opposite working ratched Wheels(702,703) can overtake the transfer functions for the drive of a metering screw(c.p.

Fig.19 in connection with Fig;2b) in tooth meshing with the toothed wneels(8o3sol2 for example over flexible shafts.

(The coupling of the latter two with the inetering screw is then effected over separated toothed wheels which lay on a common toothed wheel around the metering screw radially offset to their common drive axis as well as the ratched wheels(707,706). If the pinion(800) is shifted on its screw(801) totally to the right, after the motor has changed its running direction, the naps(792) of the screw(801) mesh with one such on the toothed wheel(803). The latter and therewith the screwed sleeve(804) is rotated now. The screw(805) is now shifted to the right with its rotation preventing linkage(808). The thrust motion of the pinion(802) is transferred over the bifurcated rod(809) of the switching bar(789) while its cross pin(811) engages the ccrrugated leaf spring(810).The latter, with its bar in the pierced socket is therefore shiftable and jointwise ccnnected with the switching bar(789) which has turning asle stationary on the housing. The pick-off of qn additional ratched wheel rotation is to prevent the transfer of motion functions in the position of the pinion (800) meshed with the toothed wheel(802). The function, which in anb case, is secured over the corrugate profil of the thread wheel(814) pressed on by a pressure spring against a rotation locking of the former, is coupled off 5 pulling of the nap disks(815,816) asunder.The nap disk (815, or thc nap wheel) is in axle mesh laterally shiftable to the retched wheel. The nap disk(816) turns free on the axis anc stands in axis contact with the wheel with corrugated profil preceeding the toothed wheel(814) over the flexible shaft. (The corrugated profil is drawn again below; The detail below to the right shows at a scale of about 4 : 1, in profile view, a broken off drawn ratched wheel.

The paw tooth(620) is fastend with the axle pin on the ratched wheel wnich is determined for the drive from the drive from the motor gear. It is pressed against one of the ratched teeth(323) -likewise fastend on the toothed wheel by two pegs- on the backside of the brocken off wheel, which transfers the movement only counter-clockwise to the flanged nozzle.

Figure 30 shows at a scale 2 : 1 a toothed wheel with electrical record and a clearance of motion, as it can be used mainly for operation gear wheels, the operation function of which works only to one direction. The insulin metering is an example of this. The axle(223) is surrounded from the electrical noconducting isolating ining(224). The arrive pin(225) projects from the axle ileee(230)and pushes against the stop pin(226) which is roofed by th spring tongue(227).

To the right of the frontal section, a longitudinal secttion is shown in the section line A - B. The toothed wneel comes between the leaf springs(228,229) on shifting laterally. The spring tongue(227) is suitable then, when drive peg is adjacent to the toothed wheel; the side, turned to the latter, of the drive pin must be isolated then (C.P.cross section B - C above). The current flow ova:~ the axle toward the leaf springs(228,229) can be tap ped. As suitable a tooth or any teeth either can be isolated or not; the no-isolated allows contact with one or both leaf springs(228,229) that the number of rotations are controlled.The current conduction over the drive pin perhaps to one or any no-isolated teeth(231) on the counter sidle of the drive pin allows the free clearance of the gear, perhaps on a function less passage of the control toothed wheel or pnion to the other operating wheels.

Figure 31 shows an optical skin control mechanism inside of the suction cup (above in a natural size) with (eventually) controllable nozzle valve(378).

The injection cylinder(9) projects under the pressure donator(81, in dashed line because it lays behind) into the suction cupSl) being sectioned-on behind).

The injection cylinder with nozzle and the pressure donator can be replaced by a cannula with sliding car rlage and insulin cartridges(c.p.Fig.5).

The transparent glass or plastic measuring window(579) lies immediately under the nozzle(3). Beside, -for example, the area of the suction cup rim,- the light measuring arrangement with light emitter(580) and light receiv er(581) are shown.

Below the detail of the optical control device is repeated at a scale of 5 : 1. The skin fields or pattern are lattice like drawn under the window(579), additionally the light bam from the light emitter (or transmitter, as from a LED )r laser) through the window, there reflected from a concave edge against the skin back over its concave edge into the light receiver. From the cable connections are reproduced in each case only two on its final segment. Du -ing the raising of the skin, the skin pat keens are dawn past the window. The computer classifies, after the stand-still of this motion out of the stored skin portion measuring fields the over the nozzle resp.

over the diaphragm the area of the nozzle (or cannula if used) laying measuring field with the corresponding light exstinction. considering the speed of skin raising. (A task which s performed today by any PC-CAD-programme analogously). t can be determined in such a manner by the ;;rearing of of the functional running without injection bc5oite the id diaphragma is opened (or a cannula is pierced, if any). In the case of more imparts of pigments or in other kinds of imparts from comparatively normalskin, deviating skin area -at a spotted surface pattern (perhaps with akne or with freckles)- the skin knob can be lowered slightly by the opening of the narrowly placed nozzle valve(578) and the puncture can be performed at the moment in which a probable healthy skin area lies over the injection) nozzle (or cannula if used).

Figure 32 shows a plan view of the preferred form of the device (c.p.Fig.1) after the arrangement of the inner mechanical equipment is concised. The position of the suction cup(l) and the insulin cartridges(113,114) as well as of any cannulas is shown through the break off, above which the subsequent described surface equipment is continued. A sensor contact(817) corresponds to each circle on the rows of the device surface, with said sensor contact(811) reporting the finger contact,in the kind of earth fault to the control unit, and activates a switch. The touching is suitably confirmed over a light source, which makes the touching point luminous.For this airn, a pin with flasky colour face can be but roofed at the end by a transparent pot(818) which is depressed against a spring and catches with an edge ring behind the ledge(819),1ightening up the colour field during its fix inq. (Detail above to the right in a frontal section).

Th ledge(819) has regular edges recesses, as the cross l~e!~s der the detail. Suches ledges can extend now alorc in each ii row and can be operated, mcunted at a com on spring resilient frame, so that all pots are released for the upward movement. A similar (perhaps inverse functioning) device renders possible the reading out of inputs also to the blind. Display windows -perhaps as a fluid display- contain a time scale which moves from above to below.The patient ins now able to report, coordimated to the extended meal, also with regard to ites glu os content, to the control unit by means of the in lunce of the pressure against the sensor contacts.

Because the glucose content of the food is reduced during the progress of the digestion, an approximate triangle figure with a large base below comes up to this operation.

The basis breadth should be indicated on a larger recording tape thereby with higher glucose and starch content of the food. The precision of this programming can be auxiliarily improved by computer, but essentially that can be exercised mainly with the control of the results indicated on a recording tape(see below). The extent of planned body activities is expressed, time related, in Watts on lateral rectangles by contact operation.Exiting from the actual measured glucose tissue level and ccnsidering the inpu of personal insulin working constants and the working profiles of the used insulins, the height and the mixing relation of the insulins is now explored by the computer and the decreasing triangle of these is brought about in concruence with that, which the patient nas drawn in; if it is necessary to warn against absurdities of the rogramming, the injection is performed according the passage. For example, an input of the food and labour charge. is drawn-in in dash-and-dot lines, formed as two triangle and two rectangles between the sensor con texts To the right, the virtual image of the derivated computer operation is shown, The programme inputs are drawn in dashed lines, whereas the computing results are reproduced 1l dash-and-dot lines. Dangerous outline break downs(821) induce the computer to warning signals while it marks the date in case the gape can be closed only with disproportionate dosage alterations.The pa tient shall then complete the food or take a measurement at the questionable date.

This extension of the possibilities for programming exceeding the condition of PCT/DE85/00313 on 1985, now allows dosag adaption also of the depot insulin adjusted to the planned routines of the day by the patient and, therewith, a more independent life style.

The dosage intending special program blocks adapted to the course of day (sport or bureau day) and the fixation for laying down of steps for emancipation of the patient related to his cooperation are, of course, the further fundament.

One of any given example for a trial and error definition of tne constant or multiplication factor for a dosage of immediatiely working insulin, may be proposed: 60 min. after a meal with 3 BE (bread units)and 90 min. after the injection of 10 Units insulin the measured value < 100 mg% may stand for K = 0,5, < 120 mg96 for K = 1; < 140 mg% for k = 2; < 160mg% for K = 3; < 180mg96 t;= 4. For this aim (of programming) the hand switch wheels(822) are arranged along the device wall(16) to adjust, cow related to their scales, sensivity constants (k), death (or warning) point with regard of the glucose content and correcting frame as well as program blocks.It shall still be mentioned that the device could be used also only for diagnostic aim (also without injection), perhaps for the-control of substances excreted by the kidneys. But the device could serve ex ceptionally for injection use, when accordingly simplified, for example, for the application of heparine. The sliding switch(717) on its rail guidance is still crawn-in above (c.p.Fig.6).

Flqure 33 sl;ows, in a longitudinal section, a suction cup (1) with an optical skin control, a variation of the skin squeezing mechanism, and a device fot the tempory prevention of the cannula piercing through the skin.

The scale is 2 : 1 for the mentioned portion including the cannula piece(4). For the clarification, the scale for the carnula sleeve and the optical measuring device is about 4 : 1 . The setscew segmetn(825) serves for the skin squeezing after the latter is raised over the suction hose(746). The setscrew segment(825) serves for the skin squeezing after the latter is raised over the suction hose(746). The setscrew is moved thereby bythe pressure spring(732) and has a rough terminal claw. In theshown stage,the pressure spring is arrested below by the supporting stripe (826;Fig.3 below) in a compressed condition.

(setting forth next page) The drug is feed for injection use out of the insulin cartridge(ll4, properly spealing out of its retaining cap) over the feed line or channel to the cannula groove(40) of the cannula piece. To hold the cannula certainly inside of the skin until the uptake of tissue liquid, the support(45) -properly three supports regularly spaced around the circumference (c.p.Fig,17, centrally)- surround with their terminal the wire bow (827) around the cannula(4). The bulb like thickened end props on a slot inside of a trough(828 on the suction cup roof.

The light source(30), containing the photo cells, is fed from the shunt wire(25). Two light cones or beams are drawn in with dashed lines, with upper portion directed toward the central skin area, where the cannula punction shall be performed. The lower light beam is directed toward an adjacent skin area of equivalent sie, to allow a comparison of attenuations.

The conditions inside of the folded bellows(26) with the sleeve(691) surrounding the light conducting fibres retreat behind the cannula piece(4) while the folded bellows are overextended. One at a time, fibres, securing a constant localisation, are diagrammed that Ls, centralizing fibres of high elasticity are diagrammed between the sleeve and the folded bellows and between folded bellows and light conducting fibre. The guide pin(6) of the apparatus is introduced, with its conical tip into the relating funnel of the end of the. folded bellows, which has two drill channels(824) for light rays, aboVe covered by (not shown) transparent membrane.The light ray leads from the photo trasmitter (perhaps a LED,580) along the folded bellows to the tilted mirror belt(823) and from there to the colour measuring layer at the lower end of light onducting fibre. The light path leads back again to he mirror belt and through the other drill channel to the light receiver(581).

Figure 35 shows in a longitudinal section at a scale of 2 : 1, a variation of a display and measuring device by means of an optical sensor thread. The cannula and the carrier thread(833) of plastic or paper, which shall be shoved through the former are overdimensionned. Only the cylinder(834) of absorbent material (as silicagel) with the reaction layer(27) on each the end serves for measuring proposals, and is enlarged outwards to the right, but is in the reality smaller.

Solely about the poisonous reaction layer, a lid-like resp.sleeve-like transparent coating is necessary as an outer membrane(38), perhaps of polycarbonate. The carrier thread is connected at the other upper end with a piston which is shiftable inside of the sleeve(691).

The guide pin(6) is introduced from the device into the bowl of this piston and engaged about its knob like swelling like a snap-fastener. This circumstance shows, that the carrier thread has been depressed for the uptake of tissue liquid. The cylinder(834) lies inside of the (longitudinal) bore of the cannula piece(4). Bent tube segments(831) approach the said cylinder through bent bores of the cannula body or piece. This is done in pairs and in opposite directions through the influence o' the pressure spring between the arms of two hinges(83?). The release fork(835) hinders the retreat of the turds segments by influence of the tension springs. Their tension mechanismus, accomplished by carrying hem from the functional block A for the cannula advance, is not shown because it is analogous to described mechanisms).The carrier thread is broken off from its reset breaking point or groove, adjacent to the reaction layer, from the measuring active cylinder (834) during further retreat. The measurement of the light attenuation, caused by colouration because of influence of glucose, is achieved through light conducting fibres inside of the bent tube segments opposite each other, -by functional division- from the light source to the light receiver (both not shown here). The light conducting cables to the bent tube segments are partially drawn in lines.

When the guide pin(6) has totally retreated it leaves the bowl in the piston(830) after the withdrawl of the cannula shaft(41) into the sleeve while the spool for the transport of the chain ring of cannula resists. The drug inlet openings lay across the bores for the bent tube segments. The annular groove in the cannula piece is replaced by two small (not shown) funnels which flow over the end of the cannula shaft with the latter bellow the cylinder(834) with the reaction layers.

Figure 36 shows in four functional stages A - D a variation of sensor cannulas, for example, for an electrical metabolism measurement in a natural size in the longitudinal section, with the sleeve(691) being shortened.

The guide pin(6) has already entered the bowl of the piston(83) at the stage A and its inner conductor therewith has electrical contact with the end of the metal thread(35, perhaps of platin) which is bent over on the bottom of the bowl, serving as an electrode and coated enzymatic and enzymatic at least on its other end (with GOD or sepharose-convalanin A or similar as the choice may be of an active or passive sensor).

At stage B, the piston(830) has been lowered to the contact with the cannula piece(4) so that the sensor thread contacts the tissue liquid outside of the cannula shaft.

At the stage C , the cannula piece has been retreated with cannula by the auxiliary thread(836) during the retraction of the guide pin into the sleeve; the sensor thread lies in an electric effective portion of the central channel of the cannula shaft, which serves as electrode jacket (being also steamed perhaps with silver). A contact thread leads from the silver layer cross outwards and contacts with the measuring instrument over an annular conducting zone(837) on the sleeve with the conduit(44).

At the stage D the piston(830) has been retracted into the sleeve by the lowering of the guide pin. Thepiston is slipped off from the border of said sleeve by means of the advance of the release fork(835) while the guide pin is retreat, and the piston remains in the sleeve for the cannula change.

Figure 37 reproduces at a scale of 2 : 1, in the longitudinal section a sensor cannula on an electric measuring base. The measuring technical equipment is analogous to that of Fig.l9. For space saving and the securing oi better contact of the sensor thread with the tissue liquid, the sensor thread is reeled inside of a spool wiLh spiral guidance, the eventual core of which being omitted on the drawing.-This spool(834) can be rotated over a square recess by means of the guide pin. The cannula itself is secured against turning thereby, for example, over a nap with guiding groove in the sleeve not shown. The sensor thread (metal thread or metal thread with the addition of a synthetic thread, which is customary by the coating) is shoved in advance in a coil again by its manufactured spiral form outside of the cannula point.

The sensor thread is retreated behind the drug stream and thereby wind up again in the spool (the corresponding cross bore to the cannula piece is not shown).

This is ne through a rotation of the guide pin in the counter correction. It can be suitable to dull the inner contour o' the cannula point to avoid a damage of the sensor laer.

Figure 38 demonstrates a mechanical gea transmission in a horizontal section at a scale of about 1 : 1.

(But considerable diminishing are possible belonging the choice of the gear wheels and at the piston of the thrust bar, because only negligible power is necessary).

The drive runs from the motor axis(53) over the transmission gear(54) to the square axle(627). On the latthe toothed wheel(630) connects slidable with the pinion(800) over the holding plates(124). (C.p.below, the frontal section along the section line A - B ).

Only one(37) of the ratched wheels is shown for the drive of both metering screws *in the horizontal section. If the lateral naps of the pinion(800) meshes with such of the toothed wheels(802,803), the latter are also turned with the, at the time, rotation direction of the pinion. The cross bar of the annular sleeve(571) is swivelled into a annular groove in the head of the leverage(996) and is able to slide the latter until a new switching by thrusting on a stationary housing ledge, which here is rounded, by means of the torsion push mechanism. This is done with the pendulum motion of the pinion(800) on its screw and serves to the cannu;a thrust resp. for the cannula transport (or motion) through the leverage(996).The end phases with the ap contact of the toothed wheels is intended with the pendulum motion for the metering, but this end phase are avoided for the movement of the leverage. The ached wheels can change their direction with spring resilience with the sliding switch(717), as shown to the right hand, but also valid for the ratched wheel (631). The reversion of motion can, of course, achieved immediately between the transmission gear(54) nd the toothed wheel(630).

Because o. the negligible friction through the meter ing, a brke ke spring(998) is suitable, which is adjust- ed against the toothed wheel(803).

Figure 39 begins with the description of an example of automatization of nearly all functions. For this a preferred sensor cannula with the connecting detail of a suction cup is shown in a longitudinal section on a scale of 3 : 1 and this in different stages.

To the first upper functional stage, the cross section through two cannulas is shown to the right, which are chain like connected to each other by means of two threads, each between cams(l0l) on the sleeve(691), from which only one thread connection is shown.

The sleeve is oval for a secured position of the drug inlet bore(103) over the drug inlet openings(750), as described in the lower stage.

The cannula piece(4) from which the shaft projects, is a portion of the sleeve(691). The sensor thread with a metal filarent(35) in the center is inserted through a bore of the suction piece. The metal thread terminates in a bcwl-like excavation(104) and makes contact there with the central wire(l05) in the pin(6). A current stream is isolated from the center ove the conducting outer layer of the sensor thread and the surface of the elastic sliding stopper which has the excavation(l04). The peripheral line(106) on the pin leads together, resp.parallel, to the central wire to the measuring instrument(74, Fig.16,51). The sensor property ccrresponds to the executions in Fg.l2, but can also differ from that.Light conducting fibres are drawn in the intermediate sleeve(l07), which are connected with the optical control device(l07, Fig.51) and was signified by light emitters(580) and light sensors(581).They permit the skin control directly over the potential puncture area. Intermediate sleeve(106), suction cup(l), screwing cap(108;Fig.50) for the insulin cartridges(ll3,144; also Fig.14) with ccnnection cannula (llO;Fig.50) are manufactured suitably as exchangeable components. The cam(102) serves the movement of the sleeve(691). The elastic sealing lip(1l2) in front of the funnel(749) in the suction cup surrounds the sliding sleeve(lll) until its withdrawal of this, thereby reventilating the suction cup.

On the second described stage the sleeve(691) was wholly shoved into the funnel, the sliding sleeve(lll) was forced from the intermediate sleeve(ll6). In the last lower stage, the sliding stopper was absolutely displaced in direction of the cannula shaft by the drift of the pin (6), so that the sensor thread has left the cannula.

Figure 40 shows, in natural size, a vertical section through the right half of a device. The upper section follows to the section line A - B of Fig.46 and shows the slant position of the sliding latches or bars(l15,116, 117) in the sidewall of the skin squeezing sliding sheet (9). The sending latch or bar(ll5) guides angularly on its end fastened sliding straps(l18,120;Fig.47) for the backward and foreward transport of the sleeve(691) in the stage D and position D of the hook-like hammer (121) of the pulling solenoid(554, suction plan E - F below). The sliding latch or bar(ll6) mcves the sliding strap(122) which is activated on hammer pcsition A(Fig.

33). The sliding latch or bar(ll7), finally, moves the levers(123,185;Fig.45,46) in hammer position C.

The middle depiction corresponds to the vertical section along the section line C - D of Fig.46 and shows, that as well the sleeve(691), the insulin cartridge(113), the metering mechanism is inclined toward the suction cup.

On the fork(46) for the cannula shifting, it is visible how a spring claw has even overcome the cam(102) on the sleeve with the cannula. But the sliding straps(l20,118) are shown bent downward into that suction plane and serving also the forward and backward motion of the fork(46). Slidable along the two rails(738) inside of the housing cover plate -of which one of both is shown-, straps(739) support the preformed folds of the roof of the suction cup(l).

The hose(7) leads from the suction cup to the plastic container(l26;upper section). A further hose(128) connects the plastic container(l26) with the plastic container(l27); a third hose(129) leads posterior to a back valve(133) to the pump(129;Fig.48).

The lower image corresponds to the vertical section along the section line E - F on Fig.46 and shows a slant pcsi- tion of the solenoid(554) and the sleeve(571) of the torsion-push-mechanism operated by it.

The end of the hammer(l21) is positioned over the slive (130) appropriate to the functional stage B, which has a edge or cant bore for the cant bar(l31). The latter is mounted, gallows like (with cross beams) and as oblique as the hammer on the housing bottom. The strut(132) is dislocated along the the sliding ledge(c.p.Fig.44) over the movement of the slide(130) with a solenoid stroke.The lever(133) opens the seat valve(134) by the valve rod.

The air inside of the suction cup is sucked then over the hose(7) to the plastic containers(l26,127) when negative pressure exists there. The slide:130) is retired to the right by the cord(136) over the reversing rolls by the tension spring(l38;Fig.46) against the strut(l35) on the plate of the switching stick or frame(l39). As shown in the detail above to the right in Fig.44, a overcoming latch is provided for the skin squeezing mechanism, to the right the detail in a vertical section through the hammer end.

The detail to the right and above(Fig.40) shows a possibility of the sliding bolts in the back-wall (upper image) of the sliding sheet(9) of bearing nearly together.

Figure 41 shows in a longitudinal section at a scale of 2 : 1 the sleeve(571) of the torsion-push-device with the hammer(l21) for the explication of the switching over between the particular functional stages A - D.

The sleeve(571) shows the inside of the zig-zag groove in which a small cross peg of the prolongated solenoid anchor or bolt engages and effects a quarter-turn of the sleeve with each stroke, as far as the solenoid bolt is secured against rotation. The rotation is transferred over the coiled spring(141) and the flank with spherical seat(142) of the hammer to the latter. The hammer shaft is rectangular to the right (that is: distal) and is prevented from rotation in the fixedly mounted bush(143). In the demonstrated O-position of the solenoid bolt, there is a circular cross section or radius inside of the bush(l43) so that the torsion effect can operate. (Of course, without coiled spring, if the connection between solenoid bolt and flank with spherical seat is respectively elastic).

The hammer area in both detail images below shows a mechanical stop sleeve(144) which as a half groove stops, in each case, the rotation over a respective operating member (A - D). For this there is an angled piece with a passage for the stop sleeve(l44) and for the horse-shoelike bent around pin(146) with terminal disk for the biased pressure spring.

The lower image shows, as the cam(147) of the hammer has lifted the sleeve(144) against its spring, that the axle rotation is released by the coiled spring(l41) yet tensioned over the sleeve(571) and eventually held in a permanent pretension). The cam of the hammer meets resistance then on the next positioned sleeve(as 144) because the latter lightly springs back against the hammer rotation. Thus the stop mechanism can be found radially distributed (c.p.Fig.44, detail to the right above).

Figure 42 shows a vertical section through the device along the section line A - B of the Fig.48 in a natural size. Both insulin cartridge (113,114) lay inside of the spring mount(311) which on its part is connected by the mount(148) with the cover plate. Above the insulin cartridge the respective metering mechanism(c.p.Fig.28a) is positioned. The sleeves(691) with cannulas are conducted by a chain on two threads over the wheel rim of the spools(714,151). The chain is circularly closed by two hinged spring clamps(l52); in each case, a sliding lid (153) is laterally provided on the housing. The stressing thread(l54), mounted in pairs, can be tensioned by means of a pair of tweezers or tongs (triangles!) with limited elasticity.Thereby the spring clamps are opened and can be romoved from the sleeves or stucked onto these. The magnet(l55) mounted by means of an angled piece on the covering plate, locates the position of the spring clamp. Rolls(156) between sliding sheet(9) and housing(l6) serve the skin squeezing mechanism. Hand switch wheels or wafers(822) permit the programming by patient and physician.

Figure 43 shows in the longitudinal section at a scale of 2 : 1 a metering mechanism(c,p.l25;Fig.42). Two solenoids(554,555) are joined together to activate the metering screw. The solenoid bolts work against small wedged teeth of a gear wheel (shown partially rolling-up) with its spherical end. The gear wheel(637) is rotated by the solenoid to the left(554) over a ratched wheel, with the gear wheel driving the metering screw(l57; Fig.48). The action of the solenoid(554) occurs respectively, but the rotation effect is increased by the intermediate gear(997). The ratched gear wheels arranged to run in opposite direction effect, one with the other the rotation of the gear wheel(637), or at least donnt hinder one another. Coarse and fine metering and therewith the total metering can be effected quickly in such a manner.

The rotation and the arresting of the wheels shown in a rolling-up are secured by disks with wave profil in which the leaf spring(654) engages respectively with arresting effect as shown to the right on a vertical view of such a disk with spring. The leaf spring suitably touches electric contacts inside of the notches of the disk and thereby reports to the electronic control unit the position of a perhaps connected metering screw and the number of its rotations. To turn back again the metering screw out of the insulin cartridge after the drug is emptied, the angled bar(l63) projects from the bolt of the solenoid, the end of which meshes to the wheel(l61) with wedged teeth (shown again in a rolling-up), if the latter is approximated to the angled bar over the sliding bar(l62) on the cover plate of the housing.The operation gear thereby takes the sliding bar with parallel axles from the mesh with the laterally fixed gear wheel(l60) which had driven the metering screw over a shaft with gear wheel.

The operation gear wheel(260) is brought into mesh for this with the toothed wheel(637) over the sliding bar (the springing along the axles being not shown), the former driving the metering screw over the shaft (not shown) with toothed wheel. This is dcne correspondingly to the other wedge tooth position in an opposIte direction.

Figure 44 shows the skin squeezing mechanism in a horizontal section at a scale 1 : 1 with shortening of the length of the left hand half. Each of the four pressure springs(729) is supported against its receiving cap(165) which is mounted on the margin of the sliding sheet(9) and on the countersideagainst the stop bloc(166). The pulling row(167) is fastened on the receiving cap and at the released bolt(168). The trigger slide(169; detail above to the left) engages in an annular groove by a spring biased cross pin.The ends of the two opposite mounted tiger slides are overlapping one another and adjtcentate,lehe bolt(l70) with edge deflections one opposite the other, the release bolt is joined to the switching stick or frame(l39) transferring its motion also to the other half of the device. The tensioning of four pressure springs(729), each, by a tow-line(171) which is fixed on the release bolt(168) and whereby the drive of this motor axis(51) leads over the gear transmission(l72;Fig.46), the three-wedges-disk(173), the coupling disk(l74) and its axle sleeve toward the bevelgear wheel(175) transmission to one of the cable winches (176,177).Both tow-lines of a small side are coupled one with other thereby after their passage of the roll (292). The tension springs(729) lay in (not made visible) excavations of the bottom plates of the housing. The connection between both sliding sheets and the suction cup (1) is effected through the supporting pillars(724,725,735, 736). The transformation of the suction cup after the release of the sliding sheets is shown in Fig.

51. The seat valve(l79) for the derivation of the air out of the suction cup through the hose(7) is positioned at a higher level and is shown off again as a detail at a scale of 2 : 1 above in the middle. The valve rod presses into its seat by means of the elasticity of the cover membrane which is fastened onto it. The swivelling lever (181), which turns around a central axis, is operated for the valve opening by a strut(l32) on a sliding ledge(182) guided in a rail.

This occurs on the functional stage B (cross resp.vertical section above to the right through the end of the hammer) by the operation of the slide(l30) when the hammer strokes with the activation of the solenoid.

The slide(l30) is guided thereby along to a cant bar(l31) as described to Fig.40 below. During the retreat of the slide(l30) by the cord(183), which has tensioned the tension spring( 38;Fig.46), the strut(l35) on the switching stick or frane(139) is carried along and the skin squeezing mechanism is released. The retrait of the four trigger slides(169; detail above to the left) against the pressure springs through the influence of the release bolt(l70) on the ledge deflections bent to counterside, one against the other, of the wedge obliquities, is explained witn the detail above to the left of the middle.

The detail of the strut above to the right shows that the said strut has a spring biased joint which permits it to the slide(130), moved by the hammer, to overcome that strut by tilting the joint without transport, if the solenoid is activated for the release of the suction -by carrying along the strut(l32). When the slide(l30) is returned by the influence of the tension spring on the cord (183),it transportes the strut(l35) and activates the skin squeezing mechanism. In the final stage of this movement to the right, the slide(l30) moves away over the strut(l35), but also because of the slant guide of the gallows, so that the strut(l35) can be moved to the left during the drop-in of the trigger slide(169). But a spring can be used instead of the resilient joint.The slide(l30) projects a bit shorter against the strut(l35)(Detail above to the left).

Figure 45 shows, in a natural size, the power transfer for the functional stage C. When the solenoid is activated, the hammer(l21) hits the lever(l85), the longer portion of which is mounted with a joint on the sliding bolt(ll5) inside of a telescopic guide. On-that joint a further lever(l23) is fixed again with telescopic guide, the rotation axis(184) bisecting the distance between the sidewall of the sliding sheet(9) and the pin(6) which can be lowered into the sleeve(691). The dashed line shows the lengthening of the distance for the (negative) solenoid stroke. By this, the lever(123) repeating the inversion of motion, its bifurcated fork end between the the final rolls on the pin(6) carries the latter and thereby shoves the metallic filament resp.sensor thread out from the cannula. Beginning with the first motion phase, the leaf spring(186) works to the slant on the fork(46) and pushes the sleeve(691) up to the stop, so that the cannula pierces the skin. Continuing the push mcvement the curved end of the leaf spring(l86) glides then from the slant of the fork(46).

In Fig.46 the sliding or braking spring(l87) here shall also be supplemented, which uses the friction for the fixation of the fork(46) and therewith of the sleeve(691) but during the retreat of the sensor thread.

Figure 46 responds to a horizontal section in natural size through the device side to the right again in a functional stage C (as the vertical section demonstrates through the hammmer end to the right). A part of the power transferring was omitted.

The tension spring(l38) stands over the cord(183) which is defelcted on rolls, connected with the leb'er(l85). The resilient spring clamps(l52) serving to close the cannula chain. Before cannula chains are changed the computer can determine, that the spring clamp can be arrested under the sliding lid(l53;Fig.42) The resilient rail with groove also serves for the centralizing of the cannula before the funnel leading into the suction cup.

The motor is mounted upon the sliding sheet(9) by the angled stop(188). The thrust motion to the housing(l6) is facilitated by the rolls(156). The dashed spring stripe over the fork(46) operates the thrust notion to the sleeve with the cannula at a cam positioned rectangularly to both(102) whjch are demonstrated. Two motor cells serve as pump(l40) sti.ggered one against the other at about 180 angle degree to a kind of circular piston motor, according to Wankel, with seals adapted for less heat development(see: Die Technik im Leben von heute, Meyers Lexikonverlag Mannheim/Vienne/Zuric 1986,p.294).

But another pump can be installed for the suction production before every use.

The three way disk (frontal view of the detail to the left) is driven from the motor axle over an axle on which it is slidable on one wedge breath in a square seat.

The three wedge lamellas project on both sides with steep flanks in opposite directions on both disk surfaces and correspond such wedge ribs on the adjacent coupling disks(l74,178). The coupling disk(174) drives the beveled-gear wheels (175) over its axle sleeve, when the coupling(178) locks the steep flanks one against the other by By means of their pressure spring after the drop-in of the opposite steep flanks of the wedge laminas.

The coupling disk or clutch plate(178) is rhythmically urged away about wedge breath on each turn, because the wedge lamina touch one another but are not able to hook in. That is done first, when the motor pole is changed in the opposite direction of rotation whereby now yet the three wedge disk(173) rhythmically is left away from the clutch plate(174). But one may use counter acting ratched wheels (the axle sleeve of the clutch plate toward the pump inserts with a peg into a longitudinal groove and permits, this way, the lateral floating mcvement).

The hose(129) leads from the motor cells to the plastic containers(l26,127;Fig.40).

Figure 47 gives in a horizontal section, in natural size, the functional stage D (corresponding to the vertical section through the end of the hammer to the right).

The hammer works to the lever(l90) the rope connection of which to the tension spring(138rFig.46) is not shown.

But a cross prop(l91) is shown as serving for the function. The sliding straps(l20,118) are arranged one after the other on the sliding rod(115). The solenoid stroke effects first the retreat of the sleeve(691) together with the sliding sleeve(lll) out of the funnel toward the suction cup, so that the latter is reventilated after the cannula is retracted -as far as the sleeve seals the drug inlet channels and protects these against pollution.

This is done, ccrresponding to the distance between the sliding straps(120,118), by the thrust of the fork(46) on the slant of the former by means of the latch or bar(l93).

The function of the spring trough or recess(l94) is explained also with Fig.48.

Figur 48 is a horizontal section through the right hand side of the device, in natural size, and shows the operations and assumptions for the functional stage A.

The position of the insuline cartridges(ll3,114) and of the metering screw(157) in the depth above the cannula is also indicated. The slanting section corresponds to the center along to the sliding bolt(ll6,Fig.40). The cross beam(196) is moved by the former over the lever(122).

The stop spring(195) of that is engaged at first with the spring trough or recess(l94;Fig.47). The cross beam therewith the sliding strap(l20) is carried along with solenoid stroke and then the sleeve with the cannula is retracted on the sliding strap by the latch or bar (192). But the arresting of the fork(46) in spite of the movement of the sliding bolt(115;Fig.47) effects that the stop spring leaves the spring trough or recess before the lever(122) stroking against the cross pin(197) on the actuating rod, the cam(759) of which engages to a zig-zag groove at the inside of the spool(l51) and moves the latter. The spoole is rotated thereby for a cannula breath as shown on the detail to the right. The actuating rod with the cross pin(l97) is spring resilient (backwardly) guided along the wall bush(l98).The analogue device is activated on the second spool(714) at the same time.

During the return of the lever(122) by influence of the spring tension, the spring trough or recess(l94) comes again into the stop spring(l95) and pushes the new sleeve with the cannula forward to the funnel(749) so that the latter is sealed up again. A new measurement and injection cycle can now begin.

A detail in cross section to the right in the centre shows the guiding bridge(l99) for the cross beam(196).

Below the detail for an optical-electric control of the switching positions of the hammer(l21) is shown. The disk(200) hides the light beam(580-581) during their depression. On a frontal plan view to the right, the position of light emitter(580) and light receiver(581) become yet clearer. When the hammer is reset after the solenoid action by spring power, the former can change quickly again from a short radius to the subsequent square zone where it is secured against rotation. A short current impact, which is interrupted by the light beam, can bring back the hammer with its radius into the fixed bush(143), so that the coiled spring(l41) is effective.

Figure 49 shows at a scale of 2: 1 in a horizontal section, and below in a vertical section, a mechanism for the coupling off of the solenoid switching mechanism and for a switching over to permanent operation of the cannula change for an exchange of the cannula chain.

The hammer (21) is shiftable in the fixed bush(143) with a largely rectangular bore. The hammer is set up from the flange(142) stating around the terminal disk of the rod (203), which is connected with the solenoid anchor or bolt. Near the end of the hammer, a disk(202) exists the rim of which is enlarged toward both sides and surrounded by at least one clamp(203) from which an axis rod(204) extends through the rotation axle of the lever (205) with clamp rings against a sideward shifting and is firmly mounted in the supports(208,209) for bearing.

Along the latter, the rocking lever(210) is shiftable on which the stick(211) is fixed which leads to the actuating rod for the cannula change(c.p.Fig.48). The vertical section through the device below shows the sliding key(212), which is guided in lateral rails (213) in the housing wall of the device drawer-like and a trapezoid profil which is pulled along under the lever (204) -resilient against the latter- resp.the rocking lever(207) so that one at a time lever lays horizontally and thereby engaging to the flange(142).

After the sliding key(212) is either pulled on or retreated, the stroke motion of the solenoid is transferred to the hammer or to the cannula transport mechanism.

Figure 50 shows a horizontal section through a step syringe as is customary in the trade. The insulin cartridge (but it could be a heparine cartridge, for the prevention against blood coagulation) os screwed into the rotary cap(215) with the cannula. The cannula is bent away and suitably welded with the wall of the funnel(749) of the suction cup.

Figure 51 shows, at a scale of 2 : 1, a horizontal section through the device, which demonstrates the folded roof of the suction cup(l) in a developed and squeezed condition.

Except for prior described portions, the battery(218) and electronic control unit(217) is shown, as long as not a computer (for a testing apply) is not plugged in.

Figure 52 reproduces also a pump for the vacuum production as borrowed from the dictionary. The spark plug is inapplicable of course. Instead of this, the central gear wheel is driven from the motor(c.p.Fig.48) and the input, signified with an arrow, is connected in any case with the hose(l29). A membraneously closed gap on a plastic container(126;Fig.40) can serve as a pressure gauge or more simply a timer device of the control electronics. The back valve(l29;Fig.40) at the orifice of the hose maintaines the pressure difference inside of the plastic container but after the motor is switched off.

Figure 52 gives a detail of the programming board on the broadside cf the device at a scale 2 : 1 above in a vertical section along the alongside of the device and below in a corresponding horizontal section. The example makes more precise the solution to Fig.15 and is a refinement of that. Over the cover plate(283) a further lid (219) is mounted on the side wall of the device detachable with its marginal ledge. The plug(220) stands in rows with corresponding holes on the lid(21)) into which the pegs project.The hole is so large, that the trans parent cap or pot(818) on the peg(220) is downwardly shiftable against the wire or leaf spring(221). Or account of the leaf spring(222) between the adjacent ledges(819) the latter makes way for the slant of the annular ccllar on the end of the cap or pot(818) and the latter on the steep flank of their annular ccllar in a depressed position. A flashy (perhaps green) colour coat on the upperside of the peg(220) is visible through the pot. In case the input with pressure up on the pot(818) is cancelled, the key(293) must be pressed therefore against the pressure spring in the guide clamp(294) of the lid border or rim.The ledges(819) have regularly spaced incisions or notches(295), so that all caps or pots of the row return upwardly to the O-position by means of their wire ore leaf springs(221) if the key is pressed. The movement of the ledges is made possible by their recess(296,above). Each ledge is secured against rotation by the profil nose(297). The profil nose surpasses the key sheet and can be turned between both pins (298,299). After the glock-wise rotation up to the stop, the profil nose can disappear in the slot(313) of the lid rim.

Figure 53 is a schematical functional set-up of the electric circuit control. The operation of the hand switch If the three sensor contacts on the rim of the suction cup(l) report earth fault(301), fed from the battery (255), effects the current to interrogate in the electronic control unit (e.c.u.300), if a locking or prohibition is programmed there. Influencing is only possible then over a hand switch wheel(822) or over the key board on the lid(219). The next interrogation relates to the presence of a cannula before the funnel of the suction cup.

The sleeves(691) for cannulas are suitably coated with metal so that the solenoid(155) on the groove before the funnel to the suction cup can escape. The conductive bridge, which connects the spring clamps(l52) between the cannula on the groove and the neighbouring one(691) is tapped over the contact on the groove and the contact spring for that. The current stream between the groove and the contact spring confirm the presence of a sleeve with cannula. The counter or computer is able to ascertain from the total amount of cannulas and from the distance of each cannula from the spring clamps, which close the chain, and from the frequence of use, if a cannula is yet an unused one. From the e.c.u.(300), the command starts for the opening of the seat valve(134).

After this, the question ensues over the light emitter (580) and the light receiver(581), rather the skin, is on the suction cup rim from inside. Light source and sensor can be directly mounted in the funnel of the suction cup; but they also can admit there light conducting fibres and receive the latters(c.p.Fig.39). The measuring signals are measured at least on two adjacent skin areas (spots) and the grey-values can be compared one with other, as Fig.60 demonstrates. The squeezing mechanism for the skin is released then.

The sliding sheets(9) have a slight deflection of their edges downwardly to the skin. They have a sharp bottom edges and a cross rippling of the edge region. One may eventually renounce the application of suction before the squeezing of the skin.

Before the suction release in the functional stage B of the hammer(l21) the release of the stage A is due to change a used cannula and to seal the funnel to the suction cup with a new one.

The interrogation from the light emitter and sensor takes place again hy the e.c.u.(300) to control the scheduled prick-in area. If the differences of measured values are too high, a command from the e.c.u.(300) to the motor shall be exited to produce suction again for a itineration of the measurements while the skin is yet slightly drawn back.

In the case the measuring differences are still to high, the alarm(304) is activated.

The button(306;Fig.44) can be pulled then over the towline(305) emerging from the seat valve(134) over the roll (307) on the cover plate, to ventilate the suction cup, in case the commands to the motor for a tensioning of the tension springs(729;Fig.44) was not yet succesful.

After suitable skin condition has been confirmed, the solenoid with the hammer(l21) is operated at the functional stage B and thereby the cannula is pricked into the skin and the sensor thread pushed under the skin. The solenoid remains activated for 2 - 4 seconds resp. for the time for saturation of the sensor thread with tissue liquid, then the sensor thread is retired.

The current, derivated from the sensor thread, is admitted to an amplifier to the measuring instrument and the measured values signals to the e.c.u.(300). After the measured values are compared with the metering programme, the solenoid(554) and the metering mechanism(l25) receive, if need be, impulses for the injection.

The injection amount is ccunted and controlled on the contacts(654). After the injection is completed, the solenoid with the hammer(121) is activated again by the e.c.u.(300) at the stage D and thereby the sleeve(691) is retired and the suction cup ventilated and the retreat of of the sliding sheets(9) by the tension of tension springs(729;Fig.44) is initiated with impulse to the motor.

The four stages for the hammer(l21) of the solenoid are listed as follows: A) ON The sleeve(691) and the elastic sliding sleeve(lll) are retired from the funnel of the suction cup by means of the fork(46) OUT The elastic sliding sleeve is pushed into the sealing lip(112) B) ON The seat valve is released OUT The stop blocs(166;;Fig.44) for the skin squeez ing are released C ON The sensor thread or metal filament is pushed in direction of the skin bey means of pin(6), on the first phase also the sleeve(691), the sliding sleeve('ll) clears the drug inlet openings OUT Sensor thread or metal filament are retired by the pin(6) D) ON The slteve(691) and the sliding sleeve(lll) are retired by means of the fork(46), cannula out from the skin, suction cup ventilated OUT The sleeve(691) is pushed toward the funnel by means of the fork(46) so that the drug inlet open ings are covered The device can be used advatageously at night for protection against low sugar levels during sleeping. For this, fastening rings or loops on the housing are provided through which retaining webs are drawn.The device can be fastened now with the suction cup against the skin of arm or leg. The three point contact on the suction cup with the skin activates the measuring function and falling short of a determined measured value causes the alarm to be activated. Because the sleeper is in the habit of turning, the device usually comes out of place always to new skin areas.

p r o g r a m m i n q According to the dosage programming of at least two sorts of insulin, be advised of the suggestions in WC 86/ 01728 (Injection device with sensor, PCT/DE 85/00313).

One proceeds there, first with the processing customary in medical practice, whereby different insulin sensivity is considered with correcting factors on programming.

The advanded computer technique with chips also for special single problems today allow further improvements for patients cooperative.

Thanks to the amplifications described in Fig.15, one can discern, for the future, between alterations of the basal secretion or the level of the basis rate of insulin and the individual sensitivity for insulin. Additional to a timed input of planned meals with triangles and of working energy with a stronger ccmbustion of carbon hydrates in rectangles, a one point input is made always by push-button in the centre of the panel or key board belonging to the planned date of the next meal.

The computer compares now the fed planes -triangles for the carbon hydrates ingestion(supply) narrowed at the margins by rectangles for the energy ccnsumation- to the rhombes -relating to the working insulin resorptionwhich are altered by the individual correcting factors, and tries a surface masking first for immediately working insulin. If the chosen date for the next injection lies out of the duration of effect of immediately working insulin, the computer shall attempt a correspondance of the surface with depot insulin, which it supplements with immediately working insulin for the initial hours.If the planned date for the next injection lies in too great a distance from a still sufficient effect of depot insulin, the ccmputer activates the alarm unction and indicates an earlier date for inection. In the case that the patient uses the injector earlier as planned, the computer ccnsiders the supposed effective rest surface caused by the antecedent injection for the new programming. By effectiveness checkings of the insulin after determined test meals with a step-like increased load with carbon hydrates, an eventual decrease of the insulin effectiveness can be ascertained. It can be placed to account for the existence of an estimable basal secretion. On this base the insulin treatment is essentially improved in the future.

The patient shall alternate timed notices of meals by input with the key(top,c.p.Fig.15), if he took up other carbon hydrates amounts as planned originally, that is earlier. The computer shall take into consideration these corrections while calculating the next insulin amounts. As well as for the input of planned meals as for their sup plementary correction -of course also according to the date- the patient can use the auxilary means of a foodstuff table on the underside of the device.Pressure to the respective symbol or picture for quality and quantity (bread or roll, egg, glass of milk a.s.o.) effects the data exposition of bread units (b.u.) on the display -perhaps on a sidewall of the device classsed with a respective nunber of the key board or panel similar to a grid square of a map, on the condition that the patient, before he compiles his bill of fare, signifies the corresponding period of input with the coordinated key (or top) to the left, with which the computer classes the point coordnaion. Of course the informations or inputs relating to the planned body stress shall also be corrected past and considered from the computer.

The plans as well as the corrections, as arbitrary additional dosages, glucose measuring results, the allowed play and the use of this as planned and administered insulin amounts are made visible on time or topically, preferably on the cargo device in contact with the mains but also in battery operation of the recording device.

The charactristic lines -traced=fully executed; dashed=planed; dash-and-dot lined=ccrrected- of the recording fac;litates the interpretation of this: Laying or prostrate triangles again for the carbon hydrates feed. prostrate rectangles for power (output) whereby the under ledge of the strip can also be used as centre line. The glucose value of the blood or tissue liquid are suitably printed up in columnes raising from the lower strip margin, the insulin metering in hanging downward columns from the upper recording stripe margin.

The recording tool is peferably mounted across the paper stripe or tape transport. Differences between expected (calculated) and measured values can be clarified by hatching But the calculated insulin resorption surfaces are signified together with their composition of different insulin sorts. (All this is demonstrated on Fig.56) Figure 54 shows above twice, in a vertical section, below, in a plan view, in natural size, the detail of the coupling betweon hammer(l21) and device operations as an alternative to the solution dealt with in Fig.40 below.

The plan view shows that the end of the hammer is enlarged with a square diameter(below in a lateral section).

The hammer is hindered in its rotation by the stop sleeve(l44). The former lies in this phase in a T-slot of the slide(316), which can operate in both directions by drive with the dcuble-active solendoid. The latter is not shown, but it lies ccmpletely to the right. (In dashed lines the bayonet like hammer is shown in another operation position). The two operation pins are visible in the related slots(317,316) wherein the length of the slots influences the operation ways. This arrangement can but be driven by means of a solenoid which works in one direction with a spring at the hammer being effective in the opposite direction. This spring resilience does not require scheduling over a tow-line for each single function as in Fig.40 - 48. (With dashed outline 'o the left the slide (316) with the slits in the displaced pcsition is shown).

It may be noted here that the spring resilience of the solenoid achieves a desired suppression of its function or power.

Above a vertical section as a further variation is demonstrated which solves alternatively tasks set in Fig.40 with tie over-coming mechanism(below). The slide with the operation pin(321) is guided in the slot(317), the slide with the operation pin(322) in the slot(318).

The slide(316, below in the plan view) is thereby divided for both slots and the one with the slot(318) lies over that of slot(317). The wedge nose(319) on the under slide evades on its slant the leaf spring like tongue of the upper slide with the slot(318) shifting to the left, but engages finally in the slot (318). Any functions can be varied, whereby the operating slide(321) is taken with to the left and the operation slide(322) to the left.

Figure 55 shows a plan view in a natural size toward a mechanism for optical sensor use for the metabolic measurment by means of a cannula and bent light admissions according to Fig.35.

The sleeve(691) with the tube segments(831) which are approached bent to the cannula piece are only dashed hinted, as are the tension springs which extend the leaf hinge(832). The narrowness in the upper(323) and the lower(324,dahed) forks are retrodden over a (not shown) angle strap in its slot guidance(326) by the influence of the lever bow(327) to the cross pin(326) on the upper fork while the solenoid is activated and the hammer moved. In this case the springs can extend the tube segments. The end of latter enter into the relating funnels on the cannula piece and permit the measurement.

Figure 56 shows a segment of a recording tape of a recording device(80;Fig.16) with minimal indices belonging to said device which are described on page 89. The standing column with 150 mg% identifies the ascertained tissue glucose level, the hanging columnes with 40E and 80E depot, the administered insulin amounts. The dashed triangle (the half of this one which has, been input into the panel) stands for a carbon hydrate load of 3 bread units, the triangle with dash-and-dot lines marks the, a little later admittedly eaten 5 breath units. Above in the quadrangle, the planned work achievement of 120 Watt is drawn-in, inside of quadrangle and next to it the admittedly from 120 Watt to 90 Watt reduced, and a little shortended and time-shifted achievement.The planned next time (dashed circle) has been postponed until later (lined circle). The glucose level was banked with 210 mg and correspondingly banked insulin amounts have been administered. The calculated deviations of sugar values and insulin metering from the earlier exspected values,and flashed the with signal connected warning with the proposual to the patient of an advanced later (next) control time (circle with dash-and-dot lines) are shown.

The time grid has been omitted.

Figure 57 shows a tabular cal, culation of the insulin dosages in consequence of the imput loads with meals and achievements by the patient. A PC was used with the programme QUATTRO PRO 5,0 from Borland for a simplified form and a an atypical case.

To the left column, a time scale is shown with time date to which 6 hours should be added. The column for the sugar values follows with still underlaying insulin effect of earlier insulin treatment. Alway read from left to right, three programm column succeed with planned meals for 3 bread units(BU), 1 BU, 6 BE and 5 BE for the lth.,3th.,and 13.th hour (real time 7, 9, 13, 19 o clock).

One supposes that the effect of immediately working beg inns first after 30 minutes ard its working decreases in 3 hours (whereby the sugar increases in 20mg% per BU).

The 4.th (broad) program column shows the influence of a work achievement of 50 Watts for 3 hours, which ifluence decreases therethrough in further 2 hours.

(16 to 18 o'clock). Quite to the right, the column representates the insulin levels, as added with the data by the computer, which increase again because a outsized dinner.

Figure 58 takes the over the calculation results of the last column of the table Fig.57. One assumes, that immediately workung insulin depresses the sugar level about 4 mg% per unit inside of an influence period of 2 hours.

The values lor depot insulin amount to 2 mg% in 12 hours.

At the lth operative column, the computer calculate the the difference to 160 mg% as the upper desirable value, and then at the 2th column the value accumulation out of the tolerance limit, whereby 180 mg% are defined as the upperst tolerance value and 80 mg% as the lower limit. It results the recommendation for 28 unit an 33 unit of immediately working insulin for 12,30 o'clock and 18,30 o'clock. The sugar level column as intermediate value is now influenced by the apply of depot insulin, as the subsequent column elucidate.

At "ds" (difference sugar) are in each calculation 10 tolerance windows are combined, so that the injection of 35 unit depot insulin at 17 o clock is recommended, to be sure with a warning because of low sugar level.

According to the counting range, 5 tolerance windows were combined for immediately workin insulin.

Figure 59 diagrammes a statistic variance function for the ascertainment of the time points for the injections using a time scale of 2,5 hours for immediately working insulin and a such of 5 hours for depot insulin.

Figure 60 shows a schematical set up of a device for a skin control to the aptitude for a puncture.

A circuit leads from the battery (Volt) to the light source, the light through a lens to the test area of the skin, and is reflected through a second lens to a photo-diode as receiver. From there a circuit leads to the amplier and voltage meter als measuring device.

Figure 61 shows a more developped example of the device in Fig.17,18 in naturale size, above in a longitudinal section, below in a cross section along the section line A - B qf the longitudinal section.

In the centre the cannula(41) with a lip seal against the probe(334) as cannula piece(43) in firm connection top the cannula shaft. Above a guide pin(6) with claws for a connection with the cannula piece. The guide pin has breaking lines and can be torn asunder by tension on upper laterally projecting stripes. A second sliding seal with lip is shiftable along the shaft and solubly pasted on the protective cap for the cannula point. A protective foil extends between the both seals. The forementioned portions are displaceable and and go to a steril package, which is formed accordingly. These portions can be shoved in a suction cup with suction source or in a special device as it is further described.

The section cup(l) two opposite projecting ledges with axle(332) for the lever(331) which can swivel in a slot of the suction cup. A wider slot in the cover pot(2) which works as a piston and can be lifted and lowered between the pins(337,338), when the cover pot is rotated as its wall slots permit. Above, the clap bow (330), swivelling around its insertion in two straps, which project from the push-on sleeve(329), serve for the screwing of said sleeve in a thread on the bottom of the cover pot. (These straps are turnede for about 45 angle degree, as shown below in the cross section).

The levers can be depressed and supports the introduction of the replaceable portions, the cover pot being removed by srewing (in the thread or bayonett catch before. Therefore, the lever(331) can be sunk.

The cover pot is then screwed and thights the suction cup through the the sliding seal(335).

After the lever(331) is slightly lowered,;the cover pot is rotatated, so that further movement of the lever causes that the cover pot is lowered. The protective cap is separated from the sliding seal, after the cannula have been retreat a straigt line as permit by the arresting leaf springs(341,cross section) touching the claws of the guide pin(6). The protective cap is removed thereby.

After the suction cup(l) is put on the skin of a patient, the levers(331) are depressed. The skin is sucked on and raises by negative pressure because of the displacement of the cover pot. The latter is held in position by the engaging of a cross peg in the lever in a recess of the (leaf) spring stop(339), which is fastended on the suction cup. Now, the physi-cian can shove the guid pin(6) downwards so that the cannula point pierces the skin. The probe is then also shoved downward under the skin in the desired extent. The cannula must be retreat, the spring stop lifted, and, finally, the suction cup remowed after the cannuia is shifted back along the probe(334).

The optical skin control is mainly advantaoeously un- dertaken by a kind of bind visor with a central hole near a suction cup edge, so that the suction has still enouah elasticity to enter into this hole and to build a little bubble aaainst the puncture area, where a light beam runs tanqentially through the small skin bubble to the sensor.

But a sensor bristle, resp.a sensor thread, can be shot through the skin from the suction CUD edpe for a tissue sugar measurement, which consists of material which can be reabsorbed. The bristle or thread can then be shoved ur- ther along into the subcutaneous tissue. (The entrance of the sensor bristle is rendered possible by a hgh initial speed similar to fluid iust also for a flexible material).

At first, the thread must be embedded :into a kind of chuck similar Fo a drill, with the aim to be able to ousch it with the chuck in the l.ongitudinal direction without a lateral evasion of the thread. But the sensor thread can be likewise produced as a drill with helical threads on its front end and can be led under the skin through a skin pore with rotation by means of such a drill chuck, perhaps by a weak rubber tube (er.d) with bip walls, which is compressed. For a further thrust, either the thread reserve is beared inside of a folded bellows on a kind of cross disks or on supporting struts which project from wall segments of a longitudinal slotted plastic sleeve nearly touchinq one another.The latter are driven asunder with the wall segments of the sleeve one after other by cone. The Joint of the cone is connected with the erd of the sensor thread, while the cone base has a bowl or naD for uptakinq the ding pin for the thread thrust.

Because a cannula wall is saved, if a sensor bristle is used, the latter can be oroduced somewhat thicker by meeting with the endowing of chemicals for influencinq of the current and with the apply of a outern Drotective sheat against a diffusion of the chemicals into the bcdv. (The skin which is thinned by the stretching during of its raising, eventually supported by adhesive or squeezinq means, reduces mcreover the extent of the scar bv the injury) . The arrangement for the introduction of a sensor bristle can be suitably coupled with the equipment with a nozzle for the pressure or jet iniection in one suction Material which can be reabsorbed are preferred, therefore, because the breaking uD of a sensor thread can nevermore he excluded before bf technical distubances before the retreat of the thread. The use of polyrnerizated terephthale acid and polylactacid is proposed to which the measuring active substances (as NAD-GOD-Perid for the active and sepharose-convaline-A for the Passive electrical sensor) can be bound. Mainly, the oolylactacid has distinct hyoroscopic properties, which is important for the uptake of tissue fluid The threads or filament of the molecule can be turned as a drill before they are coated with a protective film (perhaps with polycarbonate). In this way a kind of drill could be Droduced.

An introduction of measurinq substances into the bcdy could be avoided, if a measuring thread which is not endowed with such substances could be shoved under the skin (a thread perhaps of silk, which is hardened çor short time by formaldehyde of 2 to .9 per cent). The thread can be retrieved, if it is saturated with (body) fluid, into the hose end, and the contained glucose can be brought in reaction with the measuring layer, which is inlet in the bcre of the hose end.

Threads which 2re endowed with a measuring layer contact a metallic ccat inside of the hose end after beinp retrivied therein. The current conduction to the measuring instrument is performed by the respective wires. If there are twc conductive zones lonoitudinally separated, the hose end must be secured aoainst rotation because of the closing of electrical contacts (perhaps by derivations of the diameter from the circular shape).

The device for the introduction of a sensor bristle can be operated also With a qas Dressure capsule. For the driv inp of the sensor thread or bristle under the skin by the soes pressure beam, the bristle er.d must be enlarged and stopped at a narrowness on the end of the supporting slee ve. The current measurements can also be done outside of the (supporting) sleeve between piled up stacking sheets after the sensor thread is drawn back from the skin. (This can be done bLt also here inside of the sleeve if the respective metallic coating interior is present with contact derivation outwards).

If a metabolism measurement (of any interesting substance, as glucose, but also cholesterol and others) is chosen by the reflex optical way with use of colour changing agents, two very small cylinders cEn be punched out of two different reaction surface sorts customary to test striDs. Two of these respective cylinders are then stuck together in such a way, that bcth colour reactive layers bound the total cylinder each on one side. The total cylinder consists mainly of hygroscopic material (as kieselguhr or silicagel).Such a reaction cylinder can be firmly stayed onto a carrier thread or pin and still even pricked into the skin, whereby the thick carrier works like the disk of a drawino-pin. The metabolism measurement is performed after the nput of the carrier thread by laser scanning on both ends; on the carrier side suitably through a (central) bore or channel of that.

The arrangement for the introduction of a sensor bristle cEn be suitably coupled with the equipment for the pressure injection in one suction cup, those fittings facing then oe with other. When the period for the saturization with tissue liquid can be held shortly enough, an additional squeezing device, perhaps by means of two slides resilient one against other, can be saved. The pressure iniec- tion otherwise 2sues with a new sucking on after the metabolism measurement is completed.But the diagnosis with the sensor thread can also be transferred into a separated device using. If pulver injection of solid drugs (perhaps in crystalized condition) is applied, Dressure gas replaces the "washinp out" fluid for the injection cannel.

A measuring cannula can also be introduced under the skin into the liquid sea over the muscle skins or fascia.

The cannula consists of a capillary which is drilled in or shot in. Such a capillary can be also endowed outside or inside with a measuring layer for metabolism measurements and it can also serve for the infection of fluids (after the measurement). But the capillary wall can be punched and serve the drainage of tissue liquid toward a measurinp zone in the sleeve for the capillary; additio nal]y, of course, to the iniection of the dru or medication.

tion.

The mentioned chuck for the motion of the thin sensor bristle or thread consists perhaps of a thick walled soft rubber tube or hose end which is compressed by pressure in a longitudinal direction. For the further advance, the thread reserve is stored either inside of a folded bellows on a kind of cross disks between the fold depressions or on support inp stays, which nearly meet in the center and project from the wall segments of a lonpitudinally-r slotted plastic sleeve. The supporting stays are driven asunder, one after the other, with the wall segments of the sleeve by a cone.

The point of the ccne is connected with the end of the sensor thread, whilst the cone base has a bowl or nap for the uptake of the guiding pin for the thrust in advance.

Because the wall of the cannula is omitted, if a sensor bristle is used, the latter can be produced slightly thicker, what is opportunely for the endowing with chemicals for the influencing of current and to the ccatin with an outer Protective layer against the diffussion of chemicals into the body. (The skin, thinned during its raising eventual also with adhesive or squeezing means, anyhow makes the remaining scars smaller).

Material, which can be reabsorbed, deserves the oreferen- ce, because a breaking off (of the sensor thread) can ne vermore be totally excluded.

The device for the introduction of the sensor bristle can be also operated with a pressurized pas capsule. If the gas pressure beam drives the sensor thread or bristle under the skin, the end of the bristle must be en larqed and arrested at a narrowness on the end of the bearing sleeve. The current measurements can be performed between piled up stacking sheets outside of the supporting (or bearing) sleeve, after the sensor thread is pulled out of the skin. (But this can be done also inside the sleeves, if these are appropriately coated with metal interior with contact derivation outwards).

The threads which are endowed with the measurinp layer contact, after they are drawn back into the hose end, therein with a metallic layer over which the current conduction is performed through the appropriate wires or leads to the measuring instrument. There are Dreferrably two conducting are separated lonqitudinally by an insulating zone, resp.twc insulating zones.

If the period of saturisation with tissue fluid in the sensor thread can be held shortly, an additional squeezing device (perhaps by means of two slides or Dlates under the suction cup edge springy one against the other) can be saved, when a suction cup is used.

In other cases, the pressure or let injection throuph a nozzle occurs after the metabolism measurement, interrup- ted by a renewed sucking-on of the skin.

But the diagnosis with a sensor bristle can also be transferred in a separate device using. If pulver of a solid drug is injected (perhaps in a crystalline shape) pressurized qas replaces the "washing-out" or thinning fluid or th2 point of gentry into the injection channel.

But a measuring "cannula" can also be introduced under the skin into the liquid lake over the muscle skins or fascia which consists of a drilled or shot-in capillary.

Such a capillary can be, inside or outside, endowed with a measuring layer for metabolism measurements and it can also serve for the injection of fluid (after the measurement). But the capillary wall can also be ounched through (with finest holes) and can serve to the drainage of tissue fluid into a measuring zone in the sleeve or capillary; additionally, of course, the capillary of such a type can also serve for the drug iniec- tion.

If a dcuble-sided colour measured cylinder is used, the measuring is achieved by laser scanning in both ends of the cylinder ; on the side of the carrier suitably through a bor of it. Instead of a laser beam, a light beam can be used for the optical reflex measurement with ancillary Adens (also by use of light conducting fibres, preferably with the method of optical coupling.

with crossing and punctually welded fibres) Mainly advantageous is the fixation of a minute colourchanging sensor cylinder on its tube-like carrier by shoving its one erd into the ed of the carrier tube with a sealed connection (sticking or welding) of both portions. A Pen-like instrument with such a "drawing pin sensor" needs not an optical skin control and has a round end around the nozzle for the shot-in of the sensor cylinder. Such a instrument can be pressed against any skin parties with elastic subcutaneous conditions.

Figures 62 - 69 are described on the following pages.

Figure 62 demonstrates in the horizontal or,longitudinBl section, and in a natural size (in a lateral rolling-up of the functional portions), a device for the injecting of a sensor bristle into a skin fold. To the left, the wedge slide for the retreat of the sensor to a scale 2 1 is shown. Above, a special configuration of the sleeve cap is demonstrated, the same below to the right to a scale of 3 : 1.

The movement runs from the motor axis(53) through the translating toothed wheels(54) for the reduction of the velocity on the square axis(627), then through the sliding socket(125) and the square bar(644) to the catching follower sheet(126) for the turnable slide(127). The toothed wheel(128) is mounted above the follower sheet on the square bore and meshes permanently with the pinion(800) by means of .jutting and connection disks. The pinion is shoved along the screw, has lateral naps, and meshes with the toothed wheel(803), which has, on this place, only the function to rotate the screw in one direction. The rotation is permanentLy transferred through the toothed wheel(802) to the intermediate gear(129) ard from there to the nut(130).

The sleeve(691) was still moved against the conical bore in the suction cusp(1), and both strong pressure springs (261,262) were tightened against their four support columns(854).

The relaxing of the springs is prevented by the bolt (472) which ccrresponds in construction approximately to those behind stop knob(270). But the sliding ledge (134) is depressed with the sinking pf the grooved slide(132) by the fork(133). The sliding ledge is fixed by the stop knob(270) against its tension spring then.

This is possibLe first then, if the tension spring(235) is released and depressed on the end of the bcwden cable toward the grooved slide. (The small pressure spring behind the the stop knob stores the stopping moment).

The leaf spring(136) is in reality turned about 90 de grees around the axis of the grooved slide and secures the stability in the height of the latter. The bowden line(135) between the grooved slide(132) and the wedge slide(137), again with power storing in a spring, effects the lowering of the latter. (To the left, the lateral view of the slide frame elucidates the function of the thrust effect toward the collar(139) during its depression). The bowden cable(140) lifts the elastic piston(91), which bears the sensor bristle and has an excavation for a spherical end of that cable. This happens through the central bore in the screw bolt(352) whilst the folded bellows with high elastic septa between the fold depressions -into which the sensor bristle is stored- is compressed.

The enlarged detail above to the left shows, that the sensor bristle is surrounded by the rubber hose end(92), which itself is surrounded from the sleeve(691) after an air gap. The sleeve cap(111) projects with inner projections through slots in the sleeve(691) toward the rubber hose end and tolerates a certain pressure, exerted from the sleeve sufficiently to narrow the channel of the rubber hose end around the sensor bristle with the purpose, of pushing the latter with high speed through the skin, which is drawn up into the suction clap(1).

The detail below to the right shows the rubber hose end (92)directly laying onto the sleeve(691). The sleeve cap is downward enlarged and has inside naps which corres pond to such outside naps on the sleeve(991). The projections which reach through slots below in the sleeve(691) to the rubber hose end(92) can be fitted above with tongues to cover the slots against slipping out rubber.

The annular sleeve (577) goes in a thrust-torsion-device which effected an axis rotation about of 90 degrees with the turnable slide(127) after each lowering, and which respectively brings the projecting tongues(93) in ccntact either with the grooved slide(132) or with both grooved slides(94,95) for the release of both strong pressure springs through the bowden jinxes(96), of which only one is shown(c.p.FiS.63) The thrust-torsion mechanism is more described in Fig.#1. The sleeve(691) is pui into the prXo- ve(151) by hand and is drawn away again after consumption.

But the invention aims, of course, toward the fitting of automatic sleeve or grip change analogously described in Fig.9 to 36 of the European Patent Application No.O 301 165 (published on Febr.2th.89), though for the vertical grip or shell storing.

Figure ss gives a cross or vertical section through the device according to Fig.47 in the level above, of both bolts (472) and in a natural size. Below the detail of the bearing of the strong pressure springs(261,262) is shown on the support columns(472).

The housing wall(16) is there drawn-in and the space for the battery(255) and the electronic control unit(80) is nominated. Between the stop knob(270) and the tension spring(235) the release for the sliding ledge(134) is positioned with the tension spring for the rapid retreat of the sensor bristle out of the skin.

For this the fork(133) embraces the bcwden line(138) and is dislocated by the grooved slid(132). The latter is shifted, as well as also the grooved= slides(94,95) in another switching position, by means of one of the opposite tongues(93) in both directions, whilst it is taken by the tongue insertions between the follower sheet(126, Fig. 1) and the toothed wheel, and whilst the power is transferred from the electric motor(478) to the pinion (800) with the shifting of the latter along the screw(801, Fig. 1). When the toothed wheels(802,803) are reached, the nut(130) is activated on the sliding screw(352) through the intermediate gear(129) by the pinion at the time in opposite direction. The functional operation between left (=below) and right hand (=above) is: tightening of the springs(261,262)

release of the springs(261,262) relaxation of the springs(261,262)

(switch.over of torsion)

thrust of the sensor bristle

retreat of the sensor bristl.+shell(69)+torsion Figure 6 shows in a longitudinal section td a scale of 2 1 the sleeve(571) of the thrust-torsion-device with the hammer(121) for the explication of the switching over between the particular functional stages A - D.

The sleeve(571) shows the inside of the zig-zag groove in which a small cross peg of the prolongated solenoid anchor or bolt engages and effects a quarter-turn of the sleeve with each stroke, as far as the solenoid bolt is secured against rotation. The rotation is transferred over the coiled spring(141) ard the flank with spherical seat(142) of the hammer to the latter. The hammer shaft is rectangular to the right (that is: distal) and is prevented from rotation in the fixedly mounted bush(143). In the demonstrated O-position of the solenoid bolt, there is a circular cross section or radius inside of the bush(143) so that the torsion effect can operate. (Of course, without coiled spring, if the connection between solenoid bolt and flank with spherical seat is respectively elastic).

The hammer area in both detail images below shows a mechanical stop sleeve(144) which at a half groove stops, in each case, the rotation over a respective operating member (A - D). For this there is an angled piece with a passage for the stop sleeve(144) and for the horse-shoelike bent around pin(146) with terminal disk for the biased pressure spring.

The lower image shows, as the cam(147) of the hammer has lifted the sleeve(144) against its spring, that the axle rotation is released by the coiled spring(141) yet tensioned over the sleeve(571) and eventually held in a permanent pretension). The cam of the hammer meets resistance then on the next positioned sleeve(as 144) because the latter lightly springs back against the hammer rotation. Thus the stop mechanism can be found radially distributed. Below, to the left a cross section in the level of the four sleeves(144). The stop of the hammer end for the operating stroke is demonstrated with the four switching stages A - D.

Figure 6- schematically shows in a longitudSnal section a device for the sucking on of tissue liquid and an eventual injection of drug fluid through a capillary(106).

This is much enlarged with its sleeve(691). (Mainly, the latter is additionally shortened) . The crosses inside the wall of the sleeve symbolize the measuring layer with chemicals which react with substance (as glucose) in the tissue liquid. The capillary is punched to facilitate the afflux of liquid from the subcutaneous space (not drawn), if the upper syringe piston is pulled. The valve slide(107) is iust open. When the measurement is performed (over wires to the measuring instrument, not sown), the valve slide must be pushed (fine hatching) and then the piston of the syringe, which is filled with drug. The supply tube from the valve to the orifice of the sleeve is drawn with dashed lines.

Figure 46 shows the variant of the sleeve for the sensor bristle relating to a device of Fig.47 and others in a scale of 4 : 1 in the longitudináL section and a breaking off mechanism for the sensor bristle reaching from the right up to the left lower half. To the left, a sleeve is shown, shortened in the length, during the sensor thrust and quite aboe to the left, a cross section of the sleeve.

The sleeve(691) consists of any tongues(152), which are interraupted by longitudinal gaps, of which only three are demonstrated. A row of props projects from each tongue, which centrally enclose the sensor bristle. The entire sleeve is covered with a high elastic membrane against pollution, which membrane is not shown.

The piston(91) which is shoved foreward into the sleeve, conically rises above outwards and it spreads the tongues (135) asunder whilst the sensor bristle is pushed forewards. The wedge slides(137) behind the collar(139) of the sleeve are spread like a vice in a hinge(not shown).

The proceeding shoot-in of the sensor thread ;(or bristle) is activated according to a mechanism as in Fig.X3,28.

The rubber hose end(92), which accepts the pressure from the collar of tie sleeve(691), is supported against the support(153). The support ring again can be rotated and is connected with the frontal slides for the production of skin folds (respective the suction cup) by means of the props(154), which are indicated there only weakly as aralogously described at the cup in relation to the nut (131,13O;Fig.) The pressure which is stored on the hose end, first nar- rowes the channel around the sensor bristle.The electric tracting solenoid(555) is operated by the electroric control unit through a contact (not shown) perhaps in front of the strong pressure spring(261). This is done through the lever(159), the curved wedge slide(155), which activates a counter-ciockwise sector rotation of the support ring(153), so that the projections(157) come to be situated over the gaps(158) of the support ring and can pass through. The passage of the projections can be facilitated by relating slants in the vertical direction. (Below to the right, the plan view is shown from below to the bearing disk on the supporting ring). The sleeve is now pressed against the sleeve cap(111), and the sensor bristle is shot through th skin.Before the removal of a sleeve, the solenoid(555) must be activated for traction. The props (120), which project from the skin fold shiver (or the suction cup), and are shown perhaps too weakly, let the support ring(15S) roll up behind them. The staying between the support ring ard teh props(120) is not shown.

Inside of the rubber hose end(82), the conducting layers are indicated white dashed lines which continue in the wires(84) on both sides and contact there with leaf springs for a transmission toward the measuring instrument. On the ca,e of the method of the abduction of tissue liquid by a kind of wick, sensor layers would correspond to the white dashed lines, perhaps for the reaction with the glucose of the tissue liquid.

Figure 62 shows the variant of the introduction of a sensor bristle according to a bore in natural size in the longitudinal or horizontal section. Above to the right, the ccnstruction of the sleeve for the transport of the sensor bristle drawn out in a scale of 2 : 1 . Below the preferred variant of simplificated sleeve.

The demonstrated stage is that of a sensor bristle which is drilled under the skin in a suction cup(1). The electrical motor(478) with the translating toothed wheels(54) stands firmly in the housing bottom (omitted) for that; the square axis for the driving wheel (233) is slidable through the latter and connected with one of both carriages, which itself again run along the (dashed drawn) rails The power closing runs from the driving wheel(233), which rotates freely, to the elongated toothed wheel on the screw bolt(352). The latter cEn be moved away from the suction cup by rotation inside of the prolongated nut (130) and takes with it the sleeve(691) in a squeezing seat of its collar(238) by means of the squeezing sleeve(23B).

The rubber hose end(92) around the Censor bristle is compressed, first, through cross projections by the sleeve (69j.). The inner sleeve(97) around the rubber hcse end is supported against balls against the sleeve cap(111) and turns with it, whereby the screwed end of the sensor bristle pierces the skin.

For the largest extent under the skin, the sensor bristle is mcved through the screw bar(235), which happens inside of an inner thread of a large toothed wheel which is fixed between the nut(130) and the transverse spar(251), whereby the screw bar(235) is moved through this transverse spar with its end. The related small drive wheel(234)is driven by a second motor (not shown) or through a ccntrol gear from the motor(478). The rapid retreat of the sensor bristle takes place by influence of both pressure springs (237) between the projecting ledges on the suction cup and on the carriage(236) each, which are twice moved upon a rail. This occurs after the bolts(472;c.pFig.63tthere is only one shown) is released by a solenoid. (The latter is also not shown as also the vacuum source is omitted).

The variant of the frontal end of the sleeve(691) shows the sleeve cap(111) firmly integrated around the suction cup orifice for the sensor bristle and this, indeed, with a ball bearing for the inner sleeve(97) which absorbes the pressure of the rubber hose end. The rubber hose er.d rests on the sleeve(691) with a sudden calibre change, and rotates with the inner sleeve.

Above to the right, the detail is shown of a preferred solution between sensor sleeve and suction cup in the scale combination of 2 : 1. The rubber hose end(92) is firmly fastened with its one end in and on the sleeve(691).

The latter has a fine thread on its end, which works against that one of the nut(130), whereby both threads are adjusted one against the other with regard to their gradient.

An inner thread of the inner sleeve(111), which is a par- tion of the device, correlates'to the outer thread of the screw bolt(352). The inner sleeve(250) is tightened on the socket(117), which projects from the suction cup.

A sealing ring lies also between the inner sleeve and the sleeve(691) . The rubber hose end is compressed during the rotation of the sliding screw(352) and likewise rotates the inner sleeve(250) with the corrugated end of the front side. The inner sleeve is thereby removed from the suction cup and thus an extent as the sleeve(691) approaches the former. In use of the device, the sensor (thread) is shoved out a certain distance of the inner sleeve by the screw bar(235). (The problems of the safety covering before use are omitted: they can be solved by the drawing off of a cap or by an glowing wire loop).The skin (with dash ed-and-dottered line), which already clings to the top of the sensor thread or bristle in the punched disk(254, Fig.7) is able to evade to the free thread end first. The thread end is then thrilled through the skin by the rotation with the screw nut(13û).

Figure 68 shows the variant of a device for the shooting-in of a sensor bristle under the skin by means of a pressure gas thrust, and this is done in a horizontal or longitudi nEl section to the scale of 3 : 1. Singular images of the stacking sheets are shown above (as detail) in a vertical cross section, the sensor bristle is beared on those sheets for a time. The device can be suitably operated from a CO2 pressure gas capsule and can make use of additional devices, as such are described perhaps in Fig.

36,but also already in the European Pat.Appl.Nr. 0 2210 O5(Fig.13,17,19 etc.), mainly in that from Mc Kinnon which was cited above.

A gas thrust is conveyed out from the pressure gas hose (893) into the channel of the slfeve(691) through the tube into the channel of the sleeve(691). The pressure beam advances the end plate(2.14, very exaggerated on the sensor bristle and the latter before itself, wherby the final plate is not able to pass the narrowness(215) on the sleeve end.

The clamp(253) which is conically shoved between the collar(139) of ths sleeve and likewise a tube, serves for a gas tightly coupling the conical tube end with the fun nel of the sleeve(691). The retreat of the sensor bristle follows from the tension effect at the slenoid(555) which takes place over the lever(159) to a ledge on the carriage(236). The latter is moved along the rail (252) and in the same. (The way is drawn shortened).

Whilst thereby the wedge ledges(99) are drawn back by the carriage, the sheets are approached against their spring bcus(B5,above in a vertical view) during a pushing off o'n the bars(355) such a distance, that the sensor bristle is embraced in the narrowned channel between the stacking sheets(86) which are alternatively stringed from above and from below. Thereby a current derivation occurs from the surface of the sensor bristle. Through the electrical (in integrated) lines (84), the sheets transfer the current by ccntact of the conducting rings one with other to the measuring instrument. Each of the lines thereby responds to a contact on one sensor bristle side.

The stacked sheet, which is shown to the left, with its slots(98) for the wedged bars(99) demonstrates the singu- lar shape (for the spreading of bcth rows of the stacking sheets) . To the right, representations follow of two adjacent sheets in the stage of the wedge bar retreat and after the introduction of these into the slots(98).

The solenoid(555) is switched off again after the metabolism measurement, and the carriage(252) returns in the shown position under the working of the pressure spring (237). The wedge bars thereby spread again the stacking sheets, so that the sleeve can shoved over the sensor bristle. (Mainly if the suction is introduced from the jet pump through the pressure gas hose(893). A repetition of the sleeve retreat permits 1+5 r-z.oval for a replacement of an unused one.

The chamber(354) arises between the cone for the uptake of the sleeve in the section cup(1) and the pLnched disk(254).

this chamber is plate-like downwards, and closed by the suction cup edge. One demonstrates the slightly cEmbering of the skin against the sensor bristle through the opening of the punched plate or disk. The light beam(353) can be reflected on this small skin bubble and projected along (or through) to the related sensor before the shoot-in of the sensor bristle. The optical skin control is essentialy facilitated in this manner because surface irregularities can also b better detected. (A hair bulb follicle cculd perhaps not pass the small opening of the punched plate or disk).

sinurF 69 shows a natural size in a horizontal or longitudinal section, a device for measuring purposes in which the sensor bristle is shortened to a small double or sensor clinder(216), the bottom surface of which has measuring layers each of different sensibility reach for glucose. The carrier thread (of any riven meterial, if it is solved from the sensor layer for the measurement) with the sensor cylinder -which is here stacking in the skin- is drawn very overdimensionally because it has in reality a diameter about of 0,3 mm).

Quite to the right in a scale 4 : 1, the carrier thread, that is to say the carrier capillary(217), is shown inside of a measuring guiver. The latter consists of a stationary basic cylinder(219) and the cap cylinder(218) which is shoved onto the former, both armed with laser sources as photoemitter(580) and photosensor(581, or eventually with use of light ccnducting fibres with auxiliary lenses and postponent coupling toward the sensor as schematically drawn above. The electrical wires (6, each doubled) run to the measuring device (not shown). The shoot-in device relates perhaps to that which is described in Fig.6, whereby the sleeve(691) for the bearing of the carrier capillary or the carrier thread is shortened.

The sleeve(691) is connected with its collar(139) with the collar of the pressure tube, into which leads the pressure gas hose(833), by means of the clamp(253). After the sensor cylinder is saturated with tissue fluid, the bolt (472,Fig.1,2)is retreated and the tension spring moves the sleeve(691) back by means of the carriage(236) on the rails (252), so that the sensor cylinder leaves the skin and the suction cup is reventilated. (The suction sources are again omitted because it is known and anyone used).

The sudden calibre change between the small sensor cylinder and carrier prevents the passing through of the skin; the frame of the cylinder in the end of the carrier serves for the security against a break off of the cylinder.

Below to the left the dome-like er.d of a disanostik , pen with a are carrier with a final small sensor cylinder, which can be shot in the skin, after the pen is pressed against a skin Dart over resilient soft tissue, so that the fixation of the Pen top occurs in the trough of the skin.

The sensor cylinder can be shot into the skin by pes pressure or sprint and the broad carrier works as a kind of drawin-pin. The measuring evalutation can be Deformed in a device as shown in Fip.69 to the right.

The central beam(l08) leads as a laser beam (dottereddashed drawn) through the central channel. (dashed).

Preferably a LED can be used with light ccnductinq ib- res and auxiliary lens on both ends. The optical couD linp allows the lipht emission and receiving through the same fibre bundle.

Alditionally to Fiq.29 shall be noted, that the tri angles and rectangles, which the patient is adviced to input to a panel, shall serve, mainly, to the cleari t. It may be suitable in the reality (because the re striated number of possible keys on the oanel) that as well loads with carbon hydrates as thus with work achievement are input by respectively two points in a distance of a zero-line or by numbers. The computer is able to make visible on the display as well the differences of the chosen dimensions by the relating latice reproduction as the input straight lines as Fiqures, perhaps beside the -calculated olanes which relate to the decay quote of the insulins. The patient is enabled to make running bEck the time ouan- tization o the panel. The computer can calcuatory dislocate the input triangle base or the exit point of the loading straiqt line for carbon hydrates accor dinq to the resorbtion delay to a later time line.

But actually, the linear functions may be transferred in such being exponential with increased experience and further functions may be comprised into the proaram processi.np.

Claims

Claims:

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows: 1. A method for the diagnosis and therapy of metabolic disturbances of a living being, whereby a skin fold is produced by mechanical means and a cannula is shoved through the skin fold, and a kind of probe is transported in or under the skin, said probe being functionally connected with sensor means and attachable to a measuring device for metabolic alterations or other interesting chemical conditions in the body, including the ccnnection with the means of injection, if intended, for the dosage and metering drug amounts in relation of eventually gained measured values, thereby sign if icated that means of mobility are provided, but with regard of their position and mode of application, for a secured contact of said probe with tissue liquid under the skin during the interval needed for the uptake for analyzing metabolic or chemical substances by the probe for intended measurement.
2. A device for the diagnosis and therapy of metabolic disturbances of a living being consisting of a housing with means for producing and maintaining a skin fold, and also consisting of a thrust device to drawing near, stepwise, a cannula and sensor means for metabolism measurement to said skin fold by a kind of guide pin with means of mobility classed with the latter, serving a;;so for the movement of said cannula and sensor means toward and from the skin fold, consisting further of covers for said sensor means for the purpose of securing portions and fluid, which are to be introduce into the body, against pollutants, and consisting further of at least one measuring device which can also be partially transferred to another housing, for metabolic conditions, but preferably for the control of the skin, if suitable for puncture and this being done by means of a light source, a light receiver, and a control unit, the electronic part of which placing the gained measured values in relation to the program inputs by switch, and, if need be, operating at least one warning device, and an injection device with supply containers and at least one metering device, the entire device thereby signified by the fact that the sensor is drawn near to the base of the skin fold by means of the thrust device, or at least slanting perpendicular, with regard to the base of the skin fold.
3. A device according to claims 1 and 2, wherein the slides or at least one slide for the production and maintenance of the skin fold engages on the base of the skin fold into which the cannula pricks on a slant or sideways.
4. A methode according to claim 1, whereby negative air pressure is brought to effect inside of a suction cup as mechanical means of production of a skin fold for raising the skin prior to or along the production and maintenance of the skin fold by means of material shifting at the area of the suction cup rim.
5. A device according to claims 2and 4, wherein the negative pressure for the raising of the skin occurs inside of a kind gas-proof bag, with surfaces laying opposite to each other to their greatest extent, at the very least in a folded condition, fastened on the covering plate of the housing as well as on the movable lid, between which a power works, to expand the bag, and whereby a channel connection into the suction cup is produced at least timely.
6. A device according to claim2., wherein springs first are retained in a release stop for the production of the skin fold, the springs being connected with a kind of sliding sheets, and the activation cf a further release stop at the other end of the springs suspends the spring tension again before the housing is removed from the skin, but the release stops in each can be installed twice.
7. A method according to claims 4 and 5, whereby the tightening of the springs for the expansion of suction producing bag is accomplished for the production and maintenance of a skin fold by the drift of levers on these springs, when the lid above the bag is lowered by means of manual pressure working to the latter before the lid is arrested by release stops on the cover plate.
8. Device according to claims I and 2, wherein a kind of sliding sheets serve as mechanical means for the production and maintenance of the skin .Fold, in which the squeezing edge of the sheets is slightly bent over the skin.
9. A device according to claim ;, wherein a solenoid serves over the guide pin as said means of mobility for the cannula in the direction of the skin fold, the prolongated anchor having, as hammer, an eccentric rotable function end, which works in each case against the end of the lever after sectoral turning, the effective distance and direction of said lever being determinad by the divisional ratio of each lever arm, each rotable on an axis, and their effect on one to another and in the way other functions can be operated by the solenoid by this process.
10. A device according to claim2, wherein the thrust function and the means of mcbility the cannula is activated by one single motor which drives a toothed wheel on a sliding axle, which transfers the rotation to a pinion on a parallel screw, whereby the pinion meshes with said toothed wheel through a lateral shifting over a type of plate or bar, whereby the thrust motions, of the pinion or the bars thrust or advance in both directions, as the mctor is poled, and whereby the pinion meets with a type of lateral naps, with the likewise naps of a thoothed wheel, which is no longer laterally shiftable, perhaps, against a resilient spring and meshs in both cases with an operating gear and is able to translate any programmable number of rotations to other operating functions such as those for metering.
11. A device according to claims ; and 9, wherein for switching between a fixed functional change over to the stepwise sectoral turning of a torsion-thrust-sleeve, the hammer is connected by a kind of clamp with the anchor of the solenoid as means of mobility, which can detach the connection to the torsion-thrust-sleeve and transfer to another operation function by means of a clamp.
12. A method according to claims 4 and 4, whereby the elastic or at least flexible suction cup is formed and whereby the fold-over, if need be with rail guidance, protects the lowering of the roof against suction influence.
13. A device according to claims Z and 2, whereby a colour changing reaction layer is imposed on the end of at least one light conducting fibre as sensor for use through the cannula and for the ascertainemen': of metabolic alterations which permit the signal transmission to the measuring device through an on- and off conducting light ray.
14. A device according to claims island 3, wherein a carrier thread with a small cylinder serves as sensor means, able to be introduced into the body through the cannula, whereby the latter has colour alteration layers with different colour yields with different colour concentration of the material to be proofed, whereby the cylinder is broken off at the breaking groove to the carrier thread inside of the cannula piece after drawn back with tissue liquid saturated condition, with light conducting elements approaching the latter with a mechanisM fcr the measurement.
15. A derice according to claims 1 and 2, wherein for tapping the current for measurement of a sensor thread, which has retreated into the introduction channel nd in the course of the introduction channel, the sensor thread contacts a metall coating with its reaction layer around its metal soul.
16. A device according to claims 1 and 2, wherein a cannula consists of a sleeve with cannula piece as shaft carrier and for the drug inlet openings, thus the latter are covered by a sliding sleeve, and whereby the thread with sensor properties is stored inside of the sleeve, the end of which being fastened on a piston which is moved by the guide pin of the thrust device.
17. A Method according to claim ? , whereby light is projected into the provided puncture area for the optical skin control and in case the skin is not suitable after the ray measurement, another skin area for the control of the aptitude for the puncture is provided activated through the control unit by a device for the alteration of negative pressure as pump or nozzle.
18. A method according to claim 4, whereby light is projected into the provided puncture area for the optical light control and, in the case of the skin is not suitable after the ray measurement, a device is activated over the control unit for the alteration of the spring tension on the slides for the maintenance of the skin fold as means for material shifting and thereby of the drifting of the provided puncture area.
19. A method according to claim 4, whereby triangles are fed on a programm panel for the programming of an insulin metering for the load with carbon hydrate feed, whereby the distance of two points corresponds to the height of the exspected load and to the described points equal distance of a third point corresponds to the duration of the exspected load with carbon hydrates of the feed, and for the work achievement, preferably from te margin of the program panel, in a quadrangle plane, perhaps by two-point input, the expected measure of work achievement -as distance from the edgeand duration of work -as point distance- being put-in, while all inputs are classed with a -advantageously migratory- time window and with the possibility for posterior correction by inputs of presumed real loads and at least one of the next intended points of apple cation of the device sresp.of the injection, and whereby the computer as a part of the control unit covers as much as possible, the input planes with the programmed planes, which result from the exspected working of insulin to the glucose level in the body while the differences of individual effectiveness are taken in to acount, and whereby the heigth and type of insulin metering is destined.
20. A device according to claims d and 19, whereby the program panel on he housing consists of key rows, which are depressed for programming and likewise arrested between springy slides at the enlarged edges of the keys, while electric contacts are operated, which keys return to their exit position by the operation of the slides through the marginal recess of the latters.
21. A Metnod according to claim < , whereby tie cannula piece for the shaft is provided with a sealing membrane and enlarged to such extent that a sensor as probe can be shoved under the skin through the shaft of the cannula after the skin piercing of the latter, which occurs with the approach of said membrane, onto which the sensor is fastened to the cannu;a shaft, after which the sensor can be connected with a measuring device, and for coupling onto a syringe cone to the shaft, if suitable, a funnel can be provided for the uptake of the syringe cone into the cannula piece and an opening can be provided in the membrane, protected by a removable protecting foil, through which the syringe cone can be introduced into the funnel.
22. A method acccrding to claim 1 whereby a cannula is pricked into a skin, raised to a skin told, and whereby a probe is shoved under the skin through said cannula, which probe can be connected with a measuring device, and which is left under the skin, if the fold is released, so as the cannula and fold producing mechanical means are drawn back o';-er said probe and the injection is accomplished, if suitable, through said probe.
23. A device for the diagnosis and therapy of metabclic disturbances of a living being accord.to c1.2, c c n s i s t i n g of a housing with a portion adapted to be put on the skin of said living being and means te receive sensor means in a sterile condition and which pushes said sensor means in or through the skin without of ar introduction of a cannula surrounding that sensor means, and to retract it and to bring it into contact with chemical substances for a metabolism measurement, and comprising a mechanical and eventually electronic programme control and at least one power source, consisting further (f signal producing and transferring texans for a measuring device, which transmits the measured sigrals to a display and recording device and over meals of programme control, which can also be positioned outside of said housing, preferably to an injector with nozzle and at least one pressure dona- tor.
24. A devise according to claim 2 and 23, wherein a elastic hose end serves to support a sensor thread or bristle, which is able to take up tissue liquid in or under the skin, and is temporary compressed to guarantee a ccnduction of the foremen tior;ed sensor means against the skin and said hose end preferably fitted inside with electricaly conductive layers temporary in contact with wires toward the measuring device and said conductive layers being then in contact with adjacent chemical substances which react with an interesting metabclic substance.
25. A device according to claims 2 and 23, wherein a sensor thread or bristle as sensor means are temporary embraced by stacking sheets in a row with current conducting portions in contact with the wires toward the measuring device while the sensor means are situated outside of its protective sleeve or a hose end.
26. A device according to the claims 2 and 23, wherein ii cylinder with chemicals, which alter their colour by influence of an interesting metabolic substance, is put into the end of a carrier thread, preferably inserted and fixed a short distance in a bcre of said carrier thread.
27. A device according to the claims 2 and 23, wherein a sensor thread or bristle as sensor means is injected through the skin by a pressurized gas stroke.
28. A device according to the claims 2 and 23, wherein the puncture of the skin is performed in a suction cup as means for the production of a skin fold, near the suction cup edge in a direction which deviate Irom the suction op axis.
29. A device according to the claims 2 and 23, wherein as means for an optical skin control a kind bind or visor with a hcle is proviced near the base of the skin fold, whereby the skin can be approached to the sensor means before its use nearer as the adga- cent skin, witch leans on the blind, and which hole marks the puncture area, and whereby light is tangentially projected through the small bubble in said hole against a photo receiver in connection with a measuring device and the electronic programme control.