DE19519281A1 - Appts. for measuring metabolite and injecting drug as needed - Google Patents

Abstract

Appts. is claimed for measuring metabolism and introducing drugs as required under a raised fold of skin. The skin fold is raised by a device and held by a clamp. A canula approaches the base of the skin fold, at the side, horizontally, roughly parallel to the un-raised skin. A second device controls canula exchange and cannula advance. The second device has a mechanical controlled drive unit to move the sensor in and to the canula and to dose the drug. The drive unit is monitored by a programmable electronic control unit. The device, drive unit and monitor are enclosed in a housing together with one or more measuring devices and usually a device for optical monitoring of the skin-piercing location.

Description

Task

The invention relates to the field of medicine technology, more specifically deals with metabolism measurements, especially with the glucose measurement Diabetics and there with the measurement-dependent Insulin therapy.

The invention provides an improvement and addition to under P 44 34 381.7 on September 16, 1994, with which it forms a unity. The facility should be as possible be designed to be handy and reliable, above all for self-treatment under medical supervision.

State of the art

The invention builds on the injection into an inside skin lifted by M. Demarchi (U.S. U.S. Patent 1,934,046, Nov. 7, 33) and G.N. Hein (U.S. Patent 2,743,723) and on a large number of own patents and Patent applications starting with DE P 25 51 991.0 to P 25 51 993.1. At H.Malm (US 2,660,169 Nov. 24, 1953) spring tongues pinch the skin to the fold.

Solution of the task

Borrowing from the development of pressure jet Inectors gained knowledge that the puncture of a Dome from the side offers advantages  the cannula insertion obliquely, especially advantageous horizontal or almost horizontal to the device support or body support surface, i.e. almost perpendicular to the anhe exercise direction of the skin in the suction cup and preferably in the edge area. Because the skin is independent of the latter gig of the top of the skin is tight, needs it for a stage of intracutaneous placement of the canoe lens tip for measurement purposes here no special locking device Direction to or around the cannula to lower it to prevent first. (In an example of the invention such a device is ge as part of the device depicts a ring of three surrounding the cannula Surround supports, which are retracted into the housing base can be. The cannula can then go deeper under the skin to inject medicine.)

The firm spatial relationship of the skin to the suction bells rand allows the exact cannula advance tunable penetration depth. The parallel position of the cannula and expediently also the step syringes which the Dispensing medication also favors the flat shape of the device. The latter is easier to transport and prevents Prying off the suction cup from raised skin, secures thus its position stability during use. The clamping device in the shape of two of the skin slabs approaching from the outside were supplemented by the Example of several around the rounded suction cup rim hooks or claws spring-turned inwards. The latter have a rough end surface on those caused by suction raised skin at the base of the skin.

The injection cannula is located on the side of the suction cup rim boiled down here, it in turn hinders the front early withdrawal of the skin from the suction cup and thus also from the cannula.

In the preferred solution example an elastic  Suction cup that goes from the side of the circular shape to one Ellipse is compressed, the roof is with corre appropriate folds and is made into loops a rail prevented from going down from the negative pressure to be drawn. In this case, the vacuum can even can still be obtained after skin clamping.

The negative pressure is generated by the expansion ei elastic bag, the wide surfaces of which the surface of a cover plate for the housing and the Inside of a Dec kels is connected. This connection is preferably made via a corresponding tongue and groove design (as Dovetail or meander). The bag protrudes connect a hose to the suction cup. Together it is pressed manually against pressure springs between Caseback and lid. An articulated connection of the the compression springs partially surrounding pipe sockets the base also allows a lid closure in Stages. Lastly, contacts need to snap all tube into place Trim or report locking elements in spring grids before the device can continue to function.

The lid closure itself is latched, because with it other functions like that of spring tension for the Clamping device and especially lifting a new one Cannula into the funnel using a sliding wedge to the suction cup. In the example chosen here the clamping device consists of two laterally in the Ge tension and compression springs arranged in pairs. Their tension takes place via the evasive movement of Wedge bevels on ledges under the influence of one with the cover-lowering roller, which descends on one standing edge tab is mounted. The spring ends on the two sledges, which are opposite each other on suction cups are attached or at their laterally protruding Tabs are placed in the like via additional sliding bars the lock grid created in pairs. The  Opposite ends of the springs are on a lever around it Axis mutually displaceable. A lever lock only then becomes a sled for the Cannula advance released when the cannula comes out of the Skin is withdrawn. Both push and pull springs of the skin clamping mechanism can then come back Relaxation and also be sprung Cable in connection with the carriage just mentioned again returned to their locking position.

The cannulas are stored in sleeves with rubber threads mutually united into a closed chain ring are. Your transport to replace a used one The cannula is either placed on a sled guided pin, which is in the zigzag guiding backdrop a storage drum for the cannula chain runs, or by taking one between two cannula sleeves engaging separating wedge of a linkage over a standing trapezoidal guide upscale and after retreat of the separating wedge lowered from the cannula sleeves becomes. A sled as a slide for the cannulas transport of the single cannula in the direction of the suction cup acts first on a tube, which the sleeve with the Cannula into a funnel in the skin's carriage introduces clamping device. The intended for use The cannula is already in its sleeve during the chip nens the skin clamping device via a wedge guide on Housing slide and / or its counter slide for the opposite suction cup rim in the plane of the suction bell rim pressed down. Then a bin pushes itself sleeve on the bellows with the sensor thread inside over on the cannula attachment. Because of the Friction between the cannula hub and the surrounding cannula The sleeve first becomes the latter up to the stop in the funnel postponed. Now the friction between the cannula hub and sleeve overcome and the cannula shaft into the skin  pressed. After overcoming the between inner sleeve or pipe and a guide pin stored in the latter attached spring or its tension penetrates the end of the Guide pin in a bowl-shaped depression on End of the bellows of the cannula and pushes the latter together. The sensor thread leaves with its end finally the cannula shaft and then lies in the Subcutaneous tissue where it is full of tissue fluid can suck.

The withdrawal of the sensor thread to behind the cannula shaft with expansion or overstretching of the bellows is still taking place during the pushing movement of the Slide as a slide gate for cannula transport. For this purpose, a protruding from an outer sleeve acts Segment on a lever attached to the inner sleeve a whose opposite end acts on the guide pin and reverses its direction of movement. The outside sleeve in turn rotates with the segment by one on the Inner sleeve or the inner tube attached cylinder Spiral slot for the rotation of the segment over a knob engaging in the slot in the feed of the segment releasing position, the latter in the support ring on the inner sleeve via a recess leaves this support ring and operates the lever. After the lever stop, the cannula (after completion the metabolism measurement, for example, or possibly injections) deeper into the subcutaneous tissue lowers.

An alternative to this lever mechanism is in the form an eccentric feed presented with a kind additional planetary feed. One on the timing gear mediated partial rotation of a wheel operated the cannula sleeve and Cannula advance. The sensor thread is withdrawn via an eccentric rod attachment an eccentrically attached to the partially rotated wheel  additional wheel.

If the sensor thread is fed from a cannula shaft, which has already left the skin and is ready for injection is pushed further into the subcutaneous tissue, so the lever or eccentric mechanism can be saved. The retraction of the sensor thread is then simply in the retraction phase of the carriage for the cannula advance relocated. This withdrawal phase is marked by a any injection phase interrupted (under blockum circuit in the control gear).

As a control gear for switching between the one a centrifugal switch was used for individual function blocks elects. In a variation of one The worm gear needs the radial and spring-loaded Switch pin only after more than one revolution his position of engagement either in the Internal axis or in the outer cylinder to take away to reach. The decisive factor here is the rotational rotation speed, which is resisted by an electric motor stood or throttled over briefly hooked drive currents can be. With such a two-speed circuit becomes a block circuit for the sledges Movement for cannula advance in both directions sets. For the dosing of two drugs, barriers gears turned on to the stepped piston feed (for example) for only one type of medicine Clockwise rotation of the engine and that of the other type only to take effect when the motor turns to the left. For returning the dosing spindles to the starting position then before changing the medication cartridges must be on Hand switches are provided to control the motor directions to reverse for this purpose.

A three-speed gearbox is presented as an alternative. Thereby spindle-generated end thrust movements of the individual function blocks on the gearbox drive wheel transmitted via a linkage. The drive wheel or  Shift pinion is along the angular motor axis - in Connection to the transmission gears for speed min change - one after the other into engagement with the three Working wheels moved for the functional blocks. These Sliding movement is over a bridging sleeve Shift pinion axis as an extension of the motor axis possible light. It is limited by a cross noc kenstift within a fixed to the sliding direction Switch sleeve, which in an inclined In nenrille the latter is performed. The groove shows speaking of the engagement position between the shift pinion and work wheel each inhibiting the cam movement Notches on. Under the action of a cam movement counteracting compression spring gets into the last one Return to the starting position counter-Ausker exercise with slight rotation by a Chamfer this counter notch. When pushing again movement of the boom through the carriage of the last activated function block in the end effect phase of the latter, the cam moves to the next higher one Notch notch shifted. After two such shifts exercises the cam falls over a steep flank of the groove with subsequent longitudinal groove in the switching sleeve in the Starting position back. The shifting movement of the Linkage up to the effectiveness of the slide movement of the next function block will have an additional Gear maintain which linkage and shift pinion - separated from the latter by a compression spring - is pushed onto the shift pinion axis. With free Rotation on the axis indicates this gear wheel for switching sprocket pimples out with pimples of the latter engage in mutual contact. That too Additional gear is then mitgenom from the shift pinion men. When the pressure drops from the linkage leaves the additional, the shift pinion temporarily  widening gear with its knob engagement with the Shift pinion under the action of a leaf spring between it and the shift pinion to shift the linkage again exercise over the sled of the next function block in its final phase.

Taking the boom with the sled - well ultimately via the spindle driven by the motor - he follows, for example, through a leaf spring with a wave pro fil, on which a crossbar of the carriage in the front temporary movement finds a stop. Another lion solution leaves a pin suspended on the carriage Teeth of a gear wheel (when moving only in one direction device of a ratchet gear) and causes a partial rotation of the latter. Both devices can also trigger Cover grids, locking of the locks for the clamping device tion etc. using levers or cables. Especially Tripping processes can also be triggered by one or more or push magnets are made electrically. The functional con trolls of the mechanical control gear take place via Electrical contacts, especially on the gears the electronic control unit.

A major advantage of arranging the injection cannula transversely or approximately transversely to the suction cup axis and the puncture close to the edge of the suction cup and at the base of the cuticle is that a introduced sensor thread directly over the muscle can be placed in the body fluid. Does the sensor thread or the sensor carrier get an arcuate Preload, which is directed towards the body, so the Security of such a liquid contact of the Sen sors can still be increased. The accuracy of the Measuring distance increases when only the end section of the sensor coated thread is measuring active. This can also be done be achieved that the electrical measuring section only in  takes place within the cannula body, for example by the the thread section carrying the enzyme layer by means of the Inner covering of the narrow thread channel in the cannula attachment receive a conductive shell of known dimensions can, which moreover are separated by division Electrodes can relay signals. With the body too the cannula opening must be self-evident secured against rotation, for example by oval ones Shaping.

The metabolism measurement only outside the body in the Cannula hub closes disorders due to the intrinsic muscle flow potential, especially of the heart muscle cells. The measurable potentials with active, electrons releasing measuring method should be at 10-14 volts and Milliampre range. Appear even cheaper New developments of a passive sensor that - like on the Sepharose-Convalanin-A based on PCT / DE8 / 00313 - the isolating properties of glucose against one electrical current flow for quantitative measurement purposes exploits. Suggestions are also for optical Measuring cannulas included. So the introduction of a leaflet punched out from a standard measuring strip with optically active surface pigment under liquid attracting surface. Become two such leaflets with their non-active surface united and glued to a thread carrier, so two measurements can be taken at the same time. (Conveniently, this is done as in the usual Glucose photometers in two different sensitivity areas). Optical fibers are used as the carrier thread sets, so the facing color-active reaction zone from one to the bowl-shaped Deepening of the bellows inserted at the cannula hub Light source or a light guide from be lights up and the reflected light due to weakening be measured. A single fiber optic fader can be under  Application of the method of optical coupling both for light introduction as well as for light derivation be set. The opposite optically active layer is scanned by light rays which are along the Carrier thread at an angle through the bellows put the mirror ring on the base of the cannula on the Throw end with the layer of paint. From there the beam path leads back over the mirror ring into the Surrounding the bowl-shaped recess of the bellows total where an annular light window optical fibers of the Fit the guide pin for the cannula.

In another example, the carrier thread is the double sided measuring cylinder made of paper or a Visually indifferent fabric. During the Withdrawal of the liquid-saturated color measuring cylinder in from this point on the cannula attachment piece is replaced by a tightness engaging in a step to the carrier thread Carrier thread loosened. Each with two curved hollow needles central optical fibers are then through holes in the cannula hub from both sides like above approached the color measuring zones below. One of each Light guides serve to supply light and one each Light conduction to the photometer.

The bellows can be used to shorten the cannula as a whole also be replaced by a piston in its bowl shaped depression the button-like end of the guide pin penetrates to the cannula hub for the shaft with the ring groove for the drug supply first lower along with the sensor thread. When the Piston eventually causes a thickening at the end of the Measuring thread that the piston in the sleeve together Cannula is withdrawn. Another cut of the guide pin pushes the sensor thread into the piston and Shaft back. The piston is now going through a cross latch locked, the guide pin can again be solved by him in the desired position.  

When programming the device, reference is made to the in PCT / De85 / 00113 given solutions. Those used for program setting are stacked Lined up rings are now lined up side by side rotary knobs lined up on one edge of the device. Also here is a lockable button to release the Degrees of freedom are provided for the user in stages. An innovation in the direction of increasing freedom of movement Lifestyle is that there is appropriate use zern is made possible, also the depotinsulin doses adjust the respective course of the day, i.e. new every day program. A grid of touch is used for this contacts on one side of the housing supplemented by a - possibly interrupted - liquid display Bar starting from the current time above delimits about a half or full day period. The patient can now be assigned at the intended time his intended food intakes as well the glucose content by brushing of the touch contacts each show triangular. The points of contact here are expediently illuminated assigned diodes to make the choice visible. The width of the triangular base above corresponds then the glucose content, the removal of the triangle tip below the expected rate of absorption this glucose. The level of physical activity will time-assigned according to watts in side rectangles expressed. Starting from the currently measured glucose tissue level and taking into account the entered personal insulin activity constants and the activity profiles the insulin used is from Calculate the height and the mixing ratio the insulin is covered and administered, unless you have to be warned of inconsistencies. While the device is in contact with the network reader, the printer installed there gives measured values,  Patient inputs and dispensing dosages numerically and graphically again, allowing control.

This device also has an optical skin control important before the puncture. You can, for example from the suction cup roof over a mirror to the on Stitch site avenge, but can also over optical fibers almost parallel to the cannula shaft. There will still be control of the suction cup rim pulling skin described through a light window, being the calculator the skin texture of the under the punk skin according to the speed of the Movement of the skin field pattern determined. About a leak nozzle or a controlled nozzle can reduce the pressure in the suction bell waned to be considered a serious he to shift the calculated skin to the puncture site ben.

As a dosing alternative, bellows are used as medication containers ter in series in connection with a dosing cannula ben. Their membrane-enclosed end cup on the cannula attachment is applied by means of impulsive impacts across a cross hole of the shaft base with the cannula influence path closed emptied from the tip of the cannula through a valve plate. It should be added to the control gear that the rotation in within a function block at the beginning of a spindle drive to a slide or in the Center between two spindle drives using plates guidance with shifted gears in engagement or lever guides can be tapped from a gear. This motor-driven gear moves lengthways a threaded rod and runs with its side profile or knobs on the end or ends of this threaded rod appropriate. Profile designs of the spin driving wheels or spindle axle extensions on. Spring balancers can work between profile couplings Loosen wheels, rods or trains and so continue the shift of the motor-driven wheel further radio allow the latter.  

Description of the embodiments

Fig. 1 shows in almost natural size in a longitudinal section approximately at the level of the medication cartridges, a device according to the invention as a whole. The small bellows ( 4 ) around the measuring layer or Sen sorfaden is shown too short in the case of excess length of the cannula shaft ( 41 ). The sensor cannula is mounted in the sleeve ( 691 ), the front and rear soft-elastic protective membrane are not shown. The guide pin ( 69 ) for the cannula lies within the inner tube ( 693 ). On the inner tube, the plunger ( 694 ) is attached, which is moved by the lever ( 695 ) with cable ( 696 ) after tripping functions or before the lever ( 696 ). The linkage shown in dash-dotted lines are guided past other devices at various angles. Such a linkage to the carriage ( 697 ), the threaded block of which is displaced by the rotation of the associated spindle, the fork rods ( 698 ) preventing the threaded block from rotating. At the spindle is driven by a gear transmission and the chain ( 88 ) on the internal axis ( 715 ) of the centrifugal switch. The annular roller ( 699 ) of the latter is in constant connection with the motor axis ( 51 ) via the transmission gears ( 54 ). Via the outer cylinder ( 700 ) of the centrifugal switch, the gear ( 701 ) is driven with the associated axis. Through the chain wheel for driving the carriage ( 697 ) through, the axis of the gear ( 701 ) acts on the ratchet gears ( 702 , 703 ). The bevel gear, which rotates freely around the axis end, is in knob engagement with the movement-oriented part of the ratchet gear ( 302 ). The rotation is transmitted to the dosing spindle ( 716 ) via the bevel gear ( 705 ) with a fixed seat on its transverse axis. In order to turn the dosing spindle back after emptying or to change a medication cartridge, the slide switch ( 717 , see Fig. 2 and 6) must be moved to the left by hand in order to set the ratchet wheel ( 703 ) with opposite direction of operation. The ratchet gear ( 706 ) is also driven by the gear ( 701 ) and its axis, that when the motor reverses direction relative to the drive of the dosing spindle ( 716 ), its rotations via the pipe segment ( 709 ) to the connecting sleeve ( 710 ) via a pin guide in one - not shown - longitudinal slot of the same and the sliding on the connecting sleeve carriage ( 711 ) on the dosing spindle ( 713 ). The latter moves in the fixed thread block ( 712 ). In contrast, the spool ( 714 ) for transporting the chain ring of the cannulas can rotate freely around the metering spindle and is also stored in the fixed drum ( 718 ). The dosing spindle ( 713 ) can be rotated to the carriage ( 711 ). The latter pushes the connecting sleeve over the pipe segment ( 709 ). The associated metering plunger ( 720 ) was advanced as far as possible in the medication cartridge via the linkage ( 719 ) shown schematically in a dash-dot line. The functions via the dosing spindle ( 716 ) run analogously. There are still hinged kidney hinges ( 721 , 722 ) are provided, the stabilizing suspension has been omitted. By lifting the swivel arms against the spring tension, the coils for the chain ring of the cannulas are fed to each other, which enables the latter to be changed.

The sash ( 723 ) is connected to the edge of the elastic suction cup ( 1 ) via the support columns ( 724 , 725 ) (see Fig. 2). Two sliding strips ( 726 , 727 , see Fig. 3) establish the connection to the rest of the housing. The connecting strap ( 728 ) and the tension spring are also designed in pairs. The same applies to the connecting strap ( 730 ) between the injection carriage ( 731 , see Fig. 3) and the compression spring ( 732 ). Both feathers work against each other to pinch the skin. (Above the suction cup, the suction cup roof is shown in folds in dashed lines, as it corresponds to the functional stage during skin clamping, in which the four support columns, each with a slide plate ( 9 ), namely a sash ( 723 ) and an injection slide ( 731 As with the cover lowered (see Fig. 5), the pipe socket ( 258 ) for receiving the compression spring ( 287 ) - distributed in four on the corners of the housing - is visible. The motor-driven gear wheels ( 708 , 748 ) serve The drive for the dosing spindles ( 716 ) runs via the bevel gears ( 704 , 705 ), the transverse axis and corresponding bevel gears.The battery ( 255 ), measuring device () and electronic control device ( 80 ) are in the gaps.

Fig. 2 gives a section of the longitudinal section of Fig. 1. There are the support columns ( 725 , 724 ) on the edge of the elastic suction bell ( 1 ) from the sash (not shown) ( 723 ) and the support columns ( 735 , 736 ) with extended Called suction cup; the slide plate associated with the injection slide ( 9 ) is double a to make their displacement movement clear. To support the suction cup roof, the folds of the latter are supported by the pair of strips ( 737 ). The latter are attached to the sash and along the rail ( 738 , see Fig. 4) under the cover plate ( 283 ) displaceable Lich. The roof is attached using a bracket ( 739 ) that can be moved along the rail.

About the paired spool ( 714 ) is a chain ring held together by elastic rubber threads with sensor sleeves containing sleeves ( 691 ). The transport mechanism is explained in Fig. 3.

In a cross section along the section line AB of the longitudinal section, the mechanism for the cannula advance against the suction bell is illustrated in a 2: 1 scale. The plunger ( 694 ) is secured against rotation through the fork-shaped, fixed holder ( 740 ), in which the drum ( 714 ) rotates with a spiral slot, because there the axle pin ( 766 ) of the plunger is guided. The rotation of the drum is communicated via the knob ( 747 ) in the longitudinal slot of the outer sleeve ( 745 ). Since the end of the axle pin engages in an annular fold ( 769 ) of the outer sleeve, the outer sleeve is moved over the drum. Via the tongue ( 742 ) on the outer sleeve, the thrust movement communicates with the inner tube ( 693 ). Finally, the tongue gets into a gap in the collar ring ( 743 ) on the inner tube. The lever ( 744 ) is mounted in the gallows ( 741 ) attached to the latter. It acts on the central pin ( 767 ) and is actuated by the tongue ( 742 ) while returning the sensor thread into the cannula. (Detail B shows a frontal section along CD of detail A. Detail C shows the state after bellows compression.) The further right displacement of the guide pin ( 6 ) is effective via the spring ( 746 ) relative to the central pin. The measurement signals come from the guide pin ( 6 ) from the slot in the inner tube via the lines ( 25 ) to the measuring device. The Trich ter ( 749 ) are drawn profile projections, which designate the depth of penetration of the sleeve and cannula hub with elastic material properties. The position of the two medication inlet openings ( 750 ) corresponds to the end position of the movement of the cannula attachment piece of the cannula ( 4 ) because of an edge strip of the funnel. Drug entry openings and the ring groove of the cannula hub or body come into congruence, so the injection took cover. The pin ( 768 ) from the outer sleeve ( 745 ) protrudes into a slot in the inner tube. So the latter can be brought back to the starting position when the drive is reversed. The solution described, for example, corresponds to the use of, for example, a sensor cannula of the type described in more detail in relation to FIGS. 15 and 18.

FIG. 3 is a detail top to the suction cup (1) and injection carriage (731) in longitudinal section. The approach of the slide plate ( 9 ) of the sash ( 723 ) is just shown. The latter can be seen on the detail in the frontal section (approximately in natural size) in order to demonstrate the mechanism for lowering the cannula from the chain ring into the position in front of the lower-lying funnel to the suction cup. A ledge from the sash ( 723 ) ends with a kind of backward-facing sloping roof ( 751 ). In a sloping roof facing the opposite end, a bar ends which is connected to the injection sled. The function stage shown shows the two strips in the position before the tension and compression springs ( 8 , 732 ) are tightened for the skin clamping mechanism. (The latter is described in more detail in Fig. 4). If the springs are tensioned and the suction bell is set back into the circular shape shown in dashed lines, the two roof slopes approach and press the cannula located below them out of the chain ring under them and the sleeve below them. The mechanism for the cannula transport along the chain tenringes is clear from the transverse section along the section line AB in the above longitudinal section. In the center is a cannula sleeve ( 691 ), which was pressed down from the row of chains by the corresponding concave hollow of the roof slopes ( 751 ). The latter is still connected by stretched rubber threads. The spring holder ( 119 ) for the insulin cartridge ( 114 ) on both sides. The injection carriage ( 731 ) is mounted on rollers ( 752 ). The sliding strips ( 726 , 727 ) run in a rail guide on the housing base, the wall thickness of which has not been shown. The coil ( 714 ) for transporting the chain ring is hollowed out in a star shape.

The changeover slide on the side is listed at the bottom right in a cross section over the length of the device, i.e. perpendicular to the transverse cut. There are two sleeves ( 691 ) shown in rubber band connection, between which a transport wedge ( 753 ) separating from behind engages. The latter is moved away from the cannulas by the pendulum rod ( 752 ). A hook or cross pin ( 756 ) is deflected by a trapezoidal guide ( 755 ) so that the chain row is shifted by a cannula width. During the fall of the cross pin on the steep flank of the trapezoidal guide (dashed line) under the influence of a spring omitted, the transport wedge has withdrawn from the sleeves. The Pen delstange is ver in a disc guide along a slot of the slide ( 757 ) parallel to the sleeves. The force from the functional linkage via lever ( 695 , Fig. 1) is applied to the slide ( 757 ), which is moved along the rail ( 758 ).

Alternatively, the chain ring can be shifted by one link via the zigzag profile guide of a wheel coupled to the spool ( 714 ). The detail below gives about 6: 1 scale of it a stretch-wise roll-up and at the same time the engagement of a cam ( 759 ) which causes the sleeve to be transported back and forth from the driven rod. Here, too, the mechanism is provided in pairs with an effect on both coils.

Fig. 4 shows a cross section along the largest device extension approximately on a scale of 1: 1 near the housing side wall, which in turn is seen in pairs for both sides. The mechanism for skin clamping is to be presented. The detail in the middle shows a longitudinal section of the release grid ( 760 ) for the tensioned springs. On the right, the small detail of the spring lock grid in a transverse view (from the right), which is shown in cross-section over there. Finally, a detail below, which shows the detail of the two springs in analogy to the cross-section of the upper illustration.

By pulling the rope ( 761 ) about the displacement of the lever ( 695 , Fig. 1), the lever bracket ( 762 ) with slot guide for the axis connection with the bar ( 763 ) for the determination of the tensile strength with an articulated connection with the bar for the compression spring moved so that the lock grid ( 765 ) prevents the lever tab (top).

The sash ( 723 ) and the injection slider ( 731 ) are locked by the release grid ( 760 ) when the suction cup is unfolded. The strip with the roller ( 770 ), which extends down from the cover ( 260 ) laterally (again in pairs), is lowered when the cover is lowered against the compression springs ( 287 ). The wedge bevels on the strips ( 763 , 764 ) were pushed apart (in the stage shown). Both the tension spring ( 8 ) and the compression spring ( 732 ) are tensioned. The locking grid ( 765 ) finally detects the lever bracket ( 762 ). If the trigger grid is actuated by a cable pull from the drive for the cannula transport (function block A), the suction cup edges approach in a springy manner, since they are connected to the tension and compression springs ( 8 , 732 ). Immediately before that, the pipe socket ( 258 ) locked after lowering the cover was released after the suction bell was placed on the skin and visual skin control (cf. FIGS. 13, 15) (cf. FIG. 5).

The bag ( 257 ), the walls of which are attached to the cover ( 260 ) and cover plate ( 283 ), expands and has a lifting effect on the skin via the suction hose ( 46 ) in the suction cup ( 1 ).

The detail below shows in cross section the stage after measurement substrate uptake or injection. To do this, the blocking grid ( 765 ) was triggered by cable pull from function block A. Tension and compression springs ( 8 , 732 ) could relax by the ends of the strips ( 763 , 764 ) coming apart. The pulling apart of the strips is promoted by pulling on the cable pull ( 774 ) which is attached to the spur ( 773 ) of the strip ( 763 ). The same applies to the cable pull ( 775 ) via the deflection pulleys ( 771 , 772 ). The latter runs around the block grid ( 765 ). Both cable pulls are sprung and lead via a common pull to the control gear or function block A (see FIGS. 10, 11). The deflection roller ( 776 ) for the release cable of the locking grid has its axis in the support bracket ( 777 ).

Fig. 5 shows in a cross section along the section line CD of the longitudinal section of Fig. 1, the locking mechanism of the device cover in natural size. The attachment of the bag ( 257 ) on the top of the lid ( 260 ) and below with the cover plate ( 283 ) is done via a longitudinal rib profile of the bag in a parallel arrangement, which is inserted into corresponding grooves in the fastening surfaces. On the left the profile is drawn a distance in the form of a dovetail and on the right a meandering pattern. On the base standing on the device base along the rail ( 289 ), the carriage ( 288 ) is displaceable. The tension spring ( 290 ) prevents the pipe socket ( 258 ) and thus the cover ( 260 ) connected to it from being lowered. First the string ( 291 ) must be pulled over the roller ( 292 ) via the control gear (function block A) (left pipe socket). If the pipe socket is lowered against the compression spring ( 287 ) (right side), the edge ring ( 778 ) of the pipe socket snags on the slide ( 288 ). The latter is shown in detail in frontal section with its rail guide below. A rubber-elastic plate fastening of the pipe socket on the cover corresponds to a kind of landing net holder ( 780 ); it enables an energy-saving cover closure by simultaneously pressing down the pipe socket.

Fig. 6 shows in longitudinal section approximately on a scale of 2: 1 the detail of a centrifugal switch again, as it is already shown in Fig. 1. At the slide switch ( 717 , see Fig. 14), the ratchet gear pairs ( 703 , 702 ) and ( 707 , 706 ) were shifted to the left; the dosing spindles can thus be rewound. The motor direction makes the choice between the two. The drive runs from the transmission gearwheels ( 54 ) after the motor via a gearwheel onto the roller ( 699 ). Here, the slide ( 606 ) designed as a pin decides on the selection of the function block depending on whether it is in the screw guide of the internal axis ( 715 ) - as shown - or in the screw groove of the outer cylinder ( 699 ). The slide valve ( 606 ) contains a permanent magnetic part and is held in a more centripetal position by permanent magnets in the roll. Due to the centrifugal force, however, it is pushed outwards into the worm groove guide of the outer cylinder when the motor rotates faster, so that it rotates when the end of the channel is reached. (If the direction of rotation continues, the speed of rotation no longer plays a role for the switching function). The illustrated switching situation would transfer the force via the switching chain ( 52 ) to function block A for cannula retraction when rotating against the worm groove via the internal axis ( 715 ) via gear wheels and the freely rotating axle sleeve ( 781 ). If the direction of rotation of the motor were changed, the direction of the shift chain would only be changed at low speed. (The motor deceleration can be achieved via an electrical resistor or an interrupted, staking power supply to the motor). At a fast running speed, the power transmission runs via the outer cylinder and the wide gear to the gear ( 701 ). The latter rotates its axis and through the axle sleeve ( 781 ) through the locking gear ( 703 ). Via the gear ( 782 ) and a gear rotated on the same axis, the bevel gear ( 704 ) is driven and thus also the bevel gear ( 705 ) on the transverse axis to the corresponding metering spindle (function block B). This is done via an edge toothing of the bevel gear ( 704 ). The ratchet gear ( 702 ) has no function, since its cam ( 783 ) has left its counterpart on the bevel gear rotating freely on its axis. The opposite motor rotation is transmitted via the locking gear ( 707 ) in engagement with the gear ( 708 ) via the pipe segment ( 709 ) to the other dosing spindle. (The directions of thread rotation of the dosing spindles are expediently coordinated with one another in such a way that no changeover in the centrifugal switch is required to change the dosing).

When the slide switch ( 717 ) was actuated manually, the ratchet gear ( 706 ) was pushed to the left via an annular groove in the axle and thus lost its axle lock.

Fig. 7 gives approximately natural size in longitudinal section another solution for switching between the function blocks. Since the switchover to three different work wheels takes place here, a slide switch for rewinding the dosing spindles is not necessary. Function blocks B or C with flow and return are assigned to the dosing spindles.

From the shift rod ( 789 ) - at the end of the sliding function of block A (see Fig. 11) - by tightening the compression spring ( 495 ) the upstream of the shift pinion ( 351 ) on the motor shaft ( 53 ) - naturally after the Transmission gears for speed reduction - freely rotating gear with the leaf spring ( 785 ) approached the shift pinion ( 351 ). The latter drives the working gear ( 293 ) for block A when it is sliding on the axle. Since the cam ( 783 ) gets into the corresponding niche of the shift pinion, the upstream gear is rotated by the shift pinion. It drives the working gear ( 293 ) even when the shift pinion is just shifted to the right onto the working gear ( 790 ) for the shift block B. In the rotating pipe socket ( 786 ), the cross pin ( 788 ) of the motor axis moves within the spiral groove ( 787 ) with three bulges according to the switching positions. Each bulge provides a stop for the right-hand shift of the motor axis and after the sliding movement has subsided, the opposite direction. The latter return movement to the left takes place via the tension spring ( 784 ) between the cross strut ( 791 ) and the housing sewand. As can be seen in the detail on the left, on a scale of about 3: 1, after the functional stage B the cross pin is returned to a position according to functional block A by the tension spring. As the pressure on the selector rod ( 789 ) decreases, the compression spring ( 495 ) is released . The leaf spring ( 785 ) in a recess of the gear upstream of the shift pinion causes the latter gearwheels to separate, so that the knob ( 783 ) leaves the shift pinion. Holding plates ( 124 ) can ensure the connection to other gears for the transmission of the working function. The sliding sleeve within the motor axle connection was not shown. In a variant, the pipe socket ( 786 ) can be secured against rotation. The motor effect is then transmitted to the switching pinion from a parallel axis by means of a gearwheel which is carried in the holding plate connection with the switching pinion; the shift pinion ( 351 ) and the work wheels can then be freely rotated.

Fig. 8 gives left in a frontal section right in a longitudinal section and below in cross section in natural size a detail of the power transmission from the motor axis ( 51 ) via the working gears ( 790 , 293 , 792 ) for example se on ratchet gears ( 702 , 703 ; 707 , 706 ) and other drive elements. When using a Schaltgetrie bes of FIG. 7, the force transmission takes place expediently approximately corresponding to the arrangement in Fig. 11. The intermediate of the gear (793) circuit is done for interior design, because the mechanism for Dosierspindelverschiebung was paral lel set. Function block A was moved to the middle position in FIG. 8.

Fig. 9 shows in a longitudinal section in a schematic combination three DC magnets for triggering the function and their functional organs in approximately natural size as an alternative. The dashed line shown Ver extension of the armature ( 19 ) of the solenoid ( 556 ) designates the way to work ( 557 ). The cover mechanism for suction generation was triggered by pulling back the slide ( 288 ) by means of the string ( 291 ) via the roller ( 292 ). After the movement of the pipe socket ( 258 ) was released, the compression spring ( 287 ) became effective. The tension spring ( 290 ) has already brought the slide back into its locking position. When using a collar edge ring ( 778 ) as in Fig. 5, an unintentional lid lowering is now prevented with re-ventilation of the suction bell.

The immersion magnet ( 555 ) has not yet unlocked the release grid ( 760 ) between the sash and a bar of the injection slide ( 731 ) and has not yet caused the skin to become jammed.

Compared to the immersion magnet ( 556 ), the detail about the determination of the tension and compression spring ( 8 , 732 ) from FIG. 4 is repeated. The assigned locking grid ( 765 ) is actually only activated after the release grid ( 760 , above) and should be in the locked position for the rest of the tensioned spring. (The latter are in a relaxed state for actuating the immersion magnet ( 556 ).

Fig. 10 shows on a scale of about 2: 1 in longitudinal section a double-acting DC magnet ( 563 ) for several separate triggering functions. The guide cam ( 564 ), which is fastened to the holding bar ( 566 ) via the hook ( 568 ), ensures that the rotary piston ( 567 ) is partially rotated. The rod of the latter is actuated by the angle piece ( 569 ) on the cross strut ( 570 ) against a spring-back force transmission (not shown) to a successful organ. The ring sleeve ( 571 ) with the magnetic action moves on the elongated anchor ( 19 ) under the cross strut. The up and down movement is simultaneously converted into a partial rotation of the ring sleeve via a zigzag groove on the inside of the ring sleeve via the guide pin ( 542 ) on the elongated magnet armature. The ring with the small ( 574 ) and large ( 575 ) sector slots is attached to this. The small sector slot can pass the angle of the contra-angle ( 569 ) with a suitable rotational position. Further rotation blocks the return of the cross strut under the action of the tension spring ( 572 ) on the cross bar ( 573 ). Only when the large sector slot lets the angle through again is a release function activated on the cable pull ( 303 ). Additional working bars ( 576 , 577 ) can be operated in succession through the sub-sectors under the ring collar ( 571 ). Pushing functions also via a pivoting elbow or a cross pin on a rotary piston ( 567 ) as well as pulling functions (through the cross pin on the rotary piston or by reaching behind the sector slots ( 574 , 575 ) are possible. The slots can be selected so that the Release of the return movement of the contra-angle handpiece ( 569 ) by its tension spring takes place at a shorter time interval after one working cycle by the magnet than a second working cycle by the latter (because of its delay in response) .One or more of these multifunctional magnets could replace any motor drive, since cannula changes and -Feeding is possible, in particular by increasing the leverage of individual partial movements and with short cannula shapes.The dosage can also be included according to the pen type.

Fig. 11 gives an example of the transmission of a lever thrust movement - come from a motor gear or a magnet - on two trigger functions, for example, the decorative mechanism and the skin clamp. The scale of the mechanism itself was chosen to be about 3: 1. The wheel segment ( 794 ) is rotatable about the axis ( 795 ). The string ( 291 ) from the slider ( 288 ) and the cable ( 799 ) from the release grid ( 760 ) are selected in length and attachment point on the periphery of the wheel sector so that they are operated one after the other. The tension spring ( 796 ), which is tensioned on both sides between the wheel periphery and the device wall, can create a kind of trigger pressure point, ie a delay between the trigger functions, which can be used for optical skin monitoring. The leaf spring ( 797 ) on a cam of the driving pin ( 798 ) in a bore of the slide presses the release pin against the toothing of the wheel segment. The latter shows a blocking effect for the bolt action in one direction; the backward movement of the wheel segment then takes place via moments of force of another mechanism (not presented here) which may also be attributable to another function block.

Fig. 12 shows approximately natural size, the detail of the power transmission to a functional block of a (not shown) engine and work wheel in longitudinal section. The work wheel ( 792 ) was particularly wide and is located under the pinion ( 800 ), which is driven by it. In the functional stage shown, side knobs ( 783 ) of the pinion approach the gearwheel ( 802 ) which is firmly connected to the screw spindle ( 801 ), about which the pinion can be rotated, in order to rotate it, and thus also the screw spindle. Holding plates ( 124 ) prevent the gear ( 801 ) - which can also be a disc without a transfer function - from a side shift. Like the gearwheel ( 802 ), the gearwheel ( 803 ) is connected to the screw spindle ( 801 ), but can be rotated about it. The threaded sleeve ( 804 ) into which the screw spindle ( 805 ) projects is firmly connected to 803 . Via the linkage ( 806 ) connected to the latter, the piston rod can be moved directly for advancing the piston in the medication cartridge. Counter-acting ratchet gears ( 702 , 703 ) can take over the transfer function for driving a dosing spindle (cf. Fig. 1 in connection with Fig. 8) in tooth engagement with the gears ( 803 , 801 ), for example via flexible shafts. (Their coupling with the dosing spindle then takes place via separate gears, which abut a common gear around the dosing spindle, as well as the ratchet gears ( 707 , 706 ) set radially to their common drive axis). If the pinion ( 800 ) on its screw spindle ( 801 ) is moved all the way to the right while reversing the direction of the motor, its knobs ( 792 ) come into engagement with the same on the gearwheel ( 803 ). The latter and thus the threaded sleeve ( 804 ) is now rotated. The screw bolt ( 805 ) with the rod ( 806 ) preventing its rotation is now moved to the right. The pushing movement of the pinion ( 802 ) is communicated via the fork linkage ( 809 ) of the shift rod ( 789 ) by its cross pin ( 811 ) engaging in the corrugated leaf spring ( 810 ). The latter is displaceable with its rod in the holding bushing ( 812 ) and is connected in an articulated manner to the switching rod ( 789 ), which has an axis of rotation fixed to the housing.

In connection with the tension spring ( 792 ), the tapping of an additional ratchet wheel rotation is then shown, which prevents a transmission of movement functions in the position of the pinion ( 800 ) in engagement with the gear ( 802 ). The already secured via the wave profile of a gear ( 814 ) pressed against a compression spring against rotation blockage of the latter, the function is decoupled by pulling apart the nub washers ( 815 , 816 ). The knob disc ( 815 , or the knob wheel) can be moved laterally in axial engagement with the ratchet gear, the knob disc ( 816 ) rotates freely on the axis and is in contact with the gear wheel ( 814 ) in front of the gear ( 814 ) via a flexible shaft in axis contact. ( The wave profile is shown below). [Right in profile view and partially cut open].

The detail on the bottom right shows a broken-open ratchet wheel in profile view on a scale of about 4: 1. The ratchet tooth ( 620 ) is attached with its axis pin to the gear wheel intended for driving the motor gear. It is pressed by the leaf spring ( 635 ) - also fastened to the gearwheel by two bolts - against one of the locking teeth ( 323 ) on the back of the broken wheel which only transfers the movement clockwise to the pipe socket.

Fig. 13 shows on a scale of 2: 1 a gear with electronic feedback and movement, as it can be used especially for work gears, the work function is only in one direction. An example of this is insulin dosing. The axis ( 223 ) is surrounded by the electrically non-conductive insulating ring ( 224 ). The driver pin ( 225 ) extends from the axle sleeve ( 230 ) and, during rotation, abuts the stop mandrel ( 226 ), which is covered by a spring tongue ( 227 ). To the right of the frontal section is a longitudinal section in section line AB. When Seitenver shift the gear this gets between the Blattfe ( 228 , 229 ). The spring tongue ( 227 ) is expedient when the driver pin bears against the gearwheel; the side of the driver pin facing him must then be electrically insulated. (See cross section BC above). The current flow to the leaf springs 228 or 229 can be tapped via the axis. Depending on the purpose, one tooth or some teeth can be stripped; the non-insulated allow contact with one or both leaf springs ( 228 , 229 ) that the number of revolutions is controlled. The power line via the driver pin, for example, to the or the non-insulated tooth ( 231 ) on the opposite side of the driver pin allows the free play of the gearwheels, for example, when the shifting pinion passes without function to other work wheels.

Fig. 14 shows an optical Hautkontrollmechanis mus within a suction bell (top actual size) with (possibly) a controllable throttle valve (578). The injection cylinder ( 9 ) protrudes below the pressure sensor ( 81 , broken line because it is at the back) into the suction bell ( 3 ) cut at the back. At the edge of the suction cup, the transparent glass or plastic window ( 579 ) lies directly under the nozzle ( 3 ). In addition - for example in the suction cup edge area - the light measuring equipment with photoemitter ( 580 ) and photosensor ( 581 ).

The detail of the optical control device is repeated below on a 5: 1 scale. The skin field under the window ( 579 ) is drawn like a grid, as well as the light beam path from the phototransmitter (such as an LCD or laser) through the window, thrown back there by a reflective concave edge against the skin and from there through the window back over the convex edge into the photosensor . Of the cable connections, only two are given at their end sections.

The skin pattern is drawn past the window while the skin is raised. From the speed of the skin movement, after this movement has come to a standstill, the computer assigns the corresponding light extinctions from the stored skin partial field measuring fields to the measuring field above the nozzle or above the orifice at the location of the nozzle. (A task that is performed analogously by every PC CAD program today). It can be decided before the opening of the cover panel to abort the functional sequence without injection. If a blasted surface pattern of the skin (such as acne or freckles) has a pigmented skin or skin area that differs from normal reference skin in its optical properties in a position above the nozzle, opening the narrow throttle valve ( 578 ) can help Skin bell in the suction bell is slightly lowered and the puncture is carried out at a moment when a probably healthy skin is above the nozzle.

FIG. 15 gives a top view of the preferred form of the device (see FIG. 1) after tightening the arrangement of the internal mechanical equipment. By opening, through which the surface finish described below continues, the position of the suction cup ( 1 ) and the insulin cartridges ( 113 , 114 ) and some cannulas can be seen. The rows of circles on the surface of the device correspond in detail to a touch contact ( 817 ) which, in the manner of an earth fault to the control unit, reports skin contact and actuates a switch. The touch is expediently confirmed by a light source which lights up the point touched. For this purpose, a pen with a bright color surface can be covered at the end by a transparent pot ( 818 ), which is lowered when pressed against a spring and clings with an edge ring behind the bar ( 819 ) and is held under the appearance of the color field. (Detail top right in frontal section). The bar ( 819 ) also has regular edge incisions, as the cross section shows below the detail. Such strips can now extend along a row and mounted on a common frame against a spring so that all pots are released again for upward movement. Such or a similar (approximately inversely functioning) device also enables blind people to read the inputs. Display windows - for example as liquid indicators - contain a time grid updated from top to bottom. The patient can now, assigned to the intended food intake also with regard to the glucose content of the same by means of pressure against the touch contacts time associated with the control unit. Since the glucose content of a food is broken down in the course of digestion, this process corresponds approximately to a triangular figure with a broad base at the top. The base width is to be displayed more broadly in the case of higher glucose and starch content of the food. In the alternative, the accuracy of this programming can be mathematically improved, but can mainly be practiced on a registration strip (see below) while checking the display results. The extent of planned physical activity is assigned to watts in side rectangles by contact actuation. Starting from the currently measured glucose tissue level and taking into account the entered personal insulin action constants and the action profiles of the insulins used, the computer now determines the height and the mixing ratio of the insulin and their decay triangle is approximately coincident with that drawn by the patient, provided that there are any inconsistencies Programming does not have to be warned, the injection is made in the appropriate dosage.

An example of the input of food and workload is shown in the form of two triangles and two rectangles between the touch contacts in dash-dotted lines. To the right of this is the virtual image of the derived computer operation. The program entries are shown in dashed lines, while the calculation result is shown with dash-dotted lines. Dangerous contour bridges ( 821 ) cause the computer to issue warning signals by marking the time if the gap could only be closed with unreasonable dose changes. The patient can then supplement the food or take a control measurement at the time in question.

This expansion of the programming options via the As of PCT / DE85 / 0313 from 1985, now allows one  Dose adjustment also of depot insulin in adjustment the daily routine planned by the patient and thus one freer lifestyle.

The dosage, with the specification of special program blocks depending on the type of daily routine (sports or office day) and the determination of degrees of freedom for the patient, depending on their cooperation, is of course still the basis. For this purpose, the manual control wheels ( 822 ) are arranged along the device wall ( 16 ) in order to adjust sensitivity constants, low point with regard to the glucose content and correction frame as well as program blocks along the associated scales.

It should also be noted that the device could also be used for purely diagnostic purposes (ie without an injection device), for example for checking substrates in the body that require kidneys. Correspondingly simplified, the facility could also be used exclusively for injection purposes, for example the administration of heparin. The slide switch ( 717 ) with its rail guide along the wall of the device is still shown at the top right (see Fig. 6).

Fig. 16 shows in a longitudinal section a suction cup ( 1 ) with optical skin control of a variation of the skin clamping device and a device for the temporary prevention of the cannula on the skin penetration. The scale is 2: 1 for the above-mentioned components including the cannula attachment ( 4 ). For better clarification, the scale for the cannula sleeve and the optical metabolism measuring device is approximately 4: 1.

For clamping the skin after lifting it over the suction hose ( 46 ), the clamping ring segment ( 825 ) is used, which is moved by the compression spring ( 732 ) and has a blunt end stylus. In the illustrated stage, the compression spring is held at the bottom by the support strip ( 826 , see FIG. 17 un th) in a compressed state. For injection purposes, the medication of the ring notch ( 40 ) of the cannula body is supplied from the insulin cartridge ( 114 , actually from its holder) via the supply channel.

To hold the cannula securely in the skin until the tissue fluid is absorbed. The support ( 45 ) - actually three supports evenly distributed over the circumference (see FIG. 17, center) surround the wire bracket ( 827 ) around the cannula ( 4 ) with its end loop. Its flared end is supported in a slot in a trough ( 828 ) in the suction cup roof.

From the lead cable ( 25 ), the light source ( 30 ) is fed, which also contains the photocells. Two cones of light are shown in dashed lines, the upper of which is directed towards the central skin area into which the cannula puncture is to take place. The lower cone of light is aimed at an adjacent skin area of the same size in order to be able to compare the extinction. The conditions within the sleeve ( 691 ) surrounding the bellows ( 26 ) with the optical fiber ( 31 ) correspond to the state after the withdrawal of this optical fiber while the bellows is stretched behind the cannula attachment ( 4 ). Dash-dotted lines each show one of the position-stabilizing, ie centering fasters between the sleeve and bellows and bellows and optical fiber, which are highly elastic. The guide pin ( 6 ) of the apparatus is inserted with its conical end into the corresponding funnel of the bellows end, which has two drill channels ( 824 ) for light rays, which are covered by a (not shown) transparent membrane above. From the phototransmitter (such as an LED, 580 ) the light beam leads past the bellows onto the inclined mirror band ( 823 ) and from there to the color measurement layer at the lower end of the optical fiber. The beam path leads back to the mirror band and through the other drill channel to the light receiver ( 581 ). For the measurement layer production, two small "confetti" measuring approximately 0.3 mm in diameter were punched out, each with a different sensitivity to glucose, and were glued to one another with their liquid-avid carrier layer. That color pigment layer, which is glued to the filed end of the optical fiber ( 319 ) with an adhesive - here "PRITT" was selected, can be evaluated using a central optical fiber or central optical fibers in the guide pin ( 6 ). In order to be able to measure selectively, the method of optical coupling was used. (For this purpose - somewhere on the measuring section - incoming and outgoing light fibers cross each other in an X-shape and are point-welded together when an X-leg is cut).

FIG. 17 shows the detail of a suction bell in longitudinal section on a scale of 2: 1, which corresponds to that of FIG. 16 in the lower part. The skin was pulled up, the clamping ring segments ( 825 ), which were distributed four times over the circumference, closed around the skin. For this purpose, the support tire ( 826 , spatially below represents Darge) was manually rotated so that the compression spring ( 732 ) could drop over the steep flank of the support tire. Later turning the support tire tensions the compression springs again. The wire bracket ( 827 ) holds the skin back on its three supports ( 45 ) so that the tip of the cannula is initially held in the skin. By rotating the switching ring ( 829 ) (center of the drawing), the heads or spherical ends of the supports are slanted outwards through an elastic cover membrane. The supports are retracted (dashed line ge) and the wire bracket is raised so that the cannula passes through the rise of the skin for injection deeper under the same.

. The 18 shows a longitudinal section of a scale of 2: 1, the variant of a reading device for measurements by means of optical sensor fiber. The cannula and the carrier thread ( 833 ) made of plastic or paper to be carried out through it are again oversized. For measurement purposes, only the cylinder ( 834 ) made of absorbent material (such as silica gel) with the reaction layer ( 27 ) with the reaction layer ( 27 ), which is enlarged to the right and is actually narrower, is used at the ends. Only around the poisonous reaction layer is a cover-like or sleeve-like transparent protective coating, an outer membrane ( 38 ) - for example made of polycarbonate - required. The carrier thread is connected at the other, upper end to a piston which is displaceable within the sleeve ( 691 ), into the cup of which the guide pin ( 6 ) is inserted on the device side and is snapped around its button-like tip in the manner of a button. This fact shows that the carrier thread was already lowered to take up tissue fluid. The cylinder ( 834 ) lies within the bore of the cannula attachment ( 4 ). It is approached from opposite sides by curved bores in its body curved pipe segments ( 831 ). This is done in pairs and in opposite directions under the action of a compression spring between the legs of two hinges ( 832 ). The release fork ( 835 ) prevents the tube segments from retracting under the action of the tension springs. (Their clamping mechanism by taking function block A with them for the cannula advance was not demonstrated, because it is analogous to the mechanisms described). By further withdrawal, the carrier thread at its predetermined breaking point or notch adjacent to the reaction layer detaches from the measuring cylinder ( 834 ). The measurement of the light attenuation due to discoloration under the influence of glucose is carried out via optical fibers within the curved pipe segments, which lead via the lead cables ( 25 ) on the opposite side - i.e. under functional division - from the light source to the light receiver (both not shown here). If the guide pin ( 6 ) is completely withdrawn, it leaves the cup in the piston ( 830 ) after the cannula shaft ( 41 ) has been retracted into the sleeve in the event of resistance to the latter from the coil for transporting the chain ring of the cannulas. The medication inlet openings lie transversely to the bores for the curved tube segments. The annular groove in the cannula attachment was replaced by two small funnels (not shown) which open below the cylinder ( 834 ) with the reaction layers above the end of the cannula shaft.

Fig. 19 shows in the four stages of operation, a sensor AD cannula variation, z. B. for an electrical metabolism measurement, shortening the sleeve ( 691 ) in natural size in longitudinal section.

The guide pin ( 6 ) has already penetrated into the bowl of the piston ( 83 ) in stage A and its internal conductor thus has electrical contact with the end of the metal thread ( 35 , made of platinum, for example), which serves as an electrode and at least is enzymatically and catalytically coated at its other end. (Depending on the choice of an active or passive sensor with GOD or Sepharose-Concanavalin-A or similar).

In stage B, the piston ( 830 ) was lowered until it touched the cannula attachment ( 4 ) so that the sensor thread came into contact with tissue fluid outside the cannula shaft.

In stage C, the cannula attachment with cannula was withdrawn from the auxiliary thread ( 836 ) into the sleeve by withdrawing the guide pin; the sensor thread lies with an electrically effective component in the central channel of the cannula shaft, which serves as an electrode sheath (that is, it is vapor-coated with silver). A contact thread leads from the silver layer transversely to the outside and comes into contact with the line ( 44 ) to the measuring device via an annular guide zone ( 837 ) in the sleeve.

In stage D, the piston ( 830 ) was reinserted into the sleeve by lowering the guide pin. From its edge it is stripped off when the guide pin is withdrawn by advancing the trigger fork ( 835 ) of the pistons and remains in the sleeve for changing the cannula.

FIG. 20 shows a sensor cannula on an electrical measuring basis in longitudinal section on a scale of 2: 1, the measuring equipment of which is analogous to that of FIG. 19. In order to save space and ensure even better contact of the sensor thread with the tissue fluid, the latter is wound up inside a coil with a spiral guide, the core of which has been omitted from the drawing. This coil ( 838 ) can be rotated via an angular inlet by means of the guide pin ( 6 ). The cannula itself is secured against rotation, for example, via a knob with a guide groove in the sleeve (not shown). Outside the tip of the cannula, the sensor thread (metal thread or metal thread with the addition of a plastic thread, which is the rule due to the coating) is pushed back into the tissue fluid in a sinuous form thanks to its prefabricated spiral shape. Before the injection, it is withdrawn behind the drug stream (the corresponding cross hole for the cannula shaft attachment is not shown here) and rolled up again on the coil. This is done by rotating the guide pin in the opposite direction. It may be appropriate to blunt the inner contour of the cannula tip to avoid damaging the sensor layer.

The Fig. 21 indicates schematically a type of discharge tube in conjunction with series-connected bellows as a dosage alternative again.

Fig. 21 gives an example of a dosing method deviating from the now conventional step syringe. The desirable possibility for expensive hormones, even with different dosages, to use up the reservoir with little residue without having to inject twice on the occasion of a container change, can also be achieved with this invention. There are no technical difficulties, for example when using a ring notch on the cannula attachment instead of the two insulin cartridges always listed here, each for a quick and lasting effect, to provide each insulin cartridge twice - four in total. The computer can then provide an addition from the new cartridge to the remainder from an almost used cartridge. I pursued a similar goal with P 37 08 857.2-35. The "dosing cannula" also corresponds to the tendency of my registrations to approach the dosing site as far as possible from the cannula. The object is achieved in the present example in that bellows ( 88 ) with liquid medication per type of medicament are pushed in a separate row (here two) into cylinders, not shown. Each cannula shaft ( 41 ) is attached to the cap ( 839 ) guided in the cylinder and is inserted after removing a protective film over a pipe socket in the bottom of a bellows in the former. The cannula of the foremost container is connected through a sealing ring with the medication inlet opening ( 750 ) to the funnel ( 749 ) for the introduction of the injection cannula. If the upstream container is almost used up, its pipe socket encounters a slotted ring at its own cannula outlet and the cannula of the advancing container pierces the membrane closing the pipe socket due to a movement of the surrounding the pipe socket due to a bulging of the bellows and now dispenses medication (whereby the force acting in the direction - preferably spring or gas pressure - was not shown here).

For the advance of the injection cannula is here instead a dosing spindle an eccentric gear with a Type planetary arrangement provided. (Such an arrangement can also be operated via one or two electromagnets be especially when the impulses for dosing be forwarded in shuttle mode).

The eccentric rod ( 109 ) is connected on the one hand to the guide pin ( 6 ) for cannula transport, on the other hand it can be rotated eccentrically in the large gear ( 840 ). The small gear ( 841 ) can be rotated about its axis in the large gear around the axis of this large gear, which only describes a sector movement. The small gearwheel in turn rotates a disc with the eccentric rod ( 842 ) and determines the number of metering pulses with its number of revolutions via the slide ( 843 ).

Pressure is exerted both on the sleeve ( 691 ) of the cannula over a shoulder of the slide as well as on the cap ( 844 ) with a small valve cone, which then stops the backflow of medicament from the cannula, but also its inflow from the containers.

Due to the small cone, pressure is first inserted into skin on a side tab on the end of the cannula shaft through the elastic membrane of the wrinkled dosing chamber ( 845 ). The sensor or metal thread ( 35 ) is pushed through the central bore of the elastic cone on the cap ( 844 ) from the eccentric rod ( 109 ) while compressing the bellows ( 47 ) under the skin. (Functional stage shown below). The dosing takes place after the withdrawal of the sensor thread from the dosing chamber compressed by the slide. The medicine enters through a side opening in the cannula shaft. In the enlarged detail of the metering chamber (in the middle on the left) the clip ( 846 ) is drawn which presses the metering chamber against the suction bell (not shown).

FIG. 22 is a mechanical control gear in horizontal cut approximately in natural size again. (However, there are still considerable reductions in the choice of gears and on the piston of the push rod, since only small forces are required).

From the motor axis ( 53 ), the drive runs via the reduction gears ( 54 ) to the square axis ( 627 ) on which the gear ( 630 ) is displaceably connected to the pinion ( 800 ) via the holding plates ( 124 ).

Fig. 23 again shows a horizontal section at most on a scale of 1: 1 through part of a mechanical control gear. From the motor axis ( 53 ) of a small electric motor, the power flow runs through a small intermediate gear ( 997 ) to reduce the speed and then continues via the transmission gears ( 54 ) to the working axis. This can actuate a dosing spindle, in which case two such devices are expediently used for the dosing. It can be injected more quickly. The cannula advance could be effected by a third device of this type or by a magnet with a corresponding extension of the working stroke by means of levers.

Fig. 25 shows two for the purpose of a Dosierspindelan drives interconnected solenoids ( 554 , 555 ) in 2: 1 scale. The magnet armature with its rounded end against small spline teeth of a (in roll-up and partially shown) gear. The left magnet ( 554 ) rotates the gear ( 637 ) in small increments via a ratchet gear, which drives the metering spindle. The work of the magnet ( 555 ) is carried out accordingly, but the rotational effect on the gear ( 637 ) is increased via the intermediate gear ( 997 ). The locking gear wheels arranged against each other together cause the rotation of the gear wheel ( 637 ) or at least do not hinder one another. Coarse and fine dosing and thus total dosing can thus quickly follow for one type of medicine.

The device can also be used for protection at night can be used against hypoglycaemia during sleep, For this purpose, fastening eyelets must be provided on the housing, through which tether straps are pulled. The Einrich can now use the suction cup against the skin on the arm o 02885 00070 552 001000280000000200012000285910277400040 0002019519281 00004 02766 the leg. Triggers at programmed time Three-point contact on the suction cup with skin  Measuring function off and falling below a predetermined alarm limit triggers. Because sleeper The habit of turning usually slips and keeps getting over other skin areas.

(See below in a frontal section along section line AB). Of the ratchet gears for driving the two dosing spindles, only one ( 637 ) can be seen in horizontal section. If the pinion ( 800 ) with its side knobs on those of the gears ( 802 , 803 ) run, then these are rotated in the respective direction of pinion rotation. For the cannula advance or the cannula movement over the rod ( 996 ), after each pendulum displacement of the pinion ( 800 ) on its screw spindle for dosing, by means of the push-torsion switch with the jacket sleeve ( 571 ), the cross bar in an annular groove swiveled into the head of the boom ( 996 ) and can move this until it switches again by pushing against a fixed toolbar (rounded off here). On the pendulum movement for dosing, the end phases are searched for with the knob contact of the gears, but omitted for the movement of the boom. To switch the direction of action (for retracting the dosing spindles), the ratchet gears can be spring-loaded changed direction on the slide switch ( 717 ), as only shown on the right, but also valid for the ratchet gear ( 631 ). The reversal of movement can of course also be carried out directly between the transmission gears ( 54 ) and the gear ( 630 ). Automation via coupling to the sliding movement with the participation of the crossbar in another radial position is possible. (See also Fig. 15).

Because of the low friction during metering, a brake spring ( 998 ) directed against the gear ( 803 ) is expedient, which applies to all corresponding problem solutions (also for FIG. 12).

To Fig. 24 is to be added that the rotation and the locking of the wheels shown in winding is secured by discs with a wave profile, in which che each leaf spring ( 654 ) engages interlockingly, as can be seen on the right from the front view of such a disc with spring. The leaf spring expediently touches electrical notches in the notches in the disk and thus reports the electronic control unit the position of an approximately connected dosing spindle and the number of revolutions thereof.

Claims (32)

1. Device for the collection of metabolic measurement values and if necessary for the introduction of medication under the skin raised to a fold of a living being, characterized in that the cannula seen laterally at the base of the fold of the skin from the line of the non-raised skin, at least approximated, into which skin is pierced by a device raised and held in place by a clamping device, the cannula changing and advancing via a device, but at least the movement of the sensor in and to the cannula and the possible drug dosage via a mechanical control gear Monitoring is carried out by a programmable electronic control unit, all enclosed with at least one measuring device in a housing, expediently also having a device for optical monitoring of the skin site provided for the puncture. 2. Procedure for collecting metabolic measurements and if necessary for the administration of medication via a in or under by means of a device to a crease a cannula inserted into the skin, characterized, that the cannula in connection with this device for the crease collection from a device on the Pleat base is pierced to by means of the insertion tion of a probe via the cannula at least to to take metabolic measurements in the skin and at Need to inject medication under the skin. 3. Device according to claim 1 and 2 characterized, that the device for producing skin folds consists of a suction cup and clamping slides, which the skin lifted up by negative pressure lateral pressure on the fold base as long as  is held until the cannula, because now without Function that has been withdrawn. 4. Device according to claim 1 and 3, characterized, that the clamping slide by means of preloaded springs and Trigger grid brought against the skin and to release the feather from the skin fold over a device voltage is removed and expediently the Clamping slide can be withdrawn from the skin nen. 5. Device according to claim 1 and 4, characterized in that the tension of the springs for Skin tightening by lowering a device cover he follows. 6. Device according to claim 1 and 2, characterized, that the skin tightening over at least two around the Edge of the suction bell used for the formation of skin folds to be turned around in an arc towards each other. 7. Device according to claim 1 and 2, characterized, that to create suction in the to raise the skin fold used suction cup the volume of at least a bag that has a wide surface on the fixed cover plate of the housing and on the against one Suspension movable lid is attached. 8. Device according to claim 1 and 7, characterized, that when lowering the lid over wedge bevels Injection cannula from the elastic context with others out in a deeper position for the one  Guide brought into a hole to the suction cup becomes. 9. Device according to claim 1 and 2, characterized, that the suction bell to produce the skin fold elasti has specific properties and is intended for Skin clamp is deformed oval, leaving its roof put in pre-made folds and by at least one Rail is supported. 10. Device according to claim 1 and 2, characterized, that in the course of the cannula advance towards the suction cup after approaching the cannula and penetration of the Cannula tip into the skin a lever guide on a Holding device for the sensor via a lever direction for the retraction of the sensor becomes effective. 11. The device according to claim 1 and 10, characterized, that the place of leverage over one of the cannulas feed-causing guide pin with moving torsion sleeve with longitudinal slot to release the lever movement is determined. 12. Device according to claim 1 and 2, characterized, that as part of the mechanical control gear for switching functions between cannula movement and medication metering a centrifugal switch is used being, a slider within a continuous Cross bore of a driven roller at slower Motor rotation engaged with a non-ring shaped one Groove your moment of motion in the internal axis  announces while rapid engine revs up to Rei Exercise definition of the slide at the end of a groove, drives the slide outwards, where it corresponds to a groove of the outer cylinder surrounding the roller intervenes and taking away his movement moment another of the two mentioned functions blocks announces. 13. Device according to claim 1 and 12, characterized, that the slider has one end in either the inland axis or in the outer cylinder in a helical shape Channel engages so that it only ever at the end of the channel because of the motor drive the corresponding flee force difference must have reached. 14. Device according to claim 1 and 2, characterized, that as part of the mechanical control gear for switching functions between cannula movement and Drug doses the thrust transmission of a spindle causes the displacement of a gear pinion, whereby the gear or shift pinion a gear on the same Axle is upstream, which is suspended from the shift pinion is approached so far that it is over side knobs movement of this is rotated and thereby by Ver broadening of the effective gear surface Thrust movement until switching to the work wheel of the next function block, whereby the shift rod for the shift pinion feed one Overratch pawl so that a return spring between between the shift pinion and the upstream gear releases the latter from the knob engagement, until the shift rod of the next function block Process repeated and with the shift pinion too  whose axis is moved against a spring and a Cross pin on this axis within a spiral groove Bulge for detection in the respective switch positions, i.e. under the meshing of the shift pinion each with a work wheel to drive a function blockes what spiral groove within a pipe socket is located and a steep drop to return to the Starting switch position guaranteed. 15. Device according to claim 1 and 2, characterized, that as part of the mechanical control gear Displacement of a pinion turned on a spindle via wheel and / or lever transmission for work functions while the sprocket is on everyone the spindle hits a disc, which depending on the end or direction of rotation of the pinion the spindle or another shaft in the respective Direction of rotation over a freely selectable number of revolutions turns with. 16. Device according to claim 1 and 2, characterized, that for functions of the mechanical control gear at least one electric immersion magnet is used becomes. 17. Device according to claim 1 and 2, characterized, that in a cannula as a sensor at least one Optical fiber at the free end of a body fluid absorbing cylinder with one under the measuring metabolite under color change rea Ging layer is applied, which over the Corresponding optical fiber via light feed and discharge  speaking reagent layer changes by means of photo meters in the measuring device allowed to evaluate. 18. Device according to claim 1 and 17, characterized, that within the protective bellows for storage and displacement of the sensor over the guide pin for the movement of the bellows light in the last teren is introduced, which at the end of the in the canoe retracted probe over a Mirror onto a second color reagent layer on the free thrown end of said cylinder and from there through a mirror through the bellows a light receiver is thrown where that after signal imparting a second metabolism to the photometer measurement can be made. 19. Device according to claim 1 and 2, characterized, that about lowering a thread-like beam through the cannula into the tissue fluid at its End a body fluid on suction cylinder NEN ends with one below the one to be measured Metabolic product reacting under color change Layer is provided, this cylinder after back pull into the cannula hub detached from the carrier and about the introduction of optical fiber-guiding Hohlna light from both sides and that Forward the reflected light to a photometer. 20. Device according to claim 1 and 2, characterized, that one as an active or passive electrical sensor equipped probe through the cannula into the Body fluid introduced and then in the cannulas  approach where a conductive layer of the active surface of the sensor with an elec tric conductive layer in contact in the cannula hub occurs, at least with one, and so the flow of electricity to the measuring device. 21. Device according to claim 1 and 2, that the filiform probe on one in the cylinder of the Cannula hub attached movable piston and over the guide pin for the cannula advance of these pistons abge to contact the sensor with body fluid lowers and after the absorption of body fluid by the active part of the piston probe at least temporarily pulled out of its cylinder guide becomes. 22. Device according to claim 1 and 2, characterized, that the filiform probe is a prefabricated spiral form from which it over an inner coil in the Cannula insertion through the cannula into the body fluid can be advanced. 23. Device according to claim 1 and 2, characterized, that as a device for programming the electronics rule control unit at least on a broad side of the Housing or the cover contact or pressure switch arranged in rows that are suitable for living Stands can be operated to meet planned food needs name and their special composition net also to the electronic control unit to signali like time span and strength of planned body load.   24. Device according to claim 1 and 23, characterized, that pressure switch for programming the electro African control unit in the lowered state Spring slide temporarily held and marked can be. 25. Device according to claim 1 and 2, characterized in that the device for optical inspection of the rays of light intended for the puncture skin area in a suction cup, as a means of collecting skin folds, on a mirror nose near the funnel mouth for the cannula throws from where the light to the skin and ent thrown at the photo receiver weakened becomes the signal transmission to a photometer. 26. Device according to claim 1 and 2, characterized, that for optical monitoring of a skin area on Eig I used to have a kind of window on the edge of one Suction cup, as a means of creating a skin fold, is present, which the nature of the past pulling skin registered and the electronic Control unit is reported, so that this the Lokali suitable skin. 27. Device according to claim 1 and 2, characterized, that inside a suction cup, as a means of generating of a skin fold, the negative pressure via a nozzle is changed during use so that a from the optical monitoring device as un suitable skin area from the planned puncture site can be moved away.   28. Device according to claim 1 and 2, characterized, that as part of a mechanical control gear Roll is used, in which a pin transversely into a Bore is stored and by an additional force into a groove of the inner axis encompassed by the roller engages while under centrifugal force at higher revs the roll of the pin out into the groove or groove of the outer cylinder surrounding the roller is pushed and instead of the internal axis in the internal axis, as with slow rotation during the switching process, well the outer cylinder by a stop at the end of the groove rotated, with the revolutions of Binnenzy Linder and outer cylinder on different drive axles or functional organs are transferred. 29. Device according to claim 1 and 2, characterized, that as part of a mechanical timing gear during the changeover from one driving the shift pinion Function block the distance between leaving the driving gear until it engages with a others are bridged by a gear that is sprung approached the other gear and from there over niche knobs rotated the shift pinion serves as a bridge. 30. Device according to claim 1 and 2, characterized, that as part of a mechanical timing gear two Electromagnets are used, both against one each Butting and turning the splines of a wheel, but with the rotation caused by a magnet is amplified via a gear transmission and where both torques via ratchet gears on one working axis can be interconnected.   31. Device according to claim 1 and 2, characterized, that as a mechanical control gear, a shift pinion on a spindle or screw from another Gear on parallel axis in plate connection at its lateral displacement is rotated, making it too at least at the end of the spindle or screw with lateral Nubs of the wheel delimiting the screw in contact occurs and turns the spindle or screw with it, what drives a work function, but at the same time the shift pinion is a rod with a thrust torsion device with a cross connection with it, wel before reaching one of the wheels on the spindle or screw benende is operated on a fixed obstacle, so that a cross originating from the thrust torsion device bar for programmed work cycles from the incision in a parallel linkage with a work function swings out and interrupts their work function.   32. Device according to claim 1 and 2, characterized, that a cannula is used as a metering device, which is at the front of the cannula hub for the shaft has an elastic dosing or folding chamber, which has a side opening in the cannula shaft or past it via a hole in the cannula set is filled from a medicine container, and their Filling quantity by reduction during the feed of the cannula attachment by means of a slide in the Body is emptied through the cannula after through precisely this slide the drug flow for dosing or Wrinkle chamber interrupted by closing a valve becomes.