WO1991000748A1

WO1991000748A1 - Syringe for injecting metered quantities of various liquid therapeutic agents

Info

Publication number: WO1991000748A1
Application number: PCT/DE1990/000513
Authority: WO
Inventors: Gesine Hirsch
Original assignee: Gesine Hirsch
Priority date: 1989-07-08
Filing date: 1990-07-09
Publication date: 1991-01-24
Also published as: DE4021809C2; JPH04500622A; AU5930990A; DE4021809A1; DE4090909D2; DE9010361U1; EP0433422A1; DE4090909A1; DE9090119U1

Abstract

The invention relates to a syringe for injecting metered quantities of liquid therapeutic agents, especially insulins, with a container housing, an injection needle releasably connected to a therapeutic agent container in the housing, a counter and metering device to count and meter the quantity of the therapeutic agent to be applied and a release device to eject the therapeutic agent through the injection needle, in which: a plurality of containers (9, 10) of different liquid therapeutic agents, especially different types of insulin, are arranged in the housing (6); the injection needle (17) is part of a needle system (5) arranged in/on a needle body (4) and having an injection part (18) and a plurality of feed channels (19, 20) opening into the injection part (18) and possibly running to the needle aperture (18a); the ends of the feed channels (19, 20) are sharpened to penetrate the diaphragm (87) of the therapeutic agent containers (9, 10) or may be connected otherwise, especially via hose systems or the like, to the therapeutic agent containers (9, 10); there is at least one counter and metering device (12, 13) or a number of such devices (12, 13) corresponding to that of the therapeutic agent containers (9, 10).

Description

Sprayer for the injection of dosed quantities of various liquid therapeutic agents

The invention relates to a spray device for injecting metered amounts of various liquid therapeutic agents, in particular insulins.

Such a sprayer, for example, the insulin injection device Hoechst that ^'the market under the name "OptiPenΘ" link.

Another device exists from the company NORDISK, which is sold under the name "InsujectQ -X".

Finally, there are two spraying devices from NOVO Industries with the names "NovoPen0 I" and "NovoPen0 II".

In all of these devices, it is possible to give insulin doses abzu¬ ^'. Essentially all common insulin types

Spare sheet pen can be applied. The disadvantage of these devices is that only one injection at a time with these devices

Insulin type (for example normal insulin, long-term insulin or mixed insulin) can be injected per injection.

The invention is based on the task of creating a spraying device of the type mentioned at the beginning with which several liquid therapeutic agents, in particular the above-mentioned insulin types with their individual components in freely selectable mixing ratios, simultaneously or simultaneously or in succession with a single injection can administer.

It is irrelevant whether the substances or therapeutic agents, in particular insulins, are applied directly or indirectly (in particular after mixing in a separate or separated reservoir).

This object is achieved according to the invention by the subject matter of claim 1. Inventive further developments and advantageous configurations result from the subclaims.

Further features, details, advantages and possible applications result from the following description of preferred embodiments of the invention and from the drawing attached in the appendix. Show it:

1 shows a longitudinal section through a spraying device according to the invention with a spray housing with a cannula body which can be attached at one end, with a spray cannula system which is connected to two containers with liquid therapeutic agents arranged in a therapeutic agent container chamber - And dosing and with a Spritzaüslδseeinrichtung; 2 shows a cross section through the sprayer along the section line II-II in Fig.l;

Spare part 3 shows a cross section through the sprayer along the section line III-III in Fig.l; 4 shows a cross section through a therapeutic agent container chamber with two individual chambers separated from one another by an intermediate wall, in each of which a separate chamber

Therapeutic container (a cartridge) is arranged, the cross section of which has the shape of a semicircular surface; 5 shows a cross section through a one-piece therapeutic agent container chamber with two separate therapeutic agent containers, the cross section of which each has the shape of a semicircular surface; 6 shows an enlarged illustration of a spray cannula system in a second embodiment of the spray device according to the invention for connection to three containers arranged spatially next to one another or in a triangle at mutually equal distances, each with different therapeutic agents; 7 shows a cross section through a therapeutic agent container chamber with three individual chambers separated by partition walls, in each of which a separate therapeutic agent container (a cartridge), the cross section of which has the shape of a third circle area (for the second embodiment of the spraying device according to FIG Fig.6); 8 shows a cross section through a one-piece therapeutic agent container chamber with three separate therapeutic agent containers, the cross section of which each has the shape of a third circle area (for the second embodiment of the spraying device according to FIG. 6); 9 shows an enlarged illustration of a syringe cannula system in a third embodiment of the spraying device according to the invention for connection to four containers arranged spatially next to one another or in a square with mutually equal spacing, each with different therapeutic agents;

10 shows a cross section through a therapeutic agent container chamber with four individual chambers separated by partition walls.

Spare sheet 1 m, in each of which a separate therapeutic agent container (a cartridge) is arranged, the cross section of which in each case has the shape of a quarter circle area (for the third embodiment of the spraying device 6 according to FIG. 9);

11 shows a cross-section through a one-piece therapeutic agent container with four therapeutic agent containers, the cross-section of which each has the shape of a quarter circle surface (for the third embodiment of the spraying device according to FIG. 9);

12 shows a schematic illustration of a further embodiment of the fixing of the cannula body to the container housing by means of a locking system; 13 shows a schematic illustration of a further embodiment of the fixing of the cannula body to the container housing by means of a spring clip system (in the manner of a beer bottle closure); 14 shows a schematic illustration of a further embodiment of the fixing of the cannula body to the container housing by means of a spring ring system;

15 shows a schematic representation of a refillable

Liquid / therapeutic agent container; 16 shows a schematic illustration of a piston of the refillable liquid / therapeutic agent container according to FIG. 15;

17 shows a schematic representation of the front part of a spraying device with a cannula body which can be displaced along the longitudinal axis in order to interrupt the supply of liquid (in the open position); FIG. 18 shows a representation of the front part of the spraying device corresponding to the representation in FIG. 17 (in the closed position); 19 shows a schematic illustration of the front part of a spraying device with a cannula body which can be rotated about the longitudinal axis in order to interrupt the supply of liquid (in the opening division) and 20 shows a schematic representation of the front part of a spraying device with a cannula body rotatable about the longitudinal axis and an additional closing body which can be inserted into the spraying cannula in the direction of the arrow X from the rear of the spraying device to interrupt the

Liquid supply (in the open position).

According to FIG. 1, a spray device 1 according to the invention has a spray cannula system 5 which can be attached to one end 3 of the same and is arranged in a cannula body 4, a cup-shaped container housing 6 with two therapeutic agent container chambers (cartridge chambers) 7, 8 for receiving one container each ( a cartridge) 9, 10 with liquid therapeutic agents and two counting and metering units 12, 13 arranged and stored in a housing element 11, each with a triggering device 14, 15 at the other end 16 of the spraying device 1.

The cannula body 4, which is preferably made of plastic or the like, has an essentially fully cylindrical part 2. In part 2, the syringe cannula system 5 is embedded in such a way that the cannula tip 18 protrudes at one end on the front shoulder surface 26 and at the other end two feed channels 19, 20 protrude from the cannula body 4 on the rear shoulder surface 27. An axially extending annular extension 21 is connected to part 2 on the side on which the feed channels 19, 20 protrude. On the inner circumferential surface of the extension 21, preferably two diametrically arranged grooves 22, 23 running in the longitudinal direction are formed, in each of which a key 24, 25 is embedded. The feather keys 24, 25 can also be integrally formed on the extension 21 and can be designed to protrude accordingly.

The container housing 6 has a container base 28 with an axially front outer surface 29 and an axially rear inner surface 30. The container bottom 28 has two bores 36, 37 penetrating it in the axial direction. At the

ErsaizbJatt Container bottom 28 is connected to a step-shaped, approximately ring-cylindrical container wall 31.

On the outer circumferential surface 33 of the first step region 32 of the container wall 31 which is directly adjacent to the container bottom 28, two diametrically arranged grooves 34, 35 which run in the longitudinal direction are preferably formed. An external thread 40 is formed on the outer surface 38 of the next second step region 39. The outer lateral surface 41 of the next third step area 42 is preferably designed as a knurled surface for better handling of the spraying device 1. An external thread 45 is formed on the outer lateral surface 43 of the next fourth step region 44. Finally, preferably two diametrically arranged grooves 48, 49 are formed on the outer lateral surface 46 of the next fifth step area 47 of the container wall 31.

The inside of the container housing 6 preferably has two therapeutic agent container chambers (cartridge chambers) 7, 8 starting from the container base 28 and preferably separated from one another by a partition 50.

The interior of the container housing 6 preferably has two or more therapeutic container chambers (cartridge chambers) 7, 8 starting from the container base 28, optionally separated from one another by a partition 50.

The housing element 11 is also essentially cup-shaped and has a housing base 51 with an axially outer housing base surface 52 and an axially inner housing base surface 53. In the front region 54 of the mantle wall 55 of the housing member 11 are at the Man¬ telinnenfläche 56 preferably two longitudinally verlau- Fende, preferably Diame ^"tral arranged grooves 57,58 ausge¬ forms, in each of which a feather key is inserted 59.60.

rs The parallel keys 59, 60 can also be formed in one piece with the housing element 11.

The housing base 51 has two bores 61, 62 which penetrate it in the axial direction.

Counters and metering units 12, 13 are preferably arranged in the interior of the housing element 11 and are preferably detachably fastened in the interior of the housing. The counters and metering units 12, 13 are preferably attached to the inner housing bottom surface 53 of the housing element 11.

The triggering devices 14, 15 are preferably piston rods 65, 66 that run in the axial direction and are provided with actuating buttons 63, 64 on one end or on the outside, which are operatively connected to the counting and metering mechanisms 12, 13 and on the other hand or on the inside Printing stamps 67.68 are provided.

Further parts of the spraying device 1 according to the invention are a front fixing cap 91, a rear fixing cap 71 and one or more therapeutic agent containers 80.

The front fixing cap 91 is a cup-shaped body with a bottom wall 95 having an inner bottom surface 94 and a tubular jacket part 96. The jacket part 96 is provided with an internal thread 92 in the front region of its inside jacket surface. The bottom wall 95 of the fixing cap 91 has a centrally arranged bore 97.

The rear fixing cap 71 is a cup-shaped body with a bottom wall 75 having an inner bottom surface 74 and a tubular jacket part 76. The jacket part 76 is provided with an internal thread 72 in the front area of its inner jacket surface. The bottom wall 75 of the fixing cap 71 has a centrally arranged bore 77. The jacket part 76

Replacement bill and / or the bottom wall 75 of the fixing cap 71 is provided with at least one viewing and actuation opening 78.

The commercially available therapeutic agent container 80 consists essentially of a-a as a piece of pipe with two openings 81, 82. The filled therapeutic agent container 80 is provided at its opening 81 facing the feed channels 19, 20 with a pierceable or perforable membrane 87 and at its opening 82 facing the plunger 67 of the triggering device 14 with a closure which can be displaced in the tube piece, in particular with a piston 83, closed.

As shown in Figs. 4, 5, 7, 8, 10 and 11, the therapeutic agent containers used with the spraying device 1 according to the invention can not only be round in cross-section, but also, according to the invention, in other cross-sectional shapes, for example semicircular, third or quarter-circular , be trained. The container designed in this way can keep the space to be provided in the spraying device 1 for the container chambers 9, 10 for the therapeutic agent containers to be accommodated. As a result, the external dimensions (length and diameter) of the spraying device 1 according to the invention can also be kept small, which improves the possibilities of its storage and its manageability.

According to the invention, it is also intended to design the spraying device in such a way that the counting and dosing of different therapeutic agents contained in different therapeutic agent containers 9, 10 are carried out with only a single counting and metering unit.

According to the invention, it is further provided to use electrical servomotors, which are controlled by permanently programmed or freely programmable microprocessors, instead of springs or spring motors, to control and drive the counting and metering devices. The use of microelectronics in the field of correct dosing of therapeutic agents It is particularly recommended for spraying devices that are used by (especially young or old) patients who inherently have problems handling technical equipment properly. In such spraying devices, the "counting" is carried out by a mini-computer, the "dosing" by an electric servomotor. A built-in rechargeable battery, which can be charged by means of solar cells or via power packs at each socket, provides the necessary power supply.

The assembly of the spraying device 1 according to the invention is described below:

(1) First, the container housing 6 is "loaded" with two therapeutic agent containers 9, 10, that is to say two containers 9, 10 are inserted into the container chambers 7, 8 of the container housing 6 in the insertion direction E until the front channels ten of the containers 9, 10 come to rest on the inner surface 30 of the container bottom 28.

(2) The housing element 11 is then attached to the step region 47 of the container wall 31 of the container housing 6, the feather keys 59, 60 arranged on the region 54 of the jacket wall 55 of the housing element 11 in the step region 47 of the container wall 31 of the container housing 6 trained grooves 48.49 are fitted. In this way, the housing element 11 is arranged in a rotationally fixed manner with respect to the container housing 6. At the same time, the two pressure stamps 67, 68 of the piston rods 65, 66 lie exactly in front of the openings 81, 82 and the displaceable closures 83, 84 of the two therapeutic agent containers 9, 10 arranged there.

(3) Now the rear fixing cap 71 is pushed over the housing element 11 until its internal thread 72 engages with the external thread 45 of the fourth step region 44 of the container housing 11. By turning the fixing cap 71, its inner bottom surface 74 presses against the outer housing bottom surface 52 of the housing element 11 and

Spare sheet presses it in direction E until its front end edge strikes the rear end edge of the fourth step region 44 of the container housing 6. In this way, the housing element 11 is fixed axially with respect to the container housing 6.

(4) For the arrangement and fastening of the cannula body 4 on the container housing 6, the annular extension 21 of the cannula body 4 is pushed in the axial direction over the first step area 32 of the container housing 6, the feather keys arranged or formed on the extension 21 24, 25 come into engagement with respect to the grooves 34, 35 formed on the first step region 32. The feather keys 24, 25 of the cannula body 4 and the grooves 34, 35 of the container housing 6 are aligned or arranged or positioned such that the feed channels 19, 20 of the spray cannula system 5 are exactly in front of those on the container bottom 28 of the container housing 6 formed bores 36, 37 and in front of the openings 85, 86 lying immediately behind the bores 36, 37 and the pierceable or perforable membranes 87, 88 of the therapeutic agent containers 9, 10 arranged there.

(5) Now the front fixing cap 91 is pushed over the cannula body 4 until its internal thread 92 engages with the external thread 40 of the container housing 6. By turning the fixing cap 91, its inner bottom surface 94 presses against the front shoulder surface 26 of the cannula body 4 and presses it in the direction K until its rear end edge strikes the second step region 39 of the container housing 6 on the front end edge. In this way, the cannula body 4 is axially fixed in relation to the container housing 6.

(6) Finally, a protective cap 99 is placed over the injection cannula 18 protruding from the front fixing cap 91.

Ers is inserted in order to protect the user from injuries and to protect the injection cannula 18.

(7) The disassembly of the spraying device 1 according to the invention is generally carried out in reverse order for cleaning, maintenance or refilling purposes. Of course, only the cannula body 4 can also be removed by removing only the front fixing cap 91 for renewal. On the other hand, if the cannula body 4 remains on the spraying device 1, only the rear part of the spraying device 1 can be opened, for example in order to replace one or both therapeutic agent containers 9, 10 or the counters and metering units 12, 13 to clean, adjust or repair.

In Figs. 4, 5, 7, 8, 10 and 11 end views of therapeutic containers 9, 10 ... are shown, from which it can be seen that these are not necessarily round, but definitely also other, in particular semi, third, quarter circle surfaces - Can have chen-shaped cross sections.

The containers 9, 10 ... can be separate containers, but they can also be integrated in reservoirs made in one piece, which have special containers, each with a half, third, quarter circle cross-section, in which the same or different therapeutic agents, in particular various insulins are included.

There is now the problem that the "correct" therapeutic agent containers which guarantee the desired therapy are arranged in front of the respective counting and dosing devices 12, 13 ... This is achieved in that the containers are either themselves provided with special cross sections which ensure a clear arrangement in the container housing, or are provided with markings 100 (see FIG. 5) which correspond to corresponding markings in the container housing, so that only a certain (the desired) position of the container is possible.

Replacement According to a preferred embodiment of the invention, the liquid / therapeutic agent containers should be designed to be refillable. According to FIGS. 15, 16, a refill valve device 89 is provided on the therapeutic agent container. For reasons of sterility in particular, a chamber 90 which is filled with a sterilizing agent and is even closed off by a piston is provided for re-usability in front of and / or behind a piston 83, the sterilizing agent during the filling process; the therapeutic agent container wall is wetted. The piston 83 itself can be constructed in such a way that it contains the sterilizing agent and / or contains chambers 90 for the sterilizing agent.

A blood glucose meter can be structurally integrated in the insulin injection device, wherein a microprocessor can be used for the blood glucose measurement, which also includes the control unit for the required display elements and dose measurements and / or delivered doses and / or piston displacements.

Both the measured blood sugar values and the insulin doses delivered can be called up and / or transmitted at the appropriate times, both in the viewing / display window of the syringe / blood glucose meter and to / from a PC / AT or terminal (bidirectional data transmission from measuring device to PC / AT and PC / AT measuring device possible).

The insulin syringe / blood glucose meter contains a dosing calculation program which is also patient-oriented and / or makes a modified dosing proposal to the patient, the modified program being loadable / transferable to the ¹ insulin syringe / blood glucose meter at any time on a PC / AT terminal is.

To avoid diffusion between the containers 9, 10 and to prevent evaporation of the liquid, the

Cannula body 4 with an adjustable or displaceable

Closure device (body) or the cannula holder itself

Replacement b be provided by which the connection between the feed channels 19, 20 and the injection needle or syringe cannula 18 can be interrupted.

in the figures 17, 18 shows a preferred embodiment of the invention. Thereafter, a cannula body 112 (possibly loaded by a spring 113) is arranged and supported in a housing 129 along the longitudinal axis L of the spraying device in the arrow directions X-Y. The liquid supply from the supply channels 119, 120 to the injection needle or spray cannula 118 can be interrupted by a body formed on the cannula body 112, preferably by the cannula 111 itself.

According to a further preferred embodiment of the invention according to FIG. 19, a (possibly spring-loaded) cannula body 114 is provided, which is designed and arranged to be rotatable about the longitudinal axis L of the spraying device. The liquid supply from the supply channels 119, 120 to the injection needle or spray cannula 118 can be interrupted via a channel system 115, which is formed in the cannula body 114 and in the housing 116 accommodating the cannula body 114. The twisting of the cannula body 114 can take place in particular by means of a closure cap (not shown here) which protects the cannula tip of the spraying device.

According to a further preferred embodiment of the invention according to FIG. 20, a (possibly spring-loaded) cannula body 117 can be displaced along the longitudinal axis L of the spraying device in the arrow directions X-Y and can be rotated and arranged about the longitudinal axis L of the spraying device. The liquid supply from the supply channels 119, 120 to the injection needle or syringe cannula 118 can be interrupted by a body 121 formed on the cannula body 117 and by a channel system 122, which is formed in the cannula body 117 and in the housing 123 receiving the cannula body 117 become. The closure device or the body 121 should be of the

Replacement 14

1 back of the sprayer can be actuated from the needle tip 118.

According to FIGS. 17, 18, the closure device or the body 111, for example, can be actuated from the front of the spraying device, that is to say from the needle tip 118. The cannula body 112 is preferably attached to a spring plate 124 which is supported on a shoulder 125 of a housing part 126. The housing part 126 is in turn with a

10 housing element '127 firmly connected. The (compression) spring 113 is clamped between the housing part 126 and the housing element 127. The spring 113 presses the spring plate 124 against the shoulder 125 in the direction of the arrow X. The cannula body 112 is, as shown in FIG. 18, by means of a closure cap 128

15, the force of the spring 113 is displaceable in the direction of the arrow Y, which presses against the cannula body 112 in the direction of the arrow Y when screwing onto the housing 129 of the spraying device. The end of the body 111 mounted in the injection system 130, which is arranged near the feed channels 119, 120, closes the body

20 two feed channels 119, 120. The injection needle 118 of the injection system 130 is detachably attached to the cannula body 112, preferably screwed 131, as shown in FIGS. 17, 18 show.

25 However, the closure device closing the feed channels 119, 120 in the inoperative position of the spraying device or the body could also be attached directly to the closure cap 128. Since the closure device or the body must be made very thin, there is a risk that this (r) improper

30 Locking the sprayer bends or breaks off.

The locking devices 111, 121 could, however, also be operable from the longitudinal side of the spraying device with a corresponding structural design. 35 The closure devices 111, 121 should advantageously be insertable at the mouth of the feed channels 119, 120 into the injection channel 132, as shown in FIGS. 17, 18, 20.

By means of the adjustable or displaceable closure device, an injection and closure position can be realized, in which not only the mixing of the liquids, but also an airtight seal is ensured.

This is because there is a risk that a spraying device which is in use and which is carried over a long period of time on the body, for example in a jacket, vest or shirt pocket, will heat up in such a way that water or another is thereby produced Solvent evaporates from the therapeutic liquid. This increases the concentration of the therapeutic agent or therapeutic agents. In subsequent applications, the patient then receives his medication in concentrations that are too high and possibly hazardous to health. This and the possibility that different therapeutic agents accidentally mix with each other before their application is prevented with the help of the above-mentioned measures.

Spare sheet

Claims

Expectations:

Spraying device for injecting metered amounts of liquid therapeutic agents, in particular insulin, with a container housing, a spray cannula which is detachably connected to a therapeutic agent container arranged in the container housing, a metering and metering unit for counting and metering the amount of the applying therapeutic agent and a triggering device for dispensing the therapeutic agent through the spray cannula, characterized in that

(a) a plurality of therapeutic agent containers (9, 10) filled with various liquid therapeutic agents, in particular different types of insulin, one end of which (81) is arranged through a pierceable or perforable membrane (87) and the other end (82) thereof are each closed by a displaceable closure, in particular piston (83),

(b) the syringe cannula ^" (17) is part of a syringe cannula system (5) arranged in / on a cannula body (4), which has one injection part (18) and a plurality of in ^■ * ^• the injection part (18), opening out, if appropriate, to the needle tip (18a) extending supply ducts (19,20), comprising

(c) that the ends of the feed channels (19, 20) penetrate the membrane (87) of the therapeutic agent container

(9, 10) are sharp-edged, or can be connected to the therapeutic agent container (9, 10) in a different manner, in particular via hose systems or the like,

(d) the cannula body (4) with the aid of a first anti-rotation device (24, 25/34, 35) with respect to the

Container chambers (7, 8) are arranged in a rotationally fixed manner and are detachably fastened to them with the aid of a first fixing device (91),

(e) at least one counter and dosing unit (12, 13) or a number of counter and dosing units (12, 13) corresponding to the number of therapeutic agent containers (9, 10) are provided in a housing element (11) are arranged in a rotationally fixed manner with the aid of a second rotation-preventing device (48, 49 / 59.60) with respect to the 0 container chambers (7, 8) and to this with the aid of a second fixing device (71 ) is releasably attached,

(f) the counting and metering units (12, 13) for dispensing the therapeutic agents each have at least one triggering device 5 (14, 15), each with the displaceable

The closure, in particular the piston (65, 66) of a therapeutic agent container (9, 10) are operatively connected.

2. Spray device according to claim 1, characterized in that 0 of the cannula body (4) has a substantially polygonal cross-section, in particular cylindrical, part (2) in which the spray cannula system (5) is embedded in such a way that one end on the front shoulder surface (26) of the injection part (18) with the cannula tip (18a) 5 and at the other end on the rear shoulder surface (27) at least two feed channels (19, 20) protrude from the cannula body (4).

Spare sheet 18th

3. Spraying device according to claim 2, characterized in that an axially extending annular extension (21) is connected to the part (2) on the side on which the feed channels (19, 20) protrude, on the inner lateral surface ' one or more, in particular two, axially or longitudinally extending, preferably diametrically arranged grooves (22, 23) are formed, in each of which a key (24, 25) is let in.

4. Spraying device according to claim 2, characterized in that on the part (2) on the side on which the feed channels (19, 20) protrude, an axially extending, polygonal or elliptical or other geometric shapes having one, or one A plurality of feed channels connected through the extension is connected, which enables a positive connection.

5. Spraying device according to claim 3, characterized in that the feather keys (24, 25) on the extension (21) are also formed in one piece and are correspondingly protruding.

6. Spraying device according to one of claims 1 to 5, characterized in that the container housing (6) has a container bottom (28) with an axially front outer surface (29) and an axially rear inner surface 30, and that the container bottom (28) has two holes (36, 37) penetrating it in the axial direction.

7. Spraying device according to claim 6, characterized in that a step-shaped, approximately ring-cylindrical container wall (31) is connected to the container bottom (28).

8. Spraying device according to claim 6 or 7, characterized gekennzeich¬ net that on the outer surface (33) of the container bottom (28) immediately adjacent first step region (32) of the container wall (31) preferably two in longitudinal

E ^r Directional, diametrically arranged grooves (34, 35) are formed.

9. Spraying device according to claim -4, 6 or 7, characterized in that ^" on the outer lateral surface (33) of the container bottom (28) immediately adjacent first step area (32) of the container wall (31) or on the container bottom (28th ) even in the axial direction, polygonal or elliptical or other geometric shapes, connected by one or more bores for the supply channels (19, 20), is connected to the connecting sleeve, which enables a positive connection to the extension of the part (2) .

10. Spraying device according to one of claims 5 to 9, characterized in that an outer thread (40) is formed on the outer lateral surface (38) of the next second step region (39).

11. Spray device according to one of claims 5 to 10, characterized ge indicates that the outer lateral surface (41) of the next third step region (42) for better handling of the spray device (1) is preferably designed as a knurled surface.

12. Spraying device according to one of claims 5 to 11, characterized in that an outer thread (45) is formed on the outer lateral surface (43) of the next fourth step region (44).

13. Spraying device according to one of claims 5 to 12, characterized in that on the outer lateral surface (46) of the next fifth step region (47) of the container wall (31) preferably two longitudinally extending, preferably diametrically arranged grooves (48, 49) are formed.

Replacement sheet

14. Sprayer according to one of claims 5 to 13, characterized ge indicates that the container housing (6) in its interior preferably two or more starting from the container bottom (28), optionally separated by a partition (50) from each other therapeutics -Container chambers (cartridge chambers) (7,8).

15. Sprayer according to one of claims 1 to 14, characterized ge indicates that the housing element (11) is also substantially cup-shaped and a housing bottom (51) with an axially outer housing bottom surface (52) and an axially inner Has housing bottom surface (53).

16. Spraying device according to claim 15, characterized in that in the front region (54) of the jacket wall (55) of the housing element (11) on its jacket inner surface (56) preferably two longitudinally extending, preferably diametrically arranged grooves ( 57, 58) are formed, in each of which a key (59, 60) is embedded.

17. Sprayer according to claim 15 or 16, characterized gekennzeich¬ net that the feather keys (59, 60) with the housing element (11) are integrally formed.

18. Spraying device according to one of claims 15 to 17, characterized in that the housing base (51) has two holes (61, 62) penetrating it in the axial direction.

19. Spray device according to one of claims 1 to 18, characterized ge indicates that in the interior of the housing element (11) preferably counting and metering units (12, 13) are arranged and are preferably detachably fastened inside the housing.

20. Sprayer according to claim 19, characterized in that the attachment of the counting and metering units (12, 13) on the

Replacement sheet inner housing bottom surface (53) of the housing element (11).

21. Spraying device according to one of claims 1 to 20, characterized in that the tripping devices (14, 15) preferably have piston rods running in the axial direction and provided with actuating buttons (63, 64) on one end or on the outside (65,66) are in operative connection with the counting and metering units (12, 13) and are provided with pressure stamps (67, 68) on the other end or on the inside.

22. Spray device according to one of claims 1 to 21, marked by a front fixing cap (91), a rear fixing cap (71) and one or more therapeutic agent containers (80).

23. Sprayer according to claim 22, characterized in that the front fixing cap (91) is a cup-shaped body with an inner bottom surface (94) having a bottom wall (95) and a tubular jacket part (96) which in the front region of its inner jacket surface with a Internal thread (92) is provided, and that the bottom wall (95) of the fixing cap (91) has a centrally arranged bore (97).

24. Sprayer according to claim 22, characterized in that the rear fixing cap (71) is a cup-shaped body with an inner bottom surface (74) having a bottom wall (75) and a tubular jacket part (76) which in the front region of its inner jacket surface with a Internal thread (72) is provided.

25. Spraying device according to claim 22, characterized in that the bottom wall (75) of the fixing cap (71) has a centrally arranged bore (77) ', the jacket part (76) and / or the bottom wall (75) of the fixing cap (71) with

Replacement sheet at least one viewing and actuation opening 78 is provided.

26. Spray device according to one of claims 1 to 25, characterized in that for fixing the cannula body (4) on

Container housing (6) a union nut is used, wherein an external thread is provided on the cannula body (4) on the outer lateral surface.

27. Spraying device according to one of claims 1 to 26, characterized in that a spring in the manner of a beer bottle closure is used to fix the cannula body (4) to the container housing (6).

28. Sprayer according to one of claims 1 to 26, characterized ge indicates that a laterally arranged leaf spring is used to fix the cannula body (4) on the container housing (6).

29. Sprayer according to one of claims 1 to 26, characterized ge indicates that in order to fix the cannula body (4) on the container housing (6) on both parts locking elements are provided which can be locked into one another in the position of use.

30. Spraying device according to one of claims 1 to 29, characterized in that the therapeutic agent containers (9, 10) used in the spraying device (1) are not only round in cross section, but also in other cross-sectional shapes, in particular semi-circular, third or quarter circle, are formed.

31. Spray device according to one of claims 1 to 29, characterized ge indicates that the therapeutic container (9, 10) used in the spray device (1) is not only round in cross section, but also in other cross-sectional shapes, in particular in regular or irregularly polygonal or in other geometric cross-sectional shapes, where the individual containers can also have different volumes, in particular in fixed ratios of, for example, 1/3: 2/3 or 1/2: 1/2, etc., which are necessary for particularly sensible insulin therapy. are.

32. Spray device according to one of claims 1 to 31, characterized ge indicates that a one-piece therapeutic container of any cross-section is provided, in which several, possibly different sized chambers are arranged for the same or different therapeutic agent.

33. Spraying device according to claim 32, characterized in that the one-piece therapeutic container has a geometric

Has a cross-section of any shape that can be inserted into a therapeutic container chamber of the same cross-section in a precisely defined position in order to prevent an incorrect arrangement.

34. Spraying device according to claim 32, characterized in that the one-piece therapeutic container has a geometric or mechanical marking of any shape, which can be used in a corresponding therapeutic container chamber with a corresponding marking in a precisely defined position in order to prevent an incorrect arrangement.

35. Spraying device according to one of claims 1 to 34, characterized in that only a single counting and metering unit is used for counting and dosing different therapeutic agents contained in different therapeutic agent containers (9, 10).

36. Spraying device according to one of claims 1 to 35, characterized in that for controlling and driving the piston, counting and metering devices (12, 13) instead of

Replacement sheet 24

1 mechanically operated function also one or more electric servo or stepper motors are used, which are controlled by at least one permanently programmed or freely programmable microprocessor, the

5 "Counting" a mini-computer and "metering" the electrical actuator or stepper motor.

37. Spraying device according to one of claims 1 to 36, characterized in that the pistons or actuating buttons

10 (83, 63, 64) can be actuated with a pressure generated in particular by a pressure container.

38. Sprayer according to one of claims 1 to 37, characterized ge indicates that the dose of the therapeutic agent at the respective

15 supply channels (19, 20) and / or on the syringe cannula (17) and / or on the injection part (18) itself are measured and / or can be metered and / or pumped, the control being carried out by a microprocessor.

39. Spraying device according to one of claims 1 to 38, characterized in that the metering measurement, in particular optically, magnetically or electrically, for example by measuring resistance at the displacement of the piston (83) of the respective therapeutic agent container and / or the liquid

25 movement on the respective supply channels (19, 20) and / or on the syringe cannula (17) and / or on the injection part (18) takes place in particular by means of a doubler.

40. Spraying device according to claim 39, characterized in that 30 in particular the dose and / or the residual dose of the liquid can be made visible by means of at least one display element.

41. Spraying device according to one of claims 36 to 40, characterized in that a built-in, rechargeable battery by means of solar cells or via power packs at each socket provides the necessary power supply for the microprocessor and the actuator or stepper motor.

42. Spraying device according to one of claims 1 to 41, characterized in that

(a) two or more therapeutic containers (9, 10) can be inserted into the container housing (6) in the insertion direction (E) into the container chambers (7, 8) of the container housing (6), the front edges of the Containers (9, 10) come to rest on the inner surface (30) of the container bottom (28);

(b) the housing element (11) is attached to the step region (47) of the container wall (31) of the container housing (6), the feather keys (59, 59) arranged on the region (54) of the casing wall (55) of the housing element (11) 60) are fitted into the grooves (48, 49) formed on the step region (47) of the container wall (31) of the container housing (6), the housing element (11) being arranged in a rotationally fixed manner with respect to the container housing (6), and the two pressure stamps (67, 68) of the piston rods (65, 66) are arranged exactly in front of the openings (81, 82) and the sliding closures (83, 84) of the two therapeutic agent containers (9, 10) arranged there;

(c) the rear fixing cap (71) can be pushed over the housing element (11) until its internal thread (72) engages with the external thread (45) of the fourth step region (44) of the container housing (11), whereby the inner bottom surface (74) comes into contact with the outer housing bottom surface (52) of the housing element (11) by rotating the fixing cap (71), and the

Housing element (11) can be moved in direction (E) until its front end edge against the rear end edge of the fourth step region (44) of the container housing

(6) abuts, the housing element (11) being axially fixed with respect to the container housing (6);

(d) for the arrangement and attachment of the cannula body (4) on the container housing (6) the annular extension (21)

Replacement sheet 26

of the cannula body (4) can be pushed in the axial direction over the first step area (32) of the container housing (6), the feather keys (24, 25) arranged or formed on the extension (21) with respect to the first step area (32 ) formed grooves (34,

35) come into engagement, the feather keys (24, 25) of the cannula body (4) and the grooves (34, 35) of the container housing (6) being aligned or arranged or positioned such that the supply channels (19, 20) of the spray cannula system (5) exactly in front of the bores (36, 37) formed on the container bottom (28) of the container housing (6) and in front of the openings (85, 86) immediately behind the bores (36, 37) and the pierceable or perforable membranes (87, 88) of the therapeutic agent containers (9, 10) are arranged there;

(e) the front fixing cap (91) can be pushed over the cannula body (4) until its inside thread (92) engages with the outside thread (40) of the container housing (6), by turning the fixing cap (91) whose inner bottom surface (94) comes into contact with the front shoulder surface (26) of the cannula body (4), and the cannula body (4) can be moved in direction (K) until its rear end edge touches the front end edge of the second step region (39) of the

Container housing (6) strikes, and the cannula body (4) is axially fixed with respect to the container housing (6);

(f) to protect the user from injuries to protect the spray cannula (18) from damage, a protective cap (99) can be inserted over the spray cannula (18) protruding from the front fixing cap (91), and

(g) the spray device (1) can generally be dismantled in reverse order for cleaning, maintenance or refilling purposes, with only the cannula body also being removed

(4) can be removed by removing only the front fixing cap (91) for renewal, and on the other hand

He also - if the cannula body (4) remains on the spraying device (1) - only the rear part of the spraying device (1) can be removed, for example in order to replace one or more therapeutic agent containers (9, 10) or to replace it Counting and dosing units (12, 13) to be cleaned, adjusted or repaired.

43. Spraying device according to one of claims 1 to 42, characterized in that various therapeutic agents, in particular insulin with their individual components, are freely miscible, can be applied multanuously or in succession with a single injection, it being irrelevant whether the Therapy agents, in particular, are placed or mixed in an additional container before the injection and only then are they injected.

44. Spraying device according to one of claims 1 to 43, characterized in that the liquid / therapeutic agent containers are refillable, 0 ( _a ) providing a refill valve device on the therapeutic agent container and (b) in particular Sterility reasons for re-usability in front of and / or behind the piston (83) is provided with a chamber filled with a sterilizing agent, even 5 closed by a piston, the sterilizing agent wetting the therapeutic agent container wall during the filling process.

45. Spraying device according to claim 44, characterized in that 0 in particular the piston (83) itself is constructed such that it contains the sterilizing agent and / or the piston itself contains chambers for the sterilizing agent.

5 46. Spraying device according to one of claims 1 to 45, characterized ge indicates that in the insulin spraying device a blood glucose meter is structurally integrated, with blood glucose es-

^• Ers 28

Solution a microprocessor is used, which in particular also includes the control unit for the required display elements and dose measurements and / or delivered cans and / or piston displacements.

5

47. Spraying device according to claim 46, characterized in that both the measured blood sugar values and the insulin doses given can be called up and / or transmitted with the appropriate times, both in

10 viewing / display window of the sprayer / blood glucose meter as well as to / from a PC / AT or terminal (bidirectional data transmission measuring / sprayer - computer and vice versa).

48. Spraying device according to claim 46, characterized in that 15 the insulin injection / blood sugar measuring device contains a metering calculation program which also works in a patient-oriented manner and / or makes a modified metering suggestion to the patient, the modified program at any time on a PC / AT / Terminal in the insulin injection 20 / blood glucose meter (including remote transmission by modem or the like.) Can be loaded or transferred.

49. Spraying device according to one of claims 1 to 48, characterized in that to avoid the diffusion between

25 the containers (9,10) and to prevent evaporation

• the liquid of the cannula body (112, 114, 117) with an adjustable or displaceable closure device (111,

121) is provided, through which the connection between the

Supply channels (119, 120) and the injection needle or

30 spray cannula (118) is interruptible.

50. Spraying device according to claim 49, characterized in that the (optionally spring-loaded) cannula body (4) is displaceable in the longitudinal axis direction of the spraying device,

35 wherein the liquid supply from the supply channels (19, 20) to the injection needle or spray cannula (18) is provided by an

Ers Cannula body (4) designed piston-like plunger () is interruptible.

51. Spraying device according to claim 49, characterized in that the (optionally spring-loaded) cannula body

(114) can be rotated about the longitudinal axis (L) of the spraying device, the liquid supply from the supply channels (119, 120) to the injection needle or spray cannula (118) through a channel system (115) which is in the cannula body (114) and in the rotatable cannula body (114) receiving the housing (116) is formed, can be interrupted.

52. Spraying device according to claim 49, characterized in that the (optionally spring-loaded) cannula body (117) along the longitudinal axis (L.) of the spraying device is displaceable and rotatable about the longitudinal axis (L.) of the spraying device, the liquid supply from the Feed channels

(119.120) to the injection needle or syringe cannula (118) through a body (121) formed on the cannula body (117) as well as through a channel system (122) which in the cannula body (117) and in the housing accommodating the rotatable cannula body (117) (123) is formed, can be interrupted.

53. Spraying device according to one of claims 49 to 52, characterized in that the connecting channels (115, 122) consist of hose systems which come from the outside of the body

(111.121) can be pressed off, and thus the connection of the leads (119, 120) can be interrupted without penetrating into the leads (119, 120).

54. Spraying device according to claim 50, characterized in that the body (121) can be actuated from the rear of the spraying device to the needle tip (118).

Spare sheet 30th

55. Spraying device according to claim 50, characterized in that the body (111) can be actuated from the front of the spraying device, that is to say from the needle tip (118).

56. Spraying device according to claim 50, characterized in that the body (111, 121) can be actuated from the longitudinal side of the spraying device.

57. Sprayer according to one of claims 50 to 56, characterized

10 characterized in that the body (111, 121) can be inserted into the injection channel (132) into which the feed channels (119, 120) tire.

58. Sprayer according to one of claims 49 to 57, characterized

15 characterized in that the adjustable or displaceable closure device (111, 121) enables an injection and closure position to be realized, in which not only the mixing of the liquids but also an airtight seal is ensured.

20th

59. Spraying device according to one of claims 49 to 58, characterized in that the cannula (111) with its holder is displaceable along the longitudinal axis (L) of the spraying device and thus by pressure on the cannula body (112)

25 the cannula (111) can be brought from the open position (FIG. 17) into the closed position (FIG. 18).

60. Spraying device according to claim 59, characterized in that the displacement through the spraying device cap (128) er¬

30 olgt.

61. Spraying device according to claim 59 or 60, characterized in that when removing the spraying device cap (128) the cannula (111) by the spring (113) in the spraying position

35 (Fig. 17) can be pressed ^* .