JP2003513762A - Injection device - Google Patents

Abstract

(57) [Summary] An injection device for injecting a liquid into a subcutaneous tissue by a high-pressure jet, wherein an ampoule body (2) containing the liquid is locked to a base (1) supporting an actuator (21). They are connected via a connecting part (12). The spring member (5) for generating a force to move the pressing member (4) and the holding member (6) for holding the pressing member (4) in the basic position are designed for one injection. The substrate (1) is manufactured from plastic by an injection molding method. This makes it possible to manufacture a large number of injection devices particularly inexpensively.

Description

Detailed Description of the Invention

The present invention relates to an injection device for injecting a liquid, particularly a drug, into a subcutaneous tissue, which includes an ampoule body, a chamber provided in the ampoule body with an opening, and a volume of the chamber reduced. For releasing the movement of the pressing member from the first position for holding the pressing member, the movable pressing member that is preloaded by the spring member and pressed against the holding member, and the holding member. And an actuating member for moving the actuating member to a second position, and holding the actuating member toward the end of the ampoule piston opposite the chamber when the holding member is in the second position. And a base body for guiding the pressing member.

Such an injection device is known from WO 98/15307. In this injection device, an ampoule body having a chamber is screwed into a base body. The base body has a bearing for the actuating device which is formed integrally with the holding member.
When the actuating device is pushed, the holding member is pivoted out of the movement area of the pushing member. The force of the spring then moves the pressure member towards the end of the ampoule piston protruding from the chamber. In the position held by the holding member, the pressing member is spaced from the free end of the ampoule piston. Thus, when the actuating member is operated, the pressing member comes into contact with the free end portion of the ampoule piston with a predetermined impact. Then, the liquid in the chamber is ejected from the opening as a high-pressure jet. If the opening is placed in human skin, for example, the liquid will pass through the skin and into the subcutaneous tissue. A needle penetrating the skin for injecting the drug into the subcutaneous tissue is thereby dispensed with. The penetration depth of the liquid and the shape of the high-pressure jet can be set by the size and shape of the opening with respect to the size of the chamber and the characteristic line of the spring. A buffer member is arranged on the base body to buffer the rebound of the pressing member at the end of the movement of the ampoule piston.

After one injection, the ampoule body is removed from the base body together with the ampoule piston.
The pressing member, the actuating device and the holding member are returned to the starting position by the loading station. Then a new or freshly filled ampoule body is screwed into the substrate. The injection device is thus ready for injection.

A drawback of the known injection device is that it is very expensive to manufacture. For example,
The substrate is made from special steel that is easy to clean. The spring members are designed to tighten and relax without fatigue for thousands of injections and are therefore made from extremely expensive materials. Furthermore, the holding member requires extremely high material strength and sliding properties in order to slide along the pressing member during operation. This prevents the pressing member from accidentally slipping out after multiple uses of the injection device.

Furthermore, in the injection devices known from practice, the force necessary to form the pressure jet is provided by the filling of the gas. The injection device is designed for one-time use and therefore does not require cleaning after use. However, a chamber containing a predetermined gas is extremely difficult to manufacture. Therefore, such an injection device is extremely expensive to manufacture. Further, it is unavoidable that the filling gas escapes with time, and eventually the pressure is reduced.

[0006] The problem underlying the invention is to improve an injection device of the type mentioned at the beginning so that it can be manufactured particularly inexpensively.

In order to solve this problem, in the constitution of the present invention, the strength of the spring member and the strength of the holding member and / or the base body are set to be used for one injection, and after the first use, In addition, means were provided to prevent injection.

By virtue of this construction, particularly inexpensive materials can be used for the individual components of the injection device according to the invention. Material fatigue of the spring member usually occurs only after multiple injections, and according to the invention, the strength of the high-pressure jet does not change. Furthermore, the holding member can be manufactured from a particularly inexpensive material having low strength. In this case, damage to the holding member during operation of the actuating member is not important for an injection device for at least one-time use. Furthermore, the injection device according to the invention does not require a dampening device to limit the movement of the pressing member. This allows the injection device according to the invention to be manufactured particularly inexpensively. The danger to humans from multiple uses is reliably avoided by the injection device according to the invention designed for one-time use. The avoidance of further injections after one use means that the components may be destroyed during the first use or the injection device according to the invention may be used again without fine structural knowledge and tools. It is performed alternatively by being formed so that it cannot be prepared. Furthermore, since the injection device according to the invention is delivered in a tensioned state, no costly tightening device is required.

According to an advantageous further development of the invention, if the ampoule body is permanently attached to the substrate after assembly, a means for preventing further injection after the first use is structurally particularly Easy to get.

According to an advantageous further development of the invention, the spring element is provided for preventing further injection after the first use if it is kept inaccessible between the ampoule body and the base body after assembly. The means can be simplified.

If the substrate is made of plastic, the cost of the injection device according to the invention can be further reduced. At least the substrate may have almost any surface roughness, as cleaning of the substrate is not required according to the invention with an injection device provided for one-time use.

The cost of the injection device according to the invention can be further reduced during mass production if the substrate made of plastic is manufactured by injection molding.

The actuating device can also be pivotally mounted like the injection device known from WO 98/15307. According to another advantageous embodiment of the invention, the bearing is particularly simple to install if the bearing of the actuating device has a bearing shell which is open on one side.

According to another advantageous configuration of the invention, if the actuating device is held in the guide of the basic body so as to be slidable transversely to the direction of axial movement of the pressing member, Support of the actuating device can easily be avoided. To assemble it, simply insert the actuator into the guide. Since such an assembly is performed immediately before the injection, a safety member for avoiding an erroneous operation of the actuator is unnecessary. Such a guide can be easily provided by injection molding when manufacturing the substrate.

According to another advantageous embodiment of the invention, the actuating device is arranged on the guide, in engagement with the pressure plate, which is slidable perpendicularly to the direction of movement of the pressure member, so as to surround the basic body. With an arm, the actuating member can be structurally particularly simple to shape.

The holding member could for example be pivotally mounted on the basic body and pivoted outwards by means of the arm of the actuating device. However, in the injection device of the present invention, the holding member is
If the arm of the actuating device is fixed to the end of the arm opposite the pressing plate and enters the area of the opening in the wall of the basic body, then particularly few components are required.

The ampoule body could also be screwed onto the substrate, like the injection device known from WO 98/15307. However, if the base body has a locking connection for holding the ampoule body with the chamber, the assembly of the injection device according to the invention is simple. This allows, for example, the ampoule body to be bonded to the substrate only immediately before injection. The risk of liquid spilling out of the ampoule body when the actuating device is erroneously operated is thereby reduced.

According to another advantageous configuration of the invention, the basic body has at its end facing the ampoule body a locking hook for engaging from the rear on the side of the flange of the ampoule body opposite the spring member. If so, the locking connection between the basic body and the ampoule body can be made particularly structurally simple. A further advantage of the arrangement according to the invention is that the ampoule body of the known injection device can be used with the injection device of the invention, since the flange in the known injection device can be used as a stopper. This further reduces the manufacturing costs of the injection device according to the invention. By appropriate selection of the locking hooks, it is easily avoided that the ampoule body separates from the base body after further assembly.

According to another advantageous embodiment of the invention, the separation of the ampoule body from the basic body is reliably prevented if the safety ring engages the locking hook from the outside in the assembled state of the ampoule body. This prevents the locking hook from bending away from the ampoule body.

According to another advantageous configuration of the invention, the safety ring comprises a locking hook of the locking hook for radially connecting at least one inwardly directed hook with the ampoule body or the basic body. If it is in the upper position, the removal of the safety ring and thus the separation of the ampoule body from the basic body is reliably avoided.

The assembly of the injection device according to the invention is simpler if the locking hook has an introductory bevel at the end of the base body opposite the spring element, which forms a funnel-shaped part. become.

The injection device according to the invention can be used particularly well if the base body has a stop provided for limiting the axial movement of the ampoule body in the direction of the pressing member. it can.

According to an advantageous further development of the invention, if the basic body has a guide for the central region of the ampoule piston, the ampoule body is particularly accurate and thus costly with respect to the pressing member. No need to direct.

The spring member could also be supported on a rear-adjustable screw at the end opposite the pressing member, as in the injection device known from WO 98/15307. However, in order to further reduce the manufacturing costs of the injection device according to the invention, a cap, which supports the spring member at the end opposite the pressing member and is fixed to the basic body, contributes. The cap, like the substrate, can be manufactured from plastic by injection molding.

Assembly of the injection device according to the invention is even easier if the connection between the cap and the base has a locking connection.

If the base body is formed in the shape of a pot for accommodating the spring member and the pressing member, the number of components of the injection device according to the invention can be particularly reduced.

The injection device according to the invention can be completely preassembled on the actuating device and the ampoule body. In this case, if the safety member holding the actuating member is held in a position that locks the movement of the actuating member by applying a predetermined force, a safety device for avoiding erroneous operation of the actuating device is structurally provided It can be formed particularly easily.
In the simplest case, the safety ring can be formed as a tear section and can be discarded after withdrawal from the gap.

If the safety ring is slidably guided on the basic body and the safety member is arranged on the safety ring, the total number of components to be assembled of the injection device according to the invention can be further reduced. .

The production costs of the injection device according to the invention are further reduced if the pressing member is produced from steel by a flow extrusion process.

The present invention contemplates many configurations. In order to make the basic principles of the present invention clearer, two of them are described in detail below with reference to the drawings.

FIG. 1 shows an injection device made entirely of plastic, which has a base body 1 and an ampoule body 2 which is fastened to the base body 1. Base 1
Has a guide 3 for a longitudinally slidable pressing member 4. Pressing member 4
Are preloaded towards the support element 6 by means of a spring element 5, which is embodied as a compression spring. The spring member 5 is in this case supported by a cap 8 which is connected to the base body 1 via a locking connection 7. The ampoule body 2 has a chamber 9 with an opening 10 for containing a liquid, in particular a drug to be injected into the subcutaneous tissue. This chamber 9 is reduced by an ampoule piston 11 which is slidable relative to the ampoule body 2. The ampoule piston 11 is opposed to the pressing member 4 with an interval at the end portion on the side opposite to the chamber 9. The coupling portion between the ampoule body 2 and the base body 1 has a locking coupling portion 12 including locking hooks 13 and 14 arranged on the base body 1 and a stopper 15. The locking hooks 13 and 14 engage with the flange 16 of the ampoule body 2 from the rear, and hold the ampoule body 2 on the stopper 15. Furthermore, locking hooks 13, 1
Reference numeral 4 denotes an introduction inclined portion 1 forming a funnel-shaped portion 19 arranged at one end of the base body 1.
7 and 18. To assemble the ampoule body 2 to the base body 1, the flange 16 of the ampoule body 2 is pushed into the end portion of the base body 1 having the locking hooks 13 and 14. The locking hooks 13, 14 in this case spring-spring open radially outwards and engage the flange 16 from behind as soon as the flange 16 reaches the stop 15. Further in FIG. 1 it is shown that the base body 1 has a guide 20 for the ampoule piston 11.

The holding member 6 that holds the pressing member 4 in the illustrated position is coupled to the actuating member 21. The actuating member 21 has an arm 23 connected to the pressing plate 22. Since the pressing plate 22 and the holding member 6 are arranged on the opposite sides of the base body 1, when the pressing plate 22 is slid in the direction of the base body 1, the holding member 6 is used for the pressing member 4. Moved out of Guide 3. A malfunction of the pressing plate 22 is prevented by the safety member 24. The safety member 24 is sandwiched in the gap 25 between the pressing plate 22 and the base body 1 and has a tension strap 26. A safety member 24 is engaged with the tension strap 26 and can be pulled out from the gap 25.

In order to inject the liquid in the chamber 9 into the subcutaneous tissue, first the safety member 24 is removed and the opening 10 of the ampoule body 2 of the injection device is pressed against the skin. Then, the pressing plate 22 is pressed to move the holding member 6 from the illustrated first position to the second position located outside the guide 3 of the pressing member 4, thereby releasing the movement of the pressing member 4. To do. The pressing member 4 is pushed by the force of the spring member 5 into the ampoule piston 11
Is accelerated toward the end opposite to the chamber 9, and the ampoule piston 11 is pushed into the chamber 9. At this time, the liquid in the chamber 9 is ejected from the opening 10 as a high-pressure jet flow. The strength of the high-pressure jet, and thus the penetration depth of the liquid into the subcutaneous tissue, is adjusted by the dimension of the opening 10 with respect to the dimension of the chamber 9 and the characteristic line of the spring member 4.

FIG. 2 shows a sectional view of the injection device of FIG. 1 taken along the line II-II. From this figure it can be seen that the actuating device 21 has a total of two arms 23, 29 respectively arranged on the guides 27, 28 of the base 1. The holding member 6 is
It enters the opening 30 of the substrate 1. In order to assemble the actuating device 21 to the base body 1, for example, the arms 23 and 29 can be bent outward and pushed onto the base body 1 from one end. The arms 23 and 29 enter and engage with the guides 27 and 28. Of course, the actuating device 21 or the base body 1 can also be formed in two parts,
When assembled, they are adhered or clipped so as to be integrated.

FIG. 3 shows the injection device of FIG. 1 after use. In this figure, the holding member 6
Are located in a second position that releases the movement of the pressing member 4. The pressing member 4 is in contact with the stopper 31 of the base 1. The ampoule piston 11 is of the ampoule body 2,
It is slid towards the end with the opening 10. Since the locking joint 7 between the cap 8 and the base body 1 is inaccessible from the outside, the pressing member 4 and the spring member 5 in the base body 1 are held almost inaccessible from the outside. Furthermore, it is extremely difficult to separate the ampoule body 2 from the base body 1 because the locking hooks 13 and 14 are directed inward in the radial direction. Since the base body 1 is made of plastic, the locking joints 7, 12 will be damaged if the ampoule body 2 or the cap 8 is forcibly removed from the base body 1.
As a result, re-tensioning of the spring member 5 and replacement of the ampoule body 2 are almost avoided.

FIG. 4 shows an injection device including a base body 32 formed in a pot shape and an ampoule body 33 locked to the base body 32. The base body 32 accommodates a pressing member 35 preloaded by a spring member 34 in the direction of the ampoule body 33 and is manufactured integrally with a bearing shell 36 which is open on one side. An actuating member 37 having a holding member 38 for supporting the pressing member 35 is rotatably supported on the bearing shell 36. Furthermore, FIG. 4 shows that the safety ring 39 is guided on the base body 32 so as to be slidable in the axial direction. A safety member 40 formed integrally with the safety ring 39 supports the actuating member 37 in the position shown. Thereby, the turning of the actuating member 37 and the movement of the pressing member 35 by the force of the spring member 34 are avoided. The base body 32 has a locking hook 41 similar to the injection device of FIGS. 1 to 3, and this locking hook has a stopper 43 spaced apart from the locking hook.
It is provided to hold the flange 44 of the ampoule body 33. The introduction inclined portion 42 provided on the locking hook 41 facilitates the assembling of the ampoule body 33 to the base body 32. The position of the safety ring 39 shown in FIG. 4 is a position where the injection device can be transported. To this end, the safety ring 39 has a hook 45 directed radially inwardly, with which the safety ring 39 enters into a correspondingly formed recess 46 in the basic body 32. The hook 45 is released from the notch 46 by applying a predetermined force to be applied to the safety ring 39 in the axial direction.

To use the injection device, first the safety ring 39 is slid and removed from the actuator 37. As a result, the safety member 40 is moved out of the movement area of the actuating member 37. Next, the actuating member 37 is pushed down, whereby the pushing member 35 is moved toward the ampoule piston 47 of the amp body 33 by the force of the spring member 34.
This position is shown in FIG. In this case, the safety ring 39 is located in a position where it slides on the locking hook 41 of the base body 32 and prevents the hook from opening and bending. The hook 45 arranged on the safety ring 39 then engages between the two locking hooks 42 of the basic body 32, thereby preventing the safety ring 39 from sliding back.
Over-sliding of the safety ring 39 on the ampoule body 32 is further prevented by the hook 48 of the safety ring 39 carried by the flange 44 of the ampoule body 33. The ampoule body 33 is thus permanently attached to the base body 32. Further pressing member 3
5 and the spring member 34 are held inaccessible between the ampoule body 33 and the base body 32. The injection device can therefore no longer be used further.

The injection device can be adapted to ampoule bodies 33 having different volumes by using correspondingly formed pressing member 35 and spring member 34. Base 3
2, the actuating device 37 and the safety ring 39 can be used unchanged on all sizes of ampoule bodies 33 used in medicine. As a result, the base body 32, the actuating device 37 and the safety ring 39 can be manufactured from plastic by injection molding, in particular in mass production, and thus particularly inexpensively.

[Brief description of drawings]

[Figure 1]   FIG. 3 is a vertical sectional view of the injection device according to the present invention before injection.

[Fig. 2]   2 is a cross-sectional view of the injection device taken along the line II-II of FIG. 1.

[Figure 3]   FIG. 2 is a vertical sectional view showing a state after the injection device of FIG. 1 is injected.

[Figure 4]   It is a longitudinal cross-sectional view showing another configuration of the injection device according to the present invention.

[Figure 5]   FIG. 5 is a longitudinal sectional view showing the injection device of FIG. 4 after the first use.

[Procedure for Amendment] Submission for translation of Article 34 Amendment of Patent Cooperation Treaty

[Submission date] November 13, 2001 (2001.11.13)

[Procedure Amendment 1]

[Document name to be amended] Statement

[Name of item to be amended] Claims

[Correction method] Change

[Contents of correction]

[Claims]

[Procedure Amendment 2]

[Document name to be amended] Statement

[Correction target item name] 0001

[Correction method] Change

[Contents of correction]

The present invention relates to an injection device for injecting a liquid, particularly a drug, into a subcutaneous tissue, which includes an ampoule body, a chamber provided in the ampoule body with an opening, and a volume of the chamber reduced. For releasing the movement of the pressing member from the first position for holding the pressing member, the movable pressing member that is preloaded by the spring member and pressed against the holding member, and the holding member. And an actuating member for moving the actuating member to a second position, and holding the actuating member toward the end of the ampoule piston opposite the chamber when the holding member is in the second position. And a base body for guiding the pressing member. In this case, the ampoule body is of a type that can be connected to the base body immediately before injection.

[Procedure 3]

[Document name to be amended] Statement

[Name of item to be corrected] 0005

[Correction method] Change

[Contents of correction]

Furthermore, in the injection device known from US Pat. No. 5,730,723, the force necessary to form the pressure jet is brought about by the filling of the gas. The injection device is designed for one-time use and therefore does not require cleaning after use.
However, a chamber containing a predetermined gas is extremely difficult to manufacture. Therefore, such an injection device is extremely expensive to manufacture. Further, it is unavoidable that the filling gas escapes with time, and eventually the pressure is reduced. Furthermore, the ampoule with the component containing the filling gas is inseparable, so that the injection device cannot be assembled before injection.

[Procedure amendment 4]

[Document name to be amended] Statement

[Correction target item name] 0007

[Correction method] Change

[Contents of correction]

In order to solve this problem, in the constitution of the present invention, the strength of the spring member and the strength of the holding member and / or the base body are set to be used for one injection, and after the first use, In addition, means were provided to prevent injection.

─────────────────────────────────────────────────── ─── Continued front page    (81) Designated countries EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, I T, LU, MC, NL, PT, SE, TR), OA (BF , BJ, CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, G M, KE, LS, MW, MZ, SD, SL, SZ, TZ , UG, ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, B Z, CA, CH, CN, CR, CU, CZ, DE, DK , DM, DZ, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, J P, KE, KG, KP, KR, KZ, LC, LK, LR , LS, LT, LU, LV, MA, MD, MG, MK, MN, MW, MX, MZ, NO, NZ, PL, PT, R O, RU, SD, SE, SG, SI, SK, SL, TJ , TM, TR, TT, TZ, UA, UG, US, UZ, VN, YU, ZA, ZW

Claims (22)

[Claims] 1. An injection device for injecting a liquid, in particular a drug, into subcutaneous tissue, comprising: an ampoule body, a chamber provided in the ampoule body, the chamber having an opening, and reducing the volume of the chamber. An ampoule piston, a movable pressing member that is preloaded by a spring member and pressed against a holding member, and a holding member that releases the movement of the pressing member from a first position where the pressing member is held. An actuating member for moving to a position 2 and a holding member for the actuating member, the holding member being in a second position, the actuating member being directed toward the end of the ampoule piston opposite the chamber. In a type in which a base for guiding the pressing member is provided, the strength of the spring member (5, 34) and the holding member (6, 38) and / or the base (1, 3)
An injection device characterized in that the strength of 2) is set for use in a single injection and means are provided to prevent further injections after the first use. 2. An ampoule body (2, 33) is attached to a substrate (1
, 32), the injection device according to claim 1. 3. The spring member (5, 34) is mounted on the ampoule body (2, 33) after assembly.
3. The injection device according to claim 1 or 2, wherein the injection device is held inaccessible between the substrate and the base body (1, 32). 4. The injection device according to claim 1, wherein the base body (1, 32) is made of plastic. 5. The injection device according to claim 1, wherein the base body (1, 32) made of plastic is manufactured by an injection molding method. 6. The bearing shell of the actuating device (37) is provided with a bearing shell open on one side (
36) The injection device according to any one of claims 1 to 5, comprising: 36). 7. An actuating device (21) is held on a guide (27, 28) of the basic body (1) so as to be slidable laterally with respect to the axial movement direction of the pressing member (4). The injection device according to any one of claims 1 to 6, which is provided. 8. An actuating device (21) engages with a pressing plate (22) slidable perpendicular to the direction of movement of the pressing member (4) so as to surround the base body (1),
An arm (23, 29) arranged on the guide (27, 28),
The injection device according to any one of claims 1 to 7. 9. The holding member (6) comprises arms (23, 29) of the actuating device (21).
1) fixed to the end opposite to the pressure plate (22) and entering the wall of the basic body (1) in the region of the opening (30). The injection device according to the paragraph. 10. The base body (1, 32) according to claim 1, wherein the base body (1, 32) has a locking connection (12, 41) for holding the ampoule body (2, 33). The injection device according to the paragraph. 11. The spring member (5, 3) of the flange (16, 44) of the ampoule body (2, 33) at the end of the base body (1, 32) facing the ampoule body (2, 33).
The injection device according to any one of claims 1 to 10, which has a locking hook (13, 14, 41) for engaging from behind on the side opposite to 4). 12. The injection device according to claim 1, wherein the safety ring (39) engages the locking hook (41) from the outside in the assembled state of the ampoule body (34). . 13. The safety ring (39) comprises at least one inwardly directed hook (45, 48) in the radial direction, an ampoule body (33) or a base body (32).
Injection device according to any one of the preceding claims, characterized in that it has a position above the locking hook (41) for a form-fitting connection with. 14. A locking hook (13, 14, 41) forms a funnel-shaped portion (19) at the end of the base body (1, 32) opposite the spring member (5, 34). Injection device according to any one of claims 1 to 13, having an introduction ramp (17, 18, 42). 15. A stopper (1) provided with a base (1, 32) for limiting the axial movement of the ampoule body (2, 33) towards the pressing member (4, 35).
5, 43) The injection device according to any one of claims 1-14. 16. The injection device according to claim 1, wherein the basic body (1) has a guide (20) for the central region of the ampoule piston (11). 17. The spring member (5) is supported at an end located on the opposite side of the pressing member (4) and has a cap (8) fixed to the base body (1). Item 17. The injection device according to any one of items 1 to 16. 18. The connecting portion between the cap (8) and the base body (1) is a locking connecting portion (7).
The injection device according to any one of claims 1 to 17, further comprising: 19. The injection according to any one of claims 1 to 18, wherein the base body (32) is formed in a pot shape to accommodate the spring member (34) and the pressing member (35). apparatus. 20. A safety member (24,40) holding an actuating member (21,37).
20.) The injection device according to any one of claims 1 to 19, wherein) is held in a position that locks the movement of the actuating member (21, 37) by applying a predetermined force. 21. The safety ring (39) is slidably guided on the basic body (32) and the safety member (40) is arranged on the safety ring (39). The injection device according to claim 1. 22. The injection device according to claim 1, wherein the pressing member (4, 35) is manufactured from steel by a flow extrusion process.