DE102008011310A1 - Needle-less, medical agent injection device for forming wheals on patient's skin, has sealing flange pressed against base, and lug with outer edge overlapping nozzle outlet in longitudinal axis around preset millimeters - Google Patents

Abstract

The device has a sealing flange (61) pressed against a base (4) by a cover and/or an injector (32). A tip (63) is attached to a flexible tube (62) and releases the driving of a medium. A lubricating film (64) is made of plastic and surrounds the tip and a part of the device, where the film is movable in a longitudinal direction. The tip is activated while moving towards an end at which a medium outlet is formed. A lug for intradermal injection is provided with an outer edge that overlaps a nozzle outlet in a longitudinal axis of the device around 0.2 to 0.4 millimeters.

Description

The Invention describes an injection device consisting of a Injector and an ampoule unit for needle-free injection of a Medium.

The closest prior art are the documents WO 2007/065544 as well as WO 2007/065542 ,

These Documents disclose an injection device for needle-free Injection of a medium, with an injector and an ampoule unit, wherein the ampoule unit contains a medium to be injected Basic body has.

1 In detail, essentially shows the embodiment according to the prior art.

In 1 is in cross-section an ampoule unit according to WO 2007/065544 shown. The design shows the structural structure of the ampoule unit 1 , This consists of one with the medium 3 filled body 4 , which is completely covered by a jacket in the longitudinal axial direction. At the front end there is a nozzle 13 (preferably a steel nozzle), which is connected to the main body 4 or coat 5 via a sealing element 15 (preferably made of silicone) non-positively and positively by means of a nozzle fitting 19 is fixed mechanically and medium sealing. At the exit of the steel nozzle 13 is screwed on a cap 14 , being between the inner wall of the cap 14 and the exit of the steel nozzle 13 again a cap seal 20 (made of sterile material).

Before injection, such as in 1 screwed ampoule unit shown to remove after removing the cap 14 and the cap seal 20 after putting on a specific skin area the medium 3 to apply (or to inject under the skin).

task The invention of the present application is now the filling to improve the injection device, in particular a nearly gas-free To allow filling. Next is a goal the invention to further develop the injection device to they for other medical or non-medical purposes (eg cosmetic purposes) to use and also to allow different types of media, which are only shortly before injection or first be mixed with each other in the injection, with the inventive Injection device can be administered.

An execution improvement for filling the ampoule unit is in the 2a to 2c shown.

2a shows an exploded view of the device according to the invention, 2 B and 2c show the ampoule unit according to the invention in various designs.

Of importance for a virtually gas-free filling is a seal 16 which, as in the 2 shown, has a conical cross section and the space between the main body 4 (preferably of glass or a similar material, eg topaz) and a filling nozzle 18 lies. This filling nozzle 18 has a cylindrical part 25 on, in the ampoule unit according to the invention 1 sealing and also has another, funnel-shaped flared end 26 on.

Is now with a filling device, eg. As a filling needle, the medium to be injected into the interior of the body 4 introduced and the injection device according to the invention is erected vertically, so are due to the conical surface all bubbles or similar air bubbles up and through the filling 18 climb.

The filling nozzle 18 can be made of plastic or a metal, for. As stainless steel, be made and if this filling nozzle after filling mechanically a constriction 27 (Einkränkung, squeezing or the like.) Experiences, the interior of the ampoule unit according to the invention is completely closed from the outside, wherein a narrowing of the diameter of the filling nozzle in several places is quite advantageous to obtain a reliable absolute conclusion of the interior of the device according to the invention from the outside.

The in 2 shown filling nozzle 18 remains in place after filling and during the injection process serves to form the prior art piston rod which is spring biased together with the adjacent seal 16 To squeeze the medium contained in the body from the inside of the ampoule unit.

has the filling nozzle several constrictions, so can too a constriction serve as a predetermined breaking point to the hopper after filling, detach from the filler neck.

3 and 4 now show a further embodiment of the ampoule unit according to the invention over the prior art. It is particularly easy to see how in the back of the ampoule a piston 28 (In the figures, a displacement piston) is shown, which with its foremost end within the body and in its central region of a seal 30 is surrounded, wherein the herauszudrückende by the ampoule unit according to the invention as a medium filming 29 between the piston 28 and the body 4 or the seal 30 lies.

If the main body 4 made of glass (eg borosilicate glass), this basic body can 4 Also be coated from the inside with a lubricant, thus creating a streak-free, transparent impression.

The in the 3 shown seal 30 Upper side can be an outstanding ring 31 have, which serves as a stop for the abutment lying on the piston and when the seal is made particularly soft in this area, so a fairly soft impact is generated.

In the 3 and 4 is also shown that the seal 30 by means of a screw-on lid 32 to which the shrink sleeve or the body is pressed.

In 4 forms the lid 32 the upper degree, while - as already mentioned - in 3 the seal with a protruding beyond the screw ring 31 concludes.

5 shows the device according to the invention with a further embodiment. Here is the main body 4 not, as in the prior art, formed by a glass material, but by a material called topaz. The properties and the production of this material is known from documents of the company TOPAS Advanced Polymers GmbH, Frankfurt or Ticon GmbH, Frankfurt (a company of Celanese AG), and in particular available via http://www.topas.com , At this point it is omitted to list all the details of this topaz material here. For the purposes of the present application, these mechanical, chemical and other mechanical properties of the topaz material must be assumed to be known, especially since it is a standard material, which can be obtained from various sources, in particular via the above-mentioned Bezugsquel le. The Topas material is a Cyclo Olefin Copolymer (COC) and the essential chemical, physical and other material properties of this material have been known since 2000.

For the injection device according to the invention, it may be particularly advantageous if the wall thickness a of the main body 4 (ie topaz) is less than the wall thickness b of the sheath 5 ,

A Another alternative may be that the main body still made of a plastic or glass, but inside coated with the topaz material, which z. B. by damping or by a low-plasma application method.

One special advantage may be that the topaz material is not has to be depyrolesed first.

6 and 7 show a development of the known single-chamber injection device to a two-chamber injection device. For illustration purposes are in the 6 and 7 shown parts shown separately, but they are interleaved or screwed, z. B. in particular via the outer or inner thread AA or BB shown in both figures.

6 shows now in the already mentioned basic structure of the ampoule unit, wherein inside the body 4 a volume is formed, hereinafter referred to as a first chamber 50 referred to as. This first chamber is filled with a desired medium, for. B. a powdery, liquid-soluble active ingredient.

7 also shows a hollow cylindrical body 35 whose interior is a second chamber 51 forms.

Between both chambers 50 . 51 If a connection is provided, in the example shown, the connection consists of a hollow needle 36 , This hollow needle is at one end by a check valve 32 , which opens into the first chamber, closed. The other end of the hollow needle runs (as usual with a needle) pointed (see 6 ) and when both parts of the two-chamber injection device according to the invention are connected to each other, the tapered portion is located on a seal 38 which is destructible (or openable) from the tip of the hollow needle.

In 7 further illustrated is the second chamber with a further seal 39 completed and this seal can by a piston 40 be pressed through the cylindrical part, thus the medium, which is inside the second chamber 51 is to press through the hollow needle into the interior of the first chamber. The two media in both chambers can be coordinated so that they can mix for a specific medical purpose or can also react and thus have the desired properties after mixing or after reaction has occurred. It is also quite possible and desirable if both media of a different consistency, for. B. the medium in the first chamber is powdery and the medium in the second chamber is liquid, so that when the liquid ge in the powder is brought, the powder dissolves there and the drug to be applied arises.

At its upper end, the injection device according to the invention according to the 6 and 7 two locking pins 41 . 42 on. Will be the first locking pin 42 solved, so it is possible the piston 40 to operate manually, so that with the propulsion of the piston, the medium is propelled in the second chamber, so that the tip of the hollow needle opposite seal 38 is opened or pierced and thus the medium from the second chamber can pass through the hollow needle into the interior of the first chamber.

Of the manual propulsion of the seal can also be limited so far until the inside of the first chamber, through the medium from the second chamber is filled.

After that, the second backup 41 solved, so the entire needle-free injection device as in WO 2007/065544 . WO 2007/065542 be triggered described, so that by spring force almost the entire contents of the first chamber is pressed through the nozzle.

This in 6 illustrated check valve 32 is formed in the manner of a rubber-like closure and provided with an incision, so that when pressure from the outside (ie from the interior of the first chamber), the valve closes, but when pressure from the inside (ie from the hollow needle), the valve opens.

In 6 It can be seen that the main body 4 is again completely encased, on the side, however, on the in 7 shown counterpart is a tab 43 formed, which acts as a kind of skin or film as a predetermined breaking point, which only dissolves when after loosening the locking pin 41 the injection device according to the invention is mechanically triggered by spring force.

Both chambers 50 . 51 can - as already mentioned - with different media, in particular different consistency, filled. So it is particularly advantageous, the first chamber with a medium (preparation) in powder form, for. B. lyophilate to fill and the second chamber with a liquid medium, for. B. fill a solution with isotoic NaCl (0.9%) or with a pH-buffered solution so that powder and liquid mix together before application or extremely fast (less than 5 seconds, preferably faster than 1 second) can be used to subcutaneously administer certain medical agents to a patient.

If a technical problem is with the injected substance a specific application profile under the skin of a patient This can be achieved by various measures.

One of these measures is that the nozzle not only has a single central outlet opening (as in the cited prior art), but via a plurality of outlet openings 53 features and - like 8th in a particular example shows these openings on an imaginary ring 44 lie (see 8b ) and thus make it possible that the medium to be applied penetrates through the illustrated outlet openings at different points through the skin of the patient.

Of the Advantage of multiple outlets is that the exit surface is relatively large overall, while the individual nozzles are still very much are small.

It It goes without saying that the number of outlet openings as well as their location very variable in the front nozzle area is to train.

In the illustrated 8a the cross section also shows that the front nozzle tip is formed in the manner of a hemisphere, which is a very preferred embodiment.

It It goes without saying that the size and shape the passage surfaces of the nozzles both on the appropriate application as well as adapted to the medium, thus the desired distribution of media under the skin of the patient.

The 9 shows a further embodiment of a needleless injection device according to the invention.

It can be seen that not only a single spring is designed as a driving force, but equal to those two, both springs 55 . 56 have different error constants, so that the spring-travel characteristic curve is not linear, as is usual with a spring, but also two different linear gradients, 10a - can and even progressively - 10b - can run.

If, for example, during propulsion first the strong spring predominates in its action, this can serve to penetrate the skin layer of a patient, and when the second spring, which is weaker than the first spring, comes into effect thereafter, the medium becomes active not deeply brought under the skin from the injection device according to the invention, but the injection volume is relatively shallow under the skin and the depth of penetration of the injection volume can be determined by the strength of the second spring, while the first spring is designed primarily to first overcome the resistance that forms the natural skin through its closure.

A typical spring characteristic of such a two-spring system is in 10a shown, 13 shows a possibility of the profile of the injected medium below the skin, wherein it can be seen that this medium forms relatively wide below the skin, but not - as in 11 shown - penetrates into the lower skin layers.

12 shows another - independent - training of the invention. At the in 12 The solution presented is the aim in an optimal intradermal administration of the injection in the foreground. In this case, intradermally means that a visible wheal remains after the injection, ie the injection charge lies relatively flat in and / or under the dermis and in cross section has a significantly larger surface diameter than height (see 13a . 13b ).

To the Achieving this goal will be the invention already described Ampoule unit at its front end provided with a header, which either fixed there or there placed or again is solvable, z. B. by screwing etc. This intent has an edge that projects beyond the front surface of the nozzle, z. B. by about 0.2 to 0.8 mm. In the example shown the intent of a (circular) ring whose diameter in Essentially determines the later wheal diameter and its height h as shown about 0.2 to 0.6 mm above the front nozzle surface is located.

Also the discharge spring is relative to such an embodiment weak, so that when the injection device is applied the skin of the one who is to receive the injection, in the area of centering arched and topside very close to the outlet the nozzle is moving, if not touching. Due to the curvature, the skin is also in this area easily preloaded and can be more easily penetrated by the injection, by the vault itself but also the wheal formation supported and the spring constant of the exit spring must therefore not as strong as with an injection device, at which the injection is transported into deeper skin layers should.

A further variant of the invention, which is independent of the previously described embodiment of the invention, however, together with the previous embodiments of the invention in a single injection device can advantageously be executed or supplemented the previous embodiments of the invention is in the claims 15 to 25 claimed as well as in the 14a . 14b such as 15a and 15b disclosed.

As already stated, an injection device for needle-free injection of a medium is already generally known WO 2007/065542 , The embodiment shown there is very well suited for the use of a needle-free injection of a medium.

Like the in WO 2007/065542 illustrated embodiment, there in particular in the 5 . 6 ff., Is arranged at the end, which opposes an outlet nozzle for the medium, a triggering device, which only - comparable to a conventional ballpoint pen with conventional rear arranged pressure mechanism - must be depressed, thus the release (activation) of the triggering device and thus the activation to allow the spring drive.

As mentioned, is the whole mechanism as well as the injection result very satisfying.

If but a doctor or possibly the patient himself Needle-free injection device with the nozzle end (ie the exit end for the medium) touches the skin and want to activate the triggering device, so it comes possibly due to psychological effects (the usual fear before the needlestick) that the one, the needleless injection device at the moment he activates the tripping device (usually with your thumb) would like to trigger a little the entire injection device from the body site, on he puts them on before takes them away. At least this has one Observation in self-experiment revealed.

Finally, it was also found that the contact pressure, ie the pressure with which the injection device according to WO 2007/065542 rests on the respective skin area of the patient, is very different, depending on who operates the needle-free injection device. Again, psychological effects play a role, but the respective contact pressure before triggering the injection is also dependent on the individual who operates the needle-free injection device itself. Now it is clear that when, for example, the needle-free injection device is pressed very strong, the skin concerned has a very different voltage than when the needle-free injection device rests only loosely on the skin. These respective different initial states, which have a different skin tension, but u. U. also a different skin thickness (when the needle-free injection device is pressed very strong, the underlying skin layers are compressed, so thinner than in the initial state without edition of the needle-free injection device), so that ultimately the injection of the medium can be done under very different conditions and the also leads to different results.

In order to ensure the use of the needle-free injection device with a higher reliability and in particular to make the result of the needle-free injection itself more predictable and successful, a further embodiment of the injection device with the features according to claim 15 or 25 describe, advantageous developments are in the related Subclaims described and in 14 and 15 shown.

As in 14 to recognize that is already out WO 2007/065542 known needle-free injection device provided in its facing away from the outlet end part provided with an enclosure. Since the injection device in this area has an approximately circular diameter, the housing also has a corresponding diameter, which is slightly larger than the outer diameter of the injection device, so that encloses with its inner surface, the outer surface of the injection device in the surrounding area (slidably) , but is still displaceable in the longitudinal direction of the injection device. As in 14 To recognize the housing encloses the trigger element. Thus, if the housing is moved in the direction of the outlet end, the triggering element is also pressed inwards at the same time and the entire triggering of the needle-free injection is activated.

Thus, the triggering or the displacement of the housing does not happen unintentionally, an opening is provided in the upper part of the housing, in which a ring-like securing element, which as such already made WO 2007/065542 is known, is plugged. Only when this fuse element is pulled out of the housing, the functionality of the needle-free injection device is given.

Of the User can now use the entire needle-free injection device capture it only by the enclosure or its area engages and the injection device with its outlet end on the respective skin (pad) touches down, where the injection should be done. Now, the user of the needle-free injection device only needs still the enclosure - of course after removal of the security element - to push towards the skin area and thus the needle-free injection always takes place under the same Conditions, that means always with the same contact pressure of the injection device on the respective skin area. This ensures that whenever the needle-free invention Injection device is triggered, even the desired Injection result is reliably achieved and there for the entire injection only a time of about 10 to 500 milliseconds, preferably about 50 to 100 milliseconds is needed is even if, due to a possible pain reflex the User suddenly removes the injection device from the skin, already the entire injection takes place because the anxiety / pain reflection time much larger than the actual injection time.

It It goes without saying that the respective contact pressure (Kraft) of the injection device on the skin quite substantially thereby can be determined by also the pressure (force), which for the triggering is needed is set. The higher the pressure that is to trigger the Trigger element is needed, the higher is also the pressure of the entire injection device on the respective Skin area.

As already in WO 2007/065542 discloses the release of the drive element by pivoting or twisting a locking element ( 8th ) accomplished. This blocking element cooperates with the triggering element, which in turn is wedge-shaped. Due to the position of the blocking element to the wedge-like surface of the triggering element on the one hand or by the surface friction conditions of blocking element on the one hand and surface of the wedge-like triggering element on the other hand, the respective force (pressure), with the triggering itself is done, very precise and above all be set repeatable, so that all identical injection devices with the corresponding design at the same pressure force, so trigger at the same force with displacement of the housing.

Of course It is possible by different construction arrangement also to determine different triggering forces, what u. U. then desired, if certain media, ie z. B. certain drugs (in liquid form) are applied, preferably subcutaneously, or in certain skin layers to be registered.

Another, u. U. also independent variant of the invention is in 15a respectively. 15b executed. It is about the development of the variant as in the present 12 already basically executed.

In this variant according to 12 is used for optimal intradermal administration of the injection a header placed on the nozzle end of the ampoule unit / injection device according to the invention.

15a , more precise, however 15b , Now show a very advantageous embodiment of the outlet end, so the end of the injection device on which the nozzle unit is formed. As in particular in 15b can be seen, the nozzle is surrounded by a skirt or a jacket, preferably a shrink sleeve, which has a first portion in a front portion in which the outer diameter of the shell tapers and that - as shown - tapers so that a circular arc cross-section R2 (or deviations from it) sets. This section is followed by another section, in which the external thread is formed (preferably an M8x1 thread), on which the attachment can be screwed. Finally, joins another third section, in which the front end of the shell again linearly, ie tapered conically.

Of the first section is preferably about 1 mm long and starts at a distance seen from 4 mm from the nozzle end.

Of the second section is preferably 2 mm long and the third section, which connects to the second section is about 1 mm long.

While the nozzle in the outlet region has a diameter of about 2 mm (the nozzle opening itself has only one Diameter of 0.01 to 0.02 mm), the diameter is of the third section in the outlet area about 6 mm.

The Material of the shrink sleeve is preferably a plastic, completely Polycarbonate is particularly preferred here.

In the 15 illustrated embodiment has the particular advantage that thus very safe bursting of the ampoule during injection, ie when a particularly high pressure in the interior of the ampoule acts, can be avoided and in particular by the embodiment, as in 15 discloses that notch stresses are reduced so that overall material reliability is improved.

QUOTES INCLUDE IN THE DESCRIPTION

This list The documents listed by the applicant have been automated generated and is solely for better information recorded by the reader. The list is not part of the German Patent or utility model application. The DPMA takes over no liability for any errors or omissions.

Cited patent literature

• - WO 2007/065544 [0002, 0005, 0031]
• - WO 2007/065542 [0002, 0031, 0049, 0050, 0053, 0055, 0056, 0059]

Cited non-patent literature

• - http://www.topas.com [0020]

Claims (25)

Needle-free injection device with a first Chamber, the interior of which opens into a nozzle, with a second chamber whose interior is separated from the interior of the first chamber is, wherein the interior of both chambers is connectable to each other, thus mixing and / or reacting in the chambers in the first Chamber preferably a powdered medium, in the second Chamber preferably a liquid medium is housed and for mixing / reaction of both media, the liquid Medium is preferably transported into the first chamber. Needleless injection device according to claim 1, characterized in that both chambers via a hollow needle can be connected to each other. Needleless injection device according to claim 2, characterized in that the hollow needle by means of a valve is connected to the interior of the first chamber. Needle-free injection device according to one of the preceding Claims 1 or 2, characterized in that the hollow needle a needle end, by means of which a seal, the interior of the closes second chamber, is destructible, so that the medium in the second chamber through the interior of the hollow needle is conductive. Needle-free injection device according to one of the preceding Claims, characterized in that the injection device having two securing elements, wherein with the first securing element a connection of the inner volumes of the first and second chambers is to be prevented and the second securing device is provided, a triggering a pressing of the medium to the first chamber to prevent. Needle-free injection device according to one of the preceding Claims, characterized in that the first and / or second chamber is formed by a main body, which made of a material which is the same or similar Has properties such as borosilicate glass, z. B. a material like topaz or coated with a topaz material on the inside is. Needle-free injection device, in particular after one of the preceding claims, characterized the injection device has an outlet nozzle, whose outlet cross-section in the front part is round, preferably as a half or partial sphere is formed and more than one nozzle opening having. Needleless injection device according to claim 7, characterized in that the openings on an imaginary circular line ( 8th ) lie around the central axis of the nozzle. Needle-free injection device according to one of the preceding Claims, characterized in that for intradermal Inject the needleless ampoule unit a nozzle attachment having, which provided with an outer edge is that in the longitudinal axis of the needleless ampoule unit surmounted the nozzle outlet, preferably by about 0.1 to 0.8 mm, more preferably 0.2 to 0.4 mm. Needle-free injection device according to one of the preceding Claims, characterized in that the article of the device is solvable. Needleless injection device according to claim 10, characterized in that the attachment ( 43 ) is screwed onto the device ( 12a ). Use of a needleless injection device according to one of the preceding claims, in particular according to one of claims 9-11, for the formation of wheals with a defined intradermal spread. Needleless injection device, in particular according to one of the preceding claims, characterized in that for ejection of the medium from the first chamber, a spring system is formed, by means of which a spring characteristic can be displayed, which has two and more sections, which at an angle of not equal to 180 Degrees ( 10a , b). Injection device according to claim 13, characterized characterized in that the spring system of two springs of different Spring constant exists. Injection device for needle-free injection of a medium, comprising an injector device, wherein the injection device has a main body storing the medium to be injected and a drive element for driving a drive element for expelling the medium from the base body and for injecting the medium, wherein the drive element associated with a triggering device is, by which the actuation of the medium is triggered, characterized in that the injection device comprises an enclosure which surrounds the triggering device and at least a portion of the entire injection device, wherein the housing or at least a part thereof in the longitudinal direction of the injection device is displaceable and at Ver shift in the direction of the end of the injection device, at which the media outlet opening of the injection device is formed, the triggering device activated. Injection device according to claim 15, characterized characterized in that the housing has an opening, in which a locking element can be inserted, which is a Displacement of the enclosure prevents, as long as the locking element is plugged in. Injection device according to one of the preceding Claims, characterized in that the enclosure the injection device in the longitudinal direction by more than 10%, preferably more than 40-60% encloses. Injection device according to one of the preceding Claims, characterized in that the injection device has a substantially circular cross-section and the enclosure is substantially cylindrical with an inner diameter, which is the outer diameter of the injection device only slightly exceeds. Injection device according to one of the preceding Claims, characterized in that the enclosure is made of a plastic material. Injection device, preferably according to one of preceding claims, characterized in that the injection device at its front end a nozzle outlet which of a surrounding the nozzle surround surrounded and the enclosure has a first section, which tapers towards the outlet, that at the border a second section connects in the direction of the outlet, in which an external thread is formed and that to the second section towards the outlet, if necessary, a third Section connects, in which the outer diameter the edging continues to taper. Injection device according to claim 20, characterized characterized in that the outer diameter in the range the rim of the first section is tapered linearly or conically (R2). Injection device according to one of the preceding Claims, characterized in that the edging material the injection device, which outside the nozzle encloses, preferably is a polycarbonate material. Injection device according to claim 22, characterized in that the cross section of the injection device in the nozzle region is formed as in 15 shown. Injection device according to one of the preceding claims, characterized in that the injection device has an enclosure, which is formed in cross section as in 14 shown. Injection device, preferably according to one of preceding claims, characterized in that the pressure or force that is necessary, the triggering device activate the injection device, the force or the pressure corresponds, which in the injection on the pad, on the the injection device rests during the injection exerted becomes.