Abstract:
The invention relates to an injection device for the needle-free injection of a medium. Said injection device comprises an injector device and an ampoule unit, said ampoule unit comprising a base ( 4 ) holding the medium to be injected. Said base comprises a jacket ( 5 ) which exerts pressure on the base, and jacket completely enveloping the base in the longitudinal axial direction.

Description:
BACKGROUND 
     1. Technical Field 
     The subject matter of the present invention relates to an ampoule unit for an injection apparatus and an injection apparatus for the needle-free injection, in particular subcutaneous, intracutaneous, intramuscular, intra-articular, submucous injection, by means of an injector device and an ampoule unit. 
     2. Description of the Related Art 
     In the past 10 to 15 years, a large number of injection apparatuses for the needle-free injection of a medium have been developed; however, to this day, the injection apparatuses destroy the associated ampoule units, in which case it is sometimes not possible during application to prevent material particles along with the medium to strike or penetrate the skin at a high pressure, with high pressures and velocities frequently causing injury to skin and tissue. 
     An example is the device disclosed in DE 102 11 473 A1, in this case an ampoule for an injection apparatus for the needle-free injection of a medium into human or animal tissue, comprising an ampoule body, with a chamber disposed inside the ampoule body for holding the medium, with a nozzle for generating a high-pressure jet of the medium ejected from the ampoule, and a longitudinally movable plunger and a longitudinally movable stopper for sealing the chamber, with the ampoule body comprising a segment disposed at a distance from the nozzle and made of a material appropriate for the medium and a pressure-resistant segment disposed near the nozzle, with a circulating flow region that allows the medium to flow around the stopper disposed on the end of the pressure-resistant segment facing away from the chamber. 
     DE 695 08 104 T2 discloses a glass container for use as a needle-free injection capsule that has a hollow glass body, characterized in that compression means are provided to exert a compressive force on the hollow glass body, thereby making it possible for the container to withstand high pressure. However, the disadvantage of this type of design is that, during application, the glass very often splinters in the conically tapering anterior area of the ampoule, which leads to minor skin injuries during the application. 
     BRIEF SUMMARY 
     At least some embodiments of the present invention make available an appropriate injection apparatus and ampoule unit in which the disadvantages mentioned are eliminated or considerably reduced. In some embodiments, the device and ampoule unit provide needle-free injections of a medium through the skin with minimum injuries. 
     The injection apparatus according to the present invention for the needle-free injection of a medium comprises an injector device and an ampoule unit. The ampoule unit in turn comprises a base body for holding the medium to be injected and a jacket which exerts compressive forces on the base body. The jacket completely envelopes the base body in the direction of the longitudinal axis. Among other things, it is especially essential to some embodiments that, because the base body is completely jacketed along the longitudinal axis, the risk of glass breakage and, thus, of injury during the application is practically completely eliminated. 
     The advantage is that the compressive forces exerted by the jacket, at a minimum, compensate for the internal stresses that built up in the course of manufacturing the base body, since most base bodies are made of glass and, during the production of an ampoule-shaped glass base body, due to the different cooling rate from the outside to the inside, stresses that have a negative effect build up. Thus, when compressive forces are exerted on the base body to eject the medium to be injected, the probability of breakage and a detachment of base body particles is reduced, with a special advantage offered if the jacket exerts at least up to 100% of the compressive forces that build up during the injection on the base body, thereby ensuring complete compensation and thus a considerably lower risk of breakage. 
     The jacket is preferably shrink-fitted, applied by a casting method, by polymerization or by means of press-fitting onto the base body. 
     Shrink-fitting is performed by heating the jacket to an elevated temperature, for example, to +100° C., which causes the inside diameter to expand, thus allowing the base body to be inserted. On cooling, preferably to room temperature, the jacket contracts and clings to the base body, which causes the jacket to exert compressive forces onto the base body. The effect is the same if instead of heating the jacket, the base body is cooled, for example, in liquid nitrogen, or if the jacket is heated and the base body is cooled at the same time. In the casting process, the base body is coated with a low-melting metal alloy or a plastic material, for example, polyamide, by a spraying technique. In this case, for example, especially the base body can be mounted on a rotating mandrel and the alloy or the plastic material sprayed on at the same time by means of a spraying device. If polymerization is used, a plastic material is sprayed onto the base body in a mold; for example, the base body is located in an injection mold and a suitable plastic material is injected into the mold, i.e., into the hollow space between the inside wall of the injection mold and the base body, and thus onto the base body. If press-fitting is used, the base body is inserted under pressure into a jacket, in particular one made of a plastic material or a metal alloy or a metal, and due to fact that the inside dimension of the jacket is slightly smaller than the outside diameter of the base body, high pressure is built up and exerted onto the base body. 
     As practical experience has demonstrated, the jacket can be made of a plastic material or a metal, the base body is made of glass (e.g., borosilicate glass), since in this type of glass, the ability of small glass particles to migrate, i.e., the ability of glass components to detach themselves, thereby leading to contamination, is very low, and the jacket is made, in particular, of polyamide, a bonded fabric, especially of plastic materials with glass fibers and carbon fibers, or an MCP alloy. The MCP alloys are low-melting metal alloys containing in particular Bi, Sn and In, for example, MCP 96 and MCP 137 alloys of HEK GmbH, Kaninchenborn 24-28, D-23560 Lubeck, Germany. 
     Thus, by shrink-fitting or using a casting process, polymerization or press-fitting to apply polyamide, a bonded fabric or an MCP alloy, materials highly shrinkable on cooling, preferably to room temperature, onto the base body preferably made of borosilicate glass and by means of the resultant shrinkage, which causes high compressive forces to be exerted. The base body is sufficiently pressurized and, thus, the risk that the material of the base body will break when high pressure is exerted in order to eject the medium to be administered is avoided. 
     As a result of shrink-fitting or the casting process, polymerization or press-fitting, the compressive forces that built up are very high, and therefore, the resistance to compressive forces during application cannot be compared to that of glass ampoules enveloped by a conventional plastic material (such as disclosed in DE 102 11 473 A1). 
     In this context, it is useful if the injection apparatus comprises an injector sleeve for the needle-free injection of a medium, an injector device, a spring activation element for ejecting the medium to be injected, with the injector device, when in the spring-loaded state, set up in such a manner that, with respect to the tension of the spring activation element, only the spring activation element, the activating element, the locking element and the thrust-bearing device are exposed to the spring tension force, while the injector sleeve is not exposed to the spring tension force because the thrust-bearing device is independent of the injector sleeve. Thus, in contrast to the prior-art, it is not necessary for the injector sleeve to be made of relatively expensive metals or fiber-reinforced plastic materials since according to the present invention, the injector sleeve is no longer exposed to the spring tension force. 
     In this context, it has been found extremely useful in practice if the activating element tensioned by the spring activation element is/can be releasably arrested by a locking element and the forces generated by the spring activation element are absorbed by a thrust-bearing device. The elements, i.e., the spring activation element, the activating element, the locking element and the thrust-bearing device, thus form a “closed system” which, with respect to the forces, is pre-tensioned and which is independent of the other parts of the apparatus. 
     Since the locking element requires little space and can have a slender shape when viewed in the direction of the longitudinal axis, it is useful if the locking element is a pin-shaped element acting on the activating element to lock it. In this context, it is useful if the locking element is designed in the form of a lever, thereby making it possible for the releasing forces to be appropriately adjusted by ensuring the desired free movability via the leverage, and/or if the locking element locks the activating element in an undercut section. 
     In this context, it is also useful if a releasing element for the activating element tensioned by means of the spring activation element can be activated substantially in the direction of the injection of the medium to form a favorable application angle relative to the skin surface during the injection through the skin, depending on the medical indication, and, thus, to be easily activated. In this context, it is also useful if the activating element can be released by swiveling or rotating the locking element, in which case it is furthermore useful if the releasing element has a wedge-like shape so that, when the releasing element is activated, it engages the locking element in the direction of the injection. 
     It is furthermore of optimum advantage if the ampoule unit can be mounted onto and/or be removed from the injector device, in particular if the ampoule unit can be friction-mounted on the injector device to bring the injection apparatus into a pre-injection state, thereby moving a potentially sensitive medium to the injector device just shortly prior to application and subsequently injecting the medium without the risk of decomposition processes developing prior thereto. Thus, by assembling the injector device and the associated ampoule units to form the injection apparatus according to the present invention, it is possible to administer different media using the same injector device. 
     In this context, it is useful if the mounting and removing is implemented by means of a screw thread or a ring-shaped click-stop connection, which are embodiments that have been shown to be useful in practice. 
     In addition, it is useful if the ampoule unit is prefilled with the medium to be injected, in particular so as to be nearly or completely free from gas, to ensure that during injection, pressure is not lost due to bubble formation or that potentially present air or other gases, for example, nitrogen, are administered as well, which could lead to dangerous embolisms in the body. 
     To ensure that the injection apparatus is not accidentally released, the injection apparatus preferably comprises a safety element to protect the releasing element, the releasing element having the shape of a ring, and in particular, the injector device and/or the releasing element comprise(s) a groove for receiving the safety element so that the releasing element is protected during transport and/or against accidental release by simply inserting or removing the safety element, i.e., by pulling it off or attaching it. 
     The ampoule unit preferably comprises a longitudinally movable stopper element which seals off a surface along the longitudinal axis and which, during injection, preferably ejects the medium from the ampoule unit. 
     The ampoule unit is preferably friction-mounted to an injector device, in particular the injector device according to the present invention, to bring it into a pre-injection state, with the mounting and removing being implemented by means of the screw thread or a ring-shaped click-stop connection. 
     It is also useful if a nozzle discharged from the medium injected is disposed on the axially longitudinal end of the ampoule unit, the nozzle made in particular of steel—especially of alloy 1.4301 or 1.4435, which is an austenitic nonrusting steel known in short as X5CrNi18 10 (AISI 304), also commonly known under the trade name V2A, with the chemical composition C≦0.07%, Si≦1.0%, Mn≦2.0%, Cr=17 to 20%, Ni=8.5 to 10%, or an austenitic nonrusting steel known in short as X2CrNiMo18-14-3 (316 L), also known under the trade name SUPRA, with the chemical composition C≦0.03%, Si≦1.0%, Mn≦2.0%, Cr≦=17.0 to 18.5%, Mo≦=2.5 to 3.0%, Ni=12.5 to 1500%—and having one or at least two discharge openings to obtain a relevant medium- to high-pressure jet during administration. In case of several discharge nozzles and the resultant larger application surface, the kinetics can be adjusted as a function of the indication. 
     It is also useful if the axially longitudinal end of the ampoule unit as the discharge end for the medium to be injected is covered by a cap so as to ensure sterile conditions until shortly prior to application. 
     It is also useful if an elastic sealing element is disposed between the base body and the nozzle, in particular one made of silicone, so as to prevent partial medium slips between the base body and the steel nozzle during application, which due to a drop in pressure and/or leakage would lead to considerably inferior applicability or complete loss of applicability. 
     It is also useful if in the injection apparatus and the ampoule unit, the nozzle and nozzle screw joint form a snug sealing fit, in particular if the nozzle screw joint, when mounted and viewed in the longitudinal section, is conically tapered on the inside and, again as viewed in the longitudinal section, conforms to outside surface of the conically tapering nozzle since, in this relatively simple, yet effective manner, excellent leakproofness is provided and, thus, the nozzle is seated in the nozzle screw joint ensuring a seal and an excellent fit. In addition, because of the snug fit formed, the nozzle is oriented as desired and thus lies close to the sealing element so as to seal it as desired. In this manner, both orientation and leakproofness are implemented. 
     It is also useful if a plunger rod driving the stopper element is hollow and, in addition, if the stopper element has a material recess corresponding to the hollow space in the stopper element, since this makes it possible to fill the pharmaceutical agent subsequently applied conveniently into the base body in that a syringe-like applicator is inserted in a conventional bottling station through the hollow channel of the plunger rod and, through the material recess in the stopper element, to subsequently transfer a certain quantity of a suitable pharmaceutical agent into the base body and subsequently pinch the hollow plunger rod in one place or in several places, for example, and especially after removing the needle-shaped applicator, and thereby to fill the ampoule to be nearly or completely free from gas. 
     It is also useful if the stopper element after its release, i.e., especially during the injection of a certain pharmaceutical agent through the skin, detaches itself from the plunger rod as the plunger rod is retracted, thereby ensuring that undesirable multiple use is avoided. For example and in particular, such a design can be implemented by making the anterior part of the plunger rod strike against the posterior part of the stopper element, without being protected by undercutting the elements on retraction, so that the plunger rod can freely move toward the back without taking along the stopper element. 
     It is also useful if after activating the releasing element, the releasing element remains in the injector sleeve, in this manner avoiding undesirable multiple activations. This can be implemented for example and in particular in that on release, the locking element detaches itself from, so-to-speak “drops off,” an undercut section of the activating element and lies loosely inside the injector. 
     It is also useful if the plunger rod is pinched in at least one place, preferably in two places, so as to provide a seal. 
     In contrast to cannulas of conventional syringes which have been in contact with tissue, blood, blood components or other infectious material, the injection apparatus and the ampoule unit need not be disposed of as hazardous waste. 
     The features and advantages of the injection apparatus according to the present invention described above relevant to the ampoule unit obviously also pertain to the ampoule unit as such. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
       Using an example, the invention will be described in greater detail based on the figures below: 
         FIG. 1  shows a schematic representation of a cross-sectional view through a first embodiment of an ampoule unit according to the present invention; 
         FIG. 2  shows a schematic representation of a cross-sectional view through a second embodiment of an ampoule unit according to the present invention; 
         FIG. 3  shows an exploded cross-sectional view of an ampoule unit shown in  FIG. 1 ; 
         FIG. 4  shows a schematic cross-sectional view of the pre-tensioned “closed system” in an injector device of the injection apparatus according to the present invention; 
         FIG. 5  shows a schematic exploded cross-sectional view through an injector device of the apparatus according to the present invention with a spring-tensioned injector; 
         FIG. 6  shows a schematic exploded cross-sectional view through an injector device according to the present invention in the nontensioned state; 
         FIGS. 7   a  and  7   b  show the basic triggering principle for injecting a medium in the injection apparatus according to the present invention; 
         FIG. 8  shows a schematic cross-sectional view through another embodiment of an ampoule unit according to the present invention; 
         FIG. 9  shows a schematic exploded view through the ampoule unit shown in  FIG. 8 , and 
         FIG. 10   a  to  c  show a schematic representation of the functional principle of the self-releasing stopper element and the seal of the plunger rod. 
     
    
    
     DETAILED DESCRIPTION 
       FIG. 1  shows a schematic representation of cross-sectional view of an ampoule unit  2  which has a stopper element  16  (with a plunger rod as tentatively indicated) on one of its axially longitudinal ends. On the other axially longitudinal end of the jacketed  5  base body  4  which is filled with a medium  3  and which, in the direction of the longitudinal axis, is completely enveloped by the jacket  5 . A sealing element  15  made of silicone is disposed between the steel nozzle  13  and the base body  4  and jacket  5 . The steel nozzle  13  is mechanically attached so as to seal off the medium in a friction-locked and form-fitting manner by a nozzle screw joint  19 . At the discharge end of the steel nozzle  13 , a cap  14  is screwed on, with a cap seal  20  being disposed (for reasons of sterility) between the inside wall of the cap  14  and the discharge end of the steel nozzle  13 . Prior to the injection, the ampoule unit  2  is attached to, in particular screwed onto, an injector device  1  so that, after cap  14  and cap seal  20  have been removed and the ampoule unit has been positioned on a specific area of the skin, the medium  3  can be applied by moving the stopper element in the direction of the longitudinal axis at least partially from right to left by means of the driven plunger rod. 
     The nozzle  13  is oriented so as to be centered in the longitudinal direction via the snug fit formed with the inside wall of the nozzle screw joint  19  and, thus, lies close to the sealing element  15  to provide a seal so that on application, the medium  3  can be applied without loss and in a targeted manner. 
       FIG. 2  shows a variation of the embodiment of the ampoule unit  2  according to the present invention shown in  FIG. 1 , with the difference that instead of a nozzle screw joint  19 , the jacket is designed so that the steel nozzle  13  lies close to the inside walls of the jacket  5  in a friction-locked and form-fitting manner and, thus, forms a snug fit. Another difference is that the cap  14  does not have an additional cap seal and that the cap cannot be screwed off but is instead pulled off. 
     Based on  FIGS. 1 and 2 , the person skilled in the art can clearly see that in the direction of the longitudinal axis, the base body  4  is completely enveloped by the jacket  5 . 
     In  FIG. 3 , the ampoule unit  2  seen in  FIG. 1  is again shown in an exploded cross-sectional view to once again clearly illustrate the individual components, i.e., the plunger rod  18  that drives the stopper element  16 , the stopper element  16  that can be moved inside the base body  4  in the direction of the longitudinal axis, the base body  4  which holds the medium  3 , the jacket  5  which envelops the base body  4 , the seal  15 , preferably made of silicone, which ensures leakproofness between the steel nozzle  13  and the base body  4  and jacket  5 , the steel nozzle  13  having a tiny discharge opening and thus producing a medium- to high pressure jet when the stopper element  16  is moved, the friction-locked and form-fitting attachment of the steel nozzle  13  and the sealing element  15  to the base body  4  and the jacket  5  by means of the nozzle screw joint  19 , and the cap seal  20  providing an additional seal and finally the associated cap  14 , both of which, for reasons of sterility, are not removed until just prior to application. 
       FIG. 4  shows a schematic cross-sectional view of the elements forming the pre-tensioned closed system in the injector device of the injection apparatus according to the present invention, with the activating element  7  tensioned via the spring activation element  6  releasably locked via locking element  8  by means of a material recess, with the forces generated by the spring activation element  6  absorbed by a thrust-bearing device  9 . These four elements constitute the pre-tensioned “closed system.” 
     In  FIG. 5 , the structural design of the injector device  1  of the injection apparatus according to the present invention is shown in an exploded cross-sectional view. A stem-like releasing element  10  comprises a groove  12  for receiving a semicircular safety element  11  for locking and preventing an accidental release, for example, during transport, with a pin-shaped locking element  8  with a material recess disposed in a cover cap  21  of the injector device  1 . The locking element  8  is secured on the thrust bearing so that when the releasing element  10  and, thus, its inside wedge  22  are moved in the longitudinal direction, the wedge engages the locking element  8 , and by way of the leverage and the swivelability and rotatability, the right end of the locking element  8  facing the thrust-bearing device  9  unlocks and releases the left end of the activating element  7  so that the activating element, due to the pre-tensioned spring activation element  6  is moved in the longitudinal direction to the right and thus a plunger rod of a mounted ampoule unit  2  according to the present invention is also moved to the right, thereby ejecting the medium from the base body  4  of the ampoule unit  2 . 
     The activating element  7  is moved inside an injector sleeve  17  of the injector device  1 . 
       FIG. 6  shows the embodiment of an injector device of the injection apparatus according to the present invention seen in  FIG. 5 , but in a nontensioned state. 
     To further clarify the invention,  FIGS. 7   a  and  7   b  once more explain the functional relationship already discussed in  FIGS. 5 and 6 , with the injection apparatus shown in  FIG. 7   a  nontensioned and that shown in  FIG. 7   b  tensioned. 
       FIG. 8  shows a cross-sectional view of yet another embodiment of the ampoule unit according to the present invention in which a base body  4  made of borosilicate glass is completely jacketed in the direction of the longitudinal axis by a jacket  5  extending along the entire direction of the longitudinal axis, with the anterior end of the base body  4  lying close to a disk-shaped sealing element  15 , thereby providing a seal, which disk-shaped sealing element in turn lies close to a nozzle  13  also providing a seal. The nozzle  13  as such engages and thus seals the conically tapering part of the inside wall of the nozzle, thereby preventing leakage of the medium  3  of the solution injected and contained in the base body  4  by way of the abutment created by the resultant snug fit as a result of the sealing effect of the sealing element  15 . The nozzle  13  made of a metal is detachably closed by means of a cap  14  which engages in/attaches to undercut sections disposed on the anterior portion of the jacket. On the posterior axially longitudinal end of the base body  4 , a stopper element  16  made of silicone is disposed in the direction of the longitudinal axis so that, due to the reversible deformability of the silicone materials, a seal is also formed in this direction along the inside glass walls of the base body  4  during the axially longitudinal movement to empty the base body  4 . The stopper element  16  is driven by a hollow plunger rod  18  which comes to a stop, with the hollow space in the plunger rod  18  corresponding to a material recess of the stopper element  16  (see also  FIG. 10 ) so that filling with the medium  3  is possible by means of an automatic needle-shaped applicator inserted through the hollow plunger rod and stopper element. After emptying the base body and retracting the plunger rod  18 , the stopper element  16  detaches itself from the plunger rod  18  since the plunger rod strikes the stopper element  16  only in the emptying direction and is subsequently released. The injector sleeve  17  envelops the jacket  5  at least in part. 
       FIG. 9  is a schematic representation of the functional principle of the sealing system provided by the interaction of the base body  4 , the sealing element  15 , the nozzle  13  and the cap  14  in combination with the jacket  5 . The sealing system is implemented by the fact that the nozzle  13  clampingly engages in and forms a snug sealing fit on the conically tapering inside portion of the jacket  5  and that the nozzle  13  furthermore interacts with the sealing element  15  and the base body  4 . 
       FIGS. 10   a  and  10   b  illustrate the principle by which the plunger rod  18  and the stopper element  16  interact with each other and clearly show that during injection, an anterior part of the plunger rod  18  pushes against a posterior part of the stopper element  16  and is released in the reverse direction. 
       FIG. 10   c  shows a hollow plunger rod  18  which has been pinched in two places and which, after filling the base body with a medium, has been sealed by pinching it so that the medium can be stored under sterile conditions. 
     Finally, the following should be added: The nozzle  13 , the elastic sealing element  15  and the base body  4  are assembled by means of the jacket  5 , and the cap  14  is subsequently screwed onto the jacket  5 . The stopper element  16  and the plunger rod  18  are assembled and subsequently inserted into the base body  4  of the ampoule unit  2 . Because of the special construction of the stopper element  16  and the plunger rod  18 , all components can be assembled under normal conditions; i.e., no clean room is required. Subsequently, the complete ampoule units can be placed into so-called trays holding 20×20 units, with each tray being wrapped in separate polyethylene bags. A plurality of trays is stacked on a pallet and wrapped again. The entire pallet is subsequently sterilized by means of gamma radiation. In the sterile room, the trays are subsequently removed from the polyethylene bag and transferred to a bottling station, which bottling station fills the ampoule units through the hollow plunger rod and through the stopper elements having the corresponding material recess, in particular and for example openings. Next, the piston road is first pinched in a place A 1  farther away from the actual base body  4  and subsequently in a place A 2  closer to the base body. Using this method ensures that the content of the ampoule unit is nearly or completely free from gas. 
     The special feature of the present invention is the fact that pharmaceutical agents can now be stored for a long time (&gt;30 days) in a needle-less injection application system.