CS273339B2 - Needle-less hand-operated universal inoculating instrument with adjustable shooting-in depth - Google Patents

Description

(57) The device has a braking effect on the suction of the vaccine and the possibility of mixing, is driven by a manually tensioned spring and is suitable for preventive inoculation or for insulin dosing in the treatment of diabetes. The device is suitable for use in human and veterinary medicine of small animals.

The body (32) of the instrument has a vaccination roll (18), a vaccination piston (19), a tensioning handle (39) and a handle (31). A firing depth regulator (44) is connected to the tensioning handle (39). At the end of the inoculation roller (18), a vaccine accelerator is connected to the inoculation head. The inoculation device is actuated by rotating the tensioning handle (39) and at the same time the vaccine is aspirated from the vial. The calibrator (17) allows adjustment of the vaccine mixture by biasing the spring (40) by rotating the regulator (44) and regulating the firing depth. When not fired, the inoculant flows through the inlet accelerator (14) and the end accelerator (8) in the inoculation head at high velocity. In continuous operation showed that the sterilization device is required _in every two weeks. The parts for sterilization are released by means of a bayonet snap fastener (21j.

273 339 (11) (13) B2 (51) Int. Cl. ⁵

A 61 M 5/30

CS 273 339 B2

The present invention relates to a needleless hand-held universal vaccine with vaccine suctioning and mixing capability, which is powered by a saucer-formed energy storage unit and is suitable for preventative protective vaccination or insulin dosing in both human medicine and veterinary treatment of small animals.

With the inoculation device according to the invention, after a single setting of the firing depth - irrespective of the amount of the inoculum - it is possible to repeat with great precision, and the change of spring preload when changing the amount of inoculum, which is a prerequisite for known inoculation devices

Vaccination devices are known whose operation is made possible by the use of compressed air, a gas cylinder or a hydraulic device.

The common drawback of these devices is their complexity, large size, heavy weight and high production costs, making their expansion difficult.

A vaccination apparatus is known which comprises a seed cylinder, a seed piston and carries an ampoule. Its operation is provided by a bomb. Due to the unequal filling of the cartridge, however, a constant pressure value is not ensured. The device does not have a snap trigger, which may cause an inappropriate release when the trigger is slowly pulled, i.e., the slow exit rate of the vaccine and the vaccination may be ineffective. The injection depth cannot be controlled with this unit.

Another known inoculation device works on a similar principle, with the difference that the high-pressure gas driving the inoculation device does not control the inoculation of the vaccine but the stretching of the spring.

The spring tension corresponds to the gas pressure at a high speed, so that the vaccine cannot be mixed with other antibiotics or analgesics. Shot depth. it is also not possible to regulate with this unit.

The coil spring used in this solution exerts a great force when firing so that the inoculation device cannot be used universally.

Furthermore, a vaccination apparatus is known in which the spring preload is performed by gas and the vaccine is not aspirated but fills without ensuring continuous operation.

Subsequent vaccination may be associated with the risk of infection and inaccurate dosing, so that the effectiveness of protective vaccination is not ensured. Also with this solution, the depth of shot cannot be controlled. ‘

A vaccination apparatus is also known in which the spring for inoculation with compressed air is biased.

The cumbersome nature of this technical solution is primarily due to the complicated supply of compressed air. This solution virtually prevents individual vaccination, so insulin treatment of patients with diabetes is not addressed, because few homes are equipped with a compressor to produce compressed air.

The depth of fire cannot be adjusted even with this unit, so the unit cannot be used universally.

In addition, a vaccination apparatus is known in which the stored vaccine is passed through the nozzle into the human body by manually adjusting the branch valve. The device does not have a safety valve, so it may be the case that if the position of the valve is overlooked, the vaccine does not get into the human body by the ejection head, but flows out in the direction of the vial.

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The shooting depth cannot also be adjusted with this unit.

Also described is a vaccine powered by a siphon cartridge, which was primarily developed for inoculation with insulin and could undoubtedly fill the medical gap. After practical experience, however, siphon homhičky did not guarantee a constant pressure value in all cases, often even at the first shot due to its unequal filling and faulty seal.

The impossibility of controlling the depth of fire, the difficult change of the vaccine dose, where replacement of the standard rings regulating the change in the amount of vaccine is only possible after dismantling the vaccine head, and unstable pressure caused not only skin damage but also vaccine leakage, so vaccination was ineffective.

Also described is a vaccination device having a cylindrical body consisting of a medicament space and a pressure space. The solution consists in elements leading the medicament into the medicament space, in the medicament injection opening, in the plunger moving in the medicament space and further in the control elements.

The main drawback of this solution is that it is suitable only for injecting insulin, so it is not universal, the depth of injecting cannot be regulated, so that the pressure change at different skin parameters is not possible. Another drawback is that it is not possible to mix multiple vaccines in a single vaccination.

Also known is a vaccination device that is suitable only for subcutaneous injections. It consists of a nozzle, a liquid medicament suction and ejection unit, a suction and ejection control unit, a medicament dose regulating element and an ampoule-carrying part.

The basic drawback of this solution is that although the amount of sucked vaccine into the inoculation space is adjustable, the possibility of changing the setting during successive suction of multiple vaccines, i.e. the possibility of mixing, is not guaranteed, since the vaccine is mixed in the inoculation space.

Another drawback of the spring energy storage solution is that the inoculation device fits only subcutaneously, so it is not universal, the spring energy storage used is not. suitable to exert more force for stronger firing.

The known inoculation device also comprises elements such as coil springs, the spring characteristics of which cannot be guaranteed so that the spring force changes only minimally during the stroke length between the extended and lowered conditions.

According to this solution, the problem was to be solved by increasing the tensioning force to prevent the drug from dispersing; however, according to practical experience, this causes significant tissue damage, an almost intractable sugilaoi. *

In this solution, the considerable tensioning force required is also symbolized by the drive lever, which in the inoculation device is designed to be unscrewable, i.e. like a crank.

This inoculation device has the further disadvantage that the coil spring is to be replaced relatively frequently when the operating force is fatigue.

Another inoculation device is characterized by comprising a nozzle with a spray nozzle, a fluid reservoir, a channel system connecting the reservoir and the nozzle, a system of nozzle-closing elements, a pressure-generating lever and is articulated to the device. With this solution, the pressure value and the amount of liquid can be controlled.

In the development of this device, it has been sought to allow a large number of vaccinations in series in relation to the time period. This was achieved first of all by the large dimensions of the inoculation mechanism and the table-mounted lever generating the necessary tensioning force.

The known inoculation device has the drawback that it does not guarantee the calibrated mixing of the vaccine when sucked into the inoculation chamber, because the suction is performed in one cycle only and is not braked and the inoculation chamber corresponds to the set amount.

Another drawback of this known solution is that the vaccine cannot be operated by one person, since at least two hands of the other person are required to operate.

CS 273 339 B2

However, in the case of mounting or attaching a vaccination device to a table, so-called sechocation is not possible, which is a requirement for insulin injections.

Although the control of a hand held vaccination device is described, this is doubtful due to the heavy weight, as it may cause skin injury if moved during the injection.

Finally, a pressurized vaccination apparatus is known which comprises a working piston cooperating with a suction piston moving in a cylindrical housing, a manually operated arm articulated to the body of the apparatus and a locking structure that provides movement of the working piston according to the pressure value.

A major drawback of this design is the suction of more vaccines into the inoculation space, calibration and mixing is not ensured, since the suction is carried out in only one measure according to the set amount.

Another drawback is that external power is required to operate the vaccine, without which the vaccine is not operable. For this feature, the inoculation device is tied in place.

The cost of propulsion energy significantly increases the cost of the device, making individual use doubtful. The use of such a solution is primarily justified in hospitals and clinics.

Thus, in the aforementioned known vaccination devices, the energy required to fire the vaccine is produced in a wide variety.

The operating conditions are in all cases ensured by the inclusion of an auxiliary device as an intermediate element for the spiral spring which performs the work, the auxiliary device being an oil compressor, compressed air or a gas hob. Increasingly, weight and volume solutions are used, as well as spring tensioning using levers, which makes the control of the firing depth doubtful.

Thus, in the aforementioned known vaccination devices, the energy required to fire the vaccine is produced in a wide variety.

The lack of confidence in these vaccination devices is further increased by the impossibility of controlling the firing depth, mixing the vaccines, adjusting the amount of the vaccine during the vaccination and improperly controlling the same firing force.

These technical shortcomings of the aforementioned known vaccines have ultimately become an obstacle to the wider use of such vaccines.

Against this background, it is an object of the present invention to overcome the drawbacks of known vaccination devices, to continue the development of a siphon-operated vaccination device according to HU-PS 186.718, and to find a solution suitable for universal individual and serial vaccination of humans and small animals. Insulin without the use of various auxiliaries such as an oil compressor, a winding lever, a siphon sponge, compressed air, where the device can be brought into working condition manually, while ensuring suction braking and preparation for suction. This solution should be suitable for the appropriate control of the injection depth for individual and serial vaccination and meets the requirements, for example for interdermal, subcutaneous and intramuscular applications. Furthermore, this solution should be suitable for a one-time adjustment of the amount of vaccine or adjustment of the amount of vaccine during operation, or for mixing the vaccine without disassembling the device. springs, and should be applicable both to individual treatment of patients with diabetes and to a wide range of health care systems to vaccinate humans and small animals while saving medical material such as injection

CS 273 339 B2 needles, and staff and hospitals or clinics, while increasing the degree of vaccination efficacy.

The invention is based on the discovery that the vaccine can be introduced under the skin under a single motion by a suitable application of the spring system by controlling the amount of injection and the depth of firing, and by concentrating the suction and preload into a single movement. Thus, the above objectives can be effectively realized.

The universal nature of the invention enables the use of preventive protective vaccines to combat epidemic diseases such as typhoid, paratyphoid, tetanus, toxins combined, diphtheria, child paralysis, cholera, yellow fever, influenza, rabies and the like antidotes, to inject analgesics as a shock prevention in burns and other injuries, as well as to insulin in patients with diabetes.

Surprisingly, in the case of diabetes vaccination, insulin levels after 3 to 4 weeks of needle-free injections could be surprisingly reduced, mainly as a result of the excellent dispersal of the injected substance, the laser machining of the inoculation head and subsequent effective absorption.

The vaccination apparatus according to the invention consists of a vaccination roller attached to the apparatus body, a tensioning handle and a handle, an ampoule holder and a vaccination head accelerating the vaccine are attached to the vaccination roller, a vaccination piston is arranged in the vaccination roller. door spring and tensioning spindle. The handle includes a trigger, a spring supporting the trigger and a trigger button.

The tensioning handle is connected by means of the tensioning spindle thread to the energy-compensating arresting limiter, so that it is connected both to the energy-storing disk spring and to the nut and flange fastened at the end of the inoculating piston. The return spring is arranged between the seed roller and the flange nut, and the energy storing disc springs are arranged between the energy storer by the arresting limiter and the device body by means of a non-firing depth regulator connected to the thread. In the upper groove of the energy-storing detent there is a screw preventing its rotation and at the lower part of the energy-storing detent there is formed a recess for the detent-limiter ball located in the hole of the trigger pin holder arranged in the handle and fastened to the body of the device by a screw. with an intermediate position locking pin and a lower restrictor arresting ball, with a groove for the lower restrictor arresting ball groove formed on the release pin.

The inoculation device according to the invention is further characterized in that the compound setting lock is firmly aligned in the spring housing, which can rest on a trigger adjustment block passing through the compound setting calibrator mounted in the instrument body and the compound setting locking screw.

A further characteristic of the features of the inoculation device according to the invention is that the inoculation roller is connected to the body of the device by means of a bayonet rye cap, thereby enabling the distribution required for disinfection.

The vaccination device according to the invention is further characterized in that for the final acceleration of the vaccine, the initial diameter of the inoculation head is 3 to 7 mm, preferably 6 mm, and its narrow diameter is 0.1 to 2 mm, preferably 0.12 mm.

The vaccination device according to the invention can be characterized in that a tensioning handle is provided on the body of the device, the diameter of which is larger than the tensioning spindle. This solution makes it possible to advantageously vary the amount of tensioning torque without using an auxiliary force.

CS 273 339 B2

The tensioning handle operates in conjunction with a return spring which is adapted to the inoculation piston arranged in the inoculation cylinder in the apparatus body, so that the inoculation of the inoculum is possible.

Optionally, the tensioning handle is also operatively connected to an energy storage spring that is on the extended spindle of the inoculation piston.

In the body of the instrument is also placed a calibration structure that adjusts the mixing and its locking screw is located on the locking pin of the mixture adjustment.

Because the spring cover and the energy storage arrestor are constructed as separate bodies that are independent during operation, the aspirated vaccine is injected into the human body irrespective of the amount with the same nailing force.

The invention will now be explained in more detail with reference to the accompanying drawings, in which: FIG. 1 is a longitudinal section through the inoculation device according to the invention, but before reversing the tensioning spindle required for firing; and FIG. on a vaccination device according to the invention.

It can be seen from FIG. 1 that on the device body 32 there is a seed roller 48 at the front, a tension handle 39 at the back and a handle 31 attached from below.

A vial holder 3, a vial sleeve 6, and a vial tip 2 are provided on the seed roller 18.

At the same time, the inlet valve spring 6, the spring 5, the inlet valve, the inlet valve gasket 6 and the inlet valve ball 6 are arranged on the seed roller 18.

At the end of the inoculation roller 18, a vaccine accelerator 14 is provided, and there is a non-return valve spring holder 11, a front seal 9, an inoculation head and a back seal 10 of the inoculation head.

An inoculation head 8 is connected to the inoculation roller 18 by means of a thread, which ultimately accelerates the inoculant, and at the same time fastens the inoculant accelerator 14.

An inoculation piston 19 is provided on the inoculation roller 18, on which the teflon seal 20 of the inoculation piston is located in one or more transverse grooves for a better seal.

A corresponding flange nut 35 is screwed onto the inoculation piston 39, against which the return spring 33 is supported.

At the same time, the corresponding stop limiter 22 is screwed onto the seed roller 18.

The inoculation roller 18 is connected to the body 32 of the device by means of a bayonet quick release 21.

A spring beach 34 is loosely disposed within the body 32 of the apparatus, which is coupled to a flange nut 35.

In the body 32, there is a freely disposed arresting energy storage restrictor 36 coupled to the spring housing 34.

The locking of the accumulated energy restraint 36 against rotation is possible by means of a bolt 47 freely engaging in a groove formed therein, connected to the device body 32 by a thread.

The accumulator energy accumulator restrictor 36 is threadedly connected to the tension spindle, thereby ensuring that the energy storage disk springs 40 located in the space enclosed by the accumulator energy restrictor 36 and the non-shot depth controller 44 can be biased.

CS 273 339 B2

The non-firing depth regulator 44 is threadedly connected to the instrument body 32, and this screwing allows the spring preload to be changed and thus the firing depth controllable.

In the regulator 44, the foot bearing 41 is secured by means of a fastening spring washer in place, the foot bearing allowing better tensioning.

The tension spindle 42 threaded to the accumulated energy arresting limiter 36 rests on the foot bearing 41 only during stretching.

In the pre-fired state, the arresting energy storage restrictor 36 is in a rearwardly rotated position corresponding to its movement stroke and does not need to rest against the foot bearing 41 when firing, since the spring housing is sized so that it previously rests on the nut on the device body 32.

A tensioning arm 39 is fastened to the tension spindle 42 by means of a fastening pin 43.

When the stretching spindle 42 is rotated back before firing, its unscrewing is prevented by the fastening ring 46 located at the end of the thread of the tension spindle 42.

The upper restrictor arresting ball 37 pushed by the upwardly extending structure spring system engages when recessing into a recess 48 formed at the bottom of the accumulated energy restrictor 36, while the restrictor restraining ball 37 secures the fixed position of the accumulated restrictor 36 prior to retraction

The upper arresting ball 37 of the restrictor is co-operatively connected to the restraining pin 38 of the intermediate position freely fitting into the hole 49 formed in the pin holder 29, optionally with the lower arresting ball 37.

The pin holder 29 is attached to the device body 32 by a screw 45 «.

The trigger pin 28 fits freely into the pin holder 29, on which a circumferential groove 50 is formed. The trigger button 25 is threadedly connected to the trigger pin 28.

The trigger pin 28 moves backward as it extends in a hole formed coaxially in the apparatus body 32 and in the trigger pin holder 29 to allow the restrictor arresting ball 37 and the restraining locating restraint pin 38 to move downward, thereby releasing the fixed position of the restrained energy restrictor 36.

The trigger button 25 operates by means of a plurality 24 correspondingly movably coupled to the body 32, the fixed position of which is secured by the support spring 23 to the plurality before being withdrawn.

The trigger button 25 is supported by a mounting spring 27 disposed in the mounting spring holder 26.

The holder 31, which forms the unit 3 of the apparatus body 32, is designed to expediently comprise a stretchable structure and is provided with an appropriate bakelite wrapper from an ergonomic point of view.

In Fig. 2, a vaccine adjusting unit is shown in which the compound setting lock pin 15 is fixedly mounted in the spring housing 34 which, upon suction, restricts suction of the desired substance by moving the housing 34 backward and resting against the trigger adjustment block 30.

The trigger adjusting block 30 is maintained in the desired position by the mixture adjusting calibrator 17 attached to the instrument body 32 and the mixer adjusting locking screw 16.

The function of the universal inoculation device in aspirating the vaccine is as follows.

Vaccine with turning the tensioning handle 39 by hand clockwise7

CS 273 339 B2 puts the vaccine in the state in which it draws the vaccine from the ampoule and at the same time it is in the stretched state, ready to be fired.

When the tensioning handle 39 is rotated clockwise, the accumulator energy restraint 36 moves backward, and as a result, the nut 35 3 will move the flange, which is moved by the return spring 33 in the backward direction of the suction march 19 through the inlet roller 19 backward.

Due to the vacuum thus created, a predetermined amount of inoculum is sucked from the vial by the suction valve seal 6 into the inoculation roller 18 as the suction valve ball 4 returns against the spring.

If the accumulator energy restrictor 36 moves during a backward movement such that the restrictor arresting ball 37 snaps into the groove provided for this, the suction of the vaccine is terminated.

If a vaccine mixture is used, this is not affected by the accumulated energy detent 36 because it is so dimensioned that it only reaches the arrested position at the end of the suction cycle.

The blend adjustment calibrator 17, which can be arbitrarily arranged on the right or left side of the apparatus body 32, serves at low vaccine consumption or for adjusting the vaccine according to the desired aspiration amount.

The blend adjustment calibrator 17 resolves the inoculant miscibility by moving the blend adjustment lock 3 3 of the spring cover 34 back in the lead bar until it hits the pre-set calibration, using the blend adjustment lock 16 to trigger the trigger adjustment block 30.

If a new vaccine needs to be added to the same vaccine, the solution according to the invention ensures that if the operator stops rotating the tensioning handle 39 to the right, replaces the ampoule in the ampoule holder 3 while releasing the mix adjusting screw 16, then adjusting the trigger adjustment block 30 to the new position and continues to aspirate the vaccine to be mixed now from the new vial.

This solution according to the invention ensures that, before mixing, the spring cover 34 or the moving set-up locking pin 15, possibly moving with it, remains in the unchanged position, even if we set the trigger adjustment block 30 to another calibration position.

It follows from the foregoing that, regardless of the amount of vaccine to which the trigger adjustment block 30 has been set, or whether more vaccines have been mixed during aspiration, the accumulator energy arresting limiter 36 must be pulled backwards to each aspiration by rotating the tension handle 39 the arresting ball line 37 of the limiter.

It is needed because the firing of the firing is made possible by bringing the accumulated energy detent 36 into the detent position.

The pre-firing function is as follows:

In order to deliver the vaccine under the skin surface at the appropriate speed and pressure, an initial speed appropriate to the vaccination function shall be ensured.

The universal inoculation device according to the invention can achieve this by means of an energy storage unit with a disc spring. In order to return the inoculator to the ready-to-shoot state, the inoculator should be pulled in by turning the tensioning handle 39 clockwise as far as it will go.

This operation was already performed during suction, so the two functions are effectively combined. A particularly important role in this operation is played by the inlet head gasket 8 and the inlet head gasket 10, which essentially prevent the so-called false air leakage into the inoculation roller 18, which would adversely affect the operation and vaccination result.

Since the inoculation device of the invention can be used for different inoculation functions and further for different skin thicknesses, it may be necessary for the inoculation device to provide less nailing force than in the maximum stretched state.

This can be accomplished so that the preload of the energy storage spring 40 can be controlled by rotating the firing depth regulator 44 to the right or left.

To check the amount of biasing, a calibration scale is provided on the firing depth regulator 44, which shows in both directions how the biasing has been applied.

The preload can be adjusted in any condition of the inoculator, i.e. also in the stretched or post-shot condition. The movement of the tensioning handle 39 and the tensioning spindle 42 connected thereto in the direction of the inoculation head must be provided in order to be able to be fired. This can be achieved by turning the tensioning handle 39 counterclockwise to the length of the working stroke after the restrictor arresting ball 37 engages in the groove of the restraint of the stored energy 36, this length being indicated on the firing depth regulator 44.

The puncture of the universal vaccine when the vaccine is injected is as follows.

The inoculated device is pulled up and filled with the inoculum by pulling the movable trigger 24. In this case, the trigger pin 28 with the movable trigger 24 moves together until the groove on the trigger pin 28 is in the same line as the center line of the arresting pin 38 of the intermediate position.

In this case, the lower arresting ball 37 of the restrictor sinks down to half the diameter into the raceway formed in the trigger pin 28. As a result, the upper arresting ball 37 of the restrictor also moves downwardly by half the diameter.

By this movement ae disables the arresting of the accumulator energy restrictor 36, so that the energy storage springs 40 drive the accumulator energy restrictor 36 at high speed in the direction of the seed head, while the accumulator energy restrictor 36 pushes the spring housing 34, the flange nut 35 and inoculation piston £ 9.

The inoculating piston 19 impinges on the conical seat of the inoculating roller 18 and the inoculum flows through the inoculant inlet 14 and the inoculum head 8 at a high speed.

After practical experience, it has been found necessary to sterilize the inoculation apparatus in continuous operation every other week by removing the inoculating roller 18 by means of a bayonet quick-lock 21 by turning it counterclockwise and then sterilizing.

After sterilization, the inoculating roller 18 is rotated clockwise as far as it will go by means of the bayonet quick release 21.

Claims (3)

SUBJECT OF THE INVENTION 1. Needle-free, manually operated vaccination device with variable shooting depth for vaccination of humans and small animals, comprising a vaccination cylinder attached to the body of the device, a tensioning handle and a holder, a vial holder attached to the vaccination cylinder, a vaccine head a cylindrical inoculation piston, a disk spring for energy storage, a return spring and a tensioning spindle, a holder comprising a trigger, a support spring, and a trigger knob arranged on the apparatus body, characterized in that the tensioning handle (39) is connected to the tensioning spindle (42) to an accumulating energy arresting restrictor (36) which is connected both to a disk spring (40) for storing energy and secondly by means of a spring housing (34) with a flange nut (35) mounted on the inlet of the inoculating piston (19); 33) is arranged between a seed roller (48) and a flange nut (35), and an energy storage disk spring (40) is disposed between the accumulated energy arresting limiter (36) and the depth-of-turn regulator (44) connected to the instrument body (32) a groove (48) for the restrictor arresting ball (37) is formed in the lower part of the restraining power restraint (36), which is arranged together with the intermediate position restraining pin (38) and a lower limiter arresting ball (37) in the trigger pin holder holder (29) hole (49) disposed in the holder (31) and secured by a screw (45) to the apparatus body (32), a groove (50) formed by the trigger pin (28). Inoculation device according to claim 1, characterized in that the compound housing locking pin (15) which is arranged in front of the trigger adjustment block (30) fixed by means of the compound adjusting calibrator (17) connected to the body is firmly engaged in the spring housing (34). (32) apparatus and locking screw (16) compound setting. The inoculation device according to claim 1 or 2, characterized in that the inoculation cylinder is connected to the body (32) of the apparatus by means of a bayonet quick-release device.