WO2016151378A1

WO2016151378A1 - An innovative syringe to be employed in ozone therapy treatments

Info

Publication number: WO2016151378A1
Application number: PCT/IB2015/059081
Authority: WO
Inventors: Alessandro CARPITELLI
Original assignee: Papa Flow Technologies S.R.L.
Priority date: 2015-03-26
Filing date: 2015-11-24
Publication date: 2016-09-29
Also published as: WO2016151379A2; WO2016151379A3

Abstract

The present Invention concerns a syringe (1) for an ozone therapy treatment and comprising: - A chamber for the containment of a medical fluid; A piston (3) slidingly mobile along the chamber; An outlet hole (4) through which the medical fluid contained in the chamber is expelled outside following a motion of advancement of the piston (3). In accordance with the invention, the outlet hole (4) is provided with a first check valve (8, 9, 10). In addition, also a further hole (2) of access to the chamber is foreseen, said hole (2) being provided with a second check' valve (5, 6, 7).

Description

TITLE

AN INNOVATIVE SYRINGE TO BE EMPLOYED IN OZONE THERAPY

TREATMENTS

Technical field

The present invention concerns the technical field relative to syringes.

In particular, the invention refers to an innovative syringe that is particularly indicated in ozone therapy treatments, which is configured in such a way as to reduce leaks to the minimum.

Background art

Ozone therapy has been well known for some time and is used in the medical field to cure different pathologies, such as herniated disk. It takes advantage of the use of a gas, ozone, mixed with medical oxygen. The injection of ozone in specific points helps to reduce painful problems and has an overall beneficial effect.

As doctors and sanitary staff well know, ozone therapy can be used through different modalities. The mixture of ozone and oxygen can be administered via intraarterial, intravenous, intra-articular routes, or with simple subcutaneous injections. To this aim, 'traditional syringes are used which are loaded in specific and well- known loading stations. In particular, the syringe is connected to the loading machine, inserting the nozzle of the syringe where the needle is applied in a loading hole of the machine and, through the piston, the gas is aspired inside of the chamber of the syringe.

Such ozone therapy treatments are quite efficient although current syringes, through which such a gas is injected, are not perfectly sealed when loaded with a gas with a certain pressure and there is therefore a quick fall in the gas content with a consequent injection of a quantity of gas that is definitely inferior to the one foreseen by the protocol. The gas in pressure in fact needle ^*"«xSo"^J'wne'n^'-,' "roixowing^" the '^"xoaain'g¹, ^' 'me

th© cap thereof are immediately applied. Time intervals of around one minute are enough, between the loading of the syringe and the injection in the patient, so that there is a significant reduction of content in the syringe, the whole natu ra l 1 v to f h e=> rlpf ri mpnf nf thn <=> f f i nsnv n f rhe

Disclosure of Invention

It is therefore the aim of the present invention to realize a syringe that solves said technical inconveniences.

In particular, it is the aim of the present invention to provide a syringe that is capable of reducing gas leaks to the minimum, in particular of ozone, contained inside it.

These and other aims are thus reached with the present syringe for an ozone-therapy treatment, in accordance with claim 1.

Such a syringe comprises:

- Ά chamber (C) for the containment of the medical fluid;

- A sliding piston (3);

- An outlet hole (4), whore, in use, the needle is applied, through which the medical fluid contained in the chamber (C) is expelled outside following a motion of advancement of the piston (3) ;

In accordance with the invention, the outlet hole (4) is now provided with a first check valve (8, 9, 10) .

Through the first check valve placed in the outlet hole (4) where the needle is applied, the gas, once loaded in the syringe, is impeded from exiting from such a hole until a pre-established threshold pressure value is exceed and calibrated in such a way as to be obtainable only through the movement of the piston by the operator.

Such a valve is in fact in a "normally closed" condition and is calibrated in such a way that, until such a pressure value is not exceeded that from the inside of the chamber C of the syringe goes towards the outside of the syringe, it remains in close condition.

In that sense, once the syringe. is loaded with ozone, the gas contained in the chamber cannot exit anymore accidentally if not through the action of thrust of the piston that the sanitation operator actively operates.

By virtue of the fact that in correspondence of the outlet hole where the needle is applied such a normally closed valve has now been placed (valve that passes in open position only with pressures superior to pre- established threshold values and directed from the interior of the chamber C towards the outside), it is then evident that the loading cannot be done anymore through such a hole , as happened in the background art, since the valve would impede the entry of the gas from the loading machinery towards the chamber C of the syringe.

To that aim, a loading hole (2) has been foreseen, communicating as well with said chamber (C) , said loading hole (2) being provided with a second check valve (5, 6, 7) .

Also such a second check valve is normally closed and passes in open position only when a threshold pressure value is exceeded, this time, however, acting in the opposite direction with regards to the case of the first valve, that is from the outside of the syringe towards the inside of the chamber.

In such a manner, through the hole (2) of access to the chamber, the loading of the syringe with the ozone can be done since the application of the hole 2 with the loading machine creates that pressure necessary to the movement of the valve from the close position to the open position. When the gas has been loaded, the syringe can be disconnected from the machine and the valve returns in normally close position, impeding the gas from exiting.

Further advantages can be deduced from the dependent claims.

It is also here described a machinery for loading a syringe (1) as described, the machinery foreseeing one or more loading positions (17, 17B, 16 16F) , said loading position foreseeing a hole (16-16F) suitable for holding the conduit (2) of the syringe and provided with a stem (22) arranged in such a way as to intercept the shutter (5) so as to exert a thrust force to move said shutter (5) from the close position to the open position.

Brief description of drawings

Further features and advantages of the present syringe, as per lihe invention, will result to be clearer with the description that follows of some embodiments, made to illustrate but not to limit, with reference to the annexed drawings, wherein:

- Figur 1 shows a syringe in an axonometric view as per the invention in which the loading conduit 2 is highlighted where the check valve is placed through which the loading of the syringe is done;

- Figure 2 further shows the ■ apex of the syringe to highlight always the conduit 2 with the check valve through which the loading is done; the figure shows, further, the conduit 4 where the needle is applied and provided with the check valve 4 through which the gas is made to exit from the syringe when its piston is activated in the traditional way; Figure 3 shows a constructive detail relative to the check valve 2;

- Figures 4 and 5 show in detail the solution relative to the check valve 4 through which the exit of the gas from the syringe is controlled when the piston is activated;

- Figure 6 is an exploded section relative to the check valve 2 show in figure 3;

- Figure 7 shows the shutter 5 seen from the top and from the bottom in such a way as to highlight the longitudinal hole HE and the transversal holes (11, UB, 11C, 11D ) through which the gas is loaded in the syringe;

- Figure 8 shows an exploded section relative to the check valve 4 through which the exit of the gas from the syringe is controlled;

— Figure 9 is a relative view from the bottom and from the top of the shutter 8;

Figure 10 shows in succession the movement of the shutter 8 from a close position (phase, a) to an open position (phase b) ;

- Figure 11 shows in succession the movement of the shutter 5 from a close position (phase a) to an open position (phase b) ;

- Figure 12 schematizes a machine for loading syringes ith ozone;

- Figure 13 is a detail of coupling of the syringe with a loading hole 16G of the machine;

- Figures 14 and 15 represent further details relative to the loading hole;

- Figure 16 shows a coupling for the loading with gas of the syringe with the hole (16-16F), highlighting the action of thrust of the stem.

Description of s ome preferred embodiments

With reference to figure 1 a syringe 1 is represented according to the invention. The syringe comprises a piston 3 per se well known in the state of the art. The piston foresees a stem that terminates with a thrust flat surface, generally in the form of a disk, on which the user can place the thumb to exert the necessary pressure for the advancement of the piston 3.

The piston can in fact be inserted and slide inside a chamber formed by the cylindrical package of the syringe itself, Tho chamber terminates with an open conduit 4 on which the needle is applied. By thrusting the piston towards the conduit 4 the volume of the containment chamber is reduced and therefore a pressure is exerted that thrusts the medical liquid to make it exit through the conduit 4, and therefore through the needle, outside. A contrary movement of the piston 3 increases the volume of the containment chamber and creates an aspiration through which generally, in a traditional use, the medical liquid contained in specific small bottles is aspired.

In accordance with the invention, check valves^' are foreseen, adequately arranged, which allow to load the ozone gas in the syringe, impeding or reducing at the same time the accidental exit of the gas through the conduit 4 and, obviously, through the conduit where the gas itself is loadod in the syringe.

Going further into the descriptive detail of the invention, in correspondence of the conduit 4 where the needle is applied, a first check valve (8, 9, 10) is foreseen.

Such a first check valve, as described in figure 5 and in the exploded of figure 8, comprises a shutter 8. The shutter, as shown in figure 9, foresees a longitudinal conduit (12^'E) that joins radial conduits (12, 12B, 12c, 12D) . The longitudinal conduit is blind on one side, therefore, as it is evident from the exploded of figure 8, the passage of the gas has to take place obligatorily through the path formed by the radial conduits.

The shutter has such a size and shape as to obstruct the access to the containment chamber C (see figure 5) is conformed by an apex of t unk-conical shape, and, obviously, the base of the conduit 4 has a trunk-conical shape as well so that they couple perfectly as per figure 5, obstructing the radial holes. When the shutter slides in the direction of lifting of figure 5, such a trunk- ran6ci6.-i-h-r ^"aii a ^_ΐσ ^"tjee -'rn Vccess t^"d ^"tne^" raa^'ia^'i^' noies^" and therefore also to the longitudinal hole.

Structurally, the conduit 4 is formed by a part of apex 10 where the needle is applied in a traditional way and is screwed to a fixed part integral to the body of the syringe. Such a part of ^apex 4 forms a shoulder where the end of a spring 9 is fixed that results to be interposed between the shutter 8 and the part of apex 10. The spring is calibrated in such a way as to keep the shutter 0 in close position below a pre-determined pressure value. Once such a threshold value is reached and exceeded, the shutter starts its translation, bringing the spring in compression ,

The fact that the apex 10 is screwable on the rest of the structure that makes part of the syringe makes that the parts such as shutter and spring are substitutable or also interchangeable (for example, in the case a spring with different calibration wants to be used) .

Figure 3 shows a constructive detail relative to the conduit 2 that serves for the loading of the syringe. Also such a conduit, naturally, is provided with a second check valve (5, 6 _f 7) configured to allow the access and the loading of the gas in the containment chamber C, avoiding at the same time that the gas loaded can obviously exit from the conduit itself 2 through which such a loading has taken place.

The solution is similar to the preceding one with a shutter 5 provided with a longitudinal hole and radial holes that are well visible in the exploded of figure 6.

When the shutter ia thrusted in the direction of the arrow shown in figure 3, it translates towards the bottom and, thanks to its trunk-conical shape in the apex, frees the radial holes through which the gas flows.

Also in this case a spring 6 is therefore foreseen that keeps the shutter in a close position with respect to the apex 7 of the conduit 2.

Also the apex 7 is screwable on the rest of the body of the syringe that forms as a whole the conduit 2.

Both valves are normally closed valves and which, once a pre-determined threshold pressure value is exceeded, move towards a direction of open condition. The valve relative to the hole or conduit 4 moves in open position when a pressure value is reached and/or exceeded that acts from the containment chamber of the gas towards the outside. The valve relative to the hole 2, instead, passes in open condition reached and/or exceeded pressure values that from the external part of the syringe act , towards the internal part of the same.

Going on with the description of the invention, the figures from 12 to 16 describe a loading machinery of the ozone modified in such a way as to load such a type of syringe.

It is in fact evident that current machines are not capable of loading the modified syringes as described, since the present syringe foresees now va,lves .

Figure 12 shows a plurality of semi-ring shaped elastic elements 17 and 17B in which the body of the syringe described gets stuck, in. a snap-like manner, in such a way that the conduit 2 of each syringe is inserted in the corresponding loading hole, keeping at the same time the syringe positioned to the loading machine. The shapes of the loading machines can naturally be multiple and different also from the one described in figure 12.

Going on with the description, figure 13 shows the conduit 2 of the syringe placed in proximity of the loading hole 16G.

All the holes 16-16G are s ructurally identical and figure Ϊ3, just as a way of example, shows the case of the hole 16G.

The hole foresees a rectilinear line having a deformable wall, preferably of rubber, in such a way as to widen, allowing the insertion of the widened head 7 of the conduit 2 , The rectilinear part terminates with a widened part inside of which the respective widened head of the conduit 2 is inserted and gets stuck. In this way, the coupling is still and a rejection back of the syringe is avoided by means of the loading pressure.

Always as shown in figure 13, and still better in figure 15, a stem 22 is foreseen having a disk 19 configured to go against the final rectilinear part of the hole 16G. A spring 20 is interposed between the disk 19 and a shoulder of the hole 16G. A further disk 30 is foreseen in the stem downstream of the disk 19.

As better shown in figures 14 and 15 the stem 22 is sliding since the lodging hole inside of which it is inserted restricts again, forming a last blind portion 21.

In this way, by analyzing the sequence of figure 14 and figure 15, the stem is translatable from the advanced position of figure 14 to the retracted position of figure 15 to then go back to the position of figure 14 thanks to the action of the spring. The stem, as shown for example in figure 14 and 15, foresees upstream of the disk 19 an internal channel that forms a conduit of passage for the gas (H-shaped channel) .

The gas produced by the machine is injected in the roundish terminal area of the conduit 166 (area I in figure 14) so that, when the stem is in the advanced position of figure 14, the gas is impeded from passing in the rectilinear part of the conduit 16G because the disk 19 obstructs such a passage.

When the stem is made to retract in the position of figure 15, however, the gas can flow along the conduit 16G since it accesses through the conduit 22' obtained in the stem. In fact, the disk 30 in the retracted position of the stem, obstructs again the channel and therefore the only access that the gas has is that through the conduit H placed over with respect to the disk 30 and having the opening of access in correspondence of the chamber I and the opening of exit in correspondence of the rectilinear part of the hole. This solution with the double disk (19, 30) has the advantage of ■ keeping always closed the conduit, except for the passage 22, therefore limiting an inverse reflux effect of the gas.

The functioning is therefore described with reference to figures 10 and 11 with the relative phases a) and b) .

Above all, the loading of the syringe with ozone takes place, in case an ozone-therapy treatment wants to be operated.

To that aim, the syringe is connected to the loading machine, as that of figure 12 and 13, wherein the conduit 2 is inserted in a relative loading hole (for example the hole 16G of figure 12) .

The conduit 2 of the syringe is inserted in the respective conduit (for example the 16G) of the machine and the stem 22 enters in collision with the shutter 5- During the insertion the stem moves back until the stop, bringing itself in the position of figure 15. At this point, not being able to retract, the continuation of the stop of the conduit 2 until the blocking position translates in a thrust on the shutter 5 that thus moves as in the embodiment of. figure 16 (see sequence a) , b) of figure 11 ) .

In this position the shutter 5 is translated in open position and thanks to its trunk-conical shape frees the radial holes through which, as indicated in the direction of the dotted arrows of figure 16, allows the passage of the gas.

In particular, the gas passes through the conduit 22' and from here, through the radial and longitudinal holes of the shutter, arrives in the chamber C.

At the end of the loading, as soo as the conduit 2 is detached from the loading machine, the spring 6 brings the shutter back in the position of figure 11 phase a), avoiding any gas leaks through the conduit 2 and, at the same time, the stem 22 goes back in the close position of figure 14.

In such a condition, there cannot be either leaks through the conduit 4 since, going to figure 10 phase a) , the valve is normally closed and the spring is calibrated in such a way as _. to keep the shutter 6 in close position by pressures due to the only presence of nitrogen in the chamber C,

In order to initiate an injection of gas, therefore an exit thereof through the conduit 4, it is necessary to reach and exceed the threshold pressure and this takes place by acting normally on the piston 3, exactly as when a medical liquid is injected with a traditional syringe. The advancement of the piston 3 determines an increase in internal pressure inside of the containment chamber C, so that the shutter 8 passes from the closing phase a) to the opening phase b) of figure 1.0, allowing the outflow of the gas outside.

In a variant of the invention, it can be identical to the preceding one except for the absence of the disk 30 and of the H-shaped channel. In this case, the gas would flow through the space that is formed between the stem and the walls of the channel 16^'G.

In .a further variant, still simpler, the stem could be fixed and lacking also the disk 19, besides the disk 30 and the H-shaped channel.

It is evident that, although the present invention has been described for an ozone therapy treatment, the present syringe can be loaded with any type of fluid or gas, by simply calibrating adequately to the desired values the forces exerted by the springs (6, 8).

Claims

1. A syringe (1) for an ozone therapy treatment, comprising;

A chamber (C) for the containment of a medical fluid; A eliding piston (3);

An outlet hole (4), where, in use, the needle is applied, through which the medical fluid contained in the chamber (C) is expelled outside following a motion of advancement of the piston (3);

Characterized in that the outlet hole (4) is provided with a first check valve (8, 9, 10) and wherein a loading hole (2) is foreseen communicating with said chamber (C) , said loading holQ (2) being provided with a socond check valve (5, 6, 7) .

2 . A syringe (1), as per claim 1, wherein said check valves are normally closed, the first check valve {8, 9, 10) passing in an open condition to the reaching and/or exceeding of a threshold pressure^' value that from the internal chamber (C) of the syringe acts towards the outside, while the second check valve (5, 6, 7) passing in an open condition to the reaching and/or exceeding of a threshold pressure value that from the outside acts towards the internal chamber (c) .

3. A syringe (1), as per claim 1 or 2, wherein the first check valve (8, 9, 10) is mobile between a close position, in which it impedes the exit of the gas contained in the chamber outside, and an open position,

4. A syringe (1), as per one or more of the preceding claims from 1 to 3, wherein said first check valve (8, 9, 10) is configured in such a way that the movement between a close position and an open position takes place at the reaching and/or at the exceeding of a pre-established threshold pressure value inside of the chamber.

5. A syringe (1), as per one or more of the preceding claims, wherein said first check valve (8, 9, 10) comprises a shutter (8) and elastic means (9) arranged in such a way as to act on the shutter, (0), keeping it in a close position below a pre-datermined threshold pressure value of the fluid contained in the chamber (C) and allowing a movement of the shutter (8) in the open position at the reaching and/or exceeding of said threshold pressure value.

6. A syringe (1) , as per claim 1 or 2, wherein the second check valve- (5, 6, .7) is mobile between a close position, in which it impedes the exit of the gas contained in the chamber outside, and an open position.

7. A syringe (1), as per one or more of the preceding claims, wherein said second check valve (5, 6, 7) is configured in such a way so that the movement between a close position and an open position takes place at the reaching and/or exceeding of a pre-established threshold pressure value that acts on the check l e from the outside of the syringe towards the containment ohamber of the medical fluid.

8. A syringe (1), as per one or more of the preceding claims, wherein the second check valve (5, 6, 7) comprises a shutter (5) and elastic means (6) arranged in such a way as to act on the shutter (8), keeping it in a close position and allowing the shutter to move in open position at the reaching and/or exceeding of a threshold pressure value acting from the outside towards the chamber (C) .

9. A syringe (1) , as per one or more of the preceding claims, wherein the first check valve is applied inside of a conduit (4) where the needle is applied.

10. A syringe (1), as per claim 9, wherein said conduit (4) is formed by an apex (10) connected in a removable manner, preferably screwed, with respect to the underlying part of the conduit itself.

11. A syringe (1), as per one or more of the preceding claims, wherein a conduit (2) is foreseen arranged laterally to the body of the syringe, the second check valve being applied inside of said conduit (2) .

12. A syringe (1), as per claim 11, wherein said conduit (2) foresees an apex (7) connected in a removable manner, preferably screwed, with respect to the underlying part of the conduit (2) itself.

13. A syringe (1), as per one or more of the preceding claims, wherein said underlying parts relative to the apexes (7, 10) are integral with the body of the syringe.

14. A syringe (.1), as per one or more of the preceding claims, wherein said conduit (2) is configured to couple in a removable manner to a loading machinery for the syringe .

15. A machinery for loading a syringe (1) as per one or more of the preceding claims from 1 to 14, the machinery foreseeing one or more loading positions (17, 17B, 16- 16F) , said loading position foreseeing a stem (22) arranged in such a way that, whan in use, the syringe couples to said machinery, said stem intercepts the shutter (5) relative to the check valve (5, 6, 7) present in the loading hole, in such a way as to exert a thrust force to move said shutter (5) from the close position to the open position.