WO2011010956A1

WO2011010956A1 - A device for sterile mixing of at least two components and a method for producing a fume free cement using this device

Info

Publication number: WO2011010956A1
Application number: PCT/SE2009/000373
Authority: WO
Inventors: Sven Olerud
Original assignee: Sven Olerud
Priority date: 2008-07-23
Filing date: 2009-07-23
Publication date: 2011-01-27
Also published as: SE0801728A0; SE0801728L

Abstract

The present innovation concerns a device for simplified mixing of at least two components in a sealed and sterile environment in order to produce a formable and smell free dough with vacuum technique, whereby the dough has quality, which makes it after application to stiffen to a firm unity at which the container includes a first part (9) for storing of a component, for example powder and a gas absorption substance and a second part (2) with an ampoule (10) for storing a liquid component, which can flow down into the first part (9) after the ampoule has been broken and made it possible for passage for the liquid component from the second to the first part. The second part (2) has a central hole (26) which can be closed with a plug (11) placed at the upper end of a hollow shaft, a stem tube (19), which contains a back vent and a gas absorption substance (29), this stem (19) passes an opening (20) into the first part (9) through the powder (21) and is displaceable and turnable in the first part (9) and is furnished with a mixer disc (12) located below the plug (26) and a method to, with the device, mix at least two components in a sealed and sterile environment in or der to produce a formable and smell free dough with vacuum technique.

Description

A device for sterile mixing of at least two components and a method for producing a fume free cement using this device

The Technical field of the innovation.

The present invention relates to a device and also a method for a simplified mixing of at least two component within a sealed and sterile device designed to produce a mouldable dough for example bone-cement, completely odour free and with vacuum technique giving the dough masse qualities, which after deposition of it solidify to a firm body unit.

Techniqal background of the invention.

Within the above-mentioned technical area there are many different solutions on devices and methods in order to produce substitutes for orthopaedic purposes.

Ever since orthopaedic problems began being treated, devices and methods have been developed in order to fill up bone defects to be able to stabilize fractures and also to fixate and replace joints with artificial implants. All these procedures demand substitutes, of which nowadays are several. Some of these have drawbacks of one or another kind. One of the most used substitute materials is metacrylat, which before deposition is produced by mixing its liquid form, the monomer, with its powder form. There are some problems involved in this procedure, one is to guarantee sterility, another one is to prevent toxic and nasty-smelling fumes from the mixing from being included in the dough.

Known such sealed system and devices have different vacuum systems in order to eliminate the toxic fumes which develops during the mixing of the components.

Some examples of such techniques are disclosed in

EPO397589, US2003012079, WO9922854 , WO2006110023,

US6536937 and WO9210225.

Brief summary of the invention idea.

The present invention has the goal of eliminating the above mentioned drawbacks when producing

substitutes, when filling bone defects, when stabilizing fractures and when fixating and replacing joints with artificial implants.

According to the invention idea the above mentioned problems will be solved by the use of a new technique when mixing the including components and by evacuation of gases during the mixing and after.

According to the invention idea the above mentioned problems will be solved using an ampoule containing the liquid and a container for the powder arranged separate from each other only with a plunger, which has an opening through which, after crushing, the liquid flows down into the powder into the first part which has en central hole, which seals with a plug placed at the farthest out part of a tube containing a back-valve and a gas absorbing substance, whereby the tube passes an opening in the first part through the powder and is rotary and displaceable and movable in the first part and at which tube a stirring device is placed under the plug.

According to the invention idea a device can be made, which is easy to use and presents a method, which is easy to produce and presents a final product which does not contain undesired gases, which otherwise would reduce the firmness of the product. The process takes place completely sealed and the toxic gases which develop are not included into the dough but will be taken care of by a vacuum system.

Brief description of attached drawings.

The invention will now be describe with reference to the enclosed drawing where

Figure 1 shows embodiment of the mixer syringe according to the invention seen from the side.

Figure 2 shows the mixer syringe, in fig.l, in cross- section.

Figure 3 shows a cover for closing a tube of plastic, which contains an ampoule in vertical cross-section with an inside shaping of an ampoule.

Figure 3a shows the cover in cross-section with

horizontal section A-A, B-B, C-C and D-D in figure 3a Figure 4 shows in a vertical cross-section the plunge of the syringe.

Figure 4b shows the top end of tube end in the syringe with a ring for blades.

Figure 4c shows the plunge seen from the ampoule bottom.

Figure 4dl shows a plate in the hole of the plunge seen from above with a breaking point.

Figure 4d2 shows the plate seen from the side. Figure 5 shows the disc seen from the top.

Figure 5a shows the disc in figure 5 with the tube stem with the inside tube seen from the side in a vertical view in cross-section.

Brief summary of the invention.

The present innovation includes several parts with different functions assembled to one unit. This design is intended for mixing two substances in order to produce a mouldable dough to deliver and deposit, for example bone cement, to places where it rapidly will get firm. As such it can be used to fill up cavities or fixate implants in bone, among others in bone.

Known are substances as powder of polymetacrylate, which is mixed with a monomer form of metacrylate to get so called bone cement. In order to prevent toxic fumes, which appear during the mixing procedure, there exist today sealed systems where the fumes are evacuated with different vacuum systems.

The present innovation differs from previous systems owing to that the liquid located in an ampoule and the powder both of them are located in same device, only separated from each other with a plunge. This plunge has an opening through which, after crushing the ampoule, the liquid will flow down into the container with the powder.

The opening in the plunge is closed with a plug, which is placed upon a stem in the form of a tube.

This stem extends through an opening, for example the opening of the syringe. On top of the stem a disc with blades is located reminding of a propeller. Just over the disc there is a plug suiting the hole in the plunge. The plug can be operated from the outside with the stem in order to close the hole in the plunge. By overturning the stem, the plug is separated from the disc .

The syringe is placed vertically. The disc is put in level with the content in the syringe container. The inside gas is pressed out from the syringe via a thin air pipe in the stem by pressuring the shaft of the plunge. Then the pipe is closed.

The syringe has a special form with folding flaps in its upper part. A ring, which surrounds the flaps, can

move along them and when these flaps are pressed against the shaft of the plunge their upper threaded inner side take thread against the thread of the plunge shaft. When the plunge shaft is turned backwards a negative pressure arises in the syringe container which releases eventual air and gas in the dough. This gas is then evacuated when the connection outwards is opened when the small air tube in the shaft is turned for this function. This step can easily be repeated.

With the plunge in drawn-out position and the disc at the bottom of the container the stem is released by turning. The syringe is ready to deliver the bone cement .

Detailed description of a preferred embodiment of the invention.

The device according to the invention is intended to be delivered enclosed into a sealed plastic bag in the present of sterilization before the use of it.

With reference to fig l-5a device according to the the invention is shown in a form of a syringe comprising a syringe container 21, filled with suitable substance and a plunge 13 with a holder casing 2. This holder case 2 has the form of a tube, which inside is formed to include glass ampoule 10 and the outside is furnished with a thread 17 on which a turnable lid 1 is mounted. A rubber balloon 22 provided with a vent 23 is placed on the lid 1 in order to increase the pressure into the ampoule at the draining of this 10. The holder casing 2, i.e. the tube around the glass ampoule is fixed into the plunge 13, look at figure 4a and makes therefore the shaft of the plunge.

In the centre of the plunge 13 there is a hole 26 provided with a thread, see figure 4. Within the upper part of this hole 26 there is a matched space 27 for a rectangular plate 6 see figure 4a, 4b, 4dl and 4 d2, which is furnished with a sharp point 5. This

rectangular plate covers only the central part of the hole 26 and creates openings 7 at its side allowing the liquid to flow down into the syringe container.

Above this point plate there is a circular groove 8a for a filter 8, which will collect eventual glass splinter.

On to this filter 8 the glass ampoule 10 gets support. When the lid 1, see figure 3, on top of the holder containing the ampoule 10 is turned, the

convexity 3 at the inside of the lid 1 will press against the top of the glass ampoule, which then will break. Further turning presses the ampoule 10 against the point 5 at the plate located in the groove for this one whereby the bottom of the ampoule 10 is broken and the liquid can flow down through the filter 8 which catches eventual glass splinter and than into the syringe container 9.

Inside the container there is a disc 12

corresponding the inside diameter of the container 9, and this disc makes the mixer body. The disc has several blades 12a with intermediate openings and forms a body similar to a propeller. The disc 12 is placed on a stem 19 consisting of a tube, which passes through the opening of the syringe 29. This solution makes it possible to handle the organ from the outside of the syringe .

The upper part of this outer stem 19, is coupled to the mixer disc and have an opening against the inside of the container 25. The inside of this stem tube have also room for a another tube 14, turnable against the outer tube. This tube 14 is filled up with a substance for reabsorbing toxic gases. The top of this tube 14 is half hidden 24.

In a chosen rotator position the opening will correspond with the effect that the inside of the container will have an open connection to he outside when the plunge presses gases out from the syringe. When the inside tube is turned 180 degrees the connection is closed. This is a necessary measure to do when then the mixing procedure starts.

At the centre of the disc 12 the threaded plug 11 is anchored, the plug which will close the hole 26 in the plunge 13. When turning the stem tube 19, which comes through the opening 20, the plug 11 will be driven into the hole after which procedure the hole 26 is closed. Overturning causes the plug to be separated from its place and after that it will be fixed in the plunge 13.

With a vertical position of the syringe unit the inside mixture shows a level, which is the starting position for the disc with air and gases close to the plunge. With pressure on top of the holder 17 the gas will be eliminated through the open connection through the larger tube 19 and then into the inner one 14. To close the connection the inner tube is turned for itself in relation to the outer stem tube 19 by the handle 30 attached to the thin tube 14.

The ring 15 around the flaps 16 is moved upwards so in that way the threads 18 catches the threads at the holder 17. At anti clock-wise turning of the holder 2 (with the connection between the outer and inner tubes closed in the stem) a vacuum effect is created inside the container, air and gas bubbles are sucked out from the dough 21. Repeated turning of the inner tube 14 opens the connection to the outer tube 19 and the gas mixture will be evacuated by turning the holder 2 clockwise. Replacing the ring 15 releases the connection between the flaps 16 and the holder 2 and will allow a fast emptying of the gas by pressuring the holder 2.

This measure of creating vacuum inside the syringe container can when needed easy be repeated.

The mixing of the components inside the container is made by turning the outer stem tube 19 at the same time as the disc with the outer tube is moved up and down.

When the mixing process and then the vacuum process are ended the disc 12 with the blades is moved to the bottom of the container. The stem shaft 19 is turn anti clock-wise with force so it can be remove from the syringe .

The syringe is then ready to deliver the mixture, the dough. Modification of the invention.

It has to be emphasised that the invention of course can be modified within the scope of accompanying patent claims .

The form can be varied at the same time as the material for manufacturing of the parts belonging to the invention can be varied within the scope for the patents claim of the invention.

Nuitimber :

1. Lid

2. The second part

3. Inside bulge at the lid

4. Inside bulge

5. Sharp point to break the ampoule bottom

6. Rectangular plate

7. Openings aside the rectangular plate

8. Filter to catch glass splinter

9. The first part, contains powder

10. Ampoule with liquid

11. Plug for the plunge

12. Disc with blades

12a. Blade

13. Plunge

14. Turnable inner tube

14a. Covering of hole

15. Movable ring around flaps

16. Flaps around the shaft of the plunge

17. Thread outside the shaft to the plunge

18. Thread on flaps

19. Turnable stem with inside tubes coupled to the disc.

20. Opening of the syringe

21. Container with powder

22. Rubber membrane for lid

23. Vent in the rubber membrane

24. Opening against the container space

25. Outer tube's opening into the container

26. The open hole in the plunge

27. Space for rectangular plate

29. Gas absorbent substance

30. Handle of the inner tube..

Claims

Claims .

1. A device for simplified mixture of at least two components in a sealed and sterile achievement in order to produce an adaptable smell free dough with vacuum technique, whereby the dough masse has such qualities, which makes it after application stiff to a firm body, whereby the device comprise a first part (9) for storage of a component, for example a powder, and a second part (2) with a reservoir (10) for storage of a liquid component, which may flow down into the first part (9) after the reservoir (10) has been broken and made passage for the liquid from the second (2) to the first part (9), characterized in that the second part (2) has a central hole (26), which can be sealed with a plug (11) placed on the upper most part of a hollow stem tube (19) having a back vent and a gas absorption substance (29) whereby the stem (19) passes an opening (20) in the first part (9) through the powder (21) and is displaceable and turnable in this first part (9) and at which stem tube (19) a mixer blade is located below the plug (26) .

2. A device according to claim 1, characterized of that the device represents a injection syringe where the second part (2) is the plunge shaft with a form of a tube with a central hole (26) containing the liquid reservoir in the form of an ampoule (10) and which tube is covered with a threaded lid (1) with a bulge formation which at turning breaks the top of the ampoule and also presses the ampoule (10) against formation at the bottom of the unit causing puncture of the ampoule

(10) letting the liquid flow down through the hole (26) in the plunge (13) and further down in the first part (9) into the powder (21) .

3. A device according to patent claim 1,

characterized of that the mixer part has a disc with blades (12), which is attached to the tube formed stem shaft and at its top have a threaded plug (11), which when at turning the stem can be intruded into the hole (26) in the plunge (13) and close it until the plug

(11) separates from the disc(12).

4. A device according to patent claim 1

characterized that the tube formed stem (19) is fixed through the disc (12) and have inside an inner tube (14) which within its upper end is formed as it, at a certain turning against the outer tube gives a complete lock of the connection between the tubes through the disc (12).

5. A unit according the patent claims 1-4,

characterized of that the tube (14), which is enclosed into the stem shaft in order to remove air and gases with a flap system (16) with threads (18) which can be pressed around the syringe shaft with a movable ring

(15) around the flaps (16), which gives the possibility to turnable via the thread turn the plunge (13)

backwards with force in the device in order to create a vacuum effect in order to remove air and gases out of the dough and with this measure increase the firmness and quality of the dough.

6. Method with a unit according to the claim 1-5 for mixing at least two components, preferable

methymetacrylate powder with do liquid and together with vacuum technique suck out gases, which are formed when mixing, characterized of in a first step turning the lid, which has a bulging inside against the plunge shaft with the ampoule and in such a way crushing the top of the ampoule and at further turning the ampoule is pressed against the bottom on the inside plunge and becomes perforated and the liquid flows through the openings in the plunge down into the container whereby in step 2 the stem tube which is handled through the delivery hole attaches the plug in the central hole closes the plunge hole and separates the plug when in step 3, the mixer - the stem shaft - with disc will stir and mingle the components and evacuate gases through tube inside the stem and further in steg 4 turn the plunge backwards with force to empty the dough with vacuum and last in step 5 withdraw the stem shaft from the first part and the dough, which has high quality and long firmness when it does not contain gas or air whereby the dough is ready for delivery and application.