Device to prepare and administer two-component mixture

Abstract

A device to prepare and administer a two-component mixture, including a first chamber in which a container is housed that is hermetically closed for a liquid component, a second chamber containing a powdered component, an opening of the container of the liquid component, a mixing member placed in the second chamber for preparing the mixture and a piston able to move in the second chamber to dispense the mixture. The mixing member includes a stem, passing through an opening for dispensing the mixture in the second chamber, having an outer end equipped with a handle and an inner end provided with a mixing blade connected to the inner end with a releasable connection.

Claims

1. A method for preparing and administering a two-component mixture, actuated with a device, wherein the method comprises the following steps: breaking a container of a liquid component to release the liquid component; transferring the liquid component from a first chamber to a second chamber through a first end of the second chamber; mixing the liquid component and a powdered component via a mixing member provided within the second chamber, the mixing member attached to a stem inserted through a dispensing opening at a second opposing end of the second chamber, making a mixture, wherein said mixing member comprises the stem for actuating the mixing member itself, said stem being able to be actuated from outside of the device, said stem and said mixing member being associated through releasable connection means; removing the stem of said mixing member through the dispensing opening; and acting upon a piston to dispense said mixture through the dispensing opening.

2. The method of claim 1, wherein the container is housed in the first chamber that is hermetically closed for the liquid component.

3. The method of claim 1, wherein the second chamber contains the powdered component and communicates with said first chamber.

4. The method of claim 1, further comprising at least one of a fracturing member or a protrusion for opening said container of the liquid component provided inside the first chamber.

5. The method according to claim 1, wherein said step of transferring the liquid component from said first chamber to said second chamber is carried out through traction towards the outside of said piston.

6. The method according to claim 1, wherein said step of mixing the liquid component and the powdered component is carried out through alternative rotary and translation movements of said mixing member inside said second chamber.

7. The method according to claim 4, wherein said step of breaking said container is carried out by pressing manually on a first end of said container, causing said fracturing member to act upon and break an opposing end of the container.

8. The method according to claim 1, further comprising a step of connecting a recipient to the dispensing opening for collecting the dispensed mixture to said device.

9. A method for preparing and administering a two-component mixture, actuated with a device, wherein the method comprises the following steps: breaking a container of a liquid component; transferring the liquid component from a first chamber to a second chamber through a first end of the second chamber; mixing the liquid component and a powdered component via a mixing member provided within the second chamber, the mixing member attached to a stem inserted through a dispensing opening at a second opposing end of the second chamber, making a mixture; wherein said mixing member comprises a stem for actuating the mixing member itself, said stem being able to be actuated from outside of the device, said stem and said mixing member being associated through releasable connection means; removing the stem of said mixing member through the dispensing opening; and acting upon a piston to dispense said mixture through the dispensing opening.

10. The method of claim 9, wherein the container is housed in the first chamber that is hermetically closed for the liquid component.

11. The method of claim 9, wherein the second chamber contains the powdered component and communicates with said first chamber.

12. The method of claim 9, further comprising at least one of a fracturing member or a protrusion for opening said container of the liquid component provided inside the first chamber.

13. The method of claim 9, wherein the piston is able to move from the first end of the second chamber to the second end of said second chamber to dispense the mixture.

14. The method of claim 11, wherein the first chamber and the second chamber communicate with each other through substantially axial holes provided in a head of the piston inserted through the first end of the second chamber.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) These and further advantages will be more clearly understood by any man skilled in the art from the following description and from the attached drawings, given as non-limiting examples, in which:

(2) FIG. 1 is a perspective view of the device according to the invention;

(3) FIG. 2 is a further perspective view of the device according to the invention;

(4) FIG. 3 is a side view of the device;

(5) FIG. 4 is a section view of the device;

(6) FIG. 5 is a section view of the device in an initial step of the preparation of the mixture;

(7) FIG. 6 is a section view of the device in a subsequent step of the preparation of the mixture;

(8) FIG. 7 is a section view of the device in another step of the preparation of the mixture;

(9) FIG. 8 is a section view of the device in yet another step of the preparation of the mixture;

(10) FIG. 9 is a detailed section view of the device in a final step of the preparation of the mixture;

(11) FIG. 10 is a detailed section view of another embodiment of the device;

(12) FIG. 11 is a detailed section view of yet another embodiment of the device;

(13) FIG. 11A is a detail of FIG. 11;

(14) FIG. 12 is a detailed section view of yet another embodiment of the device; and

(15) FIG. 13 is a detailed section view of a further embodiment of the device according to the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

(16) With reference to the representation of FIG. 1, a device for preparing and administering a mixture of two components according to the invention is wholly indicated with 1.

(17) The device is particularly, but not exclusively, recommended for preparing a mixture consisting of bone cement, deriving from the union of a liquid component and a solid component, to be administered to the patient in certain types of surgery, for example osteoplastic surgery or similar. In order to obtain a suitable product, such preparation takes place, as known, in an operating room while the surgery itself is being performed.

(18) The device 1 comprises a tubular body, wholly indicated with 2, with a substantially cylindrical configuration; at one of the bases the tubular body 2 is open, and defines a circular mouth 3.

(19) The tubular body 2, at the mouth 3 and at the mid-way point, has two collars 4 that are joined and ergonomically configured that allow it to be held more easily during the preparation of the mixture; moreover, the tubular body 2 is equipped with an outer ring that can be used both to make it easier to hold and to connect or fix the device onto other machines or equipment.

(20) The tubular body 2 can, for example, be made from plastic material, or else from any other materialfor example metal or glassthat is suitable for containing the two components that will constitute the mixture.

(21) The mouth 3 of the tubular body 2 has a piston 6 engaged in it, which has the function of dispensing the prepared mixture, as will become clearer hereafter.

(22) The piston 6 is engaged in the mouth 3 so as to be able to slide axially; the piston 6 is equipped with a head 7 carrying a first sealing gasket 8 along the inner surface of the tubular body 2. Alternatively, the piston can be coupled with the tubular body 2 through a screw-nut screw connection, allowing the operator to act with greater ease considering the high density and viscosity of the mixture produced. At the opposite end with respect to the head 7, the piston 6 is provided with a substantially discoidal handle 9 that allows it to be actuated, as described hereafter.

(23) As can be seen, for example, in FIG. 4 and thereafter, the piston 6 is made internally hollow: the cavity of the piston 6 constitutes a first chamber 10 for the liquid component 11 that will constitute the mixture.

(24) The tubular body 2, on the other hand, defines a second chamber 12 inside it, in which the powdered component 13 that has to be combined with the liquid component 11 coming from the first chamber 10 is contained. The second chamber 12 is closed by the head 7 of the piston 6.

(25) In the tubular body 2 there is also an opening 14 for dispensing the mixture, indicated with 15 in FIG. 7 and thereafter; such a dispensing opening 14 is suitable for placing the second chamber 12 selectively in communication with the outside, and is opposite the mouth 3 in which the piston 6 is inserted.

(26) The first chamber 10 and the second chamber 12 of the device communicate with each other through small substantially axial holes 16 foreseen in the head 7 of the piston 6.

(27) The liquid component 11, which is volatile and toxic if released into the atmosphere, is enclosed in a hermetically closed container 17: such a container 17 consists, for example, of a glass vial. The container 17 can, nevertheless, be of another shape or another material, suitable for safely enclosing said liquid component 11. The container 17 is housed in the first chamber 10 defined in the piston 6, as can be seen in FIG. 4.

(28) The device also comprises means for opening the container 17 of the liquid component 11, wholly indicated with 18. Such means 18 for opening the container 17 comprise a fracturing member 19, associated with the handle 9 for actuating the piston 6, selectively mobile from an outer positionrepresented in FIG. 5to an inner positionrepresented in FIG. 6pressing on a first end of the container 17, to cause it to break. In greater detail, the fracturing member 19 is suitable for acting upon the head of the glass vial 17. The fracturing member 19 consists of a hollow tubular portion equipped with a widening 20 at its outer end, on which it is possible to press manually; the fracturing member 19 is engaged so as to be able to slide in a bushing 21 that closes a gap 22 for access to the first chamber 10, made in the handle 9 of the piston 6, with interposition of a second sealing gasket 23.

(29) The means 18 for opening the container 17 also comprise a protrusion 24, opposite the fracturing member 19 inside the first chamber 10, on which the second end of the container 17, i.e. the base of the glass vial, abuts. The protrusion 24 is fixedly connected to the inner face of the head 7 of the piston 6.

(30) The first chamber 10, foreseen inside the piston 6, is equipped with a filter 25 for holding back the fragments of the container 17 after it has been broken. Indeed, such fragments, especially the smallest ones, could pass through the holes 16 and mix together, inside the second chamber 12, with the liquid component and with the powdered component. The filter 25 is positioned at the inner face of the head 7 of the piston 6, adjacent to the protrusion 24.

(31) The device 1 comprises a mixing member 26, associated with the second chamber 12, suitable for the preparation of the mixture, i.e. suitable for making it quicker and easier to mix the liquid component and the powdered component.

(32) More specifically, the aforementioned mixing member 26 comprises actuation means 27, for example a through stem able to slide through the dispensing opening 14, suitable for forming the mixture foreseen in the second chamber 12.

(33) The actuation means 27 have an outer end 28 equipped with a handle 29 for manual actuation, and an inner end 30 provided with the mixing member 26, for example a mixing blade 31, which carries out the mixing of the liquid component with the powdered component.

(34) The mixing member 26, for example the mixing blade 31, is associated with the inner end of the actuation means, for example the stem 27, through releasable connection means 32 that allow the actuation means to be separated from the mixing member 26.

(35) This provision, as will become clearer hereafter, allows the actuation means of the mixing member 26 to be removed at the end of the preparation of the mixture, thus freeing the dispensing opening 14.

(36) According to another version of the present invention, the releasable connection means 32 comprise a threaded portion 33 foreseen in the inner end 30 of the stem 27, and a nut screw 34 foreseen in the mixing blade 31.

(37) According to an alternative that is not illustrated, the nut screw is located on the stem 27 and the threaded portion in the mixing member 26.

(38) Inside the second chamber 12 the device 1 comprises a constraining element 35 for the mixing blade 31.

(39) If the separation of the mixing member 26 from the stem 27 takes place by rotation, the constraining element 35 is made as an anti-rotation element: for example a shape connection for suitable portions of the mixing member 26, a pin, etc.

(40) The constraining element 35 thus allows the stem 27 to be quickly removed from the blade 31 at the end of the preparation of the mixture.

(41) According to a version of the present invention, the constraining element 35 comprises an axial pin arranged eccentrically with respect to the dispensing opening 14 of the mixture.

(42) On the mixing member 26, or on the blade 31, near to the dispensing opening 14, there is also a recess 36 (FIG. 6), or else a hole, etc., in which a corresponding portion of the blade 31 is intended to engage at the end of the preparation of the mixture, so as to make the constraining element 35 engage in the blade 31 itself.

(43) According to another version of the present invention, the recess 36 is prism-shaped and the blade 31 has a portion with a corresponding shape, and in this case the pin is not present, because the necessary anti-rotation constraining function is already achieved in this way.

(44) The tubular body 2, at the dispensing opening 14 of the mixture, comprises an appendix 37 for coupling with a further recipient for collecting the dispensed mixture, not represented in the Figures but of the type essentially known. The appendix 37 can be made in a separate piece from the tubular body 2, mounted with interposition of a third sealing gasket 38. Such a coupling appendix 37 comprises screw connection means to the recipient, wholly indicated with 39; the aforementioned screw connection means 39 can be of the type known in the field by the trade name LUER LOCK style connector or other equivalent means.

(45) It should be noted that screw connection means 39 of this type are particularly recommended since, given the high density and viscosity of the prepared mixture, it is necessary to achieve secure and effective locking of the recipient, which with other less secure connection means could detach precisely due to the pressure of the mixture, compressed by the piston 6.

(46) In practical use, the device ready for use is in a condition like the one represented in FIG. 5. The preparation of the mixture for subsequent administration begins by breaking the container 17 of the liquid component 11, as can be seen in FIG. 6. In order to break the container 17, the operator presses manually, preferably with a fast and sharp gesture, on the widening 20 of the fracturing member 19. Such pressing, combined with the opposite abutment of the container on the protrusion 24, causes the container 17 itself to shatter.

(47) At this point the liquid component 11 is freed inside the first chamber 10; through manual traction towards the outside of the piston 6 by the operator, a depression is created inside the second chamber 12. Then the liquid component 11 is drawn by the depression and transferred into the second chamber itself 12 through the holes 16.

(48) It is now possible to mix the two components to obtain the product to be administered. The operator therefore acts upon the mixing member 26 performing a quick alternative rotary and translation movement of the member 26 itself inside the second chamber 12.

(49) After having obtained optimal mixing of the two components 11, 13, the operator removes the stem 27 of the mixing member 26. In particular, the operator pulls the mixing member 26 outwards until the blade 31 is engaged in the recess 36, and therefore in the anti-rotation constraining element 35. At this point, the operator can completely unscrew the stem 27 from the blade 31, removing it and thus freeing the dispensing opening 14. Advantageously, the operator can now connect the appendix 37 to a recipient for collecting the dispensed mixture, which will then be used in the surgical intervention once filled by acting manually on the handle 9 of the piston 6.

(50) With this solution, important technical advantages are evidently obtained.

(51) A first important technical advantage consists of the fact that, once the step of preparing the mixture inside the second chamber 12 has ended during surgery, the operator can proceed, immediately and with simple gestures, to dispense the aforementioned mixture for example inside a collection recipient.

(52) A further technical advantage consists of the fact that the risks of contamination of the prepared mixture and also the risks of dispersion of the mixture itself in the environment are substantially reduced.

(53) Yet another technical advantage consists of the fact that the step of preparing the mixture is particularly quick and easy thanks to the positioning of the mixing member 26 at the dispensing opening 14, also considering the high density and viscosity of the mixture itself that generate substantial resistance to the movement of the mixing member 26.

(54) Yet another technical advantage achieved by the device according to the invention consists of the fact that the two liquid and powdered components 11, 13 are kept in areas hermetically separated from one another and with respect to the outside until the moment of actual preparation of the mixture.

(55) Another embodiment of the device according to the invention is represented in FIG. 10. In this embodiment, the releasable connection means 32 comprise a bayonet coupling. For example, the inner end 30 of the stem 27 comprises one or more grooves 40, whereas the blade comprises one or more ridges 41 suitable for engaging in the groove 40. This embodiment allows the stem 27 to be released from the blade 31 more quickly; however, this solution is recommended for devices suitable for preparing small amounts of mixture, since the bayonet coupling makes a less solid coupling with respect to one with screw means.

(56) Another embodiment of the device according to the invention is represented in FIGS. 11, 11a. In this embodiment the releasable connection means 32 comprise a traction breaking portion 42 of the stem 27. For example, such a breaking portion 42 can consist of a sort of thin membrane configured like the inner face of the blade 31, which fractures perimetrically by traction of the stem 27 and that frees the dispensing opening 14, as can be seen in FIG. 11a.

(57) Also in this embodiment the removal of the stem can take place extremely quickly.

(58) Another embodiment of the device according to the invention is represented in FIG. 12. In this embodiment, the stem 27 is made internally hollow and the releasable connection means 32 comprise a breaking portion 42 foreseen along the side surface of the stem 27 itself. By manual traction, the latter fractures into two pieces the inner one of which stays fixedly connected to the blade 31, and therefore constitutes a channel for dispensing the mixture.

(59) Another embodiment of the device according to the invention is represented in 10 FIG. 13. In this embodiment the coupling appendix 37 comprises bayonet coupling means 43 with the recipient for collecting the dispensed mixture. In particular, the appendix 37 comprises at least one ridge 44 suitable for engaging in a respective groove foreseen in the mouth of the recipient, not represented in. the Figure but of the conventional type. This solution makes it 15 possible to make the connection of the device to the collection recipient even quicker and simpler.

(60) If the device is relatively large in size, to thus produce relatively large amounts of mixture, the dispensing opening 14 must also be larger. In this case, so as to still keep the diameter of the stem 27 small, it is possible to foresee a reducer bushing, or other equivalent means, to be removed together with the stem itself 27.

(61) It has thus been seen how the invention achieves the proposed purposes. The present invention has been described according to preferred embodiments, but equivalent variants can be conceived without departing from the scope of protection offered by the following claims.