Patent Description:
Medical containers for liquids, for example blood bags, comprise one or more cannulas which allow the blood or blood components to exit from the container. The cannulas are normally closed by a valve or frangible septum, which is to be broken to allow the blood to exit from therein, for example when the bag is associated with a machine for extracting blood components.

Several devices capable of automatically breaking the frangible septum exist, so as to avoid such an operation to be carried out manually by an operator.

One of the main drawbacks of the automatic breaking devices, called "breakers", is due to the fact that different manufacturers make blood bags with different characteristics, not only in terms of overall dimensions of the bag and the diameter of the cannula, but also in terms of relative position of the frangible septum along the extension of the cannula.

A device for breaking cannulas of blood bags is known for example from <CIT> to the same Applicant, the bag comprising a breaking head and replaceable cannula positioning and breaking means. According to the type of bag and the positioning of the frangible septum in the cannula, it is possible to change and replace the positioning and breaking means so as to be certain that the breaking head is always aligned with the frangible septum.

The increased use of blood components extractors in hospitals, transfusion centres and laboratories has underlined the need to speed up the cannula breaking operations of different bags as much as possible.

Moreover, the constant arising of new and different types of bags, each with different size characteristics, has highlighted the need to reduce the response times in the adaptation of a machine for extracting blood components with respect to a new type of bag.

It is thus an object of the present invention to meet such need by providing a breaking device for breaking a closing element of a blood bag which is capable of quickly and accurately breaking the frangible septum on any type of blood bag and of limiting the intervention of an operator to the greatest extent possible.

It is a further object of the present invention to provide a device capable of quickly adapting to new types of bags without the need to modify any components thereof.

Such objects are achieved by the technical features of the invention defined in independent claims <NUM>,<NUM>,<NUM>. The dependent claims outline preferred and/or particularly advantageous aspects of the invention.

Document <CIT> is part of the prior art.

According to the aforesaid objects, the present invention makes available a breaking device for breaking a closing element of a medical container, comprising:.

Thanks to such solution, it is possible to quickly adapt the breaking device to any type of blood bag, regardless of the relative position of the frangible septum inside the cannula of the bag, without replacing or modifying the breaking device.

Another aspect of the present invention provides for the breaking device to comprise a vertically extending sliding guide element coupled to the housing.

Thanks to such solution, it is possible to move the housing of the breaking element along a vertical axial direction, avoiding possible misalignments and strengthening, in use, the resistance to lateral stresses due to the movement of the breaking element.

Another aspect of the present invention provides for the sliding guide to comprise at least one guide pin inserted protruding in a through hole made on the support plate, a vertically extending tubular structure being engaged with said pin.

Another aspect of the present invention provides for the actuator arrangement to comprise a threaded screw inserted in a through hole made in a side portion of the plate and in a through hole made in the housing, the through hole comprising a threaded surface therein. Thanks to such solution, it is possible to make a screw-leadscrew coupling which allows a quick and easy adjustment of the position of the breaking element.

Another aspect of the present invention provides for the operating device to comprise a drive shaft, the operating element to comprise a shaft connected to the drive shaft, the axis of the shaft being arranged parallel to the axis of the drive shaft.

Thanks to such solution, it is possible to significantly reduce the overall dimensions of the breaking device in a blood components extractor.

A further aspect of the present invention provides for the operating device to comprise a belt and a pair of pulleys respectively keyed onto the drive shaft and onto the shaft. Another aspect again of the present invention provides for the operating device to comprise a drive shaft, the operating element to comprise a shaft connected to the drive shaft, the shaft being arranged in alignment with the drive shaft.

Thanks to such solution, it is possible to reduce the number of components of the breaking device, thus reducing the production costs and facilitating the maintenance thereof.

A further aspect of the present invention provides for the breaking device to comprise a second operating arrangement for selectively operating the first actuator arrangement. Thanks to such solution, it is possible to avoid the operator from manually acting on the adjustment of the position of the breaking element, thus further speeding up the times and avoiding possible positioning errors.

The present invention also makes available a machine for extracting blood components from a medical container comprising a closing element, characterized in that it comprises a breaking device as defined above.

The present invention also makes available a method for breaking a closing element of a medical container, comprising the steps of:.

Further features and advantages of the present invention will become apparent from the following description, given only by way of example, with reference to the accompanying drawings, in which:.

Identical reference numbers have been used when possible to identify common identical elements in the drawings to facilitate comprehension. It is to be understood that elements and characteristics of one embodiment may conveniently be incorporated into other embodiments without further clarifications.

Reference is now made in detail to various embodiments of the invention, one or more of which are shown in the accompanying drawings. Each example is provided merely to illustrate the invention and is not intended as a limitation thereof. For example, the technical characteristics illustrated or described because they belong to one embodiment may be implemented in, or in association with, other embodiments in order to generate a further embodiment. It is understood that the present invention is comprehensive of such modifications and variants.

<FIG> illustrates a partial perspective view of a machine <NUM> for extracting blood components, i.e. a blood components extractor, and in particular of a breaking device <NUM> for breaking a closing element of a blood bag <NUM> associated with said machine <NUM>.

The machine <NUM> for extracting blood components comprises a hanging area where the bag is hung to then be processed. In particular, the hanging area comprises a pair of pins <NUM> which are particularly adapted to receive a pair of through holes made on an end, for example the upper end <NUM>, of a blood bag <NUM>. The blood bag <NUM> comprises at least one cannula <NUM> which extends along a predetermined axial direction X-X.

The breaking device <NUM> is arranged at the hanging area <NUM> and comprises a breaking element <NUM>, which in the embodiment illustrated in <FIG>, has a "U"- shaped cross section, consisting of a pair of parallel arms <NUM> defining a housing area <NUM> therein.

In use, a portion of the cannula <NUM> is positioned in the housing area <NUM>, and in particular the portion of a cannula <NUM> comprising a closing element, for example a frangible septum <NUM>, in such a manner that the interaction of the breaking element <NUM> with the closing element <NUM> allows the breaking of the latter, as is more apparent below.

Naturally, it is possible to provide different embodiments of the breaking element <NUM>, also of known type, without departing from the scope of the present invention as long as said breaking element is capable of breaking the frangible septum <NUM> of a cannula <NUM>.

The breaking device <NUM> according to the present invention comprises at least one operating arrangement comprising an operating device <NUM>, a motor by way of non-limiting example, and an operating element <NUM> operatively connected, in use, to the motor <NUM>.

In one of the possible embodiments illustrated in <FIG>, the motor <NUM> comprises a drive shaft <NUM>, onto one end of which a toothed wheel <NUM>, or pulley, is keyed. The operating element <NUM> comprises a shaft <NUM> onto which first end a toothed wheel <NUM>, or pulley, is keyed, and with which second end the breaking element <NUM> is engaged. According to this configuration, the axis of the shaft <NUM> is arranged parallel to the axis of the drive shaft <NUM>. The operating arrangement further comprises a belt <NUM> or other mechanical drive member.

The drive shaft <NUM> is operatively connected to the shaft <NUM> by means of the belt <NUM> in such a manner as to be placed, in use, into rotation by the motor <NUM>.

The breaking device <NUM> comprises a support plate <NUM> which is particularly adapted to be fixed integral with a frame of the machine <NUM> for extracting blood components. According to alternative embodiments of the present invention, the support plate <NUM> is part of the frame of the machine <NUM> for extracting blood components.

The breaking device <NUM> further comprises a housing <NUM>, arranged movable on the support plate <NUM>. The shaft <NUM> of the operating arrangement is arranged in the housing <NUM>.

The breaking device <NUM> comprises an actuator arrangement <NUM> connected to the support plate <NUM> and to the housing <NUM>, which is particularly adapted to selectively move, in use, the housing <NUM> to or from the support plate <NUM> in order to selectively position the breaking element <NUM> in an engagement position with the closing element <NUM> of the cannula <NUM>, i.e. to adjust the relative position of the breaking element <NUM> with respect to the closing element <NUM>.

As better illustrated in <FIG>, according to one of the possible embodiments of the present invention, the actuator arrangement <NUM> comprises a threaded screw <NUM> inserted in a through hole <NUM> made in a side portion of the plate <NUM> and close to the breaking head <NUM>, and in a through hole <NUM> made in the housing <NUM>. The through hole <NUM> comprises a threaded surface therein having the same characteristics as the threading of the screw <NUM> in such a manner as to form a screw-leadscrew coupling together with the threaded screw <NUM>.

Naturally, the embodiments herein described and illustrated are only one of the possible embodiments of an actuator arrangement capable of selectively positioning the breaking element <NUM> in an engagement position with the closing element <NUM> of the cannula <NUM>. For example, it is possible to provide for hydraulic, electric, electromagnetic and/or electrostatic actuators, operated manually or by means of further operating arrangements, as described below.

According to a further embodiment of the present invention, the breaking device <NUM> comprises a vertically extending sliding guide <NUM>, i.e. according to the predetermined axial direction X-X, coupled to the housing <NUM>.

In the embodiment illustrated in <FIG>, the sliding guide <NUM> comprises a guide pin <NUM> inserted protruding in a through hole made on the support plate <NUM>. A sleeve <NUM>, or other vertically extending tubular structure, is engaged with the pin <NUM>.

The housing <NUM> is slidably constrained to the sleeve <NUM> of the guide pin <NUM> by means of a second through hole <NUM>.

Naturally, the embodiments herein described and illustrated are only one of the possible embodiments of a sliding guide capable of promoting the translation of the breaking element <NUM> along a predetermined axial direction.

A further one of the embodiments of the present invention illustrated in <FIG> and <FIG> provides for an operating arrangement comprising an operating device <NUM>, a motor by way of non-limiting example, and an operating element <NUM> operatively connected, in use, to the motor <NUM>.

The motor <NUM> comprises a drive shaft <NUM> and the operating element <NUM> comprises a shaft <NUM> directly engaged with a first end thereof with the drive shaft <NUM>. The second end of the shaft <NUM> is engaged with the breaking element <NUM>. According to this configuration, the shaft <NUM> is arranged in alignment with the drive shaft <NUM>.

Here too, the actuator arrangement <NUM> comprises a threaded screw <NUM> inserted in a through hole made in a middle portion of the plate <NUM> and in a through hole made in the housing <NUM>. The through hole comprises a threading therein having the same characteristics as the threading of the screw <NUM> in such a manner as to form a screw-leadscrew coupling together with the threaded screw <NUM>.

Similarly, the sliding guide <NUM> comprises a guide pin inserted protruding in a through hole made on the support plate <NUM>. A sleeve <NUM>, or other vertically extending tubular structure, is engaged with the guide pin.

The housing <NUM> is slidably constrained to the sleeve <NUM> of the guide pin by means of a second through hole.

With reference now to <FIG>, according to a further one of the embodiments of the present invention, the breaking device <NUM> comprises a first operating arrangement comprising an operating device <NUM>, a motor by way of non-limiting example, and an operating element <NUM> operatively connected, in use, to the motor <NUM>.

As described above with reference to <FIG>, in one of the possible embodiments of the present invention, the motor <NUM> comprises a drive shaft <NUM> operatively connected to a shaft <NUM> of the operating element <NUM> by means of a belt <NUM> and a pair of pulleys <NUM>, <NUM> respectively keyed onto the drive shaft <NUM> and onto the shaft <NUM>. The breaking element <NUM> is engaged at an end of the shaft <NUM>.

The breaking device <NUM> may comprise a support plate <NUM> which is particularly adapted to be fixed integral with a frame of the machine <NUM> for extracting blood components, and a housing <NUM>, arranged movable on the support plate <NUM>. The shaft <NUM> is arranged in the housing <NUM>. According to alternative embodiments of the present invention, the support plate <NUM> is part of the frame of the machine <NUM> for extracting blood components.

The breaking device <NUM> comprises an actuator arrangement <NUM> connected to the support plate <NUM>, which is particularly adapted to selectively move, in use, the housing <NUM> to or from the support plate <NUM> in order to selectively position the breaking element <NUM> in an engagement position with the closing element <NUM> of the cannula <NUM>, i.e. to adjust the relative position of the breaking element <NUM> with respect to the closing element <NUM>. According to this embodiment, the actuator arrangement <NUM> comprises a threaded screw <NUM> inserted in a through hole <NUM> made in a middle portion of the plate <NUM> but arranged opposite to the end of the shaft <NUM> connected to the breaking head <NUM>, and in a through hole <NUM> made in the housing <NUM>. The through hole <NUM> comprises a threading therein having the same characteristics as the threading of the screw <NUM> in such a manner as to form a screw-leadscrew coupling together with the threaded screw <NUM>.

A conical toothed wheel <NUM> is fixed on the upper portion of the threaded screw <NUM>.

The breaking device <NUM> comprises a second operating arrangement, comprising a motor <NUM> and a drive shaft <NUM>. A second conical toothed wheel <NUM> is fixed on the outer end of the drive shaft <NUM>, which wheel is engaged with the first toothed wheel <NUM> to transmit, in use, a rotating movement to the threaded screw <NUM> of the actuator arrangement <NUM>. Here too, the embodiments herein described and illustrated are only one of the possible embodiments of the second actuator arrangement capable of selectively operating the first actuator arrangement to bring the breaking element <NUM> in an engagement position with the closing element <NUM> of the cannula <NUM>. For example, it is possible to provide different hydraulic, electric, electromagnetic and/or electrostatic actuators.

The breaking device <NUM> further comprises a vertically extending sliding guide <NUM> coupled to the housing <NUM>.

In the embodiment illustrated in <FIG>, the sliding guide <NUM> comprises two guide pins <NUM> each inserted protruding in a through hole made on the support plate <NUM>. A sleeve <NUM>, or other vertically extending tubular structure, is engaged with each pin <NUM>. According to this configuration, the housing <NUM> is slidably constrained to the sleeves <NUM> of the guide pins <NUM> by means of a pair of through holes <NUM> made on the two corner ends of the housing <NUM> in the portion arranged close to the shaft <NUM> connected to the breaking head <NUM>.

In use, a bag <NUM> is hung on a blood components extractor <NUM>, and in particular on the pins <NUM>. A cannula <NUM> of the bag <NUM> is inserted in the housing area <NUM> of the breaking element <NUM>. Then, the operating arrangement is actuated, and in particular the motor <NUM> is actuated, providing the drive shaft <NUM> with a reciprocating rotating motion according to a predetermined cycle. The drive shaft <NUM> transmits the reciprocating rotating motion to the shaft <NUM> by means of the pulleys <NUM>, <NUM> and the belt <NUM>. The shaft <NUM> carries the breaking head <NUM> to rotate according to a reciprocating rotating motion in two opposite directions, thus folding the portion of cannula <NUM> contained in the housing <NUM> according to two opposite directions until the frangible septum <NUM> breaks due to the transverse stresses received.

Once the frangible septum <NUM> has broken, the blood components extractor <NUM> completes the operating cycle thereof and the bag <NUM> is replaced with a new bag <NUM>.

If the new bag <NUM> comprises a cannula <NUM> in which the frangible septum <NUM> is arranged in the same relative position as the bag <NUM>, the above steps are repeated.

If the new bag <NUM> comprises a cannula <NUM> in which the frangible septum <NUM> is arranged along the predetermined axial direction X-X in a different relative position with respect to the preceding bag, and if the frangible septum <NUM> is no longer arranged in the housing <NUM>, it is necessary to modify the position of the breaking element <NUM> along the predetermined axial direction X-X prior to activating the operating arrangement so that the housing <NUM> is arranged at the frangible septum <NUM>.

According to the embodiments illustrated in <FIG>, the operator activates the actuator arrangement <NUM> by bringing the threaded screw <NUM> into rotation. The rotation direction of the threaded screw <NUM> depends on the position of the frangible septum with respect to the breaking element <NUM>. A first rotation direction brings the housing <NUM> towards the plate <NUM>, and therefore lower with respect to the machine <NUM>, along the predetermined axial direction X-X. A second rotation direction brings the housing <NUM> away from the plate <NUM>, and therefore higher with respect to the machine <NUM>, along the predetermined axial direction X-X, as illustrated in <FIG>.

Once the housing <NUM> is arranged at the frangible septum <NUM>, i.e. the breaking element <NUM> is aligned with the frangible septum, the operating arrangement is activated to allow the breaking of the frangible septum <NUM>, as described above.

According to the embodiment illustrated in <FIG>, if the frangible septum <NUM> of a bag <NUM> is not arranged in the housing <NUM>, the position of the breaking element <NUM> is modified, activating the second operating arrangement, and in particular the motor <NUM>. A rotation of the drive shaft <NUM> brings into rotation the conical toothed wheel <NUM>, which in turn drags into rotation the conical toothed wheel <NUM>, which allows the rotation of the threaded screw <NUM>.

The rotation direction of the threaded screw <NUM>, and therefore of the drive shaft <NUM>, depends on the position of the frangible septum with respect to the breaking element <NUM>. A first rotation direction brings the housing <NUM> towards the plate <NUM>, and therefore lower with respect to the machine <NUM>, along the predetermined axial direction X-X. A second rotation direction brings the housing <NUM> away from the plate <NUM>, and therefore higher with respect to the machine <NUM>, along the predetermined axial direction X-X, as illustrated in <FIG>.

Claim 1:
A breaking device for breaking a closing element of a medical container, comprising:
- an operating arrangement comprising an operating device (<NUM>) and an operating element (<NUM>) connected to the operating device (<NUM>),
- a breaking element (<NUM>) connected to the operating element (<NUM>) and particularly adapted to break the closing element (<NUM>) of the medical container (<NUM>),
wherein the breaking device (<NUM>) further comprises:
- a support plate (<NUM>),
- a housing (<NUM>) arranged movable with respect to the support plate (<NUM>) according to a predetermined axial direction (X-X), the operating element (<NUM>) being arranged in the housing (<NUM>), and
- a first actuator arrangement (<NUM>) connected to the support plate (<NUM>) and interacting with the housing (<NUM>) to selectively move the housing (<NUM>) along said predetermined axial direction (X-X) so as to selectively position the breaking element (<NUM>) in a breaking position with the closing element (<NUM>) of the medical container (<NUM>).