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Title:
METHOD AND APPARATUS TO COLLECT AND MIX HEMATIC FLUID
Document Type and Number:
WIPO Patent Application WO/2016/084001
Kind Code:
A1
Abstract:
A method (100) to collect and mix a determinate volume or weight of a hematic fluid for use in the field of medical blood transfusions comprises: starting transfer procedure (102), positioning sac and tube (104), starting the hematic fluid transfer (108) with starting mixing the hematic fluid contained in the sac, a first reading and display of the current volume or weight (110) of the hematic fluid contained in the sac, a first verification of flow rate control (112), a verification of the last fraction of volume or weight (116) to complete the final volume or weight provided in the sac for the hematic fluid transfer, stop of mixing (118), a second reading and display of the current volume or weight (120) of the hematic fluid contained in the sac, a second verification of flow rate control (122), a verification of the target volume or weight collected (126), the stoppage of the hematic fluid transfer (128) and the end of hematic fluid transfer procedure (130).

Inventors:
SALA NORBERTO (IT)
Application Number:
PCT/IB2015/059086
Publication Date:
June 02, 2016
Filing Date:
November 24, 2015
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
DELCON S R L (IT)
International Classes:
B01F11/00; A61M1/02
Domestic Patent References:
WO1995004557A11995-02-16
Foreign References:
DE19623368A11997-12-18
ITMI20122026A12014-05-29
FR2603190A11988-03-04
US3924700A1975-12-09
FR2574540A11986-06-13
FR2544220A21984-10-19
Other References:
None
Attorney, Agent or Firm:
PETRAZ, Davide Luigi et al. (Viale Europa Unita 171, Udine, IT)
Download PDF:
Claims:
CLAIMS

1. Method to collect and mix a determinate volume or weight of a hematic fluid for use in the field of medical blood transfusions, characterized in that said method comprises:

- starting transfer procedure ( 102);

- positioning sac and tube (104), wherein a collection sac is positioned on a support plate (202), and a transfer tube is connected to the collection sac and clamped by means of a clamp (208);

- verifying start-up command (106);

- if the verification of the start-up command (106) is positive, passing to the start of the hematic fluid transfer (108) with start of mixing the hematic fluid contained in the sac, otherwise, if it is negative, the verification of start-up command (106) is repeated;

- after starting the hematic fluid transfer (108), carrying out a first reading and display of the current volume or weight (1 10) of the hematic fluid contained in the sac;

- first verification of flow rate control (1 12);

- if the first verification of flow rate control (112) is positive and an error is verified in the flow rate of hematic fluid, a first signal of flow rate error (1 14) is provided and the method continues repetitively from the first reading and display of the current volume or weight (110), if the first verification of flow rate control (1 12) is negative and an error is not verified in the flow rate of hematic fluid, a verification of the last fraction of volume or weight (1 16) is provided to complete the final volume or weight provided in the sac for the hematic fluid transfer;

- if the verification of the last fraction of volume or weight (116) is positive, the method provides to stop the mixing (1 18), if the verification of the last fraction of volume or weight (1 16) is negative, the method continues repetitively from the first reading and display of the current volume or weight (1 10);

- a second reading and display of the current volume or weight (120) of the hematic fluid contained in the sac, after stop of mixing (1 18);

- second verification of flow rate control (122);

- if the second verification of flow rate control (122) is positive and an error is verified in the flow rate of hematic fluid, a second signal of flow rate error (124) is provided and the method continues repetitively from the second reading and display of the current volume or weight (120), if the second verification of flow rate control (122) is negative and an error is not verified in the flow rate of hematic fluid, a verification is provided of the target volume or weight collected (126);

- if the verification of the target volume or weight collected (126) is positive, the method provides to stop the hematic fluid transfer (128), if the verification of the target volume or weight collected (126) is negative, it continues repetitively from the second reading and display of the current volume or weight (120);

- end of hematic fluid transfer procedure (130), after the stoppage of the hematic fluid transfer (128).

2. Method as in claim 1, wherein the start of the hematic fluid transfer comprises:

- start of transfer (132);

- reading the tare (134) of a support plate (202) of the collection sac;

- starting the mixing motor (136), wherein a movement of the support plate (202) is started to mix the hematic fluid;

- opening the clamp (138) to enable the flow of hematic fluid through the tube, toward the sac;

- end of start of transfer (140).

3. Method as in claim 2, wherein after the start of transfer (132) the method provides to acquire the initial tare of the support plate (202), and subsequently a drive member (207) is started that moves the support plate (202) for the mixing and the clamp opens (208) to enable the flow of hematic fluid toward the sac and wherein, after the end of start of transfer (140), the method begins to acquire the volume or weight of the hematic fluid contained in the sac with the first reading and display of the current volume or weight (1 10) and to calculate the average flow rate of the hematic fluid, wherein the first reading and display of the current volume or weight (110) is carried out when the support plate (202) is in a horizontal position or as near as possible to horizontal.

4. Method as in claim 1, 2 or 3, wherein both the first reading and display of the current volume or weight (1 10) and also the second reading and display of the current volume or weight (120) comprise:

- start of volume or weight reading (142); - verification of support plate in reading position (144);

- reading of current volume or weight (146);

- end of volume or weight reading (148);

wherein if the verification of the support plate in reading position (144) is positive, the method continues with the reading of the current volume or weight (146), while if the verification of the support plate in reading position (144) is negative, it passes to the end of volume or weight reading (148).

5. Method as in any of the claims from 1 to 4, wherein both the first verification of flow rate control (112) and the second verification of flow rate control (122) comprise:

- start of verification of flow rate (150);

- calculation of current flow rate (1 2),

- verification of minimum flow rate (154), wherein it is verified if the current flow rate is less than a minimum pre-set flow rate;

- verification of maximum flow rate (156), wherein it is verified if the current flow rate is greater than a maximum pre-set flow rate;

- end of control with no signal of flow rate error (162);

wherein, if the verification of minimum flow rate (154) is positive, a signal of minimum flow rate error (158) is provided, if the verification of minimum flow rate (154) is negative, the method passes to the verification of maximum flow rate (156) and wherein, moreover, if the verification of maximum flow rate (156) is positive, a signal of maximum flow rate error (160) is provided, if the verification of maximum flow rate (156) is negative, it passes to the end of control with no signal of flow rate error (162).

6. Method as in any of the claims from 1 to 5, wherein the stoppage of the transfer of hematic fluid (128) comprises:

- starting the stoppage operation (164);

- closing the clamp (166) to stop the flow;

- signal of end of transfer of the hematic fluid (168);

- memorization of the results of the transfer of the hematic fluid (170);

- end of stoppage operation (172).

7. Apparatus to collect and mix a determinate volume or weight of hematic fluid for use in the field of medical blood transfusions, characterized in that said apparatus comprises:

- a support plate (202), to receive and support a collection sac fluidically connected to a transfer tube of the hematic fluid;

- a sensor unit (204) configured to detect the weight force acting on the support plate (202),

- a movement unit (206) configured to move the support plate (202) to determine the mixing of the hematic fluid in the collection sac;

- a clamp (208) to selectively stop the flow of hematic fluid in the transfer tube;

- a control card (210) configured to receive a signal of volume or weight from the sensor unit (204) and to calculate the current flow rate of hematic fluid;

- a user interface (212) provided with an insertion device (214) and a display device (216) associated to the control card (210).

8. Apparatus as in claim 7, wherein the sensor unit (204) comprises one or more load cells.

9. Apparatus as in claim 7 or 8, wherein the movement unit (206) is configured to determine an alternate rotational or oscillatory motion of the support plate (202), in particular a rotational or alternate motion chosen from either a two- dimensional motion or a three-dimensional motion.

10. Apparatus as in claim 7, 8 or 9 wherein the control card (210) comprises a central processing unit (203), an electronic memory (205) and a possible timer (215).

11. Apparatus as in any of the claims from 7 to 10, said apparatus comprising a sensor member (244) able to identify a position of the support plate (202) before detecting the weight force acting on the support plate (202).

12. Apparatus as in any of the claims from 7 to 11, wherein the movement unit (206) comprises a drive member (207), provided with a drive shaft (213), configured to determine the movement of the support plate (202) and mounted on a motor support frame (211) associated to the sensor unit (204).

13. Apparatus as in claim 12, wherein said movement unit (206) comprises a rotary disc (232) drivable in rotation by the drive shaft (213) and provided with an eccentric pin (234), an oscillation bar (236) being provided connected on one side to the support plate (202), on the other side connected slidingly to the eccentric pin (234) and hinged in an intermediate position to the motor support frame (21 1) by means of an oscillation pin (237), the oscillation bar (236) having a sliding slot (238), inside which the eccentric pin (234) is slidingly housed, to determine an oscillation of the support plate (202) in a two-dimensional plane.

14. Apparatus as in claims 11 and 13, wherein the sensor member (244) is configured to cooperate with a position blade (233) associated with the rotary disc (232).

15. Apparatus as in claim 12, wherein said movement unit (206) comprises an oscillation disc (248) which on one side is solid with the support plate (202) and on the other side is connected rotatably to the drive shaft (213) by means of a hinging device (250) configured to determine an oscillation in space of the oscillation disc (248), the oscillation disc (248) having an oscillation seating (249), cooperating with the hinging device (250).

16. Apparatus as in claim 15, wherein said hinging device (250) includes an adapter (252) inserted solid on the drive shaft (213) and, moreover, inserted in the oscillation seating (249), said adapter (252) having an inclined shaped end (254) that cooperates with the oscillation seating (249), an orientable bearing (258) being provided inserted on the shaped end (254).

17. Apparatus as in claim 16, wherein said orientable bearing (258) provides an internal ring (260), solid with the shaped end (254), an external ring (262), solid with the oscillation seating (249), intermediate balls (264) between the internal ring (260) and the external ring (262) and sliding along annular guide grooves (266) configured to allow axial mobility, as well as circular mobility, of the balls (264).

18. Apparatus as in claims 11 and 16 or 11 and 17, wherein the sensor member (244) is configured to cooperate with a position blade (233) associated with the adapter (252).

19. Apparatus as in any of the claims from 15 to 18, wherein the movement unit (206) comprises springs (268), fitted on fixed pins (270) disposed on the motor support frame (211) and inserted in through holes (272) made in the oscillation disc (248), said springs (268) being in abutment against the motor support frame (211) and the oscillation disc (248).

20. Computer program memorizable in a mean readable by a computer that contains the instructions that, once carried out by an apparatus as in any of the claims from 7 to 19, determine the execution of the method as in any of the claims from 1 to 6.

Description:
"METHOD AND APPARATUS TO COLLECT AND MIX A HEMATIC FLUID"

FIELD OF THE INVENTION

Forms of embodiment described here concern a method and an apparatus to collect and mix a determinate volume or weight of a hematic fluid, usable in the medical field in particular to collect and mix blood, blood components and/or blood products, more in particular in the course of hematic fluid transfer/collection procedures.

BACKGROUND OF THE INVENTION

It is known that, in the field of medical blood transfusions, the blood, or blood components (haemoderivatives and/or haemocomponents), or hematic fluids in general, can be taken from and/or respectively supplied to the patient using sacs, normally containing an anti-coagulant, connected to plastic tubes inside which the blood or its components flow.

For example, in the case of blood donations, the donor is made to lie on a bed, a hemostatic tourniquet is applied on one arm and a needle is inserted in a vein. The needle is connected to a tube, in turn connected to a sac to collect the blood. The blood flows spontaneously until it fills the collection sac in which an anti- coagulant solution or liquid are already contained, and also other substances or solutions useful for preserving the blood in the best possible way. Before the needle is removed at the end of the donation, some test tubes are filled so that the tests laid down by law can be carried out. The volume of blood removed is generally established by law, to guarantee an adequate preparation of the haemocomponents (concentrates of red corpuscles, platelets, plasma units), and also to prevent complications for the donor. For example, in Italy, the volume of blood taken in a donation is established by the Ministerial Decree of 3/3/2005, and is 450 ml±10%.

In this context, therefore, it is necessary to measure the volume of hematic fluid that is taken from and/or supplied to the patient, quantifying the volume of fluid in the sacs. The quantification must be sufficiently precise, reliable and repeatable over time. It is also known that the sacs must be kept continuously moved as they are filled with the hematic fluid, in order to mix the hematic fluid in the course of the procedures to transfer it and collect it in sacs, and prevent coagulation.

There is therefore a need to perfect a method and an apparatus to collect and mix a determinate volume or weight of hematic fluid that can overcome at least one of the disadvantages of the state of the art.

The Applicant has devised, tested and embodied the present invention to overcome the shortcomings of the state of the art and to obtain these and other purposes and advantages.

SUMMARY OF THE INVENTION

The present invention is set forth and characterized in the independent claims, while the dependent claims describe other characteristics of the invention or variants to the main inventive idea.

In accordance with some forms of embodiment, a method is provided to collect and mix a determinate volume or weight of a hematic fluid. According to one form of embodiment, the method comprises:

- starting transfer procedure;

- positioning sac and tube, wherein a collection sac is positioned on a support plate, and a transfer tube is connected to the collection sac and clamped by means of a clamp;

- verifying start-up command;

- if the verification of the start-up command is positive, passing to the start of the hematic fluid transfer with start of mixing the hematic fluid contained in the sac, otherwise, if it is negative, the verification of start-up command is repeated;

- after starting the hematic fluid transfer, carrying out a first reading and display of the current volume or weight of the hematic fluid contained in the sac;

- first verification of flow rate control;

- if the first verification of flow rate control is positive and an error is verified in the flow rate of hematic fluid, a first signal of flow rate error is provided and the method continues repetitively from the first reading and display of the current volume or weight, if the first verification of flow rate control is negative and an error is not verified in the flow rate of hematic fluid, a verification of the last fraction of volume or weight is provided to complete the final volume or weight provided in the sac for the hematic fluid transfer;

- if the verification of the last fraction of volume or weight is positive, the method provides to stop the mixing, if the verification of the last fraction of volume or weight is negative, the method continues repetitively from the first reading and display of the current volume or weight;

- a second reading and display of the current volume or weight of the hematic fluid contained in the sac, after the mixing has stopped;

- second verification of flow rate control;

- if the second verification of flow rate control is positive and an error is verified in the flow rate of hematic fluid, a second signal of flow rate error is provided and the method continues repetitively from the second reading and display of the current volume or weight, if the second verification of flow rate control is negative and an error is not verified in the flow rate of hematic fluid, a verification is provided of the target volume or weight collected;

- if the verification of the target volume or weight collected is positive, the method provides to stop the hematic fluid transfer, if the verification of the target volume or weight collected is negative, it continues repetitively from the second reading and display of the current volume or weight;

- end of hematic fluid transfer procedure, after the stoppage of the hematic fluid transfer.

According to one form of embodiment, the start of the hematic fluid transfer comprises:

- start of transfer;

- reading the tare of a support plate of the collection sac;

- starting the mixing motor, wherein a movement of the support plate is started to mix the hematic fluid;

- opening the clamp to enable the flow of hematic fluid through the tube, toward the sac;

- end of start of transfer.

According to one form of embodiment, after the start of transfer the method provides to acquire the initial tare of the support plate, and subsequently a drive member is started that moves the support plate for the mixing and the clamp opens to enable the flow of hematic fluid toward the sac and wherein, after the end of start of transfer, the method begins to acquire the volume or weight of the hematic fluid contained in the sac with the first reading and display of the current volume or weight and to calculate the average flow rate of the hematic fluid, wherein the first reading and display of the current volume or weight is carried out when the support plate is in a horizontal position or as near as possible to horizontal.

In some forms of embodiment, it may be possible to initially close the clamp, before starting the transfer of hematic fluid, to prevent any air entering into the tube, and subsequently, as we said, to open the clamp to enable the flow of hematic fluid through the tube, toward the sac.

According to one form of embodiment, both the first reading and display of the current volume or weight and also the second reading and display of the current volume or weight comprise:

- start of volume or weight reading;

- verification of support plate in reading position;

- reading of current volume or weight;

- end of volume or weight reading;

wherein if the verification of the support plate in reading position is positive, the method continues with the reading of the current volume or weight, while if the verification of the support plate in reading position is negative, it passes to the end of volume or weight reading.

According to one form of embodiment, both the first verification of flow rate control and the second verification of flow rate control comprise:

- start of verification of flow rate;

- calculation of current flow rate,

- verification of minimum flow rate, wherein it is verified if the current flow rate is less than a minimum pre-set flow rate;

- verification of maximum flow rate, wherein it is verified if the current flow rate is greater than a maximum pre-set flow rate;

- end of control with no signal of flow rate error;

wherein, if the verification of minimum flow rate is positive, a signal of minimum flow rate error is provided, if the verification of minimum flow rate is negative, the method passes to the verification of maximum flow rate and wherein, moreover, if the verification of maximum flow rate is positive, a signal of maximum flow rate error is provided, if the verification of maximum flow rate is negative, it passes to the end of control with no signal of flow rate error.

According to one form of embodiment, the stoppage of the transfer of hematic fluid comprises:

- starting the stoppage operation;

- closing the clamp to stop the flow;

- signal of end of transfer of the hematic fluid;

- memorization of the results of the transfer of the hematic fluid;

- end of stoppage operation.

According to some forms of embodiment, an apparatus is provided to collect and mix a determinate volume or weight of hematic fluid for use in the field of medical blood transfusions. According to one form of embodiment, the apparatus comprises:

- a support plate, to receive and support a collection sac fluidically connected to a transfer tube of the hematic fluid;

- a sensor unit configured to detect the weight force acting on the support plate;

- a movement unit configured to move the support plate to determine the mixing of the hematic fluid in the collection sac;

- a clamp to selectively stop the flow of hematic fluid in the transfer tube;

- a control card configured to receive a signal of volume or weight from the sensor unit and to calculate the current flow rate of hematic fluid;

- a user interface provided with an insertion device and a display device associated to the control card.

According to some forms of embodiment, the sensor unit comprises one or more load cells.

According to one form of embodiment, the movement unit is configured to determine an alternate rotational or oscillatory motion of the support plate, in particular a rotational or alternate motion chosen from either a two-dimensional motion or a three-dimensional motion.

According to one form of embodiment, the control card comprises a central processing unit, an electronic memory and a possible timer. According to one form of embodiment, the apparatus comprises a sensor member able to identify a position of the support plate before detecting the weight force acting on the support plate.

According to one form of embodiment, the movement unit comprises a drive member, provided with a drive shaft, configured to determine the movement of the support plate and mounted on a motor support frame associated to the sensor unit.

According to one form of embodiment, the movement unit comprises a rotary disc drivable in rotation by the drive shaft and provided with an eccentric pin, an oscillation bar being provided connected on one side to the support plate, on the other side connected slidingly to the eccentric pin and hinged in an intermediate position to the motor support frame by means of an oscillation pin. The oscillation bar has a sliding slot, inside which the eccentric pin is slidingly housed, to determine an oscillation of the support plate in a two-dimensional plane.

According to one form of embodiment, the sensor member is configured to cooperate with a position blade associated with the rotary disc.

According to one form of embodiment, the movement unit comprises an oscillation disc which on one side is solid with the support plate and on the other side is connected rotatably to the drive shaft by means of a hinging device configured to determine an oscillation in space of the oscillation disc, the oscillation disc having an oscillation seating, cooperating with the hinging device.

According to one form of embodiment, the hinging device includes an adapter inserted solid on the drive shaft and, moreover, inserted in the oscillation seating, said adapter having an inclined shaped end that cooperates with the oscillation seating, an orientable bearing being provided inserted on the shaped end.

According to one form of embodiment, the orientable bearing provides an internal ring, solid with the shaped end, an external ring, solid with the oscillation seating, intermediate balls between the internal ring and the external ring and sliding along annular guide grooves configured to allow axial mobility, as well as circular mobility, of the balls. According to one form of embodiment, the sensor member is configured to cooperate with a position blade associated with the adapter.

According to one form of embodiment, the movement unit comprises springs, fitted on fixed pins disposed on the motor support frame and inserted in through holes made in the oscillation disc. The springs are in abutment against the motor support frame and the oscillation disc.

According to some forms of embodiment, a computer program is provided, memorizable in a mean readable by a computer that contains the instructions that, once carried out by an apparatus according to the present description, determine the execution of the method for mixing a hematic fluid as described here.

These and other aspects, characteristics and advantages of the present disclosure will be better understood with reference to the following description, drawings and attached claims. The drawings, which are integrated and form part of the present description, show some forms of embodiment of the present invention, and together with the description, are intended to describe the principles of the disclosure.

The various aspects and characteristics described in the present description can be applied individually where possible. These individual aspects, for example aspects and characteristics described in the attached dependent claims, can be the object of divisional applications.

It is understood that any aspect or characteristic that is discovered, during the patenting process, to be already known, shall not be claimed and shall be the object of a disclaimer.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other characteristics of the present invention will become apparent from the following description of some forms of embodiment, given as a non- restrictive example with reference to the attached drawings wherein:

- fig. 1 is a flow chart of a method to collect and mix a hematic fluid in accordance with forms of embodiment described here;

- fig. 2 is a flow chart of part of a method to collect and mix a hematic fluid in accordance with forms of embodiment described here;

- fig. 3 is a flow chart of part of a method to collect and mix a hematic fluid in accordance with forms of embodiment described here; - fig. 4 is a flow chart of part of a method to collect and mix a hematic fluid in accordance with forms of embodiment described here;

- fig. 5 is a flow chart of part of a method to collect and mix a hematic fluid in accordance with forms of embodiment described here;

- fig. 6 is a block diagram of an apparatus to collect and mix a hematic fluid in accordance with forms of embodiment described here;

- fig. 7 is a schematic perspective view of an apparatus to collect and mix a hematic fluid in accordance with forms of embodiment described here;

- fig. 8 is a schematic perspective view of an apparatus to collect and mix a hematic fluid in accordance with other forms of embodiment described here;

- fig. 9 is a block diagram of an apparatus to collect and mix a hematic fluid in accordance with forms of embodiment described here;

- fig. 10 is a schematic perspective view of part of an apparatus to collect and mix a hematic fluid in accordance with forms of embodiment described here;

- fig. 1 1 is an enlarged detail of fig. 10;

- fig. 12 is a schematic perspective view of part of an apparatus to collect and mix a hematic fluid in accordance with other forms of embodiment described here;

- fig. 13 is an enlarged and partly sectioned detail of fig. 12.

To facilitate comprehension, the same reference numbers have been used, where possible, to identify identical common elements in the drawings. It is understood that elements and characteristics of one form of embodiment can conveniently be incorporated into other forms of embodiment without further clarifications.

DETAILED DESCRIPTION OF SOME FORMS OF EMBODIMENT

We shall now refer in detail to the various forms of embodiment of the present invention, of which one or more examples are shown in the attached drawing. Each example is supplied by way of illustration of the invention and shall not be understood as a limitation thereof. For example, the characteristics shown or described insomuch as they are part of one form of embodiment can be adopted on, or in association with, other forms of embodiment to produce another form of embodiment. It is understood that the present invention shall include all such modifications and variants. We must point out here that the expressions "blood" and "blood components" as used in the forms of embodiment described here can refer respectively to whole blood and to haemoderivatives or haemocomponents, i.e. blood components extracted from whole blood after a centrifugation process. The blood components can be concentrates of red corpuscles, platelets, plasma, buffy coats - the latter being an intermediate component formed by a mixture of plasma, red corpuscle concentrates, white corpuscle concentrates and platelets that is created after the centrifugation process of the whole blood.

We must point out here that a blood sac as used in the forms of embodiment described here can be a sterile sac, in particular a disposable sterile blood sac or for plasmapheresis or similar container made of flexible material, in particular plastic, more in particular made of polyvinyl chloride (PVC). A sac as used in the forms of embodiment described here can be a single sac or a multiple sac, for example double, triple, quadruple, multiple with six sacs, multiple sacs with sampling sac.

It is possible to use sacs with a sampling point, sacs for auto-transfusion, satellite sacs, sacs with a filter for whole blood, umbilical cord sacs, single sacs for collecting blood from the umbilical cord with possible integrated sampling. The sacs used in the forms of embodiment described here can contain an anti- coagulant solution and other additives to preserve the hematic fluid, for example an anti-coagulant solution of citrate-phosphate-dextrose-adenine (indicated as CPD-A), or a solution of additives to preserve the platelets, or a solution of SAGM additives (saline solution, adenine, glucose, mannitol) or AS-3 (saline solution, adenine, glucose and also citrate and phosphate). The sacs usable in the forms of embodiment described here can have a volume capacity from 150 ml to 600 ml, for example 150 ml, 300 ml, 350 ml, 400 ml, 450 ml, 600 ml.

We must point out here that a tube as used in the forms of embodiment described here can be a tube for use in the field of medical blood transfusions, a flexible tube, a test tube, a pipe, a standard tube for disposable blood sacs or for plasmapheresis. For example, a tube as used in the forms of embodiment described here can be a plastic tube, in particular PVC. A tube as used in the forms of embodiment described here can be an elongated hollow tubular body with a determinate diameter that can vary, by way of non-restrictive example, from about 2.7 mm to about 6 mm, and which has a lateral wall defining internally a passage channel. The lateral wall can have a determinate thickness that can vary, for example, from about 0.4 mm to about 1.0 mm.

Fig. 1 is used to describe a method 100 to collect and mix a determinate volume or weight of hematic fluid according to the present description, usable in a possible procedure to transfer/collect a desired quantity, weight or volume of hematic fluid in a collection sac. For example, the transfer procedure can be a procedure to transfer hematic fluid of the blood. It must be considered that weight and volume are correlated by the specific weight or density of the substance in question, in this case the hematic fluid, so that, depending on whether a signal of desired volume or weight is determined, read, displayed or transmitted, it could be necessary to consider a conversion. The desired weight or volume can be programmable.

The method 100 provides:

- starting transfer procedure 102 of the hematic fluid;

- positioning sac and tube 104, wherein a collection sac is positioned on a support plate or tray, and a transfer tube is connected to the collection sac and clamped by means of a clamp;

- verifying start-up command 106;

- if the verification of the start-up command 106 is positive, passing to the start of the hematic fluid transfer 108 with start of mixing the hematic fluid contained in the sac, otherwise, if it is negative, the verification of start-up command 106 is repeated;

- after starting the hematic fluid transfer 108, carrying out a first reading and display of the current volume or weight 1 10 of the hematic fluid contained in the sac;

- first verification of flow rate control 1 12;

- if the first verification of flow rate control 112 is positive, i.e. an error is verified in the flow rate of hematic fluid, a first signal of flow rate error 1 14 is provided and the method continues repetitively from the first reading and display of the current volume or weight 110, if the first verification of flow rate control 112 is negative, i.e. an error is not verified in the flow rate of hematic fluid, a verification of the last fraction of volume or weight 116 is provided to complete the final volume or weight provided in the sac for the hematic fluid transfer;

- if the verification of the last fraction of volume or weight 116 is positive, the method provides to stop the mixing 118, if the verification of the last fraction of volume or weight 116 is negative, the method continues repetitively from the first reading and display of the current volume or weight 1 10;

- a second reading and display of the current volume or weight 120 of the hematic fluid contained in the sac, after stop of mixing 1 18;

- second verification of flow rate control 122;

- if the second verification of flow rate control 122 is positive, i.e. an error is verified in the flow rate of hematic fluid, a second signal of flow rate error 124 is provided and the method continues repetitively from the second reading and display of the current volume or weight 120, if the second verification of flow rate control 122 is negative, i.e. an error is not verified in the flow rate of hematic fluid, a verification is provided of the target volume or weight collected 126;

- if the verification of the target volume or weight collected 126 is positive, the method provides to stop the hematic fluid transfer 128, if the verification of the target volume or weight collected 126 is negative, the procedure continues repetitively from the second reading and display of the current volume or weight 120;

- after the stoppage of the hematic fluid transfer 128, the method provides the end of hematic fluid transfer procedure 130.

Therefore, the transfer of the hematic fluid starts by positioning the sac on the support plate and inserting the tube into the clamp to control the flow, and hence the flow rate. The transfer proper starts at the moment the verifying start-up command 106 is positive and the hematic fluid transfer 108 starts.

In possible implementations, the verification of the last fraction of volume or weight 1 16 controls that a determinate volume remains, before the conclusion of the transfer procedure, for example 25 ml or in any case a value from 5% to 10%, in particular from 5% to 7.5% of the value of the final target volume to be achieved in the collection sac. The final target volume is in relation to the volumetric capacity of the sac as discussed above. Advantageously, to improve the precision in weighing or measuring the volume, when about 25-30 ml of the final volume is still to be transferred, the mixing movement stops and the volume is read continuously until, for example, 450 ml is reached. Then the clamp closes and the acoustic and visual signal that the hematic fluid transfer has finished is activated.

According to some forms of embodiment, the start of the hematic fluid transfer 108 can be a routine in the method according to the present description which can be implemented to manage the operations that allow to start the hematic fluid transfer.

In particular, fig. 2 is used to describe forms of embodiment of the start of the hematic fluid transfer 108 usable in combination with the forms of embodiment described using fig. 1. In particular, the start of the hematic fluid transfer 108 can include:

- start of transfer 132 of the hematic fluid;

- reading the tare 134 of a support plate or tray of the collection sac;

- starting the mixing motor 136, wherein a movement, for example a rotation or oscillation, of the support plate 202 is started to mix the hematic fluid which will gradually fill the sac;

- opening the clamp 138 to enable the flow of hematic fluid through the tube, toward the sac;

- end of start of transfer 140.

Then, after the start of transfer 132, the method provides to acquire the initial tare of the support plate and subsequently a drive member is started that makes the support plate move, for example rotate or oscillate, for mixing, and the clamp is opened to enable the flow of hematic fluid to the sac.

After the end of start of transfer 140, the method begins to acquire the volume or weight of the hematic fluid contained in the sac with the first reading and display of the current volume or weight and to calculate the mean flow rate of the hematic fluid.

The volume or weight is advantageously read when the support plate is in the horizontal position or as near as possible to horizontal ("HOME"). Therefore, reaching the "HOME" position is propaedeutic to reading the volume or weight and to making the reading as precise as possible. According to some forms of embodiment, the first reading and display of the current volume or weight 1 10 and the second reading and display of the current volume or weight 120 can be routines in the method according to the present description which can be implemented to manage the operations that allow to detect and monitor the development over time of the quantity of hematic fluid transferred to the collection sac.

In particular, fig. 3 is used to describe forms of embodiment of the first reading and display of the current volume or weight 1 10 usable in combination with the forms of embodiment described using figs. 1 and 2. The description can be valid and applied also to the forms of embodiment of the second reading and display of the current volume or weight 120. In particular, the first reading and display of the current volume or weight 1 10 can include:

- start of volume or weight reading 142;

- verification of support plate in reading position 144, i.e. if the support plate is in the HOME position as defined above;

- reading of current volume or weight 146, in which the volume of the hematic fluid contained in the sac is weighed or measured;

- end of volume or weight reading 148.

In possible implementations, if the verification of the support plate in reading position 144 is positive, the method continues with the reading of the current volume or weight 146, while if the verification of the support plate in reading position 144 is negative, it passes to the end of volume or weight reading 148.

The method 100 according to the present description provides measures and strategies, implemented through the first verification of flow rate control 1 12 and the second verification of flow rate control 122 so that the flow rate of hematic fluid through the tube is comprised between a minimum limit and a maximum limit, otherwise the first signal of flow rate error 1 14 and the second signal of flow rate error 124 are activated. The error signals can be for example visual and/or acoustic.

According to some forms of embodiment, the first verification of flow rate control 1 12 and the second verification of flow rate control 122 can be routines of the method according to the present description which can be implemented to manage the operations that allow to control the flow of hematic fluid through the tube.

In particular, fig. 4 is used to describe forms of embodiment of the first verification of flow rate control 1 12 usable in combination with the forms of embodiment described using figs. 1, 2 and 3. The description can be valid and applied also to the forms of embodiment of the second verification of flow rate control 122. In particular, the first verification of flow rate control 1 12 can include:

- start of verification of flow rate 150;

- calculation of current flow rate 152,

- verification of minimum flow rate 154, wherein it is verified if the current flow rate is less than a minimum pre-set flow rate;

- verification of maximum flow rate 156, wherein it is verified if the current flow rate is greater than a maximum pre-set flow rate;

- end of control with no signal of flow rate error 162.

If the verification of minimum flow rate 154 is positive, a signal of minimum flow rate error 158 is provided, if the verification of minimum flow rate 154 is negative, the method passes to the verification of maximum flow rate 156.

If the verification of maximum flow rate 156 is positive, a signal of maximum flow rate error 160 is provided, if the verification of maximum flow rate 156 is negative, the method passes to the end of control with no signal of flow rate error 162.

In possible implementations, the calculation of current flow rate 152 is carried out by putting into relation the volume or weight of the hematic fluid contained in the collection sac, deriving from the first reading and display of the current volume or weight 1 10 or from the second reading and display of the current volume or weight 120, with the time that has passed since the start of the hematic fluid transfer 108.

According to some forms of embodiment described here, the method provides that when a predefined fraction of volume is still to be transferred, as controlled by the verification of the last fraction of volume or weight 1 16 to complete the final weight or volume expected in the sac for the transfer of hematic fluid, the support plate is stopped in the HOME position (stop of mixing 1 18) to have a more precise reading of the quantity of hematic fluid collected.

After this, when the pre-set target volume or weight has been reached (verification of the target volume or weight collected 126), the clamp is closed (stoppage of the hematic fluid transfer 128) and the end of hematic fluid transfer procedure 130 is signaled, for example by activating a visual and/or acoustic end- of-donation signal.

According to some forms of embodiment, the stoppage of the transfer of hematic fluid 128 can be a routine in the method according to the present description which can be implemented to manage the operations that allow to finish the transfer of hematic fluid.

In particular, fig. 5 is used to describe forms of embodiment of the stoppage of the transfer of hematic fluid 128 usable in combination with the forms of embodiment described using figs. 1, 2, 3 and 4. In particular, the stoppage of the transfer of hematic fluid 128 can include:

- starting the stoppage operation 164;

- closing the clamp 166 to stop the flow;

- signal of end of transfer of the hematic fluid 168;

- memorization of the results of the transfer of the hematic fluid 170;

- end of stoppage operation 172.

Forms of embodiment described here using figs. 6, 7 and 8 also concern an apparatus 200 to collect and mix a determinate volume or weight of hematic fluid according to the present description, usable in a possible procedure to transfer/collect a desired quantity, weight or volume of hematic fluid in a collection sac. According to possible forms of embodiment, the apparatus 200 includes:

- a support plate or tray 202, to receive and support a collection sac fluidically connected to a transfer tube of the hematic fluid;

- a sensor unit 204 configured to detect the weight force acting on the support plate 202, i.e. to detect the volume or weight of the hematic fluid contained in the sac that is gradually transferred into the sac;

- a movement unit 206 configured to move the support plate or tray 202 to determine the mixing of the hematic fluid in the collection sac; - a clamp or closing pincer 208 to selectively stop the flow of hematic fluid in the transfer tube;

- a control card 210 configured to receive a signal of volume or weight from the sensor unit 204 and to calculate the current flow rate of hematic fluid;

- a user interface 212 provided with an insertion device 214 and a display device 216, both associated to the control card 210.

According to some forms of embodiment, the sensor unit 204 can be configured to detect at least the weight force of the hematic fluid that gradually fills the collection sac, acting on the support plate or tray 202. The sensor unit 204 can be set to detect a datum or signal of the weight force, or corresponding volume, by a suitable conversion, which can be programmable thanks to the control card 210. For example, the conversion of weight and volume can be carried out by the sensor unit 204 or the control card 210.

According to different implementations of the forms of embodiment described here, the weight force on the support plate or tray 202 can be detected by one or more load cells, one or more pressure sensors or one or more other sensors, which use an extensometer, a piezoelectric element, a piezo resistive element, a Hall effect element or suchlike. With this, it must be considered that a pressure is the force exerted per unitary surface, so that depending on whether one or more sensors are provided, such as pressure sensors or force sensors or load cells, it could be necessary to consider a conversion. It must be understood that depending on the specific disposition of the sensor unit 204, the sensor unit can also include at least a pressure sensor and at least a force sensor, for example a load cell.

According to other forms of embodiment, which can be combined with other forms of embodiment described here, the sensor unit 204 can include at least one sensor, like a pressure sensor or force sensor, for example a load cell, in which the at least one sensor is a sensor that is independent of an actuator that applies the pressure or force; for example the sensor does not activate, move or influence the collection sac, the support plate or tray 202 or any other part or portion of the apparatus 200. It should be noted here that one or more of the sensors included in the sensor unit 204 as used in the forms of embodiment described here can be at least a sensor element selected from the group comprising:

- a force sensor or transducer, like a load cell, for example a load cell with extensometer, a hydraulic or hydrostatic load cell, a piezoelectric load cell, a vibrating wire load cell and a capacitive load cell,

- a pressure sensor or transducer, for example the electronic type generally used to collect a force to measure deformation or divergence caused by the force applied above an area, such as a sensor with a piezo resistive sensor, a capacitive sensor, an electromagnetic sensor, a piezoelectric sensor, an optical sensor or a potentiometric sensor.

In some forms of embodiment, supplied as a non-restrictive example, the sensor unit 204 can include one or more sensors that can be a load cell. In possible example forms of embodiment, the load cell can be equipped with a mechanical shut-down system for strain 245 and a mechanical shut-down system for compression 246 (see fig. 11 for example), so as to prevent damage caused by exceeding the maximum load defined by the construction specifications.

According to some forms of embodiment, the movement unit 206 can be configured to determine an alternate motion of the support plate 202. In some forms of embodiment, the movement unit 206 can be an oscillation or rotational unit, able to determine an alternate rotational or oscillatory motion of the support plate 202. The movement unit 206 can be set to impart a desired movement speed, for example frequency of oscillation, which can be programmable thanks to the control card 210. Furthermore, the movement unit 206 can be set to perform different movement cycles or phases, in particular oscillation, with different durations and speeds, for example with different frequencies of oscillation, in programmable mode thanks to the control card 210. Moreover, again thanks to the control card 210, it is possible to program the movement unit 206 to make the support plate 202 assume different angular positions.

In possible implementations, the movement unit 206 can be configured to determine a "two-dimensional" (2D) oscillation of the support plate 202, i.e. an oscillation around a single axis of oscillation so that the travel made by the support plate 202 always lies on a single oscillation plane to which the oscillation axis is transverse, in particular orthogonal (see arrow F in fig. 7 and figs. 10, 1 1 for example). The oscillation axis can pass through the support plate 202, or be outside it.

In other possible implementations, the movement unit 206 can be configured to determine a "three-dimensional" (3D) oscillation of the support plate 202, i.e. an oscillation around two oscillation axes transverse to each other, in particular orthogonal, so that the travel made by the support plate 202 develops in space, and not on a single plane (see arrows F and G in fig. 8 and figs. 12, 13 for example). The oscillation axes can pass through the support plate 202, or be outside it.

According to some forms of embodiment, the movement unit 206 can include a drive member 207, provided with a drive shaft 213, and configured to determine the desired movement of the support plate 202. In possible implementations, the drive member 207 can be in particular a motor provided with an intrinsically rotational movement actuator or configured to convert a linear movement into a circular movement. The conversion can commonly be made using types of conversion mechanisms, for example screw actuators, ball screw actuators and roll screw actuators.

A drive member 207 as used in association with the forms of embodiment described here can be a drive member chosen from a group comprising: an electric motor, a step electric motor, a magnetic motor, a linear axle with a motor, a linear motor, such as a mechanical linear motor, a piezoelectric linear motor, an electromagnetic linear motor, an electromechanical motor, an electromagnet, a ratiometer, in particular a direct current ratiometer. For example, motors can be provided that use electromagnetism and magnetic fields for interaction between a first part formed by electric coils and a second part formed by other electric coils, or by permanent or energized magnets or a conductor.

In specific possible examples, the drive member can be configured as a linear motor, for example an induction linear motor, synchronous linear motor, brushless synchronous linear motor, homopolar linear motor, voice coil linear motor, tubular linear motor or also, as we said, a piezoelectric linear motor or an electromagnet. For example, the drive member 207 can be a direct current ratiometer with a nominal voltage of 12 V. According to possible implementations, the clamp or closing pincer 208 can be an intelligent clamp which can be configured for example to automatically stop the flow when the set volume is reached.

In possible implementations, the clamp 208 can be configured to define at least three conditions, which are:

- an open condition, in which the clamp 208 is open, does not grip the tube and allows it to be inserted and removed;

- a holding condition in which the clamp 208 holds the tube in position, for example by means of hooks, but without closing it;

- a closed condition, in which the clamp 208 is closed, compresses the tube, closing it and preventing the flow of hematic fluid.

Furthermore, in some forms of embodiment, which can be combined with all the forms of embodiment described here, the clamp 208 can be provided with a sensor to recognize the presence of the tube in the clamp. The sensor to recognize the presence of the tube in the clamp can be used to implement an automatic closing of the clamp 208, i. e. to automatically assume the closed condition when the tube is inserted in the clamp 208. As we said, the automatic closing can take place even if the expected volume or weight of the hematic fluid has been reached.

Advantageously, moreover, the clamp 208 can be implemented with a safety function, which can intervene in the event of electric power failure. In particular, the clamp 208 can be driven for safety reasons to activate or maintain the closed condition of the tube, in which the flow of hematic fluid is prevented, also in the event of an electric power failure of the apparatus 200, for example thanks to the provision of a buffer feed system of the apparatus 200 (see hereafter).

According to possible implementations, the control card 210 can include a central processing unit (CPU) 203, an electronic memory 205, possibly an electronic database and auxiliary circuits (or I/O) (not shown). For example, the CPU 203 can be any type of controller, microcontroller, processor or microprocessor used in the field of control, automation and management of the work or computer cycle.

The electronic memory 205 can be connected to the CPU 203 and can be one or more of those commercially available, such as a random access memory (RAM), read only memory (ROM), an erasable programmable memory (EPROM), an electrically erasable programmable ROM memory (EEPROM), floppy disk, hard disk, optical disks, CD-ROM, optical-magnetic disks, optical or magnetic cards, mass memory, solid-state memory cards or microcards or any other form of digital storage, local or remote. The software instructions and the data can be for example encoded and memorized in the electronic memory 205 to command the CPU 203. The auxiliary circuits can also be connected to the CPU 203 to help the processor conventionally. The auxiliary circuits can include for example at least one of: cache circuits, feed circuits, clock circuits, input/output circuits, subsystems and suchlike.

The control card 210 can include a timer 215, which can be dedicated or implemented using a clock circuit present in the auxiliary circuits of the control card 210 for this purpose.

Thanks to the timer 215, or a clock circuit, and based on the signal of volume or weight received from the sensor unit 204, the CPU 203 can calculate the current volume or weight of the hematic fluid in the collection sac during transfer, and perform the verifications of the volume or weight and controls of the flow rate as described above, which are necessary for the purposes of the method according to the present description. A program (or computer instructions) readable by the control card 210 can determine which tasks are performable according to the method 100 according to the present description. In some forms of embodiment, the program is a software readable by the control card 210. The control card 210 can include a code to generate and memorize information and data introduced or generated during the method 100 according to the present description. The electronic memory 205 can contain memorized and programmable information concerning, for example, the volume or weight of hematic fluid to be transferred/collected in the collection sacs, and also programmable information or data on the speed of movement, in particular for example oscillation, which the movement unit 206 can impart to the support plate or tray 202 to determine the desired mixing of the hematic fluid in the collection sac.

In possible implementations, the insertion device 214 of the user interface 212 can be an alphanumerical keyboard, a pushbutton, pressure keys or buttons, touch keys or buttons, physical or virtual keys/buttons. For example, a start key 214a can be provided, activated to start the transfer of hematic fluid according to the method 100 described here. For example, the verification of the start-up command 106 cited above can be implemented to verify, for example electrically, electronically, mechanically or electromechanically, that the start key 214a has been activated, for example pressed.

In possible implementations, the display device 216 of the user interface 212 can be a digital display, a liquid crystal display, a touchscreen. In this latter case, the touchscreen can integrate the functions both of the insertion device 214 and the display device 216.

According to possible implementations, the apparatus 200 can include an external casing 201 (see figs. 7 and 8 for example) which contains and encloses inside it the sensor unit 204, the movement unit 206 and the control card 210. The user interface 212 and the clamp 208 are disposed outside the casing 201. The support plate 202 is positioned in an external seating 209 defined by the casing 201. The external seating 209 can have an aperture to connect the support plate 202 to the movement unit 206 contained in the casing 201.

Fig. 9 is used to describe possible forms of embodiment, which can be combined with all the forms of embodiment described here, of an apparatus 200 which includes the support plate 202, the sensor unit 204, the movement unit 206 and the control card 210. The sensor unit 204 can be a load cell. The movement unit 206 can be a two-dimensional oscillation unit.

The apparatus 200 described using fig. 9 includes the control card 210 with CPU 203 and memory 205, the display device 216, for example a Liquid Crystal Display, the insertion device 214, for example a keyboard. The apparatus 200 described using fig. 9 can also include a visual signaler 218, for example a state light, such as a LED (Light Emitting Diode), an acoustic signaler 220, for example an acoustic alarm or buzzer, which can be used to signal errors, or to signal the start or completion of one or more steps and/or operations of the method 100 described here. Visual signaler 218 and acoustic signaler 220 can be used to supply an acoustic and visual alarm with different rings for every event, for example: position of tube in clamp 208, low flow, high flow, error in bar code reading, low battery, end of donation. The apparatus 200 described using fig. 9 can also include an identification code reader 222, such as a simple bar code, a two-dimensional bar code, known as QRcode, a radiofrequency identification code, known as RFID, which uses a tag or transponder or any other graphical or identification system that can be read or acquired. The identification code reader 222 can be used to trace subjects and apparatuses involved in the method described here.

The apparatus 200 described using fig. 9 can also include a mass memory card reader, or solid state memory reader 224, such as a memory card reader like an SD (Secure Digital) memory card or microSD, flash memory or suchlike.

Furthermore, the apparatus 200 described using fig. 9 can include a wireless connection module 226, for example for short-, medium- or long-range radio communication, for example with a Wi-Fi protocol. Other possible examples can be using a Bluetooth® protocol, or Zigbee, or NFC (Near Field Communication) protocol, or infrared communication protocol (for example Infrared Data Association, IrDA). Moreover, the apparatus 200 described using fig. 9 can include a power feed 228, for example for connection to an AC electric network, and a possible battery or energy accumulator 230, for example functioning as a buffer battery.

We must point out here that the apparatus 200 described using fig. 9 can be applied for example to the forms of embodiment described using figs. 7 and 8.

Figs. 10 and 1 1 are used to describe forms of embodiment of a movement unit 206 usable for example in combination with the forms of embodiment described using figs. 7 and 9, to determine a "two-dimensional" oscillation of the support plate 202.

The movement unit 206 can be provided with the drive member 207, mounted on a motor support frame 211. The motor support frame 211 can be for example C-shaped, formed in particular by two opposite lateral walls or blades 211a, between which the drive member 207 extends, and a transverse connection wall 21 lb. The motor support frame 21 1 supports the drive member 207, cooperating with the respective drive shaft 213.

The drive member 207 is in particular disposed so that the drive axis of rotation defined by the drive shaft 213 is always parallel to the lying plane of the support plate 202. For example, in normal use, the drive axis of rotation defined by the drive shaft 213 of the drive member 207 is disposed horizontal. In a coordinated manner, the support plate 202 is disposed to be in a horizontal position, when inactive, and can be subjected to alternate oscillations (positive and negative) with respect to the horizontal, as will be described in more detail hereafter, but without the drive axis of rotation defined by the drive shaft 213 of the drive member 207 intersecting the lying plane of the support plate 202.

The motor support frame 211 can be mounted on the sensor unit 204, in particular providing to dispose the transverse connection wall 21 lb on the sensor unit 204. In this way, the movement unit 206 remains raised, thanks to the presence of the sensor unit 204 below, which can detect the weight force. The sensor unit 204 can be a load cell, for example provided with a mechanical shutdown system for strain 245 and a mechanical shut-down system for compression 246 (fig. 11). A movement support unit 231 can be provided, on which the sensor unit 204 can be mounted, and the movement unit 206 in turn is disposed on the sensor unit 204.

In forms of embodiment described using figs. 10 and 11, the movement unit 206 can include a rotary disc 232 provided with an eccentric pin 234. The eccentric pin 234 is disposed protruding from the rotary disc 232, parallel to the central axis of the latter. The rotary disc 232 is connected to the drive shaft 213 of the drive member 207, by which it is driven to rotate and therefore can determine the oscillation or horizontal pivoting of the support plate 202. The drive shaft 213 is rotatably connected to the rotary disc 232 so that the latter is indirectly supported by the motor support frame 211.

The oscillation unit 206 is also provided with an oscillation bar 236 connected on one side to the support plate 202, on the other side connected slidingly to the eccentric pin 234 and hinged in an intermediate position to the motor support frame 211 by means of an oscillation or rotation pin 237. To connect the oscillation bar 236 to the support plate 202, a support plate 235 can be provided, attached to the oscillation bar 236 and on which an attachment block 240 is disposed, connected by means of one, two or more clamping pins 242 to the support plate 202. The clamping pins 242 can provide, for example, a bayonet- type attachment. All in all, therefore, the oscillation bar 236 and the support plate 202 are connected, defining a T configuration. In particular, the rotation of the drive shaft 213 determines the rotation of the rotary disc 232 around a drive axis of rotation defined by the drive shaft 213, and the eccentric pin 234, which is offset with respect to the drive axis of rotation, draws the oscillation bar 236 into rotation around the oscillation pin 237. We must point out here that the axis of rotation defined by the oscillation pin 237 does not coincide with the axis of rotation defined by the drive shaft 213, nor with the axis along which the eccentric pin 234 develops. The oscillation pin 237, in particular, is parallel to the axis of rotation defined by the drive shaft 213, and also to the axis along which the eccentric pin 234 develops.

In particular, the oscillation bar 236 has a sliding slit 238, with an elongated longitudinal shape, inside which the eccentric pin 234 is slidingly housed. In this way, the eccentric pin 234 draws the oscillation bar 236 into oscillation, causing the alternate oscillation motion of the support plate 202 around a single axis defined by the oscillation pin 237. The oscillation movement of the support plate 202 is therefore two-dimensional as defined above, following for example the arrow in fig. 7 and also represented in figs. 10 and 1 1.

The oscillation of the support plate 202 determined by the oscillation unit 206 according to the forms of embodiment described here can have an angular amplitude a (see fig. 10) which can be comprised for example between about 10° and about 20°, for example about 15°. Therefore, the oscillation of the support plate 202 can vary from -15%20° to +15 +20° with respect to the vertical. The angular amplitude a is correlated to the length of the sliding slit 238, and also the radial distance between the axis of rotation of the rotary disc 232 and the eccentric pin 234.

In some forms of embodiment, which can be combined with all the forms of embodiment described here, a sensor member 244 can be provided, able to detect the HOME position of the support plate 202, in particular being configured to detect the presence of a reference element in movement associated with the rotary disc 232 in the immediate vicinity of the sensitive side of the sensor member 244, without there being an actual physical contact.

The sensor member 244 can cooperate for example with the rotary disc 232, in particular with a position blade 233, protruding for example radially from the latter, which functions as a reference element in movement together with the rotary disc 232. In particular, the position blade 233 is positioned on the rotary disc 232 so that, when the position blade 233 interacts with the sensor member 244, this condition corresponds to an angular position of the rotary disc 232 that defines a horizontal position of the support plate 202.

In particular, this condition can correspond to a condition in which the oscillation bar 236 is essentially vertical and the eccentric pin 234, in its sliding travel in the sliding slit 238, is at the lowest point.

More in particular, this condition can be obtained when the position blade 233 is rotated by 90° in an anti-clockwise direction around the axis of rotation of the rotary disc 232 with respect to the vertical, i.e. in a so-called "9 o'clock" position or "3 o'clock" position, depending on whether the sensor member 244 is on the left (as in figs. 10 and 11) or on the right of the rotary disc 232.

In particular, the sensor member 244 can be configured with two opposite sensitive elements 244a to define a point through which the position blade 233 passes cyclically, i.e. with every complete round angle (360°).

It can be provided, for example, that every round angle of the position blade 233 corresponds to the horizontal position of the support plate 202, or that the horizontal position is reached every "n" round angles (n greater than or equal to 2)·

In some forms of embodiment, which can be combined with all the forms of embodiment described here, the sensor member 244 can be a proximity or presence sensor. The proximity or presence sensor can be inductive, for example, or capacitive, magnetic, ultrasound or optical. For example, a proximity or presence sensor of the optical type can be used, such as a photoelectric sensor or a photocell. The sensor member 244 can be in communication with the control card 210 to verify the HOME position as described above, for the purposes of controlling and mixing the hematic fluid.

Figs. 12 and 13 are used to describe forms of embodiment of a movement unit 206 usable for example in combination with the forms of embodiment described using figs. 8 and 9, to determine a "three-dimensional" oscillation of the support plate 202.

The movement unit 206 can be provided with the drive member 207, mounted on the motor support frame 21 1. In this case too, the motor support frame 21 1 can be C-shaped, formed in particular by two opposite lateral walls or blades 211a and a transverse connection wall 211b, to which the drive member 207 is attached suspended (fig. 12).

The drive member 207, in particular, is disposed so that the drive axis of rotation defined by the drive shaft 213 is always transverse to the lying plane of the support plate 202. For example, in normal use, the drive axis of rotation defined by the drive shaft 213 of the drive member 207 is disposed vertical.

The sensor unit 204 can be mounted between the motor support frame 21 1 and the support plate 202. This disposition makes it possible to not weigh the whole moving mechanical structure but only the support plate 202 and the corresponding collection sac. In particular, an oscillation disc 248 is provided which on one side is solid with the support plate 202, and in this case can support the sensor unit 204, for example through a connection and support system 247, and on the other side is rotatably connected to the drive shaft 213 of the drive member 207 by means of a hinging device 250 configured to determine an oscillation in space of the oscillation disc 248 around two axes of rotation. This oscillation of the oscillation disc 248 in turn determines the three-dimensional oscillation of the support plate 202. The oscillation disc 248 has an oscillation seating 249, cooperating with the hinging device 250. In this specific case, the hinging device 250 includes an adapter 252 inserted on the drive shaft 213, solid therewith, and also inserted in the oscillation seating 249. A fixed rotation support 251 is provided, with a through rotation seating 253. The fixed rotation support 251 is disposed on a support plate defined in this case by the transverse connection wall 21 1b of the motor support frame 21 1. The adapter 252 is positioned partly in the through rotation seating 253 of the fixed rotation support 251, where it is solidly coupled with the drive shaft 213 in correspondence with a lower end 252a thereof, and partly protruding therefrom to be inserted in and coupled with the oscillation seating 249. The drive shaft 213 makes the adapter 252 rotate and in this way, as explained hereafter, determines the oscillation of the oscillation disc 248.

In particular, to this end the adapter 252 has a shaped end 254 at the upper part. The shaped end 254 is inserted in the oscillation seating 249. Since it is part of the adapter 252, the shaped end 254 is made to rotate by the drive shaft 213 itself. The shaped end 254 is inclined, for example being milled, with respect to the drive axis of rotation by a desired angular amplitude β. Therefore, the rotation of 360° around the drive axis of rotation of the inclined shaped end 254 of the adapter 252 causes the oscillation disc 248 to oscillate. To this purpose, the hinging device 250 also includes an orientable bearing 258 inserted on the inclined shaped end 254 described above. The orientable bearing 258 can be connected to the inclined shaped end 254 by a clamping element 255 (fig. 13). The orientable bearing 258 provides an internal ring 260, solid with the shaped end 254, an external ring 262, solid with the oscillation seating 249, intermediate balls 264 between the internal ring 260 and the external ring 262 and sliding along annular guide grooves 266, configured to allow an axial mobility, as well as circular, of the balls 264 (fig. 13). The combination of the reciprocal movement of the internal ring 260, external ring 262 and balls 264 determines the oscillation of the oscillation disc 248 and therefore of the support plate 202. The angular amplitude β of inclination of the shaped end 254 advantageously corresponds to the angular amplitude of the oscillation, negative and positive, around the cited two axes of rotation, which is imparted to the support plate 202. For example, the angular amplitude β can be comprised between 5° and 15°, for example about 9°, and the shaped end 254 is inclined in a corresponding manner. Thanks to the configuration of the shaped end 254, the inclination of angular amplitude β is always maintained even during the rotation of the adapter 252, which, in cooperation with the orientable bearing 258 as above, allows the desired oscillation in space ("three-dimensional") of the support plate 202.

The hinging device 250 also includes a bearing 256 inserted on the lower end 252a of the adapter 252, opposite the shaped end 254, to keep the group formed by the adapter 252 and drive shaft 213 in rotation with respect to the fixed rotation support 251 , preventing any displacements with respect to the drive axis of rotation.

The movement unit 206 described using figs. 12 and 13 can include springs 268 fitted on fixed pins 270 disposed on the transverse connection wall 21 lb and inserted in through holes 272 made in the oscillation disc 248. The springs 268, which are in abutment against the motor support frame 21 1 and the oscillation disc 248, can be provided to support the oscillation disc 248 in a cushioned manner during its oscillation movement in space ("three-dimensional"), and are compressed and extended in a coordinated manner with the oscillation of the oscillation disc 248, for example they can adapt the position of the oscillation disc 248 to the plays that are created in rotation between the orientable bearing 258 and inclined shaped end 254, in particular between internal ring 260 and shaped end 254 of the adapter 252.

Also in the forms of embodiment described using figs. 12 and 13 a sensor member 244 can be provided, able to detect the HOME position of the support plate 202, which in this case, due to the oscillation in space ("three- dimensional"), corresponds to a position as near as possible to horizontal of the support plate 202. In this specific case, the HOME position of the support plate 202 which can be detected by the sensor member 244 is slightly inclined with respect to the horizontal, in any case it is the position nearest to the horizontal, so as to minimize possible errors in the detection of the weight force, in order to measure the weight or volume.

The sensor member 244 can cooperate for example with a position blade 233 (fig. 12) mounted, for example by an attachment collar 233a, on the adapter 252, in particular protruding radially therefrom with respect to the drive axis of rotation defined by the drive shaft 213 (fig. 13). The position blade 233 is solid with the adapter 252 and rotates therewith, making successive rotations of 360° around the drive axis of rotation defined by the drive shaft 213. When the position blade 233 interacts with the sensor member 244, for example with every rotation, this condition corresponds to an angular position of the oscillation disc 248 that defines a position as near as possible to the horizontal of the support plate 202. In this position, which in this specific case defines the HOME position, the volume or weight is detected by the sensor unit 204.

Forms of embodiment described here can provide the execution of various steps, passages and operations of the method for mixing a hematic fluid as described above. The steps, passages and operations can be done at least partly with instructions performed by a machine which cause the execution of certain steps by a control card, controller, system microcontroller, equipped with a general-purpose or special-purpose processor or microprocessor. Alternatively, these steps, passages and operations can be performed by specific hardware components that contain hardware logic to perform the steps, or by any combination of components for programmed computers and personalized hardware components.

Forms of embodiment of the method in accordance with the present description can be included in a program for computers that can be memorized in a computer-readable mean that includes the instructions that, once performed by the apparatus 200, determine the execution of the method discussed according to the present description. In particular, elements according to the present invention can be given as machine-readable means to memorize the instructions which can be carried out by the machine. The machine-readable means can include, without being limited to, floppy disks, optical disks, CD-ROM, optical-magnetic disks, ROM, RAM, EPROM, EEPROM, optical or magnetic cards, propagation means or other types of machine-readable means suitable to memorize electronic information.

It is clear that modifications and/or additions of parts may be made to the apparatus to collect and mix a hematic fluid as described heretofore, without departing from the field and scope of the present invention.

It is also clear that, although the present invention has been described with reference to some specific examples, a person of skill in the art shall certainly be able to achieve many other equivalent forms of the apparatus to collect and mix a hematic fluid, having the characteristics as set forth in the claims and hence all coming within the field of protection defined thereby.

Although the above refers to forms of embodiment of the invention, other forms of embodiment can be provided without departing from the main field of protection, which is defined by the following claims.