U.S. patent application number 12/870878 was filed with the patent office on 2012-03-01 for method and machine for the preparation of pharmaceutical products.
This patent application is currently assigned to HEALTH ROBOTICS S.R.L.. Invention is credited to Walter Bianco, Garcia Gaspar de Viedma Santoro, Paolo Giribona, Michele Minisini.
Application Number | 20120048424 12/870878 |
Document ID | / |
Family ID | 45695549 |
Filed Date | 2012-03-01 |
United States Patent
Application |
20120048424 |
Kind Code |
A1 |
Giribona; Paolo ; et
al. |
March 1, 2012 |
Method and Machine for the Preparation of Pharmaceutical
Products
Abstract
The preparation of pharmaceutical products is carried out in a
machine provided with at least one store for storing syringes
and/or bottles, a dosing station for transferring at least one
pharmaceutical between a syringe and a bottle, two containers for
collecting the processing waste, and a gripping and transporting
device for transferring the syringes and/or bottles between the
store and the dosing station (36) and for selectively feeding the
processing waste into the two containers.
Inventors: |
Giribona; Paolo; (Trieste,
IT) ; Bianco; Walter; (Trieste, IT) ;
Minisini; Michele; (Trieste, IT) ; de Viedma Santoro;
Garcia Gaspar; (Madrid, ES) |
Assignee: |
HEALTH ROBOTICS S.R.L.
Bolzano
IT
|
Family ID: |
45695549 |
Appl. No.: |
12/870878 |
Filed: |
August 30, 2010 |
Current U.S.
Class: |
141/311R |
Current CPC
Class: |
A61J 2200/74 20130101;
A61J 1/20 20130101; A61J 1/10 20130101; B65B 3/003 20130101; A61J
3/002 20130101 |
Class at
Publication: |
141/311.R |
International
Class: |
B65B 1/04 20060101
B65B001/04 |
Claims
1. A machine for the preparation of pharmaceutical products
comprising at least one store (4, 6) for storing syringes (5)
and/or bottles (7); a dosing station (36) for transferring at least
one pharmaceutical between a syringe (5) and a bottle (7); a
gripping and transporting device (10) for transferring the syringes
(5) and/or the bottles (7) between the store (4, 6) and the dosing
station (36); and a collection station (86) provided with a first
container (87a) for processing waste of the machine; and
characterized in that the collection station (86) is further
provided with at least a second container (87b) for the processing
waste; the gripping and transporting device (10) being adapted to
selectively feed the processing waste into said first and second
container (87a, 87b).
2. A machine according to claim 1, wherein, for each container
(87a, 87b), the collection station (86) further comprises at least
one respective chute (88, 89) for the processing waste into the
container (87a, 87b) itself.
3. A machine according to claim 1 comprising control means of the
gripping and transporting device (10) for selectively feeding the
processing waste into said first and second container (87a,
87b).
4. A method for preparing pharmaceutical products in a machine
comprising at least one store (4, 6) for storing syringes (5)
and/or bottles (7); a dosing station (36) for transferring at least
one pharmaceutical between a syringe (5) and a bottle (7); a
gripping and transporting device (10) for transferring the syringes
(5) and/or the bottles (7) between the store (4, 6) and the dosing
station (36); and a collection station (86) provided with two
containers (87a, 87b) for processing waste of the machine; the
method being characterized in that it comprises the step of:
selectively feeding the processing waste into said containers (87a,
87b) by means of said gripping and transporting device (10).
Description
[0001] The present invention relates to a machine for the
preparation of pharmaceutical products.
BACKGROUND OF THE INVENTION
[0002] A machine is known in the pharmaceutical product preparation
field comprising a store for storing syringes; a store for storing
bottles; a store for storing infusion bags; a dosing station for
the preparation of a pharmaceutical product obtained by mixing at
least one pharmaceutical substance contained in a bottle and at
least one diluent contained in an infusion bag with one another; a
robotized gripping and transporting arm for transferring the
syringes and/or bottles and/or infusion bags between the dosing
station and the respective stores; a feeding device for feeding a
diluent into a bottle containing a lyophilized or powdered
pharmaceutical; a picking device of a predetermined amount of
diluent from the infusion bags; and a station for collecting the
processing waste of the machine.
[0003] Generally, the collection station is provided with a
container, in which the processing waste, e.g. syringes, bottles,
bottle seals, needles and needle protection caps, is stored without
being separated.
[0004] Since the processing waste of the known machines for the
preparation of pharmaceutical products is not separated, the
disposal of the processing waste is made according to the methods
required for disposing the most dangerous processing waste and is
thus relatively complex and costly.
SUMMARY OF THE INVENTION
[0005] It is an object of the present invention to provide a
machine for the preparation of pharmaceutical products which is
free from the above-described drawbacks and which is simple and
cost-effective to be implemented.
[0006] According to the present invention, there is provided a
machine for the preparation of pharmaceutical products as claimed
in the attached claims.
[0007] The present invention further relates to a method for the
preparation of pharmaceutical products.
[0008] According to the present invention, there is provided a
method for the preparation of pharmaceutical products as claimed in
the attached claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] The present invention will now be described with reference
to the accompanying drawings, which illustrate a non-limitative
embodiment thereof, in which:
[0010] FIG. 1 is a diagrammatic perspective view, with parts
removed for clarity, of a preferred embodiment of the machine
according to the present invention;
[0011] FIG. 2 is a diagrammatic perspective view, with parts
removed for clarity, of a first detail of the machine in FIG.
1;
[0012] FIG. 3 is a diagrammatic perspective view, with parts
removed for clarity, of a detail in FIG. 2;
[0013] FIG. 4 is a diagrammatic perspective view, with parts
removed for clarity, of a second detail of the machine in FIG.
1;
[0014] FIG. 5 is a diagrammatic perspective view, with parts
removed for clarity, of a third detail of the machine in FIG.
1;
[0015] FIG. 6 is a diagrammatic perspective view, with parts
removed for clarity, of a detail in FIG. 5;
[0016] FIG. 7a is a diagrammatic perspective view, with parts
removed for clarity, of a fourth detail of the machine in FIG.
1;
[0017] FIG. 7b is a perspective view of a detail in FIG. 7a;
[0018] FIG. 8 is a schematic perspective view, with parts enlarged
and parts removed for clarity, of a fifth detail of the machine in
FIG. 1;
[0019] FIG. 9 is a diagrammatic front view, with parts removed for
clarity, of the detail in FIG. 8;
[0020] FIG. 10 is a diagrammatic perspective view, with parts
removed for clarity, of a sixth detail of the machine in FIG.
1;
[0021] FIG. 11 is a diagrammatic perspective view, with parts
removed for clarity, of a seventh detail of the machine in FIG.
1;
[0022] FIG. 12 diagrammatically shows the operating principle of
the detail in FIG. 11;
[0023] FIG. 13 is a diagrammatic perspective view, with parts
removed for clarity, of an eighth detail of the system in FIG. 1
shown in two different operating positions;
[0024] FIG. 14 diagrammatically shows the operating principle of
the detail in FIG. 13; and
[0025] FIG. 15 is a diagrammatic perspective view, with parts
removed for clarity, of a ninth detail of the machine in FIG.
1.
DETAILED DESCRIPTION OF THE INVENTION
[0026] With reference to FIG. 1, numeral 1 indicates as a whole a
machine for the preparation of pharmaceutical products comprising a
substantially parallelepiped containment box-like frame 2 defining
an inner chamber 3, which is maintained in substantially sterile
conditions by a pneumatic device of known type, shaped so as to
feed a flow of sterile air through the chamber 3 and prevent the
introduction of air from the external environment into the chamber
3.
[0027] The chamber 3 accommodates therein a store 4 for storing
syringes 5; a store 6 for storing bottles 7; an annular store 8 for
storing infusion bags 9; and a robotized gripping and transporting
device 10 of the syringes 5 and/or of the bottles 7.
[0028] Each syringe 5 (FIG. 3) has a longitudinal axis 11, and
comprises a cylinder 12 provided with an end flange 13 orthogonal
to axis 11, a needle (not shown) coupled to the cylinder 12, a
closing cap 14 mounted to protect the needle (not shown) from
possible contaminations, and a piston 15, which is slidingly
engaged in the cylinder 12, and is provided with an end head 16
perpendicular to axis 11.
[0029] Each bag 9 is provided with an adapter member 17 of known
type, which comprises two shaped jaws 18, mobile between a clamping
position and a releasing position of an upper edge of the bag 9,
and has a drawing pin 19 protruding upwards from one of the jaws 18
(FIG. 5).
[0030] As shown in FIGS. 1, 3, and 4, the device 10 is mounted
within the store 8, comprises a plurality of jointed arms 20 hinged
to one another, and provided with a gripping arm 21, which is
mounted on the free end of the arms 20, and is defined by two jaws
22 mobile between a clamping position and a releasing position of a
syringe 5 or a bottle 7.
[0031] With reference to FIG. 2, each store 4, 6 comprises two
reciprocally parallel belt conveyors 23, each of which extends in a
substantially vertical direction A, faces the other conveyor 23,
and is looped about a pair of pulleys (not shown), which are
coaxial with the pulleys (not shown) of the other conveyor 23, and
are mounted so as to intermittently rotate about respective
rotation axis 24 parallel to one another and transversal to
direction A.
[0032] Each store 4, 6 further comprises a plurality of transport
cradles 25, which extend between the conveyors 23, are coupled to
the conveyors 23 to oscillate, with respect to conveyors 23, about
respective axes 26 with fulcrum parallel to one another and to axes
24, and which are uniformly distributed along the conveyors 23
themselves.
[0033] As shown in FIG. 3, each cradle 25 of the store 4
(hereinafter indicated by numeral 25a) has a substantially V-shaped
transversal section, is arranged with an axis 27a thereof parallel
to axes 24, 26, is provided with a first slot 28 adapted to receive
the flange 13 of a syringe 5 to guarantee the correct longitudinal
positioning of the syringe 5 in the cradle 25a, and further has a
second slot 29 adapted to be engaged by the jaws 22 to allow the
device 10 to pick the syringe 5 from the cradle 25a itself.
[0034] With reference to FIG. 4, each cradle 25 of the store 6
(hereinafter indicated by numeral 25b) has a substantially V-shaped
transversal section, is arranged with a longitudinal axis thereof
27b inclined with respect to axis 24, 26, and is provided with a
slot 30, which is obtained near the lower end of the cradle 25b,
allows to correctly position a bottle 7 with its concavity facing
downwards, and allows the jaws 22 to pick the bottle 7 itself.
[0035] Each store 4, 6 extends through a loading station obtained
through the frame 2 to allow the operator to load the syringes 5 or
bottles 7 into the respective cradles 25a, 25b, and through a
single picking station, where the syringes 5 or the bottles 7 are
picked from the respective cradles 25a, 25b by the device 10, and
for this reason the device 10 is relatively simple and
cost-effective. Furthermore, the loading and unloading of the
syringes 5 and of the bottles 7 in, and respectively from, the
respective cradles 25a, 25b does not require the machine 1 to be
stopped at all.
[0036] As shown in FIGS. 5 and 6, the store 8 comprises an annular,
star-shaped wheel 31, which extends about the device 10, is mounted
to rotate intermittently, with respect to the frame 2 and under the
bias of an actuating device (known and not shown), about a
substantially vertical rotation axis 32, and has a plurality of
pockets 33, which are obtained along a peripheral edge of the wheel
31, open radially outwards and are each adapted to receive and
withhold a respective infusion bag 9.
[0037] The pockets 33 are fed by the wheel 31 about axis 32 and
along a circular path P extending through a loading and unloading
station 34 of the bags 8 into, and respectively from, the store 8,
a weighing station 35 of the bags 9, and a dosing station 36 for
injecting a predetermined amount of pharmaceutical into the bags 9
themselves.
[0038] Each station 34, 35, 36 is provided with a linear transfer
device 37 comprising a rectilinear guide 38 parallel to a
horizontal direction 39 transversal to axis 32, a slide 40
slidingly coupled to the guide 38 to perform rectilinear movements
along the guide 38 in direction 39, and a gripping fork 41
slidingly coupled to a slide 40 to move, with respect to the slide
40 and transversally to direction 39, between a coupling position
and a releasing position of the pin 19 of a respective adapter
member 17.
[0039] The device 37 from station 34 cooperates with a guide 42,
which is parallel to the respective guide 38, is radially aligned
with the pocket 33 arranged each time in station 34 to be slidingly
engaged by the member 17 of a respective pocket 9, and extends
between the store 8 and an opening 43 obtained through the frame 2
to allow an operator to load the bags 9 on the guide 42 and to pick
the bags 9 from the guide 42 itself.
[0040] With reference to FIGS. 7a and 7b, device 37 of station 35
cooperates with a weighing device 44 comprising a supporting mobile
member 45, which is coupled in known manner to a fixed part of the
device 44 to move vertically under the weight of the bags 9, is
fork-shaped and defines a guide 46 radially aligned with the pocket
33 arranged on each time in station 35 to be slidingly engaged by
the member 17 of a respective bag 9.
[0041] The device 37 of station 36 cooperates with a guide (not
shown), which is parallel to the respective guide 38, is radially
aligned with the pocket 33 arranged each time in station 36 to be
slidingly engaged by the member 17 of a respective bag 9, and is
adapted to stop the bag 9 itself underneath a syringe 5, which is
transferred from the device 10 between the store 4 and a gripping
and actuating assembly 47 of the syringe 5 itself.
[0042] As shown in FIGS. 8 and 9, the assembly 47 comprises a
supporting block 48, which is mounted to rotate about a horizontal
rotation axis 49 transversal to axis 32, and supports a gripping
device 50 of the cylinder 12 and a gripping device 51 of the piston
15.
[0043] The device 50 comprises two grippers 52, which are
reciprocally aligned in a direction 53, the orientation of which
depends on the position of the block 48 about axis 49, and each
comprise two respective jaws 54, which are slidingly coupled to the
block 48 to move, with respect to the block 48 itself,
transversally to direction 53, and are normally maintained in a
clamping position of the cylinder 12 by respective springs 55
arranged between the block 48 and the jaws 54 and loaded so as to
allow the axial movement of the syringe 5 through the grippers
52.
[0044] The device 50 further comprises an intermediate gripper 56,
which extends between the grippers 52, and comprises, in turn, two
jaws 57 slidingly coupled to the block 48 to move with respect to
the block 48 and under the bias of an actuating device (known and
not shown), transversally to direction 53 between a clamping
position and a releasing position of the cylinder 12 of a syringe
5.
[0045] With regards to the above, it is worth noting that the jaws
57 are shaped so as to allow one of the jaws 57 to be inserted
inside the other jaw 57 and also to clamp syringes 5 of relatively
small diameter.
[0046] The device 51 comprises two jaws 58, which are slidingly
coupled to the block 48 to move with respect to the block 48 and
under the bias of an actuating device (known and not shown),
transversally to direction 53 between a clamping position and a
releasing position of the head 16 of a syringe 5, and are further
slidingly coupled to the block 48 to perform rectilinear movements
in direction 53 itself with respect to the block 48 and under the
bias of an actuating device (known and not shown). Each jaw 58 has
a plurality of grooves 59 (two grooves 59, in the case in point)
superimposed on one another in direction 53 to allow the device 51
to receive and withhold the heads 16 of syringes 5 of different
size.
[0047] The operation of the assembly 47 will now be described
starting from an instant in which the jaws 57 and the jaws 58 are
arranged in their releasing positions and the syringe 5 is inserted
by the device 10 within the jaws 54 against the bias of the springs
55.
[0048] Once the syringe 5 is inserted within the grippers 52, the
jaws 58 are firstly closed over the head 16 and then lowered in
direction 53 so as to move the syringe 5 through the grippers 52,
arrange the flange 13 in contact with the upper jaw 52 and,
possibly, push the piston 15 fully into the cylinder 12.
[0049] The operating sequence shown above allows to correctly
position the syringe 5 in direction 53 and guarantees a correct,
constant positioning of all syringe 5 regardless of the size
thereof, of the initial position of the pistons 15 along the
respective cylinders 12, and of the axial, initial angular
positions of the syringes 5 in the grippers 52.
[0050] Finally, the jaws 57 are moved from the clamping position
thereof of the syringe 5 within the assembly 47, and the jaws 58
are moved to the clamping position thereof of the head 16 for
controlling the movement of the piston 15 during the steps of
aspirating and injecting of the pharmaceutical.
[0051] With reference to FIG. 10, the machine 1 further comprises a
mixer device 60 for mixing a lyophilized or powder pharmaceutical
and a diluent contained in a bottle 7 to one another.
[0052] The device 60 comprises a rotating plate 61, which is
mounted to alternatively rotate about a substantially horizontal
rotation axis 62, and is provided with a pair of jaws 63 coupled in
known manner to the plate 61 to move, with respect to the plate 61,
transversally to the axis 62, between a clamping position and a
releasing position of a bottle 7. Each jaw 63 is shaped so as to
display, in the case in point, a pair of seats 64, which cooperate
with corresponding seats 64 of the other jaw 63 to allow the jaws
63 to withhold bottles 7 of different size.
[0053] As shown in FIGS. 11 and 12, the path P further extends
through a picking station 65 of a predetermined amount of liquid
from the bags 9. The picking of the liquid of bag 9 is necessary
when the total weight of the pharmaceutical and of the diluent
contained in the bag 9 after having injected the pharmaceutical
needs to be equal to a determined value lower than the weight of
the diluent initially contained in the bag 9 itself alone.
[0054] The station 65 has an aspiration assembly 66 comprising a
gripping device 67 adapted to receive and withhold an extraction
needle 68, which is connected to a hydraulic aspiration circuit 69,
is transferred by the device 10 in the device 67 after having been
separated from a protective cap thereof (known and not shown), and
is moved by the device 67 in direction A between a raised resting
position, in which the needle 68 is arranged outside the bag 9, and
a lowered operating position, in which the needle 68 protrudes
within the bag 9 over the diluent contained in the bag 9
itself.
[0055] The circuit 69 comprises an extraction pump 70, a
peristaltic pump in the case in point, having an inlet
hydraulically connected to the needle 68 by means of a first pipe
71, and an outlet hydraulically connected to a collection reservoir
72 of the diluent picked from the bags 9 by means of a second pipe
73.
[0056] The bags 9 contain a determined amount of air, and for this
reason the pipe 71 is provided with a flow sensor 74, a capacitance
sensor in the case in point, which allows to discriminate between
the passage of air and of liquid along the pipe 71, and thus
correctly calculate the volume of liquid aspirated from the bags 9
by means of the pump 70. In other words, the volume of liquid
aspirated from the bags 9 is calculated only starting from the
instant in which the sensor 74 detects the passage of liquid along
the pipe 71.
[0057] With reference to FIGS. 13 and 14, the machine 1 further
comprises a feeding device 75 for feeding a diluent into a bottle 7
containing a lyophilized or powder pharmaceutical.
[0058] The device 75 comprises feeding assemblies 76, two in the
case in point, each of which comprises, in turn, a feeding
reservoir 77 (e.g. a bag 9) for the diluent; a feeding needle 78
coupled to the frame 2 and hydraulically connected to the reservoir
77 by means of a pipe 79; and a pumping device defined, in the case
in point, by a syringe 80, which is connected to an intermediate
point of the pipe 79, and is actuated in known manner to aspirate a
predetermined amount of diluent from the reservoir 77 and to feed
the diluent itself into the bottle 7.
[0059] The connection between the pipe 79 and the syringe 80
divides the pipe 79 into two segments 79a, 79b, which are arranged
in sequence and in this order between the reservoir 77 and the
needle 78, and which are provided with respective check valves 81a,
81b, of which valve 81a avoids the flow back of diluent into
segment 79a when diluent is fed to the needle 78, and valve 81b
avoids the flow back of diluent from segment 79b when the diluent
is aspirated from the reservoir 77.
[0060] The device 75 further comprises a collection reservoir 82,
which extends underneath the needles 78, is coupled in known manner
to the frame 2 to move with respect to the frame 2, in direction A
between a lowered resting position (FIG. 13b) and an operating
raised position (FIG. 13a), and is hydraulically connected to a
collection manifold 83 of the diluent. The reservoir 82 further
displays a pair of tubes 84, each of which protrudes upwards from a
bottom wall of the reservoir 82, is substantially coaxial to the
respective needle 78, and accommodates therein a protective cap 85
of the needle 78 itself arranged in the tube 84 with the concavity
facing upwards.
[0061] In use, the reservoir 82 is moved, with the caps 85 of the
needles 78, to its lowered resting position to allow inserting two
bottles 7 underneath the needles 78 and feeding the diluent into
the bottles 7 themselves.
[0062] When they are extracted from the respective bottles 7 the
bottles may have residues of the lyophilized or powder
pharmaceutical, and for this reason at the end of each injection
operating cycle of the feeding device 75, the reservoir 82 is moved
into its raised operating position so as to fit the caps 85 on the
respective needles 78, and the syringes 80 are actuated to allow to
wash the needles 78 with the diluent contained in the reservoirs
77.
[0063] The diluent fed through the needles 78 flows firstly into
the respective caps 85 and thus into the reservoir 82 and into the
manifold 83. With this regard, it is worth noting that:
[0064] the amount of diluent used to wash the needles 78 also
allows to wash the caps 85;
[0065] the caps 85 are, like the needles 78, initially sterile and
may therefore be used to wash the respective needles 78 at the end
of each programmed injection operating cycles in a working session
of the machine 1; and
[0066] the conclusion of the working session of the machine 1
requires only the replacement of needles 78 and of the respective
caps 85 and does not require the sterilization of the reservoir
82.
[0067] As shown in FIG. 15, the machine 1 is further provided with
a collection device 86 of the processing waste (e.g. syringes 5,
bottle 7, needles 78, and caps 85) accommodated within the frame 2
underneath the store 8, and comprising, in the case in point, two
collection containers 87, of which one (hereinafter indicated by
numeral 87a) communicates with the chamber 3 by means of a pair of
slides 88 and the other (hereinafter indicated by numeral 87b)
communicates with the chamber 3 itself by means of one chute only
89.
[0068] In use, the various processing waste is selectively fed by
the device 10 to the various chutes 88, 89 and, thus, to the
various containers 87a, 87b, thus allowing to separate the
processing waste.
[0069] The operation of the machine 1 is easily inferred from the
description above and no further explanations are required.
* * * * *