U.S. patent application number 14/920690 was filed with the patent office on 2018-03-15 for method for the automatic filling of containers for medication for intravenous administration in a machine for the automatic preparation of intravenous medication.
The applicant listed for this patent is KIRO GRIFOLS, S.L.. Invention is credited to Ainara Fol Ruiz de Loizaga, Borja Lizari Illarramendi, Naiara Telleria Garay.
Application Number | 20180071453 14/920690 |
Document ID | / |
Family ID | 54338527 |
Filed Date | 2018-03-15 |
United States Patent
Application |
20180071453 |
Kind Code |
A9 |
Lizari Illarramendi; Borja ;
et al. |
March 15, 2018 |
METHOD FOR THE AUTOMATIC FILLING OF CONTAINERS FOR MEDICATION FOR
INTRAVENOUS ADMINISTRATION IN A MACHINE FOR THE AUTOMATIC
PREPARATION OF INTRAVENOUS MEDICATION
Abstract
The invention describes a method for the automatic filling of
containers for medication for intravenous administration in a
machine for the automatic preparation of intravenous medication,
the said containers comprising at least one fluid inlet connector
closed by a cap that comprises an internal through conduit, said
machine comprising injectors with spikes actuated by at least
actuating means arranged in the said machine. The said method is
characterised in that the said spike causes a piercing of one of
the ends of said cap, allowing the direct injection of said
component into said container.
Inventors: |
Lizari Illarramendi; Borja;
(ARAICO ( BURGOS ), ES) ; Telleria Garay; Naiara;
(ARRASATE-MONDRAGON ( GIPUZKOA ), ES) ; Fol Ruiz de
Loizaga; Ainara; (VITORIA-GASTEIZ ( ALAVA ), ES) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
KIRO GRIFOLS, S.L. |
ARRASATE ( GIPUZKOA ) |
|
ES |
|
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20160114097 A1 |
April 28, 2016 |
|
|
Family ID: |
54338527 |
Appl. No.: |
14/920690 |
Filed: |
October 22, 2015 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 5/1420130101; A61M
2209/045 20130101; A61M 5/152 20130101; A61M 5/148 20130101; B65B
3/003 20130101 |
International
Class: |
A61M 5/14 20060101
A61M005/14; B65B 3/00 20060101 B65B003/00 |
Foreign Application Data
Date |
Code |
Application Number |
Oct 24, 2014 |
ES |
P 201431570 |
Claims
1. Method for the automatic filling of containers for medication
for intravenous administration in a machine for the automatic
preparation of intravenous medication, said containers being of the
type that comprises at least one fluid inlet connector closed by a
cap that comprises an internal through conduit, said machine being
of the type that comprises at least injection means with spikes
actuated by at least actuating means arranged in said machine,
characterised in that said spike causes a piercing of one of the
ends of the said cap, allowing the direct injection of said
component into said container.
2. Method according to claim 1, characterised in that after the
direct injection of the said component into said container, the
spike recedes into the interior of said conduit of said cap and
withdraws the dead volume of base component remaining in the
interior of the said conduit.
3. Method according to claim 1, characterised in that the base
component consists of a type of intravenous medication.
4. Method according to claim 1, characterised in that the base
component consists of a type of solvent.
5. Method for the automatic filling of at least one type of base
component, according to claim 1, characterised in that said
container is of the type used for direct intravenous infusion to
patients.
6. Method according to claim 1, characterised in that said
container comprises at least one inflatable elastomer bladder
connected to said fluid inlet connector and also comprises at least
one outlet port connected internally to said inflatable bladder and
connected externally to a tube for intravenous administration by
infusion to the patient.
7. Method according to claim 5, characterised in that said
container comprises at least one bag connected to a fluid inlet and
outlet port that is connected in its turn to a tube for intravenous
administration by infusion to the patient.
8. Method according to claim 1, characterised in that said
injection means consist of a syringe with a plunger.
9. Method according to claim 8, characterised in that after the
direct injection of said component into the interior of said
container, the syringe recedes into the interior of the said cap
and withdraws a volume of the said base component remaining in the
interior of the said cap, by means of the recession of the plunger
of the said syringe.
10. Method according to claim 1, characterised in that the
injection means consist of a bag that contains a base component,
said bag being connected to a peristaltic pump that allows said
component to be pumped through a silicone tube connected to said
pump whose distal end is terminated with a spike.
11. Method according to claim 1, characterised in that the fluid
inlet and/or outlet connectors and the closure cap are of the "Luer
Lock" type.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims priority to Spanish Patent
Application No. 201431570 filed on Oct. 24, 2014, the disclosure of
which including the specification, the drawings, and the claims is
hereby incorporated by reference in its entirety.
BACKGROUND OF THE INVENTION
[0002] The present invention is aimed at the sector of machines for
the automatic preparation of intravenous medication used
preferentially for cytostatic, cytotoxic and/or analgesic
treatments, among others.
[0003] In particular, the present invention relates to a method
used in machines of the said type for the automatic preparation of
intravenous medication that comprises at least one robotic arm
capable of preparing at least one mixture of medication for
intravenous administration automatically and without manual
intervention by the user.
SUMMARY OF THE INVENTION
[0004] Machines for the automatic preparation of intravenous
medication are known in the state of the art, such as, for example,
in the PCT patent application WO 2012/172418 or in the Spanish
patent application 201430745. This type of machine allows, through
the actuation of at least one actuator (which may be, for example,
mechanical, electromechanical or robotic, among others), the
preparation of a specific medication resulting from the mixture of
different intravenous administration base components, such as, for
example, a type of drug and a type of solvent, among others.
[0005] In the present invention, an intravenous administration
component or a base component shall be considered to mean any
medication, substance or drug for intravenous administration to
patients, as well as any necessary solvent used for mixing with at
least one medication, substance or drug for intravenous
administration.
[0006] The base components used for obtaining the said mixtures are
originally stored in special vials or bags, which are generally
arranged in a specific area inside the machine. By means of a
syringe supported and actuated by the actuator of the said machine,
the volume of base component necessary for the desired medication
mixture is drawn and deposited in a reservoir suitable for storing
the mixture of the said base component with other base components
previously deposited for the same medication mixture.
[0007] This type of reservoir in which the final mixture of
medication for intravenous administration is stored is known as an
"infusor" or "cassette". This type of reservoir, once filled with a
medication mixture, can be used directly for the intravenous
infusion of the said mixture in patients undergoing different
treatments, mainly analgesic and/or cytostatic treatments, that
involve long time periods of intravenous administration (between 24
and 72 hours) without the need for hospitalisation of the
patients.
[0008] On the one hand, the "infusor" type of filling reservoir is
a reservoir that comprises in its interior an inflatable elastomer
bladder connected to an inlet port of the infusor, through which
the different base components of the desired medication mixture are
introduced. The base components of the mixture are introduced into
the interior of the elastomer bladder, causing the said bladder to
inflate. The said inlet port consists of a threaded female "Luer
Lock" connector suitable for connection to any type of syringe or
device having a male "Luer Lock" connector, allowing a hermetic and
secure closure, preventing leaks and avoiding risks of direct
contact. It should be noted that in the healthcare field, in a
syringe whose distal extremity is of the type that comprises a
"Luer Lock" connector, the said "Luer Lock" connector is referred
to as male, while the point to which the said male "Luer Lock"
connector connects is referred to as a female "Luer Lock"
connector, such as, for example, the aforementioned inlet port of
the infusor. In addition, the said infusor comprises an outlet port
connected to a tube for direct intravenous administration to the
patient and to allow intravenous infusion. The elastomer material
of the infusor exerts a pressure on the liquid mixture contained in
its interior, generating a more or less continuous outflow for a
determined period of time. Finally, this type of infusor generally
comprises a "Luer Lock" cap that allows the inlet port of the
infusor to be aseptically closed and thus prevent the entry of
bacteria or any undesired component and/or fluid into the interior
of the reservoir.
[0009] On the other hand, the "cassette" type of reservoir is a
reservoir that comprises in its interior a bladder connected to a
single inlet/outlet point that connects to a tube for intravenous
administration to the patient, whose distal extremity also
comprises a female "Luer Lock" connector suitable for connection to
any type of syringe or device with a male "Luer Lock" connector,
allowing a hermetic and secure closure, preventing leaks and
avoiding risks of direct contact. This type of reservoir, during
the procedure of intravenous administration to the patient,
connects via the administration tube with an electric pump that
controls the speed of the outflow of the medication.
[0010] The methods known in the state of the art for filling
reservoirs of the infusor or cassette types generally always
require, before and after each filling, a prior manual step of
connection and disconnection of the male "Luer Lock" connector of
an injector (such as, for example, a syringe) to the female "Luer
Lock" connector of a reservoir of the infusor or cassette type.
This connection allows a hermetic screwed closure between the two
"Luer Lock" connectors. Similarly, these two manual steps of
connection and disconnection between the respective "Luer Lock"
connectors of the injector and the reservoir respectively are
repeated every time it is required to inject a component into a
reservoir by means of an injector. In addition, once the
corresponding component has been injected into the reservoir, it is
also necessary to plug the female "Luer Lock" connector of the
reservoir manually with a "Luer Lock" closure cap in order to
aseptically close the inlet port of the reservoir and thus prevent
the entry of bacteria or any undesired component and/or fluid into
the interior of the reservoir. These manual steps of connection and
disconnection of the "Luer Lock" connectors, which are carried out
by healthcare staff authorised to perform this type of operation,
considerably slow down the processes of filling and mixing of
components in this type of reservoir and make it impossible to
automate them, due to the need for a considerable technological
sophistication that does not currently exist. In addition, in the
manual filling of elastomer infusor reservoirs, the elastomer
bladder exerts a pressure opposite to the force exerted by the
healthcare staff during the process of filling this type of
infusor. This resistance exerted by the elastomer bladder causes
injuries to healthcare staff who regularly and very frequently
carry out this procedure of filling elastomer infusors. Moreover,
due to the high degree of toxicity of the drugs used for producing
the requisite medications, the involvement of healthcare staff in
phases or steps of the method for preparation of the said
medications, such as, for example, the steps of connection and
disconnection of the respective "Luer Lock" connectors between the
injector and the reservoir respectively, or of manual filling of
the infusors by means of syringes, can expose the said staff to a
risk of contact with the said highly toxic drugs.
[0011] It is therefore desirable to find a solution that allows the
cited drawbacks to be resolved. In particular, an aim of the
present invention is to describe an efficient and automated method
for filling intravenous administration reservoirs that makes it
possible to accelerate the process of filling this type of
reservoir by avoiding manual steps and reducing the risk of contact
for healthcare staff in the preparation of these highly toxic
products.
[0012] In order to solve the problems mentioned above, the present
invention describes a method for the automatic filling of at least
one type of base component in at least one container that comprises
at least one fluid inlet connector, by means of at least injection
means with spikes actuated by at least actuating means arranged in
a machine for the automatic preparation of intravenous solutions,
characterised in that the said spike causes a piercing of a closure
cap of the container suitable for piercing and arranged in the said
fluid inlet connector of the said container, allowing the direct
injection of the said component into the interior of the said
container. Thus, by having a pierceable cap, it is possible to
directly pierce the said cap by means of an injection means, such
as, for example, a syringe with a needle, and directly inject the
base component into the interior of the reservoir, without the need
for any connections and disconnections between the injection means
and the reservoir. In addition, this approach avoids the
participation of healthcare personnel and thus reduces any injuries
that might be caused when carrying out manual procedures for the
injection of components into the infusors. Furthermore, the present
method makes it possible to reduce the risk for healthcare staff of
contact with these highly toxic products.
[0013] Preferably, the fluid inlet connector and the closure cap
are of the "Luer Lock" type.
[0014] Preferably, the said container is of the type used for
direct intravenous infusion into patients.
[0015] In both the infusor and the cassette types of container,
during the method for filling by means of machines for the
automatic preparation of intravenous medication according to the
present invention, in some cases there can be dosage losses of
components for the final mixture that are not successfully
introduced into the interior of the infusor or cassette and are
deposited in the form of dead volumes in the interior of the said
pierceable closure cap arranged in the fluid inlet connector of the
container. Since control of the dosage introduced into a container
of the infusor or cassette type is performed by means of a
gravimetric weight check (i.e. using the density value of the base
components to convert the calculated weight measurement into a
volume value and thus determine the precise volume of the dosed
base component), the calculated weight of the infusor or cassette
that contains a dead volume of dose not administered to the patient
causes an error in the calculation of the dose volume that has been
administered to the patient. As is well known, in this type of
treatment it is very important that the respective dose (by volume)
of each base component intended to be used for the mixture should
be exactly the dose that is finally deposited in the interior of
the container of the infusor or cassette type, which is
subsequently injected into the patient by infusion. Bearing in mind
that the magnitude of the doses used in this type of mixture is
frequently of the order of millilitres (ml), an error in the dosage
of a base component for the mixture can produce irreversible
consequences, including the death of the patient.
[0016] For all of the above reasons, preferably, after the direct
injection of the said component into the interior of the said
container, the spike recedes into the interior of the said cap and
withdraws the dead volume of base component remaining in the
interior of the said cap. This therefore provides an efficient and
automated method for the filling of intravenous administration
reservoirs that makes it possible to determine and know the exact
dose volume of each base component introduced into the said
reservoir.
[0017] Preferably, the said container comprises at least one
inflatable elastomer bladder connected to the said fluid inlet
connector and also comprises at least one outlet connected
internally to the said inflatable bladder and connected externally
to a tube for intravenous administration by infusion to the
patient.
[0018] Preferably, the said container comprises at least one bag
connected to a fluid inlet and outlet connector that is connected
in its turn to a tube for intravenous administration by infusion
into the patient.
[0019] Preferably, the injection means consist of a syringe with a
plunger. In this case, after the direct injection of the said
component into the interior of the said container, the syringe
recedes into the interior of the said cap and withdraws the volume
of the said base component remaining in the interior of the said
cap, by means of the recession of the plunger of the said
syringe.
[0020] Preferably, the injection means consist of a bag that
contains a base component, the said bag being connected to a
peristaltic pump that allows the said component to be pumped
through a silicone tube connected to the said pump whose distal end
is terminated with a spike. In addition, and in order to solve the
problems mentioned previously, the present invention describes a
method for the automatic filling of at least one type of base
component, arranged originally in a first base container, into at
least one second container for intravenous infusion that comprises
at least one fluid inlet closed with a closure cap, by means of the
action of at least several actuating means arranged in a machine
for the automatic preparation of intravenous solutions, the said
machine further comprising at least several injection means for
transferring at least the said base component from the first
container to the second container, the said method comprising the
following steps: [0021] (a) extraction of at least the said base
component from the first container by means of the said injection
means actuated by the said actuating means; [0022] (b) weighing of
the syringe with at least the said base component in its interior;
[0023] (c) piercing of the closure cap arranged in the fluid inlet
of the second container by a needle of the said injection means;
[0024] (d) injection of the said base component into the said
second container; [0025] (e) extraction of the said needle from the
said second container; [0026] (f) weighing of the empty injection
means.
[0027] The said method is characterised in that during the step of
extraction of the needle from the said second container (step (e)),
the actuator places the needle of the injection means in the
interior of the cap, and by means of the withdrawal of the plunger
of the said injection means, also actuated by the actuator,
withdraws the volume of the said base component remaining in the
interior of the said closure cap. In this way, by weighing the said
injection means afterwards (step (f)), by means of the
corresponding gravimetry calculation, it is possible to know the
exact volume of dose deposited in the interior of the second
reservoir, which will subsequently be used for intravenous
administration by infusion to the patient.
[0028] Preferably, the base component may consist of a type of
intravenous medication or a type of solvent.
[0029] Preferably, the first container may be a vial that contains
at least one type of intravenous medication, or may be a bag that
contains at least one type of solvent.
[0030] Preferably, the said second container for intravenous
infusion comprises at least one inflatable elastomer bladder
connected to a fluid inlet port and at least one outlet port
connected to a tube for intravenous administration by infusion into
the patient.
[0031] Preferably, the said second container for intravenous
infusion comprises at least one bag connected to a fluid inlet and
outlet port that is connected in its turn to a tube for intravenous
administration by infusion to the patient.
[0032] Preferably, the actuating means arranged in a machine for
the automatic preparation of intravenous solutions may consist of
at least one actuator of the mechanical, electromechanical or
robotic type, among others.
BRIEF DESCRIPTION OF THE DRAWINGS
[0033] For a clearer understanding of the invention, by way of
explanatory but non-limitative example, some drawings are attached
of a preferred implementation of the invention.
[0034] FIG. 1 shows a perspective view of a container or reservoir
of the infusor type, together with a "Luer Lock" closure cap of the
type used in the method according to the present invention.
[0035] FIG. 2 shows a longitudinal cross-section of the "Luer Lock"
cap of FIG. 1.
[0036] FIG. 3 shows a perspective view of a step of the method of
the present invention in which the reservoir of the infusor type of
FIG. 1 is filled by means of a syringe.
[0037] FIG. 4 shows an enlarged longitudinal cross-section view of
a detail of FIG. 3, showing the insertion of the needle of the
syringe into the interior of the "Luer Lock" closure cap connected
to the infusor-type reservoir.
[0038] FIG. 5 shows a perspective view similar to that of FIG. 3 of
a step of the method according to the present invention in which
the contents of the syringe have been emptied into the infusor-type
reservoir.
[0039] FIG. 6 shows perspective view similar to that of FIG. 5 of a
step of the method according to according to the present invention
in which the syringe is arranged to withdraw the dead volume of the
dose from the closure cap of the reservoir.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0040] FIG. 1 shows a type of reservoir -1- for the storage of a
mixture of medication for intravenous administration according to
the method of the present invention. Said type of reservoir
illustrated in FIG. 1 is known as an "infusor" or an "elastomer
infusor" and comprises, in its interior, an inflatable elastomer
bladder -13- which, as can be seen in FIGS. 3 to 6, is connected to
an inlet port -10- to the infusor -1- through which the different
base components -7- for the desired medication mixture are
introduced. Said inlet port -10- consists of a threaded female
"Luer Lock" connector suitable for connection to any type of
syringe or device having a male "Luer Lock" connector, allowing a
hermetic and secure closure, preventing leaks and avoiding risks of
direct contact. As has been mentioned previously, in the healthcare
field, in a syringe whose distal end is of the type that comprises
a "Luer Lock" connector, the said "Luer Lock" connector is referred
to as male, while the point to which the said male "Luer Lock"
connector connects is referred to as a female "Luer Lock"
connector, such as, for example, the aforementioned inlet port -10-
of the infusor -1-. In addition, the said infusor -1- comprises an
outlet port -12-, connected to an intravenous administration tube
(not illustrated) for connecting directly to the patient and thus
allowing the intravenous infusion of the medication mixture. In
this type of reservoir, the elastomer material exerts a pressure on
the mixture liquid that it contains, generating a more or less
continuous outflow to the patient for a determined period of time.
As can also be seen in FIG. 1, this type of reservoir generally
uses a closure cap -2-, of the "Luer Lock" type, which allows the
inlet port -10- to the infusor -1- to be closed and thus prevent
the entry of bacteria or any undesired component and/or fluid into
the interior of the reservoir.
[0041] As can be seen in FIG. 2, said "Luer Lock" closure cap -2-
consists of a cylindrical body -25- that comprises an internal
volume -240-, open at one of its ends, whose internal surface
comprises helical grooves -241- forming an internal thread for
coupling with the "Luer Lock" inlet port -10- by means of the
corresponding mating thread, as can be seen in FIGS. 3 to 6. In
addition, said internal volume -240- comprises a cylindrical
conduit -21- concentric with the said volume -240- that comprises
an opening -21'- at one of its ends and the opposite end of the
said conduit -21- coincides with the other end of the body -25-
which comprises an orifice -22-. The interior -23- of said
cylindrical conduit -21- passes through between the end -21'- and
the end -22- for the possible passage of fluids. The said
cylindrical conduit -21- has a diameter smaller than the diameter
of the inlet port -10- of the infusor -1-, so that when the inlet
port -10- is closed by means of the said closure cap -2-, the
cylindrical conduit -21- penetrates the interior of the inlet port
-10- at the same time that the inlet port is screwed into the
interior of the internal volume -240-, creating an hermetic closure
of the inlet port -10-. The orifice -22- may comprise a closure
membrane capable of being pierced and penetrated by the needle -32-
of the syringe -3-.
[0042] For the method described in the present invention, an
intravenous medication container or reservoir of the infusor type
may be used, or any other type of intravenous medication reservoir
such as, for example, a reservoir of the cassette type (not
illustrated). This type of reservoir generally comprises a bag in
its interior connected to a single inlet/outlet port that connects
to an intravenous administration tube for direct connection to the
patient and whose distal extremity is also closed by means of a
closure cap of the "Luer Lock" type as previously described,
allowing closure of the inlet/outlet port of the cassette. During
the procedure of intravenous administration to the patient, this
type of reservoir is connected by means of the administration tube
to an electronic pump that controls the speed of the outflow of the
medication.
[0043] As has been previously explained, the present invention
relates to a method used in a type of machine for the automatic
preparation of intravenous medication, such as, for example, the
machine described in the PCT patent application WO 2012/172418 or
in the Spanish patent application 201430745. This type of machine
allows, through the actuation of at least one actuator (such as,
for example, a robotic arm), the preparation of a specific
medication resulting from the mixture of different intravenous
administration base components, such as, for example, a type of
drug and a type of solvent, among others. In this type of machine,
the general procedure for the automatic filling of reservoirs of
the infusor or cassette type comprises steps that are not
illustrated in the present description.
[0044] There follows a description of an example of the procedure
of filling with a solvent by means of a peristaltic pump and of
filling with a drug by using an actuator.
[0045] The procedure takes place according to the following steps,
which are illustrated in FIGS. 3 to 6.
[0046] Step a): Manual Dosing of the Solvent by Means of a
Peristaltic Pump (Not Illustrated)
[0047] In this first step, the filling of the infusor -1- with a
solvent is carried out by means of a peristaltic pump connected by
one end to a bag of base solvent and having on the other end a tube
with a "Luer Lock" connector for connecting an infusor -1- or a
vial by means of a disposable spike.
[0048] For the said filling procedure, a solvent dosing set is
used. This comprises a silicone tube that connects with the bag of
base solvent at one and, passes through the peristaltic pump and
leaves one Luer Lock end free for the connection of the medication
container (infusor -1-). Said silicone tube comprises a double
channel in the central part, designed for connection to
dual-channel peristaltic pumps, thus offering increased dosing
accuracy. Also, in this case a spike has been added at one of the
ends of the said silicone tube for piercing the bag of base
solvent, and a "Luer Lock" connector at the other end for
connecting the medication containers (infusor -1- with Luer Lock or
disposable spike for the dosing of solvent in drug vials).
[0049] The said step a) comprises the following sub-steps carried
out manually by the operator in interaction with the automatic
medication preparation machine: [0050] 1. Purging of the
peristaltic pump to eliminate any possible residues in the same;
[0051] 2. Weighing of the empty infusor -1- on a scale attached to
the machine; [0052] 3. Connection of the "Luer Lock" connector of
the inlet port of the infusor -1- to the "Luer Lock" end of the
dosing set connected to the peristaltic pump for the filling of the
infusor -1- with physiological serum as solvent; [0053] 4.
Disconnection of the infusor -1- from the dosing set at the "Luer
Lock" end; [0054] 5. Placement of the "Luer Lock" cap -2- with
membrane, also referred to as an addition point, by screwing the
same by hand on to the inlet port to the infusor -1-; [0055] 6.
Weighing of the infusor -1- on a scale attached to the machine and
placement of a label for pre-identification of the final product;
[0056] 7. Calculation by gravimetry of the dose volume of solvent
introduced into the infusor -1-; [0057] 8. Placement of the infusor
-1- in a container support of the machine by means of a holding
clamp that holds the infusor -1- by the "Luer Lock" cap -2- or
addition point; [0058] 9. Insertion of the clamp into the container
support of the machine, carefully arranging the administration
tubes of the infusor -1- in the upper part so as not to interfere
with the movement of the actuator; the said infusor -1- is arranged
in the container support of the machine in such a way that the
"Luer Lock" cap -2- or addition point is arranged below the rest of
the body of the infusor -1-; [0059] 10. Loading of the other
materials necessary for the preparation of the medication (syringe
-3- with needle, medication vials); [0060] 11. Closure of the
window of the automatic medication preparation machine;
[0061] Step b) Automatic Dosing of the Drug into the Infusor -1-
[0062] 12. Removal of the cover arranged over the needle -32-;
[0063] 13. Optionally, a procedure can be carried out for detecting
the absence of the cover by means of a module on the machine for
detecting the absence of a cover; [0064] 14. Optionally, the
syringe -3- can be weighed empty in order to calibrate the scale;
[0065] 15. Automatic presentation of the vial with the desired drug
for the mixture in the extraction position; [0066] 16. Extraction
of the drug -7- from the vial by means of the actuation of the
plunger -30- of the syringe -3- by an actuator that holds the body
of the syringe -3- with a clamp; [0067] 17. Weighing of the full
syringe -3- in order to check that the extracted dose of drug -7-
is the correct one; [0068] 18. In this sub-step, as can be seen in
FIG. 3, the needle -32-, by means of the actuation of the robotic
arm that holds the syringe -3-, is positioned in such a way as to
pierce the membrane arranged in the upper surface -22- of the "Luer
Lock" cap -2- or additive addition, the latter being arranged in
the inlet port -10- of the infusor -1-; [0069] 19. The dose of drug
-7- is then injected directly into the infusor -1- by means of the
actuation of the plunger -30- of the syringe -3- by the actuator
that holds the body of the syringe -3- by means of a clamp. As can
be seen in FIG. 5, as the drug -7- is introduced directly into the
interior of the bladder -13- of the infusor -7-, the said bladder
-13- is inflated to store the said drug -7- in its interior; [0070]
20. Once all of the drug -7- has been emptied into the interior of
the infusor -1-, the needle -32- is extracted from the "Luer Lock"
cap -2- or addition point. At this moment, as can be seen in FIG.
6, optionally the needle -32- is arranged, by means of the
actuation of the actuator, in the interior -23- of the cylindrical
conduit -21- of the said "Luer Lock" cap -2-, and, by means of a
withdrawal of the plunger -30- of the syringe -3-, any possible
volume -8- of drug dose remaining in the interior -23- of the
cylindrical conduit -21- of the said "Luer Lock" -2- is extracted;
[0071] 21. Optionally, in a final sub-step, the syringe -3- can be
weighed and the dead volume of the syringe -3- calculated by means
of gravimetry.
[0072] The said eventual volume -8-, referred to as "dead volume",
is not introduced into the bladder -13- of the infusor -1- and will
therefore not subsequently be administered to the patient.
Notwithstanding, sub-step 20 makes it possible to know precisely
the exact volume of dose introduced into the infusor -1- that will
subsequently be used to administer directly to the patient the
medication prepared in the said infusor -1-.
[0073] Sub-steps 12 to 21 (some of which are optional) can be
repeated several times according to the number of different drugs
necessary for the desired medication for the patient, without the
need to make manual connections and disconnections between a
syringe (without needle and with "Luer Lock" connector) and the
inlet port -10- of the infusor -1-.
[0074] Finally, once the desired mixture has been created, a series
of additional sub-steps may optionally be carried out: [0075] 22.
The cover is placed on the needle -32-; [0076] 23. A detection
process is carried out to check that the cover is in place, and the
syringe -3- is withdrawn to a garbage bin arranged in the machine;
[0077] 24. The motor preparation and initialisation data is
automatically stored; [0078] 25. The infusor -1- is removed from
the container support of the machine by extracting the holding
clamp from the container support; [0079] 26. The pre-identification
label of the infusor -1- is read in order to check that the correct
product has been unloaded; [0080] 27. Weighing is carried out in
order to check that the dose of drug introduced into the infusor
-1- is the correct one; [0081] 28. Finally, an administration label
is printed and glued to the infusor -1-.
[0082] Alternatively, the said method for the filling of the
infusors -1- may be carried out both for filling with drugs
extracted from vials and for solvents extracted from bags, such as,
for example, physiological serum arranged in a base bag.
Alternatively, therefore, the preamble of step a) and steps 2 to 4
could be removed and the filling with the solvent could be carried
out automatically, as for the drug.
[0083] For automatic filling with solvent and drug, the following
steps are followed:
[0084] B1. Preparation of the infusor -1- (as explained in points 5
and 6 above);
[0085] B2. Loading of the infusor -1- (as explained in points 8 to
11 above);
[0086] B3. Preparation of the syringe -3- (as explained in points
12 to 14 above);
[0087] B4. Extraction of solvent with the syringe -3- from an
infusion bag located in another position in the same compartment
that contains the infusor -1-;
[0088] B5. Weighing of the syringe -3- with solvent;
[0089] B6. Injection of the solvent into the infusor -1-;
[0090] B7. Automatic dosing of the drug (as explained in points 14
to 28 above).
[0091] Where a reservoir of the cassette type is used for filling
with a mixture of drugs and solvent, completely automatic
preparation may be advantageous even if it requires the occupation
of a container position in the interior of the automatic
preparation machine for positioning the bag of base solvent. The
order of filling with the drug and the solvent may be programmed
indiscriminately; some centres have a preference for filling with
the solvent at the end, in order to leave the administration route
of the cassette full of clean solvent.
[0092] The invention has been described by making reference to a
preferred version of the same, purely by way of example. As will be
understood, any expert in the subject, having the knowledge that
follows from the present description, drawings and claims, will be
able to introduce modifications to the object of the invention
which, if they fall within the widest scope of the claims, will be
understood to be covered by the scope of protection of the
invention.
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