U.S. patent application number 11/097227 was filed with the patent office on 2005-10-13 for method for packaging thermal reactors for conditioning fluid containers and reactors therefor.
This patent application is currently assigned to SIDAM DI AZZOLINI GRAZIANO E C. S.A.S.. Invention is credited to Azzolini, Graziano, Conti, Paolo, Ercolani, Pietro Simone.
Application Number | 20050224389 11/097227 |
Document ID | / |
Family ID | 34897805 |
Filed Date | 2005-10-13 |
United States Patent
Application |
20050224389 |
Kind Code |
A1 |
Azzolini, Graziano ; et
al. |
October 13, 2005 |
Method for packaging thermal reactors for conditioning fluid
containers and reactors therefor
Abstract
A method for packaging thermal reactors, and thermal reactors
therefor, particularly for conditioning containers of fluids for
parenteral administration and of the type that comprises an
enclosure divided into at least one first compartment and one
second compartment, mutually separated by a tearable membrane and
provided with at least one filling inlet, the method comprising:
introducing a first component in the first compartment through the
respective inlet; introducing a second component, suitable to react
with the first component with an exothermic or endothermic
reaction, in the second compartment through the respective inlet;
extracting from at least one of the first and second compartments
the air contained therein through the respective inlet; sealing the
inlet of the first compartment, containing the first component; and
sealing the inlet of the second compartment, containing the second
component.
Inventors: |
Azzolini, Graziano;
(Cavezzo, IT) ; Ercolani, Pietro Simone; (Perugia,
IT) ; Conti, Paolo; (Pisa, IT) |
Correspondence
Address: |
MODIANO & ASSOCIATI
Via Meravigli, 16
Milano
20123
IT
|
Assignee: |
SIDAM DI AZZOLINI GRAZIANO E C.
S.A.S.
|
Family ID: |
34897805 |
Appl. No.: |
11/097227 |
Filed: |
April 4, 2005 |
Current U.S.
Class: |
206/570 ;
206/803 |
Current CPC
Class: |
A61M 2205/364 20130101;
A61M 5/445 20130101 |
Class at
Publication: |
206/570 ;
206/803 |
International
Class: |
B65D 069/00 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 8, 2004 |
IT |
MO2004A000075 |
Claims
What is claimed is:
1. A method for packaging a thermal reactor, for conditioning
containers of fluids for parenteral administration, the thermal
reactor comprising an enclosure divided into at least one first
compartment and one second compartment, said first and second
compartments being separated from each other by a tearable membrane
and being provided with at least one respective filling inlet, the
method comprising the steps of: introducing a first component in
said first compartment through the respective inlet thereof,
introducing a second component, suitable to react with said first
component with an exothermic or endothermic reaction, in said
second compartment through the respective inlet thereof, extracting
from at least one of said first and second compartments air
contained therein through the respective inlet thereof, sealing the
respective inlet of the first compartment, which contains said
first component, sealing the respective inlet of the second
compartment, which contains said second component.
2. The method of claim 1, further comprising the step of
associating with said enclosure, insertion means for inserting a
tool for tearing said membrane.
3. The method of claim 2, comprising providing said insertion means
with retention and sealing means suitable to prevent escape of said
first and second components and inflow of the air that lies outside
the enclosure.
4. The method of claim 3, comprising providing said insertion means
with an inlet and said retention and sealing means with an insert
made of elastic/elastomeric material, accommodating the insert in
said inlet, crossing the insert with said tool and closing the
opening formed in the insert by said tool.
5. The method of claim 1, comprising providing at least one of said
first and second components in a loose solid form, preferably a
particle or granule form, and providing the other one of said
components in a fluid form.
6. The method of claim 1, wherein said introduction step consists
in filling said first compartment or said second compartment.
7. The method of claim 6, wherein said extraction step follows said
introduction step.
8. The method of claim 7, wherein said sealing step occurs after
said extraction step or said introduction step.
9. The method of claim 8, wherein said sealing step comprises
heat-sealing lips of said respective filling inlet.
10. The method of claim 8, wherein said sealing step comprises
applying fastening means to said respective filling inlet.
11. The method of claim 2, comprising providing said enclosure with
a first bag, with an interior forming said first compartment, and a
second bag, with walls that are at least partially constituted by
said membrane, and accomodating said second bag in said first bag,
said second bag forming said second compartment at the inside
thereof.
12. The method of claim 1, comprising providing said enclosure made
of a material of a flexible type.
13. The method of claim 1, comprising providing said enclosure with
at least one heat-conducting portion.
14. The method of claim 11, comprising providing said first and
second bags associated to each other at at least one portion of
respective walls thereof.
15. The method of claim 14, wherein said insertion means are
provided associated at said portion.
16. A thermal reactor for conditioning containers of fluids for
parenteral administration, comprising: a closed enclosure, which is
divided into at least one first compartment, which contains a first
component, and into a second compartment, which contains a second
component suitable to react with the first component with an
exothermic or endothermic reaction, said second compartment being
separated from said first compartment by a tearable membrane, and
wherein at least one of said first and second compartments
contains, respectively, the first and second components
substantially in a vacuum ambient.
17. The reactor of claim 16, wherein said enclosure comprises
insertion means for inserting a tool for tearing said membrane.
18. The reactor of claim 17, wherein said insertion means comprise
retention and sealing means, which are adapted to prevent escape of
said first and second components and inflow of air that lies
outside said enclosure.
19. The reactor of claim 18, wherein said insertion means comprise
an inlet, and said retention and sealing means comprises an insert
made of elastic/elastomeric material, said insert being
accommodated in said inlet and being adapted to form an opening
upon crossing thereof by said tool and to close said opening formed
therein by the crossing of said tool.
20. The reactor of claim 16, wherein at least one of said first and
second components is in a loose solid form, preferably a particle
or granule form, the other one of said components being in a fluid
form.
21. The reactor of claim 17, wherein said enclosure comprises a
first bag having an interior thereof that forms said first
compartment, and a second bag with walls at least partially
constituted by said membrane, said second bag being accommodated in
said first bag and having an interior that forms said second
compartment.
22. The reactor of claim 24, wherein said enclosure is made of a
flexible type.
23. The reactor of claim 17, wherein said enclosure comprises at
least one heat-conducting portion.
24. The reactor of claim 21, wherein said first and second bags are
associated to each other at at least one portion of respective
walls thereof.
25. The reactor of claim 24, wherein said insertion means are
associated at said portion.
26. The thermal reactor of claim 16 in combination with a container
of fluids for parenteral administration.
27. A first-aid kit, comprising a thermal reactor as set forth in
claim 16 and a container of a fluid for parenteral administration,
said thermal reactor and container being coupled to each other by
way of anchoring means.
28. The kit of claim 27, wherein an enclosure of said reactor
overlaps said container at least at a heat-conducting portion
thereof.
29. The kit of claim 27, comprising anchoring means selected from a
group comprising straps, adhesive tapes, snap and hook and loop
couplers.
30. The kit of claim 27, wherein said container is constituted by a
pouch.
31. The kit of claim 28, comprising a tool for tearing a separation
membrane of said enclosure.
32. The kit of claim 31, wherein said tearing tool is of a needle
type.
Description
[0001] The present invention relates to a method for packaging
thermal reactors, particularly for conditioning containers of
fluids for parenteral administration, and to the associated
reactors.
BACKGROUND OF THE INVENTION
[0002] It is known that a person affected by a sudden illness, an
accident or an injury is often in a state of shock characterized by
hypovolemia (blood volume reduction) and by hypothermia (drop in
body temperature).
[0003] One of the first treatments administered to such a person in
first-aid actions performed directly on the site of the illness,
accident or injury or during the transport of said person to a
health-care facility, consists of the parenteral administration of
fluids, such as for example physiological solutions, drugs or other
fluids, such as to allow the person to return to normovolemia and
normothermia.
[0004] These fluids are packaged in containers, such as for example
bottles or bags, which have a dispensing outlet with which the
input end of a discharge line is associated, the output end of the
line being associated with an element for injection into the person
being aided.
[0005] Often, particularly in procedures performed in open-air
locations, the fluids to be administered are at an average
temperature that is lower than the normal average body temperature
(on the order of 35.degree.-37.degree. C.).
[0006] To prevent the thermal conditions of the aided person from
deteriorating instead of improving, it is therefore necessary to
heat the fluids to a preset temperature (comprised between a
minimum value on the order of 33.degree. C. and a maximum value on
the order of 40.degree. C.) and keep them thereat, respectively
before and during their administration.
[0007] Thermal reactors are currently known which are used
particularly for the thermal conditioning, particularly the
heating, of fluid containers for parenteral administration, which
are substantially constituted by an enclosure divided into at least
two compartments that are mutually separated by a tearable
membrane, one of said compartments containing a first component,
the other compartment containing a second component, said
components being suitable to react with each other with an
exothermic reaction.
[0008] The reaction is usually a reaction of solution of the first
component (solute) in the second component (solvent).
[0009] The first component is generally in the form of solid
particles, granules or the like, and is constituted for example by
calcium chloride or the like; the second component is generally in
the form of a liquid and is constituted for example by water or the
like.
[0010] At the time of use, an operator acts manually on the
enclosure, for example with a compression or squeezing action,
applying thereto a pressure that breaks the tearable membrane and
thus allows the second component (solvent) to pour from the second
compartment into the first compartment, where it reacts with the
first component (solute), dissolving it; if the reaction is
exothermic, heat is generated.
[0011] After activating the reaction, the enclosure is placed in
contact with the container of the fluid to be administered in order
to condition it thermally and in particular to heat it to the
intended temperature.
[0012] There are also cases, such as for example a cardiac arrest,
in which it is necessary to cool a fluid as neuroprotection; in
this case, the reaction between the first component and the second
component is endothermic, i.e., it absorbs heat from the
outside.
[0013] These known types of thermal reactor are not free from
drawbacks, including the fact that the reaction between the
components that they contain can be activated unintentionally and
at inappropriate times by compressions, impacts, or accidental
squeezing to which they can be subjected during their storage,
movement and handling, which accordingly require particular care
and attention.
[0014] Therefore, known reactors may lose prematurely their
capacity to generate or absorb heat, losing their function and
becoming unusable when they are actually needed.
[0015] Another drawback of known reactors is that they contain air,
which by having a low thermal conductivity acts as an insulator and
therefore reduces the exchange of heat between the reactors and the
environment outside them and in particular between the reactors and
the containers of the fluids to be conditioned.
[0016] Moreover, the presence of air in known reactors causes
another drawback: it in fact prevents the second component, the one
in the liquid state, from diffusing and being distributed
throughout the entire volume of the first compartment that contains
the first component, the one in the solid state in the form of
particles or granules; the reaction surface is thus reduced, and
the reaction itself remains incomplete, with a consequent decrease
in the efficiency of the reactor.
SUMMARY OF THE INVENTION
[0017] The aim of the present invention is to eliminate the
drawbacks noted above of known thermal reactors, by providing a
method for packaging thermal reactors, particularly for
conditioning containers of fluids for parenteral administration,
that allows to improve the distribution and diffusion, one within
the other, of the reacting components and to increase their
reaction surface.
[0018] An object of the present invention is to obtain thermal
reactors that have an improved efficiency and an increased capacity
to exchange heat with the environment that lies outside them.
[0019] Another object of the present invention is to obtain thermal
reactors that have improved functionality and safety, can be
activated only intentionally, and do not require particular
precautions for their storage, movement and handling.
[0020] Within this aim, an object of the present invention is to
provide a structure that is simple, relatively easy to provide in
practice, safe in use, effective in operation, and has a relatively
low cost.
[0021] This aim and these and other objects that will become better
apparent hereinafter are achieved by the present method for
packaging thermal reactors, particularly for conditioning
containers of fluids for parenteral administration and of the type
that comprises an enclosure divided into at least one first
compartment and one second compartment, which are mutually
separated by a tearable membrane and are provided with at least one
filling inlet, characterized in that it comprises:
[0022] introducing a first component in said first compartment
through said respective inlet,
[0023] introducing a second component, suitable to react with said
first component with an exothermic or endothermic reaction, in said
second compartment through said respective inlet,
[0024] extracting from at least one of said first and second
compartments the air contained therein through the respective
inlet,
[0025] sealing the inlet of the first compartment, which contains
said first component,
[0026] sealing the inlet of the second compartment, which contains
said second component.
[0027] This aim and these objects are also achieved by the present
thermal reactor, particularly for conditioning containers of fluids
for parenteral administration, which comprises a closed enclosure
divided into at least one first compartment, which contains a first
component, and a second compartment, which contains a second
component suitable to react with the first component with an
exothermic or endothermic reaction and is separated from said first
compartment by a tearable membrane, characterized in that at least
one of said first and second compartments contains respectively the
first component and the second component substantially in
vacuum.
BRIEF DESCRIPTION OF THE DRAWINGS
[0028] Further characteristics and advantages of the present
invention will become better apparent from the following detailed
description of a preferred but not exclusive embodiment of a method
for packaging thermal reactors, particularly for conditioning
containers of fluids for parenteral administration, and of the
associated reactors, illustrated by way of non-limiting example in
the accompanying drawings, wherein:
[0029] FIG. 1 is a schematic view of a reactor according to the
invention before packaging;
[0030] FIG. 2 is a schematic view of the step of the method
according to the invention in which the second component is
introduced in the second compartment;
[0031] FIG. 3 is a schematic view of the step of the method
according to the invention in which the first component is
introduced in the first compartment;
[0032] FIG. 4 is a schematic view of a thermal reactor according to
the invention;
[0033] FIG. 5 is a schematic view of the activation of a thermal
reactor according to the invention;
[0034] FIG. 6 is a schematic axonometric view of a first aid kit
according to the invention;
[0035] FIG. 7 is a schematic plan view of an element of the kit of
FIG. 6.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0036] With reference to the figures, the reference numeral 1
generally designates a thermal reactor particularly for
conditioning, and more particularly for heating, containers of
fluids for parenteral administration, which can be used for example
in first-aid actions.
[0037] The reactor 1 (FIG. 4) comprises an enclosure 2, which is
closed and divided into a first compartment 3, which contains a
first component C1, and into a second compartment 4, which contains
a second component C2, which is suitable to react with the first
component C1 with an exothermic or endothermic reaction and is
separated from the first compartment 3 by a tearable membrane
5.
[0038] If the reaction is exothermic, it generates heat, which is
transmitted by the reactor 1 to the environment that lies outside
it; if the reaction is endothermic, it absorbs heat from the
environment that lies outside the reactor 1.
[0039] It should be noted that in the present description, the
distinction between the first compartment and the second
compartment and between the first component and the second
component is merely an example and does not limit the protective
scope of the present invention; moreover, alternative solutions,
which reproduce the inventive concept of the present invention and
in which the enclosure 2 is divided into more than two compartments
that contain the same component or different components, are not
excluded.
[0040] At least one of the first and second compartments 3 and 4
contains respectively the first component C1 and the second
component C2 substantially in vacuum; in the embodiment shown in
the figures, it is the first component C1 that is packaged
substantially in vacuum in the first compartment 3.
[0041] The first component C1 is in the form of a loose solid, such
as particles, granules or the like, or in liquid form; the second
component C2 is in liquid form.
[0042] In the case of an exothermic reaction, the first component
C1 can be constituted for example by calcium chloride, while the
second component C2 can be constituted by water, the solution of
the former in the latter being exothermic; however, alternative
embodiments of the reactor 1 in which the first and second
components C1 and C2 have a different chemical nature are not
excluded.
[0043] The first compartment 3 comprises a filling inlet 3a,
through which the first component C1 is introduced therein and
which is for example heat-sealed in the packaged reactor 1.
[0044] Likewise, the second compartment comprises a filling inlet
4a, through which the second component C2 is introduced therein and
which is sealed for example by means of fastening and sealing means
6 in the packaged reactor 1.
[0045] The enclosure 2 is constituted by a first bag 7 or the like,
the interior of which forms the first compartment 3, and by a
second bag 8, which is shaped like a balloon, bladder or the like,
the walls of which are at least partially constituted by the
membrane 5; said second bag is accommodated inside the first bag 7
and its interior forms the second compartment 4.
[0046] The enclosure 2, i.e., the first and second bags 7 and 8,
are made of a material of the type that is flexible, impermeable
and resistant to the chemical attack of the first and second
components C1 and C2, such as for example silicone; the first bag 7
further comprises at least one heat-conducting portion, through
which it exchanges heat with the environment that lies outside
it.
[0047] The first bag 7 and the second bag 8 are mutually associated
at portions 9 of their respective walls at which insertion means 10
are provided for inserting a tool 11 for tearing the membrane 5,
such as for example a needle 12.
[0048] The insertion means 10 are constituted by an inlet 13, which
is provided with retention and sealing means, such as an insert 14
made of elastic/elastomeric material, which is accommodated
therein; the insert 14 is suitable to be crossed by the tool 11 and
to close, once the tool 11 has been extracted, the opening formed
therein by said tool, preventing the escape of the first and second
components C1 and C2 from the enclosure 2 and the inflow of
external air therein.
[0049] The reactor 1 can be used for the thermal conditioning of
containers of fluids for parenteral administration.
[0050] FIGS. 6 and 7 illustrate a kit K for first-aid actions,
which comprises a reactor 1 coupled by anchoring means 15 to a
container of a fluid for parenteral administration, such as a pouch
16. The kit K can further comprise the tool 11 for tearing the
membrane 5, such as the needle 12.
[0051] The enclosure 2 overlaps the pouch 16 at its
thermally-conducting portion; the anchoring means 15 are of the
type of adhesive tapes 17, straps or the like.
[0052] With particular reference to the reactor 1 described and
illustrated above, the method for packaging it comprises the steps
of:
[0053] introducing the second component C2 in the second
compartment 4 (i.e., in the second bag 8) through the respective
open inlet 4a, until said second compartment is filled,
[0054] sealing the inlet 4a with the fastening and sealing means 6,
such as for example a clamp and a pad, or such as a heat seal,
[0055] introducing the first component C1 in the first compartment
3 (i.e., in the first bag 7) through the respective open inlet
3a,
[0056] extracting from the first compartment 3, which contains the
first component C1, the air contained therein through the
respective inlet 3a until a condition of substantial vacuum is
reached,
[0057] sealing the inlet 3a, for example by heat-sealing its lips,
of the first compartment 3 that contains the first component C1
packaged therein substantially in vacuum.
[0058] The method according to the invention further comprises
associating with the enclosure 2, before filling it with the first
and second components C1 and C2, i.e., during the preparation of
the first and second bags 7 and 8, the means 10 for inserting the
tool 11 for tearing the membrane 5.
[0059] The operation of the invention can be deduced easily by the
person skilled in the art.
[0060] In practice it has been found that the described invention
achieves the intended aim and objects.
[0061] The reactor according to the invention has improved
efficiency and increased heat transmission capacity; since it is in
fact substantially devoid of air inside it, it allows the second
and first components to diffuse and distribute better within each
other and to increase their reaction surface.
[0062] The reactor according to the invention, by virtue of the
absence of air and the need to act with an appropriate tearing
tool, is further safer, can be activated only intentionally, and
does not require particular care in its storage, handling and
movement.
[0063] Finally, the reactor according to the invention, packaged in
a kit, already coupled to a container of the fluid to be
administered parenterally, facilitates and speeds up the maneuvers
that health operators must perform during first-aid actions.
[0064] The reactor has in fact the appearance of a cartridge that
is ready for use and can be replaced with another backup cartridge
without requiring the operators to handle separately the depleted
reactor and fluid container and the backup ones, with an obvious
saving in time and increase in efficiency of the action.
[0065] The invention thus conceived is susceptible of numerous
modifications and variations, all of which are within the scope of
the appended claims.
[0066] All the details may further be replaced with other
technically equivalent ones.
[0067] In practice, the materials used, as well as the shapes and
the dimensions, may be any according to requirements without
thereby abandoning the scope of the protection of the appended
claims.
[0068] The disclosures in Italian Patent Application No.
MO2004A000075 from which this application claims priority are
incorporated herein by reference.
* * * * *