专利摘要:
The present invention relates to a packaging device (200) for the in situ formulation of a liquid thermosetting resin, said device (200) comprising a flexible hermetic envelope (210) having inside its two compartments (211, 212), a first compartment (211) comprising a resin and a second compartment (212) comprising a hardener, said two compartments (211, 212) being hermetically separated from one another by a removable clamping system (220) capable of having two positions of which: a first so-called storage position in which the clamping system (220) is engaged on the casing (210) to ensure a hermetic separation between the two compartments (211, 212) preventing contact between the resin and the hardener, and a second so-called mixing position in which the clamping system (220) is removed to allow the inside of the casing (220) to come into contact with each other. e resin and hardener respectively contained in the first (211) and second (212) compartments to obtain a formulation of a liquid thermosetting resin.
公开号:BE1025993B1
申请号:E2019/5069
申请日:2019-02-05
公开日:2019-09-10
发明作者:Elodie Vlamynck;Jérôme Gagnoux
申请人:Elodie Vlamynck;Jérôme Gagnoux;
IPC主号:
专利说明:

PACKAGING DEVICE FOR THE PREPARATION OF A THERMOSETTING RESIN AND ASSOCIATED KIT
Technical field and prior art
The present invention relates to the field of medical devices and more particularly that of orthotics.
The object of the present invention is to provide practitioners and in particular orthopedists with a kit comprising:
a stabilization orthosis capable of surrounding a limb or a body segment of a patient and having an anatomical receiving pocket, and a packaging device in the form of a flexible hermetic envelope comprising a resin and a hardener allowing the obtaining a liquid thermosetting resin, the introduction of this thermosetting resin into the pocket of the orthosis allows obtaining a reinforced structure stabilizing the segment during a rest or rehabilitation phase following an injury (fracture, sprain , etc.).
By orthosis within the meaning of the present invention is meant throughout this description which follows a medical device in the form of an apparatus which compensates for an absent or deficient function, assists an articular or muscular structure, or even stabilizes a limb or a patient's body segment during a rehabilitation or rest phase.
Today, kits are known for manufacturing and installing a stabilization orthosis to stabilize a body segment or a limb of a patient following a fracture or sprain injury.
Such kits conventionally include:
two packaging jars respectively containing a polyurethane resin and a hardener, and a textile piece comprising an anatomical receiving pocket capable of at least partially enveloping the body segment or the patient's limb which must be stabilized (for example the wrist) and to receive the thermosetting resin once it has been prepared.
RAIGI offers, for example, such a kit sold under the trademark RAIGIDUR® (registered trademark).
BE2019 / 5069
The Applicants submit that, so far, the receiving bag provided with such a kit is made of a porous textile material. Such a material does not provide a sealing function between the pocket and the patient's skin so that, when the practitioner injects the thermosetting resin, this resin frequently comes into contact with the patient's skin.
We also know that, in this kit, polyurethane resins are formed by mixing a polyurethane resin and an isocyanate hardener.
Such a resin is harmful, even toxic.
In fact, isocyanates, when they are not completely polymerized with the resin, are very volatile and are harmful in particular by inhalation. These include symptoms of asthma or difficulty breathing by inhalation.
Isocyanates can also cause skin irritation and even skin allergies.
They can still cause severe eye irritation.
These isocyanates are also likely to increase the risk of cancer and / or to cause serious effects on the organs following repeated or prolonged exposure.
The presence of these isocyanates therefore requires very strict precautions for use for both the patient and the practitioner who can apply several orthoses per day.
Once fully polymerized (that is to say after lamination), the resin obtained is physiologically inactive. However, during the injection of the thermosetting resin into the pocket for receiving the orthosis, this polymerization may not be completely finished if the conditions of use are not respected (mixing time, homogeneity of the mixture, etc. ).
The use of an orthosis with a porous textile material is then contraindicated because the resin in the pocket passes through the textile to come into contact with the patient's skin.
The injection of the liquid thermosetting resin into the pocket is an operation which exposes the practitioner to the danger of contact with these isocyanates because the polymerization process has not yet been completed.
For the same reasons as those mentioned above, waste related to the preparation of a polyurethane resin must also follow a secure reprocessing path.
As previously indicated, the polyurethane resin and the hardener are each packaged in separate packaging pots, respectively. The manufacture of the mixture
BE2019 / 5069 polyurethane resin with the isocyanate hardener is produced by opening the two jars and transferring one component into the jar containing the other component.
It can then be seen that the pot initially containing the hardener always comprises a residue after mixing. In terms of waste treatment, recycling is planned according to a very specific sector to limit the pollution associated with the presence of isocyanates.
The Applicants therefore consider that the solutions proposed so far for the preparation and the installation of a reinforced structure on an orthosis are not satisfactory as much for reasons of practicality (complexity of the manipulations for mixing the components, recycling requirements ) only for safety reasons (toxicity of the components, risk of exposure, etc.).
Summary and object of the present invention
The present invention aims to improve the current situation described above.
The present invention aims more particularly to remedy the various drawbacks mentioned above by proposing an orthosis and a conditioning device for the preparation and implementation of a reinforced structure making it possible to stabilize at least one body segment of a patient.
The object of the present invention relates, according to a first aspect, to an orthosis for stabilizing by a reinforced structure at least one body segment (or member) of a patient during a rest phase.
According to the present invention, the orthosis is intended to surround the at least one segment (or member) and comprises at least one piece of textile material made up so as to have a double skin forming between the two skins an anatomical receiving pocket.
Preferably, this reception pocket is capable of at least partially enveloping the at least one body segment (or member).
Preferably, this reception pocket has a passage opening for the introduction of a liquid thermosetting resin and the reception of the resin in order to form the reinforced structure, this reinforced structure being advantageously obtained by curing the resin in the pocket.
According to the present invention, the textile material is configured to ensure the impermeability of the receiving bag preventing the passage of the thermosetting resin
BE2019 / 5069 liquid towards at least one body segment when the resin is introduced inside the receiving bag.
Thus, thanks to the presence of this waterproof material, the liquid thermosetting resin is no longer in contact with the patient's skin when the resin is introduced into the pocket. This is particularly advantageous, especially when the polymerization process has not yet been completely completed and the isocyanates are still capable of exhibiting a certain toxicity.
The Applicants observe that, until now, none of the orthotics developed so far provides for such a textile material which is impervious to liquid thermosetting resin.
It will be noted here that the reinforced structure obtained by curing the resin is rigid or semi-rigid.
Preferably, the coefficient of permeability of the liquid material corresponds to a resistance to water penetration determined as follows:
On the right side: about 6.1 cm, and
On the reverse side: 6.3 cm.
This determination of water penetration was carried out according to the standards in force (NF, EN 20811 and ISO 811). The test conditions are as follows: a water temperature of 20 ° C, a test piece of 100 cm 2 and a pressure gradient of 10 cm H 2 O / minute.
During these tests, the test piece is subjected to an increasing water pressure which will make it possible to determine whether the fabric is waterproof or not. The test is stopped as soon as three drops of water appear on the surface of the sample.
To carry out this test, the fabric is held in place by a bell, which is operated using a lever. The pressurized water therefore comes from below.
The waterproofing qualities of the textile material used can also be quantified by a resistance to surface wetting.
Tests on the material used were carried out according to standard NF EN 24920.
On the reverse and right side, the textile meets the ISO2 category for partial wetting of the entire upper surface.
Preferably, the surface mass of the textile material is 421.36 g / m 2 .
Preferably, the textile material used has good elasticity.
The elasticity of the material thus allows it to best fit the patient's body segment even when the resin is poured.
In an advantageous embodiment, the textile material comprises a weaving or knitting based on polyamide fibers and elastane fibers.
BE2019 / 5069
Preferably, the textile material comprises 86% of polyamide fibers and 14% of elastane fibers.
Advantageously, the textile material comprises an interlacing of warp threads and weft threads.
Preferably, the textile material comprises:
195 warp threads over a width of 10 centimeters, and
- 220 weft threads over a length of 10 centimeters.
Advantageously, the textile material has elasticity with the following properties:
manual lengthening of the warp threads between 100 and 120%, and / or
- manual lengthening of the weft threads between 90 and 110%.
The bursting strength measured during the test carried out according to standard NF EN ISO 13938-1 corresponds to a bursting pressure substantially equal to 1517 KPa.
Advantageously, the textile material has a density substantially equal to 405 grams / m2 ± 5%.
Such a density ensures good mechanical strength of the reinforced structure.
Alternatively, the textile material used can be a 3D textile.
Advantageously, the orthosis according to the present invention takes one of the following forms to surround Pau at least one body segment (or member): a glove, a mitten, a sock, a choker, a pantyhose, a jersey, leggings, a waistcoat, a jumpsuit or a sleeve forming for example a kneepad, an elbow pad, another corset, etc.
It is therefore understood here that the orthosis according to the present invention can also be an orthosis for the lower limbs than for the upper limbs of the patient.
We. will also understand that the orthosis according to the present invention can be adapted for the patient's trunk.
The object of the present invention relates according to a second aspect to a packaging device for the in situ formulation of a liquid thermosetting resin.
According to the present invention, the device comprises a flexible hermetic envelope having inside two compartments of which:
a first compartment comprising a resin, and a second compartment comprising a hardener,
BE2019 / 5069
Still according to the present invention, the two compartments are hermetically separated from one another by a removable clamping system capable of having two positions including:
a first so-called conservation position in which the clamping system is engaged on the envelope to ensure a hermetic separation between the two compartments preventing contact between the resin and the hardener, and
- A second so-called mixing position in which the clamping system is removed to allow the resin and the hardener contained in the first and second compartments to come into contact inside the envelope in order to obtain a formulation d '' a thermosetting liquid resin.
Thanks to the present invention, the practitioner has a unique packaging device, which is easy to transport and handle.
Such a device makes it possible to mix the resin and the hardener inside a hermetic envelope, without being in contact with the mixture.
The manipulations are very simple since it is now enough for the operator to remove the clamping system to allow the mixing of the two components in order to obtain the formulation of the liquid thermosetting resin.
Advantageously, the clamping system comprises a gutter capable of receiving a deformable rod, the positioning of the rod in the gutter allows the envelope to be sandwiched between the gutter and the rod forming a sealed partition between the two compartments.
Preferably, the envelope comprises at least one breakable portion for extracting the mixture from the envelope.
Preferably, the envelope is of substantially rectangular or square shape and the removable clamping system extends transversely substantially across the width or the length of the envelope.
The object of the present invention relates, according to a third aspect, to a kit for stabilizing by a reinforced structure at least one body segment of a patient during a rest phase.
Preferably, the kit includes:
a packaging device such as that described above for the in situ formulation of a liquid thermosetting resin, and
BE2019 / 5069 an orthosis such as that described above comprising an anatomical receiving pocket configured to at least partially wrap the segment and to receive the liquid thermosetting resin in order to form the structure reinforced by hardening of the resin in the receiving pocket.
The object of the present invention finally relates according to a fourth aspect to a process for preparing a reinforced structure for the stabilization of a body segment of a patient.
Preferably, the method is implemented using a kit as described above and comprises the following steps:
a) removal of the clamping system for bringing the resin contained in the first compartment of the kit envelope into contact with the hardener contained in the second compartment of said envelope;
b) a preparation of a liquid thermosetting formulation by kneading the mixture contained in the envelope until a homogeneous mixture is obtained;
c) polymerization, at room temperature and inside the envelope, of the liquid thermosetting formulation;
d) an injection of the liquid thermosetting formulation into the pocket for receiving said orthosis; and
e) before hardening, shaping the thermosetting formulation according to the segment to form the reinforced structure.
By room temperature is typically meant a temperature between 15 ° C and 30 ° C.
The polymerization time can be between 1 and 90 minutes, advantageously between 1 and 60 minutes, advantageously between 5 and 15 minutes.
Preferably, the mixture comprises a resin of the polyurethane or polyester resin type and a hardener comprising isocyanates.
Preferably, the isocyanates are chosen from mono isocyanates, diisocyanates and / or polyisocyanates, such as diphenylmethane diisocyanate (MDI), toluene 2,4- and 2,6-diisocyanate (TDI), isophorone diisocyanate (I 'IPDI), 4,4'dicyclohexylmethane diisocyanate (H12MDI), 1,6-hexamethylene diisocyanate (HDI),
1,4-cyclohexane diisocyanate (CHDI), bis (isocyanatomethyl) cyclo-hexane (H6XDI, DDI), tetramethyxylylene diisocyanate (TMXDI), all molecular chains having isocyanate bonds and their mixtures.
BE2019 / 5069
Preferably, the liquid thermosetting resin has a viscosity of between and 2000 mPa.s.
Thus, by the different functional and structural technical characteristics above, the Applicants propose a set of solutions responding to a single inventive concept aimed at limiting contact, in particular by inhalation or with the skin, with isocyanates.
Brief description of the attached figures
Other characteristics and advantages of the present invention will emerge from the description below with reference to the appended FIGS. 1 to 5 illustrating various exemplary embodiments which are devoid of any limiting character and in which:
Figure 1 schematically shows a flat view of a packaging device according to an exemplary embodiment of the present invention;
Figure 2 schematically shows a cross-sectional view of a packaging device with a clamping system engaged on an envelope for a sealed separation between the two compartments of the envelope;
Figures 3A to 3B illustrate the different steps for the preparation of a formulation of a liquid thermosetting resin with a packaging device according to Figure 1;
Figure 4 schematically shows a sectional view of an orthosis according to an exemplary embodiment of the invention;
FIG. 5 schematically represents a body segment of a patient stabilized by wearing an orthosis according to the present invention in the form of a sleeve.
Detailed description according to an advantageous exemplary embodiment
The present invention will now be described in what follows with reference to Figures 1 to 5 appended to the description.
As a reminder, the present invention provides for the design of a complete kit for the preparation of a liquid thermosetting resin which the practitioner can prepare in situ and inject into the pocket of an orthosis in order to form a reinforced structure for the
BE2019 / 5069 stabilization of a segment of a patient following an injury (for example a sprain, a fracture, etc.).
As explained in the preamble, the techniques used so far for the preparation of such a resin use a kit comprising an orthosis and two pots to transfer one into the other to obtain a thermosetting resin.
The hardener used for the preparation of this resin conventionally comprises isocyanates.
The use of such a kit therefore implies relatively strict precautionary measures for the practitioner in order to avoid recycling of the pots according to a specific method as well as to reduce interactions with the mixture and in particular the skin or inhalation contact of the practitioner. and the patient with the hardener.
The present invention overcomes these drawbacks and simplifies the handling of the practitioner while reducing interactions with isocyanates.
In the embodiment described here and illustrated in particular in FIG. 1, there is a packaging device 200 comprising a flexible hermetic envelope 210, such an envelope can be packaged in a hermetic and opaque sachet for example.
In this example, the envelope 210 is hermetically closed by welding 210a or heat welding along its periphery. Other closing techniques can obviously be envisaged by the skilled person to ensure a hermetic closure of the pocket.
As illustrated in FIG. 1, the envelope 210 is divided into two compartments 211 and 212, these two compartments 211 and 212 being hermetically separated from one another.
The first compartment 211 here comprises a liquid resin such as a resin of the polyurethane or polyester type; the second compartment 212 comprises a hardener based on isocyanates.
It is known that isocyanates alone have a high level of toxicity as explained in the preamble.
On the other hand, when the isocyanates are brought into contact with the polyurethane resin, polymerization takes place. After complete polymerization, the isocyanates are neutralized. It is therefore preferable not to open the envelope until the components of the two compartments 211 and 212 have been mixed completely and the polymerization is not completely finished.
The concept underlying the present invention is to allow mixing inside the envelope without opening it.
BE2019 / 5069
A removable clamping system 220 is therefore provided for this purpose hermetically separating the two compartments 211 and 212.
The removal of this clamping system 220 allows communication between the two compartments 211 and 212 for bringing the polyurethane resin and the hardener into contact within the envelope 210.
In the example described here, provision is therefore made for the clamping system 220 to be configured so that, when the latter is in the conservation position, the latter is engaged on the casing 210 to ensure hermetic separation between the two compartments 211 and 212 preventing contact between the resin and the hardener.
Conversely, when the clamping system 220 is in the mixing position, the latter is removed to allow the interior of the envelope 220 to bring the resin and the hardener contained in the first 211 and second 212 compartments into contact respectively. in order to obtain a formulation of a liquid thermosetting resin.
This clamping system 220 therefore plays the role of means for sealingly contacting the compartments 211 and 212.
In the example described here, the clamping system 220 extends transversely along the width of the envelope 210 so as to form two compartments 211 and 212.
In the exemplary embodiment described here and illustrated in FIG. 2, the clamping system 220 comprises a gutter 221 capable of receiving a deformable rod 222.
As can be understood from reading FIG. 2, the engagement of the rod 222 in the gutter 221 allows the envelope 210 to be sandwiched between the gutter 221 and the rod 222.
Such sandwiching forms a sealed partition between the two compartments 211 and 212.
In the example described here, the practitioner can therefore freely transport the envelope with the contents of the two compartments 211 and 212 without the risk of the two components coming into contact with each other.
Such a flexible envelope is compact and easy to transport.
During an intervention for the installation of an orthosis in order to stabilize the segment of a patient to be treated, the practitioner removes the rod 222 from the gutter 221 during a step SI (FIG. 3A) for contacting of the two components.
In the example described here and illustrated in FIG. 3B, the practitioner then positions the envelope 210 during a step S2 so as to allow the resin to drain by gravity in order to bring the two components into contact.
BE2019 / 5069
In this case, the two components should be thoroughly mixed by kneading S3 of the envelope for at least two minutes until a homogeneous mixture is obtained (FIG. 3C).
It will be noted here that the two components have different colors. Obtaining a homogeneous mixture then corresponds to a mixture whose color is homogeneous.
To perfect the mixture, the practitioner must then in a step S4 bring the mixture from the corners of the envelope to the center to avoid residues coming to lodge in the angles (Figure 3D).
Finally, the practitioner finishes the mixing during a step S5 (FIG. 3E) by kneading for approximately 30 seconds.
During these successive kneading steps, a step of polymerization of the mixture takes place at ambient temperature in the envelope 210 so as to obtain a thermosetting liquid polymerized formulation.
When the polymerization is complete, the practitioner can open the envelope for example using a breakable portion of the envelope (not shown here).
Obviously, one could provide a hermetic stopper or any other solution allowing the spillage of the formulation contained in the envelope outside thereof.
The practitioner then injects this liquid thermosetting formulation into the anatomical receiving pocket 11 of the orthosis 100 supplied in the kit.
Before hardening, the practitioner can shape the thermosetting formulation according to the MC segment to form the reinforced structure according to the desired position to correctly stabilize the MC segment during the rest phase.
In the example described here, the orthosis 100 is intended to surround a segment MC of a patient (as illustrated in FIG. 5) and comprises at least one piece 10 of textile material made up so as to present a double skin 10a and 10b .
During manufacture, the two skins 10a and 10b therefore form an anatomical receiving pocket 11 at least partially enveloping the body segment MC.
Such an anatomical pocket is illustrated in FIG. 4.
There may be provided between the two skins 10a and 10b a passage opening for the introduction of the thermosetting liquid formulation.
Once the resin has been poured into the bag 11, it is possible to form a reinforced stabilization structure, such a structure being obtained by hardening the resin in the bag 11.
BE2019 / 5069
To avoid any contact of the patient's skin with the formulation (it may indeed be that the polymerization is not completely finished), it is planned to design a specific orthosis 100 for the reception of the thermosetting formulation.
Provision is therefore made for the use of a specific elastic textile material having a determined coefficient of permeability ensuring the impermeability of the receiving bag 11 preventing the passage of the liquid thermosetting resin towards the segment MC of the patient.
A textile material such as that described above can be envisaged for the implementation of the invention, such a material having good water resistance properties, good elasticity and good mechanical resistance.
Provision may also be made for the use of an elastic textile material.
Once the envelope is emptied, it can be thrown into a conventional recycling system without risk of pollution as is the case with existing solutions for which there is always a risk of isocyanate residue.
The above kit, made available to practitioners and in particular orthopedists for the preparation and installation of an orthosis made of thermosetting resin, is very practical to use and simplifies the manipulations currently required with current systems, all by limiting the risks of pollution.
It should be observed that this detailed description relates to a particular embodiment of the present invention, but that in no case this description does not have any limiting character with the object of the invention; on the contrary, it aims to remove any possible inaccuracy or misinterpretation of the claims which follow.
It should also be observed that the reference signs put in brackets in the following claims are in no way limiting; the sole purpose of these signs is to improve the intelligibility and understanding of the claims which follow, as well as the scope of the protection sought.
权利要求:
Claims (8)
[1]
BE2019 / 5069 CLAIMS
1. A packaging device (200) for the in situ formulation of a liquid thermosetting resin, said device (200) comprising a flexible hermetic envelope (210) having inside two compartments (211,212) including a first compartment (211) comprising a resin and a second compartment (212) comprising a hardener, said two compartments (211, 212) being hermetically separated from each other by a removable clamping system (220) capable of having two positions including:
- A first so-called conservation position in which the clamping system (220) is engaged on the envelope (210) to ensure an airtight separation between the two compartments (211, 212) preventing contact between the resin and the hardener , and
- A second so-called mixing position in which the clamping system (220) is removed to allow inside the envelope (220) a contacting of the resin and the hardener contained respectively in the first (211) and second (212) compartments to obtain a formulation of a liquid thermosetting resin.
[2]
2. Device (200) according to claim 1, wherein said clamping system (220) comprises a gutter (221) capable of receiving a deformable rod (222), the positioning of the rod (222) in the gutter (221) allows a sandwiching of the envelope (210) between said gutter (221) and said rod (222) forming a sealed partition between the two compartments (211,212).
[3]
3. Device (200) according to claim 1 or 2, wherein said envelope (210) comprises at least one breakable portion for extracting the mixture from said envelope (210).
[4]
4. Device (200) according to any one of claims 1 to 3, in which said envelope (210) is of substantially rectangular or square shape, and in which the removable clamping system (220) extends substantially transversely in the width or length of said envelope (210).
BE2019 / 5069
[5]
5. Kit for stabilizing by a reinforced structure at least one body segment (MC) of a patient during a rest phase, said kit comprising:
a packaging device (200) according to any one of claims 1 to 4 for the in situ formulation of a liquid thermosetting resin, and
- an orthosis (100) comprising an anatomical receiving pocket (11) configured to at least partially wrap said body segment (MC) and receive said liquid thermosetting resin in order to form said structure reinforced by curing said resin in said receiving pocket ( 11)
[6]
6. A method of preparing a reinforced structure for stabilizing a body segment (MC) of a patient, said method implemented using a kit according to claim 5 comprises the following steps:
a) removal (SI) of the clamping system (220) for bringing a resin contained in the first compartment (211) of the envelope (210) of the kit into contact with a hardener contained in the second compartment (212) of said envelope;
b) a preparation of a liquid thermosetting formulation by kneading (S3, S5) of the mixture contained in the envelope (210) until a homogeneous mixture is obtained;
c) polymerization, at room temperature and in said envelope (210), of said liquid thermosetting formulation;
d) an injection of the liquid thermosetting formulation into the receiving pocket (11) of said orthosis (100); and
e) before hardening, shaping the thermosetting formulation as a function of said segment (MC) to form said reinforced structure.
[7]
7. The method of claim 6, wherein the mixture comprises a resin of the polyurethane or polyester resin type and a hardener comprising isocyanates.
[8]
8. The method of claim 7, wherein the isocyanates are chosen from mono isocyanates, isocyanates and / or polyisocyanates, such as diphenylmethane diisocyanate (MDI), toluene 2,4- and 2,6-diisocyanate (TDI) , isophorone diisocyanate (PIPDI), 4,4'-dicyclohexylmethane diisocyanate (H12MDI), 1,6-hexamethylene diisocyanate (HDI), 1,4-cyclohexane diisocyanate (CHDI),
BE2019 / 5069 bis (isocyanatomethyl) cyclo-hexane (H6XDI, DDI), tetramethyxylylene diisocyanate (TMXDI). all molecular chains having isocyanate bonds and their mixtures.
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同族专利:
公开号 | 公开日
BE1025993A1|2019-09-03|
引用文献:
公开号 | 申请日 | 公开日 | 申请人 | 专利标题

法律状态:
2019-10-17| FG| Patent granted|Effective date: 20190910 |
优先权:
申请号 | 申请日 | 专利标题
FR1850998|2018-02-07|
FR1850998A|FR3077480B1|2018-02-07|2018-02-07|ORTHOSIS FOR STABILIZING AT LEAST ONE BODY SEGMENT, CONDITIONING DEVICE FOR THE PREPARATION OF A THERMOSETTING RESIN AND ASSOCIATED KIT|
FR1856463A|FR3077575B1|2018-07-13|2018-07-13|PACKAGING DEVICE FOR THE PREPARATION OF A THERMOSETTING RESIN AND ASSOCIATED KIT|
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