FR2952582A1 - DISPOSABLE OBJECT FOR SINGLE USE - Google Patents

Abstract

The present invention relates to a single-use disposable object (12) intended for the medical and / or surgical environment, characterized in that it comprises a mattress formed of a plurality of superposed layers comprising at least one relief (14), the edges peripherals of at least the outer layers being joined together to form a continuous peripheral rim (15). The present invention also relates to a single-use disposable respiratory mask (11) intended in particular for the medical and / or surgical environment, which is remarkable in that it comprises an object forming a base (12) as described above and a shell ( 13) whose peripheral edge is assembled continuously on the base (12), said base (12) being arranged to be brought into contact with the face of a patient. The present invention also relates to their respective manufacturing process.

Description

The present invention relates to a disposable disposable object intended for the medical and / or surgical environment, and in particular a respiratory mask. The present invention also relates to a method of manufacturing said object.

In the medical and especially surgical environment, the objects used by practitioners must be sterilized after each intervention for obvious reasons of public health and in particular to avoid the development and spread of nosocomial diseases.

However, the sterilization step of said objects is defined by different standards depending on the nature of the sterilization performed. In particular, circular No. 672 of 20 October 1997 of the European Pharmacopoeia, imposes a steam sterilization process by autoclave at a temperature greater than or equal to 134 ° C for at least 18 minutes. Other possible sterilization processes are ethylene oxide sterilization, and gamma ray sterilization.

Therefore, this sterilization step is particularly expensive and represents an investment in object and energy not insignificant for health care facilities. In order to eliminate said sterilization step, disposable objects have been developed. However, studies have shown that more than two-thirds of disposable objects are reused, representing a significant risk of developing nosocomial diseases. In addition, some of these so-called disposable objects are difficult to recycle. In addition to nosocomial diseases, nowadays it is more and more frequent that a patient contaminated by such a disease initiates an action.

DIALV1-FR-1_RG / CB - 2 - judicial system against the care establishment in which he was contaminated and his direction, but also against the practitioner. This type of trial is expensive and requires all actors to take out insurance contracts that are increasingly expensive to cover such risks. The object of the present invention is therefore to overcome the aforementioned drawbacks and to propose a disposable object intended for the medical and / or surgical environment economical, 100% recyclable, easy to achieve, can not be in any case reused, in order to avoid contamination of another patient. According to the invention, it is therefore proposed a disposable disposable object intended for the medical and / or surgical environment, remarkable in that it comprises a mattress formed of a plurality of superimposed layers comprising at least one relief, the edges peripherals of at least the outer layers being assembled together to form a continuous peripheral rim.

The present invention also relates to a disposable disposable respirator intended in particular for the medical and / or surgical environment, remarkable in that it comprises an object as previously described forming a base and a shell whose peripheral edge is assembled continuously on the base, said base being arranged to be brought into contact with the face of a patient. According to an alternative embodiment, the superposed layers constituting the mat are obtained from non-woven polypropylene. The present invention also relates to a method of manufacturing said single-use disposable object, which is remarkable in that it comprises the following steps: a) production of a mattress formed of a plurality of DIALV1-FR-1_RG / CB-3 layers b) forming the mattress to obtain an object comprising a relief provided with a continuous peripheral rim, c) assembling between them the peripheral edges of at least the outer layers. Finally, the present invention relates to a method of manufacturing a single-use disposable respirator, which is remarkable in that an object forming a base as described above is made and includes at least the following additional steps a) making a central opening in the base, b) assembling a shell on the base, so that at least the peripheral edge of the shell is integral with the edge of the central opening of said base. Other advantages and features will become more apparent from the following description of an alternative embodiment of an instrument according to the invention with reference to the appended figures in which: FIG. 1 is a perspective view of a object according to the invention; FIG. 2 is a perspective view of a breathing mask according to the invention, FIG. 3 is a side view of a breathing mask according to the invention. In this variant of non-limiting embodiment, an object intended for the medical and / or surgical environment of the kidney-shaped type, commonly called "bean", intended to collect, for example, surgical instruments for contaminated cotton or waste; however the object according to the invention may take any other form for example rectangular and be used for another purpose. Thus, with reference to FIG. 1, the object 1 is DIALV1-FR-1 RG / CB - 4 - obtained from a mattress of a plurality of superimposed layers. The superposed layers constituting the mattress are advantageously made from a hydrophobic plastic material such as, for example, a nonwoven polypropylene. This material is compatible with the conditions of a medical and / or surgical environment because it is already used in the manufacture of masks surgeons. In addition, this material has many qualities, it is tear-proof, very resistant to fatigue and flexion, very low density, chemically inert and 100% recyclable. The mattress of the object 1 comprises at least one relief 2 provided with a continuous peripheral rim 3, the relief 2 having a general bean shape.

Preferably, the mattress is made by alternately superimposing a layer of DYPRYL and a layer of S-TEX. These two nonwoven polypropylenes are especially manufactured by the company FIBERWEB®. Studies have shown that a mattress consisting of an alternative superposition of six layers of DYPRYL and six layers of S-TEX makes it possible to obtain the best compromise between the strength and the flexibility of the object 1, but also the best quality price report. For reasons including economic, it will advantageously limit to sixteen the number of layers superimposed. The object 1 is then obtained by shaping the mattress to obtain the relief 2 and assembling between them the peripheral edges of at least the outer layers of said mattress so as to form the peripheral rim 3.

According to an alternative embodiment, the peripheral edges of each of the superposed layers are assembled together so as to form the peripheral rim 3. Furthermore, it is understood that with such a DIALV1-FR-1RG / CB 2952582 - 5 - configuration the peripheral flange 3 may have a shape different from the overall shape of the relief 2. The object 1 according to the present invention is obtainable by the method comprising at least the following steps: - production of a formed mattress of a plurality of superposed layers, - shaping of the mattress to obtain a relief 2, - assembly between them peripheral edges of at least the outer layers so as to form a continuous peripheral rim 3. The formatting of the mattress can be achieved by any technique known to those skilled in the art, such as stamping. According to an alternative embodiment, the peripheral edges of each of the superposed layers are assembled together so as to form the peripheral rim 3. It is well understood that the shaping and assembly steps can advantageously be carried out simultaneously. Indeed, the mattress is placed under a press with an imprint, having the shape of the relief 2 of the object 1 that it is desired to obtain, and an impact of the press is made. The mechanical energy of the press is transformed into thermal energy and allows to assemble between them the peripheral edges of the different layers by thermo-welding. However, for certain configurations of the object 1, it will be necessary to have an additional heat input to obtain a perfect thermo-welding of the peripheral edges of the different layers between them. It goes without saying that the manufacturing process may also comprise a step of deburring the object 1 after it has been shaped. DIALV1-FR-1_RG / CB - 6 - With reference to FIGS. 2 and 3, the present invention also relates to a breathing mask 11 comprising an object forming a base 12 arranged to be in contact with the face of a patient and a patient. shell 13 central. This respirator 11 is particularly used during resuscitation, or during anesthesia by inhalation of anesthetic products in gaseous form. The base 12, which is preferably opaque, is manufactured as the object 1 described above. Thus, the base 12 is obtained from a mattress of a plurality of superimposed layers and comprises a relief 14 provided with a continuous peripheral rim 15. The superposed layers constituting said mattress are advantageously made from a hydrophobic plastic material such as, for example, a nonwoven polypropylene. This material is compatible with the conditions of a medical and / or surgical environment because it is already used in the manufacture of masks surgeons. Preferably, the mattress is made by alternately overlapping six layers of DYPRYL and six layers of S-TEX. These two nonwoven polypropylenes are especially manufactured by the company FIBERWEB®. In addition, the base 12 has on its relief 14 a central opening. The peripheral rim 15 is rounded and slightly folded on itself in the general U-shaped flared so as to form a support bead for the face of a patient. The use of a mattress consisting of an alternating superposition of DYPRYL layers and layers of S-TEX guarantees that the base 12 and its peripheral rim 15 hold and are flexible. Thus, the respiratory mask 11, which is designed to being squeezed in a gastight manner against the area surrounding the patient's upper respiratory tract (mouth and / or nose), DIALV1-FR-1 RG / CB 2952582 7 - to prevent gas leakage on the patient's face and The optimum ventilation will be deformable and said peripheral rim in its beaded shape will easily adapt to the morphology of the patient's face, particularly when suffering from maxillofacial trauma. As a result, the seal between the respiratory mask 11 and the patient's face will be perfect without leakage and the inhalation of anesthetic products will be optimal. Moreover, it is well understood that the fact of avoiding leaks, in particular of anesthetic products, is also very important for the safety of the practitioners. The respiratory mask 11 also comprises a central shell 13 secured to the base 12, sealingly along the edge of the central opening of said base 12. The shell 13 is advantageously transparent to allow the practitioner to see permanently the the patient's mouth and the possible presence of a rejection during the procedure. In addition, this shell 13 is preferably rigid to receive a diffuser device 16 of anesthetic products, arranged to temporarily diffuse or not these products inside the mask. This diffuser device 16 may be in the form of a cannula 17 arranged to receive a not shown feed pipe of products in gaseous form. In this respect, this shell 13 is made from a hydrophobic plastic material advantageously injectable such as for example a polypropylene. The respiratory mask 11 according to the present invention is obtainable by the manufacturing method comprising a plurality of manufacturing steps of an object forming a base 12 as described above namely: DIALV1-FR-1_RG / CB 2952582 - 8 - - realization of a mattress formed of a plurality of superimposed layers, - shaping of the mattress to obtain a relief 14, - assembly between them peripheral edges of at least the outer layers so as to form a continuous peripheral rim. According to an alternative embodiment, the peripheral edges of each of the superposed layers are assembled together so as to form the peripheral rim 15. It is well understood that the shaping and assembly steps can advantageously be performed simultaneously. Said manufacturing method also comprises at least the following additional steps: - realization of a central opening in the base (12), - assembly of a shell 13 on the base 12, so that at least the the peripheral edge of the shell 13 is integral with the edge of the central opening of said base 12. The shell 13 can be made by any technique known to those skilled in the art, such as molding. However, according to a preferred embodiment, the shell 13 of the breathing mask 11 is advantageously obtained by hot pressing molding so as to melt the outer faces of said shell 13 superficially and make them rigid at room temperature. Similarly, the step of assembling the shell 13 on the base 12 can be performed by all techniques of sealing tight plastic parts together, known to those skilled in the art. DIALV1-FR-1_RG / CB - 9 - However, according to a first embodiment, the shell 13 is assembled on the base 12 along the edge of the central opening of said base 12 by ultrasonic welding.

Similarly, according to a second embodiment, the shell 13 is assembled on the base 12 by hot pressing. These two previous embodiments are intended to weld the base 12 and the shell 13 of the breathing mask 11 by simultaneously melting the edges of the shell 13 and those of the central opening of the base 12. The present invention s applies more particularly to objects and respiratory masks intended for the medical and / or surgical environment, but it is obvious that the example which has just been given is only a particular illustration in no way limiting as to the fields of application of the invention. In particular, the breathing objects and masks according to the invention can be used in all applications involving the upper respiratory tract and requiring single-use equipment, such as decontamination. DIALV1-FR-1 RG / CB

Claims (16)

CLAIMS1 - Purpose (1, 12) disposable disposable for the medical and / or surgical environment, characterized in that it comprises a mattress formed of a plurality of superimposed layers comprising at least one relief (2, 14), the peripheral edges of at least the outer layers being joined together to form a continuous peripheral rim (3, 15). 2 - Object (1) according to the preceding claim, characterized in that the peripheral edges of each of the superposed layers are assembled together so as to form a peripheral rim (3, 15) continuous. 3 - Object (1) according to any one of claims 1 or 2, characterized in that the mattress comprises hydrophobic plastic layers such as nonwoven polypropylene. 4 - Object (1) according to any one of claims 1 to 3, characterized in that the mattress comprises layers of DYPRYL and layers of S-TEX arranged alternately. 5 - Object (1) according to any one of claims 1 to 4, characterized in that the mattress comprises six layers of DYPRYL and six layers of S-TEX. 6 - disposable respiratory mask (11) disposable for medical and / or surgical use, characterized in that it comprises an object forming a base (12) according to any one of claims 1 to 5 and a shell ( 13) whose peripheral edge is assembled continuously on the base (12), said base (12) being arranged to be brought into contact with the face of the base (12). 'a patient. 7 - Respirator mask (11) according to claim 5, characterized in that the base (12) comprises a peripheral flange (15) rounded and folded on itself in the general U-shaped flared so as to form a bead. support for a patient's face. 10 8 - respiratory mask (11) according to any one of claims 6 or 7, characterized in that the base (12) has a central opening closed by the shell (13), the peripheral edge of the shell (13) being secured to the base (12) along the edge of the central opening of said base (12). 9 - Respirator mask (11) according to any one of claims 6 to 8, characterized in that the shell (13) is transparent. 10 - Respiratory mask (11) according to any one of claims 6 to 9, characterized in that the shell (13) is made of hydrophobic plastic material such as injectable polypropylene. 11 - Method of manufacturing an object (1, 12) Disposable disposable, characterized in that it comprises at least the following steps: - realization of a mattress formed of a plurality of superimposed layers, - shaping of the mattress to obtain a relief (2, 14 ), - assembling them peripheral edges of at least the outer layers so as to form a continuous rim DIALVI-FR-1 RGICB - 12 - device (3, 15). 12 - Manufacturing process according to the preceding claim, characterized in that during the assembly step, the peripheral edges of each of the superposed layers are assembled together to form a continuous peripheral rim (3, 15). 13 - Manufacturing method according to any one of claims 11 or 12, characterized in that the shaping and assembling steps are performed simultaneously with a press provided with an imprint of the shape of the relief (2, 14). 14 - A method of manufacturing a respirator (11), characterized in that one carries a object forming a base (12) according to any one of claims 11 to 13 and in that it comprises at least the steps additional steps: - making a central opening in the base (12), - assembling a shell (13) on the base (12), so that at least the peripheral edge of the shell (13) ) is integral with the edge of the central opening of said base (12). 15 - Manufacturing method according to the preceding claim, characterized in that the assembly step the shell (13) on the base (12) is performed by ultrasonic welding. 16 - Manufacturing method according to claim 14, characterized in that the step of assembling the shell (13) on the base (12) is DIALVI-FR-1 RGICB- 13 - made by hot pressing. DIALV1-EN-1_RG / CB