EP1651143A2 - Implant with improved homogeneity for plastic surgery and method for the production thereof - Google Patents

Implant with improved homogeneity for plastic surgery and method for the production thereof

Info

Publication number
EP1651143A2
EP1651143A2 EP04767714A EP04767714A EP1651143A2 EP 1651143 A2 EP1651143 A2 EP 1651143A2 EP 04767714 A EP04767714 A EP 04767714A EP 04767714 A EP04767714 A EP 04767714A EP 1651143 A2 EP1651143 A2 EP 1651143A2
Authority
EP
European Patent Office
Prior art keywords
implant
plastic surgery
envelope
injection
flexible
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP04767714A
Other languages
German (de)
French (fr)
Inventor
Pascal Paganon
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Compagnie Europeenne dEtude et de Recherche de Dispositifs pour lImplantation par Laparoscopie SA
Original Assignee
Compagnie Europeenne dEtude et de Recherche de Dispositifs pour lImplantation par Laparoscopie SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Compagnie Europeenne dEtude et de Recherche de Dispositifs pour lImplantation par Laparoscopie SA filed Critical Compagnie Europeenne dEtude et de Recherche de Dispositifs pour lImplantation par Laparoscopie SA
Publication of EP1651143A2 publication Critical patent/EP1651143A2/en
Withdrawn legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/14—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/12—Mammary prostheses and implants

Definitions

  • the present invention relates to the technical field of artificial devices, of the implant or prosthesis type, intended to reshape the shape of a part of the human body, for aesthetic and / or therapeutic purposes.
  • the present invention relates more particularly, but not exclusively, to the field of breast implants intended to ensure breast reconstruction in the event of mastectomy, or to carry out breast augmentation of an aesthetic nature.
  • the present invention relates to a plastic surgery implant intended to be implanted in the body of a patient, said implant comprising at least one flexible pocket delimiting a predetermined internal volume, said flexible pocket being formed of at least one envelope made of a material elastomer.
  • the present invention also relates to a method of manufacturing a plastic surgery implant.
  • prosthesis or “implant”
  • 'A filling material such as silicone gel or physiological saline for example
  • These implants are generally introduced subcutaneously, through an incision made near the final implantation area of the implant.
  • breast implants In the particular case of breast implants, these are generally introduced subcutaneously at the level of the patient's thorax, on or under the pectoral muscle, by an incision which can be made near the hollow of the armpit, depending on the groove under the breast, or according to the contour of the areola of the breast.
  • Such plastic surgery implants are generally made by dipping.
  • the dipping process consists in dipping a nucleus having the desired shape for the implant (for example hemisphere, ovoid, ellipsoid) in a silicone bath dispersed in a solvent, to dry the film formed at the surface of the core by this soaking, then “unmolding” it from the core, in order to obtain a flexible pocket.
  • Each layer may be different from the others, the surface layer having in particular texture properties favoring its implantation.
  • this method implements a multitude of tasks justifying in particular the use of a conveyor carousel, and which make the cycle time for obtaining an implant relatively long.
  • the dipping process generally does not allow precise control of the thickness of the implant shell. Implants obtained by dipping, while generally satisfactory, however sometimes suffer from insufficient dimensional accuracy, which can lead to over-thicknesses in certain areas of the implant, which increases the costs of producing the implant, or to under-thicknesses in other places, which can possibly cause embrittlement of the implant.
  • the objects assigned to the invention therefore aim to remedy the various drawbacks listed above and to propose a new plastic surgery implant having improved resistance and regularity.
  • Another object of the invention is to propose a new method for manufacturing a plastic surgery implant allowing the manufacture of implants in a safer, simpler manner and at a lower cost.
  • Another object of the invention is to propose a new method for manufacturing a plastic surgery implant which enables implants to be manufactured quickly with excellent dimensional regularity.
  • Another object of the invention is to propose a new method for manufacturing a plastic surgery implant, the number of steps of which is reduced.
  • the objects assigned to the invention are achieved using a process for manufacturing a plastic surgery implant, characterized in that it comprises an injection step in which one injects using a press injection, an elastomeric material in a mold to obtain a flexible envelope intended to participate in the formation of a pocket (2).
  • a plastic surgery implant intended to be implanted in the body of a patient, said implant being capable of being obtained by a manufacturing process in accordance with one of claims 1 to 5, characterized in that said implant comprises at least one flexible pocket delimiting a predetermined internal volume, said flexible pocket being formed of at least one envelope made of an elastomeric material, the dimensional tolerance of the thickness of said at least one envelope being between 1% and 20%.
  • FIG. 1 illustrates, in a side view, a mold in the closed position allowing the implementation of the method according to the invention.
  • Figure 2 illustrates, in a side view, the mold of Figure 1 in the open position, as well as in the release position.
  • FIG. 3 illustrates, in a schematic view, a plastic surgery implant with multi-layer pocket according to the invention.
  • Figures 4 and 5 illustrate, schematically respectively in a top view and a side view, a first embodiment of a breast implant according to the invention.
  • FIG. 6 and 7 illustrate, schematically respectively in a top view and a side view, a second embodiment of a breast implant according to the invention.
  • FIG. 8 and 9 illustrate, schematically respectively in a top view and a side view, a third embodiment of a breast implant according to the invention.
  • Figures 3 to 9 show a plastic surgery implant 1 according to the invention.
  • plastic surgery is meant in what follows surgery intended to modify the shape of an organ, or part of the body, in order to correct a congenital or acquired anomaly, and / or in order to modify the aesthetic of the body of a patient, in the sense for example of an increase in volume.
  • Plastic surgery notably includes a branch called "cosmetic surgery" which is mainly concerned with the remodeling of body parts for an essentially aesthetic purpose.
  • the present invention therefore relates to plastic surgery, and preferably to cosmetic surgery.
  • the plastic surgery implant 1 is intended to be inserted under the skin of a patient to reconstruct, and / or reshape, and / or increase the volume of a part of the body, for example a breast, insofar as said implant, which has a predetermined functional volume, comes to increase or replace the biological tissues, for example and preferably the breast tissues.
  • the insertion of the plastic surgery implant 1 according to the invention is generally and preferably carried out by introducing said implant 1 subcutaneously through an incision made beforehand by the surgeon.
  • the implant 1 is a breast implant (cf. FIGS. 4 to 9)
  • said breast implant may in particular be implanted by axillary, submammary, periareolar or even transareolar route.
  • the plastic surgery implant 1 may also be, for example, an arm (forearm, biceps), leg (calves, thighs), buttock, or chest (implant) implant. breast for women, breast implant for men). Among all these examples of plastic surgery implants which fall within the scope of the invention, the breast implant will be preferred.
  • the plastic surgery implant 1 conventionally comprises at least one flexible pocket 2 delimiting, thanks to its external walls, a predetermined internal volume.
  • Said at least one flexible bag 2 is preferably made from elastomeric materials, for example based on one or more silicones.
  • the flexible pocket 2 can be produced according to a single-layer construction, that is to say that it is formed by a single envelope (not shown), or according to a multi-layer mode, in which the flexible pocket. 2 is formed of the stack of different envelopes 2A, 2B possibly having different compositions and / or properties.
  • the flexible pocket 2 may be a complex formed by a stack of layers 2A, 2B secured to one another, preferably on all of their respective surfaces.
  • the flexible pocket 2 therefore preferably has a unitary and monobloc character.
  • Such a multi-layer construction makes it possible to obtain a gradient of properties depending on the thickness of the pocket 2, that is to say for example an excellent seal imparted by the internal layer 2A, and a "velvet" texture imparted by the outer layer 2B.
  • the implant 1 may comprise two pockets of different volumes (not shown), one being contained in the other and each containing a different filling material.
  • the flexible bag 2 may include a greater number of layers, for example three, four, five or more.
  • the predetermined internal volume defined by the flexible pocket 2 contains a filling material 3, which makes it possible to give the implant 1 the desired consistency, as well as its functional volume.
  • the filling material 3 can be a liquid, a gel, or even a gas.
  • the filling material 3 could be a silicone gel, a saline solution, a physiological liquid, soybean oil, polyvinylpyrrolidone (PVP) or even a hydrogel.
  • the dimensional tolerance T of the nominal thickness e n0 m of at least one of the envelopes 2A, 2B participating in the formation of the pocket 2 is between 1% and 20%, c ' that is to say that the real thickness e rée i of the envelope 2A can vary between e n0 m (1 - T) and e n0 m (1 + T).
  • the general concept of the invention is based on the presence of an envelope 2A, 2B having a tolerance T of between 1% and 20%, whether this envelope alone constitutes the pocket 2, or that it is associated with other envelopes in a multi-layer structure.
  • one or more, or even all of the envelopes 2A, 2B may have the dimensional tolerance characteristic according to the invention.
  • the real thickness e r ean can vary, for the envelope 2A, 2B considered, between e n0 m (1 - 0.1 ) and e n0 m (1 + 0.1), i.e. between 0.9 e n0 m and 1, 1 e n0 nv
  • the thickness measurement can be carried out using a mechanical thickness comparator, and for example with the Mitutoya NO7304 mechanical comparator.
  • the set of N measurement points must of course be chosen so that all the points correspond to the same category of material. Thus, it will be ensured that in general no measurement point is positioned on a singularity of the envelope 2A, 2B, that this singularity is constituted by a plane of joints, a reinforcement (for example at the level of a valve ) or any other element.
  • the dimensional tolerance of the thickness of the envelope 2A, 2B is within a range from 15% to 20%.
  • envelope 2A, 2B made of silicone, or based on silicone. It is however entirely conceivable that this envelope is made of any other material, in particular elastomer, without departing from the scope of the invention.
  • the invention also relates to a method for manufacturing a plastic surgery implant 1, said implant 1 being intended to be implanted subcutaneously in the body of a patient.
  • the invention relates to a process for manufacturing a plastic surgery implant taken from the following group: - breast implant, - pectoral implant, - leg implant, - arm implant, - buttock implant.
  • the manufacturing process comprises an injection step in which an elastomeric material, of the silicone type, is injected, using an injection press, into a mold to obtain an envelope.
  • flexible 2A, 2B intended to participate in the formation of the pocket 2 of the implant 1.
  • the manufacturing process is therefore an injection molding process, carried out using an injection molding machine, that is to say an injection molding press.
  • injection must therefore be understood here as relating to the operation carried out using a press, and not to a simple transfer of material, of the casting type, which could be carried out without an injection press.
  • the injected elastomeric material is substantially non-foaming or foamy, and is rather in substantially “full” form.
  • the method according to the invention is designed to aim at substantially eliminating air bubbles which could become trapped within the elastomeric material.
  • the method thus makes it possible to obtain a regular and homogeneous flexible envelope, which can in particular be used to form the external shell of a surgical implant.
  • the mold comprises: - an upper cavity 40 comprising a concave conformation 40A defining in hollow a portion of the surface of the flexible envelope which it is sought to obtain, - a lower cavity 41, comprising a . concave conformation 41 B which defines in hollow a surface complementary to that of the upper cavity 40, so that when the upper cavity 40 and the complementary lower cavity 41 are pressed against each other, one obtains a closed internal volume, substantially sealed, delimited by a surface 40A, 41A whose shape corresponds to that of the flexible envelope 2A, 2B which it is desired to obtain.
  • the mold also comprises a core 42 formed by a convex body whose external surface is substantially complementary to that of the internal volume defined by the upper 40 and lower 41 cavities, except for a change of scale.
  • the external surface of the core 42 is thus a reduced uniformity of the surface of the internal volume defined by the upper 40 and lower 41 cavities.
  • the core 42 is intended to be positioned within the internal volume, preferably equidistant from the walls defining the volume internal. The arrangement described in FIG.
  • the upper 40 and lower 41 indentations include the core 42, so as to define a gap or air gap 43, which is a free space delimited on the one hand by the external surface 42A of the core 42, and on the other hand by the internal surface 40A, 41A of the internal volume defined by the upper cavity 40 associated with the complementary lower cavity 41.
  • the injection method thus comprises, prior to the injection step, a mold preparation step in which an upper cavity 40 of generally hemispherical shape and a lower cavity 41 of generally hemispherical complementary shape are pressed against each other, so as to obtain an internal volume substantially in the form of a sphere, having previously positioned between the two indentations 40, 41, concentric with said internal volume, a spherical core 42 whose diameter is less than that of said internal volume defined by the upper indentations 40 and lower 41.
  • step d injection in which an elastomeric material is injected, which may for example be gum silicone or liquid silicone, into the interstitial space between the core 42 and the upper 40 and lower 41 cavities, so as to obtain an envelope 2A, 2B of generally spherical shape intended to participate in the formation of the pocket 2 of the implant.
  • the upper imprint 40 is secured to an upper sole 44, so that the interior space 40B defined by the concave conformation 40A of the imprint 40 is in fluid communication with the upper sole 44, which itself the same carries the means for injecting elastomeric material, which are themselves in communication with the injection press (not shown).
  • the injection means preferably comprise three injection nozzles distributed angularly in a regular manner (spaced apart by 120 °) around or at the level of the apex 45 of the internal volume defined by the upper 40 and lower 41 indentations.
  • the apex 45 thus corresponds substantially to the point of the concave conformation 40A of the upper imprint 40 closest to the upper sole 44.
  • the injection nozzles all have an identical flow rate.
  • the method also implements a lower sole 46 on which is fixed a centering pin 47 of the core 42.
  • the core 42 which is for example, as shown in FIGS. 11 and 12, under the shape of a solid sphere, comprises a bore 48 whose shape is complementary to that of the centering axis 47, so as to be able to fit the core 42 on the axis 47, through the lower cavity 41 which comprises for this purpose a passage light 41 B for the centering axis 47.
  • the bore 48 and the centering axis 47 are designed so as to limit any risk of seizure between the core 42 and the centering axis 47.
  • the steels constituting the core 42 and the centering axis 47 preferably have different hardnesses, for example 49 or 50 HRc for the centering axis 47, and 35 HRc for the core 42 (Rockwell hardness). It is also envisaged to provide the centering axis 47 with a base 47A of generally substantially frustoconical shape, as well as an opposite engagement end 47B of general shape also substantially frustoconical.
  • the bore 48 formed in the core 42 comprises, at each of its ends, a lower recess 48B, the shape of which is complementary to that of the base 47A, as well as an upper recess 48A, the shape of which is complementary to that of the engagement end 47B, said centering axis 47 and bore 48 being arranged so as to promote an annular support between the base 47A of the centering axis 47 and the core 42, said annular support contributing to control the positioning of the core 42 relative to the centering axis 47.
  • a demolding axis 49 is implemented, one of the ends of which is integral with the lower sole 46, while the other end, or the leading end 49A, is intended to engage the lower recess 48B of the core 42, and has for this purpose a conformation allowing the abutment of the lower end 48B of the bore 48.
  • the core 42 is extracted from the cavity lower 41 as follows: - the upper 40 and lower 41 imprints are separated, - then the lower imprint 41 is subjected to a vertical translational movement in the direction in which the centering axis 47 extends, so to drive the core 42 out of the centering axis 47, - then the subset formed by the lower recess 41 is threaded supporting the core 42 on the demolding axis 48, so as to extract the core 42 out of the concave conformation 41A of the lower impression 41. Lastly, the actual removal of the silicone envelope from the surface of the core 42 is carried out.
  • the core 42 will advantageously be covered with a surface treatment coating limiting the adhesion of the elastomers, by example of a uniform layer of Teflon®, a few micrometers thick.
  • the method according to the invention makes it possible to rapidly produce (a cycle time can be of the order of 5 minutes), using a single machine and according to a limited number of operations, an envelope. flexible with great regularity in wall thickness.
  • a silicone envelope 2A, 2B of nominal thickness equal to 0.5 mm with a tolerance of less than ⁇ 0.08 mm and up to ⁇ 0.05 mm.
  • the method according to the invention comprises, after the injection step, a complexing step in which the flexible envelope 2A obtained at the end of the injection step is covered with a surface envelope 2B by a soaking operation, which makes it possible to obtain a flexible bag 2 similar to that illustrated in FIG. 3.
  • This dipping operation preferably takes place in the following manner: - the flexible envelope 2A obtained by injection is threaded onto a soaking core, - the assembly formed by the core covered with the flexible envelope 2A is soaked in a suitable bath , according to any well-known soaking technique, so as to cover the flexible envelope 2A with a surface envelope 2B, for example made of silicone.
  • a suitable bath according to any well-known soaking technique, so as to cover the flexible envelope 2A with a surface envelope 2B, for example made of silicone.
  • a flexible bag 2 is thus obtained which is in the form of a multi-layer complex, that is to say of a material formed by the stack of different layers of material.
  • each of the envelopes 2A, 2B forming the pocket 2 is obtained by injection, without however departing from the scope of the invention.
  • the invention finds its industrial application in the manufacture of plastic surgery implants.

Abstract

The invention relates to a method for producing an implant (1) for plastic surgery involving an injection stage, wherein an elastomeric material is injected into a mould in order to produce a flexible envelop (2A, 2B) for forming a pocket (2).

Description

IMPLANT DE CHIRURGIE PLASTIQUE A REGULARITE AMELIOREE ET PROCEDE DE FABRICATION CORRESPONDANT PLASTIC SURGERY IMPLANT WITH IMPROVED REGULARITY AND MANUFACTURING METHOD THEREOF
DOMAINE TECHNIQUETECHNICAL AREA
La présente invention se rapporte au domaine technique des dispositifs artificiels, du genre implant ou prothèse, destinés à remodeler la forme d'une partie du corps humain, à des fins esthétiques et/ou thérapeutiques.The present invention relates to the technical field of artificial devices, of the implant or prosthesis type, intended to reshape the shape of a part of the human body, for aesthetic and / or therapeutic purposes.
La présente invention se rapporte plus particulièrement, mais non exclusivement, au domaine des implants mammaires destinés à assurer une reconstruction mammaire en cas de mastectomie, ou pour réaliser des augmentations mammaires à caractère esthétique.The present invention relates more particularly, but not exclusively, to the field of breast implants intended to ensure breast reconstruction in the event of mastectomy, or to carry out breast augmentation of an aesthetic nature.
La présente invention concerne un implant de chirurgie plastique destiné à être implanté dans le corps d'un patient, ledit implant comprenant au moins une poche souple délimitant un volume interne prédéterminé, ladite poche souple étant formée d'au moins une enveloppe réalisée en un matériau élastomère.The present invention relates to a plastic surgery implant intended to be implanted in the body of a patient, said implant comprising at least one flexible pocket delimiting a predetermined internal volume, said flexible pocket being formed of at least one envelope made of a material elastomer.
La présente invention concerne également un procédé de fabrication d'un implant de chirurgie plastique.The present invention also relates to a method of manufacturing a plastic surgery implant.
TECHNIQUE ANTERIEUREPRIOR ART
Il est connu d'implanter un corps étranger dans le corps d'un patient afin de réaliser une plastie, que ce soit dans un but de reconstruction d'une partie du corps, à la suite par exemple d'un accident ou d'une maladie, ou dans un but esthétique, pour modifier l'aspect d'une partie du corps. En particulier, il est connu d'implanter un implant dans la poitrine d'une patiente afin de réaliser une plastie mammaire, dans un but de reconstruction, à la suite d'une mastectomie, et/ou dans un but esthétique, pour augmenter le volume du sein.It is known to implant a foreign body in the body of a patient in order to perform a plastic surgery, whether for the purpose of reconstructing a part of the body, for example following an accident or a disease, or for cosmetic purposes, to change the appearance of a part of the body. In particular, it is known to implant an implant in the chest of a patient in order to perform a breast plasty, for the purpose of reconstruction, following a mastectomy, and / or for aesthetic purposes, to increase the breast volume.
II est également connu d'implanter de tels corps étrangers à des fins purement esthétiques au niveau des fesses, des jambes, des bras ou des pectoraux par exemple.It is also known to implant such foreign bodies for purely aesthetic purposes in the buttocks, legs, arms or pectorals for example.
Ces corps étrangers que l'on désigne généralement sous l'appellation « prothèse », ou « implant », se présentent le plus souvent sous la forme d'une enveloppe souple réalisée par exemple en un matériau élastomere biocompatible, et refermant une certaine quantité d'un matériau de remplissage, du genre gel de silicone ou sérum physiologique par exemple, qui donne à la prothèse son volume fonctionnel.These foreign bodies which are generally designated under the name "prosthesis", or "implant", are most often in the form of a flexible envelope produced for example from a biocompatible elastomeric material, and enclosing a certain amount of 'A filling material, such as silicone gel or physiological saline for example, which gives the prosthesis its functional volume.
Ces implants sont généralement introduits en sous-cutané, par une incision réalisée à proximité de la zone d'implantation finale de l'implant.These implants are generally introduced subcutaneously, through an incision made near the final implantation area of the implant.
Dans le cas particulier des implants mammaires, ces derniers sont généralement introduits en sous-cutané au niveau du thorax du patient, sur ou sous le muscle pectoral, par une incision qui pourra être réalisée à proximité du creux de l'aisselle, selon le sillon sous-mammaire, ou encore selon le contour de l'aréole du sein.In the particular case of breast implants, these are generally introduced subcutaneously at the level of the patient's thorax, on or under the pectoral muscle, by an incision which can be made near the hollow of the armpit, depending on the groove under the breast, or according to the contour of the areola of the breast.
De tels implants de chirurgie plastique sont généralement fabriqués par trempage.Such plastic surgery implants are generally made by dipping.
Le procédé de trempage consiste à tremper un noyau présentant la forme souhaitée pour l'implant (par exemple hémisphère, ovoïde, ellipsoïde) dans un bain de silicone dispersé dans un solvant, de faire sécher le film formé à la surface du noyau par ce trempage, puis de le « démouler» du noyau, afin d'obtenir une poche souple.The dipping process consists in dipping a nucleus having the desired shape for the implant (for example hemisphere, ovoid, ellipsoid) in a silicone bath dispersed in a solvent, to dry the film formed at the surface of the core by this soaking, then “unmolding” it from the core, in order to obtain a flexible pocket.
Il est également courant de surmouler, par trempage, la poche obtenue, de façon à obtenir une enveloppe souple formée d'un empilement de couches.It is also common to overmold the bag obtained by dipping, so as to obtain a flexible envelope formed by a stack of layers.
Chaque couche peut être différente des autres, la couche superficielle présentant notamment des propriétés de texture favorisant son implantation.Each layer may be different from the others, the surface layer having in particular texture properties favoring its implantation.
Un tel procédé de fabrication par trempage, s'il donne généralement satisfaction, présente néanmoins de nombreux inconvénients.Such a dipping manufacturing method, while generally satisfactory, nevertheless has numerous drawbacks.
En effet, du fait de la présence de solvant inflammable et toxique dans le bain de trempage, il est nécessaire d'utiliser des équipements spéciaux, tant au niveau des machines que du génie civil (salle anti-déflagrante) pour garantir la santé et la sécurité des opérateurs.Indeed, due to the presence of flammable and toxic solvent in the soaking bath, it is necessary to use special equipment, both at the level of the machines and of the civil engineering (explosion-proof room) to guarantee health and operator safety.
De plus, ce procédé est particulièrement délicat à mettre en œuvre, car il nécessite un pilotage précis de la fluidité du bain de trempage, ce qui requiert une surveillance et une ré-alimentation constante en solvant, ce dernier étant généralement très volatile. Ce procédé nécessite donc un personnel particulièrement qualifié.In addition, this process is particularly delicate to implement, since it requires precise control of the fluidity of the soaking bath, which requires constant monitoring and re-supply of solvent, the latter being generally very volatile. This process therefore requires particularly qualified personnel.
Par ailleurs, ce procédé met en oeuvre une multitude de tâches justifiant notamment l'utilisation d'un carrousel de convoyage, et qui rendent le temps de cycle d'obtention d'un implant relativement long.Furthermore, this method implements a multitude of tasks justifying in particular the use of a conveyor carousel, and which make the cycle time for obtaining an implant relatively long.
De plus, le procédé par trempage ne permet généralement pas de maîtriser de façon précise l'épaisseur de l'enveloppe de l'implant. Les implants obtenus par trempage, s'ils donnent généralement satisfaction, souffrent cependant parfois d'une précision dimensionnelle insuffisante, qui peut conduire à des sur-épaisseurs en certaines zones de l'implant, ce qui augmente les coûts de production de l'implant, ou à des sous-épaisseurs en d'autres endroits, ce qui peut éventuellement engendrer une fragilisation de l'implant.In addition, the dipping process generally does not allow precise control of the thickness of the implant shell. Implants obtained by dipping, while generally satisfactory, however sometimes suffer from insufficient dimensional accuracy, which can lead to over-thicknesses in certain areas of the implant, which increases the costs of producing the implant, or to under-thicknesses in other places, which can possibly cause embrittlement of the implant.
Enfin, le champ d'application de ce procédé est d'autant plus limité qu'il ne permet pas de réaliser des variations contrôlées d'épaisseur et/ou de forme sur une même pièce. Dès lors, la conception d'un implant de chirurgie plastique devant être fabriqué par ce procédé reste conditionnée par l'écoulement d'un fluide sur un noyau, ce qui réduit considérablement les possibilités d'associer formes, dimensions, et en définitive, fonctionnalités, sur une même pièce.Finally, the field of application of this method is all the more limited since it does not allow controlled variations in thickness and / or shape to be produced on the same part. Consequently, the design of a plastic surgery implant to be manufactured by this process remains conditioned by the flow of a fluid on a core, which considerably reduces the possibilities of associating shapes, dimensions, and ultimately, functionalities. , on the same piece.
EXPOSE DE L'INVENTIONSTATEMENT OF THE INVENTION
Les objets assignés à l'invention visent en conséquence à porter remède aux différents inconvénients énumérés précédemment et à proposer un nouvel implant de chirurgie plastique présentant une résistance et une régularité améliorée.The objects assigned to the invention therefore aim to remedy the various drawbacks listed above and to propose a new plastic surgery implant having improved resistance and regularity.
Un autre objet de l'invention vise à proposer un nouveau procédé de fabrication d'un implant de chirurgie plastique permettant la fabrication d'implants de façon plus sûre, plus simple et pour un coût moindre.Another object of the invention is to propose a new method for manufacturing a plastic surgery implant allowing the manufacture of implants in a safer, simpler manner and at a lower cost.
Un autre objet de l'invention vise à proposer un nouveau procédé de fabrication d'un implant de chirurgie plastique qui permet de fabriquer des implants de façon rapide avec une excellente régularité dimensionnelle.Another object of the invention is to propose a new method for manufacturing a plastic surgery implant which enables implants to be manufactured quickly with excellent dimensional regularity.
Un autre objet de l'invention vise à proposer un nouveau procédé de fabrication d'un implant de chirurgie plastique dont le nombre d'étapes est réduit. Les objets assignés à l'invention sont atteints à l'aide d'un procédé de fabrication d'un implant de chirurgie plastique caractérisé en ce qu'il comprend une étape d'injection dans laquelle on injecte à l'aide d'une presse d'injection, un matériau élastomere dans un moule pour obtenir une enveloppe souple destinée à participer à la formation d'une poche (2).Another object of the invention is to propose a new method for manufacturing a plastic surgery implant, the number of steps of which is reduced. The objects assigned to the invention are achieved using a process for manufacturing a plastic surgery implant, characterized in that it comprises an injection step in which one injects using a press injection, an elastomeric material in a mold to obtain a flexible envelope intended to participate in the formation of a pocket (2).
Les objets assignés à l'invention sont également atteints à l'aide d'un implant de chirurgie plastique destiné à être implanté dans le corps d'un patient, ledit implant étant susceptible d'être obtenu par un procédé de fabrication conforme à l'une des revendications 1 à 5, caractérisé en ce que ledit implant comprend au moins une poche souple délimitant un volume interne prédéterminé, ladite poche souple étant formée d'au moins une enveloppe réalisée en un matériau élastomere, la tolérance dimensionnelle de l'épaisseur de ladite au moins une enveloppe étant comprise entre 1 % et 20%.The objects assigned to the invention are also achieved using a plastic surgery implant intended to be implanted in the body of a patient, said implant being capable of being obtained by a manufacturing process in accordance with one of claims 1 to 5, characterized in that said implant comprises at least one flexible pocket delimiting a predetermined internal volume, said flexible pocket being formed of at least one envelope made of an elastomeric material, the dimensional tolerance of the thickness of said at least one envelope being between 1% and 20%.
DESCRIPTIF SOMMAIRE DE L'INVENTIONSUMMARY DESCRIPTION OF THE INVENTION
D'autres objets et avantages de l'invention apparaîtront mieux à la lecture de la description qui suit, ainsi qu'à l'aide des dessins annexés donnés à titre purement illustratif et non limitatif, dans lesquels :Other objects and advantages of the invention will appear better on reading the description which follows, as well as with the aid of the appended drawings given purely by way of non-limiting illustration, in which:
- La figure 1 illustre, selon une vue de côté, un moule en position fermée permettant la mise en œuvre du procédé conforme à l'invention.- Figure 1 illustrates, in a side view, a mold in the closed position allowing the implementation of the method according to the invention.
- La figure 2 illustre, selon une vue de côté, le moule de la figure 1 en position ouverte, ainsi qu'en position de démoulage.- Figure 2 illustrates, in a side view, the mold of Figure 1 in the open position, as well as in the release position.
- La figure 3 illustre, selon une vue schématique, un implant de chirurgie plastique à poche multi-couches conforme à l'invention. - Les figures 4 et 5 illustrent, de façon schématique selon respectivement une vue de dessus et une vue de côté, un premier exemple de réalisation d'un implant mammaire conforme à l'invention.- Figure 3 illustrates, in a schematic view, a plastic surgery implant with multi-layer pocket according to the invention. - Figures 4 and 5 illustrate, schematically respectively in a top view and a side view, a first embodiment of a breast implant according to the invention.
- Les figures 6 et 7 illustrent, de façon schématique selon respectivement une vue de dessus et une vue de côté, un deuxième exemple de réalisation d'un implant mammaire conforme à l'invention.- Figures 6 and 7 illustrate, schematically respectively in a top view and a side view, a second embodiment of a breast implant according to the invention.
- Les figures 8 et 9 illustrent, de façon schématique selon respectivement une vue de dessus et une vue de côté, un troisième exemple de réalisation d'un implant mammaire conforme à l'invention.- Figures 8 and 9 illustrate, schematically respectively in a top view and a side view, a third embodiment of a breast implant according to the invention.
MEILLEURE MANIERE DE REALISER L'INVENTIONBEST WAY TO IMPLEMENT THE INVENTION
Les figures 3 à 9 montrent un implant de chirurgie plastique 1 conforme à l'invention.Figures 3 to 9 show a plastic surgery implant 1 according to the invention.
Par « chirurgie plastique », on désigne dans ce qui suit la chirurgie destinée à modifier la forme d'un organe, ou d'une partie du corps, afin de corriger une anomalie congénitale ou acquise, et/ou afin de modifier l'esthétique du corps d'un patient, dans le sens par exemple d'une augmentation de volume.By "plastic surgery" is meant in what follows surgery intended to modify the shape of an organ, or part of the body, in order to correct a congenital or acquired anomaly, and / or in order to modify the aesthetic of the body of a patient, in the sense for example of an increase in volume.
La chirurgie plastique comprend notamment une branche dénommée « chirurgie esthétique » qui s'intéresse principalement au remodelage des parties du corps dans un but essentiellement esthétique.Plastic surgery notably includes a branch called "cosmetic surgery" which is mainly concerned with the remodeling of body parts for an essentially aesthetic purpose.
La présente invention relève donc de la chirurgie plastique, et préférentiellement de la chirurgie esthétique.The present invention therefore relates to plastic surgery, and preferably to cosmetic surgery.
L'implant de chirurgie plastique 1 conforme à l'invention est destiné à être inséré sous la peau d'un patient pour reconstruire, et/ou remodeler, et/ou augmenter le volume d'une partie du corps, par exemple un sein, dans la mesure où ledit implant, qui présente un volume fonctionnel prédéterminé, vient augmenter ou remplacer les tissus biologiques, par exemple et préférentiellement les tissus mammaires.The plastic surgery implant 1 according to the invention is intended to be inserted under the skin of a patient to reconstruct, and / or reshape, and / or increase the volume of a part of the body, for example a breast, insofar as said implant, which has a predetermined functional volume, comes to increase or replace the biological tissues, for example and preferably the breast tissues.
L'insertion de l'implant de chirurgie plastique 1 conforme à l'invention est généralement et préférentiellement réalisée en introduisant ledit implant 1 en sous-cutané par le biais d'une incision pratiquée au préalable par le chirurgien.The insertion of the plastic surgery implant 1 according to the invention is generally and preferably carried out by introducing said implant 1 subcutaneously through an incision made beforehand by the surgeon.
Dans le cas particulier où l'implant 1 est un implant mammaire (cf. figures 4 à 9), ledit implant mammaire pourra être notamment implanté par voie axillaire, sous-mammaire, péri-aréolaire ou encore trans-aréolaire.In the particular case where the implant 1 is a breast implant (cf. FIGS. 4 to 9), said breast implant may in particular be implanted by axillary, submammary, periareolar or even transareolar route.
L'implant de chirurgie plastique 1 conforme à l'invention pourra être également, à titre d'exemple, un implant de bras (avant-bras, biceps), de jambe (mollets, cuisses), de fesse, ou de poitrine (implant mammaire pour les femmes, implant pectoral pour les hommes). Parmi tous ces exemples d'implants de chirurgie plastique qui entrent dans le cadre de l'invention, l'implant mammaire sera préféré.The plastic surgery implant 1 according to the invention may also be, for example, an arm (forearm, biceps), leg (calves, thighs), buttock, or chest (implant) implant. breast for women, breast implant for men). Among all these examples of plastic surgery implants which fall within the scope of the invention, the breast implant will be preferred.
L'implant de chirurgie plastique 1 conforme à l'invention comprend de façon classique au moins une poche souple 2 délimitant, grâce à ses parois extérieures, un volume interne prédéterminé.The plastic surgery implant 1 according to the invention conventionally comprises at least one flexible pocket 2 delimiting, thanks to its external walls, a predetermined internal volume.
Ladite au moins une poche souple 2 est réalisée préférentiellement à partir de matériaux élastomères, par exemple à base d'un ou plusieurs silicones. La poche souple 2 peut être réalisée selon une construction mono-couche, c'est-à-dire qu'elle est formée par une enveloppe unique (non représentée), ou selon un mode multi-couches, dans lequel la poche souple. 2 est formée de l'empilement de différentes enveloppes 2A, 2B présentant éventuellement des compositions et/ou des propriétés différentes.Said at least one flexible bag 2 is preferably made from elastomeric materials, for example based on one or more silicones. The flexible pocket 2 can be produced according to a single-layer construction, that is to say that it is formed by a single envelope (not shown), or according to a multi-layer mode, in which the flexible pocket. 2 is formed of the stack of different envelopes 2A, 2B possibly having different compositions and / or properties.
En particulier, la poche souple 2 pourra être un complexe formé d'un empilement de couches 2A, 2B solidarisées les unes relativement aux autres, de préférence sur toutes leurs surfaces respectives. La poche souple 2 présente donc préférentiellement un caractère unitaire et monobloc.In particular, the flexible pocket 2 may be a complex formed by a stack of layers 2A, 2B secured to one another, preferably on all of their respective surfaces. The flexible pocket 2 therefore preferably has a unitary and monobloc character.
Une telle construction multi-couches permet d'obtenir un gradient de propriétés selon l'épaisseur de la poche 2, c'est-à-dire par exemple une excellente étanchéité conférée par la couche interne 2A, et une texture « velours » conférée par la couche externe 2B.Such a multi-layer construction makes it possible to obtain a gradient of properties depending on the thickness of the pocket 2, that is to say for example an excellent seal imparted by the internal layer 2A, and a "velvet" texture imparted by the outer layer 2B.
Il est également envisageable, sans pour autant sortir du cadre de l'invention, que l'implant 1 comprenne deux poches de volumes différents (non représenté), l'une étant contenue dans l'autre et chacune renfermant un matériau de remplissage différent.It is also possible, without departing from the scope of the invention, for the implant 1 to comprise two pockets of different volumes (not shown), one being contained in the other and each containing a different filling material.
Dans ce qui suit, on fera plus particulièrement référence à une poche souple unique 2 formée d'un complexe bi-couches et réalisée par empilement d'une couche interne 2A et d'une couche superficielle 2B, tel que cela est illustré à la figure 3.In what follows, reference will be made more particularly to a single flexible bag 2 formed of a two-layer complex and produced by stacking an internal layer 2A and a surface layer 2B, as illustrated in the figure. 3.
Il pourra cependant être envisageable, sans pour autant sortir du cadre de l'invention, que la poche souple 2 comprenne un nombre supérieur de couches, par exemple trois, quatre, cinq ou plus.It may however be possible, without departing from the scope of the invention, for the flexible bag 2 to include a greater number of layers, for example three, four, five or more.
De façon classique, le volume interne prédéterminé défini par la poche souple 2 renferme un matériau de remplissage 3, qui permet de donner à l'implant 1 la consistance recherchée, ainsi que son volume fonctionnel. Tel que cela est bien connu de l'homme du métier, le matériau de remplissage 3 peut être un liquide, un gel, voire un gaz. A titre d'exemple, le matériau de remplissage 3 pourra être un gel de silicone, une solution saline, un liquide physiologique, de l'huile de soja, du polyvinylpyrrolidone (PVP) ou encore un hydrogel.Conventionally, the predetermined internal volume defined by the flexible pocket 2 contains a filling material 3, which makes it possible to give the implant 1 the desired consistency, as well as its functional volume. As is well known to those skilled in the art, the filling material 3 can be a liquid, a gel, or even a gas. For example, the filling material 3 could be a silicone gel, a saline solution, a physiological liquid, soybean oil, polyvinylpyrrolidone (PVP) or even a hydrogel.
Selon une caractéristique importante de l'invention, la tolérance dimensionnelle T de l'épaisseur nominale en0m d'au moins une des enveloppes 2A, 2B participant à la formation de la poche 2 est comprise entre 1% et 20%, c'est-à-dire que l'épaisseur réelle eréei de l'enveloppe 2A peut varier entre en0m(1 - T) et en0m(1 + T).According to an important characteristic of the invention, the dimensional tolerance T of the nominal thickness e n0 m of at least one of the envelopes 2A, 2B participating in the formation of the pocket 2 is between 1% and 20%, c ' that is to say that the real thickness e rée i of the envelope 2A can vary between e n0 m (1 - T) and e n0 m (1 + T).
En d'autres termes, le concept général de l'invention repose sur la présence d'une enveloppe 2A, 2B présentant une tolérance T comprise entre 1% et 20%, que cette enveloppe constitue à elle seule la poche 2, ou qu'elle soit associée à d'autres enveloppes dans une structure multi-couches.In other words, the general concept of the invention is based on the presence of an envelope 2A, 2B having a tolerance T of between 1% and 20%, whether this envelope alone constitutes the pocket 2, or that it is associated with other envelopes in a multi-layer structure.
Dans le cas d'une structure multi-couches (représentée par exemple à la figure 3), une ou plusieurs, voire toutes les enveloppes 2A, 2B pourront présenter la caractéristique de tolérance dimensionnelle conforme à l'invention.In the case of a multi-layer structure (shown for example in FIG. 3), one or more, or even all of the envelopes 2A, 2B may have the dimensional tolerance characteristic according to the invention.
A titre d'exemple, si la tolérance dimensionnelle T est de 10%, soit 0,1 , l'épaisseur réelle eréei pourra varier, pour l'enveloppe 2A, 2B considérée, entre en0m(1 - 0,1) et en0m(1 + 0,1), c'est-à-dire entre 0,9 en0m et 1 ,1 en0nvFor example, if the dimensional tolerance T is 10%, that is to say 0.1, the real thickness e r ean can vary, for the envelope 2A, 2B considered, between e n0 m (1 - 0.1 ) and e n0 m (1 + 0.1), i.e. between 0.9 e n0 m and 1, 1 e n0 nv
Afin de vérifier si une enveloppe 2A, 2B donnée répond bien au critère de tolérance dimensionnelle cité plus haut, on pourra utiliser toute méthode métrologique usuellement mise en œuvre dans le domaine industriel. A titre purement illustratif, et non limitatif, une méthode métrologique mettant en œuvre les étapes suivantes pourrait être adoptée :In order to verify whether a given envelope 2A, 2B meets the dimensional tolerance criterion mentioned above, we can use any metrological method usually implemented in the industrial field. By way of illustration only, and without limitation, a metrological method implementing the following steps could be adopted:
- calcul de l'écart E selon la formule suivante :- calculation of the difference E according to the following formula:
E = 100 (emaχ - enom) ' ©nom Si |emaχ - enom | — |©min " ©nom | ouE = 100 (e ma χ - e n om) '© name Si | e ma χ - e n om | - | © min "© name | or
E = 100 (enom - ©min) ' ©nom Si |emaχ " ©nom | ≤= |©min - ©nom | où : en0m pourrait être assimilée à la moyenne arithmétique des épaisseurs d'enveloppe relevées en un nombre N significatif de points de mesure répartis sur l'enveloppe, emin étant l'épaisseur minimum mesurée sur les N points et emax étant l'épaisseur maximum mesurée sur les N points.E = 100 (e n om - © min) '© nom Si | e ma χ "© nom | ≤ = | © min - © nom | where: e n0 m could be compared to the arithmetic mean of the envelope thicknesses noted in a significant number N of measurement points distributed over the envelope, e m i n being the minimum thickness measured on the N points and e max being the maximum thickness measured on the N points.
- comparaison de E avec T : si E < T, il s'ensuit que l'enveloppe objet de la vérification est conforme à l'objet de l'invention.- comparison of E with T: if E <T, it follows that the envelope object of the verification conforms to the object of the invention.
La mesure d'épaisseur pourra être effectuée à l'aide d'un comparateur d'épaisseur mécanique, et par exemple avec le comparateur mécanique Mitutoya NO7304.The thickness measurement can be carried out using a mechanical thickness comparator, and for example with the Mitutoya NO7304 mechanical comparator.
L'ensemble des N points de mesure doit bien sûr impérativement être choisi de façon à ce que tous les points correspondent à une même catégorie de matière. Ainsi, on veillera à ce que de façon générale aucun point de mesure ne soit positionné sur une singularité de l'enveloppe 2A, 2B, que cette singularité soit constituée par un plan de joints, un renfort (par exemple au niveau d'une valve) ou tout autre élément.The set of N measurement points must of course be chosen so that all the points correspond to the same category of material. Thus, it will be ensured that in general no measurement point is positioned on a singularity of the envelope 2A, 2B, that this singularity is constituted by a plane of joints, a reinforcement (for example at the level of a valve ) or any other element.
Avantageusement, la tolérance dimensionnelle de l'épaisseur de l'enveloppe 2A, 2B est comprise dans une plage allant de 15% à 20%. A titre d'exemple, on peut citer le cas d'une enveloppe en silicone d'épaisseur nominale sensiblement égale à 0,5 mm avec une tolérance comprise entre 15% et 20%o. Cela signifie que l'épaisseur nominale de l'enveloppe 2A, 2B est de 0,5 mm, tandis que l'épaisseur réelle peut varier de 0,5 ± 0,075 mm (lorsque la tolérance T est égale à 15%) à 0,5 ± 0,1 mm (lorsque la tolérance T est égale à 20%).Advantageously, the dimensional tolerance of the thickness of the envelope 2A, 2B is within a range from 15% to 20%. As example, we can cite the case of a silicone envelope of nominal thickness substantially equal to 0.5 mm with a tolerance of between 15% and 20% o. This means that the nominal thickness of the envelope 2A, 2B is 0.5 mm, while the actual thickness can vary from 0.5 ± 0.075 mm (when the tolerance T is equal to 15%) to 0, 5 ± 0.1 mm (when the tolerance T is 20%).
Dans ce qui précède, on a envisagé le cas d'une enveloppe 2A, 2B réalisée en silicone, ou à base de silicone. Il est cependant tout à fait envisageable que cette enveloppe soit réalisée en tout autre matériau, notamment élastomere, sans sortir du cadre de l'invention.In the foregoing, we have considered the case of an envelope 2A, 2B made of silicone, or based on silicone. It is however entirely conceivable that this envelope is made of any other material, in particular elastomer, without departing from the scope of the invention.
L'invention concerne également un procédé de fabrication d'un implant de chirurgie plastique 1 , ledit implant 1 étant destiné à être implanté en sous- cutané dans le corps d'un patient.The invention also relates to a method for manufacturing a plastic surgery implant 1, said implant 1 being intended to be implanted subcutaneously in the body of a patient.
De façon préférentielle, l'invention concerne un procédé de fabrication d'un implant de chirurgie plastique pris dans le groupe suivant : - implant mammaire, - implant pectoral, - implant de jambe, - implant de bras, - implant de fesse.Preferably, the invention relates to a process for manufacturing a plastic surgery implant taken from the following group: - breast implant, - pectoral implant, - leg implant, - arm implant, - buttock implant.
Selon une caractéristique importante de l'invention, le procédé de fabrication comprend une étape d'injection dans laquelle on injecte, à l'aide d'une presse à injection, un matériau élastomere, du genre silicone, dans un moule pour obtenir une enveloppe souple 2A, 2B destinée à participer à la formation de la poche 2 de l'implant 1. Le procédé de fabrication est donc un procédé de moulage par injection, réalisé à l'aide d'une presse à injecter, c'est-à-dire une presse de moulage par injection. Le terme « injection » doit donc être compris ici comme étant relatif à l'opération réalisée à l'aide d'une presse, et non à un simple transfert de matière, du genre coulée, qui pourrait être réalisé sans presse d'injection.According to an important characteristic of the invention, the manufacturing process comprises an injection step in which an elastomeric material, of the silicone type, is injected, using an injection press, into a mold to obtain an envelope. flexible 2A, 2B intended to participate in the formation of the pocket 2 of the implant 1. The manufacturing process is therefore an injection molding process, carried out using an injection molding machine, that is to say an injection molding press. The term "injection" must therefore be understood here as relating to the operation carried out using a press, and not to a simple transfer of material, of the casting type, which could be carried out without an injection press.
De façon préférentielle, le matériau élastomere injecté est sensiblement non moussant ou mousseux, et se présente plutôt sous forme sensiblement « pleine ».Preferably, the injected elastomeric material is substantially non-foaming or foamy, and is rather in substantially "full" form.
De façon générale, le procédé conforme à l'invention est conçu pour viser à éliminer sensiblement les bulles d'air qui pourraient se retrouver piégées au sein du matériau élastomere. Le procédé permet ainsi d'obtenir une enveloppe souple régulière et homogène, qui pourra notamment être utilisée pour former la coque externe d'un implant chirurgical.In general, the method according to the invention is designed to aim at substantially eliminating air bubbles which could become trapped within the elastomeric material. The method thus makes it possible to obtain a regular and homogeneous flexible envelope, which can in particular be used to form the external shell of a surgical implant.
Avantageusement, le moule comprend : - une empreinte supérieure 40 comprenant une conformation concave 40A définissant en creux une portion de la surface de l'enveloppe souple que l'on cherche à obtenir, - une empreinte inférieure 41 , comprenant une. conformation concave 41 B qui définit en creux une surface complémentaire de celle de l'empreinte supérieure 40, de telle sorte que lorsqu'on plaque l'une contre l'autre l'empreinte supérieure 40 et l'empreinte inférieure 41 complémentaire, on obtient un volume interne fermé, sensiblement étanche, délimité par une surface 40A, 41A dont la forme correspond à celle de l'enveloppe souple 2A, 2B que l'on souhaite obtenir.Advantageously, the mold comprises: - an upper cavity 40 comprising a concave conformation 40A defining in hollow a portion of the surface of the flexible envelope which it is sought to obtain, - a lower cavity 41, comprising a . concave conformation 41 B which defines in hollow a surface complementary to that of the upper cavity 40, so that when the upper cavity 40 and the complementary lower cavity 41 are pressed against each other, one obtains a closed internal volume, substantially sealed, delimited by a surface 40A, 41A whose shape corresponds to that of the flexible envelope 2A, 2B which it is desired to obtain.
Le moule comprend également un noyau 42 formé par un corps convexe dont la surface extérieure est sensiblement complémentaire de celle du volume interne défini par les empreintes supérieure 40 et inférieure 41 , à un changement d'échelle près. La surface externe du noyau 42 est ainsi une homothétie réduite de la surface du volume interne défini par les empreintes supérieure 40 et inférieure 41. Le noyau 42 est destiné à être positionné au sein du volume interne, de préférence à équidistance dés parois définissant le volume interne. On obtient ainsi l'agencement décrit à la figure 1 , où les empreintes supérieure 40 et inférieure 41 englobent le noyau 42, de façon à définir un interstice ou entrefer 43, qui est un espace libre délimité d'une part par la surface externe 42A du noyau 42, et d'autre part par la surface interne 40A, 41A du volume interne défini par l'empreinte supérieure 40 associée à l'empreinte inférieure complémentaire 41.The mold also comprises a core 42 formed by a convex body whose external surface is substantially complementary to that of the internal volume defined by the upper 40 and lower 41 cavities, except for a change of scale. The external surface of the core 42 is thus a reduced uniformity of the surface of the internal volume defined by the upper 40 and lower 41 cavities. The core 42 is intended to be positioned within the internal volume, preferably equidistant from the walls defining the volume internal. The arrangement described in FIG. 1 is thus obtained, where the upper 40 and lower 41 indentations include the core 42, so as to define a gap or air gap 43, which is a free space delimited on the one hand by the external surface 42A of the core 42, and on the other hand by the internal surface 40A, 41A of the internal volume defined by the upper cavity 40 associated with the complementary lower cavity 41.
Dans le cas purement illustratif correspondant aux figures 1 et 2, où l'on souhaite obtenir une enveloppe de forme sensiblement sphérique et monobloc, le procédé d'injection comprend ainsi, antérieurement à l'étape d'injection, une étape de préparation de moule dans laquelle on plaque l'une contre l'autre une empreinte supérieure 40 de forme générale hémisphérique et une empreinte inférieure 41 de forme générale hémisphérique complémentaire, de façon à obtenir un volume interne sensiblement en forme de sphère, en ayant au préalable positionné entre les deux empreintes 40, 41 , de façon concentrique audit volume interne, un noyau sphérique 42 dont le diamètre est inférieur à celui dudit volume interne défini par les empreintes supérieure 40 et inférieure 41. Cette étape de préparation de moule est suivie d'une étape d'injection, dans laquelle on injecte un matériau élastomere, qui peut être par exemple du silicone gomme ou du silicone liquide, dans l'espace interstitiel compris entre le noyau 42 et les empreintes supérieure 40 et inférieure 41 , de façon à obtenir une enveloppe 2A, 2B de forme générale sphérique destinée à participer à la formation de la poche 2 de l'implant. Avantageusement, l'empreinte supérieure 40 est solidarisée à une semelle supérieure 44, de façon à ce que l'espace intérieur 40B défini par la conformation concave 40A de l'empreinte 40, soit en communication fluidique avec la semelle supérieure 44, qui elle-même porte les moyens d'injection de matériau élastomere, lesquels sont eux-mêmes en communication avec la presse d'injection (non représentée).In the purely illustrative case corresponding to FIGS. 1 and 2, where it is desired to obtain an envelope of substantially spherical and monobloc shape, the injection method thus comprises, prior to the injection step, a mold preparation step in which an upper cavity 40 of generally hemispherical shape and a lower cavity 41 of generally hemispherical complementary shape are pressed against each other, so as to obtain an internal volume substantially in the form of a sphere, having previously positioned between the two indentations 40, 41, concentric with said internal volume, a spherical core 42 whose diameter is less than that of said internal volume defined by the upper indentations 40 and lower 41. This mold preparation step is followed by a step d injection, in which an elastomeric material is injected, which may for example be gum silicone or liquid silicone, into the interstitial space between the core 42 and the upper 40 and lower 41 cavities, so as to obtain an envelope 2A, 2B of generally spherical shape intended to participate in the formation of the pocket 2 of the implant. Advantageously, the upper imprint 40 is secured to an upper sole 44, so that the interior space 40B defined by the concave conformation 40A of the imprint 40 is in fluid communication with the upper sole 44, which itself the same carries the means for injecting elastomeric material, which are themselves in communication with the injection press (not shown).
Les moyens d'injection comprennent de façon préférentielle trois buses d'injection réparties angulairement de façon régulière (espacées entre elles de 120°) autour ou au niveau du sommet 45 du volume interne défini par les empreintes supérieure 40 et inférieure 41. Le sommet 45 correspond ainsi sensiblement au point de la conformation concave 40A de l'empreinte supérieure 40 le plus proche de la semelle supérieure 44.The injection means preferably comprise three injection nozzles distributed angularly in a regular manner (spaced apart by 120 °) around or at the level of the apex 45 of the internal volume defined by the upper 40 and lower 41 indentations. The apex 45 thus corresponds substantially to the point of the concave conformation 40A of the upper imprint 40 closest to the upper sole 44.
De façon préférentielle, les buses d'injection ont toutes un débit identique.Preferably, the injection nozzles all have an identical flow rate.
De façon avantageuse, le procédé met également en œuvre une semelle inférieure 46 sur laquelle est fixé un axe de centrage 47 du noyau 42. Le noyau 42, qui se présente par exemple, tel que cela est représenté aux figures 11 et 12, sous la forme d'une sphère pleine, comprend un alésage 48 dont la forme est complémentaire de celle de l'axe de centrage 47, de façon à pouvoir emmancher le noyau 42 sur l'axe 47, au travers de l'empreinte inférieure 41 qui comporte à cet effet une lumière de passage 41 B pour l'axe de centrage 47.Advantageously, the method also implements a lower sole 46 on which is fixed a centering pin 47 of the core 42. The core 42, which is for example, as shown in FIGS. 11 and 12, under the shape of a solid sphere, comprises a bore 48 whose shape is complementary to that of the centering axis 47, so as to be able to fit the core 42 on the axis 47, through the lower cavity 41 which comprises for this purpose a passage light 41 B for the centering axis 47.
L'alésage 48 et l'axe de centrage 47 sont conçus de façon à limiter tout risque de grippage entre le noyau 42 et l'axe de centrage 47. A cette fin, les aciers constituant le noyau 42 et l'axe de centrage 47 doivent préférentiellement présenter des duretés différentes, par exemple 49 ou 50 HRc pour l'axe de centrage 47, et 35 HRc pour le noyau 42 (dureté Rockwell). On envisage également de pourvoir l'axe de centrage 47 d'une embase 47A de forme générale sensiblement tronconique, ainsi que d'une extrémité d'engagement opposée 47B de forme générale également sensiblement tronconique. L'alésage 48 pratiqué dans le noyau 42 comprend, à chacune de ses extrémités, un évidement inférieur 48B, dont la forme est complémentaire de celle de l'embase 47A, ainsi qu'un évidement supérieur 48A, dont la forme est complémentaire de celle de l'extrémité d'engagement 47B, lesdits axe de centrage 47 et alésage 48 étant agencés de façon à favoriser un appui annulaire entre l'embase 47A de l'axe de centrage 47 et le noyau 42, ledit appui annulaire contribuant à la maîtrise du positionnement du noyau 42 par rapport à l'axe de centrage 47.The bore 48 and the centering axis 47 are designed so as to limit any risk of seizure between the core 42 and the centering axis 47. To this end, the steels constituting the core 42 and the centering axis 47 preferably have different hardnesses, for example 49 or 50 HRc for the centering axis 47, and 35 HRc for the core 42 (Rockwell hardness). It is also envisaged to provide the centering axis 47 with a base 47A of generally substantially frustoconical shape, as well as an opposite engagement end 47B of general shape also substantially frustoconical. The bore 48 formed in the core 42 comprises, at each of its ends, a lower recess 48B, the shape of which is complementary to that of the base 47A, as well as an upper recess 48A, the shape of which is complementary to that of the engagement end 47B, said centering axis 47 and bore 48 being arranged so as to promote an annular support between the base 47A of the centering axis 47 and the core 42, said annular support contributing to control the positioning of the core 42 relative to the centering axis 47.
Afin de procéder à l'opération de démoulage, on met en œuvre un axe de démoulage 49 dont l'une des extrémités est solidaire de la semelle inférieure 46, tandis que l'autre extrémité, ou l'extrémité d'attaque 49A, est destinée à engager l'évidement inférieur 48B du noyau 42, et présente à cet effet une conformation autorisant la mise en butée de l'extrémité inférieure 48B de l'alésage 48. Il est ainsi possible d'extraire le noyau 42 de l'empreinte inférieure 41 de la façon suivante : - les empreintes supérieure 40 et inférieure 41 sont désolidarisées, - puis l'empreinte inférieure 41 est soumise à un mouvement de translation verticale dans la direction selon laquelle s'étend l'axe de centrage 47, de façon à entraîner le noyau 42 hors de l'axe de centrage 47, - puis on enfile le sous-ensemble formé par l'empreinte inférieure 41 supportant le noyau 42 sur l'axe de démoulage 48, de façon à extraire le noyau 42 hors de la conformation concave 41A de l'empreinte inférieure 41. On procède en dernier lieu au démoulage proprement dit de l'enveloppe de silicone épousant la surface du noyau 42. Afin de faciliter cette opération, le noyau 42 sera avantageusement recouvert d'un revêtement de traitement de surface limitant l'adhérence des élastomères, par exemple d'une couche uniforme de Téflon®, de quelques micromètres d'épaisseur.In order to carry out the demolding operation, a demolding axis 49 is implemented, one of the ends of which is integral with the lower sole 46, while the other end, or the leading end 49A, is intended to engage the lower recess 48B of the core 42, and has for this purpose a conformation allowing the abutment of the lower end 48B of the bore 48. It is thus possible to extract the core 42 from the cavity lower 41 as follows: - the upper 40 and lower 41 imprints are separated, - then the lower imprint 41 is subjected to a vertical translational movement in the direction in which the centering axis 47 extends, so to drive the core 42 out of the centering axis 47, - then the subset formed by the lower recess 41 is threaded supporting the core 42 on the demolding axis 48, so as to extract the core 42 out of the concave conformation 41A of the lower impression 41. Lastly, the actual removal of the silicone envelope from the surface of the core 42 is carried out. In order to facilitate this operation, the core 42 will advantageously be covered with a surface treatment coating limiting the adhesion of the elastomers, by example of a uniform layer of Teflon®, a few micrometers thick.
Ainsi, le procédé selon l'invention permet de réaliser de façon rapide (le temps de cycle peut être de l'ordre de 5 minutes), à l'aide d'une seule machine et selon un nombre limité d'opérations, une enveloppe souple présentant une grande régularité d'épaisseur de paroi. A titre d'exemple, on peut ainsi réaliser une enveloppe 2A, 2B en silicone d'épaisseur nominale égale à 0,5 mm avec une tolérance inférieure à ± 0,08 mm et pouvant atteindre ± 0,05 mm.Thus, the method according to the invention makes it possible to rapidly produce (a cycle time can be of the order of 5 minutes), using a single machine and according to a limited number of operations, an envelope. flexible with great regularity in wall thickness. By way of example, it is thus possible to produce a silicone envelope 2A, 2B of nominal thickness equal to 0.5 mm with a tolerance of less than ± 0.08 mm and up to ± 0.05 mm.
Avantageusement, le procédé conforme à l'invention comprend, postérieurement à l'étape d'injection, une étape de complexage dans laquelle l'enveloppe souple 2A obtenue à l'issu de l'étape d'injection est recouverte d'une enveloppe superficielle 2B par une opération de trempage, ce qui permet d'obtenir une poche souple 2 semblable à celle illustrée à la figure 3.Advantageously, the method according to the invention comprises, after the injection step, a complexing step in which the flexible envelope 2A obtained at the end of the injection step is covered with a surface envelope 2B by a soaking operation, which makes it possible to obtain a flexible bag 2 similar to that illustrated in FIG. 3.
Cette opération dé trempage se déroule préférentiellement de la façon suivante : - l'enveloppe souple 2A obtenue par injection est enfilée sur un noyau de trempage, - l'ensemble formé par le noyau recouvert de l'enveloppe souple 2A est trempé dans un bain adéquat, selon toute technique de trempage bien connue, de façon à recouvrir l'enveloppe souple 2A d'une enveloppe superficielle 2B, par exemple en silicone. Cela permet de conjuguer le bénéfice de la rapidité de l'injection avec les effets de texture, du genre effet « velours », que l'on peut obtenir par trempage.This dipping operation preferably takes place in the following manner: - the flexible envelope 2A obtained by injection is threaded onto a soaking core, - the assembly formed by the core covered with the flexible envelope 2A is soaked in a suitable bath , according to any well-known soaking technique, so as to cover the flexible envelope 2A with a surface envelope 2B, for example made of silicone. This makes it possible to combine the benefit of the speed of the injection with the texture effects, such as the "velvet" effect, which can be obtained by soaking.
On obtient ainsi une poche souple 2 se présentant sous la forme d'un complexe multi-couches, c'est-à-dire d'un matériau formé par l'empilement de différentes couches de matière.A flexible bag 2 is thus obtained which is in the form of a multi-layer complex, that is to say of a material formed by the stack of different layers of material.
Ces couches sont au nombre de deux dans l'exemple présenté à la figure 3, étant entendu qu'un nombre supérieur de couches est tout à fait envisageable sans pour autant sortir du cadre de l'invention.These layers are two in number in the example presented in FIG. 3, it being understood that a higher number of layers is entirely possible without departing from the scope of the invention.
II est également envisageable, dans le cas d'une poche 2 multi-couches, que chacune des enveloppes 2A, 2B formant la poche 2 sojt obtenue par injection, sans pour autant sortir du cadre de l'invention.It is also conceivable, in the case of a multi-layer pocket 2, that each of the envelopes 2A, 2B forming the pocket 2 is obtained by injection, without however departing from the scope of the invention.
De nombreuses formes d'implants sont réalisables grâce au procédé conforme à l'invention, et notamment des formes d'implants mammaires telles que celles illustrées schématiquement aux figures 3 à 9.Many forms of implants can be produced using the method according to the invention, and in particular forms of breast implants such as those illustrated diagrammatically in FIGS. 3 to 9.
POSSIBILITE D'APPLICATION INDUSTRIELLEPOSSIBILITY OF INDUSTRIAL APPLICATION
L'invention trouve son application industrielle dans la fabrication d'implants de chirurgie plastique. The invention finds its industrial application in the manufacture of plastic surgery implants.

Claims

REVENDICATIONS
- Procédé de fabrication d'un implant de chirurgie plastique (1) caractérisé en ce qu'il comprend une étape d'injection dans laquelle on injecte à l'aide d'une presse d'injection, un matériau élastomere dans un moule pour obtenir une enveloppe souple (2A, 2B) destinée à participer à la formation d'une poche (2).- Method for manufacturing a plastic surgery implant (1) characterized in that it comprises an injection step in which an elastomeric material is injected using an injection press into a mold to obtain a flexible envelope (2A, 2B) intended to participate in the formation of a pocket (2).
- Procédé selon la revendication 1 caractérisé en .ce qu'il comprend, antérieurement à l'étape d'injection, une étape de préparation de moule dans laquelle on plaque l'une contre l'autre une empreinte supérieure (40) et une empreinte inférieure (41) de forme complémentaire, de façon à obtenir un volume interne fermé, en ayant au préalable positionné entre les deux empreintes (40, 41) un noyau (42) dont le volume est inférieur à celui dudit volume interne, l'étape d'injection comprenant une injection du matériau élastomere dans l'espace interstitiel compris entre le noyau (42) et les empreintes (40, 41).- Method according to claim 1 characterized in. That it comprises, prior to the injection step, a mold preparation step in which an upper imprint (40) and an imprint are pressed against each other lower (41) of complementary shape, so as to obtain a closed internal volume, having previously positioned between the two cavities (40, 41) a core (42) whose volume is less than that of said internal volume, step injection comprising an injection of the elastomeric material into the interstitial space between the core (42) and the imprints (40, 41).
- Procédé selon l'une des revendications 1 ou 2 caractérisé en ce qu'il comprend, postérieurement à l'étape d'injection, une étape de complexage dans laquelle ladite enveloppe souple . (2A) est recouverte d'une enveloppe superficielle (2B) par une opération de trempage.- Method according to one of claims 1 or 2 characterized in that it comprises, after the injection step, a lamination step in which said flexible envelope. (2A) is covered with a surface covering (2B) by a soaking operation.
- Procédé selon l'une des revendications 1 à 3 caractérisé en ce que le matériau élastomere injecté est sensiblement non moussant.- Method according to one of claims 1 to 3 characterized in that the elastomeric material injected is substantially non-foaming.
- Procédé de fabrication d'un implant de chirurgie plastique (1) pris dans le groupe suivant : - implant mammaire, - implant pectoral, - implant de jambe, - implant de bras, - implant de fesse, conforme à l'une des revendications 1 à 4.- Method for manufacturing a plastic surgery implant (1) taken from the following group: - breast implant, - pectoral implant, - leg implant, - arm implant, - buttock implant, according to one of claims 1 to 4.
- Implant de chirurgie plastique (1) destiné à être implanté dans le corps d'un patient, ledit implant étant susceptible d'être obtenu par un procédé de fabrication conforme à l'une des revendications 1 à 5, caractérisé en ce que ledit implant (1) comprend au moins une poche souple (2) délimitant un volume interne prédéterminé, ladite poche souple (2) étant formée d'au moins une enveloppe (2A, 2B) réalisée en un matériau élastomere, la tolérance dimensionnelle de l'épaisseur de ladite au moins une enveloppe (2A, 2B) étant comprise entre 1% et 20%.- Plastic surgery implant (1) intended to be implanted in the body of a patient, said implant being capable of being obtained by a manufacturing process according to one of claims 1 to 5, characterized in that said implant (1) comprises at least one flexible pocket (2) delimiting a predetermined internal volume, said flexible pocket (2) being formed of at least one envelope (2A, 2B) made of an elastomeric material, the dimensional tolerance of the thickness of said at least one envelope (2A, 2B) being between 1% and 20%.
- Implant de chirurgie plastique (1) selon la revendication 6 caractérisé en ce que la tolérance est comprise dans une plage allant de 15% à 20%.- Plastic surgery implant (1) according to claim 6 characterized in that the tolerance is in a range from 15% to 20%.
- Implant de chirurgie plastique (1) selon l'une des revendications 6 ou 7 caractérisé en ce que l'épaisseur de ladite au moins une enveloppe est sensiblement égale à 0,5 mm avec une tolérance comprise entre 15% et 20%.- Plastic surgery implant (1) according to one of claims 6 or 7 characterized in that the thickness of said at least one envelope is substantially equal to 0.5 mm with a tolerance of between 15% and 20%.
- Implant de chirurgie plastique (1) selon l'une des revendications 6 à 8 caractérisé en ce que ladite au moins une enveloppe (2A, 2B) est en silicone, ou à base de silicone. - Implant de chirurgie plastique (1) pris dans le groupe suivant : - implant mammaire, - implant pectoral, - implant de jambe, - implant de bras, - implant de fesse, conforme à l'une des revendications 6 à 9. - Plastic surgery implant (1) according to one of claims 6 to 8 characterized in that said at least one envelope (2A, 2B) is made of silicone, or based on silicone. - Plastic surgery implant (1) taken from the following group: - breast implant, - pectoral implant, - leg implant, - arm implant, - buttock implant, according to one of claims 6 to 9.
EP04767714A 2003-07-24 2004-07-16 Implant with improved homogeneity for plastic surgery and method for the production thereof Withdrawn EP1651143A2 (en)

Applications Claiming Priority (2)

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FR0309102A FR2857852B1 (en) 2003-07-24 2003-07-24 PLASTIC SURGERY IMPLANT WITH IMPROVED REGULARITY AND METHOD OF MANUFACTURING THE SAME
PCT/FR2004/001890 WO2005009711A2 (en) 2003-07-24 2004-07-16 Implant with improved homogeneity for plastic surgery and method fo the production thereof

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WO2005009711A2 (en) 2005-02-03
CA2533676A1 (en) 2005-02-03
US20070276485A1 (en) 2007-11-29
FR2857852A1 (en) 2005-01-28
FR2857852B1 (en) 2006-04-07
BRPI0412841A (en) 2006-09-26
CN1829484A (en) 2006-09-06

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