Medical device for receiving a filling element

Abstract

The present invention relates to a medical device (1) for receiving a filling element (5) such as a silicone implant, comprising a base (2) and a shell (3) which are joined together to form a receptacle (4) for receiving said filling element (5), the shell (3) comprising a rim (6) formed over all or part of its periphery; the rim (6) of the shell (3) being folded towards the inside of the shell (3) so as to be connected to the base (2), and the shell (3) being delimited, where it is joined to the base (2), by an outer contour, and finally the surface of the base (2) being smaller than the surface defined by said outer contour of the shell (3).

Description

[0001] MEDICAL DEVICE INTENDED TO RECEIVE A FILLING ELEMENT

[0002] Technical field

[0003] The invention relates to the technical field of breast surgery. In particular, the invention relates to a medical device intended to receive a filling element and a method for obtaining it.

[0004] State of the art

[0005] Breast surgery can be performed for a variety of purposes. In some cases, it is for cosmetic reasons, such as breast augmentation or a facelift. In other cases, it is for medical reasons, such as breast reduction or cancer-related surgery.

[0006] Breast surgery can be performed using different reconstruction methods. The most well-known are silicone implants, autologous tissue grafts using microsurgical techniques (DIEP), and non-vascularized transfer (lipomodeling). Among these techniques, breast implant reconstruction is the most widely used due to the constant evolution of implants and improvements in mastectomy techniques.

[0007] The appeal of breast implant reconstruction is mainly due to the emergence and improvement of biological implants, which have reduced post-operative complications and made it possible to achieve better aesthetic results.

[0008] Indeed, the most commonly used breast implant reconstruction procedure over the past 20 years has involved inserting the implant into a space created by the surgeon between the chest wall and the pectoralis major muscle. However, the manipulation and dissection of the muscles caused pain and complications in some patients.

[0009] These complications, including pain but also deformations caused by muscle spasms, were due to the technique of total coverage of the prosthesis by the muscles (pectoralis and serratus).

[0010] The emergence of so-called acellular biological matrices has revolutionized the field of breast prosthesis reconstruction.

[0011] One of the advantages of biological matrices is that they allow at least partial coverage of the breast prosthesis by improving breast projection and providing inferolateral tissue support.

[0012] As their use has progressed, surgical techniques have improved and biological matrices have allowed the placement of the breast prosthesis in the prepectoral (subcutaneous plane). This new technique is proving very promising through the use of biological matrix whose role is to secure and stabilize the position of the breast prosthesis but also to provide additional tissue support.

[0013] The so-called prepectoral technique has many advantages due to the use of biological matrices. Indeed, the procedure is shorter and less invasive because it requires less dissection and, consequently, results in less post-operative pain.

[0014] The biological matrices currently on the market come from different origins: human (allograft) or animal (xenograft) and of various typologies (dermal, peritoneal or pericardial).

[0015] Presented in flat shapes with different geometries (rectangular, square, oval, or round) with various arrangements (perforations, meshes or tabs), the objective remains common to all matrices, namely to obtain the best match between the biological matrix and the breast prosthesis used.

[0016] Document EP3445286 thus describes an implant consisting of a biological matrix made up of different segments which, after assembly around the silicone implant, are sutured together to serve as a container for said silicone implant. The use of this device requires a long conformation time in the operating room, including in particular the assembly or adaptation of the segments around the silicone implant and then the suturing of said segments in order to create an envelope.

[0017] Document US2012010728 describes a method for preforming a biological matrix that can serve as a receptacle for a silicone implant. This device has the advantage of providing a receptacle in the form of a shell for receiving the silicone breast implant, thus saving time compared to the device previously described. However, said receptacle is not closed at its base. The silicone implant must then be secured in said receptacle by suturing on an anatomical plane to allow a complete lodge around the silicone implant. The space offered to surgeons, once the assembly is introduced into the human body, makes the positioning and suturing operation on the chosen anatomical plane difficult.

[0018] According to another variant, document US2023181795 also describes a method for preforming an implant consisting of a biological matrix in order to receive a silicone implant. Said biological matrix comprises only a portion capable of serving as a receptacle. Therefore, the implant described in this document also requires securing the silicone implant by suturing within the biological matrix.

[0019] Document US2022331091 describes a medical device consisting of a preformed biological matrix comprising a dome-shaped shell connected to a disc-shaped appendage allowing the biological matrix to be closed around the silicone breast implant. While this device allows for a shorter preparation time for the operating room, it still requires an adaptation time since the base must be sutured to the preformed shell. In addition, the suture performed on the circumference of the implant requires the superposition of two planes, namely the shell and the appendage, thus creating an annoying excess thickness once the implant is introduced into the pocket. Indeed, this excess thickness due to the suture is visible through the skin sheath.

[0020] Regardless of the origin of the biological matrix used today, there is necessarily a step of adaptation of the biological matrix to the silicone implant.

[0021] This adaptation involves cutting or suturing the biological matrix by the practitioner. The success of this technique in forming a prosthesis of a suitable shape thus depends largely on the practitioner. Indeed, the difficulty of adapting a flat surface to a round or anatomically shaped breast implant can be approached differently by each person.

[0022] These adaptation periods can lead to various post-operative complications, such as infections, tissue erosion due to the presence of sutures, capsular contraction, and problems resulting from an imperfect fit between the silicone implant and the medical device.

[0023] Thus, there is a need to obtain a suitable medical device for breast reconstruction after mastectomy or breast augmentation:

[0024] *suitable for pre- or retro-pectoral implantation;

[0025] “reducing operating and handling times with said device

[0026] “drastically reducing the risk of infection, capsular contraction and tissue erosion; and

[0027] “not causing the appearance of a bothersome or visible excess thickness after implantation.

[0028] Summary of the invention

[0029] To meet this need, the invention proposes a new medical device suitable for breast surgery, in particular breast reconstruction after mastectomy or breast augmentation.

[0030] The inventors have thus implemented a medical device intended to receive a filling element comprising a base and a previously assembled shell, thus avoiding the multiple conformation / assembly stages usually carried out during the operation.

[0031] Such a device is particularly useful in the context of the invention and overcomes the drawbacks of the prior art by providing a complete medical device requiring no other operation than that of introducing therein a filling element such as a silicone implant. Furthermore, in addition to being a complete medical device, the materials, the conformation and the procedure made easier for the surgeon reduce surgical time, the risk of infection and the risk of capsular contraction while maintaining satisfactory aesthetics by not causing any annoying or visible excess thickness after implantation.

[0032] Thus, the invention relates to a medical device intended to receive a filling element, comprising a base and a shell assembled together to form a receptacle for said filling element, said shell comprising a rim formed on all or part of its periphery; the rim of said shell being folded towards the inside of the shell to be connected to the base, by an external contour, the surface of the base being less than the surface defined by said external contour of the shell.

[0033] Advantageously, the device according to the invention is suitable for being implanted in the prepectoral position (between the skin and the pectoralis major muscle), or in the retropectoral position (behind the pectoralis major muscle).

[0034] According to one embodiment, the device according to the invention comprises a shell and a base, in which the base has a substantially flat and substantially circular disc shape, and the shell has a dome shape, preferably substantially hemispherical.

[0035] According to a preferred embodiment, the shell has an anatomical or round shape of a breast.

[0036] According to one embodiment, the junction of the shell and the base is at a distance from the outer edge of the shell, preferably at least 5 mm from the outer edge of the shell. Preferably, the junction of the shell and the base is located on the lower face of the device according to the invention.

[0037] Advantageously, after implantation, the lower face of the device, and therefore the junction of the shell and the base, is not visible after implantation, which constitutes a major aesthetic advantage in the context of the invention.

[0038] By lower face of the device is meant the face of the device closest to the core, opposite the upper face.

[0039] According to one embodiment, the device according to the invention comprises a base and a shell distinct from each other and assembled to form a receptacle. In other words, in this preferred embodiment, the shell and the base do not comprise a connection between them.

[0040] According to one embodiment, the shell is positioned to cover an upper face of the base in order to define the receptacle and the rim of said shell is folded from the outer contour over an upper face of the base opposite the lower face of the base to be connected thereto. Advantageously, in this embodiment, assembly between the base and the shell is facilitated.

[0041] In another embodiment, the shell is positioned to cover an upper face of the base to define the receptacle and the rim of said shell is folded from the outer contour below a lower face of the base opposite the upper face of the base to be connected thereto.

[0042] Advantageously, in this embodiment, the base, having a surface area smaller than the surface area defined by said external contour of the shell, is thus trapped within the shell by the edge of said shell.

[0043] According to one embodiment, the base is in the form of a substantially flat and substantially circular disc and has a maximum diameter greater than the internal diameter of the rim formed by the shell.

[0044] According to another embodiment, the base is in the form of a substantially flat and substantially circular disc, and has a maximum diameter greater than the internal diameter of the rim formed by the shell and less than the external diameter of the contour of the shell.

[0045] For the purposes of the invention, a substantially circular disc is understood to mean a circular disc or an ellipsoidal disc.

[0046] For the purposes of the invention, maximum diameter means the maximum distance between two points belonging to a substantially circular shape.

[0047] Thus, the base may have a substantially circular and therefore irregular outer contour.

[0048] According to another embodiment, the shapes of said shell and the rim are preformed prior to the assembly of the shell and the base.

[0049] Advantageously, the shell and the base are preformed to order, depending on the filling element and the desired shape.

[0050] According to a preferred embodiment, the shape of the shell and the rim of said shell is obtained by molding a biological matrix having a humidity level of at least 0.1%.

[0051] Advantageously, the molding of a biological matrix having a humidity level of at least 0.1% makes it possible to give the desired shape, in particular the round or anatomical shape of a breast, to the device according to the invention, in particular so that the latter is suitable for receiving a filling element, such as a silicone implant, of the same shape.

[0052] According to one embodiment, the shape of the shell and the rim is obtained by molding a biological matrix prior to the assembly of the shell and the base. Preferably, the biological matrix forming the shell and / or the base in the medical device according to the invention is of human and / or non-human animal origin (Allograft or Xenograft).

[0053] According to a preferred embodiment, the biological matrix forming the shell and / or the base in the medical device according to the invention is of human origin.

[0054] According to another embodiment, the biological matrix is ​​chosen from biological matrices of non-human animal origin, preferably from biological matrices of porcine, bovine, equine, caprine, fish origin and their mixtures.

[0055] Preferably, the shell is obtained from the molding of an acellular biological matrix. Acellular biological matrices include a wide class of biomaterials extracted from grafts of various origins.

[0056] There are many known methods for obtaining acellular biological matrix. The methods used may be enzymatic and / or based on chemical solutions and / or relying on mechanical processes. The method used must be a method for obtaining acellular biological matrix suitable for use in surgery, particularly for soft tissue reconstruction.

[0057] According to one embodiment, the device according to the invention comprises a shell having a continuous surface. By continuous surface, within the meaning of the invention, it is meant that the surface does not have irregularities such as protrusions or perforations.

[0058] According to one embodiment, the device according to the invention comprises a base and / or a shell having a textured surface.

[0059] Advantageously, the textured surface makes it easier to assemble the shell and the base, particularly when using a bonding agent, such as a polymer.

[0060] By assembly agent, within the meaning of the invention, is meant any substance making it possible to facilitate the assembly of the shell and the base, preferably the assembly agent has properties making it possible to bond the shell and the base, even more preferably the assembly agent is a polymer.

[0061] According to one embodiment, the base is formed from a material chosen from a biological matrix or a polymer.

[0062] Preferably, when the base is formed from a polymer, this can be resorbable, non-resorbable, natural or synthetic.

[0063] According to one embodiment, the device according to the invention comprises a base made of biological matrix and a shell made of biological matrix, in which said biological matrices are of different origin or nature. According to one embodiment, the rim of the shell is formed by mechanical folding of the contour of the biological matrix towards the inner face of said matrix.

[0064] According to one embodiment, the folded edge of the shell has a substantially planar shape and the shell and the base are assembled to each other by bringing a substantially planar area of ​​the base into contact with the folded edge, the folded edge being connected to said substantially planar area.

[0065] Preferably, the base and the shell are assembled by gluing and / or suturing one to the other by bringing a substantially flat area of ​​said base into contact with the folded edge of said shell.

[0066] Advantageously, the assembly on the folded edge of the shell allows the device to benefit from shape memory. Indeed, the peripheral suture or gluing makes it possible to add a structuring element to the device allowing said device to be malleable, and therefore to present an easier insertion during implantation in humans. Thus, once implanted, the ring formed by the gluing or suture at the junction of the shell and the base unfolds and the device returns to its original shape.

[0067] Advantageously, when the base and the shell are assembled by suture, the sutures are present on the underside of the device.

[0068] Preferably, the device according to the invention does not include a suture.

[0069] According to a preferred embodiment, one of the rim and the base comprises a groove and the other of the rim and the base comprises an element complementary to said groove, the shell and the base being assembled to each other by fitting the complementary element into the groove, said complementary element being connected to said groove.

[0070] Advantageously, the shell and the base are configured to fit into each other, thus making it possible to form a complete device that does not require a step of adapting said device before implantation, in particular during the operating time.

[0071] According to one embodiment, one of the rim and the base comprises a groove and the other of the rim and the base comprises an element complementary to said groove, said complementary element being continuous or discontinuous.

[0072] Advantageously, the groove is specifically shaped to accommodate the complementary element. Thus, when the groove and the complementary element are fitted together, they form a solid and stable connection. This complementarity not only provides a secure connection between the base and the hull, but also ease of assembly.

[0073] According to one embodiment, the base comprises a groove, one of the walls of which defines a peripheral contour of the base, and in that the rim comprises a complementary groove, one of the walls of which defines a peripheral contour of the rim, in that the shell and the base are assembled to each other by inserting said wall of each of the grooves into the other groove, said grooves together defining a channel comprising at least one assembly agent connecting the shell to the base.

[0074] When the device according to the invention comprises a channel formed by the assembly of the shell and the base, said grooves may have at least one cut and / or one perforation and / or one slot.

[0075] Advantageously, said cuts, perforations and slots make it possible to maximize the adhesion of the shell and the base, in particular by allowing the diffusion of at least one assembly agent on the walls of the grooves.

[0076] Preferably, at least one assembly agent is a polymer which can be chosen from poly(glycolides), poly(lactide-co-glycolides); poly(lactic acid), poly(glycolic acid), poly(lactic acid- co-glycolic acids), polycaprolactones, poly(orthoesters), polyyanhydrides, poly(phosphazenes), polyhydroxyalkanoates, polyesters, poly(lactide-co-caprolactones), polycarbonates, tyrosine polycarbonates, polyamides, polyesteramides, poly(dioxanones), polyfalkylene alkylates), polyethers, polyvinyl pyrrolidones or PVP, polyurethanes, polyetheresters, polyacetals, polycyanoacrylates, poly(oxyethylene) / poly(oxypropylene) copolymers, polyacetals, polyketals, polyphosphates, polyphosphoesters, polyalkylene oxalates, polyalkylene succinates, poly(maleic acids), chitin, chitosan, and mixtures thereof, even more preferably at least one agent assembly is a polymer chosen from poly-4-hydroxybutyrate (P4HB) and poly-3-hydroxybutyrate-co-3-hydroxy valerate (PHBV).

[0077] According to one embodiment, at least one assembly agent is solubilized in a solvent.

[0078] According to one embodiment, said channel comprises at least one assembly agent connecting the shell to the base and at least one molecule promoting tissue integration.

[0079] Preferably, at least one molecule promoting tissue integration is chosen from an antibiotic, a growth factor, platelet-rich plasma, fat and their mixtures.

[0080] According to one embodiment, the device according to the invention comprises at least one filling element.

[0081] The filler element may be selected from a silicone implant, acellular matrix fragments, an autograft, in particular an autograft of adipose tissue, and mixtures thereof.

[0082] According to one embodiment, the device according to the invention comprises a silicone implant and fragments of acellular matrices. Advantageously, the combination of a silicone implant and fragments of acellular matrices makes it possible to optimize the filling of the receptacle formed by the combination of the base and the shell.

[0083] According to one embodiment, the base and / or the shell is provided with at least one opening capable of allowing the introduction of a filling element into said receptacle.

[0084] When the filling element is a silicone implant, the device according to the invention preferably comprises a base having an opening capable of allowing the introduction of said filling element into the receptacle formed by the assembly of the base and the shell.

[0085] Said opening of the base may take any shape and size suitable to allow the introduction and maintenance of a silicone implant in said receptacle.

[0086] When the filling element is a tissue autograft and / or fragments of acellular matrices, the device according to the invention may comprise a base and / or a shell having an opening capable of allowing the introduction of an autograft and / or fragments of acellular matrices into the receptacle formed by the assembly of the base and the shell.

[0087] Said opening of the shell can take any shape and size suitable for allowing the introduction and maintenance of an autograft of adipose tissue and / or fragment of acellular matrix in said receptacle.

[0088] According to another embodiment, the shell and / or the base comprising at least a plurality of cuts and / or perforations and / or slots distributed over the surface of said shell and / or base so as to allow elastic deformation of said shell and / or base during insertion of the filling element. For example, it may be provided that said plurality of cuts and / or perforations and / or slots form a mesh over all or part of the surface of the base and / or the shell.

[0089] Advantageously, the cuts and / or perforations and / or slits make it possible on the one hand to facilitate the correspondence between the filling element when the latter is a silicone implant and the device according to the invention, but also make it possible to minimize the quantity of materials to be implanted, thus reducing the risks of post-operative complications.

[0090] According to another aspect, the invention relates to a method of manufacturing a medical device according to any of the previously cited embodiments.

[0091] According to one embodiment, the device according to the invention comprises a base and a shell not comprising an opening. Advantageously, in this embodiment, at least one filling element chosen from an autograft and / or fragments of acellular matrices can be introduced using a syringe through said base and / or said shell.

[0092] Thus, the invention also relates to a method of manufacturing a medical device according to the invention comprising the implementation of the following steps:

[0093] (1) Preparation of a shell having a rim formed on all or part of its periphery;

[0094] (2) Preparation of a base having a surface area less than the surface area defined by said outer contour of the hull;

[0095] (3) Assembling the shell of step (1) and the base of step (2) to form a receptacle for receiving a filling element.

[0096] According to one embodiment, step (1) of preparing a shell comprises the implementation of the following steps:

[0097] (la) Conforming a biological matrix using a mold;

[0098] (lb) Formation of a rim on all or part of the periphery of the biological matrix resulting from step (la) by folding said biological matrix towards the inside of said mold; (le) Drying of the biological matrix resulting from step (lb) on said mold, so as to form a shell.

[0099] According to a preferred embodiment, the shaping step (la) is carried out on a biological matrix having a humidity level of at least 0.1%.

[0100] Advantageously, a humidity level of at least 0.1% makes it easier to place the biological matrix on the mold.

[0101] Preferably, step (la) is carried out on a mold having the shape of a dome. Preferably, the mold of step (la) has a round or anatomical shape of a breast.

[0102] According to one embodiment, the conforming step (la) is carried out on an acellular biological matrix.

[0103] Preferably, the drying step (the) is carried out by steaming or freeze-drying.

[0104] According to the embodiment, step (1) of preparing the shell also comprises a step (ld), carried out after step (la), comprising the compression of the shell resulting from step (le) on said mold.

[0105] According to one embodiment, step (1) of preparing the shell also comprises a step of compressing the biological matrix on said mold.

[0106] According to one embodiment, the rim formed at the end of step (lb) is mechanically maintained during steps (le) and (ld).

[0107] According to one embodiment, the rim formed at the end of step (lb) comprises a groove. The drying step (le) can be carried out by any technique known and adapted to the drying of acellular biological matrix of a person skilled in the art.

[0108] According to one embodiment, step (1) comprises a step of cutting the shell so as to form at least one opening.

[0109] Advantageously, at least one opening makes it possible to introduce a filling element into the receptacle through the shell and therefore into the device according to the invention. Preferably, the opening located on the shell makes it possible to introduce a filling element comprising an autograft of adipose tissue and / or fragments of acellular matrix.

[0110] According to one embodiment, step (1) comprises a step of cutting the shell so as to form a mesh over all or part of the surface of the shell.

[0111] According to one embodiment, step (1) comprises a step of cutting the shell so as to form cuts and / or perforations and / or slots on the rim, preferably on the groove formed at the end of step (lb).

[0112] According to one embodiment, step (2) of preparing a base comprises a step (2a) of shaping a biocompatible material so that the surface area of ​​the base is less than the surface area defined by said external contour of the shell resulting from step (1).

[0113] According to a preferred embodiment, the biocompatible material of step (2a) is chosen from a biological matrix or a polymer.

[0114] Preferably, the biocompatible material of step (2a) is chosen from an acellular biological matrix and / or a resorbable polymer.

[0115] According to one embodiment, step (2) comprises a step (2b) of cutting said material so as to form at least one opening.

[0116] Advantageously, the opening allows a preformed silicone implant to pass through the base and therefore into the device according to the invention.

[0117] According to one embodiment, step (2) of preparing a base also comprises a step (2c) of forming a rim on all or part of the periphery of the material resulting from step (2a) or (2b).

[0118] According to one embodiment, the rim formed at the end of step (2c) comprises a groove.

[0119] According to one embodiment, step (2) also comprises a step (2d) of cutting the base so as to form cuts and / or perforations and / or slots on the rim, preferably on the groove formed at the end of step (2c).

[0120] Advantageously, the presence of cuts and / or perforations and / or slots on the groove of the base formed at the end of step (2c) and / or on the groove of the shell formed at the end of step (lb) makes it possible to facilitate the assembly provided for in step 3, in particular when this is carried out by gluing.

[0121] According to one embodiment, the assembly step (3) consists of bringing the shell from step (1) and the base from step (2) into contact by bringing a substantially flat area of ​​the base into contact with the folded edge of the shell, the folded edge of the shell being connected to said substantially flat area of ​​the base.

[0122] According to a preferred embodiment, the assembly step (3) consists of fitting a groove present on one of the rims of the shell and the base with a complementary element present on the other of the rims of the shell and the base.

[0123] According to one embodiment, step (3) is carried out by suturing and / or gluing.

[0124] When step (3) is performed by suturing, the sutures can be performed with any sutures used in surgery, absorbable or not.

[0125] When step (3) is carried out by gluing, step (3) may comprise a step (3a) comprising a surface treatment of the shell resulting from step (1) and of the base resulting from step (2) so that the surface of said shell and of said base have a textured surface.

[0126] Preferably, the surface treatment of step (3a) is carried out by any means known to those skilled in the art, in particular sanding, milling and chemical abrasion.

[0127] According to a preferred embodiment, the assembly step (3) consists of adding at least one assembly agent in a groove one of the walls of which defines a peripheral contour of the base and / or in a complementary groove one of the walls of which defines a peripheral contour of the rim, and assembling the shell and the base to each other by inserting said wall of each of the grooves into the other groove, said grooves together defining a channel comprising said assembly agent connecting the shell to the base.

[0128] Advantageously, the assembly agent present in said channel is trapped in this space.

[0129] According to one embodiment, the assembly step (3) may comprise the addition of at least one assembly agent and at least one molecule promoting tissue integration in a groove, one of the walls of which defines a peripheral contour of the base and / or in a complementary groove, one of the walls of which defines a peripheral contour of the rim, and assembling the shell and the base to each other by inserting said wall of each of the grooves into the other groove, said grooves together defining a channel comprising at least one assembly agent and at least one molecule promoting tissue integration connecting the shell to the base. Preferably, at least one molecule promoting tissue integration is chosen from an antibiotic, a growth factor, platelet-rich plasma, fat and mixtures thereof.

[0130] According to one embodiment, step (3) is carried out by gluing, the gluing being carried out using at least one assembly agent, preferably using an assembly agent dissolved in a solvent.

[0131] According to one embodiment, when step (3) is carried out by sizing, the sizing can be carried out using at least one assembly agent chosen from poly(glycolides), poly(lactide-co-glycolides);poly(lactic acid), poly(glycolic acid), poly(lactic acid-co-glycolic acids), polycaprolactones, poly(orthoesters), po- lyanhydrides, poly(phosphazenes), polyhydroxyalkanoates (incluant notamment P4HB et poly-3- hydroxybutyrate-co-3- hydroxy valerate (PHBV)), polyesters, poly(lactide-co-caprolactones), polycarbonates, tyrosine polycarbonates, polyamides, polyesteramides, poly(dioxanones), polyfal- kylene alkylates), polyethers, polyvinyl pyrrolidones ou PVP, polyurethanes, polyetheresters, polyacetals, polycyanoacrylates, poly(oxyethylene) / poly(oxypropylene) copolymers, polyacetals, polyketals, polyphosphates, polyphosphoesters, polyalkylene oxalates, polyalkylene succinates, poly(maleic acids), chitin, chitosan, et leurs mélanges, préférentiellement au moins un agent d'assemblage est un polymère choisi parmi le poly-4-hydroxybutyrate (P4HB) et le poly-3- hydroxybutyrate-co-3- hydroxy valerate (PHBV).;

[0132] According to a particular embodiment of the invention, the method according to the invention comprises a step (X), comprising the introduction of a filling element within the shell.

[0133] Preferably, step (X) is carried out after step (3) by introducing at least one filling element into the shell through at least one opening in the base or the shell.

[0134] According to a variant, step (X) is carried out before step (3) by introducing at least one filling element within the shell before assembling the shell with the base.

[0135] According to another variant, step (X) is carried out by introducing at least one filling element chosen from an autograft of adipose tissue and / or fragments of acetic acid matrices into the device according to the invention using a syringe through the base and / or the shell.

[0136] Of course, the various features, variants and embodiments of the invention may be combined with each other in various combinations to the extent that they are not incompatible or mutually exclusive.

[0137] In addition, various other characteristics of the invention emerge from the appended description given with reference to the figures which illustrate non-limiting forms of embodiment of the invention. Brief description of the figures

[0138] [Fig. 1] schematically and partially represents a shell 2 according to an embodiment of the invention.

[0139] [Fig 2] schematically and partially represents a base 3 according to an embodiment of the invention.

[0140] [Fig 3] represents, schematically and partially, a device 1 according to an embodiment of the invention.

[0141] [Fig 4] schematically and partially represents a device 1 according to an embodiment of the invention comprising a filling element 5 such as a silicone implant.

[0142] [Fig 5] is a photograph, seen from above, of a hull 2 ​​according to one embodiment of the invention.

[0143] [Fig 6] is a photograph, seen from below, of a hull 2 ​​according to one embodiment of the invention.

[0144] [Fig 7] is a photograph, seen from above, of a base 3 according to one embodiment of the invention.

[0145] [Fig 8] is a photograph, of a vertical sectional plane, of a device 1 according to an embodiment of the invention.

[0146] [Fig 9] represents, schematically and partially, a device 1 according to an embodiment of the invention.

[0147] [Fig 10] schematically and partially represents a device 1 according to an embodiment of the invention comprising a filling element 5 such as fragments of acellular matrices and an autograft of adipose tissue.

[0148] [Fig 11] is a photograph, seen from above, of a device 1 according to one embodiment of the invention.

[0149] It should be noted that in this figure the structural and / or functional elements common to the different variants may have the same references.

[0150] Of course, various other modifications may be made to the invention within the scope of the appended claims.

[0151] Detailed description of the invention

[0152] Medical device

[0153] The invention aims to provide a complete medical device 1 that can be used directly in the operating room and is intended to receive a filling element 5. Thus, the inventors have succeeded in providing a medical device 1 that does not require a step of conformation and / or adaptation to the operating room. Consequently, no manipulation intended for conformation such as suturing, gluing or welding is necessary for the surgeon. The device 1 according to the invention only requires the introduction of a filling element inside it.

[0154] For these purposes, the invention designated by the reference 1 as a whole and illustrated in one embodiment in [Fig 3] relates to a medical device 1 intended to receive a filling element 5, comprising a base 2 and a shell 3 assembled to each other to form a receptacle 4 for said filling element 5.

[0155] The device 1 illustrated in one embodiment in [Fig 3] is obtained by a method comprising the implementation of the following steps:

[0156] (1) Preparation of a shell 3 having a rim formed on all or part of its periphery;

[0157] (2) Preparation of a base 2 having a surface area less than the surface area defined by said outer contour of the shell 3; and

[0158] (3) Assembly of the shell 3 of step (1) and the base 2 of step (2) to form a receptacle 4 intended to receive a filling element 5.

[0159] Thus, in the shell preparation of step (1), an acellular biological matrix is ​​shaped on a mold having a dome shape.

[0160] The shape of the shell 3, in particular in the form of a hollow dome, makes it possible to create a space for housing a filling element 5 such as a silicone implant within the device 1 according to the invention. According to other embodiments not illustrated, the shell 3 can take a round or anatomical shape of a breast.

[0161] In a second step, the periphery of the acellular biological matrix is ​​folded and held towards the inside of the mold so as to form a rim around the entire periphery of said matrix.

[0162] More particularly, according to the embodiment illustrated in figures [Fig 1] and [Fig 6], the rim 6 comprises a groove formed by the folding of the rim 6. According to other embodiments not illustrated, the rim 6 can take different shapes, in particular any shape allowing it to fit in a complementary manner with the base 2 or allowing a substantially flat area of ​​the base 2 to come into contact with a substantially flat area of ​​the rim 6 of the shell 3.

[0163] Finally, the acellular biological matrix is ​​dried on the mold to fix its shape, thus forming the shell 3.

[0164] According to the embodiments illustrated in [Fig 1], [Fig 3], [Fig 4] and [Fig 5] the shell 3 does not comprise an opening 10. Alternatively, according to the embodiment described in [Fig 10], the shell 3 comprises an opening 10 formed by cutting the acellular biological matrix allowing the introduction of a filling element 5 such as fragments of acellular matrices and an autograft of adipose tissue through the shell 3 and consequently within the device 1 according to the invention.

[0165] The preparation of base 2 is carried out by conforming an acellular biological matrix so that the surface area of ​​base 2 is less than the surface area defined by the exterior contour of shell 3 already formed.

[0166] The base 2 as illustrated in figures, [Fig 2], [Fig 3], [Fig 4] and [Fig 7] has a substantially flat and substantially circular disc shape comprising a groove.

[0167] According to the embodiment illustrated in [Fig 7], the base 2 does not include an opening 8.

[0168] Alternatively, according to the embodiment described in [Fig 4], the base 2 comprises an opening 8 formed by cutting the acellular biological matrix allowing a filling element 5 such as a silicone implant to be introduced through the base 2 and consequently within the device 1 according to the invention.

[0169] According to the embodiment described in [Fig 11], the shell 3 has cuts and slots in the form of a mesh, thus facilitating the introduction and placement of a filling element 5 within the device 1 according to the invention.

[0170] According to other embodiments not illustrated, the base 2 and the shell 3 have cuts and / or perforations and / or slots so as to facilitate the introduction and placement of a filling element within the device 1 according to the invention.

[0171] Finally, the base 2 and the shell 3 are assembled so as to form a receptacle 4 intended to receive a filling element 5.

[0172] The combination of the base 2 and the shell 3 as illustrated in embodiments in figures [Fig 3], [Fig 4], [Fig 9] and [Fig 10] makes it possible to obtain the device 1 according to the invention comprising a shell 3 and a base 2 assembled to each other to form a receptacle 4, the shell 3 has a rim 6 formed over its entire periphery; the rim 6 of the shell 3 is folded towards the inside of the shell 3 to be connected to the base 2, and the shell 3 is delimited, at its junction with the base 2, by an external contour, the surface of the base 2 being less than the surface defined by said external contour of the shell 3.

[0173] According to the embodiment illustrated in figures [Fig 3] and [Fig 4], the shell 3 is positioned to cover an upper face of the base 2 in order to define the receptacle 4 and the rim 6 is folded from the outer contour below a lower face of the base 2 opposite the upper face of the base 2 to be connected thereto. According to the embodiment illustrated in figure [Fig 8] and [Fig 9], the rim 6 of the shell 3 is folded from the outer contour above an upper face of the base 2 opposite the lower face of the base 2 to be connected thereto.

[0174] More particularly, the device 1 according to the invention as illustrated in [Fig 3], [Fig 4], [Fig 9] and [Fig 10] has a channel 9 formed by the assembly of the base 2 and the shell 3. More particularly and as illustrated in [Fig 8], the channel 9 is formed by the assembly of a groove, one of the walls of which defines a peripheral contour of the base 2 with a complementary groove, one of the walls of which defines a peripheral contour of the rim 6, so that the shell 3 and the base 2 are assembled to each other by inserting said wall of each of the grooves into the other groove, said grooves together defining a channel 9.

[0175] According to an embodiment not illustrated, the channel 9 formed by assembling the base 2 and the shell 3 may comprise at least one assembly agent and optionally at least one molecule promoting tissue integration.

[0176] Of course, various other modifications may be made to the invention within the scope of the appended claims.

Claims

CLAIMS

1. Medical device 1 intended to receive a filling element 5, comprising a base 2 and a shell 3 assembled together to form a receptacle 4 of said filling element, characterized in that the shell 3 comprises a rim 6 formed mainly or partly from its periphery; in that the rim 6 of the shell 3 is folded towards the inside of the shell 3 to be connected to the base 2, and in that the shell 3 is delimited, at its junction with the base 2, by an external contour, the surface of the base 2 being less than the surface defined by said external contour of the shell 3.

2. Device 1 according to the preceding claim, characterized in that the base 2 has a substantially flat and substantially circular disc shape and in that the shell 3 has a hollow dome shape.

3. Device 1 according to one of the preceding claims, characterized in that the shell 3 is positioned to cover an upper face of the base 2 in order to define the receptacle 4 and in that the rim 6 is folded from the outer contour above an upper face of the base 2 opposite the lower face of the base 2 to be connected thereto.

4. Device 1 according to the preceding claim, characterized in that the shape of said shell 3 and of the rim 6 is obtained by molding a biological matrix prior to the assembly of the shell 3 and the base 2. [Claim s] Device 1 according to one of claims 3 or 4, characterized in that the folded edge 6 has a substantially flat shape and in that the shell 3 and the base 2 are assembled to each other by bringing a substantially flat area of the base 2 into contact with the folded edge 6, the folded edge 6 being connected to said substantially flat area.

6. Device 1 according to one of the preceding claims, characterized in that one of the rim 6 and the base 2 comprises a groove and in that the other of the rim 6 and the base 2 comprises an element complementary to said groove, in that the shell 3 and the base 2 are assembled to each other by fitting the complementary element into the groove, said complementary element being connected to said groove.

7. Device 1 according to the preceding claim, characterized in that the base 2 comprises a groove, one of the walls of which defines a peripheral contour of the base 2, and in that the rim 6 comprises a complementary groove, one of the walls of which defines a peripheral contour of the rim 6, in that the shell 3 and the base 2 are assembled to each other by inserting said wall of each of the grooves into the other groove, said grooves defining together a channel 9 comprising at least one assembly agent connecting the shell 3 to the base 2.

8. Device 1 according to one of the preceding claims, in which the base 2 is provided with at least one opening 8 capable of allowing the introduction of a filling element 5, preferably a silicone implant, into said receptacle 4.

9. Device 1 according to one of claims 1 to 7, in which the shell 2 is provided with at least one opening 10 capable of allowing the introduction of a filling element 5 chosen from an autograft of adipose tissue and / or fragments of acellular matrices.

10. Device 1 according to one of the preceding claims, characterized in that it comprises at least one filling element 5 chosen from a silicone implant, fragments of acellular matrices, an autograft, and their mixtures.

11. Method of manufacturing a medical device 1 according to one of the preceding claims, characterized in that it comprises the implementation of the following steps: (1) Preparation of a shell 3 having a rim 6 formed on all or part of its periphery; (2) Preparation of a base 2 having a surface area less than the surface area defined by said outer contour of the shell 3; and (3) Assembly of the shell 3 of step (1) and the base 2 of step (2) to form a receptacle 4 intended to receive a filling element 5.

12. Method according to the preceding claim, characterized in that step (1) of preparing the shell 3 comprises the implementation of the following steps: (la) Conforming a biological matrix using a mold; (lb) Formation of a rim 6 on all or part of the periphery of the biological matrix resulting from step (la) by folding said biological matrix towards the inside of said mold; (le) Drying of the biological matrix resulting from step (lb) on said mold, so as to form a shell 3.

13. Method according to the preceding claim, characterized in that the shaping step (la) is carried out on a biological matrix having a humidity level of at least 0.1%.

14. Method according to one of claims 12 to 13, characterized in that step (la) is carried out on a mold having the shape of a dome.

15. Method according to one of claims 12 to 14, characterized in that the drying step (le) is carried out by steaming or freeze-drying.

16. Method according to one of claims 12 to 15, characterized in that the step (1) preparation of the shell 3 also comprises a step of compressing the biological matrix on said mold.

17. Method according to one of claims 12 to 16, characterized in that the biological matrix is an acellular biological matrix.

18. Method according to one of claims 12 to 17, characterized in that the step (1) of preparing the shell 3 also comprises a step (ld), carried out after the step (le) of cutting said matrix so as to form at least one opening 10.

19. Method according to one of claims 12 to 18, characterized in that the step (2) preparation of the base 2 comprises a step (2a) of shaping a biocompatible material so that the surface area of the base 2 is less than the surface area defined by said external contour of the shell 3 resulting from step (1).

20. Method according to the preceding claim, characterized in that the biocompatible material is chosen from a biological matrix or a polymer.

21. Method according to one of claims 19 or 20, characterized in that step (2) of preparing the base 2 also comprises a step (2b), carried out after step (2a) of cutting said material so as to form at least one opening 8.

22. Method according to one of claims 11 to 21, characterized in that the step (3) assembly consists of bringing the shell 3 from step (1) and the base 2 from step (2) into contact by bringing a substantially flat area of the base 2 into contact with the folded edge 6 of the shell 3, the folded edge 6 of the shell 3 being connected to said substantially flat area of the base 2.

23. Method according to the preceding claim, characterized in that one of the rim 6 and the base 2 comprises a groove and in that the other of the rim 6 and the base 2 comprises an element complementary to said groove, in that the shell 3 and the base 2 are assembled to each other by interlocking of the complementary element in the groove, said complementary element being connected to said groove.

24. Method according to one of claims 11 to 23, characterized in that the assembly step (3) is carried out by suturing and / or gluing.

25. Method according to the preceding claim, characterized in that step (3) is carried out by gluing and consists of adding at least one assembly agent in a groove one of the walls of which defines a peripheral contour of the base and / or in a complementary groove one of the walls of which defines a peripheral contour of the rim, and assembling the shell and the base to each other by inserting said wall of each of the grooves into the other groove, said grooves together defining a channel comprising said assembly agent connecting the shell to the base.

26. Method according to claim 24 or 25, characterized in that step (3) is carried out by sizing using at least one assembly agent chosen from poly(glycolides), poly(lactide-co-glycolides); poly(lactic acid), polyfglycolic acid), poly(lactic acid-co-glycolic acids), polycaprolactones, poly(orthoesters), polyyanhydrides, poly(phosphazenes), polyhydroxyalkanoates (including in particular P4HB and poly-3-hydroxybutyrate-co-3-hydroxy valerate (PHBV)), polyesters, poly(lactide-co-caprolactones), polycarbonates, tyrosine polycarbonates, polyamides, polyesteramides, poly(dioxanones), polyfalkylene alkylates), polyethers, polyvinyl pyrrolidones or PVP, polyurethanes, polyetheresters, polyacetals, polycyanoacrylates, poly(oxyethylene) / poly(oxypropylene) copolymers, polyacetals, polyketals, polyphosphates, polyphosphoesters, polyalkylene oxalates, polyalkylene succinates, poly(maleic acids), chitin, chitosan, and mixtures thereof.

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