EP4355272A1 - Biological prosthesis intended for the reconstruction of the nipple-areola complex - Google Patents

Biological prosthesis intended for the reconstruction of the nipple-areola complex

Info

Publication number
EP4355272A1
EP4355272A1 EP22735379.4A EP22735379A EP4355272A1 EP 4355272 A1 EP4355272 A1 EP 4355272A1 EP 22735379 A EP22735379 A EP 22735379A EP 4355272 A1 EP4355272 A1 EP 4355272A1
Authority
EP
European Patent Office
Prior art keywords
prosthesis
biological
nipple
section
biological prosthesis
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.)
Pending
Application number
EP22735379.4A
Other languages
German (de)
French (fr)
Inventor
Laurent LANTIERI
Anthony Peres
Guillaume HOFMANSKI
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.)
Apha Biomat
Original Assignee
Apha Biomat
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 Apha Biomat filed Critical Apha Biomat
Publication of EP4355272A1 publication Critical patent/EP4355272A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/52—Mammary prostheses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/24—Collagen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
    • 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
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/52—Mammary prostheses
    • A61F2002/526—Nipples
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0008—Rounded shapes, e.g. with rounded corners elliptical or oval
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/04—Materials or treatment for tissue regeneration for mammary reconstruction

Definitions

  • the invention relates to a new biological prosthesis made from an animal nipple-areolar plaque, useful in particular in breast reconstruction after mastectomy.
  • a mastectomy is a surgical procedure that involves removing the breast in which the tumor is located in its entirety, including the areola and the nipple. It is known that approximately 1 in 8 women will develop invasive breast cancer during her lifetime. A third of these cancers require a mastectomy. Nipple-areolar plaque (PAM) reconstruction is the final step in the post-mastectomy reconstruction journey. Different methods exist to recreate the lost anatomical portion with a risk mainly associated with a loss of projection or flattening of the nipple. It is therefore necessary to associate a prosthetic material with the surgery.
  • PAM Nipple-areolar plaque
  • the surgical techniques used involve autologous skin grafts for the areola and local flaps for the nipple. It can also be proposed the creation of a tattoo for the areola.
  • the removal of an autologous graft necessarily implies the creation of a loss of substance on another anatomical portion, therefore potential complications with a non-guaranteed aesthetic result.
  • the creation of a tattoo does not restore the lost anatomical portion.
  • the reconstruction of the MAP must make it possible to better integrate the reconstructed breast into the patient's personal psychological scheme.
  • a synthetic silicone prosthetic material has recently been introduced (under the name Fixnip). Complications related to the use of silicone implants in breast implants are widely described in the literature. In addition, recent restrictions (prohibition of macro-textured implants, ASIA syndrome, etc.) plead for the use of biological materials in this type of reconstruction, as well as the use of a silicone prosthetic material in surgery of the PAM does not appear to be consistent. In addition, placing subcutaneous implants presents a risk of ulceration with exposure of the implant.
  • the objective of the invention is to meet this need by proposing a biological prosthesis overcoming the problems of the prior art.
  • the present invention proposes using an areola-nipple plaque taken from an animal.
  • Animal skin in particular porcine skin, has already been used for several years for the manufacture of biological prostheses in wall surgery and breast reconstruction.
  • animal dermis for the manufacture of prostheses in the case of the reconstruction of the PAM would require many manipulations and assemblies of parts of dermis to obtain the desired shape, which seems difficult to achieve both from a technical point of view and from an economic point of view.
  • the present invention relates to a biological prosthesis made from a very specific part of the animal, adapted to the shape of a human PAM, which avoids these problems.
  • the invention relates to a biological prosthesis constituted in whole or in part by an areola-nipple plate belonging to the family of pigs, cattle or goats, said areola-nipple plate having been treated to allow use in the being human, preferably at least by acellularization and/or deantigenization and/or viral inactivation.
  • the prosthesis according to the invention therefore comprises a flat or substantially flat section, and a protruding section preferably disposed substantially at the center of said flat section.
  • such a prosthesis has a shape quite suitable for the reconstruction of the PAM in a woman since it is obtained from the anatomical section (PAM) in the animal, and this without having to manipulate and assemble different parts of the dermis. It is simple to manufacture, and being a biological prosthesis, it replaces the autologous grafts usually used in this type of surgical intervention.
  • FIG. 1 represents a diagram of the prosthesis according to the invention.
  • FIG. 2 represents a diagram of the removal of the part of the animal to manufacture the prosthesis according to the invention.
  • FIG. 3 represents a photograph of a prosthesis according to the invention.
  • acellularization within the meaning of the invention is meant the elimination of cellular elements. So that the prosthesis can be implanted in a recipient, the tissues taken from the donor animal are decellularized so as to reduce their immunogenicity. This process involves the elimination of cells from the donor animal while preserving the biological and mechanical qualities of the extracellular matrix.
  • deantigenization within the meaning of the invention is meant the elimination of proteins present in the tissue of the donor animal which could not be recognized by the recipient of the prosthesis. thus causing rejection of the implant.
  • the donor animal may express enzymes or proteins in the tissue which are not expressed by the recipient. It is therefore important to eliminate these elements, such as in particular the galactose epitope alpha-1,3 galactose (alpha-gai) present in the porcine species, in order to reduce the immune response after implantation in humans.
  • protuberance or “protruding section” within the meaning of the invention is meant a bump-shaped projection. This protuberance corresponds to the general shape of a nipple.
  • prosthesis within the meaning of the invention is meant a medical device used in surgery.
  • biological prosthesis or “bioprosthesis” within the meaning of the invention, a prosthesis obtained from an animal tissue.
  • the invention therefore relates to a biological prosthesis 10 as represented in FIG. 1.
  • the biological prosthesis according to the invention is a biological prosthesis 10 constituted in whole or in part by an areola-nipple plate 14 of an animal belonging to the family of pigs, cattle or goats, said areola-nipple plate having been treated so as to allow use in humans, preferably by acellularization and/or deantigenization and/or viral inactivation.
  • the biological prosthesis according to the invention is therefore a biological tissue corresponding to an areola-nipple plaque 14 taken from an animal belonging to the family of pigs, cattle or goats, then treated, preferably at least by acellularization and/or deantigenization and/or viral inactivation.
  • the biological prosthesis 10 comprises a flat or substantially flat section 18 (it is not necessarily perfectly flat due to the natural material used), and a protruding section 16 preferably disposed at the center or substantially at the center of said section 18.
  • Section 18 corresponds to the areola and section 16 to the nipple.
  • Section 18 is preferably circular or oval or substantially circular or substantially oval in shape.
  • the thickness e of the section 18 is between 0.5 and 4 mm, more preferably between 0.5 and 2 mm.
  • the thickness e for the same prosthesis can vary and a prosthesis can have different thicknesses or else substantially the same thickness, said thicknesses being preferably between 0.5 and 4 mm, preferably between 0.5 and 2 mm.
  • the thickness 12 varies according to the desired mechanical strength, because the greater the thickness, the less flexible the material. To obtain such a thickness, it may be necessary to split the dermis in the thickness, to the desired size, using sharp means such as a knife for example.
  • the protruding section 16 has a height h preferably between 0.5 and 20 mm, preferably between 7 and 10 mm.
  • the mean diameter D of section 18 is preferably between 10 and 60 mm, even more preferably between 15 and 50 mm. Section 18 may have a larger diameter at the time of sampling and be recut according to the desired final average diameter D.
  • the mean diameter d of section 16 is preferably between 5 and 20mm, preferably between 5 and 15mm.
  • the removal of the biological prosthesis according to the invention before treatment is carried out on a part of an animal belonging to the family of pigs, cattle or goats (preferably a check mark) corresponding to the ventral part of the animal comprising several nipple-areolar sections of the animal.
  • the sample is preferably taken from the ventral part (abdomen and/or thorax) of one or more zones 14, each zone 14 corresponding to an areola-nipple plaque.
  • Animal dermis, and in particular porcine dermis is particularly suitable because its mechanical strength allows it to be used in surgery. Furthermore, the composition of the extracellular matrix, particularly collagen, of the porcine dermis is similar to that of human beings.
  • the dermis is treated, in particular by acellularization and deantigenization.
  • This treatment makes it possible to eliminate in particular the cellular elements and the alpha-gai epitope which can cause an increased immune reaction and acute rejection of the implant of animal origin.
  • the mechanical strength of the biological prosthesis 10 according to the invention preferably responds to the following parameters (measured according to the methods described in the US Pharmacopeia Scaffold Bovine Dermis):
  • the biological prosthesis 10 according to the invention can be dried. Preferably, it is freeze-dried because this drying technique is particularly suitable for preservation of collagen which is a very temperature sensitive protein. For its use, the prosthesis must be rehydrated by any method known for this purpose.
  • the biological prosthesis according to the invention can be manufactured by any suitable method.
  • the sample is taken from a dead animal, just after it has been slaughtered, directly in the slaughterhouse.
  • the separation of the dermis from the rest of the integument is carried out using any sharp means, such as a knife for example, preferably directly after sampling in the slaughterhouse.
  • the dermis is split using any sharp means, such as a knife for example or a splitter. This step must be carried out with precision so as to preferably obtain a substantially uniform thickness over the whole of the prosthesis.
  • the method may include a freeze-drying step.
  • the biological prosthesis according to the invention is preferably packaged in sterile packaging.
  • the biological prosthesis retains the qualities of the extracellular matrix from which it is extracted and promotes tissue integration, thus avoiding the erosion of adjacent tissues.
  • the prosthesis according to the invention must not be removed, unlike synthetic prostheses. Indeed its biological nature will at worst lead to a simple resorption
  • the prosthesis is used according to any suitable technique. According to one embodiment, it is used by a method comprising the implementation of the following steps:
  • the invention is now illustrated by a specific example of sampling and obtaining and examples of biological prostheses according to the invention, obtained according to this method.
  • Example of a process for manufacturing a prosthesis according to the invention All the PAMs of a notch are taken after slaughter and before any other processing process.
  • the dermis of the MAP is then separated with a knife from the other subcutaneous anatomical elements of the MAP so as to preserve the cutaneous sheath as much as possible.
  • the dermis can be split using a knife or other sharp tools over the entire lower surface and in a uniform manner without cutting into the nipple.
  • the prosthesis thus obtained is then treated by various chemical treatments in order to eliminate the cellular elements and other molecules specific to the organism of the donor.
  • the prosthesis is then freeze-dried for optimal conservation but can also be preserved by impregnation with an appropriate chemical solution.
  • a final cut is made to obtain the desired final dimensions.
  • the implants are then sterilized by conventional techniques (ETO, radiation, supercritical C02, peracetic acid).
  • the PAM was taken from a sow aged 5 to 9 months and then treated according to the method described above.
  • Example 2
  • the PAM was taken from a sow aged 20 months and then treated according to the method described above.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Botany (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Zoology (AREA)
  • Biophysics (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Cosmetics (AREA)

Abstract

The invention relates to a biological prosthesis (10) consisting of a nipple-areola complex belonging to the family of pigs, cattle or goats, said nipple-areola complex having been treated for use in humans.

Description

PROTHESE BIOLOGIQUE DESTINEE A LA RECONSTRUCTION DE LA PLAQUE AREOLO-BIOLOGICAL PROSTHESIS INTENDED FOR THE RECONSTRUCTION OF THE AREOLO PLATE
MAMELONNAIRE NIPPLE
Domaine technique Technical area
L'invention se rapporte à une nouvelle prothèse biologique fabriquée à partir d'une plaque aréolo- mamelonnaire animale, utile en particulier dans la reconstruction mammaire après mastectomie. The invention relates to a new biological prosthesis made from an animal nipple-areolar plaque, useful in particular in breast reconstruction after mastectomy.
Etat de la technique State of the art
Une mastectomie est une intervention chirurgicale qui consiste à enlever le sein dans lequel se situe la tumeur dans son intégralité, y compris l'aréole et le mamelon. On sait qu'approximativement 1 femme sur 8 développera un cancer du sein invasif au cours de sa vie. Un tiers de ces cancers né cessitent une mastectomie. La reconstruction de la plaque aréolo-mamelonnaire (PAM) est l'étape finale dans le parcours de reconstruction post-mastectomie. Différentes méthodes existent pour recréer la portion anatomique perdue avec un risque majoritairement associé à une perte de pro jection où aplatissement du mamelon. Il est donc nécessaire d'associer un matériel prothétique à la chirurgie. A mastectomy is a surgical procedure that involves removing the breast in which the tumor is located in its entirety, including the areola and the nipple. It is known that approximately 1 in 8 women will develop invasive breast cancer during her lifetime. A third of these cancers require a mastectomy. Nipple-areolar plaque (PAM) reconstruction is the final step in the post-mastectomy reconstruction journey. Different methods exist to recreate the lost anatomical portion with a risk mainly associated with a loss of projection or flattening of the nipple. It is therefore necessary to associate a prosthetic material with the surgery.
Actuellement, les techniques chirurgicales utilisées impliquent des greffes de peau autologues pour l'aréole et des lambeaux locaux pour le mamelon. Il peut également être proposé la création d'un tatouage pour l'aréole. Le prélèvement d'un greffon autologue implique obligatoirement la création d'une perte de substance sur une autre portion anatomique donc de potentiels complications avec un résultat esthétique non-garantie. La création d'un tatouage ne permet pas de restaurer la portion anatomique perdue. Or, la reconstruction de la PAM doit permettre de mieux intégrer le sein re construit dans le schéma psychologique personnel de la patiente. Currently, the surgical techniques used involve autologous skin grafts for the areola and local flaps for the nipple. It can also be proposed the creation of a tattoo for the areola. The removal of an autologous graft necessarily implies the creation of a loss of substance on another anatomical portion, therefore potential complications with a non-guaranteed aesthetic result. The creation of a tattoo does not restore the lost anatomical portion. However, the reconstruction of the MAP must make it possible to better integrate the reconstructed breast into the patient's personal psychological scheme.
Un matériel prothétique synthétique en silicone a récemment été mis sur le marché (sous le nom de Fixnip). Les complications liées à l'utilisation d'implants en silicone dans les implants mammaires sont largement décrites dans la littérature. De plus, les récentes restrictions (interdiction des im plants macro-texturés, syndrome ASIA, ...) plaident pour l'utilisation de matériaux biologiques dans ce type de reconstructions si bien que l'utilisation d'un matériau prothétique en silicone en chirurgie de la PAM n'apparait pas cohérent. De plus la pose d'implants en sous cutané présente un risque d'ulcération avec exposition de l'implant. A synthetic silicone prosthetic material has recently been introduced (under the name Fixnip). Complications related to the use of silicone implants in breast implants are widely described in the literature. In addition, recent restrictions (prohibition of macro-textured implants, ASIA syndrome, etc.) plead for the use of biological materials in this type of reconstruction, as well as the use of a silicone prosthetic material in surgery of the PAM does not appear to be consistent. In addition, placing subcutaneous implants presents a risk of ulceration with exposure of the implant.
Il existe par conséquent un besoin pour prothèse adaptée à la reconstruction de la PAM, constituée en un matériau naturel, et simple de fabrication et d'utilisation. There is therefore a need for a prosthesis adapted to the reconstruction of the PAM, made of a natural material, and simple to manufacture and use.
L'objectif de l'invention est de répondre à ce besoin en proposant une prothèse biologique palliant les problématiques de l'art antérieur. The objective of the invention is to meet this need by proposing a biological prosthesis overcoming the problems of the prior art.
Résumé de l'invention Summary of the invention
A cet effet, la présente invention propose d'utiliser une plaque aréolo-mamelonnaire prélevée sur un animal. La peau animale, en particulier la peau de porcins, est déjà utilisée depuis plusieurs années pour la fabrication de prothèses biologiques en chirurgie de la paroi et de reconstruction mammaire. Néan moins, l'utilisation du derme animal pour la fabrication de prothèse dans le cas de la reconstruction de la PAM nécessiterait de nombreuses manipulations et assemblages de parties de dermes pour obtenir la forme désirée, ce qui semble difficilement réalisable à la fois d'un point de vue technique et d'un point de vue économique. To this end, the present invention proposes using an areola-nipple plaque taken from an animal. Animal skin, in particular porcine skin, has already been used for several years for the manufacture of biological prostheses in wall surgery and breast reconstruction. Nevertheless, the use of animal dermis for the manufacture of prostheses in the case of the reconstruction of the PAM would require many manipulations and assemblies of parts of dermis to obtain the desired shape, which seems difficult to achieve both from a technical point of view and from an economic point of view.
La présente invention vise une prothèse biologique fabriquée à partir d'une partie très particulière de l'animal, adaptée à la forme d'une PAM humaine, ce qui évite ces problématiques. The present invention relates to a biological prosthesis made from a very specific part of the animal, adapted to the shape of a human PAM, which avoids these problems.
En effet, l'invention vise une prothèse biologique constituée en tout ou partie par une plaque aréolo-mamelonnaire appartenant à la famille des porcins, des bovins ou des caprins, ladite plaque aréolo-mamelonnaire ayant été traitée pour permettre une utilisation chez l'être humain, préféren tiellement au moins par acellularisation et/ou déantigénisation et/ou inactivation virale. Indeed, the invention relates to a biological prosthesis constituted in whole or in part by an areola-nipple plate belonging to the family of pigs, cattle or goats, said areola-nipple plate having been treated to allow use in the being human, preferably at least by acellularization and/or deantigenization and/or viral inactivation.
La prothèse selon l'invention comprend donc une section plane ou sensiblement plane, et une sec tion protubérante disposée préférentiellement sensiblement au centre de ladite section plane.The prosthesis according to the invention therefore comprises a flat or substantially flat section, and a protruding section preferably disposed substantially at the center of said flat section.
Avantageusement, une telle prothèse possède une forme tout à fait adaptée à la reconstruction de la PAM chez une femme puisqu'elle est obtenue à partir de la section anatomique (PAM) chez l'ani mal, et ce sans avoir à manipuler et assembler différentes parties du derme. Elle est simple de fa brication, et s'agissant d'une prothèse biologique, elle se substitue aux greffons autologues usuel lement utilisés dans ce type d'interventions chirurgicales. Advantageously, such a prosthesis has a shape quite suitable for the reconstruction of the PAM in a woman since it is obtained from the anatomical section (PAM) in the animal, and this without having to manipulate and assemble different parts of the dermis. It is simple to manufacture, and being a biological prosthesis, it replaces the autologous grafts usually used in this type of surgical intervention.
D'autres caractéristiques et avantages ressortiront de la description en détail de l'invention qui va suivre. Other characteristics and advantages will emerge from the detailed description of the invention which follows.
Brève description des Figures Brief Description of Figures
[Fig. 1] : la figure 1 représente un schéma de la prothèse selon l'invention. [Fig. 1]: FIG. 1 represents a diagram of the prosthesis according to the invention.
[Fig. 2] : la figure 2 représente un schéma du prélèvement de la partie de l'animal pour fabriquer la prothèse selon l'invention. [Fig. 2]: FIG. 2 represents a diagram of the removal of the part of the animal to manufacture the prosthesis according to the invention.
[Fig. B] : la figure 3 représente une photographie d'une prothèse selon l'invention. [Fig. B]: FIG. 3 represents a photograph of a prosthesis according to the invention.
Description détaillée de l'invention Définitions Detailed description of the invention Definitions
Par « acellularisation » au sens de l'invention on entend l'élimination des éléments cellulaires. Pour que la prothèse puisse être implantée chez un receveur, les tissus prélevés sur l'animal donneur sont décellularisés de façon à diminuer leurs immunogénécités. Ce procédé implique l'élimination des cellules de l'animal donneur tout en conservant les qualités biologiques et mécaniques de la matrice extracellulaire. By “acellularization” within the meaning of the invention is meant the elimination of cellular elements. So that the prosthesis can be implanted in a recipient, the tissues taken from the donor animal are decellularized so as to reduce their immunogenicity. This process involves the elimination of cells from the donor animal while preserving the biological and mechanical qualities of the extracellular matrix.
Par « déantigénisation » au sens de l'invention on entend l'élimination de protéines présentes dans le tissu de l'animal donneur qui pourraient ne pas être reconnues par le receveur de la prothèse provoquant ainsi le rejet de l'implant. En effet, l'animal donneur peut exprimer des enzymes ou protéines dans le tissu qui ne sont pas exprimées par le receveur. Il est par conséquent important d'éliminer ces éléments, comme notamment l'épitope galactose alpha-1,3 galactose (alpha-gai) pré sent chez l'espèce porcine, afin de diminuer la réponse immunitaire après implantation chez l'homme. By "deantigenization" within the meaning of the invention is meant the elimination of proteins present in the tissue of the donor animal which could not be recognized by the recipient of the prosthesis. thus causing rejection of the implant. Indeed, the donor animal may express enzymes or proteins in the tissue which are not expressed by the recipient. It is therefore important to eliminate these elements, such as in particular the galactose epitope alpha-1,3 galactose (alpha-gai) present in the porcine species, in order to reduce the immune response after implantation in humans.
Par « protubérance » ou « section protubérante » au sens de l'invention on entend une saille en forme de bosse. Cette protubérance correspond à la forme générale d'un mamelon. By “protuberance” or “protruding section” within the meaning of the invention is meant a bump-shaped projection. This protuberance corresponds to the general shape of a nipple.
Par « prothèse » au sens de l'invention on entend un dispositif médical utilisé en chirurgie. By “prosthesis” within the meaning of the invention is meant a medical device used in surgery.
Par « prothèse biologique » ou « bioprothèse » au sens de l'invention une prothèse obtenue à partir d'un tissu animal. By “biological prosthesis” or “bioprosthesis” within the meaning of the invention, a prosthesis obtained from an animal tissue.
Dispositif médical selon l'invention Medical device according to the invention
Selon un premier aspect, l'invention vise donc une prothèse biologique 10 telle que représentée sur la figure 1. According to a first aspect, the invention therefore relates to a biological prosthesis 10 as represented in FIG. 1.
La prothèse biologique selon l'invention est une prothèse biologique 10 constituée en tout ou partie par une plaque aréolo-mamelonnaire 14 d'un animal appartenant à la famille des porcins, des bo vins ou des caprins, ladite plaque aréolo-mamelonnaire ayant été traitée de façon à permettre une utilisation chez l'être humain, préférentiellement par acellularisation et/ou déantigénisation et/ou inactivation virale. La prothèse biologique selon l'invention est donc un tissu biologique correspon dant à une plaque aréolo-mamelonnaire 14 prélevé chez un animal appartenant à la famille des porcins, des bovins ou des caprins, puis traité, préférentiellement au moins par acellularisation et/ou déantigénisation et/ou inactivation virale. The biological prosthesis according to the invention is a biological prosthesis 10 constituted in whole or in part by an areola-nipple plate 14 of an animal belonging to the family of pigs, cattle or goats, said areola-nipple plate having been treated so as to allow use in humans, preferably by acellularization and/or deantigenization and/or viral inactivation. The biological prosthesis according to the invention is therefore a biological tissue corresponding to an areola-nipple plaque 14 taken from an animal belonging to the family of pigs, cattle or goats, then treated, preferably at least by acellularization and/or deantigenization and/or viral inactivation.
La prothèse biologique 10 comprend une section 18 plane ou sensiblement plane (elle n'est pas obligatoirement parfaitement plane du fait du matériau naturel utilisé), et une section protubérante 16 disposée préférentiellement au centre ou sensiblement au centre de ladite section 18. La section 18 correspond à l'aréole et la section 16 au mamelon. The biological prosthesis 10 comprises a flat or substantially flat section 18 (it is not necessarily perfectly flat due to the natural material used), and a protruding section 16 preferably disposed at the center or substantially at the center of said section 18. Section 18 corresponds to the areola and section 16 to the nipple.
La section 18 est préférentiellement de forme circulaire ou ovale ou sensiblement circulaire ou sen siblement ovale. Section 18 is preferably circular or oval or substantially circular or substantially oval in shape.
Préférentiellement l'épaisseur e de la section 18 est comprise entre 0,5 et 4 mm, de façon préférée entre 0,5 et 2 mm. L'épaisseur e pour une même prothèse peut varier et une prothèse peut présen ter différentes épaisseurs ou bien sensiblement la même épaisseur, lesdites épaisseurs étant préfé rentiellement comprises entre 0,5 et 4 mm, de façon préférée entre 0,5 et 2 mm. Preferably the thickness e of the section 18 is between 0.5 and 4 mm, more preferably between 0.5 and 2 mm. The thickness e for the same prosthesis can vary and a prosthesis can have different thicknesses or else substantially the same thickness, said thicknesses being preferably between 0.5 and 4 mm, preferably between 0.5 and 2 mm.
Cette épaisseur est nécessaire pour pouvoir assurer une bonne résistance mécanique à l'implant. L'épaisseur 12 varie en fonction de la résistance mécanique souhaitée, car plus l'épaisseur est im portante, moins la matière est souple. Pour obtenir une telle épaisseur, il peut être nécessaire de fendre le derme dans l'épaisseur, à la dimension souhaitée, à l'aide de moyens tranchants comme un couteau par exemple. La section protubérante 16 à une hauteur h préférentiellement comprise entre 0,5 et 20mm, de façon préférée entre 7 et 10 mm. This thickness is necessary to be able to ensure good mechanical resistance to the implant. The thickness 12 varies according to the desired mechanical strength, because the greater the thickness, the less flexible the material. To obtain such a thickness, it may be necessary to split the dermis in the thickness, to the desired size, using sharp means such as a knife for example. The protruding section 16 has a height h preferably between 0.5 and 20 mm, preferably between 7 and 10 mm.
Le diamètre moyen D de la section 18, est préférentiellement compris entre 10 et 60 mm, encore plus préférentiellement entre 15 et 50 mm. La section 18 peut avoir un diamètre plus grand au moment du prélèvement et être redécoupée selon le diamètre moyen D final souhaité. The mean diameter D of section 18 is preferably between 10 and 60 mm, even more preferably between 15 and 50 mm. Section 18 may have a larger diameter at the time of sampling and be recut according to the desired final average diameter D.
La diamètre moyen d de la section 16 est préférentiellement compris entre 5 et 20mm, préféren tiellement entre 5 et 15mm. The mean diameter d of section 16 is preferably between 5 and 20mm, preferably between 5 and 15mm.
Ces différentes dimensions de la prothèse biologique sont idéales pour une utilisation en chirurgie de reconstruction de la PAM. Elles peuvent être adaptées par le praticien en fonction du diamètre du mamelon originel. These different dimensions of the biological prosthesis are ideal for use in MAP reconstruction surgery. They can be adapted by the practitioner according to the diameter of the original nipple.
Le prélèvement de la prothèse biologique selon l'invention avant traitement, est réalisé sur une partie d'un animal appartenant à la famille des porcins, des bovins ou des caprins (préférentielle ment une coche) correspondant à la partie ventrale de l'animal comprenant plusieurs sections aréolo-mamelonnaires de l'animal. Préférentiellement le prélèvement est réalisé sur la partie ven trale (abdomen et/ou thorax) d'une ou plusieurs zones 14, chaque zone 14 correspondant à une plaque aréolo-mamelonnaire. The removal of the biological prosthesis according to the invention before treatment, is carried out on a part of an animal belonging to the family of pigs, cattle or goats (preferably a check mark) corresponding to the ventral part of the animal comprising several nipple-areolar sections of the animal. The sample is preferably taken from the ventral part (abdomen and/or thorax) of one or more zones 14, each zone 14 corresponding to an areola-nipple plaque.
Le derme animal, et en particulier le derme porcin, est particulièrement adapté car sa résistance mécanique permet son utilisation en chirurgie. En outre, la composition de la matrice extracellulaire, en particulier le collagène, du derme porcin est similaire à celle des êtres humains. Animal dermis, and in particular porcine dermis, is particularly suitable because its mechanical strength allows it to be used in surgery. Furthermore, the composition of the extracellular matrix, particularly collagen, of the porcine dermis is similar to that of human beings.
Pour améliorer la compatibilité, le derme est traité, en particulier par acellularisation et déantigéni- sation. Ce traitement permet d'éliminer notamment les éléments cellulaires et l'épitope alpha-gai qui peuvent provoquer une réaction immunitaire accrue et un rejet aigu de l'implant d'origine ani male. To improve compatibility, the dermis is treated, in particular by acellularization and deantigenization. This treatment makes it possible to eliminate in particular the cellular elements and the alpha-gai epitope which can cause an increased immune reaction and acute rejection of the implant of animal origin.
Plusieurs méthodes connues de l'homme du métier existent pour traiter le derme par acellularisa tion et déantigénisation, comme par exemple celles décrites dans : Several methods known to those skilled in the art exist for treating the dermis by acellularization and deantigenization, such as for example those described in:
- Badylak et al., "Extracellular Matrix as a Biological Scaffold Material: Structure and Function," Acta Biomaterialia (2008), doi:10.1016/j.actbio.2008.09.013 - Badylak et al., "Extracellular Matrix as a Biological Scaffold Material: Structure and Function," Acta Biomaterialia (2008), doi:10.1016/j.actbio.2008.09.013
- Xu et al., Tissue Engineering, Vol. 15, 1-13 (2009). - Xu et al., Tissue Engineering, Vol. 15, 1-13 (2009).
La résistance mécanique de la prothèse biologique 10 selon l'invention répond préférentiellement aux paramètres suivants (mesurés selon les méthodes décrites dans l'US Pharmacopeia Scaffold Bo vine Dermis) : The mechanical strength of the biological prosthesis 10 according to the invention preferably responds to the following parameters (measured according to the methods described in the US Pharmacopeia Scaffold Bovine Dermis):
- Une force de rétention de suture (« Suture rétention strength ») supérieure à 5 N, - Suture retention strength greater than 5 N,
- Une résistance à la traction (« Tensile strength ») supérieure à 5 N/mm2. - Tensile strength greater than 5 N/mm2.
La prothèse biologique 10 selon l'invention, pour être conservée, peut être séchée. Préférentielle ment, elle est lyophilisée car cette technique de séchage est particulièrement adaptée à la préservation du collagène qui est une protéine très sensible à la température. Pour son utilisation la prothèse doit être réhydratée par tout procédé connu à cet effet. The biological prosthesis 10 according to the invention, to be preserved, can be dried. Preferably, it is freeze-dried because this drying technique is particularly suitable for preservation of collagen which is a very temperature sensitive protein. For its use, the prosthesis must be rehydrated by any method known for this purpose.
La prothèse biologique selon l'invention peut être fabriquée par tout procédé adapté. The biological prosthesis according to the invention can be manufactured by any suitable method.
Préférentiellement elle est obtenue par un procédé de fabrication comprenant les étapes sui vantes : Preferably, it is obtained by a manufacturing process comprising the following steps:
- prélever le tégument de l'animal sur la partie ventrale (abdomen et/ou thorax) d'une ou plusieurs zones 14, chaque zone 14 correspondant à une plaque aréolo-mamelonnaire, - take the integument of the animal on the ventral part (abdomen and/or thorax) from one or more zones 14, each zone 14 corresponding to an areola-nipple plate,
- séparer le derme du reste du tégument, - separate the dermis from the rest of the integument,
- éventuellement fendre le derme prélevé dans l'épaisseur, pour obtenir l'épaisseur e souhaitée,- possibly splitting the dermis sampled in the thickness, to obtain the desired thickness e,
- traitement du derme, au moins par acellularisation et/ou déantigénisation et/ou inactivation virale,- treatment of the dermis, at least by acellularization and/or deantigenization and/or viral inactivation,
- stérilisation. - sterilization.
Avant prélèvement, il est nécessaire de vérifier que les PAMs de l'animal ont les diamètres D et d supérieurs ou égaux à ceux souhaités pour la prothèse. Cette mesure peut être réalisée par tout moyen, par exemple à l'aide d'un pied à coulisse. Before sampling, it is necessary to verify that the animal's PAMs have diameters D and d greater than or equal to those desired for the prosthesis. This measurement can be carried out by any means, for example using a caliper.
Le prélèvement se fait sur un animal mort, juste après qu'il ait été abattu, directement en abattoir.The sample is taken from a dead animal, just after it has been slaughtered, directly in the slaughterhouse.
La séparation du derme du reste du tégument est réalisée à l'aide de tout moyen tranchant, comme un couteau par exemple, préférentiellement directement après le prélèvement en abattoir. The separation of the dermis from the rest of the integument is carried out using any sharp means, such as a knife for example, preferably directly after sampling in the slaughterhouse.
Le derme est fendu à l'aide de tout moyen tranchant, comme un couteau par exemple ou une re- fendeuse. Cette étape doit être réalisée avec précision de façon à obtenir préférentiellement une épaisseur sensiblement uniforme sur l'ensemble de la prothèse. The dermis is split using any sharp means, such as a knife for example or a splitter. This step must be carried out with precision so as to preferably obtain a substantially uniform thickness over the whole of the prosthesis.
Avant ou après stérilisation, le procédé peut comprendre une étape de lyophilisation. Before or after sterilization, the method may include a freeze-drying step.
La prothèse biologique selon l'invention est préférentiellement conditionnée dans un emballage stérile. The biological prosthesis according to the invention is preferably packaged in sterile packaging.
Avantageusement la prothèse biologique conserve les qualités de la matrice extracellulaire dont elle est extraite et favorise l'intégration tissulaire évitant ainsi l'érosion des tissus adjacents. En cas de sepsis post opératoire et/ou de récidive, la prothèse selon l'invention ne doit pas être retirée con trairement aux prothèses synthétiques. En effet sa nature biologique entraînera au pire une simple résorption Advantageously, the biological prosthesis retains the qualities of the extracellular matrix from which it is extracted and promotes tissue integration, thus avoiding the erosion of adjacent tissues. In the event of postoperative sepsis and/or recurrence, the prosthesis according to the invention must not be removed, unlike synthetic prostheses. Indeed its biological nature will at worst lead to a simple resorption
La prothèse est utilisée selon toute technique adaptée. Selon un mode de réalisation elle est utilisée par un procédé comprenant la mise en œuvre des étapes suivantes : The prosthesis is used according to any suitable technique. According to one embodiment, it is used by a method comprising the implementation of the following steps:
- dessin d'un cercle pour positionner l'aréole en fonction de la position de l'aréole controlatérale- drawing a circle to position the areola according to the position of the contralateral areola
- Incision sur un quart de la circonférence - Incision on a quarter of the circumference
- Décollement sous cutané - Subcutaneous detachment
- Enfouissement de l'implant en sous cutané - Fermeture de la voie d'abord. - Burial of the implant subcutaneously - Closure of the lane first.
L'invention est à présent illustrée par un exemple précis de prélèvement et d'obtention et des exemples de prothèses biologiques selon l'invention, obtenues selon ce procédé. The invention is now illustrated by a specific example of sampling and obtaining and examples of biological prostheses according to the invention, obtained according to this method.
. Exemple de procédé de fabrication d'une prothèse selon l'invention Toutes les PAMs d'une coche sont prélevées après abattage et avant tout autre procédé de traite ment. . Example of a process for manufacturing a prosthesis according to the invention All the PAMs of a notch are taken after slaughter and before any other processing process.
Le derme de la PAM est ensuite séparé avec un couteau des autres éléments anatomiques sous- cutanés de la PAM de façon à conserver au maximum l'étui cutané. The dermis of the MAP is then separated with a knife from the other subcutaneous anatomical elements of the MAP so as to preserve the cutaneous sheath as much as possible.
Afin d'obtenir l'épaisseur souhaitée, le derme peut être refendu à l'aide d'un couteau ou autres outils tranchants sur l'ensemble de la surface inférieure et de manière uniforme sans entamer le mamelon. In order to obtain the desired thickness, the dermis can be split using a knife or other sharp tools over the entire lower surface and in a uniform manner without cutting into the nipple.
La prothèse ainsi obtenue est alors traitée par différents traitements chimiques de façon à éliminer les éléments cellulaires et autres molécules propres à l'organisme du donneur. The prosthesis thus obtained is then treated by various chemical treatments in order to eliminate the cellular elements and other molecules specific to the organism of the donor.
La prothèse est ensuite lyophilisée pour une conservation optimale mais peut aussi être conservée par imprégnation d'une solution chimique adéquate. The prosthesis is then freeze-dried for optimal conservation but can also be preserved by impregnation with an appropriate chemical solution.
Une ultime découpe est réalisée afin d'obtenir les dimensions finales souhaitées. Les implants sont ensuite stérilisés par les techniques conventionnelles (ETO, rayonnement, C02 supercritique, acide peracétique). A final cut is made to obtain the desired final dimensions. The implants are then sterilized by conventional techniques (ETO, radiation, supercritical C02, peracetic acid).
Exemples de prothèses obtenues selon ce procédé Exemple 1 : Examples of prostheses obtained according to this process Example 1:
La PAM a été prélevée sur une truie âgée de 5 à 9 mois puis traitée selon le procédé décrit ci-avant. Les dimensions obtenues : h = 7 mm ; D = 50 mm ; e = 0,9 mm ; d = 0,5mm Exemple 2 : The PAM was taken from a sow aged 5 to 9 months and then treated according to the method described above. The dimensions obtained: h = 7 mm; D=50mm; e=0.9mm; d = 0.5mm Example 2:
La PAM a été prélevée sur une truie âgée 20 mois puis traitée selon le procédé décrit ci-avant. Les dimensions obtenues : h=25 mm ; D = 80 mm ; e = 2 mm, d = 15 mm. The PAM was taken from a sow aged 20 months and then treated according to the method described above. The dimensions obtained: h=25 mm; D=80mm; e=2mm, d=15mm.

Claims

REVENDICATIONS
[Revendication 1] Prothèse biologique (10) constituée en tout ou partie par une plaque aréolo- mamelonnaire appartenant à la famille des porcins, des bovins ou des caprins, ladite plaque aréolo-mamelonnaire ayant été traitée pour permettre une utilisation chez l'être humain. [Claim 1] Biological prosthesis (10) consisting in whole or in part of an areola-nipple plaque belonging to the family of pigs, cattle or goats, said areola-nipple plaque having been treated to allow use in human beings .
[Revendication 2] Prothèse (10) selon la revendication 1, caractérisée en ce qu'elle comprend une section (18) plane ou sensiblement plane, et une section protubérante (16).[Claim 2] A prosthesis (10) according to claim 1, characterized in that it comprises a planar or substantially planar section (18), and a protruding section (16).
[Revendication B] Prothèse biologique (10) selon la précédente revendication, caractérisée en ce que la section protubérante (16) est disposée au centre ou sensiblement au centre de la section (18). [Claim B] Biological prosthesis (10) according to the preceding claim, characterized in that the protruding section (16) is arranged at the center or substantially at the center of the section (18).
[Revendication 4] Prothèse biologique (10) selon l'une des revendication 2 ou 3, caractérisée en ce que la section (18) est de forme circulaire ou ovale ou sensiblement circulaire ou sensiblement ovale. [Claim 4] Biological prosthesis (10) according to one of Claims 2 or 3, characterized in that the section (18) is of circular or oval or substantially circular or substantially oval shape.
[Revendication 5] Prothèse biologique (10) selon l'une des revendication 2 à 4, caractérisée en ce que l'épaisseur e de la section (18) est comprise entre 0,5 et 4 mm. [Claim 5] Biological prosthesis (10) according to one of Claims 2 to 4, characterized in that the thickness e of the section (18) is between 0.5 and 4 mm.
[Revendication 6] Prothèse biologique (10) selon l'une des revendication 2 à 5, caractérisée en ce que la section protubérante (16) présente une hauteur h comprise entre 0,5 et 20mm. [Claim 6] Biological prosthesis (10) according to one of Claims 2 to 5, characterized in that the protruding section (16) has a height h of between 0.5 and 20 mm.
[Revendication 7] Prothèse biologique (10) selon l'une des revendication 2 à 6, caractérisée en ce que le diamètre moyen D de la section (18) est compris entre 10 et 60 mm.[Claim 7] Biological prosthesis (10) according to one of Claims 2 to 6, characterized in that the mean diameter D of the section (18) is between 10 and 60 mm.
[Revendication 8] Prothèse biologique (10) selon l'une des revendication 2 à 6, caractérisée en ce le diamètre moyen d de la section (16) est compris entre 5 et 15mm. [Claim 8] Biological prosthesis (10) according to one of Claims 2 to 6, characterized in that the mean diameter d of the section (16) is between 5 and 15 mm.
[Revendication 9] Prothèse biologique (10) selon l'une des précédentes revendications, caractérisée en ce que le traitement pour permettre une utilisation chez l'être humain est au moins un traitement par acellularisation et/ou déantigénisation et/ou inactivation virale. [Claim 9] Biological prosthesis (10) according to one of the preceding claims, characterized in that the treatment to allow use in humans is at least a treatment by acellularization and/or deantigenization and/or viral inactivation.
[Revendication 10] Prothèse biologique (10) selon l'une des précédentes revendications, caractérisée en ce qu'elle est lyophilisée. [Claim 10] Biological prosthesis (10) according to one of the preceding claims, characterized in that it is freeze-dried.
[Revendication 11] Prothèse biologique selon l'une des précédentes revendications, caractérisée en ce qu'il s'agit d'une prothèse biologique mammaire pour l'être humain. [Claim 11] Biological prosthesis according to one of the preceding claims, characterized in that it is a biological breast prosthesis for the human being.
EP22735379.4A 2021-06-17 2022-06-17 Biological prosthesis intended for the reconstruction of the nipple-areola complex Pending EP4355272A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR2106446A FR3124076A1 (en) 2021-06-17 2021-06-17 BIOLOGICAL PROSTHESIS INTENDED FOR THE RECONSTRUCTION OF AREOLO-NIPPET PLAQUE
PCT/EP2022/066562 WO2022263631A1 (en) 2021-06-17 2022-06-17 Biological prosthesis intended for the reconstruction of the nipple-areola complex

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KR (1) KR20240038958A (en)
BR (1) BR112023026579A2 (en)
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AU2017216898A1 (en) * 2016-02-08 2018-08-09 Lifecell Corporation Biologic breast implant
FR3052669B1 (en) * 2016-06-17 2018-06-15 Meccellis Biotech BIOLOGICAL PROSTHESIS FOR THE TREATMENT OF PARASTOMAL HERNIES
WO2021034925A1 (en) * 2019-08-21 2021-02-25 Lifecell Corporation Fixed-shape tissue matrix and related methods

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BR112023026579A2 (en) 2024-03-05

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