IT201800003509A1 - Mesh or membrane coating based on biological or biosynthetic material for prostheses, with fixing system to the prosthesis itself, and related manufacturing procedure. - Google Patents
Mesh or membrane coating based on biological or biosynthetic material for prostheses, with fixing system to the prosthesis itself, and related manufacturing procedure. Download PDFInfo
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- IT201800003509A1 IT201800003509A1 IT102018000003509A IT201800003509A IT201800003509A1 IT 201800003509 A1 IT201800003509 A1 IT 201800003509A1 IT 102018000003509 A IT102018000003509 A IT 102018000003509A IT 201800003509 A IT201800003509 A IT 201800003509A IT 201800003509 A1 IT201800003509 A1 IT 201800003509A1
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- Prior art keywords
- cap
- prosthesis
- coating
- teeth
- counter
- Prior art date
Links
- 239000011248 coating agent Substances 0.000 title claims description 29
- 238000000576 coating method Methods 0.000 title claims description 29
- 239000012528 membrane Substances 0.000 title claims description 19
- 239000000463 material Substances 0.000 title claims description 17
- 230000001851 biosynthetic effect Effects 0.000 title claims description 11
- 238000004519 manufacturing process Methods 0.000 title claims description 4
- 238000000034 method Methods 0.000 claims description 18
- 102000008186 Collagen Human genes 0.000 claims description 11
- 108010035532 Collagen Proteins 0.000 claims description 11
- 229920001436 collagen Polymers 0.000 claims description 11
- 239000011159 matrix material Substances 0.000 claims description 11
- 230000008569 process Effects 0.000 claims description 11
- 238000001035 drying Methods 0.000 claims description 6
- 238000004073 vulcanization Methods 0.000 claims description 6
- 229920001222 biopolymer Polymers 0.000 claims description 4
- 238000004108 freeze drying Methods 0.000 claims description 4
- 229920002635 polyurethane Polymers 0.000 claims description 4
- 239000004814 polyurethane Substances 0.000 claims description 4
- 239000013536 elastomeric material Substances 0.000 claims description 3
- 230000006698 induction Effects 0.000 claims description 3
- 238000003466 welding Methods 0.000 claims description 3
- 238000004026 adhesive bonding Methods 0.000 claims description 2
- 230000008878 coupling Effects 0.000 claims description 2
- 238000010168 coupling process Methods 0.000 claims description 2
- 238000005859 coupling reaction Methods 0.000 claims description 2
- 239000011347 resin Substances 0.000 claims description 2
- 229920005989 resin Polymers 0.000 claims description 2
- 229920001296 polysiloxane Polymers 0.000 description 9
- 206010062575 Muscle contracture Diseases 0.000 description 5
- 208000006111 contracture Diseases 0.000 description 5
- 239000007943 implant Substances 0.000 description 5
- 238000001356 surgical procedure Methods 0.000 description 4
- 210000000481 breast Anatomy 0.000 description 3
- 238000002513 implantation Methods 0.000 description 3
- MHAJPDPJQMAIIY-UHFFFAOYSA-N Hydrogen peroxide Chemical compound OO MHAJPDPJQMAIIY-UHFFFAOYSA-N 0.000 description 2
- 229920005830 Polyurethane Foam Polymers 0.000 description 2
- 239000002775 capsule Substances 0.000 description 2
- 238000011109 contamination Methods 0.000 description 2
- 229920001971 elastomer Polymers 0.000 description 2
- 239000000806 elastomer Substances 0.000 description 2
- 239000000835 fiber Substances 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 239000011496 polyurethane foam Substances 0.000 description 2
- 230000001954 sterilising effect Effects 0.000 description 2
- 238000004659 sterilization and disinfection Methods 0.000 description 2
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 1
- 208000005422 Foreign-Body reaction Diseases 0.000 description 1
- 206010029113 Neovascularisation Diseases 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 210000000038 chest Anatomy 0.000 description 1
- 230000008260 defense mechanism Effects 0.000 description 1
- 230000018044 dehydration Effects 0.000 description 1
- 238000006297 dehydration reaction Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000004744 fabric Substances 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 230000001939 inductive effect Effects 0.000 description 1
- 238000009776 industrial production Methods 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 230000010354 integration Effects 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 231100000241 scar Toxicity 0.000 description 1
- 238000009958 sewing Methods 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 238000011477 surgical intervention Methods 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
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
- A61F2/02—Prostheses implantable into the body
- A61F2/12—Mammary prostheses and implants
-
- 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
- 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
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
-
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
-
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0058—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements soldered or brazed or welded
-
- 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
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/005—Rosette-shaped, e.g. star-shaped
-
- 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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
- A61F2240/002—Designing or making customized prostheses
- A61F2240/004—Using a positive or negative model, e.g. moulds
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C64/00—Additive manufacturing, i.e. manufacturing of three-dimensional [3D] objects by additive deposition, additive agglomeration or additive layering, e.g. by 3D printing, stereolithography or selective laser sintering
- B29C64/10—Processes of additive manufacturing
- B29C64/106—Processes of additive manufacturing using only liquids or viscous materials, e.g. depositing a continuous bead of viscous material
- B29C64/118—Processes of additive manufacturing using only liquids or viscous materials, e.g. depositing a continuous bead of viscous material using filamentary material being melted, e.g. fused deposition modelling [FDM]
Description
Rivestimento in rete o membrana a base di materiale biologico o biosintetico per protesi, con sistema di fissaggio alla protesi stessa, e relativo procedimento di realizzazione Mesh or membrane coating based on biological or biosynthetic material for prostheses, with fixing system to the prosthesis itself, and related manufacturing procedure
La presente invenzione riguarda un rivestimento in rete o membrana a base di materiale biologico o biosintetico per protesi, con sistema di fissaggio alla protesi stessa, e relativo procedimento di realizzazione. The present invention relates to a mesh or membrane coating based on biological or biosynthetic material for prostheses, with a fastening system to the prosthesis itself, and related manufacturing process.
Più dettagliatamente l’invenzione riguarda una protesi, come ad esempio una protesi mammaria in silicone, rivestita con una rete o membrana a base di materiale biologico o biosintetico adesa alla superficie in silicone della protesi stessa. More specifically, the invention relates to a prosthesis, such as a silicone breast prosthesis, coated with a mesh or membrane based on biological or biosynthetic material adhered to the silicone surface of the prosthesis itself.
Com’è ben noto, il fenomeno della contrattura capsulare è una complicanza frequente che si verifica a seguito di un intervento chirurgico per l’impianto di protesi in silicone, come ad esempio protesi mammarie. L’impianto della protesi scatena nell’organismo una reazione detta reazione da corpo estraneo, ossia un meccanismo di difesa dell’organismo avente lo scopo di isolare la protesi, che rappresenta il corpo estraneo, dal resto dell’organismo mediante la formazione di una capsula di fibre che ingloba la protesi stessa. Dopo l’intervento chirurgico, la capsula costituita da fibre neoformate può contrarsi causando deformazioni della protesi spesso gravi, tanto da richiedere un ulteriore intervento chirurgico per la correzione dell’inestetismo provocato dalla deformazione della protesi. As is well known, the phenomenon of capsular contracture is a frequent complication that occurs following surgery for the implantation of silicone implants, such as breast implants. The implantation of the prosthesis triggers a reaction in the organism called foreign body reaction, that is a defense mechanism of the organism with the purpose of isolating the prosthesis, which represents the foreign body, from the rest of the organism by forming a capsule of fibers that encompasses the prosthesis itself. After surgery, the capsule made up of newly formed fibers can contract, causing deformations of the prosthesis that are often severe, so much so that further surgery is required to correct the imperfection caused by the deformation of the prosthesis.
Per risolvere questo problema, sono state proposte negli anni protesi ricoperte di schiuma di poliuretano medicale. Tuttavia, nei sistemi di questo tipo, il fenomeno della contrattura capsulare, come descritto in letteratura, viene solamente posticipato; inoltre è ancora dibattuto il tema degli effetti collaterali della schiuma di poliuretano. To solve this problem, prostheses covered with medical polyurethane foam have been proposed over the years. However, in systems of this type, the phenomenon of capsular contracture, as described in the literature, is only postponed; furthermore, the issue of the side effects of polyurethane foam is still debated.
Un altro metodo per ridurre il rischio di contrattura capsulare consiste nell’avvolgere la protesi di silicone con reti di collagene disponibili in commercio. Secondo questo metodo, l’operatore medico prepara la protesi direttamente in sala operatoria appena prima dell’intervento chirurgico. La protesi e la rete di collagene sterili vengono estratte dalle loro rispettive confezioni, che ne assicurano la sterilità, e manipolate dall’operatore medico per avvolgere la protesi nella rete e cucire la rete in modo tale che questa segua la forma della protesi. Il risultato finale è quindi affidato alla manualità e all’esperienza dell’operatore medico che può incontrare difficoltà nel rivestire omogeneamente la protesi con la rete. Inoltre, la fase di preparazione della protesi, oltre a prolungare i tempi nella sala operatoria, espone la protesi a rischio di contaminazione a causa della prolungata manipolazione. Un altro svantaggio è rappresentato dal rischio di compromettere l’integrità della protesi nella fase di cucitura della rete, ad esempio forando la protesi con l’ago. In tal caso, la protesi dovrà essere sostituita con una protesi integra con conseguente spreco di materiale, aumento dei costi e dei tempi nella sala chirurgica. Another method to reduce the risk of capsular contracture is to wrap the silicone prosthesis with commercially available collagen networks. According to this method, the medical operator prepares the prosthesis directly in the operating room just before surgery. The prosthesis and the sterile collagen network are extracted from their respective packages, which ensure their sterility, and manipulated by the medical operator to wrap the prosthesis in the mesh and sew the mesh so that it follows the shape of the prosthesis. The final result is therefore entrusted to the dexterity and experience of the medical operator who may encounter difficulties in homogeneously covering the prosthesis with the mesh. Furthermore, the preparation phase of the prosthesis, in addition to prolonging the time in the operating room, exposes the prosthesis to the risk of contamination due to prolonged manipulation. Another disadvantage is the risk of compromising the integrity of the prosthesis when sewing the mesh, for example by piercing the prosthesis with the needle. In this case, the prosthesis will have to be replaced with an intact prosthesis with consequent waste of material, increased costs and time in the surgical room.
Sono note altresì protesi rivestite di collagene. Alcuni esempi delle stesse possono essere ritrovati nei documenti brevettuali US4772285, US2011/035004, US2012/226352, US2009/198332. Collagen-coated prostheses are also known. Some examples of the same can be found in patent documents US4772285, US2011 / 035004, US2012 / 226352, US2009 / 198332.
Si tratta di protesi che comprendono una porzione in silicone rivestita con una rete o membrana a base di materiale biologico o biosintetico adesa in modo omogeneo e stabile alla superficie della protesi stessa. These are prostheses that include a silicone portion coated with a mesh or membrane based on biological or biosynthetic material adhered homogeneously and stably to the surface of the prosthesis itself.
Queste soluzioni, seppure in grado di risolvere alcuni dei problemi summenzionati, non ne consentono una soluzione completa, in quanto in nessuna di esse è descritto un sistema vantaggioso di fissaggio del rivestimento sulla protesi, per cui lo stesso o può disaccoppiarsi dalla protesi, oppure non è fissato alla stessa in maniera stabile nel tempo. These solutions, although capable of solving some of the aforementioned problems, do not allow a complete solution, as none of them describes an advantageous system for fixing the coating on the prosthesis, so that the same can either uncouple from the prosthesis, or not. it is fixed to it in a stable manner over time.
Alla luce di quanto sopra esposto, appare evidente la necessità di poter disporre di un rivestimento in rete o membrana a base di materiale biologico o biosintetico per protesi, con sistema di fissaggio sicuro e permanente alla protesi stessa. In the light of the foregoing, the need to have a mesh or membrane coating based on biological or biosynthetic material for prostheses, with a secure and permanent fastening system to the prosthesis itself, appears evident.
Appare inoltre bene evidente la necessità di poter disporre di un procedimento di realizzazione del rivestimento secondo l’invenzione. The need to have a process for making the coating according to the invention is also clearly evident.
Con la soluzione secondo la presente invenzione, si ottiene una protesi che consente di evitare o ridurre notevolmente il fenomeno della contrattura capsulare e quindi la necessità di intervenire chirurgicamente a seguito dell’impianto. La rete o membrana a base di materiale biologico o biosintetico che avvolge la protesi e si interfaccia con l’organismo è perfettamente fissata alla protesi stessa, ed è in grado di innescare meccanismi di integrazione della protesi nell’organismo mediante induzione della neovascolarizzazione della superficie della protesi stessa a contatto con i tessuti dell’organismo. Ciò evita la formazione di un eccessivo deposito di tessuto cicatriziale che rappresenta la causa del fenomeno della contrattura capsulare, con la possibilità di un utilizzo immediato del presidio senza necessità di manipolazione da parte degli operatori medici. With the solution according to the present invention, a prosthesis is obtained which allows to avoid or significantly reduce the phenomenon of capsular contracture and therefore the need for surgical intervention following the implant. The network or membrane based on biological or biosynthetic material that surrounds the prosthesis and interfaces with the body is perfectly fixed to the prosthesis itself, and is able to trigger mechanisms of integration of the prosthesis into the body by inducing the neovascularization of the surface of the prosthesis itself in contact with the body's tissues. This avoids the formation of an excessive deposit of scar tissue which is the cause of the capsular contracture phenomenon, with the possibility of immediate use of the device without the need for manipulation by medical operators.
In tal modo, si risolve il problema di una possibile contaminazione della protesi dovuta alla fase di manipolazione e i derivanti problemi di rischio per la salute del paziente. In this way, the problem of possible contamination of the prosthesis due to the manipulation phase and the resulting problems of risk for the patient's health is solved.
Si evita inoltre una possibile compromissione dell’integrità della protesi e quindi permette un ingente risparmio economico. It also avoids a possible compromise of the integrity of the prosthesis and therefore allows for significant economic savings.
In particolare, la solida adesione tra la protesi e il rivestimento con la rete o la membrana a base di materiale biologico o biosintetico, consente una migliore manipolazione durante l’impianto della protesi. In particular, the solid adhesion between the prosthesis and the coating with the mesh or membrane based on biological or biosynthetic material, allows for better handling during implantation of the prosthesis.
Infine, la protesi secondo la presente invenzione permette di abbreviare notevolmente i tempi chirurgici. Forma pertanto oggetto specifico della presente invenzione un rivestimento in rete o membrana a base di materiale biologico o biosintetico per protesi, detta protesi avendo una superficie posteriore che, quando applicata, è rivolta verso la persona su cui la protesi è applicata, detto rivestimento essendo caratterizzato dal fatto che prevede un sistema di fissaggio a detta protesi, detto sistema di fissaggio prevedendo una pluralità di denti o petali, realizzati su rivestimento, e ripiegabili, in fase di produzione industriale, una volta che il rivestimento è disposto su detta protesi, in modo da accoppiarsi a detta superficie posteriore della protesi, e mezzi di fissaggio dei denti o alette ripiegati su detta protesi. Finally, the prosthesis according to the present invention allows to significantly shorten the surgical times. Therefore, the specific object of the present invention is a mesh or membrane coating based on biological or biosynthetic material for prostheses, said prosthesis having a rear surface which, when applied, faces the person on whom the prosthesis is applied, said coating being characterized by the fact that it provides a fastening system to said prosthesis, said fastening system providing a plurality of teeth or petals, made on the coating, and foldable, in the industrial production phase, once the coating is placed on said prosthesis, so to be coupled to said rear surface of the prosthesis, and means for fixing the teeth or flaps folded onto said prosthesis.
Preferibilmente, secondo l’invenzione, sulla parete posteriore di detta protesi è prevista una pluralità di alloggiamenti, in numero e forma corrispondente a quelli dei denti o petali. Preferably, according to the invention, on the rear wall of said prosthesis there is a plurality of housings, in number and shape corresponding to those of the teeth or petals.
Sempre secondo l’invenzione, detto sistema di fissaggio prevede un disco, preferibilmente in materiale elastomerico liscio oppure corrugato, ricoperto di poliuretano, in collagene o in altro biopolimero di grado medicale, che ricopre un’area dei denti o petali ripiegati, detto disco essendo fissato in posizione mediante incollaggio, vulcanizzazione, autovulcanizzazione, saldatura ad induzione di radiofrequenza o mediante laser. Always according to the invention, said fixing system provides a disc, preferably in smooth or corrugated elastomeric material, covered with polyurethane, collagen or other medical grade biopolymer, which covers an area of the folded teeth or petals, said disc being fixed in position by bonding, vulcanization, self-vulcanization, radiofrequency induction welding or by laser.
L’invenzione riguarda inoltre un procedimento per la realizzazione di detto rivestimento per protesi, detto procedimento prevedendo le fasi di: The invention also relates to a process for making said prosthesis coating, said procedure providing for the steps of:
- realizzare una calotta; - make a cap;
- realizzare una controcalotta; - create a counter cap;
- applicare una matrice su detta calotta; - applying a matrix on said shell;
- accoppiare detta contro calotta su detta calotta; - sottoporre il complesso calotta – matrice – contro calotta ad una fase di asciugatura; - coupling said counter cap onto said cap; - subject the cap - matrix - against cap complex to a drying phase;
- estrarre la matrice sagomata. - extract the shaped matrix.
Preferibilmente, secondo l’invenzione, dette calotta e contro calotta sono realizzate mediante stampante 3D caricata con filo in materiale certificato per uso alimentare e farmaceutico. Preferably, according to the invention, said cap and counter cap are made by a 3D printer loaded with wire in material certified for food and pharmaceutical use.
In particolare, dette calotta e contro calotta sono ottenute a seguito di una scansione della specifica protesi a cui è destinato il rivestimento. In particular, said cap and counter cap are obtained following a scan of the specific prosthesis for which the coating is intended.
Ancora secondo l’invenzione, dette calotta e contro calotta sono realizzate in materiale traforato o non traforato. Still according to the invention, said cap and counter cap are made of perforated or non-perforated material.
Preferibilmente, secondo l’invenzione, detta fase di asciugatura è realizzata mediante liofilizzazione. Preferably, according to the invention, said drying step is carried out by lyophilization.
Sempre secondo l’invenzione, detta matrice viene fustellata a misura e preferibilmente con taglio a rete ad espansione centrifuga e dotata di denti o alette. Still according to the invention, said matrix is punched to size and preferably with centrifugal expansion mesh cut and equipped with teeth or fins.
Ulteriormente, secondo l’invenzione, detta calotta prevede un centratore, che passa attraverso un piccolo foro centralmente disposto sulla matrice, e che consente la sua centratura nella calotta, detta calotta essendo dotata di alette, in misura e numero uguale a quelle presenti sulla matrice, provviste di mezzi ad uncino, che agganciano la matrice. Furthermore, according to the invention, said cap provides a centering device, which passes through a small hole centrally placed on the matrix, and which allows its centering in the cap, said cap being equipped with fins, in the same size and number as those present on the matrix. , provided with hook means, which hook the die.
La presente invenzione verrà ora descritta, a titolo illustrativo, ma non limitativo, secondo una sua forma preferita di realizzazione, con particolare riferimento alle figure dei disegni allegati, in cui: The present invention will now be described, for illustrative but not limitative purposes, according to a preferred embodiment thereof, with particular reference to the figures of the attached drawings, in which:
la figura 1 è una vista prospettica di una forma di realizzazione di una protesi secondo l’invenzione; la figura 2 è una seconda vista prospettica della protesi con rivestimento secondo l’invenzione; Figure 1 is a perspective view of an embodiment of a prosthesis according to the invention; Figure 2 is a second perspective view of the prosthesis with coating according to the invention;
la figura 3 è una vista in pianta del rivestimento secondo l’invenzione; Figure 3 is a plan view of the coating according to the invention;
la figura 4 è una ulteriore vista prospettica della protesi con rivestimento secondo l’invenzione; le figure 5 e 6 sono viste prospettiche di stampo e controstampo utilizzati per il procedimento di realizzazione del rivestimento secondo l’invenzione; la figura 7 è una vista in sezione laterale del sistema secondo le figure 5 e 6; Figure 4 is a further perspective view of the prosthesis with coating according to the invention; Figures 5 and 6 are perspective views of the mold and counter-mold used for the process of making the coating according to the invention; figure 7 is a side sectional view of the system according to figures 5 and 6;
la figura 8 è una seconda vista in sezione laterale del sistema secondo le figure 5 e 6; e figure 8 is a second side sectional view of the system according to figures 5 and 6; And
la figura 9 è una vista prospettica di stampo e controstampo. Figure 9 is a perspective view of the mold and counter-mold.
Riferendosi inizialmente alle figure 1 – 4 dei disegni allegati, con il riferimento numerico 1 è indicata una protesi, in particolare una protesi mammaria in silicone, mentre con il riferimento numerico 2 è indicato il rivestimento secondo l’invenzione, in materiale biologico o biosintetico, quale ad esempio collagene. Referring initially to figures 1 - 4 of the attached drawings, the reference number 1 indicates a prosthesis, in particular a silicone breast prosthesis, while the reference number 2 indicates the coating according to the invention, in biological or biosynthetic material, such as collagen.
La protesi 1 destinata ad essere ricoperta può essere prodotta con metodica tradizionale o applicando allo stampo una modifica che consenta di ottenere sulla faccia posteriore della protesi 1, ovverosia quella rivolta verso il torace della paziente, degli alloggiamenti 3. The prosthesis 1 intended to be covered can be produced with the traditional method or by applying to the mold a modification that allows to obtain on the rear face of the prosthesis 1, that is the one facing the patient's chest, some housings 3.
Il rivestimento 2 presenterà sulla sua periferia esterna una pluralità di denti o petali 4, che si andranno ad accoppiare, come verrà descritto nel seguito, in detti alloggiamenti 3. The covering 2 will have on its external periphery a plurality of teeth or petals 4, which will be coupled, as will be described below, in said housings 3.
Come si vede chiaramente in figura 4, una volta ripiegati i denti o petali 4 sulla parete posteriore della protesi 1, si applica un disco 5, ad esempio in materiale elastomerico liscio oppure corrugato, ricoperto di poliuretano, o in collagene o in altro biopolimero di grado medicale, che ricopre un’area dei denti 4. As can be clearly seen in Figure 4, once the teeth or petals 4 have been folded onto the rear wall of the prosthesis 1, a disc 5 is applied, for example in smooth or corrugated elastomeric material, covered with polyurethane, or in collagen or in another biopolymer of medical grade, covering an area of the teeth 4.
Detto disco 5 è applicato mediante incollaggio, vulcanizzazione o auto vulcanizzazione. O mediante altri metodi di saldatura ad induzione di radiofrequenze o utilizzo di laser. Said disc 5 is applied by gluing, vulcanization or self-vulcanization. Either by other radio frequency induction welding methods or by using lasers.
Venendo ora ad osservare le figure 5 – 8 dei disegni, è illustrato un procedimento per la realizzazione del rivestimento 2 secondo l’invenzione. Coming now to observe figures 5 - 8 of the drawings, a process for the realization of the coating 2 according to the invention is illustrated.
In particolare, sono mostrate una calotta 6 e una contro calotta 7, realizzate ad esempio con resina o mediante stampante 3D caricata con filo in materiale certificato per uso alimentare e farmaceutico, in base alla scansione della singola protesi 1 in silicone a cui è destinato il rivestimento. In particular, a cap 6 and a counter cap 7 are shown, made for example with resin or by a 3D printer loaded with wire in material certified for food and pharmaceutical use, based on the scan of the single silicone prosthesis 1 for which the coating.
In questo modo, ogni modello o misura di protesi 1 definitiva avrà, in termini di dimensioni e forma, un suo corrispondente preciso di copertura tale da garantire la massima coerenza tra la stessa e l’impianto in elastomero, per qualunque misura. In this way, each model or size of the definitive prosthesis 1 will have, in terms of size and shape, a precise corresponding coverage such as to ensure maximum consistency between it and the elastomer implant, for any size.
Come accennato, sono previste due calotte 6, 7, preferibilmente traforate, in cui vengono applicate, prima di una fase di essiccatura, ad esempio e preferibilmente mediante liofilizzazione, matrici in forma compatta o modificata per conferire il caratteristico aspetto “a rete” al rivestimento 1. As mentioned, two caps 6, 7 are provided, preferably perforated, in which matrices are applied, before a drying step, for example and preferably by freeze-drying, in compact or modified form to give the characteristic "mesh" appearance to the coating 1.
La membrana 8 in collagene che costituisce il rivestimento 2 secondo l’invenzione viene fustellata a misura e preferibilmente con taglio a rete ad espansione centrifuga e dotata di denti o alette 4, che verranno ripiegati sotto la protesi 1, eventualmente in corrispondenza degli alloggiamenti 3. The collagen membrane 8 that constitutes the coating 2 according to the invention is punched to size and preferably with centrifugal expansion mesh cut and equipped with teeth or fins 4, which will be folded under the prosthesis 1, possibly in correspondence with the housings 3.
La calotta 6 prevede un centratore 9, che passa attraverso un piccolo foro 10 centralmente disposto sulla membrana 8, e che consente la sua centratura nella calotta 6, di formatura e liofilizzazione. The cap 6 provides a centering device 9, which passes through a small hole 10 centrally arranged on the membrane 8, and which allows its centering in the molding and freeze-drying cap 6.
La stessa calotta 6 è dotata di alette 11, in misura e numero uguale a quelle presenti sulla membrana 8, provviste di uncini 12, che agganciano la membrana 8 in collagene. The same cap 6 is equipped with fins 11, in the same size and number as those present on the membrane 8, provided with hooks 12, which hook the collagen membrane 8.
La calotta 6, come detto, è dotata di un centratore 9, da allineare al foro 10 di centratura presente sulla membrana 8. The cap 6, as mentioned, is equipped with a centering device 9, to be aligned with the centering hole 10 present on the membrane 8.
La membrana 8 viene reidratata ed agganciata alla calotta 6, risultando in questa fase pieghevole ed estremamente drappeggiabile, e quindi perfettamente adattabile alla calotta 6. La membrana 8 avrà una eccedenza rispetto al profilo della calotta 6, per la realizzazione dei summenzionati denti o petali 4. The membrane 8 is rehydrated and attached to the cap 6, resulting in this phase folding and extremely drapable, and therefore perfectly adaptable to the cap 6. The membrane 8 will have an excess with respect to the profile of the cap 6, for the realization of the aforementioned teeth or petals 4 .
La membrana 8 viene quindi agganciata alle alette 11 tramite gli uncini 12. The membrane 8 is then hooked to the fins 11 by means of the hooks 12.
Quindi, si inserisce all’interno della calotta 6 la contro calotta 7, al fine di ottenere la forma definitiva. Then, the counter cap 7 is inserted inside the shell 6, in order to obtain the final shape.
Si provvede ora alla asciugatura, preferibilmente in un liofilizzatore, per un procedimento di disidratazione controllata che consente di ottenere una calotta preformata avente misure e profilo del tutto coerenti con la protesi 1 che è destinata ad ospitare. Drying is now carried out, preferably in a lyophilizer, for a controlled dehydration process which allows to obtain a preformed cap having dimensions and profile completely consistent with the prosthesis 1 it is intended to house.
In questo modo, si possono lavorare formati di membrane 8 standardizzati per ottenere molteplici coperture, differenti tra loro per forma e dimensioni, partendo da tessuti di misura simile, specialmente nel caso delle coperture “a rete”. In this way, standardized membrane formats 8 can be processed to obtain multiple coverings, different from each other in shape and size, starting from fabrics of similar size, especially in the case of "mesh" coverings.
Quindi si inserisce la protesi 1 in silicone all’interno della calotta si chiudono i “petali” 4 verso il centro della faccia posteriore della protesi 1 stessa; per poi sovrapporre un disco 5 in silicone liscio oppure corrugato, ricoperto con poliuretano, o in collagene o in altro biopolimero che verrà, come detto, incollato assicurando la giunzione tra copertura ed elastomero, bloccando i petali della matrice. Then the silicone prosthesis 1 is inserted inside the cap, the "petals" 4 are closed towards the center of the rear face of the prosthesis 1 itself; and then overlap a disk 5 in smooth or corrugated silicone, covered with polyurethane, or in collagen or other biopolymer which, as mentioned, will be glued ensuring the junction between the cover and the elastomer, blocking the petals of the matrix.
Si procede quindi alla sterilizzazione, da effettuarsi con sistema adeguato a non interferire con la struttura fisica e molecolare del collagene (preferibilmente raggi beta o gamma, tuttavia, in taluni casi, si può prevedere il metodo di sterilizzazione ad ossido di etilene, calore secco o plasma di perossido di idrogeno). Sterilization is then carried out, to be carried out with an adequate system not to interfere with the physical and molecular structure of the collagen (preferably beta or gamma rays, however, in some cases, the sterilization method using ethylene oxide, dry heat or hydrogen peroxide plasma).
Si ottiene così una protesi in cui i due elementi, perfettamente solidali, costituiscono un tutt’uno, che consente al chirurgo un impianto agevole, evita qualsiasi rischiosa manipolazione ed è pronto all’uso. The result is a prosthesis in which the two elements, perfectly integral, form a whole, which allows the surgeon to make an easy implant, avoids any risky manipulation and is ready for use.
La presente invenzione è stata descritta, a titolo illustrativo, ma non limitativo, secondo sue forme preferite di realizzazione, ma è da intendersi che variazioni e/o modifiche potranno essere apportate dagli esperti nel ramo, senza per questo uscire dal relativo ambito di protezione come definito nelle rivendicazioni allegate. The present invention has been described, for illustrative but not limitative purposes, according to its preferred embodiments, but it is to be understood that variations and / or modifications may be made by those skilled in the art, without thereby departing from the relative scope of protection as defined in the attached claims.
Claims (12)
Priority Applications (6)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT102018000003509A IT201800003509A1 (en) | 2018-03-13 | 2018-03-13 | Mesh or membrane coating based on biological or biosynthetic material for prostheses, with fixing system to the prosthesis itself, and related manufacturing procedure. |
| ES19716586T ES2922536T3 (en) | 2018-03-13 | 2019-03-13 | Mesh or membrane coating for prostheses made of biological or biosynthetic material, which constitutes a system for fixing the prosthesis and corresponding manufacturing method |
| EP19716586.3A EP3764947B1 (en) | 2018-03-13 | 2019-03-13 | Mesh or membrane covering for prostheses made of biologic or biosynthetic material, comprising a system for fixation to the prosthesis, and corresponding manufacturing method |
| PCT/IT2019/050054 WO2019175911A2 (en) | 2018-03-13 | 2019-03-13 | Mesh or membrane covering based on biological or biosynthetic material for prosthesis, provided with fixing system for fixing to the same prosthesis, and corresponding manufacturing process thereof |
| KR1020207029234A KR20210009302A (en) | 2018-03-13 | 2019-03-13 | A mesh or membrane covering made of a biological or biosynthetic material for the prosthesis and comprising a system for fixation on the prosthesis, and a method for manufacturing the corresponding |
| US17/019,424 US20200405473A1 (en) | 2018-03-13 | 2020-09-14 | Mesh or membrane covering based on biological or biosynthetic material for prosthesis, provided with fixing system for fixing to the same prosthesis, and corresponding manufacturing process thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT102018000003509A IT201800003509A1 (en) | 2018-03-13 | 2018-03-13 | Mesh or membrane coating based on biological or biosynthetic material for prostheses, with fixing system to the prosthesis itself, and related manufacturing procedure. |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| IT201800003509A1 true IT201800003509A1 (en) | 2019-09-13 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| IT102018000003509A IT201800003509A1 (en) | 2018-03-13 | 2018-03-13 | Mesh or membrane coating based on biological or biosynthetic material for prostheses, with fixing system to the prosthesis itself, and related manufacturing procedure. |
Country Status (1)
| Country | Link |
|---|---|
| IT (1) | IT201800003509A1 (en) |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0322194A1 (en) * | 1987-12-22 | 1989-06-28 | Walter Joseph Ledergerber | Implantable prosthetic device |
| WO2007004214A2 (en) * | 2005-07-04 | 2007-01-11 | Sergey Popov | Implant assembly |
| US20090125107A1 (en) * | 2007-11-14 | 2009-05-14 | Maxwell G Patrick | Interfaced Medical Implant Assembly |
| WO2013106556A2 (en) * | 2012-01-13 | 2013-07-18 | Lifecell Corporation | Breast prostheses, methods of manufacturing breast prostheses, and methods of treatment using breast prostheses |
| US20160331504A1 (en) * | 2015-05-15 | 2016-11-17 | Lifecell Corporation | Tissue matrices and methods of treatment |
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2018
- 2018-03-13 IT IT102018000003509A patent/IT201800003509A1/en unknown
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0322194A1 (en) * | 1987-12-22 | 1989-06-28 | Walter Joseph Ledergerber | Implantable prosthetic device |
| WO2007004214A2 (en) * | 2005-07-04 | 2007-01-11 | Sergey Popov | Implant assembly |
| US20090125107A1 (en) * | 2007-11-14 | 2009-05-14 | Maxwell G Patrick | Interfaced Medical Implant Assembly |
| WO2013106556A2 (en) * | 2012-01-13 | 2013-07-18 | Lifecell Corporation | Breast prostheses, methods of manufacturing breast prostheses, and methods of treatment using breast prostheses |
| US20160331504A1 (en) * | 2015-05-15 | 2016-11-17 | Lifecell Corporation | Tissue matrices and methods of treatment |
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