ITMI20121709A1 - ORTHOTOPIC ENDOPROSTHESIS OF ARTIFICIAL BLADDER - Google Patents
ORTHOTOPIC ENDOPROSTHESIS OF ARTIFICIAL BLADDER Download PDFInfo
- Publication number
- ITMI20121709A1 ITMI20121709A1 IT001709A ITMI20121709A ITMI20121709A1 IT MI20121709 A1 ITMI20121709 A1 IT MI20121709A1 IT 001709 A IT001709 A IT 001709A IT MI20121709 A ITMI20121709 A IT MI20121709A IT MI20121709 A1 ITMI20121709 A1 IT MI20121709A1
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- Italy
- Prior art keywords
- endoprosthesis
- fabric
- casing
- endoprosthesis according
- orthotopic
- Prior art date
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- 239000004744 fabric Substances 0.000 claims description 16
- 239000012528 membrane Substances 0.000 claims description 9
- 239000011248 coating agent Substances 0.000 claims description 7
- 238000000576 coating method Methods 0.000 claims description 7
- 229920001296 polysiloxane Polymers 0.000 claims description 7
- 210000003708 urethra Anatomy 0.000 claims description 6
- 210000000626 ureter Anatomy 0.000 claims description 5
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 4
- 229910052799 carbon Inorganic materials 0.000 claims description 4
- 239000000835 fiber Substances 0.000 claims description 3
- 229920000954 Polyglycolide Polymers 0.000 description 7
- 210000001519 tissue Anatomy 0.000 description 7
- 210000002700 urine Anatomy 0.000 description 6
- 230000003115 biocidal effect Effects 0.000 description 4
- 238000000034 method Methods 0.000 description 4
- 210000003741 urothelium Anatomy 0.000 description 4
- 239000000463 material Substances 0.000 description 3
- 238000002560 therapeutic procedure Methods 0.000 description 3
- 208000035143 Bacterial infection Diseases 0.000 description 2
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 2
- 230000001580 bacterial effect Effects 0.000 description 2
- 208000022362 bacterial infectious disease Diseases 0.000 description 2
- TZCXTZWJZNENPQ-UHFFFAOYSA-L barium sulfate Chemical compound [Ba+2].[O-]S([O-])(=O)=O TZCXTZWJZNENPQ-UHFFFAOYSA-L 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 239000002775 capsule Substances 0.000 description 2
- 238000005253 cladding Methods 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 230000003176 fibrotic effect Effects 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 230000009103 reabsorption Effects 0.000 description 2
- 229920004934 Dacron® Polymers 0.000 description 1
- AEMRFAOFKBGASW-UHFFFAOYSA-N Glycolic acid Polymers OCC(O)=O AEMRFAOFKBGASW-UHFFFAOYSA-N 0.000 description 1
- 229920000544 Gore-Tex Polymers 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 238000004026 adhesive bonding Methods 0.000 description 1
- 239000012237 artificial material Substances 0.000 description 1
- 239000012620 biological material Substances 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 230000007797 corrosion Effects 0.000 description 1
- 238000005260 corrosion Methods 0.000 description 1
- 238000012631 diagnostic technique Methods 0.000 description 1
- 238000007598 dipping method Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 229920001519 homopolymer Polymers 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 239000004745 nonwoven fabric Substances 0.000 description 1
- 230000007170 pathology Effects 0.000 description 1
- 239000004633 polyglycolic acid Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 230000003746 surface roughness Effects 0.000 description 1
- 239000004408 titanium dioxide Substances 0.000 description 1
- 238000004078 waterproofing Methods 0.000 description 1
- 239000002759 woven fabric 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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/042—Urinary bladders
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time
- A61F2250/0031—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
Landscapes
- Health & Medical Sciences (AREA)
- Urology & Nephrology (AREA)
- Gastroenterology & Hepatology (AREA)
- Pulmonology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Description
Descrizione Description
La presente invenzione si riferisce ad una endoprotesi ortotopica di vescica artificiale. The present invention relates to an orthotopic endoprosthesis of an artificial bladder.
La presente invenzione trova applicazione nella sostituzione di una vescica di un paziente, nel caso in cui quest’ultima sia affetta da patologie incurabili gravi da comprometterne il corretto funzionamento. The present invention finds application in the replacement of a patient's bladder, in the event that the latter is affected by serious incurable pathologies that compromise its correct functioning.
Le endoprotesi vescicali note comprendono un involucro a palloncino realizzato con una membrana impermeabile stratificata di silicone. Known bladder endoprostheses comprise a balloon envelope made with a waterproof, layered silicone membrane.
Tale involucro à ̈ sufficientemente rigido da mantenere stabilmente la propria forma e flessibile in modo tale che possa essere compressa manualmente per garantirne lo svuotamento. This casing is rigid enough to hold its shape stably and flexible so that it can be manually compressed to ensure emptying.
L’involucro prevede un elemento di connessione posto in corrispondenza di una porzione inferiore dell’involucro per il collegamento con l’uretra del paziente. Analogamente, due corpi di connessione sono posti superiormente per consentire il collegamento con gli ureteri. The casing includes a connection element placed in correspondence with a lower portion of the casing for connection with the patient's urethra. Similarly, two connecting bodies are placed above to allow connection with the ureters.
Tali collegamenti avvengono mediante sutura oppure mediante semplice incastro. These connections are made by suturing or by simple interlocking.
Successivamente all’impianto dell’endoprotesi nel paziente, si assiste alla formazione di uno strato di tessuto muscolo-fibrotico (non impermeabile) attorno all’involucro. Si genera, in tal modo, una neovescica attorno all’endoprotesi. After implantation of the endoprosthesis in the patient, a layer of muscle-fibrotic (non-impermeable) tissue forms around the envelope. In this way, a neobladder is generated around the endoprosthesis.
Dal momento che le endoprotesi del tipo noto sono permanenti, complicanze possono sopraggiungere anche in tempi successivi alla completa riabilitazione del paziente. Since endoprostheses of the known type are permanent, complications can occur even after the complete rehabilitation of the patient.
Può capitare, infatti, che un’infezione colpisca la neovescica in modo accidentale o a seguito dell’uso di cateteri. In fact, it may happen that an infection affects the neobladder accidentally or following the use of catheters.
In tal caso, si rende necessaria una adeguata terapia antibiotica. Tali farmaci risultano efficaci nell’estinzione delle cariche batteriche annidate in tessuto biologico e presentano un effetto scarso, o addirittura nullo, su cariche batteriche annidate su materiali artificiali come quelli che compongono l’involucro. In this case, adequate antibiotic therapy is required. These drugs are effective in extinguishing bacterial loads nested in biological tissue and have little or no effect on bacterial loads nested on artificial materials such as those that make up the envelope.
Svantaggiosamente, dunque, le endoprotesi del tipo noto possono rappresentare un ostacolo all’efficacia di terapie antibiotiche. Disadvantageously, therefore, endoprostheses of the known type can represent an obstacle to the effectiveness of antibiotic therapies.
In questo contesto, il compito tecnico alla base della presente invenzione à ̈ proporre una endoprotesi ortotopica di vescica artificiale che superi l’inconveniente della tecnica nota sopra citati. In this context, the technical task underlying the present invention is to propose an orthotopic endoprosthesis of an artificial bladder which overcomes the aforementioned drawback of the prior art.
In particolare, Ã ̈ scopo della presente invenzione mettere a disposizione una endoprotesi ortotopica di vescica artificiale che limiti i rischi associati ad infezioni batteriche. In particular, it is an object of the present invention to provide an orthotopic endoprosthesis of an artificial bladder which limits the risks associated with bacterial infections.
Il compito tecnico precisato e lo scopo specificato sono sostanzialmente raggiunti da una endoprotesi ortotopica di vescica artificiale comprendente le caratteristiche tecniche esposte in una o più delle unite rivendicazioni. The specified technical task and the specified purpose are substantially achieved by an orthotopic endoprosthesis of an artificial bladder comprising the technical characteristics set forth in one or more of the appended claims.
Ulteriori caratteristiche e vantaggi della presente invenzione appariranno maggiormente chiari dalla descrizione indicativa, e pertanto non limitativa, di una forma di realizzazione preferita ma non esclusiva una endoprotesi ortotopica di vescica artificiale, come illustrato negli uniti disegni in cui: Further characteristics and advantages of the present invention will become clearer from the indicative, and therefore non-limiting, description of a preferred but not exclusive embodiment of an orthotopic endoprosthesis of an artificial bladder, as illustrated in the accompanying drawings in which:
- la figura 1 Ã ̈ una vista laterale schematica di una endoprotesi ortotopica di vescica artificiale in accordo con la presente invenzione; e - figure 1 is a schematic side view of an orthotopic endoprosthesis of an artificial bladder according to the present invention; And
- la figura 2 à ̈ una vista laterale in sezione dell’endoprotesi di figura 1. - figure 2 is a sectional side view of the endoprosthesis of figure 1.
Con riferimento alle allegate figure, con 1 Ã ̈ stata complessivamente indicata una endoprotesi ortotopica di vescica artificiale in accordo con la presente invenzione. With reference to the accompanying figures, 1 indicates as a whole an orthotopic endoprosthesis of an artificial bladder in accordance with the present invention.
L’endoprotesi 1 comprende un involucro 2 sagomato a palloncino e presentante una superficie interna 2a ed una superficie esterna 2b. The endoprosthesis 1 comprises a balloon-shaped envelope 2 having an internal surface 2a and an external surface 2b.
L’involucro 2 definisce al proprio interno un vano chiuso per il contenimento dell’urina. Il vano ha un volume sostanzialmente compreso tra 100 cm<3>e 900 cm<3>, preferibilmente essendo 400 cm<3>. Enclosure 2 defines inside a closed compartment for containing urine. The compartment has a volume substantially comprised between 100 cm <3> and 900 cm <3>, preferably being 400 cm <3>.
L’involucro 2 à ̈ realizzato mediante una membrana multistrato in silicone. The casing 2 is made with a multilayer silicone membrane.
In una forma realizzativa preferita, la membrana comprende sostanzialmente 20 strati, ciascuno dello spessore di circa 30 µm. In a preferred embodiment, the membrane substantially comprises 20 layers, each having a thickness of about 30 µm.
La membrana con cui à ̈ realizzato l’involucro 2 presenta uno spessore compreso tra 500 µm e 700 µm, preferibilmente lo spessore della membrana à ̈ sostanzialmente 600 µm. The membrane with which the envelope 2 is made has a thickness between 500 µm and 700 µm, preferably the thickness of the membrane is substantially 600 µm.
In tal modo, l’involucro 2 dunque ha una rigidezza sufficiente a mantenere la propria forma, ma à ̈ nel contempo sufficientemente flessibile per poter essere premuta dall’esterno per favore l’espulsione dell’urina. In this way, the envelope 2 therefore has a stiffness sufficient to maintain its shape, but is at the same time flexible enough to be able to be pressed from the outside to please the expulsion of the urine.
La membrana à ̈ prodotta mediante un procedimento illustrato nella domanda di brevetto WO 2007/039159 che qui si incorpora per riferimento. The membrane is produced by a process illustrated in patent application WO 2007/039159 which is incorporated herein by reference.
A titolo di esempio, il silicone utilizzato può essere costituito da copolimeri di dimetil- e metavinil-silossano rinforzati di silicio. By way of example, the silicone used may consist of silicon-reinforced dimethyl- and metavinyl-siloxane copolymers.
Vantaggiosamente, il silicone può essere additivato con additivi radio opacizzanti come solfato di bario, biossido di titanio o simili, in modo che l’endoprotesi 1 sia rilevabile mediante tecniche diagnostiche radiologiche. Advantageously, the silicone can be added with radio-opacifying additives such as barium sulphate, titanium dioxide or the like, so that the endoprosthesis 1 is detectable by radiological diagnostic techniques.
Sia sulla superficie interna 2a che sulla superficie interna 2b dell’involucro 2 sono applicati rispettivi strati di materiale altamente biocompatibile di protezione. A titolo di esempio, tale materiale à ̈ carbonio turbostratico pirolitico con uno spessore compreso tra 0,2 µm e 0,3 µm. Respective layers of highly biocompatible protective material are applied both on the internal surface 2a and on the internal surface 2b of the envelope 2. By way of example, this material is pyrolytic turbostratic carbon with a thickness between 0.2 µm and 0.3 µm.
L’applicazione dello strato di carbonio sulla superficie esterna 2b dell’involucro 2 consente di evitare il rischio che la capsula fibrotica in formazione aderisca all’involucro 2 stesso. The application of the carbon layer on the external surface 2b of the envelope 2 avoids the risk that the forming fibrotic capsule adheres to the envelope 2 itself.
L’applicazione dello strato di carbonio sulla superficie interna 2a dell’involucro 2 consente di proteggere l’involucro 2 stesso dalla corrosione causata dall’urina. The application of the carbon layer on the inner surface 2a of the casing 2 protects the casing 2 from corrosion caused by urine.
L’involucro 2 comprende inoltre un connettore 3 fissato all’involucro 2 per consentire il collegamento dell’uretra del paziente all’endoprotesi 1. The housing 2 also includes a connector 3 fixed to the housing 2 to allow the connection of the patient's urethra to the endoprosthesis 1.
In accordo con quanto illustrato, il connettore 3 à ̈ di forma troncoconica ed à ̈ incollato involucro 2 in corrispondenza di un’apertura 4 praticata nella membrana per consentire la fuoriuscita dell’urina. In particolare, il connettore 3 à ̈ incollato involucro 2 in corrispondenza di una sua base maggiore. In accordance with what is illustrated, the connector 3 has a truncated cone shape and is glued to the casing 2 in correspondence with an opening 4 made in the membrane to allow urine to escape. In particular, the connector 3 is glued to the casing 2 at its major base.
Secondo una forma realizzativa preferita, il connettore 3 ha un’altezza di 15 mm e la base maggiore di 24 mm. Inoltre, il diametro del foro in corrispondenza della base minore à ̈ di circa 6 mm e lo spessore di circa 1 mm. According to a preferred embodiment, the connector 3 has a height of 15 mm and a larger base of 24 mm. Furthermore, the diameter of the hole at the smaller base is about 6 mm and the thickness of about 1 mm.
Il connettore 3 à ̈ realizzato in silicone rinforzato internamente con una rete o retina inserita nello spessore. Tale rete o retine à ̈ realizzata preferibilmente in Dacron® o Goretex®. Il connettore 3 à ̈ realizzato mediante tecniche note come, ad esempio, stampaggio, dipping o simili. Connector 3 is made of internally reinforced silicone with a mesh or mesh inserted in the thickness. This net or nets are preferably made of Dacron® or Goretex®. The connector 3 is made by known techniques such as, for example, molding, dipping or the like.
La rete consente di suturare in maniera più semplice e stabile l’uretra del paziente al connettore 3. The mesh makes it easier and more stable to suture the patient's urethra to connector 3.
L’endoprotesi 1 comprende inoltre due elementi di connessione 5 tubolari che sono fissati, ad esempio mediante incollaggio, all’involucro 2 e sono collegabili agli ureteri del paziente. Gli elementi di connessione 5 sono disposti in posizione sostanzialmente opposta al connettore 3. The endoprosthesis 1 also comprises two tubular connection elements 5 which are fixed, for example by gluing, to the casing 2 and can be connected to the patient's ureters. The connection elements 5 are arranged in a position substantially opposite to the connector 3.
In accordo con la presente invenzione, l’endoprotesi 1 comprende un rivestimento 6 che avvolge almeno l’involucro 2. Preferibilmente, i rivestimento 6 avvolge anche il connettore 3 e gli elementi di connessione 5. In accordance with the present invention, the endoprosthesis 1 comprises a coating 6 which surrounds at least the housing 2. Preferably, the coating 6 also surrounds the connector 3 and the connection elements 5.
Il rivestimento 6 à ̈ realizzato in un tessuto di fibre di PGA (acido poliglicolico o poliglicolide), preferibilmente omopolimero. Il PGA à ̈ un polimero altamente biocompatibile e riassorbibile e resistente all’urina. In dettaglio, il tempo di riassorbimento del PGA à ̈ circa un mese. The coating 6 is made of a fabric of PGA fibers (polyglycolic acid or polyglycolide), preferably homopolymer. PGA is a highly biocompatible and resorbable and urine resistant polymer. In detail, the reabsorption time of the PGA is about one month.
Il tessuto del rivestimento 6 può essere ottenuto intrecciando in vari modi il filato di PGA, dando origine a un tessuto knit, un tessuto woven o un tessuto non tessuto. The fabric of the covering 6 can be obtained by interweaving the PGA yarn in various ways, giving rise to a knit fabric, a woven fabric or a non-woven fabric.
Preferibilmente, il tessuto del rivestimento 6 à ̈ un tessuto knit, ancor più preferibilmente un tessuto warp knit. Preferably, the cover fabric 6 is a knit fabric, even more preferably a warp knit fabric.
In tal caso, il tessuto del rivestimento 6 à ̈ dotato di una superficie con rugosità maggiore e in grado di assumere una configurazione a rete con maglie sufficientemente piccole. In this case, the fabric of the cover 6 has a surface with greater roughness and capable of assuming a mesh configuration with sufficiently small meshes.
In dettaglio, la sua trama à ̈ tale che il suo spazio interstiziale à ̈ inferiore a 200 µm, preferibilmente intorno a 160 µm, corrispondente ad un’area media dei fori pari a circa 0,02 mm<2>. Ciò garantisce una impermeabilità all’urina, evitando perdite. In detail, its texture is such that its interstitial space is less than 200 µm, preferably around 160 µm, corresponding to an average area of the holes equal to about 0.02 mm <2>. This guarantees an impermeability to urine, avoiding leaks.
Inoltre, una volta che l’endoprotesi à ̈ inserita, il rivestimento di impregna di sangue ed in particolare di plasma, il che consente ai farmaci antibiotici di essere efficaci. Furthermore, once the endoprosthesis is inserted, the coating impregnates with blood and in particular with plasma, which allows antibiotic drugs to be effective.
Inoltre, il tessuto del rivestimento 6 à ̈ preferibilmente testurizzato in modo tale da conferirgli ancora maggiore rugosità superficiale e maggiore rigidità ed impermeabilità . La maggiore rugosità del tessuto limita il rischio di aderenze della capsula fibrotica. Furthermore, the fabric of the covering 6 is preferably textured in such a way as to give it even greater surface roughness and greater rigidity and impermeability. The greater roughness of the tissue limits the risk of adhesions of the fibrotic capsule.
A puro titolo di esempio, il tessuto del rivestimento 6 ha uno spessore sostanzialmente compreso tra 0,3 mm e 0,6 mm, più preferibilmente compreso tra 0,4 mm e 0,53 mm, ancor più preferibilmente essendo sostanzialmente 0,45 mm. Inoltre, il filato con cui à ̈ realizzato il tessuto del rivestimento 6 ha una densità compresa tra 50 e 200 denier. Purely by way of example, the fabric of the covering 6 has a thickness substantially comprised between 0.3 mm and 0.6 mm, more preferably comprised between 0.4 mm and 0.53 mm, even more preferably being substantially 0.45 mm . Furthermore, the yarn with which the fabric of the cover 6 is made has a density between 50 and 200 denier.
Il rivestimento 6 à ̈ posto esternamente all’involucro 2. In altre parole, il rivestimento 6 à ̈ affacciato alla superficie esterna 2b dell’involucro 2. The cladding 6 is placed externally to the casing 2. In other words, the cladding 6 faces the external surface 2b of the casing 2.
Vantaggiosamente, il rivestimento 6 non aderisce all’involucro 2. Advantageously, the coating 6 does not adhere to the shell 2.
In fase di realizzazione dell’endoprotesi 1, il rivestimento 6, aperto, à ̈ avvolto attorno dall’involucro 2 in modo tale che sia avvolto inoltre attorno al connettore 3 e agli elementi di connessione 5. When making endoprosthesis 1, the open cover 6 is wrapped around the casing 2 so that it is also wrapped around the connector 3 and the connecting elements 5.
Il rivestimento 6 Ã ̈ poi richiuso mediante una cucitura effettuata con un fili riassorbibile. The cover 6 is then closed by a seam made with an absorbable thread.
Vantaggiosamente, il tessuto in fibra di PGA con cui à ̈ realizzato il rivestimento 6 consente la formazione di tessuto muscolo-fibrotico esternamente alla endoprotesi 1. Advantageously, the PGA fiber fabric with which the coating 6 is made allows the formation of muscle-fibrotic tissue outside the endoprosthesis 1.
Internamente, e precisamente tra l’involucro 2 ed il rivestimento 6, si assiste, durante il riassorbimento, alla formazione di uno strato di epitelio di transizione, che viene anche chiamato urotelio, rivolto internamente. Vantaggiosamente, lo strato di urotelio à ̈ impermeabile, fatto essenziale per garantire il corretto funzionamento della protesi e della neovescica che viene formandosi. Internally, and precisely between the envelope 2 and the lining 6, there is, during the resorption, the formation of a transitional epithelium layer, which is also called urothelium, facing internally. Advantageously, the urothelium layer is impermeable, an essential fact to guarantee the correct functioning of the prosthesis and of the newly formed bladder.
Durante l’impianto dell’endoprotesi 1, l’uretra e gli ureteri del paziente vengono collegati rispettivamente al connettore 3 e agli elementi di connessione 5 in modo tale che entrino in contatto e suturati con il rivestimento 6 con un filo riassorbibile. In questo modo, durante il riassorbimento l’uretra e gli ureteri si fondono con il tessuto biologico in formazione. During the implantation of the endoprosthesis 1, the patient's urethra and ureters are connected respectively to the connector 3 and to the connecting elements 5 so that they come into contact and sutured with the cover 6 with an absorbable thread. In this way, during resorption, the urethra and ureters merge with the forming biological tissue.
In tal modo, dopo che il processo di riassorbimento del rivestimento 6 si à ̈ concluso, risulta formata una neovescica formata da tessuto muscolo-fibrotico rivestito di urotelio. In altre parole, la neovescica appena formata presenta caratteristiche strutturali e di impermeabilità sufficienti per un corretto funzionamento della stessa. In this way, after the reabsorption process of the lining 6 is completed, a neobladder is formed formed by muscle-fibrotic tissue lined with urothelium. In other words, the newly formed neobladder has structural and waterproofing characteristics that are sufficient for its correct functioning.
L’involucro 2 di silicone non à ̈ dunque indispensabile per la funzionalità della neovescica e può essere rimosso mediante un successivo intervento. The silicone shell 2 is therefore not essential for the functionality of the neobladder and can be removed by a subsequent operation.
L’endoprotesi 1 in accordo con la presente invenzione risulta pertanto di natura temporanea. L’invenzione raggiunge lo scopo preposto. The endoprosthesis 1 in accordance with the present invention is therefore of a temporary nature. The invention achieves the intended purpose.
Infatti, dal momento che l’endoprotesi à ̈ temporanea e che l’involucro di materiale non riassorbile viene rimosso dopo il termine del processo di riassorbimento del rivestimento, la neovescica del paziente sarà costituita solo di materiale biologico. In fact, since the endoprosthesis is temporary and that the envelope of non-resorbable material is removed after the end of the resorption process of the lining, the patient's neobladder will only be made up of biological material.
Nel caso in cui esso sia affetto da infezioni batteriche, l’uso di terapie antibiotiche sarà pienamente efficace in quanto agirà esclusivamente su tessuto biologico e non artificiale. In the event that it is affected by bacterial infections, the use of antibiotic therapies will be fully effective as it will act exclusively on biological and not artificial tissue.
Claims (8)
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT001709A ITMI20121709A1 (en) | 2012-10-11 | 2012-10-11 | ORTHOTOPIC ENDOPROSTHESIS OF ARTIFICIAL BLADDER |
| PCT/IB2013/059253 WO2014057444A1 (en) | 2012-10-11 | 2013-10-10 | Orthotopic artificial bladder endoprosthesis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT001709A ITMI20121709A1 (en) | 2012-10-11 | 2012-10-11 | ORTHOTOPIC ENDOPROSTHESIS OF ARTIFICIAL BLADDER |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ITMI20121709A1 true ITMI20121709A1 (en) | 2014-04-12 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| IT001709A ITMI20121709A1 (en) | 2012-10-11 | 2012-10-11 | ORTHOTOPIC ENDOPROSTHESIS OF ARTIFICIAL BLADDER |
Country Status (2)
| Country | Link |
|---|---|
| IT (1) | ITMI20121709A1 (en) |
| WO (1) | WO2014057444A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2015159185A1 (en) * | 2014-04-14 | 2015-10-22 | Antonio Sambusseti | Orthotopic artificial bladder endoprosthesis |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2015140251A1 (en) * | 2014-03-21 | 2015-09-24 | Antonio Sambusseti | Drainage tube for urine in silicone with carbon coating for supporting an absorbable device for tissue reconstruction of urethral segment |
| WO2016051333A1 (en) * | 2014-09-30 | 2016-04-07 | Antonio Sambusseti | Orthotopic artificial bladder endoprosthesis |
| EP3200722A1 (en) * | 2014-09-30 | 2017-08-09 | Antonio Sambusseti | Orthotopic artificial bladder endoprosthesis |
| BR112017007676A2 (en) * | 2014-10-14 | 2017-12-19 | sambusseti Antonio | bone regeneration device |
| ITUB20161129A1 (en) * | 2016-02-26 | 2017-08-26 | Scuola Superiore Di Studi Univ E Di Perfezionamento Santanna | ARTIFICIAL BLADDER |
| CN106388971B (en) * | 2016-12-06 | 2018-08-07 | 沈阳艾米奥生物工程技术研发中心有限公司 | Artificial bladder's intelligent controlling device |
| CN106580517B (en) * | 2017-01-23 | 2018-05-25 | 夏生俊 | A kind of artificial urinary bladder device |
| IT201800006814A1 (en) * | 2018-06-29 | 2019-12-29 | EXPANDER FOR ORTHOTOPIC ENDOPROTESIS OF ARTIFICIAL BLADDER |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007039160A1 (en) * | 2005-10-03 | 2007-04-12 | Antonio Sambusseti | Patch for replacement of a portion of bladder wall following partial cystectomy |
| WO2011064110A1 (en) * | 2009-11-27 | 2011-06-03 | Antonio Sambusseti | Absorbable patch in pga for the replacement of a portion of bladder wall following partial cystectomy |
| WO2011160875A1 (en) * | 2010-06-25 | 2011-12-29 | Antonio Sambusseti | Orthotopic artificial bladder prosthesis |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ITMI20051853A1 (en) | 2005-10-03 | 2007-04-04 | Sambusseti Antonio | ORTHOTOPIC ENDOPROSTHESIS OF ARTIFICIAL BLADDER AND RELATIVE PRODUCTION METHOD |
-
2012
- 2012-10-11 IT IT001709A patent/ITMI20121709A1/en unknown
-
2013
- 2013-10-10 WO PCT/IB2013/059253 patent/WO2014057444A1/en active Application Filing
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007039160A1 (en) * | 2005-10-03 | 2007-04-12 | Antonio Sambusseti | Patch for replacement of a portion of bladder wall following partial cystectomy |
| WO2011064110A1 (en) * | 2009-11-27 | 2011-06-03 | Antonio Sambusseti | Absorbable patch in pga for the replacement of a portion of bladder wall following partial cystectomy |
| WO2011160875A1 (en) * | 2010-06-25 | 2011-12-29 | Antonio Sambusseti | Orthotopic artificial bladder prosthesis |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2015159185A1 (en) * | 2014-04-14 | 2015-10-22 | Antonio Sambusseti | Orthotopic artificial bladder endoprosthesis |
| US10092389B2 (en) | 2014-04-14 | 2018-10-09 | Antonio Sambusseti | Orthotopic artificial bladder endoprosthesis |
| EA031708B1 (en) * | 2014-04-14 | 2019-02-28 | Антонио Самбуссети | Orthotopic artificial bladder endoprosthesis |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2014057444A1 (en) | 2014-04-17 |
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