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WO2007039159A1 - Prothese vesicale artificielle orthotopique et procede de production de celle-ci - Google Patents

Prothese vesicale artificielle orthotopique et procede de production de celle-ci Download PDF

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Publication number
WO2007039159A1
WO2007039159A1 PCT/EP2006/009273 EP2006009273W WO2007039159A1 WO 2007039159 A1 WO2007039159 A1 WO 2007039159A1 EP 2006009273 W EP2006009273 W EP 2006009273W WO 2007039159 A1 WO2007039159 A1 WO 2007039159A1
Authority
WO
WIPO (PCT)
Prior art keywords
prosthesis
membrane
orthotopic
silicone
holes
Prior art date
Application number
PCT/EP2006/009273
Other languages
English (en)
Inventor
Antonio Sambusseti
Original Assignee
Antonio Sambusseti
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 Antonio Sambusseti filed Critical Antonio Sambusseti
Publication of WO2007039159A1 publication Critical patent/WO2007039159A1/fr

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
    • A61F2/02—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
    • 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
    • A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61L2430/22—Materials or treatment for tissue regeneration for reconstruction of hollow organs, e.g. bladder, esophagus, urether, uterus

Definitions

  • the present invention refers to an orthotopic artificial bladder prosthesis and a production method thereof.
  • a first solution is based on the possibility of removing the original natural bladder and replacing it with an orthotopic ileal bladder of bowel turned inside out. That is to say, during the surgical session the original bladder affected by total malignancy is removed and replaced with a new bladder obtained by cutting and fashioning the patient's bowel wall in situ, taking care to wash and clean it carefully to eliminate any source of infection, due above all to the intestinal mucus.
  • bladder prostheses obtained with the bowel wall are excessively small, having a volume of about 200 - 300 cm 3 . Furthermore these artificial bladder prostheses obtained with the bowel wall have a short average life. They are indeed unable to go beyond a life of 10 years, because of tearing of the intestinal wall which wears out in a period of less than 2-3 years.
  • a second solution consists in removing the original natural bladder without replacing it.
  • the patient's ureters are connected to two respective catheters (stents) which, passing through the lumbar wall, are iserted into two bags situated on the patients sides. These bags must be worn for life by the patient and replaced periodically to avoid infections. The bags are emptied by the patient himself whenever necessary, several times in the course of the day, by means of a special tap connected to a valve.
  • Object of the present invention is to overcome the drawbacks of the prior art, providing an orthotopic artifical bladder which is able to replace the natural bladder and which allows a considerable improvement in the patient's quality of life.
  • Another object of the present invention is to provide such an orthotopic artificial bladdes prosthesis that is reliable and long-lasting.
  • Yet another object of the present invention is to provide such an orthotopic artificial bladder prosthesis that is simple to produce.
  • the orthotopic artificial bladder prosthesis according to the invention comprises an enclosure or bag or balloon made from a multi-layered membrane of soft silicone, with a thickness of about 600 micro so as to be compressible, deflatable and collapsible.
  • Figure 1 is a perspective view of the orthotopic artificial bladder prosthesis according to the invention, connnected to the ureters and to the urethra; and Figure 2 is an enlarged cross sectional view of a portion of the prosthesis, in which the section is taken along the sectional plane II-II of Figure 1.
  • the prosthesis according to the invention consists of an enclosure or bag or balloon made from a multi-layered membrane 2 (Figure 2) of soft silicone, with a thickness of about 600 microns so as to be compressible, deflatable and collapsible.
  • the silicone used can consist, for example, of copolymers of dimethyl and netavinyl siloxane, reinforced with silicon.
  • a medical silicone is preferably used, such as for example that known by the code number MED 4735TM and marketed by Nusil Technology.
  • the multi-layered membrane 2 is preferably obtained starting from the silicone raw material, by means of a manufacturing procedure known as dipping. By means of machinery known as dipping equipment, a balloon or bag is created starting from a single layer of silicone and overlapping other layers on top of each layer until the desired thickness of about 600 microns is reached.
  • the membrane of the prosthesis 1 preferably consists of 20 layers of silicone, each having a thickness of about 30 microns.
  • This multi-layer dipping method consists in forming a first layer, evaporating it with cyclohexane for 10 minutes, overlapping the second layer, evaporating it, again with cyclohexane, for 10 minutes, and so on up to the last layer.
  • the layered silicone membrane 2 is in a semiliquid state; then, it is placed in an oven for vulcanization, at a temperature of about 150 0 C for a time ranging from 30 min to 1 h, according to the size of the prosthesis 1 that is to be produced.
  • the multi-layered silicone membrane 2 is in its optimal consistency of softness and elasticity, and no longer in the semi-liquid state.
  • the last, outermost layer 3 of the silicone membrane is advantageously texturised so as to obtain a rough surface which serves to reduce the risk of adhesion of the fibrotic capsule to the prosthesis 1.
  • the texturising process involves only the last layer 3. Once the last layer of silicone 3 has been applied by dipping, it is evaporated with cyclohexane for 10 minutes and is sprinkled with normal cooking salt (NaCl) before vulcanization. The silicone membrane with the salted final layer 3 is then placed in the oven for vulcanization.
  • the prosthesis 1 is provided with three holes 5, 5' and 6 having a larger diameter than the diameter of the ureters 20,20' and the urethra 21.
  • the two holes 5, 5' disposed in the top part of the prosthesis are suitable to receive the ureters 20, 20'; whilst the hole 6 disposed in the bottom part of the prosthesis is larger in diameter and is suitable to receive the urethra 21.
  • holes 5, 5' and 6 are made with a special surgical instrument consisting of a handpiece or punch, with a tip with a square section 3 cm long and a final diameter between 8 and 14 charrrier (Ch), to comply with the possible dimensions of the ureters 20, 20' and the urethra 21.
  • a special surgical instrument consisting of a handpiece or punch, with a tip with a square section 3 cm long and a final diameter between 8 and 14 charrrier (Ch), to comply with the possible dimensions of the ureters 20, 20' and the urethra 21.
  • the holes 5, 5' and 6 are closed by respective portions of membrane 7, 7' and 8 similar to the multi-layered membrane 2 which forms the bag of the prosthesis 1.
  • the portions of membrane 7, T and 8 can be without the texturized layer.
  • the portions of membrane 7, T and 8 are applied to the inner surface of the prosthesis 1 from the inside, by means of melting of the silicones into a single layer with the bag membrane 2, and subsequent vulcanization in an oven.
  • the inner surface of the prosthesis 1 is coated with a microfilm 4 of highly biocompatible biomaterial, such as for example pyrolytic turbostratic carbon, with a thickness of about 0,2 - 0,3 microns.
  • a microfilm 4 of highly biocompatible biomaterial such as for example pyrolytic turbostratic carbon
  • the inner coating 4 of biomaterial is carried out by making a large hole on the bottom of the prosthesis 1 , during construction, which then serves to turn the prosthesis inside out like a glove and carry out the coating with the layer of pyrolytic carbon 4 on the inner surface.
  • the hole for turning the prosthesis inside out can be the same hole 6 as for the urethra.
  • the whole processing cycle is performed in a controlled atmosphere, that is with controlled contamination, in a clean room.
  • the prosthesis is placed in a double blister pack closed with a sheet of Tyvek to avoid contamination, and sent to an ETO (ethylene oxide) sterilization cycle.
  • ETO ethylene oxide
  • the prosthesis 1 is ready to be used in a surgical session.
  • the surgeon makes three holes 9, 9' and 10 in the three portions of membrane 7, T and 8, respectively.
  • the surgeon can use the same handpiece or punch used to pierce the membrane 2.
  • the tip of the handpiece is 3 cm long, there is no risk of it may pass through the wall of the prosthesis on the other side.
  • the tip of the punch is chosen according to the size of the urethra 21 or ureters 20, 20', and the holes 9, 9' and 10 are made of the Ch measurement that the surgeon considers appropriate according to the size of the ureters 20, 20' or the urethra 21 during the surgical session.
  • the ureters 20, 20' and urethra 21 are inserted into the respective holes 9, 9' and 10, which are elastic, that is, they tighten slightly around the tube of the ureter 20, 20' or the urethra 21. Then, the portions of membrane 7, 7' and 8 are fixed respectively to the ureters 20, 20' and to the urethra 21 itself by means of four suture stitches 11, 11 ' and 12 disposed in a square, around the tube of the ureter 20, 20' and the urethra 21 and passing through the membrane and through the tissue of the ureters and the urethra.
  • Monocryl EthiconTM 4-0 e 5-0 thread can be used, produced by Johnson & Johnson and consisting of polyglecaprone, that is: a coplymer made by synthesis of glycolide (75%) and epsilon caprolactone (25%).
  • This thread is not coated, is monofilament and is not braided. The manufacturer indicates this thread as the most suitable for sutures in general for soft tissue and vessels, amongst which are included the ureters and urethra.
  • the holes for passage of the suture stitches 11, 11 ' and 12 in the ureters 20, 20' and in the urethra 21 do not constitue a risk of leakage of liquid, in that in a few hours the tissue reforms.
  • the suture stitch holes in the portions of membrane 7, T and 8 are bonded and closed with one cc (one drop) of surgical glue, such as Glubran 2TM for example, normally available commercially.
  • the MonocrylTM thread used for the suture stitches is absorbed in about 90-120 days, but begins its downward curve of loss of tension on the 22nd day, ending and losing 75% of its tensile strength on the 28th day. From the 28th day tensile strength is no longer present in the thread, but by this date the ureters 20, 20' and the urethra 21 are kept fixed by the glue and above all by the formation of the fibrotic capsule which acts as a retaining element for the ureters and urethra. It should be noted that the fibrotic or polyproteic capsule forms in about 30 days.
  • the simulation was tested by inflating the artificial bladder prosthesis with water and no leakage occurred from the suture stitches. Considering the remarkable larger size of the thread used, the real holes in the surgical session should not have any urine leakage.
  • the prosthesis 1 has a capacity of between 500 and 900 cm 3 and is collapsible. That is to say the filling and emptying mechanism of the prosthesis 1 works through the pressure differences between the air inside the prosthesis and the air outside the prosthesis.
  • the patient In order to empty the prosthesis 1 , the patient must exert pressure manually on the lower abdomen over the bladder, so as to press the prosthesis 1 to overcome the outside pressure. In this manner the urine contained in the prosthesis 1 exits through the urethra 21 and the prosthesis 1 is emptied of air and is ready to receive urine again.

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Urology & Nephrology (AREA)
  • Pulmonology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Prostheses (AREA)

Abstract

Cette invention concerne une prothèse vésicale artificielle orthotopique (1) qui comprend une enceinte, une poche ou un ballonnet formé par une membrane multicouche (2) de silicone mou dont l'épaisseur est environ égale à 600 microns de façon à être compressible, dégonflable et pliable.
PCT/EP2006/009273 2005-10-03 2006-09-25 Prothese vesicale artificielle orthotopique et procede de production de celle-ci WO2007039159A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT001853A ITMI20051853A1 (it) 2005-10-03 2005-10-03 Endoprotesi ortotopica di vescica artificiale e relativo metodo di produzione
ITMI2005A001853 2005-10-03

Publications (1)

Publication Number Publication Date
WO2007039159A1 true WO2007039159A1 (fr) 2007-04-12

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PCT/EP2006/009273 WO2007039159A1 (fr) 2005-10-03 2006-09-25 Prothese vesicale artificielle orthotopique et procede de production de celle-ci

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IT (1) ITMI20051853A1 (fr)
WO (1) WO2007039159A1 (fr)

Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009033528A1 (fr) * 2007-09-13 2009-03-19 Antonio Sambusseti Pièce pour remplacer une partie d'une paroi de vessie
WO2009077047A1 (fr) * 2007-12-18 2009-06-25 Antonio Sambusetti Endoprothèse de vessie artificielle orthotopique de type poche
ITMI20090004A1 (it) * 2009-01-07 2010-07-08 Antonio Sambusseti Endoprotesi ortotopica di vescica artificiale
WO2011160875A1 (fr) 2010-06-25 2011-12-29 Antonio Sambusseti Prothèse de vessie artificielle orthotopique
WO2012104380A1 (fr) 2011-02-04 2012-08-09 Antonio Sambusseti Greffe biocompatible, en silicone revêtu, pour un implant permanent à la suite d'une excision de la plaque ipp
WO2012120326A1 (fr) 2011-03-09 2012-09-13 Pinzi Novello Structure de vessie artificielle
ITMI20120646A1 (it) * 2012-04-18 2013-10-19 Sambusseti Antonio Dispositivo tubolare permanente per la ricostruzione di un segmento uretrale o ureterale realizzato in silicone rivestito con carbonio pirolitico turbostratico
WO2014045190A1 (fr) 2012-09-19 2014-03-27 Antonio Sambusseti Endoprothèse de vessie artificielle orthotopique
WO2014057444A1 (fr) 2012-10-11 2014-04-17 Antonio Sambusseti Endoprothèse de vessie artificielle orthotopique
ITMI20121809A1 (it) * 2012-10-24 2014-04-25 Antonio Sambusseti Sistema di anastomosi per un'endoprotesi vescicale
ITMI20130799A1 (it) * 2013-05-15 2014-11-16 Antonio Sambusseti Endoprotesi ortotopica di vescica artificiale con migliorate proprieta' antireflusso
WO2015071472A1 (fr) 2013-11-18 2015-05-21 Antonio Sambusseti Prothèse orthoptique de vessie artificielle intégrant des endoprothèses urétérales
WO2015087250A1 (fr) 2013-12-12 2015-06-18 Antonio Sambusseti Endoprothèse de vessie artificielle orthotopique
WO2016075650A1 (fr) 2014-11-13 2016-05-19 Antonio Sambusseti Dispositif élastique pour la reconstruction des coiffes des rotateurs
US9750597B2 (en) 2012-10-16 2017-09-05 Antonio Sambusseti Orthotopic artificial bladder endoprosthesis
US10092389B2 (en) 2014-04-14 2018-10-09 Antonio Sambusseti Orthotopic artificial bladder endoprosthesis
US10507095B2 (en) 2014-11-13 2019-12-17 Antonio Sambusseti Resorbable device for reconstructing rotator cuffs
WO2020002530A1 (fr) 2018-06-29 2020-01-02 DORDONI, Bianca Extenseur pour endoprothèse de vessie artificielle orthotopique

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4044401A (en) * 1975-08-04 1977-08-30 Jacques Guiset Artificial bladder
US5041136A (en) * 1989-10-27 1991-08-20 General Electric Company Implantable artificial soft bladder system
WO1995011637A1 (fr) * 1993-10-29 1995-05-04 Sure, Besloten Vennootschap Met Beperkte Aansprakelijkheid Prothese de la vessie
WO1996031173A1 (fr) * 1995-04-06 1996-10-10 Biomedica Sviluppo S.R.L. Prothese de vessie avec une valve
FR2759575A1 (fr) * 1997-02-14 1998-08-21 Assist Publ Hopitaux De Paris Implant artificiel destine au remplacement de l'appareil excreteur urinaire chez l'etre humain

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4044401A (en) * 1975-08-04 1977-08-30 Jacques Guiset Artificial bladder
US5041136A (en) * 1989-10-27 1991-08-20 General Electric Company Implantable artificial soft bladder system
WO1995011637A1 (fr) * 1993-10-29 1995-05-04 Sure, Besloten Vennootschap Met Beperkte Aansprakelijkheid Prothese de la vessie
WO1996031173A1 (fr) * 1995-04-06 1996-10-10 Biomedica Sviluppo S.R.L. Prothese de vessie avec une valve
FR2759575A1 (fr) * 1997-02-14 1998-08-21 Assist Publ Hopitaux De Paris Implant artificiel destine au remplacement de l'appareil excreteur urinaire chez l'etre humain

Cited By (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009033528A1 (fr) * 2007-09-13 2009-03-19 Antonio Sambusseti Pièce pour remplacer une partie d'une paroi de vessie
AP3021A (en) * 2007-09-13 2014-11-30 Antonio Sambusseti Patch for replacing a portion of bladder wall
WO2009077047A1 (fr) * 2007-12-18 2009-06-25 Antonio Sambusetti Endoprothèse de vessie artificielle orthotopique de type poche
JP2012514481A (ja) * 2009-01-07 2012-06-28 サンブセッティ，アントニオ 同所性人工膀胱装具
CN102271621A (zh) * 2009-01-07 2011-12-07 安东尼奥·桑布塞蒂 原位人造膀胱假体
WO2010078949A1 (fr) 2009-01-07 2010-07-15 Antonio Sambusseti Prothèse de vessie artificielle orthotopique
AU2009336804B2 (en) * 2009-01-07 2013-08-01 Antonio Sambusseti Orthotopic artificial bladder prosthesis
ITMI20090004A1 (it) * 2009-01-07 2010-07-08 Antonio Sambusseti Endoprotesi ortotopica di vescica artificiale
WO2011160875A1 (fr) 2010-06-25 2011-12-29 Antonio Sambusseti Prothèse de vessie artificielle orthotopique
RU2561864C2 (ru) * 2010-06-25 2015-09-10 Антонио САМБУССЕТИ Протез ортотопического искусственного мочевого пузыря
JP2013533017A (ja) * 2010-06-25 2013-08-22 サンブセッティ，アントニオ 同所性人工膀胱装具
US9044310B2 (en) 2010-06-25 2015-06-02 Antonio Sambusseti Orthotopic artificial bladder prosthesis
WO2012104380A1 (fr) 2011-02-04 2012-08-09 Antonio Sambusseti Greffe biocompatible, en silicone revêtu, pour un implant permanent à la suite d'une excision de la plaque ipp
WO2012120326A1 (fr) 2011-03-09 2012-09-13 Pinzi Novello Structure de vessie artificielle
ITMI20120646A1 (it) * 2012-04-18 2013-10-19 Sambusseti Antonio Dispositivo tubolare permanente per la ricostruzione di un segmento uretrale o ureterale realizzato in silicone rivestito con carbonio pirolitico turbostratico
WO2014045190A1 (fr) 2012-09-19 2014-03-27 Antonio Sambusseti Endoprothèse de vessie artificielle orthotopique
US9393099B2 (en) 2012-09-19 2016-07-19 Antonio Sambusseti Orthotopic artificial bladder endoprosthesis
WO2014057444A1 (fr) 2012-10-11 2014-04-17 Antonio Sambusseti Endoprothèse de vessie artificielle orthotopique
US9750597B2 (en) 2012-10-16 2017-09-05 Antonio Sambusseti Orthotopic artificial bladder endoprosthesis
ITMI20121809A1 (it) * 2012-10-24 2014-04-25 Antonio Sambusseti Sistema di anastomosi per un'endoprotesi vescicale
ITMI20130799A1 (it) * 2013-05-15 2014-11-16 Antonio Sambusseti Endoprotesi ortotopica di vescica artificiale con migliorate proprieta' antireflusso
WO2015071472A1 (fr) 2013-11-18 2015-05-21 Antonio Sambusseti Prothèse orthoptique de vessie artificielle intégrant des endoprothèses urétérales
WO2015087250A1 (fr) 2013-12-12 2015-06-18 Antonio Sambusseti Endoprothèse de vessie artificielle orthotopique
US10052187B2 (en) 2013-12-12 2018-08-21 Antonio Sambusseti Orthotopic artificial bladder endoprosthesis
US10092389B2 (en) 2014-04-14 2018-10-09 Antonio Sambusseti Orthotopic artificial bladder endoprosthesis
WO2016075650A1 (fr) 2014-11-13 2016-05-19 Antonio Sambusseti Dispositif élastique pour la reconstruction des coiffes des rotateurs
JP2017533776A (ja) * 2014-11-13 2017-11-16 アントニオ・サンブッセティＡｎｔｏｎｉｏ ＳＡＭＢＵＳＳＥＴＩ 回旋筋腱板の再構成のための弾性デバイス
US10507095B2 (en) 2014-11-13 2019-12-17 Antonio Sambusseti Resorbable device for reconstructing rotator cuffs
WO2020002530A1 (fr) 2018-06-29 2020-01-02 DORDONI, Bianca Extenseur pour endoprothèse de vessie artificielle orthotopique

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