WO2012104380A1 - Greffe biocompatible, en silicone revêtu, pour un implant permanent à la suite d'une excision de la plaque ipp - Google Patents

Greffe biocompatible, en silicone revêtu, pour un implant permanent à la suite d'une excision de la plaque ipp Download PDF

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Publication number
WO2012104380A1
WO2012104380A1 PCT/EP2012/051775 EP2012051775W WO2012104380A1 WO 2012104380 A1 WO2012104380 A1 WO 2012104380A1 EP 2012051775 W EP2012051775 W EP 2012051775W WO 2012104380 A1 WO2012104380 A1 WO 2012104380A1
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WIPO (PCT)
Prior art keywords
silicone
graft
membrane
use according
previous
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Ceased
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PCT/EP2012/051775
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English (en)
Inventor
Antonio Sambusseti
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Individual
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Individual
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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
    • A61F2/0063—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
    • 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
    • A61F2/26—Penis implants

Definitions

  • BIOCOMPATIBLE GRAFT IN COATED SILICONE, FOR PERMANENT IMPLANT FOLLOWING EXCISION OF THE IPP PLAQUE
  • the present invention relates to a graft in biocompatible material to be used in the field of urology, in particular as permanent dermic implant in the excision of the IPP (induratio penis plastica) plaque due to Peyronie's disease.
  • Peyronie's disease whose cause is not yet fully known, affects the male genital organ and causes in it a varyingly accentuated penile deformity due to the presence of one or more hard fibrous plaques, with a nodular appearance, located above the cavernous bodies (corpora cavernosa) of the penis, in particular at the level of the tunica albuginea (the sheath that covers the cavernous bodies of the penis and which represents the bearing structure which determines the rigidity of the penis in erection) with irreversible degeneration of the albugineous elastic component.
  • the area of fibrosis determines a curving of the penis towards the diseased side.
  • This disease is associated with severe pain and erectile dysfunction in that the disappearance of the elastic fibres of the albuginea ⁇ which takes place in favour of the growth of the dense fibrous tissue of the plaque, constitutes an alteration of the mechanical characteristics of the cavernous bodies.
  • the current trend is that of complete excision (removal) of the plaque and a consequent replacement of the removed section with a dermic implant or graft made up of autologous tissue (that of the patient, such as for example the dermis of the patient's thigh) in that a tissue is required which undergoes a natural histological transformation, maintaining the elastic fibres contained therein, to allow the recovery of the function of the organ: in fact in the processes of tissue repair the production of elastic tissue is not foreseen but only of fibrous tissue since only fibroblasts and not elastoblasts exist in the cell matrix,
  • Implants also known as grafts, allow the restoring of the original length of the side affected by the scar retraction which shorten the length of the penis, acting at the same time as support for the autologous tissue of the patient which will form with passing time over said graft.
  • the synthetic implants in the art of corporoplasty mentioned above are little used in that their physiopathological features of grafting do not allow the reconstruction of a symmetrical and congruous cavernous albugineous membrane.
  • Another surgical technique consists of surgery of resection/incision of the plaque, excision of the albuginea and of the cavernous bodies, and implanting of a graft, preferably autologous of saphenous vein, between the albuginea and the cavernous bodies.
  • a graft preferably autologous of saphenous vein
  • the object of the present invention is to provide a permanent graft for excision of IPP which overcomes the disadvantages stated above and suffered by the prior art, in particular to provide a biocompatible graft, highly elastic, which has a reduced formation of the fibrotic capsule around it, also when replacing an extended IPP plaque, and which can be used in any type of surgical operation, corporoplastic operation or excision, without generating infections, which allows a tissue reconstruction of quality similar to the original pre-excision tissue, with low tendency towards retraction, and which does not need subsequent surgical removal.
  • Another object of the present invention is that of providing such a graft which is also easily made, economical, reliable, functional and durable.
  • the graft according to the invention for implant after the excision of the plaque of IPP (induratio penis plastica) due to Peyronie's disease is made with a highly biocompatible material made up of a soft and elastic membrane, in vulcanised silicone, having at least both the upper and lower surfaces coated by a layer of pyrolytic turbostratic carbon or amorphous diamond-like carbon, preferably by pyrolytic turbostratic carbon.
  • “Membrane” here is used to identify a sheet (or slab) in polymeric material (i.e. silicone) obtained by moulding, casting, dipping and the like, and accordingly not in the form of fabrics, gauzes, nets or the like which are instead obtained by spinning of threads/yarns deriving from polymeric fibres.
  • Amorphous diamond-like carbon is a carbon coating, white or transparent, with layered structure similar to the diamond (defined in fact as “diamond-like carbon” (DLC)) with outstanding features of surface resistance such as hardness and resistance to abrasions, as well as being well tolerated by the skin and resistant to corrosion but elastic.
  • amorphous diamond-like carbon creates smooth surfaces, without incrustations.
  • This coating of amorphous diamond-like carbon can also be “doped” with various compounds to achieve oil repellency or water repellency.
  • Said layer of coating preferably covers said membrane completely, including its lateral edges.
  • the DLC (diamond-like carbon) coating process can take place according to a known technique, such as for example PVD.
  • the coating in pyrolytic turbostratic carbon also has features of surface resistance, resistance to abrasions, resistance to corrosion, Moreover said pyrolytic turbostratic carbon is neutral when in contact with cells and micro-organisms: this entails a rapid population by the cells and an accelerated assimilation of the implanted device.
  • the silicone in fact has the tendency to co-penetrate with the polypiotein fibrotic growth (red blood cells) and to fuse with the neotissues: therefore a graft in silicone can be used for a temporary implant or graft, up to 30 days, and then has to be removed as subsequently the silicone starts to graft with the fibrotic capsule and the neotissues.
  • the tissues which are reconstructed around the present membrane in coated silicone are moreover of similar quality to the original pre-excision tissue, both that of the cavernous bodies placed below the graft and that of the tunica albuginea placed over said graft, in particular they show substantially the same original elasticity. More particularly the aforesaid coated membrane allows the tissue which goes to form over it (tunica albuginea) to grow symmetrical and congraous in that this membrane has a low tendency towards retraction.
  • the aforesaid coating materials make the synthetic membrane in silicone highly biocompatible, conferring to the graft of the present invention a series of advantages as will be described herein below.
  • the Applicant has unexpectedly found that the membrane in coated silicone as described above is able to withstand high expansions and/or elongations, both in a longitudinal and transverse direction, of approximately 2-3 times its dimensions, which enables its use as permanent implant in the excision of the IPP plaque.
  • coated silicone membranes are used currently for the temporary replacement of a portion of bladder wall which, as is known, has to withstand dilations, due to its expanding and emptylng, of a much smaller extent compared to the dilations (elongation and expansion) which a graft for permanent implant in the excision of the IPP plaque has to withstand.
  • the carbon coating described above more particularly pyrolytic turbostratic carbon, has been found to be capable of not reducing the elasticity of the underlying silicone membrane.
  • the graft in accordance with the present invention is in general planar, rectangular or square in shape, with variable dimensions according to the possible approximate dimensions of the plaque.
  • a dimensional example of this graft is 5 cm x 10 cm.
  • Said graft is in the form of a membrane and can be sutured to the incision by means of suture yarn with diameter of 3/0 or 4/0, in absorbable material, for example PGA, or a non-absorbable one.
  • the graft of the invention has at least the two upper and lower surfaces coated with pyrolytic turbostratic carbon or amorphous diamond-like carbon, and the layer of said coating appears smooth without any surface texturisation.
  • Fig. la is a plan view from above of a first embodiment of the graft
  • Fig. lb is a side view of the graft illustrated in Fig. 1 a;
  • Fig. 2a is a plan view from above of a second embodiment of the graft
  • Fig. 2b is a frontal side view of the graft of Fig. 2a;
  • Figs, 3a-3c are views illustrating the possible positionings of the graft of Fig. 1 on the penile organ in ventral, dorsal, lateral position respectively;
  • Fig. 4 is a view in cross section of a penile organ which has the IPP plaque.
  • the body of the graft 1 is formed by a multilayer membrane 2, in silicone, provided with sufficient flexibility and elasticity, in such a way as to ensure the proper functioning of the penile organ after having applied said graft.
  • the overall thickness of said membrane in silicone is not binding for the purposes of the present invention even if an example can be constituted by a value of around 600 microns.
  • the thickness of the layer of coating 3 in pyrolytic turbostratic carbon or in amorphous diamond-like carbon is also not binding for the purposes of the present invention and can be for example a microfilm of approximately 0.2 - 0.3 micron.
  • this membrane 2 can be made up of twenty layers of silicone, each one having a thickness of approximately 30 microns.
  • the multilayer membrane 2 in silicone which forms the body of the graft 1 in accordance with the invention can be made according to a known technique, for example according to what is described in the international applications WO 2007/039159 and WO 2007/039160 in the name of the Applicant. That is to say the multilayer membrane 2 of soft silicone, with a thickness of approximately 600 microns, is obtained from the raw material of silicone, by means of a procedure of processing known as dipping.
  • This technique of multilayer dipping consists of forming the first layer, making it evaporate with cyclohexane for 10 minutes, superimposing the second layer, making it evaporate again with cyclohexane for 10 minutes, and so on as far as the final layer.
  • the layered membrane 2 of silicone is in a semifluid state, and is then placed in the oven for vulcanisation, at a temperature of approximately 150°C and for a time vaiying from 30 min. to 1 h, on the basis of the size of the graft that is to be formed.
  • the multilayer membrane 2 of silicone is in its consistency of optimal elasticity and softness, and no longer in the semifluid state.
  • the silicone used can be made up, for example, of copolymers of dimethyl and metavinyl siloxane, reinforced with silicon.
  • a silicone for medical use is preferably used, such as for example the soft elastomeric silicone with high tensile strength and high elongation known by the code MED 4735TM and marketed by the company Nusil Technology.
  • This silicone has an elongation which was found to be particularly suitable for the application in the construction of a graft to be applied after excision of the IPP plaque.
  • a layer of pyrolytic turbostratic carbon or of amorphous diamond-like carbon 3 is applied according to a known technique, both on the lower surface and on the upper one of this membrane 2, preferably on all the surfaces of said membrane including the lateral edges.
  • a graft in silicone made up of the same coated membrane 2 described above yet which incorporates internally, in the thickness, a synthetic mesh 4 of reinforcement (Fig. 2a), in Dacron or another similar material, also suitable for facilitating its suturing.
  • Said mesh 4 is inserted by means of a known technique, for example, moulding, dipping or similar techniques which allow said mesh to be incorporated in a layer of silicone. Subsequently the layer 3 of pyrolytic turbostratic carbon or amorphous diamond-like carbon is applied on the surface of the membrane according to a known technique.
  • the graft 1 in accordance with the invention is intended to be placed and implanted above the cavernous bodies 10 (Figs. 3a-3c, 4), and below the tunica albuginea, after having removed (excision) the IPP plaque 11 (Fig. 4) and being sutured in proximity of the tunica albuginea 12, after having performed an incision of the dermis 15 (Fig. 4) and of the Buck's fascia 14 (Fig. 4) according to the known techniques of surgery.
  • the function of said graft 1 is to encourage, from both the quality and quantity standpoint, the re-epithelialisation and the reconstruction of the cavernous bodies and of the albuginea, damaged following excision of the IPP plaque. It should also be noted that this graft 1, thanks to the elasticity of the silicone and of the coating described above, allows the physiological movement of the male organ during and after this process of re-epithelialisation and reconstruction of the cavernous bodies and of the albuginea, that is to say also after reconstruction has occurred, without impacting on performances, so that once the graft has been implanted it no longer has to be removed.
  • said graft combines a high elasticity, understood as high elongation and/or expansion, in general equal to two -three times its dimensions at rest, with a high biocompatibility, understood as the capacity to minimise the formation of granulomas, keloids, hypertrophic tissues and infections, leading to a better quality of the tissue reconstruction, in particular of the cavernous albugineous sheath, substantially similar to the original pre-excision tissue, and with low tendency towards retraction.
  • a high elasticity understood as high elongation and/or expansion, in general equal to two -three times its dimensions at rest
  • a high biocompatibility understood as the capacity to minimise the formation of granulomas, keloids, hypertrophic tissues and infections, leading to a better quality of the tissue reconstruction, in particular of the cavernous albugineous sheath, substantially similar to the original pre-excision tissue, and with low tendency towards retraction.
  • the membrane in coated silicone in accordance with the present invention can be used in a permanent and definitive manner in the excision of the IPP plaque, without any need for removal.
  • the graft 1 is prepared in a controlled environment that is to say with controlled contamination, in a white room, Once processing has finished, the graft 1 is placed in a double blister closed with sheet of Tyvek to avoid contaminations and sent to a cycle of sterilisation with base of ETO (ethylene oxide).
  • ETO ethylene oxide

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Reproductive Health (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne une greffe (1) pour un implant permanent après l'excision de la plaque IPP (induratio penis plastica) due à la maladie de La Peyronie, caractérisée en ce qu'elle comprend une membrane élastique et souple (2), en silicone vulcanisée, qui est revêtue d'une couche (3) de carbone turbostratique pyrolytique ou de carbone diamant amorphe.
PCT/EP2012/051775 2011-02-04 2012-02-02 Greffe biocompatible, en silicone revêtu, pour un implant permanent à la suite d'une excision de la plaque ipp Ceased WO2012104380A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITMI2011A000165 2011-02-04
ITMI2011A000165A IT1403916B1 (it) 2011-02-04 2011-02-04 Graft biocompatibile in silicone rivestito per innesto a seguito di exeresi della placca di ipp

Publications (1)

Publication Number Publication Date
WO2012104380A1 true WO2012104380A1 (fr) 2012-08-09

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PCT/EP2012/051775 Ceased WO2012104380A1 (fr) 2011-02-04 2012-02-02 Greffe biocompatible, en silicone revêtu, pour un implant permanent à la suite d'une excision de la plaque ipp

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IT (1) IT1403916B1 (fr)
WO (1) WO2012104380A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITMI20130800A1 (it) * 2013-05-15 2014-11-16 Antonio Sambusseti Uso di particolari polimeri biocompatibili in ambito ortopedico, gastrointestinale, respiratorio e simili
EP2853239A1 (fr) * 2013-09-29 2015-04-01 Coloplast A/S Implant de traitement de la Peyronie
WO2016120409A1 (fr) * 2015-01-30 2016-08-04 Antonio Sambusseti Greffon résorbable et biocompatible en pga à implanter consécutivement à l'excision de la plaque ipp
WO2016193007A1 (fr) * 2015-05-29 2016-12-08 Antonio Sambusseti Prothèse ligamentaire

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999059506A1 (fr) * 1998-05-21 1999-11-25 Children's Medical Center Corporation Reconstruction penienne au moyen de tissu corporel
WO2007039159A1 (fr) 2005-10-03 2007-04-12 Antonio Sambusseti Prothese vesicale artificielle orthotopique et procede de production de celle-ci
WO2007039160A1 (fr) 2005-10-03 2007-04-12 Antonio Sambusseti Piece concue pour remplacer une partie de paroi d'une vessie a la suite du cystectomie
WO2009033528A1 (fr) * 2007-09-13 2009-03-19 Antonio Sambusseti Pièce pour remplacer une partie d'une paroi de vessie
WO2009131682A1 (fr) 2008-04-23 2009-10-29 Mardil, Inc. Patch à trois couches anti-adhérent implantable

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999059506A1 (fr) * 1998-05-21 1999-11-25 Children's Medical Center Corporation Reconstruction penienne au moyen de tissu corporel
WO2007039159A1 (fr) 2005-10-03 2007-04-12 Antonio Sambusseti Prothese vesicale artificielle orthotopique et procede de production de celle-ci
WO2007039160A1 (fr) 2005-10-03 2007-04-12 Antonio Sambusseti Piece concue pour remplacer une partie de paroi d'une vessie a la suite du cystectomie
WO2009033528A1 (fr) * 2007-09-13 2009-03-19 Antonio Sambusseti Pièce pour remplacer une partie d'une paroi de vessie
WO2009131682A1 (fr) 2008-04-23 2009-10-29 Mardil, Inc. Patch à trois couches anti-adhérent implantable

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITMI20130800A1 (it) * 2013-05-15 2014-11-16 Antonio Sambusseti Uso di particolari polimeri biocompatibili in ambito ortopedico, gastrointestinale, respiratorio e simili
EP2853239A1 (fr) * 2013-09-29 2015-04-01 Coloplast A/S Implant de traitement de la Peyronie
EP3028674A1 (fr) * 2013-09-29 2016-06-08 Coloplast A/S Implant de traitement de la peyronie
US9408696B2 (en) 2013-09-29 2016-08-09 Coloplast A/S Method of treating peyronie's disease
WO2016120409A1 (fr) * 2015-01-30 2016-08-04 Antonio Sambusseti Greffon résorbable et biocompatible en pga à implanter consécutivement à l'excision de la plaque ipp
CN107208326A (zh) * 2015-01-30 2017-09-26 安东尼奥·桑布塞蒂 用于ipp斑块切除后植入物的pga材质的可再吸收性和生物相容性移植物
JP2018503447A (ja) * 2015-01-30 2018-02-08 サンブセッティ, アントニオSAMBUSSETI, Antonio Ｉｐｐプラークの切除後のインプラントのための吸収かつ生体適合可能なｐｇａの移植片
CN107208326B (zh) * 2015-01-30 2019-06-21 安东尼奥·桑布塞蒂 用于ipp斑块切除后植入物的可再吸收性移植物
US10368992B2 (en) 2015-01-30 2019-08-06 Antonio Sambusseti Resorbable and biocompatible graft in PGA for implant following excision of the IPP plaque
WO2016193007A1 (fr) * 2015-05-29 2016-12-08 Antonio Sambusseti Prothèse ligamentaire
CN107683122A (zh) * 2015-05-29 2018-02-09 安东尼奥·桑布瑟蒂 韧带假体

Also Published As

Publication number Publication date
IT1403916B1 (it) 2013-11-08
ITMI20110165A1 (it) 2012-08-05

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