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WO2011058550A1 - Implants mammaires - Google Patents

Implants mammaires Download PDF

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Publication number
WO2011058550A1
WO2011058550A1 PCT/IL2010/000928 IL2010000928W WO2011058550A1 WO 2011058550 A1 WO2011058550 A1 WO 2011058550A1 IL 2010000928 W IL2010000928 W IL 2010000928W WO 2011058550 A1 WO2011058550 A1 WO 2011058550A1
Authority
WO
WIPO (PCT)
Prior art keywords
envelope
implant
gas
implants
implant according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IL2010/000928
Other languages
English (en)
Inventor
Itay Rozenman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
ROLAN KNOWLEDGE AND SERVICES Ltd
Original Assignee
ROLAN KNOWLEDGE AND SERVICES Ltd
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 ROLAN KNOWLEDGE AND SERVICES Ltd filed Critical ROLAN KNOWLEDGE AND SERVICES Ltd
Publication of WO2011058550A1 publication Critical patent/WO2011058550A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/12—Mammary prostheses

Definitions

  • This invention relates to female breast implants for cosmetic purposes, viz. for shaping and/or augmenting breasts, and/or for reconstruction purposes, viz. for totally or partially reconstructing breasts that have been gravely damaged, possibly destroyed, by accident or by surgery e.g. for the removal of cancerous tissue.
  • the implants of this invention comprise an envelope and a filling, wherein the filling is constituted entirely, or in substantial and preferably predominant portion, by a gas of low molecular weight, preferably helium.
  • a gas of low molecular weight preferably helium.
  • the nature and amount of said filling that is not low-molecular weight gas depends in each case on the particular purpose of the specific implant in question, as will appear hereinafter. Traces of atmosphere may remain within the implant as consequence of the way in which it has been made.
  • the envelope may be multilayered; the outermost layer is for example the silicon or polyurethane known in the art. It is essentially non distensible and will resist volume changes which usually occur as a result of pressure changes. For example, in conditions of low atmospheric pressure which occur in high altitudes and will increase the volume of distensible implants.
  • envelope is essentially impervious to the gas filler whether helium or heavier, for example perfluorocarbon.
  • Each implant may serve cosmetic purposes, such as mastopexy or augmentation, or reconstruction purposes, wherein they may be part of reconstruction, such as after mastectomy or partial or total removal of the breast by accident or surgery.
  • the implant envelope may be and generally will be constituted, at least prevalently, by at least one artificial, generally polymeric, layer and there may be a plurality of implants.
  • a single implant will generally be used for each breast and will define the volume of the reconstructed breast. It will be covered all around by layers of living host tissue.
  • An important property that may be required of the envelope is that it, or parts of it, be self-sealing.
  • a structural component will be deemed herein to be self- sealing when it automatically closes, possibly with the assistance of pressure and/or heat, any perforation that is small, preferably but not necessarily having linear dimensions up to one millimeter, such as caused by a sharp needle. Said property is particularly required when the filling has been reduced with time in an existing implant and should be reported to its proper amount.
  • Elastic polymers, natural or artificial rubber may be self-sealing
  • Example of items with self-sealing properties are plastic containers for infusions or plastic caps of medicine bottle which self seal themselves after a needle is inserted .
  • an additional patch of any suitable shape of a material that is self-sealing may be attached to it, e.g. adhesively, any needed perforations will be carried out through said patch and will be self-sealed, whereby to screen the underlying perforation that will not be sealed.
  • a flat sheet may be generated; pieces of the appropriate shape may be cut from it and connected to make a flat/deflated pocket that will form the implant envelope.
  • the filling gas e.g. helium
  • the filling gas may be injected into said pocket in the quantity required to form the desired filling, and the envelope may be sealed or allowed to seal.
  • a thermoplastic material may be extruded to form the envelope from an extruder provided with an addition nozzle, a gas may be fed through said addition nozzle to form the filling by extruding it inside the envelope as it is formed by extrusion of said material, and finally said envelope may be sealed or allowed to seal.
  • the envelope material may be extruded or otherwise shaped, the filling gas may fed inside said envelope in such a way and quantity as to replace all or most of the unwanted gas it contains and, if required, to press said envelope material against said connective tissue to form the desired envelope, which finally may be sealed or allowed to seal.
  • An additional envelope layer may also be created by dipping an implant having the proper desired shape into a solution containing a solute that will form, upon drying/polymerization an outer skin about the implant and over its-envelope, or dipping the implant into a liquid that will form, upon drying/polymerization, such an outer skin.
  • a two-layer, or even a multiple-layer, envelope which will render the implant as gas-tight as possible and also increase its resistance to volume changes under pressure.
  • the liquid or solution into which the implant is dipped may be absorbed by the original envelope, so that upon drying they will not be formed an additional, outer envelope, but will modify the physical properties of the existing envelope, e.g. increase its resistance to pressure or its capability of sealing the implant content against the outside and preventing leakage of said content or penetration of other substances from the outside into the implant.
  • a factor to be considered when designing implants is the weight. Heavy implants will favor and may even cause gradual sagging. Light implants will prevent sagging.
  • a light envelope with a helium filling makes the lightest implants. Heavier gases may be added, nitrogen and C02 or perfluorocarbon being possible examples.
  • More impervious envelopes may be double envelopes, with layers made of different materials, silicone envelopes, envelopes made out of other polymers, to stop as much gas as possible from leaking out through the envelope.
  • Said implants are impervious to filling "bleeding" outside the envelope in the human body
  • implants are very light and will not succumb to gravity and will not sag with time. 4. They will be made from such non distensible material that their volume is not affected by external pressure - for example during flight.
  • This implant can be introduced into the surgical pocket under the breast through a smaller than currently used skin incision, since it will be introduced empty and deflated into position in the breast and will be filled to the desired volume while in the breast, through a nozzle which can derive from the way the envelope is generated or can be created afterwards.
  • the volume of this implant can be changed post-implantation according to the patient's desire. Gas can be added or withdrawn through said nozzle or through the self-sealing area in the envelope / patch.
  • the implant which has a very low weight renders the breast less mobile and less droopy thereby serve as an internal support to the breast and obviate the need for a bra.
  • Fig.1 Coronal section through the implant.
  • Fig. 2 Sagital section through a subpectoral implant in situ.
  • Fig. 3 Sagital section through-a reconstructed breast implant in situ.
  • Fig-. 3 a The multilayered envelope of the implant drawn in 3b.
  • Fig. 3b A section through a multilayered implant.
  • Fig. 4 A section through an implant with a front pad.
  • Fig. 5 The implant with self sealing layers attached to the inside of the envelope.
  • Fig. 6 An implant with a self sealing inflation duct and nozzle.
  • Fig. 1 shows a cross-section of implant 1 immediately after being made, not yet inserted into a breast.
  • the implant is yet in a sphere-like form with an envelope 1 and a gaseous filling 2.
  • the implant When the implant is mounted in a breast, it will be subject to different pressures depending on the situation of the specific breast, which are different from case to case and are not illustrated in Fig. 1.
  • Fig. 2 is a schematic sagital cross-section of a breast after implantation.
  • Number 4 indicates the chest wall; number 5 the pectoralis muscles; number 6 the skin; and number 7 the underlying connective tissue and breast gland.
  • Number 1 indicates an envelop of an implant such as that of Fig. 1, number 2 the filling of said implant.
  • Fig. 3 shows a breast reconstructed after complete damage.
  • Number 6 is the patient's skin layer.
  • Number 1 1 is the appropriate implant for the reconstruction of the breast, which implant has an envelope 1 and a filling 2.
  • the envelope has been so shaped as to impart to the reconstructed breast the desired outwardly shape, and may be multi-layer though this is not shown in Fig. 3, while a small portion of an example of it is schematically shown at 14 in Fig.3a and consists in four layers a,b,c,d. The same layers are shown in Fig. 3b and indicated with the same letters.
  • the outermost layer may be made of silicone, while the other layers may comprise, in any desired succession, layers of Teflon (polytetrafluoroethylene) or aluminized Teflon, Mylar or aluminized Mylar, Kapton, Vectran, Kevlar, polyurethane, polyethylene, polyester, particularly polyethylene terephthalate.
  • the thickness of the envelope or its component layers may vary from a few microns to hundreds of microns.
  • Another layer which has been shown to be very impervious is a single layer of graphene which can be used as one of the layers in the envelope of the present invention.
  • a good way of making multi-layer envelopes is by dipping, once or more than once, an implant, already provided with an envelope, into a liquid or a solution and allowing the wet envelope to dry after each dripping, whereby the outer liquid layer resulting from the dipping forms an outer solid / resilient layer of the same substance that constituted the liquid or of the solute if the liquid was a solution.
  • the original envelope of the implant can have been created by any process, and if created by extrusion the material of the implant may even have been extruded directly into the above liquid.
  • Fig.4 schematically illustrates an implant such as that of Fig. 3, which however is provided with a surface / front pad 15 of a material that is adequately soft and elastic to give the breast a good feeling, preferable to the hard feeling that would be given by the surface 16 of envelope 1 in fig. 3, if exposed.
  • Fig.5 illustrates an implant with an envelope 1 which is not self-sealing and is therefore provided with a self-sealing attachment 18 or a plurality of such attachments that adhere to said envelope so that if envelope 1 is perforated the perforation will be sealed by one such attachment.
  • Fig. 6 schematically illustrates an implant having an envelope 1 that is not self- sealing and is provided with a duct 22 having a nozzle 23.
  • duct 22 When implant 20 is mounted in place, duct 22 is placed in such a position that nozzle 23 can easily be reached from the outside, gas can be injected through duct 22, and nozzle 23 can be self-sealed when the injection has been accomplished.

Landscapes

  • Health & Medical Sciences (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)

Abstract

Cette invention concerne des implants mammaires à visée esthétique, pour remodeler et/ou augmenter le volume des seins, et/ou à visée reconstructrice pour reconstruire totalement ou partiellement une poitrine qui a été gravement endommagée, voire détruite suite à un accident ou à un acte chirurgical, par exemple, lors de l'ablation d'un tissu cancéreux. Plus particulièrement, cette invention concerne un implant mammaire, qui comprend une enveloppe et un garnissage, ledit garnissage comprenant une phase gazeuse.
PCT/IL2010/000928 2009-11-16 2010-11-09 Implants mammaires Ceased WO2011058550A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IL202160 2009-11-16
IL202160A IL202160A0 (en) 2009-11-16 2009-11-16 Female breasts implants

Publications (1)

Publication Number Publication Date
WO2011058550A1 true WO2011058550A1 (fr) 2011-05-19

Family

ID=42263530

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IL2010/000928 Ceased WO2011058550A1 (fr) 2009-11-16 2010-11-09 Implants mammaires

Country Status (2)

Country Link
IL (1) IL202160A0 (fr)
WO (1) WO2011058550A1 (fr)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015153065A1 (fr) * 2014-03-31 2015-10-08 Mentor Worldwide Llc Expanseur tissulaire directionnel
US9351824B2 (en) 2012-11-14 2016-05-31 ImplantADJUST, LLC Adjustable implant with self-sealing elastomeric membrane and methods of fabrication thereof
US9463087B2 (en) 2014-03-31 2016-10-11 Mentor Worldwide Llc Directional tissue expander
WO2019171355A1 (fr) 2018-03-09 2019-09-12 Biosense Webster (Israel) Ltd. Coque interne imperméable pour implant mammaire
CN110495971A (zh) * 2018-05-17 2019-11-26 韦伯斯特生物官能(以色列)有限公司 可扩张乳房植入物
US10820984B2 (en) 2012-11-14 2020-11-03 ImplantADJUST, LLC Implant with elastomeric membrane and methods of fabrication thereof
US12303379B2 (en) 2018-09-10 2025-05-20 Mentor Worldwide, Llc Implant with elastomeric membrane and methods of fabrication thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2151927A (en) * 1983-12-22 1985-07-31 Medasil Inflatable implant for use in the body
US5578085A (en) * 1991-11-27 1996-11-26 Board Of Regents The University Of Texas System Balloon prosthesis for the lung and methods of making and using same
US20090099656A1 (en) * 2007-10-15 2009-04-16 Hatuna Gelda Method and device for a breast implant
WO2009095259A1 (fr) * 2008-01-31 2009-08-06 Milux Holding Sa Système d'implant mammaire

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2151927A (en) * 1983-12-22 1985-07-31 Medasil Inflatable implant for use in the body
US5578085A (en) * 1991-11-27 1996-11-26 Board Of Regents The University Of Texas System Balloon prosthesis for the lung and methods of making and using same
US20090099656A1 (en) * 2007-10-15 2009-04-16 Hatuna Gelda Method and device for a breast implant
WO2009095259A1 (fr) * 2008-01-31 2009-08-06 Milux Holding Sa Système d'implant mammaire

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9351824B2 (en) 2012-11-14 2016-05-31 ImplantADJUST, LLC Adjustable implant with self-sealing elastomeric membrane and methods of fabrication thereof
US10070951B2 (en) 2012-11-14 2018-09-11 ImplantADJUST, LLC Adjustable implant with self-sealing elastomeric membrane and methods of fabrication thereof
US10820984B2 (en) 2012-11-14 2020-11-03 ImplantADJUST, LLC Implant with elastomeric membrane and methods of fabrication thereof
US10617516B2 (en) 2014-03-31 2020-04-14 Mentor Worldwide Llc Directional tissue expander
US9463087B2 (en) 2014-03-31 2016-10-11 Mentor Worldwide Llc Directional tissue expander
US9700405B2 (en) 2014-03-31 2017-07-11 Mentor Worldwide Llc Directional tissue expander
RU2698609C2 (ru) * 2014-03-31 2019-08-28 МЕНТОР УОРЛДУАЙД ЭлЭлСи Направленный растягиватель тканей
WO2015153065A1 (fr) * 2014-03-31 2015-10-08 Mentor Worldwide Llc Expanseur tissulaire directionnel
WO2019171355A1 (fr) 2018-03-09 2019-09-12 Biosense Webster (Israel) Ltd. Coque interne imperméable pour implant mammaire
US10799337B2 (en) 2018-03-09 2020-10-13 Biosense Webster (Israel) Ltd. Impermeable inner shell for a breast implant
CN112087987A (zh) * 2018-03-09 2020-12-15 伯恩森斯韦伯斯特(以色列)有限责任公司 用于乳房植入物的不可透内部壳体
CN110495971A (zh) * 2018-05-17 2019-11-26 韦伯斯特生物官能(以色列)有限公司 可扩张乳房植入物
US12303379B2 (en) 2018-09-10 2025-05-20 Mentor Worldwide, Llc Implant with elastomeric membrane and methods of fabrication thereof

Also Published As

Publication number Publication date
IL202160A0 (en) 2010-06-16

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