WO2004021935A1 - Nouvelle coque en silicone de sein artificiel implantable - Google Patents

Nouvelle coque en silicone de sein artificiel implantable Download PDF

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Publication number
WO2004021935A1
WO2004021935A1 PCT/KR2003/001883 KR0301883W WO2004021935A1 WO 2004021935 A1 WO2004021935 A1 WO 2004021935A1 KR 0301883 W KR0301883 W KR 0301883W WO 2004021935 A1 WO2004021935 A1 WO 2004021935A1
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WO
WIPO (PCT)
Prior art keywords
shell
pva
silicon
polyvinylalcohol
breast
Prior art date
Application number
PCT/KR2003/001883
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English (en)
Inventor
Hoon-Bum Lee
Original Assignee
Hb Medicals Corporation
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 Hb Medicals Corporation filed Critical Hb Medicals Corporation
Priority to AU2003261651A priority Critical patent/AU2003261651A1/en
Publication of WO2004021935A1 publication Critical patent/WO2004021935A1/fr

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Classifications

    • 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
    • A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/12—Mammary prostheses and implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/18—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
    • A61L2430/34—Materials or treatment for tissue regeneration for soft tissue reconstruction

Definitions

  • the present invention relates to the methods of forming implantable artificial breast silicon shells filled with polyvinylalcohol(PVA) and the methods of using them.
  • Mammary implant prostheses have been used for reconstructing the surgically sectioned breasts due to breast cancer, external injuries or for augmenting breasts for cosmetic surgery.
  • Typical example of such mammary implant prosthesis is a resilient and completely sealed silicon shell or bag or pouch filled with silicon gel, and this type of completely sealed silicon shell has been used for an extended period of time as an ideal material for an implantable artificial prosthesis.
  • the shape of the silicon shell at the time ofthe initial stage ofthe surgery can not be maintained because the liquid is penetrated into the inside of the silicon shell or bag due to the osmotic pressure through the silicon shell, and eventually the silicon shell is ruptured, and this created a problem.
  • saline solution is still being used as a filler material, even today, but after a long period of use of the silicon shell, it is eventually ruptured, and also this material gives unsatisfactory results from the view point of morphology and natural touch.
  • the cause of the rupture of a shell is primarily due to the physical changes to the silicon shell coming from the frictional force exerted on the part of rumples or bend on the shell and the differential modulus, when the recipient of a mammary implant prosthesis is active for an extended period of time.
  • the problems arising from morphology are that when the recipient of an implantable artificial breast silicon shell is in a lying down position, the artificial breast does not change pliable and maintain a natural shape conforming to the changes of the surrounding tissues, and that when the recipient is in a standing position, the saline inside the silicon shell is shifted to the lower part of the shell due to the fact that the specific gravity of the saline is higher than the specific gravity of the tissues in the nearby surrounding area, thereby such down-shifting of the saline causes wrinkling in the upper part of the silicon shell and also a slight collapse of the shell, eventually resulting in a cosmetic damage on the breast.
  • the wrinkling in the upper part of the silicon shell causes continuous and sustained rubbing action with the skin of the breast as well as the soft tissues in the surrounding area, eventually leading into inflammation in the tissue and possibly a puncture in the shell.
  • Such disastrous result occurs more frequently to the recipients of cosmetically reconstructive breast surgeries than those received a medically necessary surgery.
  • the feelings of unnatural sloshing or rolling motion of the filler material inside ofthe shell as well as the senses of the existence of the foreign material coming from such movement when the recipient moves around is primarily due to the fact that the specific gravity of the saline solution is higher than the specific gravity of the natural breast tissue and also the corresponding viscosity is lower instead.
  • Such slight mismatches are the causes of difference in the feelings in touching of an artificial breast and the natural one.
  • SHELL FOR A FLUID FILLED PROSTHESIS a newly shaped prosthesis material that has a shallow depth in the upper part of the inside of the shell, therefore, less volume in the upper half, and deeper in depth in the lower part of the interior shell, therefore, more volume in the lower half, and also that the thickness of the shell material in the upper part is at least twice as thick than the thickness in the lower part of the shell material, in order to provide an artificial breast appearing closer to a natural breast and also to reduce the risk of getting the shell ruptured.
  • such structure did not solve the problems of morphological and unsatisfactory feel and sense in touching the breast caused by the use of saline solution and the filler in the inside ofthe shell.
  • the primary objective of the present invention is to disclose a new filler material to fill silicon shells to form mammary implant prostheses that remedy the problems described in the Background Art Section, that is, to provide a new filler material that significantly reduces the risk of rupturing the silicon shells to be used as artificial breasts.
  • Another object of the present invention is to provide an implantable artificial breast silicon shell filled with saline solution together with the new filler material, which silicon shell is safer to use than a shell filled with conventional gel.
  • another object of the present invention is to provide mammary implant prostheses that maintains more natural shape of a breast, when implanted into a female's body, and gives more realistic feel and sense in touching similar in touching a natural breast.
  • the artificial breast shaped similar to a female's natural breast is made of resilient silicon shell which is completely sealed, hollow inside and filled with polyvinylalcohol(PVA) that expands inside the silicon shell when the PVA material absorbs the liquid state solvent injected into the shell.
  • PVA polyvinylalcohol
  • a preferred solvent for dissolving or binding the filler material is saline solution, a solvent, and known chemical composites, chemical compounds or high polymers that have been proven to be harmless to human body may be added to saline.
  • the silicon shell is equipped with one or more opening and closing holes through which the filler material and the solvent are transported into the shell, after which the opening hole is closed seal-tight automatically so that the contents inside of the silicon shell do not normally leak.
  • opening and closing mechanism is well known and is not described here.
  • an implantable artificial breast silicon shell pre-filled with PVA material structured according to the present invention is inserted through the opening made by incision and placed inside properly, after which saline solution is injected through the aforementioned opening and closing hole.
  • the PVA material then absorbs the saline solution and expands in the inside of the silicon shell.
  • the silicon shell is shaped to look very similar to a natural breast according to the design of the silicon shell structure.
  • the degree of the expansion of the PVA material is confined by the amount of the PVA material, the volume of the hollow space inside of the silicon shell and the elasticity of the silicon material according to the design of the silicon shell structure. Ideally, the shape of the artificial breast would become very similar to a female's natural breast.
  • the characteristics of the implantable artificial breast silicon shell is that the recipient of an artificial breast silicon shell filled with PVA material when fully expanded and stabilized as designed should feel and sense in touching as almost a natural breast, and also the artificial breast should maintain a shape of a natural breast regardless of her body posture or position.
  • the PVA material when absorbed saline solution which are harmless for human body remains inside the shell in the state of gel-like that has a characteristics of proper level of resilience and firmness.
  • the PVA material expanded to its full extent by absorbing the solvent saline solution and stabilized inside the silicon shell prevents the shell from being wrinkled or rumpled, resulting in protecting the shell from being folded, thereby the rupturing phenomenon ofthe shell due to friction is prevented.
  • the saline solution does not readily leak even if the shell is ruptured. This characteristics is due to the physical property of the fully expanded PVA material filling the silicon shell when saline solution is injected into the completely sealed silicon shell or pouch.
  • the concept of using PVA and saline solution in a silicon shell or pouch as a new material for structuring mammary implant prostheses is a new and noble approach disclosed here according to the present invention.
  • the PVA material, saline solution and the silicon material which are used for structuring a new kind of mammary implant prostheses are known to be harmless materials to human body, and each material is biocompatible each other. It is known that the existence of such substances in the human body does not cause any side effects.
  • the silicon shells or pouches can have many types and shapes.
  • “symmetrically half-spherical shape” which is a radially symmetrically structured shell
  • “anatomically natural-looking shape” which is shallow in depth in the upper half of the shell with small volume and deep in the lower half of the shell with large volume.
  • the anatomically natural- looking shape is preferred, but as in the conventional shell, when only saline solution is used for filling the shell, there exists a difficulty in maintaining the originally intended shape ofthe shell because the saline solution has higher specific gravity than the natural breast tissues, thereby the lower half ofthe shell has a tendency of sagging downwards and therefore, it is difficult to maintain the originally expanded shape ofthe silicon shell.
  • the symmetrically spherical shape has an advantage of maintaining a natural-looking breast shape because of the downward shifting helps shaping the shell look similar to a natural looking breast, but as described previously, the upper part of the shell become wrinkled or rumpled, thereby the shell is easily ruptured.
  • the silicon shells filled with PVA material and saline solution maintain their original shape, because the fully expanded PVA after absorbing saline solution lowers the specific gravity of the saline solution and the contact boundary between the silicon shell and the expanded PVA material helps the shell maintain its original shapes.
  • Silicon shells can be made in many different ways.
  • First example is the "blow form method”, whereby air is blown into the form carved in the shape of a female breast containing an appropriate silicon parison, thereby a silicon shell hollow inside and completely sealed is made.
  • Second example is the "dipping method”, whereby a mandrel shaped as a breast is dipped into a silicon solution, and repeat this process in order to attain desired thickness and then it is "harden” in order to transform it into a soft rubber-like shell. Again, the final product is a silicon shell hollow inside and completely sealed.
  • Third method is "casting method", whereby an appropriate amount of silicon parison is pushed into the space between the form used in the "blow form method” of the first example above and the matching form used in the "dipping method” described in the second example above. Once the shell is formed it is “hardened” to create a rubber-like soft shell. The final product is again a silicon shell hollow inside and completely sealed.
  • the expandable filler material by absorbing saline solution polyvinylalcohol(PVA)
  • PVA polyvinylalcohol
  • the PVA can be simply inserted into the hollow space inside the sealed shell or pouch, or it can be coated or applied on the inside wall ofthe shell.
  • the silicon shells containing PVA material inserted into the hollow space onside the shell by means of these methods can be implanted as artificial breasts.
  • the level of filling, coating or a combination of both is determined by the degree of expansion ofthe PVA material after absorbing the saline solution injected into the hollow space inside of the silicon shell, and the degree of expansion of the PVA material is dependent upon the property of cross-linking between the micro-particles and molecules ofthe PVA material.
  • the PVA material is basically water soluble or hydrophilic, and maintains its water solubility and at the same time exhibits solid phase by mutually cross-linking part of alcohl radicals or a secondary link, that is stringed to the main link or the primary link.
  • the cross-linking reaction takes place by the secondary or additional reaction ofthe aldehyde compounds.
  • the optimum cross-linking is determined by the specific gravity of the PVA material with the saline solution fully absorbed as well as the resulting feel and sense in touching that give the closest feel and sense in touching of the natural breast, that is, about 0.8g/cm 3 . Accordingly, according to the present invention, the optimum cross-linking is determined by finding comfortably acceptable level of sustained outer surface condition of the silicon shell when the PVA material after absorbing the injected saline solution is fully expanded under various conditions of simple filling, coating, or simple filling and coating, and such optimum conditions including the optimum amounts ofthe saline solution for each case can be found experimentally.
  • the PVA materials to be used as filler materials for the silicon shells are preferably in the solid state such as powder, chips, particles, polygons.
  • the size is not specifically limited, but the powdered material is preferred simply for the reason of ease of insertion into the silicon shell.
  • the nano-scaled or nanostructured particles of the PVA materials such as nanotubes, nanocoils and nanostrings can be used as the PVA materials.
  • PVA-based filler materials primarily because they are much smaller particles compared to the conventional powdery PVA materials, thereby they are much softer and resilient and better suited as the filler materials.
  • the PVA material can be inserted into the shell through the opening and closing hole or the PVA material can be placed inside the silicon shell during the silicon shell manufacturing process.
  • Silicon is a resilient material, thereby relatively large size ofthe
  • the PVA material can be inserted into the shell.
  • Such insertion process of the PVA into the silicon shell can be performed by using a special equipment after the silicon shell is placed through the incision during the surgery.
  • the pre- mixed material of the PVA and the saline solution is injected into the silicon shell by using a specially prepared supply tube, before the pre-mixed material of the PVA and the saline solution is fully expanded.
  • the PVA material can be composed in such a way that the state of the expandable PVA varies with the pressure and place it inside the shell.
  • the PVA material can be composed and adjusted so that the expanded PVA material maintains a liquid state at high pressure and at low pressure such as atmospheric pressure the expanded material changes into a solid state, and then such PVA material can be easily inserted into the silicon shell.
  • the syndiotactic PVA can also be used.
  • a pre-prepared PVA material can be made and tuned in such a way that the PVA material is injected into the silicon shell using a specially designed one way valve tube and connected to the silicon shell, and when the temperature ofthe filler, the expanded PVA material after absorbing the saline solution, reaches the body temperature, the specific gravity and the viscosity of the filler are changed close to those of breast tissue.
  • the coating of the PVA material can be spread over the entire interior area ofthe silicon shell or over a part ofthe interior wall, but preferably a thicker layer over the upper part ofthe interior ofthe silicon shell and a relatively thinner layer over the lower part ofthe interior ofthe silicon shell in reference to the radial center of the mammary implant prostheses. This is because when the female person is in the standing position the breast is shifted downwards, thereby the amount of the saline solution absorbed by the PVA material is increased by increasing the thickness of the coating layer of the PVA material on the inside wall if the silicon shell.
  • the delivery and coating methods are not limited to those described above.
  • the interior wall of the silicon wall can be coated by making a cross-linked PVA in a similar shape to the silicon shell and submerge it into a silicon solution and then harden it, and repeat it until a silicon shell with a desired thickness is obtained.
  • a prefabricated silicon shell is coated with a PVA liquid material, and then the PVA material is cross-linked, and eventually a PVA coated interior wall is formed.
  • the expandable filler material PVA to be inserted into the silicon shell can be made in a specifically shaped structure by design instead of in the form of powdery particles or coating. More specifically, a part or in its entirety of the expandable filler material PVA is shaped to conform to the contour of the inner wall of the silicon shell, and then they can be inserted into the pre-fabricated silicon shell or they can be placed inside of the silicon shell before the outer shell is fabricated, thereby the structured expandable filler made of PVA material or its composites is placed inside the silicon shell when the fabrication ofthe silicon shell is completed.
  • Fig. 1 is a cross-sectional drawing of a conventional silicon shell structure of an implantable artificial breast of a symmetrical half-spherical shape before and after filled with saline solution.
  • Fig. 2 A is a cross-sectional drawing of an exemplary silicon shell structure of an implantable artificial breast of a symmetrical half-spherical shape filled with the PVA particles (with an injection device attached) according to the present invention.
  • Fig. 2B is a cross-sectional drawing of an exemplary silicon shell structure of an implantable artificial breast of a symmetrical half-spherical shape filled with the PVA particles expanded after a saline solution is injected into.
  • Fig. 3 is a cross-sectional drawing of an exemplary silicon shell structure of an implantable artificial breast of an anatomically natural breast-like shape according to the present invention.
  • Fig. 4A is a cross-sectional drawing of an exemplary silicon shell structure of an implantable artificial breast of a natural-looking shape as shown in Fig.3 with PVA coat inside the silicon shell according to the present invention.
  • Fig. 4B is a cross-sectional drawing of an exemplary silicon shell structure of an implantable artificial breast of a natural-looking shape as shown in Fig. 3 with PVA coat inside the silicon shell and a saline solution injected into the shall, thereby the PVA is fully expanded for shaping.
  • Fig. 5 is a cross-sectional drawing of another exemplary silicon shell structure of an implantable artificial breast of a symmetrical half-spherical shape filled with an expandable PVA material according to another aspect ofthe present invention.
  • FIG.l is a cross-sectional drawing of a typical silicon shell 110 of a symmetrical half-spherical shape filled with saline solution 200 designed as an implantable artificial breast 100.
  • the implantable artificial breast 100 is structured with a shell 110 made of a resilient material such as silicon, and the shell 110 is equipped with an opening-and-closing hole 120 through which the saline solution 200 is injected into the shell 110.
  • the opening-and-closing hole 120 is consists of the main body 122 which is an integral part of the shell 110, feeding orifice 124 that passes through the exterior and the interior of the shell 110, and a flexible stopping cover 126 that covers the outer opening area ofthe feeding orifice 124.
  • the shell 110 When the shell 110 is not filled with saline solution, the shell 110 is in a collapsed state as shown in dotted lines, and the shape ofthe shell changes to a fully expanded shape of a breast 110 (shown as solid lines) as the shell is filled with saline solution 200 by injection through the feeding orifice 124 using a special device (not shown). Since the artificial breast 100 is made of a resilient material, the prosthesis can be folded and inserted into the space behind the breast through a small opening made by incision during surgery. Conventional prosthesis 100 is shifted downward B due to the heavy weight of the saline solution 200 itself, thereby the lower part B of the shell 110 becomes more inflated than the upper part A of the shell 110.
  • the top peak part P in the upper part A of the shell HO has a tendency of being rumpled or even folded, and the surrounding skin of the breast (not shown) is wrinkled, thereby the cosmetic look of the surrounding area of the skin ofthe breast is the undesirable result, and furthermore, the bent or folded top peak part P is at the risk of being ruptured after a prolonged use.
  • the low viscosity of the saline solution 200 has a tendency of causing the feel and sense of sloshing and rolling as it moves around more than desired inside of the artificial prosthesis 100 as the recipient of the artificial breast 100 makes moving motions.
  • the shell 310 of the implantable artificial breast 300 prior to the injected of saline solution is in the collapsed state 310, and the hollow space inside of the shell 310 made of a soft and resilient silicon material is filled with polyvinylalcohol(PVA) particles 320.
  • the PVA particles 320 are a mixture of various sizes in diameter, and can be placed inside the shell 310 during the process of fabrication of the shell 310. In Fig. 2A, it appears that the PVA particles are evenly spread inside the shell 310, but this is not necessarily the case.
  • a saline solution 200 is injected into the interior of the shell 310 through the supply tube 400 by means of the injection device 500, to which one end ofthe supply tube 400 is connected, after the other end ofthe supply tube 400 is connected to the feeding orifice 324 in the opening-and-closing hole 330.
  • the PVA particles 320 inside the shell 310 absorb the saline solution, and expand to their full extent, and as a result the shape of the silicon shell 310 becomes similar to a natural breast.
  • the degree of the expansion of the PVA particles is dependent upon the crosslinking property of the PVA material used. For example, it expands from 3 times to as high as 20 times.
  • the expanded PVA particles 340 determine the shape of the shell 310(expanded), but the shape might change slightly due to the settling effect between the PVA particles. Therefore, small pockets of saline solution only may present within the shell with the expanded PVA material depending upon the degree of the absorption of saline solution by the PVA material and the degree of cross-linking of the PVA material, and sometimes such small pockets of saline solution only may not present.
  • the implantable artificial breast 302 shown in Fig. 3 is a silicon shell 312 shaped anatomically similar to the shape of a natural breast and it differs from Figs. 2A and 2B from the point of view that the expandable PVA material 322 is a layer coated inside wall of a shell 302 instead of the form of particles as in Figs. 2A and 2B.
  • the thickness ofthe layer ofthe PVA material 322 can be uniform or thick at the upper part and thin at the lower part ofthe shell 312 as illustrated in Fig. 3.
  • the PVA material can be partially coated on the inside wall ofthe shell 312. Remaining structures and functions are about the same as Embodiment 1.
  • the implantable artificial breast 304 shown in Figs. 4A and 4B differs from
  • Embodiments 1 and 2 in that this Embodiment contains both particle type of PVA 320 and the coated layer type of PVA 322.
  • a saline solution 200 is injected into the shell 314 in Fig.3
  • both particle type 320 and coated layer type 322 ofthe PVA expand and the shape ofthe silicon shell 314 changes to anatomically similar shape to a natural breast.
  • the expanded PVA particles 320 do not necessarily maintain the shape similar to the one shown in Fig. 4B, that is, the expanded particle PVA 320 and the expanded coated layer PVA 322 may be changed at the boundary and fill the hollow inside space ofthe silicon shell 314.
  • the implantable artificial breast 306 shown in Fig. 5 is different from the previous Embodiments 300, 302, 304, in that the silicon shell 316 in that the expandable PVA material 326 is formed in a shape of a partially half sphere.
  • Use of such expandable PVA material 322 shaped as a partially half sphere is advantageous over other types because the size of this PVA material 322 is relatively small when a saline solution is not injected yet, thereby such small volume artificial breast can be readily inserted into a small incision made for the surgery.
  • the expanded shape of the silicon shell 316 after a saline solution is injected is shown in dotted lines in Fig. 5.
  • the implantable artificial breast silicon shells disclosed here improve the quality of conventional mammary implant prostheses significantly.
  • New filler material PVA disclosed here is a significant step towards the perfection of the existing mammary implant prostheses and will solve many difficult problems for both breast surgery-related patients as well as those who desire cosmetic surgery for breast reshaping or enlargements.

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

Abstract

La présente invention se rapporte à de nouvelles prothèses mammaires implantables constituées d'une coque en silicone souple et élastique qui est intérieurement vide, et de polyvinylalcool (PVA) qui est une matière expansible susceptible de se dilater à l'intérieur d'une telle coque creuse lorsqu'elle est mélangée à un fluide aqueux. Ainsi, lorsqu'on injecte une solution saline dans la coque en silicone remplie de PVA, la coque en silicone étant insérée dans la zone d'ouverture en cours de chirurgie de reconstruction ou d'expansion du sein, le PVA se dilate à l'intérieur de la coque en silicone de sorte que ladite coque adopte la forme d'un sein naturel, ladite matière PVA pouvant être fixée sur la paroi interne de la coque en silicone ou partiellement fixée et partiellement répandue à l'intérieur de la coque. Les prothèses mammaires implantables conformes à la présente invention comportent des coques en silicone pour sein artificiel implantable qui ont moins tendance à ballotter ou à rouler, moins tendance à se friper du fait de l'absence de formation d'une courbure régulière, elles empêchent la rupture de la coque et confèrent un toucher réaliste similaire à celui du tissu d'un sein naturel. En outre, même si la coque en silicone est fabriquée de manière à posséder la forme d'un sein anatomique, elle ne provoque aucun problème morphologique.
PCT/KR2003/001883 2002-09-09 2003-09-09 Nouvelle coque en silicone de sein artificiel implantable WO2004021935A1 (fr)

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AU2003261651A AU2003261651A1 (en) 2002-09-09 2003-09-09 Novel implantable artificial breast silicon shell

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006079905A2 (fr) * 2004-01-29 2006-08-03 Smart Implant Plc Prothese et procede de fabrication d'une prothese
WO2010002824A1 (fr) * 2008-06-30 2010-01-07 Allergan, Inc. Implant prothétique remplissable doté de propriétés de type gel
WO2010022130A1 (fr) * 2008-08-20 2010-02-25 Allergan, Inc. Enveloppe à scellement automatique pour prothèses gonflables
KR200470243Y1 (ko) 2008-09-16 2013-12-06 에이엠아이 어젠시 포 메디컬 이노베이션스 게엠베하 남성 긴장성 요실금을 치료하기 위한 임플란트
US8636797B2 (en) 2010-02-05 2014-01-28 Allergan, Inc. Inflatable prostheses and methods of making same
US10052190B2 (en) 2010-02-05 2018-08-21 Allergan, Inc. Inflatable prostheses and methods of making same
USD896383S1 (en) 2018-09-13 2020-09-15 Allergan, Inc. Tissue expansion device
US11160630B2 (en) 2018-09-13 2021-11-02 Allergan, Inc. Tissue expansion device

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US4795464A (en) * 1987-02-09 1989-01-03 Tertulin Eberl Artificial breast
US5407445A (en) * 1992-05-20 1995-04-18 Cytrx Corporation Gel composition for implant prosthesis and method of use
US6312466B1 (en) * 1995-05-22 2001-11-06 Board Of Regents, University Of Texas System Prosthesis containing a solution of polyethylene glycol

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4795464A (en) * 1987-02-09 1989-01-03 Tertulin Eberl Artificial breast
US5407445A (en) * 1992-05-20 1995-04-18 Cytrx Corporation Gel composition for implant prosthesis and method of use
US6312466B1 (en) * 1995-05-22 2001-11-06 Board Of Regents, University Of Texas System Prosthesis containing a solution of polyethylene glycol

Cited By (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006079905A3 (fr) * 2004-01-29 2007-05-18 Jonathan Hamilton Prothese et procede de fabrication d'une prothese
WO2006079905A2 (fr) * 2004-01-29 2006-08-03 Smart Implant Plc Prothese et procede de fabrication d'une prothese
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