(51) Int Cl.: B29C 44/06 ( )

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Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the

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EUROPEAN PATENT SPECIFICATION

(45) Date of publication and mention of the grant of the patent:

25.11.2015 Bulletin 2015/48

(21) Application number: 11008322.7 (22) Date of filing: 14.10.2011

(51) Int Cl.:

B29C 44/06(2006.01)

(54) Process for the manufacture of implants or intermediate products of such implants as well as

implants and intermediate products obtained by such process

Verfahren zur Herstellung von Implantaten oder Zwischenprodukten solcher Implantate sowie durch solch ein Verfahren erhaltene Implantate und Zwischenprodukte

Procédé pour la fabrication d’implants ou de produits intermédiaires de tels implants et implants et produits intermédiaires ainsi obtenus

(84) Designated Contracting States:

AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

(43) Date of publication of application:

17.04.2013 Bulletin 2013/16

(73) Proprietor: Polytech Health&Aesthetics GmbH

63807 Dieburg (DE) (72) Inventors: • Boegershausen, Oliver 64293 Darmstadt (DE) • O’Leary, Patrick 64832 Babenhausen (DE)

(74) Representative: Metten, Karl-Heinz

Boehmert & Boehmert Anwaltspartnerschaft mbB Patentanwälte Rechtsanwälte Pettenkoferstrasse 20-22 80336 München (DE) (56) References cited: WO-A1-90/00888 WO-A1-2010/069019 FR-A1- 2 677 539 GB-A- 2 243 324 US-A- 4 944 750 US-A- 5 296 069

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5 10 15 20 25 30 35 40 45 50 55 Description

[0001] The present invention relates to a process for

the manufacture of implants or intermediate products of such implants as well as implants and intermediate prod-ucts obtained by such process.

[0002] In the manufacture of implants such as breast

implants very high standards have to be met in a repro-ducible manner in terms of, for example, materials em-ployed and processing details used. In addition, the di-mension and the shape of an implant have to be obtained in a reliable manner within very narrow tolerances. Im-plants which do not meet such standards usually have to be discarded. Moreover, any sub-optimal implant may increase the risk of non-compliance with the patient and may even be rejected by the tissue of such patient. In case a breast implant is not accepted by the surrounding tissue there is a very high likelihood of so-called capsular contracture, that is, a hard sphere of collagen is formed around the implant thereby necessitating additional sur-gery.

[0003] It is believed that capsular contracture is

caused, among others, by small pieces which have been broken off or have become separated from the surface or the shell of the implant. Further, it has been postulated that by use of structured or textured implant surfaces capsular contracture can be repressed either completely or at least for much longer periods of time compared to other types of implants.

[0004] Therefore, much effort has been spent in

opti-mizing both the surface structure and/or material of an implant as well as its manufacture.

[0005] In US 5,296,069 a process for the manufacture

of implants is disclosed whose surfaces are coated with an amorphous material which shall not come loose theby preventing capsular contracture. This process re-quires disposing a first and a second sheet assembly on the front and the back side of an implant being already filled with gel, i.e. to a finished implant, and which has smooth surfaces. Said first sheet assembly and said sec-ond sheet assembly have to be made from a non-vulcan-ized silicone sheet and a foam sheet. It is required to pass said sheet assembly through two parallel and spaced apart rollers so as to exert a predetermined pres-sure for adhering said assembly. It is the non-vulcanized silicone sheet which in each case faces the smooth sur-face of the implant. Where the two sheets come together, they go out away from the implant; it is not possible for them to curl under the implant. The joint overlapping por-tions of said first and second sheet assemblies need to be cut off thereby generating a circumferential seam in that section of the implant which is bridging its front and the back side. It has been found that such seam may not be well accepted by the tissue of the patient. Moreover, the process according to US 5,296,069 does not elimi-nate the problem of folds, wrinkles or even voids being formed on or between the assembly sheets and the un-derlying implant. This process is therefore rather

cum-bersome and inefficient.

[0006] In FR 2,675,049 A1, a breast prosthesis is

de-scribed where a specific polyether polyurethane is glued onto a silicone envelope filled with a silicone gel. In a similar manner in FR 2 677 539 A1 a polyurethane sheet is glued to a breast implant being made of elastomeric silicone material. In order to minimize the risk of capsular contracture it is proposed to glue a first polyurethane sheet onto the front side of the implant and a second polyurethane sheet to the backside of said implant and to leave a circumferential area uncovered by said poly-urethane sheets which bridges the front and the back side of said implant.

[0007] Another similar method is disclosed in WO

9000888 A. Although it has been proposed for about 30 years to make use of textured surfaces, e.g. in the form of polyurethane foams for breast implants in order to re-duce the risk of capsular contracture - as evidenced by S. Herman, Plastic & Reconstructive Surgery, 1984, pag-es 411 to 414, and J.A. Lilla and L.M. Vistmis, Plastic & Reconstructive Surgery 1976, pages 637 to 649, - efforts are still ongoing to increase patient compliance, comfort and safety. For example, in WO 2010/069019 A1 breast implants are described having independent expandable and interactive compartments and which have an exter-nal silicone membrane which can exterexter-nally be coated with a Ricinus communis polyurethane foam covered with hydroxyapatite microcrystals or nanocrystals.

[0008] Thus, there still is a need to provide a

manufac-turing process which in itself guarantees to obtain high quality products in a reliable and reproducible manner while yet yielding affordable products.

[0009] According to a first aspect, the problem

under-lying the present invention has been solved by a process for manufacturing implants or intermediate products of such implants according to claim 1.

[0010] It is pivotal for the process of the present

inven-tion that not a finished implant which already has been filled with gel is covered with a foam sheet. Instead, it is the implant shell which is covered with a foam sheet ac-cording to the protocol of the present invention.

[0011] According to another aspect the implant shell

of step a) comprising uncured silicone in one embodi-ment is also unfinished in that it represents an interme-diate product still containing, in particular on its outer sur-face, uncured reaction sites.

[0012] The process of the present invention can for

example be used for the manufacture of breast implants, of implants for the thighs, buttocks and calves.

[0013] According to a first variant of the process of the

present invention the implant shell comprising uncured silicone, in particular being made of one or several layers of uncured silicone, which is brought in contact with a first foam sheet. Usually, said foam sheet, e.g. a poly-urethane foam sheet, is allowed to flow into the semi-liquid silicone surface of the implant, thereby surrounding each strand of the foam with silicone. It is also preferable to pull, push and/or stretch the foam sheet into the three

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5 10 15 20 25 30 35 40 45 50 55 dimensional shape of the implant thereby increasing the likelihood of avoiding folds or wrinkles. By subjecting said combined intermediate product to a curing step (step d)) the first foam sheet is tightly bonded to the implant shell. According to a second variant of the process of the present invention the implant shell provided in step a) is first subjected to a curing step thereby arriving at a com-pletely or partially vulcanized product to which subse-quently an additional layer of uncured silicone is applied. In each case, an intermediate unit is formed wherein the first foam sheet has become an integral part of the implant shell. In case of destruction foam particles as such can no longer be separated from said implant shell. Any risk of delamination is eliminated.

[0014] According to the present invention an

interme-diate product is obtained in that after process step f) there is a process step (step h)) which comprises subjecting the at least one sheet applied to the back side of the implant shell in step f) to curing so that it undergoes vul-canization, thereby bonding said sheet to the back side of the implant shell. It is preferred to make use of such a sheet which has been obtained by applying an outer un-cured silicone layer to a un-cured silicone sheet comprising one or several layers of silicone. These layers may have been cured in subsequent steps once a layer of uncured silicone has been formed. Alternatively, a set of uncured silicone layers can be cured as a whole before the addi-tional uncured outer layer is applied. It preferably is said outer layer of uncured silicone which is brought in contact with the sili-cone surface at the back side of the implant shell. In a subsequent step said sheet of step h) is cured so that it is tightly bonded to the back of the implant shell.

[0015] According to a further embodiment it is

pre-ferred that the sheet applied in step f) in addition com-prises at least one foam sheet (in the following also des-ignated as second foam sheet), in particular at least one layer of polyurethane foam, as the outer layer of said sheet thereby forming a sheet assembly (in the following also referred to as first sheet assembly).

[0016] According to another aspect of the present

in-vention another intermediate implant can be obtained in that after process step f) and prior to or after process step h) another process step (step g)) is added which com-prises filling the implant shell with at least one gel, gelat-inizable fluid or liquid. The silicone sheet or patch, which can be combined with the at least one second foam sheet or layer on its outside, can be used to stitch a needle there-through. In this way gel, gelatinizable fluid or liquid is transferred in the implant shell. Once the needle is removed said sheet or patch is subjected to a curing step thereby allowing the silicone layer or sheet to vulcanize. In this manner it is not only possible to join the second foam layer in order to become an integral part of the sheet assembly, but it is also possible to tightly join the silicone layer to the back side of the implant, and to ensure that it is fluid-tight.

[0017] Accordingly, from process step g) an implant

shell results which can be used as such for completing

the manufacturing cycle, for example, by filling the im-plant shell with at least one gel, gelatinizable fluid or a liquid (step g)) or by subjecting the at least one sheet applied to the back side of the implant shell in step f) to curing so that it undergoes vulcanization thereby bonding said sheet to the back side of the implant shell.

[0018] Thus, according to another aspect of the

present invention a finished implant can be obtained by including after process step g) or after step h) the follow-ing process steps

i) provide a third foam sheet, in particular at least one layer of polyurethane foam,

or

a second sheet assembly which comprises a sheet or layer comprising cured and/or uncured silicone, in particular uncured silicone, and at least one fourth foam sheet, in particular at least one layer of poly-urethane foam, as the outer layer of said sheet as-sembly, and

j) join said third foam sheet, or

said second sheet assembly via its silicone sheet or layer to the sheet of step f) and/or the back side of the implant shell.

[0019] In some instances it is preferred to subject the

filled implant shell to a curing step, in particular to a ther-mal curing step (step k)) after process step g), h), i) and/or j), in particular if the gel, gelatinizable gel or the fluid shall be optimized thereby, e.g. in terms of consistency or du-rability.

[0020] The first sheet assembly can be obtained by a

least one separate pressing and/or curing step, in par-ticular comprising pressing between pressing plates, in particular plates having a temperature sufficiently high to initiate curing of the silicone sheet thereby also bonding the foam sheet thereto.

[0021] The second sheet assembly can best be

ob-tained by a least one separate pressing step, in particular comprising pressing between pressing plates, in partic-ular plates having a temperature which does not initiate curing of the silicone sheet.

[0022] According to a preferred aspect of the invention,

the second sheet assembly when placed on the sheet of step f) and/or the back side of the implant shell and the gel, gelatinizable fluid or the liquid a subjected to curing in one step, i.e. at the same time. In this manner the processing can be significantly alleviated.

[0023] It is also possible to place the filled implant shell

into an external mold reflecting or having the desired shape of the individual implant prior to curing the material filled in the implant shell, and to subject the filled implant shell to a curing step when placed inside said mold.

[0024] According to a rather practical embodiment, the

implant shell in step a) is obtained by providing a mold to which layers of uncured silicone, either liquid as such and/or dissolved in a solvent, are applied in a stepwise

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5 10 15 20 25 30 35 40 45 50 55 manner, in particular comprising the at least partial evap-oration of solvent. This mold preferably already has the shape of the finished implant. By such a mode of action the shape of the mold dictates the form of the implant. The mold is preferably held by a mandrel handle on its back side, which is responsible for a hole in the back side of the implant shell which needs to be covered with a sheet or patch as specified in process step f). The implant shell according to this variant can best be obtained by dipping or casting the mold in uncured silicone, either liquid as such and/or dissolved in a solvent, in a stepwise manner. That is, after a first dipping/casting step a rather sticky and viscous layer of uncured silicone is obtained, which in case dissolved silicone has been used still may contain some solvent. This process can also be de-scribed as multiple dip coating. Once a sufficient number of uncured silicone layers have been produced on the mold, it can be placed in an oven to undergo vulcaniza-tion. Alternatively, each uncured silicone layer is subject-ed to curing before another uncursubject-ed silicone layer is add-ed, e.g. by dipping and/or casting as described above. Hence, it is also possible that the implant shell of step a) is completely cured.

[0025] In particular, in case color shall be applied to

the implant shell it is preferable that at least one silicone layer which is not the outer silicone layer of the implant shell of step a), preferably the second but last silicone layer of said implant shell, comprises at least one colorant and/or pigment, in particular titanium dioxide.

[0026] As with the formation of individual uncured

sil-icone layers in step a), it is also possible to obtain the at least one additional silicone layer of step b) by dipping or casting the implant shell in uncured silicone, either liquid as such and/or dissolved in a solvent, whereupon said layer is preferably subjected to at least partial evap-oration of the solvent thereby furnishing a layer of un-cured silicone. This additional layer of unun-cured silicone preferably is sticky and viscous.

[0027] The first foam sheet preferably is placed in one

piece over the entire front side, at least part of the region bridging the front and the back side and at least part of the back side of the implant shell. In this manner there are no seams, folds or wrinkles on the front side, on the region bridging the front and the back side and also on at least part of the back side. Thus, it is possible that the first foam sheet after having been placed on and bonded to the implant shell is free of seams and preferably also of folds on the front side as well as in particular on the region bridging the front and the back side of the implant shell. In particular in case the implant shell is still on the mold said first foam sheet can be pressed and tightly fitted to the uppermost silicone layer.

[0028] In a preferred embodiment the first, second,

third and/or fourth foam sheet comprise or are made of at least one polyurethane layer.

[0029] It is preferred that by applying step d) the foam

sheet becomes an integral part of the implant shell.

[0030] In a practical embodiment of the present

inven-tion the excess first foam sheet not bonded by curing according to step d) on the back side of the implant shell is cut off in step e).

[0031] It is preferred to take the implant shell as

ob-tained in step d) or in step e) from the mold, i.e. only after the first foam sheet has been applied to the implant shell. Evidently, with the process of the present invention there is no direct need to employ an external mold, rather an internal mold can be used in one of its embodiments.

[0032] It is evident for a person skilled in the art that in

order to obtain a commercial product well known steps as sterilization, packing and labeling would be needed.

[0033] By relying on the process of the present

inven-tion surprising advantageous effects can be obtained. This process-guarantees that there is no circumferential seam at that region of an implant which bridges its front and back sides. Implants can be obtained in a reliable manner based on the process of the present invention, which do not contain voids, folds or wrinkles. These im-plants also do not tend to delaminate.

Claims

1. Process for manufacturing implants or intermediate

products of such implants comprising

a) providing an implant shell comprising uncured silicone, having a front side, aback side and a region bridging said front and back side, c) placing a first foam sheet over the front side, the region bridging said front and back side and at least part of the back side of the uncured im-plant shell, as provided in step a),

d) subjecting the implant shell obtained in step c) to at least one curing step in order to vulcanize the uncured silicone of step a) thereby bonding the first foam sheet to the implant shell, and f) apply at least one sheet comprising partially or completely uncured silicone to the back side of the implant shell, thereby covering those parts not covered by the first foam sheet,

h) subject the at least one sheet applied to the back side of the implant shell in step f) to curing so that it undergoes vulcanization thereby bond-ing said sheet to the back side of the implant shell.

2. Process according to claim 1 further comprising after

process step f) and prior to or after process step h) process step

g) fill the implant shell with at least one gel, ge-latinizable fluid or a liquid.

3. Process according to claim 1 or 2 characterized in that the implant is a breast implant.

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4. Process according to any of the aforementioned

claims further comprising after process step a) and prior to process step c) process step

b) subjecting the uncured silicone of said implant shell to at least one curing step, in order to un-dergo complete or partial vulcanization, and ap-plying at least one uncured additional silicone layer to the implant shell so obtained, to the front side, the region bridging the front and back side and optionally also part of the back side which follows said bridging region, and wherein in process step d) the implant shell obtained in step c) is subjected to at least one curing step in order to vulcanize the uncured silicone of step a) or of the additional uncured silicone layer of step b) and, if need be, the silicone ofthe implant shell not cured yet, thereby bonding the first foam sheet to the implant shell.

claims characterized in that the first foam sheet comprises or is made of at least one polyurethane layer.

claims further comprising after process step d) and prior to process step f) process step

e) removing, in particular cutting off, excess foam sheet not bonded by curing in step d) to the back side of the implant shell.

claims characterized in that the implant shell of step a) comprising uncured silicone is unfinished in that it represents an intermediate product still containing on its outer surface uncured reaction sites.

claims characterized in that the implant shell in step a) is obtained by providing a mold to which layers of uncured silicone, either liquid as such and/or dis-solved in a solvent, are applied in a stepwise manner.

9. Process according to any of claims 4 to 8 charac-terized in that the implant shell of step a) is

com-pletely cured in step b).

10. Process according to any of claims 4 to 9 charac-terized in that the at least one additional silicone

layer of step b) is obtained by dipping and/or casting the implant shell of step b) in silicone, either liquid as such and/or dissolved in a solvent, thereby fur-nishing a layer of uncured silicone.

claims characterized in that the first foam sheet is

placed in one piece over the entire front side, at least part of the region bridging the front and the back side and at least part of the back side of the implant shell.

claims characterized in that the first foam sheet after having been placed on and bonded to the im-plant shell is free of seams and also of folds on the front side as well as on the region bridging the front and the back side of the implant shell.

13. Process according to any of claims 8 to 12 charac-terized in that the implant shell obtained in step d)

or in step e) is taken from the mold.

claims characterized in that the sheet applied in step f) in addition comprises at least one second foam sheet as the outer layer thereby forming a first sheet assembly.

claims further comprising after process step g) or step h) process steps

i) provide a third foam sheet, or

a second sheet assembly which comprises a sheet or layer comprising cured

and/or uncured silicone, in particular un-cured silicone, and at least one fourth foam sheet as the outer layer of said sheet as-sembly, and

j) join said third foam sheet, or

said second sheet assembly via its silicone sheet or layer to the sheet of step f) and/or the back side of the implant shell.

16. Process according to claim 15 characterized in that

the third foam sheet and/or the fourth foam sheet is at least one layer of polyurethane foam.

17. Process according to any of claim 14 to 16 charac-terized in that said first sheet assembly has been

obtained by a least one pressing and/or curing step, in particular comprising pressing between pressing plates, and/or wherein said second sheet assembly has been obtained by a least one pressing step.

18. Process according to any of claims 2 to 17 further

comprising after process step g), h), i) and/or j) proc-ess step

k) subjecting the filled implant shell to curing, in particular thermal curing.

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19. Process according to claim 18 characterized in that

the uncured silicone layer of the second sheet as-sembly is subjected to curing.

20. Implant or implant shell obtained according to any

of claims 1 to 19.

21. Implant or implant shell according to claim 20 char-acterized in that it is a breast implant or an implant

shell of a breast implant, respectively.

Patentansprüche

1. Verfahren zur Herstellung von Implantaten oder

Zwi-schenprodukten solcher Implantate, umfassend a) das Bereitstellen einer Implantathülle, die un-ausgehärtetes Silikon umfasst, mit einer Vorder-seite, einer Rückseite und einem Bereich zur Verbindung der Vorder- und Rückseite, c) das Anordnen einer ersten Schaumlage über der Vorderseite, dem Bereich zur Verbindung der Vorder- und Rückseite und zumindest einem Teil der Rückseite der unausgehärteten Implan-tathülle, wie sie in Schritt a) bereitgestellt wurde, d) das Unterziehen der in Schritt c) erhaltenen Implantathülle zumindest einem Aushärtungs-schritt, um das unausgehärtete Silikon aus Schritt a) zu vulkanisieren und dadurch die erste Schaumlage mit der Implantathülle zu verbin-den, und

f) das Aufbringen zumindest einer Lage, die teil-weise oder vollständig unausgehärtetes Silikon umfasst, auf die Rückseite der Implantathülle, wodurch diejenigen Teile bedeckt werden, die nicht durch die erste Schaumlage bedeckt sind, h) das Unterziehen der zumindest einen Lage, die in Schritt f) auf die Rückseite der Implantat-hülle aufgebracht wurde, einer Aushärtung, so-dass sie eine Vulkanisierung erfährt, wodurch die Lage mit der Rückseite der Implantathülle verbunden wird.

2. Verfahren nach Anspruch 1, ferner umfassend

fol-genden Verfahrensschritt nach Verfahrensschritt f) und vor oder nach Verfahrensschritt h)

g) das Füllen der Implantathülle mit zumindest einem Gel, einem gelierfähigen Fluid oder einer Flüssigkeit.

3. Verfahren nach Anspruch 1 oder 2, dadurch ge-kennzeichnet, dass das Implantat ein

Brustimplan-tat ist.

4. Verfahren nach einem der vorangehenden

Ansprü-che, ferner umfassend folgenden Verfahrensschritt

nach Verfahrensschritt a) und vor Verfahrensschritt c):

b) das Unterziehen des unausgehärteten Sili-kons der Implantathülle zumindest einem Aus-härtungsschritt, damit es eine vollständige oder teilweise Vulkanisierung erfährt, und das Auf-bringen zumindest einer zusätzlichen unausge-härteten Silikonschicht auf die so erhaltene Im-plantathülle, auf die Vorderseite, den Bereich zur Verbindung der Vorder- und Rückseite und optional auch auf einen Teil der Rückseite, der dem Verbindungsbereich folgt, wobei in Verfah-rensschritt d) die in Schritt c) erhaltene Implan-tathülle zumindest einem Aushärtungsschritt unterzogen wird, um das unausgehärtete Sili-kon aus Schritt a) oder das der zusätzlichen un-ausgehärteten Silikonschicht aus Schritt b) und nötigenfalls das Silikon der noch unausgehärte-ten Implantathülle zu vulkanisieren und dadurch die Schaumlage mit der Implantathülle zu ver-binden.

Ansprü-che, dadurch gekennzeichnet, dass die erste Schaumlage zumindest eine Polyurethanschicht umfasst oder aus einer solchen gefertigt ist.

Ansprü-che, ferner umfassend folgenden Verfahrensschritt nach Verfahrensschritt d) und vor Verfahrensschritt f):

e) das Entfernen, insbesondere das Abtrennen, von überschüssiger Schaumlage, die durch das Härten in Schritt d) nicht mit der Rückseite der Implantathülle verbunden wurde.

Ansprü-che, dadurch gekennzeichnet, dass die Implantat-hülle aus Schritt a), die unausgehärtetes Silikon um-fasst, dahingehend unfertig ist, dass sie ein Zwi-schenprodukt darstellt, das auf seiner Außenfläche noch unausgehärtete Reaktionsfelder aufweist.

Ansprü-che, dadurch gekennzeichnet, dass die Implantat-hülle in Schritt a) durch Bereitstellen einer Form er-halten wird, auf die schrittweise Schichten unausge-härteten Silikons, das entweder als solches flüssig und/oder in einem Lösungsmittel gelöst ist, aufge-bracht werden.

9. Verfahren nach einem der Ansprüche 4 bis 8, da-durch gekennzeichnet, dass die Implantathülle

aus Schritt a) in Schritt b) vollständig ausgehärtet wird.

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10. Verfahren nach einem der Ansprüche 4 bis 9, da-durch gekennzeichnet, dass die zumindest eine

zusätzliche Silikonschicht aus Schritt b) durch Ein-tauchen und/oder Übergießen der Implantathülle aus Schritt b) in bzw. mit Silikon, das entweder als solches flüssig und/oder in einem Lösungsmittel ge-löst ist, erhalten wird, wodurch eine Schicht unaus-gehärteten Silikons bereitgestellt wird.

Ansprü-che, dadurch gekennzeichnet, dass die erste Schaumlage einstückig über der gesamten Vorder-seite, zumindest einem Teil des Bereichs zur Ver-bindung der Vorder- und Rückseite sowie zumindest einem Teil der Rückseite der Implantathülle ange-ordnet ist.

Ansprü-che, dadurch gekennzeichnet, dass die Schaum-lage nach dem Anordnen auf der Implantathülle und dem Verbinden mit selbiger frei ist von Nähten und auch von Falten auf der Vorderseite sowie in dem Bereich, der die Vorder- und Rückseite der Implan-tathülle verbindet.

13. Verfahren nach einem der Ansprüche 8 bis 12, da-durch gekennzeichnet, dass die in Schritt d) oder

in Schritt e) erhaltene Implantathülle aus der Form genommen wird.

Ansprü-che, dadurch gekennzeichnet, dass die in Schritt f) aufgebrachte Lage zusätzlich zumindest eine zweite Schaumlage als Außenschicht umfasst und so eine erste Lagenanordnung ausbildet.

Ansprü-che, ferner umfassend folgende Verfahrensschritte nach Verfahrensschritt g) oder Schritt h):

i) das Bereitstellen einer dritten Schaumlage oder einer zweiten Lageranordnung, die eine Lage oder Schicht umfasst, welche ausgehär-tetes und/oder unausgehärausgehär-tetes Silikon, insbe-sondere unausgehärtetes Silikon, umfasst, und zumindest einer vierten Schaumlage als Außen-schicht der Lagenanordnung, und

j) das Verbinden der dritten Schaumlage bzw. der zweiten Lagenanordnung über ihre Silikon-lage bzw. -schickt mit der Lage aus Schritt f) und/oder mit der Rückseite der Implantathülle.

16. Verfahren nach Anspruch 15, dadurch gekenn-zeichnet, dass die dritte Schaumlage und/oder die

vierte Schaumlage zumindest eine Schicht aus Po-lyurethanschaum darstellen.

17. Verfahren nach einem der Ansprüche 14 bis 16,

da-durch gekennzeichnet, dass die erste

Lagenan-ordnung durch zumindest einen Press- und/oder Aushärtungsschritt erhalten wurde, insbesondere umfassend das Pressen zwischen zwei Pressplatten , und/oder wobei die zweite Lagenan-ordnung durch zumindest einen Pressschritt erhal-ten wurde.

18. Verfahren nach einem der Ansprüche 2 bis 17, ferner

umfassend folgenden Verfahrensschritt nach Ver-fahrensschritten g), h), i) und/oder j):

k) das Unterziehen der gefüllten Implantathülle einer Aushärtung, insbesondere einer thermi-schen Aushärtung.

19. Verfahren nach Anspruch 18, dadurch gekenn-zeichnet, dass die unausgehärtete Silikonschicht

der zweiten Lagenanordnung einer Aushärtung un-terzogen wird.

20. Implantat oder Implantathülle, die nach einem der

Ansprüche 1 bis 19 erhalten wurden.

21. Implantat oder Implantathülle nach Anspruch 20, da-durch gekennzeichnet, dass es sich dabei um ein

Brustimplantat bzw. eine Implantathülle eines Brust-implantats handelt.

Revendications

1. Procédé pour la fabrication d’implants ou de produits

intermédiaires de tels implants, comprenant a) la fourniture d’une enveloppe d’implant com-prenant de la silicone non durcie, ayant un côté frontal, un côté arrière et une région raccordant lesdits côté frontal et côté arrière,

c) le placement d’une première feuille de mous-se sur le côté frontal, sur la région raccordant lesdits côté frontal et côté arrière et sur au moins une partie du côté arrière de l’enveloppe d’im-plant non durcie telle qu’elle est fournie dans l’étape a),

d) l’exposition de l’enveloppe d’implant obtenue dans l’étape c) à au moins une étape de durcis-sement afin de vulcaniser la silicone non durcie de l’étape a), faisant ainsi adhérer la première feuille de mousse à l’enveloppe d’implant, et f) l’application d’au moins un feuille comprenant de la silicone partiellement ou complètement non durcie sur le côté arrière de l’enveloppe d’implant, couvrant ainsi ces parties non cou-vertes par la première feuille de mousse, h) l’exposition de la feuille au moins au nombre de un appliquée au côté arrière de l’enveloppe d’implant dans l’étape f) à un durcissement de

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5 10 15 20 25 30 35 40 45 50 55 telle sorte qu’elle subit une vulcanisation, faisant ainsi adhérer ladite feuille au côté arrière de l’en-veloppe d’implant.

2. Procédé selon la revendication 1, comprenant

éga-lement

après l’étape de procédé f) et avant ou après l’étape de procédé h) l’étape de procédé

g) remplissage de l’enveloppe d’implant avec au moins un gel, un fluide pouvant être gélatinisé ou un liquide.

3. Procédé selon la revendication 1 ou 2, caractérisé en ce que l’implant est un implant mammaire. 4. Procédé selon l’une quelconque des revendications

mentionnées ci-dessus, comprenant également, après l’étape de procédé a) et avant l’étape de pro-cédé c), l’étape de propro-cédé

b) l’exposition de la silicone non durcie de ladite enveloppe d’implant à au moins une étape de durcissement, afin de subir une vulcanisation complète ou partielle, et l’application d’au moins une couche de silicone supplémentaire non dur-cie à l’enveloppe d’implant ainsi obtenue, au cô-té frontal, à la région raccordant le côcô-té frontal et le côté arrière et en option également à la partie du côté arrière qui suit ladite région réa-lisant le raccordement, et dans lequel, dans l’étape de procédé d), l’enveloppe d’implant ob-tenue dans l’étape c) est exposée à au moins une étape de durcissement afin de vulcaniser la silicone non durcie de l’étape a) ou de la couche de silicone non durcie supplémentaire de l’étape b) et, si nécessaire, la silicone de l’enveloppe d’implant non encore durcie, faisant ainsi adhé-rer la première feuille de mousse à l’enveloppe d’implant.

5. Procédé selon l’une quelconque des revendications

mentionnées ci-dessus, caractérisé en ce que la première feuille de mousse comprend ou est com-posée d’au moins une couche de polyuréthane.

mentionnées ci-dessus, comprenant également, après l’étape de procédé d) et avant l’étape de pro-cédé f), l’étape de propro-cédé

e) l’enlèvement, en particulier le découpage, de la feuille de mousse en excès qui n’est pas mise en adhérence par durcissement dans l’étape d) avec le côté arrière de l’enveloppe d’implant.

mentionnées ci-dessus, caractérisé en ce que

l’enveloppe d’implant de l’étape a) comprenant de la silicone non durcie n’est pas finie en ce qu’elle représente un produit intermédiaire qui contient en-core des sites de réaction non durcis sur sa surface extérieure.

mentionnées ci-dessus, caractérisé en ce que l’en-veloppe d’implant dans l’étape a) est obtenue en fournissant un moule auquel sont appliquées par étapes des couches de silicone non durcie, soit li-quide en tant que telle et/soit dissoute dans un sol-vant.

4 à 8, caractérisé en ce que l’enveloppe d’implant de l’étape a) est entièrement durcie dans l’étape b).

4 à 9, caractérisé en ce que la couche de silicone supplémentaire au moins au nombre de un de l’étape b) est obtenue par trempage et/ou par coulée de l’enveloppe d’implant de l’étape b) dans de la silico-ne, soit liquide en tant que telle et/soit dissoute dans un solvant, fournissant ainsi une couche de silicone non durcie.

mentionnées ci-dessus, caractérisé en ce que la première feuille de mousse est placée en une seule pièce sur la totalité du côté frontal, sur au moins une partie de la région raccordant le côté frontal et le côté arrière et sur au moins une partie du côté arrière de l’enveloppe d’implant.

mentionnées ci-dessus, caractérisé en ce que la première feuille de mousse, après avoir été placée sur et mise en adhérence avec l’enveloppe d’im-plant, est exempte de jointures et également de plis sur le côté frontal ainsi que sur la région raccordant le côté frontal et le côté arrière de l’enveloppe d’im-plant.

8 à 12, caractérisé en ce que l’enveloppe d’implant obtenue dans l’étape d) ou dans l’étape e) est enle-vée du moule.

mentionnées ci-dessus, caractérisé en ce que la feuille appliquée dans l’étape f) comprend en plus au moins une deuxième feuille de mousse en tant que couche extérieure, formant ainsi un premier en-semble de feuilles.

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5 10 15 20 25 30 35 40 45 50 55 après l’étape de procédé g) ou l’étape h), les étapes de procédé

i) fourniture d’une troisième feuille de mousse, ou

d’un deuxième ensemble de feuilles qui comprend une feuille ou une couche com-prenant de la silicone durcie et/ou non dur-cie, en particulier de

la silicone non durcie, et d’au moins une quatrième feuille de mousse en tant que couche extérieure dudit ensemble de feuilles, et

j) la jonction de ladite troisième feuille de mous-se, ou

dudit deuxième ensemble de feuilles via sa feuille ou couche de silicone, à la feuille de l’étape f) et/ou au côté arrière de l’envelop-pe d’implant.

16. Procédé selon la revendication 15, caractérisé en ce que la troisième feuille de mousse et/ou la

qua-trième feuille de mousse est au moins une couche de mousse de polyuréthane.

14 à 16, caractérisé en ce que ledit premier ensem-ble de feuilles a été obtenu par au moins une étape de pressage et/ou de durcissement, comprenant en particulier le pressage entre des plaques de pressa-ge, et/ou dans lequel ledit deuxième ensemble de feuilles a été obtenu par au moins une étape de pres-sage.

mentionnées 2 à 17, comprenant également après l’étape de procédé g), h), i) et/ou j) l’étape de procédé

k) l’exposition de l’enveloppe d’implant remplie au durcissement, en particulier au durcissement thermique.

19. Procédé selon la revendication 18, caractérisé en ce que la couche de silicone non durcie du deuxième

ensemble de feuilles est exposée au durcissement.

20. Implant ou enveloppe d’implant obtenu(e) selon

l’une quelconque des revendications 1 à 19.

21. Implant ou enveloppe d’implant obtenu(e) selon la

revendication 20, caractérisé(e) en ce qu’il s’agit d’un implant mammaire ou d’une enveloppe d’im-plant d’un imd’im-plant mammaire respectivement.

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REFERENCES CITED IN THE DESCRIPTION

This list of references cited by the applicant is for the reader’s convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

Patent documents cited in the description • US 5296069 A [0005]

• FR 2675049 A1 [0006]

• FR 2677539 A1 [0006]

• WO 9000888 A [0007]

• WO 2010069019 A1 [0007]

Non-patent literature cited in the description • S. HERMAN. Plastic & Reconstructive Surgery,

1984, 411-414 [0007]

• J.A. LILLA ; L.M. VISTMIS. Plastic & Reconstructive