A SET OF TOOLS FOR MANUFACTURING IMPLANT SHELLS BASED ON SILICONE WITH A FOAM LAYER, AS WELL AS THE CORRESPONDING MANUFACTURING METHOD

Claims

1. A set (1) of tools for producing a shell (100) of a silicone-based implant, equipped with a foamed (105) layer, including: a) a mould (3) for producing an implant shell, having a front side (31), a rear side (35) and a transition zone (33) from the front side to the rear side, as well as a connecting unit provided on said rear side for a retaining means, in particular a retaining rod (5), b) at least one retaining means, in particular a retaining rod (5), which has opposite first and second ends (51, 59) and a longitudinal axis, wherein at said first end (51) a connecting unit is provided, corresponding to said connecting unit of the mould (3) for producing the implant shell, and which, in particular, has a through or receiving channel, passing substantially perpendicular to said longitudinal axis, c) a support unit (8) having a first end portion (80) with a circumferential wall surface (81) and a second end portion (89) opposite it, as well as a contact surface (83) on said first end portion (80) configured to be positioned around the rear connecting unit, in particular flush, wherein the circumferential wall surface (81) of the first end portion (80) of the support unit (8) forms a radial recess when the support surface (83) adjoins the rear side (35) of the mould (3) in the region of the transition between the rear side (35) and the first end portion, in particular at the first end portion (80), wherein the support unit (8), in particular, tapers at the first end portion (80) in the direction of the contact surface (83), d) a fixing means, in particular a fixing rod (9), which is intended for temporarily attaching the support unit (8) to the rear side (35) of the mould (3) for producing the implant shell and which, in particular, has a diameter that is smaller than the diameter of the said through or receiving channel, and a length that, in particular, is at least equal to the diameter of the second end section (89) of the support unit (8), and e) an annular structure (6) adapted to be inserted into said radial recess, or comprising: i) a mould (3) for producing an implant shell, having a front side (31), a rear side (35) and a transition zone (33) from the front side to the rear side, as well as a retaining means located on the rear side, in particular a retaining rod (5), having a longitudinal axis and containing, in particular, a through or receiving channel extending substantially perpendicular to said longitudinal axis, ii) a support unit (8) having a first end portion (80) with a circumferential wall surface (81) and a second end portion (89) opposite it, as well as a contact surface (83) on said first end portion (80) configured to be positioned around the retaining means, being located on said rear side, in particular flush, wherein the circumferential wall surface (81) of the first end portion (80) of the support unit (8) forms a radial recess, in particular an acute angle (a), in the region of the transition between the rear side (35) and the first end portion, when the support surface (83) on the first end portion (80) abuts against the rear side (35) of the mould (3) in the region of the transition between the rear side (35) and the first end portion, forming, in particular, the acute angle (a), wherein, in particular, the support unit (8) tapers at the first end portion (80) in the direction of the contact surface (83), iii) a fixing means, in particular a fixing rod (9), which is intended for temporarily attaching the support unit (8) to the rear side (35) of the mould for producing the implant shell (3), and which, in particular, has a diameter that is smaller than the diameter of the through or receiving channel, and a length that, in particular, is at least equal to the diameter of the second portion (89) of the support unit (8), and iv) an annular structure (6) adapted to be inserted into said radial recess.

2. A kit according to claim 1, characterized in that the rear side (35) of the mold (3) for producing the implant shell is made flat or, preferably, convex, in particular in the direction of its central part (30).

3. A kit according to item 1 or 2, characterized in that the rear side (35) of the mold (3) for producing the implant shell has a cone or truncated cone profile.

4. A kit according to any one of paragraphs 1-3, characterized in that the support unit (8) outside its first end section (80) is made essentially cylindrical.

5. A kit according to any one of paragraphs 1-4, characterized in that the annular structure (6) is represented by a springy-elastic, in particular a tape-like, annular structure (6), in particular, made with the possibility of non-destructive insertion onto the said form (3) and with the possibility of insertion, in a state of tension, into the said acute angle (a) between the rear side (35) and the first end section (80) of the support unit (8), or it is represented by a reversibly opening metal ring or a bendable wire, made with the possibility of insertion into the said acute angle (a) between the rear side (35) and the first end section (80) of the support unit (8) with the formation of this annular structure (6).

6. A kit according to any one of paragraphs 1-5, characterized in that the rear connecting unit for the retaining means is located in the central part (30) of the rear side (35) of the mold (3) for producing the implant shell.

7. A kit according to any one of paragraphs 1-6, characterized in that the connecting unit for the retaining means provided on the said rear side and the connecting unit at the first end (51) of the retaining means are designed with the possibility of forming a reversible detachable connection with a force and / or geometric closure.

8. A kit according to any one of paragraphs 1-7, characterized in that the connecting unit for the retaining means, located on the rear side, comprises or is a threaded hole, and the corresponding connecting unit at the first end (51) of the retaining means comprises or is a thread, in particular an exactly corresponding thread, or the rear connecting unit for the retaining means comprises or is a thread, and the corresponding connecting unit at the first end (51) of the retaining means comprises or is a threaded hole, in particular one that exactly matches.

9. A kit according to any one of claims 1 to 8, characterized in that the mold (3) for producing the implant shell and / or the support unit (8) contain metal, in particular aluminum, or plastic, in particular polyacetal, preferably polyoxymethylene, polyethersulfone, polysulfone, polyphenylsulfone, polyetheretherketone, polyetherketone, thermoplastic polyimide, polyphenylene sulfide, polyamide, polypolyphenylene ether, polycarbonate, polyethylene terephthalate and polybutylene terephthalate.

10. A kit according to any one of paragraphs 1-9, characterized in that said mold (3) is a mold for producing a breast implant shell.

11. A kit according to any one of paragraphs 1-10, characterized in that the distance between the first and second end sections (89) of the support unit (8) essentially corresponds to the distance between the passage or receiving channel and the connecting unit at the first end (51) of the retaining means, in particular the retaining rod (5).

12. A method for manufacturing a shell (100) of a silicone-based implant provided with a foamed (105) layer, comprising the steps of: A) ensure the availability of a kit (1) according to any of paragraphs 1-11, B) dipping a mould (3) for producing an implant shell, connected to said at least one retaining means, one or more times into uncured liquid silicone or uncured silicone dissolved or dispersed in a solvent, or pouring said silicone over said mould (3), connected to at least one retaining means (3), so that the front side (31), the zone (33) of transition from the front side to the back side (35) and the back side (35) up to the retaining means are covered with uncured silicone, C) preferably, said coating with uncured silicone according to step B) is subjected to at least one curing step to ensure full or partial vulcanization leading to the formation of a silicone body (101), D) attaching the support unit (8) with the first end portion (80) to the rear side (35) of the silicone body (101), which is located on the said mould (3) and is, in particular, vulcanised, as a result of which the contact surface (83) on the first end portion (80) comes into contact with it, in particular in a liquid-tight manner, and in a particular case this step includes passing the fixing means, in particular the fixing rod (9), through the through or receiving channel or inserting it into this channel, E) applying at least one layer of uncured silicone (103) to the silicone body (101) obtained in step D) up to the support unit (8) by dipping a mold (3) for producing an implant shell into it or by pouring uncured liquid silicone or uncured silicone dissolved or dispersed in a solvent over this mold (3), F) applying a foam layer (105), in particular a polyurethane foam layer, onto the layer of uncured silicone from step E) onto the front side (31), the zone (33) of transition from the front to the rear side (35) and the region of the rear side (35) which is coated with uncured silicone, wherein the material of the foam layer (105) which projects beyond the region of the rear side (35) coated with uncured silicone is pressed into a recess in the transition region, in particular into an acute angle (a), formed between the rear side and the transition region, by means of a spring-elastic, in particular band-shaped, annular structure (6) or a reversibly opening metal ring or wire which can be bent into an annular structure (6), into a recess in the transition region, in particular the acute angle (a), between the rear side (35) and the first end portion (80) of the support unit (8), and G) subjecting the article obtained in step F) to at least one curing step to vulcanize the uncured silicone from steps B) and E) or from step E) and thus joining the foam layer (105) to the shell (100) of the implant; or including stages at which: A) ensure the availability of a set (1) according to any of paragraphs 1-11, B') provide the presence of a mold (3) for producing an implant shell, comprising a housing (101) on a silicone base, in particular a vulcanized housing on a silicone base, placed on the front side (31), on the zone (33) of transition from the front to the back side and on the back side (35), C) attaching the first end portion (80) of the support unit (8) to the rear side (35) of the silicone body (101), in particular a vulcanized silicone body placed on said mould (3), in such a way that the contact surface (83) on the first end portion (80), in particular impermeable to liquid, in particular including the passage of the fixing means, in particular the fixing rod (9), through the through or receiving channel or its insertion into this channel, D') applying at least one layer of uncured silicone (103) to the silicone body (101) obtained in step C), up to the support unit (8), by dipping the mold (3) one or more times in uncured liquid silicone or uncured silicone dissolved or dispersed in a solvent, or by pouring said silicone over this mold to produce an implant shell, E') a foam layer (105), in particular a polyurethane foam layer, is applied to the uncured silicone layer from step D') on the front side (31), the transition area (33) from the front to the rear side (35) and the region of the rear side (35) covered with uncured silicone, wherein the material of the foam layer (105), which projects beyond the region of the rear side (35) covered with uncured silicone, is introduced into a recess in the transition area, in particular into an acute angle (α), between the rear side (35) and the first end section (80) of the support unit (8), and is fixed with an annular structure (6), and F') subjecting the article obtained in step E') to at least one curing step to vulcanize the uncured silicone from steps B') and E') or from step E') and thus connecting the foam layer (105) to the shell (100) of the implant.

13. The method according to claim 12, further comprising as step H) or G') removing, in particular cutting off, excess foam layer (105) that was not bonded to the back side of the implant shell (100) during the curing step in step G) or F').

14. The method according to claim 12 or 13, further comprising as step I) or H') removing the shell (100) of the implant from the mould (3).

15. The method according to any one of paragraphs 12-14, characterized in that step (F) or (E') comprises placing and fixing as an annular structure (6) a springy-elastic, in particular a tape-like, annular structure (6) or a reversibly opening metal ring or wire that can be bent into an annular structure (6), in the recess.