Kit-of-parts tool set and method for producing silicone-based implant shells provided with a foam layer

Abstract

The invention relates to a method for producing a silicone-based implant shell (100) provided with a foam layer (105) and to a kit-of-parts tool set (1) for producing such implant shells, comprising an implant shell production mould (3) with an attachment unit for a holding device present on the rear face, and a holding device (5), a support unit (8) having a first end portion (80) with a peripheral wall face (81) and an opposite, second end portion (89), and with a bearing face (83) on the first end portion (80), designed and configured to be able to bear in an area around the attachment unit present on the rear face, wherein the peripheral wall face of the first end portion (80) of the support unit (8) forms a radial indentation when the bearing face (83) bears in a transition region between the rear face (35) and the first end portion, a fixing device for temporary fixing of the support unit (8) on the rear face (35) of the implant shell production mould (3), and a ring structure (6) insertable into the indentation.

Description

This invention relates to a method for producing a silicone-based implant shell (100) having a foam layer (105), and a parts kit tooling set (1) for producing such an implant shell, the parts kit tooling set comprising: an implant shell production mold (3) having an attachment unit for a retaining device present on a rear face, and a retaining device (5); a support unit (8) having a first end portion (80) with a peripheral wall surface (81) and an opposing second end portion (89), and having a bearing surface (83) on the first end portion (80) designed and configured to be supported in a region surrounding the attachment unit present on the rear face, wherein the peripheral wall surface of the first end portion (80) of the support unit (8) forms a radial recess when the bearing surface (83) is supported in a transition region between the rear face (35) and the first end portion; a fixing device for temporarily fixing the support unit (8) to the rear face (35) of the implant shell production mold (3); and an annular structure (6) insertable into the recess.

Claims

Claims i. Kit-of-parts tool set (i) for the production of silicone-based implant shells (100) provided with a foam layer (105), comprising a) an implant shell production mold (3) with a front side (31), a back side (35) and a transition (33) from front to back side, as well as with a connection unit for a holding device, in particular a holding rod (5), on the back side, b) at least one holding device, in particular a holding rod (5), with a first and an opposite second end (51, 59) with a longitudinal axis and with a connection unit corresponding to the connection unit of the implant shell production mold (3) at the first end (51), in particular comprising a through- or receiving channel substantially perpendicular to the longitudinal axis,c) a support unit (8) with a first end section (80) with a circumferential wall surface (81) and an opposite second end section (89) and with a contact surface (83) on the first end section (80), designed and configured to be able to be placed, in particular flush, in an area around the connection unit present on the rear side, wherein the circumferential wall surface (81) of the first end section (80) of the support unit (8) forms a radial indentation when the contact surface (83) is placed in a transition region between the rear side (35) and the first end section, in particular forming an acute angle (et) at the first end section (80) to the rear side (35) of the implant shell production mold (3), wherein in particular the support unit (8) tapers at the first end section (80) in the direction of the contact surface (83), d) a fixing device, in particular a fixing rod (9),for the temporary fixation of the support unit (8) on the rear side (35) of the implant shell production mold (3), in particular with a diameter that is smaller than the diameter of the through- or receiving channel, and with a length that is in particular equal to or greater than the diameter of the second end section (89) of the support unit (8), and e) a ring structure (6) that can be inserted or is inserted into the radial indentation, or comprising, i) an implant shell manufacturing mold (3) with a front side (31), a rear side (35) and a transition (33) from the front to the rear side, as well as with a holding device on the rear side with a longitudinal axis, in particular a holding rod (5), in particular comprising a through- or receiving channel substantially perpendicular to the longitudinal axis, ii) a support unit (8) with a first end section (80) with a circumferential wall surface (81) and an opposite second end section (89) and with a contact surface (83) on the first end section (80), designed and configured to be able to be placed, in particular flush, in an area around the holding device on the rear side,wherein the circumferential wall surface (81) of the first end section (80) of the support unit (8) forms a radial indentation, in particular an acute angle (et), in a transition region between the rear side (35) and the first end section when the contact surface (83) at the first end section (80) bears against the rear side (35) of the implant shell production mold (3), wherein in particular the support unit (8) tapers at the first end section (80) in the direction of the contact surface (83), iii) a fixing device, in particular a fixing rod (9), for temporarily fixing the support unit (8) to the rear side (35) of the implant shell production mold (3), in particular with a diameter that is smaller than the diameter of the through- or receiving channel, and with a length that is in particular equal to or greater than the diameter of the second end section (89) of the support unit (8), and iv) a ring structure (6) that can be inserted or is inserted into the indentation.

2. Kit-of-parts tool set (1) according to claim 1, characterized in that the rear side (35) of the implant shell manufacturing mold (3) is flat or preferably bulges out, in particular towards the center (30) thereof.

3. Kit-of-parts tool set (1) according to claim 1 or 2, characterized in that the rear side (35) of the implant shell manufacturing mold (3) is conical or truncated cone-shaped. 4- Kit-of-parts tool set (1) according to one of the preceding claims, characterized in that the support unit (8) is substantially cylindrical beyond the first end portion (80).

5. Kit-of-parts tool set (1) according to one of the preceding claims, characterized in that the ring structure (6) is formed by a spring-elastic, in particular band-shaped, ring structure (6), in particular designed and configured to be guided non-destructively over the implant shell production mold (3) and to be applied under tension in the acute angle (α) between the rear side (35) and the first end section (80) of the support unit (8), or a reversibly openable metal ring or a bendable wire, designed and configured to be applied in the acute angle (ε) between the rear side (35) and the first end section (80) of the support unit (8) to form a ring structure (6).

6. Kit-of-parts tool set (1) according to one of the preceding claims, characterized in that the rear connection unit for a holding device is present in the center (30) of the rear side (35) of the implant shell production mold (3).

7. Kit-of-parts tool set (1) according to one of the preceding claims, characterized in that the connection unit for a holding device present on the rear and the connection unit at the first end (51) of the holding device are designed and arranged to enter into a reversibly releasable non-positive and / or positive connection.

8. Kit-of-parts tool set (1) according to one of the preceding claims, characterized in that the connection unit for a holding device on the rear side comprises or represents a threaded bore and that the corresponding connection unit on the first end (51) of the holding device comprises or represents a thread, in particular a precisely fitting thread, or that the connection unit for a holding device on the rear side comprises or represents a thread and that the corresponding The connection unit at the first end (51) of the holding device comprises or represents a threaded bore, in particular a precisely fitting one.

9. Kit-of-parts tool set (1) according to one of the preceding claims, characterized in that the implant shell production mold (3) and / or the support unit (8) comprises or consists of metal, in particular aluminum, or plastic, in particular polyacetals, preferably polyoxymethylene, polyethersulfones, polysulfones, polyphenylsulfones, polyetheretherketones, polyetherketones, thermoplastic polyimides, polyphenylene sulfides, polyamides, polyphenylene ethers, polycarbonates, polyethylene terephthalate and polybutylene terephthalate.

10. Kit-of-parts tool set (1) according to one of the preceding claims, characterized in that the implant shell manufacturing mold (3) represents a breast implant shell manufacturing mold.

11. Kit-of-parts tool set (1) according to one of the preceding claims, characterized in that the distance between the first and the second end section (89) of the support unit (8) corresponds substantially to the distance between the through- or receiving channel and the connection unit at the first end (51) of the holding device, in particular the holding rod (5).

12. A method for producing a silicone-based implant shell (100) provided with a foam layer (105), comprising the steps A) Providing a kit-of-parts tool set (1) according to one of the preceding claims, B) immersing the implant shell production mold (3) connected to the at least one holding device once or several times in or pouring the implant shell production mold (3) connected to the at least one holding device with uncured liquid silicone or with uncured silicone dissolved or dispersed in a solvent, so that the front side (31), the transition (33) from the front to the back side (35) and the back side (35) up to the holding device are covered with uncured silicone, C) preferably subjecting the covering with uncured silicone according to step B) to at least one curing step in order to achieve complete or partial vulcanization, forming a silicone base shell (101), D) fixing the support unit (8) with the first end section (80) to the rear side (35) of the, in particular vulcanized, silicone base shell (101) present on the implant shell production mold (3), so that the contact surface (83) comes to rest on the first end section (80), in particular in a liquid-tight manner, in particular comprising passing or inserting the fixing device, in particular the fixing rod (9), through or into the through- or receiving channel, E) applying at least one uncured silicone layer (103) to the silicone base shell (101) obtained according to step D) up to the support unit (8) by dipping the implant shell production mold (3) once or several times in or pouring the implant shell production mold (3) with uncured liquid silicone or with uncured silicone dissolved or dispersed in a solvent, F) Applying a foam layer (105), in particular a polyurethane foam layer, to the layer of uncured silicone according to step E) to the front side (31), the transition (33) from the front side to the back side (35) and the area of ​​the back side (35) which is covered with uncured silicone, wherein material of the foam layer (105) which extends over the area of ​​the back side (35) ? which is covered with uncured silicone, is placed and fixed by the spring-elastic, in particular band-shaped, ring structure (6) or the reversibly openable metal ring or the wire which can be bent into a ring structure (6) in an indentation in a transition region, in particular the acute angle (a), between the rear side (35) and the first end section (80) of the support unit (8), and G) subjecting the product obtained in step F) to at least one curing step in order to vulcanize the uncured silicone according to step B) and E) or according to step E) and thereby bond the foam layer (105) to the implant shell (100); or comprising the steps A) Providing a kit-of-parts tool set (1) according to one of the preceding claims, B') Providing an implant shell manufacturing mold (3), comprising a silicone base shell (101), in particular vulcanized, present on the front side (31), in the transition (33) from the front side to the back side and on the back side (35), C') Fixing the first end section (80) of the support unit (8) to the rear side (35) of the, in particular vulcanized, silicone base shell (101) present on the implant shell production mold (3), so that the contact surface (83) comes into contact with the first end section (80), in particular in a liquid-tight manner, in particular comprising passing or inserting the fixing device, in particular the fixing rod (9), through or into the through- or receiving channel, D') Applying at least one uncured silicone layer (103) to the silicone base shell (101) obtained according to step C') up to the support unit (8) by dipping the implant shell production mold (3) once or several times into or pouring uncured liquid silicone or uncured silicone dissolved or dispersed in a solvent onto the implant shell production mold (3), E') Applying a foam layer (105), in particular a polyurethane foam layer, to the layer of uncured silicone according to step D') to the front side (31), the transition (33) from the front side to the back side (35) and the area of ​​the back side (35) which is covered with uncured silicone, wherein material of the foam layer (105) which extends over the area of ​​the back side C35) ? which is covered with uncured silicone, is placed and fixed by the ring structure (6) in a recess in a transition region, in particular the acute angle (a), between the rear side (35) and the first end section (80) of the support unit (8), and F') Subjecting the product obtained in step E') to at least one curing step in order to vulcanize the uncured silicone according to step B') and E') or according to step E') and thereby bond the foam layer (105) to the implant shell (100).

13. The method of claim 12, further comprising as step H) or step G') the removal, in particular the separation, of excess foam layer (105) which was not connected to the back of the implant shell (100) by the curing step in step G) or step F').

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

15. Method according to one of claims 12 to 14, characterized in that step (F) or (E') comprises that as a ring structure (6) a spring-elastic, in particular band-shaped, ring structure (6) or a reversibly openable metal ring or a wire bendable to form a ring structure (6) is placed and fixed in the indentation.

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