TOOL PARTS KIT AND PROCEDURE FOR MANUFACTURING SILICONE-BASED PLANT CASINGS WITH A FOAM LAYER

Abstract

A method for manufacturing a silicone-based implant shell (100) provided with a foam layer (105) and a kit-of-parts tool set (1) for manufacturing such implant shells, comprising an implant shell manufacturing mold (3) with a rear-facing attachment unit for a holding device and a holding device (5), a support unit (8) with a first end section (80) having a circumferential wall surface (81) and an opposing second end section (89) and with a contact surface (83) on the first end section (80), designed and configured to be positioned in an area around the rear-facing attachment unit, wherein the circumferential wall surface of the first end section (80) of the support unit (8) forms a radial indentation in a transition area between the rear side (35) and the first end section when the contact surface (83) is applied.a fixing device for the temporary fixing of the support unit (8) to the rear (35) of the implant shell manufacturing mold (3), and a ring structure (6) that can be inserted into the indentation.

Description

[0001] The invention relates to a kit-of-parts tool set for the production of silicone-based implant shells provided with a foam layer. The invention also relates to a method for producing a silicone-based implant shell provided with a foam layer.

[0002] It is an object of the invention to provide a kit-of-parts tool set and / or a method for producing silicone-based implant shells provided with a foam layer, which overcomes the disadvantages of the prior art, in particular is simple and quick to use, meets high hygiene and / or quality requirements, is suitable for producing implant shells, in particular breast implant shells, uniformly with high precision, and / or avoids damage and other defects during production. This object is achieved by the subject matter of the independent claims.

[0003] According to a first aspect of the invention, a kit-of-parts tool set for the production of silicone-based implant shells provided with a foam layer is provided, which comprises an implant shell production mold, at least one holding device, a support unit, a fixing device and a ring structure.

[0004] The kit-of-parts tool set according to the first aspect comprises an implant shell manufacturing mold having a front side, a back side and a transition from the front side to the back side as well as having a connection unit on the back side for a holding device, in particular a holding rod.

[0005] According to the first aspect of the invention, the kit-of-parts tool set comprises at least one holding device, in particular at least one holding rod, having a first end and a second end opposite the first end, having a longitudinal axis, and having a connection unit at the first end that corresponds to the connection unit of the implant shell manufacturing mold. In particular, the holding device comprises a through- or receiving channel arranged substantially perpendicular to the longitudinal axis. Preferably, the through- or receiving channel penetrates the holding device, in particular the holding rod, perpendicular to its longitudinal axis. The holding device, in particular the holding rod, can be substantially rotationally symmetrical with respect to the longitudinal axis.

[0006] In particular, the kit-of-parts tool set according to the first aspect of the invention can have a plurality of different holding devices, in particular a plurality of different holding rods, wherein the plurality of different holding devices of the kit-of-parts tool set preferably differ in terms of their material, structure, and / or dimensions. Optionally, a kit-of-parts tool set can comprise at least one first holding device, which is designed and configured for the one or more times dipping and / or pouring of uncured silicone into an implant shell production mold connected to this first holding device in order to produce a, in particular fully vulcanized, silicone base shell.Alternatively or additionally, a kit-of-parts tool set can contain at least one second holding device, which is designed and configured for the one-time or repeated dipping and / or pouring of uncured silicone into an implant shell production mold containing the silicone base shell, connected to this second holding device, in order to then apply the foam layer thereto and, if necessary, tension it without creases. The first and / or second holding device can preferably be designed and configured to undergo at least one curing step for forming an implant base shell / silicone base shell or for fixing a foam layer, in particular a polyurethane foam layer, without damage. The first holding device and the second holding device can be made of the same material or of different materials.The first holding device and the second holding device can be formed from the same material as the implant shell manufacturing mold or from a different material, e.g. from metal such as steel or aluminum.

[0007] Accordingly, the kit-of-parts tool set according to the invention for the production of silicone-based implant shells provided with a foam layer according to the first aspect comprises a) an implant shell manufacturing mold with a front side, a back side, and a transition from front to back side, as well as with a rear connection unit for a holding device, in particular a holding rod, b) at least one holding device, in particular a holding rod, with a first and an opposite second end with a longitudinal axis and with a connection unit corresponding to the connection unit of the implant shell manufacturing mold at the first end, in particular comprising a through- or receiving channel substantially perpendicular to the longitudinal axis, c) a support unit with a first end section with a circumferential wall surface and an opposite second end section and with a contact surface on the first end section, designed and configured to be able to be placed in an area around the rear connection unit, in particular flush,wherein the circumferential wall surface of the first end section of the support unit forms a radial indentation when the support surface is in contact in a transition region between the rear side and the first end section, in particular forming an acute angle (α) at ​​the first end section to the rear side of the implant shell production mold, wherein in particular the support unit tapers at the first end section in the direction of the contact surface, d) a fixing device, in particular a fixing rod, for the temporary fixing of the support unit to the rear side of the implant shell production mold, 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 of the support unit, and e) a ring structure that can be inserted or is inserted into the radial indentation.

[0008] In this case, the contact surface of the support unit can have a, in particular maximum, extension, in particular a diameter, which is smaller than the smallest cross-sectional width of the rear side.

[0009] Alternatively, according to a second aspect of the invention, a kit-of-parts tool set is provided for the production of silicone-based implant shells provided with a foam layer, which comprises an implant shell production mold with a holding device, a support unit, a fixing device and a ring structure.

[0010] According to the second aspect of the invention, the kit-of-parts tool set comprises an implant shell manufacturing mold with a front side, a back side, and a transition from front to back side, as well as with a holding device on the back with a longitudinal axis, in particular with a holding rod, in particular comprising a through- or receiving channel substantially perpendicular to the longitudinal axis of the holding device, in particular the holding rod. The through- or receiving channel preferably penetrates the holding device, in particular the holding rod, perpendicular to its longitudinal axis. In the kit-of-parts tool set according to the second aspect of the invention, the holding device is preferably firmly connected, for example by a material fit, to the implant shell manufacturing mold. In particular, the holding device is formed integrally with the implant shell manufacturing mold.The holding device, in particular the holding rod, can be substantially rotationally symmetrical with respect to the longitudinal axis. The holding device, which is firmly connected to the implant shell manufacturing mold, is designed and configured to undergo the multiple steps of the manufacturing method together with the implant shell manufacturing mold, in particular without damage and / or destruction. The holding device, which is firmly connected to the implant shell manufacturing mold, can be made of the same material as the implant shell manufacturing mold or of a different material, for example, metal such as steel or aluminum.

[0011] Accordingly, the kit-of-parts tool set according to the invention for the production of silicone-based implant shells provided with a foam layer according to the second aspect comprises i) an implant shell manufacturing mold having a front side, a back side, and a transition from the front to the back side, as well as a rear-mounted retaining device having a longitudinal axis, in particular a retaining rod, in particular comprising a through- or receiving channel substantially perpendicular to the longitudinal axis, ii) a support unit having a first end section with a circumferential wall surface and an opposite second end section, and having a contact surface on the first end section, designed and configured to be able to be placed, in particular flush, in an area around the rear-mounted retaining device, wherein the circumferential wall surface of the first end section of the support unit forms a radial indentation, in particular an acute angle (α), in a transition region between the back side and the first end section when the contact surface on the first end section is placed against the back side of the implant shell manufacturing mold,wherein in particular the support unit tapers at the first end portion in the direction of the contact surface, iii) a fixing device, in particular a fixing rod, for the temporary fixing of the support unit to the rear side of the implant shell manufacturing mold, 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 portion of the support unit, and iv) a ring structure that can be inserted or is inserted into the recess.

[0012] In this case, the contact surface of the support unit can have a, in particular maximum, extension, in particular a diameter, which is smaller than the smallest cross-sectional width of the rear side.

[0013] According to the first or second aspect of the invention, the implant shell manufacturing mold can be designed and configured to produce an implant shell that extends uninterruptedly over both the entire front side and the entire transition between the front and back sides, as well as the entire back side with the exception of the region where the holding device is attached, in particular the center of the back side. Preferably, the implant shell manufacturing mold has a cross-sectional width in the region of the transition from the front to the back side. In the case of an implant shell manufacturing mold with a circular cross-section, the cross-sectional width can be defined by its constant circular diameter.Within the scope of the invention, other implant shell manufacturing forms are also conceivable, for example those with an egg-shaped or oval cross-section, wherein a smallest cross-sectional width, for example in the case of an oval or egg-shaped cross-section, is defined by the shortest diagonal, and wherein a largest cross-sectional width is defined by the longest diagonal.

[0014] The implant shell manufacturing shape, particularly as a breast implant shell manufacturing shape, can be symmetrical, for example, mirror-symmetrical (if, for example, an egg-shaped or oval cross-sectional shape of the implant is intended) or rotationally symmetrical (if the implant has a circular cross-sectional shape). The implant shell manufacturing shape, particularly as a breast implant shell manufacturing shape, can be anatomically or teardrop-shaped.

[0015] According to both the first and second aspects of the invention, the kit-of-parts tool set comprises a support unit with a first end section having a circumferential wall surface and an opposite second end section. The support unit has a contact surface on the first end section. The contact surface is designed and configured to be able to be placed, in particular flush, in an area on the rear side all around the connection unit and / or holding device present on the rear side. The contact surface has a, in particular maximum, extension, in particular a diameter that is smaller than the smallest cross-sectional width of the rear side. The contact surface is preferably circular. In the case of a circular contact surface, the extension can correspond to its constant outer diameter.The contact surface can have a different ring-like shape, for example oval, egg-shaped, or polygonal with rounded corners, wherein the extension of the contact surface can have a minimum extension corresponding to a smallest diagonal of the ring-like shape and a maximum extension corresponding to a largest diagonal of the ring-like shape. It can be preferred that the maximum extension of the contact surface is smaller than the smallest cross-sectional width of the implant shell production mold, in particular its rear side. Alternatively, it can be provided that the ring-like shape can be aligned or oriented according to the cross-sectional shape of the implant shell production mold, wherein in each case in the same transverse direction perpendicular to the longitudinal axis, the extension of the ring-like shape of the contact surface is smaller than the cross-sectional width of the implant shell production mold.For example, in a first radial direction with respect to the longitudinal axis, the largest cross-sectional width and a maximum extension which is smaller than the largest cross-sectional width, and in a second radial direction, a smallest cross-sectional width and a minimum extension which is smaller than the smallest cross-sectional width, can be aligned, wherein in particular the smallest cross-sectional width can be greater than, smaller than or equal to the largest extension.

[0016] When the contact surface rests against the first end portion of the support unit, the circumferential wall surface of the first end portion of the support unit forms a radial indentation, in particular an acute angle, in a transition region between the rear side and the first end portion. The indentation, which is particularly concave with respect to the radial direction, preferably extends in the circumferential direction completely around the central axis of the support unit and / or the longitudinal axis of the implant shell production mold.In particular, in a state in which the support unit is placed with the contact surface against the back of the implant shell production mold, in particular indirectly with at least one silicone base shell or the like present between the support unit and the implant shell production mold, an indentation is created in the transition region between the back and the first end portion, which can, for example, describe a groove, notch, or annular groove. It should be understood that the acute angle can be spanned in a radial cross-sectional plane between the back of the implant shell production mold and the outer side of the support unit at its first end portion adjacent to the contact surface. It can be expedient for the acute angle to be no more than 80°, in particular no more than 70°, preferably no more than 60°.Additionally or alternatively, it may be expedient for the acute angle to be at least 30°, in particular at least 40°, preferably at least 50°. In the circumferential direction, the acute angle can lie entirely in a range between 30° and 80°, in particular between 40° and 70°, preferably between 50° and 60°. In particular, the acute angle can be constant in the circumferential direction. In particular, the support unit tapers at the first end section in the direction of the contact surface. For example, the support unit can be cylindrical sleeve-shaped at its second end section and frustoconical in the first end section adjacent to the contact surface. The inner side of the support unit can have a constant inner diameter, which is preferably constant along the entire axial extent of the support unit, both in the first end section and in the second end section.The circumferential wall surface extends in a full circle around a central axis. Preferably, the support unit and the holding device are coordinated with one another such that the central axis of the support unit and the longitudinal axis of the holding device are arranged or are arranged corresponding to one another, in particular parallel, preferably collinear. The support unit can be rotationally symmetrical with respect to a central axis. In the kit-of-parts tool set according to the invention, the support unit is separate from the implant shell production mold. The support unit and the implant shell production mold can be detachably connected to one another. It can be preferred that the first end and / or the second end of the support unit is formed to match the rear side of the implant shell production mold.

[0017] According to both the first and second aspects of the invention, the kit-of-parts tool set comprises a fixing device, in particular a fixing rod, for temporarily fixing the support unit to the rear side of the implant shell production mold. In particular, the fixing device, preferably the fixing rod, has a diameter that is smaller than the diameter of the through- or receiving channel. In particular, the fixing device, preferably the fixing rod, has a length that is equal to or greater than the outer diameter at the second end region of the support unit. It may be particularly preferred for the fixing device to have a length that is greater than the rear side of the implant shell production mold. The fixing device, in particular the fixing rod, is preferably formed separately from the holding device, in particular the holding rod. The fixing device is detachably connectable or connected to the support unit and / or the holding device.The through-channel or receiving channel and the fixing device are preferably shaped to match one another; in particular, the through-channel or receiving channel and the fixing device have matching, in particular complementary and / or congruent, cross-sectional areas. According to a particularly preferred embodiment, the cross-sectional areas of the through-channel or receiving channel and / or the fixing device are circular.Alternatively, the through-passage or receiving channel can be designed and configured to movably receive the fixing device, preferably the fixing rod, in the longitudinal axial direction. In particular, the through-passage or receiving channel, such as an elongated hole, can have a longitudinal extension in the longitudinal axial direction that is greater than the width extension of the through-passage or receiving channel in the circumferential direction. The diameter of the fixing device or of the through-passage or receiving channel can generally be referred to as its cross-sectional width. It is conceivable for a kit-of-parts tool set, in particular according to the first aspect of the invention, to comprise a plurality of different fixing devices, in particular fixing rods, which differ in terms of their material, their structure, and / or their dimensions.In a kit-of-parts tool set according to the first aspect of the invention, it can be provided that a single fixing device, in particular a single fixing rod, is provided for the multiple holding devices of the kit-of-parts tool set. Alternatively, in a kit-of-parts tool set according to the first aspect of the invention, corresponding, fixing devices specific to each holding device can be provided for at least two of the multiple different holding devices. Alternatively, it can be provided, in particular, that the fixing device has an eyelet (an opening) for receiving the holding device, in particular the holding rod. The holding device and the eyelet are preferably shaped to match one another; in particular, the holding device and the eyelet have matching, in particular complementary and / or congruent, cross-sectional areas.According to a particularly preferred embodiment, the cross-sectional areas of the holding device and the eye are circular. It may be preferred that the eye is equipped with an internal thread and the holding device with an external thread complementary in shape to the internal thread. Alternatively, it may be preferred that the holding device, in particular the holding rod, and the eye are matched to one another according to a fit, for example a clearance fit or a sliding fit, in order to allow a linear movement and, if appropriate, a rotational movement of the fixing device, in particular the fixing rod, with respect to the longitudinal axis of the holding device. Optionally, the kit-of-parts tool set can additionally comprise at least one fastening means, such as a screw or threaded nut, to fix the fixing device in the longitudinal axis axial direction.In particular, the holding device can be designed and configured to cooperate with the fastening means, wherein, for example, the holding device can have an external thread complementary to the internal thread of the nut. It may be expedient for the kit-of-parts tool set to contain at least one fastening means if the fixing device is held on the holding device so as to be movable relative to the holding device in the longitudinal axial direction, for example, by means of the eye or an elongated hole.

[0018] According to both the first and the second aspect of the invention, the kit-of-parts tool set comprises a ring structure that can be or is inserted into the radial indentation, in particular the acute angle. In the following, the term ring structure can generally be used to describe a one-part or multi-part component of the kit-of-parts tool set that can be or is inserted into an indentation in the transition region between the rear side and the first end section. In general, the ring structure can be applied to the acute angle while providing a radial contact pressure, in particular as a result of a spring-elastic restoring stress, a tensile stress and / or a clamping stress of the ring structure.The ring structure can preferably be designed and configured to fix a foam layer or the like, which is placed over the implant shell manufacturing mold and, at least in the region of the first end section, over the support unit, to the kit-of-parts tool set. Particularly preferably, the ring structure is designed and configured to withstand the curing step without damage and / or destruction.

[0019] The kit-of-parts tool set according to the invention is easy and quick to use thanks to its design and small number of components, and meets the highest hygiene and / or quality requirements. With the kit-of-parts tool set according to the invention, implant shells, in particular breast implant shells, can be manufactured uniformly with high precision. Thanks to the use of the kit-of-parts tool set according to the invention, damage and other defects during production can be consistently and consistently avoided.

[0020] In one embodiment of the kit-of-parts tool set, the rear side of the implant shell production mold bulges out, in particular, towards its center, i.e., it extends away from the front side. However, the rear side of the implant shell production mold can also be flat. Additionally or alternatively, the rear side of the implant shell production mold can be conical or truncated cone-shaped. The rear side can have a rectilinear and / or convex taper, at least in sections or entirely. The rear side of the implant shell production mold is preferably symmetrical, in particular rotationally symmetrical, with respect to the longitudinal axis. Preferably, the radial course of the rear side of the implant shell production mold is continuous and / or constant according to the taper. The rear side of the implant shell production mold can, for example, be truncated spherically or truncated conically.With respect to an area defined by the annular transition, the volume of the implant shell manufacturing mold covered by the front side is preferably at least as large as, preferably larger than, the volume of the implant shell manufacturing mold covered by the back side.

[0021] In the kit-of-parts tool set according to a preferred embodiment of the first and / or second aspect, the support unit is substantially cylindrical beyond the first end portion. In particular, the second end portion has a constant cylinder diameter. The second end portion can have a wall surface that is preferably formed integrally, in particular of the same material, with the first end portion. The wall surface is preferably circumferential in the second end portion. It may be preferred that the wall surface in the second end portion is closed or free of radial openings. The first end portion can be frustoconical on the outside. The first, frustoconical end portion can have, at least in sections or entirely, a straight taper, a concave (inwardly curved) taper, or a convex (outwardly curved) taper.In particular, the taper runs continuously, preferably constantly, from the contact surface to the radially outer end of the first end section.

[0022] According to a preferred embodiment of the first and / or second aspect, the kit-of-parts tool set comprises a ring structure formed by a resilient ring structure or a reversibly openable metal ring or a flexible wire designed and configured to form a ring structure. According to a first alternative, the ring structure is resilient. In particular, the resilient ring structure is band-shaped. It may be preferred that the resilient ring structure be formed from a plastic material, a PET, such as PET-BO or BO-PET (Mylar). Preferably, the resilient ring structure is configured and configured to be guided non-destructively over the implant shell production mold and to be applied under tension, in particular resilient recovery tension, at the acute angle between the rear side and the first end portion of the support unit.According to a second alternative, a reversibly openable metal ring can be provided, which is configured and designed to be placed in the acute angle between the rear side and the first end section of the support unit, forming a ring structure. According to a further alternative, a bendable wire can be provided, which is configured and designed to be placed in the acute angle between the rear side and the first end section of the support unit, forming a ring structure.

[0023] In one embodiment of the kit-of-parts tool set according to the first aspect of the invention, the rear connection unit for the holding device is located in the center of the rear side of the implant shell manufacturing mold. It may be preferred that the connection unit for the holding device is arranged on a common longitudinal axis of the holding device and the implant shell manufacturing mold. Both the holding device and the implant shell manufacturing mold can be shaped substantially rotationally symmetrically with respect to a common longitudinal axis.

[0024] According to one embodiment of the kit-of-parts tool set according to the first aspect of the invention, the rear connection unit for the holding device and the connection unit at the first end of the holding device are designed and configured to establish a reversibly releasable non-positive and / or positive connection. The holding device and the implant shell manufacturing mold can comprise a coordinated thread pair. It may be preferred that the rear connection unit for the holding device comprises or represents a threaded bore, and that the corresponding connection unit at the first end of the holding device comprises or represents a thread, in particular a precisely fitting thread.Alternatively, it may be preferred that the connection unit for the holding device on the rear comprises or represents a thread and that the corresponding connection unit at the first end of the holding device comprises or represents a threaded bore, in particular a precisely fitting one. The connection unit of the holding device and / or for the holding device can have an inner diameter, in particular a thread diameter, of at least 8 mm, in particular at least 10 mm, preferably at least 12 mm, and / or not more than 22 mm, in particular not more than 20 mm, preferably not more than 16 mm or 15 mm. The connection unit of the holding device and / or for the holding device can have an axial height or depth of at least 10 mm, in particular at least 15 mm, preferably at least 20 mm, and / or not more than 60 mm, in particular not more than 40 mm, preferably not more than 30 mm.It has been found that such a connection unit is easy to handle and is particularly well suited to providing a stable hold for the implant shell production mold on the holding device, in particular the holding rod, in particular in the case of axial displacements of the holding device, in particular the holding rod, with respect to the implant shell production mold, for example for temporarily fixing the holding device to the implant shell production mold and / or for tensioning the foam layer on the implant shell production mold.

[0025] In one embodiment of the kit-of-parts tool set, the implant shell manufacturing mold comprises or consists of metal, in particular aluminum, or plastic, in particular polyacetals, preferably polyoxymethylene, polyethersulfones, polysulfones, polyphenylsulfones, polyaryletherketones, in particular polyetheretherketones, polyetherketones, thermoplastic polyimides, polyphenylene sulfides, polyamides, polyphenylene ethers, polycarbonates, polyethylene terephthalate, and polybutylene terephthalate. Alternatively or additionally, the support unit comprises or consists of metal, in particular aluminum, or plastic, in particular polyacetals, preferably polyoxymethylene, polyethersulfones, polysulfones, polyphenylsulfones, polyaryletherketones, in particular polyetheretherketones, polyetherketones, thermoplastic polyimides, polyphenylene sulfides, polyamides, polyphenylene ethers, polycarbonates, polyethylene terephthalate, and polybutylene terephthalate.Furthermore, additionally or alternatively, the holding device and / or the fixing device, and / or optionally the fastening means comprises metal, in particular aluminum, or plastic, in particular polyacetals, preferably polyoxymethylene, polyethersulfones, polysulfones, polyphenylsulfones, polyaryletherketones, in particular polyetheretherketones, polyetherketones, thermoplastic polyimides, polyphenylene sulfides, polyamides, polyphenylene ethers, polycarbonates, polyethylene terephthalate and polybutylene terephthalate. The implant shell manufacturing mold, the holding device, the support unit, the fixing device and optionally the fastening means can comprise or consist of different materials, or in pairs or all comprise or consist of the same materials or the same material. Aluminum, including aluminum alloys, is preferred as the metal for one or more components of the kit-of-parts tool set.Polyacetals, in particular polyoxymethylene, or polymer compounds or polymer blends comprising at least 50% polyacetals, in particular at least 50% polyoxymethylene, are preferred as plastics for one or more components of the kit-of-parts tool set.

[0026] According to a particularly preferred embodiment, the implant shell manufacturing mold represents a breast implant shell manufacturing mold.

[0027] The invention also relates to a method for producing a silicone-based implant shell provided with a foam layer. The method comprises, in this order, the following steps: A) Providing a kit-of-parts tool set as described above, in particular according to the first or second aspect of the invention, and B) immersing the implant shell production mold connected to the at least one holding device once or several times in or pouring the implant shell production mold 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, the transition from the front to the back side, and the back side 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,D) Fixing the support unit to the first end section on the back of the, in particular vulcanized, silicone base shell present on the implant shell production mold, so that the contact surface comes into contact with the first end section, in particular in a liquid-tight manner, in particular comprising passing or inserting the fixing device, in particular the fixing rod, through or into the through- or receiving channel, E) Applying at least one uncured silicone layer to the silicone base shell obtained according to step D) up to the support unit by dipping the implant shell production mold 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, F) Applying a foam layer, in particular a polyurethane foam layer, to the layer of uncured silicone according to step E) on the front side,the transition from the front to the back and the area of ​​the back covered with uncured silicone, wherein material of the foam layer that extends beyond the area of ​​the back covered with uncured silicone is applied and fixed by the ring structure in a recess in a transition area, in particular the acute angle, between the back and the first end section of the support unit, and G) subjecting the product obtained in step F) to at least one curing step in order to vulcanize the uncured silicone according to steps B) and E) or according to step E) and to connect the foam layer to the implant shell; ,

[0028] Alternatively, the procedure includes, in this order, the steps: A') Providing a kit-of-parts tool set as described above, in particular according to the first or second aspect of the invention, and B') Providing an implant shell manufacturing mold, comprising a silicone base shell, in particular vulcanized, present on the front side, in the transition from the front to the back side, and on the back side, C') Fixing the first end section of the support unit to the back side of the silicone base shell, in particular vulcanized, present on the implant shell manufacturing mold, so that the contact surface comes into contact with the first end section, in particular in a liquid-tight manner, in particular comprising passing or inserting the fixing device, in particular the fixing rod, through or into the through- or receiving channel,D') Applying at least one uncured silicone layer to the silicone base shell obtained according to step C') up to the support unit by dipping the implant shell production mold once or several times into or pouring the implant shell production mold with uncured liquid silicone or with uncured silicone dissolved or dispersed in a solvent, E') Applying a foam layer, in particular a polyurethane foam layer, to the layer of uncured silicone according to step D') on the front side, the transition from the front to the back side and the area of ​​the back side covered with uncured silicone, wherein material of the foam layer that extends beyond the area of ​​the back side covered with uncured silicone is applied and fixed by the ring structure in a recess in a transition area, in particular the acute angle, between the back side and the first end section of the support unit,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 to bond the foam layer to the implant shell.

[0029] The alternatives to the method according to the invention for producing a silicone-based implant shell provided with a foam layer differ essentially only in that, according to the first alternative, a silicone base layer is produced on the implant shell production mold of the kit-of-parts tool set and is applied using at least the implant shell production mold and at least one holding device or the holding device firmly connected to the implant shell production mold and is subjected to at least one curing step, whereas, according to the second alternative, an implant shell production mold is provided with a silicone base shell placed thereon. According to the second alternative, the silicone base shell can optionally be produced with a different tool, which in particular is not part of the kit-of-parts tool set according to the invention, and can then be held on the implant shell production mold.

[0030] Preferably, in step (D) or (C'), the contact surface on the first end section of the support unit is pressed against the rear side of the implant shell production mold and preferably against the silicone base shell arranged there. In particular, in step (D) or (C'), the support unit is used to keep the center of the rear side of the implant shell production mold free from the at least one additional uncured silicone layer that is applied over the implant base shell. In step (D) or (C'), preferably several additional uncured silicone layers, in particular at least two, preferably at least four, particularly preferably at least six, and / or no more than 20, in particular no more than ten, preferably no more than eight, additional uncured silicone layers are applied over the implant base shell.

[0031] In step (F) or (E'), the foam layer, which may also be referred to as the foam layer, can preferably first be pulled over the front side, then around the transition, and finally along the back side and over the first end section of the support unit. It may be preferred that the foam layer is subjected to tensile stress when pulled over the implant shell production mold, in particular by means of the holding device and / or the fixing device. For example, the foam layer can be subjected to tensile stress when pulled over the implant shell production mold by connecting the fixing device to the foam layer and removing it from the implant shell production mold along the holding device.The fixation device can be removed from the implant shell manufacturing mold, for example, by actuating a connection unit, such as a threaded pair, or by actuating the fixation device, for example by means of a fastener.

[0032] According to a preferred embodiment, the method further comprises, as step (H) or step (G`), the removal, in particular the separation, of excess foam layer which was not firmly, in particular not materially bonded, to the silicone base shell by the curing step in step (G) or (F`).

[0033] Optionally, according to one embodiment, the method may further comprise, in a step (I) or (H'), removing the implant shell from the implant shell manufacturing mold. The removal of the implant shell from the implant shell manufacturing mold may be performed according to a step (I) or (H') before step (H) or (G') or, preferably, after step (H) or (G').

[0034] It may be preferred that step (F) or (E') comprises that a spring-elastic, in particular band-shaped, ring structure or a reversibly openable metal ring or a wire that can be bent into a ring structure is placed and fixed in the indentation as the ring structure.

[0035] Further properties, features and advantages of the invention will become clear from the following description of a preferred embodiment of the invention with reference to the accompanying drawings, in which: Figure 1 shows a schematic sectional view of an implant shell manufacturing mold with a holding device attached thereto; Figure 2 shows a schematic side view of the components according to Figure 1 with a silicone base shell on the implant shell manufacturing mold; Figure 3 shows a schematic sectional view of a kit-of-parts tool set according to the invention; Figure 4 shows a schematic side view of the kit-of-parts tool set according to Figure 3 ; Figure 5 a schematic sectional view of the kit-of-parts tool set according to Figure 3 with an additional uncured silicone layer on the implant shell manufacturing mold; Figure 6 a schematic side view of the kit-of-parts tool set according to Figure 5 ; Figure 7 a schematic sectional view of the kit-of-parts tool set according to Figure 3with a foam layer pulled over the implant shell manufacturing mold and the support unit; and Figure 8 shows a schematic side view of the kit-of-parts tool set with a silicone-based implant shell provided with a foam layer.

[0036] It should be understood that the kit-of-parts tool set 1 according to the invention, which is illustrated below by way of example with reference to the figures and is designed and configured in particular for use in a method according to the invention, is only schematically illustrated and described by way of example in the present disclosure. Numerous variations from the preferred embodiment illustrated by way of example in the figures are conceivable within the scope of the disclosure.

[0037] Reference numeral 1 generally designates a kit-of-parts tool set according to the invention for the production of a silicone-based implant shell provided with a foam layer. An implant shell that can be produced by the production method according to the invention or with the kit-of-parts tool set according to the invention is designated by reference numeral 100.

[0038] For example, in Figure 3 The kit-of-parts tool set 1 according to the invention shown comprises an implant shell production mold 3, a support unit 8 and a fixing device, in particular a fixing rod 9. The kit-of-parts tool set 1 according to the invention can comprise at least one, preferably several, holding devices, in particular holding rods 5, which are or can be connected detachably to the implant shell production mold 3, or a holding device which is firmly, in particular integrally, connected to the implant shell production mold 3.

[0039] Figures 1 and 2 show the implant shell manufacturing mold 3 with a holding device in the form of a holding rod 5 attached thereto. The holding rod 5 is essentially rotationally symmetrical with respect to the longitudinal axis L. The implant shell manufacturing mold 3 can be symmetrical with respect to the longitudinal axis, for example mirror-symmetrical (if, for example, an egg-shaped or oval cross-sectional shape of the implant is intended) or rotationally symmetrical (if the implant has a circular cross-sectional shape). The holding rod 5 is essentially cylindrical with a constant diameter and a through- or receiving channel 50 that penetrates the holding rod 5 perpendicular to the longitudinal axis L. The through- or receiving channel 50 is arranged rearward of the front end 59 of the holding rod 5. In particular, the through- or receiving channel is arranged in the rear half, preferably the rear quarter, of the holding rod 5.

[0040] According to one aspect, the holding rod 5 or another holding device can be firmly connected, in particular materially bonded, to the implant shell production mold 3 at its front end 51. It is conceivable for the holding device and the implant shell production mold 3 to be formed integrally as a single component. According to another aspect, a connection unit is provided at the front, first end 51 of the holding rod 5, and the implant shell production mold 3 has a corresponding connection unit at its center 30. The connection units can, for example, implement a threaded pair. For example, the implant shell production mold 3 can be equipped with a threaded bore, and the holding rod 5 with a corresponding threaded bolt.At the second end 59 of the holding rod 5 opposite the first end 51, a handle for manual use of the kit-of-parts tool set 1 and / or a fastening device for mounting the kit-of-parts tool set on a holder can be provided.

[0041] The implant shell manufacturing mold 3 has a front side 31, which in an implanted state can define the ventral side of the implant, in particular the breast implant, and a rear side 35 opposite the front side 31. The implant shell manufacturing mold 3 also has a transition 33 from the front to the rear side. An imaginary plane runs through the transition 33 perpendicular to the longitudinal axis L. It may be preferred for the imaginary plane to run perpendicular to the longitudinal axis L through the radially outermost point of the transition 33.

[0042] Before (on in Figure 1above) the imaginary plane, the front side 31 curves outwards in a convex and truncated spherical shape. Behind (in Figure 1below) the imaginary plane, the rear side 35 bulges outwards in the shape of a truncated cone. With respect to the imaginary plane, the volume delimited by the front side 31 is considerably larger than the volume delimited by the rear side 35. The height of the front side 31 with respect to the imaginary plane is greater than the height of the rear side 35 with respect to the imaginary plane. Starting at the transition 33, the truncated spherical front side 31 bulges upwards considerably more steeply than the truncated conical rear side 35 inclines downwards starting at the transition 33. With respect to the imaginary plane, the upward inclination of the front side 31 at the transition 33 can be between 45° and 80°, in particular between 50° and 85°, preferably approximately 60°. With respect to the imaginary plane, the downward inclination of the rear side 35 at the transition 33 can be between 5° and 30°, in particular between 10° and 20°, preferably about 15°.The transition 33 is preferably formed as a, in particular constant, circumferential radius of the implant shell manufacturing mold 3.

[0043] The Figures 7 and 8 show the kit-of-parts tool set 1, which, in addition to the implant shell manufacturing mold 3 and the holding rod 5, comprises the fixing device, designed in the present embodiment as a fixing rod 9, and the support unit 8 as well as a ring structure 6. In the Figures 3 to 8 It is shown that the support unit 8 is held by the fixing rod 5 on the back 35 of the implant shell manufacturing mold 3.

[0044] In the preferred embodiment shown, the fixing rod 9 has a smaller circular diameter than the circular diameter of the holding rod 5. The circular cross-section of the fixing rod 9 is preferably complementary in shape to the circular cross-section of the through- or receiving channel 50. It should be understood that the fixing device, the holding device, and / or its optional through- or receiving channel can have shapes other than a circular shape. For example, the through- or receiving channel can be formed as an elongated hole extending in the longitudinal axial direction (not shown in detail). Alternatively, for example, the fixing device can be formed with a through- or receiving opening, such as an eye, for receiving the holding device, wherein, in particular, the holding device can be formed free of a through- or receiving opening (not shown in detail).

[0045] The support unit 8 has a circumferential wall surface 81 with a first end section 80 and a second end section 89 opposite the first end section 80. The support unit 8 can have a central axis M. The support unit 8 is preferably symmetrical, in particular rotationally symmetrical, with respect to the central axis M. When using the kit-of-parts tool set 1, the support unit 8 can bear against the implant shell production mold 3 in such a way that the central axis M of the support unit 8 is aligned correspondingly, in particular parallel, preferably (as shown) collinearly, to the longitudinal axis L of the implant shell production mold 3. In some embodiments of the method according to the invention, it may be sufficient if the central axis M is arranged substantially correspondingly to the longitudinal axis L, for example with an angular offset and / or radial offset within a predetermined tolerance.

[0046] The support unit 8 has a first outer diameter at the first end section 80 and a second outer diameter at the second end section 89. The second outer diameter can be larger than the first outer diameter. In the embodiment shown here, the support unit 8 has a constant, uniform inner diameter at the first end section 80 and the second end section 89. The wall thickness of the circumferential wall surface 81 is essentially constant in the second end section 89. The wall thickness tapers in the first end section 80.

[0047] Figure 3shows that the support unit 8 has a contact surface 83 on the first end section 80. The contact surface 83 is shaped to correspond to the rear side 35 of the implant shell production mold 3, so that it can lie flush therewith. The support unit 8 is preferably designed and configured so that the contact surface 83 can be or can be brought into planar annular contact with the rear side 35 of the implant shell production mold 3 or a silicone base shell 101 arranged there. This means that the contact surface 83 forms a negative shape with respect to the rear side 35. The contact surface 83 can, for example, be rotationally symmetrical if the rear side 35 is rotationally symmetrical. For example, the contact surface 83 can have an upward inclination that corresponds to the downward inclination of the rear side 35.

[0048] If the contact surface 83 is applied to the rear side 35, as for example in the Figures 3 and 5As shown, a transition region is formed on the outside between the implant shell manufacturing mold 3 and the support unit 8, which has a radial indentation. The radial indentation can, as in the example shown, be formed by an acute angle α between the contact surface 83 and the outside of the first end section 80. The acute angle α can, as in the Figures 4 and 6 shown, be completely constant. Preferably, the acute angle α is approximately 60°, as shown. The radial indentation serves to provide a receptacle for the secure, precise, and reproducible positioning of the ring structure 6.

[0049] The Figures 7 and 8The illustrated implant shell 100 essentially comprises a silicone base shell 101, a foam layer 105, and additional silicone layers 103 that cover the silicone base shell 101 and at least partially infiltrate the foam layer 105. Preferably, the foam layer 105 lies on top of the silicone base shell 101 and does not penetrate the silicone base shell 101.

[0050] The implant shell 100 can be manufactured by firstly coating the kit-of-parts tool set with the silicone base shell 101, wherein the silicone base shell 101 can alternatively be formed and cured using at least the implant shell manufacturing mold 3 of the kit-of-parts tool set 1 or is provided in a cured state for further use with the kit-of-parts tool set 1. Figures 1 and 2 show the implant shell manufacturing mold 3 covered with the silicone base shell 101, which is connected to a holding rod 5.

[0051] To produce the implant shell 100, at least one additional uncured silicone layer 103 is applied over the silicone base shell 101. For this purpose, first, as shown in the Figures 3 and 4 As shown, a first end section 80 of the support unit 8 with its circumferential wall surface 81 is pressed against the rear side 35 and the silicone base sleeve 101 there. A fixing device is used, which presses against the second end 89 of the support unit 8 opposite the first end section 80. The fixing device is attached to the holding device. For example, the fixing device can be implemented as a fixing rod 9, which is inserted into a suitable through- or receiving channel 50 of the holding rod 5. The fixing rod 9, held by the holding rod 5, is applied at two diametrically opposite points on the second end 89 of the support unit 8.

[0052] The distance between the fixation device and the implant shell production mold 3 is adjusted to the axial height of the support unit 8. In particular, the distance from the through- or receiving channel 50 to the first end 51 of the holding device can determine the distance between the fixation device and the implant shell production mold 3. Optionally, it can be provided that the distance between the fixation device and the implant shell production mold 3 is adjustable, in particular with the aid of the connection units. By means of a distance adjustment, a contact pressure for pressing the support unit 8 against the rear side 35 can be adjusted.

[0053] While the support unit 8 with the first end section 80 preferably lies in sealing contact with the rear side 35 and the silicone base shell 101 arranged there, an additional uncured silicone layer 103 can now be applied over the silicone base shell 101. After the application of individual additional uncured silicone layers, it may be expedient to carry out an intermediate step for drying and / or partially curing this individual silicone layer. By the support unit 8 lying against the rear side 35, the center 30 of the rear side 35 is kept free of the additional uncured silicone. This can be expedient to prevent the foam layer 105 to be applied later from adhering to a central area of ​​the rear side 35. The at least one additional silicone layer 103 is in the Figures 5 and 6 shown.

[0054] After the at least one additional silicone layer 103 has been applied to the implant shell manufacturing mold 3, and before this additional silicone layer 103 is fully cured, a foam layer 105 is pulled over the implant shell manufacturing mold 3. In doing so, the support unit 8 is preferably not detached from the implant shell manufacturing mold 3. The foam layer 105 is slipped over the rear side 35 of the implant shell manufacturing mold 3 and the front, first end section 80.

[0055] A ring structure 6 is then inserted into the radial indentation in the transition region between the rear side 35 and the first end section 80. As above, the ring structure 6 can, for example, be formed as a spring-elastic band, as shown, which is placed in a circular ring on the outside around the implant shell production mold 3 and the support unit 8. Alternatively (not shown in detail), a ring structure 6 can be formed, for example, as a bendable wire or a reversibly openable metal ring. With the aid of the ring structure 6, the foam layer 105, in particular on the rear side 35, is pressed radially inward against the at least one uncured silicone layer 103 transversely to the longitudinal axis L or central axis M.

[0056] If the ring structure 6 is implemented as a spring-elastic band, the ring structure 6 can first be expanded by utilizing its elasticity in order to be guided non-destructively over the remaining kit-of-parts tool set 1, in particular from the front over the implant shell manufacturing mold 3. The ring structure 6 can then be inserted under tension into the transition area from the rear side 35 to the first end section 80 of the support unit 8. In the inserted state of the ring structure 6, the tension can also be provided by utilizing the elasticity of the ring structure 6.

[0057] Alternative embodiments (not shown in detail) in which the ring structure 6, which can be formed, for example, from a wire or a metal ring, is first opened in order to be inserted into the transition region and then closed in order to fix the foam layer 105, are also conceivable.

[0058] The foam layer 105 can be fixed to the rear end of the support unit 8 using the fixing device, in particular the fixing rod 9. It may be preferable for the foam layer 105 to be subjected to a tensile stress. The foam layer 105 can be subjected to a tensile stress in the longitudinal axis-axial direction under the influence of the ring structure 6, so that the foam layer 105 conforms smoothly to the implant shell production mold 3, in particular at the front side 31, the transition 33, and / or the rear side 35. The ring structure 6 can exert a holding force on the foam layer 105, which, in particular during curing, counteracts detachment of the foam layer 105 from the implant shell production mold 3, in particular the uncured silicone layer 103 and the silicone base shell 101.

[0059] In particular, it can be provided that the outer diameter of the contact surface 83 is not larger, particularly preferably smaller, than the smallest cross-sectional width of the rear side 35 of the implant shell production mold 3 perpendicular to the longitudinal axis L. The cross-sectional width of the rear side 35 is determined by the outer circumference of the transition. The cross-sectional width of the rear side 35 can be defined by the constant circular diameter of an implant shell production mold 3 with a circular cross-section perpendicular to the longitudinal axis L. Other implant shell production molds are also conceivable within the scope of the invention, for example those with an egg-shaped or oval cross-section perpendicular to the longitudinal axis L, wherein the smallest cross-sectional width, for example in the case of an oval or egg-shaped cross-section, is defined by the shortest diagonal.

[0060] Furthermore, the support unit 8 can be pressed, in particular with the aid of the fixing device, against the rear side 35 of the implant shell production mold 3. Finally, the structure comprising the silicone base shell 101, the at least one additional uncured silicone layer 103, and the foam layer 105, held by the kit-of-parts tool set 1, is subjected to at least one curing step to vulcanize the uncured silicone and to bring about an intimate bond between the foam layer 105 and the implant shell 100. In this way, an implant shell 100 is formed that is firmly connected, in particular materially, preferably integrally, to a foam layer 105.

[0061] Subsequently, any excess foam layer that has not bonded to the back of the implant shell 100 during this curing step can be removed, for example, by a punching process. Before using the implant shell 100, it is also removed from the implant shell manufacturing mold 3.

[0062] The implant shell 100, which can be produced or is produced with the kit-of-parts tool set 1, extends seamlessly over the entire front side 31 as well as the entire transition 33 between the front side 31 and the back side 35, and the entire back side 35 with the exception of the center 30. In its finished state, the implant shell 100 has a single opening in the area of ​​the center 30 on the back side 35 and otherwise completely encloses the implant shell production mold 3 without seams or interruptions. Preferably, the individual components of the implant shell, i.e., the silicone base shell 101, the additional silicone layer 103, and / or the foam layer 105 (each taken individually), also form a seamless and / or seamless capsule, with the exception of a single opening in a central rear area.After removing the implant shell 100 from the implant shell manufacturing mold 3, the implant shell 100 has an opening (patch hole) on the rear side that can be closed by a patch. The opening can preferably have a maximum cross-sectional width, in particular a diameter, of no more than 6 cm, in particular no more than 5 cm, preferably no more than 4 cm, and / or of at least 1 cm, in particular at least 2 cm, preferably at least 3 cm.

[0063] The features of the invention disclosed in the foregoing description and claims may be essential both individually and in any combination for the realization of the invention in its various embodiments. List of reference symbols

[0064] 1 Kit-of-Parts tool set 3 Implant shell manufacturing mold 31 Front 33 Transition 35 Back 30 Center 5 Retaining rod 50 Through or receiving channel 51 First end 59 Second end 6 Ring structure 8 Support unit 80 First end section 81 Surrounding wall surface 83 Contact surface 89 Second end section 9 Fixing rod 100 Implant shell / Breast implant shell 101 Silicone base shell 103 Uncured silicone layer 105 Foam layer LLongitudinal axis MMentral axis αAcute angle

Claims

1. Kit-of-parts tool set (1) 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 the front to the 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 (α) 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) 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 e) a ring structure (6) that can be inserted or is inserted into the radial indentation, or comprising i) an implant shell production 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) having a first end section (80) with a circumferential wall surface (81) and an opposite second end section (89) and having 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 rear-side holding device, 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 (α), in a transition region between the rear side (35) and the first end section when the contact surface (83) on the first end section (80) is placed 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 the temporary fixation of the support unit (8) to the rear side (35) of the implant shell manufacturing 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 portion (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 back (35) of the implant shell manufacturing mold (3) is flat or preferably bulges, in particular towards the center (30) thereof.

3. Kit-of-parts tool set (1) according to claim 1 or 2, characterized in that the back (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 thatthe support unit (8) beyond the first end portion (80) is substantially cylindrical.

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 (α) 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 thatthe rear connection unit for a holding device is located in the center (30) of the rear side (35) of the implant shell manufacturing 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 form 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 thatthe connection unit for a holding device on the rear side comprises or represents a threaded bore and that the corresponding connection unit at the first end (51) of the holding device comprises or represents a, in particular 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 connection unit at the first end (51) of the holding device comprises or represents a, in particular precisely fitting, threaded bore.

9. Kit-of-parts tool set (1) according to one of the preceding claims, characterized in thatthe 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 thatthe distance between the first and the second end portion (89) of the support unit (8) substantially corresponds 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 of: A) providing a kit-of-parts tool set (1) according to one of the preceding claims, B) dipping 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 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, 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 into or pouring uncured liquid silicone or uncured silicone dissolved or dispersed in a solvent onto the implant shell production mold (3), F) applying a foam layer (105),in particular a polyurethane foam layer, onto the layer of uncured silicone according to step E) on the front side (31), the transition (33) from the front side to the back side (35) and the area of ​​the back side (35) covered with uncured silicone, wherein material of the foam layer (105) that extends beyond the area of ​​the back side (35) covered with uncured silicone is applied and fixed by the spring-elastic, in particular band-shaped, ring structure (6) or the reversibly openable metal ring or the wire that can be bent into a ring structure (6) into an indentation in a transition area, in particular the acute angle (a), between the back 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,to vulcanize the uncured silicone according to steps 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 production mold (3), having a silicone base shell (101) present on the front side (31), in the transition (33) from the front to the back side and on the back side (35), in particular vulcanized, C') fixing the first end section (80) of the support unit (8) to the back side (35) of the silicone base shell (101) present on the implant shell production mold (3), in particular vulcanized, 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 through 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 single or multiple immersion of the implant shell production mold (3) in or pouring the implant shell production mold (3) with uncured liquid silicone or with uncured silicone dissolved or dispersed in a solvent, E`) applying a foam layer (105), in particular a polyurethane foam layer, to the layer of uncured silicone according to step D') on the front side (31), the transition (33) from the front side to the back side (35) and the area of ​​the back side (35) covered with uncured silicone, wherein material of the foam layer (105) that extends beyond the area of ​​the back side (35) covered with uncured silicone is guided through the ring structure (6) into an indentation in a transition area, in particular the acute angle (α),between the back side (35) and the first end portion (80) of the support unit (8) and fixed, and F') subjecting the product obtained in step E') to at least one curing step in order to vulcanize the uncured silicone according to steps B') and E') or according to step E') and thereby bond the foam layer (105) to the implant shell (100).

13. The method according to 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 thatStep (F) or (E`) comprises that a spring-elastic, in particular band-shaped, ring structure (6) or a reversibly openable metal ring or a wire that can be bent into a ring structure (6) is placed and fixed in the indentation as the ring structure (6).