WO2013041365A1

WO2013041365A1 - Multi-layer breast prosthesis, and film bag for production thereof

Info

Publication number: WO2013041365A1
Application number: PCT/EP2012/067148
Authority: WO
Inventors: Stephan Volk; Georg Weber-Unger
Original assignee: Edelweiss Basics Gmbh & Co. Kg
Priority date: 2011-09-22
Filing date: 2012-09-03
Publication date: 2013-03-28
Also published as: DE102011114187A1; DE102011114187B4

Abstract

A film bag (1) for a multi-layer breast prosthesis has three plastic films (3, 4, 5), of which a first film (3) forming the front face of the prosthesis is firmly connected to a second film (4) forming the rear face of the prosthesis and to a third film (5) arranged between the two films (3, 4) in a band-shaped first area (10a) that forms the edge (8) of the finished prosthesis. The second and third films (4, 5) are firmly connected to each other in a band-shaped second area (13) lying inside the first area (10a). The first and second areas (10a, 13) each have two lateral portions which lie opposite each other, wherein a lateral portion (14) of the first area (10a) and a lateral portion (15) of the second area (13) are arranged next to each other. Each lateral portion (15) of the second area (13) has an inner edge (18) adjoining a rear chamber (20), which can be filled with plastic compound and which lies between the second and third films (4, 5). To ensure that the prosthesis also conforms to the body of the wearer at the lateral prosthesis edges, the inner edge (18) of at least one lateral portion (15) of the second area (13) has an arc-shaped profile, such that the lateral portion (15) of the second area (13) is wider at its middle (M) than at its two ends (E), of which one lies at the end of the upper prosthesis edge (11) and the other lies at the end of the lower prosthesis edge (12).

Description

Multi-layer breast prosthesis and foil pouch

for their production

The invention relates to a multilayer breast prosthesis that is portable after surgical removal of a female breast in the corresponding bust cup of a women's garment.

The invention also relates to a foil pouch for producing such a multilayer breast prosthesis.

The film bag has at least three elastically stretchable plastic films, one of which is the front of the

Prosthesis forming the first film with the back of the prosthesis forming a second film and arranged between the first and second film third film in one

band-shaped first area, which is the edge of the finished

Prosthesis is firmly connected, wherein the second and the third foil in a lying within the first region, band-shaped second region are fixedly connected to each other, wherein the first and the second region have two respective lateral portions which face each other, wherein Side portion of the first portion and a side portion of the second portion are arranged side by side and each side portion of the second portion has an inner edge adjacent to a plastic material via a filling fillable rear chamber, which lies between the second and the third film ,

Multilayer breast prostheses using a

Foil bags are made of the type described above, are known for example from EP 0808 615 A2. In the foil bag used for these multi-layer breast prostheses, the second area in which the second and third foils are firmly bonded together has a uniform shape

Width along the lateral edges of the finished prosthesis. As a result, the lateral edges of the finished prosthesis are often too stiff to cling to more tight bends of the upper body of the prosthesis wearer can. From the wearer, however, it is considered disadvantageous if the

Prosthesis is not completely along the entire edge of the prosthesis on the body of the wearer.

EP 0 778 013 A1 discloses a multi-layer prosthesis and a corresponding foil bag in which the foil delimiting the rear chamber is spaced apart from the later

End of the prosthesis ends, the distance of this foil from the

Prosthetic edge along the entire edge of the prosthesis

is consistent. As a result, a separate filling opening is required for the rear chamber, which is removed from the filling opening of the front chamber. The constant distance of the film bounding the rear chamber from the edge of the prosthesis also leads to a rigidity which remains constant along the edge of the prosthesis and which ensures a continuous gap-free adaptation of the prosthesis edge to different degrees of curvature of the prosthesis

Upper body of the wearer prevented. EP 0 778 013 A1 also discloses a modified multi-layer prosthesis and a corresponding foil pouch in which all three foils are welded together at the later common denture edge and both the front and the rear chamber extend to the edge of the prosthesis. By superimposing both chambers on the

Prosthesis edge of the prosthesis edge of the finished prosthesis is particularly stiff, so that he has little flexibility for

Adapting to differently strong bulges of the upper body of the wearer owns.

US Pat. No. 7,575,596 B2 shows an asymmetrical two-layer breast prosthesis in which the film bag on which it is based has three foils, the front side of which

Prosthesis forming first film is welded to the back of the prosthesis forming second film along the edge of the prosthesis, wherein a first chamber is formed, which is filled with a first plastic compound. A third film is welded at its outer edge at a distance from the edge of the prosthesis to the second film and forms, together with the second film, a second chamber, which is provided with a second film

Plastic compound is filled. The third film is thus located between the first film and the second film. The first plastic mass located in the first chamber is stiffer than the second one located in the second chamber

Plastic mass. The first plastic compound can be introduced into the first chamber via a branch of a forked filling channel opening into a lateral edge of the prosthesis, and the second plastic compound can be introduced into the second chamber via the other branch of the filling channel. At the two lateral edges of the prosthesis, the weld joining the first foil to the third foil runs in a constant manner

Distance from the respective lateral edge of the prosthesis. Since the in the first chamber located first plastic mass stiffer than the second chamber located in the second

Plastic composition is and the edge of the second chamber is set back relative to the prosthesis edge, the prosthesis edge and the edge region between the edge of the prosthesis and the edge of the second chamber are relatively stiff, whereby the prosthesis can not completely conform to the edge of the body at the edge, in particular if this is multiple and / or strongly curved.

From DE 93 15 935 Ul a symmetrical three-layer breast prosthesis is known in which between an outer

cup-shaped medium hard layer and an inner

cup-shaped soft layer is a hard layer in the form of a stabilizing cross is arranged, which extends with its four arms to the edge of the prosthesis. Each of the three

Layers consists of a set to the appropriate hardness plastic mass, which in plastic films

bordered, which are welded together at the edge. The outer medium-hard layer and the inner soft layer each extend to the edge of the prosthesis, so that at the edge of the prosthesis in the regions between the ends of the arms of the cross, from which the hard layer consists, three films meet and are welded together. In the sections of the edge of the prosthesis, where the arms of the hard-layered cross terminate, four foils meet, which are welded together there.

As a result, the edge of the prosthesis is given a high rigidity both at the ends of the arms of the hard layered cross and in the area between these ends

mediates, which prevents the edge of the prosthesis from getting on

To unevenness and curvature of the body of the prosthesis wearer gapless. The object of the invention is therefore, the

generic film bag to be designed so that the finished multi-layer breast prosthesis completely rests on its peripheral edge of the prosthesis on the body of the wearer, even if it is of different curvature, with the risk of

Rolling the prosthesis on its edge in the worn state

is avoided.

The object of the invention is achieved in that the inner edge of at least one lateral portion of the second

Area has an arcuate course, such that the at least one lateral portion of the second region is wider in its center than at its two ends, one of which is at the end of the later upper prosthesis edge and the other at the end of the later lower prosthesis edge.

Preferably, the at least one lateral portion of the second region is approximately twice as wide at its center as at its two ends. It has proven to be particularly advantageous if the at least one lateral section of the second region in its center, depending on the size of the prosthesis, is approximately 5 to 10 mm wide and / or if the at least one lateral section of the second region is at its two ends, depending according to prosthesis size, each 2.5 to 5 mm wide.

The film bag according to the invention is particularly suitable for the production of a triangular multi-layer breast prosthesis. In this case, both lateral portions of the second region are wider in their middle than at their two ends, which adjoins the upper and lower prosthesis edge. The prosthesis preferably has a symmetric triangular shape, but it may also have an asymmetric triangle ^¬ shape, wherein the corners are more or less rounded in both cases. Preferably, at least the filling opening for the rear chamber at the lower edge of the prosthesis, which ensures that the lateral prosthesis edges of the finished prosthesis cling to the body of the wearer over its entire length.

Other features, developments and advantages of

film bag according to the invention and the multi-layer breast prosthesis produced therefrom result from the

Subclaims.

An embodiment of the invention is illustrated in the drawings and will be described in more detail below. It shows:

Fig. 1 is a plan view of a foil bag for a

symmetrical multilayer breast prosthesis, wherein the illustrated side of the foil pouch will be the back of the finished multilayer breast prosthesis;

2a shows a cross section through part of the in Fig. 1st

illustrated film bag along the line Illa-Ila, wherein the thicknesses of the films are shown excessively large in order to make the films clearly visible;

Fig. 2b shows a cross section through another part of the in

Fig. 1 illustrated film bag along the line IIb-IIb, wherein the foil bag during his

Filling is shown and the thicknesses of the films, as shown in Figure 2a, are shown excessively large.

Fig. 3 is a perspective view of the back of a

symmetrical multilayer breast prosthesis under the Use of the film bag shown in Fig. 1 has been produced. a cross-section of that shown in Fig. 3

Breast prosthesis along the plane of symmetry SE; an enlarged section of the illustration in Figure 4a at the upper edge of the prosthesis. an enlarged section of the illustration in Figure 4a at the lower edge of the prosthesis. a top view of a foil pouch for asymmetric multi-layer breast prosthesis, wherein the illustrated side of the foil pouch will be the back of the finished multilayer breast prosthesis; and

Fig. 6 is a schematic representation of a multi-layer breast prosthesis in the cup of a brassiere wearing woman, wherein the illustrated in cross section

Multilayer breast prosthesis using a foil bag according to FIG. 1 or FIG. 5 has been produced. An inventive film bag 1 for a produced using the film bag 1 according to the invention

Multilayer breast prosthesis 2, which after surgical removal of a female breast in the corresponding bust-shell of a women's garment, e.g. a brassiere, corselette, swimsuit or bikini top is portable, in the example shown has three elastically stretchable

Polyurethane plastic films 3, 4 and 5, which, as shown in Figures 1 and 2a, are arranged one above the other. On the finished prosthesis 2, the first film 3 forms the three Foils the front 6 of the prosthesis 2. The second film 4 of the three films forms the finished prosthesis 2 the

Back side 7 of the prosthesis 2. The third film 5 of the three films is arranged between the first film 3 and the second film 4. As usual, the front side 6 of the prosthesis 2 has a convex shape adapted to the surgically removed breast, whereas the back 7 of the prosthesis 2 is curved inwardly relative to the edge 8 of the prosthesis 2 to avoid breast tissue not removed in the recess formed thereby

take. On the back 7 of the prosthesis 2 is further an inwardly bent arcuate fold 9, as known from US 6,623,523 B2 or US 6,565,604 B2,

provided that the movement behavior of the prosthesis in the

worn condition favorably influenced.

As shown in FIGS. 1 and 2a, all three foils 3, 4 and 5 are in a band-shaped first region 10a,

For example, by welding (weld S2), firmly and tightly connected. From the band-shaped first

Section 10a and the two filling openings 19a and 19b later closing weld 10b is formed by trimming the edge 8 of the finished prosthesis 2, which in

illustrated example of FIG. 3 and FIG. 4a a

is symmetrical prosthesis with approximate triangular shape, which has rounded corners and a convexly curved base is. Such a prosthesis is wearable on both sides. The

Symmetrieebene SE runs centrally through the arcuate upper edge of the prosthesis 11 and the arcuate lower

Prosthetic edge 12, as can be seen in Fig. 3, as well as through the breast tip SP (Fig. 4a).

The second film 4 and the third film 5 are in a band-shaped second region 13, for example by welding (weld SI) firmly and tightly connected. Of the second area 13 is within the first area 10a. The area 10a has two lateral portions 14 facing each other, and the area 13 also has two

lateral sections 15 which are opposite each other. One

Side portion 14 of the first area 10 a is adjacent to a side portion 15 of the second area 13

arranged and the other lateral portion 14 of the first portion 10 a is disposed adjacent to the other lateral portion 15 of the second region 13. The lateral sections 14 and 15 are the same length. The length L of the lateral sections 14 and 15 corresponds approximately to the length of that in FIG. 3

indicated lateral denture edges 16.

Outside the first area 10a there is a band-shaped third area 17, in which the second film 4 is fixedly connected to the third film 5, for example by welding (weld S1). The third area 17 is no longer present on the finished prosthesis 2, because it was cut off together with an outer part of the first area 10a and an outer part of the weld 10b during the finishing of the prosthesis. The edge 8 of the finished prosthesis 2 is therefore narrower than the first region 10 a and the

Weld 10b. The second region 13 has an inner edge 18 which adjoins a rear chamber 20 which lies between the second film 4 and the third film 5. The first region 10 a has an inner edge 21 which adjoins a front chamber 22 which is formed between the first film 3 and the third film 5. The rear chamber 20 can be filled with plastic compound via a filling opening 19a and a hose 24a inserted therein. The front chamber 22 is connected to a

Embodiment of FIG. 1 directly below the

Filling 19a lying, further filling opening 19b and a stuck hose 24b filled with plastic compound. Each plastic mass consists of one

addition-curing two-component silicone rubber composition which cures under heat to a soft elastic, gel-like body, the composition of the

Plastic compositions is chosen so that the on the finished prosthesis 2 in the front chamber 22 located

Plastic mass is softer than the plastic mass located in the rear chamber 20.

As can be seen in Fig. 1, the inner edge 18 in the region of each lateral portion 15 of the second region 13 has an arcuate, inwardly curved course, so that each lateral portion 15 of the second region 13 at its center M wider than at its two Ends E is one of which on the finished prosthesis 2 one at the end of the top

Prosthesis edge 11 and the other at the end of the lower Prothe ^¬ senrandes 12 is located. Each lateral portion 14 of the first region 10a is rectilinear except for a lower end region. The arcuate course of the inner edge 18 of each lateral portion 15 of the second region 13 is designed such that the respective lateral portion M in its center M is about twice as wide in some prosthesis sizes as at its ends E. For example, each lateral portion 15 in its middle M, depending on the size of the prosthesis, about 5 to 10 mm wide, while at its two ends, depending on the size of the prosthesis, each 2.5 to 5 mm wide. In a symmetrical prosthesis, the lateral portions 15 are designed to be identical in width.

As can be seen from Fig. 3, the upper extends

Prosthetic rim 11 between the upper ends of the lateral prosthesis edges 16 and the lower edge of the prosthesis 12 extends between the lower ends of the lateral prosthesis edges 16. The upper ends of the lateral prosthesis edges 16 lie on the same dot-dash lines, the upper

Limit of the lengths L in Fig. 1, and the lower ends of the lateral prosthesis edges 16 are the same

dotted lines that are the lower limit of the lengths L in FIG. 1.

The filling opening 19a for the rear chamber 20 and in the embodiment of FIG. 1 immediately below the filling opening 19b for the front chamber 22 are located between two opposite ends of the first

Area 10a, which at the same time the inner ends of two

are funnel-shaped band-shaped fourth regions 23, in which each of all three films, as in the first region 10a, are firmly connected to each other. The fourth regions 23 are no longer present on the finished prosthesis 2, because they are in the final processing of the prosthesis

cut off. The rear chamber filling opening 19a is also located between two opposite ends of the second area 13, and the opposite ends of the second area 13 are adjacent to and within the opposite ends of the first area 10a. Both filling openings 19a and 19b are located on the finished prosthesis 2 on the lower edge of the prosthesis 12. Both

Filling openings 19a and 19b are sealed to the finished prosthesis 2 in the area between the opposite ends of the first area 10a and fixed by a prosthesis formed during the thermal molding process

Welded seam 10b closed. Although an adhesive joint for closing the filling openings is possible, a welded joint for reasons of homogeneity with the

Welded connection in the first area 10a preference given. The lower portions of the second region 13, which are separated from one another by the filling opening 19a, which are located on the lower edge of the prosthesis 12, are approximately the same width and approximately half as wide as the lateral portions 15 at their center M. As a result, the prosthesis is retained on its lower prosthesis edge 12 sufficient rigidity in order to

Wear state, especially under dynamic load, not to roll on the lower edge of the prosthesis 12. At the top

Prosthetic rim 11 increases the width of the second region 13 within an upper portion extending between the upper ends E of the lateral portions 15 between the upper ends E and the plane of symmetry SE to a value about that at the center M of the lateral Sections 15 is. Thus, the prosthesis receives at its upper edge of the prosthesis 11 a very thin spur, which adapts well to the wearer's upper body and, as a result of the low weight, does not sag or curl even under dynamic load. The arcuate, inwardly curved course of the inner

Edge 18 of the lateral portions 15 of the second region 13 has on the finished prosthesis 2 the effect that the prosthesis 2 also in the region of its lateral edges 16 conforms to the body of the wearer, so that the entire

Prosthesis edge 8 without interruption on the body of the wearer rests without curling.

The film bag 1 according to the invention is produced in two steps: a first step in which the second film 4 lying on a table is welded to the third film 5 lying on it by means of a welding tool acting from above on the third film 5, wherein the weld seam Sl arises in the transverse direction over the first area 10a, the second area 13 and the third Area 17 extends and leaves the filling openings 19 a and 19 b. In a second subsequent step, the first film 3 is placed on the third film 5, which was previously welded to the second film 4, as described above, along the weld Sl. The first film 3 is then welded by means of a again acting on them from above welding tool with the previously welded together films 5 and 4, wherein the weld S2 is formed, which in

Transverse direction extends only over the first region 10a and goes in the depth direction through the first film 3 and the weld S1. In the longitudinal direction, the weld S2 also extends into the fourth regions 23. Thus, the weld S2 connects all three films 3, 4 and 5 in the first region 10a and in the fourth regions 23 with each other. In addition, the weld S1 connects the second film 4 with the third film 5 in the second region 13 and in the third region 17. In the first

Area 10a thus finds a double weld the

Foils 4 and 5 through the weld Sl and the weld S2 instead, as indicated in Fig. 2a by the different density puncture in the area 10a on the one hand and in the areas 13 and 17 on the other. The two welding tools give by their respective shape, the lateral contour of the

Welds Sl and S2 before. It is therefore understood that the shape of the in the first step on the superimposed

Foils 4 and 5 acting welding tool also the

arcuate, inwardly curved course of the inner edge 18 of the lateral portions 15 of the invention

Foil bag 1 determined. A multilayer breast prosthesis, as shown in FIGS. 3 and 4a, is then produced with a foil bag 1 produced in this way. This manufacturing process is as follows: First, the two chambers 20 and 23 with the respective non-crosslinked two-component Silicone rubber compound via the filling openings 19 a and 19 b and the feed tubes 24 a and 24 b inserted therein, while the film bag 1 in a two-part mold of the type as described and illustrated in DE 27 37 321 AI, arranged and of a so-called

Clamping frame is fixed. After filling and venting of the chambers 20 and 23, the filling openings 19a and 19b are closed with a mechanical slide. Thereafter, the heat treatment of the filled and sealed foil bag takes place while it is in the closed mold and is fixed. During this heat treatment, the

Curing of the two silicone rubber compounds instead.

At the same time, the three films weld together at the filling openings 19a and 19b, the mechanical slider serving as a welding tool. The resulting weld 10b connects seamlessly to the first region 10a and connects like the weld Sl all three films 3, 4 and 5 with each other, so that the filling openings 19a and 19b are now closed. After the heat treatment and a subsequent cooling phase, the cured prosthesis is removed from the mold and then subjected to a finishing operation in which the welded and welded parts lying outside of the first region 10a and the weld 10b

unwelded film parts and an outer portion of the first portion 10a and the weld 10b are cut so that only a narrow edge remains in which all three films are tightly and firmly welded together along a closed line. The invention is also in a foil bag for a

asymmetric multilayer breast prosthesis applicable. One

Such film bag is shown in Fig. 5 and designated by the reference numeral 30. The film bag 30 is consistent with the shape of the foil bag 1. It will therefore be in Fig. 5 uses the same reference numerals as in Fig. 1 for the same parts and the following description is limited to those features which are different from the corresponding features of the film bag 1.

Due to the asymmetrical shape of the prosthesis, the length LI of the lateral sections 14 and 15 at the left end of the foil pouch 30 in FIG. 5 is shorter than the length L2 of the lateral sections 14 and 15 at the right-hand end of the foil pouch 30 in FIG.

Accordingly, the arcuate is inwardly curved

Section of the inner edge 18 on the length LI shorter than the arcuate inwardly curved portion of the inner edge 18 on the length L2. Alternatively, the arcuate inwardly curved portion of the inner edge 18 'may be less curved along the length LI than along the length L2.

This alternative is indicated by the dashed line 18 'and the center M'.

In Fig. 6 is shown as a symmetrical or

asymmetric prosthesis using a

Foil pouches 1 or 30, is worn in the cup of a 40 woman's bra 50. The

The inventive design of the foil bag causes the resulting prosthesis, that along its edge

completely on the body of the wearer, which may be more or less curved, rests. LIST OF REFERENCE NUMBERS

1 foil bag

2 multilayer breast prosthesis

3 first slide

4 second slide

5 third slide

6 front side

7 back side

8 edge

9 fold

10a first area

10b weld

11 upper denture edge

12 lower denture edge

13 second area

14 lateral section

15 side section

16 lateral denture margin

17 third area

18 inner edge

18 'inner edge

19a filling opening

19b filling opening

20 rear chamber

21 inner edge

22 anterior chamber

23 fourth area

24a hose

24b hose

25 bust bowl

30 foil bags

40 woman

50 bras E end

M middle

M 'middle

SE symmetry plane

L length

LI length

L2 length

SP breast tip

Sl weld

S2 weld

Claims

A foil pouch (1) for producing a multilayer breast prosthesis (2) which is portable after the surgical removal of a female breast in the corresponding bust shell of a women's garment, comprising at least three elastically stretchable plastic films (3, 4, 5), one of which is the front ( 6) of the prosthesis (2) forming the first film (3) with a the back (7) of the prosthesis (2) forming second film (4) and between the first and second film (3, 4) arranged third film (5) in a band-shaped first region (10a) which forms the edge (8) of the finished prosthesis, wherein the second and the third foil (4, 5) lie in a band-shaped second one within the first region (10a)

Region (13) are firmly connected to each other, wherein the first and the second region (10 a, 13) two each

have lateral sections (14, 15), which are

wherein a lateral portion (14) of the first portion (10a) and a lateral portion (15) of the second portion (13) are juxtaposed and each lateral portion (15) of the second portion (13) has an inner edge (18). has the borders can be filled to a via a filling opening with plastic ^¬ mass (19a) rear chamber (20), which lies between the second and the third film (4, 5), characterized in that the inner edge (18) at least a lateral portion (15) of the second region (13) has an arcuate course such that the at least one lateral portion (15) of the second region (13) is wider at its center (M) than at both its ends (E) one of which ends up the later upper prosthesis edge (11) and the other at the end of the later lower prosthesis edge (12).

Film bag according to claim 1, characterized in that the at least one lateral portion (15) of the second region (13) in its center (M) is about twice as wide as at its two ends (E).

Foil bag according to claim 1 or 2, characterized

characterized in that the at least one lateral

Section (15) of the second region (13) in its center (M), depending on the size of the prosthesis, about 5 to 10 mm wide.

Foil bag according to claim 1 or 2, characterized

characterized in that the at least one lateral

Section (15) of the second region (13) at its two ends (E), depending on the size of the prosthesis, each 2.5 to 5 mm wide.

Foil bag according to one of the preceding claims, characterized in that both lateral sections (15) of the second region (13) are wider in their middle (M) than at their two ends (E), to which the upper or lower edge of the prosthesis ( 11, 12) connects.

Foil bag according to one of the preceding claims, characterized in that the filling opening (19a) for the rear chamber (20) and a further filling opening (19b), via the plastic mass in a between the first and the third film (3, 5) lying front Chamber (22) is filled, between two opposite ends of the first portion (10 a) are arranged and separated by the third film (5), wherein the lying opposite ends of the first portion (10 a) on the lower edge of the prosthesis (12).

A film bag according to claim 6, characterized in that the rear chamber filling opening (19a) is located between two opposite ends of the second area (13) and the opposite ends of the second area (13) adjacent to and inside the opposite ends of the first region (10a) lie.

8. Multilayer breast prosthesis (2), which after surgical ent ^¬ distance of a female breast in the corresponding

The breast cup of a women's garment is portable, wherein the multi-layer breast prosthesis is made using a foil bag (1) according to any one of the preceding claims.

9. multilayer breast prosthesis (2) according to claim 8, characterized

characterized in that the plastic mass in the rear chamber (20) is harder than the plastic mass in the front chamber (22).

10. multilayer breast prosthesis (2) according to claim 8 or 9,

characterized in that the first region (10a) on the finished prosthesis (2) is narrower than the still unfilled foil bag (1).

11. Multi-layer breast prosthesis (2) according to one of claims 8 to 10, characterized in that it has a symmetrical shape.

12. multilayer breast prosthesis according to one of claims 8 to 10, characterized in that it has an asymmetrical shape.