Title:
RETROMAMMARY PROSTHESIS
United States Patent 3860969
Abstract:
A retromammary prosthesis is formed of pre-moulded flexible sheet material in two major portions which are connected along an annular area such that, when the prosthesis is positioned within the body, the area of connection is not deformed by filling of the prosthesis and does not give rise to discomfort to the wearer. In a preferred form, a filler tube for the prosthesis is connected to the remainder by means of a housing which may be inverted so as to lie wholly within the prosthesis and receive the entire filler tube in folded condition.
Application Number:
05/430064
Publication Date:
01/21/1975
Filing Date:
01/02/1974
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Export Citation:
Primary Class:
International Classes:
A61F2/12; A61F1/24; A41C3/10
Field of Search:
3/36 128/462
Primary Examiner:
Frinks, Ronald L.
Attorney, Agent or Firm:
Drucker, William Anthony
Parent Case Data:
This application is a continuation of application Ser. No. 304,217 filed Nov. 6, 1972, now abandoned, which in turn is a continuation-in-part of my U.S. Pat. application No. 127,561 dated 24 Mar. 1971, now abandoned.
Claims:
I claim
1. A retromammary prosthesis comprising, a front wall preformed as a portion of a hollow sphere with its rim portion curved inwardly from the outer periphery thereof and into the concavity thereof and terminating therein in an annular flange,
1. A retromammary prosthesis comprising, a front wall preformed as a portion of a hollow sphere with its rim portion curved inwardly from the outer periphery thereof and into the concavity thereof and terminating therein in an annular flange,
Description:
This invention relates to a retromammary prosthesis, which is to be distinguished from a false breast or a figure improver. A retromammary prosthesis is an article which is inserted, by surgical operation, between the chest muscles and the mammary gland, and which is then expanded or inflated by filling with a fluid to impart a desired stretching and contour to the breast.
Such a prosthesis desirably has a shape which comprises a back wall, and an approximately part-spherical front wall all made of thin flexible sheet material such as an inert plastic sheeting. The manufacturing of such a shape necessarily requires a line of connection to be provided between (i) the back wall, and (ii) the curved front wall. Hitherto, this line of connection, consisting in practice of a weld, has been provided at the circumferential periphery of the back wall. Such a weld placed at such a position tends to cause creasing or folding of the sheet material when the article is inflated, and the weld area tends to have a greater mechanical strength or stiffness than the adjacent areas of single-thickness wall. Accordingly, it was not only difficult to obtain a smoothly curved contour to the inflated article, but the free edge or rim, occurring where one wall portion overlapped the other at the weld line, was presented at the periphery or point of maximum circumference of the article, where it was subjected to most pressure directly in contact with the chest muscles and was most likely to cause irritation to the wearer as a result of body movements.
A further requirement for such a prosthesis is that it must be provided with means to enable it to be filled or inflated when in situ. In other words, the prosthesis cannot be filled first, and thereafter inserted, because (a) the required degree of filling cannot be ascertained until the article is properly in position within the body, and (b) the insertion of an already filled prosthesis would necessitate a comparatively very large surgical opening to be made, as compared with the small slit which is all that is necessary for emplacement of a folded non-filled prosthesis.
The prosthesis must accordingly be provided with a filling tube which is not only long enough to be accessible from the exterior of the body for filling purposes, but which can nevertheless readily be accommodated within the body after filling has taken place, without causing mal-shaping or irritation.
The object of the present invention is to provide an improved construction of prosthesis which fulfills the above-described requirements and which (1) is pre-shaped, by moulding of the plastic material front wall, to impart precisely the desired shaping to the breast, (2) has its line of connection between the front wall and the rear wall placed at a position which avoids buckling or corrugation and which is kept spaced from the chest muscles and thus avoids irritation, (3) has its filling tube integrally formed with the remainder of the prosthesis and, whilst being long enough to permit external filling, is nevertheless capable of being housed within the prosthesis in a manner which avoids any spoiling of the contour of the prosthesis and which does not give rise to discomfort to the wearer.
An embodiment of retromammary prosthesis in accordance with the invention is hereinafter particularly described with reference to the figures of the accompanying drawings, wherein:
FIG. 1 is a perspective side elevation of the prosthesis, as it appears when partially filled and before insertion into the body;
FIG. 2 is an axial section of the prosthesis as it appears when a housing portion for filling tube has been turned inside out so as to be positioned within the spatial outline of the prosthesis;
FIG. 3 is a view showing how the folded partially-filled prosthesis is inserted through a surgical opening into its position between the chest muscles and the mammary gland;
FIG. 4 is a schematic illustraion to show how the tube housing is turned inside out by the surgeon's finger, after insertion of the prosthesis has been completed;
FIG. 5 is a schematic illustration of the filled sealed prosthesis in position in the body, after closing of the insertion opening.
Referring to FIGS. 1 and 2, the prosthesis is a hollow body made of a suitably soft and flexible plastic sheet material. The body comprises a front wall 1 and a rear wall 2. The front wall 1 is pre-shaped so as to be approximately part-spherical, when inflated, and has at its periphery an inturned flange 1a. The whole of the front wall portion 1 can readily be moulded, during manufacture, to have any desired part-spherical shape when inflated. For completion of the hollow body, the flange portion 1a is welded to the overlapped circumferential edge area 2a of the back wall. This weld results in an annular area of doubled wall thickness, but this annular area is not affected by inflation or filling of the prosthesis, and thus does not tend to change its shape or become corrugated. Moreover, it is presented towards but remains spaced from the chest muscles, so that the very shallow projection of the free edge 2b of the back wall does not give rise to any irritation to the wearer.
Centrally in the back wall portion 2 there is formed a truncated conical housing 3 which is integrally formed, during manufacture, with the remainder of the back wall and which at its larger end merges into the remainder of the back wall by a smooth radiused curve at 3a. This smooth radiused curve is present when the housing 3 is in the inturned position of FIG. 2, and also when in the out-turned position of FIG. 1.
The smaller end of the housing 3 is integrally connected to one end of a filling tube 4, into which it merges at a smooth radiused curved area 4a. When the prosthesis is in the out-turned condition of FIG. 1, this area 4a is presented as a smoothly contoured annulus 4b of the FIG. 1. The filling tube 4 is made as narrow as possible, consistent with permitting filling of the prosthesis with liquid before and after insertion in the body, and is made long enough to permit the free end to remain accessible outside the body after insertion of the prosthesis in the surgical wound. At the free end of the tube 4 there is provided a removable plastic plug 5 which can be pushed firmly into the tube 4 to keep it safely stoppered indefinitely.
Referring to FIGS. 3, 4 and 5, the prosthesis is firstly provided with a small partial filling of liquid, sufficient to make it stiff enough to be readily manipulated, but not so much as to prevent it being folded down into a long narrow "packet" 6, as seen in FIG. 3, for slipping through a surgical opening made in the breast 8, and held open by a tool held by the surgeon.
Prior to folding up into the packet 6, the prosthesis is provided with a partial filling of liquid, whereafter the main body portion is squeezed in the hand until the whole of the air content has been expelled and some of the liquid is forced out of the tube 4. The plug 5 is then inserted. At this moment, the prosthesis has the shape shown in FIG. 1.
After insertion of the prosthesis into the body, the plug 5 is removed and more liquid is inserted until the breast has assumed the desired shape, whereafter the plug is pushed firmly home in the tube 4. The housing 3 is then snapped into its inward or reversed position, by the surgeon's finger inserted through the wound, as seen in FIG. 4. The whole of the tube 4 is also folded, in zig-zag manner, until it becomes housed entirely within the housing 3, as seen in FIG. 5. The wound is then sewn up, as at 9.
When the prosthesis has been fully inserted in this manner, it does not present any projection at all to the exterior of its overall spatial contour. The small edge or lip 2a, at the weld area, is positioned at point X of FIG. 5, and thus is spaced from the rear face Y of the prosthesis pressing against the chest muscles. The tube 4 is contained wholly within the housing 3.
The prosthesis will be subjected to considerable movement, and expansion and contraction, during wear by the patient. It will be seen that those areas where joints are effected between different portions of the prosthesis are all positioned internally of the general spatial contour of the prosthesis, and are thus subjected to the least position amount of exercising. In particular, the connection between between the tube 4 and the housing 3, which might tend to be a weak point, is positioned axially of the prosthesis and spaced from its external surface in all directions.
Such a prosthesis desirably has a shape which comprises a back wall, and an approximately part-spherical front wall all made of thin flexible sheet material such as an inert plastic sheeting. The manufacturing of such a shape necessarily requires a line of connection to be provided between (i) the back wall, and (ii) the curved front wall. Hitherto, this line of connection, consisting in practice of a weld, has been provided at the circumferential periphery of the back wall. Such a weld placed at such a position tends to cause creasing or folding of the sheet material when the article is inflated, and the weld area tends to have a greater mechanical strength or stiffness than the adjacent areas of single-thickness wall. Accordingly, it was not only difficult to obtain a smoothly curved contour to the inflated article, but the free edge or rim, occurring where one wall portion overlapped the other at the weld line, was presented at the periphery or point of maximum circumference of the article, where it was subjected to most pressure directly in contact with the chest muscles and was most likely to cause irritation to the wearer as a result of body movements.
A further requirement for such a prosthesis is that it must be provided with means to enable it to be filled or inflated when in situ. In other words, the prosthesis cannot be filled first, and thereafter inserted, because (a) the required degree of filling cannot be ascertained until the article is properly in position within the body, and (b) the insertion of an already filled prosthesis would necessitate a comparatively very large surgical opening to be made, as compared with the small slit which is all that is necessary for emplacement of a folded non-filled prosthesis.
The prosthesis must accordingly be provided with a filling tube which is not only long enough to be accessible from the exterior of the body for filling purposes, but which can nevertheless readily be accommodated within the body after filling has taken place, without causing mal-shaping or irritation.
The object of the present invention is to provide an improved construction of prosthesis which fulfills the above-described requirements and which (1) is pre-shaped, by moulding of the plastic material front wall, to impart precisely the desired shaping to the breast, (2) has its line of connection between the front wall and the rear wall placed at a position which avoids buckling or corrugation and which is kept spaced from the chest muscles and thus avoids irritation, (3) has its filling tube integrally formed with the remainder of the prosthesis and, whilst being long enough to permit external filling, is nevertheless capable of being housed within the prosthesis in a manner which avoids any spoiling of the contour of the prosthesis and which does not give rise to discomfort to the wearer.
An embodiment of retromammary prosthesis in accordance with the invention is hereinafter particularly described with reference to the figures of the accompanying drawings, wherein:
FIG. 1 is a perspective side elevation of the prosthesis, as it appears when partially filled and before insertion into the body;
FIG. 2 is an axial section of the prosthesis as it appears when a housing portion for filling tube has been turned inside out so as to be positioned within the spatial outline of the prosthesis;
FIG. 3 is a view showing how the folded partially-filled prosthesis is inserted through a surgical opening into its position between the chest muscles and the mammary gland;
FIG. 4 is a schematic illustraion to show how the tube housing is turned inside out by the surgeon's finger, after insertion of the prosthesis has been completed;
FIG. 5 is a schematic illustration of the filled sealed prosthesis in position in the body, after closing of the insertion opening.
Referring to FIGS. 1 and 2, the prosthesis is a hollow body made of a suitably soft and flexible plastic sheet material. The body comprises a front wall 1 and a rear wall 2. The front wall 1 is pre-shaped so as to be approximately part-spherical, when inflated, and has at its periphery an inturned flange 1a. The whole of the front wall portion 1 can readily be moulded, during manufacture, to have any desired part-spherical shape when inflated. For completion of the hollow body, the flange portion 1a is welded to the overlapped circumferential edge area 2a of the back wall. This weld results in an annular area of doubled wall thickness, but this annular area is not affected by inflation or filling of the prosthesis, and thus does not tend to change its shape or become corrugated. Moreover, it is presented towards but remains spaced from the chest muscles, so that the very shallow projection of the free edge 2b of the back wall does not give rise to any irritation to the wearer.
Centrally in the back wall portion 2 there is formed a truncated conical housing 3 which is integrally formed, during manufacture, with the remainder of the back wall and which at its larger end merges into the remainder of the back wall by a smooth radiused curve at 3a. This smooth radiused curve is present when the housing 3 is in the inturned position of FIG. 2, and also when in the out-turned position of FIG. 1.
The smaller end of the housing 3 is integrally connected to one end of a filling tube 4, into which it merges at a smooth radiused curved area 4a. When the prosthesis is in the out-turned condition of FIG. 1, this area 4a is presented as a smoothly contoured annulus 4b of the FIG. 1. The filling tube 4 is made as narrow as possible, consistent with permitting filling of the prosthesis with liquid before and after insertion in the body, and is made long enough to permit the free end to remain accessible outside the body after insertion of the prosthesis in the surgical wound. At the free end of the tube 4 there is provided a removable plastic plug 5 which can be pushed firmly into the tube 4 to keep it safely stoppered indefinitely.
Referring to FIGS. 3, 4 and 5, the prosthesis is firstly provided with a small partial filling of liquid, sufficient to make it stiff enough to be readily manipulated, but not so much as to prevent it being folded down into a long narrow "packet" 6, as seen in FIG. 3, for slipping through a surgical opening made in the breast 8, and held open by a tool held by the surgeon.
Prior to folding up into the packet 6, the prosthesis is provided with a partial filling of liquid, whereafter the main body portion is squeezed in the hand until the whole of the air content has been expelled and some of the liquid is forced out of the tube 4. The plug 5 is then inserted. At this moment, the prosthesis has the shape shown in FIG. 1.
After insertion of the prosthesis into the body, the plug 5 is removed and more liquid is inserted until the breast has assumed the desired shape, whereafter the plug is pushed firmly home in the tube 4. The housing 3 is then snapped into its inward or reversed position, by the surgeon's finger inserted through the wound, as seen in FIG. 4. The whole of the tube 4 is also folded, in zig-zag manner, until it becomes housed entirely within the housing 3, as seen in FIG. 5. The wound is then sewn up, as at 9.
When the prosthesis has been fully inserted in this manner, it does not present any projection at all to the exterior of its overall spatial contour. The small edge or lip 2a, at the weld area, is positioned at point X of FIG. 5, and thus is spaced from the rear face Y of the prosthesis pressing against the chest muscles. The tube 4 is contained wholly within the housing 3.
The prosthesis will be subjected to considerable movement, and expansion and contraction, during wear by the patient. It will be seen that those areas where joints are effected between different portions of the prosthesis are all positioned internally of the general spatial contour of the prosthesis, and are thus subjected to the least position amount of exercising. In particular, the connection between between the tube 4 and the housing 3, which might tend to be a weak point, is positioned axially of the prosthesis and spaced from its external surface in all directions.