Title:
INFLATABLE PROSTHESIS
United States Patent 3600718
Abstract:
An improved surgically implantable mammary prosthesis comprising an inflatable shell and a filling stem for said shell for introduction of a filling fluid to inflate the shell. At the point of introduction of the stem into the shell, there is provided a capsule of sealing gel through which the stem passes. After implantation and inflation, the stem is withdrawn either wholly or partially and the gel in the capsule seals the stem outlet against leakage of the inflating fluid. The inflation system is also suitable for prostheses other than mammary prostheses.
US Patent References:
Fluid-seal air valve
Riddell - June 1928 - 1672905
Connecting and sealing means for curing bags
Weigold et al. - March 1954 - 2670499
Artificial breast form
Kausch - December 1962 - 3067431
Surgically implantable human breast prosthesis
Cronin - December 1966 - 3293663
Fluid-seal air valve
Riddell - June 1928 - 1672905
Connecting and sealing means for curing bags
Weigold et al. - March 1954 - 2670499
Artificial breast form
Kausch - December 1962 - 3067431
Surgically implantable human breast prosthesis
Cronin - December 1966 - 3293663
Application Number:
04/888795
Publication Date:
08/24/1971
Filing Date:
12/29/1969
View Patent Images:
Export Citation:
Assignee:
Corporation, Dow Corning
Primary Class:
Other Classes:
137/223, 128/DIG.021, 450/38, 141/329, 141/313
International Classes:
A61F2/12; A61F1/24; A61F1/00; A41C3/10
Field of Search:
3/1,36 128/462,DIG.21 137/223 141/313,329,330 273/65C,65D 46/87,90
Primary Examiner:
Gaudet, Richard A.
Assistant Examiner:
Frinks, Ronald L.
Claims:
That which is claimed is
1. In an inflatable prosthetic device for replacing a body part or supplementing a body contour comprising a collapsible closed shell and a filling stem for introducing fluids into said shell, the improvement which comprises:
2. The invention as defined in claim 1 wherein said body of viscous material is confined in a capsule having a thin flexible wall which is adhered to the interior surface of said shell surrounding the point of introduction of said stem into the volume bounded by said shell, said stem protruding into said volume beyond the innermost wall of said capsule and being freely slideable with respect thereto.
3. The invention as defined in claim 2 wherein fibrous reinforcement is provided on said capsule wall surrounding the point of entry of said stem from said capsule into the volume bounded by said shell.
4. The invention as defined in claim 2 wherein the inner termination of said stem is sealed and is provided with a limiting flange to prevent said stem from being pulled completely from said shell;
5. The invention as defined in claim 1 wherein said inflatable prosthetic device is a mammary prosthesis.
6. The invention as defined in claim 5 wherein said mammary prosthesis is made from a suitable physiologically inert material adapted for surgical implantation within the human breast.
1. In an inflatable prosthetic device for replacing a body part or supplementing a body contour comprising a collapsible closed shell and a filling stem for introducing fluids into said shell, the improvement which comprises:
2. The invention as defined in claim 1 wherein said body of viscous material is confined in a capsule having a thin flexible wall which is adhered to the interior surface of said shell surrounding the point of introduction of said stem into the volume bounded by said shell, said stem protruding into said volume beyond the innermost wall of said capsule and being freely slideable with respect thereto.
3. The invention as defined in claim 2 wherein fibrous reinforcement is provided on said capsule wall surrounding the point of entry of said stem from said capsule into the volume bounded by said shell.
4. The invention as defined in claim 2 wherein the inner termination of said stem is sealed and is provided with a limiting flange to prevent said stem from being pulled completely from said shell;
5. The invention as defined in claim 1 wherein said inflatable prosthetic device is a mammary prosthesis.
6. The invention as defined in claim 5 wherein said mammary prosthesis is made from a suitable physiologically inert material adapted for surgical implantation within the human breast.
Description:
BACKGROUND OF THE INVENTION
The present invention relates to improvements in prostheses for implanting within or replacement of parts of the human body and more particularly is designed for use in mammary or breast prostheses.
There are two known general types of breast prostheses. The first type is worn externally in some type of brassiere arrangement and is generally employed when breasts or portions thereof have been removed by surgery. A second type involves a prosthesis for insertion into the breasts in order to change the contour thereof. This type is generally used for cosmetic purposes and it is to this type prosthesis that the present invention primarily relates, although it may also be used with the former type.
It is known, for example, from U.S. Pat. No. 2,842,775 issued to W. J. Pangman, and from U.S. Pat. No. 3,416,160 issued to H. G. Arion, that a prosthesis may be made utilizing a collapsible closed shell and a filling stem for introducing fluids into the shell to inflate the prosthesis. When used in a surgically implantable prosthesis, the inflation technique allows the use of a relatively small incision to introduce the prosthetic device. After insertion of the device, the shell is inflated by means of a suitable fluid such as, for example, a normal saline solution or a liquid silicone material. The inflation may be accomplished to the extent desired depending on the design of the device and the desired effect. The inflatable type of device has advantages particularly in cases in which the normal breasts are not of equal contour. It should be understood, however, that this type of device is not limited to such patients.
To the best of applicant's knowledge, in all prior art inflatable prostheses of this type, it is necessary that the filling stem provided on the inflatable shell be provided with some means of sealing to prevent leakage of fluids from the shell after inflation. A common practice has been to provide either a plug for the filling stem as suggested in the aforementioned patent to Arion or to simply tie off the filling stem with a ligature.
This type of sealing suffers from certain disadvantages. First of all, it is difficult to insure against leakage in such situations since the tube which acts as the filling stem is generally of rather small diameter. Secondly, the closure must remain patent throughout the life of the device; yet since it is in contact with the human body, it must be of a material which does not introduce tissue reaction and which is not attacked by the tissues. The filling stem is presently available prostheses of this type is palpable after implantation of the device. In many cases, therefore, it is desirable to remove the filling stem after the device is in place. With those prostheses presently available, this can be accomplished only by cutting off the stem. Since sealing is required, however, at least a short nipple, which may still be palpable after implantation, must remain to provide adequate sealing either by means of plugging or ligating. It is toward these problems of the prior art to which the present invention is directed.
It is also known that implants of silicone rubber or other materials can be used, for example to fill depressions and for performing other functions. In some of these applications, inflatable devices can also be used and the present invention is directed as well toward such use.
BRIEF DESCRIPTION OF THE INVENTION
It is a primary object of the present invention, therefore, to provide an improved inflatable prosthesis usable either as a surgical implant or as an external prosthesis which provides sealing means not plagued by the problems inherent in prior art devices. In accordance with this and other objects there is provided by the present invention a mammary prosthesis comprising a collapsible closed shell and a filling stem for introducing fluids into the shell. The filling stem is mounted in a manner such that the exit port of the filling stem is freely slideable into and out of the volume bounded by the shell. A body of viscous jellylike material is affixed in the shell and surrounds the filling stem at the point where the stem passes through the shell wall into the volume bounded by the shell. The viscous material flows to seal at least the exit port of the filling stem when the stem is withdrawn to the point where the exit port is surrounded by the viscous material. If desired, the stem may be completely withdrawn from the shell and the viscous material flows to close the hole through which the stem passed into the shell interior. Similarly the same filling system can be applied to other types of prostheses and other implantable devices.
BRIEF DESCRIPTION OF THE DRAWINGS
Other objects and attendant advantages of the invention will become understood by those skilled in the art from a consideration of the following detailed description when read in conjunction with the accompanying drawings wherein:
FIG. 1 is a view in cross section of a mammary prosthesis made in accordance with the present invention;
FIG. 2 is a rear elevational view, with portions cut away, of the prosthesis illustrated in FIG. 1;
FIG. 3 is a fragmentary, cross-sectional view of the sealing device which constitutes the improvement of the present invention and which is illustrated in less detail in FIGS. 1 and 2; and
FIG. 4 is a fragmentary view similar to FIG. 3 showing a modification of the invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring now to the drawings wherein like reference characters designate like or corresponding parts throughout the figures thereof, there is shown in FIG. 1 a surgically implantable inflatable mammary prosthesis comprising a collapsible closed shell 11 and a filling stem 12 for introducing fluids into said shell. The shell 11 desirably conforms substantially to the shape of the human breast when inflated by a suitable fluid such as normal saline solution or a silicone gel such as that described in U.S. Pat. No. 3,293,663 issued Dec. 27, 1966, to Thomas D. Cronin. The specific fluid used forms no part of the present invention as such.
As known to those skilled in the art, the shell 11 may, if desired, have affixed to the back thereof a plurality of patches 13 of polyester fabric material, or the like, for ingrowth of tissue to anchor the device to the chest walls. Alternatively, an open cell foam type material or other fixation devices may be substituted for this purpose. The patches are affixed to the back by means of suitable adhesive materials, which of course must be physiologically inert. It should be understood that the device need not have tissue anchoring means at all if desired.
In accordance with the present invention, the filling stem 12 enters the volume defined by the shell 11 through a hole in the shell. The stem 12 is made freely slideable into and out of the shell for reasons which will become more fully understood after the reader considers the operation of the device. Affixed to the interior of the shell 11 at the point of entry of the filling stem 12 into the shell 11, there is provided a body of viscous jellylike sealant material 14 through which the stem 12 passes. The sealing material 14 is preferably enclosed in a capsule 16 of a thin flexible material such as silicone rubber. The capsule is adhered to the interior of the shell 11 by means of a suitable adhesive material. Preferably, there is provided at the points of entrance and exit of the filler tube 12 through the capsule 16 a layer of fabric reinforcing material 17 and 18, respectively which will be seen more clearly from FIG. 3.
FIG. 3 shows an enlarged fragmentary portion of the device of FIGS. 1 and 2 and illustrates particularly details of the sealing capsule. The reinforcing material 17 and 18 is provided to prevent tearing of the capsule 16 as the filler stem 12 slides through the capsule. In a preferred embodiment, the viscous jellylike material 14 contained in the capsule is a silicone gel of the type defined in the aforementioned patent to Cronin. More specifically, exemplary gels are described in U.S. Pat. No. 3,020,260 or can be made in other ways such as, for example, by injecting a mixture of hydroxylated siloxane and ethyl silicate into the capsule along with a suitable catalyst such as stannous octoate. The fluid will then set in place forming a soft flowable gel.
In operation, the device is inflated by the introduction of the filling fluid through the filling stem 12 and out of the exit ports 19, 21 and 22 at the terminal portion thereof. When the device has been inflated sufficiently to produce the desired contours and breast firmness, the filling stem 12 is simply pulled back through the shell wall 16 until at least the exit ports 19, 21, and 22 are within the body of viscous jellylike material 14 which flows to act as a seal against leakage to the outside of the fluid contained within the shell 11. If desired, the filling stem 12 can be completely withdrawn and the sealing gel 14 prevents leakage of the liquid filler material of the prosthesis through the hole in the shell 11 which was formerly occupied by the filling stem 12.
Thus, there is no need for plugging or attempting to ligate the filling stem 12. The fluid is simply retained within the device by a withdrawal motion. In some instances, it may be desired to leave the filling stem patent for introduction of additional fluid at a later time. In such circumstances, a modification such as that shown in FIG. 4 is desirable. In the embodiment of FIG. 4, the terminal end 22 of the filling stem 12 is sealed and a flange 23 is mounted thereon. The flange 23 acts as a limit stop to prevent total withdrawal of the filler stem 12 from the device. The stem 12 is withdrawn until the flange 23 abuts the surface of the capsule 16 or the reinforcement material 18 affixed thereto. At this point, the exit ports 19 and 21 which are spaced from the termination of the stem and the flange 23, are completely engulfed by the viscous material 14 which acts to seal them. Should additional fluid need to be injected at a later time, the stem 12 is again pushed into the device to the point that the exit ports 19 and 21 are in communication with the liquid confined by the shell 11. Additional liquid can then be injected into the device or removed from the device and the stem 12 again withdrawn.
While the invention has been specifically described in relation with an inflatable mammary prosthesis, it will be understood by those skilled in the art that the same principles can be applied to other types of inflatable devices. For example, other types of surgical implants can be made in a similar manner by shaping the shell to provide the desired contours.
Obviously, many other modifications and variations of the invention will become obvious to those skilled in the art from a consideration of the foregoing. Therefore, it is to be understood that the invention may be practiced otherwise than as specifically described.
The present invention relates to improvements in prostheses for implanting within or replacement of parts of the human body and more particularly is designed for use in mammary or breast prostheses.
There are two known general types of breast prostheses. The first type is worn externally in some type of brassiere arrangement and is generally employed when breasts or portions thereof have been removed by surgery. A second type involves a prosthesis for insertion into the breasts in order to change the contour thereof. This type is generally used for cosmetic purposes and it is to this type prosthesis that the present invention primarily relates, although it may also be used with the former type.
It is known, for example, from U.S. Pat. No. 2,842,775 issued to W. J. Pangman, and from U.S. Pat. No. 3,416,160 issued to H. G. Arion, that a prosthesis may be made utilizing a collapsible closed shell and a filling stem for introducing fluids into the shell to inflate the prosthesis. When used in a surgically implantable prosthesis, the inflation technique allows the use of a relatively small incision to introduce the prosthetic device. After insertion of the device, the shell is inflated by means of a suitable fluid such as, for example, a normal saline solution or a liquid silicone material. The inflation may be accomplished to the extent desired depending on the design of the device and the desired effect. The inflatable type of device has advantages particularly in cases in which the normal breasts are not of equal contour. It should be understood, however, that this type of device is not limited to such patients.
To the best of applicant's knowledge, in all prior art inflatable prostheses of this type, it is necessary that the filling stem provided on the inflatable shell be provided with some means of sealing to prevent leakage of fluids from the shell after inflation. A common practice has been to provide either a plug for the filling stem as suggested in the aforementioned patent to Arion or to simply tie off the filling stem with a ligature.
This type of sealing suffers from certain disadvantages. First of all, it is difficult to insure against leakage in such situations since the tube which acts as the filling stem is generally of rather small diameter. Secondly, the closure must remain patent throughout the life of the device; yet since it is in contact with the human body, it must be of a material which does not introduce tissue reaction and which is not attacked by the tissues. The filling stem is presently available prostheses of this type is palpable after implantation of the device. In many cases, therefore, it is desirable to remove the filling stem after the device is in place. With those prostheses presently available, this can be accomplished only by cutting off the stem. Since sealing is required, however, at least a short nipple, which may still be palpable after implantation, must remain to provide adequate sealing either by means of plugging or ligating. It is toward these problems of the prior art to which the present invention is directed.
It is also known that implants of silicone rubber or other materials can be used, for example to fill depressions and for performing other functions. In some of these applications, inflatable devices can also be used and the present invention is directed as well toward such use.
BRIEF DESCRIPTION OF THE INVENTION
It is a primary object of the present invention, therefore, to provide an improved inflatable prosthesis usable either as a surgical implant or as an external prosthesis which provides sealing means not plagued by the problems inherent in prior art devices. In accordance with this and other objects there is provided by the present invention a mammary prosthesis comprising a collapsible closed shell and a filling stem for introducing fluids into the shell. The filling stem is mounted in a manner such that the exit port of the filling stem is freely slideable into and out of the volume bounded by the shell. A body of viscous jellylike material is affixed in the shell and surrounds the filling stem at the point where the stem passes through the shell wall into the volume bounded by the shell. The viscous material flows to seal at least the exit port of the filling stem when the stem is withdrawn to the point where the exit port is surrounded by the viscous material. If desired, the stem may be completely withdrawn from the shell and the viscous material flows to close the hole through which the stem passed into the shell interior. Similarly the same filling system can be applied to other types of prostheses and other implantable devices.
BRIEF DESCRIPTION OF THE DRAWINGS
Other objects and attendant advantages of the invention will become understood by those skilled in the art from a consideration of the following detailed description when read in conjunction with the accompanying drawings wherein:
FIG. 1 is a view in cross section of a mammary prosthesis made in accordance with the present invention;
FIG. 2 is a rear elevational view, with portions cut away, of the prosthesis illustrated in FIG. 1;
FIG. 3 is a fragmentary, cross-sectional view of the sealing device which constitutes the improvement of the present invention and which is illustrated in less detail in FIGS. 1 and 2; and
FIG. 4 is a fragmentary view similar to FIG. 3 showing a modification of the invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring now to the drawings wherein like reference characters designate like or corresponding parts throughout the figures thereof, there is shown in FIG. 1 a surgically implantable inflatable mammary prosthesis comprising a collapsible closed shell 11 and a filling stem 12 for introducing fluids into said shell. The shell 11 desirably conforms substantially to the shape of the human breast when inflated by a suitable fluid such as normal saline solution or a silicone gel such as that described in U.S. Pat. No. 3,293,663 issued Dec. 27, 1966, to Thomas D. Cronin. The specific fluid used forms no part of the present invention as such.
As known to those skilled in the art, the shell 11 may, if desired, have affixed to the back thereof a plurality of patches 13 of polyester fabric material, or the like, for ingrowth of tissue to anchor the device to the chest walls. Alternatively, an open cell foam type material or other fixation devices may be substituted for this purpose. The patches are affixed to the back by means of suitable adhesive materials, which of course must be physiologically inert. It should be understood that the device need not have tissue anchoring means at all if desired.
In accordance with the present invention, the filling stem 12 enters the volume defined by the shell 11 through a hole in the shell. The stem 12 is made freely slideable into and out of the shell for reasons which will become more fully understood after the reader considers the operation of the device. Affixed to the interior of the shell 11 at the point of entry of the filling stem 12 into the shell 11, there is provided a body of viscous jellylike sealant material 14 through which the stem 12 passes. The sealing material 14 is preferably enclosed in a capsule 16 of a thin flexible material such as silicone rubber. The capsule is adhered to the interior of the shell 11 by means of a suitable adhesive material. Preferably, there is provided at the points of entrance and exit of the filler tube 12 through the capsule 16 a layer of fabric reinforcing material 17 and 18, respectively which will be seen more clearly from FIG. 3.
FIG. 3 shows an enlarged fragmentary portion of the device of FIGS. 1 and 2 and illustrates particularly details of the sealing capsule. The reinforcing material 17 and 18 is provided to prevent tearing of the capsule 16 as the filler stem 12 slides through the capsule. In a preferred embodiment, the viscous jellylike material 14 contained in the capsule is a silicone gel of the type defined in the aforementioned patent to Cronin. More specifically, exemplary gels are described in U.S. Pat. No. 3,020,260 or can be made in other ways such as, for example, by injecting a mixture of hydroxylated siloxane and ethyl silicate into the capsule along with a suitable catalyst such as stannous octoate. The fluid will then set in place forming a soft flowable gel.
In operation, the device is inflated by the introduction of the filling fluid through the filling stem 12 and out of the exit ports 19, 21 and 22 at the terminal portion thereof. When the device has been inflated sufficiently to produce the desired contours and breast firmness, the filling stem 12 is simply pulled back through the shell wall 16 until at least the exit ports 19, 21, and 22 are within the body of viscous jellylike material 14 which flows to act as a seal against leakage to the outside of the fluid contained within the shell 11. If desired, the filling stem 12 can be completely withdrawn and the sealing gel 14 prevents leakage of the liquid filler material of the prosthesis through the hole in the shell 11 which was formerly occupied by the filling stem 12.
Thus, there is no need for plugging or attempting to ligate the filling stem 12. The fluid is simply retained within the device by a withdrawal motion. In some instances, it may be desired to leave the filling stem patent for introduction of additional fluid at a later time. In such circumstances, a modification such as that shown in FIG. 4 is desirable. In the embodiment of FIG. 4, the terminal end 22 of the filling stem 12 is sealed and a flange 23 is mounted thereon. The flange 23 acts as a limit stop to prevent total withdrawal of the filler stem 12 from the device. The stem 12 is withdrawn until the flange 23 abuts the surface of the capsule 16 or the reinforcement material 18 affixed thereto. At this point, the exit ports 19 and 21 which are spaced from the termination of the stem and the flange 23, are completely engulfed by the viscous material 14 which acts to seal them. Should additional fluid need to be injected at a later time, the stem 12 is again pushed into the device to the point that the exit ports 19 and 21 are in communication with the liquid confined by the shell 11. Additional liquid can then be injected into the device or removed from the device and the stem 12 again withdrawn.
While the invention has been specifically described in relation with an inflatable mammary prosthesis, it will be understood by those skilled in the art that the same principles can be applied to other types of inflatable devices. For example, other types of surgical implants can be made in a similar manner by shaping the shell to provide the desired contours.
Obviously, many other modifications and variations of the invention will become obvious to those skilled in the art from a consideration of the foregoing. Therefore, it is to be understood that the invention may be practiced otherwise than as specifically described.