|Publication number||US3665520 A|
|Publication date||May 30, 1972|
|Filing date||Oct 7, 1970|
|Priority date||Oct 7, 1970|
|Also published as||CA956402A, CA956402A1|
|Publication number||US 3665520 A, US 3665520A, US-A-3665520, US3665520 A, US3665520A|
|Inventors||Colette Perras, Jacques Papillon|
|Original Assignee||Medical Eng Corp|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (6), Referenced by (80), Classifications (7)|
|External Links: USPTO, USPTO Assignment, Espacenet|
United States Patent Perras et al.
[ 51 May 30, 1972 [541 SURGICALLY IMPLANTABLE BREAST PROSTHESIS  Inventors: Colette Perras, Lacombe, Montreal; Jacques Papillon, St. Lambert, Montreal,
21 Appl. No.: 78,863
FOREIGN PATENTS OR APPLICATIONS 1,506,271 11/1967 France ..3/36 1,506,272 11/1967 France ..3/36
Primary Examiner-Richard A. Gaudet Assistant Examiner-Ronald L. Frinks Attomey-Ronald E. Barry and James E. Nilles 1 ABSIRACT A surgically implantable breast prosthesis formed from a flexible container having a front wall and a back wall; the front wall having an outer shape approximately that of the human breast and the back wall having a shape approximately that of the chest wall. The container includes a prolongation extending angularly outwardly toward the axilla region of the anatomy and overlying the pectoral muscle. The container is filled with a silicone gel and a fabric impregnated with the same material used to form the container is secured to the back wall to increase the rigidity of the back wall. A strip of Dacron felt is secured to the outer periphery of the back wall around the axilla prolongation and a small portion of the back wall of the container to support the prosthesis by tissue ingrowth into the Dacron felt.
12 Claims, 4 Drawing Figures SURGICALLY IMPLANTABLE BREAST PROSTHESIS BACKGROUND OF THE INVENTION Gel-filled silicone rubber breast prostheses have been employed for anumber of years to maintain the natural appearance of the breast. The most common breast prostheses of the gel filled type is shown in U. S. Pat. No. 3,293,663 issued to T. D. Cronin on Dec. 27, 1966. This prosthesis included a flexible container having an outer peripheral ridge and a fabric material secured to the back wall of a flexible container to secure the container to the chest wall. This prosthesis is implanted solely within the breast area of the patient. It has been found, however, that due to the natural tendency of the body to reject foreign objects, the prosthesis tends tolose its shape SUMMARY OF THE INVENTION The breast prosthesis of the present invention retains the natural appearance of the breast by the inclusion of a prolongation on the prosthesis which extends outwardly from'the breast area towards the axilla region of the anatomy. This prolongation when implanted in the patent will overlie the pectoral muscle. This prosthesisis held in position by a strip of felt material provided around the periphery of the back wall of the prolongation and around a portion of the back wall of the container. Tissue ingrowth is promoted only in the region of the strip of material leaving the major portion of the back wall free. Since the major portion of the back wall of the prosthesis is now physiologically inert, the prosthesis has greater freedom to follow the natural movements of the breast.
Distortion of the prosthesis by the force of the scar tissue is minimized by a fabric material which has been pre-impregnated with the polycarbonate material used to form the container and is secured to the inside surface of the back wall of the container. This fabric mesh increases the rigidity of the back wall with sufficient force to counteract the forces of tissue ingrowth. The fabric mesh extends across the entire back wall of the container and also across the back wall of the prolongation.
Other objects and advantages will be apparent from the following description when read in connection with the accompanying drawings.
TI-IE DRAWINGS FIG. I is a front view of a portion of the anatomy showing the approximate location of the prosthesis of this invention;
FIG. 2 is a front view of a prosthesis according to this invention for implanting on the right side of the patient;
F [6.3 is a back view of the prosthesis of FIG. 2; and
FIG. 4 is a section view taken on line 4-4 of the prosthesis of FIG. 2 showing the position of the fabric mesh.
DESCRIPTION OF THE INVENTION Referring to FIG. 1 of the drawing, the location of the prosthesis is shown in position in the right upper torso of the anatomy 12. The prosthesis 10 is so located that it follows generally the same contour for the right side of the anatomy as shown for the normal breast line 14 on the left side of the anatomy. The prosthesis 10 can be located behind the mammary gland of the patient to augment the appearance of the breast but will not interfere with the ability of the patient to nurse in the normal way, and does not interfere in any way with the functioning of the mammary gland.
In accordance with the invention, the breast prosthesis 10 is formed from a container which is filled with a soft gel 22. The container 20 is made of a material that has characteristics that resemble that of the normal human breast, such as softness and resiliency. The material must also be of a type which does not cause tissue reaction after implantation. A suitable material for the container 20 is an organopolysiloxane polycarbonate block copolymer.
The container 20 is formed with a front wall 24 having the general shape of a natural breast and a back wall 26 which follows the contour of the chest. In this respect, the back wall 26 has a generally concave appearance to fit comfortably against the chest wall. The container 20 can be formed on a mold having the general shape of the prosthesis. The mold is dipped in a liquid copolymer and rotated to form the container on the outside of the mold. The mold is repeatedly dipped and rotated to cure the copolymer until the container has the desired wall thickness. The wall of the container formed of this material has the same thickness and has little, if any, rigidity, being very soft and very flexible in compression but has great tensile strength. It should be noted that the edge or peripheral wall 25 of the container is round or curved as seen in FIG. 4.
The container 20 is formed with a prolongation 28 which is arranged to extend outwardly from the breast area toward the axilla region 30 of the anatomy. The prolongation 28 should overlie the area 32 of the pectoral muscle 32 and should be tapered outwardly toward the outer end. The axillary prolongation 28 follows the anatomical contour of the anatomy, thus providing a more natural appearance when implanted in the breast.-
The container 20 is filled with the silicone gel 22 to give the prosthesis the proper shape and resiliency. Silicone gel made in accordance with U.S. Pat. No. 3,020,260 which issued on Feb. 6, 1962 and entitled, Organosiloxane Potting Compound is a good example of a gel suitable for use in the prosthesis of this invention. The preferred gel for use in this invention is a liquid methyl silicone resin capable of being vulcanized to an elastomer blended with a dimethyl silicone fluid. A suitable fluid is General Electics VISCASIL and an appropriate resin recommended for this use is General Electrics elastomeric resin TRV-6l5. The proportion of resin to fluid may vary from 1:1 to 1:10 in order to obtain the proper gel consistency. The resin contains RzSiO-l/2 groups, RzSiO groups, and SiOz groups, where R represents methyl groups. The ratio of the groups one to the other determines the consistency of the gel.
Means are provided in the backwall 26 of the container 20 for stiffening or increasing the rigidity of the back wall in compression and thereby resist the tendency of the container to be deformed due to the force of the scar tissue. In this respect, it has been found that the scar tissue ingrowth in the entire back wall of a prosthesis as described in Cronin U.S. Pat. No. 3,293,663 tends to deform the prosthesis forcing the rigid edges of the prosthesis outward. A bulge will eventually appear around the periphery of the breast of the patient. This is prevented by means of a bio-compatible fabric material 40 such as a polyester, polypropylene or polyamide fabric in the form of a mesh which is secured to the back wall 26 of the container 20. The fabric material can be secured to the inside of the back wall or embedded therein. Any suitable means can be used for securing the fabric to the back wall, such as a silicone adhesive, or by heat sealing, or by laminating with the copolymer.
The fabric material 40 can be initially impregnated with the 'organosiloxane copolymer and cured to reduce the probability of tissue ingrowth and to increase the rigidity of the mesh. The impregnated mesh 40 can be secured to either the inside or outside surface of the back wall of the container. Impregnating the mesh with the copolymer will prevent tissue ingrowth if secured to the outside of the container. The fabric mesh 40 thereby increases the strength of the back wall in compression without increasing the thickness of the container nor the strength of the front wall 24.
The prosthesis 10 is secured to the chest wall of the patient by means of a strip 50 of felt-like material formed from a polyester material such as Dacron which is provided around the periphery of the axillary prolongation 28, and across the top portion of the back wall 26 of the container. The strip of felt S limits the amount of tissue ingrowth and at the same time provides sufficient support to maintain the prosthesis in position. The felt strip 50 is secured to the container by a silicone adhesive and is provided only along the upper edges of the prosthesis. The felt-like material limits the penetration of the adhesive to one side of the strip leaving the other side free for tissue ingrowth. The prosthesis is secured to the area of the pectoral musclealong the upper portion of the container only since the normal forces acting on the prosthesis are downward, thus leaving the major portion of the back wall 26 free or unattached to the chest wall. This arrangement for supporting the prosthesis in the breast allows for a more natural amount of movement of the breast.
Another important feature of the present invention is the elimination of any ridge or bulge around the prosthesis 10 which can be seen or felt after the prosthesis has been implanted in the patient. This has been achieved by forming the container as an integral unit having a curved wall or edge 25 between the front and back walls. Since the container material has no compressive strength and is very thin, the edge 25 will collapse when touched and cannot be felt through the skin of the patient.
RESUME The prosthesis of this invention includes a number of important features which have not previously been available in a breast prosthesis. The most important of these features is the axillary prolongation which tapers outwardly toward the axilla region of the patient. This prolongation provides a more natural appearance to the prosthesis after implant. The felt strip which is used to support and maintain the implant in position allows for greater freedom of movement of the prosthesis again providing a more natural appearance. The curved edge provided between the front wall and back wall of the container has eliminated the bulge or ridge which generally occurs around the prosthesis. The fabric material secured to the back wall of the container has increased the strength or rigidity of the back wall of the container so that the prosthesis does not become distorted after implant.
1. A surgically implantable breast prosthesis comprising,
a flexible container having a front wall and a back wall, said front wall having an outer shape approximating that of the human breast, and said back wall having an outer shape approximating that of the chest wall,
said container including a prolongation formed by said back and said front wall and extending angularly outwardly toward the axillary region of the anatomy,
a silicone gel filling the inside of said container, and
means secured to the periphery of the back wall of said axillary prolongation for permitting tissue ingrowth from the area of the pectoral muscle.
2. The prosthesis according to claim 1 including means secured to the inside of said back wall for maintaining the shape of the prosthesis.
3. The prosthesis according to claim 1 including a polyester fabric mesh impregnated with an organosiloxane copolymer secured to said back wall of said container.
4. The prosthesis according to claim 1 including a polyester fabric mesh impregnated with an organosiloxane copolymer secured to the inside surface of the back wall of said container.
5. The prosthesis according to claim I wherein said back wall and said front wall are formed as an integral unit having an arcuate wall around the outer periphery of said container.
6. A surgically implantable breast prosthesis comprising,
a flexible container having a front wall and a back wall, said front wall having a shape approximating that of the human breast, said back wall having a shape approximating that ofthe chest wall,
said container including an axillary prolongation,
a silicone'gel filling the inside ofsaid container, and means for stiffening said back wall.
7. The prosthesis according to claim 6 wherein said stiffening means comprises a polyester fabric.
8. The prosthesis according to claim 6 wherein said stiffening means comprises a fabric mesh impregnated with an organosiloxane copolymer prior to being attached to said container.
9. The prosthesis according to claim 6 including means secured to the periphery of the back wall of said prolongation for promoting tissue ingrowth to secure the prosthesis in position.
10. The prosthesis according to claim 6 wherein said container includes a curved wall around the periphery of said container formed integral with said front wall and said back wall.
11. A surgically implantable prosthesis comprising,
a flexible container molded from an organosiloxane copolymer and having an axillary prolongation,
a silicone gel completely filling said container,
means attached to said container for stiffening the back portion ofsaid container, and
means secured to the periphery of said prolongation for promoting tissue ingrowth.
12. The prosthesis according to claim 1 wherein said con tainer is formed with a curved wall around the periphery.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US2752602 *||Jul 25, 1955||Jul 3, 1956||Reser Wilhelm Dorothy||Prosthetic breast and supporting garment|
|US3293663 *||Aug 12, 1963||Dec 27, 1966||Dow Corning||Surgically implantable human breast prosthesis|
|US3366975 *||Jun 4, 1965||Feb 6, 1968||William J. Pangman||Compound prosthesis|
|US3545008 *||May 27, 1968||Dec 8, 1970||Karl F Bader Jr||Tendon prosthesis|
|FR1506271A *||Title not available|
|FR1506272A *||Title not available|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US3896506 *||Jan 13, 1975||Jul 29, 1975||Hankin George||Breast prosthesis|
|US3911503 *||Jan 21, 1974||Oct 14, 1975||Hankin George||Breast prosthesis|
|US4019209 *||Apr 22, 1976||Apr 26, 1977||Spenco Medical Corporation||Artificial breast form and method of forming|
|US4095295 *||Mar 28, 1977||Jun 20, 1978||Douglas Lake||Adjustable, fluid-filled breast implant|
|US4100627 *||Dec 29, 1976||Jul 18, 1978||Dow Corning Corporation||Low oiling gel filled flexible articles and gels therefor|
|US4205401 *||May 25, 1978||Jun 3, 1980||Dow Corning Corporation||Mammary prosthesis which resists capsular contracture|
|US4217889 *||Jul 20, 1978||Aug 19, 1980||Heyer-Schulte Corporation||Flap development device and method of progressively increasing skin area|
|US4298998 *||Dec 8, 1980||Nov 10, 1981||Naficy Sadeque S||Breast prosthesis with biologically absorbable outer container|
|US4372293 *||Dec 24, 1980||Feb 8, 1983||Vijil Rosales Cesar A||Apparatus and method for surgical correction of ptotic breasts|
|US4380569 *||Aug 3, 1981||Apr 19, 1983||Spenco Medical Corporation||Lightweight preformed stable gel structures and method of forming|
|US4592755 *||Jun 11, 1985||Jun 3, 1986||Ethyl Corporation||Mammary implant|
|US4615704 *||Nov 26, 1984||Oct 7, 1986||Dow Corning Corporation||Shape retention tissue expander and method of using|
|US4740208 *||Sep 27, 1985||Apr 26, 1988||Cavon Joseph F||Cast gel implantable prosthesis|
|US4773909 *||Dec 9, 1986||Sep 27, 1988||Memorial Hospital For Cancer And Allied Diseases||Multi-lumen high profile mammary implant|
|US5026394 *||Jan 10, 1989||Jun 25, 1991||Baker James L||Mammary implant|
|US5236454 *||Nov 4, 1991||Aug 17, 1993||Miller Archibald S||Stacked breast implant|
|US5407445 *||May 19, 1993||Apr 18, 1995||Cytrx Corporation||Gel composition for implant prosthesis and method of use|
|US5653758 *||Jun 6, 1995||Aug 5, 1997||Lipomatrix, Incorporated||Method of using a radiolucent organ displacement device for radiation therapy|
|US6290723||Jun 2, 1995||Sep 18, 2001||Winston A. Andrews||Method of making a synthetic triglyceride filler material|
|US6605116||Apr 3, 2001||Aug 12, 2003||Mentor Corporation||Reinforced radius mammary prostheses and soft tissue expanders|
|US6916339||May 29, 2000||Jul 12, 2005||Marie-Christine Missana||Breast prosthesis|
|US7766963||Sep 8, 2005||Aug 3, 2010||Alps South, LLC||External breast prosthesis|
|US7767452||Feb 28, 2007||Aug 3, 2010||Kleinsek Don A||Tissue treatments with adipocyte cells|
|US7799325||Nov 1, 2007||Sep 21, 2010||Kleinsek Donald A||Removal of hypertrophic scars|
|US7998152 *||Dec 21, 2006||Aug 16, 2011||Frank Robert E||Implantable prosthesis for periareolar mastopexy|
|US8313527||Oct 30, 2008||Nov 20, 2012||Allergan, Inc.||Soft prosthesis shell texturing method|
|US8487012||Jan 25, 2011||Jul 16, 2013||Allergan, Inc.||Open celled foams, implants including them and processes for making same|
|US8506627||Aug 12, 2009||Aug 13, 2013||Allergan, Inc.||Soft filled prosthesis shell with discrete fixation surfaces|
|US8546458||Dec 7, 2011||Oct 1, 2013||Allergan, Inc.||Process for texturing materials|
|US8679279||Nov 15, 2011||Mar 25, 2014||Allergan, Inc.||Methods for creating foam-like texture|
|US8679570||Apr 25, 2011||Mar 25, 2014||Allergan, Inc.||Foam-like materials and methods for producing same|
|US8685296||May 10, 2011||Apr 1, 2014||Allergan, Inc.||Porogen compositions, method of making and uses|
|US8801782||Dec 15, 2011||Aug 12, 2014||Allergan, Inc.||Surgical methods for breast reconstruction or augmentation|
|US8877822||Sep 27, 2011||Nov 4, 2014||Allergan, Inc.||Porogen compositions, methods of making and uses|
|US8889751||Sep 28, 2011||Nov 18, 2014||Allergan, Inc.||Porous materials, methods of making and uses|
|US8951596||Jul 15, 2013||Feb 10, 2015||Allergan, Inc.||Implants and methods for manufacturing same|
|US9044897||Sep 28, 2011||Jun 2, 2015||Allergan, Inc.||Porous materials, methods of making and uses|
|US9072821||Feb 4, 2011||Jul 7, 2015||Allergan, Inc.||Biocompatible structures and compositions|
|US9138308||Aug 2, 2012||Sep 22, 2015||Apollo Endosurgery, Inc.||Mucosal tissue adhesion via textured surface|
|US9138309||Sep 24, 2012||Sep 22, 2015||Allergan, Inc.||Porous materials, methods of making and uses|
|US9138310||Oct 24, 2012||Sep 22, 2015||Allergan, Inc.||Soft prosthesis shell texturing method|
|US9138311||Jul 29, 2013||Sep 22, 2015||Allergan, Inc.||Soft filled prosthesis shell with discrete fixation surfaces|
|US9155613||Feb 6, 2014||Oct 13, 2015||Allergan, Inc.||Methods for creating foam-like texture|
|US9205577||Sep 28, 2012||Dec 8, 2015||Allergan, Inc.||Porogen compositions, methods of making and uses|
|US9522502||Oct 13, 2014||Dec 20, 2016||Allergan, Inc.||Porous materials, methods of making and uses|
|US9539086||May 15, 2015||Jan 10, 2017||Allergan, Inc.||Soft filled prosthesis shell with variable texture|
|US9593224||Oct 1, 2014||Mar 14, 2017||Allergan, Inc.||Porogen compositions, methods of making and uses|
|US9688006||Dec 13, 2013||Jun 27, 2017||Allergan, Inc.||Device and method for making a variable surface breast implant|
|US9808338||Sep 30, 2016||Nov 7, 2017||Allergan, Inc.||Soft filled prosthesis shell with variable texture|
|US20020038147 *||Oct 31, 2001||Mar 28, 2002||Miller Archibald S.||Breast implant|
|US20050271633 *||Jul 6, 2005||Dec 8, 2005||Kleinsek Don A||Issue defect augmentation and repair with in vitro cultured fibroblasts|
|US20060039896 *||Jul 6, 2005||Feb 23, 2006||Gerigene Medical Corporation||Augmentation and repair of age-related soft tissue defects|
|US20070055371 *||Sep 8, 2005||Mar 8, 2007||Laghi Aldo A||External breast prosthesis|
|US20070065415 *||Sep 16, 2005||Mar 22, 2007||Kleinsek Donald A||Compositions and methods for the augmentation and repair of defects in tissue|
|US20070154462 *||Mar 1, 2007||Jul 5, 2007||Kleinsek Don A||Augmentation and repair of tissue defects with in vitro cultured fibroblasts|
|US20080112935 *||Oct 31, 2007||May 15, 2008||Kleinsek Donald A||Augmentation and repair of spincter defects with cells including fibroblasts|
|US20080118478 *||Nov 1, 2007||May 22, 2008||Kleinsek Donald A||Hair undifferentiated cells|
|US20080138324 *||Nov 1, 2007||Jun 12, 2008||Kleinsek Donald A||Hair mesenchymal cells|
|US20080152628 *||Oct 31, 2007||Jun 26, 2008||Kleinsek Donald A||Augmentation and repair of spincter defects with cells including mesenchymal cells|
|US20080152721 *||Oct 31, 2007||Jun 26, 2008||Kleinsek Donald A||Augmentation and repair of spincter defects with cells including adipocytic cells|
|US20080154366 *||Dec 21, 2006||Jun 26, 2008||Frank Robert E||Implantable prosthesis for periareolar mastopexy|
|US20080267923 *||Nov 1, 2007||Oct 30, 2008||Donald Kleinsek||Hair undifferentiated cells|
|US20080286242 *||Oct 31, 2007||Nov 20, 2008||Donald Kleinsek||Augmentation and repair of spincter defects with cells including mesenchymal cells|
|US20080299213 *||Oct 31, 2007||Dec 4, 2008||Donald Kleinsek||Augmentation and repair of spincter defects with cells including adipocytic cells|
|US20090016996 *||Nov 1, 2007||Jan 15, 2009||Donald Kleinsek||Hair mesenchymal cells|
|US20090074729 *||Oct 31, 2007||Mar 19, 2009||Donald Kleinsek||Augmentation and repair of spincter defects with cells including fibroblasts|
|US20090118829 *||Oct 30, 2008||May 7, 2009||Allergan, Inc.||Soft prosthesis shell texturing method|
|US20090130066 *||Oct 31, 2007||May 21, 2009||Gerigene Medical Corporation||Augmentation and repair of sphincter defects with cells including muscle cells|
|US20100042211 *||May 1, 2009||Feb 18, 2010||Allergan, Inc.||Soft filled prosthesis shell with discrete fixation surfaces|
|US20100042212 *||Aug 12, 2009||Feb 18, 2010||Allergan, Inc.||Soft Filled Prosthesis Shell With Discrete Fixation Surfaces|
|US20100292790 *||May 12, 2010||Nov 18, 2010||Allergan, Inc.||Implants and methods for manufacturing same|
|US20110093069 *||Oct 4, 2010||Apr 21, 2011||Allergan, Inc.||Implants and methdos for manufacturing same|
|US20110117267 *||Jan 21, 2011||May 19, 2011||Allergan, Inc.||Soft Prosthesis Shell Texturing Method|
|US20110184531 *||Jan 25, 2011||Jul 28, 2011||Allergan, Inc.||Open celled foams, implants including them and processes for making same|
|US20110196488 *||Jan 27, 2011||Aug 11, 2011||Allergan, Inc.||Degradation resistant implantable materials and methods|
|DE2920980A1 *||May 23, 1979||Nov 29, 1979||Dow Corning||Chirurgisch inplantierbare brustprothese|
|WO1981001650A1 *||Nov 24, 1980||Jun 25, 1981||Dow Corning||Silicone gel-filled silicone rubber article possessing reduced surface-bleed|
|WO2000074599A1 *||May 29, 2000||Dec 14, 2000||Missana Marie Christine||Breast prosthesis|
|WO2004041128A1 *||Oct 23, 2002||May 21, 2004||Laboratoires Eurosilicone||Anatomical breast implant with controllable and stable positioning|
|WO2014076339A1 *||Nov 11, 2013||May 22, 2014||Martin Federico Mayo||Breast implant|
|U.S. Classification||623/8, 450/38, 128/DIG.210|
|Cooperative Classification||Y10S128/21, A61F2/12|