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Publication numberUS3681787 A
Publication typeGrant
Publication dateAug 8, 1972
Filing dateMar 26, 1971
Priority dateMar 26, 1971
Publication numberUS 3681787 A, US 3681787A, US-A-3681787, US3681787 A, US3681787A
InventorsPerras Colette
Original AssigneeMoxness Products Inc
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Implantable breast prosthesis filled with gels of different densities
US 3681787 A
Abstract
A breast prosthesis having a porous polyester fabric for connecting the prosthesis to the chest wall and filled with layers of silicon gel material of varying viscosity to provide a more natural appearance of the breast.
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Claims  available in
Description  (OCR text may contain errors)

n51 3,681,787 51 Aug. 8, 1972 3,293,663 12/1966 Cronin.............................3/36

T mm m HF m mm G LH BT m T D E L L mm m DENSITIES FOREIGN PATENTS OR APPLICATIONS [72] Inventor: Colette Perras, Montreal, Quebec, 1,085,676 7/1954 France.............................3/36 Canada 11/1967 ....3/36 [73] Assignee: Moxness Products, Inc.,

1,506,272 France.....................

Racine,

OTHER PUBLICATIONS Mammaplasty Utilizing a Silastic lmplant,"

Wis.

22 Pl d: M h 26 1971 The 1 1e are Bulletin of the Dow Corning Center for Aid to Medi- [21] Appl. No.: 128,500

cal Research, Vol. 10, No. 2, April 1968, Midland, Mich., page 7.

Related US. Application Data [63] Continuation of Ser. No. 782,345, Dec. 9,

Primary Examiner-Richard A. Gaudet 1968 abandoned- Assistant Examiner-Ronald L. Frinks [57] ABSTRACT A breast prosthesis having a porous polyester fabric for connecting the prosthesis to the chest wall and [52] US. [51] Int. 1/24 [58] Field of Search ........3/l, 36; 128/462, 463, 464,

128/478-481, DIG. 21

filled with layers of silicon gel material of varying viscosity to provide a more natural appearance of the breast.

[56] References Cited UNITED STATES PATENTS 2,636,182 4/1953 Freedman........................3/36 8 Clains, 3 Drawing Figures IMPLANTABLE BREAST PROSTI-IESIS FILLED WITH GELS OF DIFFERENT DENSITIES This application is a continuation of application Ser. No. 782,345 filed Dec. 9, 1968, now abandoned.

This invention relates generally to a breast prosthesis suitable for implanting within the human breast. More specifically this invention relates to improved means for holding breast prosthesis in place and retaining its configuration over longer periods of time.

In recent years great strides have been made in the field of breast prosthesis. US. Pat. No. 3,293,663 issued to T. D. Cronin, Dec. 27, 1966 teaches a gel filled silicone rubber breast prosthesis that utilizes a polyester fabric to connect the prosthesis to the chest wall. The polyester fabric is positioned against the chest and retained there so that the body tissue actually grows through and fabric to anchor the prosthesis to the body. In practice there has been a tendency for this type of prosthesis to lose its configuration after a few months use. Also, the edges of the prosthesis tend to pull away from the chest wall and form a ridge or bulge around the upper portion of the breast.

This'invention overcomes the problems mentioned above by providing an improved means of anchoring the prosthesis to the body. The invention also incorporates a novel means of filling the prosthesis with materials of varying viscosity to maintain the configuration of the prosthesis over a longer period of time while also retaining the desired consistency of the breast.

Therefore it is the object of this invention to provide a new and improved breast prosthesis that more nearly resembles that of a natural human breast.

Another object of this invention is to provide a new and improved breast prosthesis that will retain its natural shape over longer periods of time.

Another object of this invention is to provide a breast prosthesis that more firmly adheres to the chest wall.

Other objects and advantages will be apparent from the following description when read in connection with the accompanying drawings, in which:

FIG. 1 is a sectional view of the breast prosthesis of this invention attached to the chest wall and positioned beneath the mammary gland;

FIG. 2 is a rear view of the prosthesis of FIG. 1;

FIG. 3 is a cross section view of the prosthesis of FIG. 1 taken along the line III-Ill.

The prosthesis of this invention is made up of an envelope or container 10 having a back section 11 which is generally flat and adapted to fit against the chest wall and a from section 12 that generally resembles the shape of a human breast. The prosthesis can be positioned beneath the mammary gland as shown in FIG. 1 as well as being used as a substitute for breasts that have been removed. This changes the configuration of the breasts but allows the wearer to nurse in a normal way and does not interfere in any way with the normal functioning of the mammary gland. The container 10 is made of a material that has characteristics that resemble that of the normal human breast such as softness and resiliency. The material also must be of a type that does not cause tissue reaction with the wearer. A suita- V ble material for the prosthesis container is silicone rubber made in accordance with the teachings of U.S. Pat. No. 3,189,662.

The container is filled with a suitable material to give the prosthesis the proper shape and resiliency. Silicone gel made in accordance with US. Pat. No. 3,020,260 is a good example of the type of material suitable for use in the prosthesis of this invention. In the preferred embodiment the container is filled with silicone rubber gels of varying density with the stifiest most viscous gel filling the outer portion of the container and the less viscous gels forming the next layers and center portion being filled with the softest material.

A 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 Electrics ViscasiP and an appropriate resin recommended for this use is General Electric's elastomeric resin TRV6l5. 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 RzSiOz groups, RzSiO groups and Si0z groups where R represents methyl groups. The ratio of the groups one to the other determines the consistency of the gel. Cross linking of the resin may be: done by means of an addition type reaction or by exposure to radiation. After mixing the resin and fluid the combination may be injected into the prosthetic container 10 and heated to initiate crosslinking (vulcanization) of the resin. Heating time and temperature may be varied over a wide range from several days at room temperature to 10 minutes at over 300 F. The gel consistency may be adjusted by any or all of the following steps:

l by altering the proportion of' the various chemical groups in the resin;

2. by altering the resin/fluid ratio;

3. by varying the viscosity of the fluid used;

4. by varying the radiation dosage.

It is desirable to fill the container before placing the prosthesis in the body. However this is not always convenient. In the illustrated prosthesis, the outer two layers l5, 16 are formed in the container prior to placing the prosthesis in the human body. There are many suitable techniques for filling the container well known in the synthetic material art. For example, the outer section of the container 10 is lined with an outer or more viscous layer 15 of gel which is allowed to set before the inner or second less viscous layer 16 is placed in the container. As the gels cure" they are vulcanized to the inside of the container and adjacent layers of gel to form an integral unit. Any desired number of layers of gel may be used to form the prosthesis. The final portion of the container may be filled with a quantity of gel 18 after the prosthesis has been planted in the body. This may be done in any number of suitable ways such as through the use of a hypodermic needle inserted through the layers of gel into the center section of the container. The gel is then forced into the container in a sufficient quantity to give the breast the desired size and configuration. After the container has been filled the ends of the stem are folded over and sealed by suitable means. The stem is then positioned underneath the prosthesis and the flesh sewed over the prosthesis.

To provide a smooth contour of the skin over the prosthesis, the edge of the container where the front and back portions are joined is provided with a narrow rim 22 around its entire periphery. This rim is solid rubber but is tapered to a very fine edge at the outer periphery so as to blend in with the body. When skin is drawn over the prosthesis it forms a smooth continuous surface and the juncture of the prosthesis and the body cannot be noticed except upon close scrutiny.

A suitable porous material 24 is connected to the back 11 of the container and attached to the body to anchor the prosthesis in place. The material is porous to allow human tissue to grow in and around the material to securely anchor the prosthesis to the chest wall. A suitable material for this purpose is a fabric of polyester fibers commonly sold under the trademark Dacron. The fabric is preferably corrugated and is affixed to the back section of the prosthesis by suitable glue that will not be absorbed or destroyed by the body cells.

As shown in the drawings, the fabric material 24 extends across the top and more than half way around the periphery leaving only the bottom edge unattached to the chest wall. in this way the fabric provides a more uniform support for the prosthesis so that it does not tend to become disfigured or pull away from the chest wall due to constant weight of the gel in the unsupported prosthesis. The porous material or fabric extends to the outer edge 25 of the rim 22 of the container 10 so as to anchor the tip of the container rim to the chest wall without forming a fold or ridge at the junction between the prosthesis and the body.

lclaim:

l. A surgically implantable breast prosthesis com prising,

a flexible container formed from a surgically implantable material and having an outer shape approximating that of the human breast,

a solid rim tapered outwardly to a fine edge provided around the outer periphery of said container,

a silicone gel filling the inside of the container,

said gel being more viscous around the outer periphery than in the center ofsaid container,

and a tissue permeable strip attached to the back of the container to provide for tissue ingrowth.

2. The prosthesis according to claim 1 wherein said container is formed from an organopolysiloxane polycarbonate.

3. The prosthesis according to claim 1 wherein said strip is formed from a polyester fabric.

4. The prosthesis according to claim 1 wherein said silicone gel includes a liner of viscous gel around the outer section of said container and a less viscous gel provided inwardly of said liner of viscous gel.

5. The prosthesis according to claim 4 wherein said liner of said viscous gel is vulcanized to said container and to said less viscous gel.

6. A surgically implantable breast prosthesis comprising,

a container formed from an organopolysiloxane polycarbonate and having an outer shape approximating that of the human breast,

a solid rim tapered outwardly to a fine edge provided around the outer periphery of said container,

a silicone gel filling the inside of the container,

said gel being more viscous around the outer periphery than in the center of said container,

and a fabric strip attached to the back of said rim to provide for tissue ingrowth.

7. The breast prosthesis according to claim 6 wherein said silicone gel includes a liner of viscous gel around the outer section of said container and a less viscous gel r d in (ll of i liner of viscous el. p i 'fi ie bre a s i pOStl l S i S according to cl im 7 wherein said liner of said viscous gel is vulcanized to said container and to said less viscous gel.

Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US2636182 *Aug 23, 1951Apr 28, 1953Ruth FreedmanArtificial body bulge
US3293663 *Aug 12, 1963Dec 27, 1966Dow CorningSurgically implantable human breast prosthesis
FR1085676A * Title not available
FR1506272A * Title not available
Non-Patent Citations
Reference
1 * Mammaplasty Utilizing a Silastic Implant, The Bulletin of the Dow Corning Center for Aid to Medical Research, Vol. 10, No. 2, April 1968, Midland, Mich., page 7.
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US4100627 *Dec 29, 1976Jul 18, 1978Dow Corning CorporationLow oiling gel filled flexible articles and gels therefor
US4134218 *Oct 11, 1977Jan 16, 1979Adams Calvin KBreast cancer detection training system
US4205401 *May 25, 1978Jun 3, 1980Dow Corning CorporationMammary prosthesis which resists capsular contracture
US4298998 *Dec 8, 1980Nov 10, 1981Naficy Sadeque SBreast prosthesis with biologically absorbable outer container
US4380569 *Aug 3, 1981Apr 19, 1983Spenco Medical CorporationGlass microspheres, vinyl polysiloxane, hydrogen polysiloxane, prosthetics
US4558112 *Jun 5, 1981Dec 10, 1985Boehringer Mannheim CorporationProsthesis;hydrosilation
US4562598 *Apr 1, 1982Jan 7, 1986Mecron Medizinische Produkte GmbhJoint prosthesis
US4648880 *Aug 30, 1984Mar 10, 1987Daniel BraumanImplantable prosthetic devices
US4650487 *Oct 6, 1981Mar 17, 1987Memorial Hospital For Cancer And Allied DiseasesMulti-lumen high profile mammary implant
US4651717 *Apr 4, 1985Mar 24, 1987Dow Corning CorporationMultiple envelope tissue expander device
US4740208 *Sep 27, 1985Apr 26, 1988Cavon Joseph FCast gel implantable prosthesis
US4773909 *Dec 9, 1986Sep 27, 1988Memorial Hospital For Cancer And Allied DiseasesMulti-lumen high profile mammary implant
US4787905 *Jul 24, 1987Nov 29, 1988Nearly MeCured polyurethane, ester plasticized
US4820303 *Nov 28, 1986Apr 11, 1989Daniel BraumanOuter plastic covering of expanded ptfe and bonded to flexible container
US5236454 *Nov 4, 1991Aug 17, 1993Miller Archibald SStacked breast implant
US5376117 *Nov 13, 1992Dec 27, 1994Corvita CorporationBreast prostheses
US5407445 *May 19, 1993Apr 18, 1995Cytrx CorporationGel composition for implant prosthesis and method of use
US6136028 *Nov 17, 1998Oct 24, 2000F + E Gesellschaft fur Bekleidungsinnovation mbH & Co., KGBreast prosthesis worn in a brassiere or the like
US6692527 *Dec 1, 1999Feb 17, 2004Howard T. BellinNon-rotating breast implant
US7105116Jun 16, 2003Sep 12, 2006Howard T. BellinNon-rotating breast implant
US7128761 *Dec 10, 2003Oct 31, 2006Axiomed Spine CorporationMethod and apparatus for replacing a damaged spinal disc
US7575596Feb 21, 2002Aug 18, 2009Amoena Medizin-Orthopädie-Technik GmbHTwo-layer external breast prosthesis with self-shaping feature and process for the manufacture thereof
US7988731Apr 24, 2006Aug 2, 2011G & G Biotechnology LtdLightweight implantable prosthetic device
US8070808Oct 25, 2006Dec 6, 2011Allergan, Inc.Variable cohesive gel form-stable breast implant
US8562388 *Dec 23, 2009Oct 22, 2013La Vie En RoseMastectomy prosthesis and bra
US20110153016 *Dec 23, 2009Jun 23, 2011La Vie En RoseMastectomy prosthesis and bra
US20120143328 *Nov 3, 2011Jun 7, 2012Allergan, Inc.Variable cohesive gel form-stable breast implant
DE2857496C2 *Oct 11, 1978Feb 11, 1988Calvin Kelly AdamsTitle not available
EP0412703A1 *Jul 31, 1990Feb 13, 1991Bristol-Myers Squibb CompanySelf-sealing tissue expander and method
EP2286761A1 *Oct 25, 2006Feb 23, 2011Allergan, Inc.Variable cohesive gel form-stable breast implant
WO2007050693A1Oct 25, 2006May 3, 2007Allergan IncVariable cohesive gel form-stable breast implant
Classifications
U.S. Classification623/8
International ClassificationA61F2/12
Cooperative ClassificationA61F2/12
European ClassificationA61F2/12