|Publication number||USRE40487 E1|
|Application number||US 10/194,853|
|Publication date||Sep 9, 2008|
|Filing date||Jul 11, 2002|
|Priority date||Oct 6, 1998|
|Also published as||US6086801|
|Publication number||10194853, 194853, US RE40487 E1, US RE40487E1, US-E1-RE40487, USRE40487 E1, USRE40487E1|
|Inventors||L. Daniel Eaton|
|Original Assignee||Board Of Trustees Of The University Of Arkansas|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (20), Classifications (25), Legal Events (2)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The present invention relates to a method for forming a breast prosthesis, and in particular to a method for forming a breast prosthesis that has a precisely uniform surface thickness and is shaped to mirror the existing breast when held in a brassiere. To form the mold for the prosthesis, a plastic sheet is formed into the shape of the natural breast. Once molds are made using this plastic sheet, the breast prosthesis outer surface may be formed within the molds. This outer surface is then turned inside out to form the outer surface for a breast prosthesis that is the mirror image of the natural breast.
The purpose of the disclosed invention is to create a comfortable, natural-appearing breast prosthesis for a patient that has lost one of her natural breasts. Typically the natural breast is lost as a result of a mastectomy procedure, although this invention may be utilized regardless of the reason the patient requires the prosthesis. A breast prosthesis should ideally mirror the size, shape, and texture of the remaining natural breast as closely as possible. In this way the patient's goal of appearing to have two natural breasts is most nearly achieved. Since the breast prosthesis is generally only worn while the patient is wearing a brassiere or other support garment, the shape of the breast prosthesis should mirror the shape of the patient's remaining natural breast while that breast is supported.
Other methods for forming a breast prosthesis shaped to mirror an existing natural breast are known in the art. U.S. Pat. No. 2,580,264 to Wright, et al. discloses a method of producing a mold for an artificial breast by turning a mold taken from the existing breast inside out. In the Wright, et al. process, a plaster of Paris mold is taken of the existing breast. A coating of quick-drying liquid latex rubber is then applied inside the plaster of Paris mold. When dried, the latex rubber forms a flexible casing that may be removed from the plaster of Paris mold. The latex rubber casing is turned inside out to form a mold for the artificial breast that will be a mirror image of the existing breast.
U.S. Pat. No. 5,527,359 to Nakamura et al. also discloses a method of producing a mold for an artificial breast by turning a mold taken from the existing breast inside out. In the Nakamura et al. process, a model of the existing breast is formed using aluminum foil. The aluminum model is then filled with plaster to form a positive model of the existing breast. The positive model is then coated with aluminum foil reinforced by thin adhesive taping. The aluminum foil/adhesive taping complex is then turned inside out to form a negative model of the artificial breast.
Other methods are also known for forming a breast prosthesis in the shape of a breast held in place by a support garment. U.S. Pat. No. 4,086,666 to Vaskys et al. discloses a method for forming a breast prosthesis in the shape of a supported breast. In addition to using a cast made of the patient's chest while not wearing a brassiere, a cast is also made of the patient's chest while wearing a brassiere. The negative cast is simply formed over the brassiere itself. A sculptor then uses the positive cast of the supported breast/brassiere combination to help visualize the appearance of the supported breast. Alternatively, Vaskys et al. discloses that measurements may be made of the patient's remaining natural breast while the patient is wearing a brassiere to assist the sculptor in forming a prosthesis in the shape of a supported breast.
U.S. Pat. No. 4,600,551 to Erb discloses a method for producing a breast prosthesis that is symmetrical to the shape of the remaining natural breast while that breast is held in a zero-gravity state. After a molding material is applied to the natural breast, the patient is immersed in a liquid that is of a density essentially equivalent to the density of the natural breast. The mold then cures while the breast is suspended in the liquid. The process thus results in a prosthesis that does not require the artistic interpretation of a sculptor to remove the effects of gravitational stress. However, Erb discloses that the shape of the breast in a zero-gravity state does not strictly conform to the shape of the breast while supported in a brassiere.
Erb also discloses a method of forming a breast prosthesis using a mold formed from a breast supported by a half-brassiere. The half-brassiere is taped to the patient's chest wall and a mold material is formed over the natural breast and brassiere. This approach results in a mold that reflects not the texture of the natural breast only, but also the texture of the brassiere and supporting tape, and thus requires the use of a sculptor in forming the prosthesis.
The prior art methods of forming a breast prosthesis each have a number of disadvantages. First, some of these methods require a human sculptor to form molds for the prosthesis from models. The addition of a sculptor greatly increases the cost and time required for the production of a breast prosthesis. In addition, a human is inherently incapable of exactly reproducing the shape of the existing natural breast in mirror-image form to create a precisely accurate mirror-image prosthesis. Instead, a human must rely on his or her artistic abilities, which inevitably introduces some error into the process.
Another disadvantage of the prior art methods is that the exterior surface of the resulting breast prosthesis will not be of uniform thickness. Simply pouring or painting a curable material onto a smooth surface will result in a cured material that is smooth on only the side that is in contact with the smooth surface. The other side of the cured material will inevitably be wavy, resulting in a cured material of nonuniform thickness. The thickness and consistency of the prosthesis surface is critical for several reasons. First, a material that has thin spots may tend to “balloon” at the thin points, resulting in a misshapen prosthesis. On the other hand, a material that is too thick will result in a prosthesis that does not feel to the touch like a natural breast. Finally, a prosthesis that has an exterior surface of nonuniform thickness will not be as nearly symmetrical with the remaining natural breast as would otherwise be possible using a consistently flat exterior surface material.
Still another disadvantage of the prior art methods for forming a breast prosthesis is the inability to form an accurate image of a breast held in a brassiere or other support garment. This shape is preferred by patients because the prosthesis will typically be worn only while the patient is wearing a support garment. Since a natural breast necessarily sags somewhat due to gravity, a prosthesis formed in the shapes of a natural breast will not be symmetrical to the remaining natural breast when a support garment is worn. The Erb method of forming a breast prosthesis while the natural breast is suspended in a controlled-density liquid is awkward, expensive, and would likely cause considerable embarrassment to the patient who must enter this liquid while her upper body is exposed. Moreover, the Erb disclosure indicates that the shape of a breast in this zero-gravity state does not correspond to the shape of a breast held in a supported garment, so the resulting prosthesis would still not mirror the patient's remaining natural breast. The other method disclosed by Erb, that of forming a mold over the patient's remaining natural breast while wearing a half-brassiere, requires additional work by an artist to remove the effects of the brassiere on the mold, which would increase the cost and time required to construct the prosthesis.
The present invention is a method for forming a breast prosthesis that is a mirror image of the remaining natural breast while overcoming the limitations of prior art methods. The method begins with a computerized scan of the chest of the patient. This scan is performed while the patient's natural breast is supported. This computerized scan results in a three-dimensional image file stored on a computer storage medium. The image file may be transmitted to a remote facility for the production of the prosthetic breast.
At the production facility, the image of the remaining natural breast is employed by a computer-controlled milling machine to form an image of the natural breast. The material from which the breast shape is milled may be either a hard resin or a softer material. If a soft material is used, it is typically necessary to take an impression of the milled breast shape which is then cast in a hard resin to form a positive image of the remaining natural breast.
The positive cast is then placed in a vacuum molding machine where a thin sheet of plastic is heated and vacuum formed to the shape of the cast. The plastic sheet is of a precisely measured and consistent thickness. After the vacuum-forming operation is complete, the thin plastic sheet is then in the form of the patient's natural breast.
The plastic sheet is then used to form a two-piece plaster mold. One piece of this mold will be a positive model of the patient's natural breast; the positive model will fit into the other piece forming a negative model of the patient's breast. A curable material such as Silastic is then injected between the two pieces of the mold to form the outer surface of the breast prosthesis. The Silastic outer surface is then turned inside out to form the prosthesis outer surface, which will thus have a shape that is the mirror image of the patient's breast. The resulting breast prosthesis exterior will be of uniform thickness and will feel to the touch quite similar to a natural breast.
This process results in a number of advantages over the prior art methods. First, no human sculptor is needed at any stage of the disclosed method. This removes inaccuracies due to the sculptor's artistic interpretation, and results in a prosthesis that is a precise mirror image of the patient's natural breast. Moreover, the cost and delay involved with the use of a sculptor are eliminated.
Another advantage is that the disclosed method allows the production of a breast prosthesis having a surface with a precisely controlled thickness and uniformity. This eliminates problems with ballooning, and allows the production of a prosthesis that feels to the touch as much like a natural breast as possible.
Also, the disclosed method allows the production of a prosthesis that mirrors the precise shape of the patient's natural breast while held in a support garment. Thus the prosthesis will appear as natural as possible during the patient's daily activities.
It is therefore an object of the present invention to provide for a breast prosthesis that is the precise mirror image of an existing natural breast.
It is a further object of the present invention to provide for a breast prosthesis that has an exterior surface of a precise and consistent thickness.
It is also an object of the present invention to provide a breast prosthesis that is in the shape of a natural breast supported by a brassiere or other support garment.
These and other objects and advantages of the present invention will be apparent from a consideration of the following detailed description of the preferred embodiments in conjunction with the appended drawings as described following.
With reference to
To form a three-dimensional image of the patient's breast, the patient is positioned so that the scanning device's camera will move in an arc around the patient's breast. The patient is fitted with a support garment during the scanning operation so that the resulting prosthesis will mirror the patient's natural breast while similarly supported; preferably this support garment would be a brassiere that is cut away so that only half of the cup remains beneath the patient's breast. A three-dimensional image of the patient's supported breast is then formed from the images taken as the camera moves around the patient's breast. Because the support garment only covers the lower portion of the patient's breast, the resulting image will only be minimally affected by the presence of the support garment. Any irregularities in the image of the patient's breast as a result of the support garment may be smoothed away using appropriate image-processing software, as is well known in the art.
The three-dimensional image file is stored on a computer storage medium, such as magnetic disks or a CD-ROM. Since the image file is stored in a digital format, it may be quickly and easily transferred to a remote production facility either by modem or by the shipment of a computer diskette, CD-ROM, or other electronic storage medium containing the image file. In addition, this image may be maintained on file so that should the patient need an additional or replacement prosthesis mold produced, the patient will not be required to undergo the scanning process again.
At the production facility, the image of the natural breast is employed by a computer-controlled milling machine to cut a three-dimensional form in the shape of the natural breast. The material from which the breast-shaped form is milled is preferably a hard resin. If a soft material is used, it is necessary to take an impression of the milled breast-shaped form which is then cast in harder material to form a positive image of the breast. In either case, the result of this process is breast positive mold 10, as shown in FIG. 1. Mold base 12 is preferably formed as an integral support for breast positive mold 10.
Referring now to
To form plastic sheet 14 into the shape shown in
Plastic sheet 14 is next used to form a two-piece plaster mold, consisting of positive prosthesis mold 16 and negative prosthesis mold 18, as shown in FIG. 3. Positive prosthesis mold 16 is formed by pouring a hard-curing plaster material into the cup formed by plastic sheet 14 and allowing the material to cure. Positive prosthesis mold 16 thus forms a model of the patient's natural breast. Negative prosthesis mold 18 is formed by pouring the hard-curing plaster material into a cylindrical container (not shown) and then pressing plastic sheet 14 into the plaster material while prosthesis mold 16 is still within plastic sheet 14. Once negative prosthesis mold 18 dries, it will form a negative model of the patient's natural breast, although it will of course be slightly larger than the patient's natural breast due to the thickness of plastic sheet 14.
A soft, curable material is then used to form prosthesis surface 20 as shown in FIG. 4. SILASTIC, a room temperature, vulcanizable silicone product that is widely available and is manufactured by Dow Corning, has been found to be effective for forming prosthesis surface 20. In one method of forming prosthesis surface 20, SILASTIC is poured into negative prosthesis mold 18, and then positive prosthesis mold 16 is placed within negative prosthesis mold 18. Alternatively, Silastic could be injected between positive prosthesis mold 16 and negative prosthesis mold 18. The resulting breast prosthesis surface 20 will be of uniform thickness, mimicking the thickness and shape of plastic sheet 14.
Once prosthesis surface 20 is dry, it may be removed from the mold and turned inside out as shown in FIG. 5. Once prosthesis surface 20 is turned inside out, it forms a shape that is the precise mirror image of the patient's natural breast. Prosthesis surface 20 can then be trimmed for a smooth edge by removing flashing 22. To form the complete prosthesis, the prosthesis surface 20 may be filled with a gel material, and a rear portion (not shown) can be attached in a conventional manner to finish the prosthesis.
In an alternative embodiment of the invention, plastic sheet 14 may be turned inside out before positive prosthesis mold 16 and negative prosthesis mold 18 are formed. In this embodiment, positive prosthesis mold 16 would be a model of the mirror image of the patient's natural breast rather than a model of the breast itself. It would be unnecessary to turn prosthesis surface 20 inside out after it is formed since it would already be in the shape of the mirror image of the patient's natural breast.
The present invention has been described with reference to certain preferred and alternative embodiments which are intended to be exemplary only and not limiting to the full scope of the present invention as set forth in the appended claims.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US2508156 *||May 20, 1948||May 16, 1950||Gillman Harry||Method of making artificial hands and replicas of other objects|
|US2580264 *||Nov 23, 1949||Dec 25, 1951||Mildred A Wright||Method of forming artificial breasts|
|US3021569 *||Jan 11, 1957||Feb 20, 1962||Lyman Joseph||Methods and means for making molded plastic articles|
|US3065511 *||Nov 16, 1959||Nov 27, 1962||Pacific Pulp Molding Co||Method of making a pattern for a die|
|US3688676 *||Jun 22, 1970||Sep 5, 1972||John S Cruickshank||Photo recording assembly|
|US3751540 *||Aug 19, 1971||Aug 7, 1973||Compo Ind Inc||Method of making a mold for reproducing parts of shoes and the like|
|US4086666 *||Apr 30, 1976||May 2, 1978||Petras Vaskys||Breast prosthesis|
|US4364880 *||Jan 16, 1981||Dec 21, 1982||Howse Jeanette W||Method for making a breast prosthesis|
|US4401492 *||Jul 6, 1982||Aug 30, 1983||Pfrommer Arthur M||Breast prosthesis and method of making the same|
|US4600551 *||May 21, 1984||Jul 15, 1986||Erb Robert A||Method for producing breast prostheses and supports|
|US4661187 *||Apr 3, 1985||Apr 28, 1987||Beasley Robert W||Method of making life-like prosthetic devices|
|US4676795 *||Oct 8, 1985||Jun 30, 1987||S+G Implants Gmbh||Prosthesis as replacement for an amputated breast|
|US4735754 *||Aug 18, 1986||Apr 5, 1988||Horst Buckner||Method for fabricating artificial body parts|
|US5108686 *||Mar 15, 1991||Apr 28, 1992||Griffin Joyce B||Method of replicating a human nipple for use as a nursing device|
|US5169578 *||Sep 19, 1990||Dec 8, 1992||Ngk Insulators, Inc.||Method for producing and method of using slip casting mold|
|US5527359 *||Mar 7, 1995||Jun 18, 1996||Nakamura Brace Co., Ltd.||Method of making positive and negative models for artificial breasts|
|US5798062||May 5, 1997||Aug 25, 1998||Thielbar; Janice Marie||Method of making a custom formed natural fit artificial breast appliance|
|US5824075||May 28, 1997||Oct 20, 1998||Thielbar; Janice Marie||Custom formed natural fit artificial breast appliance|
|US6006412 *||Jul 10, 1997||Dec 28, 1999||Bergmann Orthotic Lab, Inc.||Method for preparing an orthotic appliance|
|US6136027||Oct 22, 1997||Oct 24, 2000||Otto Bock U.S., Inc.||Custom prosthetic devices and methods of fabricating them using visible reverse imaging|
|U.S. Classification||264/40.1, 264/227, 623/8, 264/225, 264/554, 623/7, 264/222, 623/901|
|International Classification||B29C39/02, A61F2/52, A61F2/50, B29C51/10, B29C33/38|
|Cooperative Classification||Y10S623/901, A61F2002/5047, B29C2791/006, B29L2031/7532, B29C51/10, B29C33/3857, A61F2/52, B29C2791/001, B29C39/02, A61F2002/5053|
|European Classification||A61F2/52, B29C39/02|
|Feb 20, 2012||REMI||Maintenance fee reminder mailed|
|Jul 11, 2012||LAPS||Lapse for failure to pay maintenance fees|