CA2301445A1 - An external breast prosthesis - Google Patents
An external breast prosthesis Download PDFInfo
- Publication number
- CA2301445A1 CA2301445A1 CA 2301445 CA2301445A CA2301445A1 CA 2301445 A1 CA2301445 A1 CA 2301445A1 CA 2301445 CA2301445 CA 2301445 CA 2301445 A CA2301445 A CA 2301445A CA 2301445 A1 CA2301445 A1 CA 2301445A1
- Authority
- CA
- Canada
- Prior art keywords
- membrane
- tube
- shell
- front membrane
- plug
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2/52—Mammary prostheses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2002/5016—Prostheses not implantable in the body adjustable
- A61F2002/503—Prostheses not implantable in the body adjustable for adjusting elasticity, flexibility, spring rate or mechanical tension
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2002/5016—Prostheses not implantable in the body adjustable
- A61F2002/5032—Prostheses not implantable in the body adjustable for adjusting fluid pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2/52—Mammary prostheses
- A61F2002/523—Multiple breast forms made of several concentric breast-shaped layers nested into one another
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2/52—Mammary prostheses
- A61F2002/526—Nipples
Abstract
An external breast prosthesis comprised of a thin, resilient shell with a front membrane formed and toned as a human breast and incorporating an areola and nipple of appropriate dimensions and tone and a back membrane compliable with the chest wall and the shell sealably containing a liquid or gel having a consistency and mass approximating that of human breast tissue. The prosthesis includes a discretely located, non protruding, self-sealing plug seal for addition and removal of the liquid or gel. In a preferred embodiment the areola with nipple is bonded to the surface of the front membrane and the remaining portion of the front membrane is closely covered with a protective layer of lightweight, skin toned fabric. The back membrane includes an embedded layer of similar fabric for added strength. The preferred embodiment may be fabricated on a mandrel using, readily available materials.
Description
U1/L5/UU r'H1 1N:40 r'A~ HUZ 484 ;1570 1S1LLAM LIBtLAIiY DUC: Uk~LY t~JUU4 FI~,1. ~~~
ThG invention pertains to the field of prosthefiic devices and, specifically, to an external liquid filled breast prosthesis that can be fabricated wish readily available mabarials and that includes a simple plug seal means for addition and s removal of filler substance by the wearer.
ExLemas breast prostheses, as in Canadian Patents CA 1327870, ~A
to 2269482 US Pat. No. 5,798,()62, arc most commonly comprised of a two part plastic film outer shell simulatinga on oae side, the shape of a human breast and rnY the other side the surface of tix chest wall. The two parts of the shall are fhsed together at a eomt'~o~a p~'ipl'~eral edge so as to enclose a silicone gal filler and the assembly is oared at high temperature and pressure. 'fkte fabricating process for 1 s these types of prostheses calls for specialized equipment and does not lend itself to "cottage industry" type pmducfiion. A low technology method for producing silicone rubber shell membranes is described in 'CJS Pat. No. 5,527,359, but even this approach is considered more complicated than necessary for production of generic liquid filled breast prostheses. Furt~ore, the above Patent's 20 prescription for embedded fabric to strengthen the breast form portion of the shell is considered an unaccepfiable compromise in texture and resiliency. There is also no simple means for addition or rednoval of filler substance by fha wearer, as may be desired to tailor the firmness or mass of the prosthesis to the wearer's individual requirernmts. Seal means for a prosthesis shall that permits a liquid UGlL5/UO r'itl 18:40 b'AX 8UY 484 J57U H1LLAM LlBt(AftY DU(: ~)LY ~JUU5 or gel filler to be added end removed have been developed primarily for internal breast prostheses, as in US Pat. No. 4,253,201, 4,441,492, 4,775,379, 5,456,716 and 5,019,101 and for other prosthetic devioes, such as US Pat. No. 3,883,902 and 3,600,71$ but theso seal means are considered u~ocessarily complex for an external breast prosthesis where seal failure does ~Qt pose ~. potential health risk.
The present invention pertains to a simple, natural feeling, liquid fillod breast prosthesis that can be fabricated using corumonly available equipment and materials and chat includes a discretely located, easy to fahricafie and easily operated, plug seal far addition and removal of filler substance as desired.
ThG prest~t invention pertains to a liquid filled external breast prosthesis comprised of a resilient membrane shell which incorporates a. simplo plug seal, means for addition end removal of liquid or gel filler. in a preforrc.~
embodiment the front tnembarane of the shell is fabricated of silicone rubber applied in paste form to the surface of a mandrel and to which an areola, with nipple, fabricated similarly in a cavity mold, is bonded. The remaining outer surface of the front membrane is covered with a protective layer of lightweight, skin towed fabric.
A
recess in the mandrel accommodates a short rubber tube which is incorporated into the shell such that its outer end is #lush with the outer surface of the shell.
The peripheral edge of the t'uat~'el is bevelled to provide, i~t co~ju~uotion with a removable under plate, a mold for a flanged mating surface extending inwardly from the poriphet-al odgo of tho front membrane. The back membrane is fabricated separately of silicone rubber. impregnated vith lightweight fabric for U2/G5/UU r'H1 18:47 r'A~ 8UG 484 ;157H lilLLAb1 L1BHAltY DUG U~LV ~JUUt3 added strength, and is bonded to part of the fr4nt membrane mating surface and to the seal tube before the shell is removed from tha mandrel. Tlte rest of the bond is completed following removal from the mandrel. The removable plug consists of a solid cylinder that is set in the tube with one end flush with the exterior and of the cube and the other end bearing an enlarged head portion that extends beryond t$e ulterior end of the tube such as to prevent the plug from being rejected froial thG tube under the relatively Low internal prGSSUres generated in. the wearing of the prothesis. 'fhe flexibility of the shell permits the plug to be removed by applying forco 'd~rou~ fhe m'~brane to the head sufficient to push the head into the tube, thus allowing the exposed end of tho plug to be captured and withdrawn.
io The iavartion will now be described with reference to the following drawings in which:
Figure 1 shows a perspective view of an external breast prosthesis of the present irrveaiion;.
Figure 2 shows a side to side vertical section of the ex~nal breast prosthesis in the preferred embodiment through the centre of the rapple and plug coal means.
24 Figura 3 shows a longitudinal section of an altemafie ambodimarrt of the plug of tha plug seal means.
Figure 4 shows a vertical section of a mandrel that may be used to fashion the prosthesis outer membrane.
Figure 5 shows a vertical section, of the prosthesis in the region of the plug U2/L5/UU r7t1 18:47 r'A~ 8UL 484 ;f5713 ltILLAM L1BKA.KY DUG Uk~LV ~JUU7 seal means and illustrates how a fiuget raay be used to initiate removal of the plug.
The orientation of components is presenbcd herein with referoncc to att installed prosthesis of the prcsent invention. With reference to Figures 1 and the irrventi4n consists of a brcast prosthesis 1 comprised of a thin, flexible shell sealably enclosing a lumetl 25 and a removable plug scal means 30 for addition and removal of a fillar substanoe.
l0 In the preferred embodiment the shell 10 is comprised of a front membrane 11, formed in the shape of a human breast, and consisting of a. thin $lm of flexible, resilient material, such as silicone rubber, and a generally planar book membrane 20 of a similarly characterized material. 'The front membrane 11 is characterized in having a peripheral edge 12 that generally corresponds to the region where the hraast and chcst wall mcct. The front membrane 11 extends outward angularly from the chest wall from the edgy 12 aad terminates in a gern~e, compound curved surface. With reference to Figure 2 file edge 12 includes an inwardly dir'ect'ed flange 13 bearitrg a flat surface 14 ilaat is generally coplanar 2o with the bank mombrana 20. A thin, pliable areola disc 15, catxesponding in dimension and bone to a breast stools is appropriately located and bonded to the exterior surface of the front membrane l I . 'I'he ce~ral region of the areola disc I S projects outwardly in the form of a nipple I b. The remaining exterior surface of the fiont membrane 11 is preferably enclosed in a closely complying Iayer of UG/L5/UU r'H1 1H:47 r'AX HUG 4H4 J57B H1LLAM L1BHAHY DU(: I)~LV ~JUU~i elastic, skin tonal fabric 17 bonded directly to the front mombrano in a nanaw strip 1$ bordering, the edge 12 and at least in a second nan~ow strip 19 bordering the areola disc 15. The thickness of the fabric 17 closely CQlTeSpOndS to the thickness of the areola disc 15 such as to provide a smooth transition between the areola disc 15 and the fabric 17.
The back membrane 20 of the shell 10 is preferably comprised of a layer of light fabric 21 sandwiched between two tlrin layers of flexible, resilient material, such as silicone rubber, and is sealably bonded on its front surface to the flat sur,~ace X 4 of th$ flange 13 .
The plug seal means 34 is comprised of a short tube 31, fabricated of flexible, resilient material, such as silicone rubber, and is cut generally normal to its major axis at ~eriar end 32 and ax interior end 33 and is set in the front membrane 11 with its maj or axis generally normal to the exG~rior surface of the front membrane 11 in the region of the edge 12 such that the tube 31 passes through the front membrane 11 with the outer surface of the tube 31 proximal to the i~rtenior surface of mombrane 20 such that the channel 34 com~.utxicates between the lumen 25 and the exterior enviraaarlen~t of the prosthesis 1. The tube 31 is bonded to the font membrane 11 and back mambrano 20 at all contact 2U surfaces so as to soalably ineorporat a the tube 31 into the structure of the prosthesis atMl limit its ~oadom of movement to that of the back membrane 20.
The tube 31 contains a plug 35 comprised of a cylindrical solid shaft 36, of equal or slightly larger diameter and length to the channel 34. The plug 35 is generally squat'ed at ono end and includes a head 37 of larger diameter than the shaft 36 at U'tIG5IUU b'lil 18:4Ei b'A~l 8UL 484 ;f57B ltlLLAdi LlBt~AltY DUG UlLV ~JUUH
the opposite end. The plug 35 is set in the tube 31 with the head 37 adjacent to the interior end 33 of the tuba 31 and the squarcd end gencrally coincident with the exterior end 32 of the tube 31 so as not to project appreciably beyond the exterior surface of ~e lx ant mombrar~e 11. The edges of the ),~e~d 37 are bevelled such that it may be forced tl~caugh tire tube froth either direction. The diameter 3 of the head 37 is sufl'xcient to prevent it from being forced out of the tube under the relatively low internal pressures generated in riotxnal usage of the gtosthosis.
In an alternate embodiment, p'igure 3, the exposed end of the shaft 36 may bear a barrow ridge 38 to facilitate anal removal.
~tNAND. OPERATION OF THE INVENTION
The prosthesis of the present ixxvo~tiol~, can be fabricated by convcntional industrial means. p'or Gxarnple, the front membrane 11, with incorporated areola and tipple, can bt inflection molded and bonded a$erward to the back membrane 20. ~at'e simply, a9 in Figure 4, the front membrane 11 may be fabricated scparatoly by applying rubber paste onto the surface of a breast shaped mandrel 40 having a bevelled edge 41 and a recess 42 to closely accomraodate the Vibe 31.
A. removable flat molding surface 50 is applied against the undersurface of the mandrel 40 so as to define the flat surface 14 of the flange X3 wherx the nubbcr Zo paste is forced into the area of the bevelled edge 41. The areola disc 15 can be similarly fabricated on a cavity mould a~ bonded oato the front rncmbrano 11 afterward, followed by the f~bx'io 17, while the rubber is still on the mandrel 40.
The areola disc 15 may be fabricated of appropriately toned rubber or of clear rubber bonded to a lightweight, appropriately toned fabric. Ths back membrane UL/G5/UU r'H1 18:48 b'A11 8UY 484 ;f57H H1LLAM L1BHAHY UUt; UlLV ~RJUlU
20 can be fabricated separately a as sheet then bolded to a portion of the $ange 13 before removal ofthe front membrano 11 from the mandrel. The rema~der of the fxatxt to back membrane bond earl be completed afterward and excess back melnbrarra triulmGd off In tho preferrai embodiment the liquid filler consists of a mixfu~ of hypaallergenio mineral oil, white petroleum jelly and com starch in s ratios that closely simulate tile density of breast tissue while providing a white base tone for $le overlying skin toned fabric 17, hut any biocompatable liquid dr gel mixture that is also compatible with the tnat~erial of the prosthesis shell 10 may be used. With the shell 10 charged as desiorod and all air purged the plug 35 is inserted into the tube 31, head 37 end first, until tho head 3? passes the interior end 33 of the channel 34. With rofororlce to Figure 5, the glug 35 can be removed by applying force with a finger or blunt tool to the back membrane 20 adjacent the head 37 to force the shaft 3fr out of the tube 31 sufficiently to permit the shaft 36 to be captured attd withdraw with finger tips or as instrument such as a small pair of pliers.
While the overate invention has been described in conjunction wi$1 the embodiments thereof it is evident plat many atte.tives, modifications aad variations will be appareirt to those skilled in the art in light of the foregoing description. Accordingly, it is intendod to embrace all such alternafi'rvcs, nnodifications and variations as f~l within tllo spirit and broad scope of the appended claims.
ThG invention pertains to the field of prosthefiic devices and, specifically, to an external liquid filled breast prosthesis that can be fabricated wish readily available mabarials and that includes a simple plug seal means for addition and s removal of filler substance by the wearer.
ExLemas breast prostheses, as in Canadian Patents CA 1327870, ~A
to 2269482 US Pat. No. 5,798,()62, arc most commonly comprised of a two part plastic film outer shell simulatinga on oae side, the shape of a human breast and rnY the other side the surface of tix chest wall. The two parts of the shall are fhsed together at a eomt'~o~a p~'ipl'~eral edge so as to enclose a silicone gal filler and the assembly is oared at high temperature and pressure. 'fkte fabricating process for 1 s these types of prostheses calls for specialized equipment and does not lend itself to "cottage industry" type pmducfiion. A low technology method for producing silicone rubber shell membranes is described in 'CJS Pat. No. 5,527,359, but even this approach is considered more complicated than necessary for production of generic liquid filled breast prostheses. Furt~ore, the above Patent's 20 prescription for embedded fabric to strengthen the breast form portion of the shell is considered an unaccepfiable compromise in texture and resiliency. There is also no simple means for addition or rednoval of filler substance by fha wearer, as may be desired to tailor the firmness or mass of the prosthesis to the wearer's individual requirernmts. Seal means for a prosthesis shall that permits a liquid UGlL5/UO r'itl 18:40 b'AX 8UY 484 J57U H1LLAM LlBt(AftY DU(: ~)LY ~JUU5 or gel filler to be added end removed have been developed primarily for internal breast prostheses, as in US Pat. No. 4,253,201, 4,441,492, 4,775,379, 5,456,716 and 5,019,101 and for other prosthetic devioes, such as US Pat. No. 3,883,902 and 3,600,71$ but theso seal means are considered u~ocessarily complex for an external breast prosthesis where seal failure does ~Qt pose ~. potential health risk.
The present invention pertains to a simple, natural feeling, liquid fillod breast prosthesis that can be fabricated using corumonly available equipment and materials and chat includes a discretely located, easy to fahricafie and easily operated, plug seal far addition and removal of filler substance as desired.
ThG prest~t invention pertains to a liquid filled external breast prosthesis comprised of a resilient membrane shell which incorporates a. simplo plug seal, means for addition end removal of liquid or gel filler. in a preforrc.~
embodiment the front tnembarane of the shell is fabricated of silicone rubber applied in paste form to the surface of a mandrel and to which an areola, with nipple, fabricated similarly in a cavity mold, is bonded. The remaining outer surface of the front membrane is covered with a protective layer of lightweight, skin towed fabric.
A
recess in the mandrel accommodates a short rubber tube which is incorporated into the shell such that its outer end is #lush with the outer surface of the shell.
The peripheral edge of the t'uat~'el is bevelled to provide, i~t co~ju~uotion with a removable under plate, a mold for a flanged mating surface extending inwardly from the poriphet-al odgo of tho front membrane. The back membrane is fabricated separately of silicone rubber. impregnated vith lightweight fabric for U2/G5/UU r'H1 18:47 r'A~ 8UG 484 ;157H lilLLAb1 L1BHAltY DUG U~LV ~JUUt3 added strength, and is bonded to part of the fr4nt membrane mating surface and to the seal tube before the shell is removed from tha mandrel. Tlte rest of the bond is completed following removal from the mandrel. The removable plug consists of a solid cylinder that is set in the tube with one end flush with the exterior and of the cube and the other end bearing an enlarged head portion that extends beryond t$e ulterior end of the tube such as to prevent the plug from being rejected froial thG tube under the relatively Low internal prGSSUres generated in. the wearing of the prothesis. 'fhe flexibility of the shell permits the plug to be removed by applying forco 'd~rou~ fhe m'~brane to the head sufficient to push the head into the tube, thus allowing the exposed end of tho plug to be captured and withdrawn.
io The iavartion will now be described with reference to the following drawings in which:
Figure 1 shows a perspective view of an external breast prosthesis of the present irrveaiion;.
Figure 2 shows a side to side vertical section of the ex~nal breast prosthesis in the preferred embodiment through the centre of the rapple and plug coal means.
24 Figura 3 shows a longitudinal section of an altemafie ambodimarrt of the plug of tha plug seal means.
Figure 4 shows a vertical section of a mandrel that may be used to fashion the prosthesis outer membrane.
Figure 5 shows a vertical section, of the prosthesis in the region of the plug U2/L5/UU r7t1 18:47 r'A~ 8UL 484 ;f5713 ltILLAM L1BKA.KY DUG Uk~LV ~JUU7 seal means and illustrates how a fiuget raay be used to initiate removal of the plug.
The orientation of components is presenbcd herein with referoncc to att installed prosthesis of the prcsent invention. With reference to Figures 1 and the irrventi4n consists of a brcast prosthesis 1 comprised of a thin, flexible shell sealably enclosing a lumetl 25 and a removable plug scal means 30 for addition and removal of a fillar substanoe.
l0 In the preferred embodiment the shell 10 is comprised of a front membrane 11, formed in the shape of a human breast, and consisting of a. thin $lm of flexible, resilient material, such as silicone rubber, and a generally planar book membrane 20 of a similarly characterized material. 'The front membrane 11 is characterized in having a peripheral edge 12 that generally corresponds to the region where the hraast and chcst wall mcct. The front membrane 11 extends outward angularly from the chest wall from the edgy 12 aad terminates in a gern~e, compound curved surface. With reference to Figure 2 file edge 12 includes an inwardly dir'ect'ed flange 13 bearitrg a flat surface 14 ilaat is generally coplanar 2o with the bank mombrana 20. A thin, pliable areola disc 15, catxesponding in dimension and bone to a breast stools is appropriately located and bonded to the exterior surface of the front membrane l I . 'I'he ce~ral region of the areola disc I S projects outwardly in the form of a nipple I b. The remaining exterior surface of the fiont membrane 11 is preferably enclosed in a closely complying Iayer of UG/L5/UU r'H1 1H:47 r'AX HUG 4H4 J57B H1LLAM L1BHAHY DU(: I)~LV ~JUU~i elastic, skin tonal fabric 17 bonded directly to the front mombrano in a nanaw strip 1$ bordering, the edge 12 and at least in a second nan~ow strip 19 bordering the areola disc 15. The thickness of the fabric 17 closely CQlTeSpOndS to the thickness of the areola disc 15 such as to provide a smooth transition between the areola disc 15 and the fabric 17.
The back membrane 20 of the shell 10 is preferably comprised of a layer of light fabric 21 sandwiched between two tlrin layers of flexible, resilient material, such as silicone rubber, and is sealably bonded on its front surface to the flat sur,~ace X 4 of th$ flange 13 .
The plug seal means 34 is comprised of a short tube 31, fabricated of flexible, resilient material, such as silicone rubber, and is cut generally normal to its major axis at ~eriar end 32 and ax interior end 33 and is set in the front membrane 11 with its maj or axis generally normal to the exG~rior surface of the front membrane 11 in the region of the edge 12 such that the tube 31 passes through the front membrane 11 with the outer surface of the tube 31 proximal to the i~rtenior surface of mombrane 20 such that the channel 34 com~.utxicates between the lumen 25 and the exterior enviraaarlen~t of the prosthesis 1. The tube 31 is bonded to the font membrane 11 and back mambrano 20 at all contact 2U surfaces so as to soalably ineorporat a the tube 31 into the structure of the prosthesis atMl limit its ~oadom of movement to that of the back membrane 20.
The tube 31 contains a plug 35 comprised of a cylindrical solid shaft 36, of equal or slightly larger diameter and length to the channel 34. The plug 35 is generally squat'ed at ono end and includes a head 37 of larger diameter than the shaft 36 at U'tIG5IUU b'lil 18:4Ei b'A~l 8UL 484 ;f57B ltlLLAdi LlBt~AltY DUG UlLV ~JUUH
the opposite end. The plug 35 is set in the tube 31 with the head 37 adjacent to the interior end 33 of the tuba 31 and the squarcd end gencrally coincident with the exterior end 32 of the tube 31 so as not to project appreciably beyond the exterior surface of ~e lx ant mombrar~e 11. The edges of the ),~e~d 37 are bevelled such that it may be forced tl~caugh tire tube froth either direction. The diameter 3 of the head 37 is sufl'xcient to prevent it from being forced out of the tube under the relatively low internal pressures generated in riotxnal usage of the gtosthosis.
In an alternate embodiment, p'igure 3, the exposed end of the shaft 36 may bear a barrow ridge 38 to facilitate anal removal.
~tNAND. OPERATION OF THE INVENTION
The prosthesis of the present ixxvo~tiol~, can be fabricated by convcntional industrial means. p'or Gxarnple, the front membrane 11, with incorporated areola and tipple, can bt inflection molded and bonded a$erward to the back membrane 20. ~at'e simply, a9 in Figure 4, the front membrane 11 may be fabricated scparatoly by applying rubber paste onto the surface of a breast shaped mandrel 40 having a bevelled edge 41 and a recess 42 to closely accomraodate the Vibe 31.
A. removable flat molding surface 50 is applied against the undersurface of the mandrel 40 so as to define the flat surface 14 of the flange X3 wherx the nubbcr Zo paste is forced into the area of the bevelled edge 41. The areola disc 15 can be similarly fabricated on a cavity mould a~ bonded oato the front rncmbrano 11 afterward, followed by the f~bx'io 17, while the rubber is still on the mandrel 40.
The areola disc 15 may be fabricated of appropriately toned rubber or of clear rubber bonded to a lightweight, appropriately toned fabric. Ths back membrane UL/G5/UU r'H1 18:48 b'A11 8UY 484 ;f57H H1LLAM L1BHAHY UUt; UlLV ~RJUlU
20 can be fabricated separately a as sheet then bolded to a portion of the $ange 13 before removal ofthe front membrano 11 from the mandrel. The rema~der of the fxatxt to back membrane bond earl be completed afterward and excess back melnbrarra triulmGd off In tho preferrai embodiment the liquid filler consists of a mixfu~ of hypaallergenio mineral oil, white petroleum jelly and com starch in s ratios that closely simulate tile density of breast tissue while providing a white base tone for $le overlying skin toned fabric 17, hut any biocompatable liquid dr gel mixture that is also compatible with the tnat~erial of the prosthesis shell 10 may be used. With the shell 10 charged as desiorod and all air purged the plug 35 is inserted into the tube 31, head 37 end first, until tho head 3? passes the interior end 33 of the channel 34. With rofororlce to Figure 5, the glug 35 can be removed by applying force with a finger or blunt tool to the back membrane 20 adjacent the head 37 to force the shaft 3fr out of the tube 31 sufficiently to permit the shaft 36 to be captured attd withdraw with finger tips or as instrument such as a small pair of pliers.
While the overate invention has been described in conjunction wi$1 the embodiments thereof it is evident plat many atte.tives, modifications aad variations will be appareirt to those skilled in the art in light of the foregoing description. Accordingly, it is intendod to embrace all such alternafi'rvcs, nnodifications and variations as f~l within tllo spirit and broad scope of the appended claims.
Claims (5)
1. A breast prosthesis consisting of an outer shell comprised of a front membrane shaped in the form of a human breast sealably attached to or continuous with a back membrane which conforms to the chest of the wearer and a lumen enclosed by the shell and chargeable with a liquid or gel and seal means for addition and removal of said liquid or gel.
2. The front membrane of claim 1 having an inwardly directed flange along its edge, said flange having a flat surface in the plane of the back membrane for sealably mating said front membrane to said back membrane.
3. The front membrane of claim 1 including a simulated areola with centrally located raised nipple and being of natural tone.
4. The front membrane of claim 1 having a simulated areola with included nipple bonded to the outer surface of said front membrane and with the remaining said outer surface being covered with a closely compliant layer of lightweight appropriately toned fabric.
5. The seal means of claim 1 being comprised of a resilient tube member set into and with its channel axis generally normal to the outer surface of said shell and continuing inwardly therefrom and said channel communicating between the environ of said prosthesis and said lumen and said tube member supporting a plug member comprised of a solid cylindrical shaft of diameter equal to or greater than the diameter of said channel and having an expanded cylindrical head member extending inwardly beyond the innermost end of said tube, said head member being of sufficient diameter to resist expulsion of the said plug from said tube under the pressures established in the lumen during normal usage, but said head member having sufficiently small diameter to permit said plug to be inserted and removed by passing said head member through said tube.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA 2301445 CA2301445A1 (en) | 2000-02-25 | 2000-02-25 | An external breast prosthesis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA 2301445 CA2301445A1 (en) | 2000-02-25 | 2000-02-25 | An external breast prosthesis |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2301445A1 true CA2301445A1 (en) | 2001-08-25 |
Family
ID=4165590
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2301445 Abandoned CA2301445A1 (en) | 2000-02-25 | 2000-02-25 | An external breast prosthesis |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2301445A1 (en) |
Cited By (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005120402A1 (en) * | 2004-06-10 | 2005-12-22 | Vermeylen Jan, Burgerlijke Vennootschap Onder De Rechtsvorm Van Besloten Vennootschap Met Beperkte Aansprakelijkheid | Accessory to determine the required size of a breast prosthesis to be provided |
| WO2005122972A1 (en) * | 2004-06-17 | 2005-12-29 | Leyerer Roland B | Breast prosthesis |
| US8790400B2 (en) * | 2012-06-13 | 2014-07-29 | Elwha Llc | Breast implant with covering and analyte sensors responsive to external power source |
| US8795359B2 (en) * | 2012-06-13 | 2014-08-05 | Elwha Llc | Breast implant with regionalized analyte sensors and internal power source |
| US9144489B2 (en) | 2012-06-13 | 2015-09-29 | Elwha Llc | Breast implant with covering, analyte sensors and internal power source |
| US9144488B2 (en) | 2012-06-13 | 2015-09-29 | Elwha Llc | Breast implant with analyte sensors responsive to external power source |
| US9211185B2 (en) | 2012-06-13 | 2015-12-15 | Elwha Llc | Breast implant with analyte sensors and internal power source |
| US9339372B2 (en) | 2012-06-13 | 2016-05-17 | Elwha Llc | Breast implant with regionalized analyte sensors responsive to external power source |
| DE102016003448A1 (en) * | 2016-03-21 | 2017-09-21 | Amoena Medizin-Orthopädie-Technik GmbH | Breast prosthesis with plug for filling channel |
| CN111035484A (en) * | 2019-12-23 | 2020-04-21 | 南京市妇幼保健院 | Artificial breast |
| CN112107421A (en) * | 2019-06-20 | 2020-12-22 | 杨国煌 | Fluid-carrying applicator |
| US20220062008A1 (en) * | 2019-01-10 | 2022-03-03 | Amoena Medizin-Orthopädie-Technik GmbH | Volume-adaptable breast prosthesis |
| US20220079779A1 (en) * | 2019-01-10 | 2022-03-17 | Amoena Medizin-Orthopädie-Technik GmbH | Volume-adaptable breast prosthesis |
-
2000
- 2000-02-25 CA CA 2301445 patent/CA2301445A1/en not_active Abandoned
Cited By (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005120402A1 (en) * | 2004-06-10 | 2005-12-22 | Vermeylen Jan, Burgerlijke Vennootschap Onder De Rechtsvorm Van Besloten Vennootschap Met Beperkte Aansprakelijkheid | Accessory to determine the required size of a breast prosthesis to be provided |
| BE1016070A3 (en) * | 2004-06-10 | 2006-02-07 | Jan Vermeylen Plastisch Chirug | ACCESSORIES FOR DETERMINING THE DESIRED SIZE OF A BREAST PROSTESE TO BE FITTED. |
| WO2005122972A1 (en) * | 2004-06-17 | 2005-12-29 | Leyerer Roland B | Breast prosthesis |
| US9339372B2 (en) | 2012-06-13 | 2016-05-17 | Elwha Llc | Breast implant with regionalized analyte sensors responsive to external power source |
| US8795359B2 (en) * | 2012-06-13 | 2014-08-05 | Elwha Llc | Breast implant with regionalized analyte sensors and internal power source |
| US9144489B2 (en) | 2012-06-13 | 2015-09-29 | Elwha Llc | Breast implant with covering, analyte sensors and internal power source |
| US9144488B2 (en) | 2012-06-13 | 2015-09-29 | Elwha Llc | Breast implant with analyte sensors responsive to external power source |
| US9211185B2 (en) | 2012-06-13 | 2015-12-15 | Elwha Llc | Breast implant with analyte sensors and internal power source |
| US9326730B2 (en) | 2012-06-13 | 2016-05-03 | Elwha Llc | Breast implant with covering and analyte sensors responsive to external power source |
| US9333071B2 (en) | 2012-06-13 | 2016-05-10 | Elwha Llc | Breast implant with regionalized analyte sensors and internal power source |
| US8790400B2 (en) * | 2012-06-13 | 2014-07-29 | Elwha Llc | Breast implant with covering and analyte sensors responsive to external power source |
| US10034743B2 (en) | 2012-06-13 | 2018-07-31 | Elwha Llc | Breast implant with analyte sensors responsive to external power source |
| EP3222254A1 (en) * | 2016-03-21 | 2017-09-27 | Amoena Medizin-Orthopädie-Technik GmbH | Breast prosthesis with closing plug for filling channel |
| CN107212952A (en) * | 2016-03-21 | 2017-09-29 | 爱蒙娜医药整形技术有限责任公司 | Breast prosthesis with the closing block for filling channel |
| DE102016003448A1 (en) * | 2016-03-21 | 2017-09-21 | Amoena Medizin-Orthopädie-Technik GmbH | Breast prosthesis with plug for filling channel |
| US20220062008A1 (en) * | 2019-01-10 | 2022-03-03 | Amoena Medizin-Orthopädie-Technik GmbH | Volume-adaptable breast prosthesis |
| US20220079779A1 (en) * | 2019-01-10 | 2022-03-17 | Amoena Medizin-Orthopädie-Technik GmbH | Volume-adaptable breast prosthesis |
| CN112107421A (en) * | 2019-06-20 | 2020-12-22 | 杨国煌 | Fluid-carrying applicator |
| WO2020253702A1 (en) * | 2019-06-20 | 2020-12-24 | 杨国煌 | Fluid-carrying application |
| US11357657B2 (en) | 2019-06-20 | 2022-06-14 | Kuo Huang YANG | Fluid-carrying application |
| CN111035484A (en) * | 2019-12-23 | 2020-04-21 | 南京市妇幼保健院 | Artificial breast |
| CN111035484B (en) * | 2019-12-23 | 2023-02-17 | 南京市妇幼保健院 | Artificial breast |
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