WO1994016650A1 - Fixation d'une prothese du sein ou mammaire sur une surface thoracique - Google Patents

Fixation d'une prothese du sein ou mammaire sur une surface thoracique Download PDF

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Publication number
WO1994016650A1
WO1994016650A1 PCT/DK1994/000047 DK9400047W WO9416650A1 WO 1994016650 A1 WO1994016650 A1 WO 1994016650A1 DK 9400047 W DK9400047 W DK 9400047W WO 9416650 A1 WO9416650 A1 WO 9416650A1
Authority
WO
WIPO (PCT)
Prior art keywords
adhesive
breast prosthesis
bur
adhesive strip
fixation means
Prior art date
Application number
PCT/DK1994/000047
Other languages
English (en)
Inventor
Ole Jensen
Original Assignee
Euromed I/S
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Euromed I/S filed Critical Euromed I/S
Publication of WO1994016650A1 publication Critical patent/WO1994016650A1/fr

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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
    • A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
    • A61F2002/7806—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump using adhesive means
    • 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
    • A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
    • A61F2002/7881—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump using hook and loop-type fasteners

Definitions

  • the present invention relates to novel techniques of fixating a breast prosthesis or mammary prosthesis to a thoracic surface.
  • a breast prosthesis assembly comprising a separate adhesive strip or adhesive patch and a breast prosthesis body which is fixated to the adhesive strip or adhesive patch by means of releasable fixation means, such as a bur or velcro fixation, is highly advantageous as the adhesive strip or the adhesive patch may be kept in place for a prolonged period of time, such as several days, e.g. a week, allowing that the breast prosthesis body is removed when the user is e.g. sleeping, resting, bathing or showering, still keeping the adhesive strip or adhesive patch adhered to the thoracic surface.
  • a major skin irritation and discomfort situation occurs as the adhesive strip or the adhesive patch is removed.
  • the fixation of the thoracic body through the adhesive strip or the adhesive patch may in some instances cause certain troubles and discomfort to the user as the releasable fixation may in some instances fail as the weight of the breast prosthesis body may in some instances peel off the adhesive strip or the adhesive patch causing an overall removal of the adhesive strip or the adhesive patch and consequently an overall removal of the breast or mammary prosthesis assembly comprising the breast or mammary prosthesis body and the adhesive strip or the adhesive patch from the thoracic surface of the user.
  • the prior art breast or mammary prosthesis assemblies of the above described type are suffering from a permanent risk that the adhesive strip or the adhesive patch to which the breast or mammary prosthesis body is fixated may be peeled off through the weight of the breast or mammary prosthesis body.
  • An object of the present invention is to provide an adhesive strip assembly and an adhesive patch assembly for the fixation of a breast or mammary prosthesis body to a thoracic surface of a user which adhesive strip assembly or which adhesive patch assembly reduces, or to any sub ⁇ stantial extent eliminates the risk that the adhesive strip assembly or the adhesive patch assembly is peeled off from the adhesion to the tho ⁇ racic surface by the weight of the breast or mammary prosthesis body.
  • a further object of the present invention is to reduce, or to any substantial extent eliminate the risk that perspiration at the surface of contact between the breast or mammary prosthesis body and the thora ⁇ cic surface to which the breast or mammary prosthesis body is fixated may jeopardize the adhesion of the adhesive fixation of the breast or mammary prosthesis body.
  • a particular feature of the present invention relates to the fact that the force generated by the weight of the breast or mammary prosthe ⁇ sis body which in the prior art adhesive strip or adhesive patch assem ⁇ bly may result in a peeling off of the adhesive strip or adhesive patch assembly is transferred from a peeling off generating force perpendicu ⁇ lar to the thoracic surface to which the adhesive strip or adhesive patch assembly is adhered, into a shear force parallel to the surface of adhesion of the adhesive strip or adhesive patch assembly to the thora ⁇ cic surface of the user.
  • a particular advantage of the present invention relates to elimina ⁇ tion of discomfort of the user originating from perspiration at the tho ⁇ racic surface of the user to which thoracic surface the breast or mammary prosthesis body is adhered.
  • an adhesive patch assembly for fixating a breast prosthesis to a thoracic skin sur ⁇ face, comprising: an adhesive patch of a configuration corresponding to a part of a surface of contact of said breast prosthesis at said thoracic skin sur ⁇ face, said adhesive patch defining an outer rim and opposite first and second surfaces, said first surface being provided with an adhesive lay ⁇ er and being adapted to be arranged in contact with said thoracic skin surface for adhering thereto, and fixation means for releasably fixating said breast prosthesis to said adhesive patch so as to fixate said breast prosthesis to said tho ⁇ racic skin surface, said fixation means being arranged at said second surface of said adhesive patch covering a part of said second surface thereof and providing an uncovered circumferential surface segment of said second surface adjacent to said outer rim of said adhesive patch.
  • a circumferential surface segment of the second surface of the adhesive strip or adhesive patch adjacent to the outer rim of the adhesive strip or adhesive patch is provided which is adhered to the thoracic skin sur ⁇ face.
  • the circumferential surface segment of the adhesive strip or the adhesive patch causes a transfer of the force generated by the weight of the breast or mammary prosthesis body from a force orientated perpendi- cularly to the thoracic surface to which the adhesive strip or the adhe ⁇ sive patch is adhered, which force might cause a peeling off of the ad ⁇ hesive strip or the adhesive patch along the outer rim of the adhesive strip or the adhesive patch, into a shear force which is orientated pa- rallel to the thoracic surface to which the adhesive patch or the adhe ⁇ sive strip is adhered, which shear force is further transferred to the overall area of adhesion of the circumferential surface segment instead of to a peeling off along the outer rim of the adhesive strip or the adhesive patch.
  • the fixation means are fixated to the adhesive strip or the adhesive patch at the second sur- face thereof through an adhesive foil, as the fixation means are not readily fixatable to the adhesive strip.
  • the adhesive strip or the adhesive patch is made from e.g. a hydrocolloid material
  • the fixation means are constituted by an adhesive foil or a bur fix ⁇ ation means
  • a direct contact between the adhesive strip or the adhesive patch made from the hydrocolloid material and the fixation means may not provide a strong and lasting bond and fixation.
  • the adhesive foil may in some instances be constituted by an adhesive layer, or alterna ⁇ tively be constituted by an adhesive foil comprising a support foil pro ⁇ vided with an adhesive layer on one or both side surfaces.
  • the adhesive strip assembly or the adhesive patch assembly is preferably provided with a release pa ⁇ per sheet covering the first surface of the adhesive strip or the adhe ⁇ sive patch prior to the use of the assembly in question.
  • the fixation means of the adhesive strip assembly and the adhesive patch assembly according to the first and the second aspect, respective ⁇ ly, of the present invention may be constituted by an adhesive layer which is providing a sufficiently strong bonding to the breast prosthe ⁇ sis for fixating the breast prosthesis to the adhesive layer provided at the second surface of the adhesive strip or the adhesive patch.
  • the fixation means are constituted by bur fixation means adapted to cooperate with mating bur fixation means of the breast prosthesis.
  • the bur fixation means of the adhesive strip assembly and the adhesive patch assembly may be provided by a bur tape applied to the second side of the adhesive strip and the adhesive patch of the adhesive strip assembly and the adhesive patch assembly, respectively.
  • the bur fixation means of the adhesive strip assembly and the adhesive patch as ⁇ sembly according to the first and the second aspect, respectively, of the present invention may comprise bur loops or alternatively comprise bur hooks.
  • the uncovered surface segment of the second surface of the adhesive strip and the adhesive patch of the adhesive strip assembly and the ad ⁇ hesive patch assembly, respectively, characteristic of the present in ⁇ vention, may be constituted by a surface segment of the bur tape not be ⁇ ing provided with bur fixation means, which surface segment constitutes the force transfer surface segment for transferring a force orientated perpendicularly to the thoracic skin surface to which the adhesive strip assembly or the adhesive patch assembly is adhered, into a shear force parallel to the thoracic skin surface.
  • the adhesive strip or the adhesive patch of the adhesive strip as ⁇ sembly and the adhesive patch assembly, respectively, may be constituted by any minimum-skin-irritating adhesive material, such as a hydrocolloid material.
  • hydrocolloid materials are described in EP patent application No. 0017401, GB patent application No. 7909967 and further in US patents No. 3,339,546, 4,253,460, 4,258,715, 4,306,551, and 4,307,717.
  • the hydrocolloid adhesive layer may constitute the adhesive strip or the adhesive patch of the adhesive strip assembly or the adhesive patch assembly, respectively, or constitute a layer supported by a sup- port foil, such as a foil made from a plastic material.
  • the fixation means which are preferably constituted by bur fixation means may be fix ⁇ ated directly to the hydrocolloid adhesive layer or through an adhesive foil, such as a glue layer, or to a support foil supporting the hydro ⁇ colloid layer.
  • a breast prosthesis assembly comprising: a breast prosthesis body of a configuration similar to a woman's natural breast and defining a surface of contact to be arranged adjacent to said thoracic skin surface, said adhesive strip assembly comprising: an adhesive strip of a substantially curved configuration corre ⁇ sponding to a part of a circumferential part of said surface of contact of said breast prosthesis body, said adhesive strip defining an outer rim and opposite first and second surfaces, said first surface being provided with an adhesive layer and being adapted to be arranged in con ⁇ tact with said thoracic skin surface for adhering thereto, and fixation means for releasably fixating said breast prosthesis to said adhesive strip so as to fixate said breast prosthesis to said tho ⁇ racic skin surface, said fixation means being arranged at said second surface of said adhesive strip covering a part of said second surface thereof and providing an uncovered circumferential surface segment of said second surface adjacent to said outer rim of said adhesive strip.
  • a breast prosthesis assembly comprising: a breast prosthesis body of a configuration similar to a woman's natural breast and defining a surface of contact to be arranged adjacent to said thoracic skin surface, said adhesive patch assembly comprising: an adhesive patch of a configuration corresponding to a part of said surface of contact of said breast prosthesis body, said adhesive patch defining an outer rim and opposite first and second surfaces, said first surface being provided with an adhesive layer and being adapted to be arranged in contact with said thoracic skin surface for adhering thereto, and fixation means for releasably fixating said breast prosthesis to said adhesive patch so as to fixate said breast prosthesis to said tho ⁇ racic skin surface, said fixation means being arranged at said second surface of said adhesive patch covering a part of said second surface thereof and providing an uncovered surface segment of said second sur ⁇ face adjacent to said outer rim of said adhesive patch.
  • the breast prosthesis assemblies according to the third and fourth aspects of the present invention may comprise any of the characteristics of the adhesive strip assembly and the adhesive patch assembly according to the first and the second aspect, respectively, of the present inven ⁇ tion.
  • a breast prosthesis comprising: a breast prosthesis body of a configuration similar to a woman's natural breast and defining a surface of contact to be arranged adjacent to said thoracic skin surface, and a bur fixation means provided at said surface of said breast prosthesis body for fixating a perspiration pad to said surface.
  • the breast prosthesis according to the fifth aspect of the present invention is particularly advantageous as to the elimination of discom ⁇ fort of the user originating from perspiration at the thoracic surface of the user, to which thoracic surface the breast or mammary prosthesis body is adhered.
  • a perspiration pad which is fixated to the surface of contact of the breast prosthesis body according to the fifth aspect of the present invention, the risk that the adhesion of the breast prosthesis body to the thoracic skin surface, preferably through an adhesive strip assembly or an adhesive patch assembly according to the first and the second aspect, respectively, of the present invention, is reduced or ruined through excessive perspiration at the thoracic skin surface to which the breast prosthesis is adhered.
  • the breast prosthesis assembly according to the fifth aspect of the present invention is pre- ferably constituted by a breast prosthesis body comprising an outer PU foil enclosing a silicone filling thereof.
  • Fig. 1 is a perspective, partly sectional and schematic view of an adhesive strip assembly of a breast or mammary prosthesis
  • Figs. 2 and 3 are schematic and sectional views illustrating a technique of preparing a rim part of the adhesive strip assembly shown in Fig. 1,
  • Fig. 4 is a schematic and sectional view of the application of the adhesive strip assembly shown in Fig. 1 for fixating a breast prosthesis illustrating a particular feature regarding the fixation of the breast prosthesis,
  • Fig. 5 is a schematic and sectional view similar to the view of Fig. 4 illustrating a prior art adhesive strip assembly and a disadvan- tage of the prior art adhesive strip assembly,
  • Fig. 6 is a perspective, partly sectional and schematic view simi ⁇ lar to the view of Fig. 1 of an adhesive patch assembly of a breast or mammary prosthesis
  • Fig. 7 is a perspective view of a breast prosthesis to be used in connection with the adhesive strip assembly shown in Figs. 1 and 4, and further comprising a means for receiving and detachably fixating a per ⁇ spiration ebsorbing pad.
  • an adhesive strip assembly designated the reference nu ⁇ meral 10 in its entirety is shown.
  • the adhesive strip assembly 10 is of a configuration generally comprising two larger adhesive strip segments 11a and lib which are integrally connected to one another at first ends thereof in a substantially orthogonal structure and further two minor adhesive strip segments lie and lid which are integrally connected to a respective larger adhesive strip segment 11a and lib, respectively, at second ends thereof in substantially orthogonal structures.
  • the adhesive strip assembly 10 is of an overall configuration corresponding to a lar ⁇ ger part, such as a 270° segment of a circumferential surface of contact of a breast prosthesis.
  • the adhesive strip assembly 10 centrally comprises a hydrocolloid adhesive body 12 provided with shallow rim segments 14 and 16 extending along inner and outer rims 13 and 15, respectively, of the adhesive strip assembly 10 and enclosing a central, thicker part of the hydro- colloid adhesive body 12.
  • an adhesive foil 18 is arranged, which adhesive foil is provided with an adhesive layer for the fixation of a bur tape 20.
  • the bur tape 20 is of the type comprising bur loops or hooks for cooperating with a corresponding bur tape of a breast or mam- ary prosthesis comprising bur hooks or loops, respectively.
  • the hydrocolloid body 12 is opposite to the adhesive foil 18 pro ⁇ vided with a siliconized release paper 26 serving the purpose of pro ⁇ tecting the hydrocolloid adhesive body prior to use of the adhesive strip assembly 10. From the siliconized release paper 26, a flap 28 ex ⁇ tends outwardly from the adhesive strip assembly 10, which flap 28 serves the purpose of making the process of removing the siliconized re ⁇ lease paper 26 from the adhesive strip assembly easier.
  • a hydrocolloid adhesive layer 32, an adhesive foil layer 34 and a bur tape layer 36 are ar- ranged.
  • the hydrocolloid adhesive layer, the adhesive foil layer 32, and the bur tape layer 34 originate from the hydrocolloid adhesive body 12, the adhesive foil 18 and the bur tape 20, respectively, and are sepa ⁇ rated therefrom by a cut 30 which is produced at the stage of cutting the adhesive strip assembly 10 from a sandwich of layers from which the adhesive strip assembly 10 is produced.
  • the adhesive strip assemb ⁇ ly 10 is produced from a sandwich of layers comprising a siliconized re ⁇ lease paper layer from which the siliconized release paper 26 comprising the flap 28 is produced, a hydrocolloid adhesive layer from which the hydrocolloid adhesive body 12 and the hydrocolloid adhesive layer 30 are produced, an adhesive foil layer from which the adhesive foil 18 and the adhesive foil layer 32 are produced, and further a bur tape layer from which the bur tape 20 and the bur tape layer 34 are produced.
  • the layers 32, 34, and 36 are preferably separated from the hydrocolloid adhesive body 12, the adhesive foil 18 and the bur tape 20 in the very same pro ⁇ cess of cutting the adhesive strip assembly from the above described sandwich of layers or alternatively in a separate process.
  • the rim segments 22 and 24 of the bur tape 20 may be prefabricated prior to the process of cutting the adhesive strip assembly 10 from the above described sandwich as the bur tape 20 may be produced in a confi ⁇ guration in which only the central part of the bur tape is provided with bur loops and in which the rim segments 22 and 24 are not provided with any bur loops.
  • the rim segments 22 and 24 may be produced after the assembly, comprising the siliconized release paper 26, the hy- drocolloid adhesive body 12, the adhesive foil 18, and the bur tape 20 has been produced as is disclosed in Fig.
  • the bur tape 20 is shown in greater details, comprising a support foil 42 from which the loops of the bur tape 20 extend.
  • the reference nu ⁇ merals 44 and 46 define loops of the bur tape 20 provided at the thicker part of the hydrocolloid body 12 and at the rim segment 14 thereof, re ⁇ spectively.
  • the adhesive strip assembly 10 is shown in its inten- tional application for fixating a breast prosthesis, designated the re ⁇ ference numeral 60 in its entirety, to a skin surface part of a woman's thorax.
  • the breast prosthesis 60 is provided with a bur tape component comprising bur hooks 62 adapted to cooperate with the bur loops 44 of the central part of the bur tape 20 of the adhesive strip assembly 10.
  • the hydrocolloid adhesive body 12 is, as is evident from Fig. 4, fixated to a skin surface part 64 and the bur hooks 62 of the breast prosthesis 60 are fixated to the bur loops 44.
  • the force As the weight of the breast prosthe ⁇ sis 60 generates a force which is transferred to the hydrocolloid adhe- sive body 12, the force generates a deformation of the subcutaneous area 66 under the skin surface part 64 as the hydrocolloid adhesive body 12 is maintained in facial and adhesive contact with the skin surface part 64 due to the rim segment 14 of the hydrocolloid adhesive body 12 which rim segment circumferentially encloses the entire site of application and fixation of the breast prosthesis 60 relative to the skin surface part.
  • Fig. 5 illustrates a peeling-off effect originating as the weight of the breast prosthesis 60 is transmitted to the hydrocolloid adhesive body 12 of the assembly 10' and causes a peeling off of the hydrocolloid adhesive body 12 from the skin surface part 64 along the outer rim of the hydrocolloid adhesive body 12.
  • the peeling-off effect is, as is disclosed in Fig.
  • FIG. 4 and 5 are vertical sectional views illustrating the upper rim of the hydrocolloid adhesive body 12. A similar peeling-off effect may occur at the inner rim segment 14 of the hydrocolloid adhesive body 12 of the adhesive strip assembly 10' shown in Fig. 5.
  • rim segments 22 and 24 of the bur tape 20, which rim segments are not adhered or fixated to the breast prosthesis 60 eliminates to any substantial extent the possibility that the adhesive strip assembly 10 for fixating the breast prosthesis 60 is peeled off along the outer rim of the adhesive strip assembly 10 as the rim segments 14 and 16 of the hydrocolloid adhesive body 12 are exposed to forces originating from the weight of the breast prosthesis, gene ⁇ rating a force impact substantially along the surface of the skin sur ⁇ face part 64 to which the rim segments 14 and 16 adhere, rather than perpendicularly to the skin surface part 64.
  • the adhesive patch assembly 80 is of an overall configuration corresponding to a surface of contact of a breast prosthesis and basically serves the very same purpose as the ad ⁇ hesive strip assembly 10 described above with reference to Figs. 1 and 4.
  • the adhesive patch assembly 80 comprises a hydrocolloid adhesive body 82 provided with a shallow outer rim segment 84 extending along an outer rim 83 of the adhesive patch assembly 80 and enclosing a central, thick ⁇ er part of the hydrocolloid adhesive body 82.
  • an adhesive foil 88 is arranged which adhesive foil is provided with an adhesive layer for the fixation of a bur tape 90.
  • the hydrocolloid adhesive body 82, the adhesive foil 88, and the bur tape 90 correspond to and serve the same purposes as the hydro ⁇ colloid adhesive body 12, the adhesive foil 18, and the bur tape, re- spectively, of the adhesive strip assembly 10 described above.
  • the bur tape 90 is provided with bur loops, one of which is designated the reference numeral 94, and which are pro ⁇ vided at the central area of the bur tape 90, as the bur tape 90 is not provided with bur loops at the outer rim segment 92 of the bur tape 90 corresponding to the outer rim segment 84 of the hydrocolloid adhesive body 82.
  • the hydrocolloid body 82 is opposite to the adhesive foil 88 pro ⁇ vided with a siliconized release paper 86 serving the same purpose as the siliconized release paper 26 of the adhesive strip assembly 10 de ⁇ scribed above.
  • the adhesive patch assembly 80 is, like the adhesive strip assembly 10 described above, made from a sandwich of layers from which the siliconized release paper 86, the hydrocolloid adhesive body 82, the adhesive foil 88, and the bur tape 90 are produced, and the adhesive patch assembly 90 further comprises the gripping flap 28 together with the hydrocolloid adhesive layer 32, the adhesive foil layer 34, and the bur tape layer 36 described above with reference to Fig. 10.
  • the circumferential rim segment 92 of the bur tape 90 which circumferential rim segment is not provided with bur loops, may be produced in accordance with the technique described above with reference to Figs. 2 or 3 or, alternatively, the bur tape 90 may be prefabricated prior to the process of cutting the adhesive patch assembly 90 from the above described sandwich in a configuration in which only the central part of the bur tape 90 is provided with bur loops and in which the outer rim segment 92 is not provided with any bur loops.
  • the breast prosthesis 60 is shown in greater details.
  • the prosthesis 60 is provided with bur tape fixation strip segments 68a, 68b, 68c, 68d, and 68e, provided with the bur hooks 62, which strip segments together define a configuration similar to the configuration of the adhesive strip assembly 10.
  • an additional bur fixation 70 is provided, serving the purpose of fixating a perspiration pad 72 to the surface of the breast prosthesis 60 which surface is arranged adjacent to the skin surface part of the woman's thorax.
  • the breast prosthesis 60 is made from a silicone-containing PU foil which is impermeable to humidity.
  • the PU foil of the breast prosthesis 60 may cause increased perspiration which apart from discomfort to the woman in question may cause a reduction of the adhesion of the adhesive strip assembly by means of which the breast prosthesis 60 is fixated to the woman's skin surface part.
  • the present invention has been described above with refe- rence to a specific preferred embodiment of the adhesive strip assembly and further the beast prosthesis, numerous modifications and amendments are readily perceivable to a person having ordinary skill in the art within the protective scope as defined in the appending claims.
  • fixation of the breast prosthesis has been described com- prising bur tape fixation, alternative releasable fixations, such as re ⁇ leasable adhesive fixation may be applied.
  • the breast prosthesis may e.g.
  • an adhesive foil which is initially fix ⁇ ated to the adhesive strip assembly which is fixated to the woman's skin surface part, and which adhesive foil is provided with non-adhering rim segments similar to the rim segments 22 and 24 of the bur tape 20 de ⁇ scribed above.
  • the adhesive strip assembly 10 was made from a hydrocolloid adhesive body 12 composed of four adhesive strip segments 11a, lib, lie, and lid, the larger adhesive strip segments 11a and lib being of identical size, measuring overall length, identical to the maximum dimension of the ad ⁇ hesive strip assembly 10, 137 mm, and width 30 mm, the minor adhesive strip assemblies lie and lid being of identical size, measuring overall length 60 mm and width 35 mm.
  • the integral hydrocolloid body 12 composed of the adhesive strip segments lla-lld was of a maximum thickness at the centre of the hydrocolloid body of the order of 1 mm and a thickness at the inner and outer rim segments 14 and 16 of a thickness of 0.5 mm, the rim segments 14 and 16 being of a width of the order of 5 mm.
  • the bur tape 20 was constituted by a velour bur tape adhered to the hydrocolloid body 12 by means of an acrylic adhesive constituting the adhesive foil 18.
  • the release paper 26 was constituted by a siliconized release paper sheet.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Un ensemble à bande adhésive (10) conçu pour fixer une prothèse du sein (60) sur une surface de peau thoracique (64) est constitué d'une bande adhésive (12) de configuration courbe correspondant à une partie d'une surface de contact circonférentielle de la prothèse du sein au niveau de la surface de peau thoracique. Ladite bande adhésive définit un bord extérieur ainsi qu'une première et une deuxième surfaces opposées. La première surface présente une couche adhésive et est conçue pour venir en contact avec la surface de la peau thoracique, et y adhérer. Ledit ensemble à bande adhésive comprend également des moyens de fixation (20) qui permettent de fixer de manière amovible la prothèse du sein à la bande adhésive de manière à fixer cette dernière à la surface de peau thoracique. Les moyens de fixation sont prévus au niveau de la deuxième surface de la bande adhésive (12) qu'ils recouvrent partiellement, un segment de surface circonférentielle (22, 24) de la deuxième surface adjacent au bord extérieur de la bande adhésive n'étant pas recouvert. L'ensemble à bande adhésive fait partie intégrante d'un ensemble prothèse du sein englobant également la prothèse du sein (60).
PCT/DK1994/000047 1993-01-27 1994-01-27 Fixation d'une prothese du sein ou mammaire sur une surface thoracique WO1994016650A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DK94/93 1993-01-27
DK9493A DK9493D0 (da) 1993-01-27 1993-01-27 Fixating of a breast prosthesis of mammary prosthesis to af thoracic surface

Publications (1)

Publication Number Publication Date
WO1994016650A1 true WO1994016650A1 (fr) 1994-08-04

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0808615A2 (fr) * 1996-04-23 1997-11-26 Dr. HELBIG GmbH & Co. ORTHOPÄDISCHE PRODUKTE KG Prothèse mammaire et procédé pour sa fabrication
DE29712015U1 (de) * 1997-07-08 1998-11-05 AMOENA Medizin-Orthopädie-Technik GmbH & Co., 83064 Raubling Brustprothese
US5922023A (en) * 1996-05-02 1999-07-13 Amoena Medizin-Orthopaedie-Technik Gmbh & Co. Breast prosthesis
FR2805275A1 (fr) * 2000-02-21 2001-08-24 Plasto Sa Procede de fixation de protheses externes
DE20215801U1 (de) 2002-10-15 2003-01-16 Thämert Orthopädische Hilfsmittel GmbH & Co. KG, 30938 Burgwedel Brustprothese mit einer Haftschicht

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2742394A1 (de) * 1977-09-21 1979-03-29 Maria Lohse Brustprothese
DE2802375A1 (de) * 1978-01-20 1979-07-26 Bodo Knoche Brustprothese
GB2202745A (en) * 1987-03-30 1988-10-05 Craig Med Prod Ltd Attachment of external prosthesis
EP0392960A1 (fr) * 1989-04-13 1990-10-17 Coloplast A/S Dispositif de prothèse mammaire

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2742394A1 (de) * 1977-09-21 1979-03-29 Maria Lohse Brustprothese
DE2802375A1 (de) * 1978-01-20 1979-07-26 Bodo Knoche Brustprothese
GB2202745A (en) * 1987-03-30 1988-10-05 Craig Med Prod Ltd Attachment of external prosthesis
EP0392960A1 (fr) * 1989-04-13 1990-10-17 Coloplast A/S Dispositif de prothèse mammaire

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0808615A2 (fr) * 1996-04-23 1997-11-26 Dr. HELBIG GmbH & Co. ORTHOPÄDISCHE PRODUKTE KG Prothèse mammaire et procédé pour sa fabrication
EP0808615A3 (fr) * 1996-04-23 1998-01-07 Dr. HELBIG GmbH & Co. ORTHOPÄDISCHE PRODUKTE KG Prothèse mammaire et procédé pour sa fabrication
US6113634A (en) * 1996-04-23 2000-09-05 F + E Gesellschaft fur Bekleidungsinnovation mbH & Co. KG Breast prosthesis and method for making the same
US6451139B1 (en) 1996-04-23 2002-09-17 F + E Gesellschart für Bekleidungsinnovation mbH & Co. KG Method for making breast prosthesis
US5922023A (en) * 1996-05-02 1999-07-13 Amoena Medizin-Orthopaedie-Technik Gmbh & Co. Breast prosthesis
DE29712015U1 (de) * 1997-07-08 1998-11-05 AMOENA Medizin-Orthopädie-Technik GmbH & Co., 83064 Raubling Brustprothese
EP0895758A3 (fr) * 1997-07-08 1999-10-27 Amoena Medizin-Orthopädie-Technik GmbH & Co. Prothèse mammaire
FR2805275A1 (fr) * 2000-02-21 2001-08-24 Plasto Sa Procede de fixation de protheses externes
DE20215801U1 (de) 2002-10-15 2003-01-16 Thämert Orthopädische Hilfsmittel GmbH & Co. KG, 30938 Burgwedel Brustprothese mit einer Haftschicht
EP1410772A1 (fr) * 2002-10-15 2004-04-21 Thämert Orthopädische Hilfsmittel GmbH & Co. KG Elément d'attachement pour une prothèse mammaire
EP1410773A1 (fr) * 2002-10-15 2004-04-21 Thämert Orthopädische Hilfsmittel GmbH & Co. KG Elément d'attachement pour une prothèse mammaire
US7122054B2 (en) 2002-10-15 2006-10-17 Thämert Orthopädische Hilfsmittel GmbH & Co. KG Breast prosthesis having an adhesive layer

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