GB2243324A - Prosthesis production - Google Patents

Prosthesis production Download PDF

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Publication number
GB2243324A
GB2243324A GB9024797A GB9024797A GB2243324A GB 2243324 A GB2243324 A GB 2243324A GB 9024797 A GB9024797 A GB 9024797A GB 9024797 A GB9024797 A GB 9024797A GB 2243324 A GB2243324 A GB 2243324A
Authority
GB
United Kingdom
Prior art keywords
silicone rubber
skin
foamed
silicone
mould
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.)
Granted
Application number
GB9024797A
Other versions
GB9024797D0 (en
GB2243324B (en
Inventor
Aaron Sherman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of GB9024797D0 publication Critical patent/GB9024797D0/en
Publication of GB2243324A publication Critical patent/GB2243324A/en
Application granted granted Critical
Publication of GB2243324B publication Critical patent/GB2243324B/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C44/00—Shaping by internal pressure generated in the material, e.g. swelling or foaming ; Producing porous or cellular expanded plastics articles
    • B29C44/02—Shaping by internal pressure generated in the material, e.g. swelling or foaming ; Producing porous or cellular expanded plastics articles for articles of definite length, i.e. discrete articles
    • B29C44/12—Incorporating or moulding on preformed parts, e.g. inserts or reinforcements
    • B29C44/1204—Incorporating or moulding on preformed parts, e.g. inserts or reinforcements and giving the material during expanding the shape of a particular article to be supported, e.g. a human body-part
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C39/00—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
    • B29C39/02—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • B29C39/021—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor for making articles of definite length, i.e. discrete articles by casting in several steps
    • B29C39/025—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor for making articles of definite length, i.e. discrete articles by casting in several steps for making multilayered articles
    • 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
    • A61F2/5044—Designing or manufacturing processes
    • A61F2/5046—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, finite-element analysis or CAD-CAM techniques
    • A61F2002/5053—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, finite-element analysis or CAD-CAM techniques using a positive or a negative model, e.g. casting model or mould
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2083/00—Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as moulding material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
    • B29K2105/04—Condition, form or state of moulded material or of the material to be shaped cellular or porous
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7532—Artificial members, protheses

Landscapes

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

Abstract

A method of manufacturing a prosthesis, for example, an artificial breast, is provided. The prosthesis includes a first outer part formed of a silicone rubber and a second inner part formed of a foamed material. Initially a cast which simulates the breast is produced, and that cast is used as a mould into which a silicone rubber is introduced and caused or allowed to cure to form a skin in contact with the mould surface. Then a foam formulation is fed into contact with the skin and cured to form a foamed mass, after which a layer of silicone rubber is applied to the exposed surface of the foamed mass and cured, so that the foamed mass is now enclosed in an envelope of silicone rubber to form the prosthesis.

Description

PROSTHESIS PRODUCTION Field of the Invention This invention relates to the production of prostheses, which term is to be interpreted broadly as including any form of artificial or replacement part of the human body, for example, a medical model. The invention is concerned, in particular, with the production of artificial breasts for patients who have had or are due to have mastectomy operations because of breast cancer.
It is an object of the present invention to provide an improved method for the production of prostheses. It is a further object of the present invention to provide an improved method of making artificial breasts and to provide artificial breasts which are not only more comfortable to wear but which more closely simulate the patients' own breasts.
Summary of the Invention According to the broadest aspect of the present invention there is provided a method of manufacturing a prosthesis which includes a first part formed of a silicone and a second part formed of a foamed material, which method includes causing or allowing the silicone to cure while in contact with the foamed material.
The silicone is preferably a room temperature vulcanised silicone rubber, but may be a silicone adhesive.
According to a more specific aspect of the present invention there is provided a method of producing an artificial breast for a patient who has had or is due to have a mastectomy operation, said method comprising: a) producing a cast which simulates the breast which has been removed or is due to be removed, b) using said cast as a mould into which is introduced a silicone rubber, c) causing or allowing the silicone rubber to cure to form a skin in contact with the mould surface, which skin corresponds in outline to the outline of the patient's breast, d) using the skin supported by the cast as a mould into which is fed a foam formulation, e) causing or allowing the foam to cure in contact with the silicone rubber skin so as to form a foamed mass the configuration of which corresponds to the configuration of the patient's breast, and f) applying a layer of silicone rubber over the foamed mass so that the foamed mass is completely enclosed between the silicone rubber skin and said layer of silicone rubber.
The cast which is produced is a negative image of the patient's breast and may be used to produce a positive mould member which is a controlled constant amount smaller than the patient's breast. This positive mould member preferably cooperates with the cast to define the mould cavity into which the silicone rubber is introduced so that a silicone rubber skin of constant thickness is produced.
The silicone rubber is preferably an RTV silicone, i.e. a "room temperature vulcanised" silicone, the silicone being allowed to cure in the mould cavity defined between the cast and the positive mould member for a period of, for example, twenty four hours.
The foam formulation is preferably a creamed rubber which is introduced into the mould defined by the cured silicone rubber skin supported by the cast after removal of the positive mould member, the creamed rubber foam formulation containing an appropriate amount of a foaming agent which is so selected as to ensure that the resulting foamed structure is a microcellular foamed structure.
After this micro-cellular foamed structure has been allowed to cure by standing for, for example, twenty four hours, the exposed surface of the foamed surface is then covered by the layer of silicone rubber, which layer is produced by applying a silicone rubber over the surface of the foamed mass, the silicone rubber again being an RTV rubber which is left for twenty four hours to allow it to cure in contact with the foamed mass and with the edges of the silicone rubber skin supported by the mould.
The prosthesis thus formed has a confining peripheral envelope which is filled with a foamed rubber, the complete device having been produced so that it has a configuration and flexibility which correspond as far as possible to the patient's own breast. The prosthesis is light in weight and water-proof. It is accordingly comfortable to wear and durable.
Description of the Preferred Embodiment The first stage in the production of an artificial breast is the production of a cast which is a negative image of the patients breast. This cast is produced by conventional techniques and may be based on the patient's actual breast, if the mastectomy operation has not yet been carried out.
Normally, however, the cast will be produced as a negative simulation of the breast configuration appropriate to the patient. A positive mould member is then produced which has a configuration complementary to that of the cast but a few millimetres smaller than the cast.
The cast and positive mould member are placed in mating juxtaposition to define a mould cavity of substantially uniform thickness. An RTV silicone rubber is then introduced into the mould cavity and curing of the silicone rubber is effected by allowing the rubber to stand at room temperature within the mould cavity for a period of twenty four hours. The mould is opened after curing of the silicone rubber has been completed and a shaped silicone rubber skin is obtained.
This silicone rubber skin supported by the cast is then used to define part of the surface of a mould into which a foam formulation is fed. The foam formulation is a creamed rubber containing a foaming agent. The amount and characteristics of the foaming agent are such that a uniform micro-cellular foamed structure is obtained. The appropriate quantity of this creamed rubber is introduced into the mould and allowed to cure by standing at room temperature for twenty four hours.
On completion of curing of the foamed structure, the exposed surface of the structure is covered by the application of a layer of an RTV silicone rubber. The layer being of substantially uniform thickness and produced by allowing the RTV silicone rubber to cure in contact with the foam for a period of twenty four hours at room temperature. This slow curing of the silicone rubber ensures that this confining layer is effectively bonded to the foam and to the originally formed silicone rubber skin. A confining peripheral envelope of silicone rubber is thus formed, the envelope being filled with a shaped mass of foamed rubber which is bonded to the confining peripheral skin.
It is to be appreciated that, although the invention has been described in detail above in relation to the production of an artificial breast, other prostheses can be produced by the method of the invention.

Claims (8)

Claims:
1. A method of manufacturing a prosthesis which includes a first part formed of a silicone and a second part formed of a foamed material, which method includes causing or allowing the silicone to cure while in contact with the foamed material.
2. A method according to Claim 1, in which the silicone is a room temperature vulcanised silicone rubber which is cured by standing at room temperature in contact with the foamed material for a period of the order of twenty four hours whereby it becomes effectively bonded to the foamed material.
3. A method of manufacturing a prosthesis substantially as hereinbefore described.
4. A prosthesis made by any one of the preceding claims.
5. A method of producing an artificial breast for a patient who has had or is due to have a mastectomy operation, said method comprising: a) producing a cast which simulates the breast which has been removed or id due to be removed, b) using said cast as a mould into which is introduced a silicone rubber, c) causing or allowing the silicone rubber to cure to form a skin in contact with the mould surface, which skin corresponds in outline to the outline of the patient's breast, d) using the skin supported by the cast as a mould into which is fed a foam formulation, e) causing or allowing the foam to cure in contact with the silicone rubber skin so as to form a foamed mass the configuration of which corresponds to the configuration of the patient's breast, and f) applying a layer of silicone rubber over the foamed mass so that the foamed mass is completely enclosed between the silicone rubber skin and said layer of silicone rubber.
6. A method according to Claim 5, in which the silicone rubber of said skin and of said layer is a room temperature vulcanised silicone rubber and said layer is formed by curing of the silicone in contact with the foamed mass.
7. A method according to Claim 5 or Claim 6, in which the foam formulation is a creamed rubber which is introduced into the mould defined by the cured silicone rubber skin after removal of the positive mould member, the creamed rubber formulation containing a foaming agent such that the resulting foamed structure is a micro-cellular foamed structure.
8. An artificial breast formed by the method of Claim 5, or Claim 6, or Claim 7.
GB9024797A 1990-04-26 1990-11-14 Prosthesis production Expired - Lifetime GB2243324B (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
GB909009323A GB9009323D0 (en) 1990-04-26 1990-04-26 Prosthesis production

Publications (3)

Publication Number Publication Date
GB9024797D0 GB9024797D0 (en) 1991-01-02
GB2243324A true GB2243324A (en) 1991-10-30
GB2243324B GB2243324B (en) 1992-12-16

Family

ID=10674990

Family Applications (2)

Application Number Title Priority Date Filing Date
GB909009323A Pending GB9009323D0 (en) 1990-04-26 1990-04-26 Prosthesis production
GB9024797A Expired - Lifetime GB2243324B (en) 1990-04-26 1990-11-14 Prosthesis production

Family Applications Before (1)

Application Number Title Priority Date Filing Date
GB909009323A Pending GB9009323D0 (en) 1990-04-26 1990-04-26 Prosthesis production

Country Status (1)

Country Link
GB (2) GB9009323D0 (en)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993014483A1 (en) * 1992-01-15 1993-07-22 Limbs & Things Limited Surgical and/or clinical apparatus
US5370688A (en) * 1993-03-30 1994-12-06 Spenco Medical Corporation Encapsulated gel breast prosthesis and method of making
WO1999012500A1 (en) * 1997-09-09 1999-03-18 Augmentec Aktiengesellschaft Implantologie-Epithetik Method for manufacturing an epithesis
US5993590A (en) * 1997-07-01 1999-11-30 Manni-Kit, Inc. Method for coating objects with silicone
DE19917032A1 (en) * 1999-04-15 2000-11-23 Detlef Behrend Modelable breast prosthesis, with flexible, limp outer sheath is filled with open-cell flexible foam formed in situ and sheath with microporous surface coated with resorbable biomaterial with protein coating containing drugs
US7316795B1 (en) * 2004-03-02 2008-01-08 Stefan Johannes Knauss Method for overmolding a painted silicone rubber human extremity prosthesis
CN101199867B (en) * 2006-12-15 2012-08-22 张建军 Foam silastic preparing method for medicine and medical embedded false body
EP2581193A1 (en) * 2011-10-14 2013-04-17 Polytech Health&Aesthetics GmbH Process for the manufacture of implants or intermediate products of such implants as well as implants and intermediate products obtained by such process
GB2522623A (en) * 2014-01-29 2015-08-05 Robert John Watts Covers for prostheses

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0125400A1 (en) * 1983-04-18 1984-11-21 EBERL, Tertulin Breast prosthesis

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0125400A1 (en) * 1983-04-18 1984-11-21 EBERL, Tertulin Breast prosthesis

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993014483A1 (en) * 1992-01-15 1993-07-22 Limbs & Things Limited Surgical and/or clinical apparatus
GB2277826A (en) * 1992-01-15 1994-11-09 Limbs & Things Ltd Surgical and/or clinical apparatus
GB2277826B (en) * 1992-01-15 1995-03-01 Limbs & Things Ltd Surgical and/or clinical apparatus
US5370688A (en) * 1993-03-30 1994-12-06 Spenco Medical Corporation Encapsulated gel breast prosthesis and method of making
US5993590A (en) * 1997-07-01 1999-11-30 Manni-Kit, Inc. Method for coating objects with silicone
WO1999012500A1 (en) * 1997-09-09 1999-03-18 Augmentec Aktiengesellschaft Implantologie-Epithetik Method for manufacturing an epithesis
DE19917032A1 (en) * 1999-04-15 2000-11-23 Detlef Behrend Modelable breast prosthesis, with flexible, limp outer sheath is filled with open-cell flexible foam formed in situ and sheath with microporous surface coated with resorbable biomaterial with protein coating containing drugs
DE19917032C2 (en) * 1999-04-15 2002-10-02 Detlef Behrend Modelable breast prosthesis
US7316795B1 (en) * 2004-03-02 2008-01-08 Stefan Johannes Knauss Method for overmolding a painted silicone rubber human extremity prosthesis
CN101199867B (en) * 2006-12-15 2012-08-22 张建军 Foam silastic preparing method for medicine and medical embedded false body
EP2581193A1 (en) * 2011-10-14 2013-04-17 Polytech Health&Aesthetics GmbH Process for the manufacture of implants or intermediate products of such implants as well as implants and intermediate products obtained by such process
AU2012238270B2 (en) * 2011-10-14 2015-02-05 Polytech Health & Aesthetics Gmbh Process for the manufacture of implants or intermediate products of such implants as well as implants and intermediate products obtained by such process
EP3002101A1 (en) * 2011-10-14 2016-04-06 Polytech Health&Aesthetics GmbH Process for the manufacture of implants or intermediate products of such implants as well as implants and intermediate products obtained by such process
US10307945B2 (en) 2011-10-14 2019-06-04 Polytech Health & Aesthetics Gmbh Process or the manufacture of implants or intermediate products of such implants as well as implants and intermediate products obtained by such process
GB2522623A (en) * 2014-01-29 2015-08-05 Robert John Watts Covers for prostheses

Also Published As

Publication number Publication date
GB9024797D0 (en) 1991-01-02
GB2243324B (en) 1992-12-16
GB9009323D0 (en) 1990-06-20

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Legal Events

Date Code Title Description
PCNP Patent ceased through non-payment of renewal fee

Effective date: 19991114