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EP0693910A1 - Implant mammaire a enveloppe transparente aux rayonnements - Google Patents

Implant mammaire a enveloppe transparente aux rayonnements

Info

Publication number
EP0693910A1
EP0693910A1 EP93919900A EP93919900A EP0693910A1 EP 0693910 A1 EP0693910 A1 EP 0693910A1 EP 93919900 A EP93919900 A EP 93919900A EP 93919900 A EP93919900 A EP 93919900A EP 0693910 A1 EP0693910 A1 EP 0693910A1
Authority
EP
European Patent Office
Prior art keywords
shell
radiolucent
breast implant
urethane
polyester urethane
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.)
Withdrawn
Application number
EP93919900A
Other languages
German (de)
English (en)
Other versions
EP0693910A4 (fr
Inventor
Terry Russell Knapp
Winston A. Andrews
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.)
Lipomatrix Inc
Original Assignee
Lipomatrix Inc
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 Lipomatrix Inc filed Critical Lipomatrix Inc
Publication of EP0693910A4 publication Critical patent/EP0693910A4/fr
Publication of EP0693910A1 publication Critical patent/EP0693910A1/fr
Withdrawn legal-status Critical Current

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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/12—Mammary prostheses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials

Definitions

  • Breast pros heses are well known in the art and generally include a shell or envelope which is filled with a fluid or gel which desirably is used to enlarge the female breast yet retain its normal appearance, move ⁇ ment, feel, and other cosmetic characteristics.
  • the predominant breast implant had been a sili- cone envelope filled with a silicone gel.
  • re ⁇ cent health concerns have prompted the withdrawal of this implant from the market. These concerns generally relate to the health risks caused by migration of the silicone gel from within the shell, breakage of the shell, or other introduction of the silicone gel into the body.
  • mammograms typically are performed by compressing a breast between two plates which flattens the breast and enables a more uniform exposure. A controlled intensity of x-rays are then passed through the breast for a care- fully controlled time period to image any artifacts in ⁇ dicative of cancer.
  • U.S. Patent No. 4,863,470 discloses a standard breast implant comprised of a silicone shell with a silicone gel fill material.
  • this breast implant construction is well known in the prior art and, up until recently, had been the most popular implant used.
  • this patent discloses an identifica ⁇ tion marker or tab which is made from silicone with bis- muth trioxide or barium sulfate, both of which are much more "radiopaque" than the silicone used for the standard shell or fill material.
  • a marker or tab would remain opaque and thusly visible.
  • This patent also describes a technique used to read this radiopaque marker which is more similar to a chest x-ray than to a mammogram.
  • the patient lies on her back and the x- rays are directed through her breast and chest cavity.
  • energy levels at 125 kVp are common.
  • the intensity of x-rays required for this procedure sub- stantially exceeds that carefully controlled and timed dosage which is used for mammographic procedures.
  • a standard silicone gel and silicone fill material may be radiolucent, it is in reality radiopaque for standard mammographic proce ⁇ dures.
  • the material which the inventors have identified and are contemplating for use for the shell include any one or more of the following: linear aliphatic polyether urethane; linear aliphatic polyester urethane; cyclic aliphatic polyether urethane; cyclic aliphatic polyester urethane; aromatic polyether urethane; aromatic polyester urethane; polybutylene; polypropylene; crosslinked ole- finic elastomers; and styrene-ethylene/butylene-styrene block copolymer. All of these materials have an effec ⁇ tive atomic number of 6.0 within a range of ⁇ 0.5, and therefore exhibit the effective atomic number of fat which is the major component of a human breast.
  • a breast implant which includes a radiolucent shell filled with a radiolu ⁇ cent fill material thereby rendering the entire implant optimally radiolucent for mammographic procedures. It is not believed that a drawing is required or even helpful in understanding the present invention and, hence, none is being submitted.
  • the present invention includes fashioning the shell from any one of a number of materials such as: linear aliphatic polyether urethane; linear aliphatic polyester urethane; cyclic aliphatic polyether urethane; cyclic aliphatic polyester urethane; aromatic polyether urethane; aromatic polyester urethane; polybutylene; polypropylene; crosslinked ole- finic elastomers; and styrene-ethylene/butylene-styrene block copolymer.
  • materials such as: linear aliphatic polyether urethane; linear aliphatic polyester urethane; cyclic aliphatic polyether urethane; cyclic aliphatic polyester urethane; aromatic polyether urethane; aromatic polyester urethane; polybutylene; polypropylene; crosslinked ole- finic elastomers; and styrene-ethylene/butylene-styrene block copolymer.

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Transplantation (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Prostheses (AREA)
  • Apparatus For Radiation Diagnosis (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Un implant mammaire comprend une enveloppe composée d'une matière choisie dans un groupe de matières présentant une transparence aux rayonnements aux intensités de rayons X généralement utilisées pour des mammographies. L'enveloppe peut être remplie d'une matière de remplissage également transparentes aux rayonnements, conforme à la technique antérieure, afin de constituer un implant mammaire entièrement transparent aux rayonnements. Cet implant améliore la possibilité de détection de tumeurs, par mammographie, chez des patientes ayant reçu de tels implants mammaires, et permet ainsi de diagnostiquer et de traiter plus efficacement le cancer.
EP93919900A 1992-09-29 1993-08-06 Implant mammaire a enveloppe transparente aux rayonnements Withdrawn EP0693910A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US95268792A 1992-09-29 1992-09-29
US952687 1992-09-29
PCT/US1993/007384 WO1994007434A1 (fr) 1992-09-29 1993-08-06 Implant mammaire a enveloppe transparente aux rayonnements

Publications (2)

Publication Number Publication Date
EP0693910A4 EP0693910A4 (fr) 1995-08-03
EP0693910A1 true EP0693910A1 (fr) 1996-01-31

Family

ID=25493141

Family Applications (1)

Application Number Title Priority Date Filing Date
EP93919900A Withdrawn EP0693910A1 (fr) 1992-09-29 1993-08-06 Implant mammaire a enveloppe transparente aux rayonnements

Country Status (6)

Country Link
EP (1) EP0693910A1 (fr)
JP (1) JPH09506516A (fr)
AU (1) AU683223B2 (fr)
BR (1) BR9307139A (fr)
CA (1) CA2142996C (fr)
WO (1) WO1994007434A1 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6290723B1 (en) 1994-06-14 2001-09-18 Winston A. Andrews Method of making a synthetic triglyceride filler material
US5658329A (en) * 1995-02-14 1997-08-19 Mentor Corporation Filling material for soft tissue implant prostheses and implants made therewith
US5941909A (en) * 1995-02-14 1999-08-24 Mentor Corporation Filling material for soft tissue implant prostheses and implants made therewith
US5824081A (en) * 1996-09-13 1998-10-20 Lipomatrix Incorporated Hydraulic foam tissue implant

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5141581A (en) * 1972-10-08 1992-08-25 Markham Harold A Implants with a cover which resists formation of firm spherical encapsulation
US4157085A (en) * 1978-03-24 1979-06-05 Dow Corning Corporation Surgically implantable tissue expanding device and the method of its use
US4995882A (en) * 1989-08-28 1991-02-26 Washington University Radiolucent breast implant
FR2675049A1 (fr) * 1991-04-09 1992-10-16 Mas Jean Claude Prothese mammaire implantable.

Also Published As

Publication number Publication date
CA2142996A1 (fr) 1994-04-14
AU4998393A (en) 1994-04-26
CA2142996C (fr) 2004-03-02
EP0693910A4 (fr) 1995-08-03
AU683223B2 (en) 1997-11-06
BR9307139A (pt) 1999-03-30
JPH09506516A (ja) 1997-06-30
WO1994007434A1 (fr) 1994-04-14

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