EP0693910A1 - Breast implant with radiolucent shell - Google Patents

Breast implant with radiolucent shell

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Withdrawn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)
French (fr)
Other versions
EP0693910A4 (en
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/en
Publication of EP0693910A1 publication Critical patent/EP0693910A1/en
Withdrawn legal-status Critical Current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 and implants
    • 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)
  • Animal Behavior & Ethology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Transplantation (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Chemical & Material Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Prostheses (AREA)
  • Apparatus For Radiation Diagnosis (AREA)

Abstract

A breast implant includes a shell fashioned from one of a group of materials which exhibit radiolucency at those x-ray intensities normally encountered for mammographic procedures. The radiolucent shell may be filled with radiolucent fill material as previously taught to thereby comprise a fully radiolucent breast implant. The radiolucent breast implant enhances the use of mammography in detecting tumors in patients having breast implants to more effectively diagnose and treat cancer.

Description

BREAST IMPLANT WITH RADIOLUCENT SHELL Background and Summary of the Invention
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. Until recently, the predominant breast implant had been a sili- cone envelope filled with a silicone gel. However, 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.
The assignee of the present invention also holds certain rights under U.S. Patent No. 4,995,882, the dis¬ closure of which is incorporated herein by reference, which discloses and claims a breast implant comprised of a silicone shell filled with a radiolucent fill material such as peanut oil, sunflower seed oil, or any other suitable fluid with the same atomic number as breast tissue, Z=5.9. As explained in greater detail therein, 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. As is well known in the art of mam- mography, great care is taken to minimize the amount of x-ray energy used as studies have shown that certain levels of x-ray exposure will itself increase the risk of developing cancer. Typically, mammographies are conduct¬ ed at low x-ray energy levels, such as between the range of 25-60 kVp. Hence, this prior patent discloses a use¬ ful and valuable invention of utilizing a fill material which is radiolucent using standard mammographic proce- dures and protocols, and perhaps more importantly, x-ray intensities.
The inventors herein are also aware of U.S. Patent No. 4,863,470 which discloses a standard breast implant comprised of a silicone shell with a silicone gel fill material. As previously mentioned herein, this breast implant construction is well known in the prior art and, up until recently, had been the most popular implant used. In addition, 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. Hence, presuming an increased x- ray intensity which would render the standard silicone breast implant radiolucent, 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. As taught therein, the patient lies on her back and the x- rays are directed through her breast and chest cavity. For chest x-rays, 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. There¬ fore, while this patent suggests that a standard silicone gel and silicone fill material may be radiolucent, it is in reality radiopaque for standard mammographic proce¬ dures. This deficiency with this prior art implant con¬ struction was recognized and dramatically improved upon with the breast implant with radiolucent fill disclosed and claimed in prior U.S. Patent 4,995,882. As an enhancement to the breast implant with silicone shell and radiolucent fill, the inventors herein have succeeded in developing a breast implant with a shell which is also radiolucent. Therefore, with this breast implant, not only is the fill material comprised of a radiolucent material, but the shell also is radiolu¬ cent itself, using the standards for judging radiolucency as explained in prior U.S. Patent 4,995,882, i.e. using standard mammographic protocols, procedures, and intensi¬ ties. 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. Thus, with the present invention, a breast implant is disclosed 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.
Detailed Description of the Preferred Embodiment The inventors' preferred embodiment for achieving a breast implant shell which is essentially radiolucent using standard mammographic procedures, protocols, and intensities. The inventors believe that materials having an effective atomic number of 6.0 within a range of ±0.5 satisfy this criteria. As examples thereof, 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. It is anticipated that standard manu¬ facturing techniques well known to those of ordinary skill in the art for producing breast implants will be similarly used with the materials of the present inven¬ tion. In other words, it is not anticipated that there will be any difficulty encountered by those of ordinary skill in the art in making breast implant shells with the materials suggested herein as radiolucent.
There are various changes and modifications which may be made to the invention as would be apparent to those skilled in the art. However, these changes or modifications are included in the teaching of the disclo- sure, and it is intended that the invention be limited only by the scope of the claims appended hereto.

Claims

What Is Claimed Is:
1. A breast implant comprised of a shell filled with a filler, both said shell and filler being each made of materials which are themselves substantially radiolu¬ cent under accepted mammographic protocols and intensi¬ ties.
2. The implant of Claim 1 wherein said shell is a material selected from the group consisting of 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 olefinic elastomers; and sty- rene-ethylene/butylene-styrene block copolymer.
3. In a breast implant comprised of a shell filled with a fill material, the improvement comprising said shell being made of a material which is itself substan¬ tially radiolucent under accepted mammographic protocols and intensities.
4. The shell of Claim 3 wherein said shell is a material selected from the group consisting of linear aliphatic polyether urethane; linear aliphatic polyester urethane; cyclic aliphatic polyether urethane; cyclic aliphatic polyester urethane; aromatic polyether ure¬ thane; aromatic polyester urethane; polybutylene; poly¬ propylene; crosslinked olefinic elastomers; and styrene- ethylene/butylene-styrene block copolymer.
5. A breast implant comprised of a shell filled with a filler, both said shell and filler being made of materials having an effective atomic number of 6.0 within a range of about ±0.5.
EP93919900A 1992-09-29 1993-08-06 Breast implant with radiolucent shell Withdrawn EP0693910A1 (en)

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 (en) 1992-09-29 1993-08-06 Breast implant with radiolucent shell

Publications (2)

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

Family

ID=25493141

Family Applications (1)

Application Number Title Priority Date Filing Date
EP93919900A Withdrawn EP0693910A1 (en) 1992-09-29 1993-08-06 Breast implant with radiolucent shell

Country Status (6)

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

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

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4157085A (en) * 1978-03-24 1979-06-05 Dow Corning Corporation Surgically implantable tissue expanding device and the method of its use
US5141581A (en) * 1972-10-08 1992-08-25 Markham Harold A Implants with a cover which resists formation of firm spherical encapsulation
FR2675049A1 (en) * 1991-04-09 1992-10-16 Mas Jean Claude Implantable mammary prosthesis

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4995882A (en) * 1989-08-28 1991-02-26 Washington University Radiolucent breast implant

Patent Citations (3)

* 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
FR2675049A1 (en) * 1991-04-09 1992-10-16 Mas Jean Claude Implantable mammary prosthesis

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO9407434A1 *

Also Published As

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

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