WO1994007434A1 - Breast implant with radiolucent shell - Google Patents
Breast implant with radiolucent shell Download PDFInfo
- Publication number
- WO1994007434A1 WO1994007434A1 PCT/US1993/007384 US9307384W WO9407434A1 WO 1994007434 A1 WO1994007434 A1 WO 1994007434A1 US 9307384 W US9307384 W US 9307384W WO 9407434 A1 WO9407434 A1 WO 9407434A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- shell
- radiolucent
- breast implant
- urethane
- polyester urethane
- Prior art date
Links
- 210000000481 breast Anatomy 0.000 title claims abstract description 30
- 239000007943 implant Substances 0.000 title claims abstract description 27
- 239000000463 material Substances 0.000 claims abstract description 22
- JOYRKODLDBILNP-UHFFFAOYSA-N Ethyl urethane Chemical compound CCOC(N)=O JOYRKODLDBILNP-UHFFFAOYSA-N 0.000 claims description 23
- 239000004721 Polyphenylene oxide Substances 0.000 claims description 12
- 229920000570 polyether Polymers 0.000 claims description 12
- 229920003232 aliphatic polyester Polymers 0.000 claims description 8
- 125000003118 aryl group Chemical group 0.000 claims description 8
- -1 polybutylene Polymers 0.000 claims description 7
- 125000001931 aliphatic group Chemical group 0.000 claims description 4
- 125000004122 cyclic group Chemical group 0.000 claims description 4
- 229920001748 polybutylene Polymers 0.000 claims description 4
- 229920000728 polyester Polymers 0.000 claims description 4
- 239000004743 Polypropylene Substances 0.000 claims description 3
- 229920001400 block copolymer Polymers 0.000 claims description 3
- 229920001155 polypropylene Polymers 0.000 claims description 3
- 229920005996 polystyrene-poly(ethylene-butylene)-polystyrene Polymers 0.000 claims description 3
- 239000000945 filler Substances 0.000 claims 4
- 229920006285 olefinic elastomer Polymers 0.000 claims 2
- RLRINNKRRPQIGW-UHFFFAOYSA-N 1-ethenyl-2-[4-(2-ethenylphenyl)butyl]benzene Chemical compound C=CC1=CC=CC=C1CCCCC1=CC=CC=C1C=C RLRINNKRRPQIGW-UHFFFAOYSA-N 0.000 claims 1
- BXOUVIIITJXIKB-UHFFFAOYSA-N ethene;styrene Chemical group C=C.C=CC1=CC=CC=C1 BXOUVIIITJXIKB-UHFFFAOYSA-N 0.000 claims 1
- QQONPFPTGQHPMA-UHFFFAOYSA-N propylene Natural products CC=C QQONPFPTGQHPMA-UHFFFAOYSA-N 0.000 claims 1
- 125000004805 propylene group Chemical group [H]C([H])([H])C([H])([*:1])C([H])([H])[*:2] 0.000 claims 1
- 229920006132 styrene block copolymer Polymers 0.000 claims 1
- 238000000034 method Methods 0.000 abstract description 9
- 206010028980 Neoplasm Diseases 0.000 abstract description 4
- 201000011510 cancer Diseases 0.000 abstract description 3
- 238000009607 mammography Methods 0.000 abstract description 3
- 229920001296 polysiloxane Polymers 0.000 description 12
- 239000003550 marker Substances 0.000 description 3
- 230000003466 anti-cipated effect Effects 0.000 description 2
- TZCXTZWJZNENPQ-UHFFFAOYSA-L barium sulfate Chemical compound [Ba+2].[O-]S([O-])(=O)=O TZCXTZWJZNENPQ-UHFFFAOYSA-L 0.000 description 2
- 210000000038 chest Anatomy 0.000 description 2
- 229920001971 elastomer Polymers 0.000 description 2
- 239000000806 elastomer Substances 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 241000905957 Channa melasoma Species 0.000 description 1
- 235000019483 Peanut oil Nutrition 0.000 description 1
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 description 1
- WMWLMWRWZQELOS-UHFFFAOYSA-N bismuth(III) oxide Inorganic materials O=[Bi]O[Bi]=O WMWLMWRWZQELOS-UHFFFAOYSA-N 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 230000005012 migration Effects 0.000 description 1
- 238000013508 migration Methods 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
- 235000019198 oils Nutrition 0.000 description 1
- 239000000312 peanut oil Substances 0.000 description 1
- 238000009877 rendering Methods 0.000 description 1
- 235000020238 sunflower seed Nutrition 0.000 description 1
- 210000000115 thoracic cavity Anatomy 0.000 description 1
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)
- Materials For Medical Uses (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
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.
Priority Applications (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA002142996A CA2142996C (en) | 1992-09-29 | 1993-08-06 | Breast implant with radiolucent shell |
| AU49983/93A AU683223B2 (en) | 1992-09-29 | 1993-08-06 | Breast implant with radiolucent shell |
| JP6509011A JPH09506516A (en) | 1992-09-29 | 1993-08-06 | Breast implant with radiolucent encapsulation |
| EP93919900A EP0693910A1 (en) | 1992-09-29 | 1993-08-06 | Breast implant with radiolucent shell |
| BR9307139A BR9307139A (en) | 1992-09-29 | 1993-08-06 | Breast implant and shell filled with a filling material included in a breast implant |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US95268792A | 1992-09-29 | 1992-09-29 | |
| US07/952,687 | 1992-09-29 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO1994007434A1 true WO1994007434A1 (en) | 1994-04-14 |
Family
ID=25493141
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US1993/007384 WO1994007434A1 (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) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0727232A3 (en) * | 1995-02-14 | 1996-11-06 | Mentor Corp | Filling material for soft tissue implant prostheses and implants made therewith |
| WO1998010803A1 (en) * | 1996-09-13 | 1998-03-19 | Lipomatrix Incorporated | Hydraulic foam tissue implant |
| US5941909A (en) * | 1995-02-14 | 1999-08-24 | Mentor Corporation | Filling material for soft tissue implant prostheses and implants made therewith |
| US6290723B1 (en) | 1994-06-14 | 2001-09-18 | Winston A. Andrews | Method of making a synthetic triglyceride filler material |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4995882A (en) * | 1989-08-28 | 1991-02-26 | Washington University | Radiolucent breast implant |
Family Cites Families (3)
| 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 |
-
1993
- 1993-08-06 JP JP6509011A patent/JPH09506516A/en active Pending
- 1993-08-06 WO PCT/US1993/007384 patent/WO1994007434A1/en not_active Application Discontinuation
- 1993-08-06 EP EP93919900A patent/EP0693910A1/en not_active Withdrawn
- 1993-08-06 BR BR9307139A patent/BR9307139A/en not_active Application Discontinuation
- 1993-08-06 AU AU49983/93A patent/AU683223B2/en not_active Ceased
- 1993-08-06 CA CA002142996A patent/CA2142996C/en not_active Expired - Lifetime
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4995882A (en) * | 1989-08-28 | 1991-02-26 | Washington University | Radiolucent breast implant |
Non-Patent Citations (1)
| Title |
|---|
| See also references of EP0693910A4 * |
Cited By (7)
| 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 |
| EP0727232A3 (en) * | 1995-02-14 | 1996-11-06 | Mentor Corp | Filling material for soft tissue implant prostheses and implants made therewith |
| 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 |
| EP1382356A1 (en) * | 1995-02-14 | 2004-01-21 | Mentor Corporation | Filling material for soft tissue implant prostheses and implants made therewith |
| EP1382313A1 (en) * | 1995-02-14 | 2004-01-21 | Mentor Corporation | Filling material for soft tissue implant prostheses and implants made therewith |
| WO1998010803A1 (en) * | 1996-09-13 | 1998-03-19 | Lipomatrix Incorporated | Hydraulic foam tissue implant |
Also Published As
| Publication number | Publication date |
|---|---|
| BR9307139A (en) | 1999-03-30 |
| JPH09506516A (en) | 1997-06-30 |
| EP0693910A4 (en) | 1995-08-03 |
| AU683223B2 (en) | 1997-11-06 |
| CA2142996C (en) | 2004-03-02 |
| AU4998393A (en) | 1994-04-26 |
| CA2142996A1 (en) | 1994-04-14 |
| EP0693910A1 (en) | 1996-01-31 |
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