WO1994010937A1 - Radiolucent organ displacement device for radiation therapy - Google Patents
Radiolucent organ displacement device for radiation therapy Download PDFInfo
- Publication number
- WO1994010937A1 WO1994010937A1 PCT/US1993/007383 US9307383W WO9410937A1 WO 1994010937 A1 WO1994010937 A1 WO 1994010937A1 US 9307383 W US9307383 W US 9307383W WO 9410937 A1 WO9410937 A1 WO 9410937A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- implant
- bladder
- filler material
- urethane
- tissue site
- Prior art date
Links
- 238000001959 radiotherapy Methods 0.000 title claims abstract description 19
- 210000000056 organ Anatomy 0.000 title claims abstract description 11
- 238000006073 displacement reaction Methods 0.000 title abstract description 5
- 239000007943 implant Substances 0.000 claims abstract description 108
- 239000012530 fluid Substances 0.000 claims abstract description 6
- 239000000463 material Substances 0.000 claims description 48
- JOYRKODLDBILNP-UHFFFAOYSA-N Ethyl urethane Chemical compound CCOC(N)=O JOYRKODLDBILNP-UHFFFAOYSA-N 0.000 claims description 40
- 239000000945 filler Substances 0.000 claims description 35
- 239000004721 Polyphenylene oxide Substances 0.000 claims description 21
- 229920000570 polyether Polymers 0.000 claims description 21
- 238000000034 method Methods 0.000 claims description 17
- 229920003232 aliphatic polyester Polymers 0.000 claims description 14
- 125000003118 aryl group Chemical group 0.000 claims description 14
- -1 polybutylene Polymers 0.000 claims description 11
- 230000005855 radiation Effects 0.000 claims description 11
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 claims description 8
- 125000001931 aliphatic group Chemical group 0.000 claims description 7
- 229920001400 block copolymer Polymers 0.000 claims description 7
- 125000004122 cyclic group Chemical group 0.000 claims description 7
- 229920006285 olefinic elastomer Polymers 0.000 claims description 7
- 229920000728 polyester Polymers 0.000 claims description 7
- 229920005996 polystyrene-poly(ethylene-butylene)-polystyrene Polymers 0.000 claims description 7
- 238000002513 implantation Methods 0.000 claims description 6
- 239000004743 Polypropylene Substances 0.000 claims description 5
- 230000009931 harmful effect Effects 0.000 claims description 5
- 229920001155 polypropylene Polymers 0.000 claims description 5
- 239000002131 composite material Substances 0.000 claims description 4
- 229920002635 polyurethane Polymers 0.000 claims description 4
- 239000004814 polyurethane Substances 0.000 claims description 4
- 229920001971 elastomer Polymers 0.000 claims description 3
- 239000000806 elastomer Substances 0.000 claims description 3
- 229920001296 polysiloxane Polymers 0.000 claims description 3
- 241000011102 Thera Species 0.000 claims 8
- 230000001225 therapeutic effect Effects 0.000 claims 7
- 229920001748 polybutylene Polymers 0.000 claims 6
- 238000002955 isolation Methods 0.000 claims 4
- QQONPFPTGQHPMA-UHFFFAOYSA-N propylene Natural products CC=C QQONPFPTGQHPMA-UHFFFAOYSA-N 0.000 claims 2
- 125000004805 propylene group Chemical group [H]C([H])([H])C([H])([*:1])C([H])([H])[*:2] 0.000 claims 2
- 210000001519 tissue Anatomy 0.000 description 13
- 238000002560 therapeutic procedure Methods 0.000 description 8
- 206010028980 Neoplasm Diseases 0.000 description 4
- 230000008901 benefit Effects 0.000 description 3
- 201000011510 cancer Diseases 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000011282 treatment Methods 0.000 description 3
- 208000027418 Wounds and injury Diseases 0.000 description 2
- 230000006378 damage Effects 0.000 description 2
- 238000011065 in-situ storage Methods 0.000 description 2
- 208000014674 injury Diseases 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 230000007935 neutral effect Effects 0.000 description 2
- 235000012424 soybean oil Nutrition 0.000 description 2
- 239000003549 soybean oil Substances 0.000 description 2
- 235000019483 Peanut oil Nutrition 0.000 description 1
- 210000000577 adipose tissue Anatomy 0.000 description 1
- 230000005907 cancer growth Effects 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 230000012010 growth Effects 0.000 description 1
- 230000001678 irradiating effect Effects 0.000 description 1
- 210000001165 lymph node Anatomy 0.000 description 1
- 238000009607 mammography Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000012544 monitoring process 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
- 210000002307 prostate Anatomy 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 229920002379 silicone rubber Polymers 0.000 description 1
- 239000004945 silicone rubber Substances 0.000 description 1
- 235000020238 sunflower seed Nutrition 0.000 description 1
- 125000000383 tetramethylene group Chemical group [H]C([H])([*:1])C([H])([H])C([H])([H])C([H])([H])[*:2] 0.000 description 1
- 210000004291 uterus Anatomy 0.000 description 1
- 210000001835 viscera Anatomy 0.000 description 1
Classifications
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
-
- 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
- A61L27/14—Macromolecular materials
- A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00831—Material properties
- A61B2017/00902—Material properties transparent or translucent
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0815—Implantable devices for insertion in between organs or other soft tissues
Definitions
- Radiation therapy is presently one of the major options for treatment of cancer.
- radiation therapy involves radiating cancer growths and tissue sites in order to kill the cancer and prevent its spread throughout the body.
- This therapy is typical ⁇ ly used for many different kinds of cancer, including those cancers attacking the internal organs of a human such as the prostate gland, uterus, and pelvic lymph nodes.
- radia- tion which is inadvertently exposed to healthy tissue
- this effort has been directed to more exactly locating the tissue site intended to receive the therapy, and more precisely irradiating that site with a controlled energy beam. Efforts in these areas continue.
- the present limita ⁇ tions of radiation techniques there still remains a significant risk of injury or morbidity for body organs or tissues surrounding the cancerous site.
- This implant is radiolucent, even at radiation levels significantly below that ordinarily used for many kinds of radiation treatment, and is essentially comprised of an inflatable bladder having a valve which permits the bladder to be filled in situ with a radiolucent filler material.
- the implant of the present invention not only is there achieved a clear separation between the healthy and unhealthy tissue sites, but the implant is virtually invisible to the therapy so that virtually no adjustment in the therapy is required when the implant is used.
- radiation therapy protocol involve a series of treatments each of which comprises the timed irradiation of a tissue site with a very carefully calculated radiation dosage. These calcu ⁇ lations can be quite sensitive in order to reliably kill the cancerous growth while at the same time minimizing injury and morbidity to surrounding healthy tissue. The use of the implant of the present invention will have minimal effect on these calculated radiation therapy protocols.
- the implant's position may also be readily moni- tored by x-ray and will also permit the continued use of x-ray to view those tissue sites desired to be viewed as the implant is virtually transparent at these reduced energy levels used for x-ray as well. Therefore, the implant may be readily and effectively used without in ⁇ terfering with either the therapy itself, or a monitoring of the tissue sites to determine the effects of therapy as therapy progresses.
- the implant is itself comprised of a generally elastomeric bladder with a one-way fill valve.
- the blad ⁇ der may be made of a silicone/polyurethane composite and the filler material may be a highly purified and sterile neutral triglyceride derived from soybean oil. Alterna ⁇ tive materials may also be used, as explained below.
- the bladder may be readily filled via a silicone rubber fill tube which mates with the diaphragm one-way fill valve in the bladder/shell.
- the proximal end of the fill tube may mate with a triglyceride containing fill cartridge, or a fill gun or syringe may be used to deliver the filler material into the bladder/shel1.
- the size and/or shape of the bladder may be readily sized and fitted to the particular tissue site and application. No particular size and/or shape is required in order to achieve the benefits of the present invention.
- the implant may be surgically implanted at the time of initial exploration or later as part of the therapy itself.
- the implant may be implanted in an inflated and filled condition or may be implanted and filled in situ. Explantation may be via endoscopic means on an out-patient basis.
- Figure 1 depicts a generally spherical implant of the present invention
- Figure 2 depicts a generally elliptical implant of the present invention.
- the temporary surgical implant 20 of the present invention is shown in Figure 1 and is generally spheri ⁇ cally shaped, although its spherical shape is a matter of design and is only chosen as being exemplary hereof.
- the implant 20 is comprised of a bladder-like shell 22 which is filled with a filler material 24 through a one-way valve 26.
- the bladder-like shell may be made of a sili ⁇ cone/polyurethane composite elastomer and the filler material 24 may be purified and sterile neutral triglyc ⁇ eride derived from soybean oil.
- the bladder 22 may be made from any one or more of the following materials: linear aliphatic polyether urethane; linear aliphatic polyester urethane; cyclic aliphatic polyether urethane; cyclic aliphatic polyester urethane; aromatic polyether urethane; aromatic polyester urethane; poly- butylene; polypropylene; crosslinked olefinic elastomers; and styrene-ethylene/butylene-styrene block copolymer.
- the implant 20 is substantially radiolucent at reduced levels of radiation energy. This radiolucency is readily achieved by any material which has an effective atomic number (Z) which is substantially equal to 6.0 within a range of ⁇ 0.5. It is well known and understood in the art that virtually any material is radiolucent presuming that the energy level of the x-ray (for exam ⁇ ple) is increased to an appropriate level. However, radiolucency at reduced levels, such as is used for mam- mography, is not as readily achieved and such reduced level radiolucency is intended for optimum effect with the present invention. Another benefit of using the filler materials disclosed herein is that they are all considered to be biocompatible.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Transplantation (AREA)
- Surgery (AREA)
- Dermatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pathology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Prostheses (AREA)
- Radiation-Therapy Devices (AREA)
- Materials For Medical Uses (AREA)
- Surgical Instruments (AREA)
Priority Applications (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU49982/93A AU682009B2 (en) | 1992-11-18 | 1993-08-06 | Radiolucent organ displacement device for radiation therapy |
| JP6512057A JPH08503628A (ja) | 1992-11-18 | 1993-08-06 | 放射線治療用放射線透過性器官変位装置 |
| EP93919899A EP0670700A1 (en) | 1992-11-18 | 1993-08-06 | Radiolucent organ displacement device for radiation therapy |
| CA002149644A CA2149644A1 (en) | 1992-11-18 | 1993-08-06 | Radiolucent organ displacement device for radiation therapy |
| BR9307470A BR9307470A (pt) | 1992-11-18 | 1993-08-06 | Implante |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US97789192A | 1992-11-18 | 1992-11-18 | |
| US07/977,891 | 1992-11-18 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO1994010937A1 true WO1994010937A1 (en) | 1994-05-26 |
Family
ID=25525613
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US1993/007383 WO1994010937A1 (en) | 1992-11-18 | 1993-08-06 | Radiolucent organ displacement device for radiation therapy |
Country Status (7)
Cited By (1)
| 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 |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101048106B (zh) | 2004-06-23 | 2011-12-14 | 生物保护有限公司 | 用于组织移除或分离的设备系统和方法 |
| US8080057B2 (en) * | 2005-08-09 | 2011-12-20 | Steven J. Kronowitz | Methods and devices for breast reconstruction |
| US20100137999A1 (en) * | 2007-03-15 | 2010-06-03 | Bioprotect Led. | Soft tissue fixation devices |
| CN101854886B (zh) * | 2007-03-15 | 2014-12-24 | 矫正-空位有限公司 | 假体装置及其使用方法 |
| WO2008139473A2 (en) | 2007-05-14 | 2008-11-20 | Bioprotect Ltd. | Delivery device for delivering bioactive agents to internal tissue in a body |
| EP2521586A4 (en) | 2010-01-07 | 2013-06-19 | Bioprotect Ltd | SYSTEMS AND METHOD FOR CONTROLLED TISSUE DESIGNATION |
| US20130116794A1 (en) | 2010-08-04 | 2013-05-09 | Shaul Shohat | Shoulder implant |
| WO2013057566A2 (en) | 2011-10-18 | 2013-04-25 | Ortho-Space Ltd. | Prosthetic devices and methods for using same |
| ES2721007T3 (es) | 2012-09-17 | 2019-07-26 | Jamm Tech Inc | Implantes de mama con transpondedores integrados |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4671255A (en) * | 1985-10-16 | 1987-06-09 | Mcghan Medical Corporation | Tissue expander with self-contained injection reservoir and reinforcing insert |
| US4995882A (en) * | 1989-08-28 | 1991-02-26 | Washington University | Radiolucent breast implant |
| US5133742A (en) * | 1990-06-15 | 1992-07-28 | Corvita Corporation | Crack-resistant polycarbonate urethane polymer prostheses |
Family Cites Families (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3293663A (en) * | 1963-08-12 | 1966-12-27 | Dow Corning | Surgically implantable human breast prosthesis |
| US3665520A (en) * | 1970-10-07 | 1972-05-30 | Medical Eng Corp | Surgically implantable breast prosthesis |
| US3954102A (en) * | 1974-07-19 | 1976-05-04 | American Medical Systems, Inc. | Penile erection system and methods of implanting and using same |
| US4197846A (en) * | 1974-10-09 | 1980-04-15 | Louis Bucalo | Method for structure for situating in a living body agents for treating the body |
| US4205401A (en) * | 1978-05-25 | 1980-06-03 | Dow Corning Corporation | Mammary prosthesis which resists capsular contracture |
| US4298998A (en) * | 1980-12-08 | 1981-11-10 | Naficy Sadeque S | Breast prosthesis with biologically absorbable outer container |
| US4550720A (en) * | 1983-11-15 | 1985-11-05 | Medical Engineering Corporation | Capacitance device for medical implant |
| US4648880A (en) * | 1984-08-30 | 1987-03-10 | Daniel Brauman | Implantable prosthetic devices |
| US4731081A (en) * | 1984-09-11 | 1988-03-15 | Mentor Corporation | Rupture-resistant prosthesis with creasable shell and method of forming same |
| AU4798785A (en) * | 1984-10-03 | 1986-04-10 | Baylor College Of Medicine | Implant rupture mammography |
| US4795463A (en) * | 1984-10-03 | 1989-01-03 | Baylor College Of Medicine | Labeled breast prosthesis and methods for detecting and predicting rupture of the prosthesis |
| US4605691A (en) * | 1984-12-06 | 1986-08-12 | Biomatrix, Inc. | Cross-linked gels of hyaluronic acid and products containing such gels |
| US4636213A (en) * | 1985-01-24 | 1987-01-13 | Pakiam Anthony I | Implantable prosthesis |
| US4863470A (en) * | 1985-03-19 | 1989-09-05 | Medical Engineering Corporation | Identification marker for a breast prosthesis |
| US4592755A (en) * | 1985-06-11 | 1986-06-03 | Ethyl Corporation | Mammary implant |
| US4694827A (en) * | 1986-01-14 | 1987-09-22 | Weiner Brian C | Inflatable gastric device for treating obesity and method of using the same |
| US5101813A (en) * | 1986-07-17 | 1992-04-07 | Medical Engineering Corporation | Penile erectile system and method for sterilization |
| US4726360A (en) * | 1986-07-17 | 1988-02-23 | Medical Engineering Corporation | Penile prosthesis |
| US4772287A (en) * | 1987-08-20 | 1988-09-20 | Cedar Surgical, Inc. | Prosthetic disc and method of implanting |
| US4899764A (en) * | 1987-12-17 | 1990-02-13 | Dow Corning Wright | Tissue expander and method of making and using |
| US5067965A (en) * | 1990-03-20 | 1991-11-26 | Bioplasty, Inc. | Bio-osmotic gel for implant prostheses |
| US5258026A (en) * | 1992-02-06 | 1993-11-02 | Johnson Gerald W | Endoscopic augmentation mammoplasty and instruments therefor |
| US5391203A (en) * | 1992-04-13 | 1995-02-21 | Scott P. Bartlett | Method of draining and filling soft tissue implant |
| JP3084982B2 (ja) * | 1992-11-25 | 2000-09-04 | 富士電機株式会社 | 半導体装置 |
-
1993
- 1993-08-06 CA CA002149644A patent/CA2149644A1/en not_active Abandoned
- 1993-08-06 WO PCT/US1993/007383 patent/WO1994010937A1/en not_active Application Discontinuation
- 1993-08-06 JP JP6512057A patent/JPH08503628A/ja active Pending
- 1993-08-06 EP EP93919899A patent/EP0670700A1/en not_active Withdrawn
- 1993-08-06 AU AU49982/93A patent/AU682009B2/en not_active Ceased
- 1993-08-06 BR BR9307470A patent/BR9307470A/pt not_active Application Discontinuation
-
1995
- 1995-06-06 US US08/469,479 patent/US5653758A/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4671255A (en) * | 1985-10-16 | 1987-06-09 | Mcghan Medical Corporation | Tissue expander with self-contained injection reservoir and reinforcing insert |
| US4995882A (en) * | 1989-08-28 | 1991-02-26 | Washington University | Radiolucent breast implant |
| US5133742A (en) * | 1990-06-15 | 1992-07-28 | Corvita Corporation | Crack-resistant polycarbonate urethane polymer prostheses |
Non-Patent Citations (1)
| Title |
|---|
| See also references of EP0670700A4 * |
Cited By (1)
| 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 |
Also Published As
| Publication number | Publication date |
|---|---|
| AU4998293A (en) | 1994-06-08 |
| US5653758A (en) | 1997-08-05 |
| BR9307470A (pt) | 1999-06-01 |
| EP0670700A4 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html) | 1995-10-18 |
| CA2149644A1 (en) | 1994-05-26 |
| JPH08503628A (ja) | 1996-04-23 |
| AU682009B2 (en) | 1997-09-18 |
| EP0670700A1 (en) | 1995-09-13 |
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