US3834378A - Intrauterine device - Google Patents
Intrauterine device Download PDFInfo
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- US3834378A US3834378A US00336066A US33606673A US3834378A US 3834378 A US3834378 A US 3834378A US 00336066 A US00336066 A US 00336066A US 33606673 A US33606673 A US 33606673A US 3834378 A US3834378 A US 3834378A
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- United States
- Prior art keywords
- composition
- plastic matrix
- intrauterine
- accordance
- intrauterine device
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- Expired - Lifetime
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- 229910052751 metal Inorganic materials 0.000 claims abstract description 46
- 239000002184 metal Substances 0.000 claims abstract description 46
- 229920003023 plastic Polymers 0.000 claims abstract description 46
- 239000004033 plastic Substances 0.000 claims abstract description 46
- 239000011159 matrix material Substances 0.000 claims abstract description 45
- 150000003839 salts Chemical class 0.000 claims abstract description 36
- 239000011236 particulate material Substances 0.000 claims abstract description 34
- 239000002131 composite material Substances 0.000 claims abstract description 33
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 21
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 claims abstract description 20
- 239000010949 copper Substances 0.000 claims abstract description 19
- 230000035699 permeability Effects 0.000 claims abstract description 17
- 229910052802 copper Inorganic materials 0.000 claims abstract description 15
- VGGSQFUCUMXWEO-UHFFFAOYSA-N Ethene Chemical compound C=C VGGSQFUCUMXWEO-UHFFFAOYSA-N 0.000 claims abstract description 11
- 239000005977 Ethylene Substances 0.000 claims abstract description 11
- 229920001577 copolymer Polymers 0.000 claims abstract description 11
- BQCADISMDOOEFD-UHFFFAOYSA-N Silver Chemical compound [Ag] BQCADISMDOOEFD-UHFFFAOYSA-N 0.000 claims abstract description 7
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 claims abstract description 7
- 229910052709 silver Inorganic materials 0.000 claims abstract description 7
- 239000004332 silver Substances 0.000 claims abstract description 7
- 229910052725 zinc Inorganic materials 0.000 claims abstract description 7
- 239000011701 zinc Substances 0.000 claims abstract description 7
- 229910052793 cadmium Inorganic materials 0.000 claims abstract description 6
- BDOSMKKIYDKNTQ-UHFFFAOYSA-N cadmium atom Chemical compound [Cd] BDOSMKKIYDKNTQ-UHFFFAOYSA-N 0.000 claims abstract description 6
- 239000000203 mixture Substances 0.000 claims description 30
- 239000000463 material Substances 0.000 claims description 25
- 210000004291 uterus Anatomy 0.000 claims description 9
- 239000003433 contraceptive agent Substances 0.000 claims description 8
- 230000002254 contraceptive effect Effects 0.000 claims description 8
- 239000000178 monomer Substances 0.000 claims description 6
- 125000000391 vinyl group Chemical group [H]C([*])=C([H])[H] 0.000 claims description 6
- 229920002554 vinyl polymer Polymers 0.000 claims description 6
- 229910000365 copper sulfate Inorganic materials 0.000 claims description 4
- ARUVKPQLZAKDPS-UHFFFAOYSA-L copper(II) sulfate Chemical compound [Cu+2].[O-][S+2]([O-])([O-])[O-] ARUVKPQLZAKDPS-UHFFFAOYSA-L 0.000 claims description 4
- 229910000366 copper(II) sulfate Inorganic materials 0.000 claims description 4
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 abstract description 10
- TZCXTZWJZNENPQ-UHFFFAOYSA-L barium sulfate Chemical compound [Ba+2].[O-]S([O-])(=O)=O TZCXTZWJZNENPQ-UHFFFAOYSA-L 0.000 abstract description 8
- XTXRWKRVRITETP-UHFFFAOYSA-N Vinyl acetate Chemical compound CC(=O)OC=C XTXRWKRVRITETP-UHFFFAOYSA-N 0.000 abstract description 6
- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 abstract description 5
- 230000005540 biological transmission Effects 0.000 abstract description 5
- 229910052697 platinum Inorganic materials 0.000 abstract description 5
- 150000002739 metals Chemical class 0.000 abstract description 4
- 230000009286 beneficial effect Effects 0.000 description 3
- -1 polyethylene Polymers 0.000 description 3
- 241000255789 Bombyx mori Species 0.000 description 2
- 230000003399 chemotactic effect Effects 0.000 description 2
- 238000007796 conventional method Methods 0.000 description 2
- 238000003780 insertion Methods 0.000 description 2
- 230000037431 insertion Effects 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 230000003151 ovacidal effect Effects 0.000 description 2
- 230000001150 spermicidal effect Effects 0.000 description 2
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 description 1
- 206010003497 Asphyxia Diseases 0.000 description 1
- 229910000906 Bronze Inorganic materials 0.000 description 1
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 description 1
- 229910002651 NO3 Inorganic materials 0.000 description 1
- NHNBFGGVMKEFGY-UHFFFAOYSA-N Nitrate Chemical compound [O-][N+]([O-])=O NHNBFGGVMKEFGY-UHFFFAOYSA-N 0.000 description 1
- 239000004677 Nylon Substances 0.000 description 1
- 229910019142 PO4 Inorganic materials 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 208000036029 Uterine contractions during pregnancy Diseases 0.000 description 1
- 230000004308 accommodation Effects 0.000 description 1
- 229910052784 alkaline earth metal Inorganic materials 0.000 description 1
- 150000001342 alkaline earth metals Chemical class 0.000 description 1
- 229910052788 barium Inorganic materials 0.000 description 1
- DSAJWYNOEDNPEQ-UHFFFAOYSA-N barium atom Chemical compound [Ba] DSAJWYNOEDNPEQ-UHFFFAOYSA-N 0.000 description 1
- 239000010974 bronze Substances 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000013270 controlled release Methods 0.000 description 1
- KUNSUQLRTQLHQQ-UHFFFAOYSA-N copper tin Chemical compound [Cu].[Sn] KUNSUQLRTQLHQQ-UHFFFAOYSA-N 0.000 description 1
- 230000002357 endometrial effect Effects 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 239000003317 industrial substance Substances 0.000 description 1
- 150000002500 ions Chemical class 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 229910021645 metal ion Inorganic materials 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 229920001778 nylon Polymers 0.000 description 1
- 229940127234 oral contraceptive Drugs 0.000 description 1
- 239000003539 oral contraceptive agent Substances 0.000 description 1
- 231100000194 ovacidal Toxicity 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 229920002689 polyvinyl acetate Polymers 0.000 description 1
- 239000011118 polyvinyl acetate Substances 0.000 description 1
- 229920000915 polyvinyl chloride Polymers 0.000 description 1
- 239000004800 polyvinyl chloride Substances 0.000 description 1
- 229920002379 silicone rubber Polymers 0.000 description 1
- 239000004945 silicone rubber Substances 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
Images
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
- A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
- A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
- A61F6/14—Contraceptive devices; Pessaries; Applicators therefor for use by females intra-uterine type
- A61F6/148—Contraceptive devices; Pessaries; Applicators therefor for use by females intra-uterine type with sheet-like structure
-
- 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
- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
Definitions
- An intrauterine device composite which comprises a plastic matrix, such as a copolymer of ethylene and vinyl acetate, having a particulate material selected from the group consisting of metals such as copper, zinc, silver, platinum, or cadmium, and metal salts dispersed within the matrix.
- the particulate preferably includes both a metal and a salt, such as a sulfate, thereof, although solely a salt or a metal particulate may be utilized.
- a radio-opaque particulate such as barium sulfate is preferably also dispersed within the composite.
- the particulate material preferably comprises between 0.1% to 50% by weight of the composite, and the matrix preferably has a water permeability or rate of water vapor transmission of at least 0.3 grams/100 square inches/24 hours/mil at 25 C.
- the present invention relates to intrauterine device composites and more particularly to such composites comprising a plastic matrix having a particulate material dispersed therein.
- Prior art intrauterine devices have utilized structures including a metal wire in order to obtain improved results. Such prior art devices have involved the use of a plastic T-shaped device having a fine copper wire wrapped about the upper end of the stem of the T, a silkworm gut wrapped in a bronze wire,- and a copper loop having a silkworm gut tail. These prior art intrauterine devices, however, are bulky, difficult to insert, and are not necessarily well tolerated within the uterine cavity. Moreover, whenever any beneficial effect has been observed, a substantial quantity of time has been required before such beneficial effects occur, resulting in a lag time between insertion of the device and achievement of the benefits thereof.
- An intrauterine device composite which comprises a plastic matrix having a particulate material dispersed within the matrix.
- the particulate material is selected from the group consisting of metals and metal salts and comprises between 0.1% and 50% by weight of the composite.
- the particulate preferably includes both a metal and a salt, such as a sulfate thereof, although solely a metal or a salt particulate may be utilized.
- a radio-opaque particulate such as barium sulfate, is preferably also dispersed within the matrix.
- the plastic matrix preferably has a water permeability or rate of water vapor transmission of at least 0.3 grams/ 100 square inches/24 hours/mil at 25 C.
- FIGURE is a diagrammatic illustration exemplary of an intrauterine device composite in accordance with the preferred embodiment of the present invention.
- the shield device 10 disclosed in co-pending application, Ser. No. 775,729 preferably has a contour which conforms to the mid-range of the uterine cavity, and has a plurality of lateral fins 1212 which promote retention and permit accommodation to uterine contractions and variations in uterine shape extending outwardly from a central membrane portion 14.
- the central membrane portion 14 increases endometrial surface contact, as well as precludes bowel strangulation in the event of perforation.
- the present invention is not limited to the shield type of intrauterine device, but rather is applicable to all types of intrauterine devices, the shield type 10 only being shown and described by way of example.
- the intrauterine device.l0 is a composite formed of a plastic material such as a copolymer of ethylene and vinyl acetate, polyvinyl acetate, polyethylene, polypropylene, polyvinyl chloride, nylon, or silicone rubber, such as disclosed in co-pending patent application, Ser. No. 775,729.
- the plastic material is a copolymer of ethylene and vinyl acetate, such as UE 632, manufactured by United States Industrial Chemical Corporation, which contains 13-15% vinyl acetate by weight.
- the plastic matrix of which the intrauterine device 10 is preferably constructed has dispersed therein particulate material.
- the particulate material preferably includes a metal and a salt thereof, although it may comprise solely a metal or a salt.
- metals which are satisfactory for purposes of the present invention are copper, zinc, silver, platinum, or cadmium. Mostpreferably, copper particulate is preferred.
- metal salts which are satisfactory include salts of copper, zinc, silver, platinum, or cadmium.
- the salt is preferably a sulfate, carbonate, nitrate, acetate or phosphate. Most preferably, the salt is a sulfate of the metal particulate.
- the particulate metal in the intrauterine device composite 10 is at least 0.1% by weight of the overall composite.
- the metal salt is, preferably, at least 0.5% by weight of the overall composite.
- the preferred overall content of metal plus metal salt in the composite should not exceed 50% by weight of the overall composite, thereby providing a preferred range of total particulate, by weight, in the overall composite of between 0.1% to 50% by weight.
- the requisite amount of particulate material, which is biologically active is preferably related to the water permeability or rate of water vapor transmission of the plastic matrix, which is biologically inert.
- the greater the permeability of the plastic the less the requisite amount of active particulate that need be present. Conversely, the lower the permeability, the greater the requisite amount of active particulate that shouldpreferably by present.
- the water permeability or rate of water vapor transmission of the plastic is at least 0.3 grams/ square inches/24 hours/mil at 25 C.. If desired, better results may be obtained with a water permeability of at least 5 grams/I00 square inches/24 hours/mil at 25C.. Most preferably this rate is at least 10 grams/100 square inches/24 hours/mil at 25 C..
- a radioopaque particulate material may also be dispersed therein.
- this radio-opaque material is a salt of an alkaline earth metal, such as barium.
- this salt is barium sulfate.
- the resulting intrauterine device compsite consists of a plastic matrix having the particulate material dispersed throughout the matrix.
- the particulate generally referred to by the reference numeral 16, shown in the FIGURE.
- the intrauterine device composite comprises a plastic matrix of a copolymer of ethylene and vinyl acetate having a particulate of copper and cupric sulfate dispersed throughout the matrix, with the percent by weight of tlie copper and cupric sulfate particulate being between 0.5% to 10% by weight of the composite, and the water permeability of the plastic being at least 10 grams/100 square inches/24 hours/mil at 25
- the presence in the water permeable plastic matrix of the biologically active metal particulate which preferably does not exceed an amount which degrades the plastic matrix so as to eliminate the beneficial flexibility thereof, assists the tensile strength, flowability for molding and other physical properties of the intrauterine device composite.
- the presence of the metal salt particulate which is preferably a salt which is capable of relatively rapid ionization after insertion of the intrauterine device composite within'the uterine cavity, is believed to ionize much more rapidly than the free metal particulate and causes rapid release of metal ions.
- the metal salt particulate is preferably a salt which is capable of relatively rapid ionization after insertion of the intrauterine device composite within'the uterine cavity.
- the metal salt particulate is preferably a salt which is capable of relatively rapid ionization after insertion of the intrauterine device composite within'the uterine cavity
- the ionization of the salt provides early protection, whereas protection at a later time is provided by the chemotactic effect of the plastic matrix.
- the biologically active particulate is capable of enhancing the chemotactic effect of the otherwise relatively inert plastic material. By virtue of the controlled release of the biologically active particulate, relatively low concentrations thereof are capable of exerting a gameto toxic effect.
- the presence of the metal salt and/or metal exerts a spermicidal and/or ovacidal action or causes the tissue to react in such a manner so as to produce a material which itself is spermicidal and/or ovacidal
- the presence of the metal in the ion state accelerates this action, and the rapid ionization of the metal salt enhances this result.
- an intrauterine device composite By utilizing an intrauterine device composite in accordance with the preferred embodiment of the present invention, the properties and capabilities of an intrauterine device are markedly enhanced.
- An intrauterine device having a body'structure encompassing an area which can be contained within a normal uterus, made from a composition enabling flexing to conform to the uterine cavity comprising: a plastic matrix, and a particulate material comprising at least one non-magnetic metal selected from a group consisting of copper, zinc, silver, platinum and cad- .mium, and at least one salt of a metal selected from said group; said particulate material being dispersed within said plastic matrix; and said particulate material comprising between 0.1% to 10% by weight of the composition of said device.
- An intrauterine device having a composition in accordance with claim 1, wherein said particulate material comprises a metal and a salt of said metal.
- An intrauterine device having a composition in accordance with claim 1, wherein the material comprising said plastic matrix has a water permeability of at least 0.3 grams/ square inches/24 hours/mil at a temperature of 25 Centigrade.
- An intrauterine device having a composition in accordance with claim 1, wherein the material comprising said plastic matrix has a water permeability of at least 10 grams/ 100 square inches/24 hours/mil at a temperature of 25 Centigrade.
- An intrauterine device having a composition in accordance with claim 1, wherein said material comprising the plastic matrix is a copolymer of ethylene and a vinyl monomer material.
- An intrauterine contraceptive device made from a composition material as defined in claim 1 enabling flexing to conform to the uterine cavity, further comprising: a'central body having a perimeter portion with nose, tail and side portions and encompassing an area which can be contained within a normal uterus, and at least three spaced apart short spurs on each of said side portions extending outwardly from said perimeter portion.
- An intrauterine device having a composition in accordance with claim 6, wherein said material comprising the plastic matrix is a copolymer of ethylene and a vinyl monomer material.
- An intrauterine contraceptive device made from a composition material as defined in claim 1 enabling flexing to conform to the uterine cavity, further comprising; a ring-like perimeter portion having a nose portion and opposite therefrom a tail portion with side portions joining said nose and tail portions; and a plurality of spur-like retaining means extending outwardly from each said side portion.
- An intrauterine device having a composition in accordance with claim 8, wherein said particulate material comprises a metal and a salt of said metal.
- An intrauterine device having a composition in accordance with claim 9, wherein said material comprising the plastic matrix is a copolymer of ethylene and a vinyl monomer material.
- An intrauterine device having a body structure encompassing an area which can be contained within a normal uterus, made from a composition enabling flexing to conform to the uterine cavity comprising: a plastic matrix, and a particulate material comprising at least copper and a salt of copper; said particulate material being dispersed within said plastic matrix; and said particulate material comprising between 0.1% to 10% by weight of the composition of said device.
- An intrauterine device having a composition in accordance with claim 1 1; wherein said particulate material comprises copper and cupric sulfate.
- An intrauterine device having a composition in accordance with claim 12, wherein the material comprising said plastic matrix has a water permeability of at least 0.3 grams/100 square inches/24 hours/mil at a temperature of 25 Centigrade.
- An intrauterine device having a composition in accordance with claim 12, wherein the material comprising said plastic matrix has a water permeability of at least grams/ 100 square inches/24 hours/mil at a temperature of 25 Centigrade.
- An intrauterine contraceptive device made from a composition material as defined in claim 12, enabling flexing to conform to the uterine cavity, further comprising: a central body having a perimeter portion with nose, tail and side portions and encompassing an area which can be contained within a normal uterus, and at least three spaced apart short spurs on each of said side portions extending outwardly from said perimeter portion.
- An intrauterine contraceptive device made from a composition material as defined in claim 12, enabling flexing to conform to the uterine cavity, further comprising; a ring-like perimeter portion having a nose portion and opposite therefrom a tail portion with side portions joining said nose and tail portions; and a plurality of spur-like retaining means extending outwardly from each said side portion.
- An intrauterine device having a body structure encompassing an area which can be contained within a normal uterus, made from a composition enabling flexing to conform to the uterine cavity comprising: a plastic matrix, and a particulate material comprising at least copper and at least one salt of a metal selected from a group consisting of copper, zinc, silver, platinium and cadmium; said particulate material being dispersed within said plastic matrix; and said particulate material comprising between 0.1% to 10% by weight of the composition of said device.
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- Health & Medical Sciences (AREA)
- Reproductive Health (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
An intrauterine device composite is provided which comprises a plastic matrix, such as a copolymer of ethylene and vinyl acetate, having a particulate material selected from the group consisting of metals such as copper, zinc, silver, platinum, or cadmium, and metal salts dispersed within the matrix. The particulate preferably includes both a metal and a salt, such as a sulfate, thereof, although solely a salt or a metal particulate may be utilized. In addition, a radio-opaque particulate such as barium sulfate is preferably also dispersed within the composite. The particulate material preferably comprises between 0.1% to 50% by weight of the composite, and the matrix preferably has a water permeability or rate of water vapor transmission of at least 0.3 grams/100 square inches/24 hours/mil at 25* C.
Description
United States Patent [191 Lerner et a1.
[ INTRAUTERINE DEVICE [75] Inventors: Irwin S. Lerner, Greenwich, Conn;
Hugh J. Davis, Baltimore, Md.; Thad J. Earl, Defiance, Ohio [73] Assignee: A. H. Robins Company,
Incorporated, Richmond, Va.
[22] Filed: Feb. 26, 1973 [21] Appl. No.: 336,066
Related US. Application Data [63] Continuation of Ser. No. 88,538, Nov. 12, 1970,
abandoned.
[52] US. Cl. 128/130, 424/ 14 [51] Int. Cl. A61f 5/46 [58] Field of Search 128/130, 131; 424/14, 16, 424/22 [56] References Cited UNITED STATES PATENTS 3,306,286 2/1967 Ahmed .Q. 128/130 3,563,235 2/1971 Zipper 128/130 3,633,574 l/l972 Lerner 128/130 Sept. 10, 1974 Primary Examiner-Richard A. Gaudet Assistant Examiner-G. F. Dunne Attorney, Agent, or FirmStrauch, Nolan, Neale, Nies & Kurz [5 7] ABSTRACT An intrauterine device composite is provided which comprises a plastic matrix, such as a copolymer of ethylene and vinyl acetate, having a particulate material selected from the group consisting of metals such as copper, zinc, silver, platinum, or cadmium, and metal salts dispersed within the matrix. The particulate preferably includes both a metal and a salt, such as a sulfate, thereof, although solely a salt or a metal particulate may be utilized. In addition, a radio-opaque particulate such as barium sulfate is preferably also dispersed within the composite. The particulate material preferably comprises between 0.1% to 50% by weight of the composite, and the matrix preferably has a water permeability or rate of water vapor transmission of at least 0.3 grams/100 square inches/24 hours/mil at 25 C.
17 Claims, 1 Drawing Figure PATENTEDSEFTOIQN v 3.334.373
, INVENTORS IRWIN S. LERNER HUGH J. DAVIS THAD J. EARL ATTORNEYS.
INTRAUTERINE'DEVICE CROSS REFERENCE TO RELATED APPLICATION This application is a continuation of application Ser. No. 88,538 filed Nov. 12, 1970 and now abandoned.
BACKGROUND OF THE INVENTION l. Field of the Invention The present invention relates to intrauterine device composites and more particularly to such composites comprising a plastic matrix having a particulate material dispersed therein.
2. Description of the Prior Art Prior art intrauterine devices have utilized structures including a metal wire in order to obtain improved results. Such prior art devices have involved the use of a plastic T-shaped device having a fine copper wire wrapped about the upper end of the stem of the T, a silkworm gut wrapped in a bronze wire,- and a copper loop having a silkworm gut tail. These prior art intrauterine devices, however, are bulky, difficult to insert, and are not necessarily well tolerated within the uterine cavity. Moreover, whenever any beneficial effect has been observed, a substantial quantity of time has been required before such beneficial effects occur, resulting in a lag time between insertion of the device and achievement of the benefits thereof. In addition, in intrauterine devices employing a'wire wrapped about a T-stem, the wire tends to dissolve and break up thus minimizing its long range effectiveness. Furthermore, such prior art devices have a relatively low surface area for the metal which, thereby, also minimizes their effectiveness. Due to these disadvantages, prior art intrauterine devices have not achieved the wide spread usage enjoyed by oral contraceptives. The present invention overcomes these disadvantages of the prior art.
SUMMARY OF THE INVENTION An intrauterine device composite is provided which comprises a plastic matrix having a particulate material dispersed within the matrix. The particulate material is selected from the group consisting of metals and metal salts and comprises between 0.1% and 50% by weight of the composite. The particulate preferably includes both a metal and a salt, such as a sulfate thereof, although solely a metal or a salt particulate may be utilized. In addition, a radio-opaque particulate, such as barium sulfate, is preferably also dispersed within the matrix. The plastic matrix preferably has a water permeability or rate of water vapor transmission of at least 0.3 grams/ 100 square inches/24 hours/mil at 25 C.
BREIF DESCRIPTION OF THE DRAWING The FIGURE is a diagrammatic illustration exemplary of an intrauterine device composite in accordance with the preferred embodiment of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT shown. The shield device 10 disclosed in co-pending application, Ser. No. 775,729, preferably has a contour which conforms to the mid-range of the uterine cavity, and has a plurality of lateral fins 1212 which promote retention and permit accommodation to uterine contractions and variations in uterine shape extending outwardly from a central membrane portion 14. As disclosed in copending application, Ser. No. 775,729, the central membrane portion 14 increases endometrial surface contact, as well as precludes bowel strangulation in the event of perforation. However, the present invention is not limited to the shield type of intrauterine device, but rather is applicable to all types of intrauterine devices, the shield type 10 only being shown and described by way of example.
Preferably, the intrauterine device.l0, as shown and preferred in the FIGURE, is a composite formed of a plastic material such as a copolymer of ethylene and vinyl acetate, polyvinyl acetate, polyethylene, polypropylene, polyvinyl chloride, nylon, or silicone rubber, such as disclosed in co-pending patent application, Ser. No. 775,729. Most preferably, the plastic material is a copolymer of ethylene and vinyl acetate, such as UE 632, manufactured by United States Industrial Chemical Corporation, which contains 13-15% vinyl acetate by weight. As shown and preferred, in addition, the plastic matrix of which the intrauterine device 10 is preferably constructed, has dispersed therein particulate material. Most preferably, the particulate is dispersed throughout the plastic matrix. The particulate material preferably includes a metal and a salt thereof, although it may comprise solely a metal or a salt. By way of example, metals which are satisfactory for purposes of the present invention are copper, zinc, silver, platinum, or cadmium. Mostpreferably, copper particulate is preferred. By way of example, metal salts which are satisfactory include salts of copper, zinc, silver, platinum, or cadmium. The salt is preferably a sulfate, carbonate, nitrate, acetate or phosphate. Most preferably, the salt is a sulfate of the metal particulate.
Preferably, the particulate metal in the intrauterine device composite 10 is at least 0.1% by weight of the overall composite. The metal salt is, preferably, at least 0.5% by weight of the overall composite. In addition, the preferred overall content of metal plus metal salt in the composite should not exceed 50% by weight of the overall composite, thereby providing a preferred range of total particulate, by weight, in the overall composite of between 0.1% to 50% by weight.
The requisite amount of particulate material, which is biologically active, is preferably related to the water permeability or rate of water vapor transmission of the plastic matrix, which is biologically inert. The greater the permeability of the plastic, the less the requisite amount of active particulate that need be present. Conversely, the lower the permeability, the greater the requisite amount of active particulate that shouldpreferably by present. Preferably the water permeability or rate of water vapor transmission of the plastic is at least 0.3 grams/ square inches/24 hours/mil at 25 C.. If desired, better results may be obtained with a water permeability of at least 5 grams/I00 square inches/24 hours/mil at 25C.. Most preferably this rate is at least 10 grams/100 square inches/24 hours/mil at 25 C..
In addition to the presence of a particulate of a metal and a salt thereof in the preferred composite, a radioopaque particulate material may also be dispersed therein. Preferably, this radio-opaque material is a salt of an alkaline earth metal, such as barium. Most preferably, this salt is barium sulfate.
In order to form the intrauterine device composite, conventional techniques may be utilized. Once such preferred conventional technique requires intimately admixing particles of the desired plastic with finely ground particulate metal and particulate metal salts at a sufficiently high temperature for a sufficient time in order to obtain a homogeneous-like phase. The resultant impregnated plastic having the particulate material dispersed throughout is then molded under heat and pressure in a conventional manner to readily form any desired configuration such as the shield configuration illustrated in the FIGURE.
The resulting intrauterine device compsite consists of a plastic matrix having the particulate material dispersed throughout the matrix. This is illustratively shown by the particulate, generally referred to by the reference numeral 16, shown in the FIGURE. Most preferably, the intrauterine device composite comprises a plastic matrix of a copolymer of ethylene and vinyl acetate having a particulate of copper and cupric sulfate dispersed throughout the matrix, with the percent by weight of tlie copper and cupric sulfate particulate being between 0.5% to 10% by weight of the composite, and the water permeability of the plastic being at least 10 grams/100 square inches/24 hours/mil at 25 The presence in the water permeable plastic matrix of the biologically active metal particulate which preferably does not exceed an amount which degrades the plastic matrix so as to eliminate the beneficial flexibility thereof, assists the tensile strength, flowability for molding and other physical properties of the intrauterine device composite. In addition, the presence of the metal salt particulate, which is preferably a salt which is capable of relatively rapid ionization after insertion of the intrauterine device composite within'the uterine cavity, is believed to ionize much more rapidly than the free metal particulate and causes rapid release of metal ions. When only a metal salt particulate is utilized, the ionization of the salt provides early protection, whereas protection at a later time is provided by the chemotactic effect of the plastic matrix. Preferably, the biologically active particulate is capable of enhancing the chemotactic effect of the otherwise relatively inert plastic material. By virtue of the controlled release of the biologically active particulate, relatively low concentrations thereof are capable of exerting a gameto toxic effect.
Whether the presence of the metal salt and/or metal exerts a spermicidal and/or ovacidal action or causes the tissue to react in such a manner so as to produce a material which itself is spermicidal and/or ovacidal, the presence of the metal in the ion state accelerates this action, and the rapid ionization of the metal salt enhances this result.
By utilizing an intrauterine device composite in accordance with the preferred embodiment of the present invention, the properties and capabilities of an intrauterine device are markedly enhanced.
What is claimed is:
1. An intrauterine device having a body'structure encompassing an area which can be contained within a normal uterus, made from a composition enabling flexing to conform to the uterine cavity comprising: a plastic matrix, and a particulate material comprising at least one non-magnetic metal selected from a group consisting of copper, zinc, silver, platinum and cad- .mium, and at least one salt of a metal selected from said group; said particulate material being dispersed within said plastic matrix; and said particulate material comprising between 0.1% to 10% by weight of the composition of said device.
2. An intrauterine device having a composition in accordance with claim 1, wherein said particulate material comprises a metal and a salt of said metal.
3. An intrauterine device having a composition in accordance with claim 1, wherein the material comprising said plastic matrix has a water permeability of at least 0.3 grams/ square inches/24 hours/mil at a temperature of 25 Centigrade.
4. An intrauterine device having a composition in accordance with claim 1, wherein the material comprising said plastic matrix has a water permeability of at least 10 grams/ 100 square inches/24 hours/mil at a temperature of 25 Centigrade.
5. An intrauterine device having a composition in accordance with claim 1, wherein said material comprising the plastic matrix is a copolymer of ethylene and a vinyl monomer material.
6. An intrauterine contraceptive device made from a composition material as defined in claim 1 enabling flexing to conform to the uterine cavity, further comprising: a'central body having a perimeter portion with nose, tail and side portions and encompassing an area which can be contained within a normal uterus, and at least three spaced apart short spurs on each of said side portions extending outwardly from said perimeter portion.
7. An intrauterine device having a composition in accordance with claim 6, wherein said material comprising the plastic matrix is a copolymer of ethylene and a vinyl monomer material.
8. An intrauterine contraceptive device made from a composition material as defined in claim 1 enabling flexing to conform to the uterine cavity, further comprising; a ring-like perimeter portion having a nose portion and opposite therefrom a tail portion with side portions joining said nose and tail portions; and a plurality of spur-like retaining means extending outwardly from each said side portion.
9. An intrauterine device having a composition in accordance with claim 8, wherein said particulate material comprises a metal and a salt of said metal.
10. An intrauterine device having a composition in accordance with claim 9, wherein said material comprising the plastic matrix is a copolymer of ethylene and a vinyl monomer material.
11. An intrauterine device having a body structure encompassing an area which can be contained within a normal uterus, made from a composition enabling flexing to conform to the uterine cavity comprising: a plastic matrix, and a particulate material comprising at least copper and a salt of copper; said particulate material being dispersed within said plastic matrix; and said particulate material comprising between 0.1% to 10% by weight of the composition of said device.
12. An intrauterine device having a composition in accordance with claim 1 1; wherein said particulate material comprises copper and cupric sulfate.
13. An intrauterine device having a composition in accordance with claim 12, wherein the material comprising said plastic matrix has a water permeability of at least 0.3 grams/100 square inches/24 hours/mil at a temperature of 25 Centigrade.
14. An intrauterine device having a composition in accordance with claim 12, wherein the material comprising said plastic matrix has a water permeability of at least grams/ 100 square inches/24 hours/mil at a temperature of 25 Centigrade.
15. An intrauterine contraceptive device made from a composition material as defined in claim 12, enabling flexing to conform to the uterine cavity, further comprising: a central body having a perimeter portion with nose, tail and side portions and encompassing an area which can be contained within a normal uterus, and at least three spaced apart short spurs on each of said side portions extending outwardly from said perimeter portion.
16. An intrauterine contraceptive device made from a composition material as defined in claim 12, enabling flexing to conform to the uterine cavity, further comprising; a ring-like perimeter portion having a nose portion and opposite therefrom a tail portion with side portions joining said nose and tail portions; and a plurality of spur-like retaining means extending outwardly from each said side portion.
17. An intrauterine device having a body structure encompassing an area which can be contained within a normal uterus, made from a composition enabling flexing to conform to the uterine cavity comprising: a plastic matrix, and a particulate material comprising at least copper and at least one salt of a metal selected from a group consisting of copper, zinc, silver, platinium and cadmium; said particulate material being dispersed within said plastic matrix; and said particulate material comprising between 0.1% to 10% by weight of the composition of said device.
Claims (16)
- 2. An intrauterine device having a composition in accordance with claim 1, wherein said particulate material comprises a metal and a salt of said metal.
- 3. An intrauterine device having a composition in accordance with claim 1, wherein the material comprising said plastic matrix has a water permeability of at least 0.3 grams/100 square inches/24 hours/mil at a temperature of 25* Centigrade.
- 4. An intrauterine device having a composition in accordance with claim 1, wherein the material comprising said plastic matrix has a water permeability of at least 10 grams/100 square inches/24 hours/mil at a temperature of 25* Centigrade.
- 5. An intrauterine device having a composition in accordance with claim 1, wherein said material comprising the plastic matrix is a copolymer of ethylene and a vinyl monomer material.
- 6. An intrauterine contraceptive device made from a composition material as defined in claim 1 enabling flexing to conform to the uterine cavity, further comprising: a central body having a perimeter portion with nose, tail and side portions and encompassing an area which can be contained within a normal uterus, and at least three spaced apart short spurs on each of said side portions extending outwardly from said perimeter portion.
- 7. An intrauterine device having a composition in accordance with claim 6, wherein said material comprising the plastic matrix is a copolymer of ethylene and a vinyl monomer material.
- 8. An intrauterine contraceptive device made from a composition material as defined in claim 1 enabling flexing to conform to the uterine cavity, further comprising; a ring-like perimeter portion having a nose portion and opposite therefrom a tail portion with side portions joining said nose and tail portions; and a plurality of spur-like retaining means extending outwardly from each said side portion.
- 9. An intrauterine device having a composition in accordance with claim 8, wherein said particulate material comprises a metal and a salt of said metal.
- 10. An intrauterine device having a composition in accordance with claim 9, wherein said material comprising the plastic matrix is a copolymer of ethylene and a vinyl monomer material.
- 11. An intrauterine device having a body structure encompassing an area which can be contained within a normal uterus, made from a composition enabling flexing to conform to the uterine cavity comprising: a plastic matrix, and a particulate material comprising at least copper and a salt of copper; said particulate material being dispersed within said plastic matrix; and said particulate material comprising between 0.1% to 10% by weight of the composition of said device.
- 12. An intrauterine device having a composition in accordance with claim 11; wherein said particulate material comprises copper and cupric sulfate.
- 13. An intrauterine device having a composition in accordance with claim 12, wherein the material comprising said plastic matrix has a water permeability of at least 0.3 grams/100 square inches/24 hours/mil at a temperature of 25* Centigrade.
- 14. An intrauterine device having a composition in accordance with claim 12, wherein the material comprising said plastic matrix has a water permeability of at least 10 grams/100 square inches/24 hours/mil at a temperature of 25* Centigrade.
- 15. An intrauterine contraceptive device made from a composition material as defined in claim 12, enabling flexing to conform to the uterine cavity, further comprising: a central body having a perimeter portion with nose, tail and side portions and encompassing an area which can be contained within a normal uterus, and at least three spaced apart short spurs on each of said side portions extending outwardly from sAid perimeter portion.
- 16. An intrauterine contraceptive device made from a composition material as defined in claim 12, enabling flexing to conform to the uterine cavity, further comprising; a ring-like perimeter portion having a nose portion and opposite therefrom a tail portion with side portions joining said nose and tail portions; and a plurality of spur-like retaining means extending outwardly from each said side portion.
- 17. An intrauterine device having a body structure encompassing an area which can be contained within a normal uterus, made from a composition enabling flexing to conform to the uterine cavity comprising: a plastic matrix, and a particulate material comprising at least copper and at least one salt of a metal selected from a group consisting of copper, zinc, silver, platinium and cadmium; said particulate material being dispersed within said plastic matrix; and said particulate material comprising between 0.1% to 10% by weight of the composition of said device.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US00336066A US3834378A (en) | 1970-11-12 | 1973-02-26 | Intrauterine device |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US8853870A | 1970-11-12 | 1970-11-12 | |
US00336066A US3834378A (en) | 1970-11-12 | 1973-02-26 | Intrauterine device |
Publications (1)
Publication Number | Publication Date |
---|---|
US3834378A true US3834378A (en) | 1974-09-10 |
Family
ID=26778776
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US00336066A Expired - Lifetime US3834378A (en) | 1970-11-12 | 1973-02-26 | Intrauterine device |
Country Status (1)
Country | Link |
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US (1) | US3834378A (en) |
Cited By (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4194503A (en) * | 1977-11-28 | 1980-03-25 | Csatary Laszlo K | Intra-uterine contraceptive device |
US4353363A (en) * | 1978-11-23 | 1982-10-12 | Angel Sopena Quesada | Intrauterine spermicide |
FR2526307A1 (en) * | 1982-05-04 | 1983-11-10 | Chirana Zavody Zdravotnicke | CONTRACEPTIVE INTRA-UTERINE STERILET BASED ON SYNTHETIC POLYMERS COMBINED WITH METAL AND MANUFACTURING METHOD |
US4807610A (en) * | 1987-09-08 | 1989-02-28 | Nauchno-Proizvodstvennoe Objedinenie "Medinstrument" | Intrauterine contraceptive device |
US4959216A (en) * | 1984-04-19 | 1990-09-25 | University Of Queensland | Contraceptive methods and delivery systems thereof |
US5146931A (en) * | 1988-08-15 | 1992-09-15 | Kurz Karl Heinz | Device to be placed in the uterus |
US5224493A (en) * | 1991-01-30 | 1993-07-06 | Cadco Corporation | Contraceptive intracervical device and novel nonsystemic agents for the prevention of conception and disease |
CN1307956C (en) * | 2005-11-26 | 2007-04-04 | 商丘雅康药械有限公司 | Nano silver intrauterine device |
WO2009122016A1 (en) * | 2008-04-02 | 2009-10-08 | Bayer Schering Pharma Oy | An intrauterine system |
US20220031497A1 (en) * | 2020-07-31 | 2022-02-03 | Kathleen EDMUNDS | Copper-including contraceptive shield |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3306286A (en) * | 1965-04-13 | 1967-02-28 | Schueler & Company | Intrauterine device |
US3563235A (en) * | 1968-09-18 | 1971-02-16 | Searle & Co | Intrauterine contraceptive method |
US3633574A (en) * | 1968-11-14 | 1972-01-11 | Robins Co Inc A H | Intrauterine contraceptive device |
-
1973
- 1973-02-26 US US00336066A patent/US3834378A/en not_active Expired - Lifetime
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3306286A (en) * | 1965-04-13 | 1967-02-28 | Schueler & Company | Intrauterine device |
US3563235A (en) * | 1968-09-18 | 1971-02-16 | Searle & Co | Intrauterine contraceptive method |
US3633574A (en) * | 1968-11-14 | 1972-01-11 | Robins Co Inc A H | Intrauterine contraceptive device |
Cited By (19)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4194503A (en) * | 1977-11-28 | 1980-03-25 | Csatary Laszlo K | Intra-uterine contraceptive device |
US4353363A (en) * | 1978-11-23 | 1982-10-12 | Angel Sopena Quesada | Intrauterine spermicide |
FR2526307A1 (en) * | 1982-05-04 | 1983-11-10 | Chirana Zavody Zdravotnicke | CONTRACEPTIVE INTRA-UTERINE STERILET BASED ON SYNTHETIC POLYMERS COMBINED WITH METAL AND MANUFACTURING METHOD |
US4959216A (en) * | 1984-04-19 | 1990-09-25 | University Of Queensland | Contraceptive methods and delivery systems thereof |
US4807610A (en) * | 1987-09-08 | 1989-02-28 | Nauchno-Proizvodstvennoe Objedinenie "Medinstrument" | Intrauterine contraceptive device |
US5146931A (en) * | 1988-08-15 | 1992-09-15 | Kurz Karl Heinz | Device to be placed in the uterus |
US5224493A (en) * | 1991-01-30 | 1993-07-06 | Cadco Corporation | Contraceptive intracervical device and novel nonsystemic agents for the prevention of conception and disease |
CN1307956C (en) * | 2005-11-26 | 2007-04-04 | 商丘雅康药械有限公司 | Nano silver intrauterine device |
WO2009122016A1 (en) * | 2008-04-02 | 2009-10-08 | Bayer Schering Pharma Oy | An intrauterine system |
CN101983041A (en) * | 2008-04-02 | 2011-03-02 | 拜耳先灵药品股份有限公司 | An intrauterine system |
US20110056501A1 (en) * | 2008-04-02 | 2011-03-10 | Bayer Schering Pharma Oy | Intrauterine system |
AU2009232105B2 (en) * | 2008-04-02 | 2014-04-03 | Bayer Oy | An intrauterine system |
US20150051481A1 (en) * | 2008-04-02 | 2015-02-19 | Bayer Oy | Intrauterine system |
EA021575B1 (en) * | 2008-04-02 | 2015-07-30 | Байер Ой | An intrauterine system |
TWI505820B (en) * | 2008-04-02 | 2015-11-01 | Bayer Oy | An intrauterine system |
KR101592615B1 (en) * | 2008-04-02 | 2016-02-05 | 베이어 오와이 | An intrauterine system |
US20170367876A1 (en) * | 2008-04-02 | 2017-12-28 | Bayer Oy | Intrauterine system |
US20220031497A1 (en) * | 2020-07-31 | 2022-02-03 | Kathleen EDMUNDS | Copper-including contraceptive shield |
US11684509B2 (en) * | 2020-07-31 | 2023-06-27 | Kathleen EDMUNDS | Copper-including contraceptive shield |
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Owner name: A.H. ROBINS COMPANY, INCORPORATED, A DE CORP. Free format text: CHANGE OF NAME;ASSIGNOR:A.H. ROBINS COMPANY, INCORPORATED, A CORP. OF VA (INTO);REEL/FRAME:005587/0178 Effective date: 19891213 |