CA1178864A - Intrauterine contraceptive devices and methods of manufacturing such devices - Google Patents

Intrauterine contraceptive devices and methods of manufacturing such devices

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Publication number
CA1178864A
CA1178864A CA000398648A CA398648A CA1178864A CA 1178864 A CA1178864 A CA 1178864A CA 000398648 A CA000398648 A CA 000398648A CA 398648 A CA398648 A CA 398648A CA 1178864 A CA1178864 A CA 1178864A
Authority
CA
Canada
Prior art keywords
plastic material
recited
plastic
copper
molding
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA000398648A
Other languages
French (fr)
Inventor
Harry W. Rudel
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
BANSON ENTERPRISES Inc
Original Assignee
BANSON ENTERPRISES Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by BANSON ENTERPRISES Inc filed Critical BANSON ENTERPRISES Inc
Application granted granted Critical
Publication of CA1178864A publication Critical patent/CA1178864A/en
Expired legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F6/00Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A61F6/14Contraceptive devices; Pessaries; Applicators therefor for use by females intra-uterine type
    • A61F6/142Wirelike structures, e.g. loops, rings, spirals
    • A61F6/144Wirelike structures, e.g. loops, rings, spirals with T-configuration

Abstract

ABSTRACT OF THE DISCLOSURE

Disclosed is a novel I.U.D. in the shape of a "T". In one embodiment, a nylon thread has threaded upon it copper sleeves and is disposed in a mold. Injected into the mold and about the thread is polyethylene,which engages the copper sleeves The polyethylene has a lower melting point than the thread. In another embodiment, a copper helix is formed about a length of teflon spaghetti and cut into lengths. The combined spaghetti and helix is disposed into a "T"-shaped mold, and a second plastic,having a lower melting point than the teflon, is injection-molded through the spaghetti so that the spaghetti forms an exoskeleton.

Description

INTRAUTERINE CON~RACEPTIVE DEVICES l:t7~8~4 ~ND METHODS O~ l~ANUFACTURING SUCH DEVICES

BACXGROUND OF THE INVENTION

This invention relates to intrauterine contraceptive devices and, more particularly, to such devices which join copper or other metal contraceptive materials to a plastic carrier to be positioned within the uterus.
DESCRIPTION OF THE PRIOR ART
Intrauterine devices are well known as an effective means for contraception. The preferred construction o~ these I.U.D. devices combines a flexible plastic carrier for holding metal having contraceptive properties, such as copper. This combination of a plastic carrier holding copper members has been recommènded by the World Health Organization and the Population Council.
Plastic carriers are usually in the form of a "T"
or "7". In one form of construction, the copper sleeves are applied to the stem and cross-bar of the "T", or horizontal and vertical members of the "7". It is known that in such construction, the internal diameter of the copper sleeves is larger than the outer ~ -- 1 -- ~
q~
` sb/ -diameter of the member, bar, or stem of the I.U.D. When placed into position, the copper is then bent in or swedged into place.
Swedging copper sleeves onto the plastic carrier has been known to create certain problems. The swedging process may not always be reliable, and the sleeves may slip either off the carrier itself or to portions of the I.U.D. which decrease the contraceptive effectiveness. For example, it is possible that the copper sleeves might move together, which would thereby re-duce the surface area of the rings, as a whole.
Slipping the sleeves over the carrier and then swedging the sleeves into place has another disadvantage. The carrier must have ends of sufficiently small diameter so that the sleeves may fit over it. As a consequence, the terminal ends of the carrier have been known to perforate the- uterine cervix and inbed in the endometrium.
To prevent these perforations, health authorities have insisted that the ends of the I.V.D. plastic carrier.be enlarged, in the form of a small ball. However, this design eliminates the possibility of slipping on the copper sleeves over the ends ~0 of the carriers and swedging them into position. Inserting the sleeves on the carrier and reheating to form the ball ends causes the plastic to become frangible.
As an alternative, one might consider injection molding the plastic through the copper sleeves. However, this creates ~ -2-li7~864 yet another problem. Where a succession of spaced copper sleeves axe disposed, as on the stem, the injected plastic will become frangible between the copper sleeves. There is also a tendency for the plastic being forced through the copper to cover the copper sleeves, thereby reducing their effectiveness.
An alternate embodiment places a copper helix about the stem or vertical arm of the I.U.D. Typically, the helix is formed by attaching one end to the stem and winding it to the opposed end, where the wire is cut. This starting and stopping of the winding process causes the copper wire to become weakened .
at the stopping and starting points. The result is that the wire tends to easily break, causing injury.
In the past, a number of suggestions have been made to improve upon the construction of I.U.Ds. For example, Kaivola, in United States Patent No. 4,198,966, provides an I.U.D. which uses the helix about the stem. In order to avoid the splitting problem, a long helix is made and then cut to the desired length.
In order to hold the helix in position, one end is formed with an enlarged body member and the opposed end is clipped or locked into position to the cross-bar. The heavier shoulder, upon which the helix rests, provides an obvious point of irritation in the cervix.
In the prior art, combining of more than one type of plastic to form an I.U.D. is well ~nown. However, none is used .. . ... .. .. . . ..

i4 as a carrier for copper or other metallic contraceptives. Ex-amples of this are suggested by Csatary in United States Patent No. 4,182,321, Moulding in United States Patent No. 3,933,152, and Haff in United States Patent No. 3,935,860.

SUMMARY OF THE INVENTION
. .

It is an object of the present invention to provide an improved and novel I.U.D. device which has superior physiological characteristics.
It is another object of this invention to provide an I.U.D. device that may be easily manufactured.
It is another object of this device to provide an I.U.D.
which may be easily inserted into the uterus and which does not interfere with the normal physiological processes, such as the menstrual flow of the female body, and which is capable of resisting expulsionary forces of the uterus.
It is yet another object of the present invention to provide an improved and novel I.U.D. device which will retain thereon the metallic contraceptive material without piercing the uterine walls.
It is still another object of this invention to provide an I.~.D. plastic carrier which resists frangibility and retains the cont ceptive copper thereon.

_ ' .. . . ..

It is yet another object of this invention to provide a me-thod of manufacturing I.U.D. devices which is simple and inexpensive.
It is a further object of this invention to provide a method of manufacturing an I.U.D. device which combines two types of plastics with the metallic contraceptive material in such a manner as to maintain the contraceptive metal in place.
In accordance with one aspect of the present invention there is provided an intrauterine contraceptive device including a first plastic material having a first melting point and a second plastic material having a lower, second melting point. The first and second materials are combined such that the first plastic material is joined to the second material to act as a skeleton for the second plastic material.
An exposed copper member is at least in part supported by the combined first and second plastic materials, the first and second materials forming a carrier.
According to another aspect of the invention there is provided a method of making an intrauterine contraceptive device, the method including the steps of providing a first plastic material having a first melting point, providing at least one copper member and assembling the copper member upon the first material, and providing a second plastic material having a second melting point, the second melting point being lower than the first melting point. The second plastic is molded in a molten state into combination with the first plastic material, leaving the copper member exposed, the first .:

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plastic material remaining substantially in a solid state during the molding process, such that the first plastic material acts as a supporting skeleton for the second plastic material.

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11 ' ~ L788Si4 ~1 ~
The second plastic~ in a molten state, is combined with the first plastic member With the metallic member exposed, ¦ The first plastic member remainS substantially in a solid state during the molding proCess such that the first plastic member S acts as a SUpporting skeleton for the second plastic member, BRIEF DESCRIPTION OF THE DRAWING

FIG, 1 is a plan view of an I.U.D. constructed in accordance with the teachings of this invention;

FIG, 2 is a seCtion of the device of FIG, 1 taken along lines 2-2;
,-~

FIG. 3 iS a plan VieW of another l.U,D, constructed in accordance with the teachings of this invention; and :' FIG. 4 iS a section of the device of FIG. 3 taken along lines 4~4.
~ . .
DESCRIPTION OF THE PREFERRED ENBODIMENTS

For the,purposes of this example, the I . U. D. of this ~inVention assumed to be a ~T". It will be understood~ however~

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¦ that this invention is applicable to other suitable configurations such as the figure "7". This invention provides a flexible plastic carrier for positioning and retaining a metallic contra-ceptive in the uterus.
S Copper is referred to throughout as the contraceptive metal of choice. It will be understood, however, that copper refers to any other equivalent metal contraceptive material throughout the specification and claims.
As previously indicated, one of the major difficulties in swedging copper sleeves onto an I.U.D. flexible plastic carrier is that, in so doing, the sleeves may become dislodged and either fall from the I.U.D. or cause the I.U.D. plastic carrier to break. If the plastic is injection-molded through the copper sleeve, the plastic will have a tendency to ride up over the copper, reducing its contraceptive effèct or forming a weakened support member.
Turning to the drawing, there is provided an I.V.D. 10 in the shape of a "T". A plastic material in the form of a thread 12 is part of the I.V.D. 10. A second plastic material 14 is combined with the thread 12. The thread 12 pxeferably has a higher melting point than the second plastic material 14. In this example, the thread is, preferably, made of nylon.
~ mold (not shown) is used to form the I.U.D. device 10.
.

l:t 7~a64 ¦Such molds are well known in the art. The mold, itself, has ¦indentations intended to receive copper sleeves. Such sleeves ¦are also well known in the art. An indentation in the mold is ¦provided for each of the copper sleeves 16. The I.U.D. 10, as S ¦previously indicated, is "T"-shapqd with a cross-bar 18 and a ¦stem 20. The nylon thread 12 is knotted 22 and 24 at a location ¦which corresponds to the opposed ends of the stem 20. The stem's ¦ copper sleeves 16 may first be threaded upon the thread 12 and ¦ then placed in the mold. The ~ree end 26 of the thread 12 ~ay ¦ extend beyond the free end 28 of the stem 20. The function of this free end 26 will be more fully discussed below.
; The remaining copper sleeves may be placed into positionin their respective mold locations along the cross-bar 18 of the I.U.D. 10. The plastic 14, which makes up the body of the I.U.D., is then injected into the mold in a molten state. Any plastic having a lower melting point than the thread 12 may be used to form the I.U.D. Thus, for example, polyethylene or polypropylene may be used, as is commonly used as an I.U.D. carrier. It will be noted that, upon the completion of the molding process, the free end 28 of the stem 20 may have an enlarged or bàll-like end 30. In addition, the free ends of the cross-bar 18 may also have enlarged ball-like ends 32 and 34. This is the preferred con-s~ruotion in or~er to prevent the I.U.D. 10 from piercing the li78864 vaginal wall. It will be noted that the thread 12 is not in the cross-bar 18. While a thread may be disposed in the cross-bar 18, it is believed not to be necessary in satisfactorily forming the I.U.D. The thread 12 in the stem 20 of the "T" I.U.D. 10 acts as a skeleton. In this case, the endoskeleton 12 holds the plastic carrier firmly in position and prevents it from being frangible. The plastic 14 covers the thread 12 and the thread knots 22 and 24.
The molding process, itself, holds the sleeves 16 in position, as do the sleeves along the cross-bar. The extending r integrally formed end 26 of the thread 12 acts as a convenient means for removal of the I.U.D. 10. The advantageof this construction is that, unlike prior art I.U.Ds., the free end of the thread need not be attached as a separate step in the manufacturing process.
! The knotted ends 22 and 24 of the thread 12 maintainthe position of the thread 12 during the injection-molding process.
In yet another embodiment of an I.U.D. 36 (FIG 3), a helis of copper wire 38 may be wound upon a plastic tubing or spaghetti 40. Typically, this can be done by an extended length of the spaghetti 40 being supported upon a mandrel.
This plastic material 40 should be preferably made of a material with a relatively high melting point, such as nylon, or polytetrafluoroethylene which is sold under the trade mark "Teflon", or the like. By winding the copper helix over a long distance and then cutting : , _ 9 _ ~`;.i~
sb/l~(~

.

1~7~864 the spaghetti 40 into appropriate lengths, the stem 42 of the "T"-shaped I.U.D. 36 may be formed. The pre-cut helix-spaghetti combination 38 and 40 may then be inserted into a mold. Copper sleeves 42 may then be disposed in the mold at the points corresponding to sleeve location on the . cross-bar 44 of the I.U.D. 36. Molten plastic material 46, such as polyethylene or polypropylene, having a lower melting point than the spaghetti 40, may then be injected into the mold, in a rnanner well known in the art, to fill the spaghetti 40 and form both the stem 42 and the cross-bar 44. In the injection molding process, a ball~like end 48 is formed at the free end of the stem 42 and cross-bar ends 50 and 52.
The foregoing combination provides a plastic exoskeleton 40 which acts- to prevent the injected molded - plastic member from coming up betweèn the helix 38. At the ~ same time, the co~bination of the plastic sleeve and the internal plastic provides a flexible member which will not yield or break under the movement within the vaginà.
.

X

sb/`~

':

, , ~ ~ ~ 117~E16~ ~

The thread 12 m~y also be molded into the second e~bodi-ment (FIGS. 3 and 4). In this latter case,! how~ver, the thread is not necessarily molded through the entire length of the stem to form an enaoskeleton. Rather, the thread is molded at the end as a convenient means of attachment during the molding process.
One significant problem arising from the use of the removal thread has been the tendency of the end, if cut too short, to prick a penis. To avoid this, the nylon thread may be preheate 3 into a coil or helix. Upon being cut, the remaining length will bend to!one side, thereby avoiding the terminal end coming into contact with the penis.
Another aspect of this invention, quite apart from the use of the combined plastics wherein one of the plastics acts as a supporting skeleton for the other, is the joining of the thread to the I.U.D. In the past, such threads were easily removed. It has been observed, however, that by extending the threaa within the stem of the T or vertical arm of the U I.U.D., the thread can be molded in and will be retained by the I.U.D.

.~

Claims (31)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. An intrauterine contraceptive device comprising:
a) a first plastic material having a first melting point;
b) a second plastic material having a lower, second melting point; said first and second materials being combined, such that said first plastic material is joined to said second material to act as a skeleton for said second plastic material; and c) an exposed copper member, at least in part supported by said combined first and second plastic materials;
said first and second materials forming a carrier.
2. An I.U.D., as recited in Claim 1, wherein said first plastic material acts as an endoskeleton.
3. An I.U.D., as recited in Claim 2, wherein said first plastic material comprises a thread within said second plastic material, said copper engaging said second plastic material.
4. An I.U.D., as recited in Claim 3, wherein a said second plastic material is in the shape of a "T".
5. An I.U.D., as recited in Claim 3, wherein said second plastic material is in the shape of a "7".
6. An I.U.D., as recited in Claim 4, wherein said thread is within the vertical arm of said carrier "7" and knotted at the juncture of the two arms of said second plastic material.

sb/ 12
7. An I.U.D., as recited in Claim 5, wherein said thread is within the vertical arm of said carrier "7" and knotted at the juncture of the two arms of said second plastic material.
8. An I.U.D., as recited in Claim 6, wherein said copper is in the form of discrete sleeves inbedded at predetermined intervals along said second plastic material and said thread extends from the free end of said plastic.
9. An I.U.D. device, as recited in Claim 1, wherein said first plastic material comprises an exoskeleton.
10. An I.U.D. device, as recited in Claim 9, wherein said first plastic material comprises a spaghetti-like member, said copper being carried at least by said spaghetti.
11. An I.U.D., as recited in Claim 10, wherein said second plastic material is at least substantially within said first plastic material.
12. An I.U.D., as recited in Claim 11, wherein said I.U.D. is in the shape of a "T", said spaghetti defining the stem of said "T".
13. An I.U.D., as recited in Claim 11, wherein said I.U.D. is in the shape of a "7", said spaghetti defining the vertical leg of said "7".
14. An I.U.D., as recited in Claim 12, wherein said copper further comprises discreet sleeves upon the cross-bar of said "T".
15. An I.U.D., as recited in Claims 12, 13 or 14, wherein said copper comprises at least a helix about said spaghetti.
16, An I.U.D., as recited in Claim 13, wherein said copper further comprises discreet sleeyes upon the horizontal arm of said "7".
17. The method of making an intrauterine contra-ceptive comprising:
a) providing a first plastic material having a first melting point;

b) providing at least one copper member;
c) assembling the copper member upon the first material;
d) providing a second plastic material having a second melting point, the second melting point being lower than the first melting point; and e) molding the second plastic in a molten state into combination with said first plastic material, leaving the copper member exposed, the first plastic material remaining substantially in a solid state during the molding process, such that the first plastic material acts as a supporting skeleton for the second plastic material.
18. The method, as recited in Claim 17, wherein the step of molding comprises placing said first plastic material and said copper member in a mold and injection-molding said second plastic material.
19. The method, as recited in Claim 18, wherein said step of molding further comprises molding said second plastic over said first plastic material, such that said first plastic material acts as an endoskeleton.
20. The method, as recited in Claim 19, wherein said step of providing a first plastic material comprises providing a single plastic thread, the step of molding said second plastic material including molding it to a shape which comprises at least a first leg and a second leg extending laterally from the first leg.
21. The method, as recited in Claim 20, wherein said step of assembling includes knotting said thread at the junction of said first and second leg, said thread extending coaxially along said first leg.
22. The method, as recited in Claim 21, wherein said step of providing copper comprises a plurality of copper sleeves; the step of molding comprises providing a mold with indentations corresponding to the location of each of said copper sleeves upon the I.U.D.
23. The method, as recited in Claim 22, wherein the step of providing a mold comprises providing a mold of a "T"-shaped I.U.D.
24. The method, as recited in Claim 22, wherein the step of providing a mold comprises providing a mold in the shape of a "7".
25. The method, as recited in Claim 17, wherein the step of molding comprises molding said second plastic through said first plastic material, such that said first plastic material acts as an exoskeleton.
26. The method, as recited in Claim 25, wherein the step of assembling comprises placing a length of said first plastic upon a mandrel; forming a helix of the copper about said first plastic and cutting the combined copper helix and the length of first plastic to lengths corresponding to a defined length of the mold.
27. The method, as recited in Claim 26, wherein the step of providing a first plastic material comprises providing a plastic spaghetti.
28. The method, as recited in Claim 27, wherein the step of molding comprises providing a mold having the shape of the I.U.D., the spaghetti confirming to at least one section of the mold.
29. The method, as recited in Claim 28, wherein the step of molding comprises injection-molding the second plastic through the spaghetti to thereby form the carrier with an exoskeleton.
30. An I.U.D., as recited in Claim 7, wherein said copper is in the form of discrete sleeves inbedded at predetermined intervals along said second plastic material and said thread extends from the free end of said plastic.
31. An I.U.D. as recited in Claim 8 or 30, wherein the free ends of the plastic member are enlarged into substantially spiroid shape.
CA000398648A 1981-03-17 1982-03-17 Intrauterine contraceptive devices and methods of manufacturing such devices Expired CA1178864A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US24481981A 1981-03-17 1981-03-17
US244,819 1981-03-17

Publications (1)

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CA1178864A true CA1178864A (en) 1984-12-04

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Application Number Title Priority Date Filing Date
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DE (1) DE3209290A1 (en)
FI (1) FI820748L (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AP51A (en) * 1987-10-06 1989-09-16 Nauchno Proizvodstvennoe Obiedinenie Medinstrument Intrauterine contraceptive device.
JP2008534197A (en) * 2005-04-05 2008-08-28 バイエル シェーリング ファーマ オイ Ultrasound sensitive intrauterine system and method for improving ultrasound detection

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2565482A2 (en) * 1984-06-07 1985-12-13 Biomasys Improvements made to intra-uterine devices
FR2555893A1 (en) * 1983-12-01 1985-06-07 Biomasys Improvements made to intra-uterine devices
EP0147274A1 (en) * 1983-12-01 1985-07-03 BIOMASYS Société dite: Intra-uterine devices
BE901652A (en) * 1985-02-05 1985-05-29 Wildemeersch Dirk NEW AND IMPROVED INTRA-UTERINE ANTI-CONCEPTIONAL DEVICE, AND ITS DEVICE FOR INSERTION AND FIXING TO THE MATRIX.
FI873880A (en) * 1987-09-08 1989-03-09 Nauchno-Proizvodstvennoe Obiedinenie Çmedinstrumentç INTRAUTERIN KONTRACEPTIONSANORDNING.
FI874010A (en) * 1987-09-16 1989-03-16 Nauchno-Proizvodstvennoe Obiedinenie Çmedinstrumentç INTRAUTERIN CONTRACEPTIONSMEDEL.
FI84017B (en) * 1990-03-16 1991-06-28 Kms Myynti Om Kerstin Margaret FOER FARING FOER FRAMSTAELLNING AV INTRANTERINA PREVENTIVMEDEL.
ES1028231Y (en) * 1994-06-07 1995-05-16 Marcus Hospital Supplies S A INTRAUTERINE DEVICE.
PT2945580T (en) * 2013-01-17 2020-07-29 Pat&Co Bvba Copper-releasing hybrid iud with adaptable retention arm connected to frameless body

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2207939A1 (en) * 1972-02-15 1972-08-30 Schering Ag INTRAUTERINE CONTRACEPTION MEANS
DE2361206C3 (en) * 1973-12-06 1981-03-26 Schering AG Berlin und Bergkamen, 13353 Berlin Intra-sub contraceptive
FI59719C (en) * 1978-06-29 1987-05-05 Medholding Oy Process for the preparation of interuterine contraceptives.

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AP51A (en) * 1987-10-06 1989-09-16 Nauchno Proizvodstvennoe Obiedinenie Medinstrument Intrauterine contraceptive device.
JP2008534197A (en) * 2005-04-05 2008-08-28 バイエル シェーリング ファーマ オイ Ultrasound sensitive intrauterine system and method for improving ultrasound detection
US11628088B2 (en) 2005-04-05 2023-04-18 Bayer Oy Ultrasonically detectable intrauterine system and a method for enhancing ultrasound detection

Also Published As

Publication number Publication date
DE3209290A1 (en) 1982-12-09
FI820748L (en) 1982-09-18
DE3209290C2 (en) 1990-06-07

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