US3397691A

US3397691A - Intra-uterine contraceptive device

Info

Publication number: US3397691A
Application number: US554765A
Authority: US
Inventors: Majzlin Gregory
Original assignee: Individual
Current assignee: Individual
Priority date: 1966-06-02
Filing date: 1966-06-02
Publication date: 1968-08-20
Anticipated expiration: 1985-08-20

Description

Aug. 20, 1968 G. MAJZLIN 3,397,691

INTRA-UTERINE CONTRACEPTIVE DEVICE Filed June 2, 1966 INVENTOR.

GREGORY MAJZLIN ATTORNEYS gwmwzxm United States Patent 3,397,691 INTRA-UTERINE CONTRACEPTIVE DEVICE Gregory Majzliu, 92 Whitman Drive, Brooklyn, N.Y. 11234 Filed June 2, 1966, Ser. No. 554,765 9 Claims. (Cl. 128-130) The present invention relates to an improved intrauterine contraceptive device and more specifically to an intra-uterine contraceptive device which can be readily inserted into the uterus by a physician without having to anesthetize the patient, is retained in the uterus with greater security notwithstanding the expulsive force of the uterine muscular contractions and is. readily removed from the uterus, after it is no longer required, without having to subject the user to the painful process of dilating the cervical canal.

There are many instances where a woman should not bear any more children because it would be detrimental to her health or in some cases fatal. Doctors have prescribed for these women patients one of many types of contraceptive devices or drugs which are now sold commercially. However, all of these devices or drugs require a strict time schedule of use which too often is ignored by the patient, resulting in a medically inadvisable pregnancy. Further, many women react adversely to contraceptive drugs and therefore cannot use them.

Because of the disadvantages of the above devices there has been a considerable search for a contraceptive device which can be effectively used without adhering to a time schedule and which is not toxic to the human system. One such device is the intra-uterine contraceptive device. This device works on the known principle that placing a foreign object in the uterus will prevent conception or implantation of the fertilized ovum. Therefore as long as the device remains in the uterus pregnancy can be avoided.

There have been many intra-uterine contraceptive devices designed and many of these are now in use. However, one of the major drawbacks of these devices is that they are prone to be expelled from the uterus, usually without the woman being aware of it. Applicant has solved this problem with a device which takes advantage of the uterine contractions for holding it in place and which is described in copendng application Ser. No. 510,- 752 filed Dec. 1, 1965. However, although the device of the aforesaid application works successfully, it has been found that in some cases there is some difiiculty in inserting and removing the device.

The present invention provides an improvement of the former device in that the new device can be readily removed without dilating the cervical canal and surprisingly still uses to advantage the uterine contractions for retaining it in place.

The device of the present invention is the nature of a spring member having a general structure analogous to a spiral spring with a number of windings. The spring member is emplaced within the uterus in such position that the windings thereof expand and contract between the sides of the uterus.

When a foreign object in general is inserted into the uterus, the uterus will automatically start its muscular contractions. The muscular contractions occur in two sequential steps. The first muscular contraction occurs in the cervico-isthmal region of the uterus where the muscle fibers are arranged in circular fashion. This causes the walls of the uterus to approach each other and squeeze any foreign object in that region. The second muscular contraction occurs at the fundus where the muscle fibers are arranged in a generally longitudinal direction. The generally longitudinal arrangement of the muscle fibers results in a downward squeezing force which ordinarily tends to cause expulsion of a foreign object such as a conventional intra-uterine contraceptive device. The fundue contraction is analogous to squeezing a large ball by the palm and fingers of a hand.

'As explained above the spring member of the present invention is arranged to expand and contract between the sides of the uterus and is initially placed in the cervicoisthmal region. As a result, the muscular contractions of the cervico-isthmal region begin and the pressure thereof is exerted against the bottom portions of the windings of the spring member to cause these portions to compress. The spring member will resist being compressed and because the compressing force is applied substantially along only the bottom portions of the windings, there results a camming action that tends to move the spring member upwardly towards the fundus or top of the uterine cavity. After the muscles of the cervico-isthmal region relax, the muscle fibers of the fundus will start to contract. The contraction of the fundus mucles will exert pressure against the top portions of the windings of the spring member, causing these portions to compress. As the top portions of the windings become compressed, the bottom portions of the windings spread apart in an outward direction like the spreading of a fan. This spreading of the bottom portions of the windings is a very efficient action and of great advantage for securely retaining the spring member in the uterus as will be explained in greater detail below.

Another advantage of the spring member of the present application is that its windings trace a relatively large volume so that the spring member occupies a greater portion of the volume of the uterine cavity than existing intra-uterine devices. This is important since the contraceptive effect is believed to be directly related to how much of the uterine cavity is occupied by a contraceptive device, and the spring member of the present invention definitely provides a considerable improvement in this respect over conventional devices.

As mentioned above, the spring member of the invention is generally analogous to a spiral spring, and has a plurality :of windings which trace a three-dimensional volume containing a central axis of expansion and contraction. The windings are free to expand and contract along axes generally parallel to the central axis. The maximum distance between opposite windings of the spring member, measured perpendicularly to the central axis of expansion and contraction, has a critical predetermined dimension which will allow the spring member when entirely compressed to pass through the cervical canal of the intended user for emplacement in the uterus. It is essential that this perpendicular distance between opposite sides of the windings be sufliciently limited to allow the compressed spring member to pass through the cervical canal without causing injury to the intended user. For best results, the perpendicular distance is sufficiently limited to allow the compressed spring member to pass through the cervical canal without having to dilate the canal opening, and this in turn will allow emplacement and removal of the spring member without causing pain or discomfort to the intended user and without use of anesthetics. Generally speaking, the maximum useful dimension for the distance across opposite windings will be approximately 4.5 mm., there being some leeway in this limit depending upon the specific anatomical capability of the intended user to receive the spring member via the cervical canal without injury. For best results, the distance across opposite windings should be controlled within the range from about 1.to about 3 mm. since at least one of such dimensions can be passed through the cervical canal of virtually all women without causing dilation, pain and discomfort, the average canal being about 2-4 mm. across its opening.

The distance between the ends of the spring member when compressed, measured parallel to the central axis of expansion and contraction, must also be sufliciently limited to allow the compress-ed member to pass through the cervical canal. The maximum useful dimension for the distance between the ends of the spring member when compressed will be approximately 4.5 mm., although this dimension will vary also depending upon the specific anatomical capability of the user. As in the case of the preferred distance between the windings of the spring member, measured perpendicular to the axis of expansion and contraction, the distance between the ends of the compressed spring member, measured parallel to the axis of expansion and contraction, should also be controlled for best results, within the range of about 1.0 mm. to about 3 mm.

After the spring member passes through the cervical canal and reaches the uterine cavity, the windings of the spring member expand as much as the sides of the uterine cavity permit and, because of the previously mentioned fan-spreading action when the fundus muscles exert pressure on the top portions of the expanded windings, the expanded spring member will thereafter remain in place in the uterus without any tendency for expulsion.

A further advantage of the spring member of the invention is the fact that there is no possibility of the spring member becoming embedded in or perforating the uterine walls. Basically, the reason for this is the spring member does not rely on being wedged against the uterine walls to hold it in place as do conventional devices, but rather makes use of the fundus contractions to fan out the lower portions of its windings to hold itself in place in the uterus. The entire action is resilient and adjustable as compared to a wedge which does not yield in any way to the muscular contractions.

As for removing the spring member, this is readily accomplished by providing the spring member with a draw string or loop passing through the interior of the volume traced by the windings, whereby the string or loop can be pulled in a direction away from the uterus to compress the lower portions of the windings for easy passage down through the cervical canal. This removal is convenient and substantially painless when the dimensions across opposite windings of the spring member and the dimensions across the ends of the spring member when compressed are suitably selected for best results as previously described.

The spring member can be made from any plastic or metal resilient material which will not lose its resiliency when sterilized and is not injurious to living tissue. It has been found that excellent results can be obtained when the spring member is constructed of spring-tempered stainless steel. This material is very resilient, is not injur ous to living tissue, and has a very long coefiicient of friction. The latter property is important because, as previously mentioned, when the cervico-isthmal region of the uterus contracts, the spring member is forced to move up towards the fundus region of the uterus. If the material from which the spring member is made has a high coefiicient of friction, there will be excessive rubbing against the uterine walls which can cause damage to the tissue. Stainless steel will readily slide along the uterine wall and prevent any damage to the tissue.

These and other features of the present invention are best understood by reference to the following drawings which show a preferred embodiment of the invention and of which:

FIG. 1 shows a preferred embodiment of the spring member of the invention in expanded position prior to insertion into the uterus;

FIG. 2 shows the spring member of FIG. 1 inserted in the uterus without a muscular contraction in the uterus; and

FIG 3 shows the spring member ofFIG. 1 in the uterus with the muscles of the fundus in a contraction.

The spring member 10 of FIG. 1 is made of stainless steel and has the configuration of a spiral spring which has been somewhat flattened whereby the windings 12 trace a three dimensional volume of a generally rectangular cross section. Each winding 12 is composed of two

arms

14 and 16 which are connected at bends 18. The

arms

14 and 16 forming the windings 12 trace generally parallel planes which in conjunction with the bends 18 form an imaginary rectangular solid which contains a central axis 17 of expansion and contraction. Although the spring member 10 is shown with six windings 12, it will be understood that fewer or more windings can be used. The number of windings 12 will depend on the type of material used, the thickness of the material and the overall width of the spring member 10 when it is contracted for insertion into the uterus. Since the opening of the cervical canal will usually measure about 2 to 4 mm. the length of the spring member 10 when fully contracted and measured parallel to the axis 17 of expansion and contraction should not exceed this measurement for otherwise it will be very dilfcult to insert the spring member into the uterus and may require dilating the cervical canal. It has been found that when the spring member is constructed of .020 gauge stainless steel, six windings give excellent contraceptive control, are securely retained in the uterus, and the above-defined length measures only 1.5 mm. which can be easily inserted and passed through the cervical canal. Fewer or more coils can be used depending on the choice of gauge of the material from which the spring member 10 is constructed, for example, if the material has a gauge of .018, seven or eight windings can be used and if it has a gauge of .022 four or five windings can be used.

The minimum number of windings is that number which can utilize the uterine contractions for holding the spring member securely in place in the uterus. Thus, the spring member, it has been found, must have at least 1 /2 windings 12 or three arms (14, 16), taking a pair of

arms

14 and 16 as one winding.

The distance between each pair of

arms

14 and 16, measured perpendicular to the axis 17 of expansion and contraction, is limited to a predetermined value as previously mentioned to permit the spring member 10 to be inserted through the cervical canal without difliculty after it has been fully contracted. In the embodiment shown in FIG. 1, this distance measures 1.5 mm.

Referring again to FIG. 1, the terminal portions 20 of the

outer arms

14 and 16 of the spring member 10 are turned upward to form closed loops 22. The ends of the loops are then attached to the

arms

14 and 16 at 24 so as to preclude any rough or sharp edges on the spring member 10 and damage to the uterine walls. A draw string 26, such as Dacron, is passed through loops 22 and through the windings 12 and tied at 28 to form a closed loop 30.

The spring member 10 is inserted into a uterus 32 and positioned so that the windings 12 expand between the sides 34 of the uterus as shown in FIG. 2. This is done by contracting or compressing the spring member 10 into the uterus, preferably with the aid of a conventional cannula with plunger or by any other conventional apparatus of this type. The spring member 10 is placed in the cervico-

isthmal region

36 and 38 of the uterus 32 and then expands against the sides of this region of the uterus.

As a result, the cervico-

isthmal region

36 and 38 will start to contract and exert pressure against the lower portions of the windings 12 to compress the windings together. The spring member 10 will resist being compressed which results in a camming action that moves the spring member into the corpus region 40 .of the uterus 32 and up against the fundus 42. When the muscles of the

cervicoisthmus region

36 and 38 relax, the muscle fibers of the fundus will start to contract. The contraction of the fundus muscles will exert pressure against the top portions of the windings 12 of the spring member to compress these portions together which will cause the bottom portions of the windings to spread apart as shown in FIG. 3.

The muscular contractions of the fundus will also force the spring member 10 in a downward direction into the cervico-

isthmal region

36 and 38. However, since the bottom portions of the windings 12 are spread, the windings will not fit through the cervical canal and therefore the spring member 10 will remain in the uterus. After the fundus muscles relax the muscles of the cervico-isthmus region will start to contract and the above described process is repeated.

As explained above the

arms

14 and 16 forming the windings 12 trace an imaginary rectangular solid. The spring member 10 therefore has a volume of predetermined width measuring across each pair of

arms

14 and 16, perpendicularly to the axis 17 of expansion and contraction. Since the front and back walls of the uterus 32 are planar and in contact with each other, the spring member will separate these walls by approximately 1 or 2 mm. corresponding to the predetermined width. It is apparently because of this separation and the fact that relatively more of the uterine cavity is filled with the spring member 10 that materially better contraceptive control is achieved than in conventional devices.

When it is desired to remove the spring member from the uterus, a conventional hooked instrument (not shown) is inserted into the uterus to catch the string 26. The string is then pulled which will compress the bottom portion of the windings 12 and cause the compressed spring member to easily pass through the cervical canal and out through the vagina.

In a preferred embodiment, one end of a string 44 is attached to the end of loop 30 and the string has suflicient length to extend out beyond the uterus as shown in FIG. 3. This will eliminate the necessity of using an instrument for removing the spring member. The physician need only pull the string 44 by hand which will collapse the windings 12 to remove the spring member 10 from the uterus.

It will be clear from the foregoing description that the invention provides an intra-uterine contraceptive device which is retained in the uterus by means of the uterine contractions, can readily be inserted and removed from the uterus without requiring dilation of the cervical canal. It is intended to cover all changes and modifications of the preferred form of structure herein chosen for the purpose of illustration which do not constitute departures from the spirit and scope of the invention.

I claim:

1. An intra-uterine contraceptive device comprising a flattened spiral spring member of resilient material having a plurality of windings which are capable of expanding and contracting, said windings tracing a three-dimensional volume of a generally rectangular shape which contains a central axis of expansion and contraction, said windings being expandable and contractable along axes which are generally parallel to said central axis, the distance between opposite windings measured perpendicularly to said central axis and the distance between the ends of said windings when contracted being such that said spring member when so contracted may be passed through the cervical canal of the user of the device for emplacement and subsequent expansion within the uterus.

2. An intra-uterine contraceptive device as in claim 1 wherein said distance measured perpendicular to said axis is such that said device when collapsed may be passed through said cervical canal without having to dilate said canal.

3. An intra-uterine contraceptive device as in claim 1 wherein said distance between the ends of said contracted windings measured parallel to said axis may be passed through said cervical canal without having to dilate said canal.

4. The intra-uterine contraceptive device of claim 1 wherein the distance between opposite windings measured perpendicular to said axis is not greater than about 4.5 mm. and the distance between the ends of said contracted windings measured parallel to said axis is not greater than about 4.5 mm.

5. An intra-uterine contraceptive device comprising a spring member of resilient material having a plurality of windings in a configuration analogous to a flattened spiral spring, said windings tracing a three-dimensional volume of a generally rectangular shape containing a central axis of expansion and contraction, said windings being expandable and contractable along axes generally parallel to said central axis, the distance between opposite windings measured perpendicularly to said central axis and the distance between the ends of said windings when contracted having pre-determined values, said device being constructed and arranged for emplacement in the uterus by passing the device in contracted position through the cervical canal of the intended user without having to dilate said canal.

6. The intra-uterine contraceptive device of claim 5 wherein the distance between opposite windings measured perpendicularly to said central axis and the distance between ends of said winding when contracted are each from about 1 mm. to about 3 mm.

7. The intra-uterine contraceptive device of claim 4 wherein the said spring member is made from spring tempered stainless steel.

8. The intra-uterine contraceptive device of claim 4 wherein a string is passed through the said windings for removing said spring member from the uterus.

9. The intra-uterine contraceptive device of claim 8 wherein the said string is of suflicient length to extend out from the uterus.

References Cited UNITED STATES PATENTS 1,896,071 2/1933 Clark 128-130 3,200,815 8/1965 Margulies 128-130 3,323,520 6/1967 Hall 128-130 3,250,271 5/1966 Lippes 128-130 ADELE M. EAGER, Primary Examiner.

Claims

1. AN INTRA-UTERINE CONTRACEPTIVE DEVICE COMPRISING A FLATTENED SPIRAL SPRING MEMBER OF RSILIENT MATERIAL HAVING A PLURALITY OF WINDINGS WHICH ARE CAPABLE OF EXPANDING AND CONTRACTING, SAID WINDINGS TRACKING A THREE-DIMENSIONAL VOLUME OF A GENERALLY RECTANGULAR TRACING A THREE-DIMENSIONAL CENTRAL AXIS OF EXPANSION AND CONTRACTION, SAID WINDINGS BEING EXPANDABLE AND CONTRACTABLE ALONG AXES WHICH ARE GENERALLY PARALLEL TO SAID CENTRAL AXIS, THE DISTANCE BETWEEN OPPOSITE WINDINGS MEASURED PERPENDICULARLY TO SAID CENTRAL AXIS AND THE DISTANCE BETWEEN THE ENDS OF SAID WINDINGS WHEN CONTRACTED BEING SUCH THAT SAID SPRING MEMBER WHEN SO CONTRACTED MAY BE PASSED THROUGH THE