US3397690A - Intra-uterine contraceptive device - Google Patents

Description

Aug. 20, 1968 G. MAJZLIN 3,397,690

INTRA-UTERINE CONTRACEPTIVE DEVICE Filed Dec. 1, 1965 2 Sheets-Sheet 1 F/aa' INVENTOR. GREGORY MAJZLIN A r ran/vars 0, 1968 G. MAJZLIN 3,397,690

INTRA-UTERINE CONTRACEPTIVE DEVICE Filed Dec. 1, 1965 2 Sheets-Sheet 2 INVEN R. GREGORY MAJZ BY 9, wmxzm A 7' TORNEYS United States Patent 3,397,690 INTRA-UTERINE CONTRACEPTIVE DEVICE Gregory Maizlin, 92 Whitman Drive,

Brooklyn, N.Y. 11234 Filed Dec. 1, 1965, Ser. No. 510,752 9 Claims. (Cl. 128-130) ABSTRACT OF THE DISCLOSURE An intra-uterine device is provided for placement within the uterus to prevent conception and to obtain samples of uterine wall tissue. The device is made from a flexible material and has at least two arms connected together by a connecting member, said connecting member having at least one pivot point located between the arms at a-point above the level of the bottom edge of the arms and below the level of the top edge of the arms.

This invention relates to an improved intra-uterine contraceptive device and more particularly to an intrauterine contraceptive device which utilizes the muscular contractions of the uterus to firmly retain the device in place. The device is self-adjusting to fit variations of the uterine cavity.

It is well known that foreign bodies introduced into the uterus will prevent pregnancy. Although there are a number of intra-uterine contraceptive devices now being used, these have not achieved wide acceptance due to the tendency of the device to be expelled from the uterus. The expulsion of the intra-uterine contraceptive device starts with the muscular contraction which takes place when the device is introduced in the uterus cavity. Thereafter the muscles ofthe uterus work to expel the foreign body and as frequently happens the expulsion is not noticed by the user.

In accordance with the present invention, there has now been devised an intra-uterine contraceptive device with a structure especially adapted to take advantage of the uterine muscular contractions which work to firmly retain the device in place and guard against expulsion from the uterus. For this purpose there has been devised a device which comprises a flexible member having at least two arms so constructed that the lower end portions thereof are spaced apart and separated. The arms are flexibly coupled by means of a connecting member in such a way that when pressure is brought to bear against the top portion of the arms they will pivot inwardly and cause the lower portion of the arms to press out against the Walls of the uterus. As a result of the pressure of the lower portion of the arms outwardly against the walls of the uterus the device is firmly retained in place.

In order to understand the mechanism by which the device of the present invention is retained in the uterus, it is first necessary to understand the way in which the uterine muscles work.

The uterus is a hollow walled muscular organ approximately 3 inches in length. It consists of three main parts, the corpus, the cervix and the isthmus which is located at the junction of the cervix and corpus. The cervix is at the bottom of the uterus and it is approximately one inch long or one-third the entire length of the uterus. The isthmus which is the next part is located above the cervix and is approximately /2 inch long. The remaining 1 /2 inches of the uterus is called the corpus.

The uterine tubes through which the egg passes from the ovaries are located at opposite sides of the top portion of the corpus. The roof of the corpus positioned above the level of a line joining the points of entrance of the uterine tubes is called the fundus.

The introduction of a contraceptive device into the 3,397,690 Patented Aug. 20, 1968 uterus causes muscular contraction. Muscular contraction occurs in two sequential steps. The first muscular contraction occurs in the cervico-isthmal region where the muscle fibers are arranged in circular fashion. This will cause the walls to approach each other squeezing the contraceptive device located in that region. The second muscular contraction occurs at the fundus where the muscular fibers are arranged in a generally longitudinal direction. The general longitudinal arrangement of the muscular fibers results in a downward contracting force which tends to cause expulsion of the contraceptive device out of the uterine cavity through the cervix.

When the device of the present invention is inserted into the uterine cavity it is so positioned that the lower portion of the arms are located in the lower portion of the uterus and the upper portion of the arms are located in the upper portion of the uterus or within the fundal area. When in place in the uterus the muscular contractions of the cervico-isthmal region will begin and pressure will be exerted against the lower portion of the arms tending to force them together. The lower portions of the flexible arms yield but resist the pressure, which results in a camming action that tends to move the entire device upward toward the fundus or top of the uterine cavity. After the muscles of the cervico-isthmal region relax the muscular fibers of the fundus will start to contract. The contraction of the fundal muscles will exert a pressure against the top portion of the arms bending them inwardly. This will cause the arms to pivot about at least one point located between the arms and below the level of the top edge of said arms on the connecting member and thereby force the lower portion of the arms outwa'rdly. At the same time, this pressure at the top of the device will tend to move the entire device downwardly towards the cervico-isthmal region. Since the lower portion of the arms are extended outwardly they press against the walls of the cervico-isthmal region which results in firmly retaining the device in place. After the fundal muscles relax contraction will again begin in the cervico-isthmal region to repeat the above described process.

Another advantage of the structure of applicants device is the fact that only one or two sizes are required to fit nulliparous, monoparous and multiparous women. In conventional intra-uterine contraceptive devices many sizes are required in order to properly fit a woman which is often a time consuming process with the results often in doubt. Applicant by utilizing the contractions of the uterus to hold his device in place does not require the close tolerances necessary for the known intra-uterine contraceptive devices to prevent the expulsion of the device from the uterus.

These and other features of the intra-uterine contraceptive device are best understood by reference to the following drawings showing the preferred embodiments of the invention in which:

FIG. 1 is one embodiment of the intra-uterus contraceptive device.

FIG. 2 is the intra-uterus contraceptive device of FIG. 1 in collapsed position ready to be inserted into the uterus.

FIG. 3 illustrates the intra-uterine contraceptive device of FIG. 1 as it is inserted into the uterus. No muscular contraction is shown.

FIG. 4 illustrates the intra-uterine contraceptive device of FIG. 1 in the uterus where the muscles of the fundus are contracted.

FIG. 5 is another embodiment of the intra-uterine contraceptive device; and

FIG. 6 is a third embodiment of the intra-uterine contraceptive device.

The intra-uterine contraceptive device 18 which is made of any plastic or metal flexible material not injurious to living tissue is shown in FIG. 1. The device consists of two arms 20 and 22 which are joined by a connecting member 24 also made of a flexible material.

The contraceptive device 18 is inserted into the uterine cavity by bringing the arms 20 and 22 of the device together (see FIG. 2). The device is then placed in a metal or plastic flexible cannula with a plunger (not shown) and inserted with the cannula into the uterus. The cannula is a conventional insertion device and the device and its use are known in the art.

Referring to FIG. 4 the uterus is divided into three areas. The cervix 12, the isthmus 14 and the corpus 16. Located at the roof of the corpus 16 is the fundus 17. In accordance with existing methods after the cannula is inserted into the uterine cavity the plunger is pushed forward releasing the contraceptive device into the uterine cavity in the position shown in FIG. 3. Since the device is of a flexible material the two arms will return to their normal position after being released from the cannula. An alternate and improved method for placing the device in the uterus is to move the tube or cannula down upon the plunger instead of moving the plunger into the cannula. This will prevent a sudden expansion of the device in the uterus which may be painful. It will also properly position the device in the fundal area.

It is important to use a small diameter cannula in order to substantially eliminate any pain to the patient. Since the thickness of the device in its folded position will determine the diameter of the cannula, the arm 22 is preferably made shorter than arm 20 so they can overlap each other as shown in FIG. 2. This reduces the thickness of the device and enables a doctor to use a thinner cannula.

After the device is inserted into the uterus, the uterine muscles will start to contract at the cervico-isthmal region. This is shown by the force arrows indicated at A of FIG. 3. The magnitude of the force is greater at the cervicoisthmal region and decreases as the funda] region is approached. The force of the contraction will act on the lower portion of the arms 20 and 22 to push them inwardly. The arms in resisting this muscular pressure will serve to cam the device upwardly toward the fundus into the position shown in FIG. 4.

After the muscles in the cervico-isthmal region relax the muscles of the fundus start to contract and exert a force in the direction shown by the force arrows indicated at B of FIG. 4. The magnitude of the force is greater at the fundus and decreases as the cervico-isthmal region is approached. This force is applied against the connecting member 24 and as a result the central portion of the connecting member 24 is depressed into the dotted line position as shown at 26 of FIG. 4.

When the back of the connecting member 24 is bent the arms 20 and 22 move outwardly and further apart from each other. This movement is further accented by the force of the contracted fundus against the topmost portions of the arms 20 and 22 as at 30 and 32 to cause the .arms to pivot about point 26 and move the lower portions 21 and 23 of the arms outwardly. In order for this to occur, it will be understood that the force applied against the upper portion of the arms must be directed in an area above the horizontal line xx in FIG. 4 which delineates the bottom of the bend in member 24 that forms the pivotal point for the movement of the arms. If the force is below the line xx the arms will move inwardly and this will result in the device being expelled from the uterus. As explained above the force exerted by the muscles of the fundus against the connecting member 24 will bend the member 24 downwardly so as to establish a pivot point on the member 24 located between the arms and below the top edge of said arms. If the member 24 is not bent the force exerted by the muscles of the fundus against the arms will force the arms together and the device will be readily expelled from the uterus. By using the fundal muscles to bend member 24 no permanent bend in member 24-is'necessary: The device will also move downwardly as a result of the contraction of the fundus and the arms whichare now spread out beyond the normal position shown in FIG. 1 will push against the side wall of the uterus to firmly retain the device in place. The outward pressure of the arms against the uterine wall tends to cam the device upwardly against the downward pressure of the fundus and there is little if any chance of accidental expulsion.

After the fundus relaxes contraction will start again in the cervico-isthmal region thereby repeating the process described above. If desired the connecting member 24 may be weakened by reducing its thickness in the central portion thereof as shown at 28 in FIG. 1 or the central portion of the member may be permanently bent down to initiate bending by the muscles of the fundus into the position shown in dotted lines in FIG. 4.

In the preferred form of structure shown, the ends of the arms are curved inwardly to present a' curved surface which prevents irritation to the uterine wall when the lower portion of the arms press outwardly against the wall during contraction of the fundus.

To further aid in the contraceptive ability one or more arms may 'be positioned to extend downwardly from the central portion of the connecting member 24 as shown at 34 in FIG. 1. The added arms 34 reduce the available space in the uterine cavity to prevent the apposition of the uterine Walls and thereby further aid in the contraceptive effect of the device.

The device is readily removed from the uterus by a process of version when conception is desired. For this purpose one end of the arm of the device is pulled through the uterine canal causing the device to rotate so as to allow the connecting member and other arm to pass through the uterine canal without compressing the arms together.

FIG. 5 is another embodiment of the device which operates in the same manner as the device described above. As shown in this figure the arms 36 and 38 have the general shape of a U when viewed from the side in the directionof the arrows at 39. In this modified form of structure the connecting member for the arms is-a rivet 40 which permits the arms to pivot about the single point of the rivet 40 located between the arms to give a reverse scissoring effect. That is when the top portion of the two arms 36 and 38 are brought together the bottom portion of the arms move outwardly.

The device is inserted into the uterus by bringing both the top and bottom ends of the pair of arms together. The collapsed device is inserted into a cannula with plunger and then inserted into the uterus. The contraceptive device is then released in the uterine cavity by means of the cannula plunger. The device, which is made of a flexible material, will return to its normal shape of FIG. 5 after it is released from the cannula.

Once the device is in the uterus, contractions will begin in the cervico-isthmal region. The force exerted Will be against the lower ends of the arms 36 and 38 causing the arms to pivot about the rivet 40. This will cause the upper portion of the arms to move further apart thereby forcing the device towards the fundus or the upper part of the uterus. When the cervico-isthmal region relaxes, the fundal muscle fibers will start to contract. The contracted fundus will force the device in a downward direction in the cervico-isthmal region and will also cause pressure to be exerted against the top portion of the arms 36 and 38. The pressure exerted against the upper portion of the arms will cause them to move inwardly and the reversed scissoring effect will cause the lower portion of the arms to move outwardly against the upper walls of the cervico-isthmal region resulting in firmly retaining the device in place.

The device is readily removed from the uterus when conception is desired by pressing the arms together in the same manner as when the device is inserted into the uterus.

FIG. 6 is another embodiment of the device which operates in the same manner as the devices described hereinabove except the arms pivot about two points as opposed to only one point. The device has the general shape of an H as seen in FIG. 6. The arms 42 and 44 are coupled by the connecting member 46. After the device is inserted into the uterus the contraction of the muscles of the fundus will apply pressure against the top portions of the arms 42 and 44 as at 48 and 50 causing them to move inwardly resulting in the arms 42 and 44 to pivot about points 52 and 54 which are located on the connecting member 46 and which abut the arms 42 and 44. The pivoting of arms 42 and 44 is a reverse scissoring effect causing the lower portion of the arms to move outwardly against the walls of the cervico-isthmal region resulting in firmly retaining the device in place.

Although the devices shown in the present application are formed from solid leaf-like members it will be understood that solid cylindrical members or tubing can be used to construct the present device. Further the device can be molded as an integral unit or fabricated in separate pieces and then assembled.

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 and it is intended to cover all changes and modifications of the preferred form of the 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 device comprising a flexible member having at least two arms, a connecting member which couples said arms together, said connecting member having at least one pivot point located between the arms at a point above the level of the bottom edge of the arms and below the level of the top edge of said arms whereby when the top portion of the arms is moved inwardly in the area above said pivot point the bottom portion of the arms will move outwardly away from each other, said flexible member being adapted for use in a uterus.

2. The intra-uterine device of claim 1 wherein the flexible member has the general shape of an inverted U.

3. The intra-uterine device of claim 2 having at least one arm positioned to extend downwardly from the central region of said connecting member.

4. The intra-uterine device of claim 1 wherein the lower portion of said arms are curved inwardly.

5. The intra-uterine device of claim 1 wherein the flexible member has the general shape of an H and said connecting member has two pivot points about which the arms can move.

6. The intra-uterine device of claim 1 wherein the flexible member has the general shape of an X.

7. An intra-uterine device comprising a flexible memher having two arms, a connecting member being bent downward in between the top portion of said arms to form at least one pivot point located between the arms at a point above the level of the bottom edge of the arms and below the level of the top edge of said arms when the uterine muscles of the fundus apply pressure against said member to bend it downwardly whereby when pressure is applied inwardly against the top portion of the arms to bend them inwardly, the bottom portion of the arms below said pivot point will move outwardly.

8. The intra-uterine device of claim 7 wherein the flexible member has the general shape of an inverted U.

9. The intra-uterine device of claim 1, wherein the flexible member has the general shape of an M.

References Cited UNITED STATES PATENTS 2,122,579 7/1938 Meckstroth 128-130 2,681,652 6/1954 Laxton 128-132 3,200,815 8/1965 Margulies l28130 3,253,590 5/1966 Birnberg 128-130 ADELE M. EAGER, Primary Examiner.

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