US 3820535 A
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United States Patent [191 [111 3,820,535 Marco June 28, 1974 INTRAUTERINE DEVICE  Inventor: John L. Marco, 601 Dow Ave., Pnmary Emmmer R1chard Gaudet Oakhurst, NJ. 07755 Massouras 128/130 Assistant ExaminerG. F. Dunne Attorney, Agent, or FirmEdward F. Levy [5 7] ABSTRACT An intrauterine contraceptive device has a central body portion with legs or ribs projecting radially therefrom and presenting a three-dimensional configuration. The ribs are hinged to the central body portion and collapse in the manner of a parasol to provide a linear two-dimensional unit for insertion of the device into the uterine cavity. A portion of the device, such as the central body portion, may be formed of a ball chain of heavy metal to increase the contraceptive efficiency of the device.
6 Claims, 14 Drawing Figures PATENTEDJIJHZB I914 3820.535
SHEET 1 (IF 3 INTRAUTERINE DEVICE The present invention relates to intrauterine contraceptive devices of the type which are inserted into the uterine cavity in position to make contact with the walls thereof.
It having been established that the introduction of foreign bodies within the uterus will prevent pregnancies, a wide variety of intrauterine devices have been devised. Such devices have been in the form of rings, spirals, loops, shields, and other shapes.
Experience in the use of such devices has shown that the basic design of each device determines its contraceptive efficiency. One'of the chief problems encountered is the tendency for some devices to be expelled easily due to contraction of the uterus. Another problem is the tendency for some devices to produce harmful side effects such as puncturing the uterine wall. It has been found that where the device is made with thin leg, arm or rim portions, the tendency for expulsion is greater, but the danger of side effects is decreased. On the otherhand, where the legs or other parts of the device are made heavier and stronger, there is less tendency for expulsion, but a greater tendency for harmful side effects.
It has also been found that an open device, that is a device of framework or linear configuration, has certain advantages over a closed device of more solid configuration. Experience has shown that in those instances where the device has pierced the uterine wall and entered into the abdominal cavity, an open device is less likely to cause emergency problems, such as intestinal obstruction, which would require immediate surgery.
For purpose of more effective and sustained pregnancy inhibition, a three-dimensional intrauterine device is favored over a device whose parts lie in a single plane. If a three-dimensional device is designed so that it may be collapsed or folded up for insertion into the uterus with the legs pointing outwardly, thinner legs or arms may be provided without losing the advantages of expulsion resistance, and absence of side effects.
More recent studies have indicated that when a device is properly placed, its contraceptive efficiency is increased in direct relation to the amount of surface area which it contacts ,within'the uterus. It is thus evident that devices having large surface areas for extensive surface contact with the uterine walls are desirable. The difficulty with such devices, however, is that the larger surface area presented, the greater the bulk of the device, and consequently the greater the difficulty of insertion into the uterus and removal therefrom and the greater the tendency for harmful side effects.
It has also been established that when heavy metals, such as copper and zinc, are added to an intrauterine device, a chemical reaction results which increases the effectiveness of the device to reduce the pregnancy rate. It is therefore desirable for optimum contraceptive effectiveness that the device be so designed that such heavy metal may be attached or made. an integral part thereof.
Accordingly, the principal object of the present invention is to provide an intrauterine-device which will include a combination of all of the aforementioned features, while avoiding the problems and difficulties inherent in many of the devices presently in use.
Another object of the invention is to provide an intrauterine device which in inserted position has a threedimensional form and is capable of resisting accidental expulsion from the uterus, but which is foldable into narrow compact form for easy insertion and for ready removal by a physician without damages to tissues.
Another object of the invention is the provision of an intrauterine device'of the character described which is formed of thin component parts, but in which these parts are covered by a flexible diaphragm to provide a large surface area to increase the contraceptive efficiency of the device.
A further object of the invention is the provision of an intrauterine device of the character described in which heavy metal may be included as an operative portion of the device as a flexible chain of balls of the same or different heavy metals.
In accordance with the invention, there is provided an intrauterine device which is preferably formed of flexible plastic material having a central body or core with a plurality of elongated legs extending radially therefrom and capable of hinging movement relative thereto so that the legs can be collapsed in a parasol type action. The central core includes a depending elongated guide member which may be an integral part of the plastic device, or may be a chain of metal balls, the guide member serving to insert the device accurately within the uterus. At least some of the legs may be covered with a thin membrance to provide a large surface area for contact with the uterine walls.
Additional objects and advantages of the invention will become apparent during the course of the following specification when taken in connection with the accompanying drawings, in which:
FIG. 1 is a perspective view of an intrauterine contraceptive device made in accordance with the invention and a portion of an insertion tube therefor:
FIG. 2 is a top plan view of the device of FIG. 1;
FIG. 3 is a bottom plan view of the device of FIG. 1;
FIG. 4 is an elevational view showing the device of FIG. I mounted in the insertion tube with the legs thereof in retracted position;
FIG. 5 is a front sectional view of a uterus with the device of FIG. 1 shown in inserted position therein;
FIG. 6 is a side sectional view of the uterus as taken along the line 66 of FIG. 5;
FIG. 7 is a perspective view showing a modified intrauterine device;
FIG. 8 is a section taken along line 88 of FIG. 7;
FIG. 9 is a perspective view showing the device of FIG. 7 mounted in an insertion tube;
FIG. 10 is a perspective view of another modified form of intrauterine device;
FIG. 11 is an elevational view showing the device of FIG. 10 mounted in an insertion tube and folded into contracted position;
FIG. 12 is a front sectional view of a uterus with the device of FIG. 10 inserted therein;
FIG. 13 is a perspective view of another modified form of intrauterine device; and
FIG. 14 is a front sectional view of a uterus with the device of FIG. 13 inserted therein.
Referring in detail to the drawings, there is shown in FIGS. 1, 2,.3 and 4 anintrauterine device 10 made in accordance with the present invention. The device 10 is made of a soft and relatively flexible plastic material such as polyethylene, or the like which is imperious to body fluids, and comprises a central core or body portion 12 from which four integral legs, 14, 16, 18 and 20 extend radially. The pair of legs 18 and 20, which extend along the same axis are made longer than the other pairs of legs 14 and 16 which extend along an axis perpendicular to that of legs 18 and 20.
The outer portions of each of the legs 14, 16, 18 and 20 are made of channel shape, having a substantially semi-circular cross section, as shown, to provide a desired amount of rigidity and shape retaining property to the legs. At the inner portion of each leg, where the leg joins the central core 12, a portion of the channel wall is cut away to provide a flexible web 22. The webbs 22 serve as hinge means to permit the legs to be folded down to provide the parasol effect which constitutes an important feature of the present invention. FIG. 4 shows the legs in such folded or collapsed position which they would assume during insertion of the device into the uterus. Because of the memory properties of the plastic utilized in making the device 10, the legs will tend to return to their extended positions shown in FIG. 1 after the device is accurately inserted into the uterus. If desired, a thin spring wire (not shown) may be embedded within some or all of the legs to augment the memory properties thereof without being exposed to the uterine tissues.
An elongated ridge 24, having a curved surface, is located on the upper surface of the device 10 above the central core 12 to provide a rounded leading tip for the device when the legs are folded for insertion, thereby reducing the danger of puncture or damage to the uterine wall.
The device 10 also optionally includes a guide member 26 in the form of an elongated cylindrical rod or tube formed integrally with and depending from the central body member or core 12. The guide member 26 is sized to fit loosely within the top open end of an insertion tube 28 (FIG. 1) which is employed to insert and locate the device 10 in proper position within the uterine cavity, in a manner to be presently described. A length of thread or suture 30 may be secured to the guide member 26 and passed through the interior of the insertion tube 28 to insure that the device 10 remains firmly mounted on the tube 28 during the insertion operation. The thread 30 may thereafter be employed to remove the device 10 from the uterus.
The ends of the legs 18 and 20 are flattened by the addition of thin peripheral flanges 36 which provide relatively wide and flexible membranes. These provide increased surface area for contact with the uterine wall when the device is in inserted position, and the thin flexible nature of the membranes prevents any injury to said wall.
As shown in FIGS. 2 and 3, the end portions of the legs 18 and 20 are provided with small holes or openings 38 to which threads or sutures 32 and 34 are attached. These threads are employed to fold down the legs 18 and 20 during the insertion operation and are also employed to fold down said arms during removal of the device 10.
FIGS. and 6 show the position of the device after it has been inserted in the uterus 40. For maximum efficiency the deivce is made to seat high in the fundal dome so that the extended legs 18 and make contact with the wall 42 thereof defining the top of the uterine cavity 44.
It will be appreciated that while the side walls 46 and 48 are widely divergent to define the uterine cavity 44 as shown in the diagrammatic section of FIG. 5, the front and rear walls 50 and 52 lie in close proximity to each other, as shown in FIG. 6. Thus, when the device 10 is brought to its inserted position of FIG. 5, while the legs 18 and 20 turn upwardly to the extended position shown, in which they extend substantially perpendicularly to the guide member 26, the legs 14 and 16 remain folded downwardly, being compressed between the uterine front and rear walls 50 and 52, as indicated in FIG. 5.
The procedure which the physician follows in inserting the device 10 is a simple and easy one. The guide member 26 is set within the top of the insertion tube 28 with the thread 30 extending through tube 28 and trailing from the bottom thereof. The threads or sutures 32 and 34 are then drawn taut toward the bottom of the insertion tube 28 causing the legs 18 and 20 to bend downwardly until they lie along the surface of tube 28. In this condition the device 10 is introduced into the uterus by means of tube 28, care being taken to insert it with the legs 14 and 16 turned to such a position that the uterus side walls 46 and 48 press down said legs to a position where they too lie along the surface of tube 28. Thus during the initial insertion of the device 10 into the uterus, all of the legs 14, 16, 18 and 20 are hinged downwardly in the manner indicated in FIG. 4, and the device presents a small, compact unit which follows the contour of the insertion tube 30.
When the physician feels that the leading tip of the inserted device 10 has contacted the fundal wall 42, and that the device is otherwise properly located, he releases tension on the threads 32 and 34, which permits the legs 18 and 20 to spring outwardly to the extended positions shown in FIG. 5. The extended legs 18 and 20 thus provide surface contact in the fundus region of the uterus. As previously indicated, the legs 14 and 16 remain folded downwardly, as shown, between the side walls 50 and 52, and provide surface contact with such side walls in the corpus and isthmus regions of the uterus. The extended legs 18 and 20 and the compressed legs 14 and 16 cooperate to prevent undesired expulsion of the device 10 due to muscular contraction or other causes.
The flexible threads or sutures 30, 32 and 34 are made sufficiently long that their ends extend outwardly beyond the mouth of the uterus when the device 10 is properly mounted therein, as shown in FIGS. 5 and 6. Thus, when the device 10 is to be removed by a physician, the projecting ends can be engaged and grasped by a suitable instrument. When the threads 32 and 34 are drawn downwardly, the legs 18 and 20 will again fold down to retracted position, and the device 10 can be easily removed.
Where the device 10 is used for immediate post partum insertions, the threads 30, 32 and 34 may be made of ordinary suture material interwoven with absorbable gut material, such as the well-known absorbable sutures. The absorbable suture portion is made considerably longer than the permanent suture portion, so that from the interwoven threads there extends respective extension thread portions 30a, 32a and 34a composed entirely of absorbable material, which within a short time will disintegrate or dissolve, leaving the short permanent thread lengths for convenient removal.
The device is made in such a form that heavy metal may be added thereto in order to increase the contraceptive efficiency of the device. In conventional devices, copper or other heavy metals are usually em ployed in the form of springs or in the form of wire wrapped around portions of such devices. This has a tendency to stiffen the device undesirably. Copper also has a tendency to dissolve, leaving sharp edges on the springs or wires and causing traumatic conditions. In the present invention, the metal is provided in the form of balls or spheres or rods which, even when dissolving, leave rounded surfaces.
In the device 10 of FIG. 1, the guide member 26 may be made of copper or other heavy metal, formed integrally with the core 12 in the molding of the latter. Alternatively, a solid rod of heavy metal may be hung from the guide member 26. In the preferred and most effective form, however, the heavy metal is provided in the form of a chain of balls, each made of the same metal, or made of different heavy metals.
FIG. 7 shows an alternate embodiment of intrauterine device 60 in which the foldable plastic portion is identical to that of the embodiment of FIGS. 1 through 4, having radially projecting legs 62, 64, 66 and 68 joined to a central core 70 by flexible webs 72 which serve as hinges. In this embodiment, however, an integral elongated guide member, such as the guide mem ber 26 of the device 10, is not employed. Instead, the guide member is in the form of a flexible ball chain 74 composed of small balls or beads made of a heavy metal such as copper or zinc, which is recognized for its contraceptive properties.
The ball chain 74 may be tied by strong thread to the central core 70 so as to depend centrally from the device 60, but it is preferred to provide the central core 70 with a small opening 76 (FIG. 8) through which is forced the uppermost ball 78 of the chain 74 for pennanently mounting the chain centrally between the legs of the device 60. The chain 74 is sized to be received within the top of the insertion tube 28 in the manner shown in FIG. 9and acts as a guide member during the insertion operation of the device, as previously described. The thread. or suture 30 is attached to the bottom of the chain 74, and again threads 32 and 34 are connected to the ends of the arms 68 and 66.
The device 60 is inserted within the uterus in the same manner as described in connection with device 10, and assumes the same inserted position therein shown in FIGS. 5 and 6. It will be appreciated that when the device 60 is in this inserted position, the uppermost chain ball 78 will lie against the wall 42 of the fundal dome, while the remainder'of the chain will hang down, extending from the fundus region to the isthmus region of the uterus. The metal will therefore be located in various regions in which the chemical action produced thereby will be most effective.
The use of metal balls in the device 60 provides a number of advantages. The spherical surfaces present the maximum amount of surface area to body fluids for chemical reaction, and if the metal tends to dissolve, the possibility of leaving sharp or ragged edges is minimized. In addition, the ball chain has a very high degree of flexibility, much greater, for example, than the springs or sleeves previously used. Further by providing a chain of individual metal balls, the various balls of the chains may be made of different metals and thus create either chemical or electrical reactions for optimum effectiveness.
If a ball chain is to be added to a completed device 10 of the type shown in FIG. 1, it is only necessary to tie or otherwise attach the chain to the cylindrical guide member 26. It will also be appreciated that heavy metal can be added to the device 10 by attaching an individual metal ball to the end of each of the legs l4, 16, 18 and 20. I
As previously indicated, it has been found that the greater the exposed surface area of an intrauterine device, the more effective the device proved in inhibiting pregnancies. As an added feature of the device of the present invention, a flexible membrane may be attached to either of the devices 10 or 60 to provide a large surface area. FIG. 10 shows, for example, a thin flexible membrane secured to the device 60. The membrane 80 is made of thin plastic sheet material, for example a sheet of polyethylene so that it is extremely flexible and will fold up into compact form during insertion of the device. The membrane 80 may be made in the circular form shown, and is secured, by heat sealing or the like, to the under faces of the legs 62, 64, 66 and 68.
' When the device is brought to its collapsed position for insertion in the uterus, the thin flexible membrane folds up into compact form in the manner of a parasol, as shown in FIG. 11. When the device is in inserted position within the uterine cavity 44, as shown in FIG. 12, with the legs 66 and 68 in extended position, the halfsections of the membrane 80 remain folded downwardly as shown, being compressed between the side walls 50 and 52 of the uterus, and making extensive surface contact with said side walls.
Where a membrane is employed in the device, it is not necessary to provide four or more legs. FIG. 13 shows a modified embodiment of device which has only two legs 92 and 94 supporting a membrane 96. In this instance, the device 90 may be formed as an integral unit with the membrane. The legs 92 and 94 are formed of a single cylindrical length of flexible plastic material from the center of which, constituting the central core of the device, depends an integral guide member, in the form of a cylindrical rod 96. The membrane 98 is molded integrally with the under surface of legs 92 and 94 and is sufficiently thin that it will fold up readily. The membrane may be made of the elliptical shape, as shown, and at its center may be provided with an opening 100. The opening 100 exposes the central core portionat the junction of legs 92 and 94, providing a cross bar to which the'thread 30 may be tied. A chain of metal balls may also be tied thereto.
The threads or sutures 32 and 34 are attached to the ends of legs 92 and 94, and when these threads are ten-' sioned during the insertion operation, the legs 92 and 94 will bend downwardly toward each other about the central core portion which provides a hinge because of the flexible-n'ature-of the plastic material. The membrane 98 folds up in the same manner as shown in FIG. 11.
In the inserted position of the device 90, shown in FIG. 14, the extended legs 92 and 94 he along the uterine cavity top wall 42, while the half sections of the membrane 98 remain folded downwardly from said legs between the uterus side walls 50 and 52 to provide a large surface area of contact.
The intrauterine contraceptive devices shown herein combine the advantageous features of presenting a three-dimensional configuration, a thin rib or leg structure for easy insertion, the incorporation of heavy metal in the form of metal balls for improved contraceptive efficiency, and the presentation of a large surface area of contact by means of the membrane for further contraceptive effectiveness. All of these desirable features may be combined in a single unit which provides minimum expulsion tendencies and minimum potential injury or harmful side effects.
While preferred embodiments of the invention have been shown and described herein, it is obvious that numerous omissions, changes and additions may be made in such embodiments without departing from the spirit and scope of the invention.
What is claimed is: 1. An intrauterine contraceptive device comprising a central body portion an elongated guide member mounted on said central body portion and depending therefrom, and two pairs of elongated leg members hingedly connected to said central body portion and having a normal extended position in which they project radially therefrom and in a direction perpendicular to the axis of said guide member, each of said leg members having a channel shaped outer portion and an inner portion of reduced cross-sectional extent providing flexible hinge means for downward bending movement of said leg members relative to said central body portion to a retracted position in which said leg members are substantially parallel to and lie along said guide member to provide a small compact configuration for insertion of said device into the uterus.
2. An intrauterine device according to claim 1 in which at least a portion of said guide member comprises a flexible chain of heavy metal balls.
3. An intrauterine device according to claim 1 which includes a pair of elongated leg members projecting from opposite sides of said central body portion and extending along a common longitudinal axis, and a flexible thread attached to the end portion of each of said legs, each of said threads being sized and arranged to draw said leg members downwardly to their retracted position during insertion of said device to the fundus portion of the uterine cavity.
4. An intrauterine device according to claim 1 which also includes a flexible membrane secured to said leg members and extending therebetween, said membrane having a surface area covering substantially the entire upper area of said device defined by the ends of said leg members.
5. An intrauterine device according to claim 3 which also includes a flexible membrane secured to said pair of leg members along the lengths thereof and extending in opposite directions laterally from said leg members for a distance at least as long as the length of each leg member.
' 6. An intrauterine device according to claim 1 in which said guide member comprises a cylindrical body made of heavy metal.