Abstract:
An IUD in which an inner base ring made from a resilient material and formed into a generally circular shape with a bulbous free end carries a jelly-like covering material over its entire extent having formed with a plurality of bead-like protrusions.

Description:
FIELD OF THE INVENTION 
     The present invention relates generally to intra-uterine contraceptive devices, known as I.U.D., and more particularly it relates to solid I.U.D having improved physiological effect. 
     BACKGROUND OF THE INVENTION 
     I.U.D.&#39; used for the purpose of contraception are old in art, having been popularized by the development of Dr. Ernst Grafenberg&#39;s silver ring. Since that time, almost forty years ago, there have been many improvements in both the configuration and the material of the device as well as the efficiency and the public acceptance of the device. The configuration of the I.U.D.&#39;s most frequently used today may be categorized generally as coils, loops, rings and bows, the best known examples being those devices developed by Margulies, Lippes, Ota and Birnberg, respectively. 
     It has long been recognized that even though I.U.D.&#39;s are safe, reliable and efficient, there are still several very important structural aspects that can be improved. 
     It has also been recognized that although the I.U.D. must be readily removable, if possible without surgical interference, yet it must be capable of resisting expulsion caused by the involuntary uterine contractions exhibited by the fundus muscle. These are, of course, diametrically opposite conditions, but which must nevertheless be met for the I.U.D. to be effective. 
     It has also been recognized that the I.U.D. for proper reliability must have a good contact with the walls of the uterus, which belief led to the inflatable types such as described in my U.S. Pat. Nos. 3,933,153 and 3,996,932. 
     It has been also recognized in my afore-mentioned patents that contact with the inner walls of the uterus is desirable rather at a plurality of smaller regions than at large surfaces in order to minimize irritations of the inner wall of the uterus and to avoid blockage of the menstrual flow. At the same time an I.U.D. answering the above requirements must retain the last mentioned beneficial properties even under the expulsionary effects of the fundus and in addition assumes a shape which laterally increases its size with respect to the cervix under the last mentioned conditions and reliably prevents thereby its expulsion. 
     The I.U.D. devices described in my afore-mentioned patents have superior qualities and improved physiological properties, however, due to their inflatable character, they are sensitive to manufacturing conditions and their insertion requires a rather elaborate inserting device equipped with inflating needle. 
     SUMMARY OF THE INVENTION 
     It is, therefore, an object of the present invention to provide an improved and novel I.U.D. device, which has superior physiological characteristics despite its easy manufacturing and can be inserted into the uterus relatively easily 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 another object of the present invention to provide an improved and movel I.U.D. device of the above described type which due to its shaping will contact the inner walls of the uterus at a plurality of regions in a resilient manner instead of presenting a large homogeneous surface pressing against the inside of the uterus. 
     It is still another object of the present invention to provide an improved and novel I.U.D. device of the above type which under the expulsionary forces of the fundus will undergo a reduction of its size but it still retains its basic shape having a configuration the smallest dimension of which is still much larger than the opening of the cervix, such reduction in size taking place without offering any long straight or hard small surfaces to contact the walls of the uterus. 
     Briefly, in accordance with the present invention, there is provided a novel I.U.D. having a resilient discontinuous base ring onto which a jelly-like synthetic material is molded having a plurality of bead -like protrusions. 
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The present invention will become more readily apparent from the following description of the preferred embodiments thereof shown in the accompanying drawings, in which: 
     FIG. 1 is a schematic illustration of one of the embodiments of the I.U.D. device according to the present invention in situ within the uterus; 
     FIG. 2 is an illustration of the I.U.D. device of FIG. 1 in section; 
     FIG. 3 illustrates an additional embodiment of the I.U.D. device according to the present invention; 
     FIG. 4 illustrates an inserting device for use with the embodiments of the I.U.D. devices according to FIGS. 1-3. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     With reference to FIGS. 1-3 illustrating the I.U.D. devices according to the present invention, it is noted that FIG. 1 is schematic representation of the uterus 1 and of the adjacent part of the female body, such as the internal part 2 of the uterus 1 which communicates by means of tubes 3 with the ovaries, not shown, and through the cervix 4 with the vagina 5. The first preferred embodiment 10 of the I.U.D. device according to the present invention is illustrated in situ and which has a generally circular shape having the overall diameter between 20-30 mm. 
     FIG. 2 represents the I.U.D. device as shown in FIG. 1 in more detail and as can be seen in FIGS. 1 and 2, it is generally circular in shape, however, it is cut open or discontinous having a free end at 14. As can be seen in FIGS. 1 and 2 the structural details of the I.U.D. device according to the present invention include a base ring 11 made from a hard but resilient synthetic material capable of retaining its shape, such as, made from polyethylene and which has the diameter of about 1 mm. It carries on it a plurality of beads 12 which have a diameter of about 2 mm. As can be seen also in FIGS. 1 and 2 the bead 14 which is the last bead at the end of the circular shaped base ring 11 is made larger for the purpose discussed in connection with the inserting device illustrated in FIG. 4. The base ring 11 with its beads 12 is formed and prestressed to retain its circular shape and, in order when the fundus of the uterus is pressing on it, it should respond to the expulsionary forces of the fundus only to have the bead 14 enter toward the inside of the circle to start to form another convolution but still retain the circular shape even in a smaller size so that the entire device could not be expelled through the cervix 4. 
     According to the present invention the base ring 11 and the beads 12 thereon are covered with a soft physiologically inert material having a jelly-like consistency, such as silicone rubber or teflonized rubber in a thickness so that the diameter of the beads 12 with the soft material 13 thereon will be anywhere between 3-5 mm. As the bead 14 has been larger than the other beads, its final diameter with the soft synthetic material thereon will become around 5-6 mm. 
     The overall thickness of the I.U.D. device 10 with the molded synthetic material 13 thereon will vary between 3-5 mm in order to accommodate various sizes of insertion tubes, as it is well-known that according to the age of the recipient of the I.U.D, device various sizes of I.U.D. are inserted and the commercial product comes usually in three different sizes according to the size of the cervical canal 4. 
     The synthetic material 13 can be applied to the baze ring 11 in a conventional molding process and lend to it a soft jelly-like cover. 
     With reference to FIG. 3 it is noted that the basic shape of the I.U.D. device remains the same except that the base ring 11 has been replaced by a smooth ring-shaped plastic material 16 similarly prestressed and being shape-retaining and having a large bead 14 at the end and another bead at the other end thereof to which the control cord 15 is attached. The embodiment of the I.U.D. device 10 according to FIG. 3 includes the further improvement of a plurality of whiskers 17 made from the same soft synthetic material 13 as the beads are made with the additional advantage that the whiskers 17 which are soft and resilient come into contact with the wall of the uterus and have an additional physiological effect on it without the slightest possibility of entering the wall of the uterus due to their softness and resiliency. 
     Referring now to FIG. 4, it illustrates an inserting device 20 for use with the I.U.D. device as shown in FIGS. 1-3. It includes a generally cylindrical shape having a plunger 22 placed in it having a long stem 21. The I.U.D. device 10 is placed in an extended shape into the end of the inserting device 20 with only the large bead 14 remaining outside. 
     During insertion, the device with its shoulder or flange 23 is placed against the lip of the uterus while the tip is inserted into the cervix 4 and then the plunger 22 is forced against the I.U.D. device which will be forced out of the insertion device 20 and will spring into its circular shape illustrated in FIGS. 1-3. The control cord 15 being long enough will hang outside the vagina 5 as the inserting device 20 is withdrawn. 
     As has been shown, an I.U.D. device has been disclosed which retains all the advantages of my earlier aforementioned U.S. patents, namely, by coming into contact at several points with the walls of the uterus. In addition, it offers sufficient space for the menstrual flow, while at the same time it is capable of offering reliable resistance to the expulsionary forces of the fundus of the uterus 1 by permitting the free end 14 to form another convolution within the original circle while retaining the circular shape of the device 10. This advantage is afforded by the discontinuous nature of the I.U.D. device 10. In addition, the resilient and soft nature of the covering material 13 on the base ring 11 will prevent entry of the device into the wall of the uterus while good physical contact with the uterus wall is retained. 
     It is within the scope of the invention to make obvious modifications, such as using a stainless steel wire for the base ring 11 with its end formed into a loop to function as bead 14 herein. Also there is a great variety of materials available for the covering material 13. 
     It is also within the scope of the present invention to use the base ring 11 alone as an I.U.D. in which case the dimensions are simply changed to fit the size of the insertion device, that is, the size of the beads 12 and the base frame are enlarged. 
     I wish it to be understood that I do not desire to be limited to the exact details of construction shown and described, for obvious modifications will occur to a person skilled in the art.