Abstract:
An intra-uterine contraceptive device of the inflatable type provided with a plurality of protrusions for providing an unimpeded passage of the menstrual flow, such protrusions in one embodiment are wave-like configurations and in other embodiments they are arm-like extensions for providing also a plurality of contact regions with the inner wall of the uterus. Also devices are disclosed for the insertion of the contraceptive device.

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 inflatable I.U.D. having improved shape and insertion possibilities. 
     BACKGROUND OF THE INVENTION 
     I.U.D.&#39;s 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 40 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. For example, the I.U.D. must be capable of insertion using a thin-walled cannula and a push rod without the need for dilation of the cervix, such as described in U.S. Pat. No. 3,628,530 issued on Dec. 21, 1971 to Jerome Schwartz. 
     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 maximum contact with the walls of the uterus, which belief lead to the inflatable types closely conforming to the shape of the uterus, such as described in U.S. Pat. No. 3,452,749 issued July 1, 1969 to Edwin H. Riedell. 
     In U.S. Pat. No. 3,464,409 issued on Sept. 2, 1969 to James Murphy an I.U.D. is described which is inflatable through a tube after it has been inserted into the uterus and expands into a balloon-like configuration having pouch-like expansions around the periphery of the main balloon. 
     In U.S. Pat. No. 3,401,689 issued on Sept. 17, 1968 to Eugene C. Greenwood, a smooth-walled toroidal-shaped I.U.D. is described which is introduced into the uterus in a deflated condition and becomes inflated through a syringe. 
     In U.S. Pat. 3,782,376 issued on Jan. 1, 1974 to Irwin S. Lerner, an I.U.D. is described which is provided with spurs directed toward the cervix to prevent expulsion of the I.U.D. 
     It has not been, however, recognized 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 have retained the last mentioned beneficial properties even under the expulsionary effects of the fundus and in addition assume a shape which laterally increases its size with respect to the cervix under the last-mentioned conditions and reliably prevents thereby its expulsion. 
     SUMMARY OF THE INVENTION 
     It is, therefore, an object of the present invention to provide an improved and novel contraceptive device, hereinafter called I.U.D. device, which can be inserted into the uterus relatively easily without requiring medical attention 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 novel 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 as is the case in some of the heretofore known inflatable I.U.D. devices. 
     It is still another object of the present invention to provide a novel and improved I.U.D. device of the above-described inflatable type which comes on the market in an inflated form and is ready for insertion with the help of an appropriate inserting device without need for the dilation of the cervix. 
     It is a further object of the present invention to provide an improved and novel inflatable I.U.D. device which has a fluid filling material having a color code which readily indicates if the I.U.D. device has burst in situ, by virtue of the color coded fluid leaving the uterus. 
     It is still a further object of the present invention to provide an improved and novel I.U.D. which reaches the market in a deflated form packed into an inserting assembly together with an inflating syringe and which is inflated upon insertion into the uterus and filled with a gas or a color coded liquid for the purpose as hereinbefore described. 
     It is still a further object of the present invention to provide an improved and novel I.U.D. device of the above described type which is provided with a control means extending through the cervix and which serves for the removal of the I.U.D. device if so desired, and which improved I.U.D. device according to the present invention contains an x-ray sensitive material lending to it a character of easy recognition of the I.U.D. device during an x-ray process. 
    
    
     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 a similar illustration as FIG. 1 illustrating another embodiment of the I.U.D. device according to the present invention; 
     FIG. 3 is an illustration of the I.U.D. device of FIG. 2 in section; 
     FIGS. 4 and 4a illustrate an inserting device according to the present invention for use with the embodiments of the I.U.D. device according to FIGS. 1-3; 
     FIGS. 5 and 6 illustrate additional embodiments of the I.U.D. device according to the present invention; 
     FIG. 7 illustrates an inserting device in section, illustrating also a deflated I.U.D. packed into it, for use to insert the additional embodiments of the I.U.D. devices according to FIGS. 5 and 6. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     With reference to FIGS. 1-3 illustrating the so called donut-shaped I.U.D. devices according to the present invention, it is noted that FIG. 1 is a schematic representation of the uterus 1 and the adjacent parts 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 embodiment 10 of the I.U.D. device according to the present invention is illustrated in situ and which is made into donut shape and generally having the overall diameter of about 25 mm. The hollow internal void in the donut is made large enough, about 15 mm, so that the menstrual flow can pass without hindrance toward the cervix 4 and into the vagina 5. The donut-shaped I.U.D. 10 is made from flexible biologically inert synthetic material, preferably from teflonized rubber containing a certain amount of barium sulfate in order to lend x-ray sensitivity to the I.U.D. device 10 in order that it could be detected by x-ray. Other plastic materials which also may be employed are polyethylene, polypropylene, ethylene, propylene, copolymers, EPT, silicone rubber, etc. The I.U.D. device is made in one single molding step and is filled with an inert gas, but it can also be filled with air, or with a liquid material which preferably according to the present invention, is an antiseptic dye stuff having a color distinctly other than the menstrual flow in order to provide an indication to the user of the I.U.D. device in the event it has burst and the liquid has been passed. The shape of the donut I.U.D. device 10 is such that it is provided with a plurality of wave-like corrugations 11 about its entire circumference in order to provide a plurality of contact regions with the walls of the uterus 2 aiding thereby the menstrual flow and in order to avoid the situation that the I.U.D. device 10 would stick to the wall of the uterus 2 over a large surface where it could prevent passage of the menstrual flow or cause other undesirable effects due to the large contact surface, such as lend itself to internal strangulations. As can be seen in FIG. 1, a removing or control string 12 is attached to the I.U.D. device 10 in order to facilitate the removal of the I.U.D. device 10 if desired. The removing string 12 extends through the cervix 4 into the vagina 5 and it is easily detectable. The nature of the material from which the I.U.D. device is made and due to the resilient behaviour of the inflating inert gases or of the liquid contained in the I.U.D. device 10, the removal of the donut-shaped I.U.D. device 10 is relatively painless since a strong pull on the removing string 12 will change the shape of the I.U.D. device 10 into an elongated oval shape pointing downwardly and will pass through the cervix 4 without requiring a dilution of the cervix 4. On the other hand, the fact that the I.U.D. device 10 is donut shaped, any expelling natural process of the uterus 1 exerted onto the I.U.D. device 10 by the fundus of the uterus 1 will change the shape of the I.U.D. device 10 into an elongated oval which on the other hand, extends transversely within the uterus 10, therefore cannot pass through the cervix 4 since the longer lateral side of the I.U.D. device 10 will be facing the cervix 4 itself under such conditions. 
     With reference to FIG. 2 it is noted that the general shape of the I.U.D. device 10 illustrated therein is somewhat different from the donut shape of FIG. 1, however, it is still generally donut-like having the large internal void and the wave-like ondulations 11 of its shape about its circumference. It has also a larger corrugation or protrusion 15 at the top and having a leg-like protrusion 14 at the bottom to which the removing string 12 is attached. In order to safely attach the removing string 12 to the leg-like protrusion 14, it is preferred to make it solid from the general material of the I.U.D. device 10 so that a firmer pulling force could be applied to the I.U.D. device 10 through the string 12 in the event removal is desired. The material and characters of the I.U.D. device of FIG. 2 are similar to that described in connection with FIG. 1 and it is illustrated in closer detail in cross-section in FIG. 3. 
     With reference to FIGS. 4 and 4a, illustrating an inserting device for the I.U.D. devices 10 illustrated in FIGS. 1-3, it is noted that it is in the form of a surgical scissor 15 made from a plastic material and readily disposable after the I.U.D. has been inserted therewith. The inserting device 15 has a pair of two-forked prongs 16 which when the I.U.D. device 10 is placed inbetween and when the handle of the scissor is squeezed together, will squeeze down the I.U.D. device into an elongated oval shape as illustrated in FIGS. 4 and 4a, and which will not be wider than the normal size of the cervix 4. When the inserting device 15 is inserted together with the I.U.D. device 10 squeezed together in its prongs 16 up the neck portion 17 into the uterus 2, then it is opened up and the I.U.D. device 10 will pop open and leave the prongs 16 whereupon the inserting device is closed again and removed through the cervix 4 and disposed. 
     With reference to FIGS. 5-7 illustrating other embodiments of the I.U.D. device of the present invention including an associated different inserting device, it is seen that the I.U.D. device 20 of FIG. 5 when inserted into the uterus 2, and then becomes inflated as hereinafter described, expands into a generally V-shaped form with the tips and outer parts of the V-shape touching the internal walls of the uterus inner space 2. The I.U.D. device 20 of FIG. 5 is provided also with bead-like corrugations for the same purpose as the I.U.D. device described in connection with FIGS. 1, 2 and 3. Before insertion into the uterus 2 in the packed form, the I.U.D. device 20 assumes the shape 20&#39; within the inserting device 30 as hereinafter described in connection with FIG. 7. The I.U.D. device 20 has also a leg-like protrusion 23 connecting the V-shaped arms 21 through the neck portion 22 to which the removing string 12&#39; is attached. The bottom of the leg-like protrusion 23 contains a self-sealing valve mechanism which is well known in the art and which receives the needle of a syringe for inflation or filling purpose and when the needle is removed it will tightly reseal the I.U.D. device 20 so that it retains the inert gas or liquid inserted thereinto without loss. 
     With reference to FIG. 6, illustrating another embodiment of the I.U.D. device according to the present invention, it is seen that the I.U.D. device 20&#34; illustrated therein has a generally christmas tree shape having a plurality of arm-like protrusions 24 and 25 which extend laterally when the I.U.D. device 20&#34; becomes inflated or filled with a liquid as hereinafter described in connection with FIG. 7 and which come in contact with the walls of the uterus 2. The self-sealing valve means 23&#39; is similar to the one described in connection with FIG. 5. Other similar parts are designated by the reference numerals 12&#39; and 22&#39;. 
     With reference to FIG. 7 it is seen that it illustrates a general inserting assembly 30 of an I.U.D. device 20 which can be either the one illustrated in FIG. 5 or in FIG. 6 and which in its deflated form is inserted into the pipe-like construction 31 which is plastic tubing. The plastic tubing or housing 31, preferably made from PVC, contains a piston or plunger 35 guided slidably within the housing 31 and which is connected through an elongated cylindrical extension 34 thereof with the outside of the housing 31 and terminates in an opening 38 which is flared to receive a syringe for the inflation or fluid filling of the I.U.D. device 20 as hereinafter described. The plunger 35 is provided with a needle 36 protruding therefrom to a close proximity with the I.U.D. device 20 and, more particularly, with the bottom portion thereof 23 containing the self-sealing valve means. The needle 36 communicates through the extended body portion 34 of the plunger 35 with the flared opening 38. The plunger 35 together with its extended body portion 34 is adapted for sliding motion aided by the shoulder within the tube 31 and during the insertion of the I.U.D. device 20 the front portion 41 of the pipe 31 containing the I.U.D. 20 is inserted through the cervix 4 into the uterus 2 so that it abuts with the flange portion 32 against the outer walls of the uterus in the vicinity of the cervix 4. Then the plunger assembly 34, 35 is pushed forward to a small extent by means of the flange 39 whereupon the needle 36 will pierce the self sealing valve in the bottom 23 of the I.U.D. 20. Thereafter the plunger 35 is pushed forward until the flange 39 will abut against the end flange 40 of the pipe 31 whereupon the plunger 35 forces out the I.U.D. 20 nearly entirely from the tube. However, the dimensions of the assembly 30 are such that the I.U.D. with its back leg portion 23 is still within the front portion 41 of the pipe 31 with the needle inserted. At this instant the syringe containing the inert gas or the antiseptic dye stuff is applied through the opening 38 and the inert gas or the dye stuff is injected through the passage 36 a and the needle 36 into the I.U.D. 20 and inflates it to assume the solid line illustration of FIG. 5 or the christmas tree-like illustration of FIG. 6 whereupon the I.U.D. during the inflating process will pop out and leave the front portion 41 of the pipe 31. The plunger 35 is returned into its state illustrated in FIG. 7, that is with the help of the flange 39, the plunger assembly 35 is pulled back so that the needle 36 will not exert a retention force on the I.U.D. 20. It is noted that the needle 36 during the entire insertion process is completely within the housing so that no damage can be done to any of the parts of the body. Then the front portion 41 is removed from the cervix 4. It is noted that the slight retaining frictional force of the needle 36 exerted on the I.U.D. 20 during inflation will be overcome when the plunger 35 is returned and the fact that the I.U.D. 20 has not opened will not interfere with the removal of the assembly 30. 
     With further reference to FIG. 7, it is seen that the bottom portion of the piston or plunger 35 is provided with a groove 37 which serves for the guiding of the removing string 12. When the assembly 30 is removed from the vagina 5 the string 12 slides through groove 37 past the plunger 35 and remains freely hanging through the cervix 4. 
     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.