US 3457915 A
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Description (OCR text may contain errors)
July 29, 1969 F. R. ESHELMAN 3,457,915
INTRAUTERINE DEVICE Filed Aug. 1o. 1966 l #Trop/V556 United States Patent O 3,457,915 IN TRAUTERINE DEVICE Frank R. Eshelman, 907 Pammel Court, Ames, Iowa 50010 Filed Aug. 10, 1966, Ser. No. 571,602 Int. Cl. A611? /46 U.S. Cl. 12S-130 18 Claims ABSTRACT OF THE DISCLOSURE A device having a pair of resilient frames foldably secured together in substantially superimposed relationship whereby they tend to expand and spread apart upon introduction into the uterus to a shape complementary to the uterine cavity. Each of the frame elements may include interior frame elements dwelling in a plane different than that of the first mentioned frame elements.
Several such devices have achieved recognition in the art, but among the difiiculties of these devices are: (l) difliculty in insertion and removal; (2) ejection from the uterus; (3) penetration of tissue, and (4) migration of the device. The Graefenberg ring normally requires the administration of anaesthesia during insertion or removal. The coil of Margiulies (=U.S. Patent No. 3,200,815) is more easily expelled and induces considerable bleeding. The Birnberg bow (U.S. Patent No. 3,230,953) commonly punctures the organ tissues. The Lippes loop which comprises a single strand of material bent into a series of U-shaped loops to form a loose spring-like structure has also been known to puncture the uterine wall. It also has a higher expulsion rate than some of the other devices, and its use occasionally causes excess bleeding with some patients.
Therefore, a. principal object of this invention is to provide an intrauterine contraceptive device which is easily inserted into or removed from the uterine cavity.
A further object of this invention is to provide an intrauterine contraceptive device which is formed of a plurality of strands or frames to minimize the unit pressure of each strand upon the uterus walls, but which will collectively exert suflicient pressure to prevent both migration and expulsion.
A further object of this invention is to provide an intrauterine contraceptive device having a plurality of strands or frames which expand to different planes upon insertion into the uterine cavity, so that the anterior and posterior walls of the uterus, as well as the side walls, will be stimulated to create a more effective contraceptive.
A still further object of this invention is to provide an intrauterine contraceptive device which can expand upon introduction into the uterus to a shape complementary to the uterine cavity so that only the long curved strands of the device will engage the uterus walls with uniform pressure, thus preventing puncture or imbedding of the device.
These and other objects will be `apparent to those skilled in the art.
This invention consists in the construction, arrangements, and combination, of the various parts of the device, whereby the objects contemplated are attained as hereinafter more fully set forth, specifically pointed out in the claims, and illustrated in the `accompanying drawing, in which:
FIGURE 1 is a frontal section through the uterus with the device of this invention inserted therein;
FIGURE 2 is a sectional side view of the subject matter of FIGURE 1;
FIGURE 3 is a plan view of the device of this in- Patented July 29, 1969 vention in its expanded condition as shown in an initial step during fabrication;
FIGURE 4 is a plan view of the device of this invention as it exists after insertion;
FIGURE 5 is a side view of the device of this invention taken on line 5 5 of FIGURE 4;
FIGURE 6 is an elevational view of a modified form of the invention; and
|FIGURE 7 is an elevational view of a second modified form of this invention.
The numeral 10 generally designates the uterus including the cervix 12 and uterine cavity 14. The intrauterine contraceptive device 16 is comprised generally of two frame elements 18 and 18A which are identical in construction and which are foldably secured together at their respective top portions 20. The contraceptive device 16 is preferably comprised of any inert material having resilient characteristics and which is not permanently deformed upon being deflected. A suitable material would be polyethylene or polypropylene plastic, for example. Only one of the frames will be described, it being under-l stood that like numerals will be used to describe corresponding parts in the frames 18 and 18A.
The top portion 20 of each frame element 18 and 18A is substantially straight and has its ends arcuately turned downwardly or outwardly at 22 to form tapered side portions 24. Side portions 24 extend downwardly and inwardly, and are arcuately bent upon themselves at 26 to form bottom portion 28. The bottom portion 28 is comprised of a. downwardly extending stem 30 which is rounded on its lower end and which joins theltwo arcuate loop portions 32 which extend upwardly and inwardly from points 26. A exible follower element 34 is secured to stem 30 and is approximately 3 inches in length. The frames 18 and 18A are symmetrical about the axis A-A and B-B (FIGURE 3).
IEach frame 18 and 18A has an interior frame 18' and 18A', respectively, which is substantially symmetrical in shape to the shape of frames 18 and 18A, but which is correspondingly smaller so .as to dwell in spaced relationship to the outer frames 18 (and 18A) except at the two points of juncture at top portion 20 and at stem 30.
The two frames 18 and 18A are bent upon themselves about axis A-A (FIGURE 3) which passes through top portion 20, and this step brings the two frames 18 and 18A into a substantially superimposed position. The cross sectional diameter of the plastic forming frames 18 and 18A is approximately 0.040 inch, while the corresponding diameter (or thickness) of the frames 18 and 18A is a lesser diameter of approximately 0.025 inch. The inherent resiliency of the material of the frames, plus the arcuate configuration of the bottom portion 28, and particularly that of loops on both the inner and outer frame elements, causes the inner frame elements 18' and 18A' to twist diagonally outwardly from the plane of the frame elements 18 and 18A (FIGURES 4 and 5).
The contraceptive device 16 is inserted top-lirst into the uterus in its folded condition through the cervical canal 12A by any convenient means, such as by the general concept suggested in `U.S. Patent No. 3,230,953. The overall triangular shape of the device is complementary to the corresponding shape of the uterine cavity. This enables the top portion 20 and the side portions 24 to resiliently engage the corresponding walls of the uterus as shown in lFIGURE l. At the same time, the expansion of the interior frames 18' `and 18A upon insertion enables the side portions of the interior frames to also resiliently engage the opposite walls of the uterus, as shown in FIGURE 2. The construction of the lower portion of both the inner and outer frames permits the easy compression of the loops therein which allows the side portions of both the inner and outer frames to yield in an inwardly direction if necessary. While the pressure between the uterus walls and any given point on any frame is not great, the accumulated pressure on the contraceptive device 16 is such that it is not subject to migration or expulsion. Since nothing but a straight or arcuate surface is presented by the device to the uterus walls, the problems of penetration or imbedding are substantially eliminated.
While the precise phenomenon that permits an intrauterine device to inhibit conception is still not completely understood, it is believed that the stimuli of the uterus walls by such a device is a factor in achieving7 contra ccption. Hence, a greater portion of the uterus is stimulated by the device described as the three-dimensional frames extend to resiliently engage the uterus walls.
The follower element 34 extends through the cervical canal 12A and into the vagina for a short distance, and
the follower is used to determine the position of the de- Vice 16, and to aid in the removal of the device when desired. Longitudinal pulling on the follower will cause collapse of the frames to permit easy removal.
The unit 36 (FIGURE 6) is similar to the device 16 in that the unit 36 also has two frames 18C and 18D folded over on each other (FIGURE 6); the frame 18D being shown partially in an unfolded condition by dotted lines. The frames are joined in a folded condition at their straight top portions 38 which arcuately extend into the downwardly and inwardly side portions 40 which terminate in arcuate loops 42. A center stem 44 extends downwardly from the top portion 38, and a follower element 46 is secured to the lower end of the stem.
The unit 48 (FIGURE 7) is substantially identical to the unit 36, and elements of vunit 48 which correspond to elements of unit 36 have been given like numerals followed by a prime exponent. lt will be noted that the stem 44 of unit 48 is longer than the stern 44 of unit 36, and that the loops 42 of unit 48 have a reverse bend and are connected to stem 44.
The use of the units 36 and 48 is substantially the same as the unit 16, except that the former units do not utilize the interior frame construction. lIn practice, the frames 18 and 18A, 18C and 18D, 18C and 18D', do not totally engage each other in a completely superimposed position, but the preferred folded position of unit 16 is illustrated in FIGURES 2, 4 and 5. The opposing frames of units 36 and `48 would have more of a tendency to spread slightly upon insertion as the side portions of the frame expanded and sought the uterus walls.
Thus, from the foregoing, it is seen that the devices of this invention will accomplish at least all of their stated objectives.
Some changes may be made in the construction and arrangement of my intrauterine device without departing from the real spirit and purpose of my invention, and it is my intention to cover by my claims, any modified forms of structure or use of mechanical equivalents which may be reasonably included `within their scope.
1. An intrauterine device comprising,
a frame element of resilient material, said frame having a top, bottom, and two side portions, said top portion being substantially straight and having its end arcuately terminating into said side portions, said side portions being tapered downwardly and inwardly to give said frame a substantially triangular shape,
a second frame element being foldably secured to to said first frame element, said first frame element having an edge portion adjacent an edge portion of said second frame element, with said frame elements being foldably secured together at said edge portions, said first frame element being folded over in a substantially superimposed position on said second frame element.
2. The device of claim 1 wherein an interior frame element is secured within said first-mentioned frame element, and said interior frame element dwells in a plane different than that of said first-mentioned frame element.
3. The device of claim 1 wherein said bottom portion includes upwardly extending arcuate loop portions.
4. The device of claim 1 wherein a follower element is secured to said frame element.
5. The device of claim 3 wherein said loop portions are spaced from each other and adapted for independent movement with respect to each other.
6. The device of claim 3 wherein said loop portions are interconnected.
7. The device of claim 1 wherein an interior frame element is secured within said first-mentioned frame elements, and said interior frame elements dwell in a plane different than that of said first-mentioned frame elements.
8. The device of claim 7 wherein said interior frame elements are symmetrical to the shape of said first-mentioned frame elements.
9. An intrauterine device comprising,
a first frame element,
a second frame element,
said rst frame element having an edge portion adjacent an edge portion of said second frame element, with said frame elements being foldably secured together at said edge portions,
said first frame element being folded over in a substantially superimposed position on said second frame element.
10. The device of claim 9 wherein an interior frame element is secured within said first and second frame elements, and said interior frame element dwells in a plane different than that of said first and second frame elements.
11. The structure of claim 1 wherein said each of said side portions terminate in an arcuate shape at said bottom portion.
12. The structure of claim 9 wherein said first and second frame elements are formed of resilient material whereby said frame elements tend to expand and spread apart when said first frame is in said folded over substantially superimposed position on said second frame element.
13. The device of claim 9 wherein an interior frame element is secured within said first-mentioned frame element, and said interior frame element dwells in a plane different than that of said first-mentioned frame element.
14. The device of claim 9 wherein a follower element is secured to said frame element.
15. The device of claim 10 wherein said interior frame elements are symmetrical to the shape of said first-mentioned frame elements.
16'. The device of claim -9 wherein each of said frame elements have top, bottom and two side portions, said first and second frame elements being folded along the line between the top portions, and wherein said bottom portion includes upwardly extending arcuate loop portions.
17. The device of claim 16 wherein said loop portions are spaced from each other and adapted for independent movement with respect to each other.
18. The device of claim 16 wherein said loop portions are interconnected.
References Cited UNITED STATES PATENTS ADELE M. EAGER, Primary Examiner