US3431906A - Contraceptive device - Google Patents

Description

March 11, 1969 c. E. TAYLOR 3,431,906

CONTRACEPTIVE DEVICE Filed April 22. 1966 Sheet of 2 FIG. 2.

Mum TUN.

BODY OF UTERUS INTERNAL 0sCERVIX 2 EXTERNAL 0s VAG'NA I CARL E. TAYLOR INVENTOR ATTORNEY March 11, 1969 c. E. TAYLOR 3,431,906

CONTRACEPTIVE DEVICE Filed April 22, 1966Sheet 2 of 2 FIG. 6. 32 42 40 38 383a 40 42 40v3a 38 H615.

INVENT OR CARL E. TAYLOR BY ii? United States Patent f 3,431,906 CONTRACEPTIVE DEVICE Carl E. Taylor, Baltimore, Md., assignor to The Johns Hopkins University, a corporation of Maryland Filed Apr. 22, 1966, Ser. No. 551,484 US. Cl. 128130 21 Claims Int. Cl. A61f /46 ABSTRACT OF THE DISCLOSURE An intrauterine contraceptive device which features collapsing elements to reduce its size for installation eas'e. Essentially the device is a diamond shaped loop of four sides the junctions of which will bend or hinge to cause the diamond'to elongate. The acute point of the diamond comprises an attachment point for a retrieval cord and the grasping area for insertion forceps. In another embodiment the retrieval cord is first reeved through a tubular median stub element and secured to the opposite juncture. For this purpose the folding action is a reentry of the two short arms of the figure as the cord is tensioned.

This invention relates generally to pessaries and more particularly it pertains to contraceptive devices for intrauterine use.

In developing areas of the world and generally among women from poorly educated and lower socio-economic strata, there remains a great challenge to develop effective means of contraception. These women particularly require devices which can be applied once and left in place until the woman decides that she wants to get pregnant. The device can then readily be removed.

In addition to this major benefit of not requiring repetitive or continuing thought, decisions, and bother to use, the intrauterine devices have the additional advantages that they are cheap, highly effective, esthetically uncomplicated, and particularly suited for mass use.

Although the presently available intrauterine contraceptive devices are proving of great effectiveness in many parts of the world with the rapidly increasing demand, quickly expanding into millions of users, there are still several serious limitations. For example, the methods of insertion of the devices are too cumbersome and dangerous. The various tubular inserters with plungers, clamps and other metal and plastic devices that have been necessary to place present designs of contraceptive devices into the uterus, have serious limitations.

Such current devices run the danger of traumatizing the cervical canal or even perforating the uterine wall, as has happened occasionally. The cervical canal often bends anteriorly or posteriorly. Many physicians feel that it is necessary to first pass a metal sound to determine the position and direction of the canal. Especially when the intrauterine contraceptive device is being inserted in the optimum period soon after delivery the walls are especially soft and susceptible to damage.

It follows then that present intrauterine contraceptive devices should be inserted only by a physician and preferably one with special gynecological training. To meet the mass needs of developing countries it will probably be necessary to use large numbers of specially trained midwives or other auxiliaries. There is great need, therefore, for a method which has maximum safety at the time of insertion.

It is a principal object of this invention, therefore, to provide a unique-inserting intrauterine contraceptive device and method of insertion thereof which has maximum safety at the time of insertion of the device.

It is a object of this invention to provide an inexpensive 3,431,906 Patented Mar. 11, 1969 device for contraceptive or other purposes which is designed so as to permit insertion directly without the need for using a specially designed tube, clamp, or other unique instrument 0t introduce it into or remove it from the uterus.

Another object of this invention is to provide a reliable intrauterine contraceptive device with an installed shape which conforms to the uterine cavity so as to cause minimal trauma or other damage to the wall or its lining and preclude complications such as bleeding or cramps.

Yet another object of this invention is to provide a contraceptive device which features weakened or hinge points whereby in a collapsed condition is may easily be inserted through a small orifice and which will itself unfold and remain safely in place with no need for removal or replacement unless the woman desires to become pregnant.

Other objects and attendant advantages of the invention will become more readily apparent and understood from the attached specification and accompanying drawings in which:

FIG. 1 is a perspective view of a preferred embodiment of an intrauterine contraceptive device embodying features of this invention;

FIG. 2 is a sectional view through the uterus and ad jacent parts of a woman showing the initial stage of installation of the device of FIG. 1;

FIG. 3 is a view similar to FIG. 2. showing an inter mediate stage in the installation of the device of FIG. 1;

FIG. 3A is a view similar to FIG. 2 of the uterus showing the final stage in the installation of the device of FIG. 1;

FIGS. 4, 5, and 6 are plan, side and end views respectively of a second embodiment of the invention shown enlarged to scale of two;

FIG. 7 is a view depicting the device of FIG. 4 collapsed and ready for insertion;

FIG. 8 is an end view of the device folded as in FIG. 7;

FIG. 9 is a view of a third embodiment of the invention; and

FIG. 10 illustrates the collapsed condition of the device of FIG. 9.

Referring now to the details of the drawings as shown in FIG. 1 this embodiment of acontraceptive device 10 consists of a modified diamond or kite-shaped closed loop of flexible plastic. The longer orside legs 12 are decreasingly tapered from theirjunction 14 to Where they join with the shorterupper members 16. These junctions where there is an abrupt change of direction are termed hinge points and indicated byreference numerals 18.

Theupper members 16 are relatively thin and join together at an upper junction orcentral hinge point 20. Anotch 22 is provided at thelower junction 14, and athread 24 is tied thereabout.

As shown in FIG. 2, when thedevice 10 is grasped in an ordinary pair of forceps F at the sides of thelegs 12, the stresses in thedevice 10 are such that it collapses at thehinge points 18 and 20 so as to elongate and become very narrow. The extending top (or front end in insertion) being more slender and flexible will bend easily and follow the course of the cervical canal and minimize the hazard of damaging the mucosa or penetrating the wall of the uterus. Further the folded size will pass into the cervix easily without special dilation. With appropriate sizes this can be achieved even in women who have never been pregnant.

As soon as thehinge points 18 are beyond the external os as best illustrated in FIG. 3 so as to be held in position by the cervical canal the forceps F are released and placed nose first against the previously mentionednotch 22 to push thedevice 10 through and into the uterine cavity as shown in FIG. 3. As soon 'as thelegs 12 pass the internal es the device will open to its original kiteshape with a self-lifting action so as to insert itself and conform to the normal shape and contour of the uterus, as shown best in FIG. 3A.

Thethread 24 is left to protrude from the cervix so as to facilitate removal of thedevice 10 when desired.

From the above, it is readily seen that thedevice 10 has maximum safety at time of insertion.

Rather than a metal or hard plastic tubular inserter or clamp, thisdevice 10 as shown in FIGS. 1 to 3A, folds so that it can find its own way along the canal. Its soft and flexible tip can follow the uterine canal regardless of the direction it bends. As thedevice 10 passes the internal es, the elasticity of theside arms 12 lifts thedevice 10 on into the uterine cavity, so that the ordinary forceps F used to push it never has to pass beyond the cervical canal.

It is obvious, therefore, that because of the greater ease of insertion of thedevice 10, it will not be necessary to dilate the cervix or to wait until the woman is menstruating before proceeding with insertion.

Also, another advantage ofdevice 10 is that it has a shape which conforms to the contours of the uterine cavity. It does not have points or a shape which will cause pressure at specific points. This tends to minimize the bleeding and cramping which are the main complications which now lead up to of women in some series of cases to have the present devices removed.

Also the device shown in FIGS. 1, 2, 3, and 3A has its greatest strength at the base. This will make it resist the natural expulsive movements of the uterus during menstruation. Spontaneous expulsion continues to be one of the major problems with present devices. In those cases where the woman does not happen to notice that the device has been passed with menstrual discharge, there is maximum danger of an unwanted pregnancy.

In the second embodiment of the invention, the intrauterine contraceptive device as shown in FIGS. 4, 5, and 6, the retrieval thread 50 (24) is further utilized in such a way as to compress the side membersc32 as will be related. Theseside members 32 having ajunction 34 and notch 35 as in the first embodiment of thedevice 10 but are relatively longer.

The narrowed upper ends 36 of theseside members 32 join at hinge points 38 to laterally thinupper members 40 which normally are almost co-extensive so as to complete a triangular or roughly heart-shaped configuration. Theseupper members 40 come together in a somewhat reducedcentral hinge point 42.

Atongue 44 extends centrally upward from a point of attachment on thelower junction 34 and is apertured at two spaced places, anupper slot 46 and alower slot 48. A thread is tied to thecentral hinge point 42 and is reeved throughslots 46 and 48 in succession so as to depend from a point close to thenotch 35.

Thisthread 50 can be pulled and held taut merely by applying surgical forceps F or the like againstnotch 35 for the opposing force.

Alternately, the tensionedthread 50 can be grasped just belowslot 48 to retain the tension while manipulating thedevice 30. In either case, this action collapses theupper members 40 downwardly together which pulls theside members 32 together. If thetop members 40 have laterally askew hinge points 38 as best shown in FIG. 6, when folded they will take a half twist as shown in FIGS. 7 and 8 and result in a small area athinge point 38 for easy insertion.

The added length of theside members 32 when compressed and the fact that their maximum recoil elasticity is applied at the extreme forward end results in a more easily handled device and a greater self-positioning force on extension beyond the internal os.

This feature is also true in the third embodiment of the intrauterine contracep ve e 59 h9Wll i FIG 9 and 10. Here thedevice 60 is provided with an enclosure for thethread 76 to reduce friction and provide a limit to the draw. This enclosure consists of atube 74 extending upwardly from thejunction 64 of side-members 62. Thus, the thread 7-6 emerges from the center of thenotch 66 and can only be drawn to the degree where thecentral hinge point 72 of theupper members 70 contacts the upper end oftube 74. Thus assurance may be had that hinge points 68 collapse completely together to a point especially if theupper members 70 are given a permanent sinuate set as shown both in FIG. 9 and FIG. 10.

In summary, the twodevices 30 and 60 shown in FIGS. 4, 5, 6, 7, and 8, and in FIGS. 9 and 10 will have strength not only at the base but also across the top portions in dicated as 40 and 70, respectively. The strength that can be built into this portion of thedevices 30 and 60, likedevice 10, will be particularly useful in lifting each device into place since it will be exerted at the forward tip and also will hold the respective device up in the uterine cavity, thus keeping it away from the cervix where it will be subject to the maximum explusive forces, Because of thestring 50 or 76 to collapse this upper cross-section, the insertion can still be readily carried out.

The minimal cross-section and the self-inserting action of thesedevices 10, 30, and 60 will make it possible to try them for use in women who have never been pregnant. This will require smaller sizes than those used for women who have borne children. Presently available devices are not suitable for nulliparous women.

These embodiments of thedevices 10, 30, and 60 have contours which provide the greatest possible contact with the uterine surface, which appears to be necessary for maximum effectiveness. The best available evidence indicates that intrauterine devices prevent pregnancy not by causing early abortion or by interfering with the free pas sage of spermatozoa. The intrauterinecontraceptive devices 10, 30 and 60 appear to increase reflexively the peristaltic activity of the Fallopian tubes where the sperm normally fertilize the ovum. The fertilized ovum therefore is mererly passed more rapidly along the tube so that it arrives in the uterus before it has developed to the point of being able to effectively implant itself in the uterine mucosa and start normal development. The method appears to he, therefore, completely physiological.

Obviously many modifications and variations of the present invention are possible in light of the above teachings. It is, therefore, to be understood that within the scope of the appended claims the invention may be practiced otherwise than as specifically described.

What is claimed is:

1. An intrauterine contraceptive drive, comprising, structure defining a closed loop of flexible material, said loop being formed of at least one substantially isosceles triangular shape having its legs intersecting to form an apex end, flexible strand attachment means at said apex end and a base having a hinge within its length, the said base joined by the said legs to form said closed loop, with said junctures of said legs and base also forming hinges, whereby said contraceptive device can be collapsed forming a forwardly tapered flexible body for insertion into a uterus through flexing of all said hinges by manipulation at said apex end.

2. An intrauterine contraceptive device as recited in claim 1, with said base having a hinge midpoint its length.

3. An intrauterine contraceptive device as recited inclaim 2, wherein the portions of said base between the junctures of said legs with said base form an isosceles shape, with the hinge at said midpoint of said base forming the apex of said isosceles shape.

4. An intrauterine contraceptive device as recited in claim 3, wherein said material is formed of plastic.

5. An intrauterine contraceptive device as recited in claim 4, wherein said base of said loop is formed of a more flexible and pliable material than said legs of said loop.

6. An intrauterine contraceptive device as recited in claim 5, wherein said legs are decreasingly tapered from said apex of said loop to where said legs join said base thereof.

7. An intrauterine contraceptive device as recited in claim 1, wherein a recess is provided in said apex for use in insertion of said device into a uterus.

8. An intrauterine contraceptive device as recited in claim 1, and flexible strand means secured to said apex of said legs of said loop for withdrawing said device from a uterus after insertion therein.

9. An intrauterine contraceptive device, comprising, structure defining a closed loop of flexible material, having an apex end, said loop consisting of two pairs of substantially isosceles arranged legs joined to each other to form said closed loop, with all said junctures of said pairs of isosceles arranged legs forming hinges, whereby said contraceptive device can be collapsed through flexure of all said hinges by manipulation at said apex end for insertion into a uterus.

10. An intrauterine contraceptive device as recited in claim 9, wherein said closed loop is formed of substantially diamond shape, with the apex ends of said two pairs of isosceles arranged legs being positioned oppositely each other.

11. An intrauterine contraceptive device as recited in claim 9, wherein one pair of isosceles arranged legs of said two pairs of isosceles arranged legs is more pliable and flexible than the other pair of isosceles arranged legs of said two pairs of isosceles arranged legs so as to bend and follow the course of the cervical canal and minimize the hazard of damaging the mucosa or penetrating the wall of said uterus during the insertion of said device into said uterus.

12. An intrauterine contraceptive device as recited to claim 11, wherein said other pair of isosceles arranged legs of said two pairs of isosceles arranged legs is decreasingly tapered from its apex to where its legs join with the legs of said one pair of isosceles arranged legs, whereby when said leg junctures of said two pairs of isosceles arranged legs pass the internal os of the uterus when said device is collapsed, said device will open to its original diamond shape with a self-lifting action so as to insert itself and conform to the normal shape and contour of the uterus.

13. An intrauterine contraceptive device as recited in claim 9, wherein said one pair of isosceles arranged legs of said two pairs of isosceles arranged legs is of reduced height with respect to the other pair of isosceles arranged legs of said two pairs of said isosceles arranged legs.

14. An intrauterine contraceptive device as recited in claim 11, wherein said other pair of isosceles arranged legs of said two pairs of isosceles arranged legs is provided with a recess in its apex end for use in insertion of said device into a uterus.

15. An intrauterine contraceptive device as recited in claim 11, and additionally flexible strand means secured to said apex of said other pair of isosceles arranged legs of said pair of isosceles arranged legs for withdrawing said device from a uterus after insertion therein.

16. An intrauterine device as recited in claim 9, wherein the legs of said one pair of isosceles arranged legs are substantially co-linearly arranged.

17. An intrauterine device as recited inclaim 16, and additionally tongue means extending centrally upwardly from a point of attachment to the apex juncture of said other pair of isosceles arranged legs of said two pairs of isosceles arranged legs, with said tongue means having two spaced apertures formed along the longitudinal direction thereof, flexible strand means having one end thereof secured to the apex juncture of said one pair of isosceles arranged legs of said two pairs of isosceles arranged legs and extending through said spaced apertures of said tongue means, with the other end of said strand means being free to have tension manipulatively exerted on said strand means at said apex end so as to collapse said device.

18. An trauterine device as recited in claim 17, wherein said two pairs of isosceles arranged legs are positioned to form respective apex ends tending in the same direction with respect to each other.

19. An intrauterine devices as recited inclaim 16, and additionally tube means extending centrally upwardly from a point of attachment to the said apex end, flexible strand means having one end thereof secured to the said juncture of said one pair of isosceles arranged legs of said two pairs of isosceles arranged legs and extending through said tubes means, with the other end of said strand means being free to have tension exerted on said strand means at said apex end so as to collapse said device.

20. A method for inserting an intrauterine contraceptive device formed of a substantially diamond shape resilient loop structure having joints at the junctures of the sides of said diamond into a uterus, comprising, collapsing said structure at the hinges thereof by manipulatively exerting a force at the end of one acute angle of the diamond, inserting said collapsed structure into the uterus until one said pair of sides thereof has passed the internal as of said uterus, and then releasing said collapsed structure, so that the resiliency of said structure will cause said structure to open its original shape.

21. A method for inserting an intrauterine contraceptive device consisting of a structure defining a closed loop of resilient and flexible material having two pairs of substantially isosceles arranged legs forming two apex ends, and a flexible strand secured to one apex end and passing through a hole in the other apex end, with the other ends of said legs being joined to each other to form a closed loop, and with the junctures of said pairs of isosceles arranged legs forming hinges, into a uterus, comprising, collapsing said structure at the hinges thereof by manipulatively exerting a force on the strand and apex end adjacent the hole, inserting said collapsed structure into the uterus until one of said pairs of isosceles arranged legs has passed the internal es of said uterus, and then releasing said collapsed structure, so that the resiliency of said structure will cause said structure to open to its original shape.

References Cited UNITED STATES PATENTS 2,122,579 7/1938 Meckstroth 128130 2,176,559 10/1939 Meckstroth 128-l30 3,253,590 5/1966 Birnberg et al l28130 3,291,125 12/1966 Robinson 128-13O ADELE M. EAGER, Primary Examiner.

UNITED STATES PATENT OFFICE CERTIFICATE OF CORRECTION Patent No. 3,431,906 March 11 1969 Carl E. Taylor It is certified that error appears in the above identified patent and that said Letters Patent are hereby corrected as shown below:

Column 1,line 68, "unique-inserting should read unique self-insert ing Column 2, line 4, "01:" should read to line 13, "is" should read it line 28, "inter should read inter- Column 4 line 51 "drive" should read device Column 5, line 37, "to" should read in Column 6, line 15, "trauterine" should readintrauterine line 25, tubes" should read tube Signed and sealed this 31st day of March 1970.

(SEAL) Attest:

Edward M. Fletcher, Jr. E.

Attesting Officer Commissioner of Patents

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