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Publication numberUS3256878 A
Publication typeGrant
Publication dateJun 21, 1966
Filing dateMay 28, 1964
Priority dateMay 28, 1964
Publication numberUS 3256878 A, US 3256878A, US-A-3256878, US3256878 A, US3256878A
InventorsHewlett Harbor, Jerome Schwartz, Reyner Franklin C
Original AssigneeHewlett Harbor, Jerome Schwartz, Reyner Franklin C
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Intra-uterine contraceptive appliance
US 3256878 A
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Description  (OCR text may contain errors)

June 21, 1966 J. SCHWARTZ ETAL 3,256,878

INTRA-UTERINE CONTRACEPTIVE APPLIANCE Filed May 28, 1964 m 2 N 7 mm 6 5 0 a V C f 1 E L K ON RA E R m JF. W-

2 FIG. 3 FIG. 6

NI N FIG.

ATTORNEY 3 256,878 INTRA-UTERINE COlSlTRACEPTIVE APPLIANCE Jerome Schwartz, 1321 Club Drive, Hewlett Harbor,

N.Y., and Franklin C. Reyner, 29 Argyle Place, Rockville Centre, N.Y.

Filed May 28, 1964, Ser. No. 370,858 7 Claims. (Cl. 128-130) This invention relates to an intra-uterine contraceptive appliance.

While such appliances are available in several different forms, the Grafenberg ring form has achieved the broadest professional acceptance. The appliance is positioned in the uterine cavity proximate to the entry to the oviducts. The ring is resilient and may be temporarily collapsed for introduction through the cervical canal. While the invention is applicable to multiring embodiments and other configurations, the present invention will be described with reference to several modifications of the classical Grafenberg ring.

Intra-uterine devices have one of the lowest failure rates of the pregnancy-prevention devices commonly in current use. The 1964 McGraw-Hill Yearbook of Science and Technology reports a failure rate of 1.7 per one hundred woman years of use for intra-uterine contraceptive devices. One medical team reported that using the Grafenberg ring for a test involving 128 patients over a six-year period, which corresponds to 648 exposure years, only six pregnancies resulted. However, in five of the reported pregnancies, the ring was found 'to have been expelled into the cervical canal. Periodic checking of the device is therefore necessary for effective use and to further reduce the failure rate. This need for periodic checking is objectionable and restricts the use of the device. Such checking must be carried out by competent specialists in the field.

The present invention seeks to overcome these and other difiicul-ties of the prior art in that it permits the user to verify for herself the presence of the ring thus adding confidence and overcoming a serious psychological objection to the employment of this type of device.

The classical Grafenberg ring is currently made of stainless steel wire wound into a helix. The helix is then bent into a toroidal shape, about 20 mm. in diameter, and retained in that form by means of a nylon filament running through the center of the toroid and tied to the ends thereof.

The method and introduction of a Grafenberg ring is as follows:

The uterine cavity is sounded and note taken of the length and direction of the canal.. The cervical canal is then dilated with a Hegar dilator. With the ring straddling the fork of the introducer, the anterior lip of the cervix is grasped with a single tooth tenaculum and, with gentle traction, the ring is passed into the uterine cavity.

The literature reports that, as a rule, there will be some staining following the insertion of the ring probably due to abrasion of the cervical mucosa caused by the passage of the compressed ring through the canal.

A feature of the present invention is that a nonabrasive ring is employed thereby simplifying the introduction and avoiding the dangers and discomfort resulting from the insertion of the abrasive ring of the prior art.

Thus, one object of this invention is to provide an improved intra-uterine contraceptive appliance.

Still another object of this invention is to provide a readily inserted, nonabrasive intra-uterine appliance.

Still a different object of this invention is to provide an intra-uterine appliance that does not act as an irritant to the endometirum.

- United States Patent A principal object of this invention is the provision of an intra-uterine device whose presence may be verified by the user.

A particular object of this invention is the provision of a silicone rubber intra-uterine contraceptive device.

These and other features, objects and advantages of the invention will, in part, be pointed outwith particularity and will, in part, become obvious from the following more detailed description of the invention, taken in conjunction with the accompanying drawing, which forms an integral part thereof.

In the various figures of the drawing like reference characters designate like parts.

In the drawing:

FIG. 1 shows a plan view of the apparatus of this invention;

FIG. 2 is a sectional side elevation taken along line 22 of FIG. 1;

FIG. 3 is a plan view of an alternative embodiment of this invention;

FIG. 4 is an enlarged transverse section taken along line 4-4 of FIG. 3;

' FIG. 5 is an enlarged transverse section taken along line 5-5 of FIG. 3;

FIG. 6 is another alternative embodiment of the invention;

FIG. 7 is a plan view of still another alternative bodiment of the invention;

' FIG. 8 is an enlarged transverse section taken along line 8-8 of FIG. 7;

FIG. 9 is a fragmentary vertical body section showing the apparatus properly positioned; and

FIG. 10 is a schematic fragmentary section along line 10-40 of FIG. 9.

Referring now to the drawing, in FIG. 1 there is shown a stainless steel ring 12. This ring is formed by winding stainless steel wire of approximately 0.5 mm. in diameter into a helix approximately3 mm. in diameter, and then forming the helix into a toroid having an outside diameter of approximately 20 mm. One end of the helix is tapered to fit into the other end of the helix. A resilient ring is used because of the necessity of contracting the device in order to permit its insertion through the narrow cervical canal.

To avoid scraping and irritation of the canal during insertion and to avoid irritation of the uterus, the wire is covered by a resilient layer 14 of a synthetic resin. Physiologically inert silicone rubber such as General Electric SE-450 silicone rubber is suitable. Other physiologically inert materials may be employed. Nonplasticized vinyl acetate and ethylene copolymers are presently regarded as suitable for this application.

The coating 14 is molded over the ring in a conventional cavity mold to form the intra-uterine portion 16 of the device. During this molding operation, a tail portion 18, approximately mm. long and 2.5 mm. in diameter is also formed. The length of the stem portion may be varied over the range 4 cm. to 8 cm. to accommodate individual requirements. The tail is provided with one or more nodules 20. 7

FIGS. 9 and 10 show the intra-uterine portion 16 positioned in the uterus U with the tail 18 extending through the uterine canal C and the nodules 20 exposed in the vaginal vault V. Thus the user can digitally palpate the nodules to verify the presence and location of the device.

Silicone rubber is the presently preferred material because it is soft, physiologically inert, and resilient. Neither the user nor her partner during intercourse can detect the presence of the device.

A rare possibility exists of a cervical canal pregnancy. The presence of the tail member tends to prevent this type of pregnancy.

In FIGS. 3, 4 and 5, there is shown an alternative embodiment 22 wherein a nylon monofilament 24, of 0.5 mm. O.D. is embedded in the tail portion 26. The nylon is threaded through the coil 28, knotted to form a loop thereby tying the coil into a toroid, and then passed down to the location of nodules 30 where knots are formed to facilitate the formation of a strong mechanical bond with the silicone rubber coating 32. The use of the nylon filament as a reinforcement permits the use of a thinner silicone rubber tail portion 26 where desired.

In the device 34- shown in FIG. 6, the rubber coating over the nylon thread 36 has been eliminated permitting employment of the device in women who may be extremely sensitive to the presence of the tail portion 18 of FIG. 1. As in the previous embodiments, helically wound spring wire is formed into a toroid 38, the ends of which are tied together. Toroid 38 is then covered. by silicone rubber. layer 40. Knots may also be provided in the filament 36 to aid in anchoring the rubber layer 40 thereto.

Still a different arrangement is shown in FIGS. 7 and 8 where the helically wound, toroidal spring has been eliminated. The device of this embodiment is comprised of a toroidal ring portion 44 having a flexible stiffening web 46. Tail 48 is comolded therewith and is provided with nodules 50. It will be understood that the spring may be incorporated, if desired, in combination With the web.

The silicone rubber toroid may still be collapsed to permit insertion of the device.

While silicone rubber is presently preferred, other suitable materials are likely to become available in the future as the result of changes in technology. The material should be autoclavable to permit sterilization. The material should also be soft, resilient, have high tensile strength and be physiologically inert.

As has been disclosed earlier, instances are known of the expulsion of the device without the user becoming aware of the incident. With the device of this invention, the user may digitally palpate the nodule on the flexible stem. The absence of the nodules signifies that the device has been expelled. If the nodules are found too far below the cervix, then the user is immediately alerted that the device is improperly positioned. Thus the capability of self-testing is a significant advance.

There has been disclosed heretofore the best embodiments of the invention presently contemplated and it is to be understood that vanious changes and modifications may be made by those skilled in the art without departing from the spirit of the invention.

4 What is claimed is: 1. An intra-uterine contraceptive device comprising: (a) a toroidal member composed of:

(l) a resilient self-erecting supporting ring adapted to be placed under tension and thereby fold in order to fit through a normal cervical canal, said ring reverting to its initial shape when the tensile forces are released;

(2) a soft silicone rubber covering encasing said ring; and

(b) a flexible stem having a fixed end joined to said toroidal member and a free end, said stem having a length such that when said toroidal member is positioned in the uterus, said stem is adapted to lie in the cervical canal with the free end extending into the vagina.

2. The device of claim 1 wherein said self-erecting ring is a toroidal helically coiled spring.

3. The device of claim 1 wherein said stem is a nylon filament.

4. The device of claim 1 wherein said stem is formed of silicone rubber.

5. The device of claim 4 wherein said stem has embedded therein a relatively inelastic fiber.

6. The device of claim 1 including at least one nodule of greater dimension than said stem affixed to the free end of said stem.

7. An intra-uterine contraceptive device comprising:

(a) a toroidal member composed of:

(l) a resilient self-erecting supporting ring adapted to be placed under tension and thereby fold in order to fit through a normal cervical canal, said ring reverting to its initial shape when the tensile forces are released;

(2) a soft, physiologically inert synthetic resin covering encasing said ring; and

(b) a flexible stem having a fixed end joined to said toroidal member and a free end, said stem having a length such that when said toroidal member is positioned in the uterus, said stem is adapted to lie in the cervical canal with the free end extending into the vagina.

References Cited by the Examiner UNITED STATES PATENTS 3,200,815 8/1965 Margulies 128-130 ADELE M. EAGER, Primary Examiner.

Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US3200815 *Apr 24, 1962Aug 17, 1965Mount Sinai Hospital Res FoundCoil spring intra-uterine contraceptive device and method of using
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US3323520 *Apr 13, 1965Jun 6, 1967Hall Herbert HIntrauterine pessary
US3372695 *Apr 27, 1965Mar 12, 1968Prosit Service CorpMethod of overcoming incontinence
US3633574 *Nov 14, 1968Jan 11, 1972Robins Co Inc A HIntrauterine contraceptive device
US3645258 *Mar 17, 1970Feb 29, 1972Charis Aka Charilaos George MaIntrauterine device
US3659596 *Nov 6, 1969May 2, 1972Robinson Ralph RIntrauterine element
US3683905 *Mar 16, 1970Aug 15, 1972Chaft Marc EIntra-uterine contraceptive devices
US3683906 *Aug 28, 1970Aug 15, 1972Robinson Ralph RShielded intrauterine device
US3996932 *May 15, 1975Dec 14, 1976Laszlo Kalman CsataryIntra-uterine contraceptive device
US3996933 *Oct 4, 1975Dec 14, 1976Morton GutnickIntrauterine contraceptive devices and processes
US4102998 *Jul 1, 1976Jul 25, 1978Morton GutnickIntrauterine device which releases medication
Classifications
U.S. Classification128/839
International ClassificationA61F6/00, A61F6/14
Cooperative ClassificationA61F6/142
European ClassificationA61F6/14B