IL23487A - Intra-uterine contraceptive appliance - Google Patents

Description

•nimi |nj Tiin ·π PATENT ATTORNEYS · D'QIQ g ' □ PATENTS AND DESIGNS ORDINANCE SPECIFICATION Intra-uterine contraceptive appliance 1 (we) DR. JEROME SCHWARTZ, of 1321 Club Drive, Hewlett Harbor, New York, and DR. FRANKLIN 0. REYNTSR, of 29 Argyle Place, Rockville Centre, New York, U.S.A., both citizens of the do the nature of this invention and in what manner the same is to "be performed, to be particularly described and ascertained in and by the following statement: — 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 1961* 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 for a six-year period, which corresponds to 6 8 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 difficulties 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 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 of introduction of a Grafenberg ring is as follows: The uterine cavity is sounded and note taken of the lenth 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.

A principal object of this invention is the 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 out with 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; FIGo 2 is a sectional side elevation taken along line 2-2 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 embodiment 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 FIG. 10 is a schematic fragmentary section along line 10-10 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 approximately 3 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 1¼ 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 75 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, 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, 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 torpid 38, the ends of which are tied together. Toroid 38 is then covered by silicone rubber layer 10. Knots may also be provided in the filament 36 to aid in the formation of nodules 42 by 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 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 various changes and modifications may be made by those skilled in the art without departing from the spirit of the invention.

Claims (6)

1. - 7 - 23487/2 CLAIM'S ■ 1 «·■ An intra-uterine contraceptive device comprising: a) a toroidal member composed of: (1) 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 ringi 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 stem has a length of from 4 to 8 cm.

3. The device of Claim 1, therein at least one nodule of a greater dimension than said stem is affixed to the said free end of said stem.

4. The device of Claim 1 , wherein said toroidal member is a torus having an outside diameter of from 18 cm. to 25 cm*

5. The device of Claim 1 wherein said stem is formed of silicone rubber.

6. The device of Claim 1 wherein said stem is a nylon filament. 7c The device of Claim 3 wherein;said nodule is formed of silicone rubber, 8. The device of Claim 1 wherein said conception-preventing device comprises a resilient silicone rubber toroid, 9, The device of Claim 7 wherein a resilient, toroidal, helically coiled spring is embedded in said silicone rubber toroid, 10, The device of Claim 1- "Wherein said resilient stem has embedded therein a relatively inelastic fiber. 11„ The device of Claim 3 wherein said conception-preventing element is a torus having an outside diameter of from 1£ cm. to 25 cm. 12. The device of Claim 3 wherein said stem is formed of silicone rubber. 13. The device of Olaim 3, wherein said stem is a nylon filament. 1 · The device of Claim 3» wherein said conception-preventing device comprises a resilient silicone rubber toroid. 15· The device of Claim 3» wherein a resilient steroidal, helically coiled spring ie embedded in said silicone rubber. 16· The device of Claim 3» wherein said resilient stem has embedded therein a relatively inelastic fiber. 17.. An lntra-uterine contraceptive device, substantially as hereinbefore described by way of example and twith reference to the accompanying drawings. For the Applicants DR. REIKHOLD COHN AND PARTNERS