Intrauterine Device Inserter

Abstract

An inserter for an intrauterine device is shaped with a slender, elongated body and includes at one end thereof means whereby the intrauterine device may be firmly retained upon the inserter. Rotation of the inserter relative to the intrauterine device effects release of the intrauterine device from the inserter thereby permitting unobstructed withdrawal of the inserter with the intrauterine device being left in place within the uterine cavity. The inserter is particularly suitable for use with an intrauterine device comprising a ring and an attached membrane extending thereacross. With the intrauterine device in the mounted position, notch means on one side of the inserter engage the ring with the membrane extending about the opposite side of the inserter.

Description

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention pertains generally to contraceptive devices, and more particularly to an instrument for insertion of an intrauterine device.

2. Discussion of the Prior Art

Among the several female contraceptive devices presently in use most extensively, the intrauterine device ranks as of significant importance. Recent improvements in their performance resulting from contemporary, more sophisticated intrauterine devices, has enhanced acceptance of this form of contraception and further extended its utilization.

With use of intrauterine devices, there have been recently reported pregnancy rates which are superior to sequential oral contraceptives and only slightly inferior to the protection afforded by combined oral contraception. Furthermore, many of the problems and complications historically attendant the use of intrauterine devices have been reportedly greatly reduced with certain new types of the device. Reduction or elimination of these problems, which have included bleeding, inadvertent expulsion sometimes caused by contractions of the uterine wall, and strangulation of portions of the intestines which become lodged within the device, combined with improved performance could readily operate to advance the intrauterine device to the forefront of modern day contraceptive methods.

Its potential for primacy among contraceptive implements will perhaps be better appreciated from consideration of the inherent advantages of the intrauterine device. No requirement for periodic reminders, such as to take a pill or for other action, exists with the intrauterine device. There is no danger of side effects from ingestion of any orally introduced substances. No manipulation by the user is involved as with barrier types of contraceptive devices. Once in place within the uterine cavity, the intrauterine device could provide long term, effortless contraception requiring little or no attention from the user other than for periodic checks to insure that dislodgement has not occurred. Insertion and placement of the device may be performed either by a physician or by paramedical personnel with only slight potential for inconvenience or discomfort to the user. Since the insertion aspect of intrauterine device utilization could induce some hesitancy regarding its acceptance, it will be appreciated that the means utilized could be a crucial factor in the development of the intrauterine device toward more widespread use.

Generally, intrauterine device insertion means should enable accurate, secure placement without discomfort to the user. During the insertion process, the insertion means should provide firm and positive guidance of the intrauterine device until it has been properly located within the uterine cavity, whereupon there must occur appropriate disengagement and withdrawal of the insertion means. This should occur without disturbing the position of the intrauterine device and without distress to the user.

An additional advantage may be gained with an inserter which does not require both hands in its operation. Insertion usually involves gripping and straightening of the cervix in order to locate the outer cervical os and to facilitate entry through the cervical canal. This gripping is performed with a tenaculum, and if the intrauterine device inserter may be operated with one hand only, the other hand of the operator may be free and available to manipulate the tenaculum.

Accordingly, it will be seen that much of the potential for success of the intrauterine device may depend upon development of appropriate means for insertion. Provision of a insertion instrument which enables achievement of all the necessary functions for intrauterine device placement without introduction of detriments will, therefore, be an important contribution to the state and development of the art of contraception.

SUMMARY OF THE INVENTION

Briefly, the present invention may be described as an inserter for an intruterine device comprising a slender elongated body, and means proximate one end of said body for retaining an intrauterine device fixed thereupon, said retaining means being configured to effect release of said intrauterine device upon relative rotation between said body and said intrauterine device. In the preferred embodiment of the invention, the specific structure for said retaining means comprises notch means on one side of said elongated body and means preventing relative lateral movement of the intrauterine device relative to the inserter, but permitting relative rotational and longitudinal motion therebetween.

The inserter of the present invention is particularly suitable for use with an intrauterine device comprising a ring and an attached membrane extending thereacross which is maintained fixed upon the inserter by engagement of the ring within said notch means with said membrane extending about the opposite side of said inserter. For release of the intrauterine device, the inserter is rotated to disengage the ring from the notch means and then longitudinally withdrawn.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be better understood by reference to the following detailed description of the preferred embodiment thereof taken in connection with the accompanying drawings wherein:

FIGS. 1, 2, 3 and 4 are side elevations each taken from one of four different sides of the instrument embodying the present invention;

FIGS. 5, 5A, 5B and 5C are sectional views taken, respectively, along the lines 5--5, 5A--5A, 5B--5B, and 5C--5C of FIG. 2;

FIG. 6 is a side elevation showing the inserter of the present invention with an intrauterine device mounted thereon and being positioned within the uterine cavity;

FIG. 7 is a sectional view taken along the line 7--7 of FIG. 6; and

FIG. 8 is a side elevation depicting disengagement of the inserter from the intrauterine device by relative rotation therebetween from the position depicted in FIGS. 6 and 7.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now in detail to the drawings, the present invention is embodied in an inserter 10 which is formed with a slender elongated body having a forward end 12 and a handle end 14. In the utilization of the inserter 10 of the invention, an intrauterine device may be mounted upon the forward end 12 with the inserter being gripped for manipulation by an operator at or proximate the handle end 14. The inserter 10 is shaped at its forward extremity with a curved tip 16 configured to provide purchase when a very tightly closed cervical os is encountered during insertion. As best seen in FIGS. 2 and 4, the entire forward end 12 of the inserter 10, extending from the curved tip 16 to approximately the mid point thereof, is shaped in one plane with a gently sloping curved configuration. The degree of curvature of the forward end 12 facilitates the insertion of the intrauterine device by permitting adaption of the inserter 10 to the normal curvature of the cervical canal.

The body of the inserter 10 extending from the curved tip 16 to approximately a point 17 comprises a generally rectangular cross sectional configuration which, as best seen in FIG. 5, includes a pair of side walls 18 and 20 and a pair of end walls 22 and 24. From the point 17 to approximately a point labeled 25 the body of the inserter 10 comprises a generally circular cross sectional configuration best shown in FIG. 5A. Throughout the body portion generally identified by the numeral 25, the shape of the inserter 10 gradually changes form from the circular configuration depicted in FIG. 5A to a generally square cross sectional configuration best shown in FIG. 5B and comprising walls 26, 28, 30 and 32 each having smooth rounded corners therebetween. At a point 33, the body of the inserter 10 gradually slopes from a generally square cross sectional configuration to a generally flat rectangular cross sectional configuration which as best shown in the sectional view of FIG. 5C comprises the handle end 14.

A pair of notches 34 and 36 are formed proximate the curved tip 16 on the side 22 of the upper forward end of the inserter 10. The notches 34 and 36 are spaced apart a predetermined longitudinal distance, and they comprise oppositely directed surfaces, with the notch 34 having a surface 38 sloped in the direction of the curved tip 16 while the notch 36 comprises a surface 40 sloped in the opposite direction toward the handle end 14. The opposite side 24 is formed with an indentation 42 which extends for a longitudinal distance intermediate the distance between the notches 34 and 36.

The body of the inserter 10 in the vicinity of the point 25 has affixed thereon markings 44 in the form of numerical designations indicating distance between the curved tip 16 and the point at which a marking 44 is located. The markings 44 are similar to and conform with markings which are usually contained upon uteral sounds in common use especially suited for gynecological examination. The markings shown in FIGS. 2 and 4 designate length in centimeters with the thickness of the body of the inserter 10 being varied at each level where a different marking 44 is indicated. For example, the circular body portion extending forwardly of the point 25 is structured to comprise length sections of differing diameters. A forward circular section 46 of smaller diameter adjoins a lower circular section 48 having a slightly larger diameter. The lower circular section 48 comprises a marking 44 consisting of the numeral "6" which indicates that the distance between the curved tip 16 and a ridge 50 located at the point where the sections 46 and 48 adjoin is 6 centimeters in length. Similarly, differently sized square sections 52 and 54 are provided each having thereon, respectively the numerical designations "7" and "8" with ridges 58 and 60 resulting from the differing section thicknesses indicating, respectively, points at which the distance from the curved tip 16 is 7 centimeters and 8 centimeters. The square section 54 has integrally formed at the forward end thereof a pair of laterally extending tabs 62 and 64 to indicate a point on the inserter 10 which is 9 centimeters from the curved tip 16, with the designation "9" being located immediately below the tabs 62 and 64 on both sides 28 and 32 of the square section 54. The tabs 62 and 64, although they serve an additional purpose to be described hereinafter, will tend to prevent or minimize uteral perforation by limiting insertion of the device beyond a point at which they engage the cervical os. Although, if necessary, the tabs 62 and 64 may be brought to within the cervical canal, it will be found that in most cases the distance between the fundal wall of the uterus and the external cervical os does not exceed nine centimeters, and that the operator should, therefore, be made aware of a deeper insertion to prevent perforation. A second pair of laterally extending tabs 66 and 68 are likewise integrally formed at the handle end of the square section 54.

In FIGS. 6, 7 and 8, the inserter 10 of the present invention is shown in conjunction with an intrauterine device 70 which is of a special configuration and which is described and claimed in copending application Ser. No. 775,729 filed Nov. 14, 1968 and assigned to the same assignee as the present invention. The intrauterine device 70 is essentially comprised of an outer ring 72 and a membrane 74 extending across the central portion of the ring 72. A plurality of spurs 76 extend from opposite sides of the ring 72 there being five spurs 76 shown on each side of the ring 72. The spurs 76 operate to prevent expulsion of the device from the uterus. The membrane 74 is provided with an opening 78 at the forward or head end thereof and with an opening 80 at its tail end. A telltale string 82 is affixed about the ring 72 for the purposes of indicating the presence of the device and also for potential use as an aid in removing the device.

The intrauterine device 70 is affixed upon the forward end 12 of the inserter 10 by engagement of the head end and tail end of the ring 72, respectively, within the notches 34 and 36 with the membrane 74 extending about the opposite side 24 in contact with the indentation 42. As best seen in FIGS. 6 and 7, the outer ring 72 comprises a head end 72A and a tail end 72B. The head end 72A when engaged within the notch 34 is prevented from movement in a direction toward the tail end of the intrauterine device 70 by engagement upon the forwardly sloped surface 38. In a similar but reverse fashion, the tail end 72B is prevented from movement toward the head end by engagement against the rearwardly sloped surface 40 of the notch 36. The device 70 may be generally comprised of a single integral piece of molded plastic material, and consequently it will be generally resilient in nature and easily deformable for the purposes involved in its manipulation and utilization. The notches 34 and 36 are spaced apart a distance slightly greater than the head-to-tail distance between the ends 72A and 72B of the outer ring 72. Accordingly, in order to engage the device 70 upon the notches 34 and 36, the outer ring 72 must be expanded slightly thereby creating a spring force tending to contract the outer ring 72 which operates to retain the ends 72A and 72B under a slight contracting pressure in abutment with the sloped surfaces 38 and 40. This slight spring pressure prevents the ends 72A and 72B from slipping out of the notches 34 and 36 and contributes toward retention of the device 70 upon the inserter 10.

In mounting the device 70 upon the inserter 10, the curved tip 16 is first introduced into the opening 80 in a direction, as seen in FIG. 6, over the tail end 70B and under the membrane 74. The curved tip 16 is subsequently moved through the opening 78 and over the head end 72A until the outer ring 72 is positioned adjacent the notches 34 and 36. The ends 72A and 72B may then be snapped into position within the notches 34 and 36 by slightly expanding the outer ring 72 in the longitudinal direction. Lateral movement of the device 70 is prevented by the engagement of the membrane 74 against the side of the inserter 10 which is opposite the side upon which the outer ring 72 is engaged within the notches 34 and 36. It will be apparent that with the device 70 mounted upon the inserter 10 in the manner described both longitudinal and lateral movement of the device 70 will be prevented and the device 70 will then be in a position for placement within the uterine cavity by appropriate manipulation of the inserter 10.

With the intrauterine device 70 thus mounted upon the inserter 10 of the present invention, the combined structure may be packaged and shipped in a condition ready for immediate placement by an operator without there arising any need for manipulation or adjustment prior to placement. Furthermore, due to the particular mounting arrangement described, little or no liklihood will exist that the device 70 will become dislodged or disoriented during shipment. The tabs 62, 64 and 66, 68 are principally intended for facilitating securement of the device to packaging means.

The inserter 10 is preferably formed of a somewhat stiff but relatively flexible material such as molded plastic. In the preferred embodiment described herein, the inserter 10 is formed as a unitary molded plastic piece having sufficient flexiblity to permit the device to follow the path of the cervical canal when the device 70 is being inserted into the cervical cavity. The size and shape of the curved tip 16 acts to predispose the cervical canal for the intrauterine device 70 which follows thereby permitting insertion without the need for previous dilation. With the device 70 firmly mounted upon the inserter 10 as previously described, the operator may manipulate the inserter 10 by grasping the handle 14 to propel the device 70 to an appropriate location within the uterus 84 against the uterine wall 86. With the device in place within the uterine cavity as shown in FIGS. 6 and 7, the inserter 10 may be disengaged from the intrauterine device 17 by a 90.degree. rotation of the inserter 10 as indicated by the arrow 88. Rotation of the inserter 10 about its longitudinal axis in the manner indicated by the arrow 88 will permit disengagement and easy withdrawal of the inserter 10 from within the uterine cavity while allowing the device 70 to remain lodged therein in an appropriate position.

In FIG. 8 there is depicted the relative positioning between the inserter 10 and the device 70 subsequent to rotation of the inserter 10 through a 90.degree. angle and prior to movement of the inserter 10 in a direction for withdrawal from the uterine cavity. It will be noted that due to the rectangular configuration of the inserter 10 across the portion thereof in engagement with the intrauterine device 70, the distance between the walls 22 and 24 will be greater than the distance between the walls 18 and 20. Accordingly, when the inserter 10 is engaged upon the device 70 in the configuration shown in FIGS. 6 and 7, the wider dimension extending between the walls 22 and 24 will be placed across the device 70 between the ring 72 and the membrane 74. As a result, this wider lateral dimension will operate to stretch somewhat the device 70 thereby enhancing retention of the device 70 upon the inserter 10 during shipping and during insertion to within the uterine cavity. Upon rotation of the inserter 10 through the 90.degree. arc indicated by the arrow 88, the narrower dimension extending between the walls 18 and 20 will be placed between the ring 72 and the membrane 74, thereby eliminating this stretching action and expediting withdrawal of the inserter 10 from within the device 70.

It should be noted that the membrane 74 may be formed in a slightly bowed configuration to insure elimination of any stretching when the narrower dimension between walls 18 and 20 is placed across the device 70.

Rotation through the 90.degree. arc of arrow 88, will cause the ends 72A and 72B of the ring 72 to become disengaged from within the notches 34 and 36, respectively. It will be appreciated that this will occur as a result of abutment of the device 70 against the walls of the uterus. For example, as seen in FIG. 7 the device 70 will be in abutment against the wall 86 of the uterus 84. This abutment will prevent rotation of the device 70 during the time that the inserter 10 is rotated as indicated by the arrow 88. The amount of force needed to disengage the ring 72 from within the notches 34 and 36 is very slight and is such as to exert very little pressure against the walls of the uterus. When the inserter 10 is rotated in the manner described, the ends 72A and 72B will be snapped out of engagement from within the notches 34 and 36 as a result of the relative rotational motion between the inserter 10 and the device 70. The relative positioning of the members immediately following this rotation and snapping out of engagement is depicted in FIG. 8, and with the parts in this position the inserter 10 can be easily withdrawn from within the device 70 and from the uterine cavity, with the device 70 being retained in the desired position within the uterus. As a result of the lessened thickness between the walls 18 and 20 which will now extend across the device 70, withdrawal of the inserter 10 without dislodgement or disturbance of the device 70 is enhanced. Of course, it will be clear that the inserter 10 may be rotated in either direction for disengagement and withdrawal.

During the insertion process, the markings 44 will provide an indication of the extent to which the device has penetrated the cervical canal. The physical dimensioning of the inserter 10 whereby the lateral dimensions thereof are gradually altered by the increasing thickness of the sections 46, 48, 52 and 54 will enhance the ability of the operator to detect the degree of insertion of the device. Furthermore, the shape and configuration of the handle 14 will operate to enable determination of the relative rotational positioning of the device thereby permitting the operator to discern with greater accuracy the point at which 90 degrees of relative rotation has occurred between the device 70 and the inserter 10 with the device 70 in place within the uterine cavity. Additionally, the shape of the handle 14 will enable easy manipulation of the inserter 10 to effect the required rotation thereof for withdrawal from within the intrauterine device 70.

An additional advantage of the inserter 10 in determining orientation during placement relates to the fact that the point of intersection between the handle 14 and the forward body position is smooth on one side but is formed with a sloped shoulder 69 on the opposite side. This enables determination of the direction of orientation of the sloped forward end. Thus, during insertion, it can be determined from the shoulder 69 whether the inserter 10 is following the curvature of the cervical canal or is oppositely directed.

Although the present invention has been described in connection with a specific intrauterine device 70 with which it is especially suitable for use, it is to be understood that the shape and configuration of the intrauterine device which is placed by utilization of the inserter of the invention is not intended to constitute a limiting factor with regard to the scope of the invention, of which the intrauterine device forms no part. Any one of a variety of intrauterine devices which are appropriately shaped and configured to cooperate with the present invention may be utilized therewith. It will be clear, of course, that the intrauterine device must be appropriately sized and shaped for adequate mounting upon the inserter 10 but it should be understood that many modifications of the specific device 70 described herein may be effected without affecting the performance of the present invention in the placement of such a device.

It should be further understood that many modifications and variations of the device of the present invention may be accomplished by those skilled in the art within the context of the present invention, and that such variations and modifications are to be considered within the scope and purview thereof.

Claims

What is claimed is:

1. An intrauterine device inserter comprising a slender elongated body, and intrauterine device releasable retention means proximate one end of said body for retaining an intrauterine device fixed thereon during insertion into a uterus and incorporating means enabling releasing of said intrauterine device in disposition within a uterus from said intrauterine device releasable retention means upon relative rotation of said body with respect to said intrauterine device, said means enabling releasing of said intrauterine device comprising a pair of notch means of opposite sense located on one side of said body, said inserter being gradually curved from approximately its midpoint to said pair of notch means, said pair of notch means being on the outside of the curve.

2. An inserter acording to claim 1 wherein said pair of notch means comprise a pair of notches.

3. An inserter according to claim 2 wherein said pair of notches are longitudinally spaced apart a predetermined distance.

4. An inserter according to claim 1 wherein said end of said elongated body proximate said releasable retention means comprises a rectangular cross sectional configuration.

5. An inserter according to claim 4 wherein said rectangular cross sectional configuration includes a pair of shorter sides and a pair of longer sides with said notch means formed on one of said shorter sides.

6. An inserter according to claim 1 wherein said end of said elongated body proximate said releasable retention means is formed in a convex configuration at its extremity.

7. An inserter according to claim 1 wherein the end of said elongated body opposite said releasable retention means comprises non-cylindrical handle means configured to provide an indication of the rotative orientation of said body about its long axis.

8. A inserter according to claim 1 wherein said elongated body comprises means indicating on said body distances from said end proximate said releasable retention means.

9. An inserter according to claim 8 wherein said indicating means comprise variations increasing in cross-sectional diameter from said end proximate said releasable retention means and formed in said elongated body.

10. An inserter according to claim 1 wherein said elongated body includes cervical os abutment means thereon limiting insertion thereof of said inserter into a uterus.

11. An inserter according to claim 10 wherein said insertion limiting means comprise a pair of tabs formed on and extending laterally from said elongated body.

12. An arrangement for placement of an intrauterine device in a uterus comprising in combination an intrauterine device, an inserter having a slender elongated body, and intrauterine device releasable retention means on one end of said body, said intrauterine device comprising a ring and a membrane attached to said ring upon opposite sides thereof and extending therebetween, said intrauterine device releasable retention means comprising a pair of notches formed on one side of said inserter, said ring engaged across said pair of notches on said one side of said inserter, said membrane extending about the opposite side of said inserter, whereby said intrauterine device is retained in interlocked disposition on said inserter during insertion into a uterus and is released from said inserter in disposition within a uterus upon relative rotation of said body with respect to said intrauterine device.

13. An arrangement according to claim 12 wherein said pair of notches are longitudinally spaced a distance sufficient for enabling engagement of said ring within said notches whereby said intrauterine device may be releasably held upon said inserter.

14. An arrangement according to claim 13 wherein said ring is resilient and wherein said longitudinal spacing of said notches is sufficient to cause flexure of said ring when engaged thereacross.

15. An arrangement according to claim 12 wherein said inserter comprises a generally rectangular cross-sectional configuration at least along the length thereof proximate said pair of notches, said rectangular configuration defining a pair of shorter sides and a pair of longer sides with said pair of notches being formed upon one of said shorter sides and with said membrane extending about the other of said shorter sides.