US3918444A - Apparatus for inserting an intrauterine device - Google Patents

Abstract

An intrauterine device comprising a stem and at least one arm depending therefrom, such as the ''''Tatum T,'''' and apparatus for inserting it into the uterine cavity, the insertion apparatus being (1) a curved elongated inserter tube on one end of which the intrauterine device is fixedly mounted with its stem in the tube and the arms hanging outwardly from the tube and (2) a cap which fits axially and slidably over the end of the inserter tube on which the intrauterine device is mounted, the cap having (a) slots through which the arms are received, (b) axial ways on the inner surface of the inserter tube which extend from the leading ends of the slots to the leading end of the tube and (c) means of increased cross section such as a collar or flanges which prevent it from entering the cervix during insertion. By axially sliding the cap relative to the tube or vice versa the arms may be folded inwardly against the stem and into the ways.

Description

United States Patent Hoff et a].

APPARATUS FOR INSERTING AN INTRAUTERINE DEVICE [75] Inventors: Seymour Hoff; Sharon A. Kehr,

both of San Jose; Bruce B. Pharriss, Palo Alto, all of Calif.

I [73] Assignee: ALZA Corporation, Palo Alto,

Calif.

[22] Filed: Mar. 27, 1974 [21] Appl. No.: 455,237

52 US. Cl. 128/130 [51] Int. Cl. A61F 5/46 [58] Field of Search 128/127, 128, 129, 130, 128/263, 264; 81/157; 29/280 [5 6] References Cited UNITED STATES PATENTS 2,063,202 12/1936 Spicer l28/l30 2,176,559 10/1939 Meckstroth 3,516,403 6/1970 Cournut 128/130 3,763,856 10/1973 Blomberg 128/127 3,777,748 l2/l973 Abramson 128/130 Primary ExaminerLawrence W. Trapp Attorney, Agent, or Firm-Thomas E. Ciotti; Paul L. Sabatine; Edward L. Mandell [5 7] ABSTRACT An intrauterine device comprising a stem and at least one arm depending therefrom, such as the Tatum T, and apparatus for inserting it into the uterine cavity, the insertion apparatus being (I) a curved elongated inserter tube on one end of which the intrauterine device is fixedly mounted with its stem in the tube and the arms hanging outwardly from the tube and (2) a cap which fits axially and slidably over the end of the inserter tube on which the intrauterine device is mounted, the cap having (21) slots through which the arms are received, (b) axial ways on the inner surface of the inserter tube which extend from the leading ends of the slots to the leading end of the tube and (c) means of increased cross section such as a collar or flanges which prevent it from entering the cervix during insertion. By axially sliding the cap relative to the tube or vice versa the arms may be folded inwardly against the stem and into the ways.

15 Claims, 12 Drawing Figures APPARATUS FOR INSERTING AN INTRAUTERINE DEVICE BACKGROUND OF THE INVENTION l. Field of the Invention This invention relates to: a cap for use in combination with an intrauterine device and an intrauterine device inserter; and an intrauterine device combined with apparatus for inserting it into a uterine cavity.

2. Description of the Prior Art Many intrauterine devices have been designed to transform from a collapsed or compressed state in which they are inserted, using an inserter, into the uterine cavity via the cervix to an expanded state in which they occupy a predetermined position and/or space within the uterine cavity. These devices have been jointed or made of flexible materials in order to make them collapsible or compressible for insertion. Usually they are stuffed into a tube or cannula in their collapsed or compressed configuration, the tube or cannula is inserted into the uterine cavity via the vagina and cervix and the device is plunged from the tube by sticking a plunge rod up through the tube.

The above type of inserter and insertion is exemplified in U.S. Pat. No. 3,533,406 relating to the Tatum T. Briefly, the Tatum T comprises a stem and flexible cross bar and is designed to be emplaced within the uterus with the cross bar extending across the fundus and the stem extending toward the internal cervical os. As described in the patent the ends of the cross bar are folded down along the stem and the folded T is stuffed into the end of a tube having internal grooves for receiving the folded arms. In the conventional manner the T-loaded tube is inserted into the uterine cavity via the vagina and cervix and the Tis plunged therefrom with a rod. This type of inserter and insertion have several disadvantages. If the T is not preloaded into the tube the physician must load it by hand, thereby risking substantial bacterial contamination of the T and the inserter during the loading. This disadvantage can, of course, be avoided by sterilely packaging the combination already assembled, i.e., preloading the inserter. However, depending on the length of time and temperature at which the T is kept in its loaded configuration the ends of the cross bar may stress set and lose their resiliency. This may result in an incomplete unfolding of the ends once the T is inserted thereby preventing the T from taking its desired position within the uterus.

Another undesirable feature of this type of insertion is that it offers no protection to the leading end of the device and inserter against bacterial contamination during their passage through the vagina.

An alternative to stuffing a device within a tube has been offered in the form of a gelatin cap. The cap is placed over the folded device (which is usually mounted on the end of an inserter tube) sometime prior to insertion and then dissolves within the uterine cavity to permit the device to decompress or unfold. Numerous patents describe such caps, such as US. Pat. Nos. 3,628,530; 3,590,816; and 2,063,202.

However, the gelatin cap alternative has essentially all of the disadvantages of the stuffing modus operandii.

SUMMARY OF THE INVENTION The cap of this invention provides a means by which intrauterine devices having depending members, such as the Tatum T, may be pre-loaded into an inserter in an uncollapsed or uncompressed configuration, collapsed or compressed simply and sterilely just prior to use and then inserted in a form which protects the leading end of the device andinserter from contamination as they pass through the vagina and presents a minimal cross section to the cervix.

The cap of this invention is designed for use in combination with an intrauterine device inserter comprising an elongated tube adapted to be inserted into the uterine cavity via the vagina and cervix and an intrauterine device comprising a stem member and at lease one flexible (either by virtue of being jointed or being made of a flexible material) arm member depending generally outwardly from the stem member and adapted to be mounted in an uncollapsed configuration on one end of the inserter with the stem member extending down into the tube and the arm member(s) seated on the tube end and extending outwardly therefrom. The cap comprises an open ended tubular sleeve which fits axially and slidably about the end of the tube on which the intrauterine device is mounted. This sleeve has a slot for each arm member, through which the arm member(s) is received and a way on its inner surface for each arm member for slidably receiving the arm member as the sleeve is slid axially on the tube toward the other end thereof, which sliding causes the arm member(s) to be folded inwardly against the stem member and into the way(s). The sleeve also has means extending outwardly of it, such as an integral collar or integral flanges, which prevent it from substantially entering the cervix during the insertion.

BRIEF DESCRIPTION OF THE DRAWINGS In the drawings:

FIG. 1 is a top, plan, partially sectional view of an inserter/cap combination of the invention loaded with an intrauterine device;

FIG. 2 is an exploded, side elevational view, partially in section, of the loaded, leading end of the combination of FIG. 1;

FIG. 3 is a side, elevational view of the combination of FIG. 1;

FIG. 4 is an enlarged vertical sectional view of the loaded, leading end of the combination of FIG. I showing the arms of the intrauterine device being folded in accordance with the invention;

FIG. 5 is an end view of the leading end of the combination of FIG. 1 with the arms of the intrauterine device folded in accordance with the invention;

FIG. 6 is an elevational view showing the combination of FIG. 1 in use with the inserter just entering the external cervical os (the uterine cavity is depicted in section);

FIG. 7 is an elevational view similar to FIG. 6 showing the inserter just emerging from the internal cervical os;

FIG. 8 is an elevational view similar to FIG. 6 showing the combination in use with the inserter being withdrawn from the uterine cavity;

FIG. 9A is a plan view of another embodiment of the inserter cap of the invention;

FIG. 9B is a side view of the cap of FIG. 9A;

FIG. 10A is a plan view of yet another embodiment of the inserter cap of the invention; and

FIG. 10B is a side view of the cap of FIG. 10A.

DETAILED DESCRIPTION OF THE DRAWINGS In the following description the elements of the intrauterine device/inserter/cap combination are described first. Then the assembly of the combination is described and lastly the use of the combination is described.

The Elements of the Combination FIGS. 1 and 3 show the intrauterine device/inserter]- cap combination of the invention. The combination includes an intrauterine device, generally designated 10, an inserter, generally designated 11, and a cap, generally designated 12.

Intrauterine device (FIGS. 1, 2 and 4) comprises astem 13 and a pair of integral flexible diametrically opposed arms l4, 15 which in their normal position depend generally outwardly fromend 16 ofstem 13 at a slight incline toward theother end 17 ofstem 13. The incline ofarms 14, 15 is not critical to this invention and they may have no incline (i.e., depend at 90 from stem 13) or being inclined to a greater or lesser extent than shown in the drawings. Inother words device 10 may be T shaped such as the so called Tatum T of US Pat. No. 3,553,406-or it may be arrow shaped. The composition ofdevice 10 is also not critical to the invention and it may be made of any material which is suitable for intrauterine emplacement. Normally these devices will be made from polymers such as polyethylene, polypropylene, polyvinylchloride, nylon, ethylene/propylene copolymers, ethylene/vinyl acetate copolymer, polyurethane and the like. Such polymers may be made in a flexible form and are thus suitable materials for thearms 14.

Device 10 may be inert, in the sense that it is not adapted to dispense an active agent intrauterally, or it may be active" in the sense that it is adapted to so dispense an active agent. Means for making such active devices are well known and include coating or wrapping the exterior of the device with an agent, e.g., copper or copper/zinc wire as in the known copper T or by dispersing or confining an agent within one or more of the members of the device such that the agent is released by a diffusion and/or erosion mechanism.

End 17 ofdevice 10 has ahole 18 in it for fixedly receiving one end of astring 19. Afterdevice 10 is inserted in the uterus,string 19 serves as indicia of the presence of the device. It also may be used remove the device.

Inserter I1 is of the type generally described in commonly owned copending US. application Ser. No. 308,596, filed Nov. 21, 1972, the disclosure of which is incorporated herein by reference. Inserter 11 (FIGS. 1-3) basically comprises a hollow, elongated,openended tube 20. The leading end 23 (the left end as seen in FIGS. 1-4) oftube 20 has a decreasing diameter taper and is curved (FIG. 3) to facilitate its insertion into the uterine cavity.Intrauterine device 10 is intended to be fixedly mounted on the tip ofend 23 and for this purpose end 23 has a pair of notches or channels 24 (FIG. 4) for seatingly receiving thearms 14, 15 ofdevice 10.Tube 20 may be marked, as shown in FIG. 1 at 25, with depth of insertion indicia to assist the physician in inserting the device to the proper depth within the uterine cavity. Such markings are, of course, entirely optional. Thedistal end 26 oftube 20 is fitted with aplug 27 for anchoringstring 19 ofdevice 10. Alternative string anchoring means such as posts, notches and the like may be used in place ofplug 27.

4 Inserter 11 may be made of any material suitable for medical use. Typically it will be formed of a synthetic polymer such as polyethylene, polypropylene, polyvinylchloride, nylon or the like using established tech- 5 niques such as extrusion, parison forming or casting.

Cap 12 (FIGS. l-4) comprises ahollow sleeve 28 whose bore 29 is sized such that the cap can be snugly slid over theend 23 of theinserter tube 20. A pair of diametrically opposed axiallyelongated slots 30 are formed insleeve 20. The primary function ofslots 20 is to receivearms 14, 15 ofdevice 10. However, by hav ing one of their ends open at the distal edge of the sleeve (FIGS. 23) the sleeve is made radially resilient. In other words open endedslots 30 make the sleeve spring-like and capable of increasing and decreasing its diameter while snugly grippingtube 20 as it is slid therealong.Slots 30 have a pair of opposed nibs orprotrusions 33 formed on their axial edges.Nibs 33 serve as stops which engagearms 14, 15 to prevent the cap from inadvertently sliding off oftube 20 once it is placed thereon.

The leading end ofsleeve 23 has a pair ofintegral flanges 34 which extend outwardly ofsleeve 28.Flanges 34 serve two functions: they provide a flat surface which is used in folding thearms 14, 15 (described in detail below); and they provide the cap with a wide, flat surface for resting against the tissue surrounding the external cervical os to prevent the cap from substantially entering the cervix during the insertion. The leading end ofsleeve 28 also has a pair ofU-shaped notches 35 which serve to make the leading end of the mountedintrauterine device 10 visible to the physician during the initial stages of the insertion.

The inner surface ofsleeve 28 has a pair of axial ways or grooves 36 (FIGS. 45) which align withslots 30 and extend from the leading ends ofslots 30 throughflanges 34.Ways 36 are shaped and sized to slidingly receivearms 14, 15 when the latter are folded inwardly by the cap (described in detail below).

FIGS. 9A, 9B, 10A and 10B depict two alternative, but less preferable, embodiments ofcap 12. FIGS. 9A and 9B show a cap, generally designated 37, which likecap 12, basically comprises a hollow, open-ended sleeve 38. Sleeve 38 has a pair of axiallyelongated slots 39 which, likeslots 30 ofcap 12, receive flexible arms l4, 15 ofdevice 10. However,slots 39, unlikeslots 30, do not extend to and open at the distal edge of sleeve 38. Accordingly, cap 37 is not flexible radially and, in this respect, is less preferable thancap 12. This feature also makes it more difficult to assemble cap 37 with the inserter and intrauterine device thancap 12. Sleeve 38 has a pair of ways (not shown) on its inner surface which are identical in structure and function toways 36 ofcap 12. The leading end of cap 37 has a ring shapedcollar 40 having anopening 43 in it.Collar 40 serves the same purpose asflanges 34 ofcap 12. Sleeve 38 has a U-shaped notch 44 in its leading end which aligns with opening 43 incollar 40. Notch 44 serves the same purpose as either one of thenotches 35 ofcap 12. However, since cap 37 has only one notch 44, the leading end of the mounted intrauterine device is only visible in a single position rather than in two positions as incap 12. This is another less preferable feature of cap 37.

FIGS. 10A and 108 show a cap, generally designated 45, which is an even less desirable embodiment ofcap 12.Cap 45 comprises an elongated, hollow,openended sleeve 46 having a pair of opposed, axiallyelongated slots 47 which are identical in structure and function toslots 39 of the cap of FIGS. 9A and 98. Also the inner surface ofsleeve 46 has a pair of axial ways (not shown) identical in structure and function toways 36 ofcap 12. The leading end ofsleeve 46 has anotch 48 in it for the same purpose as notch 44 of cap 37 andnotches 35 ofcap 12. As discussed hereinaftercap 45 requires greater manipulation by the physician than either ofcaps 12, 37 and is thus the least preferred cap of the three shown.

The caps may be made of the same materials and by the same techniques as inserter 11.

Assembly of the Combination FIGS. 1 and 3 illustrate the intrauterine device/inserter/cap combination assembled for distribution to physicians.Intrauterine device 10 is fixedly mounted on the leadingend 23 ofinserter tube 20 with itsstem 13 extending down intotube 20 and itsarms 14, 15 seated withinnotches 24. The seating of the arms innotches 24 preventsdevice 10 from rotating.String 19 extends fromdistal end 17 ofstem 13 throughtube 20 and out end 26 thereof and is anchored tautly atend 26 by wedging it betweenplug 27 and the inner surface oftube 20. This taut anchoring preventsdevice 10 from being displaced fromend 23.

Cap 12 is placed over theend 23 oftube 20 with the distended arms l4, 15 received withinslots 30 past thenibs 33. In thisposition cap 12 is held loosely on theend 23 but is prevented from being displaced therefrom by thenibs 33.

The combination may be sterilized and packaged in the assembled form shown in FIGS. 1 and 3.

FIGS. 4 and 5 illustrate the assembled combination after thearms 14, 15 have been folded. The folding ofarms 14, 15 is a preliminary step to the insertion and may be done simply and sterilely by the physician as follows. The combination is removed from its package, held by thedistal end 26 oftube 23 and theflanges 34 ofcap 12 are braced against a sterile field 53 (FIG. 4). Thetube 23 is then pushed toward field 53 (as shown by the horizontal arrow in FIG. 4), causingtube 23 and mountedintrauterine device 10 to move axially relative to the bracedcap 12. This movement will cause thearms 14, 15 to move toward the closed ends 54 ofslots 30 and ultimately be engaged thereby (shown in phanengages thefield 53. Such engagement will prevent further movement. When the leading end ofstem 13 reaches that position (shown in solid in FIG. 4), arms l4, 15 are folded down againsttube 20 into axial alignment therewith and within thecap 12. The assembly is then withdrawn from the field and is ready to be inserted into the uterine cavity. As indicated above the entire foldingoperation may be carried out by the physician without touching the leading end of the combination and with great ease. This is a significant improvement over prior devices in not only reducing the amount of preinsertion manipulation of the device, but

also in maintaining the sterility of the combination.

6 ceived through their respectiveaxial slots 39, 47. Becauseslots 39, 47 do not have an open end, one of the arms l4, 15 must be bent to place these caps on the end oftube 20. Once they are in place these caps are prevented from falling off the end of the tube by the extension of the arms through theslots 39, 47.

Cap 37 folds the arms by the same technique ascap 12, that iscollar 40 is braced againsta sterile field andtube 20 is pushed toward the field, causing the arms to be bent inwardly by the reactive force applied thereto by cap 37 at the leading ends ofslots 39 and received by the ways on the inner surface of sleeve 38. The arms are folded bycap 45 simply by pressing its leading end against a sterile field. The arms are folded inwardly into the ways on the inner surface ofsleeve 46 by the force applied thereto at the leading ends ofslots 47.

An important advantage of the combination of this invention over prior devices is that the arms of thedevice 10 are not folded or subjected to stress during storage but may be easily and sterilely folded just prior to use. This eliminates any problems which might result from a loss of resiliency or stress setting of the arms due to being folded for a prolonged time at uncontrolled temperatures.

Use of the Combination The use of the combination of FIGS. l-5 for insertingintrauterine device 10 into a uterus is depicted in FIGS. 6-8.

The combination is gripped atdistal end 26 oftube 20, is inserted through the vagina (not shown) and the exposed tip ofstem 13 ofdevice 10 is guided gently into thecervical os 54 with theflanges 34 resting against the tissue surrounding the cervical os. It should be noted thatcap 12 keeps thedevice 10 and the leading end of the inserter 11 from substantially contacting the vaginal walls during their passage through the vagina and thus lessen the liklihood and/or extent of their bacterial contamination by such passage. Also, the U- shapednotch 35 makes said leading end visible and thereby facilitates guidance into the os.

Gentle inward pushing of the tube 20 (indicated by a vertical arrow in FIG. 6) forces the leading end thereof and the mountedintrauterine device 10 into thecervical canal 55 and up out of the cap 12 (FIG. 6). Because the arms ofdevice 10. are already folded andcap 12 does not enter the cervix, a minimum cross-sectional area is presented to the cervical 0s and canal and the cervix does not have to exert a force to bend the arms. Thus the force required to gain entry into the cervix is lesserthan with prior devices, resulting in less cervical distension, trauma and pain. Also, the possibility of contaminating the cervix with bacteria and the like is lessened becausecap 12 does not enter the cervix.

Further inward pushing of tube 20 (indicated by a vertical arrow in FIG. 7) causes thedevice 10 to be ejected fromcap 12 and move further into the cervical canal.Cap 12 maintains its position outwardly of and about the cervical 0s and does not freely slide toward the distal end oftube 20 because of the aforementioned spring-like gripping ability ofcap 12. Thus cap 12 is not able to block the physicians view of the depth of insertion indicia on thetube 20.

Continued inward pushing oftube 20 moves thedevice 10 into theuterine cavity 56 where theflexible arms 14, 15, due to their resiliency, unfold and resume their natural position (FIG. 8), Once thedevice 10 has been fully inserted to the proper depth incavity 56, plug 27 is removed fromend 26 thus freeingstring 19 anddevice 10.Tube 20 is then withdrawn (indicated by the horizontal arrow in FIG. 8) from theuterine cavity 56 back through thecervical canal 55 and vagina, leavingdevice 10 emplaced withincavity 56 with itsarms 14, fully extended and resting against the lateral walls of the uterus and itsstem 13 extending axially toward the internal cervical 0s andstring 19 extending through the cervical canal into the vagina.

Combinations including caps 37 and 45 are used and operate in the same manner ascombinations including cap 12 with the exceptions that caps 37 and 45 are free to slide ontube 20 afterdevice 10 has been ejected and thatcap 45 must be held stationary relative totube 20 in the latter stages of the insertion to prevent it from entering the cervical canal. In other words cap 45 does not include means such asflanges 34 orcollar 40 to prevent it from entering the cervix.

Various modifications of the above described embodiments may be made without departing from the spirit or scope of the invention. For instance combinations for inserting intrauterine devices with more than two arm members may be made by correspondingly increasing the number of slots and ways in the cap. Or a combination for inserting a device having only one arm member, such as a 7 shaped device may be made by having only a single slot or way in the cap. Similarly other means such as springs might be used to make the cap resilient radially. These and other modifications obvious to those of skill in the medical apparatus and- /or mechanical arts are intended to be within the scope of the following claims.

We claim:

1. A cap for use in combination with:

an intrauterine device inserter comprising an elongated tube adapted to be inserted into the uterine cavity via the cervix; and

an intrauterine device comprising a stem member and at least one flexible arm member depending generally outwardly from said stem member and adapted to be mounted on one end of the tube with the stem member extending into said tube and the arm member seated on said end and extending outwardly of the tube, said mounting being the final position of the device relative to the tube prior to insertion into the uterine cavity;

to fold said arm member inwardly down along the exterior of the inserter tube prior to inserting the in trauterine device into a uterus via the cervix, said cap comprising:

a. an open ended tubular sleeve adapted to fix axially slidably about said one end of said inserter tube;

b. a slot for each arm member in said sleeve for receiving said arm member therethrough such that the arm member extends from the interior of the sleeve through the wall of the sleeve via the slot to the exterior of the sleeve; and

c. a way for each arm member in the inner surface of the sleeve for slidably receiving said arm member as the sleeve is slid axially on said tube toward the other end thereof said way being in axial alignment with the slot and extending from the slot toward the leading end of the sleeve.

2. The cap of claim 1 including:

d. means extending outwardly of the sleeve for preventing said cap from substantially entering the cervix.

3. The cap of claim 2 wherein said means extending outwardly of said sleeve is a collar integral with and located at the leading end of the sleeve.

4. The cap of claim 1 wherein said intrauterine device has two opposed arm members and correspondingly there are two of said slots in an opposed relationship and two of said ways.

5. The cap of claim 1 wherein at least one of said slots opens at the distal end of said sleeve.

6. The cap of claim 1 including:

d. means for preventing the sleeve from sliding off said one end of the tube when said arm member is received through said slot.

7. The cap of claim 6 wherein said means for preventing said sleeve from sliding off is a transverse protrusion in said slot.

8. The cap of claim 1 including:

d. at least one aperture in the leading end of said sleeve whereby said one end of the tube is visible when the arm member is in said way.

9. The cap of claim 1 wherein said way extends axially from the leading end of said slot to the leading end of said sleeve.

10. The cap of claim 2 wherein said means extending outwardly of said sleeve is a pair of opposed flanges integral with and located at the leading end of the sleeve.

11. The cap of claim 2 wherein said intrauterine device has two opposed arm members and correspondingly there are two of said slots in an opposed relationship and two of said ways; at least one of said slots opens at the distal end of said sleeve; said ways extend axially from the leading ends of the slots to the leading end of the sleeve; said means extending outwardly of the sleeve is a pair of opposed flanges integral with and located at the leading end of the sleeve; and wherein said cap includes means for preventing the sleeve from sliding off said one end of the tube when said arm members are received through said slots and at least one aperture in the leading end of the sleeve whereby said one end of the tube is visible when the arm members are in said ways.

12. An intrauterine device combined with apparatus for inserting it within a uterine cavity comprising:

a. an inserter comprising an elongated tube adapted to be inserted into said cavity via the cervix;

b. an intrauterine device comprising a stem member and at least one flexible arm member depending generally outwardly from the stem member extending into said tube and the arm member seated on said one end and extending outwardly of the tube; and

c. a cap for folding said arm member inwardly down along the exterior of the inserter tube prior to insertion comprising an open ended tubular sleeve received axially slidably about said one end of said tube, said sleeve having a slot through which said arm member is received such that the arm member extends from the interior of the sleeve through the wall of the sleeve via the slot to the exterior of the sleeve, and a way on its inner surface in axial alignment with the slot and extending from the slot toward the leading end of the sleeve for slidably receiving said arm member as the sleeve is slid axially on said tube toward the other end thereof causing said arm member to be folded down along the exterior of the inserter tube and within said way.

13. The intrauterine device combined with apparatus for inserting it ofclaim 12 wherein said cap includes means extending outwardly of the sleeve which prevent the cap from substantially entering the cervix.

14. The intrauterine device combined with apparatus for inserting it ofclaim 13 wherein:

d. the intrauterine device has two opposed arm members located at one end of the stem and includes a string attached to the other end of the stem which extends through said tube and out the other end thereof;

e. the inserter includes means for anchoring said string at the other end of said tube and the one end of said tube has a pair of opposed notches in which said arm members are seated; and

f. said cap has two of said slots and two of said ways.

lSQThe intrauterine device combined with apparatus for inserting it of-claim 14 wherein:

g. the intrauterine device has a T shape;

h. said tube is marked with depth ofinsertion indicia;

i. said means for anchoring said string is a plug which is inserted into the other end of said tube;

j. said sleeve has at least one aperture in its leading end whereby the one end of the tube is visible when the arm members are in said ways;

k. said ways extend axially from the leading ends of said slots to the leading end of said sleeve;

1. at least one of said slots said opens at the distal end of the sleeve; and

m. said means extending outwardly of the sleeve is a pair of opposed flanges integral with and located at the leading end of the sleeve.

Claims (15)

1. A cap for use in combination with: an intrauterine device inserter comprising an elongated tube adapted to be inserted into the uterine cavity via the cervix; and an intrauterine device comprising a stem member and at least one flexible arm member depending generally outwardly from said stem member and adapted to be mounted on one end of the tube with the stem member extending into said tube and the arm member seated on said end and extending outwardly of the tube, said mounting being the final position of the device relative to the tube prior to insertion into the uterine cavity; to fold said arm member inwardly down along the exterior of the inserter tube prior to inserting the intrauterine device into a uterus via the cervix, said cap comprising: a. an open ended tubular sleeve adapted to fix axially slidably about said one end of said inserter tube; b. a slot for each arm member in said sleeve for receiving said arm member therethrough such that the arm member extends from the interior of the sleeve through the wall of the sleeve via the slot to the exterior of the sleeve; and c. a way for each arm member in the inner surface of the sleeve for slidably receiving said arm member as the sleeve is slid axially on said tube toward the other end thereof said way being in axial alignment with the slot and extending from the slot toward the leading end of the sleeve.

2. The cap of claim 1 including: d. means extending outwardly of the sleeve for preventing said cap from substantially entering the cervix.

3. The cap of claim 2 wherein said means extending outwardly of said sleeve is a collar integral with and located at the leading end of the sleeve.

4. The cap of claim 1 wherein said intrauterine device has two opposed arm members and correspondingly there are two of said slots in an opposed relationship and two of said ways.

5. The cap of claim 1 wherein at least one of said slots opens at the distal end of said sleeve.

6. The cap of claim 1 including: d. means for preventing the sleeve from sliding off said one end of the tube when said arm member is received through said slot.

7. The cap of claim 6 wherein said means for preventing said sleeve from sliding off is a transverse protrusion in said slot.

8. The cap of claim 1 including: d. at least one aperture in the leading end of said sleeve whereby said one end of the tube is visible when the arm member is in said way.

9. The cap of claim 1 wherein said way extends axially from the leading end of said slot to the leading end of said sleeve.

10. The cap of claim 2 wherein said means extending outwardly of said sleeve is a pair of opposed flanges integral with and located at the leading end of the sleeve.

11. The cap of claim 2 wherein said intrauterine device has two opposed arm members and correspondingly there are two of said slots in an opposed relationship and two of said ways; at least one of said slots opens at the distal end of said sleeve; said ways extend axially from the leading ends of the slots to the leading end of the sleeve; said means extending outwardly of the sleeve is a pair of opposed flanges integral with and located at the leading end of the sleeve; and wherein said cap includes means for preventing the sleeve from sliding off said one end of the tube when said arm members are received through said slots and at least one aperture in the leading end of the sleeve whereby said one end of the tube is visible when the arm members are in said ways.

12. An intrauterine device combined with apparatus for inserting it within a uterine cavity comprising: a. an inserter comprising an elongated tube adapted to be inserted into said cavity via the cervix; b. an intrauterine device comprising a stem member and at least one flexible arm member depending generally outwardly from the stem member extending into said tube and the arm member seated on said one end and extending outwardly of the tube; and c. a cap for folding said arm member inwardly down along the exterior of the inserter tube prior to insertion comprising an open ended tubular sleeve received axially slidably about said one end of said tube, said sleeve having a slot through which said arm member is received such that the arm member extends from the interior of the sleeve through the wall of the sleeve via the slot to the exterior of the sleeve, and a way on its inner surface in axial alignment with the slot and extending from the slot toward the leading end of the sleeve for slidably receiving said arm member as the sleeve is slid axially on said tube toward the other end thereof causing said arm member to be folded down along the exterior of the inserter tube and within said way.

13. The intrauterine device combined with apparatus for inserting it of claim 12 wherein said cap includes means extending outwardly of the sleeve which prevent the cap from substantially entering the cervix.

14. The intrauterine device combined with apparatus for inserting it of claim 13 wherein: d. the intrauterine device has two opposed arm members located at one end of the stem and includes a string attached to the other end of the stem which extends through said tube and out the other end thereof; e. the inserter includes means for anchoring said string at the other end of said tube and the one end of said tube has a pair of opposed notches in which said arm members are seated; and f. said cap has two of said slots and two of said ways.

15. The intrauterine device combined with apparatus for inserting it of claim 14 wherein: g. the intrauterine device has a T shape; h. said tube is marked with depth of insertion indicia; i. said means for anchoring said string is a plug which is inserted into the other end of said tube; j. said sleeve has at least one aperture in its leading end whereby the one end of the tube is visible when the arm members are in said ways; k. said ways extend axially from the leading ends of said slots to the leading end of said sleeve;

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