CA1125608A - Intrauterine contraceptive device - Google Patents

Abstract

ABSTRACT OF THE DISCLOSURE
An intrauterine contraceptive device (IUD) is provided for placement in the frontal plane of the upper uterine segment. The IUD comprises a member formed of flexible material and having a central portion, with a pair of upper arms extending outwardly and around from the central portion to form non-spiral loops in which the distal end of each of the arms does not return toward and overlap the central portion. This construc-tion prevents the formation of a spiral under normal compression which may cause the distal ends to extend out of the main plane of the member. This construction also allows the IUD to be retained in a stable state in the frontal plane, adapts the IUD to uterine shape variations and contains a compliance property that com-bines transverse bend resilience with axial stiffness.

Description

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: INTRAUTERINE CONTRACEPTIVE DEVI OE
BACKGROUND oP THE INVENTION

: This invention relates to an improved intrauterine . .
~ contraceptive device ~IUD).
The utility of IUD's in birth control has been -established. IUD performance, however, depends on many factors, includi.ng uterine dimensions and functions.
For e~ample, a large number of uterine shape variations can exist in the presence of a uniEorm endometrial length.
Under such circumstances, it is impossible to insert IUD's witll fixed transverse diameters into endomett^ial cavities of un};nown shapes WitllOUt tlle occasiollal occurrence of a ~8 di.sproportion }.)e twcen the IUD and Llle CclV.i ty . rl'hUS i t is desi.rable that the trallsverse diainetc-~rs of the IUD
be var:iable in re<;L)ollse to variaL1ons in uteriile ~;ha~e, in order to L>reserve the structural inLecJrity of. Ll~e device and ~IIe uteril-le cavity.
Wnile the uterus can easily accommodate a clevice of reasonable size that is placed in the frontal (hori- :
zontal) plane of i-ts endometri.al cavity, it cannot tolerate a dev:i.ce placed im an obliciue or sacJi-ttal plane :L0 of -the cavity. Such misplaced devices compress the .
endom~trium and the l-nyometrium excessi.vely, lead.ing to -~
dlstortion of the device and the cavity, ancl increase -the probabili.ty of associated bleedincl a.nd pain. Therefore, consistent pLacemellt oE t`he IVD in the hor.i.zontal plane o.E the endometriaL cavi.ty is a re~luirement o:~ correct insertion techlli.que.
It is importallt that the IUI) l~e placed ent.irely above the uteril1e .;.stl~mus. Proper IUD pOSit:iOI-illCJ
requires prior knowledge of ce~rv:ical lengtll, as well as endometrial lencJt}l. Knowin~ the lencJth of the cervix . permits one to insert t`he IUD consistently above the level of the internal cervi.cal OS, and awareness of the endome-tricll lencJth allows one to place the clevice in the u.pper uterine segme~t. It has been ound that the best perEormance was obtained when the lengtil of the IUD was shor-te.r -than the len3tll of -the endometrial cavity by 1.25 to 1.75 cm. Placement of an IUD ei~tirely in the more spacious upper u-teriJle seyment can be accomplished if the length of the IUD is approximately 1.0 to 1.75 Cill shorter -tl~an the lengt'il o the cavity.
In order to inc:rease the li~elil-lood oF the IUV

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beincJ retaineci ln the uteril1e cavity it lS pre~era})le that the IUD be of suitable si~e and placed in tl1e upper uterine segmel1t. rlle IUD sl~ould also be l~rovidecl w:ith mechal1ical means capable of resisting the effects of uterine contractions that tend to move it downwards in the direc-tion of the cervi~. Downwarcl c3ravitation of an IUD is resisted at the level where the transverse diameter of the IUD is cJreater than the trarlsverse diameter of the uterine cavity. l`l-le 1evel at wl1ich tlle surface resistal1ce occurs depends 011 the relative ~idth of the IUD and that of the cavity. Devices with fixed transverse diameters are suspended in the upper uterine segment, if the area oE IUD-uterine contact is near the fundus. Ilowever, sucl1 devices may come to rest at a lower posi-tion i.n the cav.ity, i.f the transverse diameter of the fundus is broader -than that o~ -the IUD.
It is, tllerefore, an o~ject oE the present invention to provide an IUD tilat call be relatively easily and simply p:Laced entirely above the uterine is-thmus.
Ano-tl1er object of the present invention is to provide an IUD havin~ a transverse diameter that is not fixed, but is instead variable i.n response to v-riations in uterine shape.
' ~ further object of the presel1t inventiol1 is to provid~ an IUD that is capable of resistiny the eEfects of uterine contractions that tend to move it down-.~ards in the direction of the cervix.
IUD retel1tion may be due to suspension of i-ts upper portion in the fundus and~or abutment of its lower-mos-t portio.n a~3ai.nst the uterine walls. The clynamic cyclic changes that occur in tlle fundal and isthmus .

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uterine ';e9ml'l1tS create optimal con(litiolls ~or lUD
expulsion duri ng menstruation . It is, therefore, an object of the present invention to provide an IUD 11aVi11Y
a shape in which the lower portioll thel-eof may a}~nt t:he uterine wall to rnaintain the IUD in substantially its initial hi yh position of placement .
1~ type of IUD that is constructed to prevent expulsion i5 di sclosed in llasson U . S . Patellt No .
3,467,089 and Nolan U.S. Patent No. 3,342,826. Wllile the IUDs disclosed in those patents llave increased retention capability and thus are not easily expelled, the IUDs are relatively dif f icult to remove because the lower Wil-lys must be larcJe to provide yood re tell t:iOIl .
Further, w]~ell tlle IUDs of those paterlts are im~lcantecl in the uterus, -the lower wincJs are sprecld out causi ny c3Oo~ retention, l~ut expu] sive forces will bend these win~s upwclrd:Ly ma]cin(J the i.r -transvc!rse clirmensiolls smaller. In fact, to rernove tlle IUDs of those patents, the IUD is pulled downwardly thereby forcincJ the lower wings to ~encl upwardly and permitting the IUD to be removed.
It is an ob ject of the present invention to pro-vide an IUD that has good retention capabili ty and thus is not easily expelled, but is relatively simple to rernove. To this end, the present invention provicles an IUD that inclu~ies a lower portion which tends to open, providincJ a yreater transverse diameter, when thc-~ uterus contracts and pushes -the LUD downwardly. 'l`l~us as the uterus contracts, the IIJD of the presen-t invell tion tencls increasingly to resist expulsion. ~cldiLiollally, me.~lls are provided for removing the IUD of the present invell~io ,~,,..~

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in a relatively simple manner by usinc~ a pullin~ Eorce that tencls to straic~hten out the lower portion.
~nother problem ~lith the IUl)i disclosect in U.S. Patent No. 3 467 08~ is that this prior axt IUD
is shown being constructed with elonc]ated inner wires WhiC}I serve to form the cores of the wincJs extendinc3 from an elonc~ated stem. The possibility exists that one of the inner wires may become disloclged from its inside posi-tion, causincJ it to extend throuc~}l the surroundiny resilient material. This has the potential of resultincj in perforation of the uterus, and it is therefore desir-able to avoid the necessity for usincJ any wire which could penetrate plastic in the IUD.
It is therefoLe, all o~ject of the illvention to provide an I~D ~hich does not re~uire inner wires in its construction. Cervlcal perforatiolls have beell reported witll the ~Ise of stcmmed devices, such as tlle copper T
TM
copper 7 or Saf.-t-Coil Tlle mech.~ ism of perforatio is related to the method of re-tention of the IUD.
Stemmed devices take an oblique position in -the uterine cavity eit~ler through faulty insertion or subsequent --~
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movement of the IU~ caused by uterine contractions.
; Under such circumstances the IUD is retained in the ~ ~
uterus by anchorincJ of the lower tip of its stem into ~ -the uterine wall at the level of -the isthmus or cervix.
Continued myometrial pressure causes the tip to penetrate the u-texine walL partially or completely.
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Therefore another object of the present inventior is to provide an IUV that lS constructe~ ~ithout an extending stem or tip, in order to prevent penetration of tlle uterine wal:L by such stem or -tip.
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~ relationsllip has been four-d between IUI) com-pliallce (r~siliency) and tne undesirable expulsion of the IUD from the u-terus. It has beel~ found tllat tilere is less undesirable e~pulsion whell the IUD has a sic~nificant de~ree o:E transverse bencl resilience. It i.s, therefore, an object of the present invelltion to provide an IUD having relatively high longi.tudillal stiff-ness and relati.vely hicJh transverse bend pliability.
~ type oE prior art IUD which employs a pair of oppositely extenclincJ loops is disclosed in Rosenthal U.S. Patent No. 3,374,788. In this Rosentllal patent, the loops are coiled to form a generally spiral config-urat:ion. In the l~osentlla:l patent, SUCll CoilinCJ occurs in the molded state prior to insertioll in tl~e uterus.
This has been found to be disaclvantageous, in that if the loops are initially coiled, tilen they cannot coil further to any siynificant clecJree when placed in a restrictive space. Thus if Rosenthal's IUD is ~laced in a relatively ~Mall uterine space ~in wllich the transverse diameter of the uterus is smaller than that oE the IUD), the loops may bend anteriorly or posteriorly in the most accessible plane, thereby causiny IUD distortion and undue distention of the limited u-terille depth space.
~ Kno-ttirlc~, distortion and overlappincJ upon removal may ; 25 occu~.
It is, therefore, an object of the present inven-tion to provide an IUD in which the loops are not coiled in -the moldecl state, bu-t are instead structured with a memory for coili.ng. In thi.s manner, wllen the loops are placed in a space with a smaller -transverse diameter. than ~hat of the loops, they will coil inward witllout belldi.rlg.

~L25~Q8 This shape provi.des a safety factor against IUD distortion and related symptomatology.

Other objects and advantages of the present invention will become apparent as the descrip-tion proceeds~

BRIEF DESCRIPTION OF THE INVENTION

In accordance with the present invention, there is provided an IUD which includes a double loop configuration in its upper section i.n order to utilize space created by fundal anomalies and to adapt to the compressive and distortive stress of uterine contractions. The IUD additionally includes a middle section with sufficient stlffness to resist distortion and a : lower section with a diameter enlarged sufficiently to resist downward displacement. ~::

One aspect of the invention provides an intrauterine ~
contraceptive device which includes a member adapted for ~ ~ :
~: insertion in the uterus formed of flexible materi.al and having a central portion with a first upper arm extending outwardly and around from the central portion and back toward the central portion to form a first loop. A second arm extends downwardly : 20 from the central portion, then outwardly and inwardly to form a retaining member. A thlrd upper arm extends outwardly and around from the central portion and back toward the central . portion in a direction opposite from the first arm to form another loop. The distal ends of the first and third upper arms are substantially non-ovsrlapping with respect to the central portion to pre~enk the formation of a spiral under normal 7~ ~

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compression which may cause the distal ends to extend out of the main plane of the member. The second arm defines a hinge portion and a filament is connected to the second arm, the hlnge and filament cooperating to permit the second arm to be straigh-tened easily when the filament is pulled downwardly.

Ano-ther aspect of the invention comprehends an intrauterine contracep-tive device which includes a member adapted for insertion in the uterus formed of flexible material and having a central portion and a first upper arm extending outwardly and around from the central portion and back toward the central portion to form a non-spiral loop in which the dis-tal end of the arm does not overlap the central portion.
Another upper arm extends outwardly and around from -the central portion and back toward the cen-tral portion in a direction opposite from the first arm to form another non-spiral loop in which the distal end of the other arm does not overlap the central portion, whereby under normal compression the distal ends will remain in the main plane of the member. A lower retaining member has a ~ilament connected thereto, the lower

2~ retaining member defining a hinge portion and thus being -sufficiently flexible so as to allow easy straightening of the lower retaining me~ber when -the filament is pulled downwardly.
The lower retaining member comprises a pair of loop portions -that are adjacent to each other and extend away from the central portion and then toward each other.

A more detailed explanation of the invention is .~ . .

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provided ln the following description and claims, and is illustrated in the accompanying drawings.

sRIEF DESCRIPTION OF THE DRAWINGS

FIGURE 1 is a view of an IUD constructed in accordance with the principles of the present invention, implanted in a uterus;
FIGURE 2 is a front view of an IUD constructed in accordance with the principles of the present invention; ... -FIGURE 3A is a side view thereof, taken along the plane of the line 3A - 3A of FIGURE 2;
FIGURE 3B is a bottom view thereof, taken along the plane of the line 3B - 3B of FIGURE 2;
. FIGURE 4 is a cross-sectional view thereof, taken along the plane of the line 4 - 4 of FIGURE: 2;
FIGURE 5 is a cross-sectional view thexeoE, taken along the plane of the line 5 - 5 of FIGURE` 2;
FIGURE 6 is a view of an IUD constructed in accordance .
with the principles of the present invention, implanted in a uterus with a fundal abnormality;
FIGURE 7 is a fragmen~ary cross-sectional view of an instrument designed for implanting the IUD in a uterus, with the IUD shown in full;
FIGURE 7A is a top view thereof;
FIGURE 8 is a view showing A typical means for introducing into the uterus an IUD constructed in accordance with the principles of the present invention;

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I'IGUR~ 9 is a front view of an IUD constructcd in accordance with a second embodiment of tl~e present invention;
FIG~RE 10 is a front view of an IUD constructed in accordance wi-th a third embodiment of -the present invention;
FIGUR~ 11 is a front view of an IUD constructed in accordance witll a fourth embodimellt of tlle p1-esellt invention; ., FIGURE 12 is a front view of an IUD constructed in accordance witll a fifth embodiment of the present invention;
FIGURE 13 is a front view of an IUD constructed in accordance with a sixth embodiment of the present invention;
FIGURE 14 is a front view of an IUD constructed in accordance with a seventh embodiment o:E the present invention;
FIGURE 15 is a ront view o an IUD constructed ;~ 20 in accordance with an eighth embodiment of the present invention;
. ~ FIGURE 16 is a front view of an IUD cons-tructed in accordance with a ninth embodiment of the present invention;
FIGURE 17 is a front view of an IUD constructed . in accordance with a tenth embodiment of the present : invention, FIGURE 18 is a front view of all IUD constxucted in accordance with an e1eventh embodiment of the present invention; and 10-' 1 ~ Z~ ~r~ 8 E'IGUR~ 19 is a frollt view of all IU~ constructecl in accordance with a t~7elfth embodiment of the present inven-tion.

DETI~IT.ED DESCRIPTION OF Tl-IE
ILLUST~TIVE: E~MI3ODI~IEN'l' Referring to FIGURES 1-8 of the drawings, an intrauterine device (IUD) 10 is sllowll thereill, and is shaped and preformed to provide a first resilient member 12 having a first upper loop portlon 14 and a second lower loop portion 16, which loop portions are contiguous and form a generally S-shaped configuration. I~D 10 also comprises a second member 18 having a third upper loop portion 20 and a fourtll lower loop portion 22, wllich loop portiPnS are contiguous and Eorm a gellerall~ S-shaped configuration. The generally S-shaped members 12 and 18 are connected in ~ack-to-back relationship, by molding, ; for example, so that one viewing IUD 10 sees an S~shaped : configuration on one side and a reverse S-shaped confi~-uration on the other side.
Upper loop portions 14 and 20 are considerably laryer than lower loop portions 16 and 22. The upper loop portions each essentially con~prise an arm which extends outwardly and around to form the loop ~7hile the lower loop portions 16 and 22 each essentially comprise : - - , an~arm extending outwardly and around in a direction opposite from the upper loop portion arms to fol-m tlle :
loop.
The specific shape of the upper loop portions 14 :.
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and 20 accommodate unknown variations in uterine shape a d provlde a fundal seeking property. The trunk wllicl , ' ' ' . ' ' 5~0~
interconnects the loop pOl't:iOIlS is sllOl't alld stifE to resist distortion and the lower loop portions are enlarged sufficiently to resist dowllward gravitation and expulsion.
~lthough member 12 is similar in size and con-figuration to member 18, the arm`forming loop 14 is slightly longer than the arm forming loop 20 a~ as a rounded end or bead 24 at i~s distal end. Ill tlliS mallller, when IUD 10 is inserted into the uterus, bead 24 is the first i-tem out of the tube which directs the IUD into the uterus, and bead 24 acts to lead the way into the uterus.
~s shown in the drawings, the upper loop portions 14 and 20 are not initially coilecl. Bead 24 is separate from the beginning portion of 1ool? 14 in the molclcd pre-lS insertion state and loop 14 is considered to be a non-spiral. In this manner, when loop portions 14 and 20 are`placed in a space with a smaLler transverse diameter than that of the loop portions, they will coil inward without bending anteriorly or posteriorly.
- Lower loops 16 and 22 each ~efine all op~nill~3 26 ~ through which-a filament or string 28 is conrlected ~or -~ use in rèmoving the IUD from the uterus.
Referring now ln particular to FIGURE 1, an ;~ IUD 10 is shown therein implanted in the frontal plane of the endometrlal cavity of uterus U, above the uterine isthmus. It can be seen that IUD 10 is conveniently supported within the endometrial cavi-ty by circumferelltial portions of upper loops 14 and 20. I-t can also be seen that if the endometrial cavlty ~ere narrower in transverse dimension, the IUD woùld remain conveniently placed therein because upper loops 14 and 20 would tend to become closed, or smaller, in response to the smaller dimension of the uterus. Likewise, if the endometrial cavity were wider in transverse dimension, the I~'D 10 would remain conveniently placed because upper loops 14 and 20 would open in response to the wider dimension.
It can also be seen that if an e~pulsive force would move IUD 10 clownwardly so that lower coils l~ and 22 would be uryed against the uterine wall, as the expulsive force increases downwardly the transverse diameter of lower loops would actually increase thereby providing greater resistance to expulsion.
It is preferred -that the IUD 10 be molded oE
conventional IUD material. ~s a specific exalllule, although no limitation is intended, the IUD could be molded o~ a composition comprisiny approximately 80 percent ethylene vinyl acetate (EVA), 10 percent polyester and 10 percent resin, or the IUD could b~ molded of a composition comprising approximately 80 percellt EV~ with the remalnder polyester and resin in s~litable ~roportiolls as lS well-known in the art.
Members 12 and 18 could be molded separately and then fastened together to form the unit shown in the '~
,~ drawings. ~lternatively, the entire IUD 10 could be molded as a unitary member, except for ~ilaments 28 ~ , .
~` 25 which would be attached subsequently.
In this manner, IU~ 10 has resilient arms 14, 20, 16 and 22 to provide a transverse bend resilience but also has a doubled or a thic]c sectioll 30 WhiCil, as a result of its dimensions, is relatively sti~f to give the IUD 10 proper axial stiffness. ~s shown in FIGURES 4 and 5 in particular, the cross-sectional conficJuratioll of `--13- ~

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the arms and section 30 are preferably non-circular and may be generally elliptical.
Although not illustrated in the drawings, the IUD
10 can carry anti-fertility material. There are numerous ways in which such anti-fertility material could be con-nected to I~D 10, but it is preferred that SUCIl anti-fertility material be carried by upper Loo~s 14 and 20, as well as thick section 30, on tlle -theory that the anti-fertility material is most efective when it is at a high position within the endometrial cavity. In some circum-stances, the anti-fertility material may be a copper wire;
in other instances it mày be a coating of copper or zinc on the IUD 10. Other conventional anti-fertility materials may be used, if desire~, such as hormonal a~ents, e.g., ; 15 progestero;le. The hormonal or chemical agent may be carried by the IUD 10 in the form of a sleeve or other sultable forms. In another constructioll, thc anti-fertility material may be molcled into ti~e substance of the IUD.
2~ Because of the unique construc-tion of IUD lO, there is no need for using inner wire, such as used in the IUD disclosed in U.S. Patent No. 3,467,089. Thus the potential of wire penetration is obviated by the present invention.
2$ FIGURE 6 illustrates a uterus U' having a con-genital fundal abnormality 34. ~lthough it is desil-able for the IUD to be high in the endometrial cavity, certain ; prior art IUD's are prevented from being located in the upper segment as a result of this fundal abnormality. It can be seen with reerence to FIGURE 6 in particular, however, that tlie fundal abnormality is accon~lodated by --1~- .:

~L~L2~i6~3 IUD 10, which IllD is present in -the fundus notwit'lstandincJ
the anatomic abnorMality.
The method of insertiny IUD 10 is illustrated in FIGURES 7, 7A and 8. ~n insertion tube 36 llas a funnel 38 connected to one.end thereof. Funllel 38 has a lower rim 40 which fits into an annular recessed ~ortion 42 definecl at the top 44 of insertioll tube 3G. Tlle internal diameter 46 at the lower portion of funnel 38 is equal -to the internal diameter 48 of tube 36. In this manner, a smooth, unobstructed internal wall is provided when the funnel 38 is connected to the inser-tion tube 36.
The IUD 10 to be inserted in the uterus is first inserted .~nto tube 36 by in-troducing filalllents 28 through funnel 38 and tube 36 and then pulliny filaments 28 down-wardly. Such downward forces Oll filalllellts 28 will extend and straigllten lower loops 16 and 22 in the manner ~; illustrated in FIGURE 7 and IUD 10 can ~e pull.ed do~n-wardly into tube 36 until upper loo~s 14 and 20 have substan-tially passed through funnel 38 and bead 24 is :;; the only portion remaininy outside of tube 36. Funnel ; 38 is then removed or disengaged from tube 3G. There~
~; after, tube 36 is introduced into the uterus U as illus-trated in FIGURE 8. ~ rod (not shown) is used to stabilize IUD 10 and to push i-t sliglltly :Eorward into the frontal plane of the endometrial cavity. Tube 36 is then pulled downwardly over the remainder of IUD 10 and the IUD becomes implanted in -the endometrial cavity as a coiled unit using a withdrawal method of IUD ~ :
ii~sertion. ~ tenaculum is applied on the cervix to ~
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stabilize the uterus s-traiyh-ten the ancJ1e between the ~':

body and neck of the uteru~s and to provide a counter force, when traction is applied to it, to enhance the ease and safe-ty of the insertion.
When IUD 10 is to be xemoved from the uterus, filaments 28 are pulled downward ~o t~leL-eby e.~telld or straighten arms 16 and 22 downwardly in the manner illustrated in PIGURE 7 to thereby allow the IUD to be removed in a relatively simple, efficient manner.
It is preferred that the vertical length of the IUD 10 be less than the overall width of the IUD. Addi-tionally, it is preferred that the ma~imum transverse dimension of lower loop portions 16, 22 be less t~lan 50 percent of the maximum transverse dimension of upper loop portions 14, 20. These proportions are useful in adapt-ing the IUD 10 to fit -the shape of the uterine cavity and par-ticularly the shape of the upper uterine segment.
Various modiEications of the IUD lO~of the present inventioll are showll in FIGU~S ~-19. In FIGURES 9-19, the same reference numerals are used Lo `20 represent similar structure.
In the IUD of FIGURE 9, upper loops 14, 20 are identical to upper loops 14, 20 of the FIGURES 1-8 embodiment, but lower loops 16, 22 have been modified so as to e~tend toward each other witllout curling upwardly. ~dditionally, recessed portlons 50 are defined by the lower loops to form hinges, thereby pro-, viding greater flexibility when the filaments coupled to openings 26 are pulled. This hinge effect on -tlle lower loops 16, 22 increases the ease of loading tlle IUD into inserter tube 36. The hinge effect also increases the ease of IUD removal from the uterus and establishes a . - , , .

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signiicant diEference between the force required to expel the IUD from the uterus and that required to remove it by pulling the filaments.
As stated previously downward prtssure o tl~c IU3 against -the uterine wall tends to increase tlle diameter of the lower loops and thus resist expulsion.
In contrast, pulling on the filaments easily straightens the lower loops and allows simple removal.
The FIGURE 10 embodiment is similar to the FIGURES 1-8 embodiment of the invention ~ut in the embodiment of FIGURE 10, recesses 50 are deined by lower loop portions 16, 22, to provide a hirlging action as discussed above.
~ In the embodiment of FIGURE 11, portions 51, 52, - 15 53-}and 54 have a smaller cross-sect.ional area -than the ; remaining portions o the IUD. In tllis marlller, the IUD
may carry an anti-fertility agent in tl~e forlll of a coil whlch is wound around portions 51-5~1, with tl~e cross-sectional diameter of the IUD being unchan~ed as a result of the additional coil. In other words the coil -~
which is wound about the portions 51-54 of the IUD will ~ not increase the cross-sectional diameter oE the IUD to ; any ex-tent greater than the diameter of the other por-tions oE the IUD.
In the embodiment of FIGURE 12, the distal ends of lower loop portions 16, 22 are spaced fur-ther apart ~ than in other embodiments. ~dditionally, recesses 50 are -~ deEined by the lower loop portions -to provide the hinge eEfect described above.
The embodiment of FIGURE 13 is constructed similarly to the embodiment of FIGURE 9; however, recesses ~S6~3 50 of the FIG~R~ 9 eMbodimc~n~ are not ~efined by the lower loop portions 16, 22 of the YIGURE 13 embodiment.
In the embodiments of FIGURES 14-16, the loop portions 16, 22 forming the lower retainill~J meltlber ~re integrally connected to each other to form a COIItillUOUS
single loop below upper loops 14, 20. In the embodiments of FIGURES 15 and 16, a recess 50 is defined by the lower loop to provide a hinge effect as described above.
Further, a groove 26' is provided for coupling to a filament, in a similar manner to openillgs 2G which are defined by the lower loop portions in otller embodiments.
In the FIGURES 17-18 embodiments, member 18' is discontinued and second lower loop portion 16 ls used as the retaining member. In the FIGUR~ 18 em~ocliment, member 16-defines a recess 50 to provide a hinge effect and in both the FIGUR~S 17 and 18 embodiment, opening 26 is defined adjacent the distal end o ~ortion 16 for coupling a filaM~nt thereto. Tl~e operatioll oE the IUD
of FIGUR~S 17 and 18 is similar 1o the operation of the IUD of the other embodiments.
The FIGURE 19 IUD is similar to the FIGVR~S 17 and 18 embodiments, but in the FIGUR~ 19 embodiment lower -~ portion 22 is the retaininc3 member while member 12' is discontinued. Lower member 22 defines an openinc3 26 adjacent its distal end for coupling to a filament, to be operated in the manner described above in connection with the other embodiments.
It can be seen that the IUDs of the present invention can be easily loaded into an inserter tube by pulling downwardly on the filament or filamellts. The hinging effect in specific desic31ls aids in tending to -; .

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straigh-ten the lower members. Tlle shape of the funnel member 38 of the inserter (E'IGURE 7) forces the lower loop yortions to straighten and lead them into the inserter 38 without difficulty. f~fter the IUD is loaded into the inserter, the funnel is disconnected and the insertion is then performed.
f~lthough illustrative embod.~mellts of the inven- ~
tion have been shown and described, it is to be under-stood that various modifica-tions and substitutions may be made by those skilled in the art witllout deyarti fro- the novel spirit and scope of the invention.

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Claims (17)

WHAT IS CLAIMED IS:

1. An intrauterine contraceptive device which comprises: a member adapted for insertion in the uterus formed of flexible material and having a central portion;
a first upper arm extending outwardly and around from said central portion and back toward said central portion to form a first loop; a second arm extending downwardly from said central portion, then outwardly and inwardly to form a retaining member; and a third upper arm extending outwardly and around from said central portion and back toward said central portion in a direction opposite from said first arm to form another loop, the distal ends of said first and third upper arms being substantially non-overlapping with respect to said central portion to prevent the formation of a spiral under normal compression which may cause said distal ends to extend out of the main plane of the member, said second arm defining a hinge portion;
a filament connected to said second arm, said hinge and filament cooperating to permit said second arm to be straightened easily when the filament is pulled downwardly.

2. An intrauterine contraceptive device as described in Claim 1, in which said member is formed of solid material and said central portion is rigid so as to have sufficient stiffness to resist distortion in the uterus, said central portion having a substantially equal length and width.

3. An intrauterine contraceptive device as described in Claim 1, and further including a fourth arm portion extending downwardly from said central portion, then outwardly and inwardly toward said second arm portion.

4. An intrauterine contraceptive device as described in Claim 3, in which said second and fourth arm portions are connected to form a continuous loop.

5. An intrauterine contraceptive device as described in Claim 4, in which said member comprises the integral formation of said first, second, third and fourth arms and said central portion.

6. An intrauterine contraceptive device as described in Claim 1, in which said member defines recessed portions for receiving anti-fertility material.

7. An intrauterine contraceptive device as described in Claim 6, in which said anti-fertility material comprises a metallic coil wound about said recessed portions, with the cross-sectional area of the coil wound about said recessed portions being no greater than the cross-sectional area of the non-recessed portions of said member.

8. An intrauterine contraceptive device as described in Claim 1, which is molded of a composition comprising approximately 80 percent ethylene vinyl acetate, 10 percent polyester and 10 percent polyester resin.

9. An intrauterine contraceptive device which comprises: a member adapted for insertion in the uterus formed of flexible material and having a central portion;
a first upper arm extending outwardly and around from said central portion and back toward said central portion to form a non-spiral loop in which the distal end of said arm does not overlap said central portion; another upper arm extending outwardly and around from said central portion and back toward said central portion in a direction opposite from said first arm to form another non-spiral loop in which the distal end of said other arm does not overlap said central portion, whereby under normal compression said distal ends will remain in the main plane of the member;
a lower retaining member having a filament connected thereto, said lower retaining member defining a hinge portion and thus being sufficiently flexible so as to allow easy straightening of said lower retaining member when said fila-ment is pulled downwardly, said lower retaining member com-prising a pair of loop portions that are adjacent to each other and extend away from the central portion and then toward each other.

10. An intrauterine contraceptive device as described in Claim 9, in which said loop portions forming said lower retaining member are integrally connected to each other to form a continuous single loop below said two upper loops.

11. An intrauterine contraceptive device as described in Claim 9, said lower retaining member having a transverse dimension that is less than fifty percent of the transverse dimension of both upper arms.

12. A device as described in Claim 1, wherein said hinge portion comprises a recessed portion defined by said second arm.

13. A device as described in Claim 3, said fourth arm defining a hinge portion; a filament connected to said fourth arm, said hinge and said filament cooperating to permit said fourth arm to be straightened easily when the filament is pulled downwardly.

14. A device as described in Claim 13, wherein said hinge portion comprises a recessed portion defined by said fourth arm.

15. A device as described in Claim 1, said first upper arm and said third upper arm each extending around approximately three-fourths of a circle in their uncompressed position.

16. A device as described in Claim 9, said upper arms each extending around approximately three-fourths of a circle in their uncompressed position.

17. A device as described in Claim 9, wherein said hinge portion comprises a recessed portion defined by said lower retaining member.