Note: Descriptions are shown in the official language in which they were submitted.
~2Si6~1~
: 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
.~, .
~, .
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
.
~%~c~
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
- 4
,~,,..~
3~ L25~0~
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 --~
~ . .
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.
:
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.
:
.. ,~.. ,~ :
~ 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
.~ . .
25~
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;
~'
: 3n : :
~ _g
~ .
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 :.
;
and 20 accommodate unknown variations in uterine shape
a d provlde a fundal seeking property. The trunk wllicl
--11--
,
' ' ' . ' '
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
-12-
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- ~
, . : . , .
5~6~1~
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 ~
..
stabilize the uterus s-traiyh-ten the ancJ1e between the
--15--
~':
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
-16-
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l:lZ5~
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
-17-
~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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56;~
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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