CA1110941A - Instrument and method for inserting an intrauterine contraceptive device - Google Patents
Instrument and method for inserting an intrauterine contraceptive deviceInfo
- Publication number
- CA1110941A CA1110941A CA298,261A CA298261A CA1110941A CA 1110941 A CA1110941 A CA 1110941A CA 298261 A CA298261 A CA 298261A CA 1110941 A CA1110941 A CA 1110941A
- Authority
- CA
- Canada
- Prior art keywords
- tube
- handle
- rod
- inserter
- stem
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
- A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
- A61F6/14—Contraceptive devices; Pessaries; Applicators therefor for use by females intra-uterine type
- A61F6/18—Inserters or removers ; Apparatus for loading an intra-uterine device into an insertion tube
Abstract
INSTRUMENT AND METHOD FOR
INSERTING AN INTRAUTERINE CONTRACEPTIVE
DEVICE
Abstract of the Disclosure An instrument for inserting an intrauterine contraceptive device of the kind having one or more outwardly extending arms or protrusions is described. The insertion instrument comprising an inserter tube and coacting rod maintains the arm or arms of the device in an extended configuration during storage but quickly and facilely folds the arms of the device into a protective housing or sheath for insertion into the uterus and releases the device by a withdrawal of the pro-tective housing. A uterine sound which may be employed with the insertion instrument is also described.
INSERTING AN INTRAUTERINE CONTRACEPTIVE
DEVICE
Abstract of the Disclosure An instrument for inserting an intrauterine contraceptive device of the kind having one or more outwardly extending arms or protrusions is described. The insertion instrument comprising an inserter tube and coacting rod maintains the arm or arms of the device in an extended configuration during storage but quickly and facilely folds the arms of the device into a protective housing or sheath for insertion into the uterus and releases the device by a withdrawal of the pro-tective housing. A uterine sound which may be employed with the insertion instrument is also described.
Description
Thi~ lnvention relates to an instrument ~or lnserting a sterlle ~ntrauterine contraceptive device into the uterine cavity; to a combination of contraceptive devlce and instrument for in~ert~ng same suitable ~or ste~ile pac~aglng;
and to methods for inserting contraceptive device~.
Intrauterine contraceptive devices, hereina~ter sometimes referred to as IUDs are employed by insertion into the uterus when prevention of conception is desired. The use of such devices is based on the ~nowledge that the presence of a foreign ob~ect ln the uterus discourages conception. The devlces have been of various pre~ormed conflguratlons including a ring, a spiral, a bow, one which has a shape characterlstlc o~ a "7 " and one which has a 8hape characterlstic of ~ "T."
The devices of various conflguratlonæ are designed to oc~upy a signlficant portion of the space in the uterus and therefore are of effective dlmensions which are larger than the cervical os through which they mu~t pa88, Thus, lnsertio~ of the IUD
is carrled out by use o~ an in~erter wh$ch mod~fies the con-~iguratlon of the IUD during insertion. It is contemplated that the IUD on release in the uterus assumes the original configuration. However, materials from which the devices are made generally have such properties that if any force is applied to the IUD for an extended time, the configuration assumed while the foree has been applied is retained. When the IUD fails to assume its orig~nal configuration, its e~fectiveness is ~mpaired. For this reason, lt ls undesirable to provide an ~n~ertion ~nstrument ln which the IUD is pre-positioned ,- ~
0RT~-299 ln an insertion configuration. Rather, the IUD is restrained lnto an lnsertion conf1guration for a brief few moment~
lmmediately prior to use thereby causing little or no di~-tortion or impalrment to the IUD.
Illustrative o~ thls is a practice employed with one of the ~requently employed IUD~ which is in the ~hape o~ a ~T".
One method for inserting it employs an insertiontube and a complementary piunger. The tube i8 of suffici~nt size and malleability Yor retaining the extended arms of the deYice in a folded position during insertion and is released from thls positlon by interactlon with the plunger.
Thus, when it ls desired to insert the IUD, the physician at that time fits the extended arms of the "T" into the upper end of the insertlon tube with his fingers while attempting to maintaln sterlle conditions. He then lnserts the loaded tube throu~h the cervlcal os into the uterine cavity and after locating the tube ~n the deslred po~itlon pulls downward on the tube to expel the IUD whlle he attempts to maintain the IUD in the correct po~ition ln the uterus by holding the inner plunger stationary. When the insertion tube is withdrawn the arms o~ the "T~' then un~old in the uterus.
Thls and other lnserter instruments whlch require manual place-ment of the IUD in the inserter instrument by the physician are disadvantageous because it is cumbersome, time consuming, and further, increases the posslbillty of contamination and L6~4~
improper insertlon. Moreover, where the IUD must be posltloned by human manlpulatlon~ there exists an additional hazard of erroneous placement whlch may be a source of potential inJury ~ to the patient. Thus, for ex~mple, in the case of an IUD in the shape of a "T", the arms may be folded upward which could cause in~ury to the fundu~ on lnsertlon of the unit ltself or expulsion of the "T" from the insertlon unlt. With IUDs o~ certain configuration, the IUD may be po&itioned ln the inserter by drawing back on the "tail," i.e., the string attached to the IUD for removal from the uterus. Such a method, however, is un~esirable for an IUD havlng a "T"
configuration since the arms would be drawn upward In ~ome devlces the folding of the IUD or placement in the lnserter tu~e may be made to occur a~ter the initial place-ment o~ the lnserter in the uterus thereby providing les~
control. Generally most devices contemplate expulslon of the IUD from the inserter tube by lnteraction Or the IUD with an ~nner plunger. If the plunger i8 pushed when the IUD is in place rather than belng held stationary while retracting the inserter tube there could be serious ln~ury to the fundus.
The difficulty of controlling present devices* ometimeæ leads to confu~ion for the physlcian and potential in~ury to the patlent.
It is an object of the present invention to provide an improved insertion method and insertion instrument for an ~ntrauterine contraceptiYe device having a stem with substantially transverse arms distally a~cent to and integral with the stem whlch can be employed without the need for dilation of the cer~ix.
4~
0R~-299 It ls another ob~ect o~ the present invention to pro~ide a meAns ~or rapidly ~nd ~cilely folding an intrauterine device having substantially transverse arms into a compact conflguration in an ~nsertlon lnstrument in which the folding can be carrled out immediately prior to insertion into the uteru~ thereby avoiding distortlon of the intrauterine device caused by long-te~m prefolding.
A ~urther ob~ect of this invention is to provide an integral mechanism which guards against automatic expulsion of the intrauterine dev~ce through the end o~ the insertion tube during the step of folding the trans~erse arms of the device and moving it into position.
Another ob~ect 18 to provlde an lnsertlon lnstrument in which the lntrauterine device can be precisely posltioned wlth its contoured folded tlp slightly protruding beyond the end of the insertlon tube to facilitate in~ertion through the cervlcal 08.
An additlonal ob~ect 18 to provlde an instrument which more precisely relea3es and positlon~ the lntrauterine device ln the uterus to reduce to a minlmum pos~lble ln~ury to the uterlne wall or fundus.
A further ob~ect iB to provide an insertion tnstrument o~ a malleable nature which is adaptable to belng cur~ed or bent to conf~rm ~o ~he natural intrauterine curvature pro-~lding a ~moother and more comrortable e~try lnto the uterine cavlty.
~ ~urther obJect 1~ to pro~ ~e an ln~ertion instrumen~
whlch ~aXes 1~ po8 $ble to control the la~eral orientatio~ Or the IUD in the uteri~e cavity.
0RT~-299 Another ob~ec~ ~8 to provide an in~trument of enhanced tactlle ~ensit1vity for placement control.
An additional ob~ect of the present invention is to . provide insertion system whlch minimizes handling of the portion of the instrument which will become intrauterine so that sterile conditions can be maintained.
A still further ob~ect is to provide an insertion instrument in combination with an intrauterine device said combination being adaptable to sterile packaging.
A further object is to provide an optional preferred embodiment in which a disposable sterile uterine sound o~
similar design to the insertion devlce is employed, said sound being provided with identical depth scale and indicator as provided on the insertion instrument.
In accordance wlth the present invention there is provided an insertion instrument assembly to be employed for inserting into the uterus without the necessity for cervical dilation of a flexible intrauterine contraceptive device of the kind having at least one, preferably two, substantially horizontally extending arm which comprises (a) an inserter tube adaptable for protectively housing the intrauterine devlce with the arms folded ad~acent to the stem in an axially aligned posltion and (b) a coacting rod telescopically posit~oned in the tube, said insertion instrument assembly having an insert~on end adapted to be passed through the cervlx and being further provided with means adapted to receive the intrauterine device, to fold the arms or protrusions o~ the device, to control the position o~ insertion into the : -6-5i41 oRTHo29g uterus, and to release the device in the uterine cavity.
In the preferred embodiment of the present invention, the instrument is utilized for lnserting ~ flexible contra-cepti~e device having two transverse arms distally ex-tending from a stem, generally in the shape which may be described as a "T".
The inserter tube adapted to protect~vely house said intrauterine device with the arm or arms folded adjacent to the stem in an axially aligned position, has an insertion section of a flexible nature and a manipulative section of a non-flexible nature. The insertion section ls the forward part of the tube which wlll become intr~uterine in use and ~ the manipulative section is that part which will remain extrauterine in use. The tube is provided with an externally mounted slidable stop means for engaging the cervical os. This stop is located-on the insertion section of the tube and is susceptible of bein$ ad~usted to a predetermined posltion for proper depth of insertlon. On the m~nipulative ~ectlon Or the tube poster1orly of the stop mea~s, are located a p~ir Or dia-metrically opposed axially extending aperture~. The aperture6 are adapted to receive the in~rauterine device so that the stem extends axlally within the tube and the arm or arms extend through the apertures. The tube is provided with a handle at ~ the posterior end. The handle is an integral part of the ; 25 manipulative section and has a passageway therethrough which i~ in communicatlon wlth the lumen or bore of the tube. The handle i~ bifurcated with the ~tems extending in a posterlor direction and terminating in a ~lange wlth a pro~ecting edge.
O~TH-299 The cross-sectional configuratlon of the lumen of the tube ln the flexlble insertion section is clrcular but that in the rigid manip~lative sectlon ls non-circular.
The coactlng rod to be telescopically positioned in the lnserter tube and slidable therein is o~ malleable material with a retenti~e memory and ls provided wit~ a tubular receptacle section at the ~nsertion end adapted to support the stem of the intrauterine device and with a handle at the posterlor end.
The handle is bifurcated with stems extending ln an anterior or forward dlrection and has flanges wlth edges pro~ecting oppositely to the edges in the handle of the inserter tube.
The flanges are further spatially opposed and abuttable wlth the flanges of the inserter tube handle. The rod has a non-clrcular cross-sectional confi~uratlon complementing the cross-6ectlonal conflguration of the lumen of the rlgid portlon of the inserter tube.
The stems of one of the bifurcated handles are compres~-sible and when compressed are adapted to be received in the area between the stem~ of the other handle which ~s at least as deep as the distance occupied by the arm of the intra-uterine device within the tube in insertion position as subsequently described. While the device may be made operable with either handle being the compressible handle (i.e., handle wlth compressible stems), it is preferred that the inserter tube be provided with the compressible handle. The reason for the preference ls that since it is the rearward motion of the inserter tube that is intended to release the intrauterine device, a more ~afe operation ~s pos~ible if the rod handle is held lmmobile.
The inserter tube and rod coact in a mannex such that pul-3 ling rearwardly on the inserter tube h~ndle until the flanges 4~
ORT~-299 o~ the stems o~ the inserter tube and rod handles are abutting causes a roldlng of the arms of the IUD and mo~e~ it to the in-sertion positlon with the contoured tlp ~nd the rolded arms minlmally proJectlng from the sheath provided by the lnsertlon end Or the tube. The confor~able non-circular cro~s-section of the rod and rigld portion of the inserter tube permits this to occur without twisting. The lnstrument in this positlon i~
employed for lnsertion in the uterus. Thereafter, on compres~lng ~/ the compresslble stems of one of the handles and drawing it withln the area between the 8tem8 0~ the other handle retract~ the 6heath from around the IUD and releases the lntrauterlne device at the insertion end. Followlng thls, releasing the compres~ion pressure on the ~tem causes the inwardly and outwardly pro~ecting edges of the handle susceptible Or interlocking for a unltary ~lthdrawal Or the tube and rod rrom the uterus.
The in6erter tube is prererably of rlexible material at the insertion ~ection ~o that although clrcular in cross-sectlon before loadlng with the intrauterine device, it assume6 an oval / shape when loaded and acts as a snug protective sheath or housing for the IUD. The tube at the manipulatlve end 18 Or rigid material. Although the tube may be made oval at the insertion end by use of ri~id material, the adde~ bulk result~ng ~rom thls alternative renders this le~s preferable.
In a pre~erred embodiment Or the present lnvention the handle o~ the rod i8 pro~ided ~it~ a digit placement area, a contoured tactile area ~ th~ proximal ~urrace where a physiclan may place hlE thumb or finger, whi~h prov~des the phys~cls~ wlth a means ~r sensitlvely controlling the instrument as it i8 4 ~
0R~-299 being lnserted into the uterine cavity and which communicates to him the orientation of t~e device during and after incertlon.
In another prererred embod~ment of the present invent~on, the inserter tube i8 provlded with graduatlons to be employed with the stop mean~ for more exact positioning of the lntra-uterine device, particul~rly, when employed with a companion uterlne sound. The~e embodiments are subsequently described, The ob~ects and advantages of this invention wlll be more readily apparent from the following descriptlon and accompanying drawings.
Figure 1 is a schematic front plan view in combination of a UTU shaped lntrauterine device and an insertion instrument assembly comprising an lnserter tube and a coacting rod, and showing the protruding arms of the device as initially positioned in the lnstrument.
Figure 2 is a side view of Figure 1.
Figure 3 ls a view, in cross-section, along 3-3 of Figurs l.
Figure 4 is a view, in cross-section, along 4-4 of Figure l.
Figure 5 is a view, partly ln cross-section and partly ln elevation, along 5-5 of Figure l.
Figure 6 is a view, in cross-sect~on, along 6-6 of Fi~ure 9.
~lgure 7 is an enlarged fragmentary cross-sectional vlew o~ the assembly showing the intrauterine deviceO
--10_ Figure 8 is a view, in cross-section, along 8-8 of Figure 7.
Figure 9 is an enlarged fragmentary cross-sectional view similar to Figure 7 but in moved position and showing the folded intrauterine device contained therein.
Figure 10 is a similar enlarged fragmentary view ln moved position sh~wing the unfolded arms of the intrauterine devlce.
Flgure 11 is a ~iew of a companion uterine sound Figure 12 is an enlarged view partly in cross-section and partly in elevation, along 12-12 of Figure 11.
Figure 13 is an enlar~ed view, in cross-section, along 13-13 of Figure 11, Referring to the drawings, particularly, Figure 1, 2, 7 : 15 and ô, it will be seen that the intrauterine device insertion instrument assembly 10 embodying the present invention comprises an inserter tube 11 and a coacting rod 31 tele-scopically positioned in the tube and having mounted therein an intrauterine device 50.
The inserter tube is of two sections, a forward flexible insertion sectlon lla and a rearward substantially rigid manipulative section llb which will remain extrauterine during usea Located on the exterior of the flexible section of the inserter tube is a slidably adjustable stop means 12~
a ll--4 ~
OR$H-299 ad~ustable to a position corresponding to the position to which it i5 desired to insert the mounted insertion instrument assembly lnto the uterine cavity. (A view along the axis showing the stop means surrounding the flexible insertion sectlo~ of the tube is seen ~n Figure 5.) Located on the manipulative section of the tube is a pair of diametrically opposed axially extending apertures 14 through which the intrauterlne device is initially placed ln the instrument. The tube is pro~ided at the posterior end with-a handle 15 to facilitate grasping and manipulating the instrument said handle being an integral part of the manipulative section and havlng a passageway therethrough communicating with the lumen or axlal bore 22 of the tube as hereinafter described. As best seen ln Figures 1 and 7, the handle is bifurcated, having compressible stems 17 ex-tending i~ a posterior direction said stems bracketing an area 16 through which the coacting rod 31 passes to enter into the lumen 22 of the tube. Preferably an extension 18 o~ the tube protrudes lnto the area 16~ provlding additional guiding support for the rod. The stems 17 terminate in flanges 19 with outwardly pro~ecting edges 20, said flanges adaptable for serving as abutment means (see Figure 9) and as interlocking means (see Figure 10).
The slidable stop means 12 is a disc surrounding the flexible section lla o~ the inserter tube and is preferably provided with a slot 13 to prevent occlusion of graduations 21 (see Figure 1) whlch are preferably lmprinted or embossed on the insertion ~ection. The graduations indicate the depth ORrH-~99 of the uterine cavity as measured from the tip o~ the folded intrauterlne device in the loaded $nsertlon instrument (i.e., instrument ready for insertion into t~e uterus) as ~een in ~igure 9. The graduationz 21 correspond to graduatlons 64 on a companlon uterine sound 60 (see Flgure 11) which may be and preferably is employed with the in-sertion instrument assembly 10 of the present invention.
The locat~on o~ the apertures 14 with respect to the ~op or insertion end of the tube and the flange face on the termlnal part of the handle of the tube is lmportant. The apertures are located so that the intrauterine device reaches the insertion or loaded posltion when the tube has been drawn bacXward until further movement ~s stopped (see Figure 9) as will be herelnafter more ~ully described.
The cross-sectional view of the aperture area is seen in Figure 4 and shows that the cross-sectional dimenslons of the lumen 22 may be larger in the vicinity of the aperture than the passageway in the handle portion (Figure 3 to facilitate initlal mounting of the intrauterine device.
tsee also Figure 7).
The flexible nature of the in~ertion section permits the tub~ when sub~e~ted to pressure,as occurs on the loading of the lntrauterlne device to assume an elliptical or oval cross-seetional shape thereby providing a snug sheath or protective housing for the stem and folded arms for the intrauterlne devlce. The oval cross-sectional configuration of the tube while housing the stem ~nd arms of the intra-ut~rine device i~ seen in Figure 6. The ~top me~nz 12 preferably h~s an oval cro6s-sectional con iguration of the _~3_ 0RT~-299 loaded insertion instrument and the oval cro3s-~ectlonal con riguratlon a~sumed by the tube ln the vicinity of the ~top me~n~ ls ~een ln Figure 5. (The dashed lines ~n Figure 5 ~hows the normal round cross-~ectlonal con~iguratlon o~ the tube. The modiflcatlon o~ the tube from round to oval may be seen al80 with the aid of the dot-dashed lines repre6enting the normal round ~hape seen at the upper end of the tube in Figures 1 and 2.) The crosq-~ectlonal configuration of the lumen 22 ln the manipulative sect~on of the tube as well as the cross-sectional configuration of the coacting rod is important. These portions of the insertlon instrument assembly have a non circular cross-section, i.e., it has at least one substantlally flat or flat-tened surface ln the cross-sectional con~lgurationE. Con-veniently the configurations may be a flattened ellipse or a rectangle with rounded corners or semi-circular somewhat in a shape which may be descrlbed as "D". However, it may be a s~uare,triangle, polygon or an lrregular shape with a flattened 6ide. The flat or flattened sections of the rod and tube are conformable with each other although they need not be identical in shape; the conformance prevents rotation of the rod after insertion in the uterus. This is lmportant for aiding the phy~ician to c~ntrol the plane of the intrauterine device during i~ertion and placement ln the uterus. It is mo~t use~ully accomplished by having the ~lat sur~ace of the handle ~nd rod
and to methods for inserting contraceptive device~.
Intrauterine contraceptive devices, hereina~ter sometimes referred to as IUDs are employed by insertion into the uterus when prevention of conception is desired. The use of such devices is based on the ~nowledge that the presence of a foreign ob~ect ln the uterus discourages conception. The devlces have been of various pre~ormed conflguratlons including a ring, a spiral, a bow, one which has a shape characterlstlc o~ a "7 " and one which has a 8hape characterlstic of ~ "T."
The devices of various conflguratlonæ are designed to oc~upy a signlficant portion of the space in the uterus and therefore are of effective dlmensions which are larger than the cervical os through which they mu~t pa88, Thus, lnsertio~ of the IUD
is carrled out by use o~ an in~erter wh$ch mod~fies the con-~iguratlon of the IUD during insertion. It is contemplated that the IUD on release in the uterus assumes the original configuration. However, materials from which the devices are made generally have such properties that if any force is applied to the IUD for an extended time, the configuration assumed while the foree has been applied is retained. When the IUD fails to assume its orig~nal configuration, its e~fectiveness is ~mpaired. For this reason, lt ls undesirable to provide an ~n~ertion ~nstrument ln which the IUD is pre-positioned ,- ~
0RT~-299 ln an insertion configuration. Rather, the IUD is restrained lnto an lnsertion conf1guration for a brief few moment~
lmmediately prior to use thereby causing little or no di~-tortion or impalrment to the IUD.
Illustrative o~ thls is a practice employed with one of the ~requently employed IUD~ which is in the ~hape o~ a ~T".
One method for inserting it employs an insertiontube and a complementary piunger. The tube i8 of suffici~nt size and malleability Yor retaining the extended arms of the deYice in a folded position during insertion and is released from thls positlon by interactlon with the plunger.
Thus, when it ls desired to insert the IUD, the physician at that time fits the extended arms of the "T" into the upper end of the insertlon tube with his fingers while attempting to maintaln sterlle conditions. He then lnserts the loaded tube throu~h the cervlcal os into the uterine cavity and after locating the tube ~n the deslred po~itlon pulls downward on the tube to expel the IUD whlle he attempts to maintain the IUD in the correct po~ition ln the uterus by holding the inner plunger stationary. When the insertion tube is withdrawn the arms o~ the "T~' then un~old in the uterus.
Thls and other lnserter instruments whlch require manual place-ment of the IUD in the inserter instrument by the physician are disadvantageous because it is cumbersome, time consuming, and further, increases the posslbillty of contamination and L6~4~
improper insertlon. Moreover, where the IUD must be posltloned by human manlpulatlon~ there exists an additional hazard of erroneous placement whlch may be a source of potential inJury ~ to the patient. Thus, for ex~mple, in the case of an IUD in the shape of a "T", the arms may be folded upward which could cause in~ury to the fundu~ on lnsertlon of the unit ltself or expulsion of the "T" from the insertlon unlt. With IUDs o~ certain configuration, the IUD may be po&itioned ln the inserter by drawing back on the "tail," i.e., the string attached to the IUD for removal from the uterus. Such a method, however, is un~esirable for an IUD havlng a "T"
configuration since the arms would be drawn upward In ~ome devlces the folding of the IUD or placement in the lnserter tu~e may be made to occur a~ter the initial place-ment o~ the lnserter in the uterus thereby providing les~
control. Generally most devices contemplate expulslon of the IUD from the inserter tube by lnteraction Or the IUD with an ~nner plunger. If the plunger i8 pushed when the IUD is in place rather than belng held stationary while retracting the inserter tube there could be serious ln~ury to the fundus.
The difficulty of controlling present devices* ometimeæ leads to confu~ion for the physlcian and potential in~ury to the patlent.
It is an object of the present invention to provide an improved insertion method and insertion instrument for an ~ntrauterine contraceptiYe device having a stem with substantially transverse arms distally a~cent to and integral with the stem whlch can be employed without the need for dilation of the cer~ix.
4~
0R~-299 It ls another ob~ect o~ the present invention to pro~ide a meAns ~or rapidly ~nd ~cilely folding an intrauterine device having substantially transverse arms into a compact conflguration in an ~nsertlon lnstrument in which the folding can be carrled out immediately prior to insertion into the uteru~ thereby avoiding distortlon of the intrauterine device caused by long-te~m prefolding.
A ~urther ob~ect of this invention is to provide an integral mechanism which guards against automatic expulsion of the intrauterine dev~ce through the end o~ the insertion tube during the step of folding the trans~erse arms of the device and moving it into position.
Another ob~ect 18 to provlde an lnsertlon lnstrument in which the lntrauterine device can be precisely posltioned wlth its contoured folded tlp slightly protruding beyond the end of the insertlon tube to facilitate in~ertion through the cervlcal 08.
An additlonal ob~ect 18 to provlde an instrument which more precisely relea3es and positlon~ the lntrauterine device ln the uterus to reduce to a minlmum pos~lble ln~ury to the uterlne wall or fundus.
A further ob~ect iB to provide an insertion tnstrument o~ a malleable nature which is adaptable to belng cur~ed or bent to conf~rm ~o ~he natural intrauterine curvature pro-~lding a ~moother and more comrortable e~try lnto the uterine cavlty.
~ ~urther obJect 1~ to pro~ ~e an ln~ertion instrumen~
whlch ~aXes 1~ po8 $ble to control the la~eral orientatio~ Or the IUD in the uteri~e cavity.
0RT~-299 Another ob~ec~ ~8 to provide an in~trument of enhanced tactlle ~ensit1vity for placement control.
An additional ob~ect of the present invention is to . provide insertion system whlch minimizes handling of the portion of the instrument which will become intrauterine so that sterile conditions can be maintained.
A still further ob~ect is to provide an insertion instrument in combination with an intrauterine device said combination being adaptable to sterile packaging.
A further object is to provide an optional preferred embodiment in which a disposable sterile uterine sound o~
similar design to the insertion devlce is employed, said sound being provided with identical depth scale and indicator as provided on the insertion instrument.
In accordance wlth the present invention there is provided an insertion instrument assembly to be employed for inserting into the uterus without the necessity for cervical dilation of a flexible intrauterine contraceptive device of the kind having at least one, preferably two, substantially horizontally extending arm which comprises (a) an inserter tube adaptable for protectively housing the intrauterine devlce with the arms folded ad~acent to the stem in an axially aligned posltion and (b) a coacting rod telescopically posit~oned in the tube, said insertion instrument assembly having an insert~on end adapted to be passed through the cervlx and being further provided with means adapted to receive the intrauterine device, to fold the arms or protrusions o~ the device, to control the position o~ insertion into the : -6-5i41 oRTHo29g uterus, and to release the device in the uterine cavity.
In the preferred embodiment of the present invention, the instrument is utilized for lnserting ~ flexible contra-cepti~e device having two transverse arms distally ex-tending from a stem, generally in the shape which may be described as a "T".
The inserter tube adapted to protect~vely house said intrauterine device with the arm or arms folded adjacent to the stem in an axially aligned position, has an insertion section of a flexible nature and a manipulative section of a non-flexible nature. The insertion section ls the forward part of the tube which wlll become intr~uterine in use and ~ the manipulative section is that part which will remain extrauterine in use. The tube is provided with an externally mounted slidable stop means for engaging the cervical os. This stop is located-on the insertion section of the tube and is susceptible of bein$ ad~usted to a predetermined posltion for proper depth of insertlon. On the m~nipulative ~ectlon Or the tube poster1orly of the stop mea~s, are located a p~ir Or dia-metrically opposed axially extending aperture~. The aperture6 are adapted to receive the in~rauterine device so that the stem extends axlally within the tube and the arm or arms extend through the apertures. The tube is provided with a handle at ~ the posterior end. The handle is an integral part of the ; 25 manipulative section and has a passageway therethrough which i~ in communicatlon wlth the lumen or bore of the tube. The handle i~ bifurcated with the ~tems extending in a posterlor direction and terminating in a ~lange wlth a pro~ecting edge.
O~TH-299 The cross-sectional configuratlon of the lumen of the tube ln the flexlble insertion section is clrcular but that in the rigid manip~lative sectlon ls non-circular.
The coactlng rod to be telescopically positioned in the lnserter tube and slidable therein is o~ malleable material with a retenti~e memory and ls provided wit~ a tubular receptacle section at the ~nsertion end adapted to support the stem of the intrauterine device and with a handle at the posterlor end.
The handle is bifurcated with stems extending ln an anterior or forward dlrection and has flanges wlth edges pro~ecting oppositely to the edges in the handle of the inserter tube.
The flanges are further spatially opposed and abuttable wlth the flanges of the inserter tube handle. The rod has a non-clrcular cross-sectional confi~uratlon complementing the cross-6ectlonal conflguration of the lumen of the rlgid portlon of the inserter tube.
The stems of one of the bifurcated handles are compres~-sible and when compressed are adapted to be received in the area between the stem~ of the other handle which ~s at least as deep as the distance occupied by the arm of the intra-uterine device within the tube in insertion position as subsequently described. While the device may be made operable with either handle being the compressible handle (i.e., handle wlth compressible stems), it is preferred that the inserter tube be provided with the compressible handle. The reason for the preference ls that since it is the rearward motion of the inserter tube that is intended to release the intrauterine device, a more ~afe operation ~s pos~ible if the rod handle is held lmmobile.
The inserter tube and rod coact in a mannex such that pul-3 ling rearwardly on the inserter tube h~ndle until the flanges 4~
ORT~-299 o~ the stems o~ the inserter tube and rod handles are abutting causes a roldlng of the arms of the IUD and mo~e~ it to the in-sertion positlon with the contoured tlp ~nd the rolded arms minlmally proJectlng from the sheath provided by the lnsertlon end Or the tube. The confor~able non-circular cro~s-section of the rod and rigld portion of the inserter tube permits this to occur without twisting. The lnstrument in this positlon i~
employed for lnsertion in the uterus. Thereafter, on compres~lng ~/ the compresslble stems of one of the handles and drawing it withln the area between the 8tem8 0~ the other handle retract~ the 6heath from around the IUD and releases the lntrauterlne device at the insertion end. Followlng thls, releasing the compres~ion pressure on the ~tem causes the inwardly and outwardly pro~ecting edges of the handle susceptible Or interlocking for a unltary ~lthdrawal Or the tube and rod rrom the uterus.
The in6erter tube is prererably of rlexible material at the insertion ~ection ~o that although clrcular in cross-sectlon before loadlng with the intrauterine device, it assume6 an oval / shape when loaded and acts as a snug protective sheath or housing for the IUD. The tube at the manipulatlve end 18 Or rigid material. Although the tube may be made oval at the insertion end by use of ri~id material, the adde~ bulk result~ng ~rom thls alternative renders this le~s preferable.
In a pre~erred embodiment Or the present lnvention the handle o~ the rod i8 pro~ided ~it~ a digit placement area, a contoured tactile area ~ th~ proximal ~urrace where a physiclan may place hlE thumb or finger, whi~h prov~des the phys~cls~ wlth a means ~r sensitlvely controlling the instrument as it i8 4 ~
0R~-299 being lnserted into the uterine cavity and which communicates to him the orientation of t~e device during and after incertlon.
In another prererred embod~ment of the present invent~on, the inserter tube i8 provlded with graduatlons to be employed with the stop mean~ for more exact positioning of the lntra-uterine device, particul~rly, when employed with a companion uterlne sound. The~e embodiments are subsequently described, The ob~ects and advantages of this invention wlll be more readily apparent from the following descriptlon and accompanying drawings.
Figure 1 is a schematic front plan view in combination of a UTU shaped lntrauterine device and an insertion instrument assembly comprising an lnserter tube and a coacting rod, and showing the protruding arms of the device as initially positioned in the lnstrument.
Figure 2 is a side view of Figure 1.
Figure 3 ls a view, in cross-section, along 3-3 of Figurs l.
Figure 4 is a view, in cross-section, along 4-4 of Figure l.
Figure 5 is a view, partly ln cross-section and partly ln elevation, along 5-5 of Figure l.
Figure 6 is a view, in cross-sect~on, along 6-6 of Fi~ure 9.
~lgure 7 is an enlarged fragmentary cross-sectional vlew o~ the assembly showing the intrauterine deviceO
--10_ Figure 8 is a view, in cross-section, along 8-8 of Figure 7.
Figure 9 is an enlarged fragmentary cross-sectional view similar to Figure 7 but in moved position and showing the folded intrauterine device contained therein.
Figure 10 is a similar enlarged fragmentary view ln moved position sh~wing the unfolded arms of the intrauterine devlce.
Flgure 11 is a ~iew of a companion uterine sound Figure 12 is an enlarged view partly in cross-section and partly in elevation, along 12-12 of Figure 11.
Figure 13 is an enlar~ed view, in cross-section, along 13-13 of Figure 11, Referring to the drawings, particularly, Figure 1, 2, 7 : 15 and ô, it will be seen that the intrauterine device insertion instrument assembly 10 embodying the present invention comprises an inserter tube 11 and a coacting rod 31 tele-scopically positioned in the tube and having mounted therein an intrauterine device 50.
The inserter tube is of two sections, a forward flexible insertion sectlon lla and a rearward substantially rigid manipulative section llb which will remain extrauterine during usea Located on the exterior of the flexible section of the inserter tube is a slidably adjustable stop means 12~
a ll--4 ~
OR$H-299 ad~ustable to a position corresponding to the position to which it i5 desired to insert the mounted insertion instrument assembly lnto the uterine cavity. (A view along the axis showing the stop means surrounding the flexible insertion sectlo~ of the tube is seen ~n Figure 5.) Located on the manipulative section of the tube is a pair of diametrically opposed axially extending apertures 14 through which the intrauterlne device is initially placed ln the instrument. The tube is pro~ided at the posterior end with-a handle 15 to facilitate grasping and manipulating the instrument said handle being an integral part of the manipulative section and havlng a passageway therethrough communicating with the lumen or axlal bore 22 of the tube as hereinafter described. As best seen ln Figures 1 and 7, the handle is bifurcated, having compressible stems 17 ex-tending i~ a posterior direction said stems bracketing an area 16 through which the coacting rod 31 passes to enter into the lumen 22 of the tube. Preferably an extension 18 o~ the tube protrudes lnto the area 16~ provlding additional guiding support for the rod. The stems 17 terminate in flanges 19 with outwardly pro~ecting edges 20, said flanges adaptable for serving as abutment means (see Figure 9) and as interlocking means (see Figure 10).
The slidable stop means 12 is a disc surrounding the flexible section lla o~ the inserter tube and is preferably provided with a slot 13 to prevent occlusion of graduations 21 (see Figure 1) whlch are preferably lmprinted or embossed on the insertion ~ection. The graduations indicate the depth ORrH-~99 of the uterine cavity as measured from the tip o~ the folded intrauterlne device in the loaded $nsertlon instrument (i.e., instrument ready for insertion into t~e uterus) as ~een in ~igure 9. The graduationz 21 correspond to graduatlons 64 on a companlon uterine sound 60 (see Flgure 11) which may be and preferably is employed with the in-sertion instrument assembly 10 of the present invention.
The locat~on o~ the apertures 14 with respect to the ~op or insertion end of the tube and the flange face on the termlnal part of the handle of the tube is lmportant. The apertures are located so that the intrauterine device reaches the insertion or loaded posltion when the tube has been drawn bacXward until further movement ~s stopped (see Figure 9) as will be herelnafter more ~ully described.
The cross-sectional view of the aperture area is seen in Figure 4 and shows that the cross-sectional dimenslons of the lumen 22 may be larger in the vicinity of the aperture than the passageway in the handle portion (Figure 3 to facilitate initlal mounting of the intrauterine device.
tsee also Figure 7).
The flexible nature of the in~ertion section permits the tub~ when sub~e~ted to pressure,as occurs on the loading of the lntrauterlne device to assume an elliptical or oval cross-seetional shape thereby providing a snug sheath or protective housing for the stem and folded arms for the intrauterlne devlce. The oval cross-sectional configuration of the tube while housing the stem ~nd arms of the intra-ut~rine device i~ seen in Figure 6. The ~top me~nz 12 preferably h~s an oval cro6s-sectional con iguration of the _~3_ 0RT~-299 loaded insertion instrument and the oval cro3s-~ectlonal con riguratlon a~sumed by the tube ln the vicinity of the ~top me~n~ ls ~een ln Figure 5. (The dashed lines ~n Figure 5 ~hows the normal round cross-~ectlonal con~iguratlon o~ the tube. The modiflcatlon o~ the tube from round to oval may be seen al80 with the aid of the dot-dashed lines repre6enting the normal round ~hape seen at the upper end of the tube in Figures 1 and 2.) The crosq-~ectlonal configuration of the lumen 22 ln the manipulative sect~on of the tube as well as the cross-sectional configuration of the coacting rod is important. These portions of the insertlon instrument assembly have a non circular cross-section, i.e., it has at least one substantlally flat or flat-tened surface ln the cross-sectional con~lgurationE. Con-veniently the configurations may be a flattened ellipse or a rectangle with rounded corners or semi-circular somewhat in a shape which may be descrlbed as "D". However, it may be a s~uare,triangle, polygon or an lrregular shape with a flattened 6ide. The flat or flattened sections of the rod and tube are conformable with each other although they need not be identical in shape; the conformance prevents rotation of the rod after insertion in the uterus. This is lmportant for aiding the phy~ician to c~ntrol the plane of the intrauterine device during i~ertion and placement ln the uterus. It is mo~t use~ully accomplished by having the ~lat sur~ace of the handle ~nd rod
2~ coincide with or be parallel to the plane o~ the intrauter~ne dev~ce.
ORT~-299 The tube extension 1~ provides added support for the rod~ Although ~t may be omittedg it i3 part Or the preferred embodiment and whcn employed lt~ length i8 not critlcal. It 1~ con-- venient for the tube extenæion to have a shape somewhat like an arrow pointing downward as shown in the drawings as a guide to the physician indicating the direction in which the moving force should be applied for releasing the IUD.
The coactlng rod 31 is preferably provided at the top or insertlon end with a tubular receptacle sect~on 32 (see Figures 1, 9 and 10), said tubular receptacle section being adaptable to receive the stem 51 o~ an intrauterine device. It is prov~ded at the posterior end wlth a bifurcated handle 33 with the stems 35 extending in an anterior direction and bracketing a cut out area 34 surrounding the point of attach-ment of the rod to the handle, sald stem provided with flanges 36 with inwardly pro~ecting edges 37 serving as complementary abutment means and interlocking means to the outwardly pro-. ~ecting edges 20 of the flanges 19 of inserter tube 11.
Preferably, the handle is provided with a grooved digit placement area 38 (see Figures 1 and 2) for elther the lndex finger or thumb of the physician.
Although the rod 31 may be employed without a tubular receptacle $ection 3Z at the lnsertion end, it $8 de~lrable to pro-~ide such tubular support for at least a portion of the stem and 4~ .
ORrH-299 preferably for a substantial portlon of the stem. It has been found that the terminal portlon 53 of the ~tem of the intrauterine device, which usually has a narrower area 53' (see Figure 10) which is punctured to hold the end of the wire with which the device may be Nound and which is further punctured near the very end 53" to hold the "tail"
or withdrawal string, may collapse when sub~ected to pressure ~f not supported. The tubular receptable ~ection ls preferably con-structed by providlng for a reduced section 31' of the rod to whlch a tubular receptacle section is mechanically attached.
As seen most clearly in Figure 9, the flanges 19 of the inserter tube 11 and the flanges 36 of the rod 31 are of such dimensions ao that when the inserter tube is drawn back without compression on the stems 17 of handle 15, the flanges are ln abutting relatlonship. This mechanism stopping the backward motlon of the inserter tube stops the forward motion of the intrauterine device and provides for the exact place-ment of the folded intrauterlne device in the insertion position at the forward end of the insertion tube with the contoured tip of the intrauterine device and the folded arms minimally projectlng from the insertion end and prevents accidental expulsion of the device through the end of the tube prior to its insertion in the patient.
Further, as seen in Figure 10 when stems 17 of handle 15 of the inserter tube are compressed laterally and drawn downwardly it may become cradled in the cut out area 34 and the outwardly projecting edges 20 of flanges ly and the 4 ~
0~T~-299 lnwardly pro~ecting edge~ 37 of flanges 36 are ln overlapping relationship adapted to provide for lnterlocking so that on wlthdrawal of the instrument, the tube 11 and the rod 31 may move as a unit ln an interlocked position, The distance "D"
(see Figures 9 and 10) between the forward abuttable face of flanges 36 of the rod handle and the bottom of the cut out area 34 of the handle is important. As seen in Figure 9, it should be sllghtly greater than the distance "d" between the tip of the folded lntrauter~ne device extending out of the lnserter tube and the end of the folded arm o~ the 1ntra-uterine device in the tube, The tube handle 15 and rod handle 33 preferably have flat surfaces at the proximal and remote sides which coinclde with the plane of the intrauterine device and with the planes f the flat surface of the rod 31 and of the complementary flat surface in the lumen 22 of the inserter tube, The flat ; handle surfaces are best seen in Figure 2. The rlat handles make known to the physiclan the orientatlon of the IUD and racllltates the exercise of better control.
The diglt placement area 38 ls best un~erstood when viewed ~rom the side as ~een ln Figure ~. It ls provided on the ~urface of the roa handle and thu~ in the same plane as the intrauterine dev~ce. The digit placement Qrea 38 is contoured and has a concaved rorward wall 39 against whlch the highLy se~sit~ve tip of the physlcian's thumb or finger may be presssd durlng in~ertlon, provlding better control, lncreased tactile sensitivlty~ and ~mproved safety dur~ng the very delicate pro-cedure required in the proper in~ertion of the IUD. It msy further be provtded with non-slip grooves ~or better grasp.
9 4 ~
0R~-299 Inltially the intrauterine device 50 is mounted in the insertion lnstrument lO with the arms 52 of the IUD 50 in the open or extended configuratlon and exposed as seen ln Flgure l. The mounting is carried out by inserting the IUD
50 through the apertures 14 in the inserter tube ll and positioning the IUD so that the stem 51 extends along the length of the tube (see also Figure 7), then sliding the coacting rod 31 upward or forward until the stem end of the IUD
50 is ~eated in the tubular receptacle section 32. (An enlarged view of the receptacle section 32 is seen in Figure lO.) In this inltlal posltion, the arms 52 of the "T" or the outwardly extending portion of any IUD having transverse portions ex-tending from a stem are in a static position with no ~orces which mlght cause malformatlon or distortion thereof.
Preferably the IUD is premounted, i.e., placed in the inser-tlon instrument during manufacture and the combination ster-ilized and packaged ~or shipment. The IUD may also be premounted at the site and presterilized and stored in this position, thus avoiding the need to handle the IUD at the time of use At the time of use, the phy~ician takes the presterilized insertion instrument assembly lO with the pre-loaded IUD 50 and pro~eeds ln the following manner to prepare for insertion of the IUD into the patient: The intended position or depth of insertion is determined with a uterine ~ound and the correct depth is then indicated on the insertion tube with a -18_ OR~H-299 slidable stop means 12. The uterine ~ound employed may be a standard uterine sound or a companion uterine sound similarly graduated and hereinafter described. Then the handle 33 of the rod 31 is grasped with one hand and the stems 17 of handle 15 of the inserter tube 11 are grasped wlth the other hand and the tube 11 is drawn rearwardly or downwardly toward the handle o~ th~ rod until the flanges 19 and 36 of the respective handles are in abutting relationshlp as seen ln Figure 9, As seen in Flgure 7, the downward motion of the inserter tube 11 causes the IUD 50 to be drawn upward in the tube f~rcing the arm~ 52 to fold therein. Continuatlon of thls downward motion convey~ the IUD throu~h insertlon ~ection lla of the inserter tube and to the end of the tube until no more than the rounded top of the IUD 50 and a portion o~
the folded armR 52 extend slightly beyond the end of the tube as seen ln Figure 9. When the IUD ls in the folded position, the flexible tube assumes an elliptical form as seen in Figure 6. At this point the loaded instrument may ~e curved by the physician to more closely conform to the natural curvature o~ the insertion path. The abutment of the flanges of the handles preventsinadvertent expulsion of the IUD while it is being folded in place. The insertion lnstrument with the protectively mounted IUD is then inserted in the uterus to the previously determined position~ i~e., until the 6top means 12 makes contact with the exterior of the cervical osO Then pressure ls applied to the compres-slble ~tems 17 of the bifurcated handle 15 of the inserter ORrH-299 tube 11 to remove it from the abutting position and the ln-serter tube i8 drawn backward. or downward whlle the rod 31 16 held statlonary by the handle 33 until the inserter tube handle 15 is withln the cut out area 34 of rod handle 33 as ~een in Figure 10 whereupon at the insertion end, the tube is retracted from the IUD 50 releasing the extensible arms 52 whlch flex outwardly wlthin the uterus to lts normal unfolded posltion. Thereafter, the lnsertion instrument assembly I0 is wlthdrawn from the uterus depositing the devlce whlch in it~
or~ginal conflguratlon becomes engaged wlthin the uterine walls to perform its contraceptive function. As seen in Figure 10, the oppositely facing protruding edges 20 and 37 of flanges 19 and 36 are in interlocklng relation~hip 80 that when the rod handle 33 is grasped wlth one hand ~nd drawn backward, wlthdrawal of both the tube and rod may be accomplished. The rod handle in the cut out portion optionally may be provided wlth additional grooves at the bottom of the cut out area to further interlock the protruding edge 20 but ls not considered necessary. Since the IUD is mounted initially in the same plane as the flat surface of the rod handle, the interlocking of said handle with the inserter tube handle serves to indicate the orientation of the device during and after insertion and to aid the physician in maintaining the desired alignment of the device within the uterus. Further, since the IUD i~ released by a withdrawal motion of the ~ inserter tube 11 rather than a pushing motion of the rod 31, - the forward dlrection sometimes resulting in injury to the fundus is a~olded. While the instrument is particularly -20_ 9 ~ 1 ORrH-299 adaptable for a devlce havlng the shape of a 'tT'I, it may be utlllzed for any contraceptive device havlng an el~ngated body or stem and having at least one arm or other perpen-dicularly extending bar or protrusion~which is adaptable to being folded along its stem.
The inserter tube 11 is preferably made in two separate ' !i parts of two materlals correspondlng to the two sections.
The lnsertion section lla should be of flexible mater~al and be sufflciently thln-walled to allow the shape to change from round to oval or elliptical as the tube ls loaded to house the folded lntrauterlne devlce. The lower manlpulative ~ection llb should be made of more rigid material for manipulatlve ease and to prevent the turnlng o~ the coacting rod 31 withln the tube. The coactlng rod 31 ls preferably made of malleable biologically inert plastic materlal wlth a retentlve memory. By "malleable" ls meant that the material permits external ~orces to be applied to conform the material to the desired shape but is of sufflcient ~trength to retain its structure when ~ubJected to no external force or to relatively minor external force ~uch as occurs during insertion. Thus, a physician may contour the IUD loaded in-sertlon lnstrument ln the region which will become lntrauterlne on insertlon, (l.e., the insertlon sectlon of the tube and the rod) to provide a curvature conformi~g to the curvature of the uterine cavlty. The manlpulative ~ection o~ the tube and the rod handle are also preferably made Or the same malleable material but the greater dlmenslons of these portions of the lnstrument render them ~ub~tantlally rlgid. When ~he _21-4 ~
ORT~-299 ~nsertion ~nstru~ent ie employed with the companlon uterine sound herel~after descrlbed, lt may be bent to t~e sa~e curvature lndicated by the uterlne 30und durlng the lnitial sounding by the physlclan. Sultable malleable materlals whlch may b2 employed include, ror example, polymeric materlals such as acrylonltrlle-butadlene-styrene (ABS
pla~tlc)3 or a mlxture o~ acrylonltrile-butadiene rubber and styrene-butadlene re~in,or other thermoplQstic materials with strong memory properties. The preferred flexible material is polyethylene, althoug~ polypropylene, acryllc terpolymer, etc. may be employed. Polyethylene i8 al50 the preferred material for the tubular receptacle sectlon of the rod although a more rigid material may be employed rOr thls purpose. It i8 recognized that the lnsertlon tub~
may be provided wlth an oval shape at the lnsertion end but use o~ a ~lexlble material at the insertlon end renders this unnecessary, Pre~erably, the instrum~nt is employed with a companion uterine sound 60 lllustrated in Figure ll. The sound comprises rod 61 with a rounded tip 62 and a handle 63 ~or insertion and manipulation, said rod having gradua-tions 64 imprinted thereon and further provided with a slidably movable stop means 65 for indicating the position of a cervical os. The stop means has a slot 67 to prevent occlusion of the graduatlons. The tip of the sound 62, seen in cross-section in Figure 13, is of substantially the same dimensions as the rounded tlp of the folded intrauterine d~vice. The handle 63 further has a digit placement area 66 corresponding to a s~milar digit pla~ement area 38 ln the handle o~ the rod. The graduations imprint~d on the rod lndicate 4 ~
the depth of the uterine cavity as measured from the tlp of the rod. These graduations correspond to the graduation on the inserter tube lndicating the depth of the uterine cavity as measured from the tip of the ~olded intrauterine device protruding from the insertion end of the inserter tube. The sound is made o~ the same material as the coacting rod 31 of the insert$on lnstrument so that both may be bent ln the ~ame ~y to correspona to t~e patient'~ anatomlcal variations.
In use, the sound is employed in a conventional manner by inserting into the uterine cavlty, bendlng in a dixection according to the natural curvature and slidably ad~usting the stop means. The direction of curvature of the sound i8 o~served and the lnsertlon instrument ls ~ent to conform to the observed curvature. The distance i~ read on the graduations f the sound and the stop means of the inserter tube 16 movably adJusted to the corresponding distance. The use of the companion uterine sound is advantageous in providing a more precise correspondence between the measured depth and the distance to be indicated on the instrument.
Hav~ng de~cribed the invention in specific detail and exemplified in the manner in whlch lt may be carried into practi¢e, it will be apparent to those skilled in the art that innumerable variations, appllcations, modificationæ, a~d extensions of the basic principles lnvolved may be made without departing from its spirit or scope It is to be understood that the foregoing is merely exemplary and the present invention is not to be limited to the spec~fic form or arrangements of parts herein described and shown .
ORT~-299 The tube extension 1~ provides added support for the rod~ Although ~t may be omittedg it i3 part Or the preferred embodiment and whcn employed lt~ length i8 not critlcal. It 1~ con-- venient for the tube extenæion to have a shape somewhat like an arrow pointing downward as shown in the drawings as a guide to the physician indicating the direction in which the moving force should be applied for releasing the IUD.
The coactlng rod 31 is preferably provided at the top or insertlon end with a tubular receptacle sect~on 32 (see Figures 1, 9 and 10), said tubular receptacle section being adaptable to receive the stem 51 o~ an intrauterine device. It is prov~ded at the posterior end wlth a bifurcated handle 33 with the stems 35 extending in an anterior direction and bracketing a cut out area 34 surrounding the point of attach-ment of the rod to the handle, sald stem provided with flanges 36 with inwardly pro~ecting edges 37 serving as complementary abutment means and interlocking means to the outwardly pro-. ~ecting edges 20 of the flanges 19 of inserter tube 11.
Preferably, the handle is provided with a grooved digit placement area 38 (see Figures 1 and 2) for elther the lndex finger or thumb of the physician.
Although the rod 31 may be employed without a tubular receptacle $ection 3Z at the lnsertion end, it $8 de~lrable to pro-~ide such tubular support for at least a portion of the stem and 4~ .
ORrH-299 preferably for a substantial portlon of the stem. It has been found that the terminal portlon 53 of the ~tem of the intrauterine device, which usually has a narrower area 53' (see Figure 10) which is punctured to hold the end of the wire with which the device may be Nound and which is further punctured near the very end 53" to hold the "tail"
or withdrawal string, may collapse when sub~ected to pressure ~f not supported. The tubular receptable ~ection ls preferably con-structed by providlng for a reduced section 31' of the rod to whlch a tubular receptacle section is mechanically attached.
As seen most clearly in Figure 9, the flanges 19 of the inserter tube 11 and the flanges 36 of the rod 31 are of such dimensions ao that when the inserter tube is drawn back without compression on the stems 17 of handle 15, the flanges are ln abutting relatlonship. This mechanism stopping the backward motlon of the inserter tube stops the forward motion of the intrauterine device and provides for the exact place-ment of the folded intrauterlne device in the insertion position at the forward end of the insertion tube with the contoured tip of the intrauterine device and the folded arms minimally projectlng from the insertion end and prevents accidental expulsion of the device through the end of the tube prior to its insertion in the patient.
Further, as seen in Figure 10 when stems 17 of handle 15 of the inserter tube are compressed laterally and drawn downwardly it may become cradled in the cut out area 34 and the outwardly projecting edges 20 of flanges ly and the 4 ~
0~T~-299 lnwardly pro~ecting edge~ 37 of flanges 36 are ln overlapping relationship adapted to provide for lnterlocking so that on wlthdrawal of the instrument, the tube 11 and the rod 31 may move as a unit ln an interlocked position, The distance "D"
(see Figures 9 and 10) between the forward abuttable face of flanges 36 of the rod handle and the bottom of the cut out area 34 of the handle is important. As seen in Figure 9, it should be sllghtly greater than the distance "d" between the tip of the folded lntrauter~ne device extending out of the lnserter tube and the end of the folded arm o~ the 1ntra-uterine device in the tube, The tube handle 15 and rod handle 33 preferably have flat surfaces at the proximal and remote sides which coinclde with the plane of the intrauterine device and with the planes f the flat surface of the rod 31 and of the complementary flat surface in the lumen 22 of the inserter tube, The flat ; handle surfaces are best seen in Figure 2. The rlat handles make known to the physiclan the orientatlon of the IUD and racllltates the exercise of better control.
The diglt placement area 38 ls best un~erstood when viewed ~rom the side as ~een ln Figure ~. It ls provided on the ~urface of the roa handle and thu~ in the same plane as the intrauterine dev~ce. The digit placement Qrea 38 is contoured and has a concaved rorward wall 39 against whlch the highLy se~sit~ve tip of the physlcian's thumb or finger may be presssd durlng in~ertlon, provlding better control, lncreased tactile sensitivlty~ and ~mproved safety dur~ng the very delicate pro-cedure required in the proper in~ertion of the IUD. It msy further be provtded with non-slip grooves ~or better grasp.
9 4 ~
0R~-299 Inltially the intrauterine device 50 is mounted in the insertion lnstrument lO with the arms 52 of the IUD 50 in the open or extended configuratlon and exposed as seen ln Flgure l. The mounting is carried out by inserting the IUD
50 through the apertures 14 in the inserter tube ll and positioning the IUD so that the stem 51 extends along the length of the tube (see also Figure 7), then sliding the coacting rod 31 upward or forward until the stem end of the IUD
50 is ~eated in the tubular receptacle section 32. (An enlarged view of the receptacle section 32 is seen in Figure lO.) In this inltlal posltion, the arms 52 of the "T" or the outwardly extending portion of any IUD having transverse portions ex-tending from a stem are in a static position with no ~orces which mlght cause malformatlon or distortion thereof.
Preferably the IUD is premounted, i.e., placed in the inser-tlon instrument during manufacture and the combination ster-ilized and packaged ~or shipment. The IUD may also be premounted at the site and presterilized and stored in this position, thus avoiding the need to handle the IUD at the time of use At the time of use, the phy~ician takes the presterilized insertion instrument assembly lO with the pre-loaded IUD 50 and pro~eeds ln the following manner to prepare for insertion of the IUD into the patient: The intended position or depth of insertion is determined with a uterine ~ound and the correct depth is then indicated on the insertion tube with a -18_ OR~H-299 slidable stop means 12. The uterine ~ound employed may be a standard uterine sound or a companion uterine sound similarly graduated and hereinafter described. Then the handle 33 of the rod 31 is grasped with one hand and the stems 17 of handle 15 of the inserter tube 11 are grasped wlth the other hand and the tube 11 is drawn rearwardly or downwardly toward the handle o~ th~ rod until the flanges 19 and 36 of the respective handles are in abutting relationshlp as seen ln Figure 9, As seen in Flgure 7, the downward motion of the inserter tube 11 causes the IUD 50 to be drawn upward in the tube f~rcing the arm~ 52 to fold therein. Continuatlon of thls downward motion convey~ the IUD throu~h insertlon ~ection lla of the inserter tube and to the end of the tube until no more than the rounded top of the IUD 50 and a portion o~
the folded armR 52 extend slightly beyond the end of the tube as seen ln Figure 9. When the IUD ls in the folded position, the flexible tube assumes an elliptical form as seen in Figure 6. At this point the loaded instrument may ~e curved by the physician to more closely conform to the natural curvature o~ the insertion path. The abutment of the flanges of the handles preventsinadvertent expulsion of the IUD while it is being folded in place. The insertion lnstrument with the protectively mounted IUD is then inserted in the uterus to the previously determined position~ i~e., until the 6top means 12 makes contact with the exterior of the cervical osO Then pressure ls applied to the compres-slble ~tems 17 of the bifurcated handle 15 of the inserter ORrH-299 tube 11 to remove it from the abutting position and the ln-serter tube i8 drawn backward. or downward whlle the rod 31 16 held statlonary by the handle 33 until the inserter tube handle 15 is withln the cut out area 34 of rod handle 33 as ~een in Figure 10 whereupon at the insertion end, the tube is retracted from the IUD 50 releasing the extensible arms 52 whlch flex outwardly wlthin the uterus to lts normal unfolded posltion. Thereafter, the lnsertion instrument assembly I0 is wlthdrawn from the uterus depositing the devlce whlch in it~
or~ginal conflguratlon becomes engaged wlthin the uterine walls to perform its contraceptive function. As seen in Figure 10, the oppositely facing protruding edges 20 and 37 of flanges 19 and 36 are in interlocklng relation~hip 80 that when the rod handle 33 is grasped wlth one hand ~nd drawn backward, wlthdrawal of both the tube and rod may be accomplished. The rod handle in the cut out portion optionally may be provided wlth additional grooves at the bottom of the cut out area to further interlock the protruding edge 20 but ls not considered necessary. Since the IUD is mounted initially in the same plane as the flat surface of the rod handle, the interlocking of said handle with the inserter tube handle serves to indicate the orientation of the device during and after insertion and to aid the physician in maintaining the desired alignment of the device within the uterus. Further, since the IUD i~ released by a withdrawal motion of the ~ inserter tube 11 rather than a pushing motion of the rod 31, - the forward dlrection sometimes resulting in injury to the fundus is a~olded. While the instrument is particularly -20_ 9 ~ 1 ORrH-299 adaptable for a devlce havlng the shape of a 'tT'I, it may be utlllzed for any contraceptive device havlng an el~ngated body or stem and having at least one arm or other perpen-dicularly extending bar or protrusion~which is adaptable to being folded along its stem.
The inserter tube 11 is preferably made in two separate ' !i parts of two materlals correspondlng to the two sections.
The lnsertion section lla should be of flexible mater~al and be sufflciently thln-walled to allow the shape to change from round to oval or elliptical as the tube ls loaded to house the folded lntrauterlne devlce. The lower manlpulative ~ection llb should be made of more rigid material for manipulatlve ease and to prevent the turnlng o~ the coacting rod 31 withln the tube. The coactlng rod 31 ls preferably made of malleable biologically inert plastic materlal wlth a retentlve memory. By "malleable" ls meant that the material permits external ~orces to be applied to conform the material to the desired shape but is of sufflcient ~trength to retain its structure when ~ubJected to no external force or to relatively minor external force ~uch as occurs during insertion. Thus, a physician may contour the IUD loaded in-sertlon lnstrument ln the region which will become lntrauterlne on insertlon, (l.e., the insertlon sectlon of the tube and the rod) to provide a curvature conformi~g to the curvature of the uterine cavlty. The manlpulative ~ection o~ the tube and the rod handle are also preferably made Or the same malleable material but the greater dlmenslons of these portions of the lnstrument render them ~ub~tantlally rlgid. When ~he _21-4 ~
ORT~-299 ~nsertion ~nstru~ent ie employed with the companlon uterine sound herel~after descrlbed, lt may be bent to t~e sa~e curvature lndicated by the uterlne 30und durlng the lnitial sounding by the physlclan. Sultable malleable materlals whlch may b2 employed include, ror example, polymeric materlals such as acrylonltrlle-butadlene-styrene (ABS
pla~tlc)3 or a mlxture o~ acrylonltrile-butadiene rubber and styrene-butadlene re~in,or other thermoplQstic materials with strong memory properties. The preferred flexible material is polyethylene, althoug~ polypropylene, acryllc terpolymer, etc. may be employed. Polyethylene i8 al50 the preferred material for the tubular receptacle sectlon of the rod although a more rigid material may be employed rOr thls purpose. It i8 recognized that the lnsertlon tub~
may be provided wlth an oval shape at the lnsertion end but use o~ a ~lexlble material at the insertlon end renders this unnecessary, Pre~erably, the instrum~nt is employed with a companion uterine sound 60 lllustrated in Figure ll. The sound comprises rod 61 with a rounded tip 62 and a handle 63 ~or insertion and manipulation, said rod having gradua-tions 64 imprinted thereon and further provided with a slidably movable stop means 65 for indicating the position of a cervical os. The stop means has a slot 67 to prevent occlusion of the graduatlons. The tip of the sound 62, seen in cross-section in Figure 13, is of substantially the same dimensions as the rounded tlp of the folded intrauterine d~vice. The handle 63 further has a digit placement area 66 corresponding to a s~milar digit pla~ement area 38 ln the handle o~ the rod. The graduations imprint~d on the rod lndicate 4 ~
the depth of the uterine cavity as measured from the tlp of the rod. These graduations correspond to the graduation on the inserter tube lndicating the depth of the uterine cavity as measured from the tip of the ~olded intrauterine device protruding from the insertion end of the inserter tube. The sound is made o~ the same material as the coacting rod 31 of the insert$on lnstrument so that both may be bent ln the ~ame ~y to correspona to t~e patient'~ anatomlcal variations.
In use, the sound is employed in a conventional manner by inserting into the uterine cavlty, bendlng in a dixection according to the natural curvature and slidably ad~usting the stop means. The direction of curvature of the sound i8 o~served and the lnsertlon instrument ls ~ent to conform to the observed curvature. The distance i~ read on the graduations f the sound and the stop means of the inserter tube 16 movably adJusted to the corresponding distance. The use of the companion uterine sound is advantageous in providing a more precise correspondence between the measured depth and the distance to be indicated on the instrument.
Hav~ng de~cribed the invention in specific detail and exemplified in the manner in whlch lt may be carried into practi¢e, it will be apparent to those skilled in the art that innumerable variations, appllcations, modificationæ, a~d extensions of the basic principles lnvolved may be made without departing from its spirit or scope It is to be understood that the foregoing is merely exemplary and the present invention is not to be limited to the spec~fic form or arrangements of parts herein described and shown .
Claims (12)
1. An insertion instrument for inserting into the uterus an intrauterine device having a stem and at least one substantially horizontally extending flexible arm comprising (a) an inserter tube adapted to protectively house said intrauterine device with the arm or arms folded adjacent to the stem in an axially aligned position, said tube having an insertion section of a flexible nature and an manipulative section of a non-flexible nature, said tube having (1) an externally mounted slidable stop means for engaging the cervical os, said stop means being located on the insertion section of the tube, said stop means susceptible of adjustment to a pre-determined position for insertion (ii) a pair of diametrically opposed axially extending apertures located on the manipulative section of the tube posteriorly of the stop means, said apertures adapted to receive the intrauterine device so that the stem extends axially within the tube and the arm or arms extend through said apertures; and (iii) a handle at the posterior end of the tube, said handle being an integral part of the manipulative section and having a passageway therethrough,said passageway in communication with the lumen of the tube and further being bifurcated with the stems and terminating in a flange with a projecting edge; and (b) a coacting rod of malleable material with a retentive memory in telescopic relationship to the inserter tube and slidable therein, said rod having (i) a tubular receptacle section at the in-sertion end adapted to support the stem of the intra-uterine device and (ii) a handle at the posterior end, said handle being bifurcated with stems extending in an anterior or forward direction and having flanges with edges projecting oppositely to that in the handle of the inserter tube, said flanges further being spatially opposed and abuttable with the flanges of the inserter tube handle;
wherein the lumen in the manipulative section of the tube and the coacting rod have a non-circular cross-sectional con-figuration;
wherein the stems of one of the bifurcated handles is compressible and when compressed is adapted to be received in the area between the stems of the other handle; and wherein said tube and said rod are adaptable to coacting in a manner so that (i) pulling rearwardly on the inserter tube handle until the flanges of the stems of the inserter tube and rod handles are abutting causes a folding of the arms of the intrauterine device and moves it to the inser-tion position with the contoured tip and the folded arms minimally projecting from the insertion end of the tube, (ii) compressing the compressible stem of one of the handles and drawing it within the area between the stems of the other handle releases the intrauterine device at the insertion end, and (iii) releasing the compression pressure on the stem causes the inwardly and outwardly projecting edges of the handle susceptible to interlocking for a unitary withdrawal of the tube and rod from the uterus.
wherein the lumen in the manipulative section of the tube and the coacting rod have a non-circular cross-sectional con-figuration;
wherein the stems of one of the bifurcated handles is compressible and when compressed is adapted to be received in the area between the stems of the other handle; and wherein said tube and said rod are adaptable to coacting in a manner so that (i) pulling rearwardly on the inserter tube handle until the flanges of the stems of the inserter tube and rod handles are abutting causes a folding of the arms of the intrauterine device and moves it to the inser-tion position with the contoured tip and the folded arms minimally projecting from the insertion end of the tube, (ii) compressing the compressible stem of one of the handles and drawing it within the area between the stems of the other handle releases the intrauterine device at the insertion end, and (iii) releasing the compression pressure on the stem causes the inwardly and outwardly projecting edges of the handle susceptible to interlocking for a unitary withdrawal of the tube and rod from the uterus.
2. An instrument according to Claim 1 wherein the compressible stems are those of the inserter tube handle and wherein the projecting edges for the flanges extend in an outward direction in the inserter tube handle and in an inward direction in the rod handle.
3. An instrument as in Claim 2 wherein the handle of rod is provided with a digit placement area.
4. An instrument as in Claim 1 wherein the inserter tube is provided with graduations.
5. An instrument as in Claim 1 wherein the manipulative section of the inserter tube and the coacting rod are made of acrylic-butadiene-styrene plastic and the insertion section of the inserter tube and the tubular receptacle section of the rod are made of polyethylene.
6. A combination intrauterine device and instrument for inserting the same into the uterus comprising (1) a flexible intrauterine device, said device having two transverse arms distally extending from a stem;
(2) an insertion instrument comprising (a) an inserter tube adapted to protectively house said intrauterine device with the arms folded adjacent to the stem in an axially aligned position, said tube having an insertion section of a flexible nature and a manipulative section of a non-flexible nature, said tube having (i) an externally mounted slidable stop means for engaging the cervical os, said stop means being located on the insertion section of the tube, said stop means susceptible of adjustment to a pre-determined position for insertion, (ii) a pair of diametrically opposed axially extending apertures located on the manipulative section of the tube posteriorly of the stop means, said apertures adapted to receive the intrauterine device so that the stem extends axially within the tube and the arms extend through said apertures; and (iii) a handle at the posterior end of the tube, said handle being an integral part of the manipulative section and having a passageway therethrough, said passageway in communication with the lumen Or the tube and further being bifurcated with the stems extendlng in a posterior direction and terminating in a flange with an outwardly projecting edge; and (b) a coacting rod of malleable material of retentive memory in telescopic relationship to the inserter tube and slidable therein, said rod having (1) a tubular receptacle section at the insertion end and adapted to support the stem of the intrauterine device and (ii) a handle at the posterior end, said handle being bifurcated with stems extending in an anterior or forward direction and having flanges with inwardly projecting edges, said flanges being spatially opposed and abuttable with the flanges of the inserter tube handle, and said stems further bracketing a cut out area, said cut out area being adapted to receive the compressed stems of the inserter tube handle and being at least as deep as the distance occupied by the arm of the intrauterine device within the tube when in the insertion position;
wherein the lumen in the manipulative section of the tube and the coacting rod have a non-circular cross-sectional con-figuration;
and wherein said tube and said rod are adaptable to coacting in a manner that (i) pulling rearwardly on the inserter tube handle until the flanges of the stems of the inserter tube and rod handles are abutting causes a folding of the arms of the intrauterine device and moves it to the insertion position with the contoured tip and the folded arms minimally projecting from the insertion end of the tube, (ii) compressing the stem of the inserter tube handle and further pulling rearwardly until the stem reaches the bottom of the cut out portion of the rod handle releases the intrauterine device at the insertion end and (iii) re-leasing the compression pressure causes the outwardly pro-jecting edge of the inserter tube handle and the inwardly projecting edge of the rod handle susceptible to interlocking for unitary withdrawal of the tube and rod from the uterus.
(2) an insertion instrument comprising (a) an inserter tube adapted to protectively house said intrauterine device with the arms folded adjacent to the stem in an axially aligned position, said tube having an insertion section of a flexible nature and a manipulative section of a non-flexible nature, said tube having (i) an externally mounted slidable stop means for engaging the cervical os, said stop means being located on the insertion section of the tube, said stop means susceptible of adjustment to a pre-determined position for insertion, (ii) a pair of diametrically opposed axially extending apertures located on the manipulative section of the tube posteriorly of the stop means, said apertures adapted to receive the intrauterine device so that the stem extends axially within the tube and the arms extend through said apertures; and (iii) a handle at the posterior end of the tube, said handle being an integral part of the manipulative section and having a passageway therethrough, said passageway in communication with the lumen Or the tube and further being bifurcated with the stems extendlng in a posterior direction and terminating in a flange with an outwardly projecting edge; and (b) a coacting rod of malleable material of retentive memory in telescopic relationship to the inserter tube and slidable therein, said rod having (1) a tubular receptacle section at the insertion end and adapted to support the stem of the intrauterine device and (ii) a handle at the posterior end, said handle being bifurcated with stems extending in an anterior or forward direction and having flanges with inwardly projecting edges, said flanges being spatially opposed and abuttable with the flanges of the inserter tube handle, and said stems further bracketing a cut out area, said cut out area being adapted to receive the compressed stems of the inserter tube handle and being at least as deep as the distance occupied by the arm of the intrauterine device within the tube when in the insertion position;
wherein the lumen in the manipulative section of the tube and the coacting rod have a non-circular cross-sectional con-figuration;
and wherein said tube and said rod are adaptable to coacting in a manner that (i) pulling rearwardly on the inserter tube handle until the flanges of the stems of the inserter tube and rod handles are abutting causes a folding of the arms of the intrauterine device and moves it to the insertion position with the contoured tip and the folded arms minimally projecting from the insertion end of the tube, (ii) compressing the stem of the inserter tube handle and further pulling rearwardly until the stem reaches the bottom of the cut out portion of the rod handle releases the intrauterine device at the insertion end and (iii) re-leasing the compression pressure causes the outwardly pro-jecting edge of the inserter tube handle and the inwardly projecting edge of the rod handle susceptible to interlocking for unitary withdrawal of the tube and rod from the uterus.
7. A combination as in Claim 6 wherein the handle of the rod is provided with a digit placement area.
8. A combination as in Claim 6 wherein the inserter tube is graduated.
9. A combination as in Claim 6 wherein the manipulative section of the inserter tube and the coacting rod are made of acrylic-butadiene-styrene plastic and the insertion section of the inserter tube and the tubular section of the rod are made of polyethylene.
10. A method of inserting into the uterus an intrauterine device having a stem and at least one substantially horizontal arm extending from the stem which comprises (1) providing a combination intrauterine device and insertion instrument of Claim 6, (2) adjusting the stop means on the inserter tube to the desired insertion position (3) drawing backward on the inserter tube handle until the flanges of the stems of the inserter tube handle are in abutting contact with the flanges of the stems of the coacting rod handle whereupon the arms of the device are drawn backward into a folded position and the device is urged to the insertion position at the insertion end of the tube;
(4) inserting the instrument bearing the pro-tectively mounted intrauterine device into the uterus until the stop means makes contact with the cervical os;
(5) compressing the stems of the handle of the inserter tube and drawing backward until the bottom of the cut out portion of the rod handle is reached thereby withdrawing the portion of the tube protectively housing the intrauterine device and freeing device from said tube; and (6) releasing the pressure on the stems of the inserter tube handle to place the projecting edges of the stem flanges of the handles of the inserter tube and the rod in interlocking relationship;
(7) withdrawing the instrument from the uterus.
(4) inserting the instrument bearing the pro-tectively mounted intrauterine device into the uterus until the stop means makes contact with the cervical os;
(5) compressing the stems of the handle of the inserter tube and drawing backward until the bottom of the cut out portion of the rod handle is reached thereby withdrawing the portion of the tube protectively housing the intrauterine device and freeing device from said tube; and (6) releasing the pressure on the stems of the inserter tube handle to place the projecting edges of the stem flanges of the handles of the inserter tube and the rod in interlocking relationship;
(7) withdrawing the instrument from the uterus.
11. A combination package to be employed for contraception consisting of (a) a combination intrauterine device and in-insertion instrument of Claim 6, and (b) a uterine sound consisting essentially of a rod of malleable material with retentive memory and having a handle at the posterior end wherein said rod is provided with graduations and an ex-ternally mounted slidable stop means suitable for indicating the position of the cervical os;
wherein the distance indicated by the graduations on the uterine sound correspond directly with the distance readable on the graduationæ on the inserter tube and the shape of the sound handle correspond with the shape of the coacting rod handle of the insertion instrument.
wherein the distance indicated by the graduations on the uterine sound correspond directly with the distance readable on the graduationæ on the inserter tube and the shape of the sound handle correspond with the shape of the coacting rod handle of the insertion instrument.
12. An instrument for inserting into a uterus an intrauterine device including a stem and a flexible substantially transversely extending arm comprising:
an inserter tube with an axial bore therethrough and having an insertion end and a posterior end, said tube including an aperture communicating with said bore located intermediate said ends, said aperture adapted to allow receipt of the device therethrough into said bore with the arm of said device extending through said aperture; a rod slidably positioned in said bore and having a forward end adapted to receive the stem of said device and having a rearward end extending out of the posterior end of said tube, said rod adapted to slide in said bore to thereby fold said extending arm into said bore and move said device with the folded arm toward said insertion end; disengageable stop means associated with the posterior end of said tube and the rearward end of said rod adapted to stop the movement of said folded device at a pre-insertion position at said insertion end and for preventing inadvertent expulsion of said device from said tube, said stop means being disengageable by the operator of said instrument to allow said rod to slide in the direction of said insertion end to release said device from said tube and allow said folded arm to flex outwardly;
and control means associated with said tube and said rod adapted to allow said rod to slide a controlled distance in the direction of said insertion end after said stop means has become disengaged so that said device is released in a controlled position in the uterus.
an inserter tube with an axial bore therethrough and having an insertion end and a posterior end, said tube including an aperture communicating with said bore located intermediate said ends, said aperture adapted to allow receipt of the device therethrough into said bore with the arm of said device extending through said aperture; a rod slidably positioned in said bore and having a forward end adapted to receive the stem of said device and having a rearward end extending out of the posterior end of said tube, said rod adapted to slide in said bore to thereby fold said extending arm into said bore and move said device with the folded arm toward said insertion end; disengageable stop means associated with the posterior end of said tube and the rearward end of said rod adapted to stop the movement of said folded device at a pre-insertion position at said insertion end and for preventing inadvertent expulsion of said device from said tube, said stop means being disengageable by the operator of said instrument to allow said rod to slide in the direction of said insertion end to release said device from said tube and allow said folded arm to flex outwardly;
and control means associated with said tube and said rod adapted to allow said rod to slide a controlled distance in the direction of said insertion end after said stop means has become disengaged so that said device is released in a controlled position in the uterus.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US78159277A | 1977-03-28 | 1977-03-28 | |
| US781,592 | 1977-03-28 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1110941A true CA1110941A (en) | 1981-10-20 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA298,261A Expired CA1110941A (en) | 1977-03-28 | 1978-03-06 | Instrument and method for inserting an intrauterine contraceptive device |
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| JP (1) | JPS53120882A (en) |
| AR (1) | AR217103A1 (en) |
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| BE (1) | BE865399A (en) |
| BR (1) | BR7801831A (en) |
| CA (1) | CA1110941A (en) |
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| PT (1) | PT67834B (en) |
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Families Citing this family (88)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4249525A (en) * | 1979-10-15 | 1981-02-10 | G. D. Searle & Co. | Instrument for loading an intrauterine device into an insertion tube |
| FR2511864A1 (en) * | 1981-08-31 | 1983-03-04 | Cilag Chemie Lab Sarl | Inserter for intra=uterine device - has hollow guide body with flexible cannula mounted at one end and elongate ejector sliding within it |
| EP0049660A1 (en) * | 1980-10-03 | 1982-04-14 | Laboratoires Cilag-Chimie S.A.R.L. | Instrument for inserting an intra-uterine device, and assembly thereof |
| US4549652A (en) * | 1983-06-29 | 1985-10-29 | Piact | IUD Package |
| IN161985B (en) * | 1984-03-29 | 1988-03-12 | Wildemeersch Dirk | |
| IE57545B1 (en) * | 1984-12-21 | 1992-10-21 | Akzo Nv | Assembly of intra-uterine contraceptive device and inserter |
| US4949732A (en) * | 1989-08-24 | 1990-08-21 | Gyno Pharma Inc. | Apparatus for insertion and fixation of an intra uterine contraceptive device to the uterine fundus |
| DE9201809U1 (en) * | 1992-02-13 | 1992-10-01 | Augustin, Rainer, 7801 Bremgarten, De | |
| US5370129A (en) * | 1992-08-28 | 1994-12-06 | Db Inserters, Inc. | IUD inserting apparatus |
| DE4241662A1 (en) * | 1992-12-04 | 1994-06-30 | Schering Ag | Combination of a contraceptive device for the uterus and a corresponding introducer |
| DE4318941C2 (en) * | 1993-05-27 | 1995-04-27 | Schering Ag | Combination of an intra-uterine contraceptive device and an introducer |
| FI97946C (en) * | 1994-12-15 | 1997-03-25 | Leiras Oy | An applicator for inserting an intrauterine device |
| US6705323B1 (en) | 1995-06-07 | 2004-03-16 | Conceptus, Inc. | Contraceptive transcervical fallopian tube occlusion devices and methods |
| US6176240B1 (en) * | 1995-06-07 | 2001-01-23 | Conceptus, Inc. | Contraceptive transcervical fallopian tube occlusion devices and their delivery |
| US5842474A (en) * | 1996-07-12 | 1998-12-01 | Fei Products, Inc. | IUD loading device |
| US6709667B1 (en) | 1999-08-23 | 2004-03-23 | Conceptus, Inc. | Deployment actuation system for intrafallopian contraception |
| FR2806296B1 (en) | 2000-03-16 | 2003-01-24 | Jean Pierre Solinhac | INSERTION DEVICE FOR PLACING A T-SHAPED INTRA-UTERINE DEVICE |
| FI119719B (en) * | 2003-11-19 | 2009-02-27 | Bayer Schering Pharma Oy | pusher |
| US7608092B1 (en) | 2004-02-20 | 2009-10-27 | Biomet Sports Medicince, LLC | Method and apparatus for performing meniscus repair |
| US7749250B2 (en) | 2006-02-03 | 2010-07-06 | Biomet Sports Medicine, Llc | Soft tissue repair assembly and associated method |
| US7905904B2 (en) | 2006-02-03 | 2011-03-15 | Biomet Sports Medicine, Llc | Soft tissue repair device and associated methods |
| US9801708B2 (en) | 2004-11-05 | 2017-10-31 | Biomet Sports Medicine, Llc | Method and apparatus for coupling soft tissue to a bone |
| US7909851B2 (en) | 2006-02-03 | 2011-03-22 | Biomet Sports Medicine, Llc | Soft tissue repair device and associated methods |
| US8118836B2 (en) | 2004-11-05 | 2012-02-21 | Biomet Sports Medicine, Llc | Method and apparatus for coupling soft tissue to a bone |
| US8303604B2 (en) | 2004-11-05 | 2012-11-06 | Biomet Sports Medicine, Llc | Soft tissue repair device and method |
| US8840645B2 (en) | 2004-11-05 | 2014-09-23 | Biomet Sports Medicine, Llc | Method and apparatus for coupling soft tissue to a bone |
| US8137382B2 (en) | 2004-11-05 | 2012-03-20 | Biomet Sports Medicine, Llc | Method and apparatus for coupling anatomical features |
| US7905903B2 (en) | 2006-02-03 | 2011-03-15 | Biomet Sports Medicine, Llc | Method for tissue fixation |
| US20060189993A1 (en) | 2004-11-09 | 2006-08-24 | Arthrotek, Inc. | Soft tissue conduit device |
| US8298262B2 (en) | 2006-02-03 | 2012-10-30 | Biomet Sports Medicine, Llc | Method for tissue fixation |
| US8088130B2 (en) | 2006-02-03 | 2012-01-03 | Biomet Sports Medicine, Llc | Method and apparatus for coupling soft tissue to a bone |
| US7658751B2 (en) | 2006-09-29 | 2010-02-09 | Biomet Sports Medicine, Llc | Method for implanting soft tissue |
| US9017381B2 (en) | 2007-04-10 | 2015-04-28 | Biomet Sports Medicine, Llc | Adjustable knotless loops |
| US7857830B2 (en) | 2006-02-03 | 2010-12-28 | Biomet Sports Medicine, Llc | Soft tissue repair and conduit device |
| US8128658B2 (en) | 2004-11-05 | 2012-03-06 | Biomet Sports Medicine, Llc | Method and apparatus for coupling soft tissue to bone |
| US8361113B2 (en) | 2006-02-03 | 2013-01-29 | Biomet Sports Medicine, Llc | Method and apparatus for coupling soft tissue to a bone |
| US8998949B2 (en) | 2004-11-09 | 2015-04-07 | Biomet Sports Medicine, Llc | Soft tissue conduit device |
| US7862552B2 (en) * | 2005-05-09 | 2011-01-04 | Boston Scientific Scimed, Inc. | Medical devices for treating urological and uterine conditions |
| US8562645B2 (en) | 2006-09-29 | 2013-10-22 | Biomet Sports Medicine, Llc | Method and apparatus for forming a self-locking adjustable loop |
| US8562647B2 (en) | 2006-09-29 | 2013-10-22 | Biomet Sports Medicine, Llc | Method and apparatus for securing soft tissue to bone |
| US8801783B2 (en) | 2006-09-29 | 2014-08-12 | Biomet Sports Medicine, Llc | Prosthetic ligament system for knee joint |
| US8574235B2 (en) | 2006-02-03 | 2013-11-05 | Biomet Sports Medicine, Llc | Method for trochanteric reattachment |
| US8652171B2 (en) | 2006-02-03 | 2014-02-18 | Biomet Sports Medicine, Llc | Method and apparatus for soft tissue fixation |
| US9078644B2 (en) | 2006-09-29 | 2015-07-14 | Biomet Sports Medicine, Llc | Fracture fixation device |
| US8506597B2 (en) | 2011-10-25 | 2013-08-13 | Biomet Sports Medicine, Llc | Method and apparatus for interosseous membrane reconstruction |
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| US8597327B2 (en) | 2006-02-03 | 2013-12-03 | Biomet Manufacturing, Llc | Method and apparatus for sternal closure |
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| US9538998B2 (en) | 2006-02-03 | 2017-01-10 | Biomet Sports Medicine, Llc | Method and apparatus for fracture fixation |
| US9149267B2 (en) | 2006-02-03 | 2015-10-06 | Biomet Sports Medicine, Llc | Method and apparatus for coupling soft tissue to a bone |
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| US8500818B2 (en) | 2006-09-29 | 2013-08-06 | Biomet Manufacturing, Llc | Knee prosthesis assembly with ligament link |
| US11259794B2 (en) | 2006-09-29 | 2022-03-01 | Biomet Sports Medicine, Llc | Method for implanting soft tissue |
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| US20100312051A1 (en) * | 2008-02-14 | 2010-12-09 | Brown Robert C | Method for treating stress urinary incontinence and symptomatic pelvic relaxation |
| US7935098B2 (en) * | 2008-03-31 | 2011-05-03 | Mcneil-Ppc, Inc. | Applicator for intravaginal devices |
| US8221374B2 (en) * | 2008-03-31 | 2012-07-17 | Mcneil-Ppc, Inc. | Urinary incontinence device applicator |
| US9398984B2 (en) * | 2008-03-31 | 2016-07-26 | First Quality Hygienie, Inc. | Adjustable applicator for urinary incontinence devices |
| FI20080524A0 (en) * | 2008-09-17 | 2008-09-17 | Bayer Schering Pharma Oy | An inserter |
| DK2349143T4 (en) | 2008-09-17 | 2016-11-28 | Bayer Oy | introducer |
| FI20080523A0 (en) * | 2008-09-17 | 2008-09-17 | Bayer Schering Pharma Oy | An inserter |
| US8343227B2 (en) | 2009-05-28 | 2013-01-01 | Biomet Manufacturing Corp. | Knee prosthesis assembly with ligament link |
| EP2629721B1 (en) | 2010-10-18 | 2019-03-20 | Bioceptive, Inc. | Apparatus for inserting a device or pharmaceutical into a body cavity |
| MX342006B (en) * | 2010-10-29 | 2016-09-09 | Odyssea Pharma S A | Intra-uterine insertion device. |
| US9265651B2 (en) * | 2011-09-19 | 2016-02-23 | Pregna International Limited | Loading, inserting and releasing tool for an intrauterine device |
| US9357991B2 (en) | 2011-11-03 | 2016-06-07 | Biomet Sports Medicine, Llc | Method and apparatus for stitching tendons |
| US9381013B2 (en) | 2011-11-10 | 2016-07-05 | Biomet Sports Medicine, Llc | Method for coupling soft tissue to a bone |
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| US9259217B2 (en) | 2012-01-03 | 2016-02-16 | Biomet Manufacturing, Llc | Suture Button |
| US9757119B2 (en) | 2013-03-08 | 2017-09-12 | Biomet Sports Medicine, Llc | Visual aid for identifying suture limbs arthroscopically |
| US9918827B2 (en) | 2013-03-14 | 2018-03-20 | Biomet Sports Medicine, Llc | Scaffold for spring ligament repair |
| US10136886B2 (en) | 2013-12-20 | 2018-11-27 | Biomet Sports Medicine, Llc | Knotless soft tissue devices and techniques |
| US9615822B2 (en) | 2014-05-30 | 2017-04-11 | Biomet Sports Medicine, Llc | Insertion tools and method for soft anchor |
| US9700291B2 (en) | 2014-06-03 | 2017-07-11 | Biomet Sports Medicine, Llc | Capsule retractor |
| US10039543B2 (en) | 2014-08-22 | 2018-08-07 | Biomet Sports Medicine, Llc | Non-sliding soft anchor |
| US9955980B2 (en) | 2015-02-24 | 2018-05-01 | Biomet Sports Medicine, Llc | Anatomic soft tissue repair |
| US9974534B2 (en) | 2015-03-31 | 2018-05-22 | Biomet Sports Medicine, Llc | Suture anchor with soft anchor of electrospun fibers |
| US11571329B2 (en) | 2019-11-21 | 2023-02-07 | Coopersurgical, Inc. | Packaging systems for implantable devices and related methods |
| US20220087856A1 (en) | 2020-09-23 | 2022-03-24 | Pregna International Limited | Instrument to prepare and safely place an intra-uterine device |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3374788A (en) * | 1965-06-04 | 1968-03-26 | Deseret Pharmaceutical Company | Contraceptive devices and methods |
| US3477430A (en) * | 1966-05-13 | 1969-11-11 | American Caduceus Ind Inc | Intrauterine device,inserting mechanism therefor and method of inserting same |
| US3467088A (en) * | 1966-12-22 | 1969-09-16 | Ralph R Robinson | Intrauterine device inserter |
| CH477873A (en) * | 1967-07-14 | 1969-09-15 | Apamed Anst | Intrauterine contraceptive device |
| US3515132A (en) * | 1967-12-26 | 1970-06-02 | Mcknight Charles A | Intrauterine contraceptive device |
| US3533406A (en) * | 1968-09-18 | 1970-10-13 | Population Council Inc | Intrauterine contraceptive device |
| US3635215A (en) * | 1969-08-14 | 1972-01-18 | Gam Rad | Medical removal hook |
| US3630190A (en) * | 1970-03-13 | 1971-12-28 | Schmid Inc Julius | Intrauterine probe |
| BE791734A (en) * | 1971-10-07 | 1973-03-16 | Robins Co Inc A H | UNIVERSAL DEVICE FOR INSERTION OF INTRA-UTERINE DEVICES |
-
1978
- 1978-02-23 NL NL7802043A patent/NL7802043A/en not_active Application Discontinuation
- 1978-03-03 ES ES467554A patent/ES467554A1/en not_active Expired
- 1978-03-06 CA CA298,261A patent/CA1110941A/en not_active Expired
- 1978-03-20 EG EG190/78A patent/EG13183A/en active
- 1978-03-21 SE SE7803242A patent/SE7803242L/en unknown
- 1978-03-22 AU AU34411/78A patent/AU3441178A/en active Pending
- 1978-03-22 NO NO781038A patent/NO781038L/en unknown
- 1978-03-22 DE DE19782812587 patent/DE2812587A1/en not_active Withdrawn
- 1978-03-23 FI FI780916A patent/FI780916A/en not_active Application Discontinuation
- 1978-03-23 MT MT826A patent/MTP826B/en unknown
- 1978-03-24 IT IT48606/78A patent/IT1103467B/en active
- 1978-03-27 AR AR271547A patent/AR217103A1/en active
- 1978-03-27 JP JP3427278A patent/JPS53120882A/en active Pending
- 1978-03-27 IL IL54361A patent/IL54361A0/en unknown
- 1978-03-27 BR BR7801831A patent/BR7801831A/en unknown
- 1978-03-28 DK DK135778A patent/DK135778A/en not_active Application Discontinuation
- 1978-03-28 PT PT67834A patent/PT67834B/en unknown
- 1978-03-28 GB GB12102/78A patent/GB1599945A/en not_active Expired
- 1978-03-28 ZA ZA00781737A patent/ZA781737B/en unknown
- 1978-03-28 GR GR55811A patent/GR65002B/en unknown
- 1978-03-28 BE BE186344A patent/BE865399A/en unknown
- 1978-03-28 FR FR7808972A patent/FR2385410A1/en active Pending
- 1978-03-28 MW MW9/78A patent/MW978A1/en unknown
- 1978-04-07 US US05/894,312 patent/US4143656A/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| SE7803242L (en) | 1978-09-29 |
| DK135778A (en) | 1978-09-29 |
| NL7802043A (en) | 1978-10-02 |
| NO781038L (en) | 1978-09-29 |
| FI780916A (en) | 1978-09-29 |
| ZA781737B (en) | 1979-11-28 |
| PT67834A (en) | 1978-04-01 |
| FR2385410A1 (en) | 1978-10-27 |
| JPS53120882A (en) | 1978-10-21 |
| IT7848606A0 (en) | 1978-03-24 |
| PT67834B (en) | 1980-10-02 |
| AU3441178A (en) | 1979-09-27 |
| US4143656A (en) | 1979-03-13 |
| BR7801831A (en) | 1978-12-19 |
| IL54361A0 (en) | 1978-06-15 |
| EG13183A (en) | 1980-12-31 |
| GB1599945A (en) | 1981-10-07 |
| MW978A1 (en) | 1980-02-13 |
| IT1103467B (en) | 1985-10-14 |
| AR217103A1 (en) | 1980-02-29 |
| GR65002B (en) | 1980-06-12 |
| BE865399A (en) | 1978-09-28 |
| ES467554A1 (en) | 1979-08-01 |
| MTP826B (en) | 1979-11-14 |
| DE2812587A1 (en) | 1978-10-05 |
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| MKEX | Expiry |