Description:Form 2
The Patent Act 1970
(39 of 1970)
&
The Patent Rules 2003

Complete Specification
(See section 10 and rule 13)

Title of the Invention:

STRING MANAGEMENT OF AN INSTRUMENT TO PREPARE AND SAFELY PLACE AN
INTRA-UTERINE DEVICE

Applicant: PREGNA INTERNATIONAL LIMITED
Nationality: Indian
Address: 13, Suryoday Estate, 136 Tardeo Road,
Mumbai–400034, Maharashtra, INDIA

The following specification particularly describes the invention and the manner in which it is to be performed.

The present invention comprises an improvement in, and a modification of, the invention claimed in the specification of the India application No. 202021041234.

FIELD OF THE INVENTION
The present invention relates to an intra-uterine device, particularly to an instrument which is to load and insert the intra-uterine device and the process of loading, inserting and safely placing the intra-uterine device in the uterus of a woman, hygienically.

BACKGROUND OF THE INVENTION
There are several female contraceptives available. An intra-uterine device (herein after abbreviated as IUD) is a long-term or medium-term contraceptive which is placed in the uterus of female. Most commonly available IUDs are in the shape of the English letter “T” since this shape is found appropriate to the shape of uterus.

While the IUDs are required to be in the shape of “T”, they cannot be inserted in this form as the opening of the cervix is small. For this reason, all IUDs use an insertion instrument for insertion and proper location of the IUD. Arms forming “T” of IUD are folded either upwards or downwards so that IUD can be contained in the opening of a narrow tube/inserter which then can be inserted in the uterus. This process of folding the IUD so that the instrument/inserter is ready to insert is known as loading or preparing the IUD.
Loading or preparing of IUD needs to be done minutes before it is required to be inserted in uterus, and if done earlier, or if supplied duly loaded, then the IUD shall not return to the desired “T” shape in uterus and shall not work effectively. Due to this requirement, the process of loading has to be performed by service providers just prior to inserting and placing IUD in uterus.

Up-folding IUDs and down-folding IUD have a significant difference in their preparation and placement procedure. Up-folding IUDs implies that arms forming “T” are together while stem of IUD is below folded arms.

There is a significant difference in process of inserting and placing an up-folding IUD and a down-folding IUD in uterus. While placing an up-folding IUD, the arms of the “T” start unfolding downwards as soon as IUD is made to gradually eject out of the instrument. Person placing such upfolding IUD takes a pause to allow the upfolding arms to unfold at their own pace before finally placing IUD in uterus, lest ends of arms of IUD gets entangled with side walls of uterus, preventing a far end of IUD to reach fundus! On the other hand, when placing a downfolding IUD, there is no such precaution needed as the arms of IUD unfold upwards at their own natural pace while a far end of the IUD touches fundus.

In other words, an upfolding IUD is easier to load and difficult to place in uterus, while a downfolding IUD is relatively more difficult to load and relatively easier to place.

Therefore, string entangling in the instrument remains a potential cause of disturbing safe placement of IUD in the uterus. Importantly, it is left to the service provider to randomly stop intermittently while inserting an upfolded IUD!

Such instruments being for one-time use, cost is an important factor.

Present invention effectively and economically addresses loading or preparation of upfolding IUDs for subsequent insertion and safe placement in uterus.
OBJECTIVES
The objective is to invent an instrument to load or prepare an intra-uterine device hygienically.
Another objective is to invent a simple instrument to load or prepare an intra- uterine device which is upfoldable.
Yet another objective is to invent an instrument which is capable of loading the intra uterine device in a consistent manner.
Yet another objective is to invent an instrument that causes minimal trauma to woman.
Yet another objective is to invent an instrument that ensures a horizontal orientation of the IUD, while the instrument may operate from an either horizontal orientation.
Yet another objective is to ensure suture release mechanism that ensures that the suture/thread/string is never stuck anywhere after deployment.
Yet another objective is to ensure single hand operation for insertion, deployment and retraction steps of the instrument.
Yet another objective is to ensure prevent accident or injury during insertion in any case to avoid perforation of fundus.
Yet another objective is to invent an instrument which is economical and effective.
Yet another objective is to achieve multiple stages of complete process with a single hand and knob movement.
Yet another objective is to eliminate and or minimize the guesswork of the user in complete operation while preparing/loading, deployment/release.
Yet another objective is to prepare string length prior to insertion, according to uterus size of woman.

SUMMARY OF INVENTION

The instrument according to present invention comprises a “T” shaped intra-uterine device, a graduated tube, a push rod inside the graduated tube, a dynamic stopper with a flange, operated by an operating device. The instrument further comprises a string management arrangement. The preferred embodiment is around the IUD generally comprising a frame having two arms and a stem, with both arms of the IUD foldable up and away from the stem of the IUD. Importantly and to ensure minimum trauma during insertion, faces of a dome shaped ends of the IUD ought to mutually butt against each other, achieved as an improvement in, and a modification of, the invention claimed in the specification of the India application No. 202021041234.

As an improvement in, and a modification of, the invention claimed in the specification of the India application No. 202021041234, the at least one string is provided with an obstruction means which could be an unopenably tight knot, or a kink or a small bulge.

The string of the IUD is in an unreleased or a locked condition, and taut between the lower end and the operating arrangement, when the instrument is received by a medical service provider. In the present invention, the string is NOT required to be pulled/manipulated by the medical service provider for loading or preparing the instrument, and the loading/preparing method is described below. Apropos, the terminating ends of the string can be concealed in the operating device and may or may not be visible/accessible to medical service provider.

As shall be evident, the process of loading, inserting in uterus and safely releasing the IUD is carried out by a single hand operation, and it is of great benefit to the medical service provider.
The dynamic stopper is a hexagonal channel having the flange at the IUD end of the dynamic stopper and a non-circular outer face of lesser mating perimeter than that of the flange. There are provided guide paths at least on two alternate faces of the dynamic stopper. A sliding length of the dynamic stopper is commensurate with an arm length of the arms of the IUD. A face distance of the regular hexagonal channel permits multi-point contacts on the graduated tube and allows a passage of the graduated tube tightly.
As a variation, a stretchable diameter of a circular channel, instead of hexagonal, consequent to a slit on either side allows a passage of the graduated tube tightly, consequent to a diameter of the graduated tube slightly larger than the stretchable diameter, when unstretched.
The operating device comprises a base, a cover, an operating knob, a carriage.
A graduated tube is a thin walled hollow cylinder having the diameter, an edge at the IUD end, a measurement markings and a string exit slot. An inner chamfer is provided at the IUD end of the graduated tube such that an inner edge is formed, as an improvement in, and a modification of, the invention claimed in the India application No. 202021041234.
In the instrument that is ready to use, the dynamic stopper slidably resides in the base free to slide along the guide paths constrained by the first flange guiding projections and or the second flange guiding projections, and can slide by the sliding length. The operator end of the graduated tube is slided with a little force through the tubular channel of the dynamic stopper, till the operator end of the graduated tube is disposed firmly in the larger diameter part of the knob. The dynamic stopper rides on the graduated tube. The hanging tubular construction of knob resides in the travel slot of the carrier. The push rod largely resides inside the graduated tube with the reversible collapsible fitment means of the pushrod pushed in the pushrod passageway such that the collar of the pushrod sits in the seat of the carrier. The stem of the IUD sits in the graduated tube at its IUD end, while the string is slipped in and exits from the string exit slot and is trapped between the string plug and the string socket while keeping it tautly pulled out from the hole, thus the string is in the unreleased or the locked condition. The terminating ends of the string are contained inside of the base near its operator end.

For use of the instrument, when the knob is made to slide towards the IUD end, the graduated tube and the dynamic stopper also travel towards the IUD end. The dynamic stopper travels forward by the sliding length while the graduated tube engulfs the arms of the IUD till the inner edge of the graduated tube obstructs and stops the dome shaped ends of the arms at a position when the inner chamfer constrains the faces to butt mutually against each other. Further sliding of the knob towards the IUD end causes the carrier to also move towards the IUD end due to the pusher of the knob, and consequently the pushrod also correspondingly moves. A movement of the carrier towards the IUD end causes the string plug to move away and thus unplug from the string socket and the string is in an unlocked or a released condition.
Importantly, due to the inventive dynamic stopper that moves equivalent to arm length, the medical service provider doesn’t have to approximate intermediate stop and partial release of the IUD as is prevalent in prior art products.
There is provided at least one outpoint and one inpoint on the floor of the base. The outpoint and the inpoint is essentially a tapered hole. The string exits from the outpoint and re-enters from the inpoint. The string is accessible to the medical service provider between the outpoint and the inpoint and the medical service provider has a preferred option to trim the string as per sounding measurement of uterus of woman, BEFORE inserting the graduated tube in the cervix thereby avoiding use of scissors or cutting tool inside vaginal cavity, and this is most desired, safer and therefore preferred way of using the instrument as per the present invention. The outpoint is at a trim length which is a minimum recommended excess string length expected to be hanging outside cervical os in vaginal cavity of woman. The inpoint is at a conservative length. Medical service provider has the freedom to trim the string anywhere within the conservative length. A scale is provided alongside to facilitate precision in trimming.
It is to be noted that the invention of string trimming before insertion is of significant benefit for instruments suited for all and any kind of IUD and not limited to T-shaped IUD’s, and this is an important ingredient of our invention. This ingredient of invention also implies that during release of the IUD, the instrument handles much lesser length of string than the prior art instruments wherein a long string is always present till after release of IUD in uterus. It is known that a long string has several occasions to undesirably interact with moving parts in the instrument and may get entangled while withdrawing the IUD, and this possibility is completely obviated in our invention.
The instrument operates from its either side, whether curvature up or curvature down, while maintaining a horizontal orientation.
A further improvement in, and a modification of, the invention claimed in the specification of the India application No. 202021041234 is described as the preferred embodiment, wherein the string management comprises of a barrier located on the base towards the operator end and having an alternative hole. On the carriage an alternative plug is integrally disposed on a front region of an additional wall of an extension which is also integrally disposed along on the carriage. The alternative plug is located on the carriage such that, when the carriage is assembled on the base, the alternative plug is axially aligned with the alternative hole to facilitate entering and exiting the alternative hole. The alternative plug is tapered towards its end to accommodate manufacturing tolerances and such controlled manufacturing variations.

In the instrument that is ready to use as per the preferred embodiment, the string management comprises the obstruction means of the at least one string, which is the unopenably tight knot, slipped through the alternative hole of the base towards the operator side, the alternative plug tight fitted in the alternative hole while the at least one string is taut, the obstruction means is thereby trapped towards the operator side, keeping the string in the locked condition.

For use of the instrument, when the operating knob is made to slide towards the IUD end, the graduated tube travels towards the IUD end. The dynamic stopper also travels by the sliding length while the graduated tube engulfs the arms of the IUD till the inner edge of the graduated tube obstructs and stops the dome shaped ends of the arms at a position when the inner chamfer constrains the faces to butt mutually against each other. Further sliding of the operating knob towards the IUD end causes the carrier to also move towards the IUD end, and consequently the pushrod also correspondingly moves. The alternative plug now gets disengaged from the alternative hole, the obstruction means is untrapped, the string is also consequently untrapped from in-between of the alternative plug and the alternative hole, and thus the string is in the unlocked or the released condition.

BRIEF DESCRIPTION OF DRAWINGS
Figure 1 is a perspective view of an instrument as per present invention.
Figure 2 is an exploded view of the present invention.

Figure 3 is front view of an IUD with its arms unfolded (almost horizontal), while

Figure 3A is a front view of the IUD folded (almost vertical).

Figure 3B is a front view of the IUD with the faces of a dome shaped ends mutually butting against each other.

Figure 3C is a front view of the IUD with at least one string provided with an obstruction means.
Figure 4 are two perspective views of a dynamic stopper while Figure 4A are two perspective views of another embodiment of the dynamic stopper.
Figure 5 is a perspective view of a base with enlarged views of encircled portion of the base.
Figure 6 is a perspective view of a cover while Figure 6A is another perspective view with enlarged view of encircled portion of the cover.
Figure 7 is a perspective view and a sectional view of an operating knob.
Figure 8 are two perspective views of a carrier while Figure 8A is a partial sectional view of the carrier.
Figure 9 is a perspective view of a push rod with an enlarged view of its encircled portion.
Figure 10 is a perspective view of a graduated tube with an enlarged view of its encircled portion while Figure 10A is a front perspective view of another embodiment of the graduated tube.
Figure 10B is a sectional front view of the IUD engulfed in the graduated tube as per preferred embodiment.
Figure 11 is a partial sectional side view of the carrier and the push rod engaged therein.
Figure 12 is a sectional view of a first embodiment of a string management arrangement with a string unlocked, while Figure 12A is a sectional view showing the string locked.
Figure 13 is a front view of the instrument with the graduated tube extended in accordance with uterine depth of uterus.
Figures 14 to 18 are front views of steps of insertion and safe release of the IUD in uterus.
Figure 19 and 19A is a sectional view of a second embodiment of the string management arrangement with the string locked, Figure 19A is a sectional view with the string unlocked, while Figure 19B is a perspective view and a sectional view of a floating cone.
Figure 20, 20A and 20B, are views showing string trimming arrangement after loading but before insertion of IUD, while Figure 20C shows string trimming arrangement for different kinds of IUDs.
Figures 21, 21A, are perspective views of the base and the carrier, while Figures 21B and 21C are partial sectional views of a third embodiment of the string management arrangement.
Figure 22 is a perspective view of the push rod as per another embodiment.
Figure 23 is a perspective view and a partial enlarged view of the base per the preferred embodiment.
Figure 24 is a perspective and a partial enlarged view of the carrier as per the preferred embodiment.

Figure 25 is a sectional view of a preferred embodiment of the string management arrangement, with the string locked.

DETAILED DESCRIPTION OF INVENTION
The present invention of an instrument to load and insert an upfoldable intra-uterine device and process thereof will now be described with reference to the accompanying drawings. It is to be understood that the description explains the preferred embodiments and several ways are possible around the invention. Apropos, the description should not be construed to limit the invention in any way whatsoever. The terms and expressions which have been used here are uterine device and process thereof will now be described with reference to the accompanying drawings. The terms and expressions which have been used here are merely for description and not for limitation. The term “preparing” and “loading” are used interchangeably.

Figure 1, 2 the instrument (10) according to present invention comprises a “T” shaped intra-uterine device (30), a graduated tube (16), a push rod (17) inside the graduated tube (16), a dynamic stopper (20) with a flange (25), operated by an operating device (100). The instrument (10) further comprises a string management arrangement (110), shown in Figures 12 and 12A being one of the embodiments. The operating device (100) further comprises a base (70), a cover (90), an operating knob (150), a carriage (140).

Figure 3, the preferred embodiment is around the IUD (30) generally comprising a frame having two arms (34) and a stem (33), with both arms (34) of the IUD (30) foldable away from the stem (33) of the IUD (30), as shown in Figure 3A. Figure 3B, importantly and to ensure minimum trauma during insertion, faces (36A) of a dome shaped ends (36)of the IUD (30) ought to mutually butt against each other, unlike as shown in Figure 3A, achieved as an improvement in, and a modification of, the invention claimed in the specification of the India application No. 202021041234.

The instrument (10) is shipped in the position when the IUD (30) is with its arms (34) in a “T” formation with respect to the stem (33), as it should be when placed in uterus of woman. The IUD (30) further comprises a contraceptive material (49) disposed around the stem (33), and at least one string (31) emerges from a lower end (37) of the stem (33). The string (31) has a terminating ends (35).

Figure 3C, as an improvement in, and a modification of, the invention claimed in the specification of the India application No. 202021041234, the at least one string (31) is provided with an obstruction means (31A) which could be an unopenably tight knot, or a kink or a small bulge.

The string (31) of the IUD (30) is in an unreleased or a locked condition, and taut between the lower end (37) and the operating arrangement (110), when the instrument (10) is received by a medical service provider. In the present invention, the string (31) is NOT required to be pulled/manipulated by the medical service provider for loading or preparing the instrument (10), and the loading/preparing method is described below. Apropos, the terminating ends (35) of the string (31) can be concealed in the operating device (100) and may or may not be visible/accessible to medical service provider.

As shall be evident, the process of loading, inserting in uterus and safely releasing the IUD (30) is carried out by a single hand operation, and it is of great benefit to the medical service provider. An IUD end (5) and an operator end (6) signifies direction of the instrument (10) and all parts while describing features, sub-assembly, assembly and method of use.

Figure 4, the dynamic stopper (20) is a hexagonal channel (22) having the flange (25) at the IUD end (5) of the dynamic stopper (20) and a non-circular outer face of lesser mating perimeter than that of the flange (25). There are provided guide paths (21) at least on two alternate faces of the dynamic stopper (20). A sliding length (23) of the dynamic stopper (20) is commensurate with an arm length (38) of the arms (34) of the IUD (30). A face distance (26) of the regular hexagonal channel (22) permits multi-point contacts on the graduated tube (16) and allows a passage of the graduated tube (16) tightly.
Figure 4A, as a variation, a stretchable diameter (26A) of a circular channel (22A), instead of hexagonal, consequent to a slit (26B) on either side allows a passage of the graduated tube (16) tightly, consequent to a diameter (16A) of the graduated tube (16) slightly larger than the stretchable diameter (26A), when unstretched.
Figure 5, the base (70) has two parallel walls (80) a floor (81), an open neck construction (73) with a collar (71) and a first flange guiding projections (72) at its IUD end (5) of each wall (80) or on the floor (81). There are carrier guiding projections (73) on the floor (81). On an inside of the walls (80) is provided an array of continuous incline and notches (82) alternately for a prescribed length (83). There are a plurality of cover engagement means (74) on the inside of both the walls (80). In the preferred embodiment, the cover engagement means (74) is a raised projection such as but not limited to a nub, dome, protuberance, etc. with surrounding material reduced to make room for a base engagement means (94).
The base engagement means (94) in the first embodiment is a receptacle, such as but not limited to an aperture, opening, window, etc., to commensurate with the raised projection, such that when the base (70) and cover (90) are pressed together, the raised projection is trapped in the corresponding receptacle. In another embodiment, the cover engagement means (74) can be a receptacle while the base engagement (94) means can be a raised projection. A tube guideway (84) is provided on the floor (81). Also provided is a string socket (75) with a hole (76). The base (70) is slightly curvatured.

Figure 6, 6A, the cover (90) has a slot (91), an open complementing neck construction (93), a second flange guiding projections (92), and a plurality of base engagement means (94) equal in number of the cover engagement means (74). A knob markings (95) are provided on an external side (96) of the cover (90). The cover (90) is slightly curvature in accordance with the base (70).

Figure 7, the operating knob (150) has a thumb surface (159), and at least a pointer (158) on an either knob side. There is provided a hanging tubular construction (152) on an opposite side (165) of the thumb surface (159). The tubular construction (152) has a larger diameter part (153) having a pair of pusher (156), and a smaller diameter part (154).

Figure 8, 8A, the carriage (140) has a travel slot (143) on an upper side (141), at least a pair of locking tooth (148) on an either carrier (140) side. The travel slot (143) has an assembly opening (143A) which is wider than the travel slot (143).
On the lower side (142) is a travel surface (149). There is provided a string plug (144) on the lower side (142). At the operator end (6) is a pushrod passageway (147) with a seat (146).

Figure 9, the pushrod (17) is a slender cylinder, has a collar (18), a reversibly collapsible fitment means (19) at its operator end (6) and a flat surface (13) at the IUD end (5). The reversible collapsible fitment means (19) comprises a pair of arms (19A) and (19B), separated by a slit (19C). When the reversible collapsible means (19) is pushed in the pushrod passageway (147), ends of the respective arms (19A, 19B) come closer temporarily, and separate again as the collar (18) sits in the seat (146).
Figure 10, the graduated tube (16) is a thin walled hollow cylinder having the diameter (16A), an edge (11) at the IUD end (5), a measurement markings (14) and a string exit slot (15).
Figure 10A, an inner chamfer (11B) is provided at the IUD end (5) of the graduated tube (16) such that an inner edge (11A) is formed, as an improvement in, and a modification of, the invention claimed in the India application No. 202021041234.

In the instrument (10) that is ready to use, the dynamic stopper (20) slidably resides in the base (70) free to slide along the guide paths (21) constrained by the first flange guiding projections (72) and or the second flange guiding projections (92), and can slide by the sliding length (23). The operator end (6) of the graduated tube (16) is slided with a little force through the tubular channel (22) of the dynamic stopper (20), till the operator end (6) of the graduated tube (16) is disposed firmly in the larger diameter part (153) of the knob (150). The dynamic stopper (20) rides on the graduated tube (16). The hanging tubular construction (152) of knob (150) resides in the travel slot (143) of the carrier (140). The push rod (17) largely resides inside the graduated tube (16) with the reversible collapsible fitment means (19) of the pushrod (17) pushed in the pushrod passageway (147) such that the collar (18) of the pushrod (17) sits in the seat (146) of the carrier (140), Figure 11. The stem (33) of the IUD (30) sits in the graduated tube (16) at its IUD end (5), while the string (31) is slipped in and exits from the string exit slot (15) and is trapped between the string plug (144) and the string socket (75) while keeping it tautly pulled out from the hole (76), thus the string (31) is in the unreleased or the locked condition, Figure 12, 12A. The terminating ends (35) of the string (31) are contained inside of the base (70) near its operator end (6).

For use of the instrument (10), when the knob (150) is made to slide towards the IUD end (5), the graduated tube (16) and the dynamic stopper (20) also travel towards the IUD end (5). The dynamic stopper (20) travels forward by the sliding length (23) while the graduated tube (16) engulfs the arms of the IUD (30) till the inner edge (11A) of the graduated tube (16) obstructs and stops the dome shaped ends (36) of the arms (34) at a position when the inner chamfer (11B) constrains the faces (36A) to butt mutually against each other, Figures 10A and 10B. Further sliding of the knob (150) towards the IUD end (5) causes the carrier (140) to also move towards the IUD end (5) due to the pusher (156) of the knob (150), and consequently the pushrod (17) also correspondingly moves. A movement of the carrier (140) towards the IUD end (5) causes the string plug (144) to move away and thus unplug from the string socket (75) and the string (31) is in an unlocked or a released condition, Figure 12A.
The string management arrangement (110) in this embodiment therefore comprises the string plug (144) of the carriage (140) and the string socket (75) of the base (70); and locking and unlocking the string (31) takes place as described above.
Figures 13-18, a method to load the instrument (10) and safely place the IUD (30) in uterus (50) comprises the steps of:
a) Sounding a uterus of woman and determining a uterine depth (45)
b) Sliding the operating knob (150) towards an IUD end (5) till the arms (34) of the IUD (30) are folded and fully contained in the graduated tube (16),
c) Sliding the operating knob (150) further towards the IUD end (5) till the graduated tube (16) projects out by a length of the uterine depth (45), judging by hearing an audible clicking sound produced due to the pair of locking tooth (143) negotiating with the array of inclines and notches (82) or judging by the measurement markings (14) on the graduated tube (16) aligning with the flange (25) or by the position of the pointer (158) of the operating knob (150) at the knob markings (95) on the cover (90),
d) Inserting the graduated tube (16) in the uterus (50) till the flange (25) touches cervical os (51) of the uterus (50),
e) Sliding back the operating knob (150) till the dynamic stopper (20) retracts by the sliding length (23) and stops,
f) Further inserting the graduated tube (16) in the uterus (50) till the flange (25) of retracted dynamic stopper (20) again touches the cervical os (51)
g) Sliding back the operating knob (150) as much as possible,
h) Taking out the graduated tube (16) from woman, and
i) Trimming an excess length of the strings (31) of the IUD (30).
Importantly, due to the inventive dynamic stopper (20) that moves equivalent to arm length (38), the medical service provider doesn’t have to approximate intermediate stop and partial release of the IUD (30) as is prevalent in prior art products.
Figures 19, 19A, 19B, 20, in another embodiment, the string management (110) comprises a floating cone (40) floatingly disposed on the graduated tube (16) and a tubeway (77) integratedly provided on the base (70).
The floating cone (40) has a tubular hole (41) on an inside and a conical frustum (42) on an outside. There is provided a hook (43) on the IUD side (5) of the floating cone (40). The tube way (77) has an inner cylindrical path through which the graduated tube (16) passes clearly, while the floating cone (40) gets seated firmly in the tube way (77) like any known plug and a socket arrangement.
In the instrument (10) as per second embodiment that is ready to use, the string (31) is wrapped around the hook (43) by several turns, slid through the tubular hole (41) and the tubeway (77) taut, while the floating cone (40) is firmly plugged in the tubeway (77).

For use of the instrument (10) as per second embodiment, when the knob is made to slide towards the IUD end (5), the graduated tube (16) travels towards the IUD end (5), while the floating cone (40) continues to remain plugged in the tubeway (77). The dynamic stopper (20) also travels by the sliding length (23) while the graduated tube (16) engulfs the arms (34) of the IUD (30) till the edge (11) of the graduated tube (16) is stopped by the dome shaped ends (36) of the arms (34) having come almost together. Further sliding of the knob (150) towards the IUD end (5) causes the carrier (140) to also move towards the IUD end (5), and consequently the pushrod (17) also correspondingly moves. The string (31) is unwrapped from over the hook (43) and the floating plug (40) gets plugged out, and the string (31) is in the unlocked or the released condition.
Figures 21, 21A, 21B, 21C, in yet another embodiment, the string management (110) comprises an extended receptacle (145) with an open side (145A) on the operator side (6) of the carrier (140), and an end plug (78) with a slit (79) integratedly provided on the operator end (6) of the base (70).
In the instrument (10) as per third embodiment that is ready to use, the string (31) emerges out of the extended receptacle (145), taut, sits on the slit (79), and emerges out of an opening (89) of the base (70) while the extended receptacle (145) is firmly mounted on the end plug (78), keeping the string (31) in the locked condition.
For use of the instrument (10) as per third embodiment, when the operating knob (150) is made to slide towards the IUD end (5), the graduated tube (16) travels towards the IUD end (5), while the carrier (140) and therefore the extended receptacle (145) continues to remain mounted on the end plug (78). The dynamic stopper (20) also travels by the sliding length (23) while the graduated tube (16) engulfs the arms (34) of the IUD (30) till the edge (11) of the graduated tube (16) is stopped by the dome shaped ends (36) of the arms (34) having come almost together. Further sliding of the operating knob (150) towards the IUD end (5) causes the carrier (140) to also move towards the IUD end (5), and consequently the pushrod (17) also correspondingly moves. The extended receptacle (145) now gets dismounted from the end plug (78), string (31) is untrapped from an in- between of the end plug (78) and the extended receptacle (145), and thus the string (31) is in the unlocked or the released condition.
Figure 20, 20A, 20B, 20C, there is provided at least one outpoint (87) and one inpoint (88) on the floor (81) of the base (70). The outpoint (87) and the inpoint (88) is essentially a tapered hole. The string (31) exits from the outpoint (87) and re-enters from the inpoint (88). The string (31) is accessible to the medical service provider between the outpoint (87) and the inpoint (88) and the medical service provider has a preferred option to trim the string (31) as per sounding measurement of uterus of woman, BEFORE inserting the graduated tube (16) in the cervix thereby avoiding use of scissors or cutting tool inside vaginal cavity, and this is most desired, safer and therefore preferred way of using the instrument (10) as per the present invention. The outpoint (87) is at a trim length (46) which is a minimum recommended excess string length expected to be hanging outside cervical os (51) in vaginal cavity of woman. The inpoint (88) is at a conservative length (47). Medical service provider has the freedom to trim the string (31) anywhere within the conservative length (47). A scale (48) is provided alongside to facilitate precision in trimming.

It is to be noted that the invention of string trimming before insertion is of significant benefit for instruments suited for all and any kind of IUD (30, 30A, 30B) and not limited to T-shaped IUD’s, and this is an important ingredient of our invention. This ingredient of invention also implies that during release of the IUD (30, 30A, 30B), the instrument (10) handles much lesser length of string (31) than the prior art instruments wherein a long string (31) is always present till after release of IUD in uterus (50). It is known that a long string (31) has several occasions to undesirably interact with moving parts in the instrument (10) and may get entangled while withdrawing the IUD (30, 30A, 30B), and this possibility is completely obviated in our invention.
When the medical service provider uses the option of trimming the string (31) before insertion, the method to load the instrument (10) and safely place the IUD (30) in uterus (50) with above variations comprises the steps of:
a) Sounding a uterus (50) of woman and determining a uterine depth (45)
b) Sliding the operating knob (150) towards an IUD end (5) till the arms of the IUD (30) are folded and fully contained in the graduated tube (16),
c) Sliding the operating knob (150) further towards the IUD end (5) till the graduated tube (16) projects out by a length of the uterine depth (45), judging by hearing an audible clicking sound produced due to the pair of locking tooth (143) negotiating with the array of inclines and notches (82) or judging by the measurement markings (14) on the graduated tube (16) aligning with the flange (25) or by the position of the pointer (158) of the operating knob (150) at the knob markings (95) on the cover (90),
d) Trimming an excess length of the strings (31) of the IUD (30) anywhere in the conservative length (47),
e) Inserting the graduated tube (16) in the uterus (50) till the flange (25) touches cervical os (51) of the uterus (50)
f) Sliding back the operating knob (150) till the dynamic stopper (20) retracts by the sliding length (23) and stops,
g) Further inserting the graduated tube (16) in the uterus (50) till the flange (25) of retracted dynamic stopper (20) again touches the cervical os (51)
h) Sliding back the operating knob (150) as much as possible, and
i) Taking out the graduated tube (16) and the instrument (10) from woman.
Figure 21, as another variation, the base (70) has an out opening (89) through which the string (31) is still available to the medical service provider. The medical service provider can exercise the option to manually load the IUD (30) if that suits the service provider as per his or her previous experience or convenience.
Figure 22, as yet another variation the push rod (17) has a longitudinal channel (12) or an equivalent construction to protect and shield the string (31) from getting entangled in the graduated tube (16).
The invention as described above can be worked with a permutation and combination of embodiments described above and the variations described are not mutually exclusive in any particular group or formation.
The instrument (10) operates from its either side, whether curvature up or curvature down, while maintaining a horizontal orientation.

A further improvement in, and a modification of, the invention claimed in the specification of the India application No. 202021041234 is described as under:

Figure 23, 24, in the preferred embodiment, the string management (110) comprises of a barrier (160) located on the base (70) towards the operator end (6) and having an alternative hole (76A). On the carriage (140) an alternative plug (144A) is integrally disposed on a front region (164) of an additional wall (163) of an extension (161) which is also integrally disposed along on the carriage (140). The alternative plug (144A) is located on the carriage (140) such that, when the carriage (140) is assembled on the base (70), the alternative plug (144A) is axially aligned with the alternative hole (76A) to facilitate entering and exiting the alternative hole (76A). The alternative plug (144A) is tapered towards its end to accommodate manufacturing tolerances and such controlled manufacturing variations.

In the instrument that is ready to use as per the preferred embodiment, Fig 25, the string management (110) comprises the obstruction means (31A) of the at least one string (31), which is the unopenably tight knot, slipped through the alternative hole (76A) of the base (70) towards the operator side (6), the alternative plug (144A) tight fitted in the alternative hole (76A) while the at least one string (31) is taut, the obstruction means (31A) is thereby trapped towards the operator side (6), keeping the string in the locked condition.
For use of the instrument (10), when the operating knob (150) is made to slide towards the IUD end (5), the graduated tube (16) travels towards the IUD end (5). The dynamic stopper (20) also travels by the sliding length (23) while the graduated tube (16) engulfs the arms (34) of the IUD (30) till the inner edge (11A) of the graduated tube (16) obstructs and stops the dome shaped ends (36) of the arms (34) at a position when the inner chamfer (11B) constrains the faces (36A) to butt mutually against each other. Further sliding of the operating knob (150) towards the IUD end (5) causes the carrier (140) to also move towards the IUD end (5), and consequently the pushrod (17) also correspondingly moves. The alternative plug (144A) now gets disengaged from the alternative hole (76A), the obstruction means (31A) is untrapped, the string (31) is also consequently untrapped from in-between of the alternative plug (144A) and the alternative hole (76A), and thus the string (31) is in the unlocked or the released condition.
, Claims: We claim:
01. An instrument (10) configured to prepare and safely place an intra-uterine device (30) in uterus (50) of a woman, the instrument (10) comprising a “T” shaped intra-uterine device (IUD) (30) with both arms (34) foldable away from a stem (33) of the IUD (30), a graduated tube (16), a push rod (17) inside the graduated tube (16), a dynamic stopper (20), a string management arrangement (110) whereby a string (31) of the IUD (30) is in one of a locked condition or an unlocked condition, a base (70), a cover (90), a carriage (140), an operating knob (150), and the graduated tube (16); the dynamic stopper (20) slidably resides in the base (70) and can slide by a sliding length (23), an operator end (6) of the graduated tube (16) is slided through the tubular channel (22) of the dynamic stopper (20), till the operator end (6) of the graduated tube (16) is disposed firmly in a larger diameter part (153) of the operating knob (150), the dynamic stopper (20) rides on the graduated tube (16), a hanging tubular construction (152) of the operating knob (150) resides in a travel slot (143) of the carrier (140), the push rod (17) resides inside the graduated tube (16) with a reversible collapsible fitment means (19) of the pushrod (17) pushed in a pushrod passageway (147) such that a collar (18) of the pushrod (17) sits in a seat (146) of the carrier (140);

characterized by,
the dynamic stopper (20) having a stretchable diameter (26A) of a circular channel (22A) with a slit (26B) on either side,

the string (31) of the IUD (30) provided with an obstruction means (31A) which is one of an unopenably tight knot, a kink and a small bulge, and

an inner chamfer (11B) at the IUD end (5) of the graduated tube (16) forming an inner edge (11A);
the string management arrangement (110) comprising a barrier (160) located on the base (70) towards the operator end (6) and having an alternative hole (76A), an alternative plug (144A) integrally disposed on a front region (164) of an additional wall (163) of an extension (161) integrally disposed along on the carriage (140), the alternative plug (144A) located on the carriage (140) such that, when the carriage (140) is assembled on the base (70), the alternative plug (144A) it is axially aligned with the alternative hole (76A), the alternative plug (144A) tapered towards its end;
the obstruction means (31A) of the at least one string (31), which is the unopenably tight knot, slipped through the alternative hole (76A) of the base (70) towards the operator side (6), the alternative plug (144A) tight fitted in the alternative hole (76A) while the at least one string (31) is taut, the obstruction means (31A) is thereby trapped towards the operator side (6), keeping the string in the locked condition;
when the operating knob (150) is made to slide towards the IUD end (5), the graduated tube (16) travels towards the IUD end (5), the dynamic stopper (20) also travels by a sliding length (23) while the graduated tube (16) engulfs the arms (34) of the IUD (30) till the inner edge (11A) of the graduated tube (16) obstructs and stops the dome shaped ends (36) of the arms (34) at a position when the inner chamfer (11B) constrains the faces (36A) to butt mutually against each other, a further sliding of the operating knob (150) towards the IUD end (5) causes the carrier (140) to also move towards the IUD end (5), and consequently the pushrod (17) also correspondingly moves, the alternative plug (144A) now gets disengaged from the alternative hole (76A), the obstruction means (31A) is untrapped, the string (31) is also consequently untrapped from an in-between of the alternative plug (144A) and the alternative hole (76A), and the string (31) is in the unlocked or the released condition; and a forward and a backward movement of the operating knob (150) by a sliding force on a thumb surface (159), a single hand grips the instrument (10) as well as moves the knob (150) by a thumb of the same hand.
02. The instrument (10) configured to prepare and safely place an intra-uterine device (30) as claimed in claim 01, wherein the base (70) has at least one outpoint (87) and one inpoint (88), wherein the string (31) exits from the outpoint (87) and re-enters from the inpoint (88).
03. The instrument (10) configured to prepare and safely place an intra-uterine device (30) as claimed in claim 02, wherein the outpoint (87) is at a trim length (46) which is a minimum recommended excess string (31) length expected to be hanging outside a cervical os (51) in vaginal cavity of woman.
04. The instrument (10) configured to prepare and safely place an intra-uterine device (30) as claimed in claim 02, wherein the inpoint (88) is at a conservative length (47).
05. The instrument (10) configured to prepare and safely place an intra-uterine device (30) as claimed in claim 02, wherein the outpoint (87) and the inpoint (88) have a scale (48) alongside.
06. The instrument (10) configured to prepare and safely place an intra-uterine device (30) as claimed in claim 02, wherein the base (70) is curvatured, and the cover (90) is curvatured correspondingly.
07. The instrument (10) configured to prepare and safely place an intra-uterine device (30) as claimed in claim 01, wherein the dynamic stopper (20) further comprises guide paths (21) on at least two alternate faces of the dynamic stopper (20), and wherein the stretchable diameter (26A) of the circular channel (22A), with the slits (26B) on either side allows a passage of the graduated tube (16) tightly consequent to a diameter (16A) of the graduated tube (16) larger than the face diameter (26A).
08. The instrument (10) configured to prepare and safely place an intra-uterine device (30) as claimed in claim 01, wherein the carriage (140) further comprises a knob assembly opening (143A) which is wider than a travel slot (143); on the lower side (142) is a travel surface (149).
09. The instrument (10) configured to prepare and safely place an intra-uterine device (30) as claimed in claim 01, wherein the push rod (17) has a longitudinal channel (12) along a length (17A) of the push rod (17).
10. The instrument (10) configured to prepare and safely place an intra-uterine device (30, 30A, 30B) as claimed in claim 01, wherein a method to load the instrument (10) and safely place the IUD (30) comprises the steps of:
a) Sliding the operating knob (150) towards an IUD end (5) till the arms (34) of the IUD (30) are folded and fully contained in the graduated tube (16),
b) Sliding the operating knob (150) further towards the IUD end (5) till the graduated tube (16) projects out by a length of the uterine depth (45), judging by hearing an audible clicking sound produced due to the pair of locking tooth (143) negotiating with the array of inclines and notches (82) or judging by the measurement markings (14) on the graduated tube (16) aligning with the flange (25) or by the position of the pointer (158) of the operating knob (150) at the knob markings (95) the cover (90),
c) Inserting the graduated tube (16) in the uterus (50) till the flange (25) touches cervical os (51) of the uterus (50),
d) Sliding back the operating knob (150) till the dynamic stopper (20) retracts by the sliding length (23) and stops,
e) Further inserting the graduated tube (16) in the uterus (50) till the flange (25) of retracted dynamic stopper (20) again touches the
cervical os (51),Sliding back the operating knob (150) as much as possible,
f) Taking out the graduated tube (16) from woman, and
g) Trimming an excess length of the strings (31) of the IUD (30).

11. The instrument (10) configured to prepare and safely place an intrauterine device (30, 30A, 30B) as claimed in claim 01, wherein a method to load the instrument (10) and safely place the IUD (30) comprises the steps of:
a) Sliding the operating knob (150) towards an IUD end (5) till the arms of the IUD (30) are folded and fully contained in the graduated tube (16),
b) Sliding the operating knob (150) further towards the IUD end (5) till the graduated tube (16) projects out by a length of the uterine depth (45),
c) Inserting the graduated tube (16) in the uterus (50) till the flange (25) touches cervical os (51) of the uterus (50),
d) Sliding back the operating knob (150) till the dynamic stopper (20) retracts by the sliding length (23) and stops,
e) Further inserting the graduated tube (16) in the uterus (50) till the flange of retracted dynamic stopper (20) again touches the cervical os (51),
f) Sliding back the operating knob (150) as much as possible, and
g) Taking out the graduated tube (16) from woman.
Place: Mumbai
Date: 19 July 2024 Agent of Applicant
IN/PA -413