INSTRUMENT TO PREPARE AN INTRA-UTERINE DEVICE FOR INSERTION

Abstract

An instrument 10 to prepare an intra-uterine device 30 for insertion in uterus 50 of woman, comprising a downfolding device 20, a graduated tube 16, a push rod 17, a stopper 15, and an IUD 30; the downfolding device 20 having a concave depression 41 on either side, an open channel 29 of a circular orifice 46 having a sector of angle measure 46A at least 220 and having an exit opening 48 initially marginally less than an external diameter 22B of the graduated tube 16, a root thickness 37B of the base 37 in-between the open channel 29 such that the exit opening 48 increases by the base 37 flexing; the graduated tube 16 has an internal diameter 22D of a far-end opening 22a of the graduated tube 16 sufficient to capture the stem 33 and both arms 32 of the IUD 30 in a downward triangular formation 51.

Claims

01. An instrument 10 to prepare an intra-uterine device 30 for insertion in uterus 50 of a woman, the instrument 10 comprising a downfolding device 20, a graduated tube 16, a push rod 17, a stopper 15, and an IUD 30, encased in a transparent pouch 60, characterized in that the downfolding device 20 has a fence 21 and an open channel 29, spaced by a platform 34, on a base 37, an external side 38A of the fence 21 having a depression 41 on either side, a concave, complementary to a convex shape of human thumb and human fingers, an internal side 38B of the fence 21 having a converging opening 23A, turning into a narrow zone 23B and ending into a well 24 having a depth 24A, the narrow zone 23B having a projecting ridge 27 on either side, leaving a clear passage 27A, the well 24 having an orienting step 61 on either side, the well 24 closed from a far end 42, a proximal end 43 of the converging opening 23A having, on either side, an inclined wall 44 with a local relief 45 merging with the internal side 38B of the fence 21, a diametric dimension 24B of well 24, above the orienting step 61 commensurate with an envelope dimension 38 of the IUD 30 when downfolded, the open channel 29 of a circular orifice 46 having a sector of angle measure 46A at least 220, the circular orifice 46 merges with a pair of divergent walls 47, having an exit opening 48 that is initially marginally less than an external diameter 22B of the graduated tube 16. a root thickness 37B of the base 37 in-between the open channel 29 is such that the exit opening 48 increases by the base 37 flexing and or when a lower surface 37A of the base 37 is devoid of a firm support underneath, an upper enveloping surface 28 all over the downfolding device 20 a smoothened surface devoid of sharp projection, a width 27B of the clear passage 27A comparable to a height 22C of a triangle formed at a far end of the graduated tube 16, and a depth 24A of the well 24 such that as the IUD 30 is pushed into the downloading device 20, a fundal end 32F of the IUD 30 gets stopped by the end 24C of the well 24, and an arms 32n of the IUD 30 become substantially in the same orientation as the stem 33 of IUD 30 while the orienting step 61 causes the arms 32 to fold above the orienting step 61; the graduated tube 16 has an internal diameter 22D of a far-end opening 22a of the graduated tube 16 sufficient to capture the stem 33 and both arms 32 of the IUD 30 in a triangular formation (51,52); the transparent pouch 60 has a thermoplastic sheath 39 of a prescribed flexibility, and a back 40; and the IUD 30 is parked in the downfolding device 20 with its arms 32 resting at the platform 34 and the stem 33 passing through the open channel 29 of the downfolding device 20, the IUD 30 is parked in the downfolding device 20 in the T shape which it is required to maintain inside uterus 50, the downfolding device 20 is firmly disposed in a prescribed place in the transparent pouch 60.

02. The instrument 10 to prepare the intra-uterine device 30 for insertion as claimed in claim 01, wherein the prescribed place in the transparent pouch 60 is by thermally shrinking the thermoplastic sheath 39 around the downfolding device 20.

03. The instrument 10 to prepare the intra-uterine device 30 for insertion as claimed in claim 01, wherein the prescribed place in the transparent pouch 60 is by a glue disposed between the base 37 of the downfolding device 20 and the back 40 of the transparent pouch 60.

04. A method to prepare an instrument 10 with an intra-uterine device 30 for insertion in uterus 50 of a woman, the instrument comprising of a downfolding device 20, a graduated tube 16, a push rod 17, a stopper 15, and an IUD 30, encased in a transparent pouch 60; the method comprising the steps of: Separating partially a transparent cover 39 from the back 40 of the transparent pouch 60, only to be able to access and hold a near-end opening 22 of graduated tube 16, Holding firmly the downfolding device 20 by one hand from outside the transparent cover 39, Pushing in the graduated tube 16 in the downfolding device 20, Pushing in the IUD 30 by the graduated tube 16, Folding of the arms 32 of the IUD 30 towards a stem end 36 of the IUD 30, resulting into such partially folded arms 32a, Withdrawing the graduated tube 16 backwards till the graduated tube 16 is just free from the open channel 29, Lifting the graduated tube 16 angularly above the open channel 29, Pushing in again the graduated tube 16 towards the IUD 30 capturing an ends of the arm 32n of IUD 30 such that the ends of the arms 32n enter the far-end opening 22a of graduated tube 16, Further pushing in the graduated tube 16 till a fundal end 32F of the IUD 30 gets stopped by an end 24C of the well 24 of the downfolding device 20, Turning axially the graduated tube 16 by 85 to 95 degrees on either side, Taking out the graduated tube 16 completely out of the downfolding device 20 and the transparent pouch 60 along with the IUD 30.

05. The method to prepare the instrument 10 with the intra-uterine device 30 as claimed in claim 04, wherein the capturing an ends of the arm 32n of IUD 30 is in a downward triangular formation 51.

06. The method to prepare the instrument 10 with the intra-uterine device 30 as claimed in claim 04, wherein the lifting of the graduated tube 16 angularly above the open channel 29, without withdrawing the graduated tube 16 backwards till the graduated tube 16 is just free from the open channel 29, is enabled by the exit opening 48 increasing by the base 37 flexing when a lower surface 37A of the base 37 is devoid of a firm support underneath.

07. The method to prepare the instrument 10 with the intra-uterine device 30 as claimed in claim 04, wherein the holding firmly the downfolding device 20 is by firmly holding the transparent pouch 60.

08. The method to prepare the instrument 10 with the intra-uterine device 30 as claimed in claim 07, wherein the transparent pouch 60 is firmly disposed on a surface.

Description

BRIEF DESCRIPTION OF DRAWINGS

[0031] FIG. 1 is a front view of an apparatus as per present invention.

[0032] FIG. 2 is a front view of a downfoldable IUD.

[0033] FIG. 3 is a perspective view of a downfolding device as per present invention.

[0034] FIG. 4 is a top view and a sectional side view of the downfolding device.

[0035] FIG. 5A is a front view of the downfolding device while FIG. 5B is another front view with its base flexed.

[0036] FIG. 6 is a front view of a downfolded IUD with arms downfolded.

[0037] FIG. 7 is a front view of a graduated tube.

[0038] FIG. 8 is a partial front view of a prepared IUD.

[0039] FIG. 9A is a sectional top view of the graduated tube with downfolded IUD therein in the downward triangular formation, and the graduated tube before loading an IUD, while FIG. 9B is a similar sectional top view in the upward triangular formation.

[0040] FIG. 10A-10E show steps, in perspective view, of preparing the instrument for insertion of the IUD, while FIG. 10F is a sectional side view.

[0041] FIG. 11 is a representative view of a transparent pouch.

[0042] FIG. 12 is a representative top view of a downfolding device and the IUD in two different shapes while loading.

[0043] FIG. 13 shows a simplified uterus with IUD inserted.

[0044] FIG. 14 shows a simplified uterus with IUD placed.

DETAILED DESCRIPTION OF INVENTION

[0045] Preferred embodiment of an instrument to load and insert a downfoldable intra-uterine device and process thereof according to present invention will now be described in detail, 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.

[0046] FIG. 1, the instrument 10 according to present invention comprises a downfolding device 20, a graduated tube 16, a push rod 17, a stopper 15, and an IUD 30, encased in a transparent pouch 60.

[0047] FIG. 2, the IUD 30 is essentially in a T shape, comprising a moulded frame 35 having a metallic envelope/wire 49 wrapped around a stem 33, preferably with a sleeve 26 on each of a pair of arms 32. The sleeve 26 is generally made of medical grade copper.

[0048] FIGS. 3, 4, 5A, the downfolding device 20 has a fence 21 and an open channel 29, spaced by a platform 34, on a base 37. An external side 38A of the fence 21 has a depression 41 on either side, a concave, and generally complementary to a convex shape of human thumb and human fingers and therefore acts as a receptacle; consequently a service provider can hold the downfolding device 20 firmly and which facilitates easy and secure loading of IUD into the graduated tube 16. An internal side 38B of the fence 21 has a converging opening 23A, turning into a narrow zone 23B and ending into a well 24 having a depth 24A.

[0049] The narrow zone 23B has a projecting ridge 27 on either side, leaving a clear passage 27A. The well 24 has an orienting step 61 on either side. The well 24 is closed from a far end 42. A proximal end 43 of the converging opening has, on either side, an inclined wall 44 with a local relief 45, for accommodating a step 32S in the arms 32 of the IUD 30 which may be due to the sleeve 26, and merging with the internal side 38B of the fence 21. A diametric dimension 24B of well 24, above the orienting step 61, is commensurate with an envelope dimension 38 of the IUD 30 when downfolded. The open channel 29 has a circular orifice 46 having a sector of angle measure 46A at least 220. The circular orifice 46 merges with a pair of divergent walls 47, having an exit opening 48 that is initially marginally less than an external diameter 22B of the graduated tube 16. A root thickness 37B of the base 37 in-between the open channel 29 is minimal. Consequently, the exit opening 48 increases by the base 37 flexing and or when a lower surface 37A of the base 37 is devoid of a firm support underneath as particularly shown in FIG. 5B. An upper enveloping surface 28 all over the downfolding device 20 is a smoothened surface devoid of sharp projection.

[0050] A width 27B of the clear passage 27A is comparable to a height 22C of a triangle (FIG. 9A) formed at a far end of the graduated tube 16 carrying a prepared IUD, as described below.

[0051] FIGS. 6, 7 and 8, the graduated tube 16 has an internal diameter 22D of a far-end opening 22a of the graduated tube 16 just sufficient to capture the stem 33 and both arms 32 of IUD in substantially a downward triangular formation 51. The downward triangular formation 51 is attainable by entering the IUD 30 with a downfolded arms 32n in a graduated tube 16 from the stem end 36 such that the arm ends 31 subsequently enter the graduated tube 16 with a minimal force such that the arm ends 31 are inside a graduated tube 16 up to the step 32S of the sleeve 26 on the IUD 30. Also, the graduated tube 16 is provided with measurement marks 14 so that the stopper 15 can be conveniently adjusted at precisely required position without needing measurement device and while the instrument 10 is in the transparent pouch 60.

[0052] The IUD 30 is parked in the downfolding device 20 with its arms 32 resting at the platform 34 and the stem 33 passing through the open channel 29 of the downfolding device 20. The IUD 30 is parked in the downfolding device 20 in the T shape which it is required to maintain inside uterus 50.

[0053] The downfolding device 20 is firmly disposed in a prescribed place in the transparent pouch 60. The prescribed place in the transparent pouch 60 is ensured by a tight fit of the downloading device 20 in the transparent pouch 60; or by thermally shrinking the thermoplastic sheath 39 around the downfolding device 20. As another embodiment, the prescribed place in the transparent pouch 60 is by a glue disposed between the base 37 of the downfolding device 20 and the back 40 of the transparent pouch 60.

[0054] The instrument 10 is packaged in sterile environment in the transparent pouch with a transparent cover 39 and a back 40. As a variation, the packaged instrument 10 is sterilized after packaging.

[0055] FIG. 11, the transparent pouch 60 is made of a thermoplastic sheath of thickness such that the downfolding device 20 when gripped firmly from an outside of the transparent cover 39 of the transparent pouch 60 can be gripped adequately. The upper enveloping surface 28 all over the downfolding device 20, being a smoothened surface devoid of sharp projection, facilitates such ripping without the thermoplastic sheath getting punctured or torn consequently. A shear strength of the thermoplastic sheath withstands expected transportation and storage abuse.

[0056] FIG. 10A-10E, to start the process of loading, the transparent cover 39 is partially separated (not explicitly shown such in these views) from the back 40 of the transparent pouch 60, only to be able to access and hold the near end opening 22 of graduated tube 16.

[0057] The downfolding device 20 is firmly held by one hand from outside the transparent cover 39 while the graduated tube 16 is pushed in. As a variation, the transparent pouch 60 is firmly held instead of the downfolding device 20.

[0058] As the graduated tube 16 starts pushing the IUD 30, the IUD 30 has to negotiate its shape due to the converging opening 23A in the downfolding device 20. Consequently, the arms 32 of the IUD 30 start folding towards the stem end 36, such partially folded arms 32a (FIG. 12). The downfolding device 20 guides the graduated tube 16 through towards the well 24 consequent to the open channel 29.

[0059] The depth of the well 24A of the well 24 of the downfolding device 20 is such that, as the graduated tube 16 continues to push the IUD 30, there comes a situation when a fundal end 32F of the IUD 30 gets stopped by the end 24C of the well 24, and the arms 32n of the IUD 30 become substantially in the same orientation as the stem 33 of IUD 30. The orienting step 61 ensures that the arms 32 always fold above the orienting step 61 in accordance with the downward triangular formation 51, and an upward triangular formation 52 is prevented (FIG. 9A, 9B).

[0060] At this situation, the arms 32 are captured in the far-end opening 22a by manual maneuvering of the graduated tube 16. The maneuvering essentially involves partially withdrawing the graduated tube 16 backwards out of the open channel 29 of the downloading device 20, angularly lifting the graduated tube 16 above the open channel 29, slightly turning it axially on either side so as to make the ends of the arm 32n (FIG. 12) of IUD 30 enter the far-end opening 22a of graduated tube 16 and finally pushing up the graduated tube 16 again. FIG. 10F, to take out the graduated tube 16 along with the captured IUD 30 out of the downfolding device 20, the graduated tube 16 is axially turned substantially by about 90 degrees on either side so that it can come out from the top of the downfolding device 20, clear of the projecting ridge 27.

[0061] The stopper 15 is adjusted to the required location 12 in accordance with the sounding measurement carried out independently, as is known.

[0062] The process thus far is carried out while the instrument is substantially inside the partially open transparent pouch 60. Consequently, the process is without direct manual touching and is therefore hygienic.

[0063] FIGS. 13, 14, the Instrument 10 is now fully withdrawn from the pouch and inserted in uterus 50 of the female till stopper 15 touch the external orifice of cervix. The graduated tube 16 is withdrawn, while the pushrod 17 is kept steady, thereby first releasing the arms 32n of the IUD 30 and then the stem 33 of the IUD 30 from the graduated tube 16. The folded arms 32n of IUD 30 return to its original shape of the arms 32. The graduated tube 16 is withdrawn out of the uterus 50. This two-stage withdrawal ensures that the IUD 30 is not disturbed by the withdrawal of the graduated tube 16.

[0064] Construction of the converging opening 23A of the downfolding device 20 is possible in different ways, by different radii or by providing a straight but angular slant, conceptually and eventually leading to folding of the arms 32 of IUD 30 at it is pushed inside the downfolding device 20.

[0065] As a variation, the maneuvering need not involve partially withdrawing of the graduated tube 16 backwards out of the open channel 29 of the downloading device 20, and the graduated tube 16 may still be angularly lifted above the open channel 29, since the root thickness 37B of the base 37 in-between the open channel 29 is minimal and consequently, the exit opening 48 increases by the base 37 flexing and or when a lower surface 37A of the base 37 is devoid of a firm support underneath.