APPARATUS FOR LOADING, INSERTION AND PLACEMENT OF AN INTRAUTERINE CONTRACEPTIVE DEVCE AND PROCESS THEREOF
20180207023 ยท 2018-07-26
Assignee
Inventors
Cpc classification
International classification
Abstract
A process and an apparatus for loading, insertion and placement of an intrauterine contraceptive device (IUD) for its proper and hygienic placement in the uterus, the apparatus in a sterile pouch having a transparent cover and a base; the apparatus having a loader with a passage having a first opening and a second opening running along its elongated body, a graduated tube mounted onto loader through its second opening, an IUD and a push rod miming inside the graduated tube. The IUD is parked in the loader in an expanded condition, required to maintain inside the uterus. The loader has a guide means forming the front portion of the loader and pusher means forming rear portion of the loader. A platform connects the guide means and the pusher means of the loader. The passage runs along an elongated body of the loader.
Claims
1. An apparatus for loading, insertion and placement of an intrauterine contraceptive device (IUD) in uterus, comprising: a loader with a passage having a first opening and a second opening running along its elongated body; a graduated tube mounted onto loader through its second opening; a push rod running inside the graduated tube; an IUD in an expanded condition parked in the loader; in a sterile pouch having a transparent cover and a base holding the loader having the IUD parked and slidably mounted onto the graduated tube along with the push rod.
2. The apparatus as claimed in claim 1, wherein said loader is slidably mounted onto the graduated tube.
3. The apparatus as claimed in claim 1, wherein said loader has a length dimension of a guide means coordinated with the differential distance between a distal end of the graduated tube and a root of a handle of the push rod, when a tip of the push rod touches a bulging end of the IUD, in order to achieve a position P2 when the IUD just starts projecting out from the first opening of the loader.
4. The apparatus as claimed in claim 1, wherein said IUD is parked at a platform of the loader.
5. The apparatus as claimed in claim 1, wherein said graduated tube has a measurement markings provided on its outer surface.
6. The apparatus as claimed in claim 1, wherein said push rod has a localized projection to facilitate retention of the push rod inside the graduated tube.
7. The apparatus as claimed in claim 1, wherein said loader has a stopping face at its front end facilitates as a measurement reference and as a stopper.
8. The apparatus as claimed in claim 7, wherein said stopping face forms a part of the loader.
9. The apparatus as claimed in claim 7, wherein said stopping face is provided as a separate component.
10. A loader for loading of an intra-uterine contraceptive device (IUD) having an arms and a stem, in graduated tube, comprising: a guide means has a first opening at a stopping face, forming a front portion of the loader; a pusher means has a second opening at its rear end, forming a rear portion of the loader; a platform connects the guide means of the loader to the pusher means of the loader; a passage running from the first opening of the guide means to the second opening of the pusher means along an elongated body of the loader; and a pair of C shaped exits on either side at the rear end of the guide means of the loader onto which the arms of an IUD rests while in an expanded condition.
11. A loader for loading of an intra-uterine contraceptive device (IUD) having an arms and a stem, in graduated tube, comprising: a guide means has a first opening at a stopping face, forming a front portion of the loader; a pusher means has a second opening at its rear end, forming a rear portion of the loader; a platform connects the guide means of the loader to the pusher means of the loader; a passage running from the first opening of the guide means to the second opening of the pusher means along an elongated body of the loader; an IUD retainer in a vicinity at a rear end of the guide mean; and a pair of C shaped exits on either side at the rear end of the guide means of the loader onto which the arms of an IUD rests while in an expanded condition.
12. The loader as claimed in claim 11, wherein said IUD retainer has a cantilever formed by providing slits on an upper surface of the loader towards pusher means.
13. The loader as claimed in claim 12, wherein said cantilever has teeth at its free end.
14. The loader as claimed in claim 13, wherein said teeth at its edge has an angle of 20 degree to 70 degree with respect to the platform.
15. The loader as claimed in claim 10 or claim 11, wherein said passage in the guide means begins from the pair of C shaped exits and converges to the first opening forming a negotiation passage.
16. The loader as claimed in claim 15, wherein said negotiation passage has a converging curved shape.
17. The loader as claimed in claim 15, wherein said negotiation passage has a straight and an angular slant shape.
18. The loader as claimed in claim 10 or claim 11, wherein said passage in the pusher means forms a tubular passage.
19. The loader as claimed in claim 10 or claim 11, wherein said first opening of the guide means has an area of cross section substantially same as an area of cross section of second opening of the pusher means.
20. The loader as claimed in claim 10 or claim 11, wherein said first opening has a non-circular cross section having a top that is flattened and a bottom slightly projected.
21. The loader as claimed in claim 10 or claim 11, wherein said first opening has a circular cross section.
22. The loader as claimed in claim 10 or claim 11, wherein said stopping face is a measurement reference for a sounding and a stopper.
23. The loader as claimed in claim 10 or claim 11, wherein said guide means of the loader and said pusher means of the loader are separate components.
24. The loader as claimed in claim 10 or claim 11 wherein the loader has an overall width and an overall height constrained to a minimum size, which can easily enter a vaginal cavity, after the vaginal cavity is stretched open for the IUD implantation, the overall width of the loader is less than 18 mm and the overall height of the loader is less than 12 mm.
25. A process of loading an IUD using a loader, the process comprising the steps of: separating, partially, a transparent cover from a base of a sterile pouch, to be able to access and hold a handle of a push rod and a graduated tube. holding a holding faces of a guide means, forming a front portion of the loader or a holding faces of a pusher means, forming a rear portion of the loader with one hand; pushing the graduated tube, till its proximal end is slightly ahead of a front opening of a tubular passage of the pusher means of the loader; pushing the push rod in the graduated tube; advancing the graduated tube towards a first opening at a front end of the guide means with a force F leading to an entry of the graduated tube into a negotiation passage; accommodating an arms and a stem of the IUD at a proximal end of the graduated tube; pushing the graduated tube outside the first opening at the front end of the guide means such that the graduated tube comes out of the first opening along with a captured IUD.
26. A process of loading an IUD using a loader, the process comprising the steps of: separating, partially, a transparent cover from a base of a sterile pouch, to be able to access and hold a handle of a push rod and a graduated tube. holding a holding face of the guide means or a holding faces of the pusher means with one hand; pushing the graduated tube, till its proximal end touches an edge of a teeth of a cantilever of an IUD retainer; pushing the push rod in the graduated tube; advancing the graduated tube towards a first opening at a front end of a guide means of the loader, with a force F leading to an entry of the graduated tube into a negotiation passage; accommodating an arms and a stem of the IUD at a proximal end of the graduated tube; pushing the graduated tube outside the first opening at the front end of the guide means such that the graduated tube comes out of the first opening along with a captured IUD.
27. The process of loading as claimed in claim 26, wherein, said teeth of the cantilever acts as an initial stopper for the graduated tube.
28. The loader as claimed in claim 26, wherein said teeth of the cantilever prevents the stem of the IUD from bending during a loading process.
29. The process of loading as claimed in claim 26, wherein advancing the graduated tube with the force F acting on the edge of the teeth leads to a lifting up of the cantilever providing a way for the graduated tube into the negotiation passage.
30. The process of loading as claimed in claim 26, wherein advancing the graduated tube into the negotiation passage allows the arms and the stem of the IUD to enter the graduated tube as the arms and the stem of the IUD are substantially in a same orientation.
31. The process of loading as claimed in claim 25 or claim 26, wherein said pushing of the push rod, pushes a bulging end of the IUD resting on a platform to enter into the negotiation passage.
32. The process of loading as claimed in claim 31, wherein entering of the IUD into the negotiation passage allows the IUD to negotiate its shape and initiates folding of the arms of the IUD.
33. The process of loading as claimed in claim 25 or claim 26, wherein said pushing of the push rod allows the handle of the push rod to change from a position P to a position P1.
34. The process of loading as claimed in claim 25 or claim 26, wherein said pushing of the push rod is to visualize a smooth curve of the IUD when it just starts projecting out from the first opening.
35. The process of loading as claimed in claim 25 or claim 26, wherein said pushing of the push rod is to touch a root of the handle of the solid rod to a distal end of the graduated tube to attain a position P2.
36. The process of loading as claimed in claim 25 or claim 26, wherein said pushing of the push rod is to visualize of a smooth curve of the IUD when it just starts projecting out from the first opening and touch a root of the handle of the solid rod to a distal end of the graduated tube to attain a position P2.
37. The process of loading as claimed in claim 25 or claim 26, wherein the loading, that is, folding of arms of IUD is such that the folded arms are towards the upper surface of the loader and the stem of the IUD is towards the lower surface of the loader.
38. A process of insertion and placement of an IUD in a uterus, the method comprising the steps of: adjusting a stopping face of the loader on measurement markings of the graduated tube on its outer surface; removing a loaded apparatus i.e. the graduated tube along with the captured IUD in the orifice at its proximal end coming out of a first opening of the loader, from the pouch for a process of insertion; inserting the loaded apparatus till the stopping face touches an external cervical os of the uterus; withdrawing the graduated tube gradually, keeping the push rod steady, to first free the arms of the IUD from the graduated tube; withdrawing the push rod along with the graduated tube completely from the uterus.
Description
BRIEF DESCRIPTION OF DRAWINGS
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DETAILED DESCRIPTION OF INVENTION
[0070] The preferred embodiment of an apparatus and a loader as per our invention shall now be described in detail, with reference to the accompanying drawings. The terms and expressions which have been used here are merely for description but the invention can be worked with several variations and the terms and expressions should not be construed to be limiting the invention in any way.
[0071] According to a preferred embodiment of present invention,
[0072] As shown in
[0073]
[0074] The guide means (1) has a stopping face (7) at its front end (11) which forms a part of the loader (20), acts as a measurement reference for sounding and also acts as a stopper of the loader (20) at cervical os. The guide means (1) has an IUD retainer (24) in a vicinity of its rear end (17).
[0075] As shown in
[0076] The teeth (25) of the IUD retainer (24) perform any or all of the following three functions: [0077] 1. hold the arms (32) of an IUD (30) while in expanded condition, in the pair of C-shaped exits (15), [0078] 2. act as an initial stopper for the graduated tube (40). [0079] 3. prevent the stern (33) of the IUD (30) from bending during the loading process.
[0080] The passage (9) has a first opening (12) on the stopping face (7), a second opening (14) at the rear end of the pusher means (13), and a pair of C-shaped exits (15) on either sides at the rear end (17) of the guide means (1) of the loader (20), as seen in
[0081] The passage (9) within the guide means (1) that is, between the first opening (12) of the guide means (1) and the pair of C shape exit (15) at rear end (17) of the guide means (1) is called as a negotiation passage (9a), whereby the folding of the arms (32) of the IUD (30) takes place by way of the arms (32) of the IUD (30) negotiating its way forward and get bent as a force pushes the IUD (30) into the negotiation passage (9a). The passage (9) within the pusher means (2) i.e. between front opening (18) of the pusher means (2) and second opening (14) of the pusher means (2) is called as a tubular passage (9b). The passage (9) runs along the elongated body of the loader (20) from the first opening (12) of the guide means (1) to the second opening (14) of the pusher means (2) as shown in
[0082] As seen in
[0083] The first opening (12) which thus has the non-circular cross-section with the top flattened (46) and the bottom slightly projected (47) enables a loading, that is, folding of arms (32) of IUD (30) such that the arms (32n) are always towards the upper surface (21) of the loader (20) and the stem (33) of the IUD (30) is always towards the lower surface (not numbered) of the loader (20) as shown in
[0084] As
[0085] The IUD (30) is thus parked on the platform (4), the arms (32) of the IUD (30) getting accommodated in the pair of C-shaped exits (15).
[0086] As shown in
[0087] As shown in
[0088] When the apparatus (10) is in a sterilized transparent pouch (5) as received, the graduated tube (40) is mounted in the loader (20) up to the platform (4), such that it partly remains in the tubular passage (9b) of the passage (9) while remaining portion of the graduated tube (40) extends outside from the second opening (14) on the rear end (13) of the pusher means (2). The graduated tube (40) is provided with a measurement markings (43) on its outer surface, to facilitate the positioning of the stopping face (7). The IUD (30) is parked at the platform (4). The stem (33) partially and the strings (34) fully are accommodated inside the graduated tube (40). The push rod (50) that runs inside the graduated tube (40), is kept such that a tip (42) of the push rod (50) stays slightly away from, or barely touches, the bulging end (35) of the stem (33) of the IUD (30) as shown in
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[0092] Pushing in the graduated tube (40) till its proximal end (23) touches the edge (29) of the teeth (25) of the IUD retainer (24). [0093] Pushing in the push rod (50) in the graduated tube (40). The tip (42) of the push rod (50) in turn pushes the bulging end (35) of the IUD (30) that rests on the platform (4) of the loader (20). The IUD (30) starts entering the negotiation passage (9a) but the arms (32) of the IUD (30) face minimal resistance due to the converging curved shape of the negotiation passage (9a). As a result of the pushing by the push rod (50), the arms (32) of the IUD (30) negotiate their shape and consequently, the arms (32) of the IUD (30) now starts folding. At this stage the position P of the handle (52) of the push rod (50) changes to a position P1, as shown in
This completes the process of process of loading.
[0098] The stopping face (7) is then adjusted on the measurement markings (43) of the graduated tube (40) to a predetermined position for the insertion according to the depth of the uterus (60) in accordance with the sounding measurement carried out independently as is known as shown in
[0099] The process thus far is carried out while the apparatus (10) is inside the partially open pouch (39, 45). Consequently, the IUD (30) is loaded without human touch to avoid possible infection during insertion.
[0100] The graduated tube (40), along with the IUD (30) loaded, is inserted inside the uterus (60) till stopping face (7) touches the external cervical os (53) of the woman.
[0101] The inserted graduated tube (40) is then gradually withdrawn; keeping the push rod (50) steady, to first free the arms (32n) of the IUD (30) and then release the IUD (30) from the graduated tube (40), while the IUD (30) stays in the position due to the tip (42) of the push rod (50) firmly butting on the bulging end (35) of the stem (33) of the IUD (30).
[0102] Consequent to a well-known memory feature of the thermoplastic materials, the arms (32) of the IUD (30) return back to the expanded condition, that is, T shape, leading to placement of IUD (30) in the uterus (60). The push rod (50) along with the graduated tube (40) is then withdrawn out of the uterus (60).
[0103] This two-stage withdrawalfirst only the graduated tube (40) keeping the push rod (50) steady, and then the apparatus (10), ensures that the IUD (30) is not disturbed by the withdrawal of the graduated tube (40), as shown in
[0104] Since the loader (20) is required to enter the vaginal cavity (54) in order to ensure that the stopping face (7) touches the cervical os, it is important to ensure that an overall width (410) and an overall height (480) of the loader are constrained to a minimum size, which can easily enter the vaginal cavity (54), after the vaginal cavity (54) is stretched open for an IUD (30) implantation, as is a known practice. The overall width (41) of the loader (20) is preferably less than 18 mm and the overall height (48) of the loader (20) is less than 12 mm.
[0105] Construction of the different parts of the loader (20) is possible in different ways, for example, the passage (9) could be or by providing a straight but angular slant instead of converging curve as negotiation passage (9a), conceptually and eventually leading to folding of the arms (32) of IUD at it is pushed inside the loader (20).
[0106] The negotiation passage (9a) which begins as two C-shaped exits (15) on either side of the loader (20) and converges into a first opening (12) whose area of cross-section is substantially same as that of the second opening (14) of the pusher means can be circular, as another embodiment and as shown in
[0107] The loader (20) as another embodiment can be without an IUD retainer (24) as shown in
[0116] As another embodiment, the stopping face (7) is in the form of a separate component (70) as shown in
[0117] As another embodiment, the measurement marks (43) may not be there on the graduated tube (40) and the measurement may be done with a separate measurement device.
[0118] As another embodiment the guide means (1) of the loader (20) and the pusher means (2) of the loader (20) can be separate components as shown in