DESC:Field of the invention
[001] The invention relates to a medical device, specifically, the invention relates to an
intrauterine device inserter.
Background
[002] Intrauterine device (IUD) placement is a medical procedure performed by medical
professionals. The use of IUDs is an effective and popular form of contraception. It is an
effective, easy to remove, satisfactory, and effort less method of reversible contraception
for long term use. At present two types of IUDs are commonly available - copper based IUDs
and hormonal IUDs. The IUD is placed in the uterus through a cervix with an inserter. Most
common inserters are constructed for introducing the device into the uterus in a contracted
state. These inserters usually comprise an insertion tube and a plunger/inner tube inside the
insertion tube. A string is attached to a proximal end of the IUD and extends through the full
or partial length of the insertion tube. This string is provided in IUDs for two reasons. Firstly,
it ensures the presence of the device in the body and secondly, the device is pulled out from
the body by pulling the string. The string is released either by pushing the plunger/inner
tube towards the uterus or by holding the plunger/ inner tube steady and by retracting the
insertion tube outwards. Once the device is out from the insertion tube within the uterine
cavity, the device is supposed to resume its original expanded shape.
[003] The inserters typically comprise some locking means for reversibly locking the
intrauterine system in relation to the plunger/inner tube, said locking means being
controllable by the slider and/or the insertion tube. Several mechanisms are currently
available to lock one end of the string of the inserter device. For example, in some devices,
the inserter end of the string is held by gears. Further, in some devices, the string is long due
to which it is necessary to cut the string via for example, a sharp object. Although all these
IUD insertion mechanisms work for their intended purpose, inserting these IUDs either
requires additional time.
Summary
[004] In an embodiment of the present disclosure an inserter is provided. The inserter
includes a handle having an upper cover and a bottom cover, the upper cover having a
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longitudinal opening, said opening having a longitudinal axis parallel to a longitudinal axis of
the inserter, a proximal end and a distal end; a mounting member extending from an inner
surface of the bottom cover of the handle, the mounting member having a through-hole; an
inner tube having a proximal end and a distal end, the proximal end of the inner tube
attached to the mounting member; an insertion tube movably coupled to the inner tube
with a longitudinal axis essentially parallel to a longitudinal axis of the inner tube, the
insertion tube having a proximal end and a distal end; a switch coupled to the proximal end
of the insertion tube and arranged in the longitudinal opening; and a string having a
proximal end and a distal end, the proximal end of the string removably coupled near the
proximal end of the opening, the distal end of the string coupled to a device to be inserted
inside a human anatomy.
[005] In accordance with another embodiment, a method of operating an inserter is
provided. The method includes the steps of introducing an insertion tube in a human
anatomy up to a predefined depth; moving a switch from a distal position to a proximal
positon, the movement of the switch exposes a device inside the human anatomy, the
device is connected to a distal end of a string; removing a safety knob that holds a proximal
end of the string; and withdrawing the insertion tube from the human anatomy leaving the
device inside the human anatomy.
[006] Other features of embodiments of the present disclosure will be apparent from
accompanying drawings and from detailed description that follows.
Brief Description of Drawings
[007] The summary above, as well as the following detailed description of illustrative
embodiments, is better understood when read in conjunction with the appended drawings.
For the purpose of illustrating the present disclosure, exemplary constructions of the
disclosure are shown in the drawings. However, the disclosure is not limited to specific
devices, methods and instrumentalities disclosed herein. Moreover, those in the art will
understand that the drawings are not to scale. Wherever possible, like elements have been
indicated by identical numbers.
[008] FIGs. 1A-1D depicts various exemplary two-dimensional representations of an
intrauterine device (IUD) inserter 100.
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[009] FIGs. 2A-2E provides exemplary illustrations of the assembly of the handle 10 of the
inserter 100.
[0010] FIG. 3 depicts a flowchart showing steps of operation of the device.
Detailed Description
[0011] Prior to describing the invention in detail, definitions of certain words or phrases
used throughout this patent document will be defined: the terms "include" and "comprise",
as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive,
meaning and/or; the phrases "coupled with" and "associated therewith", as well as
derivatives thereof, may mean to include, be included within, interconnect with, contain, be
contained within, connect to or with, couple to or with, be communicable with, cooperate
with, interleave, juxtapose, be proximate to, be bound to or with, have, have a property of,
or the like; Definitions of certain words and phrases are provided throughout this patent
document, and those of ordinary skill in the art will understand that such definitions apply in
many, if not most, instances to prior as well as future uses of such defined words and
phrases.
[0012] Wherever possible, same reference numbers will be used throughout the drawings
to refer to same or like parts. Moreover, references to various elements described herein
are made collectively or individually when there may be more than one element of the same
type. However, such references are merely exemplary in nature. It may be noted that any
reference to elements in the singular may also be construed to relate to the plural and viceversa
without limiting the scope of the disclosure to the exact number or type of such
elements unless set forth explicitly in the appended claims.
[0013] Particular embodiments of the present disclosure are described herein below with
reference to the accompanying drawings, however, it is to be understood that the disclosed
embodiments are merely examples of the disclosure, which may be embodied in various
forms. Well-known functions or constructions are not described in detail to avoid obscuring
the present disclosure in unnecessary detail. Therefore, specific structural and functional
details disclosed herein are not to be interpreted as limiting, but merely as a basis for the
claims and as a representative basis for teaching one skilled in the art to variously employ
the present disclosure in virtually any appropriately detailed structure.
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[0014] The present disclosure provides an easy to use inserter which can be assembled
easily for the insertion and to securely install and position an intrauterine system inside a
human anatomy.
[0015] The inserter according to the invention is suitable for the positioning of intrauterine
devices and intrauterine systems having different sizes and shapes. The inserter is especially
suitable for installing intrauterine devices having a flexible frame having for example
annular, circular, oval, spiral, toroidal, triangular, shield-like, almond-like, diamond-like,
elliptical or polygonal shape. The inserter may further comprise means for holding and
guiding the strings during the insertion so that no manual handling of said strings is needed.
[0016] In the present description and claims, the term proximal end refers to an end of an
element that is closer to a user of the inserter while the distal end refers to an end of the
element which is farther from the user of the inserter. Moreover, the terms IUS or IUD and
removal strings are used when describing the preferred embodiment of the present
invention, but these are not to be construed as limiting the claims.
[0017] FIG. 1A depicts a two-dimensional representation of an intrauterine device (IUD)
inserter 100. The inserter includes a handle 10, a safety knob 12, a switch 14, an insertion
tube 16, and a flange 18. The safety knob 12 and the switch 14 are provided with the handle
10 as explained below. The proximal end of the insertion tube 16 is enclosed inside the
handle 10 while the flange 18 is mounted on the tube 16.
[0018] The handle 10 has a distal end 10a, a proximal end 10b, an upper cover 10c (FIG. 1D)
and a bottom cover 10d (FIG. 1D). The handle 10 enables a surgeon or a user to grip and
operate the inserter 100. The upper cover 10c (FIG. 1D) of the handle 10 includes a
longitudinal opening 20. In the depicted embodiment, the opening 20 is shown to be
positioned in the mid-portion of the upper cover 10c (FIG. 1D) of the handle 10 parallel to
the longitudinal axis of the inserter. However, the opening 20 may be symmetrically or
asymmetrically positioned on the handle. Further, the width of the opening 20 can be
narrow or wide depending upon the size of the switch 14. The opening 20 has a distal end
20a and a proximal end 20b which act as the extreme positions to which the switch 14 can
be positioned (further explained in FIGs. 1B and 1C). The handle also preferably has a hole
(not shown) at its distal end 10a through which the insertion tube 16 passes and operatively
couples with the opening 20 via switch 14. The handle 10 can have many shapes and is
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designed for easy handling of the inserter 100 even by using only one hand. The handle 10
can be made of without limitation of acrylonitrile butadiene styrene (ABS), polypropylene,
high density polyethylene (HDPE), low density polyethylene (LDPE), polycarbonate,
polyvinylchloride (PVC) etc.
[0019] The safety knob 12 has a top end and a stem (not shown) coupled to the top end.
The stem (not shown) passes through a hole provided in the handle 10 further explained in
FIGs. 2A-2E. The safety knob 12 holds the proximal end of a string in position.
[0020] The movable switch 14 is arranged in the opening 20. The switch 14 can be moved in
the longitudinal direction of the insertion tube 16. Due to the movement of the switch 14,
the insertion tube 16 is extended or retracted thereby closing or exposing a T-frame
respectively. The switch can be made of plastic, polymer, etc. and can be of any shape
including without limitation square, rectangular, triangular, etc. According to an
embodiment of the present disclosure, the switch 14 comprises a means to move the slider,
which preferably is a part of the switch 14. According to another embodiment of the present
disclosure, the slider comprises at least two elements, preferably parallel, which are
combined on at least one point by a transversal member. The transversal member may form
means, for example a knob or switch, by which the slider can be moved. The handle can
comprise one or more means to adapt the slider elements and to facilitate the movement of
the switch, for example a support, a shoulder, a holder, a saddle, a groove or a slot.
[0021] The insertion tube 16 is a flexible and hollow tube whose proximal end is enclosed
inside the handle 10 while the distal end houses the T-frame. The tube 16 is moveably
coupled to the handle 10. In an embodiment, markings are provided on the tube 16 that
help a user to place the inserter at an accurate location inside a human anatomy. The tube
16 can be straight or curved tube so as to conform to the human anatomy. The insertion
tube is made of a relatively flexible material like polypropylene, low density polyethylene
(LDPE), polycarbonate, polyvinylchloride (PVC) etc.
[0022] The flange 18 is arranged around the distal end of the insertion tube 16 for marking
the depth up to which the inserter 100 is to be inserted inside a human anatomy. The flange
18 is a hollow circular structure that movable longitudinally over the insertion tube 16. To
ensure the correct positioning of the intrauterine system in the uterus, the flange 18 is
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adjusted to correspond to the depth at which the inserter 100 will be inserted, said depth
being beforehand determined by for example, using a sound or a probe.
[0023] In the FIG. 1A, the switch is positioned at the distal end 20a of the opening 20. In this
position, the insertion tube 16 is fully extended such that it covers the T-frame provided in
its lumen at the distal end 16a. The string (not shown) is held by the safety knob 12.
[0024] FIG. 1B depicts the intrauterine device (IUD) inserter 100 with the switch 14
positioned mid-way between the extreme ends of the opening 20 as denoted by the arrow
40. This may be referred as an initial position. In this position, the insertion tube 16 is not
fully extended and the wings of the T-frame are exposed.
[0025] FIG.1C depicts the intrauterine device (IUD) inserter 100 with the switch 14
positioned at the proximal end 10b of the handle 10. In this position, the insertion tube 16 is
fully retracted due to which the T-frame is completely exposed. The T-frame is a device with
two wings mounted on and extending away from a tube and contains a drug to be
periodically released with the human anatomy where the T-frame is placed. The T-frame
depicted on the figures is exemplary and can be replaced by any known T-frames that serve
the desired purpose.
[0026] FIG. 1D depicts the three-dimensional assembly of the inserter 100. In this figure, the
upper cover 10c and a bottom cover 10d of the handle 10 are clearly illustrated. Within the
two covers, the internal assembly of various components is provided and explained with
reference to the figures below.
[0027] FIGs. 2A-2E provides exemplary illustrations of the assembly of the handle 10 of the
inserter 100.
[0028] FIG. 2A depicts the inner portion of the bottom cover 10d of the inserter’s handle 10.
The inner portion includes multiple holes/protrusions 22, a knob hole 24, a mounting
member 26, and an inner tube 28. The holes/protrusions 22 are provided at the inner
periphery of the bottom cover 10d. The number of holes/protrusions 22 may vary. The
holes/protrusions 22 mate with the corresponding protrusions/holes provided on the inner
periphery of the upper cover 10c while assembling the handle 10.
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[0029] The knob hole 24 is provided to mate with the stem of the safety knob 12. A string
attached to the proximal end of a T-frame 32 (FIG. 2B) is wound around the knob hole 24 to
hold the T-frame 32 (FIG. 2B) in position.
[0030] The mounting member 26 is provided in close vicinity of the knob hole 24. In an
embodiment, the mounting member 26 contains a through-hole via which the proximal
portion of the string of the T-frame 32 (FIG. 2B) passes before being wound around the knob
hole 24. The mounting member 26 is made of a rigid material like acrylonitrile butadiene
styrene (ABS), polypropylene, high density polyethylene (HDPE), low density polyethylene
(LDPE), polycarbonate, polyvinylchloride (PVC), etc.
[0031] The inner tube 28 has a proximal end 28a and a distal end 28b. The proximal end 28a
of the inner tube 28 is fixedly attached to the mounting member 26. Alternately, the inner
tube 28 may be removably attached to the mounting member 26. The inner tube 28 is
hollow and contains a lumen through which the string of the T-frame 32 (FIG. 2B) passes.
The proximal end of the string passes through the proximal end 28a of the inner tube 28 and
then the through-hole of the mounting member 26. In an embodiment, the inner tube 28
contains a slot 30 that extends through the majority of the length of the tube 28. The slot 30
allows the string to slide freely in it, without any risk of them getting jammed between the
inner tube 28 and the insertion tube.
[0032] In an embodiment, to enable the optimal and secure positioning of the intrauterine
system in the inserter 100, the distal end of the inner tube 28 is shaped to the form of a slot
or an extension to adapt the reservoir of the intrauterine system. This ensures that the
intrauterine system, namely, the T-frame does not drop or be twisted during insertion
procedure and assumes a specified constant configuration when released.
[0033] FIG. 2B illustrates the assembly of FIG. 2A with the T-frame 32. As stated above, the
T-frame 32 is provided at the distal end 28b of the inner tube 28. The string of the T-frame
32 passes through a lumen of the inner tube 28, then the through-hole of the mounting
member 26 and is finally wound around the knob hole 24. The string is closed at the
proximal end via for example, a knot, gluing, bonding, etc. In an embodiment, the length of
the string is so selected that it corresponds to the summation of the length of the inner tube
28, width of the mounting member 26 and the distance between the mounting member 26
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and knob hole 24. This ensures that the T-frame 32 is held in position without the chances
of the string being dislocated.
[0034] FIG. 2C depicts the assembly of FIG. 2B with the insertion tube 16. The insertion tube
16 has a lumen through which the inner tube 28 is passed. The insertion tube 16 is slidably
coupled to the inner tube 28. In an embodiment, the length of the inner tube 28 and the
insertion tube 16 is same. Further, at the proximal end 16a of the insertion tube 16, the
switch 14 is fixedly attached. As shown, when the switch 14 is positioned at the distal end
20a of the opening 20, the insertion tube 16 is in the extended position and covers the Tframe
32 entirely.
[0035] FIG. 2D depicts the assembly of FIG. 2C with the insertion tube 16 completely
retracted. In this position, the switch 14 is positioned at the proximal end 20b of the
opening 20. Due to this, the insertion tube 16 completely covers the inner tube 28 enabling
the T-frame 32 to expand completely.
[0036] It may be seen from FIGs. 2C and 2D that while there is relative movement between
the two tubes 16 and 28, the movement does not dislocate the string 34 connected to the Tframe
32 rather the string 34 is held in place. Further, the string does not tangle with any
part/component of the device due to the tension in the string.
[0037] FIG. 2E illustrates the final step of the assembly of the device handle 10. The bottom
cover 10d of the inserter’s handle 10 of FIG. 2C/2D is closed by the upper cover 10c. The
protrusions/holes of the upper cover 10c mate with the corresponding counterparts of the
bottom cover 10d and hold the internal assembly in place. Thereafter, the safety knob 12 is
inserted in the corresponding hole on the upper cover 10c, the stem of which mates with
the knob hole 24 of the bottom cover 10d. The inserter 100 is completely assembled.
[0038] FIG. 3 depicts a flowchart showing steps of operation of the device. At 302, the
flange is positioned at the desired marking provided on the insertion tube. The depth of the
human anatomy is determined and accordingly, the position of flange is decided. At step
304, the distal end of the insertion tube is inserted inside the human anatomy till the flange
touches the human anatomy. The insertion tube cannot be pushed further thereafter.
Before the tube is inserted, the switch is positioned at the distal end of the opening due to
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which the insertion tube completely surrounds the T-frame and is easy to insert inside the
human anatomy.
[0039] At step 306, the switch is moved from the distal end of the opening towards the
proximal end of the opening. As explained in the figures above, this is achieved due to the
sliding movement of the switch. However, other means of moving the switch are within the
teachings of the present disclosure. Due to the sliding movement, the T-frame expands
inside the human anatomy at the inserted location.
[0040] At step 308, the safety knob is lifted which leads to the tied end of the string being
released. As the inserter is withdrawn from the human anatomy, the string along with the Tframe
remains positioned inside the desired location. In case the length of the string
exceeds the required length, the extra length can be cut.
[0041] From the above, it may be seen that the entire assembly as well as operation of the
inserter is highly simplified and does not require highly technical components. Due to this
simplified assembly, it is very easy for a surgeon to use the inserter for the intended
purpose.
[0042] Various modification or additions to the above disclosure are feasible and fall within
the teachings of the present disclosure. For example, an illumination source may be coupled
to the distal end of the insertion tube. Alternately, the inner tube may not contain a slot.
[0043] It will be apparent from the foregoing that, while particular forms of the invention
have been illustrated and described, various modifications can be made without departing
from the spirit and scope of the invention. Accordingly, it is not intended that the invention
be limited, except as by the appended claims. ,CLAIMS:An inserter comprising:
a. a handle having an upper cover and a bottom cover, the upper cover having a
longitudinal opening, said opening having a longitudinal axis parallel to a
longitudinal axis of the inserter, a proximal end and a distal end;
b. a mounting member extending from an inner surface of the bottom cover of
the handle, the mounting member having a through-hole;
c. an inner tube having a proximal end and a distal end, the proximal end of the
inner tube attached to the mounting member;
d. an insertion tube movably coupled to the inner tube with a longitudinal axis
essentially parallel to a longitudinal axis of the inner tube, the insertion tube
having a proximal end and a distal end;
e. a switch coupled to the proximal end of the insertion tube and arranged in
the longitudinal opening; and
f. a string having a proximal end and a distal end, the proximal end of the string
removably coupled near the proximal end of the opening, the distal end of
the string coupled to a device to be inserted inside a human anatomy.
2. The inserter as claimed in claim 1, wherein the inner tube comprises a lumen
through which the string is passed.
3. The inserter as claimed in claim 1, wherein the string passes through the throughhole.
4. The inserter as claimed in claim 1, wherein the inserter comprises a safety knob
removably coupled to the proximal end of the string, the safety knob holds the string
in place.
5. The inserter as claimed in claim 1, wherein the inserter comprises a flange mounted
on the insertion tube to provide an indication of the depth of a human anatomy in
which the insertion tube is to be inserted.
6. A kit comprising an intrauterine device and an inserter as claimed in clam 1.
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7. A method of operating an inserter, the method comprising:
a. moving a switch to a distal end of an opening;
b. introducing an insertion tube in a human anatomy up to a predefined depth;
c. moving the switch from the distal end to a proximal end of the opening, the
movement of the switch exposes a device inside the human anatomy, the
device is connected to a distal end of a string;
d. removing a safety knob that holds a proximal end of the string; and
e. withdrawing the insertion tube from the human anatomy leaving the device
inside the human anatomy.