U.S. patent number 3,880,156 [Application Number 05/308,596] was granted by the patent office on 1975-04-29 for inserter for contraceptive device.
Invention is credited to Seymour Hoff.
United States Patent |
3,880,156 |
Hoff |
April 29, 1975 |
**Please see images for:
( Certificate of Correction ) ** |
Inserter for contraceptive device
Abstract
A one piece inserter for a medical device such as an
intrauterine contraceptive device is provided. The inserter has a
leading end and a trailing end with the leading end comprised of a
smaller cross sectional area than the trailing end. The leading end
has both a notch and a hollowed internal area for receiving a part
of an intrauterine device in cooperation with the smaller area
adapted to receive in axial alignment the remainder of the device
in nested relation with the inserter. The inserter intrauterine
contraceptive device combination provides an assembly of reduced
volume that permits easy movement through the cervical canal into
the uterus for effectively positioning the intrauterine
contraceptive device.
Inventors: |
Hoff; Seymour (San Jose,
CA) |
Family
ID: |
23194593 |
Appl.
No.: |
05/308,596 |
Filed: |
November 21, 1972 |
Current U.S.
Class: |
128/840 |
Current CPC
Class: |
A61F
6/18 (20130101) |
Current International
Class: |
A61F
6/00 (20060101); A61F 6/18 (20060101); A61f
005/46 () |
Field of
Search: |
;128/127,128,129,130 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Dunne; G. F.
Attorney, Agent or Firm: Parrott, Bell, Seltzer, Park &
Gibson
Claims
What is claimed is:
1. A one piece inserter for an intrauterine contraceptive device
comprising a transverse member and a leg member depending
therefrom, wherein the inserter essentially consists of:
a. an elongated rounded member having a leading end and a trailing
end distant from the leading end,
b. a receiving notch in the terminus of the rounded member at its
leading end, said notch adapted to orient the intrauterine device
and to receive a part of the intrauterine contraceptive device,
c. a hollowed area continuous with the notch internally extended
within the rounded member a sufficient length and adapted to
receive internally a part of the intrauterine contraceptive device
when a device is positioned in the notch,
d. and wherein the rounded member at its leading end has a smaller
circumference than the trailing end which smaller circumference is
extended along a section of the member, with the smaller
circumference exteriorly forming a reduced leading end adapted to
exteriorly receive a part of the intrauterine contraceptive device
in nested relation to the reduced leading end of the rounded member
when an intrauterine contraceptive device is placed in the notch
and hollowed area of the single piece inserter.
2. The inserter for inserting an intrauterine contraceptive device
according to claim 1 wherein the inserter further comprises a stop
member on the elongated rounded member for limiting the depth of
the inserter when the inserter is subsequently used for positioning
an intrauterine contraceptive device in a uterus.
3. The inserter for inserting an intrauterine contraceptive device
according to claim 1 wherein the elongated member is hollowed from
its leading end to its trailing end.
4. A single piece inserter for an intrauterine contraceptive device
and an intrauterine contraceptive device essentially shaped like a
"T" essentially consisting of in combination:
a. a tubular member having a leading end and a trailing end distant
from the leading end and made from a biologically inert acceptable
material,
b. a notch in the leading end at the terminus of the tubular member
as a means for positioning and housing a part of an intrauterine
contraceptive device in the inserter,
c. a hollowed internal area formed by the inner surface of the wall
of the tubular member with the area extended from the notch at the
leading end for internally receiving in cooperation with the notch
a part of an intrauterine contraceptive device,
d. a section of smaller circumference extended along the exterior
of the tubular member from its leading end for exteriorly closely
receiving in cooperation with the notch and the internal hollowed
area a part of an intrauterine contraceptive device, and wherein
the inserter houses in nested relation,
e. an intrauterine contraceptive device shaped like a "T" having a
cross bar and depending leg with the depending leg in the hollowed
area, the cross bar in the notch and for downwardly positioning
along the smaller circumference of the one piece inserter.
Description
BACKGROUND OF THE INVENTION
The present invention relates to a novel and useful inserter for
placing an intrauterine device within a uterus. More specifically,
the invention relates to an improved one piece inserter which can
be easily loaded with an intrauterine device with little handling
and inserted within the uterus for easily positioning an
intrauterine device in the uterus with both a minimum of trauma and
risk of perforation of the uterine wall.
Inserters for placing an intrauterine device in a uterus are known
to the prior art. Generally, these inserters were of various shapes
and they consisted of two pieces, a tube or cannula and a plunger
or rod. While these inserters have enjoyed wide usage, several
major disadvantages were associated with their use. For example,
one disadvantage is that the inserters were hard to load because
they required that the intrauterine device be collapsed and forced
into the cannula which is often time consuming and difficult.
Another disadvantage inherent in the two piece inserters is that
they required a high degree of manual dexterity to assure that the
intrauterine device is effectively pushed from the cannula without
changing the preselected shape of the device. The major
disadvantage associated with the use of a two piece inserter is
that they do not provide for the automatic self release of the
device from the inserter in the uterus. That is, with a two piece
inserter it is always necessary that the device be pushed from the
inserter with the rod. Frequently, the rod is pushed too far which
leads to perforation of the uterine wall. Additionally, these prior
art assemblies comprised of an inserter and device have a large
volume, and when they are presented to the cervical canal and the
uterus there is a resultant unwanted incident of pain and trauma
accompanying their use.
SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to provide an
inserter for placing an intrauterine device in the uterus that
overcomes the disadvantages associated with the prior art.
It is a further object of the invention to provide a one piece
inserter for placing an intrauterine contraceptive device in a
female uterus which inserter is easily loaded, is easy to handle,
and easy to use for positioning the intrauterine device in the
uterus.
Another object of the invention is to provide an inserter for
holding an intrauterine contraceptive device which inserter self
releases the device in the uterus as the inserter is withdrawn
therefrom.
Yet still another object of the invention is to make available to
the art a novel and useful unit construction inserter that can be
used with safety and with a minimum of risk of perforation of the
uterine wall, and essentially free from pain and trauma.
Still a further object of the invention is to provide an inserter
that can be easily manufactured from either a single use disposable
material or from a material that lends itself to repeated use.
It is another object of the invention to provide an inserter that
can be easily removed after placing a device in the uterus.
Yet another object of the invention is to provide an inserter
intrauterine device dombination that has a smaller volume thereby
requiring a space smaller than the cervical os, cervical canal and
the uterus to substantially lessen the incident of pain and trauma
associated with placing within the female uterus an intrauterine
contraceptive device.
These and other objects of this invention will become more apparent
from the following detailed description of the invention taken in
connection with the drawings and the accompanying claims.
BRIEF DESCRIPTION OF THE DRAWINGS
In the drawings, which are not drawn to scale, but rather are set
forth to illustrate various embodiments of the invention, the
drawings are as follows:
FIG. 1 is a view illustrating the improved inserter of the
invention.
FIG. 2 is an illustration of one type of intrauterine device that
can be placed in a uterus with the inserter of the invention.
FIG. 3 illustrates an intrauterine device nested in a notch located
in the leading end of an inserter.
FIG. 4 illustrates an intrauterine contraceptive device nested in
the inserter.
FIG. 5 depicts a method of placing an intrauterine contraceptive
device in a female uterus illustrating an inserter intrauterine
contraceptive device combination with the arms of the device moving
toward the smaller area of the inserter as the combination enters
the cervical os.
FIG. 6 illustrates in combination an inserter intrauterine
contraceptive device with part of the device nested in the inserter
and the remainder thereof linearly received by the smaller end of
the inserter.
FIG. 7 is a sketch of the inserter of the invention positioning an
intrauterine contraceptive device in a uterus as the inserter is
withdrawn therefrom.
In the drawings and specification, like parts in related figures
are identified by like numbers. The terms appearing earlier in the
specification and in the description of the drawings, as well as
embodiments thereof, are further described elsewhere in the
disclosure.
DETAILED DESCRIPTION OF THE INVENTION
Turning now to the drawings in detail, which are examples of the
article of manufacture of the invention and which are not to be
construed as limiting, one embodyment of an inserter is indicated
in FIG. 1 by the numeral 10. Inserter 10 is a tubular member or rod
member having a leading end 11 and a trailing end 16. Inserter 10
at leading end 11 has a receiving area 12, shaped like a notch, a
half square, a half rectangle, a half circle, or other geometric
configuration suitable for holding and freely releasing an
intrauterine device. Inserter 10 at end 11 has an internal hollow
area 13 continuous with recess area 12 for slidably receiving
within the inserter an intrauterine device. Hollow area 13 is seen
in dashed lines and it can have various embodiments. For example,
in an inserter manufactured from a tubular material hollowed area
13 can extend the length of the inserter, as seen in FIG. 1, or in
an inserter manufactured from a rod like material hollowed area 13
internally extends at least a distance continuous from the recess
area, not shown in FIG. 1, sufficient to internally house and
easily release an intrauterine device.
Inserter 10 is further uniquely characterized as comprised of two
integrally formed sections with each section having a different
diameter. That is, inserter 10 has a section of larger diameter 14
and a section of smaller diameter 15 that merge to form a single
piece inserter 10. Larger diameter 14 extends substantially
throughout the length of the inserter from the trailing end 16 to
the point where it merges with the section of smaller diameter 15.
Smaller diameter 15 arises at leading end 11 and it extends toward
larger diameter 14 and trailing end 16. Smaller diameter 15 is of a
smaller circumference and occupies a lesser amount of space since
it is designed for closely receiving parts of an intrauterine
device, not seen in FIG. 1, in close contact to inserter 10. This
closeness or effective use of space facilitates the advance of the
device through the cervical canal and positioning in the uterus of
the intrauterine device, while at the same time it minimizes the
likelihood of injury or pain which frequently occurs with prior art
devices. That is, inserter 10, at area 15, has a smaller mass,
thereby requiring a smaller space as the inserter travels through
the cervical os, the cervical canal into a female uterus.
Inserter 10 of the invention can be manufactured from any suitable
material, and the material can be of naturally occurring or
synthetic origin. Exemplary materials include poly(olefins) such as
poly(ethylene), poly(propylene), nylon, or any suitable
commercially available plastic, surgical steel, or the like. The
inserter can be made by techniques standard in the art such as
parison forming, extrusion, casting and the like. Inserter 10 is
about 20 to 40 cm long with the larger section having a diameter of
about 4 to 8 mm, and the smaller section having a diameter of 2 to
3.5 mm, with the length of the smaller section about 12 to 20 mm.
Of course these dimensions are representative of a presently
preferred inserter, as other inserters of larger or smaller
dimensions in like proportions are embraced within the scope of the
invention.
FIG. 2 illustrates a conventional intrauterine device that can be
easily and efficiently positioned in a uterus with inserter 10 of
the invention. In FIG. 2, there is depicted an intrauterine device
20 shaped like a "T", and it is similar to the "T" described in
U.S. Pat. No. 3,533,406. The "T" is comprised of a top cross bar
identified by 21 and 22 of about 3 to 5 cm in length and a
depending leg 23 of about 3 to 5 cm in length. The inserter of the
invention can be used for inserting a "T" of the solid filament
type or for inserting a "T" intrauterine contraceptive device that
contains at least one anti-contraceptive or anti-fertility agent
that is administered from the "T". While the "T" is a presently
preferred embodiment for use with inserter 10, it is to be
understood that inserter 10 can be used with other intrauterine
devices for placing them in a uterus; that is, intrauterine
contraceptive devices having a part that can be housed in the
hollowed area and a part that can rest in the notch.
FIG. 3 illustrates another view of inserter 10 of the invention. In
FIG. 3 there is seen inserter 10, formed of a single, unit piece of
biologically acceptable material. Inserter 10 is comprised of notch
12 and inserter 10 is seen holding an intrauterine device 20
comprised of cross members 21 and 22 continuous with shaft 23.
Shaft 23 is slidably housed in leading end 11 of inserter 10.
Device 20 is positioned in notch 12 and the smaller section 15 of
inserter 10.
FIG. 4 illustrates an intrauterine device 20 housed in an inserter
10. Inserter 10 is similar to the inserter of FIG. 1 and it has an
additional embodiment illustrated in FIG. 4 of a stop member or
collar 24. Inserter 10 in FIG. 4 is about 20 to 30 cm long and
member 24 is spaced about 4 to 8 cm from lead end 11. Member 24
aids in preventing unnecessary penetration beyond the cervical
canal and this reduces the likelihood of injury to a warm blooded
uterus. In FIG. 4 at leading end 11, a section of wall 25 is
removed for illustrating device 20 received in notch 12. Top cross
bars 21 and 22 of device 20 are seen nested against smaller area 15
for decreasing the volume of the inserter 10 intrauterine
contraceptive device 20 assembly. Top cross bars 21 and 22 nested
against smaller area 15 in side-by-side generally linear relation
present a smaller volume to the cervical os and the cervical canal
during insertion and positioning of intrauterine device 20. The
smaller section 15, which is a means adapted for receiving the
intrauterine device has in the embodiment shown a length of about 1
to 3 cm. Depending member 23 of device 20 is illustrated by dashed
lines and it is housed in hollowed area 13 as seen in FIG. 1.
Device 20 is freely nested therein, and it is easily, slidably
released from inserter 10.
FIGS. 5, 6 and 7 collectively illustrate a method for using
inserter 10 for positioning intrauterine contraceptive device 20 in
a uterine cavity 30. In FIG. 5, inserter 10 is seen loaded with
intrauterine device 20 and inserter 10 carries device 20 in nested
relation to inserter 10. In actual operation, inserter 10 is first
gently moved against the cervical os 33 that blends and leads into
cervical canal 31. Members 21 and 22 of intrauterine device 20
initially are spread in open "T" formation and abutt inserter 10.
As inserter 10 enters cervical os 33, members 21 and 22 move toward
smaller area 15 of inserter 10 to eventually position in axial
alignment with inserter 10.
In FIG. 6, inserter 10 slidably carrying intrauterine contraceptive
device 20 is seen traveling through cervical canal 31 in route to
uterus 30. In FIG. 6, members 21 and 22 are now positioned in
side-by-side linear relation with inserter 10. Members 21 and 22
are in proximate contact with the wall of inserter 10 in smaller
area 15 which area 15 is a means adapted for receiving members 21
and 22. This novel design of the invention, comprised of the
inserter intrauterine device combination presents a smaller volume
to the cervical canal and substantially reduces the incident of
pain and trauma. Members 21 and 22 are held in smaller area 15 by
the walls of the cervical canal until the inserter enters uterus
30. In uterine cavity 30 members 21 and 22, free from the restrain
of the cervical wall return to their original "T" spaced
relation.
In FIG. 7, there is seen inserter 10 positioning an intrauterine
contraceptive device 20 in uterus 30. In this illustration, members
21 and 22 are now in their original open spaced "T" form. In actual
insertion of an intrauterine device, inserter 10 is gently moved
through uterus 30 until intrauterine device 20 contacts fundus
uteri 32. Then, inserter 10 is easily withdrawn from uterus 30,
while simultaneously slidably self-releasing and positioning
intrauterine device 20 in uterus 30. Inserter 10 is finally,
totally withdrawn from the host.
It will be seen that the objects set forth above, among those made
apparent from the preceding description, are efficiently attained
and, since certain changes may be made in carrying out the above
method and in the article set forth without departing from the
scope of the invention, it is intended that all matter contained in
the above description or shown in the accompanying drawing shall be
interpreted as illustrative and not in a limiting sense.
* * * * *