U.S. patent number 3,590,816 [Application Number 04/715,256] was granted by the patent office on 1971-07-06 for placement unit for intrauterine contraceptive devices.
This patent grant is currently assigned to Julius Schmid, Inc.. Invention is credited to Gerald S. Rosenthal.
United States Patent |
3,590,816 |
Rosenthal |
July 6, 1971 |
PLACEMENT UNIT FOR INTRAUTERINE CONTRACEPTIVE DEVICES
Abstract
A unit for correctly placing an intrauterine contraceptive
device (IUCD) in the female uterine cavity while preserving the
sterility of the IUCD, the unit comprising a plunger attached at
its leading end to one end of the IUCD for manipulation of the IUCD
into and out of a tubular inserter by manual control exerted upon
the trailing end of the plunger which projects beyond the trailing
end of the tubular inserter.
Inventors: |
Rosenthal; Gerald S. (Ogden,
UT) |
Assignee: |
Julius Schmid, Inc. (New York,
NY)
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Family
ID: |
27423037 |
Appl.
No.: |
04/715,256 |
Filed: |
March 22, 1968 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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461281 |
Jun 4, 1965 |
|
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515284 |
Oct 24, 1965 |
3374788 |
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Current U.S.
Class: |
128/840; 604/158;
604/285; 604/16; 604/60; 604/159 |
Current CPC
Class: |
A61K
9/0039 (20130101); A61F 6/144 (20130101) |
Current International
Class: |
A61K
9/00 (20060101); A61F 6/00 (20060101); A61F
6/14 (20060101); A61f 005/46 () |
Field of
Search: |
;128/167,128,130,129,263 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Eager; Adele M.
Parent Case Text
This invention relates in general to a new and useful improvement
means for installing intrauterine contraceptive devices. This
application is a continuation-in-part of my application Ser. No.
461,281, filed June 4, 1965, now abandoned, and a continuation of
my copending application Ser. No. 515,284, filed Oct. 24, 1965, now
U.S. Pat. No. 3,374,788.
Claims
What I claim and desire to be secured by United Stated Letters
Patent is:
1. An intrauterine assembly comprising:
an intrauterine device of a flexible material with a retentive
memory having a curved portion and a trailing end portion,
placement apparatus for placing said device within the uterine
cavity, said apparatus comprising:
a. a plunger,
b. severable means connecting the leading end portion of the
plunger to the device,
c. a tubular inserter having an internal diameter of a size within
which the plunger, said connecting means and said device can be
disposed, the combined lengths of the connecting means and the
plunger being so related to the length of the inserter that the
trailing end portion of the plunger can extend beyond the trailing
end of the inserter with a portion of the device extending beyond
the leading end of the inserter, whereby the trailing end portion
of the plunger can be pulled further out of the inserter to pull
the device through force carried by said severable connecting means
further into said inserter to assume a more linear configuration
for said device curved portion, the device being expelled out of
the inserter to assume its normal shape by pushing on the exposed
trailing end portion of the plunger to move it back into the
inserter.
2. A placement unit as claimed in claim 1 further comprising a
sealed package with the tubular inserter, the plunger and the
intrauterine device therein, with the plunger and intrauterine
device situated in a beginning position with the trailing end
portion of the plunger extending beyond the trailing end of the
inserter so that the trailing end portion of the plunger can be
grasped.
3. An intrauterine assembly as in claim 1 wherein the said
severable connecting means is located outside of said inserter when
the device has been expelled from the inserter into the uterus in a
position where said connecting means can be severed.
4. A combination according to claim 3 further comprising an
enlargement comprising a free leading end of the device.
5. A combination according to claim 4 wherein the enlargement rests
upon and projects beyond the leading portion of the inserter when
in the loaded position.
6. A combination according to claim 3 wherein the severable
connecting means comprises a tension-transmitting thread.
7. A combination according to claim 3 wherein the severable
connecting means comprises an elongated coupling piece adapted to
transfer both tensile and compressing forces between the device and
the plunger without appreciable deflection.
8. A combination according to claim 3 wherein the severable
connecting means comprises a relatively thin cord of material which
transmits tension to enable the plunger to load the device within
the inserter by pulling upon the plunger and buckles under
compression so that the force of ejection caused by pushing upon
the plunger will first collapse and gather the cord and thereafter
cause the device to be displaced.
9. An intrauterine assembly as in claim 1 wherein said severable
connecting means joins the leading end portion of the plunger to a
trailing end portion of the device.
Description
It is the primary object of the present invention to provide a unit
for correctly placing an initially sterile intrauterine
contraceptive device within the female uterus without destroying
the initial sterility.
It is another object of the present invention to provide a unit for
aseptically placing an intrauterine device into the uterus with a
minimum of discomfort to the patient.
These and other objects and features of the present invention will
become more fully apparent from the following description and
appended claims taken in conjunction with the accompanying drawings
wherein:
FIG. 1 is a top plan view of a combined intrauterine insert and
insertion means constructed in accordance with and embodying the
present invention;
FIGS. 2 and 3 are enlarged fragmentary sectional views taken along
lines 2-2 and 3-3, respectively, of FIG. 1;
FIGS. 4, 5, 6 and 7, are transverse sectional views taken along
lines 4-4, 5-5, 6-6 and 7-7, respectively, of FIG. 2;
FIG. 8 is a fragmentary transverse sectional view taken along line
8-8 of FIG. 1;
FIG. 9 is an enlarged fragmentary plan view of the insert connected
to the inserter rod or plunger;
FIG. 10 is an enlarged fragmentary plan view of the combined insert
and insertion means with the insert partially projected therefrom
preparatory to enclosure in a sterile outer envelope;
FIG. 11 is a plan view of the entire sterilized unit prior to use
by the physician;
FIG. 12 is an enlarged fragmentary sectional view showing the
insert withdrawn or loaded into the insertion device preparatory to
implantation with the uterus;
FIG. 13 is a diagrammatic transverse view of the female pelvic
region, illustrating the first stage of installing the intrauterine
insert of the present invention;
FIG. 14 is a diagrammatic frontal view of the female pelvic region
showing the second stage of installing said intrauterine
insert;
FIG. 15 is a diagrammatic transverse view of the female pelvic
region showing the third stage of installing said intrauterine
insert;
FIG. 16 is a diagrammatic frontal view of the female pelvic region
showing the final stage of installing said intrauterine insert;
FIG. 17 is a fragmentary perspective view showing the distal end of
an insertion tube and a gelatine cap forming part of the present
invention;
FIG. 18 is a top plan view of a modified intrauterine device
constructed in accordance with and embodying the present
invention;
FIGS. 19 and 20 are enlarged fragmentary sectional views taken
along lines 19-19 and 20-20, respectively, of FIG. 18;
FIGS. 21, 22, 23 and 24 are transverse sectional views taken along
lines 21-21, 22-22, 23-23 and 24-24, respectively, of FIG. 19;
FIG. 25 is a fragmentary transverse sectional view taken along line
25-25 of FIG. 18;
FIGS. 26 and 27 are enlarged plan and elevational views,
respectively, of the insert forming part of the modified
intrauterine device illustrated in FIG. 18; and
FIGS. 28 and 29 are top plan views of modified forms of
intrauterine devices equipped with placement units constructed in
accordance with and embodying the present invention.
Corresponding reference characters indicate corresponding parts
throughout the several views of the drawings.
Corresponding reference characters indicate corresponding parts
throughout the several views of the drawings.
Referring now in more detail and by reference characters to the
drawings, which illustrate practical embodiments of the present
invention, A designates an intrauterine device comprising an
elongated insertion tube 1 formed preferably of polyethylene or a
similar biologically inert synthetic resin which is of sufficient
overall thickness and polymeric density so as to be resiliently
flexible so that it will readily bend in conformity with the
contours of the vagina and cervical canal, but is nevertheless
sufficiently rigid so that it can be inserted into the cervical
canal and will not collapse under the contractile muscular pressure
of the walls thereof. The overall dimensions of the insertion tube
1 are not critical but it has been found as a matter of practical
experience that the insertion tube or tubular inserter 1 should
preferably have a length of approximately 10 or 14 inches, an
outside diameter of approximately three-eighths of an inch and a
wall thickness of approximately 80 mils. Inwardly from its distal
tip 2, the insertion tube 1 is provided externally with a red
annular indicator band 3. Actually, this indicator band 3 may be of
any desired color but, on the basis of practical experience, it has
been found that red is readily visible and serves very well to
afford the physician or gynecologist some means of determining the
distance to which the distal tip 2 has been inserted into the
cervical canal, as will be presently more fully discussed. In this
connection, it should also be noted that the indicator band 3 is
located approximately 6 centimeters or 21/2 inches from the distal
tip 2 of the insertion tube which is considered to be the normal
internal length between the external cervical os and the fundus of
the uterus for the average human female. Loosely and slidably
disposed within the insertion tube 1 and extending for a
substantial distance axially outwardly from the proximal end 4
thereof is an inserter rod or plunger 5 having a distal end 6 and a
proximal end 7. The inserter rod 5 is preferably of circular
cross-sectional shape and is formed of semirigid somewhat flexible
polyethylene or other suitable material.
As a matter of fact, the insertion tube 1 and the inserter rod 5 do
not remain within the body of the patient and therefore the
material used in fabricating them is not particularly critical
provided it has the necessary combination of rigidity and
flexibility to perform its mechanical function.
Provided for cooperation with the insertion tube 1 and inserter rod
5 is an intrauterine insert or device B molded or otherwise
suitably formed from high molecular weight polyethylene or other
similar biologically inert synthetic resin, which is substantially
rigid but is nevertheless resiliently flexible and can be deformed
under moderate manually applied force but will nevertheless resume
its initial shape when released. The intrauterine insert B
integrally includes a relatively flexible tail portion 8 of
ribbonlike or rectangular cross-sectional shape having a plurality
of spherical beads or knoblike protuberances 9 integrally formed at
uniformly spaced intervals therealong. As a result of observation
and experimentation, it has been found preferable to employ eight
such spherical beads 9 spaced by a center-to-center distance of
five-sixteenths of an inch, with the first bead 9 being directly
adjacent to the proximal end 10 of the tail portion 8, the entire
length of the tail portion 8 being approximately 33/4 inches in
length. Thus the tail portion 8 will have a smooth uninterrupted
section 11 at its distal end 12, all as best seen in FIG. 9. Formed
integrally upon and extending axially outwardly from the distal end
12 of the tail portion 8 is a retention head -13 having an
uninterrupted cross-sectional shape somewhat resembling a "figure
eight" and separating at its outer end into two spirally curled
terminal portions 14, 15, which are, in turn, of somewhat oval or
elliptical cross-sectional shape, as best seen in FIG. 8.
The proximal end 10 of the tail portion 8 is connected or fixed by
joining structure to the distal end 6 of the inserter rod or
plunger 5 by means of a tubular sleeve 16 formed preferably of
heat-shrinkable synthetic resin. The sleeve 16 is initially slid,
for a substantial distance at one of its ends, over the distal end
6 of the inserter rod 5 and the proximal end 10 of the tail portion
8 is, in turn, slid into the other end, the sleeve 16 being of
sufficient length so as to extend for a substantial distance along
the tail portion 8 and embrace at least one of the spherical beads
9. The sleeve 16 is thereupon subjected to a moderate degree of
elevated temperature sufficient to cause it to shrink tightly down
around and embrace the adjacent ends of the tail portion 8 and the
inserter rod 5, thereby holding them tightly and securely together.
It will be evident to one skilled in the art that the tail portion
8 and the inserter rod 5 can be joined in any suitable manner such
as by a split metal sleeve or by fusing the two together through
the application of heat. In the latter instance, the rod and tail
portion, of course, would have to be formed from compatible
plastics. Finally, the inserter rod 5 is provided approximately
31/4 inches from its proximal end 7 with a plainly visible black
dot 17, this distance being substantially equal to the length of
the entire retention head 13 of the insert B when the latter is
sheathed within the insertion tube 1, as indicated by the reference
letter x in FIG. 12.
The proximal end 7 of the inserter rod 5 is then slid into the
distal end of the insertion tube 1 and pushed entirely through the
length thereof until the connected end of the insert B is also
pulled into the insertion tube 1 and the proximal end 7 of the
inserter rod 5 will project from the proximal end 4 of the
insertion tube 1 with the black dot 17 visible. In this position
the retention head 13 will still be completely outside of the
insertion tube 1 and the region of juncture between the tail
portion 8 and the retention head 13 will be located approximately
at the distal end 2 of the insertion tube 1, all as best seen in
FIG. 10. In this relative position, the combined insertion tube 1,
the inserter rod 5 and insert B are enclosed within a flat
rectangular envelope 18 preferably made of heat-sealable
transparent synthetic resin sheathing. The envelope 18 is then heat
sealed and the entire unit sterilized in any suitable conventional
manner. The sterilization can be performed in a number of different
ways and can be carried out after packaging but initial
sterilization does not constitute part of the present invention
and, therefore, need not be specifically described in detail
herein. It is sufficient for present purposes merely to point out
that the intrauterine device A and the interior of the envelope 18
are surgically sterile and the envelope 18 serves to preserve the
intrauterine device A in such sterile condition during subsequent
storage and handling of the sealed envelope.
The sterile intrauterine device A and sterile insertion unit are
then removed from the sterile envelope 18 and the proximal,
trailing or protruding end of the inserter rod 5 is pulled slowly
outwardly through the proximal or trailing end of the insertion
tube 1 so that the circuitously shaped retention head 13 of the
insert B is drawn into in essentially linear relation and sheathed
in such disposition within the distal end of the insertion tube 1.
As this occurs the coiled convolutions of the terminal portions 14,
15, straighten out until, when fully sheathed, they assume the
position shown in FIG. 12. Thus, the device A is aseptically loaded
into the tubular inserter solely by manipulation of the proximal
end of the plunger and no human contact is made with the device
A.
Thereupon, with reference to FIGS. 13--16, the distal tip 2 of the
loaded insertion tube 1 is gently inserted into the cervical os and
the insertion tube 1 is slowly but firmly advanced through the
cervical canal and uterus until it contacts the fundus. At this
point in the procedure, usually both the patient and the
gynecologist will feel the pressure of contact with the fundus. As
has been above mentioned, the red band 3 is approximately 21/2
inches or 6 centimeters from the distal tip 2 of the insertion tube
1, this length being assumed to be the average anatomical distance
between the external cervical os and fundus. From this position,
the insertion tube 1 is pulled back about 1/2 inch or 1 centimeter
and the entire device A is rotated if necessary about its
longitudinal axis until the black dot on the inserter rod 5 is
facing upward. This orients the insert B in the frontal plane of
the uterus. Thereupon the inserter rod 5 is advanced slowly and
gently until the black dot on the inserter rod 5 reaches the
proximal end 7 of the insertion tube 1. Sometimes, in a patient
with a very small uterus, pressure will be felt by the patient
within the uterus before the black dot fully reaches the proximal
end 7 of the insertion tube 1 and in such case the inward pushing
movement will be terminated. Obviously, as the inserter rod 5 is
pushed inwardly the retention head 13 of the insert B will be
progressively unsheathed and the terminal portions 14, 15, will
return to their original coiled shape or position for retentive
lodgment within the cavum uteri. Thus, the sterility of the device
A and the leading portion of the plunger and insertion tube will be
preserved as no human contact therewith is made during
placement.
Thereupon, the insertion tube 1 is gently withdrawn from the
cervical canal while the inserter rod 5 is held stationary. As this
occurs the tail portion 8 of the insert B will be unsheathed and
left within the cervical canal. As has been above indicated, the
tail portion 8 is usually longer than the cervical canal and
therefore the proximal end 10 thereof will now depend loosely and
in exposed position within the interior chamber of the vagina below
the cervix. The insertion tube 1 and the inserter rod 5 are then
manually shifted in a lateral direction so as to bring the
downwardly protruding end of the tail portion 8 somewhat to one
side. A scissors or cutting forceps can then be inserted into the
vagina and the downwardly protruding end of the tail portion 8 can
be severed or cut loose from the inserter rod 5. Preferably all but
one or two of the beads 9 protruding from the cervix should be
clipped off and the cutting should preferably be done very close to
the underside of the lowermost bead 9 which is left in place. By
this means rough edges are avoided. As soon as the clipping or
cutting operation has been completed, the insertion tube 1 and
inserter rod 5 can be entirely withdrawn and discarded.
It is possible to fit a gently contoured gelatin cap 19 over the
distal end 2 of the insertion tube 1 once the retention head 13 has
been completely drawn into it, all as best seen in FIG. 17. The cap
19 prevents chafing of and irritation to the cervical canal as the
insertion tube 1 is advanced therethrough and into the uterus. In
fact, by fitting the cap 19 over the distal end 2, it is possible
for the gynecologist to insert the tube 1 without previously
dilating the cervical canal. The cap 19 is, of course, nontoxic and
dissolves within the uterus in a matter of minutes allowing the
gynecologist to perform subsequent procedures as hereinbefore
described.
As will be seen by reference to FIGS. 18 through 27, it is possible
to provide a modified intrauterine contraceptive device A.sup.1
including an insertion tube or tubular inserter 30 having a distal
tip 31, the tube 30 being provided inwardly from its distal tip 31
at a distance of about 21/2 inches with an indicator band 32 which
is similar to the indicator band 3 of the intrauterine device A.
Slidably fitted within the tube 30 is a flexible inserter rod or
plunger 33 provided with a transversely extending hole 34 at its
distal end.
Provided for cooperation with the insertion tube 30 and inserter
rod 33 is an intrauterine insert B.sup.1 integrally including a
retention head 35 which separates at one end into two spirally
curled terminal portions 36, 37, and is otherwise similar to the
retention head 13 of intrauterine insert B. Extending from the
opposite end of the retention head 35 is a relatively short tail
portion 38 of ribbonlike or rectangular cross-sectional shape, the
tail portion 38 being provided with an aperture 39. Interconnecting
the inserter rod 33 and the retention head 35 is joining structure
comprising a nylon or other suitable biologically inert string 40
which is fixed to the inserter rod or plunger 33 by being passed
through the hole 34 of the inserter rod 33 and is fixed to the
device by being passed through the aperture 39 of the tail portion
38 and is tied therebetween. Finally, the inserter rod 33 is
provided with a plainly visible black dot 41 which, when the
circuitously shaped retention head 35 is completely drawn into
generally linear relation within the tube 30 and the distal end of
the inserter rod 33 is brought into endwise abutment with such
retention head, is located at a distance from the proximal end of
the insertion tube 30 equal to the sheathed length of the insert
B.sup.1. The gynecologist, of course, can use the black dot 41 to
determine when the retention head 35 is fully unsheathed in the
patient's uterus. In other words, when the black dot 41 reaches the
proximal end of the insertion tube 30, the intrauterine insert
B.sup.1 will be fully unsheathed within the patient's uterus.
Intrauterine device A.sup.1 is utilized for emplacing the
intrauterine insert B.sup.1 within the patient's uterus in a manner
similar to that described in conjunction with intrauterine device
A. Specifically, the device is aseptically loaded solely by pulling
upon the proximal end of the plunger or rod 33 and the device is
properly implanted in the uterus solely by pushing on the proximal
end of the plunger or rod so that the distal end of the rod forces
against the proximal end 38 of the device and forces the device out
of the insertion tube, all without subjecting the device to human
contact.
After the insertion tube 30 is withdrawn, the string 40 instead of
a beaded tail portion is cut with a scissors or cutting forceps and
removed leaving the intrauterine insert B.sup.1 emplaced within the
patient's uterus. Of course, a gelatine cap 19 can be fitted over
the distal end of the insertion tube 30 so that the insertion tube
30 can be passed through the cervical canal.
It is also possible to use the various embodiments of the present
placement unit with modified forms of intrauterine devices, for
example, with device B.sup.2, as shown in FIG. 28. The overall
assembly A.sup.2 comprises the device B.sup.2 and one of the
described inserters or placement units comprising an insertion
tube, a plunger and joining structure fixed to the leading end of
the plunger and fixed to the trailing end of the device B.sup.2,
such as, for example, the described structure identified by numeral
16 in FIG. 2 or by numeral 40 in FIG. 19. Device B.sup.2 differs
primarily from the earlier-described devices in that it is provided
with a retention head 19 comprising a single spiral coil 20.
Similarly, it is possible to use the various embodiments of the
present inserters or placement units with device B.sup.3, as shown
in FIG. 29. The overall assembly A.sup.3 comprises the device
B.sup.3 and one of the described inserters or placement units
comprising an insertion tube, a plunger and joining structure fixed
to the leading end of the plunger and fixed to the trailing end of
the device B.sup.3, such as, for example, the described structure
identified by numerals 16 or 40 in FIGS. 2 and 40, respectively.
Device B.sup.3 differs from the earlier-described devices in that
it is provided with a retention head 21 comprising a sinuous or
serpentine terminal portion 22.
The invention may be embodied in other specific forms without
departing from the spirit or essential characteristics thereof. The
present embodiments are, therefore, to be considered in all
respects as illustrative and not restrictive, the scope of the
invention being indicated by the appended claims rather than by the
foregoing description, and all changes which come within the
meaning and range of equivalency of the claims are therefore to be
embraced therein.
* * * * *