U.S. patent number 3,805,767 [Application Number 05/335,816] was granted by the patent office on 1974-04-23 for method and apparatus for non-surgical, reversible sterilization of females.
Invention is credited to Robert Allan Erb.
United States Patent |
3,805,767 |
Erb |
April 23, 1974 |
METHOD AND APPARATUS FOR NON-SURGICAL, REVERSIBLE STERILIZATION OF
FEMALES
Abstract
A method and apparatus is provided for non-surgical reversible
sterilization of females. In the method of this invention an
apparatus to which a removable tip is attached is inserted into the
uterus. The tip is aligned with the uterine end of the oviduct. A
curable elastomeric composition is injected, through an aperture in
the tip, into the oviduct in an amount sufficient to fill the
portion of the oviduct adjacent to the uterus. The elastomeric
composition is allowed to solidify and adhere to the above noted
tip. The apparatus is then removed with the tip being ejected from
the apparatus so as to remain adhered to the resulting oviduct
block. The above procedure is repeated for the opposite oviduct.
The resulting oviduct blocks prevent the passage of ovum from the
ovaries to the uterus and sperm from entering the oviduct thereby
preventing conception. The oviduct blocks if desired can be removed
non-surgically by utilizing an apparatus which grips the tip
portion of the oviduct block and extracts the entire oviduct block
from the oviduct.
Inventors: |
Erb; Robert Allan (Valley
Forge, PA) |
Family
ID: |
23313333 |
Appl.
No.: |
05/335,816 |
Filed: |
February 26, 1973 |
Current U.S.
Class: |
128/831; 128/840;
606/135 |
Current CPC
Class: |
A61F
6/225 (20130101) |
Current International
Class: |
A61F
6/00 (20060101); A61F 6/22 (20060101); A61b
019/00 () |
Field of
Search: |
;128/1R,2R,130,33R |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Sites; Edward J.
Claims
I claim:
1. The method of forming non-surgically removable oviduct block in
a female comprising the step of
a. providing a shaped tip member having an aperture defined
therein; said tip member having a configuration such as to fit in
substantial sealing contact adjacent to the uterine end of the
oviduct of said female, and having a size larger than the lumen of
said oviduct; said tip member being formed from a given cured
elastomeric material
b. positioning said tip member within the uterine cavity of said
female adjacent to the uterine end of said oviduct with the
aperture of said tip member being in axial alignment with the lumen
of said oviduct
c. injecting through the aperture of said tip member into the lumen
of said oviduct a mixture of a fluid self curing elastomeric
material which will solidify in said oviduct and adhere to said tip
member, said elastomeric material being injected into said oviduct
in an amount sufficient to block the passage of ovum through said
oviduct to the uterine cavity
d. and thereafter allowing said uncured elastomeric material to
cure to a solidified mass while in contact with said tip member,
whereby an oviduct block is formed wherein the tip member remains
within the uterine cavity where it can be gripped by mechanical
means to remove the oviduct block non-surgically.
2. The method according to claim 1 wherein said tip member further
includes a loop member whereby said loop member can be gripped to
non-surgically remove said oviduct block.
3. The method according to claim 1 wherein said self-curing
elastomeric material is a self-curing silicone elastomer.
4. The method according to claim 1 wherein said self-curing
elastomeric material when solidified has a modulus of elasticity
substantially the same as said oviduct.
5. The apparatus for forming the oviduct block according to claim
1, said apparatus comprising: a tubular means of a length
sufficient to extend from vagina area of said female to the uterine
ends of said oviducts and having a diameter sufficiently small to
pass through the cervix of said female; said tubular means having
first and second terminal ends; said first terminal end having an
apertured tip member detachably connected thereto and also means
for releaseably holding and ejecting said tip member, said tubular
member including means for positioning said first terminal end with
said tip member thereon adjacent the uterine end of said oviduct,
and said tubular member further including means for transmission of
said self curing elastomeric material from a point adjacent to the
second terminal end to and through said aperture in said tip member
secured to the first terminal end.
6. The apparatus of claim 5 in which the first terminal end portion
is flexible.
7. The apparatus according to claim 5 in which the position of the
first terminal end is controlled by means operable from the second
terminal end.
8. The apparatus according to claim 5 wherein the means for holding
and ejecting said tip member comprises a slideable member
positioned within said tubular member whereby when a tip member is
secured at the first terminal end to said slideable member and said
slideable member is drawn through said tubular member toward the
second terminal end said tip is removed from said slideable
member.
9. The apparatus according to claim 5 wherein the dispensing means
is a syringe having a barrel and a plunger and wherein the plunger
is advanceable within the barrel by a rack and pawl drive operated
from the second terminal end.
Description
The invention described herein was reduced to practice in the
course of work under a grant or award from the Department of
Health, Education and Welfare.
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention is concerned with a method and apparatus for
non-surgical, reversible sterilization of females.
2. Description of the Prior Art
One of the more pressing problems which is encountered in the World
today is that of over population. The problem of over population
which has been a substantial problem for a considerable period of
time in certain highly populated areas, such as Asia and the Indian
Sub-Continent is now becoming a problem in less populated areas of
the World such as Europe and the Americas. Over population results
in such long range problems as pollution, famine and even war.
Birth control has been relied on as the principal means to control
over population. In the field of birth control the prevention of
conception is considerably more acceptable for controlling
population growth than abortion. However, the methods heretofore
suggested for contraception have had certain inherent problems
which limited the applicability and effectiveness.
The ideal contraception method should be 100 percent effective in
preventing conception; should not rely on willpower; should not
interfere with the satisfaction of sexual relationships, and should
be low in cost taking into consideration the effective life of the
contraceptive method. In addition the contraceptive method must not
have any harmful psychological side effects. An extremely important
feature of an ideal contraceptive method especially for family
planning is that it be reversible so that it will be possible to
have additional children if desired.
The most common methods of contraception which are currently
employed on a mass scale each have certain inherent deficiencies
which limit their usefulness. The use of such techniques and
devices such as rhythm, withdrawal, condoms and diaphragms and
vaginal foams all have been found to be highly unreliable. The more
recently promoted methods such as intrauterine devices and use of
contraceptive pills likewise have certain defects which limit their
effectiveness. The intrauterine devices cannot be utilized by all
females and there is some indication that they cause irritation and
discomfort and are often rejected by females. The contraceptive
pill cannot be utilized by many females due to incompatability with
their normal hormone balance. Furthermore, the use of the pill has
been found to increase the risks of certain carcigenic
conditions.
There are currently two methods in wide use which are generally
considered to be effective contraceptive methods. These are oviduct
ligation for females and vasectomy for males. In both these methods
the ducts from the reproductive organs are severed and accordingly
the contraceptive technique if properly performed and there is no
natural regeneration are 100% effective. However, both methods have
the defect that it is difficult, if not impossible, to reverse the
procedure so as to restore the normal reproductive capacity.
It has been well established by gynecologists that a primary cause
of infertility in females is blockage of the oviducts from the
ovary to the uterus. The ovum when discharged from the ovaries is
absorbed by the body and is prevented from coming in contact with
the sperm and accordingly conception does occur. Females having
this natural condition normally do not even realize it exists and
do not suffer any adverse side effect besides being infertile.
Having been made aware of this natural condition those skilled in
the art have suggested artificial blocking of the oviduct to impart
sterility.
It was reported by Corfman et al. in Obstetrices and Gynecology
Vol. 27 No. 6 pages 880-883 (June 1966) that various substances
could be injected transcervically into the oviducts.
Hefnawi et al. Amr. J. Obst and Gynec, Vol. 99, No. 3 pages 421-427
(Oct. 1, 1967) reported attempts to block the oviducts by the
injecting of medical grade elastomeric materials in the uncured
state into the oviducts and allowing the material to solidify in
the oviducts. The elastomeric material was thinned prior to
injection so as to have a relatively fluid mixture for injection.
The reported results obtained with rabbits was quite
unsatisfactory. The incidence of pregnancy after insertion of the
oviduct blocks was quite high. Effective sterilization was only
achieved if the plug was placed in the medial portion of the
oviduct. To remove the plug it was necessary to conduct laparotomy.
A further problem which was reported was the tendency for the plug
to migrate from the oviduct into either the uterine cavity or even
more dangerously into the peritoneal cavity.
Rakshit reported in the Calcutta Med J 65, No. 3 (Mar., 1968)
attempts to use various materials to block the oviducts to prevent
conception. It was suggested to use a plastic material of a nature
which solidifies after being mixed with a catalyst to form the
oviduct blocks. Rakshit specifically taught however that because of
high viscosity the silicone rubbers could not be injected
transvaginally and laparotomies were conducted to inject the
material directly into the uterus. The material was then allowed to
flow into the oviducts. It was suggested in this article by Rakshit
that it may be possible to introduce a plastic material
transcervically into the uterus and then to allow it to flow in the
oviducts. Using this method however the resulting oviduct blocks
would have to be removed surgically to reestablish fertility.
Rakshit further reported in Human Sterilization edited by Ralph
Rechart (1971) pages 213-221 the technique of attempting to form
oviduct blocks by inserting a cannula directly into the uterus
through the cervix and filling the uterus with a curable liquid
silicone plastic. The injected silicone plastic was allowed to flow
into the oviducts and cure in place to form the desired oviduct
blocks. The excess material was then removed from the uterus. The
reported results were not promising. On tests reported on 14 women
there were nine satisfactory blockages, three doubtful cases and
two negative cases. Further, in order to remove the oviduct blocks
it was necessary to conduct a laparotomy.
SUMMARY OF THE INVENTION
In accordance with this invention a method and apparatus is
provided to form oviduct blocks which prevent conception when in
place and can be non-surgically removed if desires. The apparatus
is inserted through the cervical os into the uterus. The tip on the
apparatus is then aligned with the uterine end of the oviduct. A
mixture of a fluid elastomeric material and a catalyst for
polymerizing the elastomeric mixture is injected through an
aperture in the tip into the oviduct. The elastomeric material is
allowed to solidify and to adhere to the tip. The tip is released
so that it remains with the injected elastomeric material to form
the oviduct block of this invention. The apparatus is then removed.
The oviduct block can be removed nonsurgically by inserting an
instrument into the uterus through the cervix which grips the tip
of the oviduct block and then withdrawing the oviduct block which
restores normal fertility.
BRIEF DESCRIPTION OF THE DRAWING
FIG. 1 is an illustration in partial cross-section of an apparatus
especially adopted for use in the method of this invention.
FIG. 2 is an illustration in partial cross-section of a uterus, the
cervix and a portion of the vagina. The uterus is illustrated with
an oviduct block insert in one of the oviduct and the terminal end
of the apparatus of FIG. 1 positioned for insertion of an oviduct
block into the opposite oviduct.
FIG. 3 is an enlarged illustration taken in partial cross-section
of the terminal end of the apparatus of FIG. 1.
FIG. 4 is an illustration in cross-section of the terminal end of
the apparatus of FIG. 3 shown with fluid uncured elastomeric
material shown in the internal feed tube.
FIG. 5 is an illustration shown in cross-section showing the
separation of the tip from the apparatus of FIG. 1.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
In the method of this invention an oviduct block is formed in situ
in the oviduct. The oviduct block is most preferable formed from a
medical inert plastic which has approximately the same modulus of
elasticity as the oviduct. The selection of material having the
proper modulus of elasticity appears to both prevent explusion of
the oviduct block and substantially eliminates any physical
discomfort. The materials which have been found most useful in the
method of this invention are the commercially available medical
grade silicone elastomers. The uncured silicone elastomer in the
fluid state is blended with a catalyst for solidifying the
elastomer and a dilution fluid to control the viscosity during
injection and also to control the modulus of elasticity of the
cured solidified material. It is preferable to also include a
radiopaque material in the mixture to facilitate the placement of
the oviduct block and to facilitate removal of the oviduct block if
desires.
A tip 10 is molded from an inert plastic material to which the
injected elastomeric material will adhere on solidification. In
this regard it should be noted that silicone-rubber is ideally
suited for this purpose when a silicone elastomer is used for
formation of the oviduct block.
As shown in the drawing the portion of the tip 10 which will be in
contact with uterine end of the oviduct 12 has a spherical
configuration. The tip 10 has an aperture 14 which extends
throughout the entire length of the tip 14. In addition the tip as
illustrated has a series of annular piston rings 16 molded into the
interior portion surface of the aperture 14. The tip 10 further
includes a loop 18 which is preferably a thread of a material which
is inert in uterine fluids, such as nylon.
The apparatus 20 shown in FIG. 1 is specifically designed for use
in the method of this invention. The apparatus 20 includes a
tubular extension 22, a dispensing apparatus 24, and a control
handle 26 for both operating the dispensing means and positioning
the tip 10 on the end of the tubular extension 22.
The tubular extension 22 has a rigid section which is adjacent to
the control handle 26. The opposite terminal end portion 28 on
which the tip 10 is secured is flexible. One end of each control
wire 30, 32 is attached to the end portion of the flexible section
28. The control wires 30, 32 are connected at their opposite ends
to a pair of separately controlled drums 34 (only one drum is
shown) mounted on the control hand 26. By adjustment of the drums
34 to either to collect or release the wires 30, 32 the position of
the tip 10 can be adjusted and bent in a curved configuration shown
in FIG. 2.
At the flexible terminal end 28 a metal connector 36 is provided
which has annular piston ring 38 which mates with the piston rings
16 on the tip 10. The metal connector 36 further has defined in it
a constricted area having a sharp cut off portion 40.
A tube 42 extends from the dispensing means 24, through the tubular
extension 22 to the aperture 14 in the tip 10.
The dispensing means 24 consists of a mixing syringe 44 in which
the plunger 46 is adapted to provide mixing of a fluid elastermeric
material, a catalyst and other additive as may be required. The
syringe 44 is mounted on top of the control handle 26 with the
plunger 46 in contact with a rack 48 and a pivotal mounted pawl 50.
The pawl 50 is connected to a trigger 52. Squeezing the trigger 52
causes the plunger 46 to be advanced within the syringe 46 and
material within the syringe 44 to be dispensed through the tube 42
to the tip 10.
In the method of this invention the tip 10 is inserted over the end
of the flexible portion 28 of the tubular extension. The tip 10
being premolded of a silicone rubber is somewhat elastic and
deforms somewhat until the piston ring 16 of the tip of 10 engages
and locks with the mating piston rings 38.
The tubular extension 20 with tip 10 installed is inserted into the
vagina 54, through the cervical os 56 into the uterine cavity 58.
Then, preferably using flouroscopic techniques, the tip 10 is
aligned with the uterine end of one of the oviducts 12. It should
be noted that because of the shape of the uterine cavity 58 the tip
can be guided blindly in the proper position. The relative position
of the flexible end 28 is controlled by adjustment of the drums
34.
Once the tip 10 is in position the fluid mixture of the elastomer,
catalyst and other additives are injected through the tube 42 to
the tip 10 by operation of the trigger 52 as noted above. The
uncured fluid elastomeric mixture 60 flows through the aperture 14
in the tip 10 and then into the oviduct 12. A sufficient amount of
the mixture is injected to fill approximately one third or more of
the length of the oviduct 12. Some of the material will flow back
around the tip 10 so that the surface of the tip 10 will conform to
the shape of the uterine end of the oviduct 12 as shown in the tip
10 as modified 62 which is shown in FIG. 5.
The injected elastomeric material 60 is allowed to cure and
solidify. The cured material will adhere to the tip 10 to make an
essential single unit.
Once the elastomeric material has cured, the tube 40 and the
terminal end 36 are withdrawn within the tubular extension 22. The
edge 40 cuts the cured material which remains in the tube 42 from
the cured material in the aperture 14 of the tip 10. Continued
withdrawal of the terminal end 36 results in the tip 10 being
stripped from the terminal end as shown in phantom in FIG. 5.
The procedure noted above is repeated for the opposite oviduct to
complete the sterilization procedure.
The solidified oviduct blocks each has a configuration which
conforms to the interior of the oviduct in which it is cast, thus
effectively preventing conception.
The oviduct block can remain in place until it is desired to remove
it. The use of a material having approximately the same modulus of
elasticity as the oviducts assists in maintaining the oviduct
blocks 64 in position. The natural convolution of the oviduct
likewise results in stabilization of the oviduct blocks 64. The tip
10 serves a most important function of preventing the oviduct block
64 from migrating into the intraperitoneal cavity, a problem that
was a serious and relatively common problem with other similar
prior art technique.
As noted above the oviduct block is inserted non-surgically. The
method is relatively simple to learn by those skilled in the
medical art. The time required is likewise quite short with a
skilled person being able to block both oviducts in about 15 to 30
minutes.
As noted above the oviduct block can be removed nonsurgically if
desired. An instrument of the type shown in FIG. 1 is used for this
purpose. The tip 10 is replaced with a hooked member which is
adapted to engage the loop 18. Once the loop 18 is engaged the
oviduct block 64 is withdrawn. It is also possible to use a pronged
member to grip the tip and then pull out the oviduct block.
Both the insertion and removal of the oviduct block 64 are
relatively painless. However a local anesthetic can be used if
desired.
The effectiveness of the contraception method of this invention was
found to be excellent. On rabbit tests it was found that the method
is 100% effective if the oviduct blocks are properly placed. In
further rabbit tests it was found that after the oviduct blocks
were removed that fertility was restored. There was no indication
of explusion of the oviduct blocks either in the uterine cavity or
in the intraperitoneal cavity. Histologic examination and scanning
election microscopic examination have not indicated that there is
any adverse reaction to the tissue of the oviducts.
The apparatus of this invention has been described in preferred
embodiment. It should be appreciated that the various modifications
can be made to the apparatus without departing from the scope of
this invention. For example, the control handle 26 has been
provided to enable a simple one handed operation of the apparatus.
If is possible, however, to simply use control wires which are
operated by the fingers of the hand rather than the drums. Further,
the dispensing apparatus consisting of the trigger 52, rack 48 and
pawl 50, could likewise be removed and the syringe operated
manually. Furthermore, the configuration of the tip 10 can be
modified to a different shape such as a conical configuration of
other suitable shapes and still be satisfactory for use in this
invention. These and other modifications which would be obvious to
those skilled in the art are included within the scope of the
subjoined claims.
* * * * *